THE

THEFOOD
FOODSAFETY
SAFETYACT
ACTOF
OF2013
2013
Republic
RepublicAct
Act10611
10611
Implementing
ImplementingRules
Rulesand
andRegulations
Regulations
TITLE
TITLE
 “An Act To Strengthen The Food Safety
Regulatory System In The Country To Protect
Consumer Health And Facilitate Market Access
Of Local Foods And Food Products, And For
Other Purposes”

 “FOOD SAFETY ACT OF 2013”

BACKGROUND
Chronology of the Food Safety
Act and its Implementing Rules
and Regulations (IRR)
BACKGROUND
 May 2010
◦ Initial outline prepared by Ms Irina Kireeva, Short Term
Expert on SPS Legislation of the PHL-EU Trade Related
Technical Assistance Project 2

 October 2011
◦ The Act was presented and modified through joint
meetings between the DA and the DOH and jointly
endorsed by the DA and DOH Secretaries to Congress
BACKGROUND
 05 June 2013
◦ Passed by the Joint House Committee on Health and
Agriculture and the Senate Committee on Trade

 23 August 2013
◦ Signed into law as RA 10611

 March – June 2014

◦ Draft Joint Implementing Rules and Regulations (IRR)
prepared by the DA and DOH Technical Working Groups
composed of the concerned agencies of the two
Departments
BACKGROUND
 July 2014
◦ Draft IRR was endorsed by the DA and DOH TWGs to the
DA and DOH Secretaries

 October 2014
◦ DA-DOH Joint Legal Review of IRR
◦ Meeting between DA and DOH Secretaries
Refers to the
assurance that
food will not cause
harm to the
consumer when it
is prepared or
eaten according to
its intended use
MAIN OBJECTIVES
a) Protect the public from food-borne and water-
borne illnesses and unsanitary, unwholesome,
misbranded or adulterated foods;

b) Enhance industry and consumer confidence in the

food regulatory system; and

c) Achieve economic growth and development by

promoting fair trade practices and sound regulatory
foundation for domestic and international trade
OBJECTIVES
1) Delineate and link the mandates and responsibilities
of the government agencies involved;

2) Provide a mechanism for coordination and

accountability in the implementation of regulatory
functions;

3) Establish policies and programs for addressing food

safety hazards and developing appropriate
standards and control measures
OBJECTIVES
4) Strengthen the scientific basis of the regulatory
system; and

5) Upgrade the capability of farmers, fisherfolk,

industries, consumers and government
personnel in ensuring food safety.
SIGNIFICANCE OF RA 10611
 Legal framework for the development and
implementation of food safety regulations
important to achieving a high level of consumer
health protection in the consumption of food sold
in markets and in ensuring fair trade.

 Use of science and/or risk analysis when

developing and implementing food safety
regulations
SIGNIFICANCE OF RA 10611
 Adopts a farm to fork preventive approach for the
control of hazards in the food chain.

 In the absence of adequate scientific data for

analyzing risks, provides for the adoption of
precautionary measures until data can be established
SIGNIFICANCE OF RA 10611
 Adoption of International standards (Codex
Alimentarius Commission, Other international
organizations and other countries)

 Emphasis to primary responsibility of food safety to

the private sector (food business operators) as for
safe food
DELINEATION OF
DELINEATION OF
MANDATES
MANDATES
NATIONAL GOVERNMENT AGENCIES

 Department of Agriculture ***

 Department of Health ***

 Department of Interior and Local Government

* Local Government Units

*** Food Safety Regulatory Agencies (FSRAs)

MANDATE
 Department of Agriculture
 primary production and postharvest
stages of food supply chain and foods
locally produced and imported in this
category
DEFINITION
 Primary production (under DA) refers to the
production, rearing or growing of primary
products including harvesting, milking and
farmed animal production up to slaughter; and
the rearing and growing of fish and other
seafood in aquaculture ponds. It also includes
fishing and the hunting and catching of wild
products.
DEFINITION
 Post harvest stages (under DA) refer to the
stages in the food supply chain involving the
minimal transformation of plant and animal
foods after primary production such as removal
of field heat for fruits, slaughter of animals,
sorting, grading and cutting of fresh plant and
animal foods, icing and freezing, and the
milling and storage of grain.
MANDATE
 Department of Health
 processed and pre-packaged foods,
foods locally produced or imported under
this category and the conduct of
monitoring and epidemiological studies on
food-borne illnesses
DEFINITION
 Processing (under FDA) refers to any action that
substantially alters the initial raw materials or product
or ingredients including, but not limited to, heating,
smoking, curing, maturing, drying, marinating,
extraction, extrusion and a combination of those
processes intended to produce food.
MANDATE
 Department of Interior and Local Government
(DILG) /Local Government Units (LGUs)
 proper sanitation and the safety of foods within
their territorial jurisdictions (e.g. activities in
slaughterhouses, dressing plants, fish ports, wet
markets, supermarkets, school canteens,
restaurants, catering establishments and water
refilling stations)
 Also responsible for street food sale including
ambulant vending
SHARED
SHAREDRESPONSIBILITIES
RESPONSIBILITIESOF
OF
GOVERNMENT
GOVERNMENTAGENCIES
AGENCIES
DA, DOH, DILG, LGU
DA, DOH, DILG, LGU
 SHARED RESPONSIBILITIES
The DILG, in collaboration with DA, DOH
*enforcement of food safety and sanitary rules
and regulations within its territorial jurisdiction

The LGUs (as needed by the DOH and DA)

*to assist in the implementation of food laws,
other relevant regulations
SHARED RESPONSIBILITIES
 The DA and the DOH
*shall capacitate the DILG and LGUs through
provision of the necessary technical assistance
in the implementation of their food safety
functions under their jurisdiction
*shall periodically assess the effectiveness of
these training programs in coordination with the
DILG
SHARED RESPONSIBILITIES
 The DA and the DOH (in cooperation with the
LGUs)
*monitor the presence of contaminants in food
to determine food safety hazards in the food
supply chain.
Food Safety Regulatory Agencies
(FSRAs) and Other Concerned
Agencies
Article V, Section 16 and 18
DA FSRAs
 Bureau of Animal Industry (BAI)
◦ For food derived from animals including eggs and honey
production

 National Dairy Authority (NDA)

◦ For milk production and post harvest handling

 National Meat Inspection Service (NMIS)

◦ For meats

 Bureau of Fisheries and Aquatic Resources (BFAR)

◦ For fresh fish and other seafoods including those grown by
aquaculture
DA FSRAs
 Bureau of Plant Industry (BPI)
◦ For plant foods

 Fertilizer and Pesticide Authority (FPA)

◦ For pesticides and fertilizers used in the
production of plant and animal food

 Philippine Coconut Authority

◦ For fresh coconut
DA FSRAs
 Sugar Regulatory Administration
◦ For sugar cane production and marketing

 National Food Authority (NFA)

◦ For rice, corn, and other grains
CONCERNED DA OFFICES
 Bureau of Agriculture and Fisheries
Standards (BAFS)
◦ Develop food safety standards for fresh plant,
animal, fisheries and aquaculture foods

 Food Development Center (FDC) of the NFA

◦ Provide scientific support in testing, research and
training
DOH FSRAs
 Food and Drug Administration (Center for Food
Regulation and Research)
◦ Responsible for implementing a performance-based
food safety control management system which shall
include, but not limited to, the following:

 Development of food standards and regulations

 Post-market monitoring
 Enforcement of HACCP and other risk-based control
measures
DOH FSRAs
 Food and Drug Administration (Center for Food
Regulation and Research)
 Strong participation in Codex and other international
standard setting bodies
 Communication of risks and development of interactive
exchange among stakeholders
 Establishment of laboratories for food safety and
strengthening the capabilities of existing laboratories
DOH FSRAs
 Food and Drug Administration (Center for Food
Regulation and Research)
 Development of a database for food safety hazards and
food-borne illness from epidemiological data
 Strengthening the R&D capabilities on product safety and
quality standards
 Certification of food safety inspectors
DOH FSRAs

 Bureau of Quarantine
◦ Provide sanitation and ensure food safety in
its area of responsibility in both domestic and
international ports and airports of entry,
including in-flight catering, food service
establishments, sea vessels and aircrafts as
provided for in the IRR of RA 9271 (Quarantine
Act of 2004) and PD 856 (Code on Sanitation
of the Philippines)
CONCERNED DOH OFFICES
 National Epidemiology Center (NEC) now
known as Epidemiology Bureau (EB)
 Research Institute for Tropical Medicine
(RITM)
 National Center for Disease Prevention
and Control (NCDPC) now known as
Disease Prevention and Control Bureau
(DPCB)
◦ Conduct and document epidemiological
monitoring studies on food-borne illnesses
for use in risk-based policy formulation
CONCERNED DOH OFFICES
 National Center for Health Promotion (NCHP) now
known as Health Promotion and Communication
Service (HPCS)
◦ Responsible for advocating food safety awareness,
information and education to the public
Flowchart on Work Process of DA, DOH and LGUs

●
Regulate safety of all fresh and raw agriculture & fishery resources
●
Ensure animal & plant health
●
Ensure safety of farm inputs (agrochemicals)

BOQ jurisdiction
Domestic/international
Ports and Airports of
entry,
In-flight catering,
Food service
Establishments (within
BOQ perimeter)
Sea vessels and Aircraft
Log Frame on Delineation of Jurisdiction of DA, DOH,
DILG, LGU: Food Safety from Farm to Plate Chain

Manufacturer/
Processor FDA-DOH
Distributor Jurisdiction
Importer Retailers Consumer
Exporter
FARM wholesaler (fast food
establishment
(Primary supermarket, LGU/DILG
production) wet market, water Jurisdiction
DA refilling station,
restaurant, street
Jurisdiction food, ambulant
Post Domestic/internation
vending, school
canteen etc.)
Harvest al
Ports and Airports
of entry BOQ-DOH
In-flight catering Jurisdiction
Food service
Establishments
NEC & RITM:
Conduct epidemiological Sea vessels and NCDPC Strategize actions
monitoring studies on FBD Aircraft on FS to reduce the risk of
for use in risk-based policy food contamination and
formulation FBD, address micronutrient
NCHP: Advocate deficiencies and NCD
FS awareness, IEC
campaign
 Article VI

Food
Food Safety
Safety Regulation
Regulation
Coordinating
Coordinating Board
Board (FSRCB)
(FSRCB)
FSRCB
FSRCB
Chair DOH Secretary
• Alternate Chair FDA Director General
Co-Chair DA Secretary
• Alternate Co-Chair DA Undersecretary for Policy and
Planning, R&D and Regulations
Members
•Heads of the FSRAs of the DA
• Director of the FDA Center for Food Regulation and Research
• Representative Field Operator of the DILG with the rank of a Director
• Heads of Leagues of Barangays, Municipalities, Cities and Provinces
• Representative from the DTI with the rank of a Director
• Representative from the DOST with the rank of a Director
FSRCB
 Powers and functions
◦ Monitor and coordinate the performance and implementation of the
mandates of the DA, the DOH, the DILG and the LGUs in food safety
regulation;

◦ Identify the agency responsible for enforcement based on their legal

mandates when jurisdiction over specific areas overlap;

◦ Coordinate crisis management and planning during food safety emergencies;

◦ Establish the policies and procedures for coordination among agencies

involved in food safety
FSRCB
 Powers and functions
◦ Continuously evaluate the effectiveness of enforcement
of food safety regulations and research training
programs

◦ Regularly submit reports to the Congressional

Committees on Health, Agriculture and Food, and Trade
and Industry; and

◦ Accept grants and donations from local and

international sources
 Article V, Section 13
Article V, Section 13

Responsibilities
Responsibilities of
of Food
Food
Business
Business Operators
Operators (FBOs)
(FBOs)
RESPONSIBILITIES
RESPONSIBILITIESOF
OFFBOS
FBOS
FBOs shall
shall ensure
ensure thatthat food
food satisfies
satisfies the

FBOs the
requirements of food law relevant
requirements of food law relevant to their to their
activities
activities inin the
the food
food supply
supply chain
chain and
and that
that
control
controlsystems
systemsare areininplace
placeto
toprevent,
prevent,eliminate,
eliminate,
or
orreduce
reducerisks
riskstotoconsumers
consumers

FBOs are
arethe
theprime
primeentity
entityresponsible
responsibleto
toproduce

FBOs produce
safe
safeand
andquality
qualityfood
food
PRIMARY RESPONSIBILITIES OF FBOS
 ensure safety of their food products and
compliance to the requirements of the Act.

 ensure the prevention or minimization of food

safety hazards or reduction of hazards to
acceptable levels.
PRIMARY RESPONSIBILITIES OF FBOS
 Farmers and fisherfolks as well as FBOs in small and
micro industries shall be assisted by the DA and the
DOH in coordination with the LGUs to implement the
standards and codes of practice.

 FBOs shall be encouraged to implement a HACCP-

based approach or an equivalent food safety control
program in their operations. (may be required)
PRIMARY RESPONSIBILITIES OF FBOS
 FBOs operating within the jurisdiction of the BOQ
of the DOH shall ensure that their food products
comply with Good Manufacturing Practices
(GMP)/HACCP provisions and that their food
handlers and stewards have valid BOQ health
certificates.
SPECIFIC REQUIREMENTS FOR FBOS
 All food businesses
shall designate a Food
Safety Compliance
Officer (FSCO) who has
passed a prescribed
training course for
FSCO recognized by
the DA and/or the
DOH.
SPECIFIC REQUIREMENTS FOR FBOS

◦ MICRO AND SMALL ENTERPRISES, the owner may serve

as the FSCO or a consultant FSCO may be employed on
part-time or full-time basis.

◦ LARGE- AND MEDIUM- SCALE FOOD BUSINESSES shall

designate an FSCO who is preferably a graduate of food-
related courses
SPECIFIC REQUIREMENTS FOR FBOS
 FBOs (self-initiated) shall do the following:
1) Identify hazards
2) Implement preventive controls
3) Ensure that such food is not adulterated, contaminated,
misbranded, and misleading.
4) Monitor the performance of control measures and
maintain monitoring records
*Maintenance of relevant records
5) Actively monitor sustained compliance to standards and
relevant regulatory policies (e.g. cooking demonstrations, cooking
shows, product launching of primary, postharvest, or processed food
and other similar activities)
SPECIFIC REQUIREMENTS FOR FBOS
 Upon the occurrence of any food safety incident, FBOs
shall immediately implement appropriate control
measures. FBOs shall immediately report to the
concerned FSRA any food safety incident which has
caused or contributed to the death, serious illness or
serious injury of any person. Thereafter, subject to
Rule 12.1.7, the FBO shall be summoned by the
concerned FSRA to attend a technical conference to
resolve any food safety issue or determine whether or
not a death, serious illness or serious injury suffered
by a consumer is attributable to a food safety issue.
SPECIFIC REQUIREMENTS FOR FBOS
 FBOs shall be required to:
6) Develop a PRODUCT RECALL PROGRAM (for
approval) and implement as the need arises
7) Develop a Risk Management Plan as basis for
issuance of authorizations (DOH)
8) Undertake measures prescribed by FSRAs to
address a food safety issue
9) Establish a traceability system
SPECIFIC REQUIREMENTS FOR FBOS
 FBOs shall:

10) allow authorized

officers of the FSRAs
entry or to any
establishment, access
to relevant records and
inspection of any food
transport vehicle, while
in transit or otherwise.
Prohibited Acts
Article XII, Section 37
 Art
ic le X
II,
Se ctio
n3
8

Penalties and Sanctions

Penalties and Sanctions
Fine Relevant Authorization Additional Penalty
1st Conviction 50K-100K Suspension for 1 mo None
2nd Conviction 100K-200K Suspension for 3 mos None
3rd Conviction 200K-300K Suspension for 6 mos None
Violation Resulting to
slight Physical Hospitalization and
Injury*** 200K-300K Suspension for 6 mos rehabilation
Violation Resulting in
less serious to serious Hospitalization and
Physical Injury*** 200K-300K Suspension for 12 mos rehabilation
Violation Resulting to
Death*** 300K-500K Permanent revocation Imprisonment
Penalties and Sanctions
 Any director, officer or agent of a corporation
who shall authorize, order or perform any of the
acts or practices constituting in whole or in part a
violation of the prohibited acts, and who has
knowledge or notice of noncompliance received
by the corporation from the concerned
department, shall be subjected to the penalties.