Allergens Slides Amin 031617

Food Safety and Inspection Service
Preventing Undeclared Allergens
Allergen Control Management:

A Practical Look at Allergen
Prevention and Control for FSIS-
regulated Products
Abdalla Amin
Deputy District Manager
Office of Field Operations
Alameda District Office
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Foodborne Illness Prevention
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Efforts to control allergens and minimize allergen recalls
An increase in allergen-related recalls prompted FSIS

analysis, policy clarification, verification activities, and
reiteration of establishment responsibilities
• FSIS Issued Notices 35-11, 54-11, and 29-13

• Draft Federal Register Notice published spring 2014
• Final Federal Register Notice published fall 2015
• FSIS Compliance Guidelines 2014 and 2015
• FSIS Directive 7230.1- in 2015, Ongoing Verification of Products
Formulations and Labeling Targeting the 8 most common Food
Allergens
• FSIS Constituent Updates
• FSIS-Conducting Food Safety Assessments (FSA) at Establishments
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Efforts to control allergens and minimize allergen recalls
with FSIS Directive 7230.1
• Inspection Personnel to meet with establishment during

weekly meeting to discuss FSIS Directive 7230.1
• Inspection Personnel to ask whether establishment has
developed and implemented preventive or control measures
with the HACCP plan, Sanitation SOPs, or other prerequisite
program to address allergens
• Inspection Personnel to discuss whether establishment
produces any products that contain any of the “Big 8” food
allergens
• Inspection Personnel will inform establishment that FSIS will
be verifying that establishment’s labels match its product
formulations during an ongoing “Big 8 Formulation
Verification” task occurring at a monthly frequency.
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Hazard Analysis
• Every establishment shall conduct, or have

conducted for it, a hazard analysis to determine the
food safety hazards reasonably likely to occur in the
production practice- 9 CFR 417.2
– Hazard analysis serves as the foundation for a
strong and successful HACCP plan
– Includes food safety hazards that could occur
before, during, and after entry into the
establishment
• Food safety hazard: Any biological, chemical, or physical
property that may cause food to be unsafe and Injurious
to Health
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Hazard Analysis and Allergens
• The introduction of ingredients into

product must be taken into account
during the hazard analysis
• Allergens and ingredients of public health
concern fall under the chemical hazards portion
of the hazard analysis
• Introduction of allergens and ingredients of public
health concern could occur anywhere/anytime
during the production process
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Hazard Analysis and Allergens
• The occurrence of an undeclared

allergen recall indicates the
establishment has failed to:
• Address the chemical (allergen) food safety
hazard in its hazard analysis
• Support a decision made in the hazard analysis
• Reassess its hazard analysis
• Effectively implement the controls to support a
decision (9 CFR 417.2, 417.3, 417.4, 417.5, 417.8)
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Food Safety and Inspection Service:
Practical Allergen Control
• A HACCP-based Allergen Risk Assessment

Program is a key to allergen management and
control
• Programs must be implemented to ensure

integrity and compliance with specifications
throughout the supply chain
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Food Safety and Inspection Service:
Establishment Responsibilities
Identify: Inspection of Incoming Ingredients,

Cross-referencing Components, Separation
Prevent & Control: Equipment, Sanitation,

and Processing
Declare: Packaging, Labeling, Storage
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Identify: What Steps Can I Take Right Now?
• Determine if your establishment will better control

allergens through your hazard analysis as a
prerequisite program or HACCP plan
• Evaluate each step in your process from receiving to
packaging and shipment, noting paths of allergenic
ingredients
• Identify ingredients and processing aids your
establishment utilizes that may contain allergenic
ingredients
• Review a list of all ingredients and products to
determine which products and ingredients,
including sub-ingredients, contain or do not contain
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allergens
At Receiving
• Inspection of all incoming ingredients
• Keep a list of ingredients and label records at
receiving to compare against incoming ingredients
• Maintain an approved supplier list and become
familiar with letters of guarantee (LOG) from
suppliers
• Maintain open communication of expectation with
suppliers and inquire about suppliers’ allergen
control program
• Ensure all incoming ingredients containing allergenic
material are clearly labeled and identified 12
During Storage
• Use color coding for allergen-containing
ingredients and products
• Store ingredients containing allergenic
materials in separate, designated areas that
are clearly identified and marked
• Avoid storing ingredients containing
allergens above ingredients without
• Clearly identify and mark product storage
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Prevent and Control: What Steps Can I Take Right Now?
During Mixing/Processing
• Maintain controls to ensure the addition of correct
ingredients during formulation of products
• Cleaning of equipment, utensils, and food contact
surfaces when producing both product with and
without allergens to prevent cross contact and
misbranding
• Document cleaning procedures with checklists and
spill clean-up procedures
• Employ a method for the verification and validation of
cleaning
• Careful evaluation of rework and work-in-progress
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Prevent and Control: What Steps Can I Take Right Now?
During Mixing/Processing
• Dedicate equipment or separate products by time,
space, etc.
• Color coding or mark ingredient packages, supplies,
uniforms, equipment, and utensils used for products
containing allergens throughout processing
• Avoid using same cooking medium (i.e. oil or water)
when processing both ingredients with and without
allergens
• Maintain documented process flow
• Maintain methods for tracking lot codes through
production
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Declare: What Steps Can I Take Right Now?
At Labeling
• All ingredients used in the formulation of meat, poultry, or egg
products must be declared by their common or usual name in
the ingredients statement
• Ensure systems are in place for labeling of final product
• Maintain controls to prevent product reformulation without
proper protocols to ensure final label accuracy
• Verify the facility has a label approval/sketch approval for all
products
• Cross-reference sketch label approval, if applicable, to actual
label being used in the formulation data for accuracy
• List of ingredients should include sub-ingredients
• Ensure that product is packaged in correct label
• Have procedures in place for labeling discrepancies and
product disposition 16
Hazard Analysis from Interactions with Industry
Reducing the potential of undeclared Allergens:

1. Supplier and ingredient control
2. Controlled on-site food storage
3. Segregated handling or processing
4. Equipment selection and use
5. Control of labels and packaging
6. Staff awareness
7. Allergen audits
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1. Supplier and ingredient control

• Continuous review and documentation of ingredient
specifications
• Identify ingredients intentionally containing allergens
and investigate others
• Be aware of reformulation of ingredients without
updating the specifications
• Have knowledge of suppliers’ allergen management
• Have Questionnaire/Audit/Reviews to determine the
overall suppliers’ risk of cross contact
• Raise your concerns with your suppliers
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2. Controlled on-site food storage

• Segregation or other validated controls
• Conduct risk assessment (e.g., high risk/low
threshold) and evaluate if a complete separation is
necessary
• Constant review and documentation of ingredient
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specifications
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3. Segregated handling or processing

• Segregation or other validated controls in high risk
products such as peanuts or tree nut production
• Conduct risk assessment (e.g., high risk/low threshold) and
evaluate if complete separation is necessary
• Severe allergenic reaction (anaphylactic shock) vs.
intolerance reaction (gluten)
• Constant review and documentation of ingredient
specifications, formulations, and labeling
• Time and physical separation
•
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Monitor cross contact
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4. Equipment selection and use

• This is an allergen management aspect that is often
overlooked by establishments
• Walls, floors, hoses, equipment, utensils, containers,…etc.
• Equipment and materials selection must be influenced by
cleanability and accessibility.
• Question: Can you access all surfaces easily and are they
designed to facilitate a deep allergen clean to prevent
them from becoming source of contamination?
• Similar to the fact that all surfaces and pieces of equipment
shall be cleaned and disinfected to reduce to a safe level of
bacteria, it should also be at a minimal risk of being source
of allergen cross contact.
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5. Control of labels and packaging

• Product change-over
• Multi-layer supervision over labeling and packaging (e.g.,
high risk/low threshold), evaluate if complete separation is
necessary
• Be aware of: reformulated ingredients, new allergen being
handled on site, new equipment being used, new layouts
being implemented, new production/processing
schedules, new employees unfamiliar with the
process/allergen controls, new cleaning regimen
• A review of the allergen risk assessment is crucial to ensure
that changes to the allergen status of a product is identified
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and reflected on the labels and packing
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6. Staff awareness
• Staff Movement
• Separate, visibly identify staff (at high risk production)
• Training, Training, and Training of all employees
• Training of the staff is a key element for successful allergen
control and management
• All aspects of allergen control concept and management: sources,
cross-contamination, labeling, misinformation, formulation,
ingredients, receiving, risk, human health,…etc.
• Ensure that all cooks, food handlers, and employees are aware of
the top 8 allergenic ingredients and other ingredients of public
health concern.
• Ensure personnel are trained on the cleaning procedures the
establishment employs to control food allergen cross
contamination. 23
7. Allergen audit
• Internal Audit Process/External Audit Program
• Audit should be true reflection and an ethical process to
reflect a true condition/status of your allergen management
program
• An effective audit should ideally pick a final packaged
product and conduct “Trace-back” activities from all
aspects of the process. (Check HACCP Pre-shipment
Review 9 CFR 417.8)
• The risk of allergen contamination can be validated against
the allergen declaration on labels.
• Routinely evaluate your company’s handling of allergenic
ingredients to prevent adulterated or misbranded products
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Food Safety and Inspection Service

Preventing Undeclared Allergens

Allergen Control Management:

An increase in allergen-related recalls prompted FSIS

• FSIS Issued Notices 35-11, 54-11, and 29-13

• Inspection Personnel to meet with establishment during

• Every establishment shall conduct, or have

• The introduction of ingredients into

• The occurrence of an undeclared

• A HACCP-based Allergen Risk Assessment

• Programs must be implemented to ensure

Identify: Inspection of Incoming Ingredients,

Prevent & Control: Equipment, Sanitation,

Declare: Packaging, Labeling, Storage

• Determine if your establishment will better control

Reducing the potential of undeclared Allergens:

1. Supplier and ingredient control

2. Controlled on-site food storage

3. Segregated handling or processing

4. Equipment selection and use

5. Control of labels and packaging

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