Republic of the Phitippinas
HOUSE OF REPRESENTATIVES
Quezon City, Metro Manila

Fifteenth Congress
First Reaviar Sess’

introduced by Hon. Mark Llandro L. Mendoza, Hon, Irvin M. Aleala,
Hon, Danilo £. Suarez, and Hon, Sharon $, Garin

EXPLANATORY NOTE

Food should not cause harm to consumers when it Is prepared and eaten in accordance with
its intanded use. Food-borne Illnesses occur, however, because food is exposed to hazarcs
‘that can cause iiness during {ts producticn up te its preparation for human consurnstion.

Foed porne-finess is a documented pubis health probiem. According to the Wertd Health
C-ganizttion food ang waterborna diarrraat diseases kill an astimazed 2.2 milion peoole
yeatiy i* cevelop ng countries.

awards ie she safety of food as weil as the “neascres needed to control thesa vary with the
type of food and ihe elrcumstancas under wnich it is made available.  Pathcgenic
microcrganisms and viruses grow on foods when hygienic and other conditions are poorly
controlieg. For example, residues of antibiories are in fish and meats due to the improper
use of mese drugs during production. Pesticide residues are in plant foods when pesticides
are not appiied as prescribed, Fungal toxins profiferate in corn and peanuts when
improperly dried. Toxic metals as ead, cadmium and mercury from the environment and
other sources find their way to fishes, Harmful chemicais also get into food through
inappropriate use of food additives or through intentional adulteration for economic gain
There are also emerging hazards as pathogens that are more virulent or are emerging in
new food vehicles. Globalization is partly held responsible for this as it has changed the
way ‘coc is produced, processed and distributed.

The prevention of food-borne illness is the responsibility of all in the industry who handie
feod in the food supply chain. Varification cf the effectivity of measures taken by the
industey to prevent food borne illness is, nowever, the responsibility of governments as inis
can only be achieved through regulation

The sise in incidence of food-borne iliness and tha growth in knawledge or. fod safety have
made countries vigilant about the way the safety of facd is regulated. This resutied to the

cevecopment of food safety regulaticas as eart of international protocols to whicn we are

Signatory, Many countries in tne Surcpean Union, as well as the United States, have



restructured their regulatory systems in response to these protocois, Others have
screngthened their systems as an essential step to gaining access to. markets. Upgradi
our food safety regulatory system is called for in the fight cf what is now known raga:
food safety as well as the effects o! is on ol:r trade in foods and food products,

Bullorng a sound food regulatory system will require the cooperative effort of tne three
government agencies involved in ansuring safe focd. The Department of Agriculture (04)
which is respensible for fresh foods and food commodities, the Department of Health
{DOH}, for processed and packaged fonts and the Department of Interior and Lecai
Goversments {DiLG), which supervises the regulation of food safety by the Local
Government Units {LGU’s).

There ace several weaknesses in the food safety regulatory system that have to be
aderessed. foremost among these is that the laws of eguiatory agencies have iil defined
ad a weak basis for food sati ation. fh’s has led to overextension ard

bf services as Well a¢ gags in cage.acion ive exceptions are the enabling :2ws of
she Food and Drug Administration (SDA) of the DC (ia RA 3720 and RA 9711) and ef the
Nazionai Meat Inspection Service (NM:S} of tne DA {in RA 9796). The regulation of the FOA
nowever 's combined with drugs; whiie that ef the NMIS is mainly on the safety of meat for
export and import.

Currant primary and secondary iegislacions create overleoping jurisdictions over specific
functions and areas. The mangate of |.GU's aver food safety as defined in the Local
Government Code of 1991 overlaps with the jurisdictions of the DA and the DOH. Similarty
overiapping jurisdictions occur between the DA and the DOH for food safety in the
Consumer Act {RA 7394). The enabling iaws of the Bureau of Fisheries and Aquatic
Resources for canned fish and of the NMIS for procassed meats overlap with that of the
DCH fer processed fords.

Currently there is no mechanism for coord:nation between the agencies that coud iead 10 a
coth resolution of overlapping mandates of to the utilization of each agency's
stitutiona! strengths for more effective reguietory programs. Instead compiex and
ole iegal instrumants have bees ‘ssved vy me agencies. While this is not unexpected
2 area of food safety reguiaticn ‘s cot streightforward and requires the constant
ion. of new measures, a strategy for harmonizing and streamlining the various legal
issuances through a basic food safety act appears necessary.

mui

An imoortant component of food safety regu'ations are food safety standards.
few mandatory food safety standards in national regulations. The mandate of the Bureau of
Agriculture and Fisheries Produc: Standards {BAF?S} to set standards overlaps with that of
cocher agencies as NMIS {for meat), 3FAR (for fish} and the fertilizer and Pesticide Autnority
PA} for pesticide residues. Considering the situation, s mechanism for deveicping fone
safety standards has to be put in piace by BAFPS

are

The food safety standards developed by the Codex Alimentarius Commission (CAC) are used
as basis for the acceptance of food products in trade. National Codex Organization {NCO)
was recently established to strengthen country participation at Codex. The NCO which is a
joint body of the Department of Agriculture and the Department of Health should be
recognizes as part of the food safety reguiatory system and ensured support by
goveramens.



Conformity with standards is determined through several activities, of which testing is
among the most demanding of professional skill due to the increasing complexity of food
testing methods and equipment. More professional management to bring this activity to
required levels of proficiency is necessary.

Correcting existing weaknesses in the food safety regulatory system should also involve
upgrading manpower skitts in the understanding of food safety. A wide gap currently exists
between the requirements of regulations and our understanding of these requirements.
Property closing this gap will go a long way towards improving the performance of agencies
and facilitating compliance with measures by farmers and fisherfofks and small industries.

Food safety regulations can become barriers to trade due to differences in concepts
between countries on what makes food safe. International protocols thus require that
regulations be based on science as it provides a basis for demonstrating equivalence in food
safety control measures of countries. A strong research and development (R&D) program is
necessary to support a science-based regulatory system. Epidemiological studies on food-
bome illness and surveillance studies on contaminants In foods have to be carried out.
These studies which provide a basis for the identification and assessment of risks also
‘enable agencies to provide the greatest attention to those food safety hazards that pose the
greatest risks.

Technologies that will enable the industry especially farmers, fisherfolk and small scale
industries to comply with regulations and market their products competitively should also
be established through R &D.

The regulatory system needs to be strengthened to be at par with requirements for
ensuring food safety. Considering that there are three agencies involved, this can only be
achieved if the agencies are well coordinated to work together towards this objective. A
single Food Safety Act based on common principles for food safety should provide the
needed legat framework for coordination and for streamlining legat issuances for official
controls, training and research. Making this feasible should enable the agencies to respond
effectively to changes in requirements for food safety brought about by markets, new
information and new technologies.

———_—_—_________
Hon. Irvin M. Alcala

2nd District, Quezon

Hon. Danilo E. Suarez
3™ District, Quezon



Republic of the Philippines
HOUSE OF REPRESENTATIVES
Quezon City, Metro Manila

Fifteenth Congress
First Regular Session

HOUSE BILL NO. 417

Introduced by Hon. Mark Llandro L. Mendoza, Hon. Irvin M. Alcala,
Hon. Danilo E. Suarez, and Hon. Sharon S. Garin

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, ANO FOR OTHER PURPOSES

ARTICLE 1
Title, Declaration of Policy and Objectives

SECTION 1. Short Title. - This Act shall be known as “The Food Safety Act of 2011.“

SECTION 2. Declaration of Policy. - It is the policy of the State to develop and maintain a
food safety regulatory system that will ensure the highest level of pratection of human
health in the consumption of food, fair practices in the food trade and market access of local
foods and food products.

SECTION 3. Objectives. - The objective of this Act is to strengthen the food safety
regulatory system in the country by:
{a} delineating the mandates and responsibilities of government agencies involved;
(b} providing a mechanism for coordination and accountability in the
implementation of regulatory functions;
(c} establishing policies and programs for addressing food safety hazards,
developing appropriate standards and controt measures;
(d) strengthening the scientific basis of the regulatory system, and upgrading the
capability of farmers; and
(e} fisherfolk, industries, consumers and government personnel to play their roles in
ensuring food safety.


ARTICLE I
Definition of Terms

SECTION 4. Definition of Terms. — With regards to this Act, the following key definitions are
given:

(a) “Contaminants” refers to any substance not intentionally added to food which is
present in such food as a result of the production (including operations carried
out in crop husbandry, animal husbandry and veterinary medicine)
manufacturing, processing, preparation, treatment, packing, packaging, transport
or holding of such food as a result of environmental contamination. The item
does not include insect fragments, rodent hairs and other extraneous matter.

(b) “Contro! Measure” refers to any action and activity that can be used to prevent
or eliminate a food safety hazard or to reduce it to an acceptable level.

(c) “Food” refers to any substance or product whether processed, partially
processed or unprocessed reasonably expected to be ingested by humans,
“Food” includes drinks, chewing gum and water which is intentionally
incorporated into the food during is manufacture, preparation and treatment.
“Food” shall not include Feeds, Live animals unless they are prepared for placing
in the market for human consumption, Plants prior to their harvesting, Medicinal
products, Cosmetics, Tobacco and tobacco products, Narcotics or psychotropic
substances

(d) “Feed” refers to any substance or product including additives, intended to be
used for oral feeding to animals.

(e) “Food Business” refers to any undertaking whether public or private carrying out
any of the activities related to or at any of the stages of the food supply chain,

(f) “Food Business Operator” refers to the person responsible for ensuring that the
requirements of food law are met within the food business under his/her control.

(g) “Food hygiene” (hereinafter called Hygiene) refers to the measures and
conditions necessary to control hazards that create food safety risks and to
ensure fitness for human consumption of a food of plant or animal origin taking
into account its intended use.

(h) “Food Law" refers to the laws, regulations and administrative provisions
governing food in general and food safety in particular, They cover any stage of
production, processing and distribution of food and its preparation for human
consumption.

(i) “Food Safety” refers to the assurance that food will not cause harm to the
consumer when It is prepared and/or eaten according to its intended use.

() “Food Safety Regulatory System’ refers to the combination of regulations, food
safety standards, inspection, testing, data collection and surveillance carried out
by each of the three government agencies in the implementation of their
responsibilities for the control of food safety risks in the food supply chain.

(k) “Food Supply Chain” refers to all the stages in the production of food from
primary production, postharvest handling, distribution, processing and
preparation for human consumption. Primary production includes farming of
plants and lives animals, aquacutture production of seafoods, and the
“catching” of marine fishes at sea. Postharvest handling includes minimal
transformation of plant and animal foods after primary production such as
removal of field heat for fruits, staughter of animals, sorting and grading, icing
and freezing, and the milling of grain. Distribution includes transport and storage.
Processing involves extensive transformation of food as canning, manufacture of



juices, dehydration, and the packaging of products. Preparation is the cooking or
other preparations ta which food is subject prior to its consumption.

(I) “Hazard Analyses at Critical Control Points (HACCP)" refers to the scientific and
systematic method of ensuring food safety by identifying and assessing potential
risks critical to food safety existing at points during a given stage in the food
supply chain, such as points in the processing of a food. (t also pertains to
methods of establishing permanent control methods at such points. These points
are known as critical control points. They are points in any of the stages in the
food chain {raw materials, tocation, process, recipe of the food, transportation
etc.) which should be controlled to eliminate or reduce risks to an acceptable
level.

(m)"Hazard” refers to 2 biological, chemical or physical agent in a food with a
potential to cause an adverse effect on health

(n) “Inspection” refers to the examination of facilities of food business or
establishment and their management and production systems. This also deals
with: examination of these entities’ documents, finished product testing and
feeding practices {for animal foods), and of the origin and destination of
production inputs and outputs. This és in order to verify compliance with legal
requirements in all cases.

(0) “Micro, small, medium and large scale industries” refers to the classification of
industries of the Department of Trade and Industry.

(p) “National Codex Organization” refers to the organization created by a Joint
Department Order, Department of Agriculture Administrative Order No 01 Series
of 2008 and Department of Health, Administrative Order No 2008-0030. It
establishes the policies and procedures, and defines the objectives to be reached
in country participation at the Codex Alimentarius Commission. The latter is an
organization under the aegis of the Food and Agriculture Organization and the
World Health Organization that develops and adapts science-based food safety
standards, codes of practice and other texts, for the protection of consumer
health and fair trade

{q) “Official Control” refers to all types of control made by the regulatory agency to
verify compliance with standards, operating procedures, practices and other
requirements.

(2) “Primary Production” refers to the production, rearing or growing of primary
products including harvesting, milking and farmed animal production prior to
slaughter; and the rearing and growing of fish and other seafoods in aquaculture
ponds. It also includes fishing, and the hunting and catching of wild products.

(3) “Processing” refers to any action that substantially alters the initial product
including heating, smoking, curing, maturing, drying, marinating, extraction,
extrusion and a combination of those processes.

(1) “Risk” refers to the likelihood of an adverse health effect and the severity of this
effect following exposure to a hazard

(u) “Risk Analysis” refers to the process consisting of three interrelated components:
risk assessment, risk management and risk communication.

(v) “Risk Assessment” refers to the scientific evaluation of known or potential
adverse health effects resulting from human exposure to food-borne hazards.
The scientific process consists of four phases, namely: hazard identification,
hazard characterization, exposure assessment and risk characterization. It
includes quantitative risk assessment, which emphasizes reliance on numerical
expressions of risk, and also qualitative expressions of risks, as well as an
indication of the attendant uncertainties.



(w)“Risk Management” refers to the process, distinct from risk assessment,
consisting of weighing policy altematives to accept, minimize or reduce assessed
risks and if necessary, to select and implement appropriate prevention and
control measures. It is carried out in consultation with interested parties,
considering the results of risk assessment and other possible factors.

(x) “Risk Communication” refers to the interactive exchange of information and
opinions during the course of risk analysis, on the hazards and risks; among risk
assessors and risk managers, consumers, food and feed business operators,
academia and other stakeholders including explaining the results of risk
assessment and risk management decisions and databases.

(y) “Regulatory Agency’ refers to a particular agency in the Department of Health or
the Department of Agriculture in the Philippines, responsible for verifying
compliance with official measures for the control of food safety risks, and for
compliance with the requirements of this Act. It is also any other agency ta which
specific powers have been assigned or delegated by the regulatory agency to
carry out the above tasks.

(2) “Safe for human consumption” in relation to food, means that the food has been
produced by applying all food safety requirements appropriate to its intended
use; it meets criteria for product performance and process arrived at from an
analysis of risks for specified hazards; it does not contain hazards at levels that
are harmful to human health as defined by national regulations or intemational
standards when national standards do not exist.

{aa) “Traceability” refers to the ability to trace and follow a food, feed, a food
producing animal or any substance intended to be or expected to be
incorporated into a food or feed through all stages of its production, processing
and distribution,

ARTICLE U1
Basic Principles of Food Safety

SECTION 5, Food Safety Requirements. - To ensure food safety, food should not be placed
in the market if it is unsafe. Food safety requirements shall also be guided by the following,
principles:
{a} Food shall be deemed unsafe if it is determined to be injurious to health and unfit
for human consumption;
(b) In determining whether food is unsafe, regard shall be given to the following:
1, The normal conditions of use of the food by the consumer
2. The normal conditions maintained at each stage of production, processing
and distribution,
The health of plants and animals fram where the food is derived;
4, The effect of feeds, crop protection chemicals and other production inputs
on otherwise heatthy plants and animals.
5. To the information provided to the consumer. This includes the information
provided on the label or any information generally available to the consumer.
This should aid consumers avoiding specific health effects from a particular
food or category of foods.
{c) In determining whether any food is injurious to heaith, regard shall be given to
the following:
1. probable immediate, short term or long term effects on subsequent
generations, of that food on heafth

»


2. probable cumulative effects
3. particular heaith sensitivities of a specific category of consumers where the
food is intended for that category

(d) In determining whether any food is unfit for human consumption, regard shall be
given to determining unacceptability of the food according to its intended use
due to contamination by extraneous matter, or through putrefaction,
deterioration or decay.

(e} Where unsafe food is part of a batch, lot or consignment of food of the same
class or description, it shall be presumed that all food in that batch, fot or
consignment Is also unsafe

{f} Food that complies with specific nationat provisions governing food safety shall be
deemed safe in so far as the aspects covered by national law and regulations are
concerned.

{g) Compliance of a food product with specific provisions applicable to that food shall
not prejudice the competent authorities to take appropriate measures to impose
restrictions on entry into the market or to require its withdrawal from the
market, where there is reason to suspect and the food product shows, food
safety related risks.

ARTICLE IV
General Principles

SECTION 6. Food Law Objectives. — Food law shall aim for a high tevel of protection of
human life and health in the consumption of food. tt shall also aim for the protection of
consumer interests through fair practices in the food trade.

SECTION 7. Use of Science and Risk analysis. - The following principles shall serves as basis
for the use of science and risk analysis:

{a} The development of food legislation and standards and the conduct of inspection
and other activities shall be based on the analysis of risk, except where this
approach is not feasible due to circumstances, or due ta the nature of the control
measure.

{b) Risk assessment shalt be based on sound scientific evidence and shall be
undertaken in an independent, objective and transparent manner. Scientific
information as obtained from scientific literature, epidemiological and
surveillance studies, other data that supports the risk assessment shall be used.

(c) Risk management shall take into account the results of risk assessment relevant
to local conditions, potential for enforcement, costs of compliance and others as
relevant to the situation.

{d) Risk communication shall be carried out between risk assessors and risk
managers in a transparent manner. Food safety risks shall also be communicated
to farmers, fisherfolk and food business operators to encourage compliance with
the implementation of control measures; and to relevant sectors of society
affected by the law or the risks addressed, in order to strengthen confidence in
its provisions.

{e) Food business operators are encouraged to implement a HACCP — based system
for food safety assurance in their operations. Training on hazard analysis and the
selection and management of critical control points shall be provided to industry
and government by accredited HACCP trainors.



SECTION 8. Protection of Consumer interests. - Consumer interest shall be a vital
consideration in food safety, thus:

(a) Food legisiation shall aim at the protection of consumer's interests by the
prevention of fraudulent practices, and practices which mislead the consumer;

(b) The labelling, advertising and presentation of food, including their shape,
appearance or packaging, the packaging materials used, the manner in which
they are arranged, the setting in which they are displayed, and the product
description, information which is made available about them through whatever
medium, shall not mislead consumers. Where relevant, the presentation of
goods shall provide consumers a basis to make informed choices in relation to
the food they purchase.

SECTION 9. Use of international Standards. - When international standards exist, these
shall be taken into consideration for adoption into food law in accordance with the
following policies:

(a) The standards of the Codex Alimentarius Commission shall be adopted into
national laws; except when these are in conflict with what is necessary to protect
consumers and scientific justification exists for the action taken.

(b) A body jointly organized by the DA and the DOH shail establish the policies and
procedures for country participation in the standards making processes of the
Codex Alimentarius Commission and the incorporation of Codex standards into
national regulations. The current National Codex Organization with its Terms of
Reference and Manual of Operations is herein designated as this body.

(c} Participation at Codex shall be in accordance with the principles of this Act and
shalt be financially supported by the government.

SECTION 10. Precaution. ~ In specific circumstances when the available relevant information
for use in risk assessment is insufficient to show that a food does not pose a risk to
consumer health, precautionary measures shall be adopted. When such precautionary
measures are issued, the following rules shall govern:

{a) The adopted measure shall remain enforced pending the submission of additional
information for a more objective assessment of risk and after a review of the
measure over a reasonable period of time depending on the nature of the risk
and the type of scientific information needed to clarify the scientific uncertainty.

(b) The measure shall be no more restrictive to trade than required and should be
proportionate to the level of protection required for consumers.

SECTION 11, Transparency. — The implementing agencies shall e public consultation
and public information dissemination to ensure transparency in the regulation of food.

{a) Public consultation - Public consultation during the preparation, evaluation and
revision of food legislation, shall be open, transparent and direct or through
representative bodies unless the urgency of the problem does not allow it.

(b} Public information - In case of suspicion that food may pose a risk to human
health, regulatory authorities shall take appropriate steps to infarm the general
public about the nature of the risk to heatth, the affected foods, types of food
and the necessary measures to prevent, reduce or eliminate the risk

SECTION 12. Application to Trade. — The provisions of this Act apply to foods and food
products produced, processed, distributed and prepared for the domestic and export


markets. Imported food must also be in compliance with this Act and with international
agreements to which the Philippines is party.

SECTION 13. Principat Responsibility of Food Business Operators. ~ Food business operators
at all stages of production, processing and distribution shall ensure that food satisfies the
fequirements of food law reievant to their activities in the food supply chain and shall verify
that such requirements are met.

SECTION 14. Specific Responsibilities of Food Business Operators. — Food business
operators shall have the following responsibilities in pursuance of this Act:

{a) Food business operators shall be knowledgeable of the specific requirements of
food law relevant to their activities in the food supply chain and the activities of
the government agencies that implement it. They shall adopt and apply and be
well informed of codes and principles for good practice. Farmers and fisherfolk
and micro and small industries shall be assisted to adopt these in their
operations.

(b} tf a food business operator considers or has reason to believe that a food which it
produced, processed, distributed or imported is not safe or not in compliance
with food safety requirements, it shall immediately initiate procedures to
withdraw the food in question from the market and inform the regutatory
authority,

(c) Food business operators shall collaborate with the regulatory authorities on
action taken to avoid or reduce risks posed by a food which they supply or have
supplied.

(d) Where the product may have reached the cansumer, the operator shalt
effectively and accurately inform the consumers of the reason for the
withdrawal, and if necessary, recall from consumers products already supplied to
them when other measures are not sufficient to achieve a high level of health
protection.

SECTION 15. Principal Responsibilities of Government Agencies. In pursuance of this Act,
government agencies shall have the following responsibilities:

(a} The Department of Agriculture (OA), Department of Health (DOH) shall be
responsible for food safety in specified stages of the food supply chain, the BA in
the primary production and postharvest stages, the DOH in the processing and
packaging stages. The DILG shall supervise the Local Government Units’ (LGU)
enforcement of food safety and sanitary rules and regulations as wel as the
latter's inspection and compliance monitoring of business establishments and
facilities within its territorial jurisdiction engaged in all stages of the food supply
chain. It shall be jointly responsible with LGU’s for the safety of food produced,
processed and distributed within the municipalities, including restaurants and
other food service establishments and street vended foods.

(b) The DA and the DOH shall be responsible for the establishment of policies and of
food safety standards. In carrying out this mandate, they shall coordinate with
the DILG, conduct surveitlance for biological, chemical and physical
contaminants, epidemioiogical studies on food borne-illness and other research
activities. The data from these activities will be used for evaluating the nature



and sources of food safety hazards in the food supply chain and the analysis of
risks due to these hazards.

(c} The DA, DOH and DILG shall verify through their relevant activities and through
the coordination of these activities within the FSRCB, that appropriate control
measures to conform to standards are enforced and that all laws, standards and
regulations are implemented by food business operators, farmers anc fisherfolks.
For this purpose, the DA and the DOH in compliance with their responsibilities
for food safety in the food supply chain shall provide training programs to food
control officials of the DILG and LGU's and audit through the DILG, the effectivity
of training programs and control measures implemented in the municipalities. A
system of official controls and other activities shall be maintained by each agency
as appropriate to the circumstances.

(d) Delegation of responsibilities for the performance of official controls can be
carried out. Provisions shall be made on the conditions under which this shall
take place.

{e) The DA and the DOH shall provide technical support to the DILG in the training of
manpower, on the enforcement of food safety regulations, testing of product
samples and others. They shall ensure through relevant procedures that the
DILG participates in national projects and activities on food safety including those
of the National Codex Organization

SECTION 16. Specific Responsibilities of the Department of Agriculture. — The Department
of Agriculture shall have the following responsibilities:

{a} The DA shall be responsible for the develapment of standards and the
enforcement of standards and food safety regulations at the primary production
and postharvest handling stages of the food supply chain and of the foods and
food products locally produced or imported in this category. Changes to this
provision shall be made through the Food Safety Regulation Coordinating Board
(Article Vi).

(b) The primary production activities in the food supply chain as defined in this Act
includes among others, the farming of plants and live animats for food
{including its milk and eggs), farming of seafoods and the catching of fishes and
marine products at sea. The postharvest handling activities includes but is not
limited to animal slaughter and its processes, grain milling and its processes,
freezing and its processes; and simpler activities as washing, sorting, icing and
cutting of fresh plant and animal foods.

{c) The DA shall ensure through relevant activities and through the coordination of
these activities with the DOH and the DILG that the standards and regulations
enforced shall include but will not be limited to the following:

1. The health of animals used for food

2. The safety of the water supply in agricultural farms, aquaculture farms and

bodies of water where fish and marine products are caught;

3. The safety of feed ingredients and feeds for animals used for food;
The safe use of allowed agricultural chemicals and other production inputs;
Sanitation in production and postharvest handling facilities such as facilities
for dehusking, deshelling, drying of palm fruit, packing houses for fruits and
vegetables, animal houses, holding and fattening pens, vapour heat
treatment plants for fruits, grains and other food warehouses, ships, fish
ports, trading posts, slaughterhouses and similar facilities;
6. Maximum allowed levels of contaminants as residues of pesticides and of

veterinary drugs in plant and animal foods, pathogenic microorganisms,

ye


fungal toxins in grains and other foods and other hazards in the production

and post harvest handling stages of the food supply chain;

Procedures for traceability; and
8. Other components of good agricultural, animal husbandry, aquacufture and

manufacturing practices.

Specifically, the DA shall monitor and verify that the relevant requirements of
the law are fulfilled by farmers and fisherfolk and food business operators of
domestically produced and imported foods in this category.

(d) The DA shall carry out surveillance studies for contaminants in plant and animal
foods and in the environment in coordination with other government
departments through the FSRCB.

(e) The DA Secretary shall designate the food safety regulatory agencies that will be
responsible for food safety regulatory functions at the OA and clearly describe
their mandates. The current regulatory agencies of the DA are the following: the
Bureau of Animal Industry (BAI, for live animals), the National Meat Inspection
Service (NMIS, for the safety of meats), the Bureau of Fisheries and Aquatic
Resources (BFAR, for the safety of fisheries and aquaculture products particularly
those exported to the EU), the Bureau of Plant Industry (BPI, for plant foods}, the
Fertilizer and Pesticide Authority (FPA, for pesticides) the Philippine Coconut
Authority (PCA, for caconut), the Sugar Regulatory Commission (SRC, for sugar)
and the National Food Authority (NFA, for rice and corn).

(f) On an interim bosis, the Office of the Undersecretary for Policy and Planning
Project Development and R&D shall exercise oversight of the regulatory
functions of agencies designated by the Secretary in section 16e to undertake the
regulation of food safety. It shall be provided with the needed personnel and
funds to carry out this task.

(g) On a permanent basis, the Office of the Undersecretary for Policy and Planning,
Project Development and R&D shall exercise supervision over codex activities,
the development of foad safety standards, the management of food testing
laboratories and the implementation of research and training activities in the
production and postharvest portions of the foad supply chain, as designated in
this Act. The Office shall be the Codex Contact Point. It shail be provided with the
needed functional divisions, experienced manpower, incremental staffing and
funds for the exercise of these permanent functions.

(h) As it has several agencies with food safety regulatory mandates as well as other
related regulatory responsibilities (as plant health and animal health), the DA
shall create a permanent Undersecretary and Office for Regulations to include
Food Safety Regulation. The interim functions of the Office of the Undersecretary
for Policy and Planning, Project Development and R&D (16f) shall be transferred
to this Office as soon as it is created. The new Office shall be strengthened with
appropriate functional divisions, incremental personnel and funds to carry out
its task,

{i} The Bureau of Agriculture and Fisheries Product Standards (BAFPS) shall establish
food safety standards at the primary production and postharvest stages of the
food supply chain and the appropriate mechanisms for carrying this out. BAFPS
will be under the administrative supervision of the Office of the Undersecretary
for Policy and Planning, Project Development and R&D

@) The Food Development Center shall be transferred from the National Food
Authority to the DA as the Food Safety and Quality Development Center (FSQDC}
under the Office of the Undersecretary for Policy and Planning, Project
Development and R&D. It shall supervise food safety testing laboratories at the

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DA and manage the training and research programs of the DA as indicated in

Article 1X.

{k) The FSQDC shall have the following other functions:

1. Conduct food testing for contaminants (chemical and microbiological) as the
official DA laboratory for contaminants testing;

2. identify, establish and verify food safety contral measures as delegated by
the DA for which the DA has no agency with a food safety regulatory
mandate;

3. Develop and conduct training for DA personnel and the industry on HACCP
and other training courses within its area of expertise; and

4. Provide other technical services to the DA and its food safety regulatory
agencies in the implementation of their food safety mandates.

(I) The services of FSQDC to the OA and other clients shall be pravided an a fee for
service basis in accordance with its current policies, The FSQDC shall continue to
provide all other technical services it currently provides to the industry to ensure
product quality and safety.

(m) The FSQDC shall be allowed to retain the fees collected from the provision of
services. This shall constitute a revolving fund that FSCDC can use to defray its
operating expenses. This is necessary as delays in the release of budgetary
allocations may not make it possible for the Center to provide technical services
efficiently and as planned. A revalving fund from retained fees shall be created
for this purpose.

(n} The FSQDC shall be strengthened in terms of establishing functional divisions and
incremental staffing to implement this mandate including upgrading of
equipment and facilities as provided for in DA programs. An initial budget of
one hundred fifteen million Philippine Pesos (115,000,000 PHP) shall be
appropriated for the initial year of implementation of this Act. Thereafter such
amount or as may be necessary for the cantinuaus operation of the FSQDC shall
be included in the General Appropriations Act. The assets and facilities of the
FSQDC shall be transferred to the DA.

SECTION 17. Specific Responsibilities of the Department of Health. — The Department of
Health shall have the following responsibilities under this Act:

(a) The DOH shall be responsible for the development of standards and the
enforcement of standards and the implementation of food safety regulations at
the processing and product packaging stages of the of the food supply chain and
of the foods and food products locally produced or imparted in this category.
Changes to this provision shall be made through the Food Safety Regulation
Coordinating Board (Article VI).

{b} The activities in the processing and product packaging stages of the food supply
chain as defined in this Act includes among others, the application of pre-
processing and processing techniques an plant and animal foods that
substantially changes the form and quality of the plant or animal used as raw
material. Products in this category are sold in packaged form directly to the
consumer, are processed before or after packaging to obtain the quality and
stability desired and are labelled to provide appropriate information regarding
the product, to the consumer.

(c) tt shall ensure through relevant activities and through the coordination of these
activities with the DA and DILG through the FSRCB, that standards and
regulations in food law at the processing and pre-packaging stages of the food



supply chain, are enforced. This shall include but will not be limited to standards
for the following;

9

PN AVawNE

Good Hygienic and Manufacturing Practices;
Traceability;

Safety of ingredients and packaging materials;

Adequacy of thermal and non-thermal processing procedures;

Safety of functional foods and nutraceuticals;

Safe use of allowed food additives and processing aids;

Absence of unallowed chemicals and biological contaminants;
Maximum levels of unavoidable chemical and biological contaminants;
Proper labelling and use of label claims; and

10. Others as identified.

(d) The food safety regulatory agency of the Department of Health is the Food and
Drug Administration as defined by RA 3720 and RA 9711. It shall be provided
with adequate qualified personnel, functional divisions and funds to implement
its responsibilities as indicated in this Act.

{e) The enforcement of this mandate requires coordination with the DA in the
designation of responsibilities at stages in the food supply chain where their
mandates overlap as ensuring safety of meat (under the mandate of the DA) for
processing into canned meat, or fish for canned fish and others,

(f) The DOH as the authority on the short and long term effects of food safety
hazards on human health shall conduct and document epidemiological studies on
food-borne illness for use in risk assessment. It shall establish the food safety risk
assessment bodies required for this purpose. It shall be strengthened in teems of
establishing functional divisions and incremental staffing and funds to carry out
this function.

SECTION 18. Specific Responsibilities of the Department of interior Local Government. —
The following are the responsibilities of the Department of Interior and Local Government:

{a) The DILG shall be responsible for the enforcement of the Code of Sanitation, the
food standards developed by the DA and the DOH and the enforcement of food
safety regulations at the municipal level. Changes to this provision shall be made
through the Food Safety Regulation Coordinating Board (Article VI).

(b) it shall ensure through relevant activities and through the coordination of these
activities with the DA and the DOH and through the FSRCB, that sanitation
standards and relevant food safety standards are enforced in the municipalities
particularly in slaughterhouses, public markets and in micro and small food
establishments where food is processed, prepared and/or soid. This shall include
but will not be limited to the enforcement of the following standards:

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6.

Sanitation as indicated in the Sanitation Code PD 856 particularly in public
markets, slaughterhouses, micro and small food processing establishments
and public eating places;

Code for Good Siaughtering Practices;

Code for Proper Food Handling;

Code for Good Hygienic and Manufacturing Practices;

Safe use of food additives, processing aids and sanitation chemicals; and
Proper labelling of pre-packaged foods.

(c) The OILG shall support the DOH and the DA in the collection and documentation
of food-borne iliness data, surveillance and research.


(d} The DItG shall participate in training programs, standards development and other
food safety activities taking place at the national level in coordination with the
DA and the DOH.

Article VI
Creation of a Food Safety Regulation Coordinating Board (FSRCB)

SECTION 19. Powers and Functions. — A Food Safety Regulation Coordinating Board is
hereby created which shall have the following powers and functions:

{a} Authority to link the mandates, control functions and activities of the DA, the
DOH and the DILG in food safety regulation and modify these as needed due to
changing requirements of markets, new technologies, new food safety risks and
other causes.

(b} Identify agency/s responsible for enforcement when jurisdiction over specific
functions and areas overlap between the DA, OOH and DILG. Ensure effective
enforcement where a coordinated approach to food safety regulation is
necessary.

{c) Establish the policies and procedures for coordination of regulatory systems as
implemented by the DA the DOH and the DILG.

(d) Evaluate the effectivity of standards, conformity assessment activities, the
performance of food testing laboratories and their accreditation to international
standards, Oversee the averall effectiveness of the food safety regulatory system
and of the research and training programs,

{e) Designate which organization will implement food safety regulations in the use
of new technologies as biotechnology, nanotechnology, food irradiation and
others,

{f) Coordinate crisis management and planning during food safety incidents and
monitor the Rapid Alert System for Foods as provided in Article VI of this Act.

SECTION 20. Organization. - Within 30 days from the effectivity of this Act, the Secretaries
of the DA, OOH and the DILG shall organize the FSRCB in accordance with the following
rules:

(a} The FSRCB shall be chaired by the Secretary of the DA and co-chaired by the
Secretary of the DOH or their authorized representatives at the Undersecretary
level. The members of the FSRCB shall be the Heads of food safety regulatory
agencies of the DA, the DOH and a representative of the OILG. A representative
each from the DTI and the DOST at the Director level shall also be included.

(b] Within 12 months from the effectivity of this Act or earlier, the FSRC8 shall have
completed its Procedural Manual as approved by the Chair and Co-Chair of the
FSRCB. The manual shall contain the rules for the conduct of meetings, decision-
making, and others. Funds shall be allocated for the expenses of a Working
Group created hy the FSRCB to prepare this manual.

{c) The FSRCB shall have an administrative and technical secretariat at the DOH. Both
the DOH and the DA shall be strengthened and empowered in terms of funding
and establishing functional divisions and incremental staffing to organize the
administrative and technical personnel for the operation of the FSRCB.

{d} Funds shall also be allocated by the agencies to pay for the organization of
meetings as well as the expenses for the participation of members of the FSRCB
and secretariats as well as invited experts to the meetings.


SECTION 21. Accountability for Food Safety Regulation. — The food safety regulatory
agencies of the DA, DOH and the DILG, shall be individually responsible for ensuring food
safety at the stages of the food supply chain within their specified mandates, functions and
responsibilities. They shall also be responsible to ensure the same for mandates, functions
and activities that are modified by agreement through the FSRCB. The FSRCB shall be
responsible for regulations that are implemented on a coordinated basis between the
agencies.

ARTICLE VII

Crisis Management

SECTION 22. Rapid Alert System. - A rapid alert system for the notification of a direct or
indirect risk to human health due to food should be established by the FSRCB as a network
between regulatory agencies and other relevant agencies,

SECTION 23. Emergency Measures. — Where it is evident that food originating from within
the country or imported from another country is likely to constitute a serious risk to human
health, the Government shall immediately adopt one or more of the fallowing measures,
depending on the gravity of the situation:
(a) in the case of food of nationat origin
1. Suspension of the placing on the market or use of the food in question
2. Laying down special conditions for the food in question
3, Any other appropriate interim measure
(b) In the case of food from another country
1. Suspension of imports of the food from all or parts of the third country
concerned and, where applicable from the third country of transit
2. Laying down special conditions for the food in question from all or part of the
third country concemed
3. Any other appropriate interim measures

SECTION 24. Plan for Crisis Management. - The regulatory agencies in cooperation with
other relevant government agencies shall prepare a general plan for the management of a
threat to food safety requiring coordinated action. This plan shall specify the situations
representing a direct or indirect risk to human heatth deriving from food which are not likely
to be prevented, eliminated or reduced to an acceptable level by provisions in place.

ARTICLE VIII
Implementation of Food Safety Regulations

SECTION 25. Policies on Official Controls. - Official controls are established to verify
compliance with food law and shall be prepared by each agency. Official controls include
routine surveillance checks of food establishments and more intensive checks involving
inspections, verifications, audits, sampling and testing of samples. The following shail govern
the conduct of official contrals:
{a} Implementing regulations for official contrals to be performed by each agency
shall also be prepared by each agency in accordance with the principles
established in this Act;


(b) Official controls shall be based on appropriate techniques, implemented by an
adequate number of suitably qualified and experienced personnel and with
adequate funds, facilities and equipment to carry out their duties properly;

{c) Provisions shail be made for official controls to be delegated to other competent
bodies as decided by the regulatory agency and of the conditions under which
this shall take place. When official controls are delegated, appropriate
coordination and other procedures shall be in place and effectively implemented;

{d) The frequency of official controls shall be proportionate to the severity and
likelihood of occurrence of the food safety risks being controlled;

{e) The regulatory agency or body performing official controls shall meet
operational criteria and procedures established by the agencies to ensure
impartiality and effectiveness;

(A) Official controls shall be carried out on the basis of documented procedures to
ensure that these are carried out uniformly and are of a consistently high quality;
ond

(g) The agencies responsible for the implementation of official controls shall be
strengthened and empowered in terms of funding and the establishment of
functional divisions and incremental staffing to perform official controls
according to the principles indicated in this Act.

SECTION 26. Traceability. ~ Traceability shall be established for certain commodities at
relevant stages of production, processing or distribution, when needed to ensure
compliance with food safety requirements. The rule on traceability also covers production
inputs such as feeds, food additives, ingredients, packaging materials and other substances
expected to be incorporated into a food. To ensure traceability food business operators are
required t¢
(a) be able to identify any person or campany from whom they have been supplied
with:
1. food;
2. food-producing animal;
3. production chemicals as pesticides and drugs; and
4. production and processing inputs as feeds, food additives, food ingredients,
packaging materials, or any substance expected to be incorporated into a
food,
{b) have in place, systems and procedures which allow this information to be
available to the regulatory authorities on demand.
{c) have in place systems and procedures to identify the other businesses to which
their products have been supplied. This information shall be made available to
the regulatary authorities on demand.

SECTION 27. Registration of Establishments. — Any food establishment or foreign food
establishment or food business operator engaged in production, postharvest handling,
processing, packing, holding or producing food for consumption shall be registered. Special
derogations shall be provided due to geographical location and after an assessment of risks,
especially for micro, small and medium sized operators.

SECTION 28. inspection of Food Business Operators. - Regular inspection of food business
operators shall be performed by the regulatory authorities or the control bodies delegated
to conduct the activity. In addition, the following rules shall also be followed in the conduct
of inspection:



{a) Inspection shall take into account. mandatory food safety standards the results
of HACCP inspections, the implementation of good practices and other
requirements of regulations;

{bJThe frequency of inspection shall be based on the assessment of risks.
Establishments producing high risk foods or carrying out high risk activities shall
be inspected more frequently;

{c) Unscheduled inspections shall be carried out as needed; and

{d) Inspectors shall have defined skills and shall be regularly evaluated by suitable
procedures to verify their continuing competence. Training and appropriate
procedures should also be in place to ensure that the results of inspection are
interpreted in a uniform way.

SECTION 29. Food Laboratory Testing. - Food testing shall be carried out by laboratories
accredited to international standards. They shall work in accordance with internationally
approved procedures or criteria-based performance standards and methods of analysis that
have, as far as possible been validated. To be accredited, the laboratories should meet the
following requirements:
(a) The laboratories shall be adequately funded.
(b) They shall be professionally managed and organized to ensure the absence of a
conflict of interest situation in the conduct of testing.
(€) The laboratories shall be responsible for providing evidence of the credibility of
test results from submitted samples.
(d) The agencies through the FSRCB shall minimize duplication in testing to the
extent feasible in order to achieve efficiency in laboratory operations,

ARTICLE IX
Training, Consumer Education and Research

SECTION 30. Training. ~ Farmers and fisherfolks and micro, small and medium scale food
business operators as well as government personnel shall be trained on the requirements
of food safety regulations and the understanding of these requirements. Industry
personnel and farmers and fisherfolks shall be further trained on the codes of good practice
relevant to their activities. Government personnel shall be further trained on the scientific
basis for the provisions of the law. Other training needs shall be implemented as identified,
The following rules shall be followed in the establishment of the training programs
(a) The training program shalt be developed by the FSQDC or other agencies and
private organizations accredited to provide the required training;
(b} A consumer education program shall be developed by the DA, the DOH and the
DILG as appropriate to the circumstances; and
(c) Funds will be provided for the develapment and implementation of training and
consumer education programs.

SECTION 31. Food-Bore iliness Monitoring, Surveitiance and Research, - The government
through the FSRCB and in support of risk analysis, shall implement a program for food borne
illness monitoring, surveillance for hazards in the food supply chain and establishment of
other data for risk assessment. It shall implement other research activities as technologies
for assisting industries to comply with regulations. The Bureau of Agricultural Research of
the DA and the Department of Science and Technology in cooperation with the FSRCB shall
establish the mechanisms for the conduct of research in these areas.



ARTICLE X
Policy on Fees

SECTION 32. Policy on Fees. — Fees may be collected and retained by the agency for the
inspection of production and processing facilities and for the laboratory testing of food
samples. Fees shall be based on an officially approved procedure for estimating the cost
of the activity undertaken. The fees retained shall constitute the Revolving Fund for the
g appropriations therefore subject to government accounting and

ARTICLE XI
Penalties and Sanctians

SECTION 33. Civil and Criminal Penatties. - The specific laws of each agency will lay down
the rules on measures and penatties applicable to infringements of this Act. Where there
are no such specific laws, any person that violates this Act may be assessed a penalty of not
more than PhP1,000,000 for such act or other measures as mandatory training that will
prevent the said violation. The violations and penalties shall be specified by the Secretaries
of the DA and the DOH in the Implementing Rules and Regulations (IRR).

ARTICLE XI
Transitory Provisions

SECTION 34. implementing Rules and Regulations {IRR}. - The IRR shall be prepared jointly
by the DA and the DOH ninety (90) days from the creation of the FSRCB or no more than 120
days after the effectivity of this Act.

ARTICLE XII
Miscellaneous and Final Provisions

SECTION 35. Separability Clause. - If any provision of this Act is declared invalid or
‘unconstitutional the other provisions not affected thereby shall remain in full force and
effect.

SECTION 36. Repeating Cause. — Atl laws, presidential decrees, executive orders, rules and
regulations inconsistent with the provision of this Act are hereby repealed.

ARTICLE XIV
Effectivity
SECTION 37. Effectivity. - This Act shall take effect fifteen days following its publication in at
least two (2) newspapers of general circulation or in the Official Gazette, whichever comes
first.

Approved,