Haccp Fda PDF

Chapter 1: Introduction
Status This guidance is being issued as a companion

document to “HACCP: Hazard Analysis Critical
This is the third edition of the Food and Drug Control Point Training Curriculum,” which was
Administrations’s (FDA) “Fish and Fishery Products developed by the Seafood HACCP Alliance for
Hazards and Controls Guidance.” This Guide relates Training and Education. The Alliance is an organiza-
to FDA’s final regulations (21 CFR 123) that require tion of federal and state regulators, including FDA,
processors of fish and fishery products to develop academia, and the seafood industry. FDA encourages
and implement Hazard Analysis Critical Control processors of fish and fishery products to use the two
Point (HACCP) systems for their operations. Those documents together in the development of a HACCP
final regulations were published in the Federal system. Copies of the training document may be
Register on December 18, 1995 and became effective obtained from:
on December 18, 1997. The codified portion of the
regulations is included in Appendix 8. Florida Sea Grant
IFAS - Extension Bookstore
FDA intends to revise and reissue this guidance every University of Florida
two to three years as the state of knowledge advances P.O. Box 110011
relative to fish and fishery products hazards and Gainesville, FL 32611-0011
controls. The agency will accept public comment on 1-800-226-1764
this third edition of the guidance for consideration in
drafting the fourth edition. Comments should be
submitted to: Purpose
U.S. Food and Drug Administration The primary purpose of this guidance is to assist
Dockets Management Branch (HFA-305) processors of fish and fishery products in the devel-
Room 1-23 opment of their HACCP plans. Processors of fish
12420 Parklawn Drive and fishery products will find information in this
Rockville, MD 20857 guidance that will help them identify hazards that are
associated with their products, and help them formu-
Comments should be identified with Docket Number late control strategies.
93N-0195.
Another purpose of this guidance is to help consum-
ers and the public generally to understand commer-
cial seafood safety in terms of hazards and their
controls. This guidance does not specifically address
safe handling practices by consumers or by retail
establishments, although many of the concepts
contained in this guidance are applicable to both.
This guidance is also intended to serve as a tool to be

used by federal and State regulatory officials in the
evaluation of HACCP plans for fish and fishery
products.
Continued
1
Scope & Limitations tance in this regard, Appendix 6 provides a list of the
most common food allergens that can pose a health
The controls and practices provided in this guidance risk to certain sensitive individuals.
are recommendations and guidance to the fish and
fishery products industry. This guidance provides This guidance does not cover the hazard associated
information that would likely result in a HACCP plan with the formation of Clostridium botulinum toxin in
that is acceptable to FDA. However, it is not a low acid canned foods (LACF) or shelf-stable
binding set of requirements. Processors may choose acidified foods. Mandatory controls for this hazard
to use other control measures, as long as they provide are contained in the LACF regulation (21 CFR 113)
an equivalent level of assurance of safety for the and the acidified foods regulation (21 CFR 114).
product. However, processors that chose to use other Such controls need not be included in HACCP plans
control measures (e.g. critical limits) are responsible for these products.
for scientifically establishing their adequacy.
This guidance does not cover the sanitation controls
The information contained in the tables in Chapter 3 required by the Seafood HACCP regulation. How-
and in Steps #10 and 11 in Chapters 4-21 provide ever, the maintenance of a sanitation monitoring
guidance for determining which hazards are “reason- program is an essential prerequisite to the develop-
ably likely to occur” in particular fish and fishery ment of a HACCP program. If necessary sanitation
products under ordinary circumstances. The tables controls are not included in a prerequisite sanitation
should not be used separately for this purpose. The monitoring program, they must be included in the
tables list potential hazards for specific species and HACCP plan. It is the agency’s intent to provide
finished product types. This information must be guidance on the development of sanitation standard
combined with the information in the subsequent operating processes and sanitation monitoring
chapters to determine the likelihood of occurrence. programs in the future.
This guidance is not a substitute for the performance This guidance does not describe corrective action or
of a Hazard Analysis by a processor of fish and verification records, because these records are not
fishery products, as required by FDA’s regulations. required to be listed in the HACCP plan. Nonethe-
Hazards not covered by this guidance may be rel- less, such records must be maintained, where appli-
evant to certain products under certain circumstances. cable. Likewise, it does not recount the specific
In particular, processors should be alert to new or requirements for the content of records that are set
emerging problems (e.g., the occurrence of natural out in § 123.9(a).
toxins in fish not previously associated with that
toxin). This guidance does not cover verification activities
such as reassessment of the HACCP plan and/or the
This guidance covers safety hazards associated with hazard analysis and review of consumer complaints,
fish and fishery products only. It does not cover most that are mandated by § 123.8.
hazards associated with non-fishery ingredients (e.g.,
Salmonella enteritidis in raw eggs). However, where The guidance also does not provide specific guidance
such hazards are presented by a fishery product that to importers of fish and fishery products for the
contains non-fishery ingredients, control must be development of required importer verification
included in the HACCP plan. Processors may use the procedures. However, the information contained in
principles included in this guide for assistance in the text, and, in particular, in Appendix 5, should
developing appropriate controls for these hazards. prove useful for this purpose. Additionally, it is the
For example, the hazard of food allergens and food agency’s intent to provide more specific guidance for
intolerance substances that are part of or directly importers, either in future editions of this guidance,
added to the food can be controlled using the prin- or in a separate guidance document.
ciples described in Chapter #19. As a further assis-
2
Changes in this Edition • Additional information is included about the
control of Vibrio parahaemolyticus in shellstock
Following is a summary of the most significant intended for raw consumption, including information
changes in this edition of the guidance. about water sampling for Vibrio parahaemolyticus
performed by Shellfish Control Authorities under
The information contained in Table 3-1 (Potential certain conditions;
Vertebrate Species Related Hazards) is modified as • Specific controls are now recommended for the
follows: control of Vibrio parahaemolyticus in oyster
• Dace (Rhinichthys spp.) is now listed as having a shellstock intended for raw consumption if the
potential pesticides and environmental contaminants oysters are harvested in an area which has been
hazard; confirmed as the original source of oysters associated
• Alewife or river herring (Alosa pseudoharengus) is with two or more V. parahaemolyticus illnesses in the
now listed as having a potential scombrotoxin past three years. The new control strategy example
(histamine) hazard; relies on the following critical limits for the time
• Wild-caught freshwater salmon (Oncorhynchus from harvest to refrigeration, and is based on the
spp., Salmo salar) is no longer listed as having a Average Monthly Maximum Air Temperature
potential aquaculture drug hazard, an error in the (AMMAT):
Second Edition; - For AMMAT of less than 66˚F
• Mackerel (Scomber scombrus) is no longer listed (less than 19˚C): 36 hours
as having a potential natural toxin (PSP) hazard. - For AMMAT of 66˚F to 80˚F
(19˚C to 27˚C): 12 hours
The information contained in Table 3-3 (Potential - For AMMAT greater than 80˚F
Process Related Hazards) is modified as follows: (greater than 27˚C): 10 hours;
• Smoked fish is now listed as having a potential C. • For the control of Vibrio vulnificus, the critical
botulinum hazard only when it is reduced oxygen limits recommended for the time from harvest to
packaged and distributed or stored refrigerated; refrigeration for shellstock intended for raw con-
• A number of products are now listed in Table 3-3 sumption, based on Average Monthly Maximum
as having potential glass inclusion hazards; Water Temperature (AMMWT), are now:
• Dried fish is now listed as having a potential C. - For AMMWT of less than 65˚F
botulinum hazard; (less than18˚C): 36 hours
• Fully cooked prepared foods are now listed as - For AMMWT of 65 to 74°F
having potential pathogen survival through pasteur- (18 to 23°C): 14 hours;
ization and pathogen contamination after pasteuriza- - For AMMWT of greater than 74 to 84°F
tion hazards. (greater than 23 to 28°C): 12 hours;
- For AMMWT of greater than 84°F
The recommendations in Chapter 4 for the control of (greater than 28°C): 10 hours;
pathogens from the harvest area are changed as • For the control of pathogens other than Vibrio
follows for consistency with 1998 and 1999 Interstate parahaemolyticus and Vibrio vulnificus, the critical
Shellfish Sanitation Conference actions: limits recommended for the time from harvest to
• Raw consumption warnings on tags of molluscan refrigeration for shellstock intended for raw con-
shellfish shellstock containers are now recommended sumption are now:
only if the shellstock is intended for raw consump- - For AMMAT of less than 66°F
tion and the recommended language has been (less than 19°C): 36 hours;
modified; - For AMMAT of 66 to 80°F
(19 to 27°C): 24 hours;
- For AMMAT of greater than 80°F
(greater than 27°C): 20 hours.
Continued
3
The recommendations in Chapter 4 for the control of The recommendations in Chapter 7 for the control of
pathogens from the harvest area are additionally scombrotoxin formation are changed as follows:
changed as follows: • Information is now provided about the salt-tolerant
• The information on pathogens in molluscan and facultative anaerobic nature of some of the
shellfish is now more clearly divided into two histamine-forming bacteria, raising concern for
categories: scombrotoxin formation in some salted and smoked
- The control of pathogens of human or animal fishery products and in fishery products packed in
origin; reduced oxygen environments (e.g. vacuum
- The control of naturally occurring pathogens; packaging);
• The recommended goal of pasteurization for the • The on-board chilling recommendations are
control of Vibrio vulnificus is now more clearly significantly modified as follows:
defined as the reduction of the pathogen to - Generally, fish should be placed in ice or in
nondetectable levels [i.e., less than 3 MPN/gram, as refrigerated seawater or brine at 40˚F (4.4˚C) or
defined by the National Shellfish Sanitation Program less within 12 hours of death, or placed in
(NSSP)]. refrigerated seawater or brine at 50˚F (10˚C) or
less within 9 hours of death;
The recommendations in Chapter 5 for the control of - Fish exposed to air or water temperatures above
parasites are changed as follows: 83˚F (28.3˚C), or large tuna (i.e., above 20 lbs.)
• The results of a survey of U.S. gastroenterologists that are eviscerated before on-board chilling,
on U.S. seafood-borne parasitic infections are now should be placed in ice (including packing the
cited; belly cavity of large tuna with ice) or in
• The recommended freezing times/temperatures are refrigerated seawater or brine at 40˚F (4.4˚C) or
now: less within 6 hours of death;
- Freezing and storing at -4˚F (-20˚C) or below - Large tuna (i.e., above 20 lbs.) that are not
for 7 days (total time); or eviscerated before on-board chilling should be
- Freezing at -31˚F (-35˚C) or below until solid chilled to an internal temperature of 50˚F (10˚C)
and storing at -31˚F (-35˚C) or below for 15 or less within 6 hours of death;
hours; or • It is now recommended that, when refrigerated
- Freezing at -31˚F (-35˚C) or below until solid brine or seawater is used for chilling fish on the
and storing at -4˚F (-20˚C) or below for 24 harvest vessel, the temperature of the cooling media
hours; be monitored and recorded (harvest vessel control
• Because of the changes in the recommended strategy only);
critical limits, the recommended control strategies • It is now recommended that the critical limits at
now refer only to external temperatures during receiving from the harvest vessel include a require-
freezing and to the length of time that the fish is held ment that the chilling of fish on the harvest vessel be
at the appropriate freezer temperature or the length of continued to bring the internal temperature of the fish
time that the fish is held after it is solid frozen, to 40˚F (4.4˚C) or less (harvest vessel control strat-
whichever is appropriate; egy only);
• The parasite hazard is no longer considered • It is now recognized that certain data previously
reasonably likely to occur if the finished product is expected to be recorded by the harvester on harvest
fish eggs that have been removed from the skein and vessel records may, under certain circumstances, be
rinsed. more efficiently recorded by the primary (first)
processor on receiving records (harvest vessel control
The recommendations in Chapter 6 for the control of strategy only), such as:
natural toxins are changed as follows: - Method of capture;
• PSP in lobster is no longer considered a significant - Air and water temperature;
hazard because the levels found in lobster tomale are - Method of onboard cooling;
not likely to pose a health hazard unless large quantities - Estimated date and time of death;
are eaten from a heavily contaminated area.
4
• It is now recognized that, as an alternative to the • The recommended critical limits for storage and
primary processor receiving harvest vessel records processing are significantly modified as follows:
that are maintained by the vessel operator, certain - For fish that have not been previously frozen:
harvest operations may lend themselves to monitor- the fish are not exposed to ambient temperatures
ing and record keeping entirely by the primary above 40˚F (4.4˚C) for more than 4 hours,
processor. This arrangement is suitable only if the cumulatively, if any portion of that time is at
primary processor has direct knowledge about those temperatures above 70˚F (21˚C); or the fish are
aspects of the harvesting practices that must be not exposed to ambient temperatures above 40˚F
controlled to ensure that the appropriate critical (4.4˚C) for more than 8 hours, cumulatively, as
limits are met. For example, if the harvest vessel long as no portion of that time is at temperatures
leaves from the processor’s facility and returns with above 70˚F (21˚C);
the iced or refrigerated catch to the processor’s - For fish that have been previously frozen: the
facility within the appropriate time limits for on fish are not exposed to ambient temperatures
board icing or refrigeration of the catch, under above 40˚F (4.4˚C) for more than 12 hours,
certain circumstances it may be possible for the cumulatively, if any portion of that time is at
processor to perform all of the monitoring and record temperatures above 70˚F (21˚C); or the fish are
keeping functions ordinarily performed by the not exposed to ambient temperatures above
harvester; 40˚F (4.4˚C) for more than 24 hours,
• It is now recommended that the critical limits at cumulatively, as long as no portion of that time is
receiving from the harvest vessel include a require- at temperatures above 70˚F (21˚C);
ment that fish delivered in less than 12 hours after • There is no longer a minimum length of frozen
death should exhibit evidence that chilling began on storage in the definition of “previously frozen product;”
the harvest vessel (e.g. at receipt the internal tem- • It is now recommended that ambient air temperature
perature of the fish is below ambient air and water be monitored at the processing and packaging critical
temperature); control points;
• It is now recommended that the date and time of • A new concept is introduced to assist in the assess-
off-loading be recorded on receiving records main- ment of whether the hazard is significant at receiving
tained by the primary processor; by the primary (first) processor: the hazard may not be
• It is no longer recommended that primary (first) significant if the worst case environmental conditions
processors check for the adequacy of ice, refrigerated (i.e. air and water temperatures) during the harvest
seawater, refrigerated brine, or other cooling media at season in a particular region would not permit the
receipt from the harvest vessel; formation of histamine during the time necessary to
• It is no longer recommended that secondary harvest and transport the fish to the primary processor;
processors check the internal temperature of fish • The recommendations previously provided for
received from other processors. However, it is now refrigerated storage are now also recommended for
recommended that the checks for the adequacy of ice refrigerated processing;
or other cooling media at receiving be verified • For purposes of selecting fish for histamine analysis
periodically by measuring the internal temperature of and sensory examination it is now recommended that
the fish to ensure that it is at or below 40˚F (4.4˚C); lots be identified that contain only one species;
• It is now recommended that the accuracy of time/ • It is now recommended that the number of fish
temperature data loggers or recorder thermometers tested for internal temperature at receipt by the
on vehicles delivering fish to secondary processors be primary (first) processor be one per ton for lots of 10
checked on all new suppliers’ vehicles and at least tons or more, and one per 1000 lbs. for lots of under
quarterly thereafter; 10 tons, as long as at least 12 fish per lot are examined;
• The table of approximate safe shelf-life for • It is now recommended that no less than 18 fish per
scombrotoxin-forming species which was previously lot be analyzed for histamine at receipt by the primary
present is replaced with more generalized guidance (first) processor except where the lot is smaller than 18
because the values contained in the table were fish (histamine testing control strategy only). The fish
apparently being misused as binding limits;
Continued
5
collected for analysis may be composited for analysis • Discontinued use of the supplier until corrections
if the critical limit is reduced accordingly; are made is now recommended as a corrective action
• A sample size of 60 fish and a reject level of any for all control strategy examples in which
fish at or above 50 ppm histamine is now recom- aquacultured fish are received from the producer.
mended as one option for corrective action when the
processing critical limits have been violated; The recommendations in Chapter 12 for the control of
• Another option is now provided for corrective pathogen growth and toxin formation (other than
action when the sensory critical limit has been Clostridium botulinum) as a result of time/temperature
violated (primary processor): abuse are changed as follows:
- Perform histamine analysis on the lot (i.e. fish of • A third set of recommended critical limits is now
common origin) by analyzing 60 fish (or the provided for control during processing steps: If the
entire lot for lots smaller than 60 fish) and product is held at internal temperatures both above
rejecting the lot if any are found with histamine and below 70˚F (21.1˚C), exposure times above 50˚F
greater than or equal to 50 ppm. If found, the lot (10˚C) should ordinarily be limited to 4 hours, as
may be subdivided and reanalyzed at the same long as no more than 2 of those hours are above 70˚F
rate, rejecting those portions where a unit greater (21.1˚C);
than or equal to 50 ppm is found. The fish • Additional information and guidance is now
collected for analysis may be composited for provided to assist in the development of critical limits
analysis if the critical limit is reduced accordingly; during processing and storage, including:
AND - Examples of product time/temperature profiles;
- Perform a sensory examination of all fish in the lot; - A recommendation that most microbiologically
• It is now recognized that when refrigerated fish are sensitive products be stored at or below 40˚F
transported only short distances (4 hours or less) from (4.4˚C), except where control of nonproteolytic
processor to processor, a suitable alternative to C. botulinum by refrigeration is necessary, in
requiring continuous monitoring during transit may which case storage at 38˚F (3.3˚C) is usually
be for the secondary processor to check the internal appropriate;
temperature of the fish upon receipt; • Additional verification is now recommended, as follows:
• It is no longer recommended that maximum - The accuracy of recorder thermometers and other
indicating thermometers be used to monitor ambient instruments used to monitor temperature in
air temperature in storage coolers; transportation cargo areas should be checked on
• It is now recommended that high temperature new suppliers’ vehicles and at least quarterly for
alarms used to monitor ambient air temperature in each supplier thereafter;
storage coolers be connected to a 24-hour monitoring - When visual checks of ice or cooling media are
service. used to monitor the adequacy of coolant, the
internal temperatures of the fish should be
The recommendations in Chapter 11 for the control of periodically checked to ensure that the ice or
aquaculture drugs are changed as follows: cooling media is sufficient to maintain product
• Additional information is now provided about the temperatures at 40˚F (4.4˚C) or less;
labeling of approved conditions of use on aquaculture • There is now a specific acknowledgement that
drugs; frozen product storage and receipt of frozen raw
• Information is now included about the newly materials are not likely CCPs;
approved drug, chorionic gonadotropin; • Background information on the pathogens of
• Information is now included about additional concern now indicates that the infective doses of
approved uses for formalin solution; Listeria monocytogenes and Vibrio parahaemolyticus
• An additional approved manufacturer of tricaine are unknown;
methansolfonate is now listed;
• Thiamine hydrochloride is now listed as a low
regulatory priority drug for treatment of thiamine
deficiency in salmonids;
6
• The example HACCP plans in Tables 12-1 and 12- • It is now recognized that when refrigerated fishery
2 are modified to correct an error in the Second Edition, products are transported only short distances (4 hours
in which the cooked crab cooler step was inadvert- or less) from processor to processor, a suitable alterna-
ently included as a CCP in the Gulf Coast blue crab tive to requiring continuous monitoring during transit
processing method (Table 12-1), rather than the East may be for the secondary processor to check the
Coast blue crab processing method (Table 12-2). internal temperature of the fish upon receipt;
• It is now recognized that when refrigerated fishery • It now states that 20% salt is the level needed to
products are transported only short distances (4 hours ensure the safety of a shelf stable product relative to
or less) from processor to processor, a suitable all pathogens (based on the maximum salt level for
alternative to requiring continuous monitoring during growth of S. aureus), rather than providing the appar-
transit may be for the secondary processor to check ently misleading statement that 10% salt is the level
the internal temperature of the fish upon receipt; needed in a shelf stable product for the control of C.
• It is no longer recommended that maximum botulinum type A and proteolytic types B and F;
indicating thermometers be used to monitor ambient • It now provides instruction to consult Chapter 12 for
air temperature in storage coolers; information on refrigerated storage temperature
• It is now recommended that high temperature critical limits suitable for the control of pathogens
alarms used to monitor ambient air temperature in other than C. botulinum, rather than providing the
storage coolers be connected to a 24-hour monitoring apparently misleading statement that 50˚F (10˚C) is an
service. appropriate critical limit for the control of C. botuli-
num type A and proteolytic types B and F. Refrigera-
The recommendations in Chapter 13 for the control of tion at or below 40˚F (4.4˚C) is recommended for the
C. botulinum toxin formation are changed as follows: control of all pathogens;
• The introductory material is extensively reorga- • Specific guidance is now provided for control of
nized and revised to provide greater clarity; C. botulinum toxin formation in refrigerated, reduced
• Information is now provided on a recommended oxygen packaged, pasteurized fishery products,
minimum oxygen transmission rate for oxygen- including: 1) those that receive a nonproteolytic
permeable packages (10,000 cc/m2/24 hrs); C. botulinum pasteurization process in the final
• Fishery products packaged in deep containers from container; and 2) those that receive a nonproteolytic
which the air is expressed are now identified as C. botulinum cook and are then hot filled into the final
presenting a C. botulinum toxin formation hazard; container;
• Hot smoked product in aerobic packaging is no • Specific guidance is now provided for control of C.
longer identified as presenting a C. botulinum toxin botulinum toxin formation in refrigerated, reduced
formation hazard sufficient to require preventive oxygen packaged pasteurized surimi-based products,
controls in a HACCP plan. However, note that the including a recommended control of 2.5% salt in
Association of Food and Drug Officials recommends combination with a pasteurization process in the
a minimum water phase salt content of 2.5% in finished product container of 185˚F (85˚C) (internal
aerobically-packaged smoked fish; temperature) for at least 15 minutes;
• Controls are no longer recommended specifically • The use of recorder thermometers or digital time/
for the control of C. botulinum toxin formation as a temperature data loggers throughout distribution and
result of time/temperature abuse during the process- retail storage and sales is no longer recommended as
ing of unpackaged product. Instead it is now recom- an alternative to a second barrier to toxin formation by
mended that the controls recommended for pathogens C. botulinum type E and nonproteolytic types B and F;
other than C. botulinum be applied as appropriate. • It is now acknowledged that, for refrigerated
The chapter also acknowledges that C. botulinum products that are packaged in oxygen-permeable
toxin formation is possible in unpackaged or aerobi- packaging, an oxygen-impermeable overwrap may be
cally packaged product, but that, under those condi- used to extend shelf life while the product is under the
tions, it requires the type of severe temperature abuse control of the processor, as long as the overwrap is
that is not reasonably likely to occur in most food removed before the product leaves the processor’s
processing environments; control;
Continued
7
• It is now recommended that nitrite analysis accom- The recommendations in Chapter 17 for the control of
pany water phase salt analysis, as appropriate, when pathogen survival through pasteurization are changed
such analysis is used as the means of monitoring the as follows:
brining, dry salting and/or drying steps; • Information is now provided about the target
• It is now recommended that the accuracy of time/ organism and degree of destruction for pasteurization
temperature data loggers or recorder thermometers processes, including recommendations that:
on vehicles delivering fish to secondary processors be - The target organism should ordinarily be
checked on all new suppliers’ vehicles and at least Clostridium botulinum type E and nonproteolytic
quarterly thereafter; types B and F if the product is reduced oxygen
• It is no longer recommended that maximum packaged (e.g. vacuum packaged), does not
indicating thermometers be used to monitor ambient contain other barriers that are sufficient to
air temperature in storage coolers; prevent growth and toxin formation by this
• It is now recommended that high temperature alarms pathogen, and is stored or distributed refrigerated
used to monitor ambient air temperature in storage (not frozen);
coolers be connected to a 24-hour monitoring service. - The target organism should ordinarily be
L. monocytogenes for other products
The recommendations in Chapter 14 for the control of (e.g. frozen products);
pathogen growth and toxin formation as a result of - The pasteurization process should ordinarily
inadequate drying are changed as follows: provide a 6D reduction in the numbers of the
• Controls are now provided for partial drying of target pathogen.
refrigerated, reduced oxygen packaged foods, where
drying is targeted for the control of C. botulinum type The recommendations in Chapter 18 for the control of
E and nonproteolytic types B and F. The controls are pathogen introduction after pasteurization are changed
designed to ensure that the water activity of the as follows:
finished product is below 0.97; • Information is now provided on hot filling products
• The importance of packaging in preventing rehy- such as soups and sauces that are cooked to eliminate
dration of dried products is now noted. the spores of Clostridium botulinum type E and
nonproteolytic types B and F, and then reduced
The recommendations in Chapter 16 for the control of oxygen packaged (e.g. vacuum packaged) and then
pathogen survival through cooking are changed as distributed refrigerated (not frozen). The minimum
follows: recommended hot fill temperature, 185˚F (85˚C), is
• The concept of exceptionally lethal cooking designed to minimize the risk of recontamination
processes is eliminated; between cooking and finished product packaging;
• Information is now provided about the target • It is now recommended that cooling water flow rate
organism and degree of destruction for cooking be controlled when UV treatment is used to treat
processes, including recommendations that: container cooling water.
- The target organism should ordinarily be
L. monocytogenes; The recommendations in Chapter 19 for the control of
- The cook should ordinarily provide a 6D process; allergens, food intolerance substances and prohibited
• Information is now provided about cooking pro- food and color additives are changed as follows:
cesses that are designed to eliminate the spores of • Controls similar to those previously recommended
Clostridium botulinum type E and nonproteolytic for use by primary processors are now recommended
types B and F, such as cooking of soups and sauces for use by secondary processors, except that reliance
that will be reduced oxygen packaged (e.g. vacuum on raw material labeling or documents accompanying
packaged) and distributed refrigerated. The informa- the raw material shipment (in the case of unlabeled
tion includes the recommendation that such products product) are included as recommended control
be hot filled in a continuous filling system to mini- strategies when the raw material is received from
mize the risk of recontamination between cooking another processor;
and finished product packaging.
8
• Undeclared sulfiting agents are now identified as a The recommendations in the Appendices are changed
potential hazard in cooked octopus; as follows:
• General information is now provided on the control • The maximum water phase salt level for growth of
of allergenic proteins in foods. Controls similar to Bacillus cereus is now given as 10 percent;
those previously recommended to ensure proper • The maximum water phase salt level for growth of
labeling for certain food and color additives are now Staphylococcus aureus is now given as 20 percent;
recommended if foods that contain allergenic proteins • The minimum temperature for growth of patho-
are part of or are directly added to a fishery product. genic strains of Escherichia coli is now given as
Additionally, reference is made to controlling inad- 43.7˚F (6.5˚C);
vertent introduction of allergenic proteins, because of • The maximum temperature for growth of Vibrio
cross-contact, through a rigorous sanitation regime, parahaemolyticus is now given as 113.5˚F (45.3˚C);
either as part of a prerequisite program or as part of • Maximum cumulative exposure times are now
HACCP itself. provided for Bacillus cereus, as follows: 5 days at
temperatures between 39.2 and 43˚F (4-6˚C); 17
The recommendations in Chapter 20 for the control of hours at temperatures between 44 and 50˚F (7-10˚C);
metal inclusion are changed as follows: 6 hours at temperatures between 51 and 70˚F (11-
• The reference to the point at which FDA’s Health 21˚C); and 3 hours at temperatures above 70˚F
Hazard Evaluation Board has supported regulatory (above 21˚C);
action is corrected to indicate a metal fragment of • Maximum cumulative exposure times are now
between 0.3” [7 mm] and 1.0” [25 mm]; provided for Clostridium perfringens, as follows:
• The recommended corrective actions to regain 21 days at temperatures between 50 and 54˚F (10-
control over the operation after metal is detected in 12˚C); 1 day at temperatures between 55 and 57˚F
the product now include: (13-14˚C); 6 hours at temperatures between 58 and
- Locating and correcting the source of the metal 70˚F (15-21˚C); and 2 hours at temperatures above
fragments; and 70˚F (above 21˚C);
- Making adjustments to the materials, equipment, • The maximum cumulative exposure times for
and/or process, as needed, to prevent future proteolytic Clostridium botulinum are now given as:
introduction of metal fragments; 11 hours for temperatures between 50 and 70˚F
• Injection needles and metal ties are now identified (10-21˚C); and 2 hours for temperatures above 70˚F
as additional sources of metal fragments in the (above 21˚C);
processing environment; • The maximum cumulative exposure times for
• It is now recognized that visually inspecting nonproteolytic Clostridium botulinum are now given
equipment for damage or missing parts may only be as: 7 days for temperatures between 37.9 and 41˚F
feasible with relatively simple equipment, such as (3.3 - 5˚C); 2 days for temperatures between 42 and
band saws, small orbital blenders, and wire-mesh 50˚F (6-10˚C); 11 hours for temperatures between
belts. 51 and 70˚F (11-21˚C); and 6 hours for temperatures
above 70˚F (above 21˚C);
Chapter 21 has been added to provide guidance on • The maximum cumulative exposure times for
the control of glass inclusion as a result of the use of Listeria monocytogenes are now given as: 7 days for
glass containers. temperatures between 31.3 and 41˚F (-0.4 - 5˚C); and
2 days for temperatures between 42 and 50˚F (6-
10˚C);
• The maximum cumulative exposure time for
Shigella spp. is now given as 12 hours for tempera-
tures between 51 and 70˚F (11-21˚C);
9
• Tables of lethal rates and process times for 6D Additional Copies
cooks for a range of internal product temperatures are
now provided for Listeria monocytogenes and Single copies of this guidance may be obtained as long
nonproteolytic Clostridium botulinum type B (Tables as supplies last from FDA district offices and from:
A-3 and A-4, respectively).
• The FDA guideline for hard or sharp objects, found U.S. Food and Drug Administration
in Compliance Policy Guide #555.425, is included in Office of Seafood
the listing of FDA and EPA guidance levels – gener- 200 C St., S.W.
ally 0.3” [7 mm] to 1.0” [25 mm] in length; Washington, D.C. 20204
• A listing of the most common food allergens is 202-418-3133 (phone)
included (Appendix 6). 202-418-3196 (fax)
Numerous additional references are now included in Multiple copies of this guidance may be obtained from:
the Bibliography, and a number of the original refer-
ences are corrected. Florida Sea Grant
IFAS - Extension Bookstore
In addition to using the above listing to direct you to University of Florida
relevant changes in this guidance, you should care- P.O. Box 110011
fully review the chapters that are applicable to your Gainesville, FL 32611-0011
product and process. 1-800-226-1764
This guidance is also available electronically at:
http://www.fda.gov
Select “foods;” then select “seafood;” then select “HACCP.”
10
Chapter 2: Steps in Developing Your HACCP Plan
The HACCP Plan Form The Steps
This guidance is designed to walk you through a Following is a listing of the steps that this guidance
series of eighteen steps that will yield a completed uses in HACCP plan development:
HACCP plan. A blank HACCP Plan Form is con-
tained in Appendix 1. Note that this is a two page • Preliminary Steps
form, with the second page to be used if your process - General information
has more critical control points than can be listed on
one page. The Seafood HACCP Regulation requires - Describe the food
that you prepare a HACCP plan for fish and fishery - Describe the method of distribution and storage
products that you process (where significant safety - Identify the intended use and consumer
hazards exist). The regulation does not require that - Develop a flow diagram
you use the form included in Appendix 1. However,
• Hazard Analysis Worksheet
using this standardized form will likely help you
develop an acceptable plan and will expedite regula- - Set up the Hazard Analysis Worksheet
tory review. - Identify the potential species-related hazards
- Identify the potential process-related hazards
- Complete the Hazard Analysis Worksheet
The Hazard Analysis Worksheet
- Understand the potential hazard
In order to Complete the HACCP Plan Form you will - Determine if the potential hazard is significant
need to perform a process called “hazard analysis.” - Identify the critical control points (CCP)
FDA has found that the use of a standardized Hazard • HACCP Plan Form
Analysis Worksheet assists in this process. A blank
Hazard Analysis Worksheet is contained in Appendix - Complete the HACCP Plan Form
1. Note that this is also a two page form, with the - Set the critical limits (CL)
second page to be used if your process has more - Establish monitoring procedures
processing steps than can be listed on one page. • What
While the Seafood HACCP Regulation requires that
• How
processors perform a hazard analysis, it does not
require that it be kept in writing. However, FDA • Frequency
expects that a written hazard analysis will be very • Who

useful when you perform mandatory HACCP plan - Establish corrective action procedures
reassessments, and when you are asked by regulators - Establish a recordkeeping system
to justify why certain hazards were or were not
included in your HACCP plan. - Establish verification procedures
Continued
Chapter 2: HACCP Plan Steps
11
Preliminary Steps STEP #3: DESCRIBE THE METHOD OF
DISTRIBUTION AND STORAGE.
STEP #1: GENERAL INFORMATION.
Identify how the product is distributed and stored
Record the name and address of your processing after distribution (e.g. frozen, refrigerated, on ice, or
facility in the spaces provided on the first page of the dry). Identify whether any special shipping methods,
Hazard Analysis Worksheet and the HACCP Plan such as mail order, are used.
Form (Appendix 1). Examples:
• stored and distributed frozen
STEP #2: DESCRIBE THE FOOD. • distributed on ice and then stored under
refrigeration or on ice
Identify the market name or Latin name (species) of • distributed through mail order with chemical
the fishery component(s) of the product. refrigerant and then stored under refrigeration
Examples:
• tuna Record this information in the space provided on the
• shrimp first page of the Hazard Analysis Worksheet and the
• jack mackerel HACCP Plan Form.
Fully describe the finished product food. STEP #4: IDENTIFY THE INTENDED USE
AND CONSUMER.
Examples:
• individually quick frozen, cooked, peeled shrimp
IDENTIFY HOW THE product will be used by the
• fresh tuna steaks
end user or consumer.
• frozen, surimi-based, imitation king crab legs
• fresh, raw drum, in-the-round Examples:
• raw shrimp, in-shell • to be heated (but not fully cooked) and served
• raw, shucked soft clams • to be eaten with or without further cooking
• fresh seafood salad, with shrimp and • to be eaten raw or lightly cooked
blue crab meat • to be fully cooked before consumption
• frozen, breaded pollock sticks • to be further processed into a heat and serve
• frozen lobster cakes product
Describe the packaging type. Identify the intended consumer or user of the prod-
uct. The intended consumer may be the general
Examples:
public or a particular segment of the population, such
• vacuum-packaged plastic bag
as infants or the elderly. The intended user may be
• aluminum can
another processor, who will further process the
• bulk, in wax-coated paperboard box
product.
• plastic container with snap lid
Examples:
Record this information in the space provided on the • by the general public
first page of the Hazard Analysis Worksheet and the • by the general public, including some distribution
HACCP Plan Form. to hospitals and nursing homes
• by another processing facility
Record this information in the space provided on the

first page of the Hazard Analysis Worksheet and the
HACCP Plan Form.

12
STEP #5: DEVELOP A FLOW DIAGRAM. You may already have effective controls in place for
a number of these hazards as part of your routine or
The purpose of the diagram is to provide a clear, traditional handling practices. The presence of such
simple description of the steps involved in the controls does not mean that the hazard is not signifi-
processing of your fishery product and its associated cant. The likelihood of a hazard should be judged in
ingredients as they “flow” from receipt to distribu- the absence of controls. For example, the fact that
tion. The flow diagram should cover all of the steps histamine development in a particular species of fish
in the process which your firm performs. Receiving has not been noted, may be the result of: 1) the
and storage steps for each of the ingredients, includ- inability of the fish to produce histamine; or 2) the
ing non-fishery ingredients, should be included. The existence of controls that are already in place to
flow diagram should be verified on-site for accuracy. prevent its development (e.g. harvest vessel tempera-
ture controls). In the first case the hazard is not
Figure # A-1 (Appendix 2) is an example of a flow reasonably likely to occur. In the second case the
diagram. controls should be included in the HACCP plan.
FDA plans to update Tables #3-1 and 3-2 as the

Hazard Analysis Worksheet agency becomes aware of new information.
STEP #6: SET UP THE HAZARD ANALYSIS STEP #8: IDENTIFY THE POTENTIAL
WORKSHEET. PROCESS-RELATED HAZARDS.
Record each of the processing steps (from the flow Find in Table #3-3 (Chapter 3) the finished product,
diagram) in Column 1 of the Hazard Analysis package type, and method of distribution and storage
Worksheet. that most closely matches the information that you
developed in Steps #2 and 3. Record the potential
STEP #7: IDENTIFY THE POTENTIAL hazard(s) listed in the table for that product into
SPECIES-RELATED HAZARDS. Column 2 of the Hazard Analysis Worksheet at each
processing step.
Find in Table #3-1 (Chapter 3) or Table #3-2 (Chap-
ter 3) the market name (Column 1) or Latin name You may need to include potential hazards for more
(Column 2) of the product that you identified in Step than one finished product food category in Table
#2. Use Table #3-1 for vertebrates (animals with #3-3. This will happen when your product fits more
backbones), such as finfish. Use Table #3-2 for than one description. For example if you process
invertebrates (animals without backbones), such as shrimp salad using raw shrimp as a raw material, you
shrimp, oysters, crab, and lobster. Determine if it are processing both a cooked product (i.e. the inter-
has a potential species related hazard by looking for a mediate cooked shrimp) and a salad (i.e. the finished
“✓ ” mark (or three letter code for a natural toxin) in product shrimp salad). Potential hazards from both
the right-hand columns of the table. If so, record the finished product food categories apply to your
potential hazard(s) in Column 2 of the Hazard product and should be listed in Column 2 of the
Analysis Worksheet, at each processing step. Hazard Analysis Worksheet.
Tables #3-1 and 3-2 include the best information

currently available to FDA concerning hazards that
are specific to each species of fish. You should use
your own expertise, or that of outside experts, as
necessary, to identify any hazards that may not be
included in the table (e.g. those that may be new or
unique to your region).

13
Table #3-3 includes the best information currently STEP #13: COMPLETE THE HACCP PLAN
available to FDA concerning hazards that are related FORM.
to specific processing techniques. You should use
your own expertise, or that of outside experts as Find the processing steps which you have identified
necessary, to identify any hazards that may not be as CCPs in Column 6 of the Hazard Analysis
included in the table (e.g. those that are new or Worksheet. Record the names of these processing
unique to your physical plant, equipment, or pro- steps in Column 1 of the HACCP Plan Form. Enter
cess). This is more likely with more complex or the hazard(s) for which these processing steps were
innovative products. identified as CCPs in Column 2 of the HACCP Plan
Form. This information can be found in Column 2 of
FDA plans to update Table #3-3 as the agency the Hazard Analysis Worksheet.
becomes aware of new information.
Complete the HACCP Plan Form by consulting the
STEP #9: COMPLETE THE HAZARD hazards and controls chapters of this guidance
ANALYSIS WORKSHEET. (Chapters 4 through 21) for each of the significant
hazards that you entered in Column 2 of the HACCP
Consult the hazards and controls chapters of this Plan Form. Complete Steps #14-18 in the chapters
guidance (Chapters 4 through 21) for each of the relating to each of the significant hazards. These
potential hazards that you entered in Column 2 of the steps involve: setting the critical limits; establishing
Hazard Analysis Worksheet. These chapters offer monitoring procedures; establishing corrective action
guidance for completing your hazard analysis and procedures; establishing a recordkeeping system; and
developing your HACCP plan. establishing verification procedures. When you have
finished these steps for all of the significant hazards
Complete Steps #10 through 12 in the chapters that relate to your product, you will have completed
relating to each of the potential hazards. These steps the HACCP Plan Form.
involve: understanding the potential hazard; deter-
mining if the potential hazard is significant; and You should then sign and date the first page of the
identifying the critical control points. When you HACCP Plan Form. The signature must be that of
have finished these steps for all of the potential the most responsible individual on-site at your
hazards that relate to your product, you will have processing facility or a higher level official. It
completed the Hazard Analysis Worksheet. You may signifies that the HACCP plan has been accepted for
then proceed to Step #13. implementation by your firm.

14
Chapter 3: Potential Species-Related & Process-Related Hazards
Purpose • Table #3-3

Potential Process Related Hazards
This chapter contains three tables, which provide the contains a listing of potential hazards that are
following information: associated with specific finished fishery products.
These hazards are referred to as process-related
• Table #3-1 hazards.
Potential Vertebrate Species Related Hazards
contains a listing of potential hazards that are It is important to note that the tables provide listings
associated with specific species of vertebrate fish of potential hazards. You should use the tables
(fish with backbones). These hazards are referred together with the information provided in chapters 4
to as species-related hazards; through 21 in order to determine whether the hazard
is significant for your particular product, and, if so,
• Table #3-2 how it should be controlled.
Potential Invertebrate Species Related Hazards
contains a listing of potential hazards that are
associated with specific species of invertebrate fish
(fish without backbones). These hazards are also
referred to as species-related hazards;
Continued
Chapter 3: Hazard Tables
15
Table #3-1
Potential Vertebrate Species Related Hazards
Note: ASP = amnesic shellfish poison; CFP = ciguatera fish poison;
G = gempylotoxin; PSP = paralytic fish poison; T = tetrodotoxin.
Note: This table does not provide information about methyl mercury, which may be a potential
species related hazard in some species of vertebrate fish. FDA policy concerning this matter is under re-evaluation.
See Chapter 10 (Methyl Mercury) for further information.
Market Names Latin Names Hazards
Biological Chemical
Parasites Natural Toxins Histamine Chemical Drugs

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11
AHOLEHOLE Kuhlia spp. CFP
ALEWIFE or
RIVER HERRING Alosa pseudoharengus ✓
ALFONSINO Beryx spp.

Trachichthodes spp.
ALLIGATOR Alligator
mississippiensis ✓
Alligator sienensis ✓
ALLIGATOR
AQUACULTURED Alligator
mississippiensis ✓ ✓
Alligator sienensis ✓ ✓
AMBERJACK or
YELLOWTAIL Seriola spp. CFP ✓
ANCHOVY Anchoa spp. ASP6 ✓

Anchoviella spp. ASP6 ✓
Cetengraulis
mysticetus ASP6 ✓
Engraulis spp. ASP6 ✓
Stolephorus spp. ASP6 ✓
ANGELFISH Holacanthus spp.

Pomacanthus spp.
ARGENTINE
QUEENFISH Argentina elongata
BARRACUDA Sphyraena spp. CFP ✓
6 – This hazard only applies if the product is marketed uneviscerated.

16
Biological Chemical

BARRAMUNDI Lates calcarifer ✓
BASS Ambloplites spp. ✓

Micropterus spp. ✓
Morone spp. ✓
Stereolepis gigas ✓
Synagrops bellus ✓
BASS
AQUACULTURED Morone spp. ✓ ✓
Centropristis spp. ✓ ✓
BASS, SEA Acanthistius

brasilianus ✓ 4
Centropristis spp. ✓ 4
Dicentrarchus labrax ✓ 4
Lateolabrax japonicus ✓ 4
Paralabrax spp. ✓ 4
Paranthias furcifer ✓ 4
Polyprion americanus ✓ 4
Polyprion oxygeneios ✓ 4
Polyprion yanezi ✓ 4
BIGEYE Priacanthus arenatus

Pristigenys alta
BLUEFISH Pomatomus saltatrix ✓ ✓
BLUEGILL Lepomis macrochirus ✓
BLUENOSE Hyperoglyphe
antarctica
BOMBAY DUCK Harpadon nehereus ✓
BONITO Cybiosarda elegans ✓

Gymnosarda unicolor ✓
Orcynopsis unicolor ✓
Sarda spp. ✓
BOWFIN and roe Amia calva ✓
BREAM Abramis brama

Argyrops spp.
Sparus auratus
BREAM or BOGUE Boops boops
4 – This hazard does not apply if the product is intended to be cooked by the consumer or end-user.

17
Biological Chemical

BREAM,
THREADFIN Nemipterus japonicus
BUFFALOFISH Ictiobus spp. ✓
BULLHEAD Ameiurus spp. ✓
BURBOT Lota lota ✓
BUTTERFISH Odax pullus ✓

Peprilus spp. ✓
Stromateus cinereus ✓
CAPELIN and roe Mallotus villosus ✓ 4
CARP Cyprinus carpio ✓

Hypophthalmichthys
molitrix ✓
CARP
AQUACULTURED Cyprinus carpio ✓ ✓
Hypophthalmichthys
molitrix ✓ ✓
CATFISH Ameiurus catus ✓

Brachyplatystoma spp. ✓
Ictalurus spp. ✓
Pinirampus pirinampu ✓
Platynematichthy
notatus ✓
Pseudoplatystoma
tigrinum ✓
Pylodictis oliveris ✓
CATFISH
AQUACULTURED Ictalurus spp. ✓ ✓
CATFISH, SEA Ariopsis felis

Arius spp.
Bagre marinus
CHAR Salvelinus alpinus ✓
CHAR
AQUACULTURED Salvelinus alpinus ✓ ✓
CHIMAERA Harriota raleighana

Hydrolagus spp.

18
Biological Chemical

CHUB Coregonus kiyi ✓

Kyphosus spp. ✓
Semotilus
atromaculatus ✓
CISCO or CHUB Coregonus alpenae ✓

Coregonus reighardi ✓
Coregonus zenithicus ✓
CISCO or
TULLIBEE Coregonus artedii ✓
COBIA Rachycentron canadum ✓ 4
COD Arctogadus spp. ✓ 4
Boreogadus saida ✓ 4
Eleginus gracilis ✓ 4
Gadus spp. ✓ 4
COD or
ALASKA COD Gadus macrocephalus ✓ 4
COD, MORID Lotella rhacina ✓ 4
Mora pacifica ✓ 4
Physiculus barbatus ✓ 4
Pseudophycis spp. ✓ 4
CORVINA Cilus montii ✓ 4
Micropogonias
opercularis ✓ 4
CRAPPIE Pomoxis spp. ✓
CROAKER Argyrosomus spp. ✓

Bairdiella spp. ✓
Cheilotrema saturnum ✓
Genyonemus lineatus ✓
Micropogonias spp. ✓
Nebris microps ✓
Nibea spp. ✓
Pachypops spp. ✓
Pachyurus spp. ✓
Paralonchurus spp. ✓
Plagioscion spp. ✓
Pseudotolithus spp. ✓
Pterotolithus spp. ✓
Roncador stearnsi ✓
Umbrina roncador ✓
Odontoscion dentex ✓

19
Biological Chemical

CROAKER or
CORVINA Cynoscion spp. ✓
CROAKER or
SHADEFISH Argyrosomus regius ✓
CROAKER or
YELLOWFISH Pseudosciaena
manchurica ✓
CUSK Brosme brosme
CUSK-EEL Lepophidium spp.
CUTLASSFISH Aphanopus carbo

Lepidopus caudatus
Trichiurus spp.
DACE Rhinichthys ssp. ✓
DORY Cyttus novaezealandiae

Zenopsis spp.
Zeus spp.
DRIFTFISH Hyperoglyphe spp.
DRUM Equetus punctatus ✓

Larimus spp. ✓
Pogonias cromis ✓
Stellifer spp. ✓
Totoaba macdonaldi ✓
Umbrina coroides ✓
DRUM or CUBBYU Equetus umbrosus ✓
DRUM,
FRESHWATER Aplodinotus grunniens ✓
DRUM or
LION FISH Collichthys spp. ✓
DRUM or
MEAGRE Sciaena aquila ✓
DRUM or
QUEENFISH Seriphus politus ✓

20
Biological Chemical

DRUM or
REDFISH Sciaenops ocellatus ✓
DRUM or REDFISH
AQUACULTURED Sciaenops ocellatus ✓ ✓
EEL Anguilla spp.
EEL
AQUACULTURED Anguilla anguilla ✓ ✓
Anguilla australis ✓ ✓
Anguilla dieffenbachii ✓ ✓
Anguilla japonicus ✓ ✓
EEL, CONGER Ariosoma balearicum ✓

Conger spp. ✓
Gnathophis
catalinensis ✓
Hildebrandia spp. ✓
Paraconger
caudilimbatus ✓
EEL,
FRESHWATER Anguilla rostrata ✓
EEL,
FRESHWATER
AQUACULTURED Anguilla rostrata ✓ ✓
EEL, MORAY Gymnothorax funebris CFP

Lycodontis javanicus CFP
Muraena retifera CFP
EEL, SPINY Notacanthus chemnitzi
EELPOUT Macrozoarces
americanus ✓ 4
Zoarces viviparus ✓ 4
ELEPHANT FISH Callorhynchus millii
EMPEROR Lethrinus spp.
ESCOLAR or
OILFISH Lepidocybium G ✓
flavobrunneum
Ruvettus pretiosus G ✓
Note: ASP = amnesic shellfish poison; CFP = ciguatera fish poison; G = gempylotoxin; PSP = paralytic fish poison; T = tetrodotoxin.

21
Biological Chemical

FLOUNDER Ancylopsetta dilecta ✓ 4

✓ 1
Arnoglossus scapha ✓ 4
✓ 1
Atheresthes evermanni ✓ 4
✓ 1
Bothus spp. ✓ 4
✓ 1
Chascanopsetta
crumenalis ✓ 4
✓ 1
Cleisthenes pinetorum ✓ 4
✓ 1
Colistium spp. ✓ 4
✓ 1
Cyclopsetta chittendeni ✓ 4
✓ 1
Hippoglossoides
robustus ✓ 4
✓ 1
Limanda ferruginea ✓ 4
✓ 1
Liopsetta glacialis ✓ 4
✓ 1
Microstomus achne ✓ 4
✓ 1
Paralichthys albigutta ✓ 4
✓ 1
Paralichthys oblongus ✓ 4
✓ 1
Paralichthys olivaceus ✓ 4
✓ 1
Paralichthys
patagonicus ✓ 4
✓ 1
Paralichthys
squamilentus ✓ 4
✓ 1
Pelotretis flavilatus ✓ 4
✓ 1
Peltorhampus
novaezeelandiae ✓ 4
✓ 1
Platichthys spp. ✓ 4
✓ 1
Pseudorhombus spp. ✓ 4
✓ 1
Rhombosolea spp. ✓ 4
✓ 1
Samariscus triocellatus ✓ 4
✓ 1
Scophthalmus spp. ✓ 4
✓ 1
1 – This hazard does not apply to offshore catch (e.g. areas not subject to shoreside contaminant discharges).

22
Biological Chemical

FLOUNDER
AQUACULTURED Ancylopsetta dilecta ✓ 4, 5
✓ ✓
Arnoglossus scapha ✓ 4, 5
✓ ✓
Atheresthes evermanni ✓ 4, 5
✓ ✓
Bothus spp. ✓ 4, 5
✓ ✓
Chascanopsetta
crumenalis ✓ 4, 5
✓ ✓
Cleisthenes pinetorum ✓ 4, 5
✓ ✓
Colistium spp. ✓ 4, 5
✓ ✓
Cyclopsetta
chittendeni ✓ 4, 5
✓ ✓
Hippoglossoides
robustus ✓ 4, 5
✓ ✓
Limanda ferruginea ✓ 4, 5
✓ ✓
Liopsetta glacialis ✓ 4, 5
✓ ✓
Microstomus achne ✓ 4, 5
✓ ✓
Paralichthys spp. ✓ 4, 5
✓ ✓
Pelotretis flavilatus ✓ 4, 5
✓ ✓
Peltorhampus
novaezeelandiae ✓ 4, 5
✓ ✓
Pseudorhombus spp. ✓ 4, 5
✓ ✓
Rhombosolea spp. ✓ 4, 5
✓ ✓
Samariscus
triocellatus ✓ 4, 5
✓ ✓
Scophthalmus spp. ✓ 4, 5
✓ ✓
FLOUNDER or DAB Pleuronectes limanda ✓ 4

✓ 1
Pleuronectes
proboscidea ✓ 4
✓ 1
Pleuronectes
punctatissimus ✓ 4
✓ 1
FLOUNDER or
FLUKE Paralichthys dentatus ✓ 4
✓ 1
Paralichthys
lethostigma ✓ 4
✓ 1
Paralichthys microps ✓ 4
✓ 1
Platylichthys flesus ✓ 4
✓ 1
FLOUNDER,
ARROWTOOTH Atheresthes stomias ✓ 4
1 – This hazard does not apply to offshore catch (e.g. areas not subject to shoreside contaminant discharges).
5 – This hazard only applies if fresh fish or plankton is used as feed.

23
Biological Chemical

FLYINGFISH
and roe Cypselurus spp.
Exocoetus spp.
Fodiator acutus
Hirundichthys spp.
Oxyporhamphus
micropterus
Parexocoetus
brachypterus
Prognichthys
gibbifrons
FROG Rana spp. ✓
GAR Lepisosteus spp. ✓
GEMFISH Epinnula magistralis

Nesiarchus nasutus
Lepidocybium
flavobrunneum G ✓
GEMFISH or
BARRACOUTA Rexea solandri
Thyrsites atun
GEMFISH or
CABALLA Thyrsites lepidopoides
GOATFISH Mulloidichthys spp. CFP

Mullus auratus
Parupeneus spp.
Pseudupeneus spp. CFP
Upeneichthys lineatus CFP
Upeneus spp.
GRAYLING Thymallus arcticus ✓
GREENBONE Coridodax pullus
GREENLING Hexagrammos spp.
GRENADIER Coryphaenoides spp.

Lepidorhynchus
denticulatus
Macrourus spp.
Nezumia bairdi
Trachyrhynchus
murray

24
Biological Chemical

GROUPER Caprodon schlegelii ✓ 4

CFP
Cephalopholis spp. ✓ 4
CFP
Diplectrum formosum ✓ 4
CFP
Epinephelus spp. ✓ 4
CFP
Mycteroperca spp. ✓ 4
CFP
GROUPER or GAG Mycteroperca

microlepsis ✓ 4
CFP
GROUPER or HIND Epinephelus guttatus ✓ 4

CFP
GROUPER or
JEWFISH Epinephelus itajara ✓ 4
CFP
GRUNION Leuresthes tenuis
GRUNT Anisotremus
interruptus
Conodon nobilis
Haemulon spp.
Orthopristis
chrysoptera
Pomadasys crocro
GRUNT or
CATALINA Anisotremus taeniatus
GRUNT or
MARGATE Haemulon album
Haemulon
surinamensis
GRUNT or
SWEETLIPS Plectorhynchus spp.
HADDOCK Melanogrammus
aeglefinus
HAKE Urophycis spp.
HALIBUT Hippoglossus spp. ✓ 4
HALIBUT
AQUACULTURED Hippoglossus spp. ✓ 4, 5
✓ ✓
HALIBUT or
CALIFORNIA
HALIBUT Paralichthys
californicus ✓ 4

25
Biological Chemical

HAMLET,
MUTTON Epinephelus afer
HERRING Etrumeus teres ✓ 4

✓ ✓
Harengula thrissina ✓ 4
✓ ✓
Ilisha spp. ✓ 4
✓ ✓
Opisthopterus tardoore ✓ 4
✓ ✓
Pellona ditchela ✓ 4
✓ ✓
Alosa spp. ✓ ✓
HERRING or
SEA HERRING
or SILD and roe Clupea spp. ✓ 4
✓
HERRING,
THREAD Opisthonema spp. ✓ ✓
HIND Epinephelus guttatus ✓ 4

CFP
Epinephelus
adscensionis ✓ 4
CFP
Epinephelus
drummondhayi ✓ 4
CFP
HOGFISH Lachnolaimus
maximus ✓ 4
CFP
JACK Caranx spp. ✓ 4

CFP ✓
Oligoplites saurus ✓ 4
CFP ✓
Selene spp. ✓ 4
CFP ✓
Seriola rivoliana ✓ 4
CFP ✓
Urapsis secunda ✓ 4
CFP ✓
JACK or
BLUE RUNNER Caranx crysos ✓ 4
CFP ✓
JACK or
CREVALLE Alectis indica ✓ 4
CFP ✓
JACK or
RAINBOW RUNNER Elagatis bipinnulata ✓ 4
CFP ✓
JACK or
ROOSTERFISH Nematistius pectoralis ✓ 4
CFP ✓
JOBFISH Aphareus spp. ✓ 4

CFP ✓
Aprion virescens ✓ 4
CFP ✓
Pristipomoides spp. ✓ 4
CFP ✓

26
Biological Chemical

KAHAWAI Arripis spp. ✓ 4

CFP ✓
KINGFISH Menticirrhus spp.
KINGKLIP Genypterus spp.
LADYFISH Elops spp.
LING Molva spp.
LING,
MEDITERRANEAN Molva macrophthalmus
LINGCOD Ophiodon elongatus
LIZARDFISH Synodus spp.
LUMPFISH roe Cyclopterus lumpus
MACKEREL Gasterochisma
melampus ✓ 4
✓
Grammatorcynus spp. ✓ 4
✓
Rastrelliger kanagurta ✓ 4
✓
Scomber scombrus ✓ 4
✓
MACKEREL, ATKA Pleurogrammus

monopterygius ✓ 4
MACKEREL, CHUB Scomber spp. ✓ 4

✓
MACKEREL, JACK Trachurus spp. ✓ 4

✓
MACKEREL,
SPANISH Scomberomorus spp. ✓ 4
✓
Scomberomorus cavalla ✓ 4
CFP ✓
MAHI-MAHI Coryphaena spp. ✓
MAHI-MAHI
AQUACULTURED Coryphaena spp. ✓ ✓ ✓
MARLIN Makaira spp. ✓

Tetrapturus spp. ✓
MENHADEN Brevoortia spp.

Ethmidium maculatum
MILKFISH Chanos chanos ✓

27
Biological Chemical
MILKFISH
AQUACULTURED Chanos chanos ✓ ✓
MONKFISH Lophius spp. ✓ 4
MORWONG Aplodactylus
meandratus
Cheilodactylus spp.
Nemadactylus spp.
MULLET Agonostomus
monticola ✓ 4
✓
Aldrichetta forsteri ✓ 4
✓
Crenimugil crenilabis ✓ 4
✓
Mugil spp. ✓ 4
✓
Mullus spp. ✓ 4
✓
Neomyxus chaptalii ✓ 4
✓
Xenomugil thoburni ✓ 4
✓
MUSKELLUNGE Esox masquinongy ✓
OPAH Lampris guttatus
OPALEYE Girella nigricans
OREO DORY Allocyttus niger

Pseudocyttus
maculatus
OSCAR Astronotus ocellatus ✓
OSCAR
AQUACULTURED Astronotus ocellatus ✓ ✓
PACU Myleus pacu
PADDLEFISH
and roe Polyodon spp. ✓
PADDLEFISH
and roe
AQUACULTURED Polyodon spp. ✓ ✓
PARROTFISH Scarus spp. CFP2
PATAGONIAN
TOOTHFISH or
CHILEAN SEA BASS Dissotichus eleginoides ✓ 4
2 – Indicates that the cigutera hazard is only associated with this species in the tropical Pacific Ocean.

28
Biological Chemical

PERCH Hermosilla azurea ✓

Perca fluviatilis ✓
PERCH, LAKE or
YELLOW Perca flavescens ✓
PERCH, NILE Lates niloticus ✓
PERCH, NILE
AQUACULTURED Lates niloticus ✓ ✓
PERCH, OCEAN Sebastes spp. ✓ 4
PERCH, PILE Rhacochilus vacca ✓
PERCH, SILVER Bairdiella chrysoura ✓
PERCH, WHITE Morone americana ✓
PICAREL Spicara maena ✓
PICKEREL Esox spp. ✓
PIKE Esox lucius ✓
PILCHARD or
SARDINE Sardina pilchardus ✓
Sardinops spp. ✓
PLAICE Hippoglossoides
platessoides ✓ 4
Pleuronectes platessa ✓ 4
Pleuronectes
quadrituberculatus ✓ 4
POLLOCK Pollachius pollachius ✓ 4
Pollachius virens ✓ 4
POLLOCK or
ALASKA POLLOCK Theragra
chalcogramma ✓ 4
POMFRET Brama spp.

Taracetes rubescens
POMPANO Alectis ciliaris CFP

Parastromateus niger
Trachinotus spp.

29
Biological Chemical
POMPANO or
PERMIT Trachinotus kennedyi
Trachinotus falcatus
POMPANO or
POMPANITO Trachinotus rhodopus
PORGY Calamus spp.

Chrysophrys auratus
Dentex spp.
Diplodus spp.
Lagodon rhomboides
Pagrus spp.
Pterogymnus laniarus
Stenotomus caprinus
PORGY or SCUP Stenotomus chrysops
PUFFER Arothron spp. T

Fugu spp. T
Lagocephalus spp.
Sphoeroides maculatus
RACEHORSE Congiopodus
leucopaecilus
ROCKFISH Helicolenus papillosus ✓ 4
Scorpaena cardinalis ✓ 4
Sebastes spp. ✓ 4
ROCKLING Ciliata spp.

Enchelyopus cimbrius
ROSEFISH Helicolenus
dactylopterus
ROUGHY Paratrachichthys
trailli
ROUGHY, ORANGE Hoplostethus atlanticus
ROUGHY, SILVER Hoplostethus

mediterraneus
SABLEFISH Anoplopoma fimbria ✓ 4
SALMON and roe,

AQUACULTURED Oncorhynchus spp. ✓ 4, 5
✓ ✓
Salmo salar ✓ 4, 5
✓ ✓

30
Biological Chemical

SALMON and roe

(WILD)
(FRESHWATER) Oncorhynchus spp. ✓
Salmo salar ✓
SALMON and roe,

(WILD) (OCEAN) Oncorhynchus spp. ✓ 4
Salmo salar ✓ 4
SANDDAB Citharichthys sordidus ✓
SANDPERCH Mugiloides chilensis

Parapercis spp.
SARDINE Harengula spp. ✓

Sardinella spp. ✓
SAUGER Stizostedion canadense
SAURY Cololabis saira ✓

Scomberesox saurus ✓
SCAD Caranx mate ✓ 4
Decapterus spp. ✓ 4
Selar
crumenophthalmus ✓ 4
Trachurus spp. ✓ 4
SCULPIN Hemitripterus
americanus
Myoxocephalus
polyacanthocephalus
Scorpaenichthys
marmoratus
SEA BREAM Archosargus

rhomboidalis
Chrysophrys unicolor
Pagellus spp.
SEAROBIN Chelidonichthys spp.

Peristedion miniatum
Prionotus carolinus
Pterygotrigla picta
SEATROUT Cynoscion spp. ✓ 4
SHAD and roe Alosa spp. ✓ ✓

31
Biological Chemical

SHAD, GIZZARD Dorosoma spp. ✓ ✓

Nematalosa vlaminghi ✓ ✓
SHARK Carcharhinus spp.

Cetorhinus maximus
Galeocerdo cuviere
Galeorhinus spp.
Hexanchus griseus
Lamna ditropis
Negaprion brevirostris
Notorynchus
cepedianus
Prionace glauca
Sphyrna spp.
Triaenodon obesus
Triakis semifasciata
SHARK or
PORBEAGLE Lamna nasus
SHARK or
SMOOTHHOUND Mustelus spp.
SHARK, ANGEL Squatina spp.
SHARK, DOGFISH
or CAPE SHARK Centrophorus spp.
Mustelus spp.
Scyliorhinus spp.
Squalus spp.
SHARK, MAKO Isurus spp.
SHARK, THRESHER Alopias spp.
SHEEPHEAD Semicossyphus pulcher ✓

Archosargus
probatocephalus ✓
SHINER Notropis spp. ✓
SILVERSIDE Atherinops spp. ✓

Basilichthys australis ✓
Menidia menidia ✓
SKATE Bathyraja spp. ✓

Raja spp. ✓

32
Biological Chemical

SKILLFISH Erilepis zonifer

SMELT Allosmerus elongatus ✓
Argentina spp. ✓
Hypomesus spp. ✓
Osmerus spp. ✓
Plecoglossus altivelis ✓
Retropinna retropinna ✓
Spirinchus spp. ✓
Thaleichthys pacificus ✓
SNAKEHEAD Channa striata
Ophicephalus
obscurus
SNAPPER Apsilus dentatus
Etelis spp. CFP
Lutjanus spp. CFP
Macolor spp.
Ocyurus chrysurus
Pristipomoides spp. ✓ 4
CFP ✓
Rhomboplites
aurorubens
Symphorichthys
spilurus
SNOOK Centropomus spp. ✓
SOLE or FLOUNDER Aseraggodes spp. ✓ 4
Austroglossus spp. ✓ 4
Buglossidium luteum ✓ 4
Clidoderma
asperrimum ✓ 4
Embassichthys
bathybius ✓ 4
Eopsetta exilis ✓ 4
Eopsetta jordani ✓ 4
Errex zachirus ✓ 4
Glyptocephalus spp. ✓ 4
Gymnachirus melas ✓ 4
Hippoglossina spp. ✓ 4
Lepidopsetta bilineata ✓ 4
Microchirus spp. ✓ 4
Microstomus kitt ✓ 4
Microstomus pacificus ✓ 4
Pleuronectes
americanus ✓ 4
Pleuronectes vetulus ✓ 4
Psettichthys
melanostictus ✓ 4
Solea vulgaris ✓ 4
Synaptura orientalis ✓ 4
Trinectes spp. ✓ 4
Xystreurys liolepis ✓ 4

33
Biological Chemical

SOLE or
FLOUNDER
AQUACULTURED Aseraggodes spp. ✓ 4, 5
✓ ✓
Austroglossus spp. ✓ 4, 5
✓ ✓
Buglossidium luteum ✓ 4, 5
✓ ✓
Clidoderma
asperrimum ✓ 4, 5
✓ ✓
Embassichthys
bathybius ✓ 4, 5
✓ ✓
Eopsetta exilis ✓ 4, 5
✓ ✓
Eopsetta jordani ✓ 4, 5
✓ ✓
Errex zachirus ✓ 4, 5
✓ ✓
Glyptocephalus spp. ✓ 4, 5
✓ ✓
Gymnachirus melas ✓ 4, 5
✓ ✓
Hippoglossina spp. ✓ 4, 5
✓ ✓
Lepidopsetta bilineata ✓ 4, 5
✓ ✓
Microchirus spp. ✓ 4, 5
✓ ✓
Pleuronectes
americanus ✓ 4, 5
✓ ✓
Pleuronectes vetulus ✓ 4, 5
✓ ✓
Psettichthys
melanostictus ✓ 4, 5
✓ ✓
Solea vulgaris ✓ 4, 5
✓ ✓
Synaptura orientalis ✓ 4, 5
✓ ✓
Trinectes spp. ✓ 4, 5
✓ ✓
Xystreurys liolepis ✓ 4, 5
✓ ✓
SPADEFISH Chaetodipterus spp.
SPEARFISH Tetrapturus spp.
SPOT Leiostomus xanthurus ✓
SPRAT or
BRISTLING Sprattus spp. ✓ 4
✓
SQUIRRELFISH Holocentrus spp. CFP

Myripristis spp.
Sargocentron spp.
STURGEON and roe Acipenser spp. ✓

Huso huso ✓
Pseudoscaphirhynchus
spp. ✓
Scaphirhynchus spp. ✓
STURGEON and roe

AQUACULTURED Acipenser spp. ✓ ✓
Huso huso ✓ ✓
Pseudoscaphirhynchus
spp. ✓ ✓
Scaphirhynchus spp. ✓ ✓

34
Biological Chemical

SUCKER Carpiodes spp. ✓

Catostomus
commersoni ✓
Cycleptus elongatus ✓
SUCKER or
REDHORSE Moxostoma
macrolepidotum ✓
SUNFISH
(not Mola mola) Archoplites interruptus ✓
Lepomis spp. ✓
SURFPERCH Amphistichus spp. ✓
Cymatogaster
aggregata ✓
Embiotoca spp. ✓
Hyperprosopon ✓
argenteum
Rhacochilus toxotes ✓
SWORDFISH Xiphias gladius
TANG Acanthurus spp. CFP3
Ctenochaetus spp. CFP3
Tenthis spp. CFP3
Zebrasoma spp. CFP3
TARPON Megalops atlanticus ✓
TAUTOG Tautoga onitis ✓
THORNYHEAD Sebastolobus spp. ✓ 4
✓
THREADFIN Eleutheronema
tetradactylum
Galeoides decadactylus
Polydactylus spp.
TILAPIA Tilapia spp. ✓
TILAPIA
AQUACULTURED Tilapia spp. ✓ ✓
TILEFISH Caulolatilus spp.
Lopholatilus
chamaeleonticeps
Malacanthus plumieri
Prolatilus jugularis
TOMCOD Microgadus spp. ✓ 4
3 – Indicates that the cigutera hazard is only associated with this species in the tropical Pacific Ocean.

35
Biological Chemical

TONGUESOLE Cynoglossus spp. ✓ 4
TREVALLY Caranx sexfasciatus ✓ 4

CFP ✓
TRIGGERFISH Balistes spp. CFP

Canthidermis
sufflamen CFP
Melichthys niger CFP
Navodon spp.
TRIPLETAIL Datnioides
quadrifasciatus
Lobotes spp.
TROUT
(AQUACULTURE) Oncorhynchus
aguabonita ✓ ✓
Oncorhynchus clarki ✓ ✓
Oncorhynchus gilae ✓ ✓
Oncorhynchus mykiss ✓ ✓
Salmo trutta ✓ ✓
Salvelinus fontalis ✓ ✓
Salvelinus malma ✓ ✓
Salvelinus namaycush ✓ ✓
Stenodus leucichthys ✓ ✓
TROUT,
RAINBOW or
STEELHEAD Oncorhynchus mykiss ✓ 4
TRUMPETER Latridopis spp. ✓

Latris lineata ✓
TUNA (small) Allothunnus fallai ✓ 4

✓
Auxis spp. ✓ 4
✓
Euthynnus spp. ✓ 4
✓
Katsuwonus pelamis ✓ 4
✓
Thunnus tonggol ✓ 4
✓
TUNA (large) Thunnus alalunga ✓

Thunnus albacares ✓
Thunnus atlanticus ✓
Thunnus maccoyii ✓
Thunnus obesus ✓
Thunnus thynnus ✓

36
Biological Chemical

TURBOT Hypsopsetta guttulata ✓ 4
Pleuronichthys spp. ✓ 4
Psettodes spp. ✓ 4
Reinhardtius
hippoglossoides ✓ 4
Scophthalmus
maximum ✓ 4
WAHOO Acanthocybium
solandri ✓
WALLEYE Stizostedion spp. ✓
WAREHOU Seriolella spp.
WEAKFISH Cynoscion spp.

Macrodon ancylodon
WHITEFISH Coregonus spp. ✓

Prosopium
cylindraceum ✓
WHITING Merluccius gayi

Merluccius hubbsi
Merluccius merluccius
WHITING, BLUE Micromesistius spp.
WHITING or
PACIFIC WHITING Merluccius productus
WHITING,
NEW ZEALAND Macruronus
novaezelandiae
WOLFFISH Anarhichas spp. ✓ 4
YELLOWTAIL or
AMBERJACK Seriola lalandei CFP ✓
ZANDER Stizostedion lucioperca ✓

37
Table #3-2
Potential Invertebrate Species Related Hazards
Biological Chemical
Pathogens Parasites Natural Toxins Chemical Drugs

ABALONE Haliotis spp. ✓

Marinauris roei ✓
Notohaliotis ruber ✓
Schismotis laevigata ✓
AQUACULTURED
INVERTEBRATES ALL SPECIES ✓ ✓ ✓ ✓
ARKSHELL Anadara subcrenata ✓ ✓ ✓

Arca spp. ✓ ✓ ✓
CLAM, BENTNOSE Macoma nasuta ✓ ✓ ✓
CLAM BUTTER Saxidomus spp. ✓ ✓ ✓
CLAM, CALICO Macrocallista maculata ✓ ✓ ✓
CLAM, GEODUCK Panopea abrupta ✓ ✓ ✓

Panopea bitruncata ✓ ✓ ✓
CLAM, HARD Arctica islandica ✓ ✓ ✓

Meretricinae spp. ✓ ✓ ✓
Meretrix spp. ✓ ✓ ✓
Venus mortoni ✓ ✓ ✓
CLAM,
HARDSHELL or
QUAHOG Protothaca thaca ✓ ✓ ✓
Mercenaria spp. ✓ ✓ ✓
CLAM,
LITTLENECK Protothaca staminea ✓ ✓ ✓
Protothaca tenerrima ✓ ✓ ✓
Tapes aureus ✓ ✓ ✓
Tapes decussatus ✓ ✓ ✓
Tapes semidecussata ✓ ✓ ✓
Tapes variegata ✓ ✓ ✓
Tapes virginea ✓ ✓ ✓
Venerupis
philippinarum ✓ ✓ ✓
CLAM, MARSH Corbicula japonica ✓ ✓ ✓
CLAM, PISMO Tivela stultorum ✓ ✓ ✓

38
Biological Chemical

CLAM, RAZOR Ensis spp. ✓ ✓ ✓

Siliqua spp. ✓ ✓ ✓
Solen spp. ✓ ✓ ✓
Tagelus spp. ✓ ✓ ✓
CLAM, SANGUIN Sanguinolaria spp. ✓ ✓ ✓
CLAM, SOFTSHELL Mya arenaria ✓ ✓ ✓
CLAM, SURF
SURFCLAM Mactra spp. ✓ ✓ ✓
Mactrellona alata ✓ ✓ ✓
Mactromeris spp. ✓ ✓ ✓
Mactrotomas spp. ✓ ✓ ✓
Simomactra spp. ✓ ✓ ✓
Spisula spp. ✓ ✓ ✓
Tresus spp. ✓ ✓ ✓
CLAM, SURF
AQUACULTURED Mactra schalinensis ✓ ✓ ✓
CLAM, VENUS Chione spp. ✓ ✓ ✓

Macrocallista nimbosa ✓ ✓ ✓
CLAM, WEDGE Paphies spp. ✓ ✓ ✓
COCKLE Cardium spp. ✓ ✓ ✓

Clinocardium spp. ✓ ✓ ✓
Dinocardium robustum ✓ ✓ ✓
Serripes groenlandicus ✓ ✓ ✓
CONCH Strombus spp.
COQUINA Donax spp. ✓ ✓ ✓
COQUINA, FALSE Iphigenia brasiliana ✓ ✓ ✓
CRAB, BLUE Callinectes sapidus ✓
CRAB, BROWN Geryon fenneri
CRAB,
BROWN KING Lithodes aequispina
CRAB, CENTOLLA Lithodes antarcticus

Lithodes murrayi
CRAB, DEEPSEA Paralomis granulosa

39
Biological Chemical
CRAB, DUNGENESS Cancer magister ✓ 2

✓
CRAB, JONAH Cancer borealis ✓ 2
CRAB, KING Paralithodes

camtschaticus
Paralithodes platypus
CRAB, KING or
HANASAKI Paralithodes brevipes
CRAB, KOREAN
or KEGANI Erimacrus isenbeckii
CRAB, LITHODES Neolithodes brodiei
CRAB, RED Geryon quinquedens
CRAB, RED ROCK Cancer productus ✓ 2
CRAB, ROCK Cancer irroratus

Cancer pagurus
CRAB, SNOW Chionoecetes angulatus

Chionoecetes bairdi
Chionoecetes opilio
Chionoecetes tanneri
CRAB, SPIDER Jacquinotia edwardsii

Maja squinado
CRAB, STONE Menippi spp.
CRAB, SWIMMING Callinectes arcuatus ✓

Callinectes toxotes ✓
Portunus spp. ✓
CRAWFISH or
CRAYFISH Cambarus spp. ✓
Cherax spp. ✓
Euastacus armatus ✓
Pacifastacus spp. ✓
Paranephrops spp. ✓
Procambarus spp. ✓
Astacus spp. ✓

40
Biological Chemical
CRAWFISH or
CRAYFISH
AQUACULTURED Cambarus spp. ✓ ✓
Cherax spp. ✓ ✓
Euastacus armatus ✓ ✓
Pacifastacus spp. ✓ ✓
Paranephrops spp. ✓ ✓
Procambarus spp. ✓ ✓
Astacus spp. ✓ ✓
CUTTLEFISH Sepia spp.
JELLYFISH Rhopilema spp.
KRILL Euphausia spp. ✓

Meganyctiphanes
norvegica
Thysandoessa inermis
LANGOSTINO Cervimunida johni

Munida gregaria
Pleuroncodes monodon
LIMPET Acmaea testitudinalis

Cellana denticulata
Diodora aspera
Fissurella maxima
Lottia gigantea
Patella caerulea
LOBSTER Homarus spp. ✓ 7
LOBSTER,
NORWAY Nephrops norvegicus
LOBSTER, ROCK Jasus spp.
LOBSTER, ROCK
or SPINY Palinurus spp.
Panulirus spp.
LOBSTER,
SLIPPER Ibacus ciliatus
Scyllarides spp.
Thenus orientalis
LOBSTERETTE Metanephrops spp.

Nephropsis aculeata
7 – This hazard only applies if the lobster are held in pounds.

41
Biological Chemical
MUSSEL Modiolus spp. ✓ ✓ ✓

Mytilus spp. ✓ ✓ ✓
Perna canaliculus ✓ ✓ ✓
OCTOPUS Eledone spp. ✓ 1
Octopus spp. ✓ 1
OYSTER Crassostrea spp. ✓ ✓ ✓

Ostrea spp. ✓ ✓ ✓
Tiostrea spp. ✓ ✓ ✓
PEN SHELL Atrina pectinata ✓ ✓ ✓
PERIWINKLE Littorina littorea

Lunatatia spp.
SCALLOP Aequipecten spp. ✓2 ✓2 ✓

Amusium spp. ✓2 ✓2 ✓
Argopecten nucleus ✓2 ✓2 ✓
Chlamys spp. ✓2 ✓2 ✓
Patinopecten
yessoensis ✓2 ✓2 ✓
Pecten spp. ✓2 ✓2 ✓
Placopectin
magellanicus ✓2 ✓2 ✓
SCALLOP
AQUACULTURED Aequipecten spp. ✓2 ✓2 ✓
Amusium spp. ✓2 ✓2 ✓
Argopecten nucleus ✓2 ✓2 ✓
Chlamys spp. ✓2 ✓2 ✓
Patinopecten
yessoensis ✓2 ✓2 ✓
Pecten spp. ✓2 ✓2 ✓
Placopectin
magellanicus ✓2 ✓2 ✓
SCALLOP or
BAY SCALLOP Argopecten irradians ✓2 ✓2 ✓
SCALLOP, CALICO Argopecten gibbus ✓2 ✓2 ✓
SCALLOP or
WEATHERVANE Patinopecten caurinus ✓2 ✓2 ✓
SEA CUCUMBER Cucumaria spp. ✓

Holothuria spp. ✓
Parastichopus spp. ✓
Stichopus spp. ✓
1 – This hazard only applies if the product is intended to be consumed raw or partially cooked.

42
Biological Chemical
SEA URCHIN roe Echinus esculentus ✓

Evechinus chloroticus ✓
Heliocidaris spp. ✓
Loxechimus spp. ✓
Paracentrotus spp. ✓
Pseudocentrotus spp. ✓
Strongylocentrotus spp. ✓
SEABOB Xiphopenaeus kroyeri
SHRIMP Crangon spp.

Metapenaeus affinis
Palaemon serratus
Palaemonetes vulgaris
Pandalopsis dispar
Pandalus spp.
Penaeus spp.
Plesionika martia
SHRIMP
AQUACULTURED Crangon spp. ✓ ✓
Exopalaemon styliferus ✓ ✓
Macrobrachium spp. ✓ ✓
Metapenaeus spp. ✓ ✓
Palaemon serratus ✓ ✓
Palaemonetes vulgaris ✓ ✓
Pandalopsis dispar ✓ ✓
Pandalus spp. ✓ ✓
Penaeus spp. ✓ ✓
Plesionika martia ✓ ✓
SHRIMP,
FRESHWATER Macrobrachium spp.
SHRIMP,
FRESHWATER
AQUACULTURED Macrobrachium spp. ✓ ✓
SHRIMP, ROCK Sicyonia brevirostris
SHRIMP, ROYAL Pleoticus robustus
SHRIMP or
PINK SHRIMP Pandalus borealis
Pandalus jordani

43
Biological Chemical
SHRIMP or
PRAWN Hymenopenaeus
sibogae
SNAIL or
ESCARGOT Otala spp. ✓
Helix pomatia ✓
Achatina fulica ✓ 1
SQUID Alloteuthis media ✓ 1
Berryteuthis magister ✓ 1
Dosidicus gigas ✓ 1
Illex spp. ✓ 1
Loligo spp. ✓ 1
Lolliguncula spp. ✓ 1
Nototodarus spp. ✓ 1
Ommastrephes spp. ✓ 1
Rossia macrosoma ✓ 1
Sepiola rondeleti ✓ 1
Sepioteuthis spp. ✓ 1
Todarodes sagittatus ✓ 1
TOP SHELL Turbo cornutus

Nonodonta turbinata
WHELK or
SEA SNAIL Buccinum spp.
Busycon spp.
Neptunea spp. ✓ 2
1 – This hazard only applies if the product is intended to be consumed raw or partially cooked.

44
Table #3-3
Potential Process Related Hazards
Finished Product Food Package Type Method of Hazards

Distribution
and Storage Biological Chemical Physical
Pathogen C. botulinum Toxin S. aureus Pathogen Pathogen Pathogen Allergens/ Metal Glass
growth- growth formation- toxin batter survival survival contamination Additives inclusion inclusion
temperature inadequate through through after
abuse drying cooking pasteurization pasteurization
CHP 12 CHP 13 CHP 14 CHP 15 CHP 16 CHP 17 CHP 18 CHP 19 CHP 20 CHP 21
Cooked shrimp, crab, Vacuum packaged Frozen ✓ ✓ ✓ ✓

lobster, and other fish, (e.g. mechanical
including cooked meat, vacuum, steam
sections, and whole fish, sweep, hot fill),
and including surimi- MAP, CAP,
based analog products hermetically sealed
or packed in oil
Cooked shrimp, crab, Vacuum packaged Other than ✓ ✓ ✓ ✓ ✓

lobster, and other fish, (e.g. mechanical frozen
45
including cooked meat, vacuum, steam
sections, and whole fish, sweep, hot fill),
and including surimi- MAP, CAP,
based analog products hermetically sealed

or packed in oil
Cooked shrimp, crab, Other than vacuum All ✓ ✓ ✓ ✓

lobster, and other fish, packaged, MAP,
including cooked meat, CAP, hermetically
sections, and whole fish, sealed or packed
and including surimi- in oil
based analog products
Pasteurized crab, lobster, Vacuum packaged Frozen ✓ ✓ ✓ ✓ ✓

and other fish, including (e.g. mechanical
pasteurized surimi-based vacuum, steam
analog products sweep, hot fill),
MAP, CAP,
hermetically sealed
or packed in oil
Note: MAP = modified atmosphere packaging; CAP = controlled atmosphere packaging

Distribution
Pasteurized crab, lobster, Vacuum packaged Other ✓ ✓ ✓ ✓ ✓ ✓

and other fish, including (e.g. mechanical than frozen
pasteurized surimi-based vacuum, steam
analog products sweep, hot fill),
MAP, CAP,
hermetically sealed
or packed in oil
Pasteurized crab, lobster, Other than vacuum All ✓ ✓ ✓ ✓ ✓

and other fish, including packaged, MAP,
pasteurized surimi-based CAP, hermetically
analog products sealed or packed
in oil
46
Smoked fish Vacuum packaged Frozen ✓ ✓ ✓
(e.g. mechanical
vacuum, steam

sweep, hot fill),
MAP, CAP,
hermetically sealed
or packed in oil
Smoked fish Vacuum packaged Other than ✓ ✓ ✓ ✓

(e.g. mechanical frozen
vacuum, steam
sweep, hot fill),
MAP, CAP,
hermetically sealed
or packed in oil
Smoked fish Other than vacuum All ✓ ✓ ✓

packaged, MAP,
CAP, hermetically
sealed or packed in
oil

Distribution
Salads and cocktails Vacuum packaged Frozen ✓ ✓ ✓ ✓

prepared from (e.g. mechanical
ready-to-eat fishery vacuum, steam
products sweep, hot fill),
MAP, CAP,
hermetically sealed
or packed in oil
Salads and cocktails Vacuum packaged Other than ✓ ✓ ✓ ✓ ✓
prepared from (e.g. mechanical frozen
ready-to-eat fishery vacuum, steam
products sweep, hot fill),
MAP, CAP,
hermetically sealed
47
or packed in oil
Salads and cocktails Other than vacuum All ✓ ✓ ✓ ✓

prepared from packaged, MAP,
ready-to-eat fishery CAP, hermetically
products sealed or packed
in oil
Raw, breaded shrimp, All All ✓ ✓ ✓
finfish, oysters, clams,
squid, and other fish
Stuffed crab, shrimp, All All ✓ ✓ ✓
finfish, and other fish
Dried fish All All ✓ ✓ ✓ ✓ ✓

Distribution
Raw oysters, clams Vacuum packaged Frozen ✓ ✓ ✓ ✓

and mussels (e.g. mechanical
vacuum, steam
sweep, hot fill),
MAP, CAP,
hermetically sealed
or packed in oil
Raw oysters, clams Vacuum packaged Other than ✓ ✓ ✓ ✓ ✓

and mussels (e.g. mechanical frozen
vacuum, steam
sweep, hot fill),
MAP, CAP,
hermetically sealed
48
or packed n oil
Raw oysters, clams Other than vacuum All ✓ ✓ ✓ ✓

and mussels packaged, MAP,
CAP, hermetically
sealed or packed
in oil
Raw fish other than Vacuum packaged Frozen ✓ ✓

oysters, clams and (e.g. mechanical
mussels (includes vacuum, steam
non-finfish species) sweep, hot fill),
MAP, CAP,
hermetically sealed
or packed in oil

Distribution
Raw fish other than Vacuum packaged Other than ✓ ✓ ✓ ✓

oysters, clams and (e.g. mechanical frozen
mussels (includes non- vacuum, steam
finfish species) sweep, hot fill),
MAP, CAP,
hermetically sealed
or packed in oil
Raw fish other than Other than vacuum All ✓ ✓

oysters, clams and packaged, MAP,
mussels (includes non- CAP, hermetically
finfish species) sealed or packed
in oil
49
Partially cooked or Vacuum packaged Frozen ✓ ✓ ✓ ✓
uncooked prepared (e.g. mechanical
foods vacuum, steam

sweep, hot fill),
MAP, CAP,
hermetically sealed
or packed in oil
Partially cooked or Vacuum packaged Other than ✓ ✓ ✓ ✓ ✓

uncooked prepared (e.g. mechanical frozen
foods vacuum, steam
sweep, hot fill),
MAP, CAP,
hermetically sealed
or packed in oil
Partially cooked or Other than vacuum All ✓ ✓ ✓ ✓

uncooked prepared packaged, MAP,
foods CAP, hermetically
sealed or packed
in oil

Distribution
Fully cooked prepared Vacuum packaged Frozen ✓ ✓ ✓ ✓ ✓ ✓ ✓

foods (e.g. mechanical
vacuum, steam
sweep, hot fill),
MAP, CAP,
hermetically sealed
or packed in oil
Fully cooked prepared Vacuum packaged Other than ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓

foods (e.g. mechanical frozen
vacuum, steam
sweep, hot fill),
MAP, CAP,
hermetically sealed
50
or packed in oil
Fully cooked prepared Other than vacuum All ✓ ✓ ✓ ✓ ✓ ✓ ✓

packaged, MAP,

foods
CAP, hermetically
sealed or packed in
oil
Fermented, acidified, All All ✓ ✓* ✓ ✓ ✓

pickled, salted, and low
acid canned foods

* Note: Controls for this hazard need not be included in HACCP plans for shelf-stable, acidified and low acid canned foods.
See 21 CFR 113 and 114 for mandatory controls.
Chapter 4: Pathogens From the Harvest Area (A Biological Hazard)
Hazard Analysis Worksheet Significant elements of Shellfish Control Authorities’

efforts to control the harvesting of molluscan shell-
STEP #10: UNDERSTAND THE POTENTIAL fish include: 1) a requirement that containers of in-
HAZARD. shell molluscan shellfish (shellstock) bear a tag that
identifies the type and quantity of shellfish, harvester,
• Pathogens in molluscan shellfish harvest location, and date of harvest; 2) a require-
ment that molluscan shellfish harvesters be licensed
Pathogens found in waters from which molluscan (note that licensing may not be required in all juris-
shellfish are harvested can cause disease in consum- dictions); 3) a requirement that processors that shuck
ers. Molluscan shellfish include: 1) oysters; 2) molluscan shellfish or ship, reship, or repack the
clams; 3) mussels; and, 4) scallops, except where the product be certified; and, 4) a requirement that
final product is the shucked adductor muscle only. containers of shucked molluscan shellfish bear a
The pathogens of concern include both bacteria and label with the processor’s name, address, and certifi-
viruses (e.g., hepatitis A virus, Norwalk virus, cation number.
Norwalk-like viruses).
Some bacterial pathogens of human sewage or
Pathogens from the harvest area are of particular animal waste origin, such as Vibrio cholerae 01, and
concern in molluscan shellfish because: 1) environ- Salmonella spp., that may be present in low numbers
ments in which molluscan shellfish grow are com- at the time that molluscan shellfish are harvested,
monly subject to contamination from sewage, which may increase to more hazardous levels if they are
may contain pathogens, and to naturally occurring exposed to time/temperature abuse. To minimize the
bacteria, which may also be pathogens; 2) molluscan risk of pathogen growth, Shellfish Control Authori-
shellfish filter and concentrate pathogens that may be ties place limits on the time between harvest and
present in surrounding waters; and, 3) molluscan refrigeration. The length of time is dependent upon
shellfish are often consumed whole, either raw or the average monthly maximum air temperature
partially cooked. (AMMAT) at the time of harvest, which is deter-
mined by the Shellfish Control Authority.
• Control of pathogens of human/animal origin
These controls serve to minimize the risk of mollus-
Certain pathogens, such as Vibrio cholerae 01, can shellfish containing pathogens of sewage or
Salmonella spp., Shigella spp., Campylobacter jejuni, animal origin, but do not fully eliminate the risk. As a
hepatitis A virus, Norwalk virus, and Norwalk-like result, consumption of raw or undercooked mollus-
viruses, are of sewage or animal origin. To minimize can shellfish may not be safe for individuals with
the risk of molluscan shellfish containing these certain health conditions, such as liver disease,
pathogens, State and foreign government agencies, chronic alcohol abuse, diabetes, and stomach, blood,
called Shellfish Control Authorities, classify waters and immune disorders. For this reason Shellfish
in which molluscan shellfish are found, based, in Control Authorities require that shellstock intended
part, on an assessment of water quality. As a result of for raw consumption bear a tag that instructs retailers
these classifications, molluscan shellfish harvesting is to inform their customers that consuming raw or
allowed from some waters, not from others, and only undercooked shellfish may increase the risk of
at certain times or under certain conditions from foodborne illness, especially for individuals with
others. Shellfish Control Authorities then exercise certain medical conditions.
control over the molluscan shellfish harvesters to
ensure that harvesting takes place only when and
where it has been permitted.
Continued
Chapter 4: Pathogens – Receiving
51
Processors can also eliminate the hazard of “patho- Naturally occurring pathogens may be present in
gens from the harvest area” by properly cooking or relatively low numbers at the time that molluscan
retorting the product. Guidance on cooking controls shellfish are harvested, but may increase to more
is provided in Chapter 16. Mandatory retorting hazardous levels if they are exposed to time/tempera-
controls are described in the low acid canned foods ture abuse. To minimize the risk of Vibrio
regulation (21 CFR 113). It should be noted that parahaemolyticus and Vibrio cholerae non 01
neither cooking nor retorting will eliminate the pathogen growth, Shellfish Control Authorities place
hazards of “natural toxins” or “chemical contamina- limits on the time between harvest and refrigeration.
tion” that may be associated with molluscan shellfish As with pathogens of sewage or animal origin, the
that are harvested from closed waters (see Chapters 6 length of time is dependent upon the average monthly
and 9). These hazards must be controlled at receiv- maximum air temperature (AMMAT) at the time of
ing. Additionally, the laws and regulations of states harvest, which is determined by the Shellfish Control
that participate in the National Shellfish Sanitation Authority.
Program require that all molluscan shellfish be
harvested from waters authorized for harvesting by In most cases, control for V. vulnificus similarly
the Shellfish Control Authority, regardless of how it involves limits on the time from harvest to refrigera-
will be processed. tion. The length of time is dependent upon the
average monthly maximum water temperature
• Control of naturally occurring pathogens (AMMWT) at the time of harvest, which is also
determined by the Shellfish Control Authority.
Certain pathogens, such as Vibrio vulnificus, Vibrio
parahaemolyticus, and Vibrio cholerae non 01, are As with pathogens of sewage origin, the above
naturally occurring. Their presence is not associated controls for naturally occurring pathogens minimize
with human sewage or animal waste. V. vulnificus the risk of molluscan shellfish containing these
illness is associated with the consumption of raw pathogens, but do not fully eliminate the risk. For this
oysters harvested from the Gulf of Mexico during the same reason, Shellfish Control Authorities require
warm weather months. V. parahaemolyticus and V. that shellstock intended for raw consumption bear a
cholerae non 01 illness is associated with the con- tag containing a warning relative to raw and
sumption of raw oysters harvested during the warm undercooked consumption (described above).
weather months from the Atlantic, Pacific, and Gulf
of Mexico regions of the U.S., and similar climates The controls for V. vulnificus and V.
world-wide. To minimize the risk of illness from the parahaemolyticus discussed in this chapter only
consumption of molluscan shellfish containing these apply to molluscan shellfish if they are intended for
pathogens, Shellfish Control Authorities place certain raw consumption. For example, they would not be
controls on the harvest of molluscan shellfish. applied to oyster shellstock from the Gulf of Mexico
if tags on the containers of shellstock indicate that
Control for V. parahaemolyticus involves monitoring they must be shucked and cooked before consump-
by Shellfish Control Authorities of waters that have tion.
been confirmed as the original source of oysters
associated with two or more V. parahaemolyticus V. vulnificus, V. parahaemolyticus, and V. cholerae
illnesses in the past three years. Monitoring is non 01 can be eliminated or reduced to nondetectable
performed for both total V. parahaemolyticus num- levels by cooking, pasteurizing, and retorting.
bers and for the presence of virulent strains of V. Guidance for these control mechanisms can be found
parahaemolyticus (i.e. tdh+ strains). As a result of in Chapters 16 (cooking) and 17 (pasteurization) and
the monitoring, Shellfish Control Authorities may the low acid canned foods regulation (21 CFR 113).
temporarily close some waters to the harvesting of Other mechanisms, such as freezing and hydrostatic
oysters that are intended for raw consumption. pressure, are being studied.

52
Appropriate controls to prevent further growth of guidance for harvest vessels and for aquaculture, in
these pathogens during processing, storage, and an effort to minimize the likelihood that these
transportation between processors is discussed in operations will contribute pathogens to fish and
Chapter 12. fishery product.
• Pathogens in fish other than molluscan shellfish The guidance contained in the remainder of this
chapter applies to molluscan shellfish, only.
It is possible that, in performing your hazard analy-
sis, you may have identified pathogens from the STEP #11: DETERMINE IF THE POTEN-
harvest area as a potential hazard for fish types other TIAL HAZARD IS SIGNIFICANT.
than molluscan shellfish. In some cases, this would
be an appropriate decision, as pathogens, may be At each processing step, determine whether “patho-
found on raw fish as a result of near-shore harvest gens from the harvest area” is a significant hazard.
water contamination, contamination on the harvest The criteria are:
vessel and poor aquacultural practices.
1. Is it reasonably likely that unsafe levels of pathogens
This hazard can be controlled by the processor by from the harvest area will be introduced at the receiv-
proper cooking, pasteurizing, or retorting. Guidance ing step (e.g. are pathogens present in the raw material
for these control mechanisms can be found in Chap- at unsafe levels)?
ters 16 (cooking) and 17 (pasteurizing), and the low
acid canned foods regulation, 21 CFR 113 (retorting). Under ordinary circumstances, it would be reason-
ably likely that pathogens from the harvest area could
For many products (e.g. raw fish fillets) there is no enter the process at unsafe levels at the receiving step
cooking, pasteurizing, or retorting step performed by from the following types of fish:
the processor. For most of these products, cooking is • Raw oysters;
performed by the consumer or end user before • Raw clams;
consumption. FDA is not aware of any HACCP • Raw mussels;
controls that may exist internationally for the control • Raw scallops
of pathogens in fish and fishery products that are (See information provided under “Intended use”).
intended to be fully cooked by the consumer or end
user before consumption, other than a rigorous Under ordinary circumstances, it would be reason-
sanitation regime as part of either a prerequisite ably likely that V. vulnificus could enter the process
program or as part of HACCP itself. The Seafood from oysters harvested from the Gulf of Mexico
HACCP Regulation requires such a regime. The (i.e., States which have been confirmed as the
proper application of sanitation controls is essential original source of oysters associated with two or
because of the likelihood that any pathogens that may more V. vulnificus illnesses).
be present in seafood products are introduced
through poor handling practices (e.g. by the aquacul- Under ordinary circumstances, it would be reason-
tural producer, the fisherman, or the processor). ably likely that V. parahaemolyticus could enter the
process from oysters harvested in an area which has
FDA is interested in information regarding any been confirmed as the original source of oysters
HACCP controls beyond sanitation that may be both associated with two or more V. parahaemolyticus
necessary and practical for the control of pathogens illnesses in the past three years.
in fish and fishery products that are intended to be
fully cooked by the consumer or end user before
consumption. However, the agency makes no
recommendations in this Guide and has no specific
expectations with regard to such controls in proces-
sors’ HACCP plans. The agency plans to develop
Continued
53
2. Can unsafe levels of pathogens from the harvest If the answer to either question 1 or 2 is “Yes” the
area, which were introduced at the receiving step, be potential hazard is significant at that step in the
eliminated or reduced to an acceptable level at this process and you should answer “Yes” in Column 3 of
processing step? (Note: If you are not certain of the the Hazard Analysis Worksheet. If neither criterion
answer to this question at this time, you may answer is met you should answer “No.” You should record
“No.” However, you may need to change this answer the reason for your “Yes” or “No” answer in Column
when you assign critical control points in Step 12.) 4. You need not complete Steps #12 through 18 for
this hazard for those processing steps where you have
“Pathogens from the harvest area” should also be recorded a “No.”
considered a significant hazard at any processing step
where a preventive measure is or can be used to It is important to note that identifying this hazard as
eliminate unsafe levels of pathogens that are reason- significant at a processing step does not mean that it
ably likely to come in with the raw materials, or must be controlled at that processing step. The next
where a preventive measure is adequate to reduce the step will help you determine where in the process the
likelihood of occurrence of the hazard to an accept- critical control point is located.
able level. Preventive measures for pathogens from
the harvest area could include: • Intended use
• Checking incoming molluscan shellfish to ensure In determining whether a hazard is significant you
that they are properly tagged or labeled; should also consider the intended use of the product,
• Making sure that incoming molluscan shellfish are which you developed in Step #4. For most raw
supplied by a licensed harvester (where licensing is molluscan shellfish products you should assume that
required by law) or by a certified dealer; the product will be consumed raw. You should,
• Killing the pathogens by cooking (covered in therefore, identify the hazard as significant if it meets
Chapter #16), pasteurizing (covered in Chapter the above criteria.
#17), or retorting (covered by the low acid canned
foods regulation, 21 CFR 113). It should be noted However, where the product consists of scallop
that neither cooking nor retorting will eliminate adductor muscle only, it is reasonable to assume that
the hazards of “natural toxins” or “chemical the product will be cooked before consumption. In
contamination” that may be associated with this case you would not need to identify “pathogens
molluscan shellfish that are harvested from closed from the harvest area” as a significant hazard. You
waters; should then enter “No” in Column 3 of the Hazard
• Minimizing the growth of V. cholerae, Analysis Worksheet for each of the processing steps.
V. parahaemolyticus, V. vulnificus, and For each “No” entry briefly explain in Column 4 that
L. monocytogenes by limiting the time from the product is not ordinarily consumed raw. In this
harvest to refrigeration. case, you need not complete Steps #12 through 18 for
• Including a warning on tags on containers of this hazard.
molluscan shellfish intended for raw consumption
that instructs retailers to inform their customers Additionally, the controls for V. vulnificus and
that consuming raw or undercooked shellfish may V. parahaemolyticus that are discussed in this chapter
increase the risk of foodborne illness, especially only need be applied to molluscan shellfish if they
for individuals with certain medical conditions. are intended for raw consumption. For example, they
need not be applied to oyster shellstock from the
List such preventive measures in Column 5 of the Gulf of Mexico if tags on the containers of shellstock
Hazard Analysis Worksheet at the appropriate indicate that they must be shucked and cooked before
processing step(s). consumption.

54
Similarly, the raw consumption warning need not be In this case enter “Yes” in Column 6 of the
applied to containers of shucked shellfish, because these Hazard Analysis Worksheet for the cooking or
products are generally cooked before consumption. retorting step, and enter “No” for the receiving
step. In addition, note in Column 5 that the
STEP #12: IDENTIFY THE CRITICAL hazard is controlled by the cooking or retorting
CONTROL POINTS (CCP). step. (Note: if you have not previously
identified “pathogens from the harvest area” as
For each processing step where “pathogens from the a significant hazard at the cooking or retorting
harvest area” is identified in Column 3 of the Hazard step in Column 3 of the Hazard Analysis
Analysis Worksheet as a significant hazard, deter- Worksheet, you should change the entry in
mine whether it is necessary to exercise control at Column 3 to “Yes.”) If you chose to follow
that step in order to control the hazard. Figure #A-2 this approach you should refer to Chapter 16
(Appendix 3) is a CCP decision tree that can be used (cooking) or to the low acid canned foods
to aid you in your determination. regulation (retorting) for further guidance.
The following guidance will also assist you in b. If the product will not be cooked or retorted
determining whether a processing step is a CCP for sufficiently to kill pathogens during processing
“pathogens from the harvest area”: in your facility, you should identify the
1. Will the product be cooked or retorted sufficiently receiving step as a CCP, where you can
to kill pathogens during processing in your exercise control over the source of the
facility? molluscan shellfish and the time from harvest
to refrigeration to control pathogens from the
a. If it will be, you may identify the cook step or harvest area. If the finished product is
retorting step as the CCP. In this case you shellstock intended for raw consumption,
would not need to identify the receiving step as you should also identify the labeling step as
a CCP for the hazard of “pathogens from the a CCP, where you can ensure that the raw
harvest area.” However, it should be noted that consumption warning is on the tag.
neither cooking nor retorting will eliminate the
hazards of “natural toxins” or “environmental Example:
chemical contaminants and pesticides” that A processor that shucks raw oysters and ships
may be associated with molluscan shellfish a raw product checks the tags of incoming
that are harvested from closed waters (see shellstock (in-shell oysters), the license of the
Chapters 6 and 9). These hazards must be harvesters that supply the shellstock, and the
controlled at receiving. Additionally, the laws length of time between harvesting and
and regulations of states that participate in the refrigeration. The processor identifies
National Shellfish Sanitation Program require receiving as the CCP for this hazard.
that all molluscan shellfish be harvested from
waters authorized for harvesting by the Example:
Shellfish Control Authority. A processor that ships oyster shellstock checks
the tags of incoming shellstock, the license of
Example: the harvesters that supply the shellstock, and
A canned clam chowder processor sets the the length of time between harvesting and
critical control point for pathogens from the refrigeration. The processor identifies
harvest area at the retorting step, and does not receiving as a CCP for this hazard. The
identify the receiving step as a critical control processor also identifies the labeling step as a
point for this hazard. CCP for this hazard, and checks for the
presence of the raw consumption warning.
Continued
55
In this case, You should enter “Yes” in Column In this case enter “Yes” in Column 6 of the
6 of the Hazard Analysis Worksheet for the Hazard Analysis Worksheet for the
receiving step. This control approach will be pasteurizing step. (Note: if you have not
referred to as “Control Strategy Example 1” in previously identified pathogens from the
Steps #14 through 18. Note that this control harvest area as a significant hazard at the
strategy is identical to Control Strategy pasteurizing step in Column 3 of the Hazard
Example 6 for “environmental chemical Analysis Worksheet, you should change the
contaminants and pesticides” (Chapter 9) and entry in Column 3 to “Yes”.) If you chose to
Control Strategy Example 1 for “natural follow this approach you should refer to
toxins” (Chapter 6). If you choose an identical Chapter 17 (pasteurizing) for further guidance.
control strategy for two or more of these
hazards, you may combine the hazards in the b. If the product will not be pasteurized
HACCP Plan Form. sufficiently to kill V. vulnificus during
processing in your facility, you should identify
You only need to answer Questions 2 and 3 if you the receiving step as a CCP, where you can
answered “no” to Question 1. exercise control over the time from harvest to
refrigeration to control V. vulnificus. You
2. If the finished product is raw oyster shellstock should also identify the labeling step as a CCP
intended for raw consumption and is from the Gulf for this hazard, where you can ensure that the
of Mexico (i.e., States which have ever been raw consumption warning is on the tag.
confirmed as the original source of oysters
associated with two or more V. Vulnificus illnesses), Example:
will it be pasteurized sufficiently to kill V. vulnificus Another oyster processor on the Gulf of
during processing in your facility (i.e. reduced to a Mexico sets the critical controls point for
nondetectable level; less than 3 MPN/gram, as V. vulnificus at the receiving step and the
defined by the NSSP)? Other mechanisms, such as tagging step.
freezing and hydrostatic pressure, are being studied
and may also be suitable for control of these In this case, you should enter “Yes” in Column
pathogens. 6 of the Hazard Analysis Worksheet for the
receiving step. This control approach will be
a. If it will be, you may identify the referred to as “Control Strategy Example 2” in
pasteurization step as the CCP for control of Steps #14-18.
V. vulnificus. In this case you will not need to
identify the receiving step as a CCP for the Note that the controls listed under “2,” above,
control of V. vulnificus. should be considered in addition to those listed
under “1,” above and “3,” below. In some
Example: cases, two or more types of controls will be
An oyster processor on the Gulf of Mexico sets necessary.
the critical control point for V. vulnificus at the
3. If the finished product is raw oyster shellstock
pasteurizing step, and does not identify the
intended for raw consumption and is from an area
receiving step as a critical control point for
which has been confirmed as the original source
that pathogen.
of oysters associated with two or more
V. parahaemolyticus illnesses in the past three years,
will it be pasteurized sufficiently to kill
V. parahaemolyticus during processing in your
facility? Other mechanisms, such as freezing and
hydrostatic pressure, are being studied and may
also be suitable for control of these pathogens.

56
a. If it will be, you may identify the The time to refrigeration controls for V. vulnificus
pasteurization step as the CCP for control of that are discussed in this chapter need only be
V. parahaemolyticus. In this case you will not applied by the primary processor (the processor who
need to identify the receiving step as a CCP for takes possession of the molluscan shellfish from the
the control of V. parahaemolyticus. harvester), since this is the processor that is in the
best position to control the time from harvest to
Example: refrigeration.
An oyster processor sets the critical control
point for V. parahaemolyticus at the It is important to note that you may select a control
pasteurizing step, and does not identify the strategy that is different from those which are
receiving step as a critical control point for suggested above, provided that it assures an equiva-
that pathogen. lent degree of safety of the product.
In this case enter “Yes” in Column 6 of the Proceed to Step #13 (Chapter 2) or to Step #10 of the
Hazard Analysis Worksheet for the pasteurizing next potential hazard.
step. (Note: if you have not previously
identified pathogens from the harvest area as a HACCP Plan Form
significant hazard at the pasteurizing step in
Column 3 of the Hazard Analysis Worksheet, STEP #14: SET THE CRITICAL LIMITS (CL).
you should change the entry in Column 3 to
“Yes”.) If you chose to follow this approach For each processing step where “pathogens from the
you should refer to Chapter 17 (pasteurizing) harvest area” is identified as a significant hazard on
for further guidance. the HACCP Plan Form identify the maximum or
minimum value to which a feature of the process
b. If the product will not be pasteurized must be controlled in order to control the hazard.
sufficiently to kill V. parahaemolyticus during
processing in your facility, you should identify You should set the CL at the point that if not met the
the receiving step as a CCP, where you can safety of the product may be questionable. If you set
exercise control over the time from harvest to a more restrictive CL you could, as a result, be
refrigeration to control V. parahaemolyticus. required to take corrective action when no safety
You should also identify the labeling step as a concern actually exists. On the other hand, if you set
CCP for this hazard, where you can ensure that a CL that is too loose you could, as a result, allow
the raw consumption warning is on the tag. unsafe product to reach the consumer.
Example: As a practical matter it may be advisable to set an

Another oyster processor sets the critical operating limit that is more restrictive than the CL.
control point for V. parahaemolyticus at the In this way you can adjust the process when the
receiving step and the tagging step. operating limit is triggered, but before a triggering of
the CL would require you to take corrective action.
In this case, You should enter “Yes” in Column You should set operating limits based on your
6 of the Hazard Analysis Worksheet for the experience with the variability of your operation and
receiving step. This control approach will be with the closeness of typical operating values to the
referred to as “Control Strategy Example 3” in CL.
Steps 14-18.
Following is guidance on setting critical limits for the
Note that the controls listed under “3,” above, control strategy examples discussed in Step #12.
should be considered in addition to those listed
under “1,” and “2” above. In many cases, two
or more types of controls will be necessary.
Continued
57
• CONTROL STRATEGY EXAMPLE 1 - AND
SOURCE CONTROL All finished product shellstock intended for raw
consumption must bear a tag that instructs
Critical Limit: All shellstock (in-shell molluscan retailers to inform their customers that consuming
shellfish) containers must bear a tag that raw or undercooked shellfish may increase the
discloses the date and place they were harvested risk of foodborne illness, especially for
(by State and site), type and quantity of individuals with certain medical conditions.
shellfish, and by whom they were harvested
(i.e., the identification number assigned to the (Note: Average Monthly Maximum Air Temperature
harvester by the Shellfish Control Authority, where (AMMAT) is determined by the Shellfish Control
applicable or, if such identification numbers are Authority)
not assigned, the name of the harvester or the
name or registration number of the harvester’s (Note: only the primary processor (the processor that
vessel). For bulk shipments of shellstock, where takes possession of the molluscan shellfish from the
the shellstock is not containerized, accept harvester) need apply controls relative to the identifi-
shellstock only if it is accompanied by a bill of cation of the harvester, the harvester’s license, the
lading or other similar shipping document that approval status of the harvest waters, or the time-of-
contains the same information; harvest to time-of-refrigeration.)
AND
All molluscan shellfish must have been harvested • CONTROL STRATEGY EXAMPLE 2 -
from waters authorized for harvesting by a V. VULNIFICUS CONTROL
Shellfish Control Authority. For U.S. Federal
Critical Limit: Maximum time from harvest to
waters, no molluscan shellfish may be harvested
refrigeration (Note: these apply only to certain
from waters that are closed to harvesting by an
products, as described in Steps #11 and 12):
agency of the federal government;
• For AMMWT of less than 65˚F
AND
(less than18˚C): 36 hours
All containers of shucked molluscan shellfish
• For AMMWT of 65 to 74˚F (18 to 23˚C):
must bear a label that identifies the name,
14 hours;
address, and certification number of the packer
• For AMMWT of greater than 74 to 84˚F
or repacker of the product;
(greater than 23 to 28˚C): 12 hours;
AND
• For AMMWT of greater than 84˚F
All molluscan shellfish must be from a harvester
(greater than 28˚C): 10 hours
that is licensed as required (note that licensing
AND
may not be required in all jurisdictions) or from a
All finished product shellstock intended for raw
processor that is certified by a Shellfish Control
Authority.
retailers to inform their customers that consuming
AND
raw or undercooked shellfish may increase the
The following criteria is met for the maximum
risk of foodborne illness, especially for
time from harvest to refrigeration:
individuals with certain medical conditions.
• For AMMAT of less than 66˚F
(less than 19˚C): 36 hours;
(Note: Average Monthly Maximum Water Tempera-
• For AMMAT of 66 to 80˚F
ture (AMMWT) is determined by the Shellfish
(19 to 27˚C): 24 hours;
Control Authority.)
• For AMMAT of greater than 80˚F
(greater than 27˚C): 20 hours.
(Note: only the primary processor (the processor that
takes possession of the molluscan shellfish from the
harvester) need apply controls for time-of-harvest to
time-of-refrigeration.)

58
• CONTROL STRATEGY EXAMPLE 3 – STEP #15: ESTABLISH MONITORING
V. PARAHAEMOLYTICUS CONTROL PROCEDURES.
Critical Limit: Maximum time from harvest to refrig- For each processing step where “pathogens from the
eration (Note: these apply only to certain products, as harvest area” is identified as a significant hazard on
described in Steps #11 and 12): the HACCP Plan Form, describe monitoring proce-
• For AMMAT of less than 66˚F dures that will ensure that the critical limits are
(less than 19˚C): 36 hours consistently met.
• For AMMAT of 66˚F to 80˚F
(19˚C to 27˚C): 12 hours To fully describe your monitoring program you
• For AMMAT of greater than 80˚F should answer four questions: 1) What will be
(greater than 27˚C): 10 hours monitored? 2) How will it be monitored? 3) How
AND often will it be monitored (frequency)? 4) Who will
All finished product shellstock intended for raw perform the monitoring?
retailers to inform their customers that It is important for you to keep in mind that the
consuming raw or undercooked shellfish may feature of the process that you monitor and the
increase the risk of foodborne illness, especially method of monitoring should enable you to deter-
for individuals with certain medical conditions. mine whether the CL is being met. That is, the
monitoring process should directly measure the
(Note: Average Monthly Maximum Air Temperature feature for which you have established a CL.
(AMMAT) is determined by the Shellfish Control
Authority.) You should monitor often enough so that the normal
variability in the values you are measuring will be
(Note: only the primary processor (the processor that detected. This is especially true if these values are
takes possession of the molluscan shellfish from the typically close to the CL. Additionally, the greater
harvester) need apply controls for time-of harvest to the time span between measurements the more
time of refrigeration.). product you are putting at risk should a measurement
show that a CL has been violated.
Much of Control Strategy Example 1 is specifically
mandated by 21 CFR 123.28. However, for those Following is guidance on establishing monitoring
provisions that are not specifically included in the procedures for the control strategy examples dis-
regulation, you may select a different control strat- cussed in Step #12. Note that the monitoring fre-
egy, provided that it assures an equivalent degree of quencies that are provided are intended to be consid-
safety of the product. ered as minimum recommendations, and may not be
adequate in all cases.
Enter the critical limit(s) in Column 3 of the HACCP
Plan Form.
Continued
59
What Will Be Monitored? How Will Monitoring Be Done?
• CONTROL STRATEGY EXAMPLE 1 - • CONTROL STRATEGY EXAMPLE 1 -

SOURCE CONTROL SOURCE CONTROL
What: The tags on containers of incoming How: Visual checks;

shellstock. The Bill of Lading or other similar AND
shipping document accompanying bulk For time of harvest:
shipments of shellstock; • Obtain information from Shellfish Control
AND Authority;
The harvest site listed on the tag or on the Bill of OR
Lading or other similar shipping document; • Check harvester’s log;
AND OR
The labels on containers of incoming shucked • Note time of departure from dock;
molluscan shellfish; OR
AND • Ask harvester.
The license of fishermen, where applicable;
AND
The certification number of suppliers (other than • CONTROL STRATEGY EXAMPLES 2 & 3
fishermen) of shellstock or shucked molluscan
shellfish; How: Visual checks;
AND AND
Time harvesting began; For time of harvest:
AND • Obtain information from Shellfish Control
Time shellstock was placed under refrigeration; Authority;
AND OR
The raw consumption advisory on tags on • Check harvester’s log;
containers of finished product shellstock OR
intended for raw consumption. • Note time of departure from dock;
OR
• CONTROL STRATEGY EXAMPLES 2 & 3 • Ask harvester.
What: Time harvesting began;

AND How Often Will Monitoring Be Done
Time shellstock was placed under refrigeration; (Frequency)?
AND
The raw consumption advisory on tags on • CONTROL STRATEGY EXAMPLE 1 -
containers of finished product shellstock SOURCE CONTROL
intended for raw consumption.
Frequency: For checking incoming tags: every
container;
AND
For checking harvest site: every lot;
AND
For checking incoming labels: at least three
containers randomly selected from throughout
every lot;
AND
For checking licenses: every delivery;

60
AND STEP #16: ESTABLISH CORRECTIVE
For checking certification numbers: every ACTION PROCEDURES.
delivery;
AND For each processing step where “pathogens from the
For checking time-of-harvest and time-of- harvest area” is identified as a significant hazard on
refrigeration: every delivery; the HACCP Plan Form, describe the procedures that
AND you will use when your monitoring indicates that the
For checking raw consumption advisory on CL has not been met.
finished product tags: each lot of finished
product or each lot of tags (at receipt of tags). These procedures should: 1) ensure that unsafe
product does not reach the consumer; and, 2) correct
• CONTROL STRATEGY EXAMPLES 2 & 3 the problem that caused the CL deviation. Remem-
ber that deviations from operating limits do not need
Frequency: Every delivery; to result in formal corrective actions.
AND
Following is guidance on establishing corrective
For checking raw consumption advisory on
action procedures for the control strategy examples
finished product tags: each lot of finished
discussed in Step #12.
product or each lot of tags (at receipt of tags).
• CONTROL STRATEGY EXAMPLE 1 -
SOURCE CONTROL
Who WIll Perform the Monitoring?
Corrective Action: Reject incoming shellstock
• CONTROL STRATEGY EXAMPLE 1 - that is not properly tagged or is not
SOURCE CONTROL accompanied by a proper shipping document;
AND
Who: Monitoring may be performed by the Reject incoming shucked molluscan shellfish that
receiving employee, a supervisor, a member of is not properly labeled;
the quality control staff, or any other person AND
who has an understanding of the nature of Reject incoming molluscan shellfish that has
the controls. been harvested from unapproved waters;
AND
• CONTROL STRATEGY EXAMPLES 2 & 3 Reject incoming molluscan shellfish that is not
from a licensed harvester or certified processor;
Who: Monitoring may be performed by the receiving AND
employee, a supervisor, a member of the quality Reject incoming shellstock that does not meet
control staff, or any other person who has an the time-of-harvest to time-of-refrigeration
understanding of the nature of the controls. critical limits;
AND
(Note: only the primary processor (the processor that
Relabel finished product shellstock intended for
raw consumption that does not bear a tag that
harvester) need apply controls relative to the identifi-
contains the raw consumption warning;
cation of the harvester, the harvester’s license, the
OR
approval status of the harvest waters, or the time-of-
Reject any incoming tags to be used on finished
harvest to time-of-refrigeration.)
product shellstock intended for raw consumption
Enter the “What,” “How,” “Frequency,” and “Who” that do not contain the raw consumption warning;
monitoring information in Columns 4, 5, 6, and 7, AND
respectively, of the HACCP Plan Form. Discontinue use of supplier until evidence is
obtained that harvesting, tagging, and/or labeling
practices have changed.
Continued
61
• CONTROL STRATEGY EXAMPLES 2 & 3 STEP #17: ESTABLISH A RECORDKEEPING
SYSTEM.
Corrective Action: Reject lots that do not
meet the CL; For each processing step where “pathogens from the
OR harvest area” is identified as a significant hazard on
Relabel the shellstock with tags that identify its the HACCP Plan Form, list the records that will be
use for shucking and cooking only; used to document the accomplishment of the moni-
OR toring procedures discussed in Step #15. The records
Subject the shellstock to a pasteurization should clearly demonstrate that the monitoring
process that reduces V. vulnificus or Vibrio procedures have been followed, and should contain
parahaemolyticus, as appropriate, in the the actual values and observations obtained during
shellstock to a non-detectable level (i.e. less monitoring.
than 3 MPN/gram, as defined in the NSSP).
See Chapter 17 for further guidance on Following is guidance on establishing a
pasteurization. recordkeeping system for the control strategy ex-
AND amples discussed in Step #12.
Relabel finished product shellstock that does not
bear a tag that contains the raw consumption • CONTROL STRATEGY EXAMPLE 1 -
warning; SOURCE CONTROL
OR
Reject any incoming tags to be used on finished For shellstock:
product shellstock that do not contain the raw
consumption warning; Records: Receiving record that documents:
AND • Date of harvest;
Discontinue use of supplier until evidence is AND
obtained that harvesting, tagging, and/or labeling • Location of harvest by State and site;
practices have changed. AND
• Quantity and type of shellfish;
Note: If an incoming lot that fails to meet a receiving AND
critical limit is mistakenly accepted, and the error is • Name of the harvester, name or registration
later detected, the following actions should be taken: number of the harvester’s vessel, or an
1) the lot and any products processed from that lot identification number issued to the harvester
should be destroyed, diverted to a nonfood use or to a by the Shellfish Control Authority;
use in which the critical limit is not applicable, or AND
placed on hold until a food safety evaluation can be • Number and date of expiration of the
completed; and 2) any products processed from that harvester’s license, where applicable;
lot that have already been distributed should be AND
recalled and subjected to the actions described above. • Certification number of the shipper, where
applicable;
(Note: only the primary processor (the processor that AND
takes possession of the molluscan shellfish from the • Time harvesting began;
harvester) need apply controls relative to the identifi- AND
cation of the harvester, the harvester’s license, the • Time shellstock was placed under refrigeration;
approval status of the harvest waters, or the time-of- AND
harvest to time-of-refrigeration.) • AMMAT, where applicable;
AND
Enter the corrective action procedures in Column 8 of • For shellstock intended for raw consumption,
the HACCP Plan Form. labeling record that documents the presence of
the raw consumption warning.

62
For shucked molluscan shellfish: STEP #18: ESTABLISH VERIFICATION
PROCEDURES.
Records: Receiving record that documents:
• Date of receipt; For each processing step where “pathogens from the
AND harvest area” is identified as a significant hazard on
• Quantity and type of shellfish; the HACCP Plan Form, establish verification proce-
AND dures that will ensure that the HACCP plan is: 1)
• Name and certification number of the packer adequate to address the hazard of “pathogens from
or repacker. the harvest area”; and, 2) consistently being fol-
lowed.
• CONTROL STRATEGY EXAMPLES 2 & 3
Following is guidance on establishing verification
Records: Receiving record that documents: procedures for the control strategy examples dis-
• Time harvesting began; cussed in Step #12.
AND
• Time shellstock was placed under • CONTROL STRATEGY EXAMPLE 1 -
refrigeration; SOURCE CONTROL
AND
• AMMWT; Verification: Review monitoring and corrective
AND action records within one week of preparation.
• For shellstock intended for raw consumption,
labeling record that documents the presence of • CONTROL STRATEGY EXAMPLES 2 & 3
the raw consumption warning.
Verification: Review monitoring and corrective
(Note: only the primary processor (the processor that action records within one week of preparation.
harvester) need apply controls relative to the identifi- Enter the verification procedures in Column 10 of the
cation of the harvester, the harvester’s license, the HACCP Plan Form.
approval status of the harvest waters, or the time-of-
harvest to time-of-refrigeration.)
Enter the names of the HACCP records in Column 9

of the HACCP Plan Form.

63
TABLE #4-1
Control Strategy Example 1 - Source control
This table is an example of a portion of a HACCP plan relating to the control of pathogens from the harvest area for a
primary processor (processor that takes possession of the oysters from the harvester) of shellstock oysters (shellstock shipper),
using Control Strategy Example 1 - Source controls. It is provided for illustrative purposes only. Pathogens from the
harvest area may be only one of several significant hazards for this product. Refer to Tables 3-1, 3-2, and 3-3 (Chapter 3)
for other potential hazards (e.g. natural toxins, chemical contaminants, pathogens during processing, and metal fragments).
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
Critical Control Significant Critical Limits Monitoring Corrective Records Verification
Point (CCP) Hazard(s) for each Preventive Action(s)
Measure What How Frequency Who
Receiving - Pathogens from • All incoming • Incoming • Visual • Every sack • Receiving • Reject • Receiving • Review
shellstock harvest area shellstock must be shellstock employee untagged sacks record monitoring
tagged tags and corrective
Se action records
• All shellstock • Harvest site • Visual • Every lot • Receiving • Reject • Receiving within one week
64
must be from on tags employee lots from record of preparation
eT
open waters unapproved
waters
ex
t f Exa
• All shellstock • License of • Visual • Every delivery • Receiving • Reject • Receiving
must be from fisherman employee lots from record
or mp

licensed fishermen.
Fu le unlicensed
ll R O fishermen
• Maximum time • Time of • Harvester’s • Every delivery • Receiving • Reject • Receiving
from harvest to harvest log employee lot record
eco nly
refrigeration: AMMAT
<66°F: 36 hours;
mm
AMMAT 66-80°F: • Time placed in • Visual • Every delivery • Receiving • Discontinue use • Receiving
24 hours; AMMAT en refrigeration employee of supplier until record
>80°F: 20 hours. evidence is
obtained that
da
tio harvesting,
tagging, and/or
labeling practices
ns
have changed
Receiving - Pathogens from • All shellstock labels • Tags for • Visual • Three tags from • Receiving • Reject tags • Receiving • Review
labels harvest area must contain the raw finished product each lot of tags employee record monitoring
consumption warning shellstock and corrective
action records
within one week
of preparation
Chapter 5: Parasites (A Biological Hazard)
Hazard Analysis Worksheet The effectiveness of freezing to kill parasites depends

on several factors, including the temperature of the
STEP #10: UNDERSTAND THE POTENTIAL freezing process, the length of time needed to freeze
HAZARD. the fish tissue, the length of time the fish is held
frozen, the fat content of the fish, and the type of
Parasites (in the larval stage) consumed in uncooked, parasite present. The temperature of the freezing
or undercooked, unfrozen seafood can present a process, the length of time the fish is held frozen, and
human health hazard. Among parasites, the nema- the type of parasite appear to be the most important
todes or roundworms (Anisakis spp., Pseudoterranova factors. For example, tapeworms are more suscep-
spp., Eustrongylides spp. and Gnathostoma spp.), tible to freezing than are roundworms. Flukes appear
cestodes or tapeworms (Diphyllobothrium spp.) to be more resistant than roundworms.
and trematodes or flukes (Chlonorchis sinensis,
Opisthorchis spp., Heterophyes spp., Metagonimus Freezing and storing at -4˚F (-20˚C) or below for 7
spp., Nanophyetes salminicola and Paragonimus days (total time), or freezing at -31˚F (-35˚C) or
spp.) are of most concern in seafood. Some products below until solid and storing at -31˚F (-35˚C) or
that have been implicated in human infection are: below for 15 hours, or freezing at -31˚F (-35˚C) or
ceviche (fish and spices marinated in lime juice); below until solid and storing at -4˚F (-20˚C) or below
lomi lomi (salmon marinated in lemon juice, onion for 24 hours is sufficient to kill parasites. FDA’s Food
and tomato); poisson cru (fish marinated in citrus Code recommends these freezing conditions to
juice, onion, tomato and coconut milk); herring roe; retailers who provide fish intended for raw consumption.
sashimi (slices of raw fish); sushi (pieces of raw fish Note: these conditions may not be suitable for freezing
with rice and other ingredients); green herring particularly large fish (e.g. thicker than six inches).
(lightly brined herring); drunken crabs (crabs mari-
nated in wine and pepper); cold-smoked fish; and, The effectiveness of hydrostatic pressure in the
undercooked grilled fish. A recent survey of U.S. elimination of parasites from fish flesh is being
gastroenterologists has confirmed that seafood-borne studied.
parasitic infections occur in the U.S. with sufficient
frequency to make preventive controls necessary Brining and pickling may reduce the parasite hazard
during the processing of parasite-containing species in a fish, but they do not eliminate it, nor do they
of fish that are intended for raw consumption. minimize it to an acceptable level. Nematode
larvae have been shown to survive 28 days in an
• Controlling parasites 80˚ salinometer brine (21% salt by weight).
The process of heating raw fish sufficiently to kill Fish that contain parasites in their flesh may also
bacterial pathogens is also sufficient to kill parasites. contain parasites within their egg skeins, but gener-
Guidance concerning cooking and pasteurizing to kill ally not within the eggs themselves. For this reason,
pathogens is provided in Chapters 16 and 17. Regu- eggs that have been removed from the skein and
latory requirements for retorting (low acid canned rinsed are not likely to contain parasites.
foods) are contained in 21 CFR 113. This Guide
does not provide further guidance on retorting. Trimming away the belly flaps of fish or candling and
physically removing parasites are effective methods
for reducing the numbers of parasites. However, they
do not completely eliminate the hazard, nor do they
minimize it to an acceptable level.
Continued
Chapter 5: Parasites
65
STEP #11: DETERMINE IF THE HAZARD IS 2. Can the parasite hazard be eliminated or reduced to
SIGNIFICANT. an acceptable level here? (Note: If you are not certain
of the answer to this question at this time, you may
Determine if “parasites” is a significant hazard at answer “No.” However, you may need to change this
each processing step. answer when you assign critical control points in
Step #12.)
1. Is it reasonably likely that parasites will be intro-
duced at the receiving step (e.g. do they come in with Parasites should also be considered a significant
the raw material)? hazard at any processing step where a preventive
measure is or can be used to eliminate (or reduce the
Tables #3-1 and 3-2 (Chapter 3) list those species for likelihood of occurrence to an acceptable level)
which FDA has information that a potential parasite parasites that are reasonably likely to come in with
hazard exists. Ordinarily, you should identify the the raw material. Preventive measures for parasites
receiving step for these species as having a significant can include:
parasite hazard if you will market the fish for con- • Retorting (covered in 21 CFR 113);
sumption without cooking by the end user (e.g. raw). • Cooking (covered in Chapter 16);
• Pasteurizing (covered in Chapter 17);
Species that normally have parasites as a result of • Freezing (covered in this chapter);
consuming infected prey, apparently do not have the • Brining or pickling (not a complete control);
same parasite hazard when raised on pelleted food in • Candling and physical removal
an aquaculture operation. You need not consider (not a complete control);
such aquacultured fish as having a parasite hazard. • Trimming away the belly flap
(not a complete control).
On the other hand, aquacultured fish that are fed
processing waste and by-catch fish may have a List such preventive measures in Column 5 of the
parasite hazard, even when wild caught fish of that Hazard Analysis Worksheet, at the appropriate
species do not normally have a parasite hazard. processing step(s).
Species of fish other than those identified in Tables
#3-1 and 3-2 may have a parasite hazard in certain If the answer to either question 1 or 2 is “Yes” the
localized areas. You should consider this possibility potential hazard is significant at that step in the
in your hazard analysis. process and you should answer “Yes” in Column 3 of
the Hazard Analysis Worksheet. If neither criterion
If the finished product is fish eggs that have been is met you should answer “No.” You should record
removed from the skein and rinsed, it is not reason- the reason for your “Yes” or “No” answer in Column
ably likely that it will contain parasites. You need not 4. You need not complete Steps #12 through 18 for
consider such product as having a parasite hazard. this hazard for those processing steps where you have
However, unrinsed fish eggs or fish eggs that remain recorded a “No.”
in the skein ordinarily will have a parasite hazard if
the species is identified in Tables #3-1 or 3-2 as You should also consider the likelihood that, without
having a parasite hazard. proper controls, parasites would survive your cook-
ing process. Some cooking processes (e.g. retorting)
It is not reasonably likely that parasites will enter the may be exceptionally lethal to parasites, because the
process at other processing steps. process is designed to kill more heat-stable bacterial
pathogens. In such cases, even significant under-
processing would not jeopardize the safety of the
product relative to parasites, and it may not be
necessary to identify “parasites” as a significant
hazard.
66
It is important to note that identifying this hazard as mining whether a processing step is a CCP for
significant at a processing step does not mean that it “parasites”:
must be controlled at that processing step. The next
step will help you determine where the critical control 1. Does the process contain a heating step, such as
point is located. retorting, cooking, or pasteurizing, that is designed to
kill pathogens?
• Intended use
a. If it does, you may identify the heating step as
In determining whether a hazard is significant, you the CCP.
should also consider the intended use of the product,
which you developed in Step #4. If the fish is in- In this case, you should enter “Yes” in Column
tended to be cooked by the consumer before con- 6 of the Hazard Analysis Worksheet for the
sumption, then you do not need to consider the hazard heating step, and enter “No” for the receiving
significant even if the species is listed as having a step. In addition, for the “No” entry, note in
potential parasite hazard in Table #3-1 or 3-2. Simi- Column 5 that the hazard is controlled by the
larly, if you have assurance that the fish will be heating step. (Note: if you have not previously
processed by a subsequent processor, restauranteur or identified “parasites” as a significant hazard at
institutional user (e.g. prison, nursing home) in a way the heating step in Column 3 of the Hazard
that will kill the parasites, you do not need to identify Analysis Worksheet, you should change the
parasites as a significant hazard. entry in Column 3 to “Yes”.) See Chapters 16
(cooking) and 17 (pasteurizing) for further
Example: guidance on this control strategy.
A primary processor receives whole salmon from the
harvest vessel and re-ices the fish for shipment to a Example:
second processor. The primary processor has assur- A hot-smoked salmon processor could set the
ance that the second processor butchers the fish and critical control point for parasites at the hot-
freezes it for the sushi market. The primary processor smoking step, and would not need to identify
would not need to identify parasites as a significant the receiving step as a critical control point for
hazard. this hazard.
It is important to note that, at certain levels in certain b. If the process does not contain a heating step,
species of fish, parasites constitute filth, and, as a you should identify a freezing step as the CCP.
result, cause the fish to be adulterated. See Compli-
ance Policy Guide section 540.590. However, since In this case you should enter “Yes” in Column
these defect action levels relate to a filth issue, 6 of the Hazard Analysis Worksheet for the
preventive controls to assure that they are not ex- freezing step, and enter “No” for the receiving
ceeded need not be included in your HACCP plan. step. In addition, for the “No” entry, note in
Column 5 that the hazard is controlled by the
STEP #12: IDENTIFY THE CRITICAL freezing step. (Note: if you have not previously
CONTROL POINTS (CCP). identified “parasites” as a significant hazard at
the freezing step in Column 3 of the Hazard
For each processing step where “parasites” is identi- Analysis Worksheet, you should change the
fied in Column 3 of the Hazard Analysis Worksheet as entry in Column 3 to “Yes”.) This control
a significant hazard, determine whether it is necessary approach will be referred to as “Control
to exercise control at that step in order to control the Strategy Example 1” in Steps #14 through 18.
hazard. Figure #A-2 (Appendix 3) is a CCP decision
tree that can be used to aid you in your determination.
The following guidance will also assist you in deter-

Continued
67
Example: • CONTROL STRATEGY EXAMPLE 1 - FREEZING
A salmon processor that sells the finished
product for raw consumption should identify a Critical Limit: Freezing and storing at -4˚F (-20˚C) or
freezing step as the CCP for parasites. The below for 7 days (total time);
processor would not need to identify the OR
receiving step as a critical control point for Freezing at -31˚F (-35˚C) or below until solid
this hazard. and storing at -31˚F (-35˚C) or below for 15
hours;
It is important to note that you may select a OR
control strategy that is different from that Freezing at -31˚F (-35˚C) or below until solid
which is suggested above, provided that it and storing at -4˚F (-20˚C) or below for 24 hours.
assures an equivalent degree of safety of the
product. Note: these conditions may not be suitable for freezing
particularly large fish (e.g. thicker than six inches).
Proceed to Step #13 (Chapter 2) or to Step #10 of the
next potential hazard. Enter the critical limit(s) in Column 3 of the HACCP
Plan Form.
HACCP Plan Form STEP #15: ESTABLISH MONITORING

PROCEDURES.
STEP #14: SET THE CRITICAL LIMITS (CL).
For each processing step where “parasites” is identi-
For each processing step where “parasites” is identified as a significant hazard on the HACCP Plan
fied as a significant hazard on the HACCP Plan Form Form, describe monitoring procedures that will
identify the maximum or minimum value to which a ensure that the critical limits are consistently met.
feature of the process must be controlled in order to
control the hazard. To fully describe your monitoring program you
should answer four questions: 1) What will be
You should set the CL at the point that if not met the monitored? 2) How will it be monitored? 3) How
safety of the product will be questionable. If you set often will it be monitored (frequency)? 4) Who will
a more restrictive CL you could, as a result, be perform the monitoring?
required to take corrective action when no safety
concern actually exists. On the other hand, if you set It is important for you to keep in mind that the
a CL that is too loose you could, as a result, allow feature of the process that you monitor and the
unsafe product to reach the consumer. method of monitoring should enable you to deter-
mine whether the CL is being met. That is, the
As a practical matter it may be advisable to set an monitoring process should directly measure the
operating limit that is more restrictive than the CL. feature for which you have established a CL.
In this way you can adjust the process when the
operating limit is triggered, but before a triggering of You should monitor often enough so that the normal
the CL would require you to take corrective action. variability in the values you are measuring will be
You should set operating limits based on your detected. This is especially true if these values are
experience with the variability of your operation and typically close to the CL. Additionally, the greater
with the closeness of typical operating values to the the time span between measurements the more
CL. product you are putting at risk should a measurement
control strategy example discussed in Step #12.
68
Following is guidance on establishing monitoring Who Will Perform the Monitoring?
procedures for the control strategy example discussed
in Step #12. Note that the monitoring frequencies • CONTROL STRATEGY EXAMPLE 1 - FREEZING
that are provided are intended to be considered as
minimum recommendations, and may not be ad- Who: Monitoring may be performed by the freezer
equate in all cases. operator, a production supervisor, a member of
the quality control staff, or any other person who
has an understanding of the monitoring device
What Will Be Monitored? and the critical limit.
• CONTROL STRATEGY EXAMPLE 1 - FREEZING STEP #16: ESTABLISH CORRECTIVE

ACTION PROCEDURES.
What: Freezer temperature;
AND For each processing step where “parasites” is identi-
Length of time fish is held at freezer temperature fied as a significant hazard on the HACCP Plan
or held frozen, as appropriate. Form, describe the procedures that you will use when
your monitoring indicates that the CL has not been
How Will Monitoring Be Done? met.
• CONTROL STRATEGY EXAMPLE 1 - FREEZING These procedures should: 1) ensure that unsafe
How: Use a recording thermometer, digital the problem that caused the CL deviation. Remem-
time/temperature data logger, or similar device; ber that deviations from operating limits do not need
AND to result in formal corrective actions.
Visual check on time and solid frozen condition,
as appropriate. Following is guidance on establishing corrective
action procedures for the control strategy example
How Often Will Monitoring Be Done
(Frequency)? • CONTROL STRATEGY EXAMPLE 1 - FREEZING
• CONTROL STRATEGY EXAMPLE 1 - FREEZING Corrective Action: Take one or more of the
following actions as necessary to regain control
For temperature: over the operation after a critical limit deviation:
• Make repairs or adjustments to the freezer;
Frequency: Continuous monitoring, with visual OR
check at least once during the cycle, but no less • Move some or all of the product in the freezer
than once per day. to another freezer;
AND
For time: Refreeze and store the product at -4˚F (-20˚C)
or below for 7 days (total time), or refreeze
Frequency: Start and end of each freezing cycle; at -31˚F (-35˚C) or below until solid and store
OR at -31˚F (-35˚C) or below for 15 hours, or
Time when fish is solid frozen and end of refreeze at -31˚F (-35˚C) or below until solid and
freezing cycle for each freezing cycle. store at -4˚F (-20˚C) or below for 24 hours.
Note: these conditions may not be suitable for freezing

particularly large fish (e.g. thicker than six inches).
Continued
69
STEP #17: ESTABLISH A RECORDKEEPING STEP #18: ESTABLISH VERIFICATION
SYSTEM. PROCEDURES.
For each processing step where “parasites” is identi- For each processing step where “parasites” is identi-
fied as a significant hazard on the HACCP Plan fied as a significant hazard on the HACCP Plan
Form, list the records that will be used to document Form, establish verification procedures that will
the monitoring procedures discussed in Step #15. ensure that the HACCP plan is: 1) adequate to
The records should clearly demonstrate that the address the hazard of “parasites”; and, 2) consistently
monitoring procedures have been followed, and being followed.
should contain the actual values and observations
obtained during monitoring. Following is guidance on establishing verification
Following is guidance on establishing a record in Step #12.
keeping system for the control strategy example
discussed in Step #12. • CONTROL STRATEGY EXAMPLE 1 - FREEZING
• CONTROL STRATEGY EXAMPLE 1 - FREEZING Verification: When digital time/temperature data

loggers, or recorder thermometers are used for
Records: Temperature recorder chart, digital time/ monitoring, check for accuracy against a known
temperature data logger printout, with notations accurate thermometer (NIST-traceable) at least
for start and end of freezing cycle or time when once per day;
fish is solid frozen and end of freezing cycle, as AND
appropriate. Review monitoring, corrective action and
verification records within one week of
preparation.
Enter the verification procedures in Column 10 of the

HACCP Plan Form.
70
TABLE #5-1
Control Strategy Example 1 - Freezing
This table is an example of a portion of a HACCP plan relating to the control of parasites for a processor of
frozen salmon fillets with pin bones removed, where the finished product is distributed to other processors for the production
of lox, using Control Strategy Example 1 - Freezing. It is provided for illustrative purposes only. Parasites may be only one
of several significant hazards for this product. Refer to Tables 3-1, 3-2, and 3-3 (Chapter 3) for other potential hazards
(e.g. chemical contaminants, aquaculture drugs, food and color additives, and metal fragments).
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
Freezing Parasites Freeze at -31˚F or • Temperature of • Recorder • Continuous, • Freezer operator • Adjust freezer • Recorder chart • Review
below until solid and hold blast freezer and themometers with visual with notations monitoring,
at -4˚F or below for storage freezer check at end of • Refreeze product for solid frozen corrective
24 hours
Se each freezing and end of action and
71
cycle each cycle verification
records within
eT
ex one week of
preparation
• Length of time • Visual check of • When fish is • Freezer operator • Same
t f Exa
held frozen when first solid frozen and • Check the
or mp
Fu le fish is solid at end of each accuracy of
frozen and at end freezing cycle the temperature
of freezing cycle recording
ll R O
eco nly devices daily
mm
en
da
tio
ns
Notes:
72
Chapter 6: Natural Toxins (A Chemical Hazard)
Hazard Analysis Worksheet eaten, the viscera of lobster and crabs are. However, the
levels of PSP toxin that are found in lobster tomale are
STEP #10: UNDERSTAND THE POTENTIAL not likely to pose a health hazard unless large quantities
HAZARD. are eaten from a heavily contaminated area.
Contamination of fish with natural toxins from the Neurotoxic shellfish poisoning in the U.S. is gener-
harvest area can cause consumer illness. Most of ally associated with the consumption of molluscan
these toxins are produced by species of naturally shellfish harvested along the coast of the Gulf of
occurring marine algae (phytoplankton). They Mexico, and, sporadically, along the southern Atlan-
accumulate in fish when they feed on the algae or tic coast. There has been a significant occurrence of
on other fish that have fed on the algae. There are toxins similar to NSP in New Zealand, and some
also a few natural toxins which are naturally occur- suggestions of occurrence elsewhere.
ring in certain species of fish.
Diarrhetic shellfish poisoning is generally associated
There are five recognized fish poisoning syndromes with the consumption of molluscan shellfish. There
in the United States: paralytic shellfish poisoning has been no documented occurrence to date in the
(PSP), neurotoxic shellfish poisoning (NSP), U.S. However, instances have been documented in
diarrhetic shellfish poisoning (DSP), amnesic shell- Japan, southeast Asia, Scandinavia, western Europe,
fish poisoning (ASP), and ciguatera fish poisoning Chile, New Zealand, and eastern Canada.
(CFP). Scombrotoxin formation, the subject of
Chapter 7, is not considered a natural toxin. Amnesic shellfish poisoning is generally associated
with the consumption of molluscan shellfish from the
• Species involved northeast and northwest coasts of North America. It
has not yet been a problem in the Gulf of Mexico,
This section will provide information about species although the algae that produces the toxin has been
and geographic areas which have been linked to one found there. ASP toxin has recently been identified
of the five fish poisoning syndromes by historical as a problem in the viscera of Dungeness crab, tanner
occurrence of the syndrome. However, it is impor- crab, red rock crab, and anchovies along the west
tant to note that historical occurrence may be an coast of the United States. The viscera of anchovies
inadequate guide to future occurrence in the case of are also eaten.
natural toxins, since the source algae vary in their
distribution. Processors need to be alert to the Marine toxins are not ordinarily a problem in scal-
lops if only the adductor muscle is consumed.
potential for emerging problems.
However, products such as roe-on scallops and whole
Paralytic shellfish poisoning in the U.S. is generally scallops do present a potential hazard for natural
toxins.
associated with the consumption of molluscan
shellfish from the northeast and northwest coastal Ciguatera toxin is carried to humans by contaminated
regions of the U.S. PSP in other parts of the world fin fish from the extreme southeastern U.S., Hawaii,
has been associated with molluscan shellfish from and subtropical and tropical areas worldwide. In the
environments ranging from tropical to temperate south Florida, Bahamian, and Caribbean regions,
waters. In addition, in the U.S., PSP toxin has barracuda, amberjack, horse-eye jack, black jack,
recently been reported from the viscera of mackerel, other large species of jack, king mackerel, large
lobster, Dungeness crabs, tanner crabs, and red rock groupers, and snappers are particularly likely to
crabs. While the viscera of mackerel are not normally contain ciguatoxin. These species are not generally
Continued
Chapter 6: Natural Toxins
73
associated with ciguatera in the northern Gulf of Significant elements of Shellfish Control Authorities’
Mexico. Many other species of large fish-eating efforts to control the harvesting of molluscan shell-
fishes may be suspect. In Hawaii and throughout the fish include: 1) a requirement that containers of in-
central Pacific, barracuda, amberjack, and snapper shell molluscan shellfish (shellstock) bear a tag that
are frequently ciguatoxic, and many other species identifies the type and quantity of shellfish, harvester,
both large and small are suspect. Mackerel and harvest location, and date of harvest; 2) a requirement
barracuda are frequently ciguatoxic from mid to that molluscan shellfish harvesters be licensed; 3) a
northeastern Australian waters. requirement that processors that shuck molluscan
shellfish or ship, reship, or repack the shucked product
• Natural toxin detection be certified; and, 4) a requirement that containers of
shucked molluscan shellfish bear a label with the
FDA has established action levels for all of the processor’s name, address, and certification number.
natural toxins except CFP.
• PSP- 0.8 ppm (80ug/100g) saxitoxin equivalent; An established water classification system similar to
• NSP- 0.8 ppm (20 mouse units/100g) brevetoxin-2 the molluscan shellfish system is not in place for
equivalent; controlling CFP in fin fish. However, some states
• DSP- 0.2 ppm okadaic acid plus 35-methyl okadaic issue advisories regarding reefs that are known to be
acid (DXT 1); toxic. In areas where there is no such advisory
• ASP- 20 ppm domoic acid, except in the viscera of system, fishermen and processors must depend on
Dungeness crab, where 30 ppm is permitted. first-hand knowledge about the safety of the reefs
from which they obtain fish.
There are no validated, rapid methods that are
suitable for shipboard, dockside, or commercial Where PSP or ASP have become a problem in fin fish
testing of lots of fish for any of these toxins. or crustaceans, states generally have closed or restricted
the appropriate fisheries. In addition, removal and
• Natural toxin control destruction of the viscera will eliminate the hazard.
Natural toxins cannot be reliably eliminated by heat. • Escolar, puffer fish, and whelk
However, severe heating processes, such as retorting,
may be effective at reducing the levels of some There are naturally occurring toxins in some species
natural toxins. that do not involve marine algae. Escolar or oilfish
(i.e. Lepidocybium flavobrunneum, Ruvettus pretiosus)
To minimize the risk of molluscan shellfish contain- contains a strong purgative oil, called gempylotoxin,
ing natural toxins from the harvest area, State and that may cause diarrhea when consumed. FDA
foreign government agencies, called Shellfish advises against importation and interstate marketing
Control Authorities, classify waters in which mollus- of these fish.
can shellfish are found, based, in part, on the pres-
ence of natural toxins. As a result of these classifica- Puffer fish, or fugu, may contain tetrodotoxin.
tions, molluscan shellfish harvesting is allowed from Poisonings from tetrodotoxin have usually been
some waters, not from others, and only at certain associated with the consumption of puffer fish from
times, or under certain conditions, from others. waters of the Indo-Pacific ocean regions. However,
Shellfish Control Authorities then exercise control several reported cases of poisonings, including
over the molluscan shellfish harvesters to ensure that fatalities, involved puffer fish from the Atlantic
harvesting takes place only when and where it has Ocean, Gulf of Mexico, and Gulf of California.
been permitted. Molluscan shellfish include oysters, There have been no confirmed cases of poisonings
clams, mussels, and scallops, except where the from Spheroides maculatus but there is still reason
scallop product contains the shucked adductor for concern.
muscle only.

74
Tetramine is a toxin that is found in the salivary “Natural toxins” should also be considered a signifi-
glands of Neptunia spp., a type of whelk. The hazard cant hazard at any processing step where a preventive
can be controlled by removing the glands. measure is or can be used to eliminate (or is adequate
to reduce the likelihood of occurrence to an accept-
FDA makes no recommendations in this Guide and able level) unsafe levels of natural toxins that are
has no specific expectations with regard to controls reasonably likely to come in with the raw material.
for tetrodotoxin or tetramine in processors’ HACCP Preventive measures for “natural toxins” can include:
plans. • Making sure that incoming fish have not been
caught in an area that has been closed because of a
STEP #11: DETERMINE IF THE natural toxin problem;
POTENTIAL HAZARD IS SIGNIFICANT. • Making sure that incoming fin fish have not been
caught in an area for which there is a CFP advisory
At each processing step, determine whether “natural or for which you have knowledge there is a CFP
toxins” is a significant hazard. The criteria are: problem;
• Checking incoming molluscan shellfish to ensure
1. Is it reasonably likely that unsafe levels of that they are properly tagged or labeled;
natural toxins will be introduced here (e.g. does it • Making sure that incoming molluscan shellfish are
come in on the raw material at an unsafe level)? supplied by a licensed harvester (where licensing is
required by law) or by a certified dealer.
Tables #3-1 and 3-2 (Chapter 3) identify the species
of fish for which natural toxins is known to be a List such preventive measures in Column 5 of the
potential hazard. Under ordinary circumstances, it Hazard Analysis Worksheet at the appropriate
would be reasonably likely to expect that, without processing step(s).
proper controls, natural toxins from the harvest area
could enter the process at unsafe levels at the receiv- If the answer to either question 1 or 2 is “Yes” the
ing step from those species. There may be circum- potential hazard is significant at the receiving step
stances in your geographic area that would allow you and you should answer “Yes” in Column 3 of the
to conclude that it is not reasonably likely for a Hazard Analysis Worksheet. If neither criterion is
particular natural toxin to occur at unsafe levels in met you should answer “No.” You should record the
fish from your area. You should be guided by the reason for your “Yes” or “No” answer in Column 4.
historical occurrence of the toxin, at levels above the You need not complete Steps #12 through 18 for this
established guidance levels, in your geographic area. hazard for those processing steps where you have
However, you should remain alert to the potential for recorded a “No.”
emerging problems.
It is important to note that identifying this hazard as
If you are receiving fish, other than molluscan significant at a processing step does not mean that it
shellfish, from another processor you should not need must be controlled at that processing step. The next
to identify “natural toxins” as a significant hazard. step will help you determine where in the process the
This hazard should have been fully controlled by the critical control point is located.
primary (first) processor.
2. Can natural toxins which were introduced at unsafe

levels at an earlier step be eliminated or reduced to an
acceptable level here? (Note: If you are not certain of
the answer to this question at this time, you may
answer “No.” However, you may need to change this
answer when you assign critical control points in
Step #12).
Continued
75
• Intended use 18. Note that this control strategy is identical to
Control Strategy Example 1 for “pathogens from the
In determining whether a hazard is significant you harvest area” (Chapter 4) and Control Strategy
should also consider the intended use of the product, Example 6 for “environmental chemical contaminants
which you developed in Step #4. However, in most and pesticides” (Chapter 9). If you choose an identi-
cases, it is not likely that the significance of this cal control strategy for two or more of these hazards,
hazard will be affected by the intended use of the you may combine the hazards in the HACCP Plan
product. One exception is with products in which Form.
only the muscle tissue will be consumed. For ex-
ample, where the finished product is only the shucked It is important to note that you may select a control
adductor muscle of the scallop, or the muscle tissue strategy that is different from that which is suggested
of a crab or finfish, it is reasonable to assume that the above, provided that it assures an equivalent degree of
product as consumed will not contain natural toxins. safety of the product.
Similarly, in species, such as mackerel, in which the
viscera is not normally consumed, it is reasonable to Proceed to Step #13 (Chapter 2) or to Step #10 of the
assume that the product as consumed will not contain next potential hazard.
natural toxins. In either case you should then enter
“No” in Column 3 of the Hazard Analysis Worksheet
for each of the processing steps. For each “No” entry HACCP Plan Form
briefly explain in Column 4 that the product is
consumed without the viscera. In this case, you need STEP #14: SET THE CRITICAL LIMITS (CL).
not complete Steps #12 through 18 for this hazard.
For each processing step where “natural toxins” is
STEP #12: IDENTIFY THE CRITICAL identified as a significant hazard on the HACCP Plan
CONTROL POINTS (CCP). Form identify the maximum or minimum value to
which a feature of the process must be controlled in
For each processing step where “natural toxins” is order to control the hazard.
identified in Column 3 of the Hazard Analysis
Worksheet as a significant hazard, determine whether You should set the CL at the point that if not met the
it is necessary to exercise control at that step in order safety of the product will be questionable. If you set a
to control the hazard. Figure #A-2 (Appendix 3) is a more restrictive CL you could, as a result, be required
CCP decision tree that can be used to aid you in your to take corrective action when no safety concern
determination. actually exists. On the other hand, if you set a CL that
is too loose you could, as a result, allow unsafe
The following guidance will also assist you in product to reach the consumer.
determining whether a processing step is a CCP for
“natural toxins”: As a practical matter it may be advisable to set an
operating limit that is more restrictive than the CL. In
1. Where preventive measures, such as those described this way you can adjust the process when the operat-
in Step #11 are available to you, the hazard of ing limit is triggered, but before a triggering of the CL
“natural toxins” can best be controlled at the receiving would require you to take corrective action. You
step. should set operating limits based on your experience
with the variability of your operation and with the
In these cases, you should enter “Yes” in Column 6 closeness of typical operating values to the CL.
of the Hazard Analysis Worksheet for the receiving
step. This control approach will be referred to as Following is guidance on setting critical limits for the
“Control Strategy Example 1” in Steps #14 through control strategy example discussed in Step #12.

76
• CONTROL STRATEGY EXAMPLE 1 - (Note: only the primary processor [the processor
SOURCE CONTROL that takes possession of the molluscan shellfish
from the harvester] need apply controls relative
Critical Limit: No fish may be harvested from: to the identification of the harvester, the
• An area that is closed to fishing by foreign, harvester’s license, or the approval status of the
federal, state, or local authorities; harvest waters.)
OR
• An area that is the subject of a CFP advisory; Enter the critical limit(s) in Column 3 of the HACCP
OR Plan Form.
• An area for which you have knowledge that
there is a CFP problem; STEP #15: ESTABLISH MONITORING
AND PROCEDURES.
All shellstock (in-shell molluscan shellfish) must
bear a tag that discloses the date and place they For each processing step where “natural toxins” is
were harvested (by State and site), type and identified as a significant hazard on the HACCP Plan
quantity of shellfish, and by whom they were Form, describe monitoring procedures that will
harvested (i.e., the identification number ensure that the critical limits are consistently met.
assigned to the harvester by the shellfish control
authority, where applicable or, if such To fully describe your monitoring program you
identification numbers are not assigned, the name should answer four questions: 1) What will be
of the harvester or the name or registration monitored? 2) How will it be monitored? 3) How
number of the harvester’s vessel). For bulk often will it be monitored (frequency)? 4) Who will
shipments of shellstock (loose shellstock), the perform the monitoring?
shellstock must be accompanied by a bill of
lading or other similar shipping document that It is important for you to keep in mind that the
contains the same information. feature of the process that you monitor and the
AND method of monitoring should enable you to deter-
All molluscan shellfish must have been harvested mine whether the CL is being met. That is, the
from waters authorized for harvesting by a monitoring process should directly measure the
shellfish control authority. For U.S. Federal feature for which you have established a CL.
waters, no molluscan shellfish may be harvested
from waters that are closed to harvesting by an You should monitor often enough so that the normal
agency of the federal government. variability in the values you are measuring will be
AND detected. This is especially true if these values are
All containers of shucked molluscan shellfish typically close to the CL. Additionally, the greater
must bear a label that identifies the name, the time span between measurements the more
address, and certification number of the packer product you are putting at risk should a measurement
or repacker of the product. show that a CL has been violated.
AND
All molluscan shellfish must be from a harvester Following is guidance on establishing monitoring
that is licensed as required (note that licensing procedures for the control strategy example dis-
may not be required in all jurisdictions) or from a cussed in Step #12. Note that the monitoring fre-
processor that is certified by a shellfish control quencies that are provided are intended to be consid-
authority. ered as minimum recommendations, and may not be
Continued
77
What Will Be Monitored? How Often Will Monitoring Be Done
(Frequency)?
SOURCE CONTROL • CONTROL STRATEGY EXAMPLE 1 -
SOURCE CONTROL
For molluscan shellfish:
For Molluscan Shellfish:
What:
• The tags on containers of shellstock. The Bill Frequency:
of Lading or other similar shipping document • For checking tags: every container;
accompanying bulk shipments of shellstock; AND
AND • For checking harvest site: every lot;
• The harvest site listed on the tag or on the Bill AND
of Lading or other similar shipping document; • For checking labels: at least three containers
AND randomly selected from throughout every lot;
• The labels on containers of shucked molluscan AND
shellfish; • For checking licenses: every delivery;
AND AND
• The license of fishermen, where applicable; • For checking certification numbers: every
AND delivery.
• The certification number of suppliers (other
than fishermen) of shellstock or shucked For other fish:
molluscan shellfish;
Frequency: Every lot of fish received.
For other fish:
What: The harvest area location. Who Will Perform the Monitoring?

How Will Monitoring Be Done? SOURCE CONTROL
• CONTROL STRATEGY EXAMPLE 1 - Who: Monitoring may be performed by a receiving

SOURCE CONTROL or production employee or supervisor, a member
of the quality control staff, or any other person
For molluscan shellfish: who has an understanding of the nature of the
controls.
How: Make visual checks;
(Note: only the primary processor [the processor
For other fish: that takes possession of the molluscan shellfish
from the harvester] need apply controls relative
How: Ask the harvester for the harvest site at the time to the identification of the harvester, the
of receipt, or obtain the information from the harvester’s license, or the approval status of the
harvester’s catch record, where applicable. harvest waters.)
Enter the “What,” “How,” “Frequency,” and “Who”

monitoring information in Columns 4, 5, 6, and 7,
respectively, of the HACCP Plan Form.

78
STEP #16: ESTABLISH CORRECTIVE Note: If an incoming lot that fails to meet a receiving
ACTION PROCEDURES. critical limit is mistakenly accepted, and the error is
later detected, the following actions should be taken:
For each processing step where “natural toxins” is 1) the lot and any products processed from that lot
identified as a significant hazard on the HACCP Plan should be destroyed, diverted to a nonfood use or to a
Form, describe the procedures that you will use when use in which the critical limit is not applicable, or
your monitoring indicates that the CL has not been met. placed on hold until a food safety evaluation can be
completed; and 2) any products processed from that
These procedures should: 1) ensure that unsafe lot that have already been distributed should be
product does not reach the consumer; and, 2) correct recalled and subjected to the actions described above.
the problem that caused the CL deviation. Remem-
ber that deviations from operating limits do not need (Note: only the primary processor [the processor
to result in formal corrective actions. that takes possession of the molluscan shellfish from
the harvester] need apply controls relative to the
Following is guidance on establishing corrective identification of the harvester, the harvester’s license,
action procedures for the control strategy example or the approval status of the harvest waters.)
For other fish that fail to meet the CL:
SOURCE CONTROL Corrective Action: Reject the lot;
AND
For molluscan shellfish: • Discontinue use of supplier until evidence is
obtained that harvesting practices have
Corrective Action: changed.
• Reject shellstock that is not properly tagged or
is not accompanied by a proper shipping Enter the corrective action procedures in Column 8 of
document; the HACCP Plan Form.
AND
• Reject shucked molluscan shellfish that is not STEP #17: ESTABLISH A RECORDKEEPING
properly labeled; SYSTEM.
AND
• Reject molluscan shellfish that has been For each processing step where “natural toxins” is
harvested from unapproved waters; identified as a significant hazard on the HACCP Plan
AND Form, list the records that will be used to document
• Reject molluscan shellfish that is not from a the accomplishment of the monitoring procedures
licensed harvester or certified processor; discussed in Step #15. The records should clearly
AND demonstrate that the monitoring procedures have
• Discontinue use of supplier until evidence is been followed, and should contain the actual values
obtained that harvesting, tagging, and/or and observations obtained during monitoring.
labeling practices have changed.
Following is guidance on establishing a
recordkeeping system for the control strategy ex-
ample discussed in Step #12.

79
• CONTROL STRATEGY EXAMPLE 1 - STEP #18: ESTABLISH VERIFICATION
SOURCE CONTROLS PROCEDURES.
For molluscan shellfish shellstock: For each processing step where “natural toxins” are
identified as a significant hazard on the HACCP Plan
Records: A receiving record that documents: Form, establish verification procedures that will
• Date of harvest; ensure that the HACCP plan is: 1) adequate to
AND address the hazard of “natural toxins”; and, 2)
• Location of harvest by State and site; consistently being followed.
AND
• Quantity and type of shellfish; Following is guidance on establishing verification
AND procedures for the control strategy example discussed
• Name of the harvester, name or registration in Step #12.
number of the harvester’s vessel, or an
identification number issued to the harvester • CONTROL STRATEGY EXAMPLE 1 -
by the shellfish control authority; SOURCE CONTROL
AND
• Number and date of expiration of the Verification: Review monitoring and corrective
harvester’s license, where applicable; action records within one week of preparation.
AND
• Certification number of the shipper, where Enter the verification procedures in Column 10 of the
applicable. HACCP Plan Form.
(Note: only the primary processor [the processor

that takes possession of the molluscan shellfish from
the harvester] need apply controls relative to the
identification of the harvester, the harvester’s license,
or the approval status of the harvest waters.)
For shucked molluscan shellfish:
Records: Receiving record that documents:

• Date of receipt;
AND
AND
• Name and certification number of the packer or
repacker.
For other fish:
Records: Receiving record that documents the harvest

area.


80
TABLE #6-1
This table is an example of a portion of a HACCP plan relating to the control of natural toxins for a fish processor
in Hawaii that receives locally harvested barracuda, using Control Strategy Example 1 - Source control.
It is provided for illustrative purposes only. Natural toxins may be only one of several significant hazards for this product.
Refer to Tables 3-1, 3-2, and 3-3 (Chapter 3) for other potential hazards (e.g. chemical contaminants).
Table #4-1 (Chapter 4) provides guidance for source controls for molluscan shellfish.
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
Receiving - Natural toxins - CFP No fish may be harvested Identify harvest Ask fishermen Every lot Receiving Reject lot Receiving record Review
fresh fish from an area that is area for the harvest employee monitoring
covered by a State CFP location and corrective
advisory, or for which
Se Discontinue use action records
81
there is information from of supplier until within one week
fishermen, news media, evidence is obtained of preparation
eT
academia, or other
ex that harvesting
sources that there is a practices have
current CFP problem. changed
t f Exa

or mp
Fu le
ll R O
eco nly
mm
en
da
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ns
Notes:

82
Chapter 7: Scombrotoxin (Histamine) Formation (A Chemical Hazard)
Hazard Analysis Worksheet Once the enzyme histidine decarboxylase has been
formed, it can continue to produce histamine in the
STEP #10: UNDERSTAND THE POTENTIAL fish even if the bacteria are not active. The enzyme
HAZARD. can be active at or near refrigeration temperatures.
The enzyme is likely to remain stable while in the
Scombrotoxin formation as a result of time/tempera- frozen state and may be reactivated very rapidly after
ture abuse of certain species of fish can cause con- thawing.
sumer illness. The illness is most closely linked to
the development of histamine in these fish. In most Freezing may inactivate the enzyme-forming bacteria.
cases histamine levels in illness-causing fish have Both the enzyme and the bacteria can be inactivated
been above 200 ppm, often above 500 ppm. How- by cooking. However, once histamine is formed, it
ever, there is some evidence that other chemicals cannot be eliminated by heat (including retorting) or
(e.g. biogenic amines, such as putrescine and cadav- freezing. After cooking, recontamination of the fish
erine) may also play a role in the illness. The with the enzyme-forming bacteria is necessary for
possible role of these chemicals in consumer illness additional histamine to form. For these reasons,
is discussed in Chapter 8. histamine development is more likely in raw, unfro-
zen fish.
Scombroid poisonings have primarily been associ-
ated with the consumption of tuna, mahi mahi, and The kinds of bacteria that are associated with hista-
bluefish. However, Table #3-1 (Chapter 3) lists a mine development are commonly present in the salt
number of species that are also capable of developing water environment. They naturally exist on the gills
elevated levels of histamine when temperature and in the gut of live, salt water fish, with no harm to
abused. the fish. Upon death, the defense mechanisms of the
fish no longer inhibit bacterial growth, and histamine-
• Scombrotoxin formation forming bacteria start to grow and produce histamine.
Evisceration and removal of the gills in a sanitary
Certain bacteria produce the enzyme histidine manner may reduce, but not eliminate, the number of
decarboxylase during growth. This enzyme reacts histamine-forming bacteria. However, when done
with free histidine, a naturally occurring chemical under insanitary conditions, these steps may acceler-
that is present in larger quantities in some fish than in ate the process of histamine development in the edible
others. The result is the formation of histamine. portions of the fish by spreading the bacteria to the
flesh of the fish.
Histamine-forming bacteria are capable of growing
and producing histamine over a wide temperature With some harvesting practices, such as long lining,
range. Growth is more rapid, however, at high-abuse death can occur before the fish is removed from the
temperatures (e.g. 70˚F [21.1˚C]) than at moderate- water. Under the worst conditions histamine forma-
abuse temperatures (e.g. 45˚F [7.2˚C]). Growth is tion can already be underway before the fish is landed
particularly rapid at temperatures near 90˚F (32.2˚C). on the vessel. This condition can be aggravated when
Histamine is more commonly the result of high the fish is allowed to remain on the line for a period
temperature spoilage than of long term, relatively low of time after death, a situation that in certain tuna
temperature spoilage. Nonetheless, there are a species may cause its internal temperature to increase
number of opportunities for histamine to form under to a more favorable growth range for the enzyme-
more moderate abuse temperature conditions. forming bacteria.
Continued
Chapter 7: Histamine
83
The potential for histamine formation is increased The time required to lower the internal temperature
when the flesh of the fish is directly exposed to the of fish after capture will be dependent upon a number
enzyme-forming bacteria. This occurs when the fish of factors, including:
are processed (e.g. butchering or filleting).
• The harvest method;
At least some of the histamine-forming bacteria are - Delays in removing fish from a long line may
halotolerant (salt-tolerant) or halophilic (salt-loving). significantly limit the amount of time left for
This causes some salted and smoked fish products chilling and may allow some fish to heat up after
produced from scombrotoxin-forming species to death;
continue to be suspect for histamine development. - The quantity of fish landed in a purse seine or on
Further, a number of the histamine-forming bacteria a long line may exceed a vessel’s ability to
are facultative anaerobes that can grow in reduced rapidly chill the product;
oxygen environments. • The size of the fish;
• The chilling method;
• Controlling scombrotoxin formation - Ice alone takes longer to chill fish than does an ice
slurry or recirculated refrigerated sea water or
Rapid chilling of fish immediately after death is the brine, a consequence of reduced contact area and
most important element in any strategy for preventing heat transfer;
the formation of scombrotoxin, especially for fish - The quantity of ice or ice slurry and the capacity
that are exposed to warmer waters or air, and for of refrigerated sea water or brine systems must
large tuna that generate heat in the tissues of the fish be suitable for the quantity of catch.
following death. It is recommended that:
Once chilled, the fish should be maintained as close
• Generally, fish should be placed in ice or in as possible to the freezing point (or held frozen) until
refrigerated seawater or brine at 40˚F (4.4˚C) or it is consumed. Exposure to ambient temperature
less within 12 hours of death, or placed in should be minimized. The allowable exposure time is
refrigerated seawater or brine at 50˚F (10˚C) or less dependent primarily upon the speed with which the
within 9 hours of death; fish were chilled on-board the harvest vessel and
• Fish exposed to air or water temperatures above whether the fish has been previously frozen (e.g. on-
83˚F (28.3˚C), or large tuna (i.e., above 20 lbs.) board the harvest vessel).
that are eviscerated before on-board chilling, should
be placed in ice (including packing the belly Unfrozen scombrotoxin-forming fish has a safe shelf-
cavity of large tuna with ice) or in refrigerated life (days before elevated levels of histamine are
seawater or brine at 40˚F (4.4˚C) or less within 6 formed) that is dependent upon the harvest methods,
hours of death; the on-board handling, and the time/temperature
• Large tuna (i.e., above 20 lbs.) that are not exposures throughout processing, transit, and storage.
eviscerated before on-board chilling should be This safe shelf-life can be as little as 5 to 7 days for
chilled to an internal temperature of 50˚F (10˚C) or product stored at 40˚F (4.4˚C).
less within 6 hours of death.
Any exposure time above 40˚F (4.4˚C) significantly
This will prevent the rapid formation of the enzyme reduces the expected safe shelf-life. For this reason,
histidine decarboxylase. Once this enzyme is formed, fish that have not been previously frozen should not
control of the hazard is unlikely. be exposed to temperatures above 40˚F (4.4C) for
more than 4 hours, cumulatively, if any portion of that
Further chilling towards the freezing point is also time is at temperatures above 70˚F (21˚C); or the fish
desirable to safe-guard against longer-term, low- should not be exposed to ambient temperatures above
temperature development of histamine. Additionally, 40˚F (4.4˚C) for more than 8 hours, cumulatively, as
the shelf-life of the fish is significantly compromised long as no portion of that time is at tempera
when product temperature is not rapidly dropped to
near freezing.
84
tures above 70˚F (21˚C) after chilling on board the alone will not normally provide adequate assurance
harvest vessel. The safety of these limits is dependent that the hazard has been controlled. Because hista-
upon proper handling at sea. mine is generally not uniformly distributed in a
decomposed fish, a guidance level of 50 ppm has
Fish that have been previously frozen can safely been set. If 50 ppm is found in one section, there is
withstand considerably more exposure to elevated the possibility that other sections may exceed 500 ppm.
temperatures during post-harvest handling. Such fish
should not be exposed to temperatures above 40˚F Observations for the presence of honeycombing in
(4.4C) for more than 12 hours, cumulatively, if any precooked tuna loins intended for canning is also a
portion of that time is at temperatures above 70˚F valuable means of screening for fish that have been
(21˚C); or the fish should not be exposed to ambient exposed to the kinds of temperature abuse that can
temperatures above 40˚F (4.4˚C) for more than 24 lead to histamine development. Any fish that demon-
hours, cumulatively, as long as no portion of that time strate the trait should be destroyed.
is at temperatures above 70˚F (21˚C), after chilling on
board the harvest vessel. The safety of these limits is STEP #11: DETERMINE IF THIS
again dependent upon proper handling at sea. POTENTIAL HAZARD IS SIGNIFICANT.
Extended frozen storage (e.g. 24 weeks) or cooking At each processing step, determine whether
minimizes the risk of additional histamine develop- “scombrotoxin formation” is a significant hazard.
ment by inactivating the enzyme-forming bacteria The criteria are:
and, in the case of cooking, the enzyme itself. As
previously mentioned, recontamination with enzyme- 1. Is it reasonably likely that unsafe levels of histamine
forming bacteria and significant temperature abuse is will be introduced at this processing step (do unsafe
necessary for histamine formation under these levels come in with the raw material)?
conditions. Such recontamination may not be likely
if the fish is processed under a conscientious sanita- Table #3-1 (Chapter 3) lists those species of fish that
tion program. are generally known to be capable of producing
elevated levels of histamine if temperature abused.
• Detection
This is because they contain naturally high levels of
free histidine. It is also because they are marine fish
Sensory evaluation is generally used to screen fish that are likely to harbor the kinds of bacteria that
produce histidine decarboxylase. It is, therefore,
for spoilage odors that develop when the fish is
reasonable to assume that, without proper on-board
exposed to time/temperature abuse. It is an effective
controls, these species of fish will contain unsafe
means of detecting fish that have been subjected to a
levels of histamine upon receipt by the primary (first)
variety of abusive conditions.
processor.
However, odors of decomposition that are typical of However, if the worst case environmental conditions
relatively low temperature spoilage may not be (i.e. air and water temperatures) during the harvest
present if the fish has undergone high temperature season in a particular region would not permit the
spoilage. This condition makes sensory examination formation of histamine during the time necessary to
alone an ineffective control for scombrotoxin. harvest and transport the fish to the primary proces-
sor, on-board controls may not be necessary. For
Chemical testing is an effective means of detecting example, such conditions might exist if the fish are
the presence of histamine in fish flesh. However, the
harvested when air and water temperatures do not
validity of such testing is dependent upon the design
exceed 40˚F (4.4˚C), or when the combination of air
of the sampling plan. The amount of sampling
and water temperature and harvest/transport time are
required to accommodate such variability is necessar-
such that histamine formation is not reasonably likely
ily quite large. For this reason, chemical testing
to occur, as documented by a scientific study.
Continued
85
It is also reasonable to assume that, without proper • Making sure through harvest vessel records that
controls during refrigerated (not frozen) transporta- incoming fish were properly handled on-board the
tion between processors, scombrotoxin-forming harvest vessel, including:
species of fish will contain unsafe levels of histamine - Rapidly chilling the fish immediately after death;
upon receipt by the secondary processor (including - Controlling on-board refrigeration (other than
warehouses). However, this may not be the case if frozen storage) temperatures;
the product being received is a cooked or frozen fish - Proper on-board icing;
or fishery product. • Testing incoming fish for histamine levels;
• Making sure that incoming fish were handled
Nevertheless, you may need to exercise control when properly during refrigerated transportation from
receiving a refrigerated (not frozen) product from the previous processor, including:
another processor to prevent pathogen growth or - Controlling refrigeration temperatures during transit;
toxin formation (see Chapter 12). - Proper icing during transit;
• Checking incoming fish to ensure that they are
2. Is it reasonably likely that unsafe levels of histamine not at an elevated temperature at time of receipt;
will form at this processing step? • Checking incoming fish to ensure that they are
properly iced or refrigerated at time of receipt;
To answer this question you should consider the • Performing sensory examination on incoming fish
potential for time/temperature abuse in the absence of to ensure that they do not show signs of decom
controls. You may already have controls in your position;
process that minimize the potential for time/tempera- • Controlling refrigeration temperatures in your plant;
ture abuse that could result in unsafe levels of • Proper icing in your plant;
histamine. This and the following steps will help you • Controlling the amount of time that the product
determine whether those or other controls should be is exposed to temperatures that would permit
included in your HACCP plan. histamine formation during processing and storage.
Time/temperature abuse that occurs at successive List such preventive measures in Column 5 of the
processing and storage steps may be sufficient to Hazard Analysis Worksheet at the appropriate
result in unsafe levels of histamine, even when abuse processing step(s).
at one step alone would not result in such levels. For
this reason, you should consider the cumulative effect If the answer to either question 1, 2 or 3 is “Yes” the
of time/temperature abuse during the entire process. potential hazard is significant at that step in the
Information is provided in Step #10 to help you process and you should answer “Yes” in Column 3 of
assess the significance of time/temperature abuse that the Hazard Analysis Worksheet. If none of the
may occur in your process. criteria is met you should answer “No.” You should
record the reason for your “Yes” or “No” answer in
3. Can the formation of unsafe levels of histamine that Column 4. You need not complete Steps #12 through
are reasonably likely to occur be eliminated or reduced 18 for this hazard for those processing steps where
to an acceptable level at this processing step? (Note: you have recorded a “No.”
If you are not certain of the answer to this question at
this time, you may answer “No.” However, you may It is important to note that identifying this hazard as
need to change this answer when you assign critical significant at a processing step does not mean that it
control points in Step #12.) must be controlled at that processing step. The next
step will help you determine where in the process the
“Scombrotoxin formation” should also be considered critical control point is located.
a significant hazard at any processing or storage step
where a preventive measure is or can be used to
eliminate the hazard, if it is reasonably likely to
occur. Preventive measures for “scombrotoxin
formation” can include:
86
• Intended use Example:
A fresh mahi mahi processor identifies a series of
In determining whether a hazard is significant you processing and storage steps (e.g. butchering,
should also consider the intended use of the product, packaging, and refrigerated storage) as presenting a
which you developed in Step #4. However, because reasonable likelihood of scombrotoxin formation.
of the stable nature of histamine, the intended use of The processor controls temperature during storage
the product is not likely to affect the significance of and time of exposure to unrefrigerated conditions
this hazard. during the processing steps. The processor identifies
each of these processing and storage steps as CCPs
STEP #12: IDENTIFY THE CRITICAL for this hazard.
CONTROL POINTS (CCP).
In this case, you should enter “Yes” in Column 6 of
For each processing step where “scombrotoxin the Hazard Analysis Worksheet for each of those
formation” is identified in Column 3 of the Hazard processing steps. This control approach will be
Analysis Worksheet as a significant hazard, deter- referred to as “Control Strategy Example 1, 2 and 3”
mine whether it is necessary to exercise control at in Steps #14-18. It may apply to any of the three
that step in order to control the hazard. Figure #A-2 previously described control strategies.
(Appendix 3) is a CCP decision tree that can be used
to aid you in your determination. It is important to note that you may select a control
strategy that is different from that which is suggested
The following guidance will also assist you in above, provided that it assures an equivalent degree
determining whether a processing step is a CCP for of safety of the product.
scombrotoxin formation:
• Likely CCPs
1. If you identified scombrotoxin formation as a
significant hazard at the receiving step in Step #11, Following is further guidance on processing steps
you should also identify receiving as a CCP for this that are likely to be identified as critical control
hazard. Preventive measures, such as the first six points for this hazard:
described in Step #11, should be available to you at • Receiving;
that step. • Processing, such as:
- Thawing;
In this case you should enter “Yes” in Column 6 of - Brining;
the Hazard Analysis Worksheet for the receiving step. - Heading and gutting;
A control approach which includes screening incom- - Manual filleting and steaking;
ing fish through harvest vessel records for on-board - Stuffing;
handling practices will be referred to as “Control - Mixing;
Strategy Example 1” in Steps #14-18. A control - Portioning;
approach which includes screening incoming fish • Packaging;
through histamine testing will be referred to as • Final chilling after processing and packaging;
“Control Strategy Example 2” in Steps #14-18. A • Raw material, in-process product, and finished
control approach which includes screening incoming product refrigerated storage.
fish to ensure proper handling during transit from the
previous processor will be referred to as “Control (Note: Rather than identify each processing step as
Strategy Example 3” in Steps #14-18. an individual CCP when the controls are the same at
those steps, it may be more convenient to combine
2. If you identified scombrotoxin formation as a into one CCP those processing steps that together
significant hazard at a processing or storage step in contribute to a cumulative time/temperature exposure.)
Step #11, it may be necessary for you to also identify
that processing step as a CCP for this hazard. Preven-
tive measures, such as the last three described in Step
#11, should be available to you at those steps.
Continued
87
• Unlikely CCPs As a practical matter it may be advisable to set an
operating limit that is more restrictive than the CL.
Time/temperature controls will usually not be needed In this way you can adjust the process when the
at processing steps that meet the following condi- operating limit is triggered, but before a triggering of
tions: the CL would require you to take corrective action.
• Continuous, mechanical processing steps that are You should set operating limits based on your experi-
brief, such as: ence with the variability of your operation and with
- Mechanical filleting; the closeness of typical operating values to the CL.
• Processing steps that are brief and unlikely to
contribute significantly to the cumulative time/ Following is guidance on setting critical limits for the
temperature exposure, such as: control strategy examples discussed in Step #12.
- Date code stamping;
- Case packing; • CONTROL STRATEGY EXAMPLE 1 -
• Processing steps where the product is held in a HARVEST VESSEL CONTROL
frozen state, such as:
- Assembly of orders for distribution; For receipt by primary (first) processor:
- Frozen product storage;
• Retorting and post-retorting steps (if the product is Critical Limit: All lots received are accompanied by
covered by the LACF regulations, 21 CFR 113); harvest vessel records that show:
• Canned tuna “precooking” and steps after pre- • Generally, the fish were:
cooking, if sanitation practices are sufficient - Placed in ice, or in refrigerated seawater or
to prevent recontamination with enzyme-forming brine at 40˚F (4.4˚C) or less, within 12 hours
bacteria. of death;
OR
Proceed to Step #13 (Chapter 2) or to Step #10 of the - Placed in refrigerated seawater or brine at
next potential hazard. 50˚F (10˚C) or less within 9 hours of death
and chilling continued to bring the internal
temperature of the fish to 40˚F (4.4˚C) or less;
HACCP Plan Form OR
• Fish exposed to air or water temperatures
STEP #14: SET THE CRITICAL LIMITS (CL). above 83˚F (28.3˚C), ), or large tuna (i.e.,
above 20 lbs.) that are eviscerated before
For each processing step where “scombrotoxin on-board chilling, should be placed in ice
formation” is identified as a significant hazard on the (including packing the belly cavity of large
HACCP Plan Form, identify the maximum or mini- tuna with ice) or in refrigerated seawater or
mum value to which a feature of the process must be brine at 40˚F (4.4˚C) or less within 6 hours of
controlled in order to control the hazard. death;
OR
You should set the CL at the point that if not met the • Large tuna (i.e., above 20 lbs.) that are not
safety of the product may be questionable. If you set eviscerated before on-board chilling: The
a more restrictive CL you could, as a result, be internal temperature of the fish was brought to
required to take corrective action when no safety 50˚F (10˚C) or less within 6 hours of death
concern actually exists. On the other hand, if you set and chilling continued to bring the internal
a CL that is too loose you could, as a result, allow temperature of the fish to 40˚F (4.4˚C) or less;
unsafe product to reach the consumer.
88
OR • CONTROL STRATEGY EXAMPLE 2 -
• Other critical limits for on-board handling HISTAMINE TESTING
(e.g. maximum refrigerated brine or seawater
temperature, maximum fish size, maximum For receipt by primary (first) processor:
fish to brine/seawater/ice ratio, maximum
ambient temperature exposure time before Critical Limit: Analysis of a representative sample of
chilling) necessary to achieve a cooling rate fish shows less than 50 ppm histamine in all
that will prevent development of histamine in fish in the sample;
the specific species, as established through a AND
scientific study; • Sensory examination of a representative
AND sample of fish shows no more than 2.5%
• For fish held refrigerated (not frozen) on-board decomposition (persistent and readily
the vessel: The fish were stored at or below perceptible) in the sample. For example, no
40˚F (4.4˚C) thereafter; more than 3 fish in a sample of 118 fish may
AND show signs of decomposition;
• Sensory examination of a representative AND
sample of fish shows no more than 2.5% • For fish held iced or refrigerated (not frozen)
decomposition (persistent and readily on-board the vessel and delivered 24 or more
perceptible) in the sample. For example, no hours after death: The internal temperature
more than 3 fish in a sample of 118 fish may should be 40˚F (4.4˚C) or below;
show signs of decomposition; OR
AND • For fish held iced or refrigerated (not frozen)
• For fish held iced or refrigerated (not frozen) on-board the vessel and delivered from 12 to
on-board the vessel and delivered 24 or more less than 24 hours after death: The internal
hours after death: The internal temperature temperature should be 50˚F (10˚C) or below;
should be 40˚F (4.4˚C) or below; OR
OR • For fish held iced or refrigerated (not frozen)
• For fish held iced or refrigerated (not frozen) on-board the vessel and delivered in less than
on-board the vessel and delivered from 12 to 12 hours after death: The internal temperature
less than 24 hours after death: The internal should demonstrate that appropriate chilling
temperature should be 50˚F (10˚C) or below; methods were used onboard the harvest vessel.
OR Chilling of the fish must begin on the harvest
• For fish held iced or refrigerated (not frozen) vessel regardless of the time from death to
on-board the vessel and delivered in less than delivery, unless the environmental conditions
12 hours after death: The internal temperature (e.g. air and water temperatures) are
should demonstrate that appropriate chilling consistently below 40˚F (4.4˚C) from the time
methods were used onboard the harvest vessel. of death to delivery.
Chilling of the fish must begin on the harvest
vessel regardless of the time from death to
delivery, unless the environmental conditions
(e.g. air and water temperatures) are
consistently below 40˚F (4.4˚C) from the time
of death to delivery.
Continued
89
• CONTROL STRATEGY EXAMPLE 3 - OR
TRANSIT CONTROL • The fish are not exposed to ambient
temperatures above 40˚F (4.4˚C) for more than
For receipt by secondary processor (including 24 hours, cumulatively, as long as no portion
warehouse): of that time is at temperatures above 70˚F
(21˚C).
Critical Limit: For fish delivered refrigerated (not
frozen): All lots received are accompanied by (Note: Only one of the above two limits may
transportation records that show that the fish be selected. They may not be added for a total
were held at or below 40˚F (4.4˚C) throughout exposure of 12 hours.)
transit;
OR Enter the critical limit(s) in Column 3 of the HACCP
For fish held under ice or chemical cooling Plan Form.
media: There is an adequate quantity of ice or
other cooling media at the time of delivery to STEP #15: ESTABLISH MONITORING
completely surround the product. PROCEDURES.
• CONTROL STRATEGY EXAMPLE 1, 2 & 3 For each processing step where “scombrotoxin forma-
tion” is identified as a significant hazard on the HACCP
For processing steps: Plan Form, describe monitoring procedures that will
ensure that the critical limits are consistently met.
Critical Limit: During processing and refrigerated (not
frozen) storage that occurs before cooking (e.g. To fully describe your monitoring program you
canned tuna “precook”): For fish that have not been should answer four questions: 1) What will be
previously frozen: monitored? 2) How will it be monitored? 3) How
• The fish are not exposed to ambient often will it be monitored (frequency)? 4) Who will
temperatures above 40˚F (4.4˚C) for more than perform the monitoring?
4 hours, cumulatively, if any portion of that
time is at temperatures above 70˚F (21˚C); It is important for you to keep in mind that the
OR feature of the process that you monitor and the
• The fish are not exposed to ambient method of monitoring should enable you to deter-
temperatures above 40˚F (4.4˚C) for more than mine whether the CL is being met. That is, the
8 hours, cumulatively, as long as no portion of monitoring process should directly measure the
that time is at temperatures above 70˚F (21˚C); feature for which you have established a CL.
(Note: Only one of the above two limits may You should monitor often enough so that the normal
be selected. They may not be added for a total variability in the values you are measuring will be
exposure of 12 hours.) detected. This is especially true if these values are
typically close to the CL. Additionally, the greater
OR the time span between measurements the more
• For fish that have been previously frozen: product you are putting at risk should a measurement
The fish are not exposed to ambient show that a CL has been violated.
temperatures above 40˚F (4.4˚C) for more than
12 hours, cumulatively, if any portion of that Following is guidance on establishing monitoring
time is at temperatures above 70˚F (21˚C); procedures for the control strategy examples dis-
cussed in Step #12. Note that the monitoring fre-
quencies that are provided are intended to be consid-
ered as minimum recommendations, and may not be
90
What Will Be Monitored? AND
Date and time of off-loading;
HARVEST VESSEL CONTROL Decomposition in the lot;
AND
For receipt by primary (first) processor: For fish held iced or refrigerated (not frozen)
on-board the vessel: The internal temperature of a
What: Harvest vessel records containing the representative number of the largest fish in the
following information: lot at the time of delivery, concentrating on those
• Method of capture*; that show signs of having been mishandled
AND (e.g. inadequately iced).
• Date and time of landing;
AND * The asterisked information above may be docu-
• Where applicable to the critical limit, the air mented by the primary (first) processor on the
and water temperatures at time of landing on receiving records, rather than by the harvest vessel
board the vessel*; operator on the harvest vessel records, if the primary
AND processor is knowledgeable about such factors. The
• Estimated earliest date and time of death for other on-board handling information should be
fish landed at the same time (if other than time documented by the vessel operator. All of the
of landing)*; relevant information should be maintained by the
AND primary processor.
• Where applicable to the critical limit, method
of cooling* and temperature of cooling media; As an alternative to the primary processor receiving
AND harvest vessel records that are maintained by the
• Where applicable to the critical limit, date and vessel operator, certain harvest operations may lend
time cooling began; themselves to monitoring and record keeping entirely
AND by the primary processor. This arrangement is
• Where applicable to the critical limit, cooling suitable only if the primary processor has direct
rate, as evidenced by: knowledge about those aspects of the harvesting
- Internal fish temperatures after 6 hours of practices that must be controlled to ensure that the
cooling (or time when 50˚F [10˚C] is appropriate critical limits are met.
reached) for a representative number of the
largest fish in the lot; Example:
OR A primary processor receives bluefish from several
- Those factors of the cooling process that day-boats that catch the fish when the air and water
have been established through a scientific temperatures are below 83˚F (28.3˚C). The day-
study as critical to achieving the cooling rate boats take on ice at the processor’s facility immedi-
critical limits (e.g. refrigerated brine or ately before setting out for the day, and return within
seawater temperature, fish size, fish to brine/ 12 hours to the processor’s facility with the iced
seawater/ice ratio); catch. The processor monitors and records: the date
AND and time of departure of the vessels after they take on
• For fish held iced or refrigerated (not frozen) ice; the date and time of the vessels’ return; the
on-board the vessel: The storage temperature, ambient water and air temperatures of the fishing
as evidenced by: grounds; and the adequacy of icing of the catch. The
- The temperature of refrigerated seawater or processor also conducts sensory evaluations and
brine in which the fish are stored; checks the internal temperature of the catch upon
OR arrival. The harvest vessel operators perform no
- The presence of an adequate quantity of ice monitoring or record keeping.
to surround the fish;
Continued
91
• CONTROL STRATEGY EXAMPLE 2 - • CONTROL STRATEGY EXAMPLES 1, 2 & 3
HISTAMINE TESTING
For processing steps:
For receipt by primary (first) processor:
What: For raw material, in-process, or finished
What: Histamine content in the fish flesh; product refrigerated storage, or for refrigerated
AND processing: The temperature of the cooler or the
Decomposition in the lot; refrigerated processing area;
AND OR
Date and time of off-loading; For raw material, in-process, or finished
AND product storage under ice or chemical cooling
For fish held iced or refrigerated (not frozen) media: The adequacy of ice or chemical cooling
on-board the vessel: The internal temperature of a media;
representative number of the largest fish in the AND
lot at the time of delivery, concentrating on those For processing and packaging: The length of
that show signs of having been mishandled time the fish are exposed to unrefrigerated
(e.g. inadequately iced). conditions (i.e., above 40˚F [4.4˚C]), and the
ambient temperatures during the exposure periods.
TRANSIT CONTROL
How Will Monitoring Be Done?
For receipt by secondary processor (including
warehouse): • CONTROL STRATEGY EXAMPLE 1 -
HARVEST VESSEL CONTROL
What: For fish delivered refrigerated (not frozen):
The internal temperature of the fish throughout For receipt by primary (first) processor:
transportation;
OR How: Review of harvest vessel records.
For fish delivered refrigerated (not frozen): Temperature monitoring on the vessel should
The temperature of the truck or other carrier be performed using dial thermometers, digital
throughout transportation; time/temperature data loggers, or recorder
OR thermometers;
For fish delivered refrigerated (not frozen), with AND
a transit time of four hours or less: The internal Sensory examination of at least 118 fish in each
temperature of a representative number of fish in lot (or the entire lot, for lots smaller than 118
the lot at the time of delivery; fish). Lots should consist of only one specie of
OR fish. Note: If the fish are received frozen, this
For fish held under ice or chemical cooling monitoring procedure may be performed by a
media: The adequacy of ice or chemical sensory examination on the warmed flesh
cooling media at the time of delivery. produced by drilling the frozen fish (drill
method). It may also be performed after thawing,
rather than at receipt;
AND
For fish held iced or refrigerated (not frozen)
on-board the vessel: Use a dial or digital
thermometer to measure the internal temperature
of a representative number of the largest fish in
each lot, concentrating on those that show signs
92
of having been mishandled (e.g. inadequately from throughout the lot. Lots that show a high
iced). For example, when receiving 10 tons or level of temperature variability may require a
more of fish, measure a minimum of one fish per larger sample size.
ton, and when receiving less than 10 tons of fish,
measure a minimum of one fish per 1000 pounds. • CONTROL STRATEGY EXAMPLE 3 -
Measure a minimum of 12 fish, unless there are TRANSIT CONTROL
fewer than 12 fish in the lot, in which case
measure all of the fish. Randomly select fish For receipt by secondary processor (including
from throughout the lot. Lots that show a high warehouse):
level of temperature variability may require a
larger sample size. How: For fish delivered refrigerated (not frozen):
• Use a time/temperature integrator for internal
• CONTROL STRATEGY EXAMPLE 2 - product temperature monitoring during transit;
HISTAMINE TESTING OR
• Use a digital time/temperature data logger for
For receipt by primary (first) processor: internal product temperature or ambient air
temperature monitoring during transit;
How: Histamine analysis of a minimum of 18 fish per OR
lot where the fish are the same species and of • Use a recorder thermometer for ambient air
common origin, unless there are fewer than 18 temperature monitoring during transit;
fish in the lot, in which case test all of the fish. OR
The fish collected for analysis may be • Use a dial or digital thermometer for internal
composited for analysis if the critical limit is product temperature monitoring at receipt;
reduced accordingly. For example, a sample of OR
18 fish may be composited into 6 units of 3 For fish held under ice or chemical cooling media:
fish each, provided the critical limit is reduced Make visual observations of the adequacy of ice or
from 50 ppm to 17 ppm for each unit; other cooling median a sufficient number of containers
AND (e.g. cartons, totes, etc.) to represent all of the product.
Sensory examination of at least 118 fish in each
lot (or the entire lot for lots smaller than 118 • CONTROL STRATEGY EXAMPLES 1, 2 & 3
fish). Lots should consist of only one specie of
fish. Note: If the fish are received frozen, this For processing steps:
monitoring procedure may be performed using
the drill method. It may also be performed after How: For raw material, in-process, or finished
thawing, rather than at receipt; product refrigerated storage or for refrigerated
AND processing:
For fish held iced or refrigerated (not frozen) • Use a digital time/temperature data logger;
on-board the vessel: Use a dial or digital OR
thermometer to measure the internal temperature • Use a recorder thermometer;
of a representative number of the largest fish in OR
each lot, concentrating on those that show signs • Use a high temperature alarm within 24-hour
of having been mishandled (e.g. inadequately monitoring;
iced). For example, when receiving 10 tons or OR
more of fish, measure a minimum of one fish per For raw material, in-process, or finished product
ton, and when receiving less than 10 tons of fish, storage under ice or chemical cooling media:
measure a minimum of one fish per 1000 pounds. Make visual observations of the adequacy of ice
Measure a minimum of 12 fish, unless there are or chemical cooling media in a sufficient number
fewer than 12 fish in the lot, in which case of containers (e.g. cartons, totes, etc.) to represent
measure all of the fish. Randomly select fish all of the product.;
Continued
93
AND • CONTROL STRATEGY EXAMPLES 1, 2 & 3
For processing and packaging:
• Make visual observations of the length of For processing steps:
exposure to unrefrigerated conditions
(i.e., above 40˚F [4.4˚C]); Frequency: For raw material, in-process, or finished
AND product refrigerated storage, or for refigerated
• Use a dial or digital thermometer to determine processing: Continuous monitoring by the
ambient air temperature. instrument itself, with visual check of the
instrument at least once per day;
Example: OR
A canned tuna processor using raw material that was For raw material, in-process, or finished product
not previously frozen has identified a series of storage under ice or chemical cooling media:
processing steps as critical control points for • At least twice per day;
scombrotoxin formation. The processor establishes a OR
critical limit of no more than four cumulative hours • For finished product storage, at least
of exposure to unrefrigerated temperatures in excess immediately prior to shipment;
of 40˚F (4.4˚C) during these processing steps. The AND
processor uses marked product to monitor the For processing and packaging: At least every
progress of the product through the processing steps. two hours.
The time that the marked product is removed from
and returned to refrigeration is monitored visually
and recorded and the ambient air temperature is Who Will Perform the Monitoring?
determined using a digital thermometer and re-
corded. • CONTROL STRATEGY EXAMPLES 1, 2 & 3
Who: With recorder thermometers, time/temperature

How Often Will Monitoring Be Done integrators, high temperature alarms, maximum
(Frequency)? indicating thermometers, and digital data loggers,
monitoring is performed by the equipment itself.
• CONTROL STRATEGY EXAMPLES 1 & 2 However, anytime that such instruments are
used, a visual check should be made at least once
For receipt by primary (first) processor: per day in order to ensure that the critical limits
have consistently been met. Monitoring on-board
Frequency: Every lot received. the harvest vessel is performed by a member of
the vessel’s crew. However, the on-board records
• CONTROL STRATEGY EXAMPLE 3 - should be reviewed as part of monitoring at
TRANSIT CONTROL receipt to ensure that the critical limits were
consistently met. These checks, as well as dial
For receipt by secondary processor thermometer checks, time of exposure checks,
(including warehouse): and adequacy of ice or other cooling media checks
may be performed by the receiving employee,
Frequency: Every lot received. the equipment operator, a production supervisor,
a member of the quality control staff, or any
other person who has an understanding of the
process and the monitoring procedure. Sensory
examinations and histamine analyses should be
performed by individuals who are qualified by
training and experience.
94
Enter the “What,” “How,” “Frequency,” and “Who” AND
monitoring information in Columns 4, 5, 6, and 7, When the sensory examination critical limit has
respectively, of the HACCP Plan Form. been violated:
• Reject the lot;
STEP #16: ESTABLISH CORRECTIVE OR
ACTION PROCEDURES. • Perform histamine analysis on all fish that
show decomposition (persistent and readily
For each processing step where “scombrotoxin perceptible) and reject the lot if any are found
formation” is identified as a significant hazard on the with histamine greater than or equal to 50 ppm.
HACCP Plan Form, describe the procedures that you If found, the lot may be subdivided and
will use when your monitoring indicates that the CL reanalyzed at the rate recommended above
has not been met. (i. e. 60 fish per lot), rejecting those portions
where a unit greater than or equal to 50 ppm is
These procedures should: 1) ensure that unsafe found;
product does not reach the consumer; and, 2) correct OR
the problem that caused the CL deviation. Remem- • Perform histamine analysis on the lot (i.e. fish
ber that deviations from operating limits do not need of common origin) by analyzing 60 fish (or
to result in formal corrective actions. the entire lot for lots smaller than 60 fish)
and rejecting the lot if any are found with
Following is guidance on establishing corrective hista mine greater than or equal to 50 ppm.
action procedures for the control strategy examples If found, the lot may be subdivided and
discussed in Step #12. reanalyzed at the same rate, rejecting those
portions where a unit greater than or equal to
• CONTROL STRATEGY EXAMPLE 1 - 50 ppm is found. The fish collected for analysis
HARVEST VESSEL CONTROL may be composited for analysis if the critical
limit is reduced accordingly. For example, a
For receipt by primary (first) processor: sample of 60 fish may be composited into 20
units of 3 fish each, provided the action point
Corrective Action: In the absence of harvester is reduced from 50 ppm to 17 ppm for each unit;
records, or when one of the harvester critical AND
limits has been violated, or when the internal • Perform a sensory examination of all fish in
temperature critical limit at receiving has been the lot;
violated: AND
• Reject the lot; Any individual fish found to be decomposed
OR (persistent and readily perceptible) should be
• Perform histamine analysis on the lot (i.e. fish destroyed or diverted to a non-food use;
of common origin) by analyzing 60 fish (or the AND
entire lot for lots smaller than 60 fish) and Discontinue use of supplier until evidence is
rejecting the lot if any are found with histamine obtained that harvesting practices have changed.
greater than or equal to 50 ppm. If found, the
lot may be subdivided and reanalyzed at the
same rate, rejecting those portions where a unit
greater than or equal to 50 ppm is found. The
fish collected for analysis may be composited
for analysis if the critical limit is reduced
accordingly. For example, a sample of 60 fish
may be composited into 20 units of 3 fish each,
provided the action point is reduced from
50 ppm to 17 ppm for each unit;
Continued
95
HISTAMINE TESTING • Perform a sensory examination of all fish in
the lot;
For receipt by primary (first) processor: AND
Any individual fish found to be decomposed
Corrective Action: When the histamine level or (persistent and readily perceptible) should be
internal temperature critical limit at the receiving destroyed or diverted to non-food use;
step has been violated: AND
• Reject the lot; Discontinue use of supplier until evidence is
OR obtained that harvesting practices have changed.
• Subdivide the lot and analyze each portion at
the rate recommended above (i.e. 60 fish per • CONTROL STRATEGY EXAMPLE 3 -
lot), rejecting those portions where a unit with TRANSIT CONTROL
50 ppm or more histamine is found. The fish
collected for analysis may be composited for For receipt by secondary processor (including
analysis if the critical limit is reduced warehouse):
accordingly. For example, a sample of 60 fish
may be composited into 20 units of 3 fish each, Corrective Action: In the absence of
provided the action point is reduced from transportation records or when a critical limit
50 ppm to 17 ppm for each unit.; at this processing step has been violated:
AND • Reject the lot;
When the sensory examination critical limit has OR
been violated: • Perform histamine analysis on the lot (i.e fish
• Reject the lot; of common origin) by analyzing 60 fish (or the
OR entire lot for lots smaller than 60 fish) and
• Perform histamine analysis on all fish that rejecting the lot if any are found with
show decomposition (persistent and readily histamine greater than or equal to 50 ppm.
perceptible) and reject the lot if any are found If found, the lot may be subdivided and
with histamine greater than or equal to 50 ppm. reanalyzed at the same rate, rejecting those
If found, the lot may be subdivided and portions where a unit greater than or equal to
reanalyzed at the rate recommended above 50 ppm is found. The fish collected for analysis
(i.e. 60 fish per lot), rejecting those portions may be composited for analysis if the critical
where a unit greater than or equal to 50 ppm is limit is reduced accordingly. For example, a
found; sample of 60 fish may be composited into 20
OR units of 3 fish each, provided the action point
• Perform histamine analysis on the lot (i.e. fish is reduced from 50 ppm to 17 ppm for each unit.;
of common origin) by analyzing 60 fish (or the OR
entire lot for lots smaller than 60 fish) and • Hold the product until it can be evaluated
rejecting the lot if any are found with histamine based on its total transit time/temperature
greater than or equal to 50 ppm. If found, the exposure and reject any product that has
lot may be subdivided and reanalyzed at the exceeded the critical limits described for the
same rate, rejecting those portions where a unit “Processing Steps” at Step 14;
greater than or equal to 50 ppm is found. The AND
fish collected for analysis may be composited Discontinue use of supplier or carrier until
for analysis if the critical limit is reduced evidence is obtained that transportation practices
accordingly. For example, a sample of 60 fish have changed.
may be composited into 20 units of 3 fish each,
provided the action point is reduced from
50 ppm to 17 ppm for each unit;
96
• CONTROL STRATEGY EXAMPLES 1, 2 & 3 STEP #17: ESTABLISH A RECORDKEEPING
SYSTEM.
For processing steps:
For each processing step where “scombrotoxin
Corrective Action: Take one or several of the formation” is identified as a significant hazard on the
following actions as necessary to regain control HACCP Plan Form, list the records that will be used
over the operation after a CL deviation: to document the accomplishment of the monitoring
• Add ice to the affected product; procedures discussed in Step #15.
OR
• Make repairs or adjustments to the The records should clearly demonstrate that the
malfunctioning cooler; monitoring procedures have been followed, and
OR should contain the actual values and observations
• Move some or all of the product in the obtained during monitoring.
malfunctioning cooler to another cooler;
OR Following is guidance on establishing a
• Return the affected in-process product to the recordkeeping system for the control strategy ex-
cooler; amples discussed in Step #12.
OR
• Freeze the affected product; • CONTROL STRATEGY EXAMPLE 1 -
OR HARVEST VESSEL CONTROL
• Modify the process as needed to reduce the
exposure time/temperature; For receipt by primary (first) processor:
AND
Take one of the following actions to product Records: Harvest vessel records, containing the
involved in the critical limit deviation: information described in Step #15.
• Destroy the product; AND
OR Receiving records showing
• Divert the product to a non-food use; • Date and time of off-loading;
OR AND
• Perform histamine analysis on the lot of • Results of sensory examination;
affected product by analyzing 60 fish (or the AND
entire lot for lots smaller than 60 fish). If any • For fish held iced or refrigerated (not frozen)
fish are found with histamine at 50 ppm or on-board the vessel: Internal temperatures of
greater the lot should be destroyed or diverted the fish.
to a non-food use.
Note: If an incoming lot that fails to meet a receiving HISTAMINE TESTING
critical limit is mistakenly accepted, and the error is
later detected, the following actions should be taken: For receipt by primary (first) processor:
1) the lot and any products processed from that lot
should be destroyed, diverted to a nonfood use or to a Records: Receiving records showing:
use in which the critical limit is not applicable, or • Date and time of off-loading;
placed on hold until a food safety evaluation can be AND
completed; and 2) any products processed from that • Results of histamine analysis;
lot that have already been distributed should be AND
recalled and subjected to the actions described above. • Results of sensory examination;
AND
Enter the corrective action procedures in Column 8 of • For fish held iced or refrigerated (not frozen)
the HACCP Plan Form. on-board the vessel: Internal temperatures of
the fish.
Continued
97
• CONTROL STRATEGY EXAMPLE 3 - STEP #18: ESTABLISH VERIFICATION
TRANSIT CONTROL PROCEDURES.
For receipt by secondary processor For each processing step where “scombrotoxin
(including warehouse): formation” is identified as a significant hazard on the
HACCP Plan Form, establish verification procedures
Records: Receiving records showing: that will ensure that the HACCP plan is: 1) adequate
• The results of the time/temperature integrator to address the hazard of “scombrotoxin formation”;
checks; and, 2) consistently being followed.
OR
• Printouts from digital time/temperature data Following is guidance on establishing verification
logger; procedures for the control strategy examples dis-
OR cussed in Step #12.
• Recorder thermometer charts;
• The results of internal product temperature HARVEST VESSEL CONTROL
monitoring at receipt;
AND For receipt by primary (first) processor:
• The date and time of departure and arrival of
the vehicle; Verification: Review monitoring, corrective action,
OR and verification records within one week of
• The results of the ice or other cooling media preparation;
checks. AND
Collect a representative sample of the raw
• CONTROL STRATEGY EXAMPLES 1, 2 & 3 material, in-process product, or finished product
and analyze for histamine at least quarterly;
For processing steps: AND
When dial or digital thermometers are used for
Records: For raw material, in-process, or finished monitoring, check for accuracy against a known
product refrigerated storage, or for refrigerated accurate thermometer (NIST-traceable) when
processing: first used and at least once per year thereafter.
• Printouts from digital time/temperature data (Note: optimal calibration frequency is
logger; dependent upon the type, condition, and past
OR performance of the monitoring instrument.)
• Recorder thermometer charts;
• Storage records showing the results of the high HISTAMINE TESTING
temperature alarm checks;
OR For receipt by primary (first) processor:
For raw material, in-process, or finished product
storage under ice or chemical cooling media: Verification: Review monitoring, corrective action,
Storage records showing the results of the ice or and verification records within one week of
other cooling media checks; preparation;
AND AND
For processing and packaging: Processing When dial or digital thermometers are used for
records showing the results of time/temperature monitoring, check for accuracy against a known
exposure checks. accurate thermometer (NIST-traceable) when
first used and at least once per year thereafter
98
(Note: Optimal calibration frequency is • CONTROL STRATEGY EXAMPLES 1, 2 & 3
dependent upon the type, condition, and past
performance of the monitoring instrument.) For processing steps:
• CONTROL STRATEGY EXAMPLE 3 - Verification: Review monitoring, corrective action,

TRANSIT CONTROL and verification records within one week of
preparation;
For receipt by secondary processor (including AND
warehouse): When digital time/temperature data loggers,
recorder thermometers, or high temperature
Verification: Review monitoring, corrective action, alarms are used for in-plant monitoring, check
and verification records within one week of for accuracy against a known accurate
preparation; thermometer (NIST-traceable) at least once per
AND day;
When digital time/temperature data loggers or AND
recorder thermometers are used for monitoring When dial or digital thermometers are used for
of transport conditions at receipt, check for monitoring, check for accuracy against a known
accuracy against a known accurate thermometer accurate thermometer (NIST-traceable) when
(NIST-traceable). Verification should be first used and at least once per year thereafter.
conducted on new suppliers’ vehicles and at least (Note: Optimal calibration frequency is
quarterly for each supplier thereafter. Additional dependent upon the type, condition, and past
verifications may be warranted based on performance of the monitoring instrument.);
observations at receipt (e.g., refrigeration units OR
appear to be in poor repair, or readings appear to When visual checks of ice or cooling media are
be erroneous); used to monitor the adequacy of coolant,
OR periodically measure internal temperatures of
When dial or digital thermometers are used for fish to ensure that the ice or cooling media is
monitoring conditions at receipt, check for sufficient to maintain product temperatures at
accuracy against a known accurate thermometer 40˚F (4.4˚C) or less.
(NIST-traceable) when first used and at least
once per year thereafter. (Note: Optimal Enter the verification procedures in Column 10 of the
calibration frequency is dependent upon the type, HACCP Plan Form.
condition, and past performance of the monitoring
instrument.);
OR
When visual checks of ice or cooling media are
used to monitor the adequacy of coolant,
periodically measure internal temperatures of
fish to ensure that the ice or cooling media is
sufficient to maintain product temperatures at
40˚F (4.4˚C) or less.
99
TABLE #7-1
Control Strategy Example 1 - Harvest vessel control

This table is an example of a portion of a HACCP plan relating to the control of scombrotoxin formation for a fresh mahi mahi
processor that receives the fish on ice from harvest vessels, using Control Strategy Example 1 - Harvest vessel control.
It is provided for illustrative purposes only. Histamine formation may be only one of several significant hazards for this product.
Refer to Tables 3-1, 3-2, and 3-3 (Chapter 3) for other potential hazards (e.g. food and color additives, metal fragments).
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
Receiving - Scombrotoxin • All lots received are accompanied • Harvest vessel • Visual review of • Every lot received • Receiving supervisor • Reject lot • Harvester vessel • Histamine
fresh mahi mahi on formation by harvest vessel records that records the records Discontinue use of records analysis on one
ice from harvest show: 1) icing on board the supplier until evidence incoming lot
vessels harvest vessel was performed in is obtained that every three
accordance with the vessel’s harvesting practices months (10 fish
cooling rate study that validates have changed per sample)
cooling to 50˚F or below within
6 hrs. of death regardless of • Review
maximum exposure temperature, monitoring,
or placement on ice within 12 hrs. corrective
100
of death if the maximum exposure action and
Se
temperature does not exceed verification
83˚F; 2) method of capture; records within
eT
3) date and time of landing; one week of
ex
4) estimated time of death; preparation
5) method of cooling; 6) date and
t f Exa
time cooling began; 7) sea and air
temperature if exposure temp-
or mp
erature exceeds 83˚F; 8) adequacy
of ice during on-board holding.
Fu le
• No more than 2.5% • Amount of • Sensory examination • Every lot received • Quality control • Reject lot • Receiving record • Same
ll R O
decomposition (persistent decomposition (118 fish per lot; or staff Discontinue use of
and readily perceptible) in in incoming lot all fish in the lot if supplier until evidence
eco nly
the incoming lot <118 fish) is obtained that
harvesting practices
mm
en have changed
• If the fish are delivered in less • Internal • Digital thermometer • Every lot received • Receiving supervisor • Reject lot • Receiving record • Same
than 12 hours after death, an temperature of fish (1 fish/1000 lbs for Discontinue use of
da
internal temperature below at time of delivery lots up to 10 tons; supplier until evidence
ambient air and water 1 fish/ton for lots 10 is obtained that
tio
temperatures; if the fish are tons or greater; harvesting practices
delivered 12 or more hours minimum of 12 fish/ have changed
ns
after death, an internal lot)
temperature of 50˚F or below;
if the fish are delivered 24 or • Date and time of • Clock • Every lot received • Receiving supervisor • Receiving record • Check accuracy
more hours after death, an off-loading of digital
internal temperature of 40˚F thermometer
or below once per year
TABLE #7-1, continued
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
Raw material storage Scombrotoxin formation • Product completely • Adequacy of ice • Visual • Every lot at time • Production • Add ice • Processing record • Review
covered in ice throughout surrounding examination of removal from supervisor monitoring and
storage product raw material • Hold lot and evaluate corrective
storage cooler and based on total time/ action records
at least twice a temperature exposure within one week
day for lots not during raw material of preparation
removed and finished product
storage and butcher-
ing/packaging.
Destroy lot if time
above 40˚F exceeds
4 hours cumulatively
if any of that time
is above 70˚F, or if
time above 40˚F
exceeds 8 hours
cumulatively as long
as no portion of that
time is above 70˚F.
Butchering/ Scombrotoxin formation • Product is not exposed • Time of product • Visual tracking of • Every batch of fish • Quality control • Destroy lot • Processing record • Review
Se
101
packaging to temperatures above exposure to time for marked marked when supervisor monitoring and
40˚F for more than 4 hours unrefrigerated product to move removed from raw corrective
eT
cumulatively if any of that
ex conditions during through butchering/ material storage. action records
time is above 70˚F, or above butchering/ packaging. within one week
40˚F for more than 8 hours packaging of preparation
t f Exa
as long as no portion of that
time is above 70˚F hours
or mp
cumulatively
Fu le
Finished product Scombrotoxin formation • Product completely • Adequacy of ice • Visual • Every lot at time • Shipping • Add ice • Shipping record • Review
ll R O
storage covered in ice throughout surrounding examination of removal from supervisor monitoring and
storage product finished product • Hold lot and evaluate corrective
eco nly
storage cooler for based on total time/ action records
shipment temperature exposure within one week
mm
during raw material of preparation
en and finished product
storage and butcher-
ing/packaging.
da
Destroy lot if time
above 40˚F exceeds
tio
4 hours cumulatively
if any of that time
ns
is above 70˚F, or if
time above 40˚F
exceeds 8 hours
cumulatively as long
as no portion of that
time is above 70˚F.
TABLE #7-2
Control Strategy Example 2 - Histamine testing
This table is an example of a portion of a HACCP plan relating to the control of scombrotoxin
formation for a canned tuna processor, using Control Strategy Example 2 - Histamine testing.
It is provided for illustrative purposes only. Histamine formation may be only one of several significant hazards for this product.
Refer to Tables 3-1, 3-2, and 3-3 (Chapter 3) for other potential hazards (e.g. C. botulinum).
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
Receiving - Scombrotoxin • Less than 50 ppm histamine • Fish flesh for • Histamine analysis • Every lot received • Quality assurance • Subdivide lot and • Reports of analysis • Review
frozen tuna from formation in all fish in the sample histamine content of 18 fish per lot staff examine 60 fish per monitoring,
harvest vessels sub-lot for histamine. corrective
Reject sub-lots action and
with one or more verification
fish at 50 ppm or records within
greater one week of
preparation
Se
102
• No more than 3 • Amount of • Sensory • Every lot received • Quality assurance • Reject the lot • Quality assurance
eT
decomposed fish (persistent decomposition in examination staff record
and readily perceptible) in incoming lot (118 fish per lot, • Discontinue use
ex
a 118 fish sample or all fish if lot is of supplier until
t f Exa <118 fish) evidence is
obtained that
or mp
harvesting practices
have changed
Fu le
ll R O
Thawing, butchering Scombrotoxin • No more than 24 hours at • Time of product • Visual observation • Start marked • Quality assurance • Make adjustments • Processing record • Review
eco nly
and precook staging formation ambient air temperatures exposure to of time for marked product at start of staff to the thawing, monitoring and
above 40˚F or, if temperatures unrefrigerated product to move every thaw process butchering and corrective
mm
ever exceed 70˚F, no more conditions through process precook staging action records
than 12 hours above 40˚F, during thawing, process within one week
cumulative time for thawing, butchering and of preparation
en
butchering, and precook da precook staging AND
staging.
• Analyze
tio
representative
sample of lot for
ns
histamine. Divert
to non-food use
if any unit is
50 ppm or greater
Chapter 8: Other Decomposition-Related Hazards (A Chemical Hazard)
Chapter 7 covers scombrotoxic poisonings in certain ing illnesses that are associated with the consumption
species of fish. These poisonings occur as a result of of decomposed shrimp.
the formation of high levels of histamine during decom-
position of the fish at improper holding temperatures. The agency intends to further evaluate the relation-
ship between decomposition and illness. Guidance
There are indications that decomposition can result in will be issued when the causes of these health effects
the production of other toxins (e.g. biogenic amines, are better understood and appropriate control mea-
such as putrescine and cadaverine) that have the sures can be recommended.
potential to cause illness, even in the absence of
histamine formation. Such illnesses have been In the meantime, FDA requests that interested parties
reported in a number of fish species. FDA has also with information on this potential hazard supply any
received a number of consumer complaints concern- available data to the agency.
Chapter 8: Decomposition
103
Notes:
Chapter 8: Decomposition
104
Chapter 9: Environmental Chemical Contaminants & Pesticides (A Chemical Hazard)
Hazard Analysis Worksheet Significant elements of Shellfish Control Authorities’

efforts to control the harvesting of molluscan shell-
STEP #10: UNDERSTAND THE POTENTIAL fish include: 1) a requirement that containers of in-
HAZARD. shell molluscan shellfish (shellstock) bear a tag that
identifies the type and quantity of shellfish, harvester,
Environmental chemical contaminants and pesticides harvest location, and date of harvest; 2) a require-
in fish pose a potential human health hazard. Fish are ment that molluscan shellfish harvesters be licensed;
harvested from waters that are exposed to varying 3) a requirement that processors that shuck mollus-
amounts of industrial chemicals, pesticides, and toxic can shellfish or ship, reship, or repack the shucked
elements. These contaminants may accumulate in product be certified; and, 4) a requirement that
fish at levels that can cause illness. The hazard is containers of shucked molluscan shellfish bear a
most commonly associated with long-term exposure label with the processor’s name, address, and certifi-
to these contaminants; illnesses associated with a cation number.
single exposure (one meal) are very rare. Concern
for these contaminants primarily focuses on fish STEP #11: DETERMINE IF THIS
harvested from fresh water, estuaries, and near-shore POTENTIAL HAZARD IS SIGNIFICANT.
coastal waters (e.g. areas subject to shoreside con-
taminant discharges), rather than from the open At each processing step, determine whether “environ-
ocean. Pesticides used near aquaculture operations mental chemical contaminants and pesticides” is a
may also contaminate fish. significant hazard. The criteria are:
The hazard of methyl mercury is covered in Chapter 10. 1. Is it reasonably likely that unsafe levels of environ-
mental chemical contaminants or pesticides will be
• Control of chemical contaminants introduced at the receiving step (e.g. does the raw
material come in with an unsafe level of an environ-
Federal tolerances, action levels, and guidance levels mental chemical contaminant or pesticide)?
are established for some of the most toxic and
persistent contaminants that are found in fish. These Tables #3-1 and 3-2 (Chapter 3) identify the species
levels are listed in Table #9-1. States often use the of fish for which “environmental chemical contami-
Federal tolerances, action levels, and guidance levels nants and pesticides” is a potential hazard. Under
for deciding whether to issue consumption advisories ordinary circumstances, it would be reasonably likely
or to close waters for commercial harvesting of all or to expect that, without proper controls, unsafe levels
certain species of fish. of environmental chemical contaminants and pesti-
cides could enter the process at the receiving step
In the case of molluscan shellfish, State and foreign from those species. There may be circumstances in
government agencies, called Shellfish Control your geographic area that would allow you to con-
Authorities, consider the degree of chemical contami- clude that it is not reasonably likely for unsafe levels
nation as part of their classification of harvesting of environmental chemical contaminants and pesti-
waters. As a result of these classifications, molluscan cides to occur in fish from your area. You should be
shellfish harvesting is allowed from some waters, not guided by the historical occurrence of environmental
from others, and only at certain times or under chemical contaminants and pesticides, at levels above
certain conditions from others. Shellfish Control the established tolerances, action levels, or guidance
Authorities then exercise control over the molluscan levels, in fish from your geographic area.
shellfish harvesters to ensure that harvesting takes
place only when and where it has been permitted.
Continued
Chapter 9: Chemicals
105
Except in the case of molluscan shellfish, the hazard • Review, at time of receipt of aquacultured fish, of
of “environmental chemical contaminants and environmental chemical contaminant and pesticide
pesticides” should be fully controlled by the primary test results of soil and water or fish flesh samples
processor. For this reason, secondary processors of for those contaminants that are reasonably likely to
fish other than molluscan shellfish need not identify be present, and monitoring of present land use
this hazard as a significant hazard. practices in the area immediately surrounding the
production area (tests and monitoring may be
2. Can unsafe levels of environmental chemical con- performed by the aquacultural grower, a State
taminants and pesticides, which were introduced at an agency, or a third party organization);
earlier step, be eliminated or reduced to an acceptable • On-farm visits to the aquacultural grower to collect
level here? (Note: If you are not certain of the answer and analyze soil and water samples or fish samples
to this question at this time, you may answer “No.” for environmental chemical contaminants and
However, you may need to change this answer when pesticides that are reasonably likely to be present,
you assign critical control points in Step 12) and to review present land use practices in the area
immediately surrounding the production area;
“Environmental chemical contaminants and pesti- • Environmental chemical contaminant and pesticide
cides” should also be considered a significant hazard testing of fish flesh at time of receipt for those
at any processing step where a preventive measure is, contaminants that are reasonably likely to be
or can be, used to prevent or eliminate (or is adequate present;
to reduce the likelihood of occurrence to an accept- • Receipt of evidence (e.g. third party certificate)
able level) unsafe levels of environmental chemical that the producer operates under a third party-
contaminants and pesticides that are reasonably audited Quality Assurance Program for
likely to occur. Preventive measures for environmen- environmental chemical contaminants and
tal chemical contaminants and pesticides can include: pesticides (e.g. the National Aquaculture
Association’s Fish Producers Quality Assurance
• Making sure that incoming fish have not been Program).
harvested from waters that are closed to the
commercial harvest of that specie due to List such preventive measures in Column 5 of the
environmental chemical contaminants or Hazard Analysis Worksheet at the appropriate pro-
pesticides; cessing step(s). In the case of an integrated opera-
• Making sure that incoming fish have not been tion, where fish processing and grow-out are per-
harvested from waters that are under a formed by the same firm, it may be possible and
consumption advisory by a federal, state or local desirable to exercise preventive measures early in the
regulatory authority based on a determination by process (ideally when the grow-out site is selected),
the authority that fish harvested from the waters are rather than at receipt of the fish at the processing
reasonably likely to contain contaminants above plant. Such preventive measures will not be covered
the federal tolerances, action levels, or guidance in this chapter.
levels. Note: many consumption advisories are not
based on such a determination. If the answer to either question 1 or 2 is “Yes,” the
• Checking incoming molluscan shellfish to ensure potential hazard is significant at that step in the
that they are properly tagged or labeled; process and you should answer “Yes” in Column 3 of
• Screening incoming molluscan shellfish to ensure the Hazard Analysis Worksheet. If neither criterion is
that they are supplied by a licensed harvester met you should answer “No.” You should record the
(where licensing is required by law) or by a reason for your “Yes” or “No” answer in Column 4.
certified dealer; You need not complete Steps #12 through 18 for this
• Receipt of the aquacultural grower’s lot-by-lot hazard for those processing steps where you have
certification of harvesting from uncontaminated recorded a “No.”
waters, coupled with appropriate verification (see
Step #18 - Verification);
106
It is important to note that identifying this hazard as Example:
significant at a processing step does not mean that it A processor of aquacultured catfish that
must be controlled at that processing step. The next regularly purchases from the same growers could
step will help you determine where in the process the visit the growers before the fish are harvested.
critical control point is located. The processor could collect and analyze soil and
water samples or fish samples for environmental
• Intended use chemical contaminants and pesticides that are
reasonably likely to be present and review
In determining whether a hazard is significant you present land use at the pond site and in the
should also consider the intended use of the product, adjacent areas. The processor could then set
which you developed in Step #4. However, in most the critical control point for environmental
cases, it is unlikely that the significance of this chemical contaminants and pesticides at the
hazard will be affected by the intended use of the pre-harvest step.
product.
In this case, you should enter “Yes” in Column 6
STEP #12: IDENTIFY THE CRITICAL of the Hazard Analysis Worksheet for the pre-
CONTROL POINTS (CCP). harvest step. This control approach will be
referred to as “Control Strategy Example 1” in
For each processing step where “environmental Steps #14 through 18. (Note: if you have not
chemical contaminants and pesticides” is identified previously identified “environmental chemical
in Column 3 of the Hazard Analysis Worksheet as a contaminants and pesticides” as a significant
significant hazard, determine whether it is necessary hazard at the pre-harvest step in Column 3 of the
to exercise control at that step in order to control the Hazard Analysis Worksheet, you should change
hazard. Figure #A-2 (Appendix 3) is a CCP decision the entry in Column 3 to “Yes.”)
tree that can be used to aid you in your determina-
tion. b. If no such relationship exists, then you may
identify the receiving step as the CCP for
The following guidance will also assist you in “environmental chemical contaminants and
determining whether a processing step is a CCP for pesticides.” At the receiving step you may
“environmental chemical contaminants and pesti- exercise one of the following preventive
cides”: measures:
Is the raw material an aquacultured product? • Receipt of the aquacultural grower’s lot-by-lot
certification of harvesting from uncontami-
1. If it is, is your relationship with the grower one that nated waters, coupled with appropriate
enables you to visit the farm before receipt of the fish? verification (see Step #18 - Verification).
a. If you have such a relationship with the grower, Example:
then you may identify a pre-harvest step as the A processor of aquacultured shrimp that
CCP for “environmental chemical contaminants purchases raw material shrimp through various
and pesticides.” The preventive measure for brokers could receive lot-by-lot certificates from
this type of control is on-farm visits to the the growers. The certificates would state that the
aquacultural grower to collect and analyze soil shrimp were not harvested from waters that were
and water samples or fish samples for so contaminated by chemicals as to make it
environmental chemical contaminants and reasonably likely that the levels in the fish flesh
pesticides that are reasonably likely to be would be in excess of established tolerances or
present, and to review present land use practices action levels.
in the area immediately surrounding the
production area.
Continued
107
In this case, you should enter “Yes” in Column Example:
6 of the Hazard Analysis Worksheet for the A processor of aquacultured shrimp that
receiving step. This control approach will be purchases raw material shrimp through various
referred to as “Control Strategy Example 2” in brokers could screen all incoming lots of shrimp
Steps #14 through 18. for pesticides that are likely to be used around
the grow-out area.
• Review of environmental chemical contaminant
and pesticide test results of soil and water In this case, you should enter “Yes” in Column 6
samples or of fish flesh samples for those of the Hazard Analysis Worksheet for the
contaminants that are reasonably likely to be receiving step. This control approach will be
present, and monitoring of present land use referred to as “Control Strategy Example 4” in
practices in the area immediately surrounding Steps #14 through 18.
the production area (tests and monitoring to be
performed by the aquacultural grower, a State • Receipt of evidence (e.g. continuing or lot-by-lot
agency, or a third party organization). third party certificate) that the producer operates
under a third party-audited Quality Assurance
Example: program that covers environmental chemical
A processor of farm-raised catfish purchases contaminants and pesticides.
catfish from a grower with which the processor
has no long term relationship. The processor Example:
requires all new suppliers to provide the results A processor of aquacultured trout that regularly
of soil and water chemical contaminant tests for purchases raw material trout from the same
those contaminants that are reasonably likely to grower could obtain a third party certificate,
be present, and reports on present agricultural valid for one year, that attests that the grower
and industrial land use at and near the pond site. operates under a Quality Assurance Program
The land use reports are updated annually. The that covers environmental chemical
testing and reports are done by the grower, a contaminants and pesticides.
trade association, or the State Agriculture
Department. In this case, you should enter “Yes” in Column 6 of
the Hazard Analysis Worksheet for the receiving
In this case, you should enter “Yes” in Column 6 step. This control approach will be referred to as
of the Hazard Analysis Worksheet for the “Control Strategy Example 5” in Steps #14
receiving step. This control approach will be through 18.
referred to as “Control Strategy Example 3” in
Steps #14 through 18. 2. If the product is not an aquacultured product, you
may identify the receiving step as the CCP for
• Environmental chemical contaminant and “environmental chemical contaminants and pesticides.”
pesticide testing of fish flesh for those At the receiving step you may exercise the following
contaminants that are reasonably likely to be preventive measures:
present. This screening can be performed by
rapid analytical methods which may indicate Source control, including:
the presence of industrial chemicals, pesticides • Making sure that incoming fish have not been
and/or toxic elements. If the rapid screening harvested from waters that are closed to
test indicates that contaminants are present, commercial harvest due to environmental
further testing and/or follow-up with the chemical contaminants or pesticides;
supplier would be necessary.
108
• Making sure that incoming fish have not been It is important to note that you may select a control
harvested from waters that are under a strategy that is different from those which are
consumption advisory by a federal, state or local suggested above, provided that it assures an equiva-
regulatory authority based on a determination by lent degree of safety of the product.
the authority that fish harvested from the waters
are reasonably likely to contain contaminants Proceed to Step #13 (Chapter 2) or to Step #10 of the
above the federal tolerances, action levels, or next potential hazard.
guidance levels. Note: many consumption
advisories are not based on such a determination.
• Checking incoming molluscan shellfish to HACCP Plan Form
ensure that they are properly tagged or labeled.
• Checking incoming molluscan shellfish to STEP #14: SET THE CRITICAL LIMITS (CL).
ensure that they are supplied by a licensed
harvester (where licensing is required by law) For each processing step where “environmental
or by a certified dealer. chemical contaminants and pesticides” is identified
as a significant hazard in the HACCP Plan Form
Examples: identify the maximum or minimum value to which a
A processor purchases oysters directly from the feature of the process must be controlled in order to
harvester. The processor checks the harvest control the hazard.
location on the tags attached to the sacks of
oysters. The processor then compares the harvest You should set the critical limit at the point that if not
area location to information on closed waters. met the safety of the product is questionable. If you
The processor also checks the harvester’s State set a more restrictive critical limit you could, as a
license. result, be required to take corrective action when no
safety concern actually exists. On the other hand, if
A processor purchases flounder directly from the you set a critical limit that is too loose you could, as
harvester. The processor asks the harvester a result, allow unsafe product to reach the consumer.
where the fish were caught. The processor then
compares the harvest area location to his As a practical matter it may be advisable to set an
knowledge of the areas that are closed to operating limit that is more restrictive than the
commercial fishing by state or local regulatory critical limit. In this way you can adjust the process
authorities or that are under consumption when the operating limit is triggered, but before a
advisories based on federal tolerance/action triggering of the critical limit would require you to
level/guidance levels. take corrective action. You should set operating
limits based on your experience with the variability
In this case, you should enter “Yes” in Column 6 of your operation and with the closeness of typical
of the Hazard Analysis Worksheet for the operating values to the critical limit.
receiving step. This control approach will be
referred to as “Control Strategy Example 6” in Following is guidance on setting critical limits for the
Steps #14 through 18. Note that for molluscan control strategy examples discussed in Step #12.
shellfish this control strategy is identical to
Control Strategy Example 1 for “pathogens from
the harvest area” (Chapter 4) and Control
Strategy Example 1 for “natural toxins”
(Chapter 6). If you choose an identical control
strategy for two or more of these hazards, you
may combine the hazards in the HACCP Plan
Form.
Continued
109
• CONTROL STRATEGY EXAMPLE 1 - ON-FARM VISIT aquacultural grower, a State agency, or a third
party organization). (Note: EPA has developed
Critical Limit: Levels of environmental chemical water quality documents that may be suitable for
contaminants and pesticides that are reasonably evaluating water quality in local situations);
likely to be present in soil and water samples OR
must not be so high that they are likely to result Analyses of fish flesh for each delivery that
in levels in the fish flesh that are above the show that levels of environmental chemical
established tolerances, action levels, or guidance contaminants and pesticides that are reasonably
levels (Note: federal guidance levels for likely to be present are below the established
environmental chemical contaminants and tolerances, action levels, or guidance levels (tests
pesticides in soil and water have not been may be performed by the aquacultural grower, a
established); State agency, or a third party organization);
OR AND
No lot of fish may exceed the established Annually, reports from all suppliers that show
tolerances, action levels, or guidance levels for that agricultural and industrial practices in the
environmental chemical contaminants and area immediately surrounding the aquaculture
pesticides for those contaminants that are production area are not reasonably likely to cause
reasonably likely to be present; contamination of the fish flesh above the
AND established tolerances, action levels, or guidance
Agricultural and industrial practices in the area levels (monitoring may be performed by the
immediately surrounding the production area aquacultural grower, a State agency, or a third
must not be reasonably likely to cause party organization).
contamination of the fish flesh above the
established tolerances, action levels, or guidance • CONTROL STRATEGY EXAMPLE 4 -
levels. CHEMICAL CONTAMINANT TESTING
• CONTROL STRATEGY EXAMPLE 2 - Critical Limit: No lot of fish may exceed the
SUPPLIER’S CERTIFICATION established tolerances, action levels, or guidance
levels for environmental chemical contaminants
Critical Limit: Certificate accompanying all lots and pesticides for those contaminants that are
received (lot-by-lot) that indicates that the fish reasonably likely to be present.
were not harvested from waters that were so
contaminated by chemicals as to make it • CONTROL STRATEGY EXAMPLE 5 - QA PROGRAM
reasonably likely that the levels in the fish flesh
would be in excess of established tolerances, Critical Limit: Third party certificate indicating that
action levels, or guidance levels. the producer operates under a third party-audited
Quality Assurance program that covers
• CONTROL STRATEGY EXAMPLE 3 - environmental chemical contaminants and
RECORDS OF TESTING AND MONITORING pesticides, either for each lot of incoming
aquacultured fish or for each producer of
Critical Limit: Analyses of the soil and water from incoming aquacultured fish.
all new suppliers that show that levels of
environmental chemical contaminants and • CONTROL STRATEGY EXAMPLE 6 -
pesticides that are reasonably likely to be present SOURCE CONTROL
in the soil and water are not so high that they are
likely to result in levels in the fish flesh that are Critical Limit: No fish may be harvested from an
above the established tolerances, action levels, or area that is closed to commercial fishing by
guidance levels (tests may be performed by the foreign, federal, state, or local authorities;
Continued
110
TABLE #9-1
Environmental Chemical Contaminant and Pesticide Tolerances,

Action Levels, and Guidance Levels
Deleterious Substance Level Food Commodity Reference
Aldrin/Dieldrina 0.3 ppm All fish Compliance Policy Guide sec. 575.100
Benzene hexachloride 0.3 ppm Frog legs Compliance Policy Guide sec. 575.100
Chlordane 0.3 ppm All fish Compliance Policy Guide sec. 575.100
Chlordeconeb 0.3 ppm All fish Compliance Policy Guide sec. 575.100
0.4 ppm Crabmeat
DDT, TDE, DDEc 5.0 ppm All fish Compliance Policy Guide sec. 575.100
Diquatd 0.1 ppm All fish 40 CFR 180.226
Fluridoned 0.5 ppm Fin fish and crayfish 40 CFR 180.420
Glyphosated 0.25 ppm Fin fish 40 CFR 180.364
3.0 ppm Shellfish
Toxic elements:
Arsenic 76 ppm Crustacea FDA Guidance Document
86 ppm Molluscan bivalves FDA Guidance Document
Cadmium 3 ppm Crustacea FDA Guidance Document
Chromium 12 ppm Crustacea FDA Guidance Document
Lead 1.5 ppm Crustacea FDA Guidance Document
1.7 ppm Molluscan bivalves FDA Guidance Document
Nickel 70 ppm Crustacea FDA Guidance Document
Methyl Mercuryf 1 ppm All fish Compliance Policy Guide sec. 540.600
Heptachlor
/Heptachlor Epoxidee 0.3 ppm All fish Compliance Policy Guide sec. 575.100
Mirex 0.1 ppm All fish Compliance Policy Guide sec. 575.100
Polychlorinated
Biphenyls (PCB’s)d 2.0 ppm All fish 21 CFR 109.30
Simazined 12 ppm Fin fish 40 CFR 180.213a
2,4-Dd 1.0 ppm All fish 40 CFR 180.142
a The action level for aldrin and dieldrin are for residues of the pesticides individually or in combination.
However, in adding amounts of aldrin and dieldrin, do not count aldrin or dieldrin found at below 0.1 ppm.
b Previously listed as Kepone, the trade name of chlordecone.
c The action level for DDT, TDE, and DDE are for residues of the pesticides individually or in combination.
However, in adding amounts of DDT, TDE, and DDE, do not count any of the three found below 0.2 ppm.
d The levels published in 21 CFR & 40 CFR represent tolerances, rather than guidance levels or action levels.
e The action level for heptachlor and heptachlor epoxide are for the pesticides individually or in combination.
However, in adding amounts of heptachlor and heptachlor epoxide, do not count heptachlor or heptachlor
epoxide found below 0.1 ppm.
f See Chapter 10 for additional information.
Note: the term “fish” refers to fresh or saltwater fin fish, crustaceans, other forms of aquatic animal life
other than birds or mammals, and all mollusks, as defined in 21 CFR 123.3(d).
111
AND (Note: only the primary processor [the processor that
No fish may be harvested from an area that is takes possession of the molluscan shellfish from the
under a consumption advisory by a federal, state, harvester] need apply controls relative to the identifi-
or local regulatory authority based on a cation of the harvester, the harvester’s license, or the
determination by the authority that fish approval status of the harvest waters.)
harvested from the waters are reasonably likely
to contain contaminants above the federal • Tolerances, action levels, and guidance levels
tolerances, action levels, or guidance levels.
Note: many consumption advisories are not Environmental chemical contaminant and pesticide
based on such a determination. tolerances, action levels, and guidance levels for
AND poisonous or deleterious substances in the edible
For molluscan shellfish: portion wet weight of fish are listed in Table #9-1.
• All containers of shellstock (in-shell molluscan
shellfish) must bear a tag that discloses the Enter the critical limit(s) in Column 3 of the HACCP
date and place they were harvested (by State Plan Form.
and site), type and quantity of shellfish, and
by whom they were harvested (i.e., the STEP #15: ESTABLISH MONITORING
identification number assigned to the harvester PROCEDURES.
by the shellfish control authority, where
applicable or, if such identification numbers For each processing step where “environmental
are not assigned, the name of the harvester or chemical contaminants and pesticides” is identified
the name or registration number of the as a significant hazard on the HACCP Plan Form,
harvester’s vessel). For bulk shipments of describe monitoring procedures that will ensure that
shellstock, where the shellstock is not the critical limits are consistently met.
containerized, all shellstock must be
accompanied by a bill of lading or other To fully describe your monitoring program you
similar shipping document that contains the should answer four questions: 1) What will be
same information. monitored? 2) How will it be monitored? 3) How
AND often will it be monitored (frequency)? 4) Who will
• All molluscan shellfish must be harvested from perform the monitoring?
waters authorized for harvesting by a shellfish
control authority. For U.S. Federal waters, no It is important for you to keep in mind that the
molluscan shellfish may be harvested from feature of the process that you monitor and the
waters that are closed to harvesting by an method of monitoring should enable you to deter-
agency of the federal government. mine whether the critical limit is being met. That is,
AND the monitoring process should directly measure the
• All containers of shucked molluscan shellfish feature for which you have established a critical
must bear a label that identifies the name, limit.
address, and certification number of the packer
or repacker of the product. You should monitor often enough so that the normal
AND variability in the values you are measuring will be
• All containers of molluscan shellfish must be detected. This is especially true if these values are
from a fisherman that is licensed as required typically close to the critical limit. Additionally, the
(note that licensing may not be required in all greater the time span between measurements the
jurisdictions) or from a processor that is more product you are putting at risk should a mea-
certified by a Shellfish Control Authority. surement show that a critical limit has been violated.
112
Following is guidance on establishing monitoring • CONTROL STRATEGY EXAMPLE 6 -
procedures for the control strategy examples dis- SOURCE CONTROL
cussed in Step #12. Note that the monitoring fre-
quencies that are provided are intended to be consid- What: Location and status (e.g. open, closed) of the
ered as minimum recommendations, and may not be harvest area;
adequate in all cases. AND
For molluscan shellfish:
• The tags on containers of shellstock. The Bill
What Will Be Monitored? of Lading or other similar shipping document
accompanying bulk shipments of shellstock;
• CONTROL STRATEGY EXAMPLE 1 - ON-FARM VISIT AND
• The harvest site listed on the tag or on the Bill
What: Environmental chemical contaminant and of Lading or other similar shipping document;
pesticide levels in soil and water or in fish flesh AND
for those contaminants that are reasonably likely • The labels on containers of shucked molluscan
to be present; shellfish;
AND AND
Agricultural and industrial practices near the • The license of fishermen, where applicable;
production area. AND
• The certification number of suppliers (other
• CONTROL STRATEGY EXAMPLE 2 - than fishermen) of shellstock or shucked
SUPPLIER’S CERTIFICATION molluscan shellfish.
What: Presence of a certificate indicating harvesting

from uncontaminated waters. How Will Monitoring Be Done?
• CONTROL STRATEGY EXAMPLE 3 - • CONTROL STRATEGY EXAMPLE 1 - ON-FARM VISIT

RECORDS OF TESTING AND MONITORING
How: Collect and analyze soil and water samples or
What: Soil and water, or fish flesh, chemical fish flesh samples from each production area;
contaminant test results for those contaminants AND
that are reasonably likely to be present; Ask questions about and observe agricultural
AND and industrial practices in the production area,
Agricultural and industrial practices monitoring such as:
results. • What crops are grown in the area immediately
surrounding the production area?
CHEMICAL CONTAMINANT TESTING • What pesticides are used on these crops, how
are they applied, and at what time of year?
What: Fish flesh for environmental chemical AND
contaminants and pesticides that are reasonably • What industrial discharges enter the watershed
likely to be present. surrounding the production site?
• CONTROL STRATEGY EXAMPLE 5 - QA PROGRAM
What: Third party certificate indicating operation

under third-party audited QA program.
Continued
113
SUPPLIER’S CERTIFICATION RECORDS OF TESTING AND MONITORING
How: Visual for presence of certificate. Frequency: For soil and water test results:
all new suppliers;
• CONTROL STRATEGY EXAMPLE 3 - OR
RECORDS OF TESTING AND MONITORING For fish flesh test results: each delivery;
AND
How: Visual of test results and monitoring reports. For monitoring reports: at least once every year.

CHEMICAL CONTAMINANT TESTING CHEMICAL CONTAMINANT TESTING
How: Obtain samples and analyze for environmental Frequency: Each lot received.
chemical contaminants and pesticides using rapid
screening methods. • CONTROL STRATEGY EXAMPLE 5 - QA PROGRAM
• CONTROL STRATEGY EXAMPLE 5 - QA PROGRAM Frequency: Each lot received checked for presence
of certificate. Certificates may be issued on a lot-
How: Visual for presence of certificate. by-lot or continuing basis, but at least annually.

SOURCE CONTROL SOURCE CONTROL
How: Ask harvester; Frequency: Each lot received;

AND AND
For molluscan shellfish: visual checks. For Molluscan Shellfish:
• For checking tags: every container;
AND
How Often Will Monitoring Be Done • For checking harvest site: every lot;
(Frequency)? AND
• For checking labels: at least three containers
• CONTROL STRATEGY EXAMPLE 1 - ON-FARM VISIT randomly selected from throughout every lot;
AND
Frequency: For testing soil or water: before first • For checking licenses: every delivery;
delivery from each production area; AND
OR • For checking certification numbers: every
For testing fish flesh: before each delivery; delivery.
AND
For monitoring: at least once per year for each
aquaculture production site. Who Will Perform the Monitoring?
• CONTROL STRATEGY EXAMPLE 2 - • CONTROL STRATEGY EXAMPLE 1 - ON-FARM VISIT

SUPPLIER’S CERTIFICATION
Who: Field agent (employee or contractor) or any
Frequency: Each lot received. other person who has an understanding of
chemical contaminants and their limits.
114
• CONTROL STRATEGY EXAMPLE 2 - STEP #16: ESTABLISH CORRECTIVE
SUPPLIER’S CERTIFICATION ACTION PROCEDURES.
Who: Receiving dock employee, production For each processing step where “environmental
employee, production supervisor, a member of chemical contaminants and pesticides” is identified
the quality control staff, or any other personnel as a significant hazard on the HACCP Plan Form,
who has an understanding of the control describe the procedures that you will use when your
measure. monitoring indicates that the critical limit has not
been met.
RECORDS OF TESTING AND MONITORING These procedures should: 1) ensure that unsafe
Who: Receiving dock personnel, production the problem that caused the critical limit deviation.
employee, production supervisor, a member of Remember that deviations from operating limits do
the quality control staff, or any other personnel not need to result in formal corrective actions.
who has an understanding of chemical
contaminants and their limits. Following is guidance on establishing corrective
• CONTROL STRATEGY EXAMPLE 4 - discussed in Step #12.
CHEMICAL CONTAMINANT TESTING
• CONTROL STRATEGY EXAMPLE 1 - ON-FARM VISIT
Who: Member of the quality control staff or contract
laboratory. Corrective Action: Do not have product shipped
to plant, if the CL is not met;
• CONTROL STRATEGY EXAMPLE 5 - QA PROGRAM AND
Discontinue use of supplier until evidence is
Who: Receiving employee or supervisor, production obtained that the cause of the chemical
supervisor, a member of the quality control staff, contamination has been eliminated.
or any other person who has an understanding of
the control procedure. • CONTROL STRATEGY EXAMPLE 2 -
SOURCE CONTROL Corrective Action: Reject lot, if the CL is not met;
OR
Who: Receiving dock personnel, production Hold the lot until a certificate can be provided;
employee, production supervisor, a member of OR
the quality control staff, or any other personnel Hold and analyze the lot for environmental
who has an understanding of the control chemical contaminants and pesticides. This
measure. screening can be performed by rapid analytical
methods which may indicate the presence of
(Note: only the primary processor [the processor that industrial chemicals, pesticides and/or toxic
takes possession of the molluscan shellfish from the elements. If the rapid screening test indicates
harvester] need apply controls relative to the identifi- that contaminants are present, further testing
cation of the harvester, the harvester’s license, or the and/or follow-up with the supplier would be
approval status of the harvest waters.) necessary.

Continued
115
RECORDS OF TESTING AND MONITORING • Discontinue use of the supplier until evidence
is obtained that the supplier will comply
Corrective Action: Reject lot, if the CL is not met; with the established source control practices.
AND
Discontinue use of supplier until evidence is (Note: only the primary processor [the processor that
obtained that the cause of the chemical takes possession of the molluscan shellfish from the
contamination has been eliminated. harvester] need apply controls relative to the identifi-
cation of the harvester, the harvester’s license, or the
• CONTROL STRATEGY EXAMPLE 4 - approval status of the harvest waters.)
CHEMICAL CONTAMINANT TESTING
Note: If an incoming lot that fails to meet a receiving
Corrective Action: Reject lot, if the CL is not met; critical limit is mistakenly accepted, and the error is
AND later detected, the following actions should be taken:
Discontinue use of supplier until evidence is 1) the lot and any products processed from that lot
obtained that the cause of the chemical should be destroyed, diverted to a nonfood use or to a
contamination has been eliminated. use in which the critical limit is not applicable, or
placed on hold until a food safety evaluation can be
• CONTROL STRATEGY EXAMPLE 5 - QA PROGRAM completed; and 2) any products processed from that
lot that have already been distributed should be
Corrective Action: Reject lot, if the CL is not met. recalled and subjected to the actions described above.
• CONTROL STRATEGY EXAMPLE 6 - Enter the corrective action procedures in Column 8 of

SOURCE CONTROL the HACCP Plan Form.
Corrective Action: Reject lot, if the CL is not met;

STEP #17: ESTABLISH A RECORDKEEPING
OR SYSTEM.
For fish under a consumption advisory based on For each processing step where “environmental
a federal tolerance/action level/guidance level: chemical contaminants and pesticides” is identified
Sample the lot and analyze for the appropriate as a significant hazard on the HACCP Plan Form, list
environmental contaminant. Reject the lot if the the records that will be used to document the accom-
results exceed the federal tolerance/action level/ plishment of the monitoring procedures discussed in
guidance level; Step #15. The records should clearly demonstrate
AND that the monitoring procedures have been followed,
For molluscan shellfish: and should contain the actual values and observations
• Reject shellstock that is not properly tagged obtained during monitoring.
or is not accompanied by a proper shipping
document; Following is guidance on establishing a
AND recordkeeping system for the control strategy ex-
• Reject shucked molluscan shellfish that is not amples discussed in Step #12.
properly labeled;
AND • CONTROL STRATEGY EXAMPLE 1 - ON-FARM VISIT
• Reject molluscan shellfish that has been
harvested from unapproved waters; Records: Test results;
AND AND
• Reject molluscan shellfish that is not from a On-site audit report.
licensed harvester or certified processor;
116
SUPPLIER’S CERTIFICATION • Number and date of expiration of the
harvester’s license, where applicable;
Records: Copy of certificate; AND
AND • Certification number of the shipper, where
Receiving record showing lots received and applicable;
presence/absence of certificate. AND
For shucked molluscan shellfish: a receiving
• CONTROL STRATEGY EXAMPLE 3 - record that documents:
RECORDS OF TESTING AND MONITORING • Date of receipt;
AND
Records: Test results; • Quantity and type of shellfish;
AND AND
Monitoring reports. • Name and certification number of the packer or
repacker.
CHEMICAL CONTAMINANT TESTING (Note: only the primary processor [the processor that
Records: Test results. harvester] need apply controls relative to the identifi-
cation of the harvester, the harvester’s license, or the
• CONTROL STRATEGY EXAMPLE 5 - QA PROGRAM approval status of the harvest waters.)
Records: Third party certificate; Enter the names of the HACCP records in Column 9
AND of the HACCP Plan Form.
Receiving record showing lots received and
presence/absence of certificate. STEP #18: ESTABLISH VERIFICATION
PROCEDURES.
SOURCE CONTROL For each processing step where “environmental
chemical contaminants and pesticides” is identified
Records: Receiving records that document the as a significant hazard on the HACCP Plan Form,
harvest location and status (e.g. open, closed) of establish verification procedures that will ensure that
the harvest area; the HACCP plan is: 1) adequate to address the
AND hazard; and, 2) consistently being followed.
For molluscan shellfish shellstock: a receiving
record that documents: Following is guidance on establishing verification
• Date of harvest; procedures for the control strategy examples dis-
AND cussed in Step #12.
• Location of harvest by State and site;
AND • CONTROL STRATEGY EXAMPLE 1 - ON-FARM VISIT
AND Verification: Review monitoring and corrective
• Name of the harvester, name or registration action records within one week of preparation.
number of the harvester’s vessel, or an
identification number issued to the harvester
by the shellfish control authority;
117
SUPPLIER’S CERTIFICATION RECORDS OF TESTING AND MONITORING
Verification: Visit all new aquacultured fish Verification: Review monitoring and corrective
suppliers within the year and all existing fish action records within one week of preparation.
suppliers at a predetermined frequency (e.g. 25%
per year) to collect and analyze soil and/or water • CONTROL STRATEGY EXAMPLE 4 -
samples, as appropriate, for environmental CHEMICAL CONTAMINANT TESTING
chemical contaminants and pesticides, and
review agricultural and industrial practices in the Verification: Review monitoring and corrective
production area; action records within one week of preparation.
OR
Collect a representative sample of the raw • CONTROL STRATEGY EXAMPLE 5 - QA PROGRAM
material, in-process product, or finished product
at least quarterly and analyze for drug residues; Verification: Review monitoring and corrective
AND action records within one week of preparation.
Review monitoring, corrective action, and
verification records within one week of • CONTROL STRATEGY EXAMPLE 6 -
preparation. SOURCE CONTROL

action records within one week of preparation.

HACCP Plan Form.
118
TABLE #9-2
Control Strategy Example 1 - On-farm visits
This table is a an example of a portion of a HACCP plan relating to the control of environmental chemical contaminants and
pesticides in pond-raised catfish, using Control Strategy Example 1 - On-farm visit. It is provided for illustrative purposes only.
Chemical contaminants may be only one of several significant hazards for this product. Refer to Tables 3-1, 3-2, and 3-3
(Chapter 3) for other potential hazards (e.g. aquaculture drugs and metal fragments).
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
Pre-harvest Chemical contaminants • Levels of environmental • Environmental • Collect samples • Before harvest • Field agent will • Do not have • Test results • Review
chemical contaminants chemical and analyze for submit samples product shipped monitoring
and pesticides in fish contaminant and environmental to contract to plant and corrective
flesh may not exceed pesticide levels chemical laboratory action records
Seestablished tolerances, in fish flesh contaminants AND within one week
action levels, and samples before and pesticides of preparation
119
guidance levels for those harvest for those using rapid • Discontinue use
eT
contaminants that are
ex contaminants that screening of supplier until
reasonably likely to be are reasonably methods evidence is
present likely to be obtained that the
t f Exa
present cause of the
or mp
Fu le chemical
contamination
has been
ll R O
eco nly eliminated
• Agricultural and • Agricultural and • Ask questions • Once per year • Field agent • Same • Field agent • Review
industrial practices in industrial and observe report monitoring
mm
the area immediately practices near agricultural and and correction
surrounding the pond the pond industrial action records
en
must not be reasonably practices within one week
da
likely to cause tio of preparation
contamination of the
fish flesh above the
ns
established tolerances,
action levels, or
guidance levels.
TABLE #9-3
Control Strategy Example 2 - Supplier’s Certification
This table is an example of a portion of a HACCP plan relating to the control of environmental chemical contaminants and pesticides
in aquacultured salmon, using Control Strategy Example 2 - Supplier’s certification. It is provided for illustrative purposes only.
Chemical contaminants may be only one of several significant hazards for this product. Refer to Tables 3-1, 3-2, and 3-3
(Chapter 3) for other potential hazards (e.g. aquaculture drugs, chemical contaminants, and metal fragments).
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
Receiving Environmental chemical Certificate accompanying Presence of a Visual Each lot received Receiving dock Reject lot • Copy of • Review
contaminants and all lots received indicates certificate employee certificate monitoring,
pesticides that the fish were not corrective
harvested from waters that • Receiving action, and
were so contaminated by
Se record verification
chemicals as to make it records within
120
reasonably likely that the one week of
eT
levels in the fish flesh
ex preparation
would be in excess of
established tolerances, • Visit all new
t f Exa
action levels, or guidance suppliers and
or mp
levels. Fu le 25% of existing
suppliers each
year and collect
ll R O
soil and/or
water samples
eco nly
and review
agricultural and
mm
industrial
practices in
en
the area
da
tio
ns
TABLE #9-4
Control Strategy Example 3 - Records of testing and monitoring
This table is an example of a portion of a HACCP plan relating to the control of environmental chemical contaminants
and pesticides in farmed-raised trout, using Control Strategy Example 3 - Records of testing and monitoring.
It is provided for illustrative purposes only. Chemical contaminants may be only one of several significant hazards for this product.
Refer to Tables 3-1, 3-2, and 3-3 (Chapter 3) for other potential hazards (e.g. aquaculture drugs and metal fragments).
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
Receiving Environmental chemical • Analyses of fish flesh • Levels of • Visual • Each delivery • Quality control • Reject lot, • Test results • Review
contaminants and for each delivery that environmental staff monitoring
pesticides show that levels of chemical AND and corrective
environmental chemical contaminants action records
contaminants and and pesticides in • Discontinue use within one week
pesticides that are soil and water of supplier until of preparation
reasonably likely to be samples for those evidence is
Se
121
present are below the contaminants that obtained that the
established tolerances, are reasonably source of the
eT
action levels, or likely to be chemical
ex
guidance levels (tests present contamination
may be performed by has been
t f Exa
the aquacultural grower, eliminated
or mp
a State agency, or a
Fu le
trade association)
ll R O
• Annually, reports from • Agricultural and • Visual • Once per year • Quality control • Same • Monitoring • Review
all suppliers that show industrial staff reports monitoring
eco nly
that agricultural and practices near the and correction
industrial practices in production area action records
mm
the area immediately within on week
surrounding the en of preparation
production area are not
reasonably likely to
da
cause contamination of tio
the fish flesh above the
established tolerances,
ns
action levels, or
guidance levels
(monitoring may be
performed by the
aquacultural grower, a
State agency, or a trade
association)
TABLE #9-5
Control Strategy Example 4 - Chemical contaminant testing
and pesticides in pond-raised shrimp, using Control Strategy Example 4 - Chemical contaminant testing. It is provided for
illustrative purposes only. Chemical contaminants may be only one of several significant hazards for this product. Refer to Tables
3-1, 3-2, and 3-3 (Chapter 3) for other potential hazards (e.g. aquaculture drugs, food and color additives, and metal fragments).
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
Receiving Environmental chemical No lot of fish may exceed Fish flesh for Obtain samples Each lot received Receiving • Reject lot Test results Review
contaminants and the established tolerances, chemical residues and analyze for employee will monitoring and
pesticides action levels, or guidance that are reasonably environmental submit sample to AND corrective action
levels for environmental likely to be present chemical quality control records within
chemical contaminants
Se contaminants and staff • Discontinue use one week of
and pesticides that are pesticides using of supplier until preparation
122
reasonably likely to be rapid screening evidence is
eT
present
ex methods obtained that the
cause of the
chemical
t f Exa
contamination
or mp
Fu le has been
ll R O eliminated
eco nly
mm
en
da
tio
ns
TABLE #9-6
Control Strategy Example 5 - QA program
and pesticides for an aquacultured trout processor, using Control Strategy Example 5 - QA program.
It is provided for illustrative purposes only. Chemical contaminants may be only one of several significant hazards for this product.
Refer to Tables 3-1, 3-2, and 3-3 (Chapter 3) for other potential hazards (e.g. aquaculture drugs and metal fragments).
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
Receiving Environmental chemical Third party certificate Presence of third Visual, for Each lot checked Receiving dock Reject lot • Certificate Review
contaminants and indicating that the party certificate presence of to see if covered employee monitoring and
pesticides producer operates under certificate by certificate, AND • Receiving record corrective action
a Quality Assurance which is renewed records within
Program that covers
Se annually Discontinue use of one week of
environmental chemical the supplier until preparation
123
contaminants and evidence is
eT
pesticides
ex obtained that the
supplier will
comply with the
t f Exa
established source
or mp
Fu le control practices
ll R O
eco nly
mm
en
da
tio
ns
TABLE #9-7
This table is an example of a portion of a HACCP plan relating to the control of environmental chemical contaminants and
pesticides in wild-caught flounder, using Control Strategy Example 6 - Source control. It is provided for illustrative purposes only.
Guidance for processors of molluscan shellfish using source control is provided in Table #4-1 (Chapter 4).
Chemical contaminants may be only one of several significant hazards for this product.
Refer to Tables 3-1, 3-2, and 3-3 (Chapter 3) for other potential hazards (e.g. parasites and metal fragments).
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
Receiving Environmental chemical No fish may be harvested Location of Ask harvester Each lot received Receiving dock Reject lot Receiving record Review
contaminants and from an area that is closed harvest area employee monitoring and
pesticides to commercial fishing by AND corrective action
Se
foreign federal, state, or record within one
124
local authorities Discontinue use of week of
eT
the supplier until preparation
ex
No fish may be harvested evidence is obtained
from an area that is under that the supplier will
t f Exa
a consumption advisory comply with the
or mp
by a federal, state, or local
Fu le established source
regulatory authority based control practices
on a determination by the
ll R O
authority that fish
harvested from the waters
eco nly
are reasonably likely to
contain contaminants
mm
above the federal en
tolerances, action levels,
or guidance levels. Note:
da
many consumption tio
advisories are not based
on such a determination.
ns
Chapter 10: Methyl Mercury (A Chemical Hazard)
The draft Fish and Fishery Products Hazards and While FDA has not changed the 1.0 ppm action level,
Controls Guide (February 16, 1994) listed methyl the agency is re-evaluating it in light of significant
mercury as a potential safety hazard for bonito, new data on the health effects of methyl mercury
halibut, Spanish mackerel, king mackerel, marlin, from consumption of fish. These data have become
shark, swordfish, and bluefin tuna. The selection of available since the action level was developed.
these species was based on historical data on levels
of methyl mercury found in fish consumed in the When the action level re-evaluation is completed,
U.S. The selection was also based on an FDA action FDA will, among other things, update this Guide by
level of 1.0 ppm in the edible portion of fish. including advice on how to assess the significance of
a potential methyl mercury hazard in fish, and what
controls, if any, are necessary to ensure the safety of
fish in this regard.
Chapter 10: Mercury

125
Notes:
Chapter 10: Mercury

126
Chapter 11: Aquaculture Drugs (A Chemical Hazard)
Hazard Analysis Worksheet STEP #11: DETERMINE IF THIS

POTENTIAL HAZARD IS SIGNIFICANT.
STEP #10: UNDERSTAND THE POTENTIAL
HAZARD. At each processing step, determine whether “aquac-
ulture drugs” is a significant hazard. The criteria are:
Unregulated/unapproved drugs administered to
aquacultured fish pose a potential human health 1. Is it reasonably likely that unsafe levels of aquacul-
hazard. These substances may be carcinogenic, ture drugs will be introduced at this processing step
allergenic, and/or may cause antibiotic resistance in (e.g. do raw materials come in with unsafe levels of
man. To control this hazard in food animals, all aquaculture drugs, or are they used at this step)?
drugs, whether for direct medication or for addition
to feed, must be approved by FDA. Under certain Under ordinary circumstances, it would be reason-
conditions authorized by FDA, unapproved new ably likely to expect that unsafe levels of aquaculture
animal drugs may be used in conformance with the drugs could enter the process during the receiving of
terms of an Investigational New Animal Drug any type of aquacultured fish, including:
(INAD) application. • Fin fish;
• Crustaceans;
Incentives for the use of animal drugs in aquatic • Aquatic animals, such as alligator.
animal species include the need to: 1) treat and
prevent disease; 2) control parasites; 3) affect repro- Under ordinary circumstances it would also be
duction and growth; and, 4) tranquilization (e.g. reasonably likely to expect that unsafe levels of
during transit). Relatively few drugs have been aquaculture drugs could enter the process during the
approved for aquaculture. As a result, aquaculture holding of live lobster (e.g. lobster pounds).
growers may use unapproved drugs, general purpose
chemicals that are not labeled for drug use, and Under ordinary circumstances it would not be
approved drugs in a manner that deviates from the reasonably likely to expect that aquaculture drugs
labeled instructions. could enter the process during the receiving of wild-
caught fish. Currently, FDA is not aware of drug use
When a drug is approved by FDA’s Center for in the grow-out of molluscan shellfish. If the agency
Veterinary Medicine, the conditions of the approval becomes aware of such use, this Guide, and, in
are listed on its label. These conditions include: the particular, Table #3-2 (Chapter 3) will be updated
species for which the drug is approved; the approved accordingly. On a regional basis, it may be reason-
dosage; the approved route of administration; the able for you to conclude that aquaculture drug use is
approved frequency of use; and the approved indica- not a significant hazard for other species, because
tions for use. Only a licensed veterinarian may they are not used by producers in your region.
legally prescribe or use a drug under conditions that
2. Can the presence of unsafe levels of aquaculture
are not listed on the label. This restriction is more
drugs, which are reasonably likely to occur, be elimi-
fully explained in 21 CFR 530.
nated or reduced to an acceptable level here? (Note:
If you are not certain of the answer to this question at
Labels of approved drugs list mandatory withdrawal
this time, you may answer “No.” However, you may
times, where applicable. These withdrawal times
need to change this answer when you assign critical
must be observed to ensure that the edible tissue is
control points in Step #12)
safe when it is offered for sale. Tissue residue
tolerances have been established for some drugs.
Continued
Chapter 11: Drugs
127
“Aquaculture drugs” should also be considered a List such preventive measures in Column 5 of the
significant hazard at any processing step where a Hazard Analysis Worksheet at the appropriate
preventive measure is, or can be, used to eliminate processing step(s). Ordinarily this will be either the
the hazard (or reduce the likelihood of its occurrence receiving step or the preharvest step. However, in the
to an acceptable level), if it reasonably likely to occur. case of an integrated operation, where fish processing
and grow-out, and, perhaps feed manufacture, are
Preventive measures for the control of aquaculture performed by the same firm, it may be possible and
drugs used in aquaculture operations can include: desirable to exercise preventive measures early in the
• On-farm visits to review drug usage (other than process (ideally at feed manufacture), rather than at
INADs) before receipt of the product, coupled receipt of the fish at the processing plant. Such
with a supplier’s lot-by-lot certificate that any preventive measures will not be covered in this
INADs used were used in conformance with the chapter. For the holding of live fish (e.g. lobster
application requirements; pounds) the preventive measure will usually be
• Receipt of supplier’s lot-by-lot certification of applied at the holding step.
proper drug usage, coupled with appropriate
verification (See Step #18 - Verification); If the answer to either question 1 or 2 is “Yes,” the
• Review of drug usage records (other than INADs) potential hazard is significant at that step in the
at receipt of the product, coupled with a supplier’s process and you should answer “Yes” in Column 3 of
lot-by-lot certificate that any INADs used were the Hazard Analysis Worksheet. Except in the case
used in conformance with the application of an integrated aquaculture operation, this will
requirements; usually be the receiving step. If none of the criteria
• Drug residue testing; are met you should answer “No.” You should record
• Receipt of evidence (e.g. third party certificate) the reason for your “Yes” or “No” answer in Column
that the producer operates under a third party- 4. You need not complete Steps #12 through 18 for
audited Quality Assurance Program for aquaculture this hazard for those processing steps where you have
drug use. recorded a “No.”
(Note: The use of Investigational New Animal Drugs It is important to note that identifying this hazard as
(INAD) is confidential unless an exception is made significant at a processing step does not mean that it
by the sponsor of the drug research. Thus, review of must be controlled at that processing step. The next
INAD drug usage records by the processor may not step will help you determine where in the process the
be practical in certain situations. Written certifica- critical control point is located.
tion from the grower to the processor stating that any
INAD drug usage is in accordance with authoriza- • Intended use
tions from FDA/Center for Veterinary Medicine, will
be acceptable on a lot-by-lot basis.) In determining whether a hazard is significant you
should also consider the intended use of the product,
Preventive measures for the control of aquaculture which you developed in Step #4. However, for
drugs used during the holding of live fish (e.g. lobster aquaculture drugs, it is unlikely that the intended use
pounds) can include controlled application of animal will affect the significance of the hazard.
drugs in a manner consistent with:
• The established withdrawal times;
• The labeled instructions for use;
• Extralabel use of FDA-approved drugs, under a
veterinarian’s supervision in accordance with FDA
regulations and guidelines;
• The conditions specified in the FDA “low
regulatory priority aquaculture drug” list;
• The conditions of an INAD application.
Chapter 11: Drugs

128
STEP #12: IDENTIFY THE CRITICAL In this case, you should enter “Yes” in Column 6 of
CONTROL POINTS (CCP). the Hazard Analysis Worksheet for the pre-harvest
step. This control approach will be referred to as
For each processing step where “aquaculture drugs” “Control Strategy Example 1” in Steps #14 through
is identified in Column 3 of the Hazard Analysis 18. (Note: if you have not previously identified
Worksheet as a significant hazard, determine whether “aquaculture drugs” as a significant hazard at the pre-
it is necessary to exercise control at that step in order harvest step in Column 3 of the Hazard Analysis
to control the hazard. Figure #A-2 (Appendix 3) is a Worksheet, you should change the entry in Column 3
CCP decision tree that can be used to aid you in your to “Yes.”)
determination.
b. If you have no such relationship with the grower,
The following guidance will also assist you in then you may identify the receiving step as the CCP
determining whether a processing step is a CCP for for “aquaculture drugs.” At the receiving step you
“aquaculture drugs”: may exercise one of the following preventive
measures:
Is the hazard the result of the use of aquaculture • Supplier’s lot-by-lot certification of proper drug
drugs during the raising of fish (i.e. aquaculture) or usage, coupled with appropriate verification
during the holding of live fish (e.g. lobster pounds)? (See Step #18 - Verification).
1. If it is the result of aquaculture, is your relationship Example:

with the grower one that enables you to visit the farm A processor of aquacultured shrimp that
before receipt of the fish? purchases raw material shrimp through various
brokers could receive lot-by-lot certificates from
a.If you have such a relationship with the grower, the growers. The certificates would state that all
then you may identify a pre-harvest step as the drugs were used in conformance with applicable
CCP for “aquaculture drugs.” The preventive regulations and labeled instructions. The
measure for this type of control is on-farm visits to processor combines this monitoring procedure
review drug usage, coupled with a supplier’s lot- with quarterly raw material testing for verification.
by-lot certificate that any INADs used were used in
conformance with the application requirements. In this case, you should enter “Yes” in Column 6 of
the Hazard Analysis Worksheet for the receiving step.
Example: This control approach will be referred to as “Control
A processor of aquacultured catfish that Strategy Example 2” in Steps #14 through 18.
regularly purchases from the same growers
would visit the grower before the fish are • Review of drug usage records (other than INADs)
harvested and review the grower’s drug usage at receipt of the product, coupled with a supplier’s
practices and records. The processor could also lot-by-lot certificate that any INADs used were
receive a guarantee that any INADs used were used in conformance with the application
used in conformance with the application requirements.
requirements. The processor could then set the
critical control point for aquaculture drugs at the Example:
pre-harvest step. A processor of aquacultured shrimp that
purchases raw material shrimp through various
brokers could receive records of drug use (other
than INADs) from the growers when the product
is delivered. Additionally, the processor could
receive a lot-by-lot certificate that would state
that any INADs were used in conformance with
the application requirements.
Continued
Chapter 11: Drugs
129
In this case, you should enter “Yes” in Column 6 of Example:
the Hazard Analysis Worksheet for the receiving step. A processor of aquacultured trout that regularly
This control approach will be referred to as “Control purchases raw material trout from the same
Strategy Example 3” in Steps #14 through 18. grower could obtain a third party certificate,
valid for one year, that attests that the grower
• Drug screening on all lots at receipt. This operates under a Quality Assurance Program
screening can be performed by rapid analytical which covers aquaculture drug usage.
methods which may indicate the presence of a
family of drugs, rather than any specific drug. If In this case, you should enter “Yes” in Column 6 of
the rapid screening test indicates that a family of the Hazard Analysis Worksheet for the receiving step.
drugs is present, further testing and/or follow-up This control approach will be referred to as “Control
with the supplier would be necessary. Strategy Example 5” in Steps #14 through 18.
Note: A limited number of drug screening tests for 2. If the hazard is the result of live fish holding (e.g.
aquaculture are available. Tests are not available to lobster pounds), then you may identify the holding step
assay for all drugs that might be used in all as the CCP for “aquaculture drugs.” The preventive
aquacultured species. Processors should be cau- measure for this type of control is the controlled
tioned that tests that have not been validated may be application of animal drugs (e.g. oxytetracycline) in a
unreliable. These tests may fail to detect a residue or manner consistent with: the established withdrawal
may give a false positive. FDA has not validated any times; the labeled instructions for use; extralabel use of
of the aquaculture screening tests; nor has the an FDA-approved drug, under a veterinarian’s supervi-
Association of Official Analytical Chemists (AOAC). sion in accordance with FDA regulations and guide-
Processors should assure themselves that the tests lines; the conditions specified in the FDA “low regula-
that they intend to use have otherwise been validated tory priority aquaculture drug” list; and, the conditions
and are appropriate for the species and tissue to be of an INAD application.
tested.
Example:
Example: A processor that uses oxytetracycline in the
A processor of aquacultured shrimp that holding of live lobster in a lobster pound would
purchases raw material shrimp through various use the drug in accordance with the established
brokers could screen all incoming lots of shrimp withdrawal time and any other labeled
with a bank of validated rapid tests that target instructions.
the families of drugs likely to be used during
grow-out. In this case, you should enter “Yes” in Column 6 of
the Hazard Analysis Worksheet for the holding step.
In this case, you should enter “Yes” in Column 6 of This control approach will be referred to as “Control
the Hazard Analysis Worksheet for the receiving step. Strategy Example 6” in Steps #14 through 18.
This control approach will be referred to as “Control
Strategy Example 4” in Steps #14 through 18. It is important to note that you may select a control
strategy that is different from those which are
• Receipt of evidence (e.g. continuing or lot-by-lot suggested above, provided that it assures an equiva-
third party certificate) that the producer operates lent degree of safety of the product.
under a third party-audited Quality Assurance
program for aquaculture drug use. Proceed to Step #13 (Chapter 2) or to Step #10 of the
next potential hazard.
Chapter 11: Drugs

130
HACCP Plan Form OR
• Listed on the FDA “low regulatory priority
STEP #14: SET THE CRITICAL LIMITS (CL). aquaculture drug” list;
OR
For each processing step where “aquaculture drugs” • Permitted by FDA for use in food fish under
is identified as a significant hazard on the HACCP the conditions of an INAD (as evidenced by a
Plan Form, identify the maximum or minimum value lot-by-lot written certificate from the grower).
to which a feature of the process must be controlled
in order to control the hazard. • CONTROL STRATEGY EXAMPLE 2 -
You should set the critical limit at the point that if not
met the safety of the product may be questionable. If Critical Limit: Certificate indicating proper drug
you set a more restrictive critical limit you could, as a usage accompanying each lot of incoming
result, be required to take corrective action when no aquacultured fish.
safety concern actually exists. On the other hand, if
you set a critical limit that is too loose you could, as • CONTROL STRATEGY EXAMPLE 3 -
RECORDS OF DRUG USE
a result, allow unsafe product to reach the consumer.
Critical Limit: Animal drugs used on fish only if the
As a practical matter it may be advisable to set an drugs have been:
operating limit that is more restrictive than the • Approved by FDA and used in accordance with
critical limit. In this way you can adjust the process proper withdrawal times and other labeled
when the operating limit is triggered, but before a conditions;
triggering of the critical limit would require you to OR
take corrective action. You should set operating • Approved by FDA and used in an extra-label
limits based on your experience with the variability manner under a veterinarian’s supervision in
of your operation and with the closeness of typical accordance with FDA regulations and guide
operating values to the critical limit. lines. The regulations and guidelines are
available from the FDA Center for Veterinary
Following is guidance on setting critical limits for the Medicine, HFV-230, 7500 Standish Place,
control strategy examples discussed in Step #12. Rockville, MD 20855;
OR
• CONTROL STRATEGY EXAMPLE 1 - • Listed on the “low regulatory priority
ON-FARM VISITS aquaculture drug” list;
OR
Critical Limit: Animal drugs are used on fish only if
• Permitted by FDA for use in food fish under
the drugs have been:
the conditions of an INAD (as evidenced by a
• Approved by FDA and used in accordance with
lot-by-lot written certificate from the grower).
proper withdrawal times and other labeled
conditions;
OR
RESIDUE DRUG TESTING
• Approved by FDA and used in an extra-label
manner under a veterinarian’s supervision in
Critical Limit: No fish will be accepted that contains
accordance with FDA regulations and guide
unapproved drug residues (other than those used
lines. The regulations and guidelines are
within the provisions of an INAD application or
available from the FDA Center for Veterinary
used in accordance with the criteria specified in
Medicine, HFV-230, 7500 Standish Place,
the “low regulatory priority aquaculture
Rockville, MD 20855;
drug” list).
Continued
Chapter 11: Drugs
131
• CONTROL STRATEGY EXAMPLE 5 - QA PROGRAM • Formalin solution
Supplied by Natchez Animal Supply Co., Natchez,
Critical Limit: Third party certificate indicating that MS or Argent Laboratories, Redmond, WA, may
the producer operates under a third party-audited only be used in salmon, trout, catfish, largemouth
Quality Assurance program for aquaculture drug bass, and bluegill for the control of protozoa and
use, either for each lot of incoming aquacultured monogenetic tremetodes, and on the eggs of
fish or for each producer of incoming salmon, trout and pike (esocids) for control of
aquacultured fish. fungi of the family Saprolegniacea,
(21 CFR 529.1030);
• CONTROL STRATEGY EXAMPLE 6 - • Formalin solution
CONTROL DURING HOLDING Supplied by Western Chemical, Inc., Ferndale, WA,
may be used to control: external protozoa and
Critical Limit: Animal drugs are used on fish only if monogenetic tremetodes on all fin fish species;
the drugs have been: external protozoan parasites on shrimp; and fungi
• Approved by FDA and used in accordance with of the family Saprolegniaceae on the eggs of all fin
proper withdrawal times and other labeled fish species, (21 CFR 529.1030);
conditions; • Tricaine methanesulfonate (MS-222)
OR Supplied by Argent Laboratories, Redmond, WA,
• Approved by FDA and used in an extra-label and Western Chemical, Inc., Ferndale, WA, may
manner under a veterinarian’s supervision in only be used in the families Ictaluridae (catfish),
accordance with FDA regulations and Salmonidae (salmon and trout), Esocidae (pike),
guidelines. The regulations and guidelines are and Percidae (perch) when the fish is intended to
available from the FDA Center for Veterinary be used for food. It may not be used within 21 days
Medicine, HFV-230, 7500 Standish Place, of harvesting fish for food. In other fish and in
Rockville, MD 20855; cold-blooded animals, the drug should be limited to
OR hatchery or laboratory use, (21 CFR 529.2503);
• Listed on the FDA “low regulatory priority • Oxytetracycline
aquaculture drug” list; For feed use, supplied by Pfizer, Inc., may only be
OR used in salmonids, catfish, and lobster. Withdrawal
• Permitted by FDA for use in food fish under times are: marking in pacific salmon, 7 days;
the conditions of an INAD. disease control in salmonids, 21 days; catfish,
21 days; lobster, 30 days (21 CFR 558.450).
• FDA-approved aquaculture drugs Oxytetracycline tolerance in the flesh is 2.0 ppm,
(21 CFR 556.500).
FDA approved aquaculture drugs with their approved • Sulfamerazine
sources, species and withdrawal times are listed Supplied by Roche Vitamins, Inc., may only be
below. Additional details on conditions of use (e.g. used in trout. It may not be used within 21 days of
disease conditions and dosage levels) can be obtained harvest (21 CFR 558.582). Sulfamerazine tolerance
from: the Code of Federal Regulations as cited in the flesh is zero, (21 CFR 556.660). Note: this
below; the labeling for the drug; the FDA Center for product is currently not marketed.
Veterinary Medicine (www.fda.gov/cvm/index/ • Sulfadimethoxine/ormetoprim combination
aquaculture); or “Guide to Drug, Vaccine, and Supplied by Roche Vitamins, Inc., may only be
Pesticide Use in Aquaculture,” Texas Agricultural used in salmonids and catfish. Withdrawal times
Extension Service, Publication B-5085. are: salmonids, 42 days; catfish, 3 days (21 CFR
• Chorionic Gonadotropin 558.575). Sulfadimethoxine/ormetoprim
Supplied by Intervet, Inc., Millsboro, DE, may be combination tolerance in the flesh is 0.1 ppm for
used as an aid in improving spawning function in both drugs, (21 CFR 556.640).
male and female brood finfish, (21 CFR 522.1081);
Chapter 11: Drugs

132
• FDA low regulatory priority aquaculture drugs • Onion (whole form)
Used to treat external crustacean parasites, and to
FDA’s Center for Veterinary Medicine has identified a deter sea lice from infesting external surface of
number of “low regulatory priority aquaculture drugs.” salmonids at all life stages.
The following list identifies these compounds and • Papain
provides their indicated use and usage levels. These Used in a 0.2% solution to remove the gelatinous
compounds have undergone review by the Food and matrix of fish egg masses in order to improve
Drug Administration and have been determined to be hatchability and decrease the incidence of disease.
new animal drugs of low regulatory priority. Additional • Potassium Chloride
information on this subject can be obtained from: the Used as an aid in osmoregulation; relieves stress
FDA Center for Veterinary Medicine (www.fda.gov/ and prevents shock. Dosages used would be those
cvm/index/aquaculture); or “Guide to Drug, Vaccine, necessary to increase chloride ion concentration to
and Pesticide Use in Aquaculture,” Texas Agricultural 10-2000 mg/L.
Extension Service, Publication B-5085. • Povidone Iodine
• Acetic Acid Used in a 100 ppm solution for 10 minutes as an
Used in a 1000 to 2000 ppm dip for 1 to 10 egg surface disinfectant during and after water
minutes as a parasitide for fish. hardening.
• Calcium Chloride • Sodium Bicarbonate
Used to increase water calcium concentration to Used at 142 to 642 ppm for 5 minutes as a means
insure proper egg hardening. Dosages used would of introducing carbon dioxide into the water to
be those necessary to raise calcium concentration anesthetize fish.
to 1-20 ppm CaCO3. Used up to 150 ppm • Sodium Chloride
indefinitely to increase the hardness of water for Used in a 0.5% to 1.0% solution for an indefinite
holding and transporting fish in order to enable fish period as an osmoregulatory aid for the relief of
to maintain osmotic balance. stress and prevention of shock; and 3% solution for
• Calcium Oxide 10 to 30 minutes as a parasitide.
Used as an external protozoacide for fingerlings to • Sodium Sulfite
adult fish at a concentration of 2000 mg/L for 5 Used in a 15% solution for 5 to 8 minutes to treat
seconds. eggs in order to improve their hatchability.
• Carbon Dioxide Gas • Thiamine Hydrochloride
Used for anesthetic purposes in cold, cool, and Used to prevent or treat thiamine deficiency in
warm water fish. salmonids. Eggs are immersed in an aqueous
• Fuller’s Earth solution of up to 100 ppm for up to four hours
Used to reduce the adhesiveness of fish eggs to during water hardening. Sac fry are immersed in
improve hatchability. an aqueous solution of up to 1,000 ppm for up to
• Garlic (whole form) one hour.
Used for control of helminth and sea lice • Urea & Tannic Acid
infestations of marine salmonids at all life stages. Used to denature the adhesive component of fish
• Hydrogen Peroxide eggs at concentrations of 15g urea and 20g NaCl/5
Used at 250-500 mg/L to control fungi on all liters of water for approximately 6 minutes, followed
species and life states of fish, including eggs. by a separate solution of 0.75 g tannic acid/5 liters
• Ice of water for an additional 6 minutes. These
Used to reduce metabolic rate of fish during transport. amounts will treat approximately 400,000 eggs.
• Magnesium Sulfate
Used to treat external monogenic trematode
infestations and external crustacean infestations in
fish at all life stages. Used in all freshwater
species. Fish are immersed in a 30,000 mg
MgSO4/L and 7000 mg NaCl/L solutions for 5 to
10 minutes.
Continued
Chapter 11: Drugs
133
The Agency is unlikely to object to the use of low You should monitor often enough so that the normal
regulatory priority substances if the following variability in the values you are measuring will be
conditions are met: 1) the substances are used for the detected. This is especially true if these values are
stated indications; 2) the substances are used at the typically close to the critical limit. Additionally, the
prescribed levels; 3) the substances are used accord- greater the time span between measurements the
ing to good management practices; 4) the product is more product you are putting at risk should a mea-
of an appropriate grade for use in food animals; and, surement show that a critical limit has been violated.
5) there is not likely to be an adverse effect on the
environment. Following is guidance on establishing monitoring
procedures for the control strategy examples dis-
The Agency’s enforcement position on the use of cussed in Step #12. Note that the monitoring fre-
these substances should not be considered an ap- quencies that are provided are intended to be consid-
proval, nor an affirmation of their safety and effec- ered as minimum recommendations, and may not be
tiveness. The Agency reserves the right to take a adequate in all cases.
different position on the use of any or all of these
substances at some time in the future.
What Will Be Monitored?
Classification of these substances as new animal
drugs of low regulatory priority does not exempt • CONTROL STRATEGY EXAMPLE 1 -
facilities from complying with other Federal, State, ON-FARM VISITS
and local environmental requirements. For, example,
facilities using these substances would still be What: On-farm drug usage procedures;
required to comply with National Pollutant Discharge AND
Elimination System (NPDES) requirements. Producer certificate indicating proper INAD
usage.
Plan Form. • CONTROL STRATEGY EXAMPLE 2 -
STEP #15: ESTABLISH MONITORING
PROCEDURES. What: Producer certificate indicating proper drug
usage.
For each processing step where “aquaculture drugs”
is identified as a significant hazard on the HACCP • CONTROL STRATEGY EXAMPLE 3 -
Plan Form, describe monitoring procedures that will RECORDS OF DRUG USE
What: On farm drug usage procedures;
To fully describe your monitoring program you AND
should answer four questions: 1) What will be Producer certificate indicating proper INAD
monitored? 2) How will it be monitored? 3) How usage.
often will it be monitored (frequency)? 4) Who will
perform the monitoring? • CONTROL STRATEGY EXAMPLE 4 -
It is important for you to keep in mind that the
feature of the process that you monitor and the What: Fish flesh for drug residues.
method of monitoring should enable you to deter-
mine whether the critical limit is being met. That is, • CONTROL STRATEGY EXAMPLE 5 - QA PROGRAM
the monitoring process should directly measure the
feature for which you have established a critical What: Third party certificate indicating operation
limit. under third-party audited QA program.
Chapter 11: Drugs

134
• CONTROL STRATEGY EXAMPLE 6 - Note: A limited number of drug screening tests for
CONTROL DURING HOLDING aquaculture are available, and these have not been
validated by FDA or AOAC. This topic is further
What: Type of aquaculture drug used; discussed in Step #12.
AND
Date and quantity of drug use; • CONTROL STRATEGY EXAMPLE 5 - QA PROGRAM
AND
Any other conditions of drug use that are How: Visual for presence of third party certificate.
relevant to: the established withdrawal times; the
labeled instructions for use; the extralabel use of • CONTROL STRATEGY EXAMPLE 6 -
an FDA-approved drug used under a CONTROL DURING HOLDING
veterinarians’s supervision in accordance with
FDA regulations and guidelines; the conditions How: Visually observe drug use and distribution.
specified in the FDA “low regulatory priority
aquaculture drug” list; or, the conditions of the
INAD application; How Often Will Monitoring Be Done
AND (Frequency)?
Date of distribution of the finished product.
ON-FARM VISITS
Frequency: At least once per year for each
• CONTROL STRATEGY EXAMPLE 1 - aquaculture site.
ON-FARM VISITS
How: Survey farm husbandry procedures, ask SUPPLIER’S CERTIFICATION
questions, and review drug usage records;
AND Frequency: Each lot received.
Visual for presence of INAD certificate.
• CONTROL STRATEGY EXAMPLE 2 - RECORDS OF DRUG USE
Frequency: Each lot received.
How: Visual for presence of lot-by-lot certificate.
• CONTROL STRATEGY EXAMPLE 3 - RESIDUE DRUG TESTING
RECORDS OF DRUG USE
Frequency: Each lot received.
How: Review drug records;
AND • CONTROL STRATEGY EXAMPLE 5 - QA PROGRAM
Visual for presence of INAD certificate.
Frequency: Each lot received checked for presence
• CONTROL STRATEGY EXAMPLE 4 - of certificates. Certificates may be issued on a
RESIDUE DRUG TESTING lot-by-lot or continuing basis, but at least
annually.
How: Obtain samples and analyze for drugs, using
rapid screening methods.
Continued
Chapter 11: Drugs
135
CONTROL DURING HOLDING CONTROL DURING HOLDING
Frequency: Every time aquaculture drugs are used Who: Production employee or supervisor, member
during holding; of the quality control staff, or any other
AND personnel who has an understanding of drug
Every time the product is distributed. usage and limits.

Who Will Perform the Monitoring? monitoring information in Columns 4, 5, 6, and 7,
ON-FARM VISITS STEP #16: ESTABLISH CORRECTIVE
ACTION PROCEDURES.
Who: Field agent (employee or contractor) or any
other person who has an understanding of animal For each processing step where “aquaculture drugs”
drug usage and limits. is identified as a significant hazard on the HACCP
Plan Form, describe the procedures that you will use
• CONTROL STRATEGY EXAMPLE 2 - when your monitoring indicates that the critical limit
SUPPLIER’S CERTIFICATION has not been met.
Who: Receiving employee or supervisor, production These procedures should: 1) ensure that unsafe
supervisor, member of the quality control staff, product does not reach the consumer; and, 2) correct
or any other person who has an understanding of the problem that caused the critical limit deviation.
the control procedure. Remember that deviations from operating limits do
not need to result in formal corrective actions.
RECORDS OF DRUG USE Following is guidance on establishing corrective
Who: Production supervisor, member of the discussed in Step #12.
quality control staff, or any other personnel who
has an understanding of animal drug usage and • CONTROL STRATEGY EXAMPLE 1 -
limits. ON-FARM VISITS
• CONTROL STRATEGY EXAMPLE 4 - Corrective Action: Reject product, if the CL is

RESIDUE DRUG TESTING not met;
AND
Who: Member of the quality control staff or contract Discontinue use of supplier until evidence is
laboratory. obtained that drug treatment practices have
changed.
Who: Receiving employee or supervisor, production SUPPLIER’S CERTIFICATION
supervisor, a member of the quality control staff,
or any other person who has an understanding of Corrective Action: Reject lot, if the CL is not met;
the control procedure. AND
Discontinue use of supplier until a commitment is
obtained that a certificate will accompany each lot.
Chapter 11: Drugs

136
• CONTROL STRATEGY EXAMPLE 3 - completed; and 2) any products processed from that
RECORDS OF DRUG USE lot that have already been distributed should be
recalled and subjected to the actions described above.
Corrective Action: Reject lot, if the CL is not met;
AND Enter the corrective action procedures in Column 8 of
Discontinue use of supplier until evidence is the HACCP Plan Form.
obtained that drug treatment practices have
changed. STEP #17: ESTABLISH A RECORDKEEPING
SYSTEM.
RESIDUE DRUG TESTING For each processing step where “aquaculture drugs”
is identified as a significant hazard on the HACCP
Corrective Action: Reject lot, if the CL is not met; Plan Form, list the records that will be used to
AND document the accomplishment of the monitoring
Discontinue use of supplier until evidence is procedures discussed in Step #15. The records should
obtained that drug treatment practices have clearly demonstrate that the monitoring procedures
changed. have been followed, and should contain the actual
values and observations obtained during monitoring.
Following is guidance on establishing a
Corrective Action: Reject lot, if the CL is not met; recordkeeping system for the control strategy ex-
AND amples discussed in Step #12.
Discontinue use of supplier until a certificate is
provided. • CONTROL STRATEGY EXAMPLE 1 -
ON-FARM VISITS
CONTROL DURING HOLDING Records: On-site audit report;
AND
Corrective Action: Hold the product until the drug INAD certificate.
residue is at or below tolerance. This may be
accomplished by collecting and analyzing a • CONTROL STRATEGY EXAMPLE 2 -
representative sample of the product, using an SUPPLIER’S CERTIFICATION
approved method;
OR Records: Certificate;
Destroy the product; AND
OR Receiving record showing lots received and
Divert the product to non-food use. presence/absence of certificate.
AND
Modify drug use practices • CONTROL STRATEGY EXAMPLE 3 -
RECORDS OF DRUG USE
critical limit is mistakenly accepted, and the error is Records: Grower’s drug records;
later detected, the following actions should be taken: AND
1) the lot and any products processed from that lot INAD certificate;
should be destroyed, diverted to a nonfood use or to a AND
use in which the critical limit is not applicable, or Receiving record showing lots received and
placed on hold until a food safety evaluation can be presence/absence of certificate.
Continued
Chapter 11: Drugs
137
RESIDUE DRUG TESTING SUPPLIER’S CERTIFICATION
Records: Analytical results. Verification: Visit all new aquacultured fish

suppliers within the year and all existing fish
• CONTROL STRATEGY EXAMPLE 5 - QA PROGRAM suppliers at a predetermined frequency to review
the grower’s drug usage procedures;
RECORDS: Third party certificate; OR
AND Collect a representative sample of the raw
Receiving record showing lots received and material, in-process product, or finished product
presence/absence of certificate. at least quarterly and analyze for drug residues.
AND
• CONTROL STRATEGY EXAMPLE 6 - Review monitoring, corrective action and
CONTROL DURING HOLDING verification records within one week of preparation.
Records: Drug use records; • CONTROL STRATEGY EXAMPLE 3 -

AND RECORDS OF DRUG USE
Records indicating date of distribution of drug-
treated product. Verification: Review monitoring and corrective
of the HACCP Plan Form. • CONTROL STRATEGY EXAMPLE 4 -
STEP #18: ESTABLISH VERIFICATION
PROCEDURES. Verification: Review monitoring and corrective
For each processing step where “aquaculture drugs”
is identified as a significant hazard on the HACCP • CONTROL STRATEGY EXAMPLE 5 - QA PROGRAM
Plan Form, establish verification procedures that will
ensure that the HACCP plan is: 1) adequate to Verification: Review monitoring and corrective
address the hazard of “aquaculture drugs”; and, 2) action records within one week of preparation.
consistently being followed.
Following is guidance on establishing verification CONTROL DURING HOLDING
cussed in Step #12. Verification: Review monitoring and corrective
ON-FARM VISITS Enter the verification procedures in Column 10 of the
HACCP Plan Form.
Chapter 11: Drugs

138
TABLE #11-1
Control Strategy Example 1 - On-farm visits
This table is an example of a portion of a HACCP plan relating to the control of aquaculture drugs in farm-raised catfish,
using Control Strategy Example 1 - On-farm visits. It is provided for illustrative purposes only.
Aquaculture drugs may be only one of several significant hazards in this product. Refer to Tables 3-1, 3-2, and 3-3
(Chapter 3) for other potential hazards (e.g. chemical contaminants and metal fragments).
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
Pre-harvest Aquaculture drugs Animal drugs used on fish • On farm drug • Survey farm • Once per year for • Field agent • Reject • On-site audit • Review
only if the drugs have usage procedures husbandry each aquaculture report monitoring
been: a) approved by FDA procedures, ask site AND and corrective
and used in accordance questions, and action records
with proper withdrawal
Se review drug • Discontinue use within one week
times and other labeled records of supplier until of preparation
139
conditions; b) approved evidence is
eT
by FDA and used in an
ex obtained that
Chapter 11: Drugs

extra-label manner under drug treatment
a veterinarian’s practices have
t f Exa
supervision in accordance changed
or mp
with FDA regulations and
Fu le
guidelines; c) listed on the • Certificate • Visual • Same • Same • Reject • Certificate of
“low regulatory priority indicating proper INAD usage
ll R O
aquaculture drug” list; or, INAD usage
d) permitted by FDA for
eco nly
use in food fish under the
conditions of an INAD
mm
(as evidenced by a lot-by-
lot written certificate
en
from the grower)
da
tio
ns
TABLE #11-2
Control Strategy Example 2 - Supplier’s certification
This table is an example of a portion of a HACCP plan relating to the control of aquaculture drugs in pond-raised shrimp,
using Control Strategy Example 2 - Supplier’s certification. It is provided for illustrative purposes only.
(Chapter 3) for other potential hazards (e.g. chemical contaminants, food and color additives, and metal fragments).
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
Receiving Aquaculture Drugs Certificate indicating Presence of a Visual Each lot received Receiving dock • Reject lot • Grower’s drug • Visit all new
proper drug usage certificate employee usage certificate pond-raised
accompanying all lots of indicating proper AND shrimp
incoming pond-raised drug usage • Receiving record suppliers within
shrimp
Se • Discontinue use the year and
until supplier all existing
140
agrees to provide suppliers at
eT
ex certificate for 25% per year on
Chapter 11: Drugs

each lot a rotating basis
to review the
t f Exa
grower’s drug
or mp
Fu le usage
ll R O procedures
• Review
monitoring,
eco nly
corrective
action, and
mm
verification
records within
en
one week of
da
tio preparation
ns
TABLE #11-3
Control Strategy Example 3 - Records of drug use
This table is an example of a portion of a HACCP plan relating to the control of aquaculture drugs in pond-raised shrimp,
using Control Strategy Example 3 - Records of drug use. It is provided for illustrative purposes only.
(Chapter 3) for other potential hazards (e.g. chemical contaminants, food and color additives, and metal fragments).
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
Receiving Aquaculture Drugs Animal drugs used on fish • On-farm drug • Review drug • Each lot • Production • Reject lot • Grower’s drug • Review
only if the drugs have usage procedures records at received supervisor usage records monitoring
been: a) approved by FDA receipt AND and corrective
and used in accordance • Receiving record action records
with proper withdrawal
Se • Discontinue use within one week
times and other labeled of supplier until of preparation
141
conditions; b) approved evidence is
eT
by FDA and used in an
ex obtained that
Chapter 11: Drugs

extra-label manner drug treatment
under a veterinarian’s practices have
t f Exa
supervision in accordance changed
or mp
with FDA regulations and
Fu le
guidelines; c) listed on the • Certificate • Visual • Same • Same • Same • Certificate of
“low regulatory priority indicating INAD usage
ll R O
aquaculture drug” list; or proper INAD
d) permitted by FDA for usage
eco nly
use in food fish under the
conditions of an INAD
mm
(as evidence by a lot-by-
lot written certificate)
en
da
tio
ns
TABLE #11-4
Control Strategy Example 4 - Residue drug testing
This table is an example of a portion of a HACCP plan relating to the control of aquaculture drugs in farm-raised catfish,
using Control Strategy Example 4 - Residue drug testing. It is provided for illustrative purposes only.
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
Receiving Aquaculture Drugs No fish will be accepted Fish flesh for drug Obtain samples Each lot received Quality assurance • Reject lot • Analytical Review
that contains unapproved residues and analyze for personnel results monitoring and
drug residues (other than drugs using rapid AND corrective action
those used under an INAD screening methods records within
application or included on
Se • Discontinue use one week of
the “low regulatory Note: A limited of supplier until preparation
142
priority aquaculture drug” number of drug evidence is
eT
list)
ex screening tests for obtained that
aquaculture are drug treatment
Chapter 11: Drugs

available, and these practices have
t f Exa
have not been changed
or mp
validated by FDA
or AOAC. This
Fu le
topic is further
ll R O
discussed in Step
#12.
eco nly
mm
en
da
tio
ns
TABLE #11-5
Control Strategy Example 5 - QA program
This table is an example of a portion of a HACCP plan relating to the control of aquaculture drugs for an aquacultured trout
processor, using Control Strategy Example 5 - QA program. It is provided for illustrative purposes only.
Aquaculture drugs may be only one of several significant hazards for this product. Refer to Tables 3-1, 3-2, and 3-3
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
Receiving Aquaculture Drugs Third party certificate Presence of third Visual, for Each lot checked to Receiving dock • Reject lot • Third party Review
indicating that the party certificate presence of see if covered by employee certificate of monitoring and
producer operates under certificate certificate, which AND operation corrective action
a third party audited is renewed records within
Quality Assurance
Se annually • Discontinue use • Receiving record one week of
Program that covers until a certificate preparation
143
aquaculture drug usage is obtained
eT
ex
Chapter 11: Drugs

t f Exa
or mp
Fu le
ll R O
eco nly
mm
en
da
tio
ns
TABLE #11-6
Control Strategy Example 6 - Control during holding
This table is an example of a portion of a HACCP plan relating to the control of aquaculture drugs for a processor that holds live
lobster in a lobster pound, using Control Strategy Example 6 - Control during holding. It is provided for illustrative purposes only.
Aquaculture drugs may be only one of several significant hazards for this product. Refer to Tables 3-1, 3-2, and 3-3
(Chapter 3) for other potential hazards (e.g. natural toxins and food and color additives).
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
Holding Aquaculture Drugs • Lobster will be withheld • Type of • Visual • Every time • Production • Hold the product • Drug use record Review
from distribution for 30 aquaculture drug observation of aquaculture employee monitoring and
days after treatment used drug use drugs are used AND corrective action
with oxytetracycline in records within
Seaccordance with the • Date and quantity • Visual • Every time • Production • Collect a sample • Drug use record one week of
labeled directions for of drug use observation of aquaculture employee of the finished preparation
144
use drug use drugs are used product and have
eT
ex analyzed for
• No other aquaculture • Date of finished • Visual • Every time • Shipping oxytetracycline • Shipping record
Chapter 11: Drugs

drugs will be used product observation of aquaculture supervisor residue by contact
t f Exa
distribution drug use drugs are used laboratory. If 2.0
or mp
ppm or less,
release. If higher
Fu le
than 2.0 ppm,
ll R O
hold product an
additional 5 days
eco nly
mm and then retest
en AND
da • Destroy the lot
when
unapproved
tio
drugs are used
ns
AND
• modify drug use

practices
Chapter 12: Pathogen Growth & Toxin Formation (Other than Clostridium botulinum)
as a Result of Time/Temperature Abuse (A Biological Hazard)
Hazard Analysis Worksheet • Controlling the amount of moisture that is available

for pathogen growth, water activity, in the product by
STEP #10: UNDERSTAND THE POTENTIAL drying (covered in Chapter 14);
HAZARD.
• Controlling the amount of moisture that is available
Pathogen growth and toxin formation as a result of for pathogen growth, water activity, in the product by
time/temperature abuse of fish and fishery products formulation (covered in Chapter 13);
can cause consumer illness. This hazard is limited to
bacterial pathogens since human viral pathogens • Controlling the amount of salt or preservatives,
(viruses) are not able to grow in food. Temperature such as sodium nitrite, in the product (covered in
abuse occurs when product is allowed to remain at Chapter 13);
temperatures favorable to pathogen growth for
sufficient time to result in unsafe levels of pathogens • Controlling the level of acidity, pH, in the product
or their toxins in the product. Table #A-1 (Appendix (covered by the acidified foods regulations, 21 CFR
4) provides guidance about the conditions under 114 for shelf-stable products; and for refrigerated
which certain pathogens are able to grow. The acidified products in Chapter 13).
pathogens listed are those of greatest concern in fish
and fishery products. Note: The use of irradiation for fish or fishery products
has not been approved by FDA. Irradiated fish and
Pathogens can enter the process on raw materials. fishery products may not be distributed in the U.S.
They can also be introduced into foods during
processing from the air, unclean hands, insanitary • Managing time and temperature of exposure
utensils and equipment, unsafe water, and sewage,
and through cross contamination between raw and The time/temperature combinations that will ensure
cooked product. safety in your product are dependent upon a number
of factors, including:
• Strategies for controlling pathogen growth
• The types of pathogens that are expected to be
There are a number of strategies for the control of present and able to grow in your product. See
pathogens in fish and fishery products. They include: information contained in Step #11.
• Managing the amount of time that food is exposed • The infective or toxic dose of these pathogens or
to temperatures that are favorable for pathogen their toxins. The infective or toxic dose is the total
growth and toxin production (covered in this chapter; number of a pathogen, or the total amount of a toxin,
for Clostridium botulinum, in Chapter 13, and for that is necessary to produce human illness. The dose
Staphylococcus aureus in hydrated batter mixes in often varies considerably for a single pathogen based
Chapter 15); on the health of the consumer and the virulence
(infective capability) of the particular strain of the
• Killing pathogens by cooking (covered in Chapter pathogen.
16), pasteurizing (covered in Chapter 17), or retorting
(covered by the low acid canned foods regulations, For many of the pathogens listed in Table #A-1
21 CFR 113); (Appendix 4) the infective dose is known or sus-
pected to be very low (from one to several hundred
Continued
Chapter 12: Pathogens – Growth
145
organisms). These include: Campylobacter jejuni, STEP #11: DETERMINE IF THIS
Escherichia coli, Salmonella spp., Shigella spp., and POTENTIAL HAZARD IS SIGNIFICANT.
Yersinia enterocolitica. The infective dose for other
pathogens, such as Vibrio vulnificus, Vibrio At each processing step, determine whether “patho-
parahaemolyticus and Listeria monocytogenes is not gen growth and toxin production as a result of time/
known. In the case of both of these categories of temperature abuse” is a significant hazard. The
pathogens it is advisable to prevent any significant criteria are:
growth. Stated another way, product temperatures
should be maintained below the minimum growth 1. Is it reasonably likely that unsafe levels of pathogens
temperature for the pathogen or should not be will be introduced at this processing step (do unsafe
allowed to exceed that temperature for longer than levels come in with the raw material or will the process
the lag growth phase (i.e the slow growth phase introduce them)?
during which pathogens are acclimating to their
environment) of the pathogen at those temperatures. It is reasonable to assume that pathogens of various
types, including those listed in Table #A-1 (Appendix
Still other pathogens (e.g. Vibrio cholerae) require 4), will be present on raw fish and fishery products
large numbers in order to cause disease or require and non-fishery ingredients. They may only be
large numbers in order to produce toxin (e.g. Staphy- present at low levels or only sporadically, but even
lococcus aureus, Clostridium perfringens, Bacillus such occurrences warrant consideration because of
cereus). The infective dose of Vibrio cholerae is the potential for growth and toxin production.
suspected to be 1,000,000 total cells. S. aureus toxin
does not normally reach levels that will cause food Pathogens also may be introduced during processing,
poisoning until the numbers of the pathogen reach even after cooking (as described in Step #10). Well
100,000 to 1,000,000/gram. Clostridium perfringens designed sanitation programs (prerequisite programs)
does not produce toxin in the human gut unless at will minimize the introduction of pathogens. How-
least 100,000,000 total bacteria are consumed. ever, in most cases it is not reasonable to assume that
Limited growth of these pathogens may not compro- they will fully prevent the introduction of pathogens.
mise the safety of the product. However, time/ For this reason, controls should be in place to mini-
temperature controls must be adequate to prevent mize the risk of pathogen growth after the cook step.
growth before the stage of the infective or toxic dose
is reached. For example, the prudent processor will 2. Is it reasonably likely that pathogens will grow to
design controls to ensure that the numbers of S. unsafe levels and/or produce toxin at this processing
aureus do not exceed 10,000/gram. step?
• The numbers of these pathogens that are likely to In order to answer this question you must first
be present. This is highly dependent upon the quality determine which of those pathogens that are reason-
of the harvest water, how the raw material was ably likely to be present in your product would be
handled before it was delivered to your plant, and the able to grow if proper time/temperature controls are
effectiveness of your sanitation control program. As not maintained. Consider:
a practical matter, the initial number of pathogens is
of limited importance when you calculate critical • the moisture available to support pathogen growth
limits for pathogens that have a low infective dose. in the product (water activity);
Therefore, you will be designing a critical limit that • the amount of salt and preservatives in the product;
prevents any significant growth. • the acidity (pH) of the product;
• the availability of oxygen (aerobic vs anaerobic) in
On the other hand, for those pathogens that have a the product;
relatively high infective dose, the initial number of • the presence of competing spoilage organisms in
pathogens may be significant. the food.

146
Table #A-1 (Appendix 4) provides guidance on some In summary, under ordinary circumstances (e.g.
conditions of a food that limit the growth of those without data to the contrary) you should consider that
pathogens that are most relevant to fish and fishery it is reasonably likely that a pathogen in Table #A-1
products. This table can help you to decide if a (Appendix 4) will grow to an unsafe level or produce
particular pathogen will grow in your food if it is toxin in your product at a particular processing step if
temperature abused. all of the following conditions are met:
Certain pathogens grow well in temperature abused • It is reasonably likely to be present (see question 1,
raw fish (e.g. raw molluscan shellfish) and others above);
do not. Those which grow well in temperature • It is not inhibited by a condition of the food (see
abused raw fish include: Vibrio vulnificus, Vibrio Table A-1 [Appendix 4]);
parahaemolyticus, Vibrio cholerae, and Listeria • If your product is raw fish (e.g. raw molluscan
monocytogenes. Those which ordinarily do not grow shellfish): it will grow in temperature abused raw
well, because they compete poorly with the normal fish (see information in this question, above);
spoilage bacteria, include: Campylobacter jejuni, • It is reasonably likely that, in the absence of
pathogenic strain of Escherichia coli, Salmonella controls, cumulative time/temperature abuse
spp., Shigella spp., Staphylococcus aureus, and conditions such as those described in Table #A-2
Yersinia enterocolitica. (Appendix 4) could occur, and the processing step
could contribute significantly to that cumulative
Most will grow well in temperature abused cooked abuse.
fish if their growth is not controlled by means such as
drying, salting, or acidification because competing 3.Can the growth to unsafe levels and/or toxin produc-
bacteria are destroyed by the cooking process. tion of pathogens, which is reasonably likely to occur,
Others may grow if the natural condition of the raw be eliminated or reduced to an acceptable level at this
fish is changed, such as through salting or reduced processing step? (Note: If you are not certain of the
oxygen packaging. answer to this question at this time, you may answer
“No.” However, you may need to change this answer
Remember that you should consider the potential for when you assign critical control points in Step #12.)
time/temperature abuse in the absence of controls.
You may already have controls in your process that “Pathogen growth and toxin formation as a result of
minimize the potential for time/temperature abuse time/temperature abuse” should also be considered a
that could result in unsafe levels of pathogens or significant hazard at any processing step where a
toxins. This and the following steps will help you preventive measure is, or can be, used to eliminate (or
determine whether those or other controls should be reduce the likelihood of occurrence to an acceptable
included in your HACCP plan. level) the hazard, if it reasonably likely to occur.
Time/temperature abuse that occurs at successive Step #10 discusses a number of pathogen control
processing steps (including storage steps) may be strategies. This section covers control of pathogen
sufficient to result in unsafe levels of pathogens or growth and toxin production that occurs as a result of
toxins, even when abuse at one step alone would not time/temperature abuse. Preventive measures for
result in such levels. For this reason, you should such growth can include:
consider the cumulative effect of time/temperature
abuse during the entire process. Table #A-2 (Appen- • Maintaining product under refrigeration and
dix 4) provides guidance about the kinds of time/ controlling refrigeration temperatures;
temperature abuse that may cause a product to be • Proper icing;
unsafe. • Controlling the amount of time that product is
exposed to temperatures that would permit
pathogen growth and/or toxin production;
Continued
147
• Rapidly cooling fish; HACCP controls beyond sanitation that may be both
• Making sure that the temperature of incoming necessary and practical for the control of pathogens
microbiologically sensitive (e.g. raw and cooked in fish and fishery products that are intended to be
ready-to-eat fishery products) was properly fully cooked by the consumer or end user before
controlled during transportation. consumption. However, the agency makes no
recommendations in this Guide and has no specific
List such preventive measures in Column 5 of the expectations with regard to such controls in proces-
Hazard Analysis Worksheet at the appropriate sors’ HACCP plans. The agency plans to develop
processing step(s). Good Manufacturing Practice guidelines for harvest
vessels and for aquaculture, in an effort to minimize
If the answer to either question 1, 2 or 3 is “Yes” the the likelihood that these operations will contribute
potential hazard is significant at that step in the pathogens to fish and fishery products.
process and you should answer “Yes” in Column 3 of
the Hazard Analysis Worksheet. If none of the If your product is intended to be fully cooked by the
criteria is met you should answer “No.” You should consumer or end user before consumption, you
record the reason for your “Yes” or “No” answer in should enter “No” in Column 3 of the Hazard
Column 4. You need not complete Steps #12 through Analysis Worksheet for each of the processing steps.
18 for this hazard for those processing steps where For each “No” entry briefly explain in Column 4 that
you have recorded a “No.” the hazard will be controlled by the consumer or end
user cook. In this case, you need not complete Steps
It is important to note that identifying this hazard as #12 through 18 for this hazard.
significant at a processing step does not mean that it
must be controlled at that processing step. The next One exception to this general rule relates to the
step will help you determine where in the process the formation of heat-stable toxins, such as that which is
critical control point is located. produced by Staphylococcus aureus. The toxin
produced by S. aureus is not destroyed by cooking,
• Intended use even retorting. Its formation should, therefore, be
prevented in all fish and fishery products. However,
In determining whether a hazard is significant you as previously mentioned, S. aureus does not grow
should also consider the intended use of the product, well in raw fish, unless the growth of competing
which you developed in Step #4. FDA is not aware spoilage organisms is inhibited (e.g., by salting or
of any HACCP controls that may exist internationally vacuum packaging). Bacillus cereus also produces a
for the control of pathogens in fish and fishery heat-stable toxin.
products that are intended to be fully cooked by the
consumer or end user before consumption, other than
a rigorous sanitation regime as part of either a
prerequisite program or as part of HACCP itself. The
Seafood HACCP Regulation requires such a regime.
The proper application of sanitation controls is
essential because of the likelihood that any pathogens
that may be present in seafood products are intro-
duced through poor handling practices (e.g. by the
aquacultural producer, the fisherman, or the processor).
FDA is interested in information regarding any

148
STEP # 12: IDENTIFY THE CRITICAL The other limitation is that certain toxins (e.g.
CONTROL POINTS (CCP). Staphylococcus aureus and Bacillus cereus toxins)
are heat stable. Heat treatment, including retorting,
For each processing step where “pathogen growth may not be adequate to eliminate the toxin once it is
and toxin formation as a result of time/temperature formed. In this case time/temperature control may be
abuse” is identified in Column 3 of the Hazard necessary at the processing steps at which growth
Analysis Worksheet as a significant hazard, deter- and toxin production may occur.
mine whether it is necessary to exercise control at
that step in order to control the hazard. Figure #A-2 2. If there is no cook step, pasteurization step, or
(Appendix 3) is a CCP decision tree that can be used retorting step later in the process, then it may be
to aid you in your determination. necessary to identify each processing step at which you
have identified this hazard as significant as a critical
The following guidance will also assist you in control point for the hazard. Exposure of the product
determining whether a processing step is a CCP for to temperatures that will permit growth and/or toxin
this hazard: formation should be controlled at these steps.
Is there a cook step, a pasteurization step, or a Example:

retorting step later in your manufacturing process? A crab meat processor identifies a series of post-cook
processing and storage steps (e.g. backing, picking,
1. If there is, you may in most cases identify the cook packing, and refrigerated storage) as presenting a
step, pasteurization step, or retorting step as the CCP. reasonable likelihood of pathogen growth and toxin
Processing steps prior to cooking, pasteurization, or formation. The processor does not subject the
retorting will then not usually need to be identified as product to a final pasteurization process and ac-
CCPs for this hazard. knowledges that it may be consumed without further
cooking. The processor controls temperature during
Example: refrigerated storage, and time of exposure to
A cooked shrimp processor could set the critical unrefrigerated conditions during the processing
control point for “pathogen growth and toxin forma- steps. The processor identifies each of the post-cook
tion as a result of time/temperature abuse” at the processing and storage steps as CCPs for this
cook step, and would not need to identify each of the hazard.
processing steps prior to cooking as critical control
points. In this case, you should enter “Yes” in Column 6 of
the Hazard Analysis Worksheet for each of those
Guidance for this pathogen control strategy (e.g. heat processing steps. This control approach is referred to
treatment) is contained in: Chapter 16 (cooking); as “Control Strategy Example 1” in Steps 14-18.
Chapter 17 (pasteurization); and, the Low Acid
Canned Foods Regulations, 21 CFR 113 (retorting). Note: Rather than identify each step as an individual
CCP when the controls are the same at those steps, it
There are two important limitations to this strategy. may be more convenient to combine into one CCP
One is that the cooking, pasteurizing, or retorting those steps that together contribute to cumulative
process must be sufficient to eliminate the pathogens time/temperature exposure.
of concern. If it is not, time/temperature control may
still be necessary at the processing steps at which It is important to note that you may select a control
growth may occur. strategy that is different from that which is suggested
above, provided that it assures an equivalent degree
of safety of the product.
Continued
149
Following is guidance on processing steps that are ingredients are to be used in a product that will be
likely to be identified as critical control points for heated sufficient to kill any pathogens that may be
this hazard because time/temperature control is present, these processing steps may not need to be
necessary to control pathogen growth and/or toxin designated as CCPs. However, in making this
production. The guidance is divided into two fin- determination, you should consider the potential for
ished product types, because the hazard control Staphylococcus aureus or Bacillus cereus toxin
strategies differ. The two finished product types are formation. Remember that these toxins are not likely
cooked, ready-to-eat and raw, ready-to-eat. to be inactivated by heat.
• Cooked, ready-to-eat Time/temperature controls may be required at the

following steps (CCPs):
These products are cooked by the processor and may
be eaten with no further cooking by the consumer. • Receiving;
Examples include: cooked crab meat, lobster meat • Cooling after cooking;
and crayfish meat, surimi-based analog products, • Processing after cooking, such as:
seafood salads, and hot-smoked fish. Note that - Slicing hot-smoked salmon;
smoked fish is also covered in Chapter 13. - Mixing seafood salad;
- Picking crabmeat;
Cooked, ready-to-eat products, especially fabricated • Packaging;
products, may develop pathogen hazards as a result • In-process and finished product refrigerated
of cross contamination and growth. Contributing (not frozen) storage.
factors to this risk are manual handling steps, mul-
tiple ingredients, room temperature processing, and Time/temperature controls will usually not be needed
multiple cooling steps. Cumulative exposure to at processing steps that meet the following conditions:
temperature abuse after the cook step must be taken
into consideration. • Continuous, mechanical processing steps that are
brief, such as:
A final pasteurization step (e.g. pasteurized - Mechanical size grading of cooked shrimp;
crabmeat) or retorting step (e.g. canned, hot-smoked - Mechanical forming of surimi-based analog
salmon) may make identification of critical control products;
points at prior processing steps unnecessary for most - Individual quick freezing;
pathogens. However, neither pasteurization nor • Processing steps that are brief and unlikely to
retorting is sufficient to inactivate Staphylococcus contribute significantly to the cumulative time/
aureus toxin. Bacillus cereus also produces a heat- temperature exposure to unrefrigerated conditions,
stable toxin. For this hazard you should consider the such as:
possibility that the toxin will be produced before the - Date code stamping;
final heat treatment, and control toxin formation, if - Case packing;
necessary. • Processing steps where the product is held in a
In some cases cooked, ready-to-eat ingredients, such - Glazing;
as lobster meat, pasteurized crabmeat, smoked fish, - Assembly of orders for distribution;
and surimi-based analog products, are received for - Frozen product storage;
storage, or assembly into a product that will not • Processing steps where the product is held at
receive further cooking by the processor, such as a temperatures above 140oF, such as:
seafood salad. In these cases, the ingredient receiv- - Initial stage of cooling;
ing and storage steps may also require time/tempera- - Hot holding.
ture controls and be designated as CCPs (unless the
ingredient is received and stored frozen). If these

150
In the processing of many food products, especially • Raw, ready-to-eat
products that contain meat or rice, rapid cooling after
cooking is important to the safety of the product. These products are not heated during processing to a
This is the case for two reasons. First, spore-forming temperature that will kill pathogens. They are often
pathogens, such as Clostridium perfringens and consumed without cooking. Examples include: cold-
Bacillus cereus, may survive the cooking process and smoked fish and raw oysters, clams, and mussels.
grow and/or produce toxin in the product during
cooling and subsequent handling. In fact, the heat Like cooked, ready-to-eat products, raw ready-to-eat
from the cooking process may actually initiate products may develop pathogen hazards as a result of
growth of the surviving spores. Second, the cooked cross contamination and growth. They may also
product may be recontaminated with pathogens after contain pathogens that were present in the raw
cooking. Because the normally-occurring spoilage material, and which are capable of growth in the
organisms are no longer present to compete with the finished product. For example, oysters harvested
pathogens in cooked product, rapid growth and toxin during the warm weather months may contain Vibrio
formation by the pathogens may be possible. vulnificus or Vibrio parahaemolyticus, bacterial
pathogens which are capable of growth in the raw
In deciding whether the cooling step after cooking is product.
significant in your product, consider the following.
Some cooking processes, such as the retort cooking Time/temperature controls may be required at the
of blue crabs (typical of the East coast processing following processing steps (CCPs):
technique) may be adequate to kill even the spores of
C. perfringens and B. cereus. In some processes • Receiving;
cooling is performed: 1) before any significant • Processing, such as:
handling of the cooked product; and 2) in the same - Shucking;
container in which the product was cooked. Again, - Portioning;
this technique is typical of East coast retort process- • Packaging;
ing of blue crab. Under these conditions cooling • Raw material, in-process, and finished
after cooking may not need to be identified as a product storage.
critical control point for this hazard. However, such
a determination is dependent upon strict adherence to Time/temperature controls will usually not be needed
good sanitation practices, to further minimize the risk at processing steps that meet the following condi-
of recontamination with pathogens. tions:
When significant handling occurs before or during • Continuous, mechanical processing steps that are
the cooling process, when the cooked product comes brief, such as mechanical filleting;
into contact with equipment that was not heated • Processing steps that are brief and unlikely to
along with the product, or when the cooking process contribute significantly to the cumulative time/
is not adequate to kill the spores of C. perfringens temperature exposure to unrefrigerated conditions,
and B. cereus, cooling after cooking may need to be such as:
identified as a critical control point for this hazard. - Date code stamping;
- Case packing;
• Processing steps where the product is held in a
- Assembly of orders for distribution;
- Frozen storage.

Continued
151
HACCP Plan Form AND/OR
The presence of sufficient cooling media to
STEP #14: SET THE CRITICAL LIMITS (CL). achieve either of the above purposes (e.g.
adequate ice to completely surround the
For each processing step where “pathogen growth product);
and toxin formation as a result of time/temperature AND/OR
abuse” is identified as a significant hazard on the Limits for critical aspects of the process that
HACCP Plan Form identify the maximum or mini- affect the rate of cooling, as established by a
mum value to which a feature of the process must be cooling rate study (e.g. volume or size of product
controlled in order to control the hazard. being cooled).
You should set the CL at the point that if not met the Refer to the data provided in Table #A-2 (Appendix
safety of the product may be questionable. If you set 4) for assistance in establishing appropriate cumula-
a more restrictive CL you could, as a result, be tive time/temperature exposure critical limits for the
required to take corrective action when no safety pathogens that are significant hazards in your prod-
concern actually exists. On the other hand, if you set uct. The critical limits described are intended to keep
a CL that is too loose you could, as a result, allow the pathogens from reaching the rapid growth phase
unsafe product to reach the consumer. (i.e. keep them in the lag phase). In summary, the
table indicates that:
As a practical matter it may be advisable to set an
operating limit that is more restrictive than the CL. • If the product is held at internal temperatures above
In this way you can adjust the process when the 70˚F (21.1˚C) during processing, exposure time
operating limit is triggered, but before a triggering of should ordinarily be limited to two hours (three hours
the CL would require you to take corrective action. if Staphylococcus aureus is the only pathogen of
You should set operating limits based on your concern);
experience with the variability of your operation and
with the closeness of typical operating values to the CL. • If the product is held at internal temperatures above
50˚F (10˚C), but not above 70˚F (21.1˚C), exposure
Following is some general guidance on setting time should ordinarily be limited to six hours (twelve
critical limits for the control strategy example hours if Staphylococcus aureus is the only pathogen
discussed in Step #12. More specific guidance of concern);
follows.
• If the product is held at internal temperatures both
• CONTROL STRATEGY EXAMPLE 1 - above and below 70˚F (21.1˚C), exposure times
TIME/TEMPERATURE CONTROL above 50˚F (10˚C) should ordinarily be limited to 4
hours, as long as no more than 2 of those hours are
Critical Limit: A combination of product internal above 70˚F (21.1˚C).
temperatures and times that will prevent growth
of target pathogens to unsafe levels and/or will Keep in mind that pathogen growth is relatively slow
prevent toxin formation; at temperatures below 70˚F (21.1˚C). In most cases
AND/OR growth is very slow below 50˚F (10˚C), and 40˚F
A combination of ambient (e.g. air, water, (4.4˚C) is below the minimum growth temperature of
or brine) temperatures and times of exposure that most pathogens, although there are some exceptions.
will prevent growth of target pathogens to unsafe On the other hand, pathogens grow relatively fast at
levels and/or will prevent toxin formation; temperatures above 70˚F (21.1˚C).
Continued
152
FIGURE 12-1: Internal Temperature Profile — Blue Crabmeat Processing
Partial Cooling Only After Cook With Significant Handling Before Full Cooling
140˚F (60˚C)
Backing Begins
Place in Cooler Picking Begins Packing Ends
70˚F (21.1˚C)
50˚F (10˚C)
40˚F (4.4˚C)
2 HR. 2 HOURS
MAX. MAX.
FIGURE 12-2: Internal Temperature Profile — Blue Crabmeat Processing

Cooling After Cook in Original Container With No Significant Handling During Cooling
140˚F (60˚C)
Cooling in Original Container
No Significant Handling
Picking Begins Packing Ends
70˚F (21.1˚C)
50˚F (10˚C)
40˚F (4.4˚C)
6 HOURS
MAX.

153
The time/temperature relationships in the table are significant handling, or contacts any processing
designed to refer to the time that your product is held equipment that was not heated along with the prod-
at a particular internal product temperature. You may uct, need not be considered as part of the cumulative
need to study temperature fluctuations in your time/temperature exposure. It is advisable to fully
product under normal operating conditions in order cool product before it is further handled, in order to
to relate the values in the table to cumulative time or minimize pathogen growth and toxin formation.
exposure to unrefrigerated conditions. Drawing a However, if significant handling does take place
graph depicting the time/temperature profile through- before cooling is completed, the cumulative time/
out your processing may help you in calculating the temperature exposure to unrefrigerated conditions
cumulative time/temperature exposure of your (described earlier) should be calculated from the time
product. Figures 12-1 and 12-2 are examples of that the product is first handled after cooking.
time/temperature profiles for crabmeat processing.
Remember that the values provided in Table If you identified cooling after cooking as a critical
A-2 (Appendix 4) are cumulative exposure through- control point for this hazard in Step #13 (e.g.,
out processing. because of the potential for Clostridium perfringens
or Bacillus cereus growth or toxin formation, the
For product-specific calculations you may choose to product should generally be cooled from 140˚F
use predictive microbiology models, such as the (60˚C) to 70˚F (21.1˚C) or below within two hours
U.S.D.A. Pathogen Modeling Program (PMP) or the and to 40˚F (4.4˚C) or below within another four
United Kingdom’s Food MicroModel (FMM). hours. The cooling rate critical limit is separate from
However, validating the reliability of predictions the cumulative time/temperature critical limit de-
from such models for your food is essential. scribed earlier.
Finished product storage critical limits should be Based on the type of monitoring that will be per-
based on the minimum growth temperatures of the formed, it may be more convenient to state critical
pathogens of concern. You should establish a maxi- limits as a maximum time, a maximum temperature,
mum storage temperature that will control pathogen or a combination of time and temperature. Generally,
growth and toxin formation throughout the shelf life a critical limit that combines time and temperature is
of your product. It is not always necessary or superior because it more closely approximates the
practical to establish a maximum storage temperature actual growth characteristics of pathogens. If a
that is below the minimum growth temperature of all critical limit references a temperature only, the
of the pathogens of concern. A maximum storage temperature should ordinarily be at or near the
temperature of 40˚F (4.4˚C) is often selected and is minimum growth temperature of the target pathogen.
generally safe for most refrigerated, microbiologi- If the critical limit references a time only, the time
cally sensitive products. However, where refrigera- should ordinarily represent a safe exposure time for
tion is necessary to control the growth of the target pathogen under the worst conditions that
nonproteolytic Clostridium botulinum, a maximum are reasonably likely to occur (i.e. nearest its opti-
storage temperature of 38˚F (3.3˚C) is usually mum growth temperature).
appropriate (see Chapter 13 for additional informa-
tion). You should consider the same factors when Example:
you set critical limits for raw material and in-process A crab meat processor (retort process) identifies a
refrigerated product storage. series of post-cook processing and storage steps (e.g.
backing, picking, packing, and refrigerated storage)
Cooked, ready-to-eat products provide an additional as critical control points for pathogen growth and
complication. Survival of most pathogens through a toxin formation. The product is packaged in a plastic
cook step is unlikely if proper controls are used (see container with a snap lid (aerobic). This minimizes
Chapter 16). Therefore, cooling after cooking that the risk of Clostridium botulinum and Clostridium
occurs before the product receives any further perfringens growth. However, the potential exists for

154
the other pathogens listed in Table #A-1 (Appendix 4) STEP #15: ESTABLISH MONITORING
to be present and to grow, because neither the water PROCEDURES.
activity, acidity, or salt content of the food will inhibit
them. Initial cooling takes place in the cooking For each processing step where “pathogen growth
crates. The product may not be fully cooled before and toxin formation as a result of time/temperature
handling. The processor sets the following critical abuse” is identified as a significant hazard on the
limits: HACCP Plan Form, describe monitoring procedures
that will ensure that the critical limits are consistently
• For the finished product cooler: a maximum cooler met.
temperature of 40˚ F (4.4˚ C);
To fully describe your monitoring program you
• For backing, picking, and packing: a maximum should answer four questions: 1) What will be
cumulative time of 2 hours at product internal monitored? 2) How will it be monitored? 3) How
temperatures above 50˚F (10˚C), starting when the often will it be monitored (frequency)? 4) Who will
cooked crabs are first handled. Alternatively, the perform the monitoring?
processor could set a critical limit of no more than 4
hours at product internal temperatures above 50˚F It is important for you to keep in mind that the
(10˚C), no more than 2 of which are above 70˚F feature of the process that you monitor and the
(21.1˚). These limits are necessary because the crabs method of monitoring should enable you to deter-
are handled while still warm (e.g. above 70˚F mine whether the CL is being met. That is, the
[21.1˚C]). Cooling that takes place after the product monitoring process should directly measure the
is handled is included in the limit. feature for which you have established a CL.
Example: You should monitor often enough so that the normal

Another crab meat processor also identifies a series variability in the values you are measuring will be
of post-cook processing and storage steps (e.g. detected. This is especially true if these values are
backing, picking, packing, and refrigerated storage) typically close to the CL. Additionally, the greater
as critical control points. The product is packaged in the time span between measurements the more
the same way. However, this product is cooled fully product you are putting at risk should a measurement
before handling and ice is used on the product during show that a CL has been violated.
processing to control time/temperature abuse. The
processor sets the following critical limits: Following is guidance on establishing monitoring
• For the finished product cooler: sufficient ice to in Step #12. Note that the monitoring frequencies
fully cover the containers at all times; that are provided are intended to be considered as
minimum recommendations, and may not be ad-
• For backing, picking, and packing: a maximum equate in all cases.
product temperature of 50˚ F (10˚ C) at all times.
Specifying a time of exposure is not necessary in this
case, because it is not reasonably likely that the
product would be held long enough that significant
pathogen growth could occur at this temperature
(e.g. 2 to 21 days) depending upon the pathogen.

Plan Form.
Continued
155
What Will Be Monitored? For unrefrigerated processing and packaging:
• CONTROL STRATEGY EXAMPLE 1 - What: The length of time of exposure of the product
TIME/TEMPERATURE CONTROL to unrefrigerated conditions, and either the
internal temperature of the product or the
For receiving of refrigerated (not frozen) cooked, ambient temperature;
ready-to-eat or raw, ready-to-eat fishery products OR
to be stored, or processed without further cooking: The length of time of exposure of the product to
unrefrigerated conditions when the critical limit
What: The internal temperature of the fishery assumes a temperature greater than 70˚F
product throughout transportation; (21.1˚C);
OR OR
The temperature of the truck or other carrier The length of time of exposure of the product to
throughout transportation; unrefrigerated conditions when a study
OR demonstrates that under ordinary conditions
For fishery products with a transit time of four product does not exceed 70˚F (21.1˚C) when
hours or less: The internal temperature of a exposed for the length of time specified by the
representative number of containers in the lot at critical limits and that time/temperature
time of delivery; combination is adequate to control the growth of
OR the pathogens of concern;
The adequacy of ice or chemical cooling media OR
at time of delivery. The internal temperature of the product (where
temperatures are held below a temperature at
For raw material, in-process, or finished product which growth is minimized [e.g. 50˚F (10˚C) for
refrigerated storage or for refrigerated processing: Salmonella spp.] or held above 140˚F [60˚C]
during processing);
What: The temperature of the cooler or refrigerated OR
processing area. The ambient air temperature (where ambient air
temperature is low enough to control microbial
For raw material, in-process, or finished product growth [e.g. 50˚F (10˚C) for Salmonella spp.]).
storage under ice or chemical cooling media:
What: The adequacy of ice or chemical cooling media. How Will Monitoring Be Done?
For cooling after cooking: • CONTROL STRATEGY EXAMPLE 1 -

TIME/TEMPERATURE CONTROL
What: The internal temperature of the product, and
the length of time between the end of the cook For receiving of refrigerated (not frozen) cooked,
(or the time that the product internal temperature ready-to-eat or raw, ready-to-eat products to be
fell below 140˚F [60˚C]) and the time that stored, or processed without further cooking:
measurement was made;
How: Use a time/temperature integrator for product
OR
internal temperature monitoring during transit;
The critical aspects of the process that affect the
OR
rate of cooling, as established by a cooling rate
Use a maximum indicating thermometer for
study (e.g. product internal temperature at the
ambient air temperature monitoring during
start of cooling, cooler temperature, quantity of
transit;
ice, quantity or size of product being cooled).

156
OR Example:
Use a digital time/temperature data logger for A crayfish processor has identified cooling after the
product internal temperature or ambient air cook step as a critical control point for pathogen
temperature monitoring during transit; growth and toxin formation. The processor estab-
OR lished a cooling critical limit of no more than two
Use a recorder thermometer for ambient air hours from 140˚ F (60˚ C) to 70˚F (21.1˚ C) and no
temperature monitoring during transit; more than four more hours from 70˚ F (21.1˚ C) to
OR 40˚ F (4.4˚ C). The processor uses marked batches
Use a dial or digital thermometer for internal of cooked product to monitor the cooling process.
product temperature monitoring at receipt; The time that the marked batch is removed from the
OR cooker is monitored visually and the internal tem-
Make visual observations of the adequacy of ice perature of the product in that batch two hours after
or other cooling media in a sufficient number of cooking and four more hours after cooking is moni-
containers to represent all of the product. tored with a dial thermometer.
For raw material, in-process, or finished product Example:

refrigerated storage or for refrigerated processing: Another crayfish processor has similarly identified
cooling as a critical control point and has estab-
How: Use a digital time/temperature data logger; lished the same critical limit. The processor uses a
OR digital time/temperature data logger to monitor the
Use a recorder thermometer; cooling rate of the cooked product.
OR
Use a high temperature alarm with 24-hour Example:
monitoring. Another crayfish processor has similarly identified
cooling as a critical control point. This processor
For raw material, in-process, or finished product has performed a cooling rate study that determined
storage under ice or chemical cooling media: that a cooling rate of no more than two hours from
How: Make visual observations of the adequacy of 140˚ F (60˚ C) to 70˚ F (21.1˚ C) and no more than
ice or chemical cooling media in a sufficient four more hours from 70˚ F (21.1˚ C) to 40˚ F
number of containers to represent all of the (4.4˚ C) can be achieved as long as certain condi-
product. tions are met in the cooling process. The study
determined that the following critical limits must be
For cooling after cooking: met: a cooler temperature of no more than 60˚ F
(15.6˚ C) during the first two hours of cooling and no
How: Use a dial or digital thermometer and visual more than 40˚ F (4.4˚ C) during the remainder of
check on time of cooling; cooling; and, no more than 1000 lbs of crayfish in the
OR cooler. The processor monitors the cooler tempera-
Use a digital time/temperature data logger; ture with a recorder thermometer and monitors the
OR weight of product at receiving with a scale.
Use appropriate instruments (e.g. dial
thermometer, digital time/temperature data For unrefrigerated processing and packaging:
logger) and/or visual observations as necessary
to measure the critical aspects of the process that How: Use a dial or digital thermometer for product or
affect the rate of cooling, as established by a ambient air temperature;
cooling rate study. AND/OR
Make visual observations of length of exposure
to unrefrigerated conditions.
Continued
157
Example: Example:
A crab meat processor has identified a series of A lobster meat processor has identified the meat
processing steps (e.g. backing, picking, and packing) removal process as a critical control point for
as critical control points for pathogen growth. The pathogen growth. The operation is performed under
processor established a critical limit of no more than near refrigeration conditions (50˚F [10˚C]). The
two cumulative hours of exposure to unrefrigerated processor has determined that exposure time suffi-
temperature during these processing steps. The cient to jeopardize the safety of the product at these
processor uses marked product containers to monitor temperatures is not reasonably likely to occur. The
the progress of the product through the three process- processor only monitors ambient air temperature
ing steps. The time that the marked container is with a digital data logger.
removed from and returned to refrigeration is moni-
tored visually.
Example: (Frequency)?
Another crabmeat processor with identical CCPs,
has established a more complex set of critical limits - • CONTROL STRATEGY EXAMPLE 1 -
no more than two cumulative hours with product TIME/TEMPERATURE CONTROL
internal temperatures above 70˚ F (21.1˚ C), and no
more than six cumulative hours with product internal For receiving of refrigerated (not frozen) cooked,
temperatures above 50˚ F (10˚ C). This processor ready-to-eat or raw, ready-to-eat products to be
also uses marked containers to monitor the progress stored, or processed without further cooking:
of the product through the process. However, in
addition to monitoring time, the processor also Frequency: Each shipment.
monitors product internal temperature for the marked
containers. This monitoring technique provides the For raw material, in-process, or finished product
processor more flexibility in processing but requires refrigerated storage or for refrigerated processing:
more monitoring effort.
Frequency: Continuous monitoring by the instrument
Example: itself, with visual check of the instrument at least
Another crabmeat processor that fully cools the once per day.
product before handling has identified the same
CCPs. The processor has determined through study For raw material, in-process, or finished product
that, under ordinary circumstances, in 3 1/2 hours of storage under ice or chemical cooling media:
exposure to ambient (room) temperature the product
will remain below 70oF (21.1oC). The processor has Frequency: At least twice per day;
set a critical limit of 3 1/2 hours out of refrigeration. OR
The processor monitors visually the time that picking For finished product storage, at least immediately
begins after each batch of crabs is brought into the prior to shipment.
processing room and the time that the last of the
containers of crabmeat from this batch has been For cooling after cooking:
placed on ice.
Frequency: At least every two hours;
OR
For critical aspects of the cooling process, as often
as necessary to ensure control of the process.

158
For unrefrigerated processing and packaging: Following is guidance on establishing corrective
action procedures for the control strategy example
Frequency: At least every two hours; discussed in Step #12.
OR
Each batch. • CONTROL STRATEGY EXAMPLE 1 -
Who Will Perform the Monitoring?? For receiving of refrigerated (not frozen) cooked,
ready-to-eat or raw, ready-to-eat products to be
• CONTROL STRATEGY EXAMPLE 1 - stored, or processed without further cooking:
Corrective Action: Reject shipment, if the CL is
Who: With recorder thermometers, time/temperature not met;
integrators, high temperature alarms, maximum OR
indicating thermometers, and digital data loggers, Hold the product until it can be evaluated based
monitoring is performed by the equipment itself. on its total time/temperature exposure;
However, anytime that such instrumentation is AND
used, a visual check should be made at least once Discontinue use of supplier or carrier until
per day in order to ensure that the critical limits evidence is obtained that transportation practices
have consistently been met. These checks, as have changed.
well as dial thermometer checks, time of expo
sure checks, and adequacy of ice or other cooling Note: If an incoming lot that fails to meet a receiving
media checks may be performed by the receiving critical limit is mistakenly accepted, and the error is
employee, the equipment operator, a production later detected, the following actions should be taken:
supervisor, a member of the quality control staff, 1) the lot and any products processed from that lot
or any other person who has an understanding of should be destroyed, diverted to a nonfood use or to a
the process and the monitoring procedure. use in which the critical limit is not applicable, or
placed on hold until a food safety evaluation can be
Enter the “What,” “How,” “Frequency,” and “Who” completed; and 2) any products processed from that
monitoring information in Columns 4, 5, 6, and 7, lot that have already been distributed should be
respectively, of the HACCP Plan Form. recalled and subjected to the actions described above.
STEP #16: ESTABLISH CORRECTIVE For other critical control points:

ACTION PROCEDURES.
Corrective Action: Take one or several of the
For each processing step where “pathogen growth following actions as necessary to regain control
and toxin formation as a result of time/temperature over the operation after a CL deviation:
abuse” is identified as a significant hazard on the • Add ice to the affected product;
HACCP Plan Form, describe the procedures that you OR
will use when your monitoring indicates that the CL • Make repairs or adjustments to the
has not been met. malfunctioning cooler;
OR
These procedures should: 1) ensure that unsafe • Move some or all of the product in the
product does not reach the consumer; and, 2) correct malfunctioning cooler to another cooler;
the problem that caused the CL deviation. Remem- OR
ber that deviations from operating limits do not need • Return the affected in-process product to the
to result in formal corrective actions. cooler;
Continued
159
OR Following is guidance on establishing a
• Freeze the affected product; recordkeeping system for the control strategy ex-
OR ample discussed in Step #12.
• Modify the process as needed to reduce the
time/temperature exposure; • CONTROL STRATEGY EXAMPLE 1 -
AND TIME/TEMPERATURE CONTROL
Take one of the following actions to product
involved in the critical limit deviation: For receiving of refrigerated (not frozen) cooked,
• Destroy the product; ready-to-eat or raw, ready-to-eat products to be
OR stored or processed without further cooking:
• Hold the product until it can be evaluated
based on its total time/temperature exposure; Records: Receiving record showing the results of
OR the time/temperature integrator checks;
• Cook or recook the product. In this case, OR
special attention must be paid to the fact that Printout from digital time/temperature data
any Staphylococcus aureus or Bacillus cereus logger;
toxin that may be present may not be OR
inactivated by heat; Recorder thermometer chart;
OR OR
• Divert the product to a use in which the Receiving record showing the results of the
critical limit is not applicable (e.g. divert maximum indicating thermometer checks;
crabmeat to a stuffed flounder operation). In OR
this case, special attention must be paid to the The results of internal product temperature
fact that any Staphylococcus aureus or Bacillus monitoring at receipt;
cereus toxin that may be present may not be AND
inactivated by heat; The date and time of departure and arrival of the
OR vehicle;
• Divert the product to a non-food use. OR
Receiving record showing the results of the ice
Enter the corrective action procedures in Column 8 of or other cooling media checks.
the HACCP Plan Form.
For raw material, in-process, or finished product
STEP #17: ESTABLISH A RECORDKEEPING refrigerated storage or refrigerated processing:
SYSTEM.
Records: Printout from digital time/temperature
For each processing step where “pathogen growth data logger;
and toxin formation as a result of time/temperature OR
abuse” is identified as a significant hazard on the Recorder thermometer chart;
HACCP Plan Form, list the records that will be used OR
to document the accomplishment of the monitoring Storage record showing the results of the high
procedures discussed in Step #15. The records temperature alarm checks.
should clearly demonstrate that the monitoring
procedures have been followed, and should contain For raw material, in-process, or finished product
the actual values and observations obtained during storage under ice or chemical cooling media:
monitoring.
Records: Storage record showing the results of the
ice or other cooling media checks.

160
For cooling after cooking: • CONTROL STRATEGY EXAMPLE 1 -
Records: Processing record showing the results of
the time/temperature checks; Verification: Review monitoring, corrective action,
OR and verification records within one week of
Printout from digital time/temperature data preparation;
logger; AND
OR When digital time/temperature data loggers,
Appropriate records (e.g. processing record recorder thermometers, or high temperature
showing the results of the time and temperature alarms are used for in-plant monitoring, check
checks and/or volume of product in cooler, for accuracy against a known accurate
printout from digital time/temperature data thermometer (NIST-traceable) at least once
logger) as necessary to document the monitoring per day;
of the critical aspects of the process that affect AND
the rate of cooling, as established by a cooling When digital time/temperature data loggers or
rate study. recorder thermometers are used for monitoring of
transport conditions at receiving, check for
For unrefrigerated processing and packaging: accuracy against a known accurate thermometer
(NIST-traceable). Verification should be
Records: Processing records showing the results of conducted on new suppliers’ vehicles and at least
time and/or temperature checks; quarterly for each supplier thereafter. Additional
OR verifications may be warranted based on
Printout from digital time/temperature data observations at receipt (e.g. refrigeration units
logger. appear to be in poor repair, or readings appear to
be erroneous);
Enter the names of the HACCP records in Column 9 AND
of the HACCP Plan Form. When visual checks of ice or cooling media are
used to monitor the adequacy of coolant,
STEP #18: ESTABLISH VERIFICATION periodically measure internal temperatures of
PROCEDURES. fish to ensure that the ice or cooling media is
sufficient to maintain product temperatures at
For each processing step where “pathogen growth 40˚F (4.4˚C) or less;
and toxin formation as a result of time/temperature AND
abuse” is identified as a significant hazard on the When dial or digital thermometers or maximum
HACCP Plan Form, establish verification procedures indicating thermometers are used for monitoring,
that will ensure that the HACCP plan is: 1) adequate check for accuracy against a known accurate
to address the hazard; and, 2) consistently being thermometer (NIST-traceable) when first used
followed. and at least once per year thereafter. (Note:
optimal calibration frequency is dependent upon
Following is guidance on establishing verification the type, condition, and past performance of the
procedures for the control strategy example discussed monitoring instrument.)
in Step #12.
HACCP Plan Form.
Continued
161
TABLE #12-1
Control Strategy Example 1 - Time/temperature control - Version 1
This table is an example of a portion of a HACCP plan relating to the control of pathogen growth and toxin formation
as a result of time/temperature abuse for a processor of blue crabmeat (typical of Gulf Coast boiling processing method),
using Control Strategy Example 1 - Time/temperature control. It is provided for illustrative purposes only. Pathogen growth
and toxin formation may be only one of several significant hazards for this product. Refer to Tables 3-1, 3-2, and 3-3
(Chapter 3) for other potential hazards (e.g. Chemical contaminants, pathogen survival through cooking, and metal fragments).
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
Backing Pathogen growth and No more than 2 hrs. Time of product Visual observation Start marked Production • Immediately ice Production record Review
toxin formation cumulative time during exposure to of marked container every supervisor product or move monitoring and
backing, picking and unrefrigerated containers two hours during to cooler corrective action
packing conditions backing records within
Se • Hold and one week of
Note: This CL is evaluate based preparation
162
necessary because the on total time/
eT
crabs are handled at
ex temperature
internal temperatures exposure
above 70˚F during
t f Exa
backing

or mp
Fu le
Backed crab Pathogen growth and Cooler maintained at or Cooler Digital time/ Continuous with Production • Move to Data logger • Check accuracy
ll R O
cooler toxin formation below 40˚F temperature temperature data visual check once supervisor alternate cooler printout of data logger
logger per day and/or add ice against a standard
eco nly
thermometer
once per day;
mm
en • Hold and • Review
evaluate based monitoring,
da
tio on total time/ corrective
temperature action, and
exposure verification
ns
records within
one week of
preparation
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
Picking Pathogen growth and No more than 2 hrs. Time of product Visual observation Start marked Production • Immediately ice Production record Review
toxin formation cumulative time during exposure to of marked container appx. supervisor product or move monitoring and
backing, picking, and unrefrigerated containers every two hours to cooler corrective action
packing conditions during picking records within
• Hold and one week of
evaluate based preparation
on total time/
temperature
exposure
Packing Pathogen growth and No more than 2 hrs. Time of product Visual observation Start marked Production • Immediately ice Production record Review
toxin formation cumulative time during exposure to of marked container appx. supervisor product or move monitoring and
backing, picking, and unrefrigerated containers every two hours to cooler corrective action
packing conditions during picking records within
• Hold and one week of
evaluate based preparation
Se
163
on total time/
eT
ex temperature
t f Exa exposure
Finished product Pathogen growth and Cooler maintained at or Cooler Digital time/ Continuous with Production • Move to Data logger • Check accuracy

or mp
cooler toxin formation below 40˚F temperature temperature data visual check once employee alternate cooler printout of data logger
Fu le
logger per day and/or add ice against a standard
thermometer
ll R O
once per day;
eco nly
• Hold and • Review
mm
on total time/ corrective
en
da temperature action, and
records within
tio
ns one week of
preparation
TABLE #12-2
Control Strategy Example 1 - Time/temperature control - Version 2
as a result of time/temperature abuse for a processor of blue crabmeat (typical of the East coast retort processing method),
using Control Strategy Example 1 - Time/temperature control. It is provided for illustrative purposes only. Pathogen growth
and toxin formation may be only one of several significant hazards for this product. Refer to Tables 3-1, 3-2, and 3-3 (Chapter 3)
for other potential hazards (e.g. chemical contaminants, pathogen survival through cooking, and metal fragments).
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
Cooked crab Pathogen growth and • Crabs cooled from • Cooked crab • Dial thermometer • Start marked • Production • Move part of • Production • Check accuracy
cooler toxin formation 140˚F to 70˚F in 2 hrs. internal in marked batch approx. supervisor load to alternate record of data logger
and 70˚F to 40˚F in 4 temperature batches of every two hours cooler and/or against a standard
Note: Control is more hrs. cooked crabs during cooking add ice thermometer
necessary at this step Se once per day;
because the processor has • Hold and
164
not established that the evaluate based • Check accuracy
eT
cook step is adequate to ex on total time/ of digital
kill the spores of temperature thermometer
Clostridium perfringens exposure against a standard
t f Exa
or Bacillus cereus once per day

or mp
• Cooler maintained at • Cooler • Digital time/ • Continuous with • Production • Same • Data logger • Review
Fu le
or below 40˚F after temperature temperature data visual check supervisor printout monitoring,
ll R O
cooling completed logger once per day corrective
action, and
eco nly
verification
records within
mm
one week of
preparation
en
da
tio
ns
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
Picking/boning/ Pathogen growth and No more than 3 1/2 hours Time of product • Visual • Every batch • Picking room • Pasteurize or • Cooked crab • Review
packing toxin formation cumulative time during exposure to observation of supervisor freeze the record monitoring and
picking, boning, and unrefrigerated time that picking product corrective
packing (beginning when conditions begins for each action records
cooked crabs are first batch of cooked • Hold and within one
handled in picking room) crabs that is evaluate based week of
brought into the on total time/ preparation
Note: This critical limit is picking room temperature
based on a study that exposure • Study showing
demonstrates that, under • Visual • Every batch • Packing room • Packing record temperature
ordinary circumstances, observation of employee profile of
the product does not time that the last product during
exceed 70˚F in 3 1/2 container of processing
hours exposure to crabmeat from
ambient temperature the batch is
Se packed on ice
165
eT
ex
Finished product Pathogen growth and Finished product Adequacy of ice Visual observation Each case Shipping • Re-ice Shipping record • Review
t f Exa
storage toxin formation containers completely immediately employee monitoring and

or mp
surrounded with ice
Fu le before shipping • Hold and corrective
evaluate based action records
on total time/ within one week
ll R O
temperature of preparation
exposure
eco nly
mm
en
da
tio
ns
Notes:

166
Chapter 13: Clostridium botulinum Toxin Formation (A Biological Hazard)
Hazard Analysis Worksheet

The vegetative cells of all types are easily killed by
STEP #10: UNDERSTAND THE POTENTIAL heat. C. botulinum is able to produce spores. In this
HAZARD. state the pathogen is very resistant to heat. The
spores of the proteolytic group are much more
Clostridium botulinum toxin formation can result in resistant to heat than are those of the nonproteolytic
consumer illness and death. This chapter covers the group. Table A-4 (Appendix 4) provides guidance
potential for C. botulinum growth and toxin forma- about the conditions under which the spores of the
tion as a result of time/temperature abuse during most heat resistant form of nonproteolytic C. botuli-
processing, storage and distribution. The growth of num, type B, are killed. However, there are some
other pathogens and the formation of other toxins as indications that substances that may be naturally
a result of time/temperature abuse during processing present in some products, such as lysozyme, may
are covered in Chapters 7 (histamine formation), enable nonproteolytic C. botulinum to more easily
12 (pathogen growth during processing other than recover after heat damage, resulting in the need for a
C. botulinum), and 15 (Staphylococcus aureus toxin considerably more aggressive process to ensure
formation in hydrated batter mixes). Additionally, destruction.
the prevention of C. botulinum toxin formation
during storage and distribution of the finished Temperature abuse occurs when product is exposed
product by drying is covered in Chapter 14. The to temperatures favorable for C. botulinum growth
prevention of C. botulinum toxin formation during for sufficient time to result in toxin formation. Table
storage and distribution of the finished product by #A-1 (Appendix 4) provides guidance about the
specialized cooking and hot filling procedures is conditions under which C. botulinum and other
covered in Chapter 16. The prevention of C. botuli- pathogens are able to grow.
num toxin development during storage and distribu-
tion of the finished product by pasteurization in the Packaging conditions that reduce the amount of
finished product container is covered in Chapter 17. oxygen present in the package (e.g. vacuum packag-
ing) extend the shelf life of product by inhibiting the
When C. botulinum grows it can produce a potent growth of aerobic spoilage bacteria. The safety
toxin, which can cause death by preventing breath- concern with these products is the increased potential
ing. It is one of the most poisonous naturally occur- for the formation of C. botulinum toxin before
ring substances known. The toxin can be destroyed spoilage makes the product unacceptable to consumers.
by heat (e.g. boiling for 10 minutes), but processors
cannot rely on this as a means of control. C. botulinum forms toxin more rapidly at higher
temperatures than at lower temperatures. The
There are two major groups of C. botulinum, the minimum temperature for growth and toxin forma-
proteolytic group (i.e. those that break down pro- tion by C. botulinum type E and nonproteolytic types
teins) and the nonproteolytic group (i.e. those that do B and F is 38˚F (3.3˚C). For type A and proteolytic
not break down proteins). The proteolytic group types B and F, the minimum temperature for growth
includes C. botulinum type A and some of types B is 50˚F (10˚C). As the shelf life of refrigerated foods
and F. The nonproteolytic group includes C. botuli- is increased, more time is available for C. botulinum
num type E and some of types B and F. growth and toxin formation. As storage temperatures
increase, the time required for toxin formation is
significantly shortened. Processors should expect
that at some point during storage, distribution,
Continued
Chapter 13: C. botulinum
167
display or consumer handling of refrigerated foods, • Sources of C. botulinum
proper refrigeration temperatures will not be main-
tained (especially for the nonproteolytic group). C. botulinum can enter the process on raw materials.
Surveys of retail display cases indicate that tempera- The spores of C. botulinum are very common in
tures of 45-50˚F (7-10˚C) are not uncommon. nature. They have been found in the gills and viscera
Surveys of home refrigerators indicate that tempera- of fin fish, crabs, and shellfish. C. botulinum type E
tures can exceed 50˚F (10˚C). is the most common form found in fresh water and
marine environments. Types A and B are generally
In reduced oxygen packaged products in which the found on land, but may also be occasionally found in
spores of nonproteolytic C. botulinum are inhibited water. It should be assumed that C. botulinum will
or destroyed (e.g., smoked fish, pasteurized be present in any raw fishery product, particularly in
crabmeat, pasteurized surimi), normal refrigeration the viscera.
temperatures of 40˚F (4.4˚C) are appropriate
because they will limit the growth of proteolytic • Reduced oxygen packaging
C. botulinum and other pathogens that may be
present. Even in products where nonproteolytic There are a number of conditions that can result in
C. botulinum is the target organism for the pasteur- the creation of a reduced oxygen packaging environ-
ization process and vegetative pathogens, such as ment. They include:
Listeria monocytogenes, are not likely to be present
(e.g. pasteurized crabmeat, pasteurized surimi), a • Vacuum packaging or modified or controlled
storage temperature of 40˚F (4.4˚C) is still appropri- atmosphere packaging. These packaging methods
ate because of the potential survival through the directly reduce the amount of oxygen in the package;
pasteurization process and recovery of spores of
nonproteolytic C. botulinum aided by naturally • Packaging in hermetically sealed containers (e.g.
occurring substances, such as lysozyme. In this case double seamed cans, glass jars with sealed lids, heat
refrigeration serves as a prudent second barrier. sealed plastic containers), or packing in deep contain-
ers from which the air is expressed (e.g. caviar in
In reduced oxygen packaged products in which large containers), or packing in oil. These and similar
refrigeration is the sole barrier to outgrowth of processing/packaging techniques prevent the entry of
nonproteolytic C. botulinum and the spores have not oxygen into the container. Any oxygen present at the
been destroyed (e.g. vacuum packaged raw fish, time of packaging may be rapidly depleted by the
unpasteurized crayfish meat), the temperature must activity of spoilage bacteria, resulting in the forma-
be maintained at 38˚F (3.3˚C) or below from packing tion of a reduced oxygen environment.
to consumption. Ordinarily processors can ensure
that temperatures are maintained at or below 38˚F Packaging that provides an oxygen transmission rate
(3.3˚C) while the product is in their control. How- of 10,000 cc/m2/24hrs (e.g. 1.5 mil polyethylene) can
ever, current distribution channels do not ensure the be regarded as an oxygen-permeable packaging
maintenance of these temperatures after the product material for fishery products. This can be compared
leaves their control. The use of time temperature to an oxygen-impermeable package which might
integrators on each consumer package may be an have an oxygen transmission rate as low as or lower
appropriate means of enabling temperature control than 100 cc/m2/24hr (e.g. 2 mil polyester). An
throughout distribution. Alternatively, products of oxygen permeable package should provide sufficient
this type may be safely marketed frozen, with exchange of oxygen to allow aerobic spoilage
appropriate labeling. For some products, control of organisms to grow and spoil the product before toxin
C. botulinum can be achieved by breaking the is produced under moderate abuse temperatures.
vacuum seal before the product leaves the processor’s However, use of an oxygen permeable package will
control. not compensate for the restriction to oxygen ex-
change created by practices such as packing in oil or
in deep containers from which the air is expressed.

168
• Control of C. botulinum in the finished product • Heating the product sufficiently to destroy the
spores of C. botulinum type E and nonproteolytic
There are a number of strategies to prevent types B and F (covered in Chapter 16); and then
C. botulinum toxin formation during storage and minimizing the risk of recontamination by hot filling
distribution of finished fishery products. They the product into the final container in a continuous
include: filling system (covered in Chapter 18); and then
controlling the growth of the surviving C. botulinum
For products that do not require refrigeration type A and proteolytic types B and F and other
(i.e. shelf-stable products): pathogens that may be present in the finished product
with refrigerated storage (covered in this chapter and
• Heating the finished product in its final container Chapter 12);
sufficiently by retorting to destroy the spores of
C. botulinum types A,B,E, and F (e.g. canned fish) • Controlling the amount of moisture that is available
(covered by the low acid canned foods regulations, in the product (water activity) sufficient to inhibit the
21 CFR 113). Note: these controls are not required to growth of C. botulinum type E and nonproteolytic
be included in your HACCP plan; types B and F by drying (covered in Chapter 14); and
then controlling the growth of
• Controlling the level of acidity (pH) in the finished C. botulinum type A, and proteolytic types B and F,
product sufficient to prevent the growth of C. botuli- and other pathogens that may be present in the
num types A,B,E, and F (4.6 or below) (e.g. shelf- finished product through refrigerated storage (cov-
stable acidified products) (covered by the acidified ered in this chapter and Chapter 12);
foods regulations, 21 CFR 114). Note: these controls
are not required to be included in your HACCP plan; • Controlling the level of acidity (pH), salt, moisture
(water activity), or some combination of these
• Controlling the amount of moisture that is available barriers, in the finished product sufficiently to
in the product (water activity) sufficient to prevent the prevent the growth of C. botulinum type E and
growth of C. botulinum types A,B,E, and F and other nonproteolytic types B and F by formulation (i.e. pH
pathogens that may be present in the product (i.e. 5 or below; salt 5% or more; or water activity below
0.85 or below) (e.g. shelf-stable dried products) 0.97) (covered in this chapter); and then controlling
(covered by Chapter 14); the growth of C. botulinum type A and proteolytic
types B and F and other pathogens that may be
• Controlling the amount of salt in the product present in the finished product with refrigerated
sufficient to prevent the growth of C. botulinum types storage (e.g. refrigerated acidified [“pickled”]
A, B, E, and F and other pathogens that may be products) (covered in this chapter and Chapter 12);
present in the product (i.e. 20% salt or more)(e.g.
shelf-stable salted products)(covered in this chapter). • Controlling the amount of salt and preservatives,
such as sodium nitrite, in the finished product, in
For products that require refrigeration: combination with other barriers, such as smoke, heat
damage and competitive bacteria, sufficient to
• Heating the finished product in its final container prevent the growth of C. botulinum type E and
sufficiently by pasteurization to destroy the spores of nonproteolytic types B and F (covered in this chap-
C. botulinum type E and nonproteolytic types B and F ter); and then controlling the growth of C. botulinum
(covered in Chapter 17); and then controlling the type A and proteolytic types B and F and other
growth of the surviving C. botulinum type A and pathogens that may be present in the finished product
proteolytic types B and F in the finished product with with refrigerated storage (e.g. salted, smoked, or
refrigerated storage (e.g. pasteurized crabmeat, some smoke-flavored fish) (covered in this chapter and
pasteurized surimi-based products) (covered in this Chapter 12);
chapter and Chapter 12);
Continued
169
• Controlling the amount of salt in the finished • Evisceration of fish before processing. Because
product, in combination with heat damage from spores are known to be present in the viscera of fish,
pasteurization in the finished product container, any product that will be preserved by salting, drying,
sufficient to prevent the growth of C. botulinum type pickling, or fermentation must be eviscerated prior to
E and nonproteolytic types B and F (covered in this processing (see Compliance Policy Guide sec.
chapter); and then controlling the growth of C. 540.650). Without evisceration, toxin formation is
botulinum type A and proteolytic types B and F and possible during the process even with strict control of
other pathogens that may be present in the finished temperature. Evisceration must be thorough and
product with refrigerated storage (e.g. some pasteur- performed to minimize contamination of the fish
ized surimi-based products) (covered in this chapter flesh. If even a portion of the viscera or its contents is
and Chapter 12); left behind, the risk of toxin formation by C. botuli-
num remains. Small fish, less than 5 inches in length
• Control of C. botulinum during processing and (e.g. anchovies and herring sprats), that are processed
storage in a manner that prevents toxin formation, and that
reach a water phase salt content of 10 percent in
There are a number of strategies to prevent refrigerated products, or a water activity of below
C. botulinum toxin formation during the processing 0.85 (Note: this value is based on the minimum water
and storage of fishery products. They include: activity for growth of S. aureus) or a pH of 4.6 or less,
in shelf-stable products are exempt from the eviscera-
• Managing the amount of time that food is exposed tion requirement.
to temperatures that are favorable for C. botulinum
growth and toxin formation during finished product Examples of C. botulinum Control
storage (covered in this chapter). in Specific Products:
Note: The guidance in this chapter emphasizes • Control in refrigerated, reduced oxygen packaged
preventive measures for the control of C. botulinum smoked and smoke-flavored fish
in products that are contained in reduced oxygen
packaging. As was previously described, this is Achieving the proper concentration of salt and nitrite
because such an environment extends the shelf life of in the flesh of refrigerated, reduced oxygen packaged
the product in a way that favors C. botulinum growth smoked and smoke-flavored fish is necessary to
and toxin formation over aerobic spoilage. It is also prevent the formation of toxin by C. botulinum type E
possible for C. botulinum to grow and produce toxin and nonproteolytic types B and F during storage and
in unpackaged or aerobically packaged product. This distribution. Salt works along with smoke and any
is because of the development within the product of nitrites that are added to prevent growth and toxin
microenvironments that support its growth. How- formation by C. botulinum type E and nonproteolytic
ever, toxin formation under these circumstances types B and F (Note: nitrites may only be used in
requires the type of severe temperature abuse that is salmon, sable, shad, chubs, and tuna - FDA Compli-
not reasonably likely to occur in most food process- ance Policy Guide sections 540.500 and 540.200).
ing environments. Nonetheless, the Good Manufac-
turing Practice Regulations, 21 CFR 110, require In hot-smoked products, heat damage to the spores of
refrigeration of foods that support the growth of C. botulinum type E and nonproteolytic types B and F
pathogenic microorganisms. In addition Chapter 12 also helps prevent toxin formation. In these products,
provides recommendations for storage controls for control of the heating process is critical to the safety
pathogens other than C. botulinum. of the finished product. It is important to note,
however, that this same heating process also reduces
the numbers of naturally occurring spoilage organ-
isms. The spoilage organisms would otherwise have
competed with, and inhibited the growth of,
C. botulinum.

170
In cold-smoked fish, it is important that the product • Control in refrigerated, reduced oxygen packaged,
does not receive so much heat that the number of pasteurized fishery products
spoilage organisms are significantly reduced. This is
because spoilage organisms must be present to inhibit Refrigerated, reduced oxygen packaged, pasteurized
the growth and toxin formation of C. botulinum type products fall into two categories: 1) those which are
E and nonproteolytic types B and F. This inhibition pasteurized in the final container); and 2) those which
is important in cold-smoked fish because the heat are pasteurized in a kettle (i.e. cooked) and then hot
applied during this process is not adequate to weaken filled into the final container (e.g.”heat and fill” soups
the C. botulinum spores. Control of the temperature and sauces). In both cases, ordinarily the heating
during the cold-smoking process to ensure survival of process must be sufficient to destroy the spores of C.
the spoilage organisms is, therefore, critical to the botulinum type E and nonproteolytic types B and F.
safety of the finished product. In neither case is it likely that the heating process will
be sufficient to destroy the spores of C. botulinum
The interplay of these inhibitory effects (i.e. salt, type A and proteolytic types B and F. Therefore, strict
temperature, smoke, nitrite) is complex. Control of refrigeration control (i.e. at or below 40˚F [4.4˚C])
the brining or dry salting process is clearly critical to must be maintained during storage and distribution to
ensure that there is sufficient salt in the finished prevent growth and toxin formation by C. botulinum
product. However, preventing toxin formation by type A and proteolytic types B and F, and because of
C. botulinum type E and nonproteolytic types B and the potential survival through the pasteurization
F is made even more complex by the fact that ad- process and recovery of spores of nonproteolytic C.
equate salt levels are not usually achieved during botulinum aided by naturally occurring substances,
brining. Proper drying is also critical in order to such as lysozyme. In the case of the lysozyme effect,
achieve the finished product water phase salt level refrigeration serves as a prudent second barrier.
(i.e. the concentration of salt in the water portion of
the fish flesh) needed to inhibit the growth and toxin In the second category of products, filling the product
formation of C. botulinum. into the final container while it is still hot in a
continuous filling system (i.e. “hot filling”) is also
The above described control procedures are covered critical to the safety of the finished product, because it
in this chapter. minimizes the risk of recontamination of the product
with pathogens, including C. botulinum type E and
Processors should ordinarily restrict brining, dry nonproteolytic types B and F. This strategy applies to
salting, and smoking loads to single species and to products such as soups and sauces that are filled
fish portions of approximately uniform size. This directly from the cooking kettle, where the risk of
minimizes the complexity of controlling the operation. recontamination is minimized. It does not apply to
products such as crabmeat, lobster meat, or crayfish
The combination of inhibitory effects that are present meat, or other products that are handled between
in smoked and smoke-flavored fish are not adequate cooking and filling. Control of hot filling is covered
to prevent toxin formation by C. botulinum type A in Chapter 18. Chapter 18 also covers other controls
and proteolytic types B and F. Strict refrigeration that may be necessary to prevent recontamination,
control (i.e. at or below 40˚F [4.4˚C]) during storage including controlling container sealing and controlling
and distribution must be maintained to prevent contamination of container cooling water. These
growth and toxin formation by C. botulinum type A controls may be critical to the safety of both catego-
and proteolytic types B and F and other pathogens ries of products.
that may be present in these products (covered in this
chapter and Chapter 12). Examples of properly pasteurized products are: blue
crabmeat pasteurized to a cumulative lethality of F185˚F
(F85˚C) = 31 min., z=16˚F (9˚C); surimi-based prod-
ucts, soups, or sauces pasteurized at an internal
temperature of 194˚F (90˚C) for at least 10 minutes.
Continued
171
In some pasteurized surimi-based products, salt in Much like smoked products, in some of these prod-
combination with a milder pasteurization process in ucts the interplay of these inhibitory effects (i.e. salt,
the finished product container work to prevent growth water activity, and pH) can be complex. Control of
and toxin formation by C. botulinum type E and the brining, pickling, or formulation steps is, there-
nonproteolytic types B and F. Control of the formula- fore, critical to ensure that there are sufficient
tion process is clearly critical in these products to barriers in the finished product to prevent the growth
ensure that there is sufficient salt in the finished and toxin formation of C. botulinum type E and
product. The formulation controls discussed in this nonproteolytic type B and F during storage and
chapter for the production of “pickled” fishery distribution. These control procedures are covered in
products are also suitable for the control of surimi- this chapter.
based product formulation. Control of the in-con-
tainer pasteurization process is also critical. An Processors should ordinarily restrict brining and
example of a properly pasteurized surimi-based pickling loads to single species and to fish portions of
product in which 2.5% salt is present is one that has approximately uniform size. This minimizes the
been pasteurized at an internal temperature of 185˚F complexity of controlling the operation.
(85˚C) for at least 15 minutes. This process may not
be suitable for other types of products, because of the The above discussed controls are not sufficient to
unique formulation and processing involved in the prevent toxin formation by C. botulinum type A and
manufacture of surimi-based products. proteolytic types B and F. Strict refrigeration control
(i.e. at or below 40˚F [4.4˚C]) during storage and
In-container pasteurization is covered in Chapter 17. distribution must, therefore, be maintained to prevent
Cooking is covered in Chapter 16. Control of refrig- growth and toxin formation by C. botulinum type A
erated storage is covered in this chapter and in and proteolytic types B and F, and other pathogens
Chapter 12. that may be present in these products (covered in this
chapter).
• Control in refrigerated, reduced oxygen packaged
“pickled” fish, caviar, and similar products • Control in refrigerated, reduced oxygen packaged
raw, unpreserved fish and unpasteurized, cooked
In “pickled” fish, caviar, and similar products that fishery products
have not been preserved sufficiently for them to
be shelf-stable, growth and toxin formation by For refrigerated, reduced oxygen packaged raw,
C. botulinum type E and nonproteolytic types B and F unpreserved fish (e.g. vacuum packaged fresh fish
is controlled by either: fillets) and unpasteurized, cooked fishery products
(e.g. vacuum packaged, unpasteurized crabmeat,
• Adding sufficient salt to produce a water phase salt lobstermeat, or crayfish meat), the sole barrier to
level (i.e. the concentration of salt in the water- toxin formation by C. botulinum type E and
portion of the fish flesh) of at least 5 percent; nonproteolytic types B and F during finished product
storage and distribution is refrigeration. These types
• Adding sufficient acid to reduce the acidity (pH) to of C. botulinum will grow at temperatures as low as
5.0 or below; 38˚F (3.3C). As was previously stated, maintenance
of temperatures at or below 38˚F (3.3˚C) after the
• Reducing the amount of moisture that is available product leaves the processor’s control cannot nor-
for growth (water activity) to below 0.97 (e.g., by mally be ensured. Time temperature integrators on
adding salt or other substances that “bind” the each consumer package may be an appropriate means
available water); or of providing such control. If you intend to use a
reduced oxygen packaging technique for these
• Making a combination of salt, pH, and/or water products and you intend to market the products
activity adjustments that, when combined, prevent the refrigerated without time temperature integrators on
growth of C. botulinum type E and nonproteolytic each consumer package, you will need to evaluate the
types B and F (to be established by a scientific study). effectiveness of other preventive measures, either

172
singularly, or in combination. Such evaluation will • The product is dried sufficiently to reduce the
usually necessitate the performance of inoculated water activity to 0.85 or below (Note: this value is
pack studies under moderate abuse conditions. A based on the minimum water activity for growth and
suitable protocol for the performance of such studies toxin formation of S. aureus,)(covered in Chapter 14).
is contained in a 1992 publication by the National
Advisory Committee on Microbiological Criteria for STEP #11: DETERMINE IF THIS
Foods, “Vacuum or modified atmosphere packaging POTENTIAL HAZARD IS SIGNIFICANT.
for refrigerated, raw fishery products.
At each processing step, determine whether “C.
• Control in frozen, reduced oxygen packaged fishery botulinum toxin formation” is a significant hazard.
products The criteria are:
If your product is immediately frozen after process- 1. Is it reasonably likely that C. botulinum will grow
ing, maintained frozen throughout distribution, and and produce toxin during finished product storage and
labeled to be held frozen and to be thawed under distribution?
refrigeration immediately before use (e.g. “Impor-
tant, keep frozen until used, thaw under refrigeration The factors that make C. botulinum toxin formation
immediately before use”), then formation of C. during finished product storage and distribution
botulinum toxin may not be a significant hazard. reasonably likely are those that may result in the
formation of a reduced oxygen packaging environ-
• Control in unrefrigerated (shelf-stable), reduced ment. These are discussed in Step #10, under the
oxygen packaged fishery products heading, “Reduced oxygen packaging.”
Examples of shelf-stable, reduced oxygen packaged 2.Can the growth and/or toxin production of
fishery products are dried fish, acidified fish, canned C. botulinum, which is reasonably likely to occur, be
fish and salted fish. Because these products are eliminated or reduced to an acceptable level at this
marketed without refrigeration, either: 1) the spores processing step? (Note: If you are not certain of the
of Clostridium botulinum types A,B, E and F must be answer to this question at this time, you may answer
destroyed after the product is placed in the finished “No.” However, you may need to change this answer
product container (covered by the low acid canned when you assign critical control points in Step #12.)
foods regulations, 21 CFR 113); or 2) a barrier, or
combination of barriers, must be in place that will “C. botulinum toxin formation” should also be
prevent growth and toxin formation by Clostridium considered a significant hazard at any processing step
botulinum types A,B, E and F, and other pathogens where a preventive measure is, or can be, used to
that may be present in the product. Suitable barriers eliminate (or reduce the likelihood of occurrence to
include: an acceptable level) the hazard, if it is reasonably
likely to occur.
• Sufficient salt is added to produce a water phase
salt level (the concentration of salt in the water- Preventive measures for C. botulinum toxin forma-
portion of the fish flesh) of at least 20 percent tion during processing can include:
(Note: this value is based on the maximum salt level
for growth of S. aureus.) (covered in this chapter) • controlling refrigeration temperatures;
• proper icing;
• Sufficient salt is added to reduce the water activity • controlling the amount of time that the product is
to 0.85 or below (covered in this chapter); exposed to temperatures that would permit
C. botulinum toxin formation;
• Sufficient acid is added to reduce the pH to 4.6 or • rapidly cooling the fish.
below (covered by the acidified foods regulations, 21
CFR 114);
Continued
173
Preventive measures for C. botulinum toxin formation It is important to note that identifying this hazard as
during finished product distribution and storage are significant at a processing step does not mean that it
discussed in Step #10, under the heading, “Control of must be controlled at that processing step. The next
C. botulinum in the finished product.” step will help you determine where in the process the
critical control point is located.
List such preventive measures in Column 5 of the
Hazard Analysis Worksheet at the appropriate process- • Intended use and method of distribution and storage
ing step(s).
In determining whether a hazard is significant you
Preventive measures of the type just described should should also consider the intended use and method of
be available to most of the “at risk” products described distribution and storage of the product, which you
above (i.e. vacuum packaged fish, modified atmo- developed in Step #4. Due to the extremely toxic
sphere packaged fish, fish packaged in hermetically nature of C. botulinum toxin, it is unlikely that the
sealed containers, fish packed in oil, fish packed in significance of the hazard will be affected by the
deep containers in which the air is expressed). No- intended use of your product.
table products for which these preventive measures are
not available include: refrigerated, reduced oxygen However, if your product is immediately frozen after
packaged raw, unpreserved fish (e.g. vacuum pack- processing, maintained frozen throughout distribu-
aged, fresh fish fillets) and reduced oxygen packaged, tion, and labeled to be held frozen and to be thawed
unpasteurized, cooked fishery products (e.g. vacuum under refrigeration immediately before use (e.g. “Impor-
packaged, unpasteurized crabmeat, lobstermeat, or tant, keep frozen until used, thaw under refrigeration
crayfish meat). For these products, the sole barrier to immediately before use”), then formation of C.
toxin formation by C. botulinum type E botulinum toxin may not be a significant hazard.
and nonproteolytic types B and F during finished
product storage and distribution is refrigeration. STEP #12: IDENTIFY THE CRITICAL
These types of C. botulinum will grow at temperatures CONTROL POINTS (CCP).
as low as 38˚F (3.3C). As was previously stated,
maintenance of temperatures at or below 38˚F (3.3˚C) For each processing step where “C. botulinum toxin
after the product leaves the processor’s control cannot formation” is identified in Column 3 of the Hazard
normally be ensured. Time temperature integrators on Analysis Worksheet as a significant hazard, determine
each consumer package may be an appropriate means whether it is necessary to exercise control at that step
of providing such control. If you intend to use a in order to control the hazard. Figure #A-2 (Appen-
reduced oxygen packaging technique for these prod- dix 3) is a CCP decision tree that can be used to aid
ucts and you intend to market the products refriger- you in your determination.
ated without time temperature integrators on each
consumer package, you will need to evaluate the The following guidance will also assist you in deter-
effectiveness of other preventive measures, either mining whether a processing step is a CCP for C.
singularly, or in combination. Such evaluation will botulinum toxin formation:
usually necessitate the performance of inoculated pack
studies under moderate abuse conditions. 1. Is there an acidification step (equilibrium pH of 4.6
or below), a drying step or an in-package pasteuriza-
If the answer to either question 1 or 2 is “Yes” the tion step (target organism C. botulinum type E and
potential hazard is significant at that step in the nonproteolytic types B and F) a combination of cook
process and you should answer “Yes” in Column 3 of and hot-fill steps (target organism C. botulinum type E
the Hazard Analysis Worksheet. If none of the criteria and nonproteolytic types B and F), or a retorting step
is met you should answer “No.” You should record the (commercial sterility) in the process?
reason for your “Yes” or “No” answer in Column 4.
You need not complete Steps #12 through 18 for this a. If there is, you may in most cases identify the
hazard for those processing steps where you have acidification step, drying step, pasteurization
recorded a “No” or where noted above. step, cook and hot-fill steps or retorting step as

174
the CCP(s) for this hazard. Other processing Note: acidification and retorting controls required by
steps where you have identified “C. botulinum 21 CFR 113 and 114 need not be included in your
toxin formation” as a significant hazard will then HACCP plan.
not require control and will not need to be
identified as CCPs for the hazard. However, the b. If there is no acidification step, drying step,
following products require control of temperature pasteurization step, cooking and hot-filling, or
during finished product storage and distribution: retorting step(s) in the process, then decide
products pasteurized in the final container to kill which of the following categories best describes
C. botulinum type E and nonproteolytic types B your product:
and F and refrigerated to control the growth of • smoked or smoke-flavored fish;
C. botulinum type A and proteolytic types B and • “pickled” fish, salted fish and similar products;
F and other pathogens that may be present (e.g. • other products for which C. botulinum toxin
pasteurized crabmeat, pasteurized surimi); 2) formation is a significant hazard.
products cooked to kill C. botulinum type E and
nonproteolytic types B and F, and then hot filled If your product fits into the third category (other
into the final container, and then refrigerated to products), you will have to establish other preventive
control the growth of C. botulinum type A and measures, either singularly, or in combination that
proteolytic types B and F, and other pathogens are effective in controlling the hazard, and develop a
that may be present; and 3) products dried to HACCP plan accordingly.
control the growth of C. botulinum type E and
nonproteolytic types B and F and refrigerated to If your product fits into the first category (smoked or
control the growth of C. botulinum type A and smoke-flavored fish), you should follow the guidance
proteolytic types B and F and other pathogens contained in the rest of this chapter contained under
that may be present. In these cases, you should the heading “Control Strategy Example 1 – Salting/
also identify the finished product storage step as smoking.”
a CCP for the hazard. Such control is covered in
this chapter and in Chapter 12. Additionally, If your product fits into the second category (“pick-
some pasteurized surimi-based products rely on led” fish), you should follow the guidance in the rest
a combination of salt and a relatively mild of this chapter contained under the heading “Control
pasteurization process in the finished product Strategy Example 2 - Pickling.”
container for the control of C. botulinum type E
and nonproteolytic types B and F. In these • CONTROL STRATEGY EXAMPLE 1 –
products, you should also identify the formulation SALTING/SMOKING
step as a CCP for the hazard. Such control is
covered in this chapter under Control Strategy The following questions apply to salted, smoked, and
Example 2 – “Pickling.” smoke-flavored fish:
Guidance for these C. botulinum toxin control 1. Is the temperature of the heating/smoking process
strategies is contained in the following locations: important to the safety of the product?
• Chapters 16 and 18, for control of cooking and For both cold-smoked and hot-smoked fish products
hot-filling; the temperature of heating/smoking is critical. The
• Chapters 17 and 18, for control of pasteurization; heating/smoking step for hot-smoked fish must be
• Chapter 14, for control of drying; sufficient to damage the spores and make them more
• Acidified foods regulations, 21 CFR 114, for susceptible to inhibition by salt. The smoking step
control of acidification; for cold-smoked fish must not be so severe that it
• Low acid canned foods regulations, 21 CFR 113, kills the natural spoilage bacteria. These bacteria are
for control of retorting. necessary so that the product will spoil before toxin
production occurs. It is likely that they will also
Continued
175
produce acid, which will further inhibit C. botulinum The above described control approach is referred to
growth and toxin formation. as “Control Strategy Example 1” in Steps #14-18.
It is important to note that you may select a control
For these products you should enter “Yes” in Column strategy that is different from that which is suggested
6 of the Hazard Analysis Worksheet for the heating/ above, provided that it assures an equivalent degree
smoking step. of safety of the product.
2. Is the water phase salt level and, when permitted, Proceed to Step #13 (Chapter 2) or to Step #10 of the
the nitrite level, important to the safety of the product? next potential hazard.
For all products in this category the water phase salt • CONTROL STRATEGY EXAMPLE 2 – PICKLING
level is critical to the safety of the product. Nitrite,
when permitted, allows a lower level of salt to be The following questions apply to “pickled” fish and
used. Salt, and nitrite are the principal inhibitors to similar products (and to some pasteurized surimi-
C. botulinum type E and nonproteolytic types B and based products that rely on a combination of salt and
F toxin formation in these products. The water phase a relatively mild pasteurization process in the fin-
salt level needed to inhibit toxin formation is par- ished product container for the control of C. botuli-
tially achieved during brining or dry salting, and num type E and nonproteolytic types B and F):
partially achieved during drying. Control must be
exercised over both operations. 1. Is the water phase salt level, water activity, and/or
pH level important to the safety of the product?
You should enter “Yes” in Column 6 of the Hazard
Analysis Worksheet for the brining or dry salting step For all products in this category the water phase salt
and the drying step. level, water activity, and/or pH level is critical to the
safety of the product, because they are the principle
3. Is the finished product storage temperature impor- inhibitors to growth and toxin formation by C.
tant to the safety of the product? botulinum type E and nonproteolytic type B and F.
The levels of these inhibitors needed to inhibit toxin
Toxin formation by C. botulinum type A and pro- formation are achieved during the pickling, brining,
teolytic B and F is not inhibited by salt levels below or formulation step. Control must be exercised over
10%, nor by the combination of inhibitors present in the relevant step.
most smoked or smoke-flavored fish. B. cereus can
grow and form toxin at salt concentrations as high as You should enter “Yes” in Column 6 of the Hazard
18%. Therefore, in these products, finished product Analysis Worksheet for the pickling, brining, or
storage temperature must be controlled. formulation step, as appropriate.
In this case, you should enter “Yes” in Column 6 of 2. Is the finished product storage temperature impor-
the Hazard Analysis Worksheet for the finished tant to the safety of the product?
product storage step.
Unless pickling, brining, or formulation results in a
In some cases smoked or smoke-flavored fish are water phase salt level of at least 20% (Note: this
received as ingredients for assembly into another value is based on the maximum salt concentration for
product, such as a salmon pate. In other cases, they growth of S. aureus), a pH of 4.6 or below, or a water
are received simply for storage and further distribu- activity of 0.85 or below (Note: this value is based on
tion (e.g. by a warehouse). In these cases, the the minimum water activity for growth of S. aureus),
receiving and storage steps may also require time/ storage and distribution temperature will be critical to
temperature controls, and should be designated as ensure the safety of the product.
CCPs.

176
In this case, you should enter “Yes” in Column 6 of Following is guidance on setting critical limits for the
the Hazard Analysis Worksheet for the finished control strategy examples discussed in Step #12.
product storage step.
• CONTROL STRATEGY EXAMPLE 1 - SMOKING
In some cases “pickled” fish or similar products are
received as ingredients for assembly into another For controlling toxin formation by cold smoking:
product, such as receipt of bulk “pickled” herring for
repackaging into retail-size containers. In other Critical Limit: The smoker temperature must not
cases, they are received simply for storage and exceed 90˚F (32.2˚C).
further distribution (e.g. by a warehouse). In these
cases, the receiving and storage steps may also For controlling toxin formation by hot smoking:
require time/temperature controls, and should be
designated as CCPs. Critical Limit: The internal temperature of the fish
must be maintained at or above 145˚F (62.8˚C)
The above described control approach is referred to throughout the fish for at least 30 minutes.
as Control Strategy Example 2" in Steps #14-18. It is
important to note that you may select a control For controlling toxin formation by brining, dry
strategy that is different from that which is suggested salting, and/or drying:
above, provided that it assures an equivalent degree
of safety of the product. Critical Limit: The minimum or maximum values for
the critical factors of the brining/dry salting, and/or
Proceed to Step #13 (Chapter 2) or to Step #10 of the drying processes established by a scientific study.
next potential hazard. The critical factors are those that are necessary to
assure that the finished product has:
STEP #14: SET THE CRITICAL LIMITS (CL). • For refrigerated, reduced oxygen packaged
(e.g. vacuum or modified atmosphere
For each processing step where “C. botulinum toxin packaged) smoked fish or smoke-flavored fish,
formation” is identified as a significant hazard on the not less than 3.5 percent water phase salt, or,
HACCP Plan Form, identify the maximum or mini- where permitted, the combination of 3.0
mum value to which a feature of the process must be percent water phase salt and not less than
controlled in order to control the hazard. 100 ppm nitrite.
You should set the CL at the point that if not met, the The critical factors may include: brine strength; brine
safety of the product is questionable. If you set a to fish ratio; brining time; brining temperature;
more restrictive CL you could, as a result, be re- thickness, texture, fat content, quality, and species of
quired to take corrective action when no safety fish; drying time; input/output air temperature,
concern actually exists. On the other hand, if you set humidity, and velocity; smoke density; drier loading.
a CL that is too loose you could, as a result, allow
unsafe product to reach the consumer. • CONTROL STRATEGY EXAMPLE 2 - PICKLING
As a practical matter it may be advisable to set an For controlling toxin formation by pickling,
operating limit that is more restrictive than the CL. brining, or formulation:
operating limit is triggered, but before a triggering of Critical Limit: The minimum or maximum values
the CL would require you to take corrective action. for the critical factors of the pickling, brining,
You should set operating limits based on your or formulation process established by a
experience with the variability of your operation and scientific study. The critical factors are those
with the closeness of typical operating values to the CL. that are necessary to assure that the finished
product has:
Continued
177
For refrigerated, reduced oxygen packaged other than C. botulinum provided in the critical limits
fishery products: section (Step #14) of Chapter 12, which is also
adequate for the control of C. botulinum.
• A water phase salt level of at least 5 percent;
OR For controlling toxin formation at receipt of
• A pH of 5.0 or below; “pickled,” smoked or smoke-flavored fish for
OR storage or further processing:
• A water activity of below 0.97;
OR Critical Limit: The product must not be exposed to a
• a water phase salt level of at least 2.5% in combination of times and temperatures that will
surimi-based products, when combined with a allow growth or toxin formation by C. botulinum or
pasteurization process in the finished product other pathogens that may be present in the product.
container of 185˚F (85˚C) for at least 15 Refer to the guidance for the control of pathogens
minutes (covered in Chapter 17); other than C. botulinum provided in the critical limits
OR section (Step #14) of Chapter 12, which is also
• A combination of water phase salt, pH, and/or adequate for the control of C. botulinum.
water activity that, when combined, have
been demonstrated to prevent the growth of Enter the critical limit(s) in Column 3 of the HACCP
C. botulinum type E and nonproteolytic type B Plan Form.
and F.
STEP #15: ESTABLISH MONITORING
For unrefrigerated (shelf-stable), reduced oxygen PROCEDURES.
packaged products:
For each processing step where “C. botulinum toxin
• A water phase salt level of at least 20 percent formation” is identified as a significant hazard on the
(based on the maximum salt level for growth HACCP Plan Form, describe monitoring procedures
of S. aureus; that will ensure that the critical limits are consistently
OR met.
• A pH of 4.6 or below;
OR To fully describe your monitoring program you
• A water activity of 0.85 or below (based on the should answer four questions: 1) What will be
minimum water activity for growth and toxin monitored? 2) How will it be monitored? 3) How
formation of S. aureus). often will it be monitored (frequency)? 4) Who will
perform the monitoring?
The critical factors may include: brine strength; acid
strength; brine/acid to fish ratio; brining/pickling It is important for you to keep in mind that the
time; brining/pickling temperature; thickness, feature of the process that you monitor and the
texture, fat content, quality, and species of fish. method of monitoring should enable you to deter-
mine whether the CL is being met. That is, the
• CONTROL STRATEGY EXAMPLES 1 & 2 monitoring process should directly measure the
feature for which you have established a CL.
For controlling toxin formation during refriger-
ated (not frozen) finished product storage: You should monitor often enough so that the normal
Critical Limit: The product must not be exposed to a detected. This is especially true if these values are
combination of times and temperatures that will typically close to the CL. Additionally, the greater
allow growth or toxin formation by C. botulinum or the time span between measurements, the more
other pathogens that may be present in the product. product you are putting at risk should a measurement
Refer to the guidance for the control of pathogens show that a CL has been violated.

178
Following is guidance on establishing monitoring OR
procedures for the control strategy examples dis- The water phase salt, pH, and/or water activity of
cussed in Step #12. Note that the monitoring fre- the finished product.
ered as minimum recommendations, and may not be • CONTROL STRATEGY EXAMPLES 1 & 2
For controlling toxin formation during refriger-
ated (not frozen) finished product storage:
What Will Be Monitored?
What: The temperature of the cooler;
• CONTROL STRATEGY EXAMPLE 1 - SMOKING OR
The adequacy of ice or other cooling media.
For controlling toxin formation by cold smoking:
For controlling toxin formation at receipt of
What: The smoker temperature. refrigerated (not frozen) “pickled,” smoked or
smoke-flavored fish for storage or further
For controlling toxin formation by hot smoking: processing:
What: The internal temperature at the thickest What: The internal temperature of the fish throughout
portion of three of the largest fish in the smoking transportation;
chamber. OR
The temperature of the truck or other carrier
For controlling toxin formation by brining, dry throughout transportation;
salting, and/or drying: OR
For fishery products with a transit time of four
What: The critical aspects of the established brining, hours or less: The internal temperature of a
dry salting, and/or drying processes. These may representative number of containers in the lot at
include: brine strength; brine to fish ratio; time of delivery;
brining time; brining temperature; thickness, OR
texture, fat content, quality, and species of fish; The adequacy of ice or other cooling media at
drying time; input/output air temperature, time of delivery.
humidity, and velocity; smoke density; drier
loading.
OR How Will Monitoring Be Done?
The water phase salt and, where appropriate,
nitrite level of the finished product. • CONTROL STRATEGY EXAMPLE 1 - SMOKING
• CONTROL STRATEGY EXAMPLE 2 - PICKLING For controlling toxin formation by cold smoking:
For controlling toxin formation by pickling, How: Use a digital time/temperature data logger;
brining, or formulation: OR
Use a recorder thermometer;
What: The critical aspects of the established pickling, OR
brining, or formulation process. These may Use a maximum indicating thermometer;
include: brine/acid strength; brine/acid to fish OR
ratio; brining/pickling time; brine/acid Use a high temperature alarm.
temperature; thickness, texture, fat content,
quality, and species of fish;
Continued
179
For controlling toxin formation by hot smoking: • CONTROL STRATEGY EXAMPLES 1 & 2
How: Use a digital time/temperature data logger with For controlling toxin formation during refriger-
three probes. ated (not frozen) finished product storage:
For controlling toxin formation by brining. dry How: Use a digital time/temperature data logger;
salting, and/or drying: OR
Use a recorder thermometer;
How: Monitor the drying time and the input/output OR
air temperature (as specified by the study) with Use a high temperature alarm with 24-hour
a temperature recording device or digital time/ monitoring;
temperature data logger. The device should be OR
installed where it can be easily read and the Make visual observations of the adequacy of
sensor for the device should be installed to ice or other cooling media in a sufficient number
ensure that it accurately measures the input/ of containers to represent all of the product.
output air temperature;
AND For controlling toxin formation at receipt of
Monitor brine strength with a salinometer; refrigerated (not frozen) “pickled,” smoked or
AND smoke-flavored fish for storage or further
Monitor the brine temperature with a dial or processing:
digital thermometer;
AND How: Use a time/temperature integrator for product
Monitor all other critical factors specified by internal temperature monitoring during transit;
the study with equipment appropriate for the OR
measurement; Use a digital time/temperature data logger for
OR product internal temperature or ambient air
Collect a representative sample of finished temperature monitoring during transit;
product and conduct water phase salt analysis, OR
and, when appropriate, nitrate analysis. Use a recorder thermometer for ambient air
temperature monitoring during transit;
• CONTROL STRATEGY EXAMPLE 2 – PICKLING OR
Use a maximum indicating thermometer for
For controlling toxin formation by pickling, ambient air temperature monitoring during
brining, or formulation: transit;
OR
How: Monitor brine strength with a salinometer; Use a dial or digital thermometer for internal
AND product temperature monitoring at receipt;
Monitor acid strength with a pH meter or by OR
titration; Make visual observations of the adequacy of ice
AND or other cooling media in a sufficient number of
Monitor brine/acid temperature with a dial or containers to represent all of the product.
digital thermometer;
AND
Monitor all other critical factors specified by the
study with equipment appropriate for the
measurement;
OR
Collect a representative sample of finished
product and conduct water phase salt, pH, and/or
water activity analysis.
180
How Often Will Monitoring Be Done • CONTROL STRATEGY EXAMPLE 2 - PICKLING
(Frequency)?
For controlling toxin formation by pickling,
• CONTROL STRATEGY EXAMPLE 1 - SMOKING brining, or formulation:
For controlling toxin formation by cold smoking: Frequency: Monitor brine/acid strength at the start
of the brining/pickling/formulation process;
Frequency: Continuous monitoring by the instrument AND
itself, with visual check of the monitoring Monitor the brine/acid temperature at the start of
instrument at least once per batch. the brining/pickling/formulation process and at
least every two hours thereafter;
For controlling toxin formation by hot smoking: AND
Monitor the brine/acid to fish ratio at the start of
Frequency: Continuous monitoring by the instrument the brining/pickling/formulation process;
itself, with visual check of the monitoring AND
instrument at least once per batch. Monitor all other critical factors specified by the
study as often as necessary to maintain control;
For controlling toxin formation by brining, dry OR
salting, and/or drying: Water phase salt, pH, and/or water activity
analysis should be determined for each batch of
Frequency: Temperature requirements of the drying finished product.
process should be monitored continuously by the
instrument itself, with visual check of the • CONTROL STRATEGY EXAMPLES 1 & 2
monitoring instrument at least once per batch;
AND For controlling toxin formation during refriger-
Time requirements of the drying process should ated (not frozen) finished product storage:
be monitored for each batch;
AND Frequency: Continuous monitoring by the instrument
Monitor brine strength at least at the start of the itself, with visual check of the monitoring
brining process; instrument at least once per day;
AND OR
Monitor the brine temperature at the start of the For ice or other cooling media, check at least
brining process and at least every two hours twice per day, or immediately prior to shipment.
thereafter;
Monitor the brine to fish ratio at the start of the refrigerated (not frozen) “pickled,” smoked or
brining process; smoke-flavored fish for storage or further
AND processing:
study as often as necessary to maintain control. Frequency: Each shipment.
OR
Water phase salt and, when appropriate, nitrite
should be determined for each lot or batch of
finished product.
Continued
181
Who Will Perform the Monitoring? • CONTROL STRATEGY EXAMPLE 1 - SMOKING
• CONTROL STRATEGY EXAMPLES 1 & 2 For controlling toxin formation by cold smoking:
Who: With recorder thermometers, time/ Corrective Action: Take one or more of the
temperature integrators, high temperature following actions as necessary to regain control
alarms, maximum indicating thermometers, and over the operation after a CL deviation:
digital time/temperature data loggers, monitoring • Make repairs or adjustments to the smoking/
is performed by the equipment itself. However, drying chamber;
anytime that such instruments are used, a visual OR
check should be made at least once per day • Move some or all of the product to another
(at least once per batch, as appropriate) in order smoking/drying chamber;
to ensure that the critical limits have consistently AND
been met. These checks, as well as dial Take one of the following actions to the product
thermometer checks, salinometer checks, involved in the critical limit deviation:
pH meter checks, titrations and adequacy • Destroy the product;
of ice or other cooling media checks may be OR
performed by the receiving employee, the • Hold the product until its safety can be
equipment operator, a production supervisor, a evaluated;
member of the quality control staff, or any other OR
person who has an understanding of the process, • Divert the product to a use in which the critical
the monitoring procedure, and the critical limits. limit is not applicable (e.g. packaging that is
not hermetically sealed, or low acid canned
Enter the “What,” “How,” “Frequency,” and “Who” food [LACF] or frozen product);
monitoring information in Columns 4, 5, 6, and 7, OR
respectively, of the HACCP Plan Form. • Divert the product to a non-food use.
STEP #16: ESTABLISH CORRECTIVE AC- For controlling toxin formation by hot smoking:
TION PROCEDURES.
Corrective Action: Take one or more of the
For each processing step where “C. botulinum toxin following actions as necessary to regain control
formation” is identified as a significant hazard on the over the operation after a CL deviation:
HACCP Plan Form, describe the procedures that you • Make repairs or adjustments to the heating
will use when your monitoring indicates that the CL chamber;
has not been met. OR
• Move some or all of the product to another
These procedures should: 1) ensure that unsafe heating chamber;
product does not reach the consumer; and, 2) correct AND
the problem that caused the CL deviation. Remember Take one of the following actions to the product
that deviations from operating limits do not need to involved in the critical limit deviation:
result in formal corrective actions. • Destroy the product;
OR
Following is guidance on establishing corrective • Hold the product until its safety can be
action procedures for the control strategy examples evaluated;
discussed in Step #12. OR
• Reprocess the product;

182
OR AND
• Divert the product to a use in which the critical Take one of the following actions to the product
limit is not applicable (e.g. packaging that is involved when finished product testing shows
not hermetically sealed, or LACF or frozen that the water phase salt level and/or nitrite level
product); is below the critical limit:
OR • Destroy the product
• Divert the product to a non-food use. OR
• Divert the product to a use in which the critical
For controlling toxin formation by brining, limit is not applicable (e.g. packaging that is
dry salting, and/or drying: not hermetically sealed, or LACF or frozen
product);
Corrective Action: Take one or more of the OR
following actions as necessary to regain control • Divert to a non-food use.
over the operation after a CL deviation:
• Adjust the brine and/or nitrite concentration; • CONTROL STRATEGY EXAMPLE 2 - PICKLING
OR
• Adjust the air velocity or input air temperature For controlling toxin formation by pickling,
to the drying chamber; brining, or formulation:
OR
• Extend the drying process to compensate for a Corrective Action: Take one or more of the
reduced air velocity or temperature or elevated following actions as necessary to regain control
humidity; over the operation after a CL deviation:
OR • Adjust the brine/acid strength or brine/acid to
Adjust the brine strength or brine to fish ratio; fish ratio;
OR OR
• Extend the brining time to compensate for an • Extend the brining/pickling time to compensate
improper brine temperature; for an improper brine/acid temperature;
AND AND
Take one of the following actions to the product Take one of the following actions to the product
involved when there has been a failure to involved when there has been a failure to
maintain specified critical factors of the brining, maintain the specified critical factors of the
dry salting or drying process: pickling, brining, or formulation process:
• Destroy the product; • Destroy the product;
OR OR
• Hold the product until it can be evaluated • Hold the product until it can be evaluated
based on its water phase salt and/or nitrate based on its water phase salt, pH, and/or water
level; activity level;
OR OR
• Reprocess the product; • Reprocess the product;
OR OR
• Divert the product to a use in which the critical • Divert the product to a use in which the critical
limit is not applicable (e.g. packaging that is limit is not applicable (e.g. packaging that is
not hermetically sealed, or LACF or frozen not hermetically sealed, or LACF or frozen
product); product);
OR OR
• Divert the product to a non-food use. • Divert the product to a non-food use.
Continued
183
Take one of the following actions to the product refrigerated (not frozen) “pickled,” smoked or
involved when finished product testing shows smoke-flavored fish for storage or further process-
that water phase salt is below 5 percent, or the ing:
pH is above 5.0, or the water activity is 0.97 or
above, or the intended combination of water Corrective Action: Reject products that do not
phase salt, pH, and/or water activity has not been meet the time/temperature or adequacy of ice or
achieved, as appropriate: other cooling media critical limit at receiving;
• Destroy the product; OR
OR Hold the product until it can be evaluated based
• Divert the product to a use in which the critical on its total time/temperature exposure.
limit is not applicable because C. botulinum AND
growth in the finished product will be Discontinue use of supplier or carrier until
controlled by some other means evidence is obtained that transportation practices
(e.g. packaging that is not hermetically sealed, have changed.
or LACF or frozen product);
OR Note: If an incoming lot that fails to meet a receiving
• Reprocess the product (if reprocessing does not critical limit is mistakenly accepted, and the error is
jeopardize the safety of the product); later detected, the following actions should be taken:
OR 1) the lot and any products processed from that lot
• Divert to a non-food use. should be destroyed, diverted to a nonfood use or to a
use in which the critical limit is not applicable, or
• CONTROL STRATEGY EXAMPLES 1 & 2 placed on hold until a food safety evaluation can be
completed; and 2) any products processed from that
For controlling toxin formation during refriger- lot that have already been distributed should be
ated (not frozen) finished product storage: recalled and subjected to the actions described above.
Corrective Action: Take one or several of the Enter the corrective action procedures in Column 8 of
following actions as necessary to regain control the HACCP Plan Form.
• Add ice to the affected product STEP #17: ESTABLISH A RECORDKEEPING
OR SYSTEM.
• Make repairs or adjustments to the
malfunctioning cooler; For each processing step where “C. botulinum toxin
OR formation” is identified as a significant hazard on the
• Move some or all of the product in the HACCP Plan Form, list the records that will be used
malfunctioning cooler to another cooler; to document the accomplishment of the monitoring
OR procedures discussed in Step #15. The records
• Freeze the product; should clearly demonstrate that the monitoring
AND procedures have been followed, and should contain
Take one of the following actions to the product the actual values and observations obtained during
involved in the critical limit deviation: monitoring.
• Destroy the product;
OR Following is guidance on establishing a record-
• Hold the product until it can be evaluated keeping system for the control strategy examples
based on its total time/temperature exposure; discussed in Step #12.
OR
• Divert the product to a non-food use.

184
• CONTROL STRATEGY EXAMPLE 1 - SMOKING size and species of fish, time of brining/pickling)
as necessary to document the monitoring of the
For controlling toxin formation by cold smoking: critical factors of the brining/pickling process, as
established by a study;
Records: Printout from digital time/temperature OR
data logger; Results of the finished product water phase salt,
OR pH, or water activity determinations.
Recorder thermometer chart;
OR • CONTROL STRATEGY EXAMPLES 1 & 2
Record showing the results of the maximum
indicating thermometer checks; For controlling toxin formation during refriger-
OR ated (not frozen) finished product storage:
Record showing the results of the high
temperature alarm checks. Records: Printout from digital time/temperature
data logger;
For controlling toxin formation by hot smoking: OR
Recorder thermometer chart;
Records: Printout from digital time/temperature OR
data logger; Storage record showing the results of the high
AND temperature alarm checks.
Smoking log showing the time that the product
reached 145˚F (62.8˚C) and the time that the For controlling toxin formation at receipt of
heating process ended. refrigerated (not frozen) “pickled,” smoked or
smoke-flavored fish for storage or further
For controlling toxin formation by brining, dry processing:
salting, and/or drying:
Records: Receiving record showing the results of
Records: Temperature recorder chart or data logger the time/temperature integrator checks;
printout for drier input/output air temperature; OR
AND Printout from digital time/temperature data
Appropriate records (e.g. processing record logger;
showing the results of the brine strength and OR
temperature, brine to fish ratio, size and species Recorder thermometer chart;
of fish, time of brining) as necessary to OR
document the monitoring of the critical factors of Receiving record showing the results of the
the brining, dry salting, and/or drying process, as maximum indicating thermometer checks;
established by a study; OR
OR The results of internal product temperature
Results of the finished product water phase salt monitoring at receipt;
determination, and, when appropriate, nitrite AND
determination. The date and time of departure and arrival of the
vehicle;
• CONTROL STRATEGY EXAMPLE 2 - PICKLING OR
Receiving record showing the results of the ice
For controlling toxin formation by pickling, or other cooling media checks.
brining, or formulation:
Records: Appropriate records (e.g. processing of the HACCP Plan Form.
record showing the results of the brine/acid
strength and temperature, brine/acid to fish ratio,
Continued
185
STEP #18: ESTABLISH VERIFICATION the ability of the established minimum salting
PROCEDURES. and/or drying process should be taken into
consideration in the process establishment. A
For each processing step where “C. botulinum toxin record of the process establishment should be
formation” is identified as a significant hazard on the maintained;
HACCP Plan Form, establish verification procedures AND
that will ensure that the HACCP plan is: 1) adequate When digital time/temperature data loggers,
to address the hazard of C. botulinum toxin produc- recorder thermometers, or high temperature
tion; and, 2) consistently being followed. alarms are used for in-plant monitoring, check
for accuracy against a known accurate thermometer
Following is guidance on establishing verification (NIST-traceable) at least once per day;
procedures for the control strategy examples dis- AND
cussed in Step #12. When digital time/temperature data loggers or
recorder thermometers are used for monitoring of
• CONTROL STRATEGY EXAMPLE 1 - SMOKING transport conditions at receiving, check for
accuracy against a known accurate thermometer
Verification: Review monitoring, corrective action, (NIST-traceable). Verification should be conducted
and verification records within one week of on new suppliers’ vehicles and at least quarterly
preparation; for each supplier thereafter. Additional
AND verifications may be warranted based on
Process establishment (except where finished observations at receipt (e.g. refrigeration units
product water phase salt analysis and, where appear to be in poor repair, or readings appear to
appropriate, nitrite analysis is the monitoring be erroneous);
procedure): The adequacy of the brining/dry AND
salting and/or drying process should be When dial or digital thermometers or maximum
established by a scientific study. It should be indicating thermometers are used for monitoring,
designed to consistently achieve a water phase check for accuracy against a known accurate
salt level of: 3.5 percent or 3.0 percent with not thermometer (NIST-traceable) when first used
less than 100 ppm nitrite for refrigerated, and at least once per year thereafter (Note:
reduced oxygen packaged (e.g. vacuum or Optimal calibration frequency is dependent upon
modified atmosphere packaged) smoked fish or the type, condition, and past performance of the
smoke-flavored fish. Expert knowledge of monitoring instrument);
salting and/or drying processes is required to AND
establish such a process. Such knowledge can be Other calibration procedures as necessary to
obtained by education or experience or both. ensure the accuracy of the monitoring instruments;
Establishment of brining/dry salting and drying AND
processes requires access to adequate facilities Finished product sampling and analysis to
and the application of recognized methods. The determine water phase salt and, where
drying equipment must be designed, operated appropriate, nitrite analysis at least once every
and maintained to deliver the established drying three months (except where such testing is
process to every unit of product. In some performed as part of monitoring).
instances, brining/dry salting and/or drying
studies will be required to establish minimum • CONTROL STRATEGY EXAMPLE 2 - PICKLING
processes. In other instances, existing literature,
which establish minimum processes or adequacy Verification: Review monitoring, corrective action,
of equipment, are available. Characteristics of and verification records within one week of
the process, product, and/or equipment that affect preparation;

186
AND AND
Process establishment (except where finished When digital time/temperature data loggers or
product water phase salt, pH, or water activity recorder thermometers are used for monitoring
analysis is the monitoring procedure): The of transport conditions at receiving, check for
adequacy of the pickling/brining/formulation accuracy against a known accurate thermometer
process should be established by a scientific (NIST-traceable). Verification should be conducted
study. For refrigerated, reduced oxygen on new suppliers’ vehicles and at least quarterly
packaged products it should be designed to for each supplier thereafter. Additional
consistently achieve: a water phase salt level of verifications may be warranted based on
at least 5 percent; a pH of 5.0 or below; a water observations at receipt (e.g. refrigeration units
activity of below 0.97; a water phase salt level of appear to be in poor repair, or readings appear to
at least 2.5% in surimi-based products, when be erroneous);
combined with a pasteurization process in the AND
finished product container of 185˚F (85˚C) for at When visual checks of ice or cooling media are
least 15 minutes; or, a combination of salt, pH, used to monitor the adequacy of coolant,
and/or water activity that, when combined, periodically measure internal temperatures of the
prevent the growth of C. botulinum type E and product to ensure that the ice or cooling media is
nonproteolytic types B and F (established by sufficient to maintain product temperatures at or
scientific study). For unrefrigerated (shelf- below 40˚F (4.4˚C);
stable), reduced oxygen packaged products, it AND
should be designed to consistently achieve: a When dial thermometers or maximum indicating
water phase salt level of at least 20% (based on thermometers are used for monitoring, check for
the maximum water phase salt level for growth accuracy against a known accurate thermometer
of S. aureus); a pH of 4.6 or below; or a water (NIST-traceable) when first used and at least
activity of 0.85 or below (based on the minimum once per year thereafter (Note: Optimal
water activity for growth of S. aureus. Expert calibration frequency is dependent upon the type,
knowledge of pickling/brining/formulation condition, and past performance of the
processes is required to establish such a process. monitoring instrument);
Such knowledge can be obtained by education or AND
experience or both. Establishment of pickling/ Daily calibration of pH meters against standard
brining/formulation processes requires access to buffers;
adequate facilities and the application of AND
recognized methods. In some instances, pickling/ Other calibration procedures as necessary to
brining/formulation studies will be required to ensure the accuracy of the monitoring
establish minimum processes. In other instances, instruments;
existing literature, which establish minimum AND
processes, are available. Characteristics of the Finished product sampling and analysis to
process and/or product that affect the ability of determine water phase salt, pH, or water activity
the established minimum pickling/brining/ level, as appropriate, at least once every three
formulation process should be taken into months (except where such testing is performed
consideration in the process establishment. as part of monitoring).
A record of the process establishment should be
maintained; Enter the verification procedures in Column 10 of the
AND HACCP Plan Form.
When digital time/temperature data loggers,
recorder thermometers, or high temperature
alarms are used for in-plant monitoring, check
for accuracy against a known accurat thermometer
(NIST-traceable) at least once per day;
Continued
187
TABLE #13-1
Control Strategy Example 1 – Smoking
This table is an example of a portion of a HACCP plan relating to the control of C. botulinum toxin formation for a processor
of vacuum packaged hot-smoked salmon, using Control Strategy Example 1 - Smoking. It is provided for
illustrative purposes only. C. botulinum toxin formation may be only one of several significant hazards for this product.
Refer to Tables 3-1, 3-2, and 3-3 (Chapter 3) for other potential hazards (e.g. aquaculture drugs, chemical contaminants,
parasites, growth of other pathogens, survival of other pathogens through the cook step, and metal fragments).
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
Brining • C. botulinum toxin • Minimum brining time • Length of • Visual • Start and end of • Brine room • Extend brining • Production • Documentation
formation in finished 6 hours brining process brining process employee process record of brining/
product drying process
Se establishment
188
• Minimum salt • Salt • Salinometer • Start of brining • Brine room • Add salt • Production • Review
eT
concentration of brine
ex concentration process employee record monitoring,
at start of brining 60o of brine corrective

salimeter action, and
t f Exa
verification
or mp
Fu le records within
• Minimum ratio of • Weight of brine • Visual to mark • Start of brining • Brine room • Add brine • Production one week of
brine:fish 2:1 (as determined on tank process employee record preparation
ll R O
by volume)
• Monthly
eco nly
• Weight of fish • Scale • Each batch • Brine room • Remove some • Production calibration of
employee fish and reweigh record scale
mm
• Maximum fish
en • Fish thickness • Caliper • Each batch • Brine room • Hold and • Production • Quarterly water
thickness 1 1/2" (10 fish) employee evaluate based record phase salt
da
tio on finished analysis
(Note: To produce a product water
minimum water phase salt phase salt
ns
level in the loin muscle of analysis
3.5%)
Note: The critical limits in this example are for illustrative purposes only, and are not related to any recommended process.
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
Smoking/drying/ • C. botulinum toxin • Minimum time open • Time of open • Visual • Each batch • Smoker • Extend drying • Production • Documentation
heating formation in finished vent 2 hours vent employee process, and record of brining/
product drying process
• Hold and establishment
evaluate
• Review
• Internal temperature of • Internal • Digital data • Continuous with • Smoker • Extend heating • Data logger monitoring,
fish held at or above temperature logger with visual at end of employee process, and printout corrective
145˚F for at least 30 of fish and time probes in 3 of batch action, and
minutes at that thickest fish in • Make repairs or verification
temperature cold spot of adjustments to records within
oven the smoking one week of
chamber, and preparation
• Hold and • Smoking log • Daily

evaluate calibration of
Se data logger
189
• Quarterly water
phase salt
eT
analysis
ex

t f Exa
or mp
Fu le
ll R O
Finished product • C. botulinum toxin • Maximum cooler • Cooler air • Digital data • Continuous, • Production • Adjust or repair • Data logger • Review
storage formation during temperature 40˚F temperature logger with visual once employee cooler, and printout monitoring,
eco nly
finished product (based on growth of per day corrective
mm
storage vegetative pathogens) • Hold and action, and
evaluate based verification
en
da on time/ records within
temperature of one week of
exposure preparation
tio
ns
• Daily check of
data logger
accuracy
TABLE #13-2
Control Strategy Example 2 – Pickling
This table is an example of a portion of a HACCP plan relating to the control of Clostridium botulinum for a processor
of pickled herring, using Control Strategy Example 2 - Pickling. It is provided for illustrative purposes only.
C. botulinum toxin formation may be only one of several significant hazards for this product. Refer to Tables 3-1, 3-2, and 3-3
(Chapter 3) for other potential hazards (e.g. histamine, chemical contaminants, parasites, and metal fragments).
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
Pickling C. botulinum toxin Maximum finished Finished product Collect sample of Each pickling QC personnel Continue pickling Analytical results • Daily
formation in finished product pH in the loin pH in the loin product from each tank, each cycle process until pH calibration of
product muscle of 5.0 muscle pickling tank at meets the CL pH meter
the end of each
Se pickling cycle and • Review
analyze for pH monitoring,
190
using a pH meter corrective
eT
ex action, and
verification

records within
t f Exa
one week of
or mp
Fu le preparation
ll R O
Finished product C. botulinum toxin Maximum cooler Cooler air High temperature Continuous, with Production • Adjust or repair Production record • Daily accuracy
eco nly
storage formation during temperature 40˚F temperature alarm with 24- visual check of employee cooler, and with daily alarm check of high
finished product (based on growth of hour monitoring operation once check temperature alarm
mm
storage vegetative pathogens) en per day
• Hold and • Review
da
on time/ corrective
tio
temperature of action, and
ns
records within
one week of
preparation
Chapter 14: Pathogen Growth & Toxin Formation
as a Result of Inadequate Drying (A Biological Hazard)
Hazard Analysis Worksheet This chapter covers the control of the drying process
to prevent the growth and toxin production of patho-
STEP #10: UNDERSTAND THE POTENTIAL gens, including S. aureus and C. botulinum in the
HAZARD. finished product. Such control is critical to product
safety.
Pathogen growth in the finished product as a result of
inadequate drying of fishery products can cause This chapter does not cover the growth of pathogens,
consumer illness. Examples of dried fish products including S. aureus, that may occur as a result of
are: salmon jerky; octopus chips; dried shrimp; and, time/temperature abuse during processing, including
stock fish. before or during the drying process. That hazard is
covered in Chapter 12. It also does not cover the
• Control of drying control of C. botulinum type A and proteolytic types
B and F, and other pathogens that may be present,
Dried products are usually considered shelf stable including S. aureus, during refrigerated storage of
and are, therefore, often stored and distributed reduced oxygen packaged, partially dried products.
unrefrigerated. The characteristic of dried foods that That hazard is covered in Chapters 12 and 13.
makes them shelf stable is their low water activity
(Aw). Water activity is the measure of the amount of Controlling pathogen growth and toxin formation by
water in a food that is available for the growth of drying is best accomplished by:
microorganisms, including pathogens. A water
activity of 0.85 or below will prevent the growth and • Scientifically establishing a drying process that
toxin production of all pathogens, including Staphy- reduces the water activity to 0.85 or below, if the
lococcus aureus and Clostridium botulinum, and is product will be stored and distributed unrefrigerated
necessary for a shelf-stable dried product. S. aureus (shelf-stable);
grows at a lower water activity than other pathogens,
and should, therefore, be considered the target • Scientifically establishing a drying process that
pathogen for drying for shelf-stable products. reduces the water activity to below 0.97, if the
product will be stored refrigerated (not frozen) in
Some dried products that are reduced oxygen pack- reduced oxygen packaging;
aged (e.g. vacuum packaged, modified atmosphere
packaged) are dried only enough to control growth • Designing and operating the drying equipment so
and toxin production by C. botulinum type E and that every unit of product receives at least the estab-
nonproteolytic types B and F, and are then refriger- lished minimum process;
ated to control growth and toxin formation by
C. botulinum type A and proteolytic types B and F, • Packaging the finished product in a container that
and other pathogens that may be present in the will prevent rehydration.
product, including S. aureus. A water activity of
below 0.97 will prevent the growth of C. botulinum You should select a packaging material that will
type E and nonproteolytic types B and F, and is prevent rehydration of the product under the expected
necessary for these refrigerated, partially dried conditions of storage and distribution. Additionally,
products. More information on C. botulinum and finished product package closures should be free of
reduced oxygen packaging is contained in Chapter 13. gross defects that could expose the product to
moisture during storage and distribution.
Continued
Chapter 14: Drying
191
Pathogen growth is not a concern in dried products • Controlling the amount of moisture that is available
that are stored, distributed, displayed and sold frozen, for pathogen growth, water activity, in the product by
and are so labeled. These products need not meet the formulation (covered in Chapter 13);
control measures outlined in this chapter since drying
in this case is not critical to product safety. Similarly, • Controlling the amount of salt or preservatives,
drying may not be critical to the safety of dried such as sodium nitrite, in the product (covered in
products that are stored refrigerated, unless they are Chapter 13);
reduced oxygen packaged, since refrigeration may be
sufficient to prevent pathogen growth in aerobically • Controlling the level of acidity, pH, in the product
packaged products. (covered by the acidified foods regulations, 21 CFR
114 for shelf-stable acidified products; and for
The drying operation used in the production of refrigerated acidified products in Chapter 13);
smoked or smoke-flavored fish is not designed to
result in a finished product water activity of 0.85 or • Managing the amount of time that food is exposed
below. Drying controls for these products are de- to temperatures that are favorable for pathogen
scribed in Chapter 13. growth and toxin production (covered in Chapter 12;
for C. botulinum, in Chapter 13; and for S. aureus in
Because spores of Clostridium botulinum are known hydrated batter mixes, in Chapter 15);
to be present in the viscera of fish, any product that
will be preserved by salting, drying, pickling, or • Killing pathogens by cooking (covered in Chapter
fermentation must be eviscerated prior to processing 16), pasteurizing (covered in Chapter 17), or retorting
(see Compliance Policy Guide sec. 540.650). With- (covered by the low acid canned foods regulations,
out evisceration, toxin formation is possible during 21 CFR 113).
the process even with strict control of temperature.
Evisceration must be thorough and performed to STEP #11: DETERMINE IF THIS
minimize contamination of the fish flesh. If even a POTENTIAL HAZARD IS SIGNIFICANT.
portion of the viscera or its contents is left behind, the
risk of toxin formation by C. botulinum remains. At each processing step, determine whether “patho-
Small fish, less than 5 inches in length, that are gen growth and toxin formation as a result of inad-
processed in a manner that prevents toxin formation, equate drying” is a significant hazard. The criteria are:
and that reach a water phase salt content of 10 percent
in refrigerated products, or a water activity of below 1. For shelf-stable products, is it reasonably likely that
0.85 (Note: this value is based on the minimum water S. aureus will grow and form toxin in the finished
activity for growth of S. aureus) or a pH of 4.6 or less product if the product is inadequately dried?
in shelf-stable products, are exempt from the eviscera-
tion requirement. Table #A-1 (Appendix 4) provides information on the
conditions under which S. aureus will grow. If your
• Strategies for controlling pathogen growth food meets these conditions before drying, then
drying will usually be important to the safety of the
Pathogens can enter the process on raw materials. product, because it provides the barrier to S. aureus
They can also be introduced into foods during pro- growth. Under ordinary circumstances, it would be
cessing from the air, unclean hands, insanitary reasonably likely that S. aureus will grow and form
utensils and equipment, unsafe water, and sewage. toxin in such products during finished product
There are a number of strategies for the control of storage and distribution, if drying is not properly
pathogens in fish and fishery products. They include: performed. However, see also the information
contained in “Intended use and method of distribu-
• Controlling the amount of moisture that is available tion and storage,” below.
drying (covered in this chapter);
Chapter 14: Drying

192
2. For shelf-stable products, can S. aureus toxin “Pathogen growth and toxin formation as a result of
formation, which is reasonably likely to occur, be inadequate drying” should be considered a significant
eliminated or reduced to an acceptable level at this hazard at any processing step where a preventive
processing step? (Note: If you are not certain of the measure is, or can be, used to eliminate (or reduce to
answer to this question at this time, you may answer the likelihood of occurrence to an acceptable level)
“No.” However, you may need to change this answer the hazard, if it is reasonably likely to occur.
when you assign critical control points in Step #12.)
Step #10 discusses a number of pathogen control
“Pathogen growth and toxin formation as a result of strategies. This chapter covers control of pathogens
inadequate drying” should also be considered a by drying. Delivering a properly designed drying
significant hazard at any processing step where a process can be an effective preventive measure for
preventive measure is, or can be, used to eliminate the control of pathogens. If this preventive measure
(or reduce the likelihood of occurrence to an accept- is applied list it in Column 5 of the Hazard Analysis
able level) the hazard, if it is reasonably likely to occur. Worksheet at the drying step.
3. For refrigerated (not frozen), reduced oxygen If the answer to question 1, 2, 3 or 4 is “Yes” the
packaged products, is it reasonably likely that potential hazard is significant at the drying step in the
C. botulinum type E and nonproteolytic types B and F process and you should answer “Yes” in Column 3 of
will grow and form toxin in the finished product if the the Hazard Analysis Worksheet. If neither criterion
product is inadequately dried? is met you should answer “No.” You should record
the reason for your “Yes” or “No” answer in Column
Table #A-1 (Appendix 4) provides information on the 4. You need not complete Steps #12 through 18 for
conditions under which C. botulinum type E and this hazard for those processing steps where you have
nonproteolytic types B and F will grow. If your recorded a “No.”
refrigerated (not frozen), reduced oxygen packaged
food meets these conditions before drying, then It is important to note that identifying this hazard as
drying will usually be important to the safety of the significant at a processing step does not mean that it
product, because it provides the barrier to growth must be controlled at that processing step. The next
and toxin formation by C. botulinum type E and step will help you determine where in the process the
nonproteolytic types B and F. Under ordinary critical control point is located.
circumstances, it would be reasonably likely that
C. botulinum type E and nonproteolytic types B and • Intended use and method of distribution and storage
F will grow and form toxin in such products during
finished product storage and distribution, if drying In determining whether a hazard is significant you
is not properly performed. However, see also the should also consider the intended use and method of
information contained in “intended use and method distribution and storage of the product, which you
of distribution and storage,” below. developed in Steps #4 and 3, respectively. Because
of the highly stable nature of S. aureus toxin and the
4. For refrigerated (not frozen), reduced oxygen extremely toxic nature of C. botulinum toxin, it is
packaged products, can C. botulinum type E and unlikely that the intended use will affect the signifi-
nonproteolytic types B and F toxin formation, which is cance of the hazard.
reasonably likely to occur, be eliminated or reduced to
an acceptable level at this processing step? (Note: If However, the hazard may not be significant if: 1) the
you are not certain of the answer to this question at product is immediately frozen after processing,
this time, you may answer “no.” However, you may maintained frozen throughout distribution, and
need to change this answer when you assign critical labeled to be held frozen and to be thawed under
control points in Step #12.) refrigeration immediately before use (e.g. “Impor-
tant, keep frozen until used, thaw under refrigeration
immediatley before use”); or 2) the product is
Continued
Chapter 14: Drying
193
unpackaged or aerobically packaged, and is distrib- A salmon jerky processor could set the critical
uted refrigerated throughout the chain of commerce, control point for controlling the hazard of “pathogen
and is labeled to be kept refrigerated. In both of growth and toxin formation as a result of inadequate
these cases, the hazard of pathogen growth is con- drying” at the drying step. The processor would not
trolled by the control of temperature, rather than by need to identify the processing steps prior to drying
the drying of the product. In these cases, you may as critical control points for that hazard. However,
enter “No” in Column 3 of the Hazard Analysis these steps may be CCPs for the control of other
Worksheet for each of the processing steps. In hazards, such as the growth of pathogens as a result
addition, for each “No” entry briefly explain in of time/temperature abuse during processing, covered
Column 4 that the hazard is controlled by freezing or by Chapter 12.
refrigeration. In this case, you need not complete
Steps #12 through 18 for this hazard. However, refer Proceed to Step #13 (Chapter 2) or to Step #10 of the
to Chapter 12 for the control of pathogen growth by next potential hazard.
refrigeration.
HACCP Plan Form
STEP #12: IDENTIFY THE CRITICAL
CONTROL POINTS (CCP). STEP #14: SET THE CRITICAL LIMITS (CL).
For each processing step where “pathogen growth For the drying step, identify the maximum or mini-
and toxin formation as a result of inadequate drying” mum value to which a feature of the process must be
is identified in Column 3 of the Hazard Analysis controlled in order to control the hazard.
Worksheet as a significant hazard, determine whether
it is necessary to exercise control at that step in order You should set the CL at the point that if not met the
to control the hazard. Figure #A-2 (Appendix 3) is a safety of the product is questionable. If you set a
CCP decision tree that can be used to aid you in your more restrictive CL you could, as a result, be re-
determination. quired to take corrective action when no safety
concern actually exists. On the other hand, if you set
You should identify the drying step as the critical a CL that is too loose you could, as a result, allow
control point for this hazard. Therefore, you should unsafe product to reach the consumer.
answer “Yes” in Column 6 of the Hazard Analysis
Worksheet at the drying step and “No” in that column As a practical matter it may be advisable to set an
for the other processing steps for which the hazard operating limit that is more restrictive than the CL.
was identified as a significant hazard. In addition, In this way you can adjust the process when the
for each “No” entry make sure that Column 5 indi- operating limit is triggered, but before a triggering of
cates that the hazard is controlled at the drying step. the CL would require you to take corrective action.
(Note: if you have not previously identified “patho- You should set operating limits based on your
gen growth and toxin formation as a result of inad- experience with the variability of your operation and
equate drying” as a significant hazard at the drying with the closeness of typical operating values to the CL.
step in Column 3 of the Hazard Analysis Worksheet,
you should change the entry in Column 3 to “Yes”.) Following is guidance on setting critical limits for the
drying step.
This control approach is referred to as “Control
Strategy Example 1” in Steps #14-18. It is important
to note that you may select a control strategy that is
different from that which is suggested above, pro-
vided that it assures an equivalent degree of safety of
the product.
Example:
Chapter 14: Drying

194
• CONTROL STRATEGY EXAMPLE 1 - It is important for you to keep in mind that the feature
CONTROL OF DRYING of the process that you monitor and the method of
monitoring should enable you to determine whether
Critical Limit: The minimum or maximum values for the CL is being met. That is, the monitoring process
the critical factors established by a scientific should directly measure the feature for which you
study (i.e. for shelf-stable products, those which have established a CL.
must be met in order to ensure that the finished
product has a water activity of 0.85 or less; for You should monitor often enough so that the normal
refrigerated [not frozen], reduced oxygen variability in the values you are measuring will be
packaged products, those which must be met in detected. This is especially true if these values are
order to ensure that the finished product has a typically close to the CL. Additionally, the greater
water activity of less than 0.97). These will the time span between measurements the more
likely include drying time, input/output air product you are putting at risk should a measurement
temperature, humidity, and velocity, and flesh show that a CL has been violated.
thickness. Other critical factors that affect the
rate of drying of the product may also be Following is guidance on establishing monitoring
established by the study; procedures for the drying step. Note that the moni-
OR toring frequencies that are provided are intended to
The minimum percent weight loss established by be considered as minimum recommendations, and
a scientific study (i.e. for shelf-stable products, may not be adequate in all cases.
those which must be met in order to ensure that
the finished product has a water activity of 0.85
or less; for refrigerated [not frozen], reduced What Will Be Monitored?
oxygen packaged products, those which must be • CONTROL STRATEGY EXAMPLE 1 -
met in order to ensure that the finished product CONTROL OF DRYING
has a water activity of less than 0.97);
OR What: Critical factors of the established drying
For shelf-stable products: Maximum finished process that affect the ability of the process to
product water activity of 0.85 or less; ensure the desired finished product water activity
OR (i.e. 0.85 or below for shelf stable products, less
For refrigerated (not frozen), reduced oxygen than 0.97 for refrigerated [not frozen], reduced
packaged products: Maximum finished product oxygen packaged products). These may include
water activity of less than 0.97. drying time, air temperature, humidity, and
velocity, and flesh thickness;
Enter the critical limit(s) in Column 3 of the HACCP OR
Plan Form. Percent weight loss;
OR
STEP #15: ESTABLISH MONITORING Water activity.
PROCEDURES.
For the drying step, describe monitoring procedures

met.

monitored? 2) How will it be monitored? 3) How
often will it be monitored (frequency)? 4) Who will
Continued
Chapter 14: Drying
195
How Will Monitoring Be Done? OR
Using all or a portion of the lot, determine
• CONTROL STRATEGY EXAMPLE 1 - the percent weight loss by weighing the product
CONTROL OF DRYING before and after drying;
OR
For batch drying equipment: Collect a representative sample of finished
product and conduct water activity analysis.
How: Monitor the drying time and the input/output
air temperature (as specified by the study) with a
temperature recording device or digital time/ How Often Will Monitoring Be Done
temperature data logger. The device should be (Frequency)?
installed where it can be easily read and the
sensor for the device should be installed to • CONTROL STRATEGY EXAMPLE 1 -
ensure that it accurately measures the air input/ CONTROL OF DRYING
output temperature;
AND For batch drying equipment:
study with equipment appropriate for the Frequency: Temperature requirements of the drying
measurement; process should be monitored continuously by the
OR instrument itself, with visual check of the
Using all or a portion of the batch, determine monitoring instrument at least once per batch;
the percent weight loss by weighing the product AND
before and after drying; Time requirements of the drying process should
OR be monitored for each batch;
Collect a representative sample of finished AND
product and conduct water activity analysis. Monitor all other critical factors specified by the
study as often as necessary to maintain control;
For continuous drying equipment: OR
Percent weight loss should be determined for
How: Monitor the input/output air temperature (as each batch of finished product;
specified by the study) with a temperature OR
recording device or digital time/temperature data Water activity should be determined for each
logger. The device should be installed where it batch of finished product.
can be easily read and the sensor for the device
should be installed to ensure that it accurately For continuous drying equipment:
measures the air input/output temperature;
AND Frequency: Temperature requirements of the drying
Monitor the time by measuring either: process should be monitored continuously by the
• The RPM of the belt drive wheel, using a stop instrument itself, with visual check of the
watch or tachometer; monitoring instrument at least once per day;
OR AND
• The time necessary for a test unit or belt Time requirements of the drying process should
marking to pass through the equipment, using a be monitored at least once per day, and whenever
stop watch; any changes in belt speed are made;
AND AND
Monitor all other critical factors specified by the Monitoring of all other critical factors specified
study with equipment appropriate for the by the study as often as necessary to maintain
measurement; control;
Chapter 14: Drying

196
OR an understanding of the operation of the
Percent weight loss should be determined for equipment and the critical limit. In assigning
each lot of finished product; responsibility for monitoring you should
OR consider the complexity of the monitoring
Water activity should be determined for each lot equipment. For example, accurately performing
of finished product. water activity analyses requires considerable
training.
Who Will Perform the Monitoring? Enter the “What,” “How,” “Frequency,” and “Who”
• CONTROL STRATEGY EXAMPLE 1 - respectively, of the HACCP Plan Form.
CONTROL OF DRYING
STEP #16: ESTABLISH CORRECTIVE
For batch drying equipment: ACTION PROCEDURES.
Who: Time and temperature monitoring is For the drying step, describe the procedures that you
performed by the equipment itself. However, a will use when your monitoring indicates that the CL
visual check should be made of the recorded data has not been met. These procedures should: 1)
at least once at the end of each cycle in order to ensure that unsafe product does not reach the con-
ensure that the critical limits have consistently sumer; and, 2) correct the problem that caused the
been met. These checks, as well as the monitoring CL deviation. Remember that deviations from
of the other critical factors in the drying process, operating limits do not need to result in formal correc-
the percent weight loss, or the water activity may tive actions.
be performed by the equipment operator, a
production supervisor, a member of the quality Following is guidance on establishing corrective
control staff, a member of the maintenance or action procedures for the drying step.
engineering staff, or any other person who has an
understanding of the operation of the equipment • CONTROL STRATEGY EXAMPLE 1 -
and the critical limit. In assigning responsibility CONTROL OF DRYING
for monitoring you should consider the complexity
of the monitoring equipment. For example, Corrective Action: Take one or more of the
accurately performing water activity analyses following actions as necessary to regain control
requires considerable training. over the operation after a CL deviation:
• Adjust the air temperature or velocity;
For continuous drying equipment: OR
• Adjust the length of the drying cycle to
Who: Temperature monitoring is performed by the compensate for a temperature or velocity drop,
equipment itself. However, a visual check humidity increase, or inadequate percent
should be made of the recorded data at least daily weight loss;
in order to ensure that the critical limits have OR
consistently been met. These checks, as well as • Adjust the belt speed to increase the length of
the monitoring of the drying time and the other the drying cycle;
critical factors in the drying process, the percent AND
weight loss, or the water activity may be When there has been a failure to maintain
performed by the equipment operator, a specified critical factors of the drying process, or
production supervisor, a member of the quality when the prescribed minimum percent weight
control staff, a member of the maintenance or loss is not met, take one of the following actions
engineering staff, or any other person who has to the product involved in the deviation:
Continued
Chapter 14: Drying
197
OR STEP #17: ESTABLISH A RECORDKEEPING
• Redry the product (provided that redrying does SYSTEM.
not present an unacceptable opportunity for
pathogen growth); For the drying step, list the records that will be used
OR to document the accomplishment of the monitoring
• Segregate and hold the product (under procedures discussed in Step #15. The records
refrigerated conditions) for an evaluation of should clearly demonstrate that the monitoring
the adequacy of the drying process. The procedures have been followed, and should contain
evaluation may involve water activity determi the actual values and observations obtained during
nation on a representative sample of the finished monitoring. Following is guidance on establishing a
product. If the evaluation shows that the recordkeeping system for the drying step.
product has not received an adequate drying
process the product should be destroyed, • CONTROL STRATEGY EXAMPLE 1 -
diverted to a non-food use, or redried; CONTROL OF DRYING
OR
• Divert the product to a use in which the critical For batch drying equipment:
limit is not applicable because pathogen growth
in the finished product will be controlled by Records: Temperature recorder charts or digital
means other than drying (e.g. divert inadequately time/temperature data logger printout;
dried fish to a frozen fish operation); AND
OR Records that are appropriate for the other critical
• Divert the product to a non-food use. factors (e.g. drying log that indicates input/output
AND air humidity and/or velocity);
When finished product testing shows that the OR
water activity is above 0.85, take one of the Records of weight before and after drying;
following actions to the product involved in the OR
deviation: Records of water activity analysis for each lot
• Destroy the product; of product.
OR
• Re-dry the product (where re-drying does not For continuous drying equipment:
create a hazard for pathogen growth);
OR Records: Temperature recorder charts or digital
• Divert the product to a use in which the critical time/temperature data logger printout;
limit is not applicable because pathogen AND
growth in the finished product will be Drying log that indicates the RPM of the belt
controlled by means other than drying (e.g. drive wheel or the time necessary for a test unit
divert inadequately dried fish to a frozen fish or belt marking to pass through the drier;
operation); AND
OR Records that are appropriate for the other critical
• Divert the product to a non-food use. factors (e.g. drying log that indicates input/output
air humidity and/or velocity);
Enter the corrective action procedures in Column 8 of OR
the HACCP Plan Form. Records of weight before and after drying;
OR
Records of water activity analysis for each lot
of product.

Chapter 14: Drying

198
STEP #18: ESTABLISH VERIFICATION designed, operated and maintained to deliver the
PROCEDURES. established drying process to every unit of
product. In some instances, drying studies will
For the drying step, establish verification procedures be required to establish the minimum process.
that will ensure that the HACCP plan is: 1) adequate In other instances, existing literature which
to address the hazard of “pathogen growth and toxin establish minimum processes or adequacy of
formation as a result of inadequate drying; and, 2) equipment, are available. Characteristics of the
consistently being followed. Following is guidance process, product and/or equipment that affect the
on establishing verification procedures for the drying ability of the established minimum drying
step. process should be taken into consideration in the
process establishment. A record of the process
• CONTROL STRATEGY EXAMPLE 1 - establishment should be maintained;
CONTROL OF DRYING AND
Finished product sampling and analysis to
Verification: Process establishment (except where determine water activity at least once every three
finished product water activity analysis is the months (except where such testing is performed
monitoring procedure): The adequacy of the as part of monitoring);
drying process should be established by a AND
scientific study. For shelf-stable products, it Check the accuracy of the temperature recording
should be designed to ensure the production of a device or digital time/temperature data loggers
shelf stable product with a water activity of 0.85. against a known accurate thermometer
For refrigerated (not frozen), reduced oxygen (NIST-traceable) at least once per day;
packaged products, it should be designed to AND
ensure a finished water activity of less than 0.97. Calibrate other instruments as necessary to
Expert knowledge of drying process calculations ensure their accuracy;
and the dynamics of mass transfer in processing AND
equipment is required to establish such a drying Review monitoring, corrective action, and
process. Such knowledge can be obtained by verification records within one week of
education or experience or both. Establishment preparation.
of drying processes requires access to adequate
facilities and the application of recognized Enter the verification procedures in Column 10 of the
methods. The drying equipment must be HACCP Plan Form.
Chapter 14: Drying

199
TABLE #14-1
Control Strategy Example 1 - Control of drying
as a result of inadequate drying for a processor of shelf-stable salmon jerky, using Control Strategy Example 1 - Control of drying.
It is provided for illustrative purposes only. Pathogen growth and toxin formation as a result of inadequate drying may be
only one of several significant hazards for this product. Refer to Tables 3-1, 3-2, and 3-3 (Chapter 3)
for other potential hazards (e.g. aquaculture drugs, chemical contaminants, parasites, and metal fragments).
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
Drying (forced Pathogen growth and • Maximum product • Product • Preset slicer to • Once per day • Slicer operator • Readjust slicer • Processing log • Documentation
convection oven) toxin formation thickness 1/4" thickness just less than before of drying
1/4" operations process
Se establishment
200
• Minimum drying time • Drying time • Digital time/ • Continuous, • Oven operator • Continue drying • Data logger • Review
eT
5 hours
ex temperature with visual printout monitoring,
Chapter 14: Drying

data logger check each verification and
batch corrective
t f Exa
action records
or mp
Fu le within one
week of
preparation
ll R O
• Minimum oven • Oven air input • Digital time/ • Continuous, • Oven operator • Extend drying • Data logger • Check the
eco nly
temperature 140oF temperature temperature with visual process printout accuracy of the
data logger check each data logger
mm
en batch daily.
To achieve a final water • Segregate • Analyze
da
activity of 0.85 or less tio product and hold finished product
for evaluation. sample once
Evaluate by every 3 months
ns
performing for water
water activity activity
analysis on
finished product.
Re-dry if more
than 0.85
Chapter 15: Staphylococcus aureus Toxin Formation
in Hydrated Batter Mixes (A Biological Hazard)
Hazard Analysis Worksheet • Strategies for controlling pathogen growth
STEP #10: UNDERSTAND THE POTENTIAL There are a number of strategies for the control of
HAZARD. pathogens in fish and fishery products. They include:
Staphylococcus aureus toxin formation in hydrated • Managing the amount of time that food is exposed
batter mixes can cause consumer illness. This toxin to temperatures that are favorable for pathogen
in particular is a concern because the toxin cannot be growth and toxin production (covered in this chapter
destroyed by heating steps that may be performed by for S. aureus in hydrated batter mix; Chapter 13 for
the processor or the consumer. Pathogens other than C. botulinum; and Chapter 12 for other pathogens
S. aureus, such as those described in Chapter 12, are, and conditions);
in many cases, less likely to grow in hydrated batter
mixes, and are likely to be killed by the heating steps • Killing pathogens by cooking (covered in Chapter
that follow. 16), pasteurizing (covered in Chapter 17), or retorting
(covered by the low acid canned foods regulations,
• Control of Staphylococcus aureus in batter mixes 21 CFR 113);
S. aureus can enter the process on raw materials. It • Controlling the amount of moisture that is available
can also be introduced into foods during processing for pathogen growth, water activity, in the product by
from unclean hands and insanitary utensils and drying (covered in Chapter 14);
equipment.
The hazard develops when a batter mix is exposed to for pathogen growth, water activity, in the product by
temperatures favorable for S. aureus growth for formulation (covered in Chapter 13);
sufficient time to permit toxin development. S. aureus
toxin does not normally reach levels that will cause • Controlling the amount of salt or preservatives,
food poisoning until the numbers of the pathogen such as sodium nitrite, in the product (covered in
reach 100,000 to 1,000,000/gram. S. aureus will Chapter 13);
grow at temperatures as low as 41-43˚F (5.0-6.1˚C)
and at a water activity as low as .85 (additional • Controlling the level of acidity, pH, in the product
information on conditions favorable to (covered by the acidified foods regulations, 21 CFR
S. aureus growth are provided in Table #A-1 (Appen- 114 for shelf-stable acidified products; and for
dix 4). However, toxin formation is not likely at refrigerated acidified products in Chapter 13).
temperatures lower than 50˚F (10˚C). For this
reason, toxin formation can be controlled by mini-
mizing exposure of hydrated batter mixes to tempera-
tures above 50˚F (10˚C). Exposure times greater
than 12 hours for temperatures between 50˚F (10˚C)
and 70˚F (21.1˚C) could result in toxin formation.
Exposure times greater than 3 hours for temperatures
above 70˚F (21.1˚C) could also result in toxin
formation.
Continued
Chapter 15: Batter
201
STEP #11: DETERMINE IF THIS Step #10 discusses a number of pathogen control
POTENTIAL HAZARD IS SIGNIFICANT. strategies. This chapter covers control of S. aureus
toxin formation that occurs as a result of time/
At each processing step, determine whether temperature abuse at the hydrated batter mix storage/
“S. aureus toxin formation in hydrated batter mixes” recirculation step. A preventive measure for toxin
is a significant hazard. The criteria are: formation can include controlling the amount of time
that batter mixes are exposed to temperatures above
1. Is it reasonably likely that S. aureus will grow and 50˚F (10˚C).
form toxin in the hydrated batter mix at the hydrated
batter mix storage/recirculation step? List this preventive measure in Column 5 of the
Hazard Analysis Worksheet at the batter mix storage/
Remember that you should consider the potential for recirculation step.
time/temperature abuse in the absence of controls.
You may already have controls at the hydrated batter If the answer to either question 1 or 2 is “Yes” the
mix storage/recirculation step that minimize the potential hazard is significant at that step in the
potential for time/temperature abuse that could result process and you should answer “Yes” in Column 3 of
in S. aureus growth and toxin formation. This and the Hazard Analysis Worksheet. If none of the
the following steps will help you determine whether criteria is met you should answer “No.” You should
those or other controls should be included in your record the reason for your “Yes” or “No” answer in
HACCP plan. Column 4. You need not complete Steps #12 through
18 for this hazard for those processing steps where
Step #10 provides information to help you decide if you have recorded a “No.”
the time/temperature conditions of your hydrated
batter mix storage/recirculation step are significant It is important to note that identifying this hazard as
for this hazard. significant at a processing step does not mean that it
2.Can S. aureus growth and toxin formation, which is step will help you determine where the critical
reasonably likely to occur, be eliminated or reduced to control point is located.
an acceptable level at this processing step?
(Note: If you are not certain of the answer to this • Intended use
question at this time, you may answer “No.” How-
ever, you may need to change this answer when you In determining whether a hazard is significant you
assign critical control points in Step #12.) should also consider the intended use of the product,
which you developed in Step #4. However, because
“S. aureus toxin formation in hydrated batter mixes” of the highly stable nature of S. aureus toxin, it is
should also be considered a significant hazard at any unlikely that the intended use will affect the signifi-
processing step where a preventive measure is, or can cance of the hazard.
be, used to eliminate (or reduce the likelihood of
occurrence to an acceptable level) the hazard, if it is
reasonably likely to occur.
Chapter 15: Batter

202
STEP #12: IDENTIFY CRITICAL CONTROL HACCP Plan Form
POINTS (CCP).
For each processing step where “S. aureus growth
and toxin formation in hydrated batter mixes” is For the hydrated batter mix storage/recirculation step,
identified in Column 3 of the Hazard Analysis identify the maximum or minimum value to which a
Worksheet as a significant hazard, determine whether feature of the process must be controlled in order to
it is necessary to exercise control at that step in order control the hazard.
to control the hazard. Figure #A-2 (Appendix 3) is a
CCP decision tree that can be used to aid you in your You should set the CL at the point that if not met the
determination. safety of the product may be questionable. If you set
a more restrictive CL you could, as a result, be
You should identify the hydrated batter mix storage/ required to take corrective action when no safety
recirculation step as the critical control point for this concern actually exists. On the other hand, if you set
hazard. For hand battering operations, where hy- a CL that is too loose you could, as a result, allow
drated batter mix is stored at each hand battering unsafe product to reach the consumer.
station, each station should be identified as a CCP.
As a practical matter it may be advisable to set an
This control approach will be referred to as “Control operating limit that is more restrictive than the CL.
Strategy Example 1” in Steps #14-18. It is important In this way you can adjust the process when the
to note that you may select a control strategy that is operating limit is triggered, but before a triggering of
different from that which is suggested above, pro- the CL would require you to take corrective action.
vided that it assures an equivalent degree of safety of You should set operating limits based on your
the product. experience with the variability of your operation and
with the closeness of typical operating values to the CL.
You should answer “Yes” in Column 6 of the Hazard
Analysis Worksheet at the hydrated batter mix Following is guidance on setting critical limits for the
storage/recirculation step and “No” in that column hydrated batter mix storage/recirculation step.
for the other processing steps for which the hazard
was identified as a significant hazard. In addition, • CONTROL STRATEGY EXAMPLE 1 -
for each “No” entry make sure that Column 5 indi- HYDRATED BATTER MIX CONTROL
cates that the hazard is controlled at the hydrated
batter mix storage/recirculation step. (Note: if you Critical Limit: Hydrated batter mix temperatures
have not previously identified “S. aureus growth and should not exceed 50˚F (10˚C) for more than
toxin formation in hydrated batter mixes” as a twelve hours, cumulatively;
significant hazard at the hydrated batter mix storage/ AND
recirculation step in Column 3 of the Hazard Analy- Hydrated batter mix temperatures should not
sis Worksheet, you should change the entry in exceed 70˚F (21.1˚C) for more than three hours,
Column 3 to “Yes”.) cumulatively.
Example: Enter the critical limit(s) in Column 3 of the HACCP

A breaded fish processor could set the critical control Plan Form.
point for controlling the hazard of “S. aureus growth
and toxin formation in hydrated batter mixes” at the
hydrated batter mix storage/recirculation step. The
processor would not need to identify other processing
steps as critical control points for that hazard.

Continued
Chapter 15: Batter
203
STEP #15: ESTABLISH MONITORING How Will Monitoring Be Done?
PROCEDURES.
For the hydrated batter mix storage/recirculation step, HYDRATED BATTER MIX CONTROL
describe monitoring procedures that will ensure that
the critical limits are consistently met. How: Use a digital time/temperature data logger;
OR
To fully describe your monitoring program you Use a recorder thermometer;
should answer four questions: 1) What will be OR
monitored? 2) How will it be monitored? 3) How Use a maximum indicating thermometer;
often will it be monitored (frequency)? 4) Who will OR
perform the monitoring? Use a high temperature alarm;
OR
It is important for you to keep in mind that the Use an indicating thermometer.
feature of the process that you monitor and the
method of monitoring should enable you to deter-
mine whether the CL is being met. That is, the How Often Will Monitoring Be Done
monitoring process should directly measure the (Frequency)?
You should monitor often enough so that the normal HYDRATED BATTER MIX CONTROL
detected. This is especially true if these values are Frequency: Continuous monitoring, with visual
typically close to the CL. Additionally, the greater check at least once per day;
the time span between measurements the more OR
product you are putting at risk should a measurement For indicating thermometers: at least every two
show that a CL has been violated. hours.
Following is guidance on establishing monitoring

procedures for the hydrated batter mix storage/ Who Will Perform the Monitoring?
recirculation step. Note that the monitoring frequen-
cies that are provided are intended to be considered • CONTROL STRATEGY EXAMPLE 1 -
as minimum recommendations, and may not be HYDRATED BATTER MIX CONTROL
Who: With recorder thermometers, high temperature
alarms, maximum indicating thermometers, and
What Will Be Monitored? digital data loggers, monitoring is performed by
the equipment itself. However, when such
• CONTROL STRATEGY EXAMPLE 1 - instruments are used, a visual check should be
HYDRATED BATTER MIX CONTROL made at least once per day in order to ensure that
the critical limits have consistently been met.
What: The temperature of the hydrated batter mix. These checks, as well as indicating thermometer
checks, may be performed by a production
employee, a production supervisor, a member of
the quality control staff, or any other person who
has an understanding of the process and the
monitoring procedure.
Chapter 15: Batter

204
Enter the “What,” “How,” “Frequency,” and “Who” Enter the corrective action procedures in Column 8 of
monitoring information in Columns 4, 5, 6, and 7, the HACCP Plan Form.
STEP #16: ESTABLISH CORRECTIVE SYSTEM.
ACTION PROCEDURES.
For the hydrated batter mix storage/recirculation step,
For the hydrated batter mix storage/recirculation step, list the records that will be used to document the
describe the procedures that you will use when your accomplishment of the monitoring procedures
monitoring indicates that the CL has not been met. discussed in Step #15. The records should clearly
These procedures should: 1) ensure that unsafe demonstrate that the monitoring procedures have
product does not reach the consumer; and, 2) correct been followed, and should contain the actual values
the problem that caused the CL deviation. Remem- and observations obtained during monitoring.
to result in formal corrective actions. Following is guidance on establishing a
recordkeeping system for the hydrated batter mix
Following is guidance on establishing corrective storage/recirculation step.
action procedures for the hydrated batter mix storage/
recirculation step. • CONTROL STRATEGY EXAMPLE 1 -
HYDRATED BATTER MIX CONTROL
HYDRATED BATTER MIX CONTROL Records: Printout from digital time/temperature
data logger;
Corrective Action: Take one or more of the OR
following actions to regain control over the Recorder thermometer chart;
operation after a CL deviation: OR
• Add ice to the hydrated batter mix storage/ Record showing the results of the maximum
recirculation tank; indicating thermometer checks;
OR OR
• Make repairs or adjustments to the hydrated Record showing the results of the high
batter mix refrigeration equipment; temperature alarm checks;
AND OR
Take one of the following actions to product Record showing the results of the indicating
involved in the critical limit deviation: thermometer checks.
• Destroy the product and the remaining
hydrated batter mix; Enter the names of the HACCP records in Column 9
OR of the HACCP Plan Form.
• Divert the product and the remaining hydrated
batter mix to a non-food use;
OR
• Hold the product and hydrated batter until it
can be evaluated based on its total time/
temperature exposure;
OR
• Hold the product and hydrated batter
mix until the hydrated batter mix can be
sampled and analyzed for the presence of
staphylococcal enterotoxin.
Continued
Chapter 15: Batter
205
STEP #18: ESTABLISH VERIFICATION HYDRATED BATTER MIX CONTROL
PROCEDURES.
Verification: Review monitoring, corrective action,
For the hydrated batter mix storage/recirculation step, and verification records within one week of
establish verification procedures that will ensure that preparation;
the HACCP plan is: 1) adequate to address the hazard AND
of “S. aureus growth and toxin formation in hydrated When digital time/temperature data loggers,
batter mixes”; and, 2) consistently being followed. recorder thermometers, or high temperature
alarms are used, check for accuracy against a
Following is guidance on establishing verification known accurate thermometer (NIST-traceable) at
procedures for the hydrated batter mix storage/ least once per day;
recirculation step. AND
When indicating thermometers or maximum
• CONTROL STRATEGY EXAMPLE 1 - indicating thermometers are used, check for
accuracy against a known accurate thermometer
(NIST-traceable) when first used and at least
once per year thereafter. (Note: optimal
calibration frequency is dependent upon the
type, condition, and past performance of the
monitoring instrument.)

HACCP Plan Form.
Chapter 15: Batter

206
TABLE #15-1
Control Strategy Example 1 - Hydrated batter mix control
This table is an example of a portion of a HACCP plan relating to the control of S. aureus toxin formation in hydrated batter
mixes for a breaded fish processor, using Control Strategy Example 1 - Hydrated batter mix control. It is provided for illustrative
purposes only. S. aureus toxin formation in the hydrated batter mix may be only one of several significant hazards for this product.
Refer to Tables 3-1, 3-2, and 3-3 (Chapter 3) for other potential hazards (e.g. chemical contaminants and metal fragments).
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
Batter mix S. aureus growth and Hydrated batter mix Hydrated batter Recorder Continuous with Production • Adjust hydrated Recorder • Check accuracy
recirculation toxin formation temperature not to mix temperature thermometer visual check once employee batter mix thermometer of recorder
exceed 50oF for more per day refrigeration chart thermometer
than 12 hrs, nor 70oF for equipment once per day;
more than 3 hrs,
Se
cumulative • Review
207
• Destroy monitoring,
eT
ex hydrated batter corrective
Chapter 15: Batter

mix and any action and
product verification
t f Exa
produced during records within
or mp
Fu le deviant period one week of
ll R O preparation
eco nly
mm
en
da
tio
ns
Notes:
Chapter 15: Batter

208
Chapter 16: Pathogen Survival Through Cooking (A Biological Hazard)
Hazard Analysis Worksheet Table #A-3 provides 6D process times for a range of
cooking temperatures, with L. monocytogenes as the
STEP #10: UNDERSTAND THE POTENTIAL target pathogen.
HAZARD.
Lower degrees of destruction may be acceptable if
Pathogen survival through a cook step can cause supported by a scientific study of the normal
consumer illness. Cooking is a relatively severe heat innoculum in the food. It is also possible that higher
treatment, usually performed before the product is levels of destruction may be necessary in some foods,
placed in the finished product container. if there is an especially high normal innoculum.
Generally, after cooking, fishery products are re- • Goal of cooking — refrigerated, reduced oxygen
ferred to as cooked, ready-to-eat. Examples of packaged products
cooked, ready-to-eat products are: crab meat, lobster
meat, crayfish meat, cooked shrimp, surimi-based When cooking is performed immediately before
analog products, seafood salads, seafood soups and reduced oxygen packaging (e.g. vacuum packaging,
sauces and hot-smoked fish. modified atmosphere packaging), for product that
will be marketed under refrigeration, it may be
• Goal of cooking — most products necessary for the cooking process to be sufficient to
eliminate the spores of Clostridium botulinum type E
One of the purposes of cooking products that will be and nonproteolytic types B and F. This is the case
aerobically packaged is to eliminate vegetative cells when the product does not contain other barriers that
of pathogens (or reduce them to an acceptable level) are sufficient to prevent growth and toxin formation
that may have been introduced to the process by the by this pathogen (e.g. many refrigerated, vacuum
raw materials or by processing that occurs before the packaged hot-filled soups and sauces). Generally, a
cook step. Selection of the target pathogen is critical. 6D process is suitable. However, lower degrees of
Generally, Listeria monocytogenes is selected, destruction may be acceptable if supported by a
because it is regarded as the most heat tolerant, food- scientific study of the normal innoculum in the food.
borne pathogen that does not form spores. Cooking It is also possible that higher levels of destruction
processes are not usually designed to eliminate may be necessary in some foods, if there is an
spores of pathogens. Determining the degree of especially high normal innoculum. Table #A-4
destruction of the target pathogen is also critical. provides 6D process times for a range of cooking
Generally, a reduction of six orders of magnitude (six temperatures, with C. botulinum type B (the most
logarithms) in the level of contamination is suitable. heat resistant form of nonproteolytic C. botulinum) as
This is called a “6D” process. FDA’s draft L. the target pathogen. An example of a product that is
monocytogenes risk assessment indicates that ap- properly cooked to eliminate nonproteolytic C.
proximately 7% of raw fish are contaminated with botulinum is a soup or sauce that is pasteurized at an
from 1 to 103 CFU/g, and that approximately 92% are internal temperature of 194˚F (90˚C) for at least 10
contaminated at less than 1 CFU/g. Less than 1% of minutes. The lethal rates and process times provided
raw fish are contaminated at levels greater than 103 in the table may not be sufficient for the destruction
CFU/g, and none at levels greater than 106 CFU/g. of nonproteolytic C. botulinum in soups or sauces
FDA’s action level for L. monocytogenes in ready-to- containing dungeness crabmeat, because of the
eat products, nondetectable, corresponds to a level of potential that naturally occuring substances, such as
less than 1 CFU/25g. lysozyme, may enable the pathogen to more easily
recover after damage.
Continued
Chapter 16: Cooking
209
Reduced oxygen packaged soups or sauces that are • Strategies for controlling pathogen growth
cooked immediately before packaging to control
nonproteolytic C. botulinum, but not proteolytic There are a number of strategies for the control of
C. botulinum, and that do not contain barriers to its pathogens in fish and fishery products. They include:
growth, must be refrigerated or frozen to control
proteolytic C. botulinum. Control of refrigeration is • Killing pathogens by cooking (covered in this
critical to the safety of these products. Further chapter), pasteurizing (covered in Chapter 17), or
information on C. botulinum and reduced oxygen retorting (covered by the low acid canned foods
packaging is contained in Chapter 13. regulations, 21 CFR 113);
Cooking processes that target nonproteolytic • Managing the amount of time that a food is ex-
C. botulinum have much in common with pasteuriza- posed to temperatures that are favorable for pathogen
tion processes, which are discussed in Chapter 17. growth and toxin production (covered in Chapter 12;
Like products that are pasteurized in the final con- and for C. botulinum, in Chapter 13; and for S.
tainer, products that are cooked and then placed in aureus in hydrated batter mixes, in Chapter 15);
the final container also are at risk for recontamination
after they are placed in the finished product con- • Controlling the amount of moisture that is available
tainer. Controls, such as container seal integrity and for pathogen growth, water activity, in the product by
protection from contamination by cooling water, are drying (covered in Chapter 14);
critical to the safety of these products. They are
covered in Chapter 18. Additionally, because these • Controlling the amount of moisture that is available
products are cooked before they are packaged, they for pathogen growth, water activity, in the product by
are at risk for recontamination between cooking and formulation (covered in Chapter 13);
packaging. The risk of this recontamination must be
minimized by filling the container in a continuous • Controlling the amount of salt or preservatives,
filling system while the product is still hot (i.e. hot such as sodium nitrite, in the product (covered in
filling), another critical step for the safety of these Chapter 13);
products. This control strategy is suitable for prod-
ucts that are filled directly from the cooking kettle, • Controlling the level of acidity, pH, in the product
where the risk of recontamination is minimized. It is (covered by the acidified foods regulations, 21 CFR
not ordinarily suitable for products such as crabmeat, 114 for shelf-stable acidified products; and for
lobster meat, or crayfish meat, or other products that refrigerated acidified products in Chapter 13).
are handled between cooking and filling. Hot filling
is also covered in Chapter 18. STEP #11: DETERMINE IF THIS
POTENTIAL HAZARD IS SIGNIFICANT.
• Control of cooking
At each processing step, determine whether “patho-
Controlling pathogen survival through the cook step gen survival through cooking” is a significant hazard.
is accomplished by: The criteria are:
• Scientifically establishing a cooking process that 1. Is it reasonably likely that unsafe levels of pathogens
will eliminate pathogens of public health concern or will be introduced at this processing step (do unsafe
reduce their numbers to acceptable levels; and, levels of pathogens come in with the raw material or
will the process introduce unsafe levels of pathogens)?
• Designing and operating the cooking equipment so
that every unit of product receives at least the estab-
lished minimum process.
Chapter 16: Cooking

210
It is reasonable to assume that pathogens of various If the answer to either question 1 or 2 is “Yes” the
types, including those listed in Table #A-1 (Appendix potential hazard is significant at that step in the
4), will be present on raw fish and fishery products. process and you should answer “Yes” in Column 3 of
They may only be present at low levels or only the Hazard Analysis Worksheet. If neither criterion
occasionally, but even such occurrences warrant is met you should answer “No.” You should record
consideration because of the potential for growth and the reason for your “Yes” or “No” answer in Column
toxin production. 4. You need not complete Steps #12 through 18 for
this hazard for those processing steps where you have
Pathogens may also be introduced during processing, recorded a “No.”
as described in Step #10. Well designed sanitation
programs will minimize the introduction of patho- It is important to note that identifying this hazard as
gens. Such sanitation controls need not be part of significant at a processing step does not mean that it
your HACCP plan if they are monitored under your must be controlled at that processing step. The next
sanitation program (prerequisite program). In most step will help you determine where in the process the
cases it is not reasonable to assume that they will critical control point is located.
fully prevent the introduction of pathogens. For this
reason, you should consider it reasonably likely that • Intended use and method of storage and distribution
low numbers of pathogens will be present in the
product, even after a cook step. Remember, control of In determining whether a hazard is significant you
pathogen growth (e.g. after a cook step) is covered in should also consider the intended use of the product,
Chapter 12. which you developed in Step #4. However, for cooked,
ready-to-eat fishery products, it is unlikely that the
2. Can unsafe levels of pathogens that were introduced intended use will affect the significance of the
at an earlier processing step be eliminated or reduced hazard.
to an acceptable level at this processing step? (Note:
If you are not certain of the answer to this question at However, if your product is immediately frozen after
this time, you may answer “No.” However, you may processing, maintained frozen throughout distribu-
need to change this answer when you assign critical tion, and labeled to be held frozen and to be thawed
control points in Step #12). under refrigeration immediately before use (e.g.
“Important, keep frozen until used, thaw under
“Pathogen survival through cooking” should also be refrigeration immediately before use”), then forma-
considered a significant hazard at any processing step tion of C. botulinum toxin may not be a significant
where a preventive measure is, or can be, used to hazard.
eliminate (or reduce the likelihood of occurrence to
an acceptable level) the hazard, if it is reasonably STEP #12: IDENTIFY THE CRITICAL
likely to occur. CONTROL POINT (CCP).
Step #10 discusses a number of pathogen control For each processing step where “pathogen survival
strategies. This section covers the control of patho- through cooking” is identified in Column 3 of the
gens during a cook step. Delivering a properly Hazard Analysis Worksheet as a significant hazard,
designed cooking process can be an effective preven- determine whether it is necessary to exercise control
tive measure for the control of pathogens. If this at that step in order to control the hazard. Figure
preventive measure is applied list it in Column 5 of #A-2 (Appendix 3) is a CCP decision tree that can be
the Hazard Analysis Worksheet at the cooking step. used to aid you in your determination.
The following guidance will also assist you in

determining whether a processing step is a CCP for
“pathogen survival through cooking”:
Continued
Chapter 16: Cooking
211
Will the finished product be pasteurized in the final This control approach will be referred to as “Control
container? Strategy Example 1” in Steps #14-18. It is important
to note that you may select a control strategy that is
1. If it will be, you may identify the pasteurization step different from that which is suggested above, provided
as the CCP. In this case you will not need to identify that it assures an equivalent degree of safety of the
the cook step as a CCP for the hazard of “pathogen product.
survival through cooking.”
Example: next potential hazard.
A crabmeat processor cooks, picks, packs, and
pasteurizes the crabmeat. The processor sets the
critical control point for “pathogen survival through HACCP Plan Form
cooking” at the pasteurization step, and does not
identify the cooking step as a critical control point STEP #14: SET THE CRITICAL LIMITS (CL).
for this hazard.
For the cook step identify the minimum or maximum
In this case, you should identify the pasteurization value to which a feature of the process must be
processing step as the critical control point for this controlled in order to control the hazard.
hazard. Therefore, you should answer “Yes” in
Column 6 of the Hazard Analysis Worksheet at the The CL will be the minimum or maximum param-
pasteurization step, and “No” in that column at the eters established by a scientific study (see Step #18 -
other processing steps for which the hazard was Verification) as necessary for adequate cooking (e.g.
identified as a significant hazard. (Note: if you have time and temperature of the cooking process). If you
not previously identified “pathogen survival though set a more restrictive CL (e.g. 2˚F higher/2 minutes
cooking” as a significant hazard at the pasteurization longer) you could be required to take corrective
step in Column 3 of the Hazard Analysis Worksheet, action when no safety concern actually exists. On
you should change the entry in Column 3 to “Yes.”) the other hand, if you set a CL that is too loose you
If you choose to follow this approach you should could allow unsafe product to reach the consumer.
refer to Chapter 17, Pathogen survival through
pasteurization, for further guidance. In particular, As a practical matter it may be advisable to set an
you should note that, if the cook step is not identified operating limit that is more restrictive than the CL.
as a CCP, the pasteurization step must be effective in In this way you can adjust the process when the
eliminating pathogens that may be present in an operating limit is triggered, but before a triggering of
improperly cooked product. the CL would require you to take corrective action.
You should set operating limits based on your
2. If the product will not be pasteurized, you should experience with the variability of your operation and
identify the cooking step as the CCP. Therefore, you with the closeness of typical operating values to the CL.
should answer “Yes” in Column 6 of the Hazard
Analysis Worksheet at the cooking step, and “No” in Following is guidance on setting critical limits for the
that column at the other processing steps for which the cook step:
hazard was identified as a significant hazard. (Note:
if you have not previously identified “pathogen
survival though cooking” as a significant hazard at
the cooking step in Column 3 of the Hazard Analysis
Worksheet, you should change the entry in Column 3
to “Yes”).
Chapter 16: Cooking

212
• CONTROL STRATEGY EXAMPLE 1 - Following is guidance on establishing monitoring
CONTROL OF COOKING procedures for cooking. Note that the monitoring
frequencies that are provided are intended to be
Critical Limit: The minimum or maximum values for considered as minimum recommendations, and may
the critical factors established by a scientific not be adequate in all cases.
study. These will likely include length of the
cook cycle (speed of the belt for a continuous
cooker), and temperature of the steam or water What Will Be Monitored?
used for cooking (or visual observation of
minutes at a boil). Other critical factors that • CONTROL STRATEGY EXAMPLE 1 -
affect the rate of heating of the product may also CONTROL OF COOKING
be established by the study. Product internal
temperatures at the end of the cooking cycle are What: Critical factors of the established cooking
not ordinarily suitable CLs, because of process. These may include:
variability from unit to unit. • Time and temperature of the cooking process;
AND
Enter the critical limit(s) in Column 3 of the HACCP • Other critical factors that affect the rate of
Plan Form. heating of the product, as specified by the
study, including, but not limited to, initial
STEP #15: ESTABLISH MONITORING temperature and size of product.
PROCEDURES.
For the cook step, describe monitoring procedures How Will Monitoring Be Done?
met.
CONTROL OF COOKING
To fully describe your monitoring program you For batch cooking equipment:
monitored? 2) How will it be monitored? 3) How How: Monitor the cooking time and temperature
often will it be monitored (frequency)? 4) Who will with a temperature recording device or a digital
perform the monitoring? time/temperature data logger. The device should
be installed where it can be easily read and the
It is important for you to keep in mind that the sensor for the device should be installed to
feature of the process that you monitor and the ensure that it accurately measures the coldest
method of monitoring should enable you to deter- temperature of the cooking equipment (cold spot
mine whether the critical limit is being met. That is, to be determined by study). Where cooking is
the monitoring process should directly measure the performed at the boiling point, visual observation
feature for which you have established a critical of minutes at a boil may be an acceptable
limit. alternative;
AND
You should monitor often enough so that the normal The start and end of each cooking cycle should
variability in the values you are measuring will be be determined visually;
detected. This is especially true if these values are AND
typically close to the critical limit. Additionally, the Monitor other critical factors with equipment
greater the time span between measurements the appropriate to the critical factor (e.g. initial
more product you are putting at risk should a mea- temperature with a dial thermometer or
surement show that a critical limit has been violated. equivalent).
Continued
Chapter 16: Cooking
213
For continuous cooking equipment: For continuous cooking equipment:
How: Monitor the cooking temperature with a Frequency: Monitor the cooking temperature
temperature recording device or a digital time/ continuously by the instrument itself, with a
temperature data logger. The device should be visual check of the monitoring instrument at least
installed where it can be easily read and the once per day;
sensor for the device should be installed to AND
ensure that it accurately measures the coldest Monitor the time at least once per day, and
temperature of the cooking equipment (cold whenever any changes in belt speed are made;
spot to be determined by study). Due to the AND
extended time of operation of such equipment, Monitor other critical factors with sufficient
it is unlikely that visual observation of boiling frequency to achieve control.
will be an acceptable alternative, even if cooking
is performed at the boiling point;
AND Who Will Perform the Monitoring?
Monitor the time by measuring either:
• The RPM of the belt drive wheel, using a stop
CONTROL OF COOKING
watch or tachometer;
OR For batch cooking equipment:
• The time necessary for a test unit or belt
marking to pass through the equipment, using a Who: Monitoring of cooking temperature is
stop watch; performed by the equipment itself, except in the
AND case of visual observation of minutes at a boil.
Monitor other critical factors with equipment However, a visual check should be made of the
appropriate to the critical factor (e.g. initial recorded data at least once at the end of each
temperature with a dial thermometer or cycle in order to ensure that the critical limits
equivalent). have consistently been met. These checks, as
well as the monitoring of the cooking time,
visual observations of boiling, where applicable,
How Often Will Monitoring Be Done and monitoring of other critical factors may be
(Frequency)? performed by the equipment operator, a
production supervisor, a member of the quality
• CONTROL STRATEGY EXAMPLE 1 - control staff, or any other person who has an
CONTROL OF COOKING understanding of the equipment and the
monitoring procedure.
For batch cooking equipment:
For continuous cooking equipment:
Frequency: Monitor the cooking temperature
continuously by the instrument itself, with a WHO: Monitoring of cooking temperature is
visual check of the monitoring instrument at least performed by the equipment itself. However, a
once per batch; visual check should be made at least once per
AND day in order to ensure that the critical limits have
The start and end of each cooking cycle should consistently been met. These checks, as well as
be determined visually; the monitoring of the cooking time and of other
AND critical factors may be performed by the
Monitor other critical factors with sufficient equipment operator, a production supervisor, a
frequency to achieve control. member of the quality control staff, or any other
person who has an understanding of the
equipment and the monitoring procedure.
Chapter 16: Cooking

214
Enter the “What,” “How,” “Frequency,” and “Who” OR
monitoring information in Columns 4, 5, 6, and 7, • Divert the product to a use in which the critical
respectively, of the HACCP Plan Form. limit is not applicable (e.g. divert improperly
cooked shrimp to a shrimp canning operation);
STEP #16: Establish corrective action procedures. OR
• Divert to a non-food use.
For the cook step, describe the procedures that you
will use when your monitoring indicates that the Enter the corrective action procedures in Column 8 of
critical limit has not been met. the HACCP Plan Form.
These procedures should: 1) ensure that unsafe
product does not reach the consumer; and, 2) correct SYSTEM.
For the cook step, list the records that will be used to
to result in formal corrective actions. document the accomplishment of the monitoring
Following is guidance on establishing corrective procedures discussed in Step #15. The records
action procedures for cooking: should clearly demonstrate that the monitoring
procedures have been followed, and should contain
• CONTROL STRATEGY EXAMPLE 1 - the actual values and observations obtained during
CONTROL OF COOKING monitoring.
Corrective Action: Take one or more of the Following is guidance on establishing a

following actions, as necessary, to regain control recordkeeping system for cooking.
• Adjust the steam supply to increase the • CONTROL STRATEGY EXAMPLE 1 -
processing temperature; CONTROL OF COOKING
OR
• Extend the length of the cooking cycle to For batch cooking equipment:
compensate for a temperature drop;
OR Records: Either:
• Adjust the belt speed to increase the length of • Temperature recorder chart or a digital time/
the cook cycle; temperature data logger printout;
AND OR
Take one of the following actions to the product • Cooking log that indicates visual observation
involved in the critical limit deviation: of boiling, where cooking is performed at the
• Destroy the product; boiling point;
OR AND
• Reprocess the product; Cooking log that indicates the start and end of
OR each cooking cycle;
• Segregate and hold the product for an
evaluation of the adequacy of the cooking For continuous cooking equipment:
process. If the product has not received an
adequate cook, the product should be Records: Temperature recorder chart or a digital
destroyed, diverted to a non-food use, or time/temperature data logger printout;
reprocessed to eliminate potential pathogens of AND
public health concern; Cooking log that indicates the RPM of the belt
drive wheel or the time necessary for a test unit
or belt marking to pass through the tank.
Continued
Chapter 16: Cooking
215
For all cooking equipment: and toxin formation by this pathogen
(e.g. refrigerated, vacuum packaged hot-filled
Records: Records that are appropriate for the other soups and sauces). Generally, a 6D process is
critical factors (e.g. cooking log that indicates the suitable, regardless of the target pathogen.
initial temperature). However, lower degrees of destruction may be
acceptable if supported by a scientific study of
Enter the names of the HACCP records in Column 9 the normal innoculum in the food. Tables #A-3
of the HACCP Plan Form. and A-4 provide 6D process times for a range
of internal product temperatures, with
STEP #18: ESTABLISH VERIFICATION L. monocytogenes and C. botulinum type B (the
PROCEDURES. most heat resistant form of nonproteolytic
C. botulinum) as the target pathogens, respectively.
For the cook step, establish verification procedures The values provided in Table #A-4 may not be
that will ensure that the HACCP plan is: 1) adequate sufficient for the destruction of nonproteolytic
to address the hazard of “pathogen survival through C. botulinum in products containing dungeness
cooking”; and, 2) consistently being followed. crabmeat, because of the potential protective
effect of naturally occuring substances, such as
Following is guidance on establishing verification lysozyme. Expert knowledge of thermal process
procedures for cooking. calculations and the dynamics of heat transfer in
processing equipment is required to establish
• CONTROL STRATEGY EXAMPLE 1 - such a cooking process. Such knowledge can be
CONTROL OF COOKING obtained by education or experience, or both.
Establishing cooking processes requires access to
Verification: Process establishment: The adequacy suitable facilities and the application of
of the cooking process should be established by a recognized methods. The cooking equipment
scientific study. It should be designed to ensure should be designed, operated, and maintained to
an appropriate reduction in the numbers of deliver the established process to every unit of
pathogens of public health concern. Selecting product. In some cases, thermal death time, heat
the target organism is critical. In most cases it penetration, temperature distribution and
will be a relatively heat tolerant vegetative inoculated pack studies will be required to
pathogen, such as Listeria monocytogenes. establish the minimum process. In many cases,
However in some cases where outgrowth of establishing the minimum process may be
spore-forming pathogens, such as Clostridium simplified by repetitively determining the
perfringens and Bacillus cereus, during the post- process needed to reach an internal product
cook cooling step must be prevented by temperature that will assure the inactivation of
eliminating these pathogens during the cook all vegetative pathogens of public health concern
(e.g., because cooling after cooking is not under the most difficult heating conditions likely
controlled – see Chapter 12) then they will be the to be encountered during processing. In other
target organisms. Additionally, when cooking is instances, existing literature or federal, state or
performed immediately before reduced oxygen local regulations which establish minimum
packaging (e.g. vacuum packaging, modified processes or adequacy of equipment, are
atmosphere packaging), for product that will be available. Characteristics of the process, product
marketed under refrigeration, it may be necessary and/or equipment that affect the ability of the
for the cooking process to be sufficient to established minimum cooking process should be
eliminate the spores of Clostridium botulinum taken into consideration in the establishment of
type E and nonproteolytic types B and F. This is the process. A record of process establishment
the case when the product does not contain other should be maintained;
barriers that are sufficient to prevent growth
Chapter 16: Cooking

216
AND AND
Check the accuracy of the temperature recording Calibrate other instruments as necessary to
device or digital time/temperature data logger by ensure their accuracy;
comparing it to a mercury-in-glass thermometer AND
(or equivalent instrument) at least once per day. Review monitoring, corrective action and
The recording device should be adjusted to agree verification records within one week of
as nearly as possible, but never higher than the preparation.
thermometer;
AND Enter the verification procedures in Column 10 of the
Calibrate the mercury-in-glass thermometer (or HACCP Plan Form.
equivalent instrument) at the cooking
temperature against a known accurate standard
thermometer (NIST-traceable). This should be
done when the thermometer is installed and at
least once per year after that (Note: optimal
type, condition, and past performance of the
monitoring instrument);
Chapter 16: Cooking

217
TABLE #16-1
Control Strategy Example 1 - Control of cooking
This table is an example of a portion of a HACCP plan relating to the control of pathogen survival through cooking for a processor
of wild-caught cooked shrimp, using a continuous steam cooker, using Control Strategy Example 1 - Control of cooking.
It is provided for illustrative purposes only. Pathogen survival through cooking may be only one of several significant hazards
for this product. Refer to Tables 3-1, 3-2, and 3-3 (Chapter 3) for other potential hazards (e.g. chemical contaminants,
pathogen growth and toxin formation during processing, food and color additives, and metal fragments).
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
Cooking Pathogen survival • Minimum time: • Length of the • Belt speed • Once per day • Cooker operator • Extend process • Cooking record • Documentation
2.5 min. cook cycle measurement and after any or elevate of process
with stopwatch adjustment temperature to establishment
compensate for
deviation from • Review
Se
218
CL monitoring,
verification,
eT
ex and corrective
action records
Chapter 16: Cooking

AND within one
t f Exa
week of
preparation
or mp
Fu le
• Minimum temperature: • Temperature of • Digital time/ • Continuous. • Cooker operator • Segregate and • Data logger • Check the
210oF steam in the temperature Visual check hold for printout accuracy of the
ll R O
cooker data logger once per day evaluation. data logger
against the
eco nly
mercury-in-
glass
mm
thermometer
en daily
(Note: To achieve a • Calibrate the
da
6D reduction of mercury-in-
L. monocytogenes) glass
tio
ns thermometer
yearly
• Maximum shrimp size: • Shrimp size • Scale • Hourly and after • Grader operator • Grading record • Calibrate the
40 count/pound every raw material scale monthly
lot change or
grader adjustment
Chapter 17: Pathogen Survival Through Pasteurization (A Biological Hazard)
Hazard Analysis Worksheet For pasteurization processes that target nonproteolytic

C. botulinum, generally a reduction of six orders of
STEP #10: UNDERSTAND THE POTENTIAL magnitude (six logarithms, e.g. from 103 to 10-3) in
HAZARD. the level of contamination is suitable. This is called a
“6D” process. However, lower degrees of destruction
Survival of pathogens through the pasteurization may be acceptable if supported by a scientific study
process can cause illness to the consumer. Pasteur- of the normal innoculum in the food. It is also
ization is a mild or moderate heat treatment, usually possible that higher levels of destruction may be
performed on fishery products after the product is necessary in some foods, if there is an especially high
placed in the hermetically sealed finished product normal innoculum. Table #A-4 provides 6D process
container. The purpose of pasteurization is to either: times for a range of cooking temperatures, with
1) make the product safe for an extended refrigerated C. botulinum type B (the most heat resistant form of
shelf-life, which, in most cases, involves eliminating nonproteolytic C. botulinum) as the target pathogen.
the spores of Clostridium botulinum type E and The lethal rates and process times provided in the
nonproteolytic B and F (the types of C. botulinum table may not be sufficient for the destruction of
most commonly found in fish); or 2) eliminate or nonproteolytic C. botulinum in dungeness crabmeat,
reduce the numbers of other target pathogens (e.g. because of the potential that naturally occuring
Listeria monocytogenes, Vibrio vulnificus). substances, such as lysozyme, may enable the
pathogen to more easily recover after heat damage.
Selection of the target pathogen is critical. If a target
pathogen other than C. botulinum type E and Examples of properly pasteurized products are: blue
nonproteolytic types B and F is selected, you must crabmeat pasteurized to a cumulative lethality of
consider the potential that C. botulinum type E or F185˚F (F85˚C) = 31 min., z=16˚F (9˚C); surimi-based
nonproteolytic types B and F will survive the pasteur- products pasteurized at an internal temperature of
ization process and grow under normal storage 194˚F (90˚C) for at least 10 minutes.
conditions or moderate abuse conditions. Ordinarily,
the potential exists if the product is reduced oxygen In some pasteurized surimi-based products, salt in
packaged (e.g. vacuum packaged, modified atmo- combination with a milder pasteurization process in
sphere packaged), does not contain other barriers that the finished product container work to prevent
are sufficient to prevent growth and toxin formation growth and toxin formation by C. botulinum type E
by this pathogen, and is stored or distributed refriger- and nonproteolytic types B and F. An example of a
ated (not frozen). For example, vacuum packaged properly pasteurized surimi-based product in which
lobster meat that is pasteurized to kill L. 2.5% salt is present is one that has been pasteurized
monocytogenes but not C. botulinum type E or at an internal temperature of 185˚F (85˚C) for at least
nonproteolytic types B and F must be frozen to 15 minutes. This process may not be suitable for
prevent growth and toxin formation by C. botulinum other types of products, because of the unique
type E and nonproteolytic types B and F. Surveys of formulation and processing involved in the manufac-
retail display cases and home refrigerators indicate ture of surimi-based products.
that temperatures above the minimum growth tem-
perature of C. botulinum type E and nonproteolytic Reduced oxygen packaged foods that are pasteurized
types B and F (38˚F [3.3˚C]) are not uncommon. to control nonproteolytic C. botulinum, but not
Therefor, refrigeration alone cannot be relied upon proteolytic C. botulinum, and that do not contain
for control of the C. botulinum hazard. barriers to its growth, must be refrigerated or frozen
to control proteolytic C. botulinum. Control of
Continued
Chapter 17: Pasteurization
219
refrigeration is critical to the safety of these products. • Controlling the introduction of pathogens after the
Further information on C. botulinum and reduced pasteurization process (covered in Chapter 18);
oxygen packaging is contained in Chapter 13.
• Controlling the level of acidity, pH, in the product
In cases where Listeria monocytogenes is selected, a (covered by the acidified foods regulation, 21 CFR
6D process is also generally suitable. FDA’s draft L. 114 for shelf-stable acidified products; and for
monocytogenes risk assessment indicates that ap- refrigerated acidified products in Chapter 13);
proximately 7% of raw fish are contaminated with
from 1 to 103 CFU/g, and that approximately 92% are • Controlling the amount of moisture that is available
contaminated at less than 1 CFU/g. Less than 1% of for pathogen growth, water activity, in the product by
raw fish are contaminated at levels greater than 103 drying (covered in Chapter);
CFU/g, and none at levels greater than 106 CFU/g.
FDA’s action level for L. monocytogenes in ready-to- • Controlling the amount of moisture that is available
eat products, nondetectable, corresponds to a level of for pathogen growth, water activity, in the product by
less than 1 CFU/25g. Table #A-3 provides 6D formulation (covered in Chapter 13);
process times for a range of pasteurization tempera-
tures, with L. monocytogenes as the target pathogen. • Controlling the amount of salt or preservatives,
such as sodium nitrite, in the product (covered in
Lower degrees of destruction may be acceptable if Chapter 13);
supported by a scientific study of the normal
innoculum in the food. It is also possible that higher • Managing the amount of time that food is exposed
levels of destruction may be necessary in some foods, to temperatures that are favorable for pathogen
if there is an especially high normal innoculum. growth and toxin production (covered in Chapter 12;
for C. botulinum, in Chapter 13; and for S. aureus in
Products that are pasteurized in the finished product hydrated batter mix, in Chapter 15).
container are at risk for recontamination after pas-
teurization. Controls, such as container seal integrity STEP #11: DETERMINE IF THIS
and protection from contamination by cooling water, POTENTIAL HAZARD IS SIGNIFICANT.
are critical to the safety of these products. They are
covered in Chapter 18. At each processing step, determine whether “patho-
gen survival through pasteurization” is a significant
• Control of pasteurization hazard. The criteria is:
In order to ensure that the targeted pathogens are 1. Is it reasonably likely that unsafe levels of pathogens
eliminated, it is critical that the pasteurization will be introduced at this processing step (do unsafe
process be scientifically established. The pasteuriza- levels of pathogens come in with the raw material or
tion equipment must also be designed and operated will the process introduce unsafe levels of pathogens)?
so that every unit of product receives at least the
established minimum process. It is reasonable to assume that pathogens of various
types, including those listed in Table #A-1 (Appendix
• Strategies for controlling pathogen growth 4), will be present on raw fish and fishery products.
They may only be present at low levels or only
There are a number of strategies for the control of occasionally, but even such occurrences warrant
pathogens in fish and fishery products. They include: consideration because of the potential for growth and
toxin production.
• Killing pathogens by pasteurization (covered in
this chapter), cooking (covered in Chapter 16), or Pathogens may also be introduced during processing,
retorting (covered by the low acid canned foods from the air, unclean hands, insanitary utensils and
regulation, 21 CFR 113);

220
equipment, unsafe water, and sewage. Well designed • Intended use and method of storage and distribution
sanitation programs will minimize the introduction of
pathogens. Such sanitation controls need not be part In determining whether a hazard is significant you
of a HACCP plan if they are monitored under your should also consider the intended use of the product,
sanitation program (prerequisite program). In most which you developed in Step #4. However, for most
cases it is not reasonable to assume that they will fishery products which are currently pasteurized, it is
fully prevent the introduction of pathogens. For this unlikely that the intended use will affect the signifi-
reason, you should consider it reasonably likely that cance of the hazard.
low numbers of pathogens will be present in the
product, even after a cook step. However, if your product is immediately frozen after
processing, maintained frozen throughout distribution,
2. Can unsafe levels of pathogens, which were intro- and labeled to be held frozen and to be thawed under
duced at an earlier processing step, be eliminated or refrigeration immediately before use (e.g. “Important,
reduced to an acceptable level here? (Note: If you are keep frozen until used, thaw under refrigeration
not certain of the answer to this question at this time, immediately before use”), then formation of C.
you may answer “No.” However, you may need to botulinum toxin may not be a significant hazard.
change this answer when you assign critical control
points in Step #12.) STEP #12: IDENTIFY THE CRITICAL
CONTROL POINTS (CCP).
“Pathogen survival through pasteurization” should
also be considered a significant hazard at any process- For each processing step where “pathogen survival
ing step where a preventive measure is, or can be, through pasteurization” is identified in Column 3 of
used to eliminate (or reduce the likelihood of occur- the Hazard Analysis Worksheet as a significant hazard,
rence to an acceptable level) the hazard, if it is determine whether it is necessary to exercise control at
reasonably likely to occur. that step in order to control the hazard. Figure #A-2
(Appendix 3) is a CCP decision tree that can be used
Step #10 discusses a number of pathogen control to aid you in your determination.
strategies. This section covers the control of patho-
gens by pasteurization. Delivering a properly designed You should identify the pasteurization processing step
pasteurization process can be an effective preventive as the critical control point for this hazard. Therefore,
measure for the control pathogens. If this preventive you should answer “Yes” in Column 6 of the Hazard
measure is applied, list it in Column 5 of the Hazard Analysis Worksheet at the pasteurization step, and
Analysis Worksheet at the pasteurization step. “No” in that column at the other processing steps for
which the hazard was identified as a significant
If the answer to either question 1 or 2 is “Yes” the hazard. (Note: if you have not previously identified
potential hazard is significant at that step in the “pathogen survival through pasteurization” as a
process and you should answer “Yes” in Column 3 of significant hazard at the pasteurization step in Column
the Hazard Analysis Worksheet. If none of the 3 of the Hazard Analysis Worksheet, you should
criteria is met you should answer “No.” You should change the entry in Column 3 to “Yes”).
record the reason for your “Yes” or “No” answer in
Column 4. You need not complete Steps #12 through This control approach is referred to as “Control
18 for this hazard for those processing steps where Strategy Example 1” in Steps #14-18. It is important
you have recorded a “No.” to note that you may select a control strategy that is
different from that which is suggested above, provided
It is important to note that identifying this hazard as that it assures an equivalent degree of safety of the
significant at a processing step does not mean that it product.
step will help you determine where in the process the Proceed to Step #13 (Chapter 2) or to Step #10 of the
critical control point is located. next potential hazard.
Continued
221
HACCP Plan Form gen may be a vegetative pathogen such as L.
monocytogenes or V. vulnificus.
For the pasteurization step identify the minimum or Plan Form.
maximum value to which a feature of the process
must be controlled in order to control the hazard. STEP #15: ESTABLISH MONITORING
PROCEDURES.
The CL will be the minimum or maximum param-
eters established by a scientific study (see Step #18 - For the pasteurization step, describe monitoring
Verification) as necessary for adequate pasteurization procedures that will ensure that the critical limits are
(e.g. time and temperature of the pasteurization consistently met.
process, container size). If you set a more restrictive
CL (e.g. 2˚F higher/2 minutes longer) you could be To fully describe your monitoring program you
required to take corrective action when no safety should answer four questions: 1) What will be
concern actually exists. On the other hand, if you set monitored? 2) How will it be monitored? 3) How
a CL that is too loose you could allow unsafe product often will it be monitored (frequency)? 4) Who will
to reach the consumer. perform the monitoring?
As a practical matter it may be advisable to set an It is important for you to keep in mind that the
operating limit that is more restrictive than the CL. feature of the process that you monitor and the
In this way you can adjust the process when the method of monitoring should enable you to deter-
operating limit is triggered, but before a triggering of mine whether the critical limit is being met. That is,
the CL would require you to take corrective action. the monitoring process should directly measure the
feature for which you have established a critical limit.
experience with the variability of your operation and You should monitor often enough so that the normal
with the closeness of typical operating values to the CL. variability in the values you are measuring will be
detected. This is especially true if these values are
Following is guidance on setting critical limits for the typically close to the critical limit. Additionally, the
pasteurization step: greater the time span between measurements the
more product you are putting at risk should a mea-
• CONTROL STRATEGY EXAMPLE 1 - surement show that a critical limit has been violated.
CONTROL OF PASTEURIZATION
Following is guidance on establishing monitoring
Critical Limit: The minimum or maximum values for procedures for pasteurization. Note that the monitor-
the critical factors established by a scientific ing frequencies that are provided are intended to be
study. These may include length of the considered as minimum recommendations, and may
pasteurization cycle (speed of the belt for a not be adequate in all cases.
continuous pasteurizer), temperature of the water
bath, initial temperature of the product, container
size (e.g. can dimensions, pouch thickness), What Will Be Monitored?
and product formulation. Product internal
temperatures during the pasteurization cycle are • CONTROL STRATEGY EXAMPLE 1 -
not ordinarily suitable CLs because of variability CONTROL OF PASTEURIZATION
from container to container.
WHAT: Critical factors established by a scientific
As described in Step #10, the critical limits must be study. These may include length of the
established for the target pathogen. In most cases this pasteurization cycle (speed of the belt for a
will be C. botulinum type E and nonproteolytic types continuous pasteurizer), temperature of the water
B and F. However, in certain cases the target patho- bath, initial temperature of the product, container

222
size (e.g. can dimensions, pouch thickness), and How Often Will Monitoring Be Done
product formulation. (Frequency)?

How Will Monitoring Be Done? CONTROL OF PASTEURIZATION
• CONTROL STRATEGY EXAMPLE 1 - For batch pasteurizers:

CONTROL OF PASTEURIZATION
Frequency: Monitor the pasteurization temperature
For batch pasteurizers: continuously, with a visual check at least once
per batch;
How: Monitor the pasteurization time and AND
temperature with a temperature recording device The start and end of each pasteurization cycle
or a digital time/temperature data logger. The should be determined visually;
device should be installed where it can be easily AND
read and the sensor for the device should be Monitor other critical factors with sufficient
installed to ensure that it accurately measures the frequency to achieve control.
coldest temperature of the pasteurizing equipment
(cold spot to be determined by study); For continuous pasteurizers:
AND
The start and end of each pasteurization cycle Frequency: Monitor the pasteurization temperature
should be determined visually; continuously, with a visual check at least once
AND per day;
Monitor other critical factors with equipment AND
appropriate to the critical factor (e.g. initial Monitor the time at least once per day, and
temperature with a dial thermometer or whenever any changes in belt speed are made;
equivalent). AND
Monitor other critical factors with sufficient
For continuous pasteurizers: frequency to achieve control.
How: Monitor the pasteurization temperature with a Who Will Perform the Monitoring?
temperature recording device or a digital time/
temperature data logger. The device should be • CONTROL STRATEGY EXAMPLE 1 -
installed where it can be easily read and the CONTROL OF PASTEURIZATION
sensor for the device should be installed to
ensure that it accurately measures the coldest For batch pasteurizers:
temperature of the pasteurizing equipment (cold
spot to be determined by study); Who: Monitoring of pasteurization temperature is
AND performed by the equipment itself. However, a
Monitor the time by measuring either: visual check should be made at least once at the
• The RPM of the belt drive wheel, using a stop end of each cycle in order to ensure that the
watch or tachometer; critical limits have consistently been met.
OR These checks, as well as the monitoring of the
• The time necessary for a test unit or belt pasteurization time and other critical factors may
marking to pass through the tank, using a stop be performed by the equipment operator, a
watch; production supervisor, a member of the quality
AND control staff, or any other person who has an
Monitor other critical factors with equipment understanding of the equipment and the
appropriate to the critical factor (e.g. initial monitoring procedure.
temperature with a dial thermometer or
equivalent).
Continued
223
For continuous pasteurizers: OR
• Adjust the belt speed to increase the length of
Who: Monitoring of pasteurization temperature is the pasteurization cycle;
performed by the equipment itself. However, a AND
visual check should be made at least once per Take one of the following actions to the product
day in order to ensure that the critical limits have involved in the critical limit deviation:
consistently been met. These checks, as well as • Destroy the product;
the monitoring of the pasteurization time and OR
other critical factors may be performed by the • Reprocess the product;
equipment operator, a production supervisor, a OR
member of the quality control staff, or any other • Segregate and hold the product for an
person who has an understanding of the evaluation of the adequacy of the pasteurization
equipment and the monitoring procedure. process. If the product has not received
adequate pasteurization, the product should be
Enter the “What,” “How,” “Frequency,” and “Who” destroyed, diverted to a non-food use, or
monitoring information in Columns 4, 5, 6, and 7, reprocessed to eliminate potential pathogens of
respectively, of the HACCP Plan Form. public health concern;
OR
STEP #16: ESTABLISH CORRECTIVE • Divert the product to a use in which the critical
ACTION PROCEDURES. limit is not applicable (e.g. divert improperly
pasteurized crabmeat to a crabmeat canning
For the pasteurization step, describe the procedures operation);
that you will use when your monitoring indicates that OR
the critical limit has not been met. • Divert to a non-food use.
These procedures should: 1) ensure that unsafe Enter the corrective action procedures in Column 8 of
product does not reach the consumer; and, 2) correct the HACCP Plan Form.
ber that deviations from operating limits do not need STEP #17: ESTABLISH A RECORDKEEPING
to result in formal corrective actions. SYSTEM.
Following is guidance on establishing corrective For the pasteurization step, list the records that will be
action procedures for pasteurization. used to document the accomplishment of the monitor-
ing procedures discussed in Step #15. The records
• CONTROL STRATEGY EXAMPLE 1 - should clearly demonstrate that the monitoring
CONTROL OF PASTEURIZATION procedures have been followed, and should contain
the actual values and observations obtained during
Corrective Action: Take one or more of the monitoring.
following actions as necessary to regain control
over the operation after a CL deviation: Following is guidance on establishing a record-
• Adjust the steam supply to increase water bath keeping system for pasteurization.
temperature;
• Extend the length of the pasteurization cycle to CONTROL OF PASTEURIZATION
compensate for a temperature drop or a low
initial temperature; For batch pasteurizers:
OR
• Process at a higher temperature to compensate Recods: Temperature recorder chart or a digital
for a low initial temperature; time/temperature data logger printout;

224
AND education or experience, or both. Establishing
Pasteurization log that indicates the start and end pasteurization processes requires access to
of each pasteurization cycle; suitable facilities and the application of
AND recognized methods. The pasteurization
Records that are appropriate for the other critical equipment should be designed, operated, and
factors (e.g. pasteurization log that indicates the maintained to deliver the established process to
initial temperature). every unit of product. In some cases, thermal
death time, heat penetration, temperature
For continuous pasteurizers: distribution and inoculated pack studies will be
required to establish the minimum process. In
Recods: Temperature recorder chart or a digital other instances, existing literature or federal,
time/temperature data logger printout; state or local regulations which establish
AND minimum processes or adequacy of equipment,
Pasteurization log that indicates the RPM of the are available. Characteristics of the process,
belt drive wheel or the time necessary for a test product and/or equipment that affect the
unit or belt marking to pass through the tank; adequacy of the established minimum
AND pasteurization process should be taken into
Records that are appropriate for the other critical consideration in the establishment of the process.
factors (e.g. pasteurization log that indicates the A record of process establishment should be
initial temperature). maintained;
AND
Enter the names of the HACCP records in Column 9 Check the accuracy of the temperature recording
of the HACCP Plan Form. device or time/temperature data logger by
comparing it to a mercury-in-glass thermometer
STEP #18: ESTABLISH VERIFICATION (or equivalent instrument) at least once per day.
PROCEDURES. The recording device should be adjusted to agree
as nearly as possible, but never higher than the
For the pasteurization step, establish verification thermometer.
procedures that will ensure that the HACCP plan is: AND
1) adequate to address the hazard of pathogen Calibrate the mercury-in-glass thermometer (or
survival through pasteurization; and, 2) consistently equivalent instrument) at the pasteurization
being followed. temperature against a known accurate standard
thermometer (NIST-traceable). This should be
Following is guidance on establishing verification done when the thermometer is installed and at
procedures for pasteurization. least once per year after that. (Note: optimal
• CONTROL STRATEGY EXAMPLE 1 - type, condition, and past performance of the
CONTROL OF PASTEURIZATION monitoring instrument.)
AND
Verification: Process establishment: The adequacy Calibrate other instruments as necessary to
of the pasteurization process should be ensure their accuracy.
established by a scientific study. It should be AND
designed to ensure an appropriate reduction in Review monitoring, corrective action and
the numbers of the target pathogen. Expert verification records within one week of
knowledge of thermal process calculations and preparation.
the dynamics of heat transfer in processing
equipment is required to determine the target Enter the verification procedures in Column 10 of the
pathogen and to establish such a pasteurization HACCP Plan Form.
process. Such knowledge can be obtained by

225
TABLE #17-1
Control Strategy Example 1 - Control of pasteurization
This table is an example of a portion of a HACCP plan relating to the control of pasteurization for pasteurized, refrigerated
blue crab meat, using Control Strategy Example 1 - Control of pasteurization. It is provided for illustrative purposes only.
Pathogen survival through pasteurization may be only one of several significant hazards for this product.
Refer to Tables 3-1, 3-2, and 3-3 (Chapter 3) for other potential hazards (e.g. chemical contaminants, pathogen growth
and toxin formation during processing, recontamination after pasteurization, and metal fragments).
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
Batch Pathogen survival • Minimum initial • Initial • Dial • Coldest can • Pasteurizer • Extend process • Pasteurization • Documentation
Pasteurization product temperature temperature thermometer entering each operator or elevate log of process
37oF batch temperature to establishment
Se compensate for
deviation from
226
• Minimum length of • Time up to • Wall clock/ • Each batch • Pasteurizer CL • Pasteurization • Review
eT
pasteurization cycle
ex 189oF and time temperature operator log monitoring,
120 minutes cycle ends recording verification,
device and corrective
t f Exa

AND action records
or mp
Fu le within one
week of
preparation
ll R O
• Minimum water bath • Temperature of • Temperature • Continuously, • Recorder • Segregate and • Recorder • Check the
eco nly
temperature 189oF water bath recording each batch. thermometer hold for thermometer accuracy of the
device Visual check at with visual by evaluation. chart temperature
mm
en end of batch. pasteurizer recording
operator device against
the mercury-
da
tio in-glass
thermometer
daily
ns
• Calibrate the
mercury-
in-glass
thermometer
yearly
Chapter 18: Introduction of Pathogens After Pasteurization
and Specialized Cooking Processes (A Biological Hazard)
Hazard Analysis Worksheet pasteurization processes, which are discussed in

Chapter 17. For example, control of recontamination
STEP #10: UNDERSTAND THE POTENTIAL after they are placed in the finished product container
HAZARD. is critical to the safety of these products. Addition-
ally, because these products are cooked before they
The introduction of pathogens after pasteurization and are packaged, they are at risk for recontamination
certain cooking processes can cause consumer illness. between cooking and packaging. The risk of this
recontamination is minimized by filling the container
Pasteurization is a mild or moderate heat treatment, in a continuous filling operation while the product is
usually performed on fishery products after the still hot (i.e. hot filling), another critical step for the
product is placed in the hermetically sealed finished safety of these products. This control strategy is
product container. The purpose of pasteurization is to suitable for products that are filled directly from the
either: 1) make the product safe for an extended cooking kettle, where the risk of recontamination is
refrigerated shelf-life, which, in most cases, involves minimized. It is not ordinarily suitable for products
eliminating the spores of Clostridium botulinum type such as crabmeat, lobster meat, or crayfish meat, or
E and nonproteolytic B and F (the types of C. botuli- other products that are handled between cooking and
num most commonly found in fish); or 2) eliminate or filling. Hot filling is covered in this chapter.
reduce the numbers of other target pathogens (e.g.
Listeria monocytogenes, Vibrio vulnificus, Vibrio • Control of pathogen introduction after pasteurization
parahaemolyticus). and after cooking that is performed immediately before
reduced oxygen packaging
In addition to eliminating pathogens, the pasteuriza-
tion process also greatly reduces the number of There are three primary causes of recontamination
spoilage bacteria present in the fishery product. after pasteurization and after cooking that is per-
These bacteria normally restrict the growth of patho- formed immediately before reduced oxygen packag-
gens through competition. Rapid growth of patho- ing. They are:
gens that may be introduced after pasteurization is,
therefore, a concern. This chapter covers control of • Defective container closures;
recontamination after pasteurization. • Contaminated container cooling water;
• Recontamination between cooking and reduced
For some products that are marketed refrigerated, oxygen packaging.
cooking is performed immediately before reduced
oxygen packaging (e.g. vacuum packaging, modified Poorly formed or defective container closures can
atmosphere packaging). For these products, the increase the risk of pathogens entering the container,
cooking process is targeted to eliminate the spores of especially during container cooling performed in a
Clostridium botulinum type E and nonproteolytic water bath. Contaminated cooling water can enter
types B and F, particularly when the product does not through the container closure, especially when the
contain other barriers that are sufficient to prevent closure is defective. Container closure can be
growth and toxin formation by this pathogen (e.g. controlled by adherence to seal guidelines that are
many refrigerated, vacuum packaged hot-filled soups provided by the container or sealing machine manu-
and sauces). These cooking processes, which are facturer. Control is accomplished through periodic
discussed in Chapter 16, have much in common with seal inspection.
Continued
Chapter 18: Post-pasteurization
227
Contamination of cooling water can be controlled by • Controlling the amount of moisture that is avail-
ensuring that a measurable residual of chlorine, or able for pathogen growth, water activity, in the
other approved water treatment chemical, is present product by formulation (covered in Chapter 13);
in the cooling water, or by ensuring that ultraviolet
(UV) treatment systems are operating properly. • Controlling the amount of salt or preservatives,
such as sodium nitrite, in the product (covered in
Recontamination between cooking and reduced Chapter 13);
oxygen packaging in continuous filling systems
where the product is packaged directly from the • Managing the amount of time that food is exposed
kettle can be controlled by hot filling at temperatures to temperatures that are favorable for pathogen
at or above 185˚F (85˚C). FDA is interested in growth and toxin production (covered in Chapter 12;
information on the value of adding a time component for C. botulinum, in Chapter 13; and for S. aureus in
(e.g. 3 minutes) to this hot filling temperature batter mix, in Chapter 15).
recommendation, to provide limited lethality for any
nonproteolytic C. botulinum spores present on the STEP #11: DETERMINE IF THIS
packaging material. POTENTIAL HAZARD IS SIGNIFICANT.
It may also be prudent to use packaging that has been At each processing step determine whether “intro-
manufactured or treated to inactivate spores of C. duction of pathogens after pasteurization” is a
botulinum type E and nonproteolytic types B and F significant hazard. The criteria are:
(e.g. gamma irradiation, hot extrusion). FDA is
interested in comment on the utility of such mea- 1. Is it reasonably likely that pathogens will be intro-
sures. duced at this processing step (consider post-pasteur-
ization processing steps, only)?
• Strategies for controlling pathogen growth
It is reasonable to assume that, in the absence of
There are a number of strategies for the control of controls, pathogens of various types may enter the
pathogens in fish and fishery products. They include: finished product container during a water bath
cooling process or between cooking and reduced
• Controlling the introduction of pathogens after the oxygen packaging.
pasteurization process and after cooking process
performed immediately before reduced oxygen 2. Can the introduction of pathogens after pasteuriza-
packaging (covered in this chapter); tion be eliminated or reduced to an acceptable level
here? (Note: If you are not certain of the answer to
• Killing pathogens by cooking (covered in Chapter this question at this time, you may answer “No.”
16), pasteurizing (covered in Chapter 17), or retorting However, you may need to change this answer when
(covered by the low acid canned foods regulations, you assign critical control points in Step #12)
21 CFR 113);
“Introduction of pathogens after pasteurization”
• Controlling the level of acidity, pH, in the product should also be considered a significant hazard at any
(covered by the acidified foods regulations, 21 CFR processing step where a preventive measure is, or
114 for shelf-stable acidified products; and for can be, used to eliminate (or reduce the likelihood of
refrigerated acidified products in Chapter 13); occurrence to an acceptable level) the hazard, if it is
reasonably likely to occur.
drying (covered in Chapter 14);

228
Step #10 discusses a number of pathogen control However, if your product is immediately frozen after
strategies. This section covers control of pathogen processing, maintained frozen throughout distribu-
introduction that can occur after the pasteurization tion, and labeled to be held frozen and to be thawed
process and between cooking and reduced oxygen under refrigeration immediately before use (e.g.
packaging. Preventive measures for the introduction “Important, keep frozen until used, thaw under
of pathogens at these times can include: refrigeration immediately before use”), then forma-
tion of C. botulinum toxin may not be a significant
• Controlling container sealing; hazard.
• Controlling the residual of chlorine, or other
approved water treatment chemical, in container STEP #12: IDENTIFY THE CRITICAL
cooling water; CONTROL POINTS (CCP).
• Controlling UV light intensity of bulbs used for
treating container cooling water and the flow rate For each processing step where “introduction of
of the cooling water moving through the UV pathogens after pasteurization” is identified in
treatment system; Column 3 of the Hazard Analysis Worksheet as a
• Hot filling the product into the final container in a significant hazard, determine whether it is necessary
continuous filling system. to exercise control at that step in order to control the
hazard. Figure #A-2 (Appendix 3) is a CCP decision
List such preventive measures in Column 5 of the tree that can be used to aid you in your determina-
Hazard Analysis Worksheet at the appropriate tion.
processing step(s).
You should identify the container sealing step, the
If the answer to either question 1 or 2 is “Yes” the water bath container cooling step, and the hot filling
potential hazard is significant at that step in the step (where applicable) as the critical control points
process and you should answer “Yes” in Column 3 of for this hazard. Therefore, you should answer “Yes”
the Hazard Analysis Worksheet. If neither criterion in Column 6 of the Hazard Analysis Worksheet for
is met you should answer “No.” You should record the container sealing, water bath container cooling,
the reason for your “Yes” or “No” answer in Column and hot filling steps. (Note: if you have not previ-
4. You need not complete Steps #12 through 18 for ously identified “pathogen introduction after pasteur-
this hazard for those processing steps where you have ization” as a significant hazard at the container
recorded a “No.” sealing, water bath container cooling, and hot filling
steps in Column 3 of the Hazard Analysis Worksheet,
It is important to note that identifying this hazard as you should change the entries in Column 3 to “Yes”).
significant at a processing step does not mean that it
must be controlled at that processing step. The next This control approach is referred to as “Control
step will help you determine where in the process the Strategy Example 1” in Steps #14-18. It is important
critical control point is located. to note that you may select a control strategy that is
different from that which is suggested above, pro-
• Intended use and method of storage and distribution vided that it assures an equivalent degree of safety of
the product.
should also consider the intended use of the product, Proceed to Step #13 (Chapter 2) or to Step #10 of the
which you developed in Step #4. However, for those next potential hazard.
fishery products which are currently pasteurized, it is
unlikely that the intended use will affect the signifi-
cance of the hazard.
Continued
229
HACCP Plan Form For hot filling:
STEP #14: SET THE CRITICAL LIMITS (CL). Critical Limit: Product temperature of 185˚F (85˚C) or
higher as the product enters the final container.
At each processing step where “introduction of
pathogens after pasteurization” is identified as a Enter the critical limit(s) in Column 3 of the HACCP
significant hazard on the HACCP Plan Form (e.g. Plan Form.
container sealing, water bath container cooling and
hot filling) identify the maximum or minimum value STEP #15: ESTABLISH MONITORING
to which a feature of the process must be controlled PROCEDURES.
in order to control the hazard.
For each processing step where “introduction of
You should set the CL at the point that if not met the pathogens after pasteurization” is identified as a
safety of the product may be questionable. If you set significant hazard on the HACCP Plan Form (e.g.
a more restrictive CL you could, as a result, be container sealing, container cooling tank and hot
required to take corrective action when no safety filling), describe monitoring procedures that will
concern actually exists. On the other hand, if you set ensure that the critical limits are consistently met.
unsafe product to reach the consumer. To fully describe your monitoring program you
As a practical matter it may be advisable to set an monitored? 2) How will it be monitored? 3) How
operating limit that is more restrictive than the CL. often will it be monitored (frequency)? 4) Who will
In this way you can adjust the process when the perform the monitoring?
operating limit is triggered, but before a triggering of
the CL would require you to take corrective action. It is important for you to keep in mind that the
You should set operating limits based on your feature of the process that you monitor and the
experience with the variability of your operation and method of monitoring should enable you to deter-
with the closeness of typical operating values to the mine whether the CL is being met. That is, the
CL. monitoring process should directly measure the
control strategy example identified in Step #12. You should monitor often enough so that the normal
• CONTROL STRATEGY EXAMPLE 1 - detected. This is especially true if these values are
CONTROL OF RECONTAMINATION typically close to the CL. Additionally, the greater
the time span between measurements the more
For container sealing: product you are putting at risk should a measurement
Critical Limit: Container or sealing machine
manufacturer’s seal guidelines. Following is guidance on establishing monitoring
procedures for the control option discussed in Step
For container cooling: #12. Note that the monitoring frequencies that are
provided are intended to be considered as minimum
Critical Limit: Measurable residual of chlorine, or recommendations, and may not be adequate in all
other approved water treatment chemical, at the cases.
discharge point of the container cooling tank;
OR
Equipment manufacturer’s UV light intensity and
flow rate guidelines.

230
What Will Be Monitored? OR
- For pouches: Visual examination should be
• CONTROL STRATEGY EXAMPLE 1 - sufficient to detect gross closure defects,
CONTROL OF RECONTAMINATION including: cuts, fractures, non-bonding,
malformation, puncture, abrasion, blister,
For container sealing: contaminated seal, delamination, seal creep,
wrinkle, flex cracks, crushed package or other
What: Container integrity obvious defects;
OR
For container cooling: - For glass containers, visual examination
should be sufficient to detect gross closure
What: Residual chlorine, or other approved water and glass defects, including: cap tilt, cocked
treatment chemical, in the cooling water; cap, crushed lug, stripped cap, cut through,
OR and chipped and cracked glass finish;
Intensity of UV light; AND
AND Detailed examination of containers (destructive):
Cooling water flow rate. • Recommendations for seal evaluation
measurements that ensure a reliable hermetic
For hot filling: seal should be obtained from the container or
sealing machine manufacturer. They should
What: Product temperature as the product enters the include:
final container. - For double seamed metal and plastic cans:
The examination should include a teardown
examination of the can. If the micrometer
How Will Monitoring Be Done? method is used, three (3) measurements,
approximately 120˚ apart around the double
• CONTROL STRATEGY EXAMPLE 1 - seam, should be made. Measurements should
CONTROL OF RECONTAMINATION include: cover hook, body hook, width,
tightness, and thickness. If the optical
For container sealing: method (seamscope or projector) is used, cuts
should be made at at least two (2) different
How: Visual examination of containers locations, excluding the side seam juncture.
(non-destructive): Measurements should include body hook,
• Recommendations for visual examinations that overlap, tightness, and thickness;
ensure a reliable hermetic seal should be OR
obtained from the container or sealing machine - For pouches: The examination should
manufacturer. They should include: include: burst testing or vacuum or bubble
- For double seamed metal and plastic cans: testing. It may also include: drop testing, peel
The external features of the double seam testing (tensile strength), residual gas testing,
should be examined for gross closure defects, electroconductivity testing, and dye testing;
including: cutovers, seam sharpness, false OR
seams, deadheading, droop, damage to the - For glass containers: The examination should
countersink wall indicating a broken chuck, include cold water vacuum testing.
cable cuts, and product overlapping the Additional examinations can include: security
flange. In addition, visual examination values (lug-tension) for lug-type caps; and,
should include examination of the entire pull-up (lug position) for lug-type, twist caps.
container for product leakage or other
obvious defects;
Continued
231
For container cooling: OR
For UV light meter and flow rate meter:
How: Measure residual of chlorine, or other at least daily.
approved water treatment chemical, at the
discharge point of the container cooling tank; For hot filling:
OR
Use a UV light meter; Frequency: Continuous monitoring by the instrument
AND itself, with visual check of the instrument at least
Use a flow rate meter. once per batch of cooked product.
For hot filling:

Who Will Perform the Monitoring?
How: Use a digital time/temperature data logger;
Use a recorder thermometer. CONTROL OF RECONTAMINATION
For container sealing:

(Frequency)? Who: Monitoring may be performed by the sealing
machine operator, a production supervisor, a
• CONTROL STRATEGY EXAMPLE 1 - member of the quality control staff, or any
CONTROL OF RECONTAMINATION person who is trained and qualified to conduct
container examinations.
For container sealing:
For container cooling:
Frequency: Visual examination of containers: At
least one container from each sealing head at least Who: Monitoring may be performed by the
every 30 minutes of sealing machine operation. equipment operator, a production supervisor, a
At a minimum this should include visual member of the quality control staff or any other
examinations made at the beginning of person who has an understanding of the testing
production, and immediately following a jam in procedure and the critical limits.
the sealing machine, or machine adjustment,
repair, or prolonged shut down; For hot filling:
AND
Detailed examination of containers: At least one Who: With recorder thermometers and digital data
container from each sealing head at least every loggers, monitoring is performed by the
four hours of sealing machine operation. At a equipment itself. However, when such
minimum this should include examinations made instruments are used a visual check should be
at the beginning of production and immediately performed at least once per batch of cooked
following a jam in the sealing machine, or product in order to ensure that the critical limits
machine adjustment, repair, or prolonged shut have consistently been met. These checks may
down. be performed by a production employee, a
For container cooling: control staff, or any other person who has an
understanding of the process and the monitoring
Frequency: For residual water treatment chemical: procedure.
Sufficient frequency to assure control, but no less
frequently than once every four hours of use;

232
Enter the “What,” “How,” “Frequency,” and “Who” For container cooling:
respectively, of the HACCP Plan Form. Corrective Action: If no measurable residual
chlorine, or other approved water treatment
STEP #16: ESTABLISH CORRECTIVE chemical, is detected, add chlorine or adjust the
ACTION PROCEDURES. chlorine metering system and recheck for
chlorine residual;
At each processing step in which “introduction of OR
pathogens after pasteurization” is identified as a If UV intensity is inadequate, replace or clean the
significant hazard in the HACCP Plan Form (e.g. bulbs or shields;
container sealing, water bath container cooling and AND
hot filling), describe the procedures that you will use If flow exceeds the critical limit, adjust or
when your monitoring indicates that the CL has not replace the pump.
been met.
For hot filling:
product does not reach the consumer; and, 2) correct Corrective Action: Take one or more of the following
the problem that caused the CL deviation. Remem- actions to regain control over the operation after a CL
ber that deviations from operating limits do not need deviation:
to result in formal corrective actions. • Adjust the cooking equipment to increase the
processing temperature;
Following is guidance on establishing corrective OR
action procedures for the control option discussed in • Adjust the post-cook process to minimize time
Step #12. delays;
AND
• CONTROL STRATEGY EXAMPLE 1 - Take one of the following actions to the product
CONTROL OF RECONTAMINATION involved in the critical limit deviation:
For container sealing: OR
• Recook the product;
Corrective Action: Identify and correct the source OR
of the defect after a CL deviation; • Segregate and hold the product for a safety
AND evaluation. If the product is found to be
Evaluate the seriousness of the defects, and, if unsafe, it should be destroyed, diverted to a
necessary, identify, segregate, and hold the non-food use, or recooked to eliminate
affected product for appropriate follow-up potential pathogens of public health concern;
action. That may include, but is not limited to, OR
100% visual inspection of all affected containers • Divert the product to a use in which the critical
to remove the defective containers; limit is not applicable (e.g. divert to a canning
OR operation);
Repack the affected product. OR
• Divert to a non-food use.
Enter the corrective action procedures in Column 8 of

the HACCP Plan Form.
Continued
233
SYSTEM. PROCEDURES.
At each processing step in which “introduction of At each processing step in which “introduction of
pathogens after pasteurization” is identified as a pathogens after pasteurization” is identified as a
significant hazard and critical control point in the significant hazard in the HACCP Plan Form (con-
HACCP Plan Form (e.g. container sealing, water bath tainer sealing, water bath container cooling and hot
container cooling and hot filling), list the records that filling), establish verification procedures that will
will be used to document the accomplishment of the ensure that the HACCP plan is: 1) adequate to
monitoring procedures discussed in Step #15. The address the hazard of “introduction of pathogens
records should clearly demonstrate that the monitor- after pasteurization”; and, 2) consistently being
ing procedures have been followed, and should followed.
contain the actual values and observations obtained
during monitoring. Following is guidance on establishing verification
procedures for the control option discussed in Step
Following is guidance on establishing a #12.
recordkeeping system for the control option dis-
cussed in Step #12. • CONTROL STRATEGY EXAMPLE 1 -
CONTROL OF RECONTAMINATION
CONTROL OF RECONTAMINATION For container sealing:
For container sealing: Verification: Obtain container seal guidelines from

container or sealing machine manufacturer;
Records: Record of visual examination of AND
containers; Review monitoring and corrective action records
AND within one week of preparation.
Record of detailed examination of containers.
Records: Record of residual chlorine, or other action records within one week of preparation.
approved water treatment chemical, levels;
OR For hot filling:
Record of UV intensity testing;
AND Verification: Review monitoring and corrective action
Record of flow rate testing. records within one week of preparation.
For hot filling: Enter the verification procedures in Column 10 of the

HACCP Plan Form.
Records: Printout from digital time/temperature data
logger;
OR
Recorder thermometer chart.


234
TABLE #18-1
Control Strategy Example 1 - Control of recontamination
This table is an example of a portion of a HACCP plan relating to the control of the introduction of pathogens after pasteurization
for a processor of pasteurized blue crab meat, packed in 301 X 408 size steel cans, using Control Strategy Example 1 - Control of
recontamination. It is provided for illustrative purposes only. Pathogen recontamination after pasteurization may be only one of several
significant hazards for this product. Refer to Tables 3-1, 3-2, and 3-3 (Chapter 3) for other potential hazards (e.g. chemical contaminants,
pathogen growth and toxin formation during processing, pathogen survival through pasteurization, and metal fragments).
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
Container sealing Pathogen introduction • No visible cutovers, • Container • Visual seam • One can per • Seamer operator • Identify and • Visual seam • Review
seam sharpness, false integrity examination seaming head correct the source examination monitoring and
seams, deadheading, every 1/2 hr, at of the defect, and record corrective action
Sedroop, damage to the startup, after records within
countersink wall jams, adjustments, • Evaluate the one week of
235
indicating a broken chuck, repairs, and seriousness of preparation
eT
cable cuts, product
ex prolonged the defect, and
overlapping the flange, shutdowns hold for further • Can seam guide-
product leakage, or other evaluation if lines from can
t f Exa
obvious defects. necessary manufacturer

or mp
Fu le
• Cover hook: .070" • Container • Double seam • One can per • Seamer operator • Same • Double seam • Same
minimum; body hook integrity teardown seaming head teardown record
ll R O
.072-.088"; width: examination, every 4 hrs, at
.125" maximum; using micrometer startup, after
eco nly
thickness .052-.058"; at 3 points on jams, adjustments,
tightness 80%. seam, 120oF repairs, and
mm
en apart. prolonged
da shutdowns
tio
ns
Water bath Pathogen introduction Measurable residual Residual chlorine Rapid test Every batch Pasteurizer Add chlorine and Processing Review
container cooling chlorine in water bath operator recheck for record monitoring and
residual corrective action
records within
one week of
preparation
Notes:

236
Chapter 19: Allergens, Food Intolerance Substances and
Prohibited Food & Color Additives (A Chemical Hazard)
Hazard Analysis Worksheet introduction of allergenic proteins must be controlled

through a rigorous sanitation regime, either as part of
STEP #10: UNDERSTAND THE POTENTIAL a prerequisite program or as part of HACCP itself.
HAZARD. The Seafood HACCP Regulation requires such a
regime.
Certain food and color additives can cause an
allergic-type reaction (food intolerance) in consum- STEP #11: DETERMINE IF THIS
ers. Examples of such food and color additives that POTENTIAL HAZARD IS SIGNIFICANT
are used on fish and fishery products include:
sulfiting agents and FD&C Yellow #5. Sulfiting At each processing step, determine whether “allergens/
agents are mostly used during on-board handling of additives” is a significant hazard. The criteria are:
shrimp and lobster to prevent the formation of
“black spot.” They are sometimes used by cooked 1. Is it reasonably likely that a food or color additive
octopus processors as an antioxidant, to retain the that can cause an allergic-type reaction (e.g. sulfiting
red color of the octopus skin. FD&C Yellow #5 is agents or FD&C yellow #5) or a prohibited substance
used during in-plant processing. These food and (e.g. safrole and FD&C Red #4) will be introduced at a
color additives are permitted for use in foods, with level that can cause an allergic-type reaction at this
certain restrictions, but their presence must be processing step (e.g. does it come in with the raw
declared on the label. This label declaration is material or will the process introduce it)?
particularly important to sensitive individuals.
For example, under ordinary circumstances, it would
Certain other food and color additives are prohibited be reasonably likely to expect that food or color
from use in food because of a determination by FDA additives that can cause an allergic-type reaction
that they present a potential risk to the public health. could enter the process under the following circum-
Examples of such food and color additives include: stances:
safrole and FD&C Red #4.
• Sulfiting agents may be used on shrimp and lobster
Additionally, a number of foods contain allergenic between capture and delivery to the processor.
proteins that can pose a health risk to certain sensi- However, in some regions even with these products
tive individuals. Appendix 6 contains a list of such (e.g. some aquacultured shrimp) this practice may
foods that account for most of all food allergies. not be reasonably likely.
While the controls in this chapter are not directly
applicable to the hazard of allergenic proteins, if • Sulfiting agents may also be used in the processing
these foods are part of or are directly added to your of cooked octopus.
fishery product, you may use the principles con-
tained in this chapter to ensure that the product is Sulfiting agents added directly to a finished food
properly labeled. However, these controls are not must be declared on a product’s labeling regardless
designed to prevent the unintentional introduction of of the concentration of the sulfiting agent. When not
allergenic proteins from such foods into your fishery directly added to the finished food, sulfiting agents
product because of cross-contact (e.g. use of com- must be declared on a product’s labeling when the
mon equipment, improper production scheduling, or level is at or above 10 ppm.
improper use of rework material). Unintentional
Continued
Chapter 19: Allergens/Additives
237
• FD&C Yellow #5 may be used in the processing of List such preventive measures in Column 5 of the
formulated fishery products or in the production of Hazard Analysis Worksheet at the appropriate
smoked fish. processing step(s).
2. Can the hazard be eliminated or reduced to an If the answer to either question 1 or 2 is “Yes” the
acceptable level here? (Note: If you are not certain of potential hazard is significant at that step in the
the answer to this question at this time, you may process and you should answer “Yes” in Column 3 of
answer “No.” However, you may need to change this the Hazard Analysis Worksheet. If neither criterion
answer when you assign critical control points in is met you should answer “No.” You should record
Step #12) the reason for your “Yes” or “No” answer in Column
4. You need not complete Steps #12 through 18 for
“Allergens/additives” should also be considered a this hazard for those processing steps where you have
significant hazard at a processing step if a preventive recorded a “No.”
measure is or can be used to prevent or eliminate the
hazard or is adequate to reduce the likelihood of It is important to note that identifying this hazard as
occurrence of the hazard to an acceptable level, if it significant at a processing step does not mean that it
is reasonably likely to occur. Preventive measures must be controlled at that processing step. The next
for allergic-type reactions that can result from the step will help you determine where in the process the
presence of certain food and color additives (e.g. critical control point is located.
sulfiting agents and FD&C yellow #5) could include:
• Intended use
• Declaring the presence of food and color additives
that can cause an allergic-type reaction on finished In determining whether a hazard is significant you
product labeling; should also consider the intended use of the product,
• Testing incoming shrimp or lobster for residues of which you developed in Step #4. However, in the
sulfiting agents at or above 10 ppm; case of allergens/additives, it is not likely that the
• Receiving a supplier’s certification of the lack of significance of the hazard will be affected by the
sulfiting agent use on incoming lots of shrimp or intended use of the product.
lobster (with appropriate verification – see Step
#18); STEP #12: IDENTIFY THE CRITICAL
• Reviewing the labeling (or accompanying CONTROL POINTS (CCP).
documents, in the case of unlabeled product) on
shipments of shrimp or lobster received from For each processing step where “allergens/additives”
another processor for the presence of a sulfiting is identified in Column 3 of the Hazard Analysis
agent declaration Worksheet as a significant hazard, determine whether
it is necessary to exercise control at that step in order
A preventive measure for the presence of prohibited to control the hazard. Figure #A-2 (Appendix 3) is a
food and color additives could include: CCP decision tree that can be used to aid you in your
determination.
• Testing incoming lots of fish for the presence of
prohibited food and color additives which there is The following guidance will also assist you in
reason to believe may be present. determining whether a processing step is a CCP for
“allergens/additives”:
• Receiving a supplier’s certification that prohibited
food and color additives were not used on the incom- 1. In the case of shrimp or lobster for which you have
ing lot of fish (with appropriate verification – see identified sulfiting agents as a significant hazard, will
Step #18). the finished product label declare the presence of
sulfiting agents?

238
a. If it will, you may identify the finished product Example:
labeling step as the CCP. Alternately, you may A frozen shrimp processor that receives shrimp
identify the receipt of product labels as the CCP directly from the harvest vessel and does not
(where you can check labels for the presence of a label finished product with a sulfiting agent
sulfiting agent declaration). The raw material declaration could set the critical control point
receiving step would then not require control and for sulfiting agents (allegens/additives) at the
would not need to be identified as a CCP for the raw material receiving step and test incoming
hazard of improper use of allergens/additives. lots of shrimp for the presence of sulfiting agents.
The processor would not need to have a critical
In this case enter “Yes” in Column 6 of the control point for this hazard at finished product
Hazard Analysis Worksheet for the finished labeling.
product labeling step or receipt of product labels
step, and enter “No” for the raw material Example:
receiving step. In addition, for the raw material A frozen shrimp processor that receives shrimp
receiving step enter in Column 5 that the hazard from another processor and does not label
is controlled by the finished product labeling step finished product with a sulfiting agent declaration
or the receipt of product labels step. (Note: if could set the critical control point for sulfiting
you have not previously identified “allergens/ agents (allegens/additives) at the raw material
additives” as a significant hazard at the finished receiving step and reject incoming lots that are
product labeling step or receipt of product labels identified as having been treated with a sulfiting
step in Column 3 of the Hazard Analysis agent (e.g. identified on the labeling or, in the
Worksheet, you should change the entry in case of unlabeled product, on documents
Column 3 to “Yes”.) This control approach will accompanying the shipment). The processor
be referred to as “Control Strategy Example 1” would not need to have a critical control point
in Steps #14 through 18. for this hazard at finished product labeling.
Example: c. If the finished product labeling will only declare

A frozen shrimp processor that labels all the presence of sulfiting agents when it is present
finished product with a sulfiting agent in the raw material, you may identify the finished
declaration could set the critical control point product labeling step or the receipt of product
for sulfiting agents (allergens/additives) at labels step (where you can check labels for the
the finished product labeling step. The processor presence of a sulfiting agent declaration) as the
would not need to have a critical control point CCP. Testing or certification at the raw material
for this hazard at the shrimp receiving step. receiving step will be necessary to ensure control
at the CCP. However, the raw material receiving
b. If the finished product labeling will not declare step would not need to be identified as a CCP for
the presence of sulfiting agents, you may identify the hazard of “allergens/additives.”
the raw material receiving step as the CCP.
In this case enter “Yes” in Column 6 of the
In this case enter “Yes” in Column 6 of the Hazard Analysis Worksheet for the finished
Hazard Analysis Worksheet for the raw material product labeling step or the receipt of product
receiving step. This control approach will be labels step, and enter “No” for the raw material
referred to as “Control Strategy Example 2” in receiving step. In addition, for the raw material
Steps #14 through 18. receiving step enter in Column 5 that the hazard
is controlled by the finished product labeling step
or the receipt of product labels step. (Note: if
you have not previously identified “allergens/
additives” as a significant hazard at the finished
Continued
239
product labeling step or receipt of product labels In this case enter “Yes” in Column 6 of the Hazard
step in Column 3 of the Hazard Analysis Analysis Worksheet for the finished product labeling
Worksheet, you should change the entry in step or receipt of product labels step, and enter “No”
Column 3 to “Yes”.) This control approach will for the treatment step. In addition, for the treatment
be referred to as “Control Strategy Example 3” in step enter in Column 5 that the hazard is controlled
Steps #14 through 18. by the finished product labeling step or receipt of
product labels step. (Note: if you have not previously
Example: identified “allergens/additives” as a significant
A frozen shrimp processor that receives shrimp hazard at the finished product labeling step or receipt
directly from the harvest vessel and labels of product labels step in Column 3 of the Hazard
finished product with a sulfiting agent declaration Analysis Worksheet, you should change the entry in
only if testing at receipt identifies a residue of a Column 3 to “Yes”.) This control approach will also
sulfiting agent could set the critical control point be referred to as “Control Strategy Example 1” in
for sulfiting agents (allergens/additives) at the Steps #14 through 18.
finished product labeling step or the receipt of
product labels step. The processor would not Example:
need to have a critical control point for this A smoked sablefish processor that treats the fish
hazard at the raw material receiving step. with FD&C Yellow #5 before smoking could set
the critical control point for FD&C Yellow #5
Example: (allergens/additives) at the finished product
A frozen shrimp processor that receives shrimp labeling step or receipt of product labels step.
from another processor and labels finished The processor would not need to have a critical
product with a sulfiting agent declaration only if control point for this hazard at the treatment
the incoming lot was identified as having been step.
treated with a sulfiting agent (e.g. identified on
the labeling or, in the case of unlabeled product, Example:
on documents accompanying the shipment), A cooked octopus processor that treats the fish
could set the critical control point for sulfiting with a sulfiting agent could set the critical
agents (allergens/additives) at the finished control point for sulfiting agents (allergens/
product labeling step or the receipt of product additives) at the finished product labeling step or
labels step. The processor would not need to receipt of product labels step. The processor
have a critical control point for this hazard at the would not need to have a critical control point
raw material receiving step. for this hazard at the treatment step.
2. In the case of cooked octopus for which you have 3. In the case of products for which you have identified
identified sulfiting agents as a significant hazard, and prohibited food and color additives (e.g. safrole and
in the case of products for which you have identified FD&C Red #4) as a significant hazard in incoming raw
FD&C Yellow #5 as a significant hazard because you materials you should identify the raw material receiving
use one of these food and color additives in the product step as the CCP.
formulation, you should identify the finished product
labeling step or receipt of product labels step (where In this case enter “Yes” in Column 6 of the Hazard
you can check labels for the presence of a sulfiting Analysis Worksheet for the raw material receiving
agent or FD&C Yellow #5 declaration, as appropriate) step. This control approach will be referred to as
as the CCP. The processing step at which you add a “Control Strategy Example 2” in Steps #14 through 18.
sulfiting agent or FD&C Yellow #5 would then not
require control and would not need to be identified as It is important to note that you may select a control
a CCP for the hazard of “allergens/additives.” strategy that is different from those which are
suggested above, provided that it assures an equiva-
lent degree of safety of the product.

240
Proceed to Step #13 (Chapter 2) or to Step #10 of the OR
next potential hazard. The labeling or shipping documents for incoming
lots of shrimp or lobster received from another
HACCP Plan Form processor must not contain a sulfiting agent
declaration;
STEP #14: SET THE CRITICAL LIMITS (CL). OR
Incoming lots of raw materials must not contain
For each processing step where “allergens/additives” a detectable level of prohibited food and color
is identified as a significant hazard on the HACCP additives;
Plan Form identify the maximum or minimum value OR
to which a feature of the process must be controlled Incoming lots of raw materials must be
in order to control the hazard. accompanied by a supplier’s lot-by-lot certificate
that prohibited food and color additives were not
You should set the CL at the point that if not met the used.
safety of the product may be questionable. If you set
a more restrictive CL you could, as a result, be • CONTROL STRATEGY EXAMPLE 3 -
required to take corrective action when no safety LABELING CONTROLS WITH RAW MATERIAL
concern actually exists. On the other hand, if you set SCREENING
unsafe product to reach the consumer. Critical Limit: Finished product labels for product
processed from raw materials that contain a
As a practical matter it may be advisable to set an detectable level of sulfite must contain a
operating limit that is more restrictive than the CL. sulfiting agent declaration.
operating limit is triggered, but before a triggering of Enter the critical limit(s) in Column 3 of the HACCP
the CL would require you to take corrective action. Plan Form.
experience with the variability of your operation and STEP #15: ESTABLISH MONITORING
with the closeness of typical operating values to the CL. PROCEDURES.
Following is guidance on setting critical limits for the For each processing step where “allergens/additives”
control strategy examples discussed in Step #12. is identified as a significant hazard on the HACCP
Plan Form, describe monitoring procedures that will
• CONTROL STRATEGY EXAMPLE 1 - ensure that the critical limits are consistently met.
LABELING CONTROLS
Critical Limit: All finished product labels must should answer four questions: 1) What will be
contain a sulfiting agent or FD&C Yellow #5 monitored? 2) How will it be monitored? 3) How
declaration, as appropriate. often will it be monitored (frequency)? 4) Who will
RAW MATERIAL SCREENING It is important for you to keep in mind that the
feature of the process that you monitor and the
Critical Limit: Incoming lots of shrimp or lobster method of monitoring should enable you to deter-
must not contain a detectable level of sulfite; mine whether the CL is being met. That is, the
OR monitoring process should directly measure the
Incoming lots of shrimp or lobster must be feature for which you have established a CL.
accompanied by a supplier’s lot-by-lot certificate
that sulfiting agents were not used;
Continued
241
You should monitor often enough so that the normal • CONTROL STRATEGY EXAMPLE 3 -
variability in the values you are measuring will be LABELING CONTROLS WITH RAW MATERIAL
detected. This is especially true if these values are SCREENING
typically close to the CL. Additionally, the greater
the time span between measurements the more What:Finished product labels for presence of
product you are putting at risk should a measurement sulfiting agent declaration;
show that a CL has been violated. AND
One of the following:
Following is guidance on establishing monitoring • Representative sample of each lot for sulfiting
procedures for the control strategy examples dis- agent residual analysis;
cussed in Step #12. Note that the monitoring fre- OR
quencies that are provided are intended to be consid- • Supplier’s lot-by-lot certificate that no sulfiting
ered as minimum recommendations, and may not be agent was used on the lot (with appropriate
adequate in all cases. verification – see Step #18);
OR
Labeling or accompanying documents for each
What Will Be Monitored? lot received from another processor, for the
presence of a sulfiting agent declaration.
LABELING CONTROLS
What: Finished product labels for presence of
sulfiting agent or FD&C Yellow #5 declaration, • CONTROL STRATEGY EXAMPLE 1 -
as appropriate. LABELING CONTROLS
• CONTROL STRATEGY EXAMPLE 2 - How: Visual examination.

RAW MATERIAL SCREENING
What:Representative sample of each lot at receipt RAW MATERIAL SCREENING
for sulfiting agent residual analysis, or prohibited
food and color additive residual analysis, as How: Screening test for sulfiting agents or prohibited
appropriate; food and color additives, as appropriate;
OR OR
Supplier’s lot-by-lot certificate that no sulfiting Visual examination of certificates;
agent, or prohibited food and color additive, OR
as appropriate, was used on the lot (with Visual examination of the labeling or
appropriate verification – see Step #18); accompanying documents, for lots received from
OR another processor.
Labeling or accompanying documents for each
lot received from another processor, for the
presence of a sulfiting agent declaration.

242
• CONTROL STRATEGY EXAMPLE 3 - At least one label from every case of labels or
LABELING CONTROLS WITH RAW MATERIAL one label from each pallet of pre-labeled
SCREENING packaging material received at the firm.
OR
How: Visual examination of labels; Once per day for on-site computer generated
AND labels.
One of the following: AND
• Screening test for sulfiting agents; Each lot of incoming shrimp or lobster.
OR
• Visual examination of certificates;
OR Who Will Perform the Monitoring?
Visual examination of the labeling or
accompanying documents, for lots received from • CONTROL STRATEGY EXAMPLE 1 -
another processor. LABELING CONTROLS
Who: Monitoring may be performed by the labeling

How Often Will Monitoring Be Done equipment operator, the receiving employee, a
(Frequency)? production supervisor, a member of the quality
control staff, or any other person who has an
• CONTROL STRATEGY EXAMPLE 1 - understanding of the proper content of the label.
LABELING CONTROLS
Frequency: At least one label from every case of RAW MATERIAL SCREENING
labels or one label from each pallet of pre-labeled
packaging material delivered to the packaging Who: Monitoring may be performed by the receiving
area; employee, a production supervisor, a member of
OR the quality control staff, or any other person who
At least one label from every case of labels or that has an understanding of the proper screening
one label from each pallet of pre-labeled procedure. Assignment of responsibility for
packaging material received at the firm. testing procedures should be based, in part, on
OR the degree of difficulty of the analysis.
Once per day for on-site computer generated
labels. • CONTROL STRATEGY EXAMPLE 3 -
LABELING CONTROLS WITH RAW MATERIAL
• CONTROL STRATEGY EXAMPLE 2 - SCREENING
Who: Monitoring may be performed by the labeling
equipment operator, the receiving employee, a
Frequency: Each incoming lot.
control staff, or any other person that has an
LABELING CONTROLS WITH RAW MATERIAL
understanding of proper content of the label or
SCREENING
the screening procedure, as appropriate.
Assignment of responsibility for testing
Frequency: At least one label from every case of procedures should be based, in part, on the
labels or one label from each pallet of pre-labeled degree of difficulty of the analysis.
packaging material delivered to the packaging
area; Enter the “What,” “How,” “Frequency,” and “Who”
OR monitoring information in Columns 4, 5, 6, and 7,
Continued
243
STEP #16: ESTABLISH CORRECTIVE • CONTROL STRATEGY EXAMPLE 3 -
ACTION PROCEDURES. LABELING CONTROLS WITH RAW MATERIAL
SCREENING
For each processing step where “allergens/additives”
is identified as a significant hazard on the HACCP Corrective Action: Segregate and relabel any
Plan Form, describe the procedures that you will use improperly labeled product;
when your monitoring indicates that the CL has not AND
been met. Segregate and return or destroy any label stock
or pre-labeled packaging stock that does not
These procedures should: 1) ensure that unsafe contain the proper declaration.
the problem that caused the CL deviation. Remem- Enter the corrective action procedures in Column 8 of
ber that deviations from operating limits do not need the HACCP Plan Form.
to result in formal corrective actions.
Following is guidance on establishing corrective SYSTEM.
discussed in Step #12. For each processing step where “allergens/additives”
is identified as a significant hazard on the HACCP
• CONTROL STRATEGY EXAMPLE 1 - Plan Form, list the records that will be used to
LABELING CONTROLS document the accomplishment of the monitoring
procedures discussed in Step #15. The records
Corrective Action: Segregate and relabel any should clearly demonstrate that the monitoring
improperly labeled product; procedures have been followed, and should contain
AND the actual values and observations obtained during
Segregate and return or destroy any label stock monitoring.
or pre-labeled packaging stock that does not
contain the proper declaration. Following is guidance on establishing a record-
keeping system for the control strategy examples
• CONTROL STRATEGY EXAMPLE 2 - discussed in Step #12.
Corrective Action: Reject any incoming lot in LABELING CONTROLS
which sulfiting agent or prohibited food and
color additive, as appropriate, is detected or Records: Record of labeling checks.
declared or which is not accompanied by a
supplier’s certificate. • CONTROL STRATEGY EXAMPLE 2 -
critical limit is mistakenly accepted, and the error is Records: Test results for sulfiting agent or prohib-
later detected, the following actions should be taken: ited food and color additives, as appropriate;
1) the lot and any products processed from that lot OR
should be destroyed, diverted to a nonfood use or to a Supplier’s lot-by-lot certificates;
use in which the critical limit is not applicable, or OR
placed on hold until a food safety evaluation can be Record of raw material labeling or
completed; and 2) any products processed from that accompanying document checks.
lot that have already been distributed should be
recalled and subjected to the actions described above.

244
LABELING CONTROLS WITH RAW MATERIAL RAW MATERIAL SCREENING
SCREENING
Verification: Review monitoring, corrective action,
Records: Record of labeling checks; and, where applicable, verification records within
AND one week of preparation;
One of the following: AND
• Sulfiting agent test results; When supplier’s certificates are used for
OR monitoring, collect at least one representative
• Supplier’s lot-by-lot certificates; sample per quarter, randomly selected from
OR among your suppliers, and analyze for sulfiting
Record of raw material labeling or agents or prohibited food and color additives, as
accompanying document checks. appropriate. Additionally, collect at least one
representative sample for each new supplier, and
Enter the names of the HACCP records in Column 9 analyze for sulfiting agents or prohibited food
of the HACCP Plan Form. and color additives, as appropriate.
STEP #18: ESTABLISH VERIFICATION • CONTROL STRATEGY EXAMPLE 3 -

PROCEDURES. LABELING CONTROLS WITH RAW MATERIAL
SCREENING
For each processing step where “allergens/additives”
is identified as a significant hazard on the HACCP Verification: Review monitoring, corrective action,
Plan Form, establish verification procedures that will and, where applicable, verification records within
ensure that the HACCP plan is: 1) adequate to one week of preparation;
address the hazard of improper use of food and color AND
additives; and, 2) consistently being followed. When supplier’s certificates are used for
monitoring, collect at least one representative
Following is guidance on establishing verification sample per quarter, randomly selected from
procedures for the control strategy examples dis- among your suppliers, and analyze for sulfiting
cussed in Step #12. agents. Additionally, collect at least one
representative sample for each new supplier, and
• CONTROL STRATEGY EXAMPLE 1 - analyze for sulfiting agents.
LABELING CONTROLS
Verification: Review monitoring and corrective HACCP Plan Form.

245
TABLE #19-1
Control Strategy Example 1 - Labeling controls
This table is an example of a portion of a HACCP plan relating to the control of sulfiting agents for a processor of wild-caught
shrimp, using Control Strategy Example 1 – Labeling controls. It is provided for illustrative purposes only.
Allergens/additives may be only one of several significant hazards for this product.
Refer to Tables 3-1, 3-2, and 3-3 (Chapter 3) for other potential hazards (e.g. chemical contaminants, and metal fragments).
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
Labeling receipt Sulfiting agents All finished product Finished product Visual One label from Receiving Segregate and Label receiving Review
labels must contain labels for each case of employee return any labels record monitoring and
sulfiting agent presence of labels at receipt that do not contain correction action
declaration sulfiting agent the sulfiting agent records within
Se declaration declaration one week of
preparation
246
eT
ex
t f Exa

or mp
Fu le
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en
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TABLE #19-2
Control Strategy Example 2 - Raw material screening
frozen shrimp, using Control Strategy Example 2 – Raw material screening. It is provided for illustrative purposes only.
Allergens/additives may be only one of several significant hazards for this product.
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
Shrimp receiving Sulfiting agents Incoming lots of shrimp Supplier’s lot-by- Visual Every lot of Receiving Reject any Copies of • Test one lot per
must be accompanied by lot certificate that incoming shrimp employee incoming lot of supplier’s quarter for
a supplier’s certificate no sulfiting agents shrimp that is not guarantees sulfiting agent
that sulfiting agents were were used on accompanied by residue, and test
not used on the lot
Se the lot a supplier’s one lot from
certificate each new
247
supplier of
eT
ex shrimp for
sulfiting agent
residue
t f Exa

or mp
Fu le • Review
monitoring,
correction
ll R O
action and
verification
eco nly
records within
one week of
mm
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da
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ns
TABLE #19-3
Control Strategy Example 3 - Labeling controls with raw material screening
frozen shrimp, using Control Strategy Example 3 – Labeling controls with raw material screening. It is provided for illustrative
purposes only. Allergens/additives may be only one of several significant hazards for this product.
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
Finished product Sulfiting agents Finished product labels • Finished • Visual • One label from • Packaging • Segregate and Label check Review
labeling for product processed product labels each case of machine relabel any record monitoring and
from sulfite-containing for presence of labels delivered operator improperly corrective action
raw material shrimp must sulfiting agent to packaging labeled product records within
contain a sulfiting agent
Se declaration one week of
declaration preparation
248
• Three shrimp • malachite green • Three shrimp • Quality control • Segregate and
eT
ex collected test from each lot of employee return any label
randomly from raw material stock that does
each lot of raw shrimp not contain the
t f Exa
material shrimp proper

or mp
Fu le for sulfiting declaration
agent residual
analysis
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mm
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Chapter 20: Metal Inclusion (A Physical Hazard)
Hazard Analysis Worksheet • Blades from automatic filleting equipment;

• Injection needles;
STEP #10: UNDERSTAND THE POTENTIAL • Metal ties used on raw material, in-process, or
HAZARD. finished product containers or equipment.
Metal fragments can cause injury to the consumer. Under ordinary circumstances it would not be
reasonably likely to expect that metal fragments
Metal-to-metal contact, especially in mechanical could enter the food from the following sources:
cutting or blending operations, other equipment with
metal parts that can break loose, such as moving wire • Manual cutting, shucking, gutting, or boning
mesh belts, injection needles, screens, portion control knives;
equipment, metal ties and can openers are likely • Metal processing tables or storage tanks;
sources of metal that may enter food during processing. • Wire mesh baskets or utensils.
FDA’s Health Hazard Evaluation Board has sup- 2. Can metal fragments, which were introduced at an
ported regulatory action against product with metal earlier step, be eliminated or reduced to an acceptable
fragments of 0.3” (7 mm) to 1.0” (25mm) in length. level at this processing step? (Note: If you are not
See FDA Compliance Policy Guide #555.425. certain of the answer to this question at this time, you
may answer “No.” However, you may need to
STEP #11: DETERMINE IF THIS change this answer when you assign critical control
POTENTIAL HAZARD IS SIGNIFICANT. points in Step #12.)
At each processing step, determine whether “metal “Metal inclusion” should also be considered a
inclusion” is a significant hazard. The criteria are: significant hazard at any processing step where a
preventive measure is or can be used to prevent or
1. Is it reasonably likely that metal fragments will be eliminate the inclusion of metal fragments, that have
introduced at this processing step (e.g. does it come in been introduced to the product at a previous step, or
with the raw material or will the process introduce it)? is adequate to reduce the likelihood of occurrence of
the hazard to an acceptable level. Preventive mea-
For example, under ordinary circumstances, it would sures for “metal inclusion” can include:
be reasonably likely to expect that metal fragments
could enter the process from the following sources as • Periodically checking cutting or blending equipment
a result of worn, damaged or broken equipment parts: or wire-mesh belts for damage or missing parts;
• Passing the product through metal detection or
• Mechanical crabmeat pickers; separation equipment.
• Wire-mesh belts used to convey product in a batter/
breading operation; Visually inspecting equipment for damage or missing
• Teeth from saw blades used to cut portions or parts may only be feasible with relatively simple
steaks; equipment, such as band saws, small orbital blenders,
• Wire from mechanical mixer blades; and wire-mesh belts. Other, more complex, equip-
ment may contain to many parts, some of which may
• Blades from mechanical chopping or blending
equipment; not be readily visible, to make such visual inspection
• Rings, washers, nuts, or bolts from sauce cooling, reliable in a reasonable time period.
liquid dispensing, and portioning equipment;
Continued
Chapter 20: Metal
249
List such preventive measures in Column 5 of the In this case, you should enter “No” in Column 3 of
Hazard Analysis Worksheet at the appropriate the Hazard Analysis Worksheet for each of the
processing step(s). processing steps. In addition, for each “No” entry
briefly explain in column 4 that the hazard is con-
If the answer to either question 1 or 2 is “Yes” the trolled by a subsequent processor. In this case, you
potential hazard is significant at that step in the need not complete Steps #12 through 18 for this
process and you should answer “Yes” in Column 3 of hazard.
the Hazard Analysis Worksheet. If neither criterion
is met you should answer “No.” You should record STEP #12: IDENTIFY THE CRITICAL
the reason for your “Yes” or “No” answer in Column CONTROL POINTS (CCP).
4. You need not complete Steps #12 through 18 for
this hazard for those processing steps where you have For each processing step where “metal inclusion” is
recorded a “No.” identified in Column 3 of the Hazard Analysis
Worksheet as a significant hazard, determine whether
It is important to note that identifying this hazard as it is necessary to exercise control at that step in order
significant at a processing step does not mean that it to control the hazard. Figure #A-2 (Appendix 3) is a
must be controlled at that processing step. The next CCP decision tree that can be used to aid you in your
step will help you determine where in the process the determination.
critical control point is located.
The following guidance will also assist you in
• Intended use determining whether a processing step is a CCP for
“metal inclusion”:
should also consider the intended use of the product, Will the product be run through a metal detector, or
which you developed in Step #4. In most cases you through a screen, magnet, flotation tank, or other
should assume that the product will be consumed in a equipment for separation of metal fragments, on or
way that would not eliminate any metal fragments after the last step where metal inclusion is identified
that may be introduced during the process. In this as a significant hazard?
case, you would need to identify the hazard as
significant if the above criteria are met. 1. If it will be, you may identify final metal detection or
separation as the CCP. Processing steps prior to metal
However, in some cases, if you have assurance that detection will then not require control and will not need
the product will be run through a metal detector, for to be identified as CCPs for the hazard of metal
detection of metal fragments, or through screens or a fragments.
magnet, for separation of metal fragments, by a
subsequent processor you may not need to identify In this case enter “Yes” in Column 6 of the Hazard
metal fragment inclusion as a significant hazard. Analysis Worksheet for the metal detection or
separation step, and enter “No” for the other process-
Example: ing steps where “metal inclusion” was identified as a
A primary processor produces frozen fish blocks by significant hazard. In addition, for each “No” entry,
mechanically heading, eviscerating, and filleting fish note in Column 5 that the hazard is controlled by the
in-the-round. The primary processor sells exclusively final metal detection or separation step. (Note: if you
to breaded fish stick processors and has been given have not previously identified “metal inclusion” as a
assurance by these processors that the finished, significant hazard at the metal detection or separation
breaded product will be subjected to a metal detector. step in Column 3 of the Hazard Analysis Worksheet,
The primary processor would not need to identify you should change the entry in Column 3 to “Yes”.)
“metal inclusion” as a significant hazard. This control approach will be referred to as “Control
Strategy Example 1” in Steps #14 through 18.
Chapter 20: Metal

250
Example: It is important to note that you may select a control
A breaded fish processor could set the critical control strategy that is different from those which are
point for “metal inclusion” at the packaged product suggested above, provided that it assures an equiva-
metal detection step, and would not need to have lent degree of safety of the product.
critical control points for this hazard at each of the
steps at which there was a reasonably likelihood that Proceed to Step #13 (Chapter 2) or to Step #10 of the
metal fragments could be introduced. next potential hazard.
You should recognize that by setting the critical

control point at or near the end of the process, rather HACCP Plan Form
than at the point of potential metal fragment entry
into the process, you are likely to have more labor STEP #14: SET THE CRITICAL LIMITS (CL).
and materials invested in the product before the
problem is detected or prevented. For each processing step where “metal inclusion” is
2. If the product will not be run through such a device, Form identify the maximum or minimum value to
you should have procedures to periodically check the which a feature of the process must be controlled in
processing equipment for damage or lost parts at each order to control the hazard.
processing step where “metal inclusion” is identified as
a significant hazard. In this case you should identify You should set the CL at the point that if not met the
those processing steps as CCPs. It would not ordinarily safety of the product may be questionable. If you set
be necessary to identify these steps as CCPs in addition a more restrictive CL you could, as a result, be
to identifying a final metal detection or separation step required to take corrective action when no safety
as a CCP. concern actually exists. On the other hand, if you set
Visually inspecting equipment for damage or missing unsafe product to reach the consumer.
parts may only be feasible with relatively simple
equipment, such as band saws, small orbital blenders, As a practical matter it may be advisable to set an
and wire-mesh belts. Other, more complex, equip- operating limit that is more restrictive than the CL.
ment may contain to many parts, some of which may In this way you can adjust the process when the
not be readily visible, to make such visual inspection operating limit is triggered, but before a triggering of
reliable in a reasonable time period. the CL would require you to take corrective action.
In this case, You should enter “Yes” in column 6 of experience with the variability of your operation and
the Hazard Analysis Worksheet for each of those with the closeness of typical operating values to the CL.
processing steps. This control approach will be
referred to as “Control Strategy Example 2” in Steps Following is guidance on setting critical limits for the
#14 through 18. control strategy examples discussed in Step #12.
Example: • CONTROL STRATEGY EXAMPLE 1 -

A processor that cuts tuna steaks from whole fish has METAL DETECTION OR SEPARATION
identified the band saw cutting step as the only step
that is reasonably likely to introduce metal fragments Critical Limit: No metal fragments in finished
to the process. The processor does not have a final product. (Note: FDA’s Health Hazard Evaluation
metal detection or separation step. The processor Board has supported regulatory action against
checks the condition of the band saw blade every four product with metal fragments of 0.3" [7 mm] to
hours to ensure that it has not been damaged. The 1.0" [25mm] in length. See also FDA Compliance
processor identifies the band saw cutting step as the Policy Guide #555.425.)
CCP for this hazard.
Continued
Chapter 20: Metal
251
• CONTROL STRATEGY EXAMPLE 2 - What Will Be Monitored?
EQUIPMENT CHECKS
Critical Limit: No broken or missing metal parts EQUIPMENT CHECKS
from equipment at the CCPs for “metal inclusion”
What: The presence of metal fragments in product
Enter the critical limit(s) in Column 3 of the HACCP passing the CCP.
Plan Form.
STEP #15: ESTABLISH MONITORING METAL INCLUSION PREVENTION PROCEDURES
PROCEDURES.
What: The presence of broken or missing metal parts
For each processing step where “metal inclusion” is from equipment at the CCPs.
Form, describe monitoring procedures that will
ensure that the critical limits are consistently met. How Will Monitoring Be Done?
To fully describe your monitoring program you • CONTROL STRATEGY EXAMPLE 1 -

should answer four questions: 1) What will be METAL DETECTION OR SEPARATION
monitored? 2) How will it be monitored? 3) How
often will it be monitored (frequency)? 4) Who will How: Use a metal detection device;
perform the monitoring? OR
Use a magnet for separating metal fragments
It is important for you to keep in mind that the from a product stream, where feasible (e.g. dry
feature of the process that you monitor and the ingredients);
method of monitoring should enable you to deter- OR
mine whether the CL is being met. That is, the Use screens for separating metal fragments from
monitoring process should directly measure the a product stream, where feasible (e.g. dry or
feature for which you have established a CL. liquid ingredients).
You should monitor often enough so that the normal • CONTROL STRATEGY EXAMPLE 2 -
variability in the values you are measuring will be EQUIPMENT CHECKS
typically close to the CL. Additionally, the greater How: Visually check the equipment for broken or
the time span between measurements the more missing parts.
product you are putting at risk should a measurement
show that a CL has been violated. Examples:
• Check saws for missing teeth;
Following is guidance on establishing monitoring • Check that all parts are secure on blending
procedures for the control strategy examples dis- equipment;
cussed in Step #12. Note that the monitoring fre- • Check for missing links in metal belts.
ered as minimum recommendations, and may not be
Chapter 20: Metal

252
How Often Will Monitoring Be Done • CONTROL STRATEGY EXAMPLE 2 -
(Frequency)? EQUIPMENT CHECKS
• CONTROL STRATEGY EXAMPLE 1 - Who: Monitoring may be performed by the

METAL DETECTION OR SEPARATION equipment operator, a production supervisor, a
member of the quality control staff, a member of
Frequency: Subject all product to the control. the maintenance or engineering staff, or any other
Check that device is operating or is in place at person who has a thorough understanding of the
start of each production day. proper condition of the equipment.
• CONTROL STRATEGY EXAMPLE 2 - Enter the “What,” “How,” “Frequency,” and “Who”
EQUIPMENT CHECKS
Frequency: Check before starting operations respectively, of the HACCP Plan Form.
each day;
Check every four hours during operation; ACTION PROCEDURES.
AND
Check at the end of operations each day; For each processing step where “metal inclusion” is
AND identified as a significant hazard on the HACCP Plan
Check whenever there is an equipment Form, describe the procedures that you will use when
malfunction that could increase the likelihood your monitoring indicates that the CL has not been met.
that metal could be introduced into the food.
Who Will Perform the Monitoring? the problem that caused the CL deviation. Remember
that deviations from operating limits do not need to
• CONTROL STRATEGY EXAMPLE 1 - result in formal corrective actions.
METAL DETECTION OR SEPARATION
Following is guidance on establishing corrective
Who: Monitoring is performed by the equipment action procedures for the control strategy examples
itself. A check should be made at least once per discussed in Step #12.
day to ensure that the device is operating or is in
place. This may be performed by the equipment • CONTROL STRATEGY EXAMPLE 1 -
operator, a production supervisor, a member of METAL DETECTION OR SEPARATION
the quality control staff, a member of the
maintenance or engineering staff, or any other Corrective Action: Take the following corrective
person who has an understanding of the operation action to regain control over the operation after a
of the equipment. CL deviation:
• Attempt to locate and correct the source of the
fragments found in product by the metal
detector or separated from the product stream
by the magnets, screens, or other devices;
Continued
Chapter 20: Metal
253
AND • CONTROL STRATEGY EXAMPLE 2 -
Make adjustments to the materials, equipment, EQUIPMENT CHECKS
and/or process, as needed, to prevent future
introduction of metal fragments; Corrective Action: Take one of the following
AND corrective actions to regain control over the
Take the following action to product involved in operation after a CL deviation:
a CL deviation: • Stop production;
• Destroy; AND
OR • If necessary, adjust or modify the equipment to
• Divert to non-food use; reduce the risk of recurrence;
OR AND
• Rework to eliminate metal fragments; Take one of the following actions to product
OR involved in a CL deviation:
• Hold and evaluate any product in which the metal • Destroy all product produced since the previous
detector has detected metal fragments; satisfactory equipment check;
AND OR
Take one of the following actions to the product • Run all product produced since the previous
when product is processed without a properly satisfactory equipment check through a metal
functioning metal detector or separation device: detector;
• Destroy the product; OR
OR • Divert all product produced since the previous
• Hold all product produced since controls were satisfactory equipment check to a use in which
last confirmed as functioning properly until it it will be run through a metal detector (e.g.
can be run through a metal detector; divert fish fillets to a breading operation that is
OR equipped with a metal detector);
• Hold all product produced since controls were OR
last confirmed as functioning properly until an • Divert all product produced since the previous
inspection of the processing equipment that satisfactory equipment check to a non-food use.
could contribute metal fragments can be
completed to determine whether there are any Enter the corrective action procedures in Column 8 of
broken or missing parts; the HACCP Plan Form.
OR
• Divert all product produced since controls were
last confirmed as functioning properly to a use
in which it will be run through a metal detector
(e.g. divert fish fillets to a breading operation
that is equipped with a metal detector);
OR
• Divert all product produced since controls
were last confirmed as functioning properly
to a non-food use;
AND
• Repair or replace the metal detector or
separation device
Chapter 20: Metal

254
SYSTEM. PROCEDURES.
For each processing step where “metal inclusion” is For each processing step where “metal inclusion” is
identified as a significant hazard on the HACCP Plan identified as a significant hazard on the HACCP Plan
the accomplishment of the monitoring procedures ensure that the HACCP plan is: 1) adequate to
discussed in Step #15. The records should clearly address the hazard of metal inclusion; and, 2) consis-
demonstrate that the monitoring procedures have tently being followed.
been followed, and should contain the actual values
and observations obtained during monitoring. Following is guidance on establishing verification
Following is guidance on establishing a cussed in Step #12.
amples discussed in Step #12. • CONTROL STRATEGY EXAMPLE 1 -
METAL DETECTION OR SEPARATION
METAL DETECTION OR SEPARATION Verification: Test the effectiveness of the metal
detection device, or check the condition of the
Records: Record documenting that the metal magnet, screen, or other metal separation device
detection or separation device is operating or is at least once per day, before start of operations;
in place, as appropriate. AND
Review monitoring, corrective action and
• CONTROL STRATEGY EXAMPLE 2 - verification records within one week of
EQUIPMENT CHECKS preparation.
Records: Record of equipment inspections. • CONTROL STRATEGY EXAMPLE 2 -

EQUIPMENT CHECKS
of the HACCP Plan Form. Verification: Review monitoring and corrective
Enter the verification procedures in column 10 of the

HACCP Plan Form.
Chapter 20: Metal

255
TABLE #20-1
Control Strategy Example 1 - Metal detection or separation
This table is an example of a portion of a HACCP plan relating to the control of metal fragment inclusion for a processor of
frozen fish sticks, using Control Strategy Example 1 - Metal detection or separation. It is provided for illustrative purposes only.
Metal inclusion may be only one of several significant hazards for this product. Refer to Tables 3-1, 3-2, and 3-3 (Chapter 3)
for other potential hazards (e.g. chemical contaminants and Staphylococcus aureus toxin formation in the hydrated batter mix).
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
Metal detection Metal inclusion No detectable metal Presence of Metal detector Every finished Production • Destroy any Metal detector • Test metal
fragments in finished detectable metal product package, employee product rejected operation log detector with
product fragments in with operation by metal three test units
finished product check before detector before
Se start-up production each
• Identify source day, and
256
of metal found recalibrate if
eT
ex in product and needed
Chapter 20: Metal

fix damaged
equipment • Review
t f Exa
monitoring,
or mp
Fu le • If product is corrective
processed action and
without metal verification
ll R O
detection hold records within
for metal one week of
eco nly
mm detection preparation
en
da
tio
ns
TABLE #20-2
Control Strategy Example 2 - Equipment Checks
This table is an example of a portion of a HACCP plan relating to the control of metal fragment inclusion
for a processor of frozen tuna steaks, using Control Strategy Example 2 - Metal inclusion prevention procedures.
It is provided for illustrative purposes only. Metal inclusion may be only one of several significant hazards for this product.
Refer to Tables 3-1, 3-2, and 3-3 (Chapter 3) for other potential hazards (e.g. histamine and parasites).
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
Band saw Metal inclusion No damage to saw blade Check saw blade Visual Before start-up, Saw operator • Stop production Equipment Review
for damage every four hours maintenance log monitoring and
during operation, • Adjust corrective action
at end of day, and equipment records within
Se after equipment one week of
jam • Isolate product preparation
257
since last visual
eT
ex check
Chapter 20: Metal

• Hold product
t f Exa
until it can be
or mp
Fu le run through
metal detector
and destroy
ll R O
eco nly rejects
mm
en
da
tio
ns
Notes:
Chapter 20: Metal

258
Chapter 21: Glass Inclusion (A Physical Hazard)
DRAFT
This chapter is provided as draft guidance at this Under ordinary circumstances, it would be reason-
time. FDA requests that interested parties with ably likely to expect that glass fragments could enter
information on the hazard of glass inclusion and its the process during processing of any product that is
control provide comments on the content of the packed in a glass container. Likely areas of concern
chapter. for glass container breakage are:
Hazard Analysis Worksheet • Receiving;

• Storage, when cases are moved mechanically;
STEP #10: UNDERSTAND THE POTENTIAL • Mechanized Cleaning;
HAZARD. • Conveyor Lines;
• Mechanized Filling;
Glass fragments can cause injury to the consumer. • Hot-filling;
FDA’s Health Hazard Evaluation Board has sup- • Mechanized Capping;
ported regulatory action against products with glass • Pasteurizing.
fragments of 0.3” (7 mm) to 1.0” (25 mm) in length.
See FDA Compliance Policy Guide #555.425. 2. Can glass fragments from glass containers, which
were introduced at an earlier step, be eliminated or
Glass inclusion can occur whenever processing reduced to an acceptable level at this processing step?
involves the use of glass containers. Normal handling (Note: If you are not certain of the answer to this
and packaging methods, especially mechanized question at this time, you may answer “No.” How-
methods, can result in breakage. Most products ever, you may need to change this answer when you
packed in glass containers are intended as a ready-to- assign critical control points in Step 12.)
eat commodity.
“Glass inclusion” should also be considered a
The purpose of this chapter is to address only the significant hazard at any processing step where a
hazard of glass fragments that results from the use of preventive measure is or can be used to prevent or
glass containers. Glass fragments originating from eliminate the inclusion of glass fragments from glass
other sources must be addressed where applicable in containers, that have been introduced at a previous
a prerequisite sanitation program. The Seafood step, or is adequate to reduce the likelihood of
HACCP Regulation requires such a program. occurrence of the hazard to an acceptable level.
Preventive measures for “glass inclusion” can
include:
STEP #11: DETERMINE IF THIS
POTENTIAL HAZARD IS SIGNIFICANT. • Visual examination of empty glass containers;
• Cleaning (water or compressed air) and inverting
At each processing step, determine whether “glass empty glass containers;
inclusion” is a significant hazard. The criteria are: • Periodically monitoring processing lines for
evidence of glass breakage;
1. Is it reasonably likely that glass fragments from glass • Proper adjustment of capping equipment
containers will be introduced at this processing step (not a complete control);
(e.g. does it come in with the raw material or will the • Visual examination of glass containers containing
process introduce it)? transparent liquid fishery products;
• Passing the product through x-ray equipment or
other defect rejection system.
Continued
Chapter 21: Glass
259
List such preventive measures in Column 5 of the Will the containers be run through x-ray equipment
Hazard Analysis Worksheet at the appropriate or other defect rejection system, undergo visual
processing step(s). inspection for detection of glass fragments, or be
cleaned (water or compressed air) and inverted on or
If the answer to either question 1 or 2 is “Yes” the after the last step where glass inclusion is identified
potential hazard is significant at that step in the as a significant hazard?
process and you should answer “Yes” in Column 3 of
the Hazard Analysis Worksheet. If neither criterion is 1. If it will be, you may identify final glass detection or
met you should answer “No.” You should record the separation as the CCP. Processing steps prior to glass
reason for your “Yes” or “No” answer in Column 4. detection or separation will then not require control
You need not complete Steps 12 through 18 for this and will not need to be identified as CCPs for the
hazard for those processing steps where you have hazard of glass inclusion.
recorded a “No.”
In this case enter “Yes” in Column 6 of the Hazard
It is important to note that identifying this hazard as Analysis Worksheet for the glass detection or separa-
significant at a processing step does not mean that it tion step, and enter “No” for the other processing
must be controlled at that processing step. The next steps where “glass inclusion” was identified as a
step will help you determine where in the process the significant hazard. In addition, for each “No” entry,
critical control point is located. note in Column 5 that the hazard is controlled by the
glass detection or separation step. (Note: if you have
• Intended use not previously identified “glass inclusion” as a
significant hazard at the glass detection or separation
In determining whether a hazard is significant you step in Column 3 of the Hazard Analysis Worksheet,
should also consider the intended use of the product, you should change the entry in Column 3 to “Yes”.)
which you developed in Step 4. In most cases you This control approach will be referred to as “Control
should assume that the product will be consumed in a Strategy Example 1” in Steps 14 through 18.
way that would not eliminate any glass fragments
that may be introduced during the process. In this Example:
case, you would need to identify the hazard as A pickled herring processor that mechanically packs
significant if the above criteria are met. the product into glass jars could set the critical
control point for “glass inclusion” at the packaged
STEP #12: IDENTIFY THE CRITICAL product x-ray examination step, and would not need
CONTROL POINTS (CCP). to have critical control points for this hazard at each
of the steps at which there was a reasonable likeli-
For each processing step where “glass inclusion” is hood that glass fragments could be introduced.
identified in Column 3 of the Hazard Analysis
Worksheet as a significant hazard, determine whether Example:
it is necessary to exercise control at that step in order A processor that manually packs caviar into glass
to control the hazard. Figure A-2 (Appendix 3) is a jars has identified the glass container receiving and
CCP decision tree that can be used to aid you in your storage steps as the only steps that are reasonably
determination. likely to introduce glass fragments into the process.
The processor does not have finished product x-ray
The following guidance will also assist you in equipment. The processor manually inspects each
determining whether a processing step is a CCP for container during the filling process. The processor
“glass inclusion”: identifies the container inspection step as the CCP
for this hazard.
Chapter 21: Glass

260
Example: product that has moved through that area since the
Another processor that manually packs caviar into last inspection is placed on hold to be run through
glass jars has identified the glass container receiving off-line x-ray equipment. The processor identifies
and storage steps as the only steps that are reason- receiving, storage, mechanical conveying, mechani-
ably likely to introduce glass fragments into the cal filling, and mechanical capping as the CCP’s for
process. The processor does not have finished this hazard.
product x-ray equipment. Just before filling, the
empty glass jars are inverted and cleaned, using It is important to note that you may select a control
filtered, compressed air. The processor identifies the strategy that is different from those which are
container cleaning and inverting step as the CCP for suggested above, provided that it assures an equiva-
this hazard. lent degree of safety of the product.
You should recognize that by setting the critical Proceed to Step 13 (Chapter 2) or to Step 10 of the
control point at or near the end of the process, rather next potential hazard.
than at the point of potential glass fragment entry
into the process, you are likely to have more labor HACCP Plan Form
and materials invested in the product before the
problem is detected or prevented. STEP #14: SET THE CRITICAL LIMITS (CL).
2. If the containers will not be run through detection For each processing step where “glass inclusion” is
equipment, visually inspected, or cleaned and inverted identified as a significant hazard on the HACCP Plan
on or after the last step where “glass inclusion” is Form identify the maximum or minimum value to
identified as a significant hazard, you should have which a feature of the process must be controlled in
procedures to periodically check the processing areas order to control the hazard.
and equipment for glass breakage at each processing
step where “glass inclusion” is identified as a significant You should set the CL at the point that if not met the
hazard. In this case you should identify those process- safety of the product may be questionable. If you set
ing steps as CCPs. It would not ordinarily be necessary a more restrictive CL you could, as a result, be
to identify these steps as CCPs in addition to identifying required to take corrective action when no safety
a final glass detection or separation step as a CCP. concern actually exists. On the other hand, if you set
In this case, you should enter “Yes” in column 6 of unsafe product to reach the consumer.
the Hazard Analysis Worksheet for each of those
processing steps. This control approach will be As a practical matter it may be advisable to set an
referred to as “Control Strategy Example 2” operating limit that is more restrictive than the CL. In
in Steps 14 through 18. this way you can adjust the process when the operat-
ing limit is triggered, but before a triggering of the
Example: CL would require you to take corrective action. You
A processor bottles clam juice and has identified should set operating limits based on your experience
receiving, storage, mechanical conveying, mechani- with the variability of your operation and with the
cal filling, and mechanical capping, as processing closeness of typical operating values to the CL.
steps reasonably likely to introduce glass fragments
into the process. The processor does not have on-line Following is guidance on setting critical limits for the
x-ray equipment. The processor visually inspects all control strategy examples discussed in Step 12.
processing areas for broken glass at start-up and
once every four hours. If broken glass is observed,
the line is stopped, the glass is removed and the
Continued
Chapter 21: Glass
261
• CONTROL STRATEGY EXAMPLE 1 - Following is guidance on establishing monitoring
GLASS DETECTION OR SEPARATION procedures for the control strategy examples dis-
cussed in Step 12. Note that the monitoring frequen-
Critical Limit: No glass fragments in finished product. cies that are provided are intended to be considered
(Note: FDA’s Health Hazard Evaluation Board as minimum recommendations, and may not be
has supported regulatory action against products adequate in all cases.
with glass fragments of 0.3” [7 mm] to 1.0”
[25 mm] in length. See also FDA Compliance
Policy Guide #555.425.) What Will Be Monitored?
EQUIPMENT CHECKS GLASS DETECTION OR SEPARATION
Critical Limit: No broken glass at the CCPs for What: The presence of glass fragments in glass
“glass inclusion”. containers passing the CCP.
Enter the critical limit(s) in Column 3 of the HACCP • CONTROL STRATEGY EXAMPLE 2 -
Plan Form. EQUIPMENT CHECKS
STEP #15: ESTABLISH MONITORING What: The presence of broken glass on or near
PROCEDURES. equipment at the CCP’s.
For each processing step where “glass inclusion” is
Form, describe monitoring procedures that will How Will Monitoring Be Done?
To fully describe your monitoring program you GLASS DETECTION OR SEPARATION
monitored? 2) How will it be monitored? 3) How How: Use of x-ray equipment or other defect rejection
often will it be monitored (frequency)? 4) Who will system;
perform the monitoring? OR
Visual examination of empty glass containers;
It is important for you to keep in mind that the OR
feature of the process that you monitor and the Visual examination of glass containers
method of monitoring should enable you to deter- containing transparent liquid fishery products;
mine whether the CL is being met. That is, the OR
monitoring process should directly measure the Cleaning (water or compressed air) and inverting
feature for which you have established a CL. of empty glass containers.
You should monitor often enough so that the normal
typically close to the CL. Additionally, the greater the
time span between measurements the more product
you are putting at risk should a measurement show
that a CL has been violated.
Chapter 21: Glass

262
• CONTROL STRATEGY EXAMPLE 2 - Who Will Perform the Monitoring?
EQUIPMENT CHECKS
How: Visually check the glass handling areas for GLASS DETECTION OR SEPARATION
broken glass.
Who: For x-ray detection, other defect rejection systems,
Examples: glass separation equipment and visual examination,
• Check pallets and cases of empty jars for damage, monitoring is performed by the equipment itself
broken jars, and glass fragments; or by properly trained and qualified inspection
• Check mechanical glass cleaning equipment and personnel. A check should be made at least once
surrounding floors for broken glass; per day to ensure that the device is operating or
• Check floors around conveyors for broken glass; that the appropriate personnel are on hand. This
• Check filling and capping equipment and check may be performed by the equipment
surrounding floors for broken glass; operator, a production supervisor, a member of
• Check hot-filling and pasteurizing equipment and the quality control staff, a member of the
surrounding floors for broken glass. maintenance or engineering staff, or any other
person who has an understanding of the operation
of the equipment or the staffing needs.
(Frequency)? • CONTROL STRATEGY EXAMPLE 2 -
EQUIPMENT CHECKS
GLASS DETECTION OR SEPARATION Who: Monitoring may be performed by the
equipment operator, a production supervisor, a
Frequency: Continuous. Each container is subjected member of the quality control staff, a member of
to detection or separation. For x-ray equipment, the maintenance or engineering staff, production
other defect rejection systems and glass separation personnel, or any other person who has a
equipment, check that the device is operating at thorough understanding of the proper condition
least at the start of each production day. For of the equipment and surrounding area. In
visual inspection, check that appropriate assigning responsibility for
personnel are assigned to the processing step at this monitoring function you
the start of each production day. should consider the complexity of the equipment
and the level of understanding necessary to
• CONTROL STRATEGY EXAMPLE 2 - evaluate its condition.
EQUIPMENT CHECKS
Frequency: Check before starting operations each day; monitoring information in Columns 4, 5, 6, and 7,
AND respectively, of the HACCP Plan Form.
Check at least every four hours during operation;
Check at the end of operations each day; ACTION PROCEDURES.
AND
Check whenever there is an equipment or other For each processing step where “glass inclusion” is
malfunction that could increase the likelihood identified as a significant hazard on the HACCP Plan
that glass containers could be damaged. Form, describe the procedures that you will use when
your monitoring indicates that the CL has not been met.
Continued
Chapter 21: Glass
263
These procedures should: 1) ensure that unsafe OR
product does not reach the consumer; and, 2) correct • Divert all product produced since controls
the problem that caused the CL deviation. Remember were last confirmed as functioning properly to
that deviations from operating limits do not need to a non-food use;
result in formal corrective actions. AND
• Repair or replace the glass detection or
Following is guidance on establishing corrective separation equipment.
discussed in Step 12. • CONTROL STRATEGY EXAMPLE 2 -
EQUIPMENT CHECKS
GLASS DETECTION OR SEPARATION Corrective Action: Take one of the following
corrective actions to regain control over the
Corrective Action: Take the following corrective operation after a CL deviation:
actions to regain control over the operation after • Stop production;
a CL deviation: AND
• Stop operations and attempt to locate and • If necessary, adjust or modify the materials,
correct the source of the glass fragments; equipment and/or processes to reduce the risk
AND of recurrence;
• Make adjustments to the materials, equipment, AND
and/or process, as needed, to prevent future • Remove all broken glass from the equipment
introduction of glass fragments; and surrounding area;
AND AND
Take one of the following corrective actions to Take one of the following actions to the product
product in which glass fragments were involved in the critical limit deviation:
detected: • Destroy all product produced since the
• Destroy the product; previous satisfactory equipment check;
OR OR
• Rework the product to eliminate the glass • Hold all product produced since the previous
fragments; satisfactory equipment check until it can be
OR examined by x-ray equipment or other defect
• Divert the product to non-food use; rejection system, or visual inspection if
OR appropriate;
• Hold and evaluate the product; OR
AND • Divert all product produced since the previous
Take one of the following corrective actions satisfactory equipment check to a non-food use.
when product is processed without properly
functioning glass detection or separation equipment Enter the corrective action procedures in Column 8 of
or without proper visual inspection: the HACCP Plan Form.
• Destroy all product produced since controls
were last confirmed as functioning properly;
OR
• Hold all product produced since controls were
last confirmed as functioning properly until it
can be examined by x-ray equipment or other
defect rejection system, or visual inspection,
where appropriate;
Chapter 21: Glass

264
SYSTEM. PROCEDURES.
For each processing step where “glass inclusion” is For each processing step where “glass inclusion” is
identified as a significant hazard on the HACCP Plan identified as a significant hazard on the HACCP Plan
the accomplishment of the monitoring procedures ensure that the HACCP plan is: 1) adequate to
discussed in Step 15. The records should clearly address the hazard of glass inclusion; and, 2) consis-
demonstrate that the monitoring procedures have tently being followed.
been followed, and should contain the actual values
and observations obtained during monitoring. Following is guidance on establishing verification
Following is guidance on establishing a cussed in Step 12.
amples discussed in Step 12. • CONTROL STRATEGY EXAMPLE 1 -
GLASS DETECTION OR SEPARATION
GLASS DETECTION OR SEPARATION Verification: Test the effectiveness of the x-ray
equipment, other defect reject system or glass
Records: Records documenting that the glass detection separation equipment at least once per day,
or separation device is operating, or that glass before start of operations;
inspection personnel are assigned to the AND
processing step, as appropriate. Review monitoring, corrective action and
verification records within one week of preparation.
EQUIPMENT CHECKS • CONTROL STRATEGY EXAMPLE 2 -
EQUIPMENT CHECKS
Records: Records of equipment and processing area
inspection results. Verification: Review monitoring and corrective action
records within one week of preparation.
of the HACCP Plan Form. Enter the verification procedures in column 10 of the
HACCP Plan Form.
Chapter 21: Glass

265
TABLE #21-1
Control Strategy Example 1 - Glass Detection or Separation
This table is an example of a portion of a HACCP plan relating to the control of glass inclusion for a processor of pickled herring
in glass jars, using Control Strategy Example 1 - Glass Detection or Separation. It is provided for illustrative purposes only.
Glass inclusion may be only one of several significant hazards for this product. Refer to Tables 3-1, 3-2, 3-3 (Chapter 3)
for other potential hazards (e.g., parasites, histamine, chemical contaminants, unapproved food & color additives,
metal fragments, Clostridium botulinum toxin formation, and pathogen growth as a result of temperature abuse).
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
X-ray equipment Glass inclusion No detectable glass Presence of X-ray device Every finished Production • Destroy any X-ray operation • Test x- ray
fragments in finished detectable glass product package, employee product rejected log device before
product fragments in with operation by x-ray production each
finished products check before equipment day, and
Se startup recalibrate if
AND needed
266
eT
ex • Stop operations • Review
Chapter 21: Glass

and identify monitoring,
source of glass corrective
t f Exa
found in product action and
or mp
Fu le and fix damaged verification
equipment records within
one week of
ll R O
eco nly AND preparation.
• If product is
processed
mm
without x-ray
equipment, hold
en
for detection by
da
tio off-line x-ray
ns equipment
TABLE #21-2
Control Strategy Example 2 - Equipment Checks
This table is an example of a portion of a HACCP plan relating to the control of glass inclusion for a processor of clam juice in
glass jars, using Control Strategy Example 2 – Equipment checks. It is provided for illustrative purposes only. Glass inclusion may
be only one of several significant hazards for this product. Refer to Tables 3-1, 3-2, and 3-3 (Chapter 3) for other potential hazards
(e.g., pathogens from the harvest area, chemical contaminants, natural toxins, unapproved food & color additives, and metal fragments)
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
Receiving Glass inclusion No broken glass on Presence of Visual Each pallet of Receiving • Reject pallets Receiving report Review
pallets of empty jars broken glass or jars personnel with more than 3 monitoring and
physical damage damaged cases or corrective action
to cases with broken jars. records within
• Isolate pallets one week of
with 1 to 3 preparation.
Se
damaged cases
267
and open and
eT
ex inspect all cases.
• Reject cases that
Chapter 21: Glass

contain broken
t f Exa
or mp glass.
Fu le
Mechanical Glass Inclusion No broken glass at the Broken glass on Visual Before start-up, Capper operator • Stop production Equipment Review
filling and filler/capper station & around filler/ every 4 hours maintenance log monitoring and
ll R O
capping capper station during operation, AND corrective action
after breaks, and • Adjust capping records within
eco nly
after equipment equipment one week of
jams. preparation
mm
AND
• Isolate and hold
en
da product since
last satisfactory
check until it
tio
ns can be run
through off-line
x-ray and
destroy rejects
AND
• Remove broken
glass from area.
Note: Storage and conveying of empty jars are not identified as CCPs because cases of empty jars are handled manually, without forklifts or mechanized conveyors
Notes:
Chapter 21: Glass

268
Appendix 1: Forms
This appendix contains a blank model HACCP Plan Form and a blank model Hazard Analysis Worksheet.
Continued
Appendix 1: Forms
269
HACCP Plan Form
Firm Name: Product Description:
Firm Address: Method of Storage and Distribution:
Intended Use and Consumer:
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)

Measure
What How Frequency Who
Signature of Company Official: Date:
Page 1 of _____
HACCP Plan Form
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)

Measure
What How Frequency Who
Page _____of _____

Hazard-Analysis Worksheet
Firm Name: Product Description:
Firm Address: Method of Storage and Distribution:
Intended Use and Consumer:
(1) (2) (3) (4) (5) (6)
Ingredient/processing step Identify potential hazards Are any Justify your decisions What preventative measures Is this step
introduced, controlled or potential for column 3. can be applied to prevent a critical
enhanced at this step(1) food-safety the significant hazards? control
hazards point?
significant? (Yes/No)
(Yes/No)
Biological
Chemical
Physical
Biological
Chemical
Physical
Biological
Chemical
Physical
Biological
Chemical
Physical
Page 1 of _____
Hazard-Analysis Worksheet
(1) (2) (3) (4) (5) (6)
Ingredient/processing step Identify potential hazards Are any Justify your decisions What preventative measures Is this step
introduced, controlled or potential for column 3. can be applied to prevent a critical
enhanced at this step(1) food-safety the significant hazards? control
hazards point?
significant? (Yes/No)
(Yes/No)
Biological
Chemical
Physical
Biological
Chemical
Physical
Biological
Chemical
Physical
Biological
Chemical
Physical
Biological
Chemical
Physical
Page _____ of _____

Notes:
Appendix 1: Forms
274
Appendix 2: Sample Product Flow Diagram
This appendix contains a sample product flow diagram that can be used as a model when you develop your
own flow diagram.
Continued
Appendix 2: Flow Diagram
275
FIGURE #A-1
Sample Product Flow Diagram (Salmon Fillets)
Receiving Freeze
Fish Pump Glaze
Sort Weigh/Package
Refrigerated Storage Frozen Storage
Head Ship
Gut
Wash
Fillet
Inspect
Appendix 2: Flow Diagram

276
Appendix 3: CCP Decision Tree
This appendix contains a decision tree that may be used to assist you in the identification of critical control
points. You should not rely exclusively on the decision tree, as error may result.
The decision tree is derived from that developed by the National Advisory Committee on Microbiological
Criteria for Foods (NACMCF).
Continued
Appendix 3: Decision Tree
277
FIGURE #A-2
CCP Decision Tree
Q1. Does this step involve a hazard of sufficient risk and severity
to warrant its control?
▼ ▼
Yes No Not a CCP
▼
▼
Q2. Does a control measure for the hazard exist at this step?
▼
▼ ▼
Yes No Modify the step,

process or
product
▼
Is control
at this step
necessary Yes
▼
for safety?
No Not a CCP Stop*

▼
Q3. Is control at this step necessary to prevent, eliminate or reduce

the risk of the hazard to consumers?
▼ ▼
Yes No Not a CCP Stop*

▼
CCP
* Proceed to the next step in process.
Appendix 3: Decision Tree

278
Appendix 4: Bacterial Pathogen Growth and Inactivation
This appendix contains information on the growth It is not possible to furnish recommendations for
and inactivation of bacterial pathogens. each pathogen, process, type of seafood, and tem-
perature or combination of temperatures. Program-
Table #A-1 contains information on: the minimum mable models to predict growth rates for certain
water activity (aw), acidity (pH), and temperature; pathogens associated with various foods under
the maximum, pH, water phase salt, and temperature; differing conditions have been developed by the U.S.
and oxygen requirements that will sustain growth for Department of Agriculture (“Pathogen Modeling
the bacterial pathogens that are of greatest concern in Program” [PMP]) and the United Kingdom (“Food
seafood processing. Data shown are the minimum or MicroModel” [FMM]). These programs can provide
maximum values, the extreme limits reported among growth curves for selected pathogens. You indicate
the references cited. These values may not apply to the conditions, such as pH, temperature, and salt
your processing conditions. concentration that you are interested in and the
models provide pathogen growth predictions
Table #A-2 contains information on maximum, (e.g., growth curve, time of doubling, time of lag
cumulative time/internal temperature combinations phase, generation time). FDA does not endorse or
for exposure of fish and fishery products that, under require the use of such modelling programs, but
ordinary circumstances, will be safe for the bacterial recognizes that the predictive growth information
pathogens that are of greatest concern in seafood they provide may be of assistance to some proces-
processing. These maximum, cumulative exposure sors. However, you are cautioned that significant
times are derived from published scientific informa- deviations between actual microbiological data in
tion. Because the nature of bacterial growth is specific products and the predictions do occur,
logarithmic, linear interpolation using the time/ including those for the lag phase of growth. There-
temperature guidance is not appropriate. fore, you should validate the time-temperature limits
derived from such predictive models.
In summary, the table indicates that:
Table #A-3 contains information on the destruction
• If the product is held at internal temperatures above of Listeria monocytogenes. Lethal rate, as used in
70˚F (21˚C) during processing, exposure time should this table, is the relative lethality of one minute at the
ordinarily be limited to two hours (three hours if designated internal product temperature as compared
Staphylococcus aureus is the only pathogen of to the lethality of one minute at the reference internal
concern); product temperature of 158˚F (70˚C) (i.e. z = 13.5˚F
[7.5˚C]). For example, one minute at 145˚F (63˚C) is
• If the product is held at internal temperatures above 0.117 times as lethal as one minute at 158˚F (70˚C).
50˚F (10˚C), but not above 70˚F (21˚C), exposure The times provided are the length of time at the
time should ordinarily be limited to six hours (twelve designated internal product temperature necessary to
hours if Staphylococcus aureus is the only pathogen deliver a 6D process for L. monocytogenes. The
of concern); length of time at a particular internal product tem-
perature needed to accomplish a six logarithm
• If the product is held at internal temperatures both reduction in the number of L. monocytogenes (6D) is,
above and below 70˚F (21.1˚C), exposure times in part, dependent upon the food in which it is being
above 50˚F (10˚C) should ordinarily be limited to 4 heated. The values in the table are generally conser-
hours, as long as no more than 2 of those hours are vative and apply to all foods. You may be able to
above 70˚F (21.1˚C). establish a shorter process time for your food by
Continued
Appendix 4: Pathogen Tables
279
conducting scientific thermal death time studies. above 194˚F [90˚C] z = 18˚F [10˚C];). The times
Additionally, lower degrees of destruction may be provided are the length of time at the designated
acceptable in your food if supported by a scientific internal product temperature necessary to deliver a
study of the normal innoculum in the food. 6D process for C. botulinum. The values in the table
are generally conservative. However, they may not be
Table #A-4 contains information on the destruction sufficient for the destruction of nonproteolytic C.
of Clostridium botulinum type B (the most heat botulinum in dungeness crabmeat, because of the
resistant form of nonproteolytic Clostridium botuli- potential protective effect of lysozyme. You may be
num). Lethal rate, as used in this table, is the relative able to establish a shorter process time for your food
lethality of one minute at the designated internal by conducting scientific thermal death time studies.
product temperature as compared to the lethality of Additionally, lower degrees of destruction may be
one minute at the reference product internal tempera- acceptable in your food if supported by a scientific
ture of 194˚F (90˚C) (i.e. for temperatures less than study of the normal innoculum in the food.
194˚F [90˚C] z = 12.6˚F [7.0˚C]; for temperatures

280
Table #A-1
Limiting Conditions for Pathogen Growth
Pathogen min. aw min. pH max. pH max.% water min. temp. max. temp. oxygen requirement
(using salt) phase salt
Bacillus cereus .92 4.3 9.3 10 39.2˚F 131˚F**** aerobe

4˚C 55˚C
Campylobacter jejuni .987 4.9 9.5 1.5 86˚F 113˚F micro-
30˚C 45˚C aerophilic*
Clostridium botulinum,
type A, and proteolytic B and F .935 4.6 9 10 50˚F 118.4˚F anaerobe**
10˚C 48˚C
Clostridium botulinum,
type E, and nonproteolytic B and F .97 5 9 5 37.9˚F 113˚F anaerobe**
3.3˚C 45˚C
Clostridium perfringens .93 5 9 7 50˚F 125.6˚F anaerobe**
10˚C 52˚C
pathogenic strains of .95 4 9 6.5 43.7˚F 120.9˚F facultative anaerobe***
Escherichia coli 6.5˚C 49.4˚C
281
Listeria monocytogenes .92 4.4 9.4 10 31.3˚F 113˚F facultative anaerobe***
-0.4˚C 45˚C
Salmonella spp. .94 3.7 9.5 8 41.4˚F 115.2˚F facultative anaerobe***

5.2˚C 46.2˚C
Shigella spp. .96 4.8 9.3 5.2 43˚F 116.8˚F facultative anaerobe***
6.1˚C 47.1˚C
Staphylococcus aureus – growth .83 4 10 20 44.6˚F 122˚F facultative anaerobe***
7˚C 50˚C
Staphylococcus aureus – toxin .85 4 9.8 10 50˚F 118˚F
10˚C 48˚C
Vibrio cholerae .97 5 10 6 50˚F 109.4˚F facultative anaerobe***
10˚C 43˚C
Vibrio parahaemolyticus .94 4.8 11 10 41˚F 113.5˚F facultative anaerobe***
5˚C 45.3˚C
Vibrio vulnificus .96 5 10 5 46.4˚F 109.4˚F facultative anaerobe***
8˚C 43˚C
Yersinia enterocolitica .945 4.2 10 7 29.7˚F 107.6˚F facultative anaerobe***
-1.3˚C 42˚C
* requires limited levels of oxygen ** requires the absence of oxygen *** grows either with or without oxygen **** growth significantly delayed (>24 hr.) at 131˚F (55˚C)
Table #A-2
Time/Temperature Guidance for Controlling Pathogen Growth and Toxin Formation in Seafoods
Potentially Hazardous Product Maximum Cumulative

Condition Temperature Exposure Time
Growth and toxin formation by 39.2-43˚F (4-6˚C) 5 days

Bacillus cereus 44-50˚F (7-10˚C) 17 hours*
51-70˚F (11-21˚C) 6 hours*
Above 70˚F (above 21˚C) 3 hours
Growth of Campylobacter jejuni 86-93˚F (30-34˚C) 48 hours

Germination, growth, and toxin 50-70˚F (10-21˚C) 11 hours

formation by Clostridium botulinum type A, Above 70˚F (above 21˚C) 2 hours
and proteolytic B and F
Germination, growth, and toxin formation 37.9-41˚F (3.3-5˚C) 7 days

by Clostridium botulinum type E, 42-50˚F (6-10˚C) > 2 days
and nonproteolytic B and F 51-70˚F (11-21˚C) 11 hours
Growth of Clostridium 50-54˚F (10-12˚C) 21 days

perfringens 55-57˚F (13-14˚C) 1 day
58-70˚F (15-21˚C) 6 hours*
Above 70˚F (above 21˚C) 2 hours*
Growth of pathogenic strains of 44.6-50˚F (7-10˚C) 14 days

Escherichia coli 51-70˚F (11-21˚C) 6 hours
Growth of Listeria monocytogenes 31.3-41˚F (-0.4-5˚C) 7 days

42-50˚F (6-10˚C) 2 days
51-70˚F (11-2˚C) 12 hours*
Growth of Salmonella species 41.4-50˚F (5.2-10˚C) 14 days

51-70˚F (11-21˚C) 6 hours
Growth of Shigella species 43-50o˚F (6.1-10˚C) 14 days*

51-70˚F (11-21˚C) 12 hours*
Growth and toxin formation by 44.6-50˚F (7-10˚C) 14 days

Staphylococcus aureus 51-70˚F (11-21˚C) 12 hours*
Growth of Vibrio cholerae 50˚F (10˚C) 21 days

51-70˚F (11-21˚C) 6 hours*
Growth of Vibrio parahaemolyticus 41-50˚F (5-10˚C) 21 days

51-70˚F (11-21˚C) 6 hours*
Growth of Vibrio vulnificus 46.4-50˚F (8-10˚C) 21 days

51-70˚F (11-21˚C) 6 hours
Growth of Yersinia enterocolitica 29.7-50˚F (-1.3-10˚C) 1 days

51-70˚F (11-21˚C) 6 hours
Above 70˚F (above 21˚C) 2.5 hours
* Additional data needed.

282
Table #A-3
Inactivation of Listeria monocytogenes
Internal Product Internal Product Time for 6D

Temperature (˚F) Temperature (˚C) Lethal Rate Process (minutes)
145 ...................................................... 63 ........................................................ 0.117 ............................................... 17.0

147 ...................................................... 64 ........................................................ 0.158 ............................................... 12.7
149 ...................................................... 65 ........................................................ 0.215 ................................................. 9.3
151 ...................................................... 66 ........................................................ 0.293 ................................................. 6.8
153 ...................................................... 67 ........................................................ 0.398 ................................................. 5.0
154 ...................................................... 68 ........................................................ 0.541 ................................................. 3.7
156 ...................................................... 69 ........................................................ 0.736 ................................................. 2.7
158 ...................................................... 70 ........................................................ 1.000 ................................................. 2.0
160 ...................................................... 71 ........................................................ 1.359 ................................................. 1.5
162 ...................................................... 72 ........................................................ 1.848 ................................................. 1.0
163 ...................................................... 73 ........................................................ 2.512 ................................................. 0.8
165 ...................................................... 74 ........................................................ 3.415 ................................................. 0.6
167 ...................................................... 75 ........................................................ 4.642 ................................................. 0.4
169 ...................................................... 76 ........................................................ 6.310 ................................................. 0.3
171 ...................................................... 77 ........................................................ 8.577 ................................................. 0.2
172 ...................................................... 78 ...................................................... 11.659 ................................................. 0.2
174 ...................................................... 79 ...................................................... 15.849 ................................................. 0.1
176 ...................................................... 80 ...................................................... 21.544 ................................................. 0.09
178 ...................................................... 81 ...................................................... 29.286 ................................................. 0.07
180 ...................................................... 82 ...................................................... 39.810 ................................................. 0.05
182 ...................................................... 83 ...................................................... 54.116 ................................................. 0.03
183 ...................................................... 84 ...................................................... 73.564 ................................................. 0.03
185 ...................................................... 85 .................................................... 100.000 ................................................. 0.02
Note: z = 13.5˚F (7.5˚C)
Table #A-4
Inactivation of nonproteolytic Clostridinum botulinum type B
Internal Product Internal Product Time for 6D

Temperature (˚F) Temperature (˚C) Lethal Rate* Process (minutes)
185 ...................................................... 85 ........................................................ 0.193 ............................................... 51.8

187 ...................................................... 86 ........................................................ 0.270 ............................................... 37.0
189 ...................................................... 87 ........................................................ 0.370 ............................................... 27.0
190 ...................................................... 88 ........................................................ 0.520 ............................................... 19.2
192 ...................................................... 89 ........................................................ 0.720 ............................................... 13.9
194 ...................................................... 90 ........................................................ 1.000 ............................................... 10.0
196 ...................................................... 91 ........................................................ 1.260 ................................................. 7.9
198 ...................................................... 92 ........................................................ 1.600 ................................................. 6.3
199 ...................................................... 93 ........................................................ 2.000 ................................................. 5.0
201 ...................................................... 94 ........................................................ 2.510 ................................................. 4.0
203 ...................................................... 95 ........................................................ 3.160 ................................................. 3.2
205 ...................................................... 96 ........................................................ 3.980 ................................................. 2.5
207 ...................................................... 97 ........................................................ 5.010 ................................................. 2.0
208 ...................................................... 98 ........................................................ 6.310 ................................................. 1.6
210 ...................................................... 99 ........................................................ 7.940 ................................................. 1.3
212 .................................................... 100 ...................................................... 10.000 ................................................. 1.0
Note: for temperatures less than 194˚F [90˚C] z = 12.6˚F [7.0˚C]; for temperatures above 194˚F [90˚C] z = 18˚F [10˚C].
*Note: these lethal rates and process times may not be sufficient for the destruction of nonproteolytic C. botulinum
in dungeness crabmeat, because of the potential that substances that may be naturally present, such as lysozyme,
may enable the pathogen to more easily recover from heat damage.

283
Notes:

284
Appendix 5: FDA & EPA Safety Levels in Regulations and Guidance
This appendix contains a listing of FDA and EPA levels relating to safety attributes of fish and fishery products
published in regulations and guidance. In many cases, these levels represent the point at or above which the
agency will take legal action to remove products from the market. Consequently, the levels contained in this
table may not always be suitable for critical limits.
Continued
Appendix 5: Guidance Levels
285
Table #A-5
FDA & EPA Safety Levels in Regulations and Guidance
Product Level Reference
Ready to eat fishery products Enterotoxigenic Escherichia coli Compliance Program 7303.842
(minimal cooking by consumer) (ETEC) - 1 x 103 ETEC/g, LT or ST positive.
Ready to eat fishery products Listeria monocytogenes - presence of organism. Compliance Program 7303.842
(minimal cooking by consumer)
All fish Salmonella species- presence of organism. Sec 555.300

Compliance Policy Guide
All fish Staphylococcus aureus - 1. positive for Compliance Program 7303.842

staphylococcal enterotoxin, or
2. Staphylococcus aureus level is equal to or
greater than 104/g (MPN).
Ready to eat fishery products Vibrio cholerae - presence of toxigenic 01 Compliance Program 7303.842
(minimal cooking by consumer) or non-01.
Ready to eat fishery products Vibrio parahaemolyticus - levels equal to or greater Compliance Program 7303.842
(minimal cooking by consumer) than 1 x 104/g (Kanagawa positive or negative).
Ready to eat fishery products Vibrio vulnificus - presence of pathogenic organism. Compliance Program 7303.842
(minimal cooking by consumer)
All fish Clostridium botulinum - 1. Presence of viable spores Compliance Program 7303.842
or vegetative cells in products that will support their
growth; or
2. Presence of toxin.
Clams and oysters, and mussels Microbiological - 1. E. coli - MPN of 230/100 grams Sec 560.600
fresh or frozen - imports (average of subs or 3 or more of 5 subs); or Compliance Policy Guide
2. APC - 500,000/gram (average of subs or 3 or more
of 5 subs).
Clams, oysters, and mussels, Microbiological - 1. E. coli or fecal coliform - 1 or more Compliance Program 7303.842
fresh or frozen - domestic of 5 subs exceeding MPN of 330/100 grams or 2 or more
exceeding 230/100 grams; or
2. APC - 1 or more of 5 subs exceeding 1,500,000/gram
or 2 or more exceeding 500,000/gram.
Salt-cured, air-dried Not permitted in commerce Sec 540.650

uneviscerated fish (Note: small fish exemption). Compliance Policy Guide
Tuna, mahi mahi, Histamine - 500 ppm based on toxicity. 50 ppm Sec 540.525
and related fish defect action level, because histamine is generally Compliance Policy Guide
not uniformly distributed in a decomposed fish. Therefore, if
50 ppm is found in one section, there is the possibility
that other units may exceed 500 ppm.
Note: the term “fish” refers to fresh or saltwater fin fish, crustaceans,
other forms of aquatic animal life other than birds or mammals, and all mollusks, as defined in 21 CFR 123.3(d).

286
All fish Polychlorinated Biphenyls (PCBs) - 2.0 ppm 21 CFR 109.30

(edible portion)*.
Fin fish and shellfish Aldrin and dieldrin - 0.3 ppm (edible portion). Sec 575.100
Frog legs Benzene Hexachloride - 0.3 ppm (edible portion). Sec 575.100
All fish Chlordane - 0.3 ppm (edible portion). Sec 575.100

All fish Chlordecone - 0.4 ppm in crabmeat and 0.3 ppm Sec 575.100
in other fish (edible portion). Compliance Policy Guide
All fish DDT, TDE and DDE - 5.0 ppm (edible portion). Sec 575.100
All fish Heptachlor and heptachlor epoxide - 0.3 ppm Sec 575.100
(edible portion). Compliance Policy Guide
All fish Mirex - 0.1 ppm (edible portion). Sec 575.100

All fish Diquat - 0.1 ppm*. 40 CFR 180.226
Fin fish and crayfish Fluridone - 0.5 ppm*. 40 CFR 180.420
Fin fish Glyphosate - 0.25 ppm*. 40 CFR 180.364
Shellfish Glyphosate - 3.0 ppm*. 40 CFR 180.364
Fin fish Simazine - 12 ppm*. 40 CFR 180.213a
All fish 2,4-D - 1.0 ppm*. 40 CFR 180.142
Salmonids, catfish and lobster Oxytetracycline - 2.0 ppm 21 CFR 556.500
All fish Sulfamerazine - no residue permitted. 21 CFR 556.660
Salmonids and catfish Sulfadimethoxine/ormetoprim combination - 0.1 ppm. 21 CFR 556.640
All fish Unsanctioned drugs** – no residue permitted Sec 615.200

Crustacea Toxic elements: 76 ppm arsenic; 3 ppm cadmium; FDA Guidance Document
12 ppm chromium; 1.5 ppm lead; 70 ppm nickel.
* These values are tolerances.

** Sanctioned drugs are approved drugs and drugs used under an INAD. See Chapter 11 for additional information.
Note: the term “fish” refers to fresh or saltwater fin fish, crustaceans, other forms of aquatic animal life other than birds or mammals, and all mollusks, as defined in 21 CFR 123.3(d).

287
Clams, oysters, and mussels Toxic elements: 86 ppm arsenic; 4 ppm cadmium; 13 ppm FDA Guidance Documents
chromium; 1.7 ppm lead; 80 ppm nickel.
All fish Methyl mercury – 1.0 ppm*** Sec 540.600

All fish Paralytic shellfish poison - 0.8 ppm (80ug/100g) Sec 540.250 Compliance Policy
saxitoxin equivalent. Guide, and Compliance Program
7303.842
Clams, mussels and oysters, Neurotoxic shellfish poison - 0.8 ppm (20 mouse units/ National Shellfish Sanitation
fresh, frozen or canned 100 gram) brevetoxin-2 equivalent. Program Manual of Operations
All fish Amnesic shellfish poison - 20 ppm domoic acid, Compliance Program 7303.842
except in the viscera of dungeness crab,
where 30 ppm is permitted.
All fish Hard or sharp foreign object - generally 0.3 [7mm] Sec 555.425 Compliance Policy
to 1.0 [25mm] in length Guide
*** See Chapter 10 for additional information
Note: the term “fish” refers to fresh or saltwater fin fish, crustaceans,
other forms of aquatic animal life other than birds or mammals, and all mollusks, as defined in 21 CFR 123.3(d).

288
Appendix 6: Food Allergens
Following is a listing, for which there is general scientific consensus, of the most common food allergens
that can pose a health risk to certain sensitive individuals (Sec. 555.250 Compliance Policy Guide):
• Allergens
Peanuts
Soybeans
Milk
Eggs
Fish
Crustacea
Tree nuts
Wheat

289
Notes:

290
Appendix 7: Bibliography
The general reference section contains citations that • U.S. Food and Drug Administration. 2000.
are applicable to this guidance in general. Of par- National Shellfish Sanitation Program, Guide for the
ticular interest is the reference for the Federal Control of Molluscan Shellfish. DHHS/PHS/FDA/
Register of December 18, 1995, which itself lists Office of Seafood, Washington, D.C.
over 200 citations. References listed for each chapter
specifically pertain to the information contained in • U.S. Food and Drug Administration. 1997. Code
that chapter. of Federal Regulations. 21 CFR Parts 123 and 1240,
Procedures for the Safe and Sanitary Processing and
• General References Importing of Fish and Fishery Products. DHHS/
PHS/FDA/Office of Seafood, Washington, D.C.
• Ahmed, F.E. (ed). 1991. Seafood Safety. National [Originally published in: Federal Register, Monday,
Academy Press, Washington, D.C. 432 p. December 18, 1995, Part II, Department of Health
and Human Services, Food and Drug Administration,
• Molluscan Shellfish Steering Committee, NMFS. 21 CFR Parts 123 and 1240, Procedures for the Safe
1990. Model Seafood Surveillance Project. NOAA/ and Sanitary Processing and Importing of Fish and
National Marine Fisheries Service, Office of Trade Fishery Products; Final Rule].
and Industry Services, Washington, D.C.
• U.S. Food and Drug Administration. 1997.
• National Advisory Committee on Microbiological Food Code. DHHS/PHS/FDA, Washington, DC.
Criteria for Foods (NACMCF). 1992. Hazard
Analysis and Critical Control Point System. Intl. J. • U.S. Food and Drug Administration. 1997.
Food Microbiol. 16:1-23. Foodborne Pathogenic Microorganisms and
Natural Toxins. Available at internet site:
• Pierson, M.D. and D.A. Corlett, Jr., (eds). HACCP; http://vm.cfsan.fda.gov/list.html.
Principles and Applications. Van Nostrand Reinhold,
New York. • U.S. Food and Drug Administration. 1989.
Federal Food, Drug, and Cosmetic Act. HHS
• Natl. Research Council, Committee on Food Publication No. (FDA) 89-1051. DHHS/PHS/U.S.
Protection, Subcomm. on Microbiol. Criter. 1985. Food and Drug Administration, Washington, D.C.
An Evaluation of the Role of Microbiological
Criteria for Foods and Food Ingredients. National • Chapter 4: Pathogens – Receiving
Academy Press, Washington, D.C.
• Savage, R.A. 1995. Hazard analysis critical control National Shellfish Sanitation Program, Guide for the
point: a review. Food Rev. Int’l. 11:575-595. Control of Molluscan Shellfish. DHHS/PHS/FDA/
Office of Seafood, Washington, D.C.
Continued
291
• Chapter 5: Parasites • Deardorff, T.L. and R.M. Overstreet. 1990. Sea-
food-transmitted zoonoses in the United States: the
• Adams, A.M., K.D. Murrell, and J.H. Cross. 1997. fish, the dishes and the worms, p. 211-265. In (Ward,
Parasites of fish and risks to public health. Rev. sci. D. and C.R. Hackney, eds.) Microbiology of Marine
tech. Off. Int. Epiz. 16(2):652-660. Food Products, Van Nostrand and Reinhold, New
York, NY.
• Agersborg, H.P.K. 1918. Nematodes in marketable
fishes. Science 48:493-495. • Deardorff, T.L., R.B. Raybourne, and R.S.
Desowitz. 1984. Behavior and viability of third-
• American Gastroenterological Association (AGS). stage larvae of Terranova sp. (Type HA) and Anisakis
2000. Determination of the incidence of gastrointes- simplex (type I) under coolant conditions. J. Food
tinal parasitic infections from the consumption of raw Protect. 47(1):49-52.
seafood in the U.S. [Report under FDA Contract 223-
97-2328 with Life Sciences Research Office, Ameri- • Deardorff, T.L. and R. Throm. 1988. Commercial
can Society for Nutritional Sciences]. AGN, blast-freezing of third-stage Anisakis simplex larvae
Bethesda, MD. 9 p. encapsulated in salmon and rockfish. J. Parasit
74(4):600-603.
• Baylis, H.A. 1944. Capsularia marina and the
Ascaridae of marine hosts. Parasitol. 36:119-121. • Eckert, J. 1996. Workshop summary: food safety:
meat- and fish-borne zoonoses. Vet. Parasitol.
• Berland, B. 1961. Nematodes from some 64:143-147.
Norwegian marine fishes. Sarsia 2:1-50.
• Eslami, A. and B. Mokhayer. 1997. Nematode
• Bier, J.W. 1988. Anisakiasis. In Balows, A., W.J. larvae of medical importance found in market fish in
Hausler, Jr., M. Ohashi, and A. Turano (eds), Iran. Pahlavi Medical Journal 8:345-348.
Laboratory Diagnosis of Infectious Diseases, Vol. I.
Springler-Verlag, New York. • Gardner, M.A. 1990. Survival of Anisakis in cold-
smoked salmon. Can. Inst. Food Sci. Technol. J.
• Bouree, P., A. Paugam, and J.C. Petithory. 1995. 23:143-144.
Review - Anisakidosis: Report of 25 cases and review
of the literature. Comp. Immun. Microbiol. Infect. • Hauck, A.K. 1977. Occurrence and survival of the
Dis. 18(2):75-84. larval nematode Anisakis sp. in the flesh of fresh,
frozen, brined and smoked Pacific herring, Clupea
• Daniel, R.J. 1950. A guide to marketable fish. Proc. harengus pallasi, J. Parasitol. 63:515-519.
Lpool. Biol. Soc. 57:App1, pp.68.
• Hauksson, E. 1989. Investigations on the sealworm
• Deardorff, T.L. and M.L. Kent. 1989. Prevalence problem in Icelandic waters: recent findings and
of larval Anisakis simplex in pen-reared and wild - future research. In: Moller, H.(ed), Nematode
caught salmon (Salmonidae) from Puget Sound, Problems in North Atlantic Fish. International
Washington. J. Wildl. Dis. 25:416-419. Council for the Exploration of the Sea. Copenhagen,
C.M./F:6:30-31.
• Deardorff, T.L., M.J. Klicks, M.E. Rosenfeld,
R.A. Rychlinski, and R.S. Desowitz. 1982. Larval • Jansen, T., K. Andersen, and S. des Clers. 1994.
ascaroid nematodes from fishes near the Hawaiian Sealworm (Pseudoterranova decipiens) infections in
Islands, with comments on pathogenicity experi- demersal fish from two areas in Norway. Can. J.
ments. Pacific Science 36:187-201. Zool. 72:598-608.
292
• Karl, H. and M. Leinemann. 1989. Viability of • Templeman, W., H.J. Squires, and A.M. Fleming.
nematode larvae (Anisakis sp.) In frozen herrings. 1957. Nematodes in the fillets of cod and other fishes
Archiv fur Lebensmittelhygiene 40(1):14-16. in Newfoundland and neighbouring areas. J. Fish.
Res. Bd. Can. 14:831-897.
• Lagoin, Y. 1980. Infection of humans by the
nematode Anisakis simplex in herrings. Bull. Acad. • Verhamme, M.A.M. and C.H.R. Ramboer. 1988.
Vet. de France 53:139-146. Anisakiasis caused by herring in vinegar: a little
known medical problem. Gut. 29:843-847.
• Lile, N. 1989. The parasite fauna of four
Pleuronectidae flatfish from north Norway and the • Williamson, H.C. 1910. Nematodes in the muscle of
influence of host zoogeography, phylogeny and the cod (Gadus callarias). Rep. Fish. Bd. Scot. 28:61-62.
ecology on parasite distribution. Can. Sci. Institute of
Biology and Geology (IBG), University of Tromoso. • Williamson, H.C. 1919. The distribution of
pp 68. parasite-infected fish. Ann. App. Biol. 6:48-52.
• Margolis, L. and J.R. Arthur. 1979. Synopsis of the • World Health Organization (WHO). 1995. Control
parasites of fishes of Canada. J. Fish. Res. Board Can. of foodborne trematode infections: Report of a WHO
19:101-119. study group. WHO, Geneva. WHO Technical Report
Series No. 849, 157 pp.
• Martin, O. 1921. Ueber Ascaridenlarven aus dem
Fleische von seefischen. Z. IntekKr. 22:13-36. • Wulker, G. 1929. Der Wirtswechsel der
parasitischen Nematoden von Meeresfischen. Verb.
• McClelland, G., R.K. Misra and D.J. Martell. 1990. Dtsch. Zool. Ges. 33:147-157.
Larval anisakine nematodes in various fish species
from Sable Island Bank and vicinity. • Wulker, G. 1930a. Ueber nematoden aus
pp.83-118. In: Population biology of sealworm Nordseetieren I. Zool. Anz. 87:293-302.
(Pseudoterranova decipiens) in relation to its
intermediate and seal hosts. Can. Bull. Fish. • Wulker, G. 1930b. Ueber nematoden aus
Aquat. Sci. Vol. 222. Nordseetieren I. Zool. Anz. 88:1-16.
• Ogawa, K. 1996. Marine parasitology with special • Chapter 6: Natural Toxins

reference to Japanese fisheries and mariculture. Vet.
Parasitol. 64:95-105. • Arakawa, O., T. Noguchi, and Y. Onoue. 1995.
Paralytic shellfish toxin profiles of xanthid crabs
• Polyanskii, Y. 1966. Parasites of the fish of the Zosimus aeneus and Atergatis floridus collected on
Barents Sea. Translations of the Zoological Institute reefs of Ishigaki Island. Fish. Sci. 61(4):659-662.
of the Academy of Sciences of the U.S.S.R. 19:1955.
(Israel Prog. for Scient. Translations, Jerusalem). • Clifford, M.N., R. Walker, P. Ijomah, J. Wright, C.K.
Murray, R. Hardy, E.P. Martlbauer, E. Usleber, and G.
• Punt, A. 1941. Recherches sur quelques nematodes Terplan. 1993. Do saxitoxin-like substances have a
parasites des poissons de la Mer du Nord. Mem. Mus. role in scombrotoxicosis? Food Addit. Contamin.
Hist. Nat. Belg. 98:1-110. 9(6):657-667.
• Sakanari, J.A. and J.H. McKerrow. 1989. • Hall, S. and G. Strichartz (eds). 1990. Marine
Anisakiasis. Clin. Microbiol Rev. 2:278-284. Toxins: Origin Structure, and Molecular
Pharmacology. ACS Symposium Series 418,
American Chemical Society, Washington, DC.
Continued
293
• Halstead, B.W. 1967. Poisonous and Venomous • Tsai, Y-H., D-F. Hwang, T-J. Chai, and S.S. Jeng.
Marine Animals of the World, Vol. 2 - Invertebrates. 1996. Occurrence of paralytic shellfish toxin in
U.S. Government Printing Office, Washington, DC. Taiwanese crab Atergatopsis germaini. Toxicon
34(4):467-474.
• Halstead, B.W. 1988. Poisonous and Venomous
Marine Animals of the World (Second Revised • Withers, N. 1988. Marine toxins and venoms.
Edition). The Darwin Press, Inc., Princeton, NJ. In Tu, A.T. (ed), Handbook of Natural Toxins, Vol. 3.
Marcel Dekker, New York.
• Hwang, D-F. and Y-H. Tsai. 1999. Toxins in toxic
Taiwanese crabs. Food. Rev. 15(2):145-162. • Yasumoto, T. and M. Murata. 1993. Marine toxins.
Chem. Rev. 93:1897-1909.
• Hwang, D-F., Y-H. Tsai, T-j. Chai, and S-S Jeng.
1996. Occurrence of tetrodotoxin and paralytic • Chapter 7: Histamine
shellfish poison in Taiwan crab Zosimus aeneus.
Fish. Sci. 62(3):500-501. • Arnold, S. and D. Brown. 1978. Histamine toxicity
from fish products. Adv. Food Res. 24: 113-154.
• Kawai, N., Y. Nakayama, S. Matsuoka, and T. Mori.
1985. Lipid composition of various tissues of • Baranowski, J.D., A.F. Hilmer, P.A. Brust, M.
Lepidocybium flavobrunneum. Yukagaku 34:25-31. Chongsiriwatana, and R.J. Premaratne. 1990. De-
composition and histamine content in mahimahi
• Lawrence, J.F., M. Maher, and W. Watson-Wright. (Coryphaena hippurus). J. Food Prot. 53(3): 217-
1994. Effect of cooking on the concentration of 222.
toxins associated with paralytic shellfish poison in
lobster hepatopancreas. Toxicon 33(12):1669-1673. • Behling, A.R. and S.L. Taylor. 1982. Bacterial
histamine production as a function of temperature
• Ochiai, Y., S. Watabe, K. Hashimoto, H. Narita, Y. and time of incubation. J. Food Sci. 47:1311-1317.
Ukishima, and M. Nara. 1984. Biochemical identifi-
cation of two gempylid fish causative of a food • Bjeldanes, L.F., D.E. Schultz, and M.M. Morris.
poisoning. Bull. Japan. Soc. Sci. Fish. 50:721-725. 1978. On the aetiology of scrombroid poisoning:
cadaverine potentiation of histamine toxicity in the
• Perez-Zarza, M.C., V. Ruiz-Gutierrez, and L. Bravo. guinea pig. Food Cosmet. Toxicol. 16:157-159.
1993. Lipid composition of two purgative fish:
Ruvettus pretiosus and Lepidocybium flavobrunneum. • Concon, J. (ed). 1988. Food Toxicology.
Grasas y Aceites 44:47-52. Marcel Dekker, Inc., New York. p. 511-605.
• Spark, A.A. and A.A. deWit. 1980. Wax esters in • Eitenmiller, R. and S. DeSouza. 1984. Enzymatic
edible fish. Identification of wax esters. Fishing mechanisms for amine formation in fish, p. 431-442.
Industry Research Institute (South Africa), Annual In Ragelis, E. (ed), Seafood Toxins. American
Report (no. 34), pp. 45-47. Chemical Society, Washington, D.C.
• Tsai, Y-H., D-F. Hwang, T-J. Chai, and S.S. Jeng. • Farn, G. and C. Sims. 1987. Chemical indices of
1995. Occurrence of tetrodotoxin and paralytic decomposition in tuna, p. 175-184. In Kramer, D.
shellfish poison in the Taiwanese crab Lophozozymus and J. Liston (eds), Seafood Quality Determination
pictor. Toxicon 33(12):1669-1673. (Book #15 of Developments in Seafood Science).
Elsevier, New York.
294
• Fletcher, G.C., G. Summers, and P.W.C. van Veghel. • Taylor, S.L., J.Y. Hui, and D.E. Lyons. 1984.
1998. Levels of histamine and histamine-producing Toxicology of scombroid poisoning, p. 417-430.
bacteria in smoked fish from New Zealand markets. In Ragelis, E. (ed), Seafood Toxins. American
J. Food Prot. 61(8):1064-1070. Chemical Society, Washington, D.C.
• Hernández-Herrero, M.M., A.X. Roig-Sagués, J.J. • Taylor, S. and S. Summer. 1987. Detection of
Rodríguez-Jerez and M.T. Mora-Ventura. 1999. histamine, cadaverine, and putrescine, p. 235-246.
Halotolerant and halophilic histamine-forming In Kramer, D. and J. Liston (eds), Seafood Quality
bacteria isolated during the ripening of salted ancho- Determination (Book #15 of Developments in
vies (Engraulis encrasicholus). J. Food Prot Seafood Science). Elsevier, New York.
62(5):509-514.
• van Spreckens, K. 1987. Histamine production by
• Hilmer, A.F. and D. H. Yoshinaga. 1984. Histamine psychrophilic flora, p. 309-318. In Kramer, D. and J.
Formation in Tuna, p. 443-451. In Ragelis, E (ed), Liston (eds), Seafood Quality Determination (Book
Seafood Toxins. American Chemical Society, Wash- #15 of Developments in Seafood Science). Elsevier,
ington, D.C. New York.
• Hilmer, A.F., D.H. Yoshinaga, and W. Nip. 1981. • Chapter 8: Decomposition

Histamine formation and honeycombing during
decomposition of skipjack tuna. Katsuwonus • Arnold, S.H. and D.W. Brown. 1978. Histamine
pelamis, at elevated temperatures. Marine Fisheries toxicity from fish products. Adv. Food Res.
Rev. 43(10):9-14. 24:113-154
• Inestia, C. 1973. Significance and Detection of • Bjeldanes, L.F., D.E. Schultz, and M.M. Morris.
Histamine in Food, p. 327-347. In Microbiological 1978. On the aetiology of scrombroid poisoning:
Safety of Food. Academic Press, New York. cadaverine potentiation of histamine toxicity in the
guinea pig. Food Cosmet. Toxicol. 16:157-159.
• Lehane, L. and J. Olley. 2000. Review - Histamine
fish poisoning revisited. Int. J. Food Microbiol. 58: 1- • Concon, J. 1988. Food Toxicology. Part A. Prin-
37. ciples and concepts. Marcel Dekker, Inc.,
New York. p. 626-627.
• Silva, C.C.G., J.B. Da Ponte, and M.L.N. Enes
Dapkevicius. 1998. Storage temperature effect on • Eitenmiller, R. and S. DeSouza. 1984. Enzymatic
histamine formation in big eye tuna and skipjack. J. mechanisms for amine formation in fish, p. 431-442.
Food Sci. 63(4):644-647. In Ragelis, E. (ed), Seafood Toxins. American
Chemical Society, Washington, D.C.
• Stratton, J. and S. Taylor. 1991. Scombroid
poisoning, p. 331-347. In Ward, D. and C. Hackney • Farn, G. and C. Sims. 1987. Chemical indices of
(eds), Microbiology of Marine Food Products. decomposition in tuna, p. 175-184. In Kramer, D.
Van Nostrand Reinhold, New York. and J. Liston (eds), Seafood Quality Determination
(Book #15 of Developments in Seafood Science).
• Taylor, S. 1988. Marine toxins of microbial origin. Elsevier, New York.
Food Technol. 42:94-98.
• Parrot, J. and G. Nicot. 1986. Absorption de
• Taylor, S. 1985. Histamine poisoning associated l’histamine par l’appareil digestif, p.148-161. In
with fish, cheese, and other foods, p. 1-47. World Handbuch der Experimentellen Pharmakologie, Vol.
Health Organization, VPH/FOS/85.1. 18. Springer-Verlag, New York.
Continued
295
• Stratton, J. and S. Taylor. 1991. Scombroid • U.S. Environmental Protection Agency. Tolerances
poisoning, p. 343. In Ward, D. and C. Hackney (eds), and exemptions from tolerances for pesticide
Microbiology of Marine Food Products. Van chemicals in or on raw agricultural products.
Nostrand Reinhold, New York. In Code of Federal Regulations 40 CFR 180.
U.S. Government Printing Office, Washington, D.C.
• Taylor, S. 1988. Marine toxins of microbial origin.
Food Technol. 42:94-98. • U.S. Food and Drug Administration. 1993.
Guidance Document for Chromium in Shellfish.
• Taylor, S. 1985. Histamine poisoning associated DHHS/PHS/FDA/CFSAN/Office of Seafood, Wash-
with fish, cheese, and other foods. pp. 1-47. World ington, DC.
Health Organization, VPH/FOS/85.1.
• Taylor, S.L., J.Y. Hui, and D.E. Lyons. 1984. Guidance Document for Arsenic in Shellfish.
Toxicology of scombroid poisoning, p. 417-430. DHHS/PHS/FDA/CFSAN/Office of Seafood, Wash-
In Ragelis, E. (ed), Seafood Toxins. American ington, D.C.
Chemical Society, Washington, D.C.
• Taylor, S. and S. Summer. 1987. Detection of Guidance Document for Lead in Shellfish.
histamine, cadaverine, and putrescine, p. 235-246. In DHHS/PHS/FDA/CFSAN/Office of Seafood, Wash-
Kramer, D. and J. Liston (eds), Seafood Quality ington, D.C.
Determination (Book #15 of Developments in
Seafood Science). Elsevier, New York. • U.S. Food and Drug Administration. 1993.
Guidance Document for Nickel in Shellfish.
• Chapter 9: Chemicals DHHS/PHS/FDA/CFSAN/Office of Seafood, Wash-
ington, D.C.
• Catfish Farmers of America. 1993. Catfish Quality
Assurance (Publication 1873). Cooperative Extension • U.S. Food and Drug Administration. 1993.
Service, Mississippi State University, Mississippi Guidance Document for Cadmium in Shellfish.
State, MS. DHHS/PHS/FDA/CFSAN/Office of Seafood, Wash-
ington, D.C.
• Striped Bass Growers Association. 1996. The
Hybrid Striped Bass Industry from Fish Farmer to • U.S. Food and Drug Administration. 1989.
Consumer. Striped Bass Growers Associated, P.O. Pesticide residues in food and feed enforcement
Box 11280, Columbia, SC. criteria. In Compliance Policy Guides, Sect.
575.100. DHHS/PHS/FDA/Center for Food Safety
• U.S. Trout Farmer’s Association. 1994. Trout and Applied Nutrition, Washington, D.C.
Producers Quality Assurance Program. USTFA, P.O.
Box 220, Charles Town, WV. • U.S. Food and Drug Administration. Unavoidable
contaminants in food for human consumption. In
• U.S. Environmental Protection Agency. 1995. Code of Federal Regulations 21 CFR 109.30. U.S.
Final Water Quality Guidance for the Great Lakes Government Printing Office, Washington, D.C.
System. In Federal Register, Vol. 60, No. 56.
• Chapter 11: Drugs
• U.S. Environmental Protection Agency. 1992.
Water Quality Standards; Establishment of Numeric • Catfish Farmers of America. 1993. Catfish Quality
Criteria for Priority Toxic Pollutants; States’ Assurance (Publication 1873). Cooperative Extension
Compliance. In Federal Register, Vol. 57, No. 246. Service, Mississippi State University, Mississippi
State, MS.
296
• Joint Subcommittee on Aquaculture. 1994. Guide to • Hood, M.A., G.E. Ness, G.E. Rodrick, and N.J.
Drug, Vaccine, and Pesticide Use in Aquaculture Blake. 1983. Effects of storage on microbial loads of
(Publication B-5085). Texas Agricultural Extension two commercially important shellfish species,
Service, College Station, TX. Crassostrea virginica and Mercenaria
campechiensis. Appl. Environ. Microbiol. Apr:1221-
• Striped Bass Growers Association. 1996. The 1228.
Hybrid Striped Bass Industry from Fish Farmer to
Consumer. Striped Bass Growers Associated, P.O. • Huss, H.H. 1997. Control of indigenous pathogenic
Box 11280, Columbia, SC. bacteria in seafood. Food Control. 8:91-98.
• U.S. Trout Farmer’s Association. 1994. Trout • Huss, H.H., 1993. Assurance of seafood quality.
Producers Quality Assurance Program. USTFA, P.O. FAO Fisheries Technical Paper, No. 334.Rome, FAO.
Box 220, Charles Town, WV. 169p.
• U.S. Food and Drug Administration. 2000. • Huss, H.H. (ed,). 1993. Quality and quality changes
Extralabel Drug Use in Animals. In Code of Federal in fresh fish. FAO Fisheries Technical
Regulations 21 CFR 530. U.S. Government Printing Paper, No. 346. Rome, FAO.
Office, Washington, DC.
• Huss, H H., A. Reilly, P.K Ben Embarek. 2000.
• U.S. Food and Drug Administration. 2000. Prevention and control of hazards in seafood. Food
Certain other dosage form new animal drugs. Control. 11:149-156.
In Code of Federal Regulations 21 CFR 529.
U.S. Government Printing Office, Washington, D.C. • Jørgensen, L. V., and H. H. Huss. 1998. Prevalence
and growth of Listeria monocytogenes in
• U.S. Food and Drug Administration. 2000. naturally contaminated seafood. Int. J. Food
Tolerances for residues of new animal drugs in food. Microbiol. 42:127-131.
In Code of Federal Regulations 21 CFR 556. U.S.
Government Printing Office, Washington, DC. • Morris, G. J., and R.E. Black. 1985. Cholera and
other vibrioses in the United States. New Engl. J.
• Chapter 12: Pathogens – Growth Med. 12:343-350.
• Ahmed, F.E. (ed.). 1991. Seafood Safety. National • Nielsen, H.-J.S, and P. Zeuthen. 1984. Growth of
Academy Press, Washington, D.C. pathogenic bacteria in sliced vacuum-packed bolo-
gna-type sausage as influenced by temperature and
• Baek, S-Y., S-Y. Lim, D-H. Lee, K-H. Min, and C- gas permeability of packaging film. Food Microb.
M. Kim. 2000. Incidence and characterization of 1:229-243
Listeria monocytogenes from domestic and imported
foods in Korea. J. Food Prot. 63:186-189. • Palumbo, S.A. 1986. Is Refrigeration enough to
restrain foodbourne pathogens? J. Food Prot. 49:
• Gecan, J.S., R. Bandler, and W.F. Staruskiewcz. 1003-1009.
1994. Fresh and frozen shrimp: A profile of filth,
microbiological contamination, and decomposition. • Peixotto, S.S., G. Finne, M.O. Hanna, and C.
J. Food Prot. 57:154-158. Vanderzant, 1979. Presence, growth and survival of
Yersinia entercolitica in oysters, shrimp and crab. J.
Food Prot. 42:974-981.
Continued
297
• Philips, F.A.and T. Peeler. 1972. Bacteriological • Ward, D.R and C.R. Hackney, (eds ). 1991. Micro-
survey of the blue crab industry. Appl. Microbiol. biology of Marine Food Products. Van Nostrand
Dec.:958-966. Reinhold, New York.
• Refrigerated Foods and Microbiological Criteria • Wentz, B.A, A.P. Duran, A. Swartzentruber, A.H.
Committee of the National Food Processors Associa- Schwab, F.D. McClure, D. Archer, and R.B. Read, Jr.
tion. 1988. Factors to be considered in establishing 1985. Microbiological quality of crabmeat during
good manufacturing practices for the production of processing. J. Food Prot. 48:44-49.
refrigerated foods. Dairy and Food Sanit. 8:288-291.
• Wong, H.-C., M.-C. Chen, S.-H. Liu, D,-P. Lin.
• Rivituso, C.P. and Snyder. 1981. Bacterial growth at 1999. Incidence of highly genetically diversified
foodservice operating temperatures. J. Food Prot. Vibrio parahaemolyticus in seafood imported from
44:770-775. Asian countries. Int. J Food Microbiol. 52:181-188.
• Rosso, L., S. Bajard, J.P. Flandrois, C. Lahellec, J. • Chapter 13: C. botulinum

Fournaud, and P. Veit. 1996. Differential growth of
Listeria monocytogenes at 4 and 8˚C: Consequences • Anon. 1991. Cured, salted, and smoked fish
for the shelf life of chilled products. 59:944-949. establishments good manufacturing practices. In
Model Code, Association of Food and Drug Officials,
• Satoshi, I, A. Nakama, Y. Arai, Y. Kokubo, T. Retail Food Subcommittee (J. Joseph Corby, chair).
Maruyama, A Saito, T. Yoshida, M. Terao, S.
Yamamoto, and S. Kumagai. 2000, Prevalence and • Baird-Parker, A.C. and B. Freame. 1967. Combined
contamination levels of Listeria monoocytogenes in effect of water activity, pH and temperature on the
retail foods in Japan. Int. J. Food Microb. 59:73-77. growth of Clostridium botulinum from spore and
vegetative cell inocula. J. Appl. Bact. 30:420-429.
• Son, N.T., and G.H. Fleet. 1980. Behavior of
pathogenic bacteria in the oyster, Crassostrea • Betts, G.D. and J.E. Getts. 1995. Growth and heat
commercialis, during depuration, relaying and resistance of psychrotrophic Clostridium botulinum
storage. Appl. Environ. Microbiol. Dec:994-1002. in relation to ‘sous vide’ products. Food Control
6:57-63.
Foodborne Pathogenic Microorganisms and Natural • Boyd, J.W. and B.A. Southcott. 1971. Effects of
Toxins (“Bad Bug Book”). Available at internet site: sodium chloride on outgrowth and toxin production
http://www.cfsan.fda.gov/~mow/intro.html of Clostridium botulinum type E in cod homogenates.
J. Fish. Res. Bd. Canada 28:1071-1075.
• U.S. Food and Drug Administration. 1999. Food
Code. DHHS/PHS/FDA, Washington, DC. Available • Christiansen, L.N., J. Deffner, E.M. Foster and H.
at internet site: http://vm.cfsan.fda.gov/~dms/ Sugiyama. 1968. Survival and outgrowth of
foodcode.html Clostridium botulinum type E spores in smoked fish.
Appl. Microbiol. 133-137.
• Wallace, B. J., J. J. Guzewich, M. Cambridge, S
Altekruse.1999. Seafood-associated disease out- • Controlled/modified atmosphere/vacuum packaging
breaks in New York, 1980-1994. Amer. J Prev. of foods. 1989. A.L. Brody, ed., Food and Nutrition
Med.17:48-54. Press, Inc. Trunball, CT.
298
• Daniels, R.W. 1991. Applying HACCP to new- • Hilderbrand, K.S. 1992. Fish Smoking Procedures
generation refrigerated foods at retail and beyond. for Forced Convection Smokehouses, Special Report
Food Technol. 45:122, 124. 887. Oregon State Extension Service, Newport, OR.
• Dufresne, I, J.P. Smith, J.N. Liu and I. Tarte. 2000. • Kautter, D.A, P.K. Lynt, T. Lily and H.M. Solomon.
Effect of films of different oxygen transmission rate 1981. Evaluation of the botulism hazard from
on toxin production by Clostridium botulinum type E nitrogen-packed sandwiches. J. Food Prot. 44:59-61.
in vacuum packaged cold and hot smoked trout
fillets. J. Food Safety 20:251-268. • Kornacki, J.L. and D.A. Gabis. 1990. Microorgan-
isms and Refrigeration Temperatures. Dairy, Food
• Eklund, M.W., G.A. Pelroy, R. Paranjpye, M.E. and Environ.San. 10:192-195.
Peterson and F.M. Teeny. 1982. Inhibition of
Clostridium botulinum types A and E toxin produc- • Lerke, P. and L. Farber. 1971. Heat pasteurization
tion by liquid smoke and NaCl in hot-process smoke- of crab and shrimp form the Pacific coast of the US:
flavored fish. J. Food Prot. 44:935-941. public health aspects. J. Food Sci. 36:277-279.
• Eklund, M.W., R.N. Raranjpye, F.T. Poysky, M.E. • Lyon, W.J. and C.S. Reddmann. 2000. Bacteria
Peterson and G.A. Pelroy. Control of nonproteolytic associated with processed crawfish and potential
Clostridium botulinum types B and E in crab analogs toxin production by Clostridium botulinum type E in
by combinations of heat pasteurization and water vacuum-packaged and aerobically packaged crawfish
phase salt. (submitted J. Food Prot.). tails. J. Food Prot. 63:1687-1696.
• European Chilled Food Federation. 1997. Guide- • McClure, P.J., M.B. Cole and J.P.P.M. Smelt. 1994.
lines for good hygienic practice in the manufacture of Effects of water activity and pH on growth of
chilled foods. Clostridium botulinum. J. Appl. Bact. Symp. Suppl.
76:105S-114S.
• Farber, J.M. 1991. Microbiological aspects of
modified atmosphere packaging technology - a • Natl. Advis. Comm. Microbiol. Criter. Foods.
review. J. Food Prot. 54:58-70. 1992. Vacuum or Modified Atmosphere Packaging
for Refrigerated Raw Fishery Products. DHHS/PHS/
• Garren, D.M, M.A Harrison and Y.W. Huang. 1994. FDA/State Training Branch, Rockville, MD. 21 p.
Clostridium botulinum type E outgrowth and toxin
production in vacuum-skin packaged shrimp. Food • Peck, M.W. 1997. Clostridium botulinum and the
Microbiol. 11:467-472. safety of refrigerated processed foods of extended
durability. Trends in Food Sci. and Tech. 8:186-192.
• Gould, G.W. 1999. Sous vide foods:conclusions of
an ECFF botulinum working party. Food Control • Pelroy, G.A, M.W. Eklund, R.N. Paranjpye,
10:47-51. E.M.Suzuki and M.E. Peterson. 1982. Inhibition of
Clostridium botulinum types A and E toxin formation
• Graham, A.F., D.R. Mason and M.W. Peck. 1996. by sodium nitrite and sodium chloride in hot process
Predictive model of the effect of temperature, pH and (smoked) salmon. J. Food Prot. 45:833-841.
sodium chloride on growth from spores of non-
proteolytic Clostridium botulinum. Int. J. Food • Peterson, M.E., G.A. Pelroy, R.N. Paranjpye, F.T.
Microbiol. 31:69-85. Poysky, J.S. almond and M.W. Eklund. 1993. Param-
eters for control of Listeria monocytogenes in
• Hauschild, A.H.W. and R. Hilsheimer. 1979. Effect smoked fishery products: sodium chloride and
of salt content and pH on toxigenesis by Clostridium packaging method. J. Food Prot. 56:938-943.
botulinum in caviar. J. Food Prot. 42:245-248.
Continued
299
• Reddy, N.R., D.J. Armstrong, E.J. Rhodehamel, and • Skinner, G.E. and J.W. Larkin. 1998. Conservative
D.A. Kautter. 1992. Shelf-life extension and safety prediction of time to Clostridium botulinum toxin
concerns about fresh fishery products packaged formation for use with time-temperature indicators to
under modified atmospheres: a review. J. Food ensure the safety of foods. J. Food Prot. 61:1154-
Safety. 12:87-118. 1160.
• Reddy, N.R, A. Paradis, M.G. Roman, H.M. • Sugiyama, H., and K.S. Rutledge. 1978. Failure of
Solomon, and E.J. Rhodehamel. 1996. Toxin devel- Clostridium botulinum to grow in fresh mushrooms
opment by Clostridium botulinum in modified packaged in plastic film overwraps with holes. J.
atmosphere-packaged fresh tilapia fillets during Food Prot. 41:348-350.
storage. J. Food Sci. 61:632-635.
• U.S. Food and Drug Administration. 1996. Import
• Reddy, N.R., M.G. Roman, M. Villanueva, H.M. Alert 16-74: Automatic detention of salt-cured
Solomon, D.A. Kautter, and EJ Rhodehamel. 1996. uneviscerated fish. DHHS/PHS/FDA/Center for
Shelflife and Clostridium botulinum toxin develop- Food Safety and Applied Nutrition, Washington, D.C.
ment during storage of modified atmosphere-pack-
aged fresh catfish fillets. J Food Sci. 62:878-884. • Chapter 14: Drying
• Reddy, N.R., H.M. Solomon, H. Yep, M.G. Roman, • Hilderbrand, K.S. 1992. Fish Smoking Procedures
and E.J. Rhodehamel. 1997. Shelflife and toxin for Forced Convection Smokehouses, Special Report
development by Clostridium botulinum during 887. Oregon State University, Extension Service,
storage in modified atmosphere-packaged fresh Corvallis, OR.
aquacultured salmon fillets. J Food Prot. 60:1055- • Hilderbrand, K.S., Jr. 1996. Personal communica-
1063. tion. Oregon State University, Extension Service,
Corvallis, Oregon.
• The Refrigerated Foods and Microbiological
Criteria Committee of the National Food Processors • McClure, P.J., M.B. Cole and J.P.P.M. Smelt. 1994.
Association. 1988. Safety considerations for new Effects of water activity and pH on growth of
generation refrigerated foods. Dairy and Food Clostridium botulinum. J. Appl. Bact. Symp. Suppl.
Sanitation. 8:5-7. 76:105S-114S.
• Rhodehamel, E.J. 1992. FDA’s concerns with sous • Tatini, S.R. 1973. Influence of food environments
vide processing. Food Technol. 46:73-76. on growth of Staphylococcus aureus and production
of various enterotoxins. J. Milk Food Technol.
• Rhodehamel, E.J., H.M. Solomon, T. Lilly, Jr., D.A. 36:559-563.
Kautter and J.T. Peeler. 1991.Incidence and heat
resistance of Clostridium botulinum type E spores in • Chapter 15: Batter
menhaden surimi. J. Food Sci. 56:1562-1563,1592.
• Baird-Parker, A.C. 1971. Factors affecting the
• Schmidt, R.V., R.V. Lechowich and J.F. Folinazzo. production of bacterial food poisoning toxins.
1961. Growth and toxin production by type E J. Appl. Bact. 34:181-197.
Clostridium botulinum below 40F. J. Food Sci.
26:626-630. • Beckers, H.J., F.M. van Leusden, and P.D. Tips.
1985. Growth and enterotoxin production of
• Segner, W.P, C.F. Schmidt and J.K. Boltz. 1966. Staphylococcus aureus in shrimp. J. Hyg., Camb.
Effect of sodium chloride and pH on the outgrowth 95:685-693.
of spores of type E Clostridium botulinum at optimal
and suboptimal temperatures. Appl. Microbiol.
14:49-54.
300
• Bryan, F.L. 1979. Staphylococcus aureus in Food • Lotter, L.P. and L. Leistner. 1978. Minimal water
Microbiology: Public Health and Spoilage Aspects. activity for enterotoxin A production and growth of
The Avi Publ. Co., Inc. Westport, CT. Staphylococcus aureus. Appl. Environ. Microbiol.
36:377-380.
• Buchanan, R.L. 1991. Microbiological criteria for
cooked, ready-to-eat shrimp and crabmeat. Food • Ostovar, K. and M.J. Bremier. 1975. Effect of
Technol. 45:157-160 thawing on growth of Staphylococcus aureus in
frozen convenience food items. J. Milk Food
• Dahl Sawyer, C.A. and J.J. Pestka. 1985. Technol. 38:337-339.
Foodservice systems: Presence of injured bacteria in
foods during food product flow. Ann. Rev. • Potter, L. and L. Leistner. 1978. Minimal water
Microbiol. 39:51-67. activity for enterotoxin A production and growth of
Staphylococcus aureus. Appl. Environ. Microbiol.
• Deibel, K.E. 1995. Potential of Staphylococcus 36:377-380.
aureus to produce enterotoxin in fish batter at various
temperatures, p. 33. In Medallion Lab (ed), • Raj. H.D. 1970. Public health bacteriology of
Proceedings of the IFT Annual Meeting. Medallion processed frozen foods. Lab. Practice 19:374-377,
Lab, Minneapolis, MN. 394.
• Dengremont, E. and J.M. Membre. 1995.
• Sutherland, J.P., A.J. Bayliss, and T.A. Roberts.
Statistical approach for comparison of the growth
1994. Predictive modelling of growth of Staphylo-
rates of five strains of Staphylococcus aureus.
coccus aureus: the effects of temperature, pH and
Appl. Environ. Microbiol. 61:4389-4395.
sodium chloride. Int. J. Food Microbiol. 21:217-236.
• Duran, A.P., B.A. Wentz, J.M. Lanier, F.D. • Chapter 16: Cooking
McClure, A.H. Schwab, A. Swartzentruber, R.J.
Barnard, and R.B. Read. 1983. Microbiological • European Chilled Food Federation. 1997. Guide-
quality of breaded shrimp during processing. J. Food lines for good hygienic practice in the manufacture of
Protect. 46:974-977. chilled foods.
• Godwin, G.J., R.M. Grodner, and A.F. Novak. • Hilderbrand, K.S., Jr. 1996. Personal communica-
1977. Twenty-four hour methods for bacteriological tion. Oregon State University, Extension Service,
analyses in frozen raw breaded shrimp. J. Food Sci. Corvallis, Oregon.
42:750-754.
• Lum, Kenneth C. 1996. Personal communication.
• Greenwood, M.H., E.F.C. Coetzee, B.M. Ford, P. National Food Processors Association, Seattle, WA.
Gill, W.L. Hooper, S.C.W. Matthews, S. Patrick,
J.V.S. Pether, and R.J.D. Scott. 1985. The bacterio- • Mackey, B.M. and N. Bratchell. 1989. The heat
logical quality of selected retail, ready-to-eat food resistance of Listeria monocytogenes. A review.
products. III. Cooked crustaceans and mollusks. Letters in Appl. Microbiol. 9:89-94.
Environ. Health 93:236-239.
• National Advisory Committee on Microbiological
• Hughes, A. and A. Hurst. 1980. The effect of NaCl Criteria for Foods. 1990. Recommendations of the
on the upper temperature limit for growth of and National Advisory Committee on Microbiological
enterotoxin synthesis by Staphylococcus aureus. Criteria for Foods for Cooked Ready-to-Eat Shrimp
Can. J. Microbiol. 26:507-510. and Cooked Ready-to-Eat Crabmeat. Executive
secretariat, Food Safety and Inspection Service, U.S
Dept. Agriculture, Washington, D.C.
Continued
301
• National Advisory Committee on Microbiological • Lynt, R.K., H.M. Solomon, T. Lilly and D.A.
Criteria for Foods. 1990. Recommendations of the Kautter. 1977. Thermal death time of Clostridium
National Advisory Committee on Microbiological botulinum type E in meat of the blue crab. J. Food
Criteria for Foods for Refrigerated Foods Containing Sci. 42:1022-1025.
Cooked, Uncured Meat or Poultry Products that are
Packaged for Extended Refrigerated Shelf Life and • Lynt, R.K., D.A. Kautter and H.M. Solomon. 1982.
that are Ready-to-Eat or Prepared with Little or No Differences and similarities among proteolytic and
Additional Heat Treatment. Executive secretariat, nonproteolytic strains of Clostridium botulinum types
Food Safety and Inspection Service, U.S Dept. A, B, E and F: A review. J. Food Prot. 45:466-474.
Agriculture, Washington, D.C.
• Mackey, B.M. and N. Bratchell. 1989. The heat
• National Advisory Committee on Microbiological resistance of Listeria monocytogenes. A review.
Criteria for Foods. 1991. Listeria monocytogenes: Letters in Appl. Microbiol. 9:89-94.
Recommendations of the National Advisory Commit-
tee on Microbiological Criteria for Foods for Refrig- • Peterson, M. E., G.A. Pelroy, F.T Poysky, R.N.
erated Foods. Intl. J. Food Microbiol. 14:185-246. Paranjpye, R.M. Dong, G.M. Pigott, and M.W.
Eklund. 1997. Heat-pasteurization process for
• U.S. Food and Drug Administration. Thermally inactivation of nonproteolytic types of Clostridium
processed low-acid foods packaged in hermetically botulinum in picked dungeness crabmeat. J. Food
sealed containers. In Code of Federal Regulations 21 Prot. 60:928-934.
CFR 113. U.S. Government Printing Office, Wash-
ington, D.C. • Rippen, T., C. Hackney, G. Flick, G. Knobl, and D.
Ward. 1993. Seafood Pasteurization and Minimal
• U.S. Food and Drug Administration and U.S. Processing Manual. Virginia Cooperative Extension
Department of Agriculture. 2001. Draft assessment Publication 600-0061. Virginia Sea Grant Publication
of the relative risk to public health from foodborne VSG 93-09.
Listeria monocytogenes amoung selected categories
of ready-to-eat foods. • U.S. Food and Drug Administration. Thermally
processed low-acid foods packaged in hermetically
• Chapter 17: Pasteurization sealed containers. In Code of Federal Regulations 21
CFR 113. U.S. Government Printing Office, Wash-
• Cockey, R.R. and M.C. Tatro. 1974. Survival ington, D.C.
studies with spores of Clostridium botulinum type E
in pasteurized meat of the blue crab Callinectes • U.S. Food and Drug Administration and U.S.
sapidus. Appl. Microbiol. 27:629-633. Department of Agriculture. 2001. Draft assessment
of the relative risk to public health from foodborne
• Eklund, M.W., R.N. Raranjpye, F.T. Poysky, M.E. Listeria monocytogenes amoung selected categories
Peterson and G.A. Pelroy. Control of nonproteolytic of ready-to-eat foods.
Clostridium botulinum types B and E in crab analogs
by combinations of heat pasteurization and water • Chapter 18: Post-pasteurization
phase salt. (submitted J. Food Prot.).
• Gavin, A., and L.M. Wedding (eds.) 1995. Canned
• European Chilled Food Federation. 1997. Guide- Foods – Principles of Thermal Process Control,
lines for good hygienic practice in the manufacture of Acidification, and Container Closure Evaluation.
chilled foods. National Food Processors Institute, Washington, D.C.
231 p.
• Lum, Kenneth C. 1996. Personal communication.
National Food Processors Association, Seattle, WA.
302
• Chapter 19: Allergens/Additives • Chapter 20: Metal
• U.S. Food and Drug Administration. 1990. Food • Olsen, A.R. 1998. Regulatory action criteria for
Labeling Regulations Implementing the Nutrition filth and other extraneous materials. I. Review of
Labeling and Education Act of 1990. In Federal hard or sharp foreign objects as physical hazards in
Register, Vol. 58, No. 3. food. Regulatory Toxicology and Pharmacology.
28:181-189.
• Nutrition Labeling and Education Act of 1990, Pub.
L. 101-535, 104 Stat. 535. • U.S. Food and Drug Administration. 1999. Foods –
Adulteration involving hard or sharp foreign objects.
• U.S. Food and Drug Administration. Substances In Compliance Policy Guides Section, Sect. 555.425.
prohibited from use in human food (Cyclamates and DHHS/PHS/FDA/Center for Food Safety and
its derivatives). In Code of Federal Regulations CFR Applied Nutrition, Washington, D.C.
21 189.135; 100.130.
Government Printing Office, Washington, D.C. • Chapter 21: Glass
• U.S. Food and Drug Administration. Substances • Olsen, A.R. 1998. Regulatory action criteria for
prohibited from use in human food (Safrole). In Code filth and other extraneous materials. I. Review of
of Federal Regulations CFR 21 189.180. hard or sharp foreign objects as physical hazards in
Government Printing Office, Washington, D.C. food. Regulatory Toxicology and Pharmacology.
28:181-189.
• U.S. Food and Drug Administration. Substances
prohibited from use in human food. In Code of • U.S. Food and Drug Administration. 1999. Foods –
Federal Regulations CFR 21 74.1304, 74.2303, Adulteration involving hard or sharp foreign objects.
81.10, 81.30. In Compliance Policy Guides Section, Sect. 555.425.
Government Printing Office, Washington, D.C. DHHS/PHS/FDA/Center for Food Safety and
Applied Nutrition, Washington, D.C.
• U.S. Food and Drug Administration. 1976. Termi-
nation of Provisional Listing and Certification of • Appendix 4: Pathogen Tables
FD&C Red No.4 for Use in Maraschino Cherries and
Ingested Drugs. In Federal Register, Vol. 41, No. 186 TABLE A-1
- Thursday, September 23, 1976.
• Bergdoll, M.S. 1989. Staphylococcus aureus,
• U.S. Food and Drug Administration, Final rule, p. 463-523. In Doyle, M.P. (Ed), Foodborne Micro-
CFR Part 101. 1986. Food Labeling: Declaration of bial Pathogens. Marcel Dekker, Inc. New York.
Sulfiting agents; In Federal Register, 25012, Vol. 51,
No. 131, Wednesday, July 9, 1986. • Beuchat, L.R. 1974. Combined effects of water
activity, solute, and temperature on the growth of
• U.S Food and Drug Administration. 1992. State- Vibrio parahaemolyticus. Appl. Microbiol.
ment of Policy: Foods derived from New Plant 27:1075-1080.
Varieties. In Federal Register, Vol. 57, No. 104,
Friday, May 29, 1992. • Buchanan, R.L. and L.K. Bagi. 1997. Effect of
water activity and humectant identity on the growth
kinetics of Escherichia coli O157:H7. Food
Microbiol. 14: 413-423.
Continued
303
• Buchanan, R.L. and L.A. Klawitter. 1992. The • Fujino, T., G. Sakaguchi, and Y. Takeda (eds).
effect of incubation temperature, initial pH, and 1973. International Symposium on Vibrio
sodium chloride on the growth kinetics of Escheri- parahaemolyticus. Saikon, Tokyo.
chia coli. Food Microbiol. 9:185-196.
• George, S.M., L.C.C. Richardson, and M.W. Peck.
• Campanini, M., A. Casolari, and S. Gola. 1977. 1996. Predictive models of the effect of temperature,
Bacterial growth and limiting pH. Industria Con- pH, and acetic and lactic acids on the growth of
serve 52:326-331. Listeria monocytogenes. Intl. J. Food Microbiol. 31:
73-90.
• Catsaras, M. And D. Grebot. 1984. Multiplication
des Salmonella dans la viande hachee. Bull. Acad. • Halpin-Dohnalek, M.I. and E.H. Marth. 1989.
Vet. France. 57:501-512. Staphylococcus aureus: Production of extracellular
compounds and behavior in foods - a review. J. Food
• Colwell, R.R.(ed.). 1984. Vibrios in the Environ- Protect. 52:267-282.
ment. John Wiley Interscience, New York.
• Hauschild, A.H.W. 1989. Clostridium botulinum,
• Curtis, L.M., M. Patrick, and C. de W. Blackburn. p. 111-189. In Doyle, M.P. (ed), Foodborne Bacte-
1995. Survival of Campylobacter jejuni in foods and rial Pathogens. Marcel Dekker, Inc., New York.
comparison with a predictive model. Lett. Appl.
Microbiol. 21: 194-197. • Holler, C., D. Witthuhn, and B. Janzen-Blunck.
1998. Effect of low temperatures on growth, struc-
• Doyle, M.P. and D.J. Roman. 1989. Growth and ture, and metabolism of Campylobacter coli SP10.
survival of Campylobacter fetus subsp. jejuni as a Appl. Environ. Microbiol. 64: 581-587.
function of temperature and pH. J. Food Protect.
44:596-601. • Holley, R.A. and M. Proulx. 1986. Use of egg
washwater pH to prevent survival of Salmonella at
• Fernandez, P.S., S.M. George, C.C. Stills, and M.W. moderate temperatures. Poultry Sci. 65:922-928.
Peck. 1997. Predictive model of the effect of CO2,
pH, temperature, and NaCl on the growth of Listeria • Huss, H.H. 1997. Control of indigenous patho-
monocytogenes. Intl. J. Food Microbiol. 37: 37-45. genic bacteria in seafood. Food Control 8: 91-98.
• Fluer, F.S. and Y.V. Ezepchuk. 1970. • International Commission on Microbiological

Microbiologiya 39:396-410. (Source: Specifications for Foods (ICMSF). 1996. Microor-
Rhodehammel, E.J. and S.M. Harmon. Chapter 14. ganisms in Foods 5. Characteristics of Microbial
Bacillus cereus. In FDA Bacteriological Analytical Pathogens. ICMSF, International Union of Biologi-
Manual, 8th ed. (1995), AOAC International, cal Societies. Blackie Academic & Professional,
McLean, VA). London.
• Food and Agriculture Organization of the United • Johnson, K.M., C.L. Nelson, and F.F. Busta. 1983.
Nations. 1999. Report of the FAO expert consulta- Influence of temperature on germination and growth
tion on the trade impact of Listeria in Fish Products. of spores of emetic and diarrheal strains of Bacillus
FAO Fisheries Report. No. 604. Rome, FAO. 34 pp. cereus in a broth medium and in rice. J. Food Sci.
48: 286-287.
• Fuhs, A. and G.J. Bonde. 1957. The nutritional
requirements of Clostridium perfringens. J. Gen.
Microbiol. 16:317-329.
304
• Jyhshium, L., S.L. In, J.L. Slonczewski, and J.W. • Prost, E. And H. Riemann. 1967. Food-borne
Foster. 1995. Comparative analysis of extreme acid salmonellosis. Ann. Rev. Microbiol. 21:495-528.
survival in Salmonella typhimurium, Shigella
flexneri, and Escherichia coli. J. Bacteriol. • Reed, G.H. 1993. Foodborne illness (Part 2):
177:4097-4104. Salmonellosis. Dairy, Food, Environ. San. 13:706.
• Kang, C.K., M. Woodburn, A. Pagenkopf, and R. • Reed, G.H. 1994. Foodborne illness (Part 3):
Cheney. 1969. Growth, sporulation, and germina- Clostridium perfringens gastroenteritis. Dairy, Food
tion of Clostridium perfringens in media of con- and Environ. San. 14:16-17.
trolled water activity. Appl. Microbiol. 18:798-805.
• Reed, G.H. 1994. Foodborne illness (Part 4):
• Kauppi, K.L., S.R. Tatini, F. Harrell and P. Feng. Bacillus cereus gastroenteritis. Dairy, Food and
1996. Influence of substrate and low temperature on Environ. San. 14:87.
growth and survival of verotoxigenic Escherichia
coli. Food Microbiol. 13: 397-405. • Reed, G.H. 1994. Foodborne illness (Part 8):
Escherichia coli Dairy, Food, Environ. San.
• Kramer, J.M. and J.M. Gilbert. Chapter 2. Bacillus 14:329-330.
cereus and other Bacillus species. In: Foodborne
Bacterial Pathogens, M.P. Doyle (ed.), Marcel • Reed, G.H. 1994. Foodborne illness (Part 11):
Dekker, Inc., New York. Yersinosis. Dairy, Food, Environ. San. 14:536.
• Krieg, N.R. (Ed). 1984. Bergey’s Manual of • Roberts, T.A. and C.M. Derrick. 1978. The effect
Systematic Bacteriology, Volume 1. Williams & of curing salts on the growth of Clostridium
Wilkins, Baltimore, MD. perfringens (welchii) in a laboratory medium.
J. Food Technol. 13:394-353.
• Miles, D.W., T. Ross, J. Olley, and T.A. McMeekin.
1997. Development and evaluation of a predictive • Rusul, G. and N.H. Yaacob. 1995. Prevalence of
model for the effect of temperature and water activity Bacillus cereus in selected foods an detection of
on the growth rate of Vibrio parahaemolyticus. Intl. enterotoxin using TECRA-VIA and BCET-RPLA.
J. Food Microbiol. 38: 133-142. Intl. J. Food Microbiol. 25: 131-139.
• Palumbo, S.A., J.E. Call, F.J. Schultz, and A.C. • Sneath, P.H.A. (Ed.). 1986. Bergey’s Manual of
Williams. 1995. Minimum and maximum tempera- Systematic Bacteriology, Volume 2. Williams &
tures for growth and enterotoxin production by Wilkins, Baltimore, MD.
hemorrhagic strains of Escherichia coli. J. Food
Protect. 58:352-356. • Subcommittee on Microbiological Criteria. 1985.
An Evaluation of the Role of Microbiological Crite-
• Pradhan, L., P. Kanekar, and S.H. Godbole. 1985. ria for Foods and Food Ingredients. Committee on
Microbiology of spoiled mango pickles. Tolerance to Food Protection, Natl. Research Council. National
salt, acidity, and oil of the microbes isolated from Academy Press, Washington, D.C. 256 p.
spoiled mango pickles. J. Food Sci. Technol. India
22:339-341. • Sutherland, J.P., A.J. Bayliss, and D.S. Braxton.
1995. Predictive modeling of growth of Escherichia
• Presser, K.A., T. Ross and D.A. Ratkowsky. 1998. coli O157:H7: The effects of temperature, pH and
Modelling the growth limits (growth/no growth sodium chloride. Intl. J. Food Microbiol. 25:29-49.
interface) of Escherichia coli as a function of tem-
perature, pH, lactic acid concentration, and water • Syndicat National des Fabricants de Plats Prepares.
activity. Appl. Environ. Microbiol. 64: 1773-1779. 1995. Aide a la maitrise de l’hygiene alimentaire.
Collection Alesial, Alesial Services, Paris.
Continued
305
• Tatani, S.R. 1973. Influence of food environments • Aryanta, R.W., G.H. Fleet, and K.A. Buckle. 1991.
on growth of Staphylococcus aureus and production The occurrence and growth of microorganisms
of various enterotoxins. J. Milk Food Technol. during the fermentation of fish sausage. Int. J. Food
36:559. Microbiol. 13:143-156.
• Twedt, R.M., P.L. Spaulding, and H.E. Hall. 1969. • Badhey, H., D.J. Cleri, R.F. D’Amato, J.R.
Vibrio parahaemolyticus. J. Bacteriol. 98:511-518. Vernaleo, V. Veinni, J. Tessler, A.A. Wallman, A.J.
Mastellone, M. Giuliani, and L. Hochstein. 1986.
• U.S. Food and Drug Administration and Food Two fatal cases of type E adult food-borne botulism
Safety Inspection Service. 1992. Preventing with early symptoms and terminal neurologic signs.
foodborne listeriosis. DHHS/FDA and USDA/FSIS. J. Can. Microbiol. 23:616-618.
Washington, D.C.
• Baird-Parker, A.C. 1971. Factors affecting the
• U.S. Food and Drug Administration. 1997. production of bacterial food poisoning toxins. J.
Foodborne Pathogenic Microorganisms and Appl. Bacteriol. 34:181-197.
Natural Toxins. Available at internet site:
http://vm.cfsan.fda.gov/list.html. • Baird-Parker, A.C. and B. Freame. 1967.
Combined effect of water activity, pH and t
TABLE A-2 emperature on the growth of Clostridium botulinum
from spore and vegetative cell inocula. J. Appl.
• Abrahamsson, K., B. Gullmar, and N. Molin. 1966. Bacteriol. 30:420-429.
The effect of temperature on toxin formation and
toxin stability of Clostridium botulinum type E in • Baker, D.A., C. Genigeorgis, and G. Garcia. 1990.
different environments. Can. J. Microbiol. 12:385- Prevalence of Clostridium botulinum in seafood and
394. significance of multiple incubation temperatures for
determination of its presence and type in fresh retail
• Adams, M.R. C.L. Little, and M.C. Easter. 1991. fish. J. Food Protect. 53:668-673.
Modeling the effect of pH, acidulant, and tempera-
ture on the growth of Yersinia enterocolitica. J. Appl. • Baker, D.A., C. Genigeorgis, J. Glover, and V.
Bacteriol. 71:65-71. Razavilar. 1990. Growth and toxigenesis of
Clostridium botulinum type E in fishes packaged
• Adesiyun, A.A. 1984. Enterotoxigenicity of under modified atmospheres. Int. J. Food Microbiol.
Staphylococcus aureus strains isolated from Nigerian 10:269-290.
ready-to-eat foods. J. Food Protect. 47:438-440.
• Baynes, N.C., J. Comrie, and J.H. Prain. 1983.
• Ajmal, M. 1968. Growth and toxin production of Detection of bacterial growth by the Malthus conduc-
Clostridium botulinum type E. J. Appl. Bacteriol. tance meter. Medi. Lab. Sci. 40:149-158.
31:120-123.
• Beckers, H.J., F.M. van Leusden, and P.D. Tips.
• Ando, Y. 1971. The germination requirements of 1985. Growth and enterotoxin production of
spores of Clostridium botulinum type E. Japan. J. Staphylococcus aureus in shrimp. J. Hyg., Camb.
Microbiol. 15:515-525. 95:685-693.
• Ando, Y. and H. Iida. 1970. Factors affecting the • Beltran, A., C. Pelaez, and A. Moral. 1989.
germination of spores of Clostridium botulinum type Keeping quality of vacuum-packed smoked sardine
E. Japan. J. Microbiol. 14:361-370. fillets: microbiological aspects. Z. Lebensm Unters
Forsch. 188:232-236.
306
• Ben Embarek, P.K. 1994. Presence, detection, and • Buchanan, R.L. and L.A. Klawitter. 1992.
growth of Listeria monocytogenes in seafoods: A The effect of incubation temperature, initial pH,
review. Int. J. Food Microbiol. 23:17-34. and sodium chloride on the growth kinetics of
Escherichia coli. Food Microbiol. 9:185-196.
• Ben Embarek, P.K. and H.H. Huss. 1993. Heat
resistance of Listeria monocytogenes in vacuum • Buchanan, R.L. 1991. Microbiological criteria for
packaged pasteurized fish fillets. Int. J. Food cooked, ready-to-eat shrimp and crabmeat. Food
Microbiol. 20:85-95. Technol. 45:157-160
• Ben Embarek, P.K. and H.H. Huss. 1992. Growth • Buchanan, R.L. 1991. Using spreadsheet software
of Listeria monocytogenes in lightly preserved fish for predictive microbiology applications. J. Food
products, p. 293-303. In Huss, H.H. et al (eds), Safety. 11:123-134.
Quality Assurance in the Fish Industry, Proceedings
of an International Conference, Copenhagen, Den- • Buchanan, R.L. and M.L. Cygnarowicz. 1990.
mark, August 26-30, 1991. Elsevier Sci. Publ. B.V., A mathematical approach toward defining and
Amsterdam. calculating the duration of the lag phase.
Food Microbiol. 7:237-240.
• Beuchat, L.R. 1974. Combined effects of water
activity, solute, and temperature on the growth of • Buchanan, R.L. and J.G. Phillips. 1990. Response
Vibrio parahaemolyticus. Appl. Microbiol. surface model for predicting the effects of tempera-
27:1075-1080. ture, pH, sodium chloride content, sodium nitrite
concentration and atmosphere on the growth of
• Beuchat, L.R. 1973. Interacting effects of pH, Listeria monocytogenes. J. Food Prot. 53:370-
temperature, and salt concentration on growth and 376,381.
survival of Vibrio parahaemolyticus. Appl.
Microbiol. 25:844-846. • Carlin, F., C. Nguyen-the and A. Abreu da Silva.
1995. Factors affecting the growth of Listeria
• Boutin, B.K., J.G. Bradshaw, and W.H. Stroup. monocytogenes on minimally processed fresh endive.
1982. Heat processing of oysters naturally contami- J. Appl. Bacteriol. 78:636-646.
nated with Vibrio cholerae Serotype O1. J. Food
Prot. 45:169-171. • Carlson, V.L. and G.H. Snoeyenbos. 1972. Rela-
tionship of population kinetics of Salmonella
• Boyd, J.W. and B.A. Southcott. 1971. Effects of typhimurium and cultural methodology. Am. J. Vet.
sodium chloride on outgrowth and toxin production Res. 33:177-184.
of Clostridium botulinum Type E in cod
homogenates. J. Fish. Res. Bd. Can. 28:1071-1075. • Casales, M.R., C.E. Del Valle, and C.L. Soule.
1985. Critical heating point for thermal processing
• Brocklehurst, T.F. and B.M. Lund. 1990. The of mussels in cans. J. Food Sci. 50:836-837.
influence of pH, temperature and organic acids on
the initiation of growth of Yersinia enterocolitica. • Chitchester, C.O. and H.D. Graham (eds). 1973.
J. Appl. Bacteriol. 69:390-397. Microbial Safety of Fishery Products. Academic
Press, New York.
• Bryan, F.L. 1979. Staphylococcus aureus. In:
Food Microbiology: Public health and Spoilage • Christiansen, L.N., J. Deffner, E.M. Foster, and H.
Aspects. The Avi Publ. Co., Inc. Westport, CT. Sugiyama. 1968. Survival and outgrowth of
Clostridium botulinum type E spores in smoked fish.
• Buchanan, R.L. 1993. Predictive food Appl. Microbiol. 16:553-557.
microbiology. Trends Food Sci. Technol. 4:6-11.
Continued
307
• Cole, M.B., M.V. Jones, and C. Holyoak. 1990. • Dalgaard, P. and L.V. Jorgensen. 1998. Predicted
The effect of pH, salt concentration and temperature and observed growth of Listeria monocytogenes in
on the survival and growth of Listeria seafood challenge tests and in naturally contaminated
monocytogenes. J. Appl. Bacteriol. 69:63-72. cold-smoked salmon. Intl. J. Food Microbiol. 40:
105-115.
• Colwell, R.R.(ed.). 1984. Vibrios in the Environ-
ment. John Wiley Interscience, New York. • Davies, A.R. and A. Slade. 1995. Fate of
Aeromonas and Yersinia on modified-atmosphere
• Connor, D.E., V.N. Scott, D.T. Bernard, and D.A. packaged (MAP) cod and trout. Lett. in Appl.
Kautter. 1989. Potential Clostridium botulinum Microbiol. 21:354-358.
hazards associated with extended shelf-life refriger-
ated foods; a review. J. Food Safety. 10:131-153. • Dengremont, E. and J.M. Membre. 1995. Statisti-
cal approach for comparison of the growth rates of
• Cook, D.W. 1994. Effect of time and temperature five strains of Staphylococcus aureus. Appl. Environ.
on multiplication of Vibrio vulnificus in postharvest Microbiol. 61:4389-4395.
Gulf Coast shellstock oysters. Appl. Environ.
Microbiol. 60:3483-3484. • DePaola, A., G.M. Capers, and D. Alexander. 1994.
Densities of Vibrio vulnificus in the intestines of fish
• Cook, D.W. and A.D. Ruple. 1992. Cold storage from the U.S. Gulf Coast. Appl. Environ. Microbiol.
and mild heat treatment as processing aids to reduce 60:984-988.
the number of Vibrio vulnificus in raw oysters. J.
Food Protect. 55:985-989. • Destro, M.T., M.F.F. Leitao, and J.M. Farber.
1996. Use of molecular typing methods to trace the
• Cook, D.W. and A.D. Ruple. 1989. Indicator dissemination of Listeria monocytogenes in a shrimp
bacteria and Vibrionaceae multiplication in post- processing plant. Appl. Environ. Microbiol.
harvest shellstock oysters. J. Food Protect. 52:343- 62:705-711.
349.
• Dickerson, R.W. and M.R. Berry, Jr. 1976.
• Cortesi, M.L., T. Sarli, A. Santoro, N. Murru, and T. Heating curves during commercial cooking of the
Pepe. 1997. Distribution and behavior of Listeria blue crab. J. Milk Food Technol. 39:258-262.
monocytogenes in three lots of naturally-contami-
nated vacuum-packed smoked salmon stored at 2 and • Dickerson, R.W., Jr. and R.B. Read, Jr. 1973.
10˚C. Intl. J. Food Microbiol. 37: 209-214. Cooling rates of foods. J. Milk Food Technol.
36:167-171.
• Craven, S.E. 1980. Growth and sporulation of
Clostridium perfringens in foods. Food Technol. 34: • Dickson, J.S., G.R. Siragusa, and J.E. Wray Jr.
80-87. 1992. Predicting the growth of Salmonella
typhimurium on beef by using the temperature
• Dahl Sawyer, C.A. and J.J. Pestka. 1985. function integration technique. Appl. Environ.
Foodservice systems: Presence of injured bacteria in Microbiol. 58:3482-3487.
foods during food product flow. Ann. Rev.
Microbiol. 39:51-67. • Deibel, K.E. 1995. Potential of Staphylococcus
aureus to produce enterotoxin in fish batter at various
• Datz, M., C. Janetzki-Mittmann, S. Franke, F. temperatures, p. 33. In Medallion Lab (ed), Proceed-
Gunzer, H. Schmidt, and H. Karch. 1996. Analysis ings of the IFT Annual Meeting. Medallion Lab,
of the enterohemorrhagic Escherichia coli O157 Minneapolis, MN.
DNA region containing lambdoidphage gene p and
shiga-like toxin structural genes. Appl. Environ.
308
• Diez de Medina, D., G. Flick, R. Whittman, A • Eklund, M.W., F.T. Poysky, R.N. Paranjpye, L.C.
Diallo, and R. Croonenberghs. 1995. Growth of Lashbrook, M.E. Peterson, and G.A. Pelroy. 1995.
Listeria monocytogenes in fresh blue crab Incidence and sources of Listeria monocytogenes in
(Callinectes sapidus) meat in the presence of cold-smoked fishery products and processing plants.
naturally occurring microflora during refrigerated J. Food Prot. 58:502-508.
storage, p. 178. In IFT (ed), Abstracts of IFT Annual
Meeting 1995. Virginia Polytechnic Institute, • Eklund, M.W., D.I. Weiler, and F.T. Poysky. 1967.
Blacksburg, VA. Outgrowth and toxin production of non-proteolytic
type B Clostridium botulinum at 3.3 to 5.6˚C. J.
• Dillon, R. and T. Patel. 1993. Effect of cold Bacteriol. 93:1461-1462.
smoking and storage temperature on Listeria
monocytogenes in inoculated cod fillets (Gadus • Fapohunda, A.O., K.W. McMillen, D.L. Marshall,
morhus). Food Res. Int. 26:97-101. and W.M. Waites. 1994. Growth of selected cross-
contaminating bacterial pathogens on beef and fish at
• Dillon, R. and T. Patel. 1992. Listeria in seafoods: 15˚ and 35˚C. J. Food Prot. 57:337-340.
a review. J. Food Prot. 55:1009-1015.
• Farber, J.M. 1991. Listeria monocytogenes in fish
• Dillon, R., T. Patel, and S. Ratnam. 1994. Occur- products. J. Food Prot. 54:922-924.
rence of Listeria in hot and cold smoked seafood
products. Int. J. Food Microbiol. 22:73-77. • Farber, J.M. and J.Z. Losos. 1988. Listeria
monocytogenes: a foodborne pathogen. Can. Med.
• Doyle, M.P. (ed). 1989. Foodborne Bacterial Assoc. J. 138:413-318.
Pathogens. Marcel-Dekker, New York.
• Fernandes, C.F., G.J. Flick, and T.B. Thomas.
• Duran, A.P., B.A. Wentz, J.M. Lanier, F.D. 1998. Growth of inoculated psychrotrophic patho-
McClure, A.H. Schwab, A. Swartzentruber, R.J. gens on refrigerated fillets of aquacultured Rainbow
Barnard, and R.B. Read. 1983. Microbiological Trout and Channel Catfish. J. Food Protect. 61: 313-
quality of breaded shrimp during processing. J. Food 317.
Prot. 46:974-977.
• Fernandez, P.S., S.M. George, C.C. Stills, and M.W.
• Elsea, W.R., W.E. Mosher, R.G. Lennon, V. Peck. 1997. Predictive model of the effect of CO2,
Markellis, and P.F. Hoffman. 1971. An epidemic of pH, temperature, and NaCl on the growth of Listeria
food-associated pharyngitis and diarrhea. Arch. monocytogenes. Intl. J. Food Microbiol. 37: 37-45.
Environ. Health. 23:48-56.
• Fuchs, R.S. and P.J.A. Reilly. 1992. The incidence
• El-Shenawy, M.A. and E.H. Marth. 1988. Sodium and significance of Listeria monocytogenes in
benzoate inhibits growth of or inactivates Listeria seafoods, p. 217-229. In Huss, H.H., M. Jakobsen,
monocytogenes. J. Food Prot. 51:525-530. and J. Liston (eds), Quality Assurance in the Fish
Industry. Proc. Int. Conf. Aug. 26-30, 1991,
• El-Shenawy, M.A. and E.H. Marth. 1988. Inhibi- Copenhagen. Elsevier Sci. Publ. B.V., Amsterdam.
tion and inactivation of Listeria monocytogenes by
sorbic acid. J. Food Prot. 51:842-847. • Fujino, T., G. Sakaguchi, and Y. Takeda (eds).
1973. International Symposium on Vibrio
• Eklund, M.W., G.A. Pelroy, R. Paranjpye, M.E. parahaemolyticus. Saikon, Tokyo.
Peterson, and F.M. Teeny. 1982. Inhibition of
Clostridium botulinum Types A and E toxin produc-
tion by liquid smoke and NaCl in hot-process smoke-
flavored fish. J. Food Prot. 45:935-941.
Continued
309
• Garren, D.M., M.A. Harrison, and Y.W. Huang. • Gourama, H., W.Y. Tsai, and L.B. Bullerman.
1995. Growth and production of toxin of 1991. Growth and production of enterotoxins A and
Clostridium botulinum type E in rainbow trout under D by Staphylococcus aureus in salad bar ingredients
various storage conditions. J. Food Prot. 58:863-866. and clam chowder. J. Food Prot. 54:844-847.
• Garren, D.M., M.A. Harrison, and Y-W. Huang. • Goverde, R.L.J., J.G. Kusters, and J.H.J. Huls in ‘t
1994. Clostridium botulinum type E outgrowth and Veld. 1994. Growth rate and physiology of Yersinia
toxin production in vacuum skin packaged shrimp. enterocolitica; influence of temperature and presence
Food Microbiol. 11:467-472. of the virulence plasmid. J. Appl. Bacteriol.
77:96-104.
• Garthright, W.E. 1991. Refinements in the predic-
tion of microbial growth curves. Food Microbiol. • Grecz, N. and L.H. Arvay. 1982. Effect of
8:239-248. temperature on spore germination and vegetative cell
growth of Clostridium botulinum. Appl. Environ.
• George, S.M., B.M. Lund, and T.F. Brocklehurst. Microbiol. 43:331-337.
1988. The effect of pH and temperature on initiation
of growth of Listeria monocytogenes. Lett. Appl. • Greenwood, M.H., E.F.C. Coetzee, B.M. Ford, P.
Microbiol. 6:153-156. Gill, W.L. Hooper, S.C.W. Matthews, S. Patrick,
J.V.S. Pether, and R.J.D. Scott. 1985. The bacterio-
• George, S.M., L.C.C. Richardson, and M.W. Peck. logical quality of selected retail, ready-to-eat food
1996. Predictive models of the effect of temperature, products. III. Cooked crustaceans and mollusks.
pH, and acetic and lactic acids on the growth of Environ. Health. 93:236-239.
Listeria monocytogenes. Intl. J. Food Microbiol.
31: 73-90. • Griffin, M.R., E. Dalley, M. Fitzpatrick, and S.H.
Austin. 1983. Campylobacter gastroenteritis
• Gibbs, P.A., A.R. Davies, and R.S. Fletcher. 1994. associated with raw clams. J. Med. Soc. N.J.
Incidence and growth of psychrotrophic Clostridium 80:607-609.
botulinum in food. Food Control. 5:5-7.
• Groubert, T.N. and J.D. Oliver. 1994. Interaction
• Gibson, A.M., N. Bratchell, and T.A. Roberts. of Vibrio vulnificus and the Eastern oyster,
1988. Predicting microbial growth: growth responses Crassostrea virginica. J. Food Prot. 57:224-228.
of salmonellae in a laboratory medium as affected by
pH, sodium chloride and storage temperature. Int. J. • Guyer, S. and T. Jemmi. 1991. Behavior of
Food Microbiol. 6:155-178. Listeria monocytogenes during fabrication and
storage of experimentally contaminated smoked
• Gill, C.O. and L.M. Harris. 1982. Survival and salmon. Appl. Environ. Microbiol. 57:1523-1527.
growth of Campylobacter fetus subsp. jejuni on meat
and in cooked foods. Appl. Environ. Microbiol. • Hanninen, M.L., H. Korkeala, and P. Pakkala.
44:259-263. 1984. Growth and survival characteristics of
Campylobacter jejuni in liquid egg. J. Hyg., Camb.
• Godwin, G.J., R.M. Grodner, and A.F. Novak. 92:53-58.
1977. Twenty-four hour methods for bacteriological
analyses in frozen raw breaded shrimp. J. Food • Hany, O.E., R. Siddiqi, and M.A. Khan. 1993.
Science. 42:750-754. Growth response of Listeria monocytogenes NCTC
7973 in two different media at four incubation
• Gould, G.W. 1999. Sous vide foods: conclusions temperatures. Annals Acad. Med. Singapore.
of an ECFF botulinum working party. Food Control 22:300-302.
10: 47-51.
310
• Harrison, M.A., Y-W. Huang, C-H. Chao, and T. • Ingham, S.C., R.A. Alford, and A.P. McCown.
Shineman. 1991. Fate of Listeria monocytogenes on 1990. Comparative growth rates of Salmonella
packaged, refrigerated, and frozen seafood. J. Food typhimurium and Pseudomonas fragi on cooked crab
Prot. 54:524-527. meat stored under air and modified atmosphere.
J. Food Prot. 53:566-567.
• Hathcox, A.K., L.R. Beuchat, and M.P. Doyle.
1995. Death of enterohemorrhagic Escherichia coli • International Commission on Microbiological
O157:H7 in real mayonnaise and reduced-calorie Specifications for Foods (ICMSF). 1996.
mayonnaise dressing as influenced by initial Microorganisms in Foods 5. Characteristics of
population and storage temperature. Appl. Environ. Microbial Pathogens. ICMSF, International Union of
Microbiol. 61:4172-4177. Biological Societies. Blackie Academic &
Professional, London. 520 p.
• Helmy, Z.A., A. Abd-El-Bakey, and E.I. Mohamed.
1984. Factors affecting germination and growth of • Islam, M.S., M.K. Hasan, and S.I. Khan. 1993.
Bacillus cereus spores in milk. Zbl. Mikrobiol. 139: Growth and survival of Shigella flexneri in common
135-141. Bangladeshi foods under various conditions of time
and temperature. Appl. Environ. Microbiol. 59:652-
• Hobbs, G. 1976. Clostridium botulinum and its 654.
importance in fishery products. Adv. Food Res.
22:135-185. • James, D.G. and J. Olley. 1971. Spoilage of shark.
Aust. Fish. 30:11-13.
• Hudson, J.A. and S.M. Avery. 1994. Growth of
Listeria monocytogenes, Aeromonas hydrophila, and • Jemmi, T. and A. Keusch. 1992. Behavior of
Yersinia enterocolitica on cooked mussel tissue under Listeria monocytogenes during processing and
refrigeration and mild temperature abuse. J. Food storage of experimentally contaminated hot-smoked
Safety 14: 41-52. trout. Int. J. Food Microbiol. 15:339-346.
• Hudson, J.A. and S.J. Mott. 1993. Growth of • Jones, J.E., S.J. Walker, J.P. Sutherland, M.W. Peck,
Listeria monocytogenes, Aeromonas hydrophila, and and C.L. Little. 1994. Mathematical modelling of
Yersinia enterocolitica on cold-smoked salmon under the growth, survival and death of Yersinia
refrigeration and mild temperature abuse. Food enterocolitica. Int. J. Food Microbiol. 23:433-447.
• Jorgensen, L.V. and H.H. Huss. 1998. Prevalence
• Hughes, A. and A. Hurst. 1980. The effect of NaCl and growth of Listeria monocytogenes in naturally
on the upper temperature limit for growth of and contaminated seafood. Intl. J. Food Microbiol. 42:
enterotoxin synthesis by Staphylococcus aureus. 127-131.
Can. J. Microbiol. 26:507-510.
• Juneja, V.K., J.E. Call, B.S. Marmer and A.J. Miller.
• Huss, H.H. 1992. Development and use of the 1994. The effect of temperature abuse on
HACCP concept in fish processing. Int. J. Food Clostridium perfringens in cooked turkey stored
Microbiol. 15:33-44. under air and vacuum. Food Microbiol. 11: 187-193.
• Huss, H.H. 1997. Control of indigenous patho- • Juneja, V.K. and B.S. Marmer. 1996. Growth of
genic bacteria in seafood. Food Control 8: 91-98. Clostridium perfringens from spore inocula in sous-
vide products. Intl. J. Food Microbiol. 32: 115-123.
Continued
311
• Juneja, V.K., B.S. Marmer, J.G. Phillips and S.A. • Lotter, L.P. and L. Leistner. 1978. Minimal water
Palumbo. 1996. Interactive effects of temperature, activity for enterotoxin A production and growth of
initial pH, sodium chloride, and sodium pyrophos- Staphylococcus aureus. Appl. Environ. Microbiol.
phate on the growth kinetics of Clostridium 36:377-380.
perfringens. J. Food Protect. 59: 963-968.
• Lu, J.Y., R.D. Pace, and W.D. Plahar. 1991. Stor-
• Kaneko, T. and R.R. Colwell. 1973. Ecology of age conditions and microbial quality of smoked dry
Vibrio parahaemolyticus in Chesapeake Bay. J. herring in Ghana. J. Food Prot. 54:557-559.
Bacteriol. 113:24-32.
• Lund, B.M., A.F. Graham, S.M. George, and D.
• Karim, P. and B. Embarek. 1994. Presence, Brown. 1990. The combined effect of incubation
detection, and growth of Listeria monocytogenes in temperature, pH, and sorbic acid on the probability of
sea-foods: a review. Int. J. Food Microbiol. growth of non-proteolytic, type B Clostridium
23:17-34. botulinum. J. Appl. Bacteriol. 69:481-492.
• Kaspar, C.W. and M.L. Tamplin. 1993. Effects of • Mackey, B.M., T.A. Roberts, J. Mansfield, and G.
temperature and salinity on the survival of Vibrio Farkas. 1980. Growth of Salmonella on chilled
vulnificus in seawater and shellfish. Appl. Environ. meat. J. Hyg., Camb. 85:115-124.
Microbiol. 59:2425-2429.
• Matches, J.R. 1982. Microbial changes in pack-
• Koff, R.S. and H.S. Sear. 1967. Internal ages, p. 46-70. In Martin, R. (ed), Proceedings of the
temperature of steamed clams. New Engl. J. Med. First National Conference on Seafood Packaging and
276:737-739. Shipping. National Fisheries Institute, Seattle, WA.
• Lachia, R.V., G.J. Silverman, and R. Sharp. 1988. • Matches, J.R. and J. Liston. 1972. Effect of pH on
Guide to the Salvage of Temperature-Abused Food low temperature growth of Salmonella. J. Milk Food
Products in Military Commissaries. Technical Technol. 35:49-52.
Report on Project No. AAF87-12,II. U.S. Army
Natick Research, Development and Engineering • Matches, J.R. and J. Liston. 1968. Low tempera-
Center, Natick, MA. 36 p. ture growth of Salmonella. J. Food Sci. 33:641-645.
• Leung, C-K., Y-W. Huang, and O.C. Pancorbo. • Matches, J.R., J. Liston, and L.P. Daneault. 1971.
1992. Bacteria pathogens and indicators in catfish Survival of Vibrio parahaemolyticus in fish homoge-
and pond environments. J. Food Prot. 55:424-427. nate during storage at low temperature. Appl.
• Lindberg, C.W. and E. Borch. 1994. Predicting the
aerobic growth of Yersinia enterocolitica O:3 at • Maurelli, A.T., B. Blackmon, and R. Curtiss III.
different ph-values, temperatures and L-lactate 1984. Temperature-dependent expression of viru-
concentrations using conductance measurements. lence genes in Shigella species. Infect. Immun.
Int. J. Food Microbiol. 22:141-153. 43:195-201.
• Little, C.L. and S. Knochel. 1994. Growth and • Molin, G. and I-M. Stenstroem. 1984. Effect of
survival of Yersinia enterocolitica, Salmonella, and temperature on the microbial flora of herring fillets
Bacillus cereus in brie stored at 4, 8, and 20˚C. Int. stored in air of carbon dioxide. J. Appl. Bacteriol.
J. Food Microbiol. 24:137-145. 56:275-282.
312
• Molin, G., I-M. Stenstroem, A. Ternstroem. 1983. • Pelroy, G.A., M.W. Eklund, R.N. Paranjpye, E.M.
The microbial flora of herring fillets after storage Suzuki, and M.E. Peterson. 1982. Inhibition of
in carbon dioxide, nitrogen, or air at 2 degrees C. Clostridium botulinum Types A and E toxin forma-
J. Appl. Bacteriol. 55:49-56. tion by sodium nitrite and sodium chloride in hot-
process (smoked) salmon. J. Food Prot. 45:833-841.
• Motes, M.L. Jr. 1991. Incidence of Listeria spp. in
shrimp. oysters, and estuarine waters. J. Food Prot. • Pelroy, G., M. Peterson, R. Paranjpye, J. Almond,
54:170-173. and M. Eklund. 1994. Inhibition of Listeria
monocytogenes in cold-process (smoked) salmon by
• Murphree, R.L. and M.L. Tamplin. 1995. Uptake sodium nitrite and packaging method. J. Food Prot.
and retention of Vibrio cholerae O1 in the eastern 57:114-119.
oyster, Crassostrea virginica. Appl. Environ.
Microbiol. 61:3656-3660. • Peters, A.C., L. Thomas, and J.W.T. Wimpenny.
1991. Effects of salt concentration on bacterial
• Murphy, S.K. and J.D. Oliver. 1992. Effects of growth on plates with gradients of pH and tempera-
temperature abuse on survival of Vibrio vulnificus in ture. FEMS Microbiol. Lett. 77:309-314.
oysters. Appl. Environ. Microbiol. 58:2771-2775.
• Peterson, M.E., G.A. Pelroy, R.N. Paranjpye, F.T.
• National Advisory Committee on Microbiological Poysky, J.S. Almond, and M.W. Eklund. 1993.
Criteria for Foods. 1992. Microbiological criteria for Parameters for control of Listeria monocytogenes in
raw molluscan shellfish. J. Food Prot. 55:463-480. smoked fishery products: sodium chloride and
packaging method. J. Food Prot. 56:938-943.
• National Advisory Committee on Microbiological
Criteria for Foods. 1992. Vacuum or Modified • Potter, L. and L. Leistner. 1978. Minimal water
Atmosphere Packaging for Refrigerated Raw Fishery activity for enterotoxin A production and growth of
Products. Executive secretariat, Food Safety and Staphylococcus aureus. Appl. Environ. Microbiol.
Inspection Service, U.S. Dept. Agriculture, Washing- 36:377-380.
ton, D.C.
• Raj. H.D. 1970. Public health bacteriology of
• National Advisory Committee on Microbiological processed frozen foods. Lab. Practice.
Criteria for Foods. 1991. Listeria monocytogenes: 19:374-377 & 394.
Recommendations of the National Advisory Committe
on Microbiological Criteria for Foods. Int’l. J. Food • Ratkowsky, D.A., R.K. Lowry, T.A. McMeekin,
Microbiol. 14:185-246. A.N. Stokes, and R.E. Chandler. 1983. Model for
bacterial culture growth rate throughout the entire
• Ostovar, K. and M.J. Bremier. 1975. Effect of biokinetic temperature range. J. Bacteriol.
thawing on growth of Staphylococcus aureus in 154:1222-1226.
frozen convenience food items. J. Milk Food
Technol. 38:337-339. • Ratkowsky, D.A., J. Olley, T.A. McMeekin, and
A. Ball. 1982. Relationship between temperature
• Pedrosa-Menabrito, A. and J.M. Regenstein. 1990. and growth rate of bacterial cultures. J. Bacteriol.
Shelf-life extension of fresh fish - a review. Part II - 149:1-5.
Preservation of fish. J. Food Qual. 13:129-146.
• Rey, C.R., H.W. Walker and P.L. Rohrbaugh. 1975.
• Pedrosa-Menabrito, A. and J.M. Regenstein. 1988. The influence of temperature on growth, sporulation,
Shelf-life extension of fresh fish - a review. Part I - and heat resistance of spores of six strains of
Spoilage of fish. J. Food Qual. 11:117-127. Clostridium perfringens. J. Milk Food Technol. 38:
461-465.
Continued
313
• Richards, J.C.S., A.C. Jason, G. Hobbs, D.M. • Segner, W.P., C.F. Schmidt, and J.K. Boltz. 1971.
Gibson, and R.H. Christie. 1978. Electronic mea- Minimal growth temperature, sodium chloride
surement of bacterial growth. J. Phys. E.: Sci. tolerance, pH sensitivity, and toxin production of
Instrum. 11:560-568. marine and terrestrial strains of Clostridium botuli-
num type C. Appl. Microbiol. 22:1025-1029.
• Roberts, D. and R.J. Gilbert. 1979. Survival and
growth of non-cholera vibrios in various foods. J. • Shaw, M.K., A.G. Marr, and J.L. Ingraham. 1971.
Hyg., Camb. 82:123-131. Determination of the minimal temperature for growth
of Escherichia coli. J. Bacteriol. 105:683-684.
• Roberts, T.A. and A.M. Gibson. 1983. Chemical
methods for controlling Clostridium botulinum in • Skinner, G.E. and J.W. Larkin. 1998. Conservative
processed meats. Food Technol. 40:163-171,176. prediction of time to Clostridium botulinum toxin
formation for use with time-temperature indicators to
• Roberts, T.A. and G. Hobbs. 1968. Low tempera- ensure the safety of foods. J. Food Protect. 61: 1154-
ture growth characteristics of clostridia. J. Appl. 1160.
Bacteriol. 31:75-88.
• Smith, M.G. 1985. The generation time, lag time,
• Romick, T.L., H.P. Fleming, and R.F. McFeeters. and minimum temperature of growth of coliform
1996. Aerobic and anaerobic metabolism of Listeria organisms on meat, and the implications for codes of
monocytogenes in defined glucose medium. Appl. practice in abattoirs. J. Hyg., Camb. 94:289-300.
Environ. Microbiol. 62:304-307.
• Smith, G.R. and A. Turner. 1989. The production
• Rørvik, L.M. and M. Yndestad. 1991. Listeria of Clostridium botulinum toxin in mammalian, avian,
monocytogenes in foods in Norway. Int. J. Food and piscine carrion. Epidemiol. Infect. 102:467-471.
• Sokari, T. 1991. Distribution of enterotoxigenic
• Rørvik, L.M., M. Yndestad, M., and E. Skjerve. Staphylococcus aureus in ready-to-eat foods in
1991. Growth of Listeria monocytogenes in eastern Nigeria. Int. J. Food Microbiol. 12:275-279.
vacuum-packed, smoked salmon during storage at
4˚C. Int. J. Food Microbiol. 14:111-118. • Subcomm. on Microbiol. Criter. 1985. An
Evaluation of the Role of Microbiological Criteria
• Rusul, G. and N.H. Yaacob. 1995. Prevalence of for Foods and Food Ingredients. Committee on Food
Bacillus cereus in selected foods an detection of Protection, Natl. Research Council. National Acad-
enterotoxin using TECRA-VIA and BCET-RPLA. emy Press, Washington, D.C. 256 p.
Intl. J. Food Microbiol. 25: 131-139.
• Sutherland, A.D. 1993. Toxin production by
• Schiemann, D.A. 1988. Examination of Bacillus cereus in dairy products. J. Dairy Res. 60:
enterotoxin production at low temperature by 569-574.
Yersinia enterocolitica in culture media and foods.
J. Food Prot. 51:571-573. • Sutherland, J.P., A. Aherne, and A.L. Beaumont.
1996. Preparation and validation of a growth model
• Schiemann, D.A. 1980. Yersinia enterocolitica: for Bacillus cereus: the effects of temperature, pH,
observations on some growth characteristics and sodium chloride and carbon dioxide. Intl. J. Food
response to selective agents. Can. J. Microbiol. Microbiol. 30: 359-372.
26:1232-1240.
314
• Sutherland, J.P. and A.J. Bayliss. 1994. Predictive • U.S. Food and Drug Administration. 2000.
modelling of growth of Yersinia enterocolitica: the National Shellfish Sanitation Program, Guide for the
effects of temperature, pH, and sodium chloride. Int. Control of Molluscan Shellfish, Part I, Sanitation of
J. Food Microbiol. 21:197-215. Shellfish Growing Areas. DHHS/FDA/CFSAN,
Office of Seafood, Washington, DC.
• Sutherland, J.P., A.J. Bayliss, and T.A. Roberts.
1994. Predictive modelling of growth of Staphylo- • U.S. Food and Drug Administration. 1997.
coccus aureus: the effects of temperature, pH and Foodborne Pathogenic Microorganisms and
sodium chloride. Int. J. Food Microbiol. 21:217-236. Natural Toxins. Available at internet site:
http://vm.cfsan.fda.gov/list.html.
• Swartzentruber, A., A.H. Schwab, A.P. Duran, B.A.
Wents, and R.B. Read, Jr. 1980. Microbiological • Walker, S.J., P. Archer, and J.G. Banks. 1990.
quality of frozen shrimp and lobster tail in the retail Growth of Listeria monocytogenes at refrigeration
market. Appl. Environ. Microbiol. 40:765-769. temperatures. J. Appl. Bacteriol. 68:157-162.
• Syndicat National des Fabricants de Plats Prepares. • Wang, C. and L.A. Shelef. 1992. Behavior of
1995. Aide a la maitrise de l’hygiene alimentaire. Listeria monocytogenes and the spoilage microflora
Collection Alesial, Alesial Services, Paris. in fresh cod fish treated with lysozyme and EDTA.
Food Microbiol. 9:207-213.
• Telzak, E.E., E.P. Bell, D.A. Kautter, L. Crowell,
L.D. Budnick, D.L. Morse, and S. Schultz. 1990. • Ward, D.R. and C.R. Hackney (eds). 1991. Micro-
International outbreak of type E botulism due to biology of Marine Food Products. Van Nostrand
uneviscerated fish. J. Infect. Dis. 161:340-342. Reinhold, New York.
• Thayer, D.W., W.S. Muller, R.L. Buchanan, and • Watkins, W. and S. McCarthy (eds). 1995. Pro-
J.G. Phillips. 1987. Effect of NaCl, pH, tempera- ceedings of the 1994 Vibrio vulnificus Workshop,
ture, and atmosphere on growth of Salmonella Second Printing. DHHS/FDA/CFSAN, Office of
typhimurium in glucose-mineral salts medium. Appl. Seafood, Washington, D.C.
Environ. Microbiol. 53:1311-1315.
• Weagant, S.D., P.N. Sado, K.G. Colburn, J.D.
• Thomas, L.V., J.W.T. Wimpenny, and A.C. Peters. Torkelson, F.A. Stanley, M.H. Krane, S.E. Shields,
1992. Testing multiple variables on the growth of a and C.F. Thayer. 1988. The incidence of Listeria
mixed inoculum of Salmonella strains using gradient species in frozen seafood products. J. Food Prot.
plates. Int. J. Food Microbiol. 15:165-175. 51:655-657.
• Thomas, L.V., J.W.T. Wimpenny, and A.C. Peters. • Weber, J.T., R.G. Hibbs Jr., A. Darwish, B. Mishu,
1991. An investigation of the effects of four vari- A.L. Corwin, M. Rakha, C.L. Hatheway, S. el
ables in the growth Salmonella typhimurium using Sharkawy, S.A. el- Rahim, M.F. al-Hamd, et al.
two types of gradient gel plates. Int. J. Food 1993. A massive outbreak of type E botulism
Microbiol. 14:261-275. associated with traditional salted fish in Cairo.
J. Infect. Dis. 167:451-454.
• Tilton, R.C. and R.W. Ryan. 1987. Clinical and
ecological characteristics of Vibrio vulnificus in the • Weichart, D. and J.D. Oliver. 1992. Low tempera-
northeastern United States. Diagn. Microbiol. Infect. ture induced non-culturability and killing of Vibrio
Dis. 6:109-117. vulnificus. FEMS Microbiol. Lett. 79:205-210.
Continued
315
• West, P.A. 1989. The human pathogenic vibrios - TABLE A-3
a public health update with environmental perspec-
tives. Epidem. Infect. 103:1-34. • European Chilled Food Federation. 1997. Guide-
lines for good hygienic practice in the manufacture of
• Whiting, R.C. and K.A. Naftulin. 1992. Effect of chilled foods.
headspace oxygen concentration on growth and toxin
production by proteolytic strains of Clostridium • Mackey, B.M. and N. Bratchell. 1989. The heat
botulinum. J. Food Prot. 55:23-17. tilapia fillets resistance of Listeria monocytogenes. Lett. Appl.
during storage. J Food Sci. 61:632-635. Microbiol. 9:89-94.
• Wright, A.C., R.T. Hill, J.A. Johnson, M.C. TABLE A-4

Roghman, R.R. Colwell, and J.G. Morris, Jr. 1996.
Distribution of Vibrio vulnificus in the Chesapeake • European Chilled Food Federation. 1997. Guide-
Bay. Appl. Environ. Microbiol. 62:717-724. lines for good hygienic practice in the manufacture of
chilled foods.
• Zaika, L.L., E. Moulden, L. Weimer, J.G. Phillips,
and R.L. Buchanan. 1994. Model for the combined • Mackey, B.M. and N. Bratchell. 1989. The heat
effects of temperature, initial pH, sodium chloride resistance of Listeria monocytogenes. A review.
and sodium nitrite concentrations on anaerobic Letters in Appl. Microbiol. 9:89-94.
growth of Shigella flexneri. Int. J. Food Microbiol.
23:345-358. • Peterson, M. E., G.A. Pelroy, F.T Poysky, R.N.
Paranjpye, R.M. Dong, G.M. Pigott, and M.W.
• Zaika, L.L., J.G. Phillips, J.S. Fanelli and O.J. Eklund. 1997. Heat-pasteurization process for
Scullen. 1998. Revised model for aerobic growth of inactivation of nonproteolytic types of Clostridium
Shigella flexneri to extend the validity of predictions botulinum in picked dungeness crabmeat. J. Food
at temperatures between 10 and 19˚C. Intl. J. Food Prot. 60:928-934.
Microbiol. 41: 9-19.
• U.S. Food and Drug Administration and U.S.
• Zwietering, M.H., I. Jongenburger, F.M. Rombouts, Department of Agriculture. 2001. Draft assessment
and K. van’t Riet. 1990. Modeling of the bacterial of the relative risk to public health from foodborne
growth curve. Appl. Environ. Microbiol. Listeria monocytogenes amoung selected categories
56:1875-1881. of ready-to-eat foods.
316
FDA/CFSAN Fish and Fisheries Products Hazards & Controls Guidance: 3rd Ed., Appendix 8 - Seafood HACCP Regulation
U.S. Food & Drug Administration

Center for Food Safety & Applied Nutrition
FISH AND FISHERIES PRODUCTS
HAZARDS AND CONTROLS GUIDANCE:
Third Edition June 2001
APPENDIX 8
Seafood HACCP Regulation
(Return to table of contents.)
Title 21 of the Code of Federal Regulations Part 123 – Fish & Fishery
Products
● Subpart A – General Provisions
Sec.
123.3 Definitions
123.5 Current good manufacturing practice
123.6 Hazard Analysis and Hazard Analysis Critical Control Point (HACCP) plan
123.7 Corrective actions
123.8 Verification
123.9 Records
123.10 Training
123.11 Sanitation control procedures
123.12 Special requirements for imported products
● Subpart B – Smoked & Smoke-Flavored Fishery Products
123.15 General
123.16 Process controls
● Subpart C – Raw Molluscan Shellfish
123.20 General
http://www.cfsan.fda.gov/~comm/haccp4x8.html (1 of 15) [9/30/2002 11:22:36 AM]

123.28 Source controls

Authority: Secs. 201, 402, 403, 406, 409, 701, 704, 721, 801, 903 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321, 342, 343, 346, 348, 371, 374, 379e, 381, 393); secs. 301, 307, 361
of the Public Health Service Act (42 U.S.C. 241, 242l, 264).
● Subpart A – General Provisions
❍ Sec. 123.3 Definition
The definitions and interpretations of terms in section 201 of the Federal Food, Drug, and
Cosmetic Act (the act) and in part 110 of this chapter are applicable to such terms when
used in this part, except where they are herein redefined. The following definitions shall also
apply:
a. Certification number means a unique combination of letters and numbers assigned by a
shellfish control authority to a molluscan shellfish processor.
b. Critical control point means a point, step, or procedure in a food process at which control
can be applied, and a food safety hazard can as a result be prevented, eliminated, or reduced
to acceptable levels.
c. Critical limit means the maximum or minimum value to which a physical, biological, or
chemical parameter must be controlled at a critical control point to prevent, eliminate, or
reduce to an acceptable level the occurrence of the identified food safety hazard.
d. Fish means fresh or saltwater finfish, crustaceans, other forms of aquatic animal life
(including, but not limited to, alligator, frog, aquatic turtle, jellyfish, sea cucumber, and sea
urchin and the roe of such animals) other than birds or mammals, and all mollusks, where
such animal life is intended for human consumption.
e. Fishery product means any human food product in which fish is a characterizing
ingredient.
f. Food safety hazard means any biological, chemical, or physical property that may cause a
food to be unsafe for human consumption.
g. Importer means either the U.S. owner or consignee at the time of entry into the United
States, or the U.S. agent or representative of the foreign owner or consignee at the time of
entry into the United States, who is responsible for ensuring that goods being offered for
entry into the United States are in compliance with all laws affecting the importation. For
the purposes of this definition, ordinarily the importer is not the custom house broker, the
freight forwarder, the carrier, or the steamship representative.
h. Molluscan shellfish means any edible species of fresh or frozen oysters, clams, mussels,
or scallops, or edible portions of such species, except when the product consists entirely of
the shucked adductor muscle.
i. Preventive measure means physical, chemical, or other factors that can be used to control
an identified food safety hazard.

j. Process-monitoring instrument means an instrument or device used to indicate conditions

during processing at a critical control point.
k. (1) Processing means, with respect to fish or fishery products: Handling, storing,
preparing, heading, eviscerating, shucking, freezing, changing into different market forms,
manufacturing, preserving, packing, labeling, dockside unloading, or holding.
(2) The regulations in this part do not apply to:
■ (i) Harvesting or transporting fish or fishery products, without otherwise
engaging in processing.
■ (ii) Practices such as heading, eviscerating, or freezing intended solely to
prepare a fish for holding on board a harvest vessel.
■ (iii) The operation of a retail establishment.
l. Processor means any person engaged in commercial, custom, or institutional processing of
fish or fishery products, either in the United States or in a foreign country. A processor
includes any person engaged in the production of foods that are to be used in market or
consumer tests.
m. Scombroid toxin-forming species means tuna, bluefish, mahi mahi, and other species,
whether or not in the family Scombridae, in which significant levels of histamine may be
produced in the fish flesh by decarboxylation of free histidine as a result of exposure of the
fish after capture to temperatures that permit the growth of mesophilic bacteria.
n. Shall is used to state mandatory requirements.
o. Shellfish control authority means a Federal, State, or foreign agency, or sovereign tribal
government, legally responsible for the administration of a program that includes activities
such as classification of molluscan shellfish growing areas, enforcement of molluscan
shellfish harvesting controls, and certification of molluscan shellfish processors.
p. Shellstock means raw, in-shell molluscan shellfish.
q. Should is used to state recommended or advisory procedures or to identify recommended
equipment.
r. Shucked shellfish means molluscan shellfish that have one or both shells removed.
s. Smoked or smoke-flavored fishery products means the finished food prepared by:
(1) Treating fish with salt (sodium chloride), and
(2) Subjecting it to the direct action of smoke from burning wood, sawdust, or
similar material and/or imparting to it the flavor of smoke by a means such as
immersing it in a solution of wood smoke.
t. Tag means a record of harvesting information attached to a container of shellstock by the
harvester or processor.

❍ Sec. 123.5 Current good manufacturing practice
a. Part 110 of this chapter applies in determining whether the facilities, methods, practices,
and controls used to process fish and fishery products are safe, and whether these products
have been processed under sanitary conditions.
b. The purpose of this part is to set forth requirements specific to the processing of fish and
fishery products.
❍ Sec. 123.6 Hazard Analysis and Hazard Analysis Critical Control Point
(HACCP) Plan
a. Hazard analysis. Every processor shall conduct, or have conducted for it, a hazard
analysis to determine whether there are food safety hazards that are reasonably likely
to occur for each kind of fish and fishery product processed by that processor and to
identify the preventive measures that the processor can apply to control those hazards.
Such food safety hazards can be introduced both within and outside the processing
plant environment, including food safety hazards that can occur before, during, and
after harvest. A food safety hazard that is reasonably likely to occur is one for which a
prudent processor would establish controls because experience, illness data, scientific
reports, or other information provide a basis to conclude that there is a reasonable
possibility that it will occur in the particular type of fish or fishery product being
processed in the absence of those controls.
b. The HACCP Plan. Every processor shall have and implement a written HACCP
plan whenever a hazard analysis reveals one or more food safety hazards that are
reasonably likely to occur, as described in paragraph (a) of this section. A HACCP
plan shall be specific to:
(1) Each location where fish and fishery products are processed by that
processor; and
(2) Each kind of fish and fishery product processed by the processor. The plan
may group kinds of fish and fishery products together, or group kinds of
production methods together, if the food safety hazards, critical control points,
critical limits, and procedures required to be identified and per formed in
paragraph (c) of this section are identical for all fish and fishery products so
grouped or for all production methods so grouped.
c. The contents of the HACCP plan. The HACCP plan shall, at a minimum:
(1) List the food safety hazards that are reasonably likely to occur, as identified
in accordance with paragraph (a) of this section, and that thus must be
controlled for each fish and fishery product. Consideration should be given to
whether any food safety hazards are reasonably likely to occur as a result of the
following:
■ (i) Natural toxins;
■ (ii) Microbiological contamination;

■ (iii) Chemical contamination;

■ (iv) Pesticides;
■ (v) Drug residues;
■ (vi) Decomposition in scombroid toxin- forming species or in any other
species where a food safety hazard has been associated with
decomposition;
■ (vii) Parasites, where the processor has knowledge or has reason to know
that the parasite-containing fish or fishery product will be consumed
without a process sufficient to kill the parasites, or where the processor
represents, labels, or intends for the product to be so consumed;
■ (viii) Unapproved use of direct or indirect food or color additives; and
■ (ix) Physical hazards;
(2) List the critical control points for each of the identified food safety hazards,
including as appropriate:
■ (i) Critical control points designed to control food safety hazards that
could be introduced in the processing plant environment; and
■ (ii) Critical control points designed to control food safety hazards
introduced outside the processing plant environment, including food
safety hazards that occur before, during, and after harvest;
(3) List the critical limits that must be met at each of the critical control points:
(4) List the procedures, and frequency thereof, that will be used to monitor each
of the critical control points to ensure compliance with the critical limits;
(5) Include any corrective action plans that have been developed in accordance
with Sec. 123.7(b), to be followed in response to deviations from critical limits
at critical control points;
(6) List the verification procedures, and frequency thereof, that the processor
will use in accordance with Sec. 123.8(a);
(7) Provide for a recordkeeping system that documents the monitoring of the
critical control points. The records shall contain the actual values and
observations obtained during monitoring.
d. Signing and dating the HACCP plan.
(1) The HACCP plan shall be signed and dated, either by the most responsible
individual on-site at the processing facility or by a higher level official of the
processor. This signature shall signify that the HACCP plan has been accepted
for implementation by the firm.
(2) The HACCP plan shall be dated and signed:
■ (i) Upon initial acceptance;

■ (ii) Upon any modification; and

■ (iii) Upon verification of the plan in accordance with Sec. 123.8(a)(1).
e. Products subject to other regulations. For fish and fishery products that are subject
to the requirements of part 113 or 114 of this chapter, the HACCP plan need not list
the food safety hazard associated with the formation of Clostridium botulinum toxin
in the finished, hermetically sealed container, nor list the controls to prevent that food
safety hazard. A HACCP plan for such fish and fishery products shall address any
other food safety hazards that are reasonably likely to occur.
f. Sanitation. Sanitation controls may be included in the HACCP plan. However, to
the extent that they are monitored in accordance with Sec. 123.11(b) they need not be
included in the HACCP plan, and vice versa.
g. Legal basis. Failure of a processor to have and implement a HACCP plan that
complies with this section whenever a HACCP plan is necessary, otherwise operate in
accordance with the requirements of this part, shall render the fish or fishery products
of that processor adulterated under section 402(a)(4) of the act. Whether a processor's
actions are consistent with ensuring the safety of food will be determined through an
evaluation of the processor's overall implementation of its HACCP plan, if one is
required.
❍ Sec. 123.7 Corrective actions
a. Whenever a deviation from a critical limit occurs, a processor shall take corrective
action either by:
(1) Following a corrective action plan that is appropriate for the particular
deviation, or
(2) Following the procedures in paragraph (c) of this section.
b. Processors may develop written corrective action plans, which become part of their
HACCP plans in accordance with Sec. 123.6(c)(5), by which they predetermine the
corrective actions that they will take whenever there is a deviation from a critical
limit. A corrective action plan that is appropriate for a particular deviation is one that
describes the steps to be taken and assigns responsibility for taking those steps, to
ensure that:
(1) No product enters commerce that is either injurious to health or is otherwise
adulterated as a result of the deviation; and
(2) The cause of the deviation is corrected.
c. When a deviation from a critical limit occurs and the processor does not have a
corrective action plan that is appropriate for that deviation, the processor shall:
(1) Segregate and hold the affected product, at least until the requirements of
paragraphs (c)(2) and (c)(3) of this section are met;

(2) Perform or obtain a review to determine the acceptability of the affected

product for distribution. The review shall be performed by an individual or
individuals who have adequate training or experience to perform such a review.
Adequate training may or may not include training in accordance with Sec.
123.10;
(3) Take corrective action, when necessary, with respect to the affected product
to ensure that no product enters commerce that is either injurious to health or is
otherwise adulterated as a result of the deviation;
(4) Take corrective action, when necessary, to correct the cause of the
deviation;
(5) Perform or obtain timely reassessment by an individual or individuals who
have been trained in accordance with Sec. 123.10, to determine whether the
HACCP plan needs to be modified to reduce the risk of recurrence of the
deviation, and modify the HACCP plan as necessary.
d. All corrective actions taken in accordance with this section shall be fully
documented in records that are subject to verification in accordance with Sec.
123.8(a)(3)(ii) and the recordkeeping requirements of Sec. 123.9.
❍ Sec. 123.8 Verification
a. Overall verification. Every processor shall verify that the HACCP plan is adequate
to control food safety hazards that are reasonably likely to occur, and that the plan is
being effectively implemented. Verification shall include, at a minimum:
(1) Reassessment of the HACCP plan. A reassessment of the adequacy of the
HACCP plan whenever any changes occur that could affect the hazard analysis
or alter the HACCP plan in any way or at least annually. Such changes may
include changes in the following: Raw materials or source of raw materials,
product formulation, processing methods or systems, finished product
distribution systems, or the intended use or consumers of the finished product.
The reassessment shall be performed by an individual or individuals who have
been trained in accordance with Sec. 123.10. The HACCP plan shall be
modified immediately whenever a reassessment reveals that the plan is no
longer adequate to fully meet the requirements of Sec. 123.6(c).
(2) Ongoing verification activities. Ongoing verification activities including:
■ (i) A review of any consumer complaints that have been received by the
processor to determine whether they relate to the performance of critical
control points or reveal the existence of unidentified critical control
points;
■ (ii) The calibration of process-monitoring instruments; and,
■ (iii) At the option of the processor, the performing of periodic

end-product or in-process testing.

(3) Records review. A review, including signing and dating, by an individual

who has been trained in accordance with Sec. 123.10, of the records that
document:
■ (i) The monitoring of critical control points. The purpose of this review
shall be, at a minimum, to ensure that the records are complete and to
verify that they document values that are within the critical limits. This
review shall occur within 1 week of the day that the records are made;
■ (ii) The taking of corrective actions. The purpose of this review shall be,
at a minimum, to ensure that the records are complete and to verify that
appropriate corrective actions were taken in accordance with Sec. 123.7.
This review shall occur within 1 week of the day that the records are
made; and
■ (iii) The calibrating of any process control instruments used at critical
control points and the performing of any periodic end- product or
in-process testing that is part of the processor's verification activities.
The purpose of these reviews shall be, at a minimum, to ensure that the
records are complete, and that these activities occurred in accordance
with the processor's written procedures. These reviews shall occur within
a reasonable time after the records are made.
b. Corrective actions. Processors shall immediately follow the procedures in Sec.
123.7 whenever any verification procedure, including the review of a consumer
complaint, reveals the need to take a corrective action.
c. Reassessment of the hazard analysis. Whenever a processor does not have a
HACCP plan because a hazard analysis has revealed no food safety hazards that are
reasonably likely to occur, the processor shall reassess the adequacy of that hazard
analysis whenever there are any changes that could reasonably affect whether a food
safety hazard now exists. Such changes may include, but are not limited to changes
in: Raw materials or source of raw materials, product formulation, processing
methods or systems, finished product distribution systems, or the intended use or
consumers of the finished product. The reassessment shall be performed by an
individual or individuals who have been trained in accordance with Sec. 123.10.
d. Recordkeeping. The calibration of process- monitoring instruments, and the
performing of any periodic end-product and in-process testing, in accordance with
paragraphs (a)(2)(ii) through (iii) of this section shall be documented in records that
are subject to the recordkeeping requirements of Sec. 123.9.
❍ Sec. 123.9 Records
a. General requirements. All records required by this part shall include:

(1) The name and location of the processor or importer;
(2) The date and time of the activity that the record reflects;

(3) The signature or initials of the person performing the operation; and
(4) Where appropriate, the identity of the product and the production code, if
any. Processing and other information shall be entered on records at the time
that it is observed.
b. Record retention.
(1) All records required by this part shall be retained at the processing facility
or importer's place of business in the United States for at least 1 year after the
date they were prepared in the case of refrigerated products and for at least 2
years after the date they were prepared in the case of frozen, preserved, or
shelf-stable products.
(2) Records that relate to the general adequacy of equipment or processes being
used by a processor, including the results of scientific studies and evaluations,
shall be retained at the processing facility or the importer's place of business in
the United States for at least 2 years after their applicability to the product
being produced at the facility.
(3) If the processing facility is closed for a prolonged period between seasonal
packs, or if record storage capacity is limited on a processing vessel or at a
remote processing site, the records may be transferred to some other reasonably
accessible location at the end of the seasonal pack but shall be immediately
returned for official review upon demand.
c. Official review. All records required by this part and all plans and procedures
required by this part shall be available for official review and copying at reasonable
times.
d. Public disclosure.
(1) Subject to the limitations in paragraph (d)(2) of this section, all plans and
records required by this part are not available for public disclosure unless they
have been previously disclosed to the public as defined in Sec. 20.81 of this
chapter or they relate to a product or ingredient that has been abandoned and
they no longer represent a trade secret or confidential commercial or financial
information as defined in Sec. 20.61 of this chapter.
(2) However, these records and plans may be subject to disclosure to the extent
that they are otherwise publicly available, or that disclosure could not
reasonably be expected to cause a competitive hardship, such as generic-type
HACCP plans that reflect standard industry practices.
e. Tags. Tags as defined in Sec. 123.3(t) are not subject to the requirements of this
section unless they are used to fulfill the requirements of Sec. 123.28(c).
f. Records maintained on computers. The maintenance of records on computers is
acceptable, provided that appropriate controls are implemented to ensure the integrity
of the electronic data and signatures.

❍ Sec. 123.10 Training
At a minimum, the following functions shall be performed by an individual who has

successfully completed training in the application of HACCP principles to fish and fishery
product processing at least equivalent to that received under standardized curriculum
recognized as adequate by the U.S. Food and Drug Administration or who is otherwise
qualified through job experience to perform these functions. Job experience will qualify an
individual to perform these functions if it has provided knowledge at least equivalent to that
provided through the standardized curriculum.
a. Developing a HACCP plan, which could include adapting a model or generic-type
HACCP plan, that is appropriate for a specific processor, in order to meet the
requirements of Sec. 123.6(b);
b. Reassessing and modifying the HACCP plan in accordance with the corrective
action procedures specified in Sec. 123.7(c)(5), the HACCP plan in accordance with
the verification activities specified in Sec. 123.8(a)(1), and the hazard analysis in
accordance with the verification activities specified in Sec. 123.8(c); and
c. Performing the record review required by Sec. 123.8(a)(3);
The trained individual need not be an employee of the processor.
❍ Sec. 123.11 Sanitation control procedures
a. Sanitation SOP. Each processor should have and implement a written sanitation
standard operating procedure (herein referred to as SSOP) or similar document that is
specific to each location where fish and fishery products are produced. The SSOP
should specify how the processor will meet those sanitation conditions and practices
that are to be monitored in accordance with paragraph (b) of this section.
b. Sanitation monitoring. Each processor shall monitor the conditions and practices
during processing with sufficient frequency to ensure, at a minimum, conformance
with those conditions and practices specified in part 110 of this chapter that are both
appropriate to the plant and the food being processed and relate to the following:
(1) Safety of the water that comes into contact with food or food contact
surfaces, or is used in the manufacture of ice;
(2) Condition and cleanliness of food contact surfaces, including utensils,
gloves, and outer garments;
(3) Prevention of cross-contamination from insanitary objects to food, food
packaging material, and other food contact surfaces, including utensils, gloves,
and outer garments, and from raw product to cooked product;
(4) Maintenance of hand washing, hand sanitizing, and toilet facilities;
(5) Protection of food, food packaging material, and food contact surfaces from
adulteration with lubricants, fuel, pesticides, cleaning compounds, sanitizing

agents, condensate, and other chemical, physical, and biological contaminants;

(6) Proper labeling, storage, and use of toxic compounds;
(7) Control of employee health conditions that could result in the
microbiological contamination of food, food packaging materials, and food
contact surfaces; and
(8) Exclusion of pests from the food plant.
The processor shall correct in a timely manner, those conditions and practices that are
not met.
c. Sanitation control records. Each processor shall maintain sanitation control
records that, at a minimum, document the monitoring and corrections
prescribed by paragraph (b) of this section. These records are subject to the
requirements of Sec. 123.9.
d. Relationship to HACCP plan. Sanitation controls may be included in the
HACCP plan, required by Sec. 123.6(b). However, to the extent that they are
monitored in accordance with paragraph (b) of this section they need not be
included in the HACCP plan, and vice versa.
❍ Sec. 123.12 Special requirements for imported products
This section sets forth specific requirements for imported fish and fishery products.
a. Importer verification. Every importer of fish or fishery products shall either:
(1) Obtain the fish or fishery product from a country that has an active
memorandum of understanding (MOU) or similar agreement with the Food and
Drug Administration, that covers the fish or fishery product and documents the
equivalency or compliance of the inspection system of the foreign country with
the U.S. system, accurately reflects the current situation between the signing
parties, and is functioning and enforceable in its entirety; or
(2) Have and implement written verification procedures for ensuring that the
fish and fishery products that they offer for import into the United States were
processed in accordance with the requirements of this part. The procedures
shall list at a minimum:
■ (i) Product specifications that are designed to ensure that the product is
not adulterated under section 402 of the Federal Food, Drug, and
Cosmetic Act because it may be injurious to health or have been
processed under insanitary conditions, and,
■ (ii) Affirmative steps that may include any of the following:
■ A. Obtaining from the foreign processor the HACCP and

sanitation monitoring records required by this part that relate to the
specific lot of fish or fishery products being offered for import;

■ B. Obtaining either a continuing or lot- by-lot certificate from an

appropriate foreign government inspection authority or competent
third party certifying that the imported fish or fishery product is or
was processed in accordance with the requirements of this part;
■ C. Regularly inspecting the foreign processor's facilities to ensure
that the imported fish or fishery product is being processed in
accordance with the requirements of this part;
■ D. Maintaining on file a copy, in English, of the foreign
processor's HACCP plan, and a written guarantee from the foreign
processor that the imported fish or fishery product is processed in
accordance with the requirements of this part;
■ E. Periodically testing the imported fish or fishery product, and
maintaining on file a copy, in English, of a written guarantee from
the foreign processor that the imported fish or fishery product is
processed in accordance with the requirements of this part or,
■ F. Other such verification measures as appropriate that provide an
equivalent level of assurance of compliance with the requirements
of this part.
b. Competent third party. An importer may hire a competent third party to assist with
or perform any or all of the verification activities specified in paragraph (a)(2) of this
section, including writing the importer's verification procedures on the importer's
behalf.
c. Records. The importer shall maintain records, in English, that document the
performance and results of the affirmative steps specified in paragraph (a)(2)(ii) of
this section. These records shall be subject to the applicable provisions of Sec. 123.9.
d. Determination of compliance. There must be evidence that all fish and fishery
products offered for entry into the United States have been processed under
conditions that comply with this part. If assurances do not exist that the imported fish
or fishery product has been processed under conditions that are equivalent to those
required of domestic processors under this part, the product will appear to be
adulterated and will be denied entry.
● Subpart B – Smoked & Smoke-Flavored Fishery Products
❍ Sec. 123.15 General
This subpart augments subpart A of this part by setting forth specific requirements for
processing smoked and smoke-flavored fishery products.
❍ Sec. 123.16 Process controls
In order to meet the requirements of subpart A of this part, processors of smoked and
smoke-flavored fishery products, except those subject to the requirements of part 113 or 114

of this chapter, shall include in their HACCP plans how they are controlling the food safety
hazard associated with the formation of toxin by Clostridium botulinum for at least as long
as the shelf life of the product under normal and moderate abuse conditions.
● Subpart C – Raw Molluscan Shellfish
❍ Sec. 123.20 General
This subpart augments subpart A of this part by setting forth specific requirements for
processing fresh or frozen molluscan shellfish, where such processing does not include a
treatment that ensures the destruction of vegetative cells of microorganisms of public health
concern.
❍ Sec. 123.28 Source controls
a. In order to meet the requirements of subpart A of this part as they apply to

microbiological contamination, chemical contamination, natural toxins, and related
food safety hazards, processors shall include in their HACCP plans how they are
controlling the origin of the molluscan shellfish they process to ensure that the
conditions of paragraphs (b), (c), and (d) of this section are met.
b. Processors shall only process molluscan shellfish harvested from growing waters
approved for harvesting by a shellfish control authority. In the case of molluscan
shellfish harvested from U.S. Federal waters, the requirements of this paragraph will
be met so long as the shellfish have not been harvested from waters that have been
closed to harvesting by an agency of the Federal government.
c. To meet the requirements of paragraph (b) of this section, processors who receive
shellstock shall accept only shellstock from a harvester that is in compliance with
such licensure requirements as may apply to the harvesting of molluscan shellfish or
from a processor that is certified by a shellfish control authority, and that has a tag
affixed to each container of shellstock. The tag shall bear, at a minimum, the
information required in Sec. 1240.60(b) of this chapter. In place of the tag, bulk
shellstock shipments may be accompanied by a bill of lading or similar shipping
document that contains the information required in Sec. 1240.60(b) of this chapter.
Processors shall maintain records that document that all shellstock have met the
requirements of this section. These records shall document:
(1) The date of harvest;
(2) The location of harvest by State and site;
(3) The quantity and type of shellfish;
(4) The date of receipt by the processor; and
(5) The name of the harvester, the name or registration number of the
harvester's vessel, or an identification number issued to the harvester by the
shellfish control authority.

d. To meet the requirements of paragraph (b) of this section, processors who receive
shucked molluscan shellfish shall accept only containers of shucked molluscan
shellfish that bear a label that complies with Sec. 1240.60(c) of this chapter.
Processors shall maintain records that document that all shucked molluscan shellfish
have met the requirements of this section. These records shall document:
(1) The date of receipt;
(2) The quantity and type of shellfish; and
(3) The name and certification number of the packer or repacker of the product.
Part 1240 – Control of Communicable Diseases

2. The authority citation for 21 CFR part 1240 continues to read as follows:
Authority: Secs. 215, 311, 361, 368 of the Public Health Service Act (42 U.S.C. 216, 243, 264, 271).
3. Section 1240.3 is amended by revising paragraph (r), and by adding new paragraphs (s), (t), and (u) to
read as follows:
● Sec. 1240.3 General Definitions
r. Molluscan shellfish. Any edible species of fresh or frozen oysters, clams, mussels, and
scallops or edible portions thereof, except when the product consists entirely of the shucked
adductor muscle.
s. Certification number means a unique combination of letters and numbers assigned by a
shellfish control authority to a molluscan shellfish processor.
t. Shellfish control authority means a Federal, State, or foreign agency, or sovereign tribal
government, legally responsible for the administration of a program that includes activities
such as classification of molluscan shellfish growing areas, enforcement of molluscan
shellfish harvesting controls, and certification of molluscan shellfish processors.
u. Tag means a record of harvesting information attached to a container of shellstock by the
harvester or processor.
4. Section 1240.60 is amended by revising the section heading, by redesignating the existing text
as paragraph (a) and adding the word "molluscan" before the word "shellfish" the two times that it
appears, and by adding new paragraphs (b), (c), and (d) to read as follows:
● Sec. 1240.60 Molluscan Shellfish
b. the date and place they were harvested (by State and site), type and quantity of shellfish,
and by whom they were harvested (i.e., the identification number assigned to the harvester
by the shellfish control authority, where applicable or, if such identification numbers are not
assigned, the name of the harvester or the name or registration number of the harvester's
vessel). In place of the tag, bulk shellstock shipments may be accompanied by a bill of

lading or similar shipping document that contains the same information.

c. All containers of shucked molluscan shellfish shall bear a label that identifies the name,
address, and certification number of the packer or repacker of the molluscan shellfish.
d. Any molluscan shellfish without such a tag, shipping document, or label, or with a tag,
shipping document, or label that does not bear all the information required by paragraphs (b)
and (c) of this section, shall be subject to seizure or refusal of entry, and destruction.
See also:
FDA Seafood List
Foodborne Pathogenic Microorganisms and Natural Toxins Handbook (Bad Bug Book)
Seafood Information and Resources
Seafood HACCP | Fish & Fisheries Products Hazards & Controls Guidance: 3rd Edition (2001)
Foods Home | FDA Home | Search/Subject Index | Disclaimers & Privacy Policy | Accessibility/Help
Hypertext updated by cjm/dms/kwg 2002-JUN-17

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Chapter 1: Introduction

Status This guidance is being issued as a companion

This guidance is also intended to serve as a tool to be

This guidance is also available electronically at:

Select “foods;” then select “seafood;” then select “HACCP.”

The HACCP Plan Form The Steps

expects that a written hazard analysis will be very • Who

Record this information in the space provided on the

Chapter 2: HACCP Plan Steps

FDA plans to update Tables #3-1 and 3-2 as the

Tables #3-1 and 3-2 include the best information

Chapter 2: HACCP Plan Steps

Chapter 2: HACCP Plan Steps

Purpose • Table #3-3

Market Names Latin Names Hazards

Parasites Natural Toxins Histamine Chemical Drugs

AHOLEHOLE Kuhlia spp. CFP

ALFONSINO Beryx spp.

ANCHOVY Anchoa spp. ASP6 ✓

ANGELFISH Holacanthus spp.

BARRACUDA Sphyraena spp. CFP ✓

6 – This hazard only applies if the product is marketed uneviscerated.

Chapter 3: Hazard Tables

Parasites Natural Toxins Histamine Chemical Drugs

BARRAMUNDI Lates calcarifer ✓

BASS Ambloplites spp. ✓

BASS, SEA Acanthistius

BIGEYE Priacanthus arenatus

BLUEFISH Pomatomus saltatrix ✓ ✓

BLUEGILL Lepomis macrochirus ✓

BOMBAY DUCK Harpadon nehereus ✓

BONITO Cybiosarda elegans ✓

BOWFIN and roe Amia calva ✓

BREAM Abramis brama

BREAM or BOGUE Boops boops

Chapter 3: Hazard Tables

Parasites Natural Toxins Histamine Chemical Drugs

BUFFALOFISH Ictiobus spp. ✓

BULLHEAD Ameiurus spp. ✓

BURBOT Lota lota ✓

BUTTERFISH Odax pullus ✓

CAPELIN and roe Mallotus villosus ✓ 4

CARP Cyprinus carpio ✓

CATFISH Ameiurus catus ✓

CATFISH, SEA Ariopsis felis

CHAR Salvelinus alpinus ✓

CHIMAERA Harriota raleighana

Chapter 3: Hazard Tables

Parasites Natural Toxins Histamine Chemical Drugs

CHUB Coregonus kiyi ✓

CISCO or CHUB Coregonus alpenae ✓

COBIA Rachycentron canadum ✓ 4

COD Arctogadus spp. ✓ 4

COD, MORID Lotella rhacina ✓ 4

CORVINA Cilus montii ✓ 4

CRAPPIE Pomoxis spp. ✓

CROAKER Argyrosomus spp. ✓

Chapter 3: Hazard Tables

Parasites Natural Toxins Histamine Chemical Drugs