REPUBLIC OF THE PHILIPPINES
HOUSE OF REPRESENTATIVES
Quezon City, Manila

AUG ca)

FIFTEENTH CONGRESS.

THIRD REGULAR SESSION
: 2330 -
COMMITTEE REPORT NO. 230
15 AUG 2012
Submitted by the Committee on Health on
Re House Bill No. 6474

Recommending its approval in substitution of House Bill Nos. 3428 2972 8 4417

Sponsors: Reps. Alfredo D. Marafion Ill, Rufus B. Rodriguez, Maximo B. Rodriguez,
Angelo B. Palmones, Mark Liandro L. Mendoza, Irvin M. Alcala & Sharon S.
Garin

Mr. Speaker:

The Committee on Health to which were referred House Bill No. 3428 introduced by
Reps, Rufus B. Rodriguez, entitled.

“AN ACT
“TO ESTABLISH A COMPREHENSIVE PROGRAM TO ENSURE THE
SAFETY OF FOOD PRODUCTS INTENDED FOR HUMAN
CONSUMPTION’

House Bill No. 3972, introduced by Rep. Angelo Palmones, entitled

“AN ACT
TO ENSURE THAT FOODS AVAILABLE TO THE PUBLIC ARE SAFE BY
CONSOLIDATING THE EFFORTS OF AND STRENGTHENING uA
CONCERNED GOVERNMENT AGENCIES AND OTHER ?URPOSES”

and, i

House Bili No. 4417. introduced by Rep. Mark Llandro L. Mendoza, erititied

“AN ACT
TO STRENGTHEN THE FOOD SAFETY REGULATORY SYS7EM IN THE =>
COUNTRY TO PROTECT CONSUMER HEALTH AND FACILITATE
MARKET ACCESS LOCAL FOODS AND FOOD PRODUCTS. AND
FOR OTHER PURPOSES’



has considered the same and recommends that the attached House Bill No.

pA entitled:
“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”

be approved in substitution of House Bill Nos. 3428, 3972 and 4417 with Reps. Rufus B
Rodriguez, Maximo B. Rodriguez, Angelo Palmones, Mark Llandro L. Mendoza, Irvin M
Alcala, Danilo E. Suarez, and Sharon S. Garin as authors thereof

Respectfully submitted,

Committee on Health

THE HONORABLE SPEAKER
House of Representatives
Quezon City


c of the Philippines
HOUSE OF REPRESENTATIVES

Fifteenth Congress
Third Regular Session
1 6A7A

nouse ait wo__ 5274

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

introduced by Reps. Rufus B. Rodriguez, Maximo B. Rodriguez, Angelo
Palmones, Mark Liandro L. Mendoza, Irvin M. Aicala, Danilo E. Suarez,
and Sharon S. Garin

Be it enacted by the Senate and the House of Representatives of the
Philippines in Congress assembied:

ARTICLE|
Declaration of Policy and Objectives

TH This Act shall be known as the “Food Safety Act of

SECTION 1. Shor
2012."

SEC. 2. Declaration of Policy. — Section 18, Article li of the 1987 Philippine
Constitution declares that the State shall protect and promote the right to
health of the people and instill health consciousness among them.
Furthermore, Section 9, Article XVI provides that the State shall protect
consumers from trade malpractices and from substandard or hazardous
products. Towards these ends, the State shall maintain a farm to fork food
safety regulatory system that ensures a high level of food safety, promotes
fair trade and advances the global competitiveness of Philippine foods and

food products.

SEC. 3. Objectives. To strengthen the food safety regulatory system in the
country, the State shall adopt the following specific 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

©. achieve economic growth and development by promoting fair trade
practices and sound regulatory foundation for domestic and

international trade.


Towards the attainment of these ob}
implemented

following measures shall be

(a) delineate and link the mandates and responsibilities of the government
agencies involved

(b) provide a mechanism for coordination and accountability in the
implementation of regulatory functions;

(c) establish policies and programs for addressing food safety hazards and
developing appropriate standards and control measures:

(d) strengthen the scientific basis of the regulatory system; and

(e) upgrade the capability of farmers, fisherfolk. industries, consumers and
government personnel in ensuring food safety.

SemrudsHsHKDe

ARTICLE Il
Definition of Terms

SEC. 4. Definition of Terms. - For purposes of this Act, the following terms
shall be defined as follows.

(a) Advertising refers to the business of conceptualizing, presenting or
making available to the public, through any form of mass media, fact, data or
information about the attrioutes, features, quality or availability of food and its
related products for the purpose of promoting its sale or distribution;

(b) Adulteration refers to an intentional act which leads to the production of

26 food which:

27 1. bears or contains any poisonous or deleterious substance that may
28 render it injurious to the health of the public:

29 2. bears or contains any added poisonous or deleterious substance in
30 amounts exceeding established maximum limits or standards for Good

Manufacturing Practice;

3. contains in whole or in part filthy. putrid or decomposed substance that
is unfit for human consumption;

4, has been prepared, packed or held under unsanitary conditions;

5. in whole or in part, is the product of a diseased animal or an animal
which has died through ways other than slaughter,

6. is in a container having in whole or in part any poisonous or deleterious
substance,

7. has been intentionally subjected to radiation unless the use of radiation
is in conformity with an existing regulation or exemption;

8. becomes injurious to health because of the omission or abstraction of a
vaiuable constituent: or if any substance has been substituted wholly or
in part; or if damaged or made inferior which has been concealed in
any manner, or if any substance has been added thereto or mixed or
packed therewith so as to increase its bulk or weight or reduce its
strength or to make it appear better or greater than it ts,

9. has not been prepared in accordance with current acceptable
manufacturing prectice as promulgated by way of regulation: and

10.uses expired ingredients

wv


19
20

) Authorization refers to the per
2 a regulatory agency to a natural or juridical person who has submitted an
application for a food business operation from primary produ
harvest handling, distribution, processing, manufacture, importation,
exportation, sale, and offer for sale, distribution, transfer and preparation for
human consumption, The authorization can take the form of a permit, license,
cattificate of registration and certificate of compliance or exemption or any
similar document:

(d) Contaminant 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 indusiry, animal husbandry and veterinary
medicine) manufacturing. processing, preparation, treatment, packing,
packaging, transport or holding of such food as a result of environmental

contamination,

(2) Control Measure refers to any action and activity that can be used to
prevent or eliminate food safety hazard or to reduce it to an acceptable level;

(f) Crisis Management refers to a proactive approach of addressing a
situation, where a risk to consumers, animal or plant health cannot be
controlled by normai existing mechanisms, through a plan which can be
activated when such emergency arises;

(g) Food refers to any substance or product whether processed, partially
processed or unprocessed that is intended for human consumption. It
includes drinks, chewing gum, water and other substa which are
intentionally incorporated into the food during its manui 2, preparation

and treatment;

es, intended to

(h) Feed refers to any substance or product, including addit
be used for oral feeding to animals

fectious or toxic
ion of food,

(i) Food-bome IlInesses refer to diseases, usually either i
in nature, caused by agents that enter the body through the i

or private, that

() Food Business refers to any undertaking, whether public
carries out, any of the activities reiated to, or any

supply chain;

d in the food
suring that the
ol;

(k) Food Business Operator refers to @ person enga
business including one's agents and is responsible for
requirements of this Act are met by the food business under

(I) Food Hygiene (hereinafter referred to as Hygiene) refers ic the measures
and conditions necessary to contro! hazards that could lead to food-borne
illnesses and to ensure fitness for human consumption of a food of plant or
animal origin taking into account its intended use



OMI DAnY

19

(m) Food Law refers to the laws, reg: and a
governing food in general, donated food and food safe
production, processing, distribution and preparation for hun

© Provisions
at any stage of
consumption;

(n) Food Safety refers to the assurance that food will not cause harm to the
consumer when it is prepared or eaten according to its intended use:

(0) Food Safety Regulatory Agencies (FSRAs) refer to the following
national government agencies.

Under the Department of Agriculture (DA) - the Bureau of Animal Industry,
National Meat Inspection Service, Bureau of Fisheries and Aquatic
Resources, Bureau of Plant industry. Fertilizer and Pesticide Authority,
Phiippine Coconut Authority, Sugar Regulatory Administration and the
National Food Authority :

Under the Department of Health (DOH) - the Food and Drug Administration,
Center for Food Regulation and Research and the Bureau of Quarantine;

(p) Food Safety Officer refers to a professionally qualifizd and properly
trained officer appointed by a food safety regulatory agency or by Local
Government Units (LGUs) in accordance with the appropriate Civil Service

rules and regulations

(q) Food Safety Regulatory System refers to the combination of regulations,
food safety standards, inspection, testing, data collection, monitoring and
other activities carried out by food safety regulatory agencies and by the
LGUs in the implementation of their responsibilities for the control of food

safety risks in the food supply chain

{r) Food Supply Chain refers to all stages in the production of food from
primary production, post harvest handling. distribution, >rocessing and
preparation for human consumption. Preparation is the caoking or other
treatments to which food is subjected prior to its consumption

(s) Good Agricultural Practices (GAP) refer to the practices that address
environmental, economic, and social sustainability for on-farm processes, and
which result in safe and quality food and non-food agricultural oroducts

(t) Good Manufacturing Practices refer to a quality assurance system
aimed at ensuring that products are consistently manufactured packed,
repacked, or held to quality standards appropriate for the intended use. It is
thus concerned with both manufacturing and quality contro! procedure

¢ conditions.
food at ail

(u) Good Hygienic Practices refer to all practices regardi
and measures necessary to ensure the safety and suttabi

stages of the food chain;

ience-

which are

{v) Hazard Analyses at ©
based system which identifies, evaluates, and controls hazards


40
41
cad

44
a5

9g a given stage in the food

significant for food safety
supply chain

(w) Hazard refers to biological, chemical or physical agent in food with a
potential to cause adverse effect on health

(x) Inspection refers to the examination of food, food production facilities or
establishments, and the management and production systems of food
businesses, including the examination of documents, finished product testing
and of the origin and destination of production inputs and outputs to verify
compliance with legal requirements by an agency mandated to perform food
safety regulatory and/ or enforcement functions;

{y) Label refers to the dispiay of written, printed or graphic matter upon the
immediate container, tag, literature or other suitable material affixed thereto
for the purpose of giving information as to identify components, ingredients,
attributes, directions for use, specifications and such other information as may
be required by law or regulations.

{z} Micro, smail and medium enterprise (MSME) refers to food businesses
as defined within the classification of industries by the Department of Trade
and industry,

(aa) Misbranding refers to deliberate labelling or advertising of food that is
misteading, where the labelling and/or advertising claims certain food
properties that cannot be supported by a reliable source, a certifying body or
by scientific evidence;

(bb) Official Control refers to all types of controls and control activities made
by regulatory agencies to verify compliance with standards, operating
procedures, practices and other regulatory requirements. It includes routine .
menitoring of food establishments and more intensive checks involving
inspections, verifications, audits, sampling and testing of samples

(oc) Post harvest stages 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 of grain

(dd)Primary production 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 aiso includes fishing, and the hunting and catching of

wild products;

(e2)Processing Ss to any action that substantially alters the initial raw
materials or product or ingredients including. but not limited to, heating,
smoking, curing, maturing, drying, inating. extraction, extrusion and a
combination of those processes intended to produce food;



(ff) Risk refers to the likelinood of an adverse health effect and the severity of
this effect following exposure te a hazard.

(99)Risk Analysis refers to 2 process consisting of three interrelated
components: risk assessment. risk Management and risk communication;

(hh)Risk Assessment refers to the scientific evaluation of known or potential
adverse health effects resulting from human exposure to biological, chemical
and physical hazards;

(ii) Risk Management refers to the process of weighing policy alternatives to
accept, minimize or reduce assessed risks and if necessary, to select and
implement appropriate prevention and contro! measures,

(ij) 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, risk managers, consumers, food and feed business
operators, academia and other stakeholders;

(kk) Food Safety Standards refer to the formal documents containing the
requirements that foods or food processors have to comply with to safeguard
human health. They are implemented by authorities and enforced by law; and
are usually developed and published under the auspices of a national
standards body:

(ll) Traceability refers to the ability to fallow the movement of a food through
specified stages of production, processing, and distribution; and

(mm) Monitoring refers to the systematic gathering of data through the
sampling of commodities as well as monitoring of food borne diseases,
collation and interpretation of collected data.

ARTICLE Ill
Basic Principles of Food Safety

SEC.5. Food Safety Requirements. - To ensure food safety, the following
general guidelines shall be observed:

(a) In determining whether food is unsafe, the following shall be considered:

1. The normal conditions of the use of food by the consumer,

2 The normal conditions maintained at each stage of production,
processing, handiing, storage and distribution,

3. The health of plants and animals from where the food is derived,

4. The effect of feeds, crop protection chemicals and other production
inputs on otherwise healthy plants and animals: and

5 The information provided to the consumer. This includes the information
provided on the iabel or any information generally available to the



iy

img specific heaith

consumer This should aid consumers in ay
effects from a particular food or category of foods

(b) in determining whether food is injurious to health, regard shall be given to
the following:

1. The probable immediate, short term or long term effects on subsequent
generations of that food on health;

2. The probable cumulative effects; and

3 The particular health sensitivities of @ specific category of consumers
where the food is intended for that category

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

(d) 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, lot
or consignment is aiso unsafe;

‘od that complies with specific national law or regulations governing food
fety shall be deemed safe insofar as the aspects covered by national law
d regulations are concerned. However, imported food that is deciared
unsafe by the competent authority of the exporting country efter entry into the
country shall be withdrawn from the market and distribution channels; and

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

ARTICLE IV
Genera! Principles

SEC. 6. Food Law Objectives. - Food jaw shall aim for a high level of
protection of human life and health in the production and consumption of food.
It shall also aim for the protection of consumer interests through fair practices

in the food trade.

SEC. 7. Use of Science-based Risk Analysis. - The following shall guide the
use of science and risk analysis in food safety regulation

(a) The development of food safety legislation and standards and the conduct
of inspection and other official control activities shall be basec on the analysis
Of risk, except where this approach is not feasible due to circumstances, or
due to the nature of the contro! measure;

(b) Risk assessment shall be based on sound
undertaken in an independent, objective and transparent +



26

information as obizined from scientific literature, epidemiological and
monitoring studies and other data that supports the risk assessment shail be
used,

i risk assessment
ompliance and

(c) Risk management shall take into account the results
relevant to local conditions, potential for enforcement, cost
‘others as may be relevant io the situation

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

(8) Food business operators shall be encouraged to implement a HACCP —
based system for food safety assurance in their operations

SEC. 8. Protection of Consumer Interests. — The protection of consumer
interest shall be geared towards the foliowing

(a) Prevention of adulteration, misbranding, fraudulent practices, and other
practices which mislead the consumer; and

(b) Prevention of misrepresentation in the labelling and false advertising in the
presentation of food, including their shape, aopearance or packaging, the
packaging materials used, the manner in which they are arranged, the setting
in which they are displayed, and the product description including the
information which is made available about them through whatever medium.
Where relevant, the presentation of goods shall provide consumers a basis to
make informed choices in relation to the food they purchase.

SEC. 9. Setting of Food Safety S is. — The DA and DOH shall set the
mandatory food safety standards. The following shall guide the setting of
standards: *

(a) Standards shall be established on the basis of science, risk analysis,
scientific advice from expert body/bodies, standards of other countries,
existing Philippine National Standards (PNS) and the standards of the Codex
Alimentarius Commission (Codex), where these exist and are applicabie;

(b) Codex standards shall be adopted except when these are in conflict with
what is necessary to protect consumers and scientific justification exists for

the action taken;

(c) The DA and the DOH shaii establish the policies and procedures for
country participation at Codex and the incorporation of Codex standards into

Codex Organization (NCO) is
1 DA and the DOH



49

dinator for Codex activities for their

shall designate a thi
respective departments, and

(d) Participation at Codex shall be in accordance with the principles of this
Act and shall be financially supported by the government

SEC. 10. Precaution. - In specific circumstances when the available relevant
information for use in risk assessment is insufficient to show that a certain
type of food or foad product 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 scientific information based on the nature of the risk and type of
information needed to clarify the scientific uncertainty: and

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

SEC. 11. Transparency. - The implementing agencies shall conduct public
consultation and disseminate relevant information to ensure the following:

(a) 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, and

(b) In cases where it is suspected that food may pose a risk to human health
regulatory authorities shall take appropriate steps to inform the general public
about the nature of the risk to health, the affected foods, types of food and

the necessary measures to prevent, reduce or eliminate the risk

SEC. 12. Application to Trade. - Foods imported, proauced, processed and
distributed for domestic and export markets shall comply with the following

requirements

(a) Food to be imported into the country must come from countries with an
equivalent food safety regulatory system and shall comply with international
agreements to which the Philippines is a party,

(b) Imported foods shall undergo cargo inspection and clearance procedures
by the DA and the DOH at the first oort of entry to determine compliance with
national regulations. This inspection by the DA and the DOH shalll always take
place prior to assessment for tariff and other charges by the Bureau of
Customs (BOC). The BOC and the Association of International Shipping Lines
(AISL) shall provide the DA and DOH documents such as the Inwerd Foreign
Manifest of Arriving Vessels to enable the DA end DOH to identify shipments
requiring food safety inspection. Shipments not complying with national
regulations shall be disposed according to polici ablished by the DA and

the DOH; and

9


8

th national regulations and
mporting country. Returned shipments shall undergo border
tion clearance in Section

ARTICLE V
Responsibilities on Food Safety

SEC. 13. Principal Responsibility of Food Business Operators. - Food
business operators shall ensure that food satisfies the requirements of food
iaw relevant to their activities in the food supply chain and that control
systems are in piace to prevent, eliminate or reduce risks to consumers.

SEC. 14. Specific Responsibilities of Food Business Operators - Food
business operators shall have the following responsibilities under 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 procedures adopted by relevant government agencies that
implement the law. They shall adopt, apply and be well informed of codes
and principles for good practices Micro and small industries shall be assisted
to facilitate their adoption of such practices

{b} If 2 food business operator considers or has reason to believe that @ 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

regulatory authority,

{c) Food business operators shall aliow inspection of their businesses and
collaborate with the regulatory authorities on action taken to avoid risks posed
by the food product/s which they have supplied: and

(d) Where the unsafe or non-compliant food product may have reached the
consumer, the operator shall eff ly and accurately inform the consumers
of the reason for the withdrawal, and if necessary, recall the same from the

market

SEC. 15. Principal Responsibilities of Government Agencies, - The DA, DOH,
DILG and LGUs shall nave the following responsibilities.

(2) The DA shall de responsible for food safety in the primary production and
post harvest stages of food supply chain and foods locally produced or

imported in this category.

{b) The DOH shall be responsible for y of processed and pre-
packaged foods, foods locally oroduced or imported under this category and
the conduct of monitoring and epideinioiogical studies on food - borne

illnesses,

nesses such és.

10


4g

40

markets supermart hoo! canteens, restaurants, catering establishments
and water refilling stations The LGU shall also be responsitie for street food
sale. including ambulant vendi

(d)The Deparment of the Interior and Local Government (DILG), in
collaboration with the DA, DOH and other government agencies shall
supervise the enforcement of food safety and sanitary rules and regulations
as well as the inspection and compliance of business establishments and

facilities within its territorial jurisdiction

{e) The LGUs may be called upon by the DOH and the DA to assist in the
implementation of food laws, other relevant regulations ana those that will
hereafter be issued,

(f} The DA and the DOH shall capacitate the LGUs and provide necessary
technical assistance in the implementation of their food safety functions under
their jurisdiction in compliance with this responsibility they shall provide
training to the DILG and LGUs and shall periodically asses the effectiveness
of these training programs in coordination with the DILG:

(g) The DA and DOH, in cooperation with the LGUs, shall monitor the
presence of biological, chemical. physical contaminants in food to determine
the nature and sources of food safety hazards in the food supply chain

SEC. 16. Specific Responsibilities of the Department of Agriculture. - The DA
shall be responsible for the development and enforcement of food safety
standards and regulations for foods in the primary production and post
harvest stages of the food supply chain. It shall monitor and ensure tnat the
relevant requirements of the law are complied with by farmers. fisherfolks and
food business operators. Pursuant thereto, the DA Secretary shali ensure that
the food safety regulatory mandates and functions for fresh plant, animal
fisheries and aquaculture foods of the DA agencies are clearly defined The
agencies under the DA with facd safety regulatory fun: he following

{aj Bureau of Animal Industry (BAI), for food derived from a7
2ggs and honey production

including

(b} National Dairy Authority (NDA), for milk production ard post harvest
handling:

tion Service (NMIS)}, for

{c) National Meat Ins;

fresh fish and

{d) Bureau of Fisheries and Aquatic Resot
dather seafoods inciuding those grown by aquaculture.

fe} Bureau of Plant industry (BP#}, for plant foods.

FPA), for pe

rtilizer and Pesticide Authority
the production of piani and animal fo



19
20

)

46

{g) Philippine Coconut Authority (PCA). for fresh coconut;

(h) Sugar Reguiatory Administration (SRA), for sugar: and

(}) National Food Authority (NFA), for rice, corn and other grains.
The Bureau of Fisheries and Agriculture Product Standards (BAFPS) shall
develop food safety standards including those for organic agriculture. The
BAFPS shall establish the mechanism for the development of science-
based food safety standards for fresh plant, animal, fisheries and
aquaculture foods and shail use the services of experts from the FSRA,
other government agencies, academe and private sector

The Food Development Center (FDC) of the NFA shal! provide scientific
support in testing, research and training.

When necessary and when funds allow, the appropriate food safety units
shall be created within the above-stated agencies. To strengthen these
organizations, they shall be provided with the necessary personnel out of
the existing manpower of the DA

Finally, the DA shall, in coordination with other goverment agencies.
monitor the presence of contaminants in foods of plant, animal and fishery
origin and shail formulate and implement measures to address incidents of
food contamination

SEC. 17. The Office of the Undersecretary for Food Safety and Phytosanitary
Regulation. — There shall be designated 2 permanent Undersecreiary out of
the existing Undersecretares of the DA to nead the Office for Food Safety
and Sanitary and Phytosanitary Regulation and who shalf exercise the
oversight functions of food safety regulatory activities.

Phytosanitary
ter and the
@ DA and the

The Undersecretary for Food Safety and Senitary a
Regulation shall directly supervise the Food Development
BAFPS and shall be the coordinator for Codex activ’
Codex Contact Point

The Office of the Undersecretary for Food Safety ana Sanitary and
Phytosanitary Regulation shall be provided with the necessary manpower and
funds from existing resources to ensure the smooth and efficient discharge of
its functions.

SEC. 18. Specific Responsibilities of the DOH - The DOH shall bear the
following specific responsibilities

and product

(a) The DOH shall ensure the safety of all food proce:
packaging activities:


1
5
4
°
8

9
10
i
3:
i4
15
16
17
18
19
20
2

48
so

(b! The FDA Canter for Food R: h shall be responsible
for implementing a performance-based food safety control management
system which shail inciude, but not limited to, the following

i. Development of food standards and regulations;

Post- market monitoring:

ii. Enforeement of HACCP and other risk based control measures;

\v. Strong participation in Codex and other intemational standard setting
bodies;

v. Communication of risks and development of interactive exchange
among stakeholders;

Establishment of laboratories for food safety and strengthening the
capabilities of existing laboratories;

vi.

Development of a database of food safety hazards and food— borne
illness from epidemiological data;

vii.

vill, Strengthening’ R&D capabilities on product safety and quality
standards; and

ix. Certification of food safety inspectors

(c) The Bureau of Quarantine (BOQ), shall provide sai ion and ensure food
safety in its area of responsibility inboth domestic and international ports and
airports of entry, including In-flight catering, food service establishments, sea
vessels and aircraft as provided for in the Implementing Rules and
Regulations (IRR) of RA 9271 and P.D. 856, otherwise known es the
Sanitation Code of the Philippines.

(d) The National Epidemiology Center (NEC), Research Institute of Tropical
Medicine (RITM) and the National Center for Disease Prevention and Contral
(NCDPC) shall conduct ‘and document epidemiological monitaring studies on
food-borne illnesses for usé in risk-based policy formulation. Food safety risk
assessment bodies shall be established for this purpose

{e) The National Cenier. for Health Promotion (NCHP) shail be responsibie for
advocating food safety awareness, information and education to the public.

{f} The NCDPC shall strategize actions to help ensure the safety of food,
feduce the tisk of food contamination and food-bome diseases, address the
double burden of micronutriant deficiencies and non-communicable diseases

anq‘to régularly evaluate the progress made.

Research shall be

(g} The DOH and the FDA Center for Food Regulation
strengthened in terms of establishing food safety functional divisions and

13


Sewmigauauny

fis and be provided with

incremental staffing of food safety officers and ex
funds including the fees collected from services

SEC, 19. Specific Responsibilities of the DILG and LGUs - The DILG and
local governments shall bear the following responsibilities.

(2) The LGUs snail be responsible for the enforcement of the Code of
Sanitation (PD No 856 December 23, 1975), food safety standards and food
safety regulations where food is produced, processed, prepared and/or sold in
their territorial jurisdiction. This shall include, but shall not be limited to, the

following
1, Sanitation particularly in public markets, slaughterhouses, micro and

small food processing establishments and public eating places;
2. Codes of Practice for production, post harvest handling, processing

and hygiene;
3. Safe use of food additives, processing aids and sanitation chemicals;

and
4, Proper labelling of pre-packaged foods.
(b)The DILG shall support the DOH and the DA in the collection and
documentation of food-borne illness date monitoring and research

(c) The DILG and LGUs shall participate in training programs, standards
development and other food safety activities to be undertaken by the DA, the

DOH and other concerned national agencies

Article Vi
Food Safety Regulation Coordinating Board (FSRCB)

SEC. 20. Powers and Functions. — There is hereby created a Food Safety
Regulation Coordinating Board. herein after referred to as the Board, with the
following powers and functions

and implementation of the
od safety regulation:

(a) Monitor and coordinate the performar
mandates of the DA, DOH, DILG and LGUs in

(b) Identify the agency responsible for enforcement based on their legal
mandates when jurisdiction over specific areas overlap;

and planning during food safety

(c) Coordinate crisis management
emergencies

and procedures for coordination among agencies

(d) Establish the p
involved in food safety

(e) Continuously evaluate the effectiveness of enforcement of food safety
tegulations and research and training programs:

ra! Committees on Health.

Congres!

(f) Regularly submit reports to the Congres:
Agriculture and Food and Trade and Industry, and


‘pt grants and donations from local and international sources.

SE! ey of this Act, the
Secretaries of the DA, DOH and the DILG shall organize the Board in
accordance with the following rules:

C. 24. Organization — Within 30 days from the effecii

(a) The Board shall be chaired by the DOH Secretary ang <o- chaired by the
DA Secretary The altemate chair for the DOH shall be tne FDA Director
General and the alternate co-chair for the DA Secretary shall be the
Undersecretary for Food Safety and Sanitary and Phytosanitary Regulation
The members of the Board shall be the Heads of the food safety regulatory
agencies of the DA. the Director of the FDA Center for Food Regulation and
Research, a representative field operator of the DILG wit’: the rank of a
Director, and a representative each from the DTI and the DOST with the rank
of & Director. Directors of other DOH agencies with food safety concerns shall
join the meeting as it may be deemed necessary by the DOH The Heads of
Leagues of Barangays, Municipalities, Cities and Provinces shall be invited as
needed;

{b) Within 12 months from the effectivity of this Act, the Board shall submit a
Manuai of Procedures containing the rules for the conduct of meetings and

decision-making, among others

(c) The Board shall be assisted by administrative and technical secretariat at
the DOH. Both the DOH and the DA shall establish functional divisions and
shail organize the administrative and technical personnel for the operation of
the Board. The personnel needed under this section shail bs taken from the
existing manpower of each department.

(d) Funds shall be allocated by the respected agencies concerned with food
fety to pay for the organization of meetings. part ion of Board
bers, secretariat, experts and the expenses of a Working Group to be
aied by the Board to prepare its manual of precedures.

SEC. 22. Accountability for Food Safety Regulation - The FSRAs of the DA
& DOH. in coordination with the LGUs, shall be responsible in ensuring food
safety at various stages of the food supply chain within their specified
mandates

ARTICLE Vil
Crisis Management

SEC. 23. Rapid Alert System. - A rapid alert system for the notification of a
direct or indirect risk to human health due to food shall be establisned by the
FSRCB.

SEC. 24, Emerg

from within the



or more of the following measures.

DOH and DA shall im
depending on the gravity of the sit

a) In the case of food of national origin

2. Suspension of its distribution in the market or the use of the food in
question;

2. Laying down special conditions for the food in question; and
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
concemed 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 concerned; and

3. Any other appropriate interim measures.

SEC. 25. Pian for Crisis Management. - The Board, in coordination with the
FSRAs and other relevant government agencies, shall prepare 2 general plan
for the management of a threat to food safety such as radiation contamination
of food, food shortage requiring coordinated action and other crisis situations
which may compromise food safety This plan shall specify the situations
representing @ direct or indirect risk to human health deriving from food which
are not likely to be prevented, eliminated or reduced to an acceptabie level.

ARTICLE Viti
Implementation of Food Safety Regulations

SEC. 26. Policies on Official Controls. - Official controls are established to
verify compliance with food laws and regulations and shall be prepared by
each agency. The following shall govern the exercise of officia/ controls:

(a) Official controls shall be implemented by way of regulations prepared by
the food safety regulatory agencies in accordance with the principles
established in this Act

{b) The frequency of official controls shall be proportionate to <he severity and
likelihood of occurrence of the food safety risks being contralied,

{c) Official controls shali be based on appropriate techniques, m1
an adequate number of suitably qualified and experienc
with adequate funds, facilities and equipment,

16


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

(e) Any personnel of food safety regulatory agencies such as, but not limited
to, food inspectors shall perform official controls at the highest level of
competence and integrity, ever mindful of conflict of interest situations;

(f) Policies and procedures for official controls shall be documented in a
Manual of Operations to ensure consistent, high quality, uniformity,
predictability and transparency,

(g)Provisions shall be made for official controls to be delegated to other
competent bodies as determined by the regulatory agency and of the
conditions under which this shall take place. When official controls are
delegated, appropriate coordination and other procedures including
oversight shall be in place and effectively implemented. The accountability
over the delegated function shall remain with the regulatory agency: and

{h) The agencies responsible for the implementation of official controls shall
be provided with the necessary funding and technical support out of their
existing budget to perform official controls according to the principles
indicated in this Act

SEC. 27. Traceability. - Traceabi i
stages of production. post harvest handling, processing or distribution, when
needed to ensure compliance with food safety req ents. The rule on
traceability shall also cover 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 to:

{a) Be able to identify any person or company from whom they have been
supplied with:

1, Food,

2. A food-producing animal

3, Production chemicals as pesticides and drugs; and
4.

. Production, post harvest handling and processing inputs such as
feeds, food additives, food ingredients, packaging materials, or any
substance expected to be incorporated into food or food product

(b) Establish and implement systems and procedures which allow the above
information to be available to the regulatory authorities on demand, and

(c) Establish systems and procedures to identify the other businesses to
which their products have been supplied. This information shali be made

available to the regulatory authorities upon demand.


1
A
4
5
6
8
9

Traceability in case of food-borne disease outbreak shall be established by
the National Epidemiology Center (NEC) of the DOH

SEC. 28. Licensing, Registration of Establishments. - Appropriate
authorizations shall be developed and issued in the form of a permit, license
and certificate of registration or compliance that would cover establishments,
facilities engaged in production, post harvest, handling, processing, packing,
holding or producing food for consumption in accordance with the mandated
issuances of regulatory agency issuing such authorizations. Special
derogations shali be provided due to geographical location and after an
assessment of risks, espscially for micro, smal! and medium sized food

business operators and health products.

SEC. 29. Inspection of Food Business Operators. - Regular inspection of
food business operators shall be performed by the FSRAs or the control
bodies delegated to conduct the activity. In addition, the following rules shall
be followed in the conduct of inspections:

(a) Inspection shall take into account compliance with mandatory food safety
standards, the implementation of HACCP, good manufacturing practices and
other requirements of regulations:

(b) The frequency of inspections 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) Inspectors shall have defined skills on risk-based inspection and shall be
regularly evaluated based on suitabie procedures to verify their continuing
competence; and

(d) Appropriate procedures shall be in place to ensure that the results of
inspection are interpreted in a uniform manner.

SEC. 30. Food Testing Laboratories. - The following shell guide the
management and operation of food testing laboratories

(a) Food testing shall be carried out by laboratories accredited in accordance
with international standards. Those that are not currently accredited shail
apply for accreditation within a specified period of time

(b) Testing shal! be carried out using the internationally approved procedures
or methods of analysis that have Deen validated:
nt conflict of

and managed to pr

{c) Laboratories shall be or
interest in the conduct of testing,

with the required expertise and

vith analys!

(d) Laboratories shall be stat
professional competence; and


16

19
20

{s)FSRAs may recognize private testing laboratories =-credited by the
Philippine Accreditation Office (PAO) of the Department of Trade and industry
(DTI) to support their testing neeas

ARTICLE IX

Training and Consumer Education

SEC. 31. Training. - Skills training and other instruct:onal/educational
activities shall be regularly provided to food business operators, food handlers
and to government personnel as follows:

(a) Food business operators particularly micro, small and medium scale
enterprises shall be trained on the requirements of food safety regulations and
the understanding of tnese requirements. Personne/ shail be treined on
HACCP, on the codes of good practice and on technologies that will enable
them to comply with regulations

(b) Mandatory training on safe food handling and similar courses shall be
implemented for food handlers of food businesses; and

(c) Government personne! shall be trained on the scientiic basis for the
provisions of the iaw and on the conduct of official controls:

ing needs and
ams shall be

The different food safety regulatory agencies shall identify
the appropriate training programs. Mandatory training pro.
developed and implemented by accredited training providers

SEC, 32. Consumer Education. - A consumer education orogram shall be
developed by the DA, DOH and LGUs in partnership with the Department of
Education, the implementation of which shail be carried out by the latter

ment and

SEC. 33. Funding. - Funds shall be provided for the <
implementation of training and consumer education programs

ARTICLE X
Food-borne Iliness Monitoring, Surveillance and Research

SEC. 34. Food-borne illness Monitoring and Surveillance. - \ ie government,
in support of ‘risk analysis, shall implement the following programs.

(a) An integrated food borne disease monitoring system that links to the
sources of food contamination in collaboration with the DOH National
Epidemiology Center and the National Cer fe se Prevention and
Contro!:

(b) Identification of hazards in the food supply chain and assessmient of ievels
of exposure to the hazards

19


SEC. 35. Research - The goverment and academe shall develop and
implement a program of research on cost effective technologies and codes of
practice for assisting farmers, fisherfolks, micro, smali and medium scale
enterprises and other stakeholders to enable them to comply with food safety
regulations

ARTICLE XI
Policy on Fees

SEC. 36. Collection of Fees. - The DA, DOH and the LGUs, where
applicable, shall be allowed to collect fees for the inspection of food products,
production and processing facilities, issuance of import or export certificates,
laboratory testing of food samples and other fees as may be deemed

necessary.

Fees shall be based on an officially-approved procedure for estimating the
cost of the activity undertaken and shall be subject to government accounting
and auditing rules and regulations.

ARTICLE XII
Prohibitions, Penalties and Sanetions

SEC. 37, Prohibited Acts. — It shall be unlawful for any person to:

a) manufacture for sale, offer for Séle, ‘distribute 'in ‘commierce, ‘or import
into the Philippines eny food or food product which is not in conformity
with an applicable food quality or safety standard promulgated in
aceordance with this Act,

manufseture for sale, offer for sate, distribute ‘in cotinierce, Or import
into the Philippines any food or food product which has been declared
as banned food product by a rule promulgated in accordarice With this

Aet,

z

¢) refuse access to pertinent records or entry of inspection officers of the
FSRA;

4) fail to comply with an order relating to notifications to recall unsafe
prodkicts:

Adulterate, misbrand mislabel, falsely advertise any food product
which misteads the consunters end carry Out'any other acts contrary 1
Good Manufacturing Practices:

e

peraie 2 food business without the appropriate authorization

@) Connive with food business ‘operators or food inspectors, which “will
resuit in food Safety risks to the consumers; and

h) Violate the Implementing Rules and Regulations of this Act

20


1

Gnas

oa

20

38
39
4g
41

a
43
44
45
48

48
49

50

SEC. 38. Penaity. - Any person who shall violate any provision of this Act
shall suffer the penaities provided hereunder

(a) For the first conviction, a fine of not less than Fifty thousand pesos
{P50,006.00) but not more than One hundred thousand pesos
{P100,000.00) and suspension of appropriate authorization for one (1)
month shall be imposed

(b) For the second conviction, a fine of not less than One hundred
thousand pesos (P100900.00) but not more than Two hundred
thousand pesos (P200.000.00) and suspension of appropriate
authorization for three (3) months shall be imposed

(c) For the third conviction, a fine of not less than Two hundred thousand
pesos (P200,000.90) but not more than Three hundred thousand pesos
(P300,900,00) and suspension of appropriate athorization for six (6)
months shall be imposed,

(d) For violation resulting in slight physical injury of @ person, upon
conviction, a fine of not less than Two hundred thousand pesos
(P200,000.00) but riot more than Three hundred thousand pesos
(P300,000.00) and suspension of appropriate authorization for six (6)
months shali be imposed. The offender shall also pay the
hospitalization anc rehabilitation cost of 2 parson,

(e) For violation resulting in less serious or serious physica! injury of a
person, upon conviction. a fine of not less than Two hundred thousand
pesos (P200,000.00} but not more than Three hundred thousand pesos
(P300,000,00) and suspension of appropriate authorization for one (1)
year shall be imposed. The offender shall also pay the hospitalization
and rehabilitation cost of 2 person:

(f) For violation resulting in death of 2 person, upon conviction, the penalty
of imprisonment of not less ) months and one {1} day but not
more than six (6) years and one (/) day and a fine of not less than
Three hundred thousand pesos (P300,000,00) but not more than Five
hundred thousand pesos (P500,000.00} and permanent revocation of
appropriate authorization to operate a food business shall be imposed

ithorization, the imposable

ff the offender does rot have the appropriate
fines shall be doubled

If the offender is a government personnel, in addition to the penalty srescribed
herein, said personnel shall be subjected to the appropiate civil service laws

if the offender is a naturaized citizen, in addition to the penalty prescribed
herein the naturalization and the registration in the civil register of
said citizen shall be cancelied. immediate deportation after payment of fine
and service of sentence shall also be imposed



If the offender is an alien. said
payment of fine and service of senter
the country

ien shall be summarily deported after
and perpetually barred from entering

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 Section 37 hereof, and whe has knowledge or notice of non-compliance
received by the corporation from the concemed department, shall be
‘subjected to the penalties under this Section

In case the violation is committed by. or in the interest of a foreign juridical
person duly licensed to engage in business in the Philippines. such license to
engage in business in the Philippines shall immediately be revoked

ARTICLE Xill
FINAL PROVISIONS

SEC. 39. implementing Rules and Regulations. - The DA and the DOH shall
jointly issue the Implementing Rules and Regulations within ninety (90) days
after the effectivity of this Act

SEC. 40. Separability Clause. - If any provision of this Act is declared invalid
‘of unconstitutional, the other provisions not affected thereby shall remain in

full force and effect,

SEC. 41. Repealing Ciause. - All ‘aws, presidential decrees, executive orders,
tules and regulations inconsistent with the provisions of this Act are hereby
repealed, amended or modified accordinaly.

SEC. 42. Effectivity. - This Act shall take effect fifteen (15) days after its
publication in two (2) newspapers of general circulation.

Approved.


FACT SHEET

5474
House Bill No.
(In substitution of House Bill Nos. 3428. 3972 & 4417)
(As Approved by the Committee on February 22 2072)

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

Introduced by REPS. RUFUS B. RODRIGUEZ, MAXIMO B. RODRIGUEZ,
ANGELO B. PALMONES, MARK LEANDRO MENDOZA, IRVIN M.
ALCALA, DANILO &. SUAREZ SHARON S. GARIN AND
ALFREDO D. MARANON lif

Committee Referral: COMMITTEE ON HEALTH 7

Committee Chaimerson: HON. ALFREDO D. MARANON Hi

OBJECTIVES:
¢ To protect the public from food-borne and water-borne illnesses and

unsanitary, unwholesome, misbranded or adulterated foods

To enhance industry and consumer confidence in the food regulatory

system

© To contribute to economic growth and development t ting fair
trade practices and by sound regulation of domestic and international

trade

KEY PROVISIONS:

* Creates a Food Safety Regulation Coordinating Bo: ed by the
Secretary of the Department of Agriculture (DA) and co-chaired by the
Secretary of the Department of Health (DOH), which has the following
powers and function: (1) authority to link the mandates, control
functions and activities of the DA, the DOH and the Department of
Interior and Local Government {DILG) in food safety regulation, (2)
identify agency responsible for enforcement in case of overlapping
functions, (3) establish policies and procedures for coordi
regulatory systems as implemented by the DA, DO}
coordinate crisis management efforts during inciden
Safety, am

* Lays down the principies of food safety which
limited to, the determination of whether or not foo:
consumption: determination of whether or not
health. and determination of whether or not food is u
consumption

* Mandates the DOH to use scientific and risk analysis ic ensure that the
public is protected from foods and food products that are
human consumption. Such anaiysis shall be guided he

(1) development of safety legislation and  siar

ong ot
but are not
safe for human
injurious to
sate for human



assessment based on sound scientific evidence undertaken in an
independent. objective and transparent manner (3) risk management
en account of sof sment vant to local
conditions, potential for enforcement and cost of compliance, etc (4)
isk communication carried out between risk assessors and risk
managers in a tansparent manner and (5) feud business operators
implementing a HACCP-based system for food safety assurance in
their operations,
Protects consumer interest through the prevention of adulteration,
misbranding, fraudulent practices and other practices which mislead
the consumer
Sets Food Safety Standards in accordance with the Philippine National
Standards and the standards of the Codex Alimentarius Commission;
Provides transparency by way of mandating the DOH to give enough
information to the public regarding foods that may pose risk to human
health, the affected foods, types of food and the necessary measure to
prevent, reduce or eliminate the risk,
Delineates to business operators and government agencies such as
DA, DILG and the Local Government Units (LGUs) specific
responsibilities of determining whether or not certain food or food
product satisfies the requirements for food safety.
Provides emergency measures when it is evident tha! food originating
from within the country or imported from other country is likely to
constitute seriou: 2 health. Suc! s include the
suspension of mar produced foods and suspension of
importation of imparted foods:
Provides for a Crisis Management sysiem and procedures to address
cases of possible radiation contamination of food: food shortage
requiring combined action and which may
compromise food safety,
Provides for traceability by having in place a system by which the
regulatory authorities can easily pinpoint the food business operator to
which the foods or food products have deen supplied and also for easy
identification of person or company from whom food business
operators are getting their supplies.
Mandates the Food Safety Regulatory Agencies (FSRA) to conduct
regular inspection of food business operators to ensure compliance
with the safety standards and Good Manufacturing Practices, among
others;
Mandates that food testing shall be carried out by testing laboratories
accredited by the Philippine Accreditation Office of the Department of
rade and industry (DTI):
Provides consumer education and training for food business operators,
food handiers and government personnel, of which training needs shall
be identified by the FSRA’s and the training program shall be
developed and implemented by the accredited training providers:
Provides for, on iup of the adr alive penallies, 2 yedualed penalty
which starts from a minimum fine of Fifty thousand p+ (P50,090.00)
for the first conviction to a maximum of One million pesos
4P1,000,000.00) ad 1 onment of nat less th: nths and



one (1} day to not more than six (6) years and one day ‘or final
conviction in case of death

RELATED LAWS:
« R.A. No. 7394, aiso known as the “Consumer Act of the Philippines"

« R.A, No. 9711, also known as the “Food and Drug Administration Act"
« The Revised Penal Code