OFFICE OF Ts GECHE TARY

FIFTEENTH CONGRESS OF THE )
REPUBLIC OF THE PHILIPPINES )

First Regular Session ) 10 Gl -6 PIS7
SENATE
RECEIVER PY f
S.No_ 302

Introduced by Senator Antonio “Sonny” F, Trillanes IV

EXPLANATORY NOTE

Article II Section 15 of the 1987 Constitution declares that the State shall protect and
promote the right to health of the people and instill health consciousness among them. In
this vein, this measure seeks to establish a Food Safety Administration under the
Department of Health to protect the public health by preventing food-bome illness,
ensuring the safety of food, improving research on contaminants leading to food-borne
illness, and improving security of food from intentional contamination, and for other
purposes.

The recent panics over salmonella and melanin poisoning, and other offshoots of unsafe
food products in the market, have provoked a growing concer and demand for food
safety in the country. Moreover, these call for more stringent regulation on the part of
government to protect our nation’s food supply and safeguard our people’s health. Every
Filipino deserves to have healthy and safe food in their tables. The assurance of food
safety should go hand in hand with the pursuit of food security.

In this light, this bill directs the Administrator of the Food Safety Administration to: (1)
administer a national food safety program; and (2) ensure that persons who produce,
process, or distribute food prevent or minimize food safety hazards. Furthermore, it sets
forth requirements for the Administrator to carry out such duties, including: (1) requiring
food establishments to adopt preventive process controls; (2) enforcing performance
standards for food safety; (3) establishing an inspection program; (4) strengthening and
expanding foodborne illness surveillance systems; (5) requiring imported food to meet
the World Health organization standards in food safety; and (6) establishing a national
traceability system for food. This bill also provides for the transfer of functions and
resources to the Administration from government entities concerned with the
enforcement of food safety laws.

It is hoped that the passage of this measure improve the government's ability to prevent
food-borne illness outbreaks and ensure that the government responds quickly and
effectively when outbreaks do occur.

In view of the foregoing, immediate approval of this measure is earnestly sought.

aie oth iv

Senator


Rone

OFFICE 1+

FIFTEENTH CONGRESS OF THE )
REPUBLIC OF THE PHILIPPINES )
First Regular Session ) 1G M6 PLE?
SENATE
RECEIVED BY
$.No_ 852

Introduced by Senator Antonio “Sonny” F. Trillanes IV

AN ACT
TO ESTABLISH THE FOOD SAFETY ADMINISTRATION WITHIN THE
DEPARTMENT OF HEALTH TO PROTECT THE PUBLIC HEALTH BY
PREVENTING FOOD-BORNE ILLNESS, ENSURING THE SAFETY OF FOOD,
IMPROVING RESEARCH ON CONTAMINANTS LEADING TO FOOD-BORNE
ILLNESS, AND IMPROVING SECURITY OF FOOD FROM INTENTIONAL
CONTAMINATION, AND FOR OTHER PURPOSES.

Be it enacted in the Senate and House of Representatives of the Philippines in Congress
assembled

CHAPTER I
GENERAL PROVISIONS

SECTION 1. Short Title. - This Act may be cited as the “Food Safety Modernization

Act of 2010.”

SEC. 2. Definition of Terms, — In this Act:
(a) administration - The term ‘Administration’ means the Food Safety Administration
established under this Act.
(b) administrator - The term ‘Administrator’ means the Administrator of Food Safety appointed
under section 3(2) of this Act.

(©) adulterated - The term ‘adulterated’ includes bearing or containing a contaminant that causes
illness or death amorig sensitive populations; a

(@) Category 1 Food Establishment - The term ‘category 1 food establishment’ means a food
establishment (other than a seafood processing establishment) that slatighters, for the purpose of
producing food, animals, and poultry that are not subject to inspection undgs the Republic Act

9296, otherwise known as the Meat Inspection Code of the Philippines.



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(©) Category 2 Food Establishment - The term ‘category 2 food establishment’ means a seafood
processing establishment or other food establishment (other than a category 1 establishment) not
subject to inspection under the Republic Act 9296, otherwise known as the Meat Inspection
Code of the Philippines, that processes raw seafood or other raw animal products, whether fresh
or frozen, or other products that the Administrator determines by regulation to pose a significant
risk of hazardous contamination.
(£) Category 3 Food Establishment - The term ‘category 3 food establishment’ means a food
establishment (other than a category I or category 2 establishment) that processes cooked,
pasteurized, or otherwise ready-to-eat seafood or other animal products, fresh produce in ready-
to-eat raw form, or other products that pose a risk of hazardous contamination.
(g) Category 4 Food Establishment - The term ‘category 4 food establishment’ means a food
establishment that processes all other categories of food products not described in paragraphs (4)
through (6).
(h) Category 5 Food Establishment - The term ‘category 5 food establishment’ means a food
establishment that stores, holds, or transports food products prior to delivery for retail sale.
(i) contaminant - The term ‘contaminant’ includes a bacterium, chemical, natural toxin or
manufactured toxicant, virus, parasite, prion, physical hazard, or other human pathogen that
when found on or in food can cause human illness, injury, or death.
@ hazardous contamination - The term ‘hazardous contamination’ refers to the presence of a
contaminant in food at levels that pose a risk of human illness, injury, or death or are capable of
reaching levels that pose such risk during the shelf life of the product.
(k) food - The term ‘food’ means a product intended to be used for food or drink for a human or
an animal and components thereof.
(I) food establishment -
(1) In general - The term ‘food establishment’ means a slaughterhouse (except those regulated
under the Republic Act 9296, otherwise known as the Meat Inspection Code of the
Philippines), factory, warehouse, or facility owned or operated by a person located in any
locality that processes food or a facility that holds, stores, or transports food or food

ingredients.



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(2) Exclusions - For the purposes of registration, the term ‘food establishment’ does not
include a food production facility as defined in paragraph (13), restaurant, other retail food
establishment, nonprofit food establishment in which food is prepared for or served directly to
the consumer, or fishing vessel (other than a fishing vessel engaged in processing).
(m) food production facility - ‘The term ‘food production facility’ means any farm, ranch,
orchard, vineyard, aquaculture facility, or confined animal-feeding operation.
(n) foreign food establishment - The term “foreign food establishment’ means any category 1
through 5 food establishment or food production facility located outside the Philippines that
processes or produces food or food ingredients for consumption in the Philippines.
(0) misbranded - The term ‘misbranded’ has the meaning given that term in section 10.1.1.a of
Republic Act No. 3720, otherwise known as the Food, Drug, and Cosmetic Act of the
Philippines.
(p) process - The term ‘process’ or ‘processing’ means the commercial slaughter, packing,
preparation, or manufacture of food.

CHAPTER IT
‘ABLISHMENT OF THE FOOD SAFETY ADMINISTRATION

SEC. 3. Food Safety Administration. —
(a) Establishment -

(1) In general - There is established in the Department of Health an agency to be known as
the ‘Food Safety Administration’.
(2) Head of the Administration - The Administration shall be headed by the Administrator of
Food Safety, who shall be appointed by the President, by and with the advice and consent of
the Senate, for a term of three (3) years, and who may be reappointed.
(3) Delegation - All the authorities and responsibilities assigned to the Secretary of Health in
the food safety law are hereby assigned to the Administrator.

(b) Duties of Administrator - The Administrator shall —

(1) administer and enforce the food safety law:



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(2) serve as the food safety leader within the Department of Health and coordinator of all
Department activities related to ensuring the safety, quality, and proper labeling of the food
supply;
(3) represent the Philippines in relevant international food safety bodies and discussions;
(4) promulgate regulations to ensure the safety and security of the food supply from all forms
of contamination, including intentional contamination; and
(5) oversee within the Department of Health —
(A) all activities related to foodborne illness surveillance and investigation of
foodborne illness outbreaks;
(B) implementation of food safety inspection, enforcement, and research efforts to
protect the public health;
(C) development of consistent and science-based standards for safe food;
(D) coordination and prioritization of food safety research and education programs with
other agencies;
(E) prioritization of food safety efforts and deployment of food safety resources to
achieve the greatest possible benefit in reducing food-borne illness;
(F) coordination of the response to food-borne illness outbreaks with other national and
local agencies; and

(G integration of food safety activities with national and local agencies.

SEC. 4. Consolidation of Food Safety Functions. —

(a) Transfer of Functions and Resources - All offices and personnel (including facilities and
financial resources; and all related functions of any officer or employee of the component) of the
Department of Health (hereinafter referred to as the DOH) Department of Agriculture (DA), and
Department of Science and Technology (DOST) that relate to administration or enforcement of
the food safety law, as determined by the President, be transferred to the Food Safety
Administration.

(b) Renaming and Reservation of Agency Identity - The Bureau of Food and Drugs (BFAD) in

the Department of Health (DOH) is hereby renamed the National Drug Bureau.


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(d) Sharing of Facilities and Resources - The Food Safety Administration and the National Drug
Bureau, may enter into such agreements concerning the sharing of facilities and other resources
as may be appropriate to make efficient use of such facilities and resources and achieve their

respective missions.

SEC. 5. Additional Duties of the Administration. —

(a) Officers and Employees - The Administrator may —
(1) appoint officers and employees for the Administration in accordance with the provisions
of Republic Act No. 6040 amending the Civil Service Act of 1959, relating to appointment in
the competitive service; and
(2) fix the compensation of those officers and employees in accordance with the existing
Salary Standardization Law, relating to classification and General Schedule pay rates.

(b) Experts and Consultants - The Administrator may —
(1) procure the services of temporary or intermittent experts and consultants subject to the
provisions of the Labor Code and other pertinent legislation and
(2) pay in connection with those services the travel expenses of the experts and consultants,
including transportation and per diem in lieu of subsistence while away from the homes or
regular places of business of the individuals, as authorized by pertinent laws.

(c) Bureaus, Offices, and Divisions - The Administrator may establish within the Administration

such bureaus, offices, and divisions as the Administrator determines are necessary to perform the
duties of the Administrator.
(@ Advisory Committees-
(1) In general - The Administrator shall establish advisory committees that consist of
representatives of scientific expert bodies, academics, industry specialists, and consumers.
(2) Duties - The duties of an advisory committee established under paragraph (1) may

include developing recommendations with respect to the development of new processes,

research, communications, performance standards, and inspection.


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CHAPTER IL
ADMINISTRATION OF FOOD SAFETY PROGRAM

SEC. 6. Administration of National Program. -
(a) In General - The Administrator shall —
(1) develop, administer, and annually update a national food safety program (referred to in
this section as the ‘program’) to protect public health; and
(2) ensure that persons who produce, process, or distribute food meet their responsibility to

prevent or minimize food safety hazards related to their products.

(b) Comprehensive Analysis - The program shall be based on a comprehensive analysi
hazards associated with different food and with the processing of different food, including the
identification and evaluation of--
(1) the severity of the potential health risks;
(2) the sources of potentially hazardous contamination or practices extending from the farm
or ranch to the consumer that may increase the risk of food-borne illness;
(3) the potential for persistence, multiplication, or concentration of naturally occurring or
added contaminants in food;
(4) the potential for hazardous contamination to have cumulative toxic effects,
multigenerational effects, or effects on specific categories of consumers;
(5) opportunities across the food production, processing, distribution, and retail system to
reduce potential health risks; and
(6) opportunities for intentional contamination of food or food ingredients.
(c) Program Elements - In carrying out the program, the Administrator shall —
(1) adopt and implement a national system for the registration of food establishments and
foreign food establishments, as in this Act;
(2) adopt and implement a national system for regular unannounced inspection of food

establishments;



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(3) require and enforce the adoption of preventive process controls in food establishments,
based on the best available scientific and public health considerations and best available
technologies;
(4) establish and enforce science-based standards for--

(A) potentially hazardous substances that may contaminate food; and

(B) safety and sanitation in the processing and handling of food;
(5) implement a statistically valid sampling program with the stringency and frequency to
independently monitor that industry programs and procedures that prevent food
contamination are effective on an ongoing basis and that food meets the standards established
under this Act;
(© implement appropriate surveillance procedures and requirements to ensure the safety and
security of imported food;
(7) coordinate and collaborate with other agencies and national or local governments in
carrying out inspection, enforcement, research, and monitoring;
(8) implement a national system to identify the food products posing the greatest public
health risk and to analyze the effectiveness of existing food safety programs, in conjunction
with and other government agencies;
(9) develop public education, risk communication, and advisory programs;
(10) implement an applied research program to further the purposes of this Act;
(11) coordinate and prioritize food safety research and educational programs with other
government agencies and with national and local governments; and
(12) provide technical assistance to farmers and food establishments that are small business
concerns (meeting the requirements of Republic Act No. 6977, otherwise known as the
Magna Carta for Small Enterprises as amended by Republic Act No. 9501 and the
regulations promulgated thereunder) to assist with compliance with the requirements of this,

Act.

SEC.7. Registration of Food Establishments And Foreign Food
Establishments.



(@) In general - Any food establishment or foreign food establishment engaged in manufacturing,
processing, packing, or holding food for consumption in the Philippines shall register annually
with the Administrator.
(b) Registration Requirements-
(1) In general - To be registered under subsection (a), a food establishment shall submit a
registration or re-registration to the Administrator.
(2) Registration - Registration under this section shall begin within 90 days of the enactment
of this Act. Each such registration shall be submitted to the Secretary through an electronic
portal and shall contain such information as the Secretary, by guidance, determines to be
appropriate, Such registration shall contain the following information:
(A) The name, address, and emergency contact information of each domestic food
establishment or foreign food establishment that the registrant owns or operates under
this Act and all trade names under which the registrant conducts business in the
Philippines relating to food.
(B) The primary purpose and business activity of each domestic food establishment or
foreign food establishment, including the dates of operation if the domestic food
establishment or foreign food establishment is seasonal.
(C) The types of food processed or sold at each domestic food establishment or, for
foreign food establishments selling food for consumption in the Philippines, the specific
food categories of that food, or such other categories as the Administrator may designate
in guidance, action level, or regulations for evaluating potential threats to food protection,
(D) The name, address, and 24-hour emergency contact information of the Philippines
distribution agent for each domestic food establishment or foreign food establishment,
who shall maintain information on the distribution of food, including lot information, and
wholesaler and retailer distribution.
(B) An assurance that the registrant will notify the Administrator of any change in the
products, function, or legal status of the domestic food establishment or foreign food
establishment (including cessation of business activities) not later than 30 days after such
change.
(3) Procedure - Upon receipt of a completed registration described in paragraph (1), the
Administrator shall notify the registrant of the receipt of the registration, designate each
establishment as a category 1, 2, 3, 4, or 5 food establishment, and assign a registration
number to each domestic food establishment and foreign food establishment.
(4) List - The Administrator shall annually compile a list of domestic food establishments
and a list of foreign food establishments that are registered under this section. The
Administrator may establish the manner of and any fees required for re-registration and any

circumstances by which either such list may be shared with other governmental authorities.



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The Administrator may remove from either list the name of any establishment that fails to
reregister, and such delisting shall be treated as a suspension.
(5) Suspension of Registration-
(A) In General - The Administrator may suspend the registration of a domestic food
establishment or foreign food establishment, including the facility of an importer, for
violation of a food safety law that is either repeated or could result in serious adverse
health consequences or death to humans or animals.
(B) Notice and Opportunity for Hearing - The Administrator shall provide notice of an
intent to suspend the registration of an establishment under this paragraph to a registrant
and provide the registrant with an opportunity for an administrative hearing within three
(3) working days. The Administrator may issue a written order of suspension following
the hearing, if the Administrator finds that a violation described in subparagraph (A) has
occurred,
(C) Judicial Review - The issuance of an order of suspension under subparagraph (B)
shall be considered to be a final agency action subject to judicial review.
(7) Reinstatement - A registration that is suspended under this section may be reinstated
based on a showing that adequate process controls have been instituted that would prevent
future violations and there are assurances from the registrant that the violations will not be
repeated.

SEC. 8. Preventive Process Controls to Reduce Adulteration of Food. —
(a) In General - The Administrator shall, upon the basis of best available public health, scientific,
and technological data, promulgate regulations to ensure that food establishments carry out their
responsibilities under the food safety law.
(b) Regulations - Not later than one (1) year after the date of the enactment of this Act, the
Administrator shall promulgate regulations that require all food establishments, within time
frames determined by the Administrator —
(1) to adopt preventive process controls that —
(A) reflect the standards and procedures recognized by relevant authoritative bodies;
(B) are adequate to protect the public health;
(C) meet relevant regulatory and food safety standards;
(D) limit the presence and growth of contaminants in food prepared in a food
establishment using the best reasonably available techniques and technologies; and
(E) are tailored to the hazards and processes in particular establishments or environments;
(2) to establish a sanitation plan and program that meets standards set by the Administrator;
(3) to meet performance standards for hazardous contamination established under this Act;
(4) to implement recordkeeping to monitor compliance with regulatory requirements;


(5) to implement recordkeeping and labeling of all food and food ingredients to facilitate
their identification and traceability in the event of a recall or market removal;
(6) to implement product and environmental sampling at a frequency and in a manner
sufficient to ensure that process controls are effective on an ongoing basis and that regulatory
standards are being met;
(7) to label food intended for final processing outside commercial food establishments with
instructions for handling and preparation for consumption that will destroy microbial
contaminants; and
(8) to provide for agency access to records kept by the food establishments and submission of
copies of records to the Administrator, as the Administrator determines appropriate.
(©) Specific Hazard Controls - The Administrator may require any person with responsibility for
or control over food or food ingredients to adopt specific hazard controls, if such controls are
needed to ensure the protection of the public health.

SEC. 9. Performance Standards for Contaminants in Food. —
(a) In General - To protect the public health, the Administrator shall establish by guidance
document, action level, or regulation and enforce performance standards that define, with respect
to specific foods and contaminants in food, the level of food safety performance that a person
responsible for producing, processing, or selling food shall meet.
(b) Identification of Contaminants; Performance Standards-
(1) List of Contaminants - Not later than 6 months after the date of the enactment of this Act,
‘the Administrator shall publish in the Register a list of the contaminants in foods that have
the greatest adverse impact on public health in terms of the number and severity of illnesses
and number of deaths associated with foods regulated under this Act. Where appropriate, the
Administrator shall indicate whether the risk posed by a contaminant is generalized or
specific to particular foods or ingredients.
(2) Performance Standards -
(A) Establishment - The Administrator shall establish by guidance document, action
level, or regulation a performance standard for each contaminant in the list under
paragraph (1) at levels appropriate to protect against the potential adverse health effects
of the contaminant.
(Timing - The Administrator shall establish a performance standard under
subparagraph (A) for each contaminant in the list under paragraph (1)--
(jas soon as practicable; or
Gi) in the case of a contaminant described in subparagraph (C), by the date described
in such subparagraph.
(© Significant Contaminants - The list under paragraph (1) (and any revision thereto)
shail identify the five (5) most significant contaminants in the list (in terms of the number

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and severity of illnesses and number of deaths associated with foods regulated under this
Act). Not later than three (3) years after a contaminant is so identified, the Administrator
shall promulgate a performance standard under subparagraph (A) for the contaminant.
(3) Review; Revision- Not less than every three (3) years, the Administrator shall review and,
if necessary, revise —
(A) the list of contaminants under paragraph (1); and
(B) each performance standard established under paragraph (2).
(©) Performance Standards -
(1) In General - The performance standards established under this section may include ~
(A) health-based standards that set the level of a contaminant that can safely and lawfully
be present in food;
(B) zero tolerances, including any zero tolerance performance standards in effect on the
day before the date of the enactment of this Act, when necessary to protect against
significant adverse health outcomes;
(©) process standards, such as log reduction criteria for cooked products, when sufficient
to ensure the safety of processed food; and,
(D) in the absence of data to support a performance standard described in subparagraph
(A), (B), or (), standards that define required performance on the basis of reliable
information on the best reasonably achievable performance, using best available
technologies, interventions, and practices.
(2) Best Reasonably Achievable Performance Standards - In developing best reasonably
achievable performance standards under paragraph (1)(D), the Administrator shall collect, or
contract for the collection of, data on current best practices and food safety outcomes related
to the contaminants and foods in question, as the Administrator determines necessary.
(3) Revocation By Administrator - All performance standards, tolerances, action levels, or
other similar standards in effect on the date of the enactment of this Act shall remain in effect
until revised or revoked by the Administrator.
(@ Enforcement -
(1) In General - In conjunction with the establishment of a performance standard under this
section, the Administrator shall develop a statistically valid sampling program with the
stringency and frequency sufficient to independently monitor whether food establishments
are complying with the performance standard and implement the program within 1 year of
the promulgation of the standard.
(2) Inspections - If the Administrator determines that a food establishment fails to meet a
standard promulgated under this section, the Administrator shall, as appropriate—
(A) detain, seize, or condemn food from the food establishment;
(B) order a recall of food from the food establishment;
(C) increase the inspection frequency for the food establishment;



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(D) withdraw the mark of inspection from the food establishment, if in use; or

(E) take other appropriate enforcement action concerning the food establishment,

including withdrawal of registration.
(e) Newly Identified Contaminants - Notwithstanding any other provision of this section, the
Administrator shall establish interim performance standards for newly identified contaminants as
necessary to protect the public health.

SEC. 10. Inspections of Food Establishments. ~
(a) In General - The Administrator shall establish an inspection program, which shall include
statistically valid sampling of food and facilities to enforce performance standards. The
inspection program shall be designed to ‘determine if each food establishment —
(1) is operated in a sanitary manner;
(2) has continuous preventive control systems, interventions, and processes in place to
minimize or eliminate contaminants in food;
(3) is in compliance with applicable performance standards established under this Act, and
other regulatory requirements;
(4) is processing food that is not adulterated or misbranded;
(5) maintains records of process control plans under this Act, and other records related to the
processing, sampling, and handling of food; and
(6) is otherwise in compliance with the requirements of the food safety law.
(b) Establishment Categories and Inspection Frequencies - The resource plan required under this
Act, including the description of resources required to carry out inspections of food
establishments, shall be based on the following categories and inspection frequencies, subject to
subsections (c), (d), and (e):
(1) Category 1 Food Establishments - A category 1 food establishment shall be subject to
ante mortem, postmortem, and continuous inspection of each slaughter line during all
operating hours, and other inspection on a daily basis, sufficient to verify that--
(A) diseased animals are not offered for slaughter;
(B) the food establishment has successfully identified and removed from the slaughter
line visibly defective or contaminated carcasses, has avoided cross-contamination, and
has destroyed or reprocessed such carcasses in a manner acceptable to the Administrator; *
and
(C) applicable performance standards and other provisions of the food safety law,
including those intended to eliminate or reduce pathogens, have been satisfied.
(2) Category 2 Food Establishments - A category 2 food establishment shall —
(A) have ongoing verification that its processes are controlled; and
(B) be randomly inspected at least weekly.
(3) Category 3 Food Establishments - A category 3 food establishment shall —


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(A) have ongoing verification that its processes are controlled; and
(B) be randomly inspected at least monthly.
(4) Category 4 Food Establishments- A category 4 food establishment shall —
(A) have ongoing verification that its processes are controlled; and
(B) be randomly inspected at least quarterly.
(5) Category 5 Food Establishments- A category 5 food establishment shall —
(A) have ongoing verification that its processes are controlled; and
(B) be randomly inspected at least annually.
(c) Establishment of Inspection Procedures - The Administrator shall establish procedures under
which inspectors shall take random samples, photographs, and copies of records in food
establishments.
(d) Alternative Inspection Frequencies - With respect to a subcategory of food establishment
under category 2, 3, 4, or 5, the Administrator may establish alternative increasing or decreasing
inspection frequencies for subcategories of food establishments or individual establishments, to
foster risk-based allocation of resources. Before establishing an alternative inspection frequency
for a subcategory of food establishments or individual establishments, the Administrator shall
take into consideration the evidence described in paragraph (2)(D) and the overall record of
compliance described in paragraph (2)(E) for such subcategory. In establishing alternative
inspection frequencies under this subsection, the Administrator shall comply with the following
criteria and procedures: :
(1) Subcategories of food establishments and their alternative inspection frequencies shall be
defined by regulation, subject to paragraphs (2) and (3).
(2) In defining subcategories of food establishments and their alternative inspection
frequencies under paragraphs (1) and (2), the Administrator shall consider--
(A) the nature of the food products being processed, stored, or transported;
(B) the manner in which food products are processed, stored, or transported;
(C) the inherent likelihood that the products wil! contribute to the risk of food-borne
illness; :
(D) the best available evidence concerning reported illnesses associated with the foods
processed, stored, held, or transported in the proposed subcategory of establishments; and
(E) the overall record of compliance with food safety law among establishments in the
proposed subcategory, including compliance with applicable performance standards and
the frequency of recalls.
(3) The Administrator may adopt alternative inspection frequencies for increased or
decreased inspection for a specific establishment and shall annually publish a list of
establishments subject to alternative inspections.
(4) In adopting alternative inspection frequencies for a specific establishment, the
Administrator shall consider-~



(A) the criteria in paragraph (2), together with any evidence submitted from the
individual food establishment supporting a request for an alternative inspection
frequency, including the establishment's record for implementing effective preventive
process control systems;

(B) whether products from the specific establishment have been associated with a case or
an outbreak of food-borne illness; and

(C) the establishment’s record of compliance with food safety law, including compliance

era anrone

with applicable performance standards and the frequency of recalls.
9 (©) Effective Date - The inspection mandates shall go into effect 2 years after the date of the

10 — enactment of this Act.

11 (®) Maintenance and Inspection of Records -~

12 (1) In General -
13 (A) Records- A food establishment shall

14 (i) maintain such records as ‘the Administrator shall require by regulation, including
15 all records relating to the processing, distributing, receipt, or importation of any food;
16 and .

7 (ii) permit the Administrator, in addition to any authority transferred to the
18 Administrator pursuant to this Act, upon presentation of appropriate credentials and at
19 reasonable times and in a reasonable manner, to have access to and copy all records
20 maintained by or on behalf of such food establishment representative in any format
21 (including paper or electronic) and at any location, that are necessary to assist the
22 Administrator--

23 () to determine whether the food is contaminated or not in compliance with the
24 food safety law; or

25 (I) to track the food in commerce.

26 (B) Required Disclosure - A food establishment shall have an affirmative obligation to
27 disclose to the Administrator the results of testing or sampling of food, equipment, or
28 material in contact with food that is positive for any contaminant.

29 (2) Maintenance Of Records - The records in paragraph (1) shall be maintained for a
30 reasonable period of time, as determined by the Administrator.

31 (3) Requirements - The records in paragraph (1) shall include records describing ~

32 (A) the origin, receipt, delivery, sale, movement, holding, and disposition of food or
33 ingredients;

34 (B) the identity and quantity of ingredients used in the food;

35 (C) the processing of the food;

36 (D) the results of laboratory, sanitation, or other tests performed on the food or in the
37 food establishment;

38 (E) consumer complaints concerning the food or packaging of the food;



eI AHR EK H

(F) the production codes, open date codes, and locations of food production; and
(G) other matters reasonably related to whether food is adulterated or misbranded, or
otherwise fails to meet the requirements of this Act.
(g) Protection of Sensitive Information-
(2) In General - The Administrator shall develop and maintain procedures to prevent the
unauthorized disclosure of any trade secret or commercially valuable confidential
information obtained by the Administrator.

SEC. 11. Food Production Facilities. —
(a) Authorities - In carrying out the duties of the Administrator and the purposes of this Act, the
Administrator shall have the authority, with respect to food production facilities, to —
(1) visit and inspect food production facilities in the Philippines and in foreign countries to
determine if they are operating in compliance with the requireménts of the food safety law;
(2) review food safety records;
(3) set good practice standards to protect the public and animal health and promote food
safety;
(4) conduct monitoring and surveillance of animals, plants, products, or the environment, as
appropriate; and
(5) collect and maintain information relevant to public health and farm practices.
(b) Inspection of Records - A food production facility shall permit the Administrator upon
presentation of appropriate credentials and at reasonable times and in a reasonable manner, to
have access to and ability to copy all records maintained by or on behalf of such food production
establishment in any format (including paper or electronic) and at any location, that are
necessary to assist the Administrator —
(1) to determine whether the food is contaminated, adulterated, or otherwise not in
compliance with the food safety law; or
(2) to track the food in commerce.
(c) Regulations - Not later than one (1) year after the date of thé enactment of this Act, the
Administrator, shall promulgate regulations to establish science-based minimum standards for
the safe production of food by food production facilities. Such regulations shall--
(1) consider all relevant hazards, including those occurring naturally, and those that may be
unintentionally or intentionally introduced;
(2) require each food production facility to have a written food safety plan that describes the
likely hazards and preventive controls implemented to address those hazards;
(3) include, with respect to growing, harvesting, sorting, and storage operations, minimum
standards related to fertilizer use, nutrients, hygiene, packaging, temperature controls, animal
encroachment, and water;


(4) include, with respect to animals raised for food, minimum standards related to the
animal’s health, feed, and environment which bear on the safety of food for human
consumption;
(8) provide a reasonable period of time for compliance, taking into account the needs of
small businesses for additional time to comply;
(6) provide for coordination of education and enforcement activities by national and local
officials; and
(7) include a description of the variance process under subsection (d) and the types of
permissible variances which the Administrator may grant under such process.
(d) Variances - foreign countries that export produce intended for consumption in the Philippines
may request from the Administrator variances from the requirements of the regulations under
subsection (c). A request shall —
(1) be in writing;
(2) describe the reasons the variance is necessary:

(3) describe the procedures, processes, and practices that will be followed under the variance

to ensure produce is not adulterated; and

(4) contain any other information required by the Administrator.
(©) Approval or Disapproval of Variances - If the Administrator determines after review of a
request under subsection (d) that the requested variance provides equivalent protections to those
promulgated under subsection (c), the Administrator may approve the request. The Administrator
shall deny a request if it is —

(1) not sufficiently detailed to permit a determination;

(2) fails to cite sufficient grounds for allowing a variance; or

(3) does not provide reasonable assurances that the produce will not be adulterated.
(®) Enforcement - The Administrator may coordinate with the agency or department designated
by each local government unit to perform activities to ensure compliance with this section.
(g) Imported Produce - Not later than one (1) year after the date of the enactment of this Act, the
Administrator shall promulgate regulations to ensure that raw agricultural commodities and
minimally processed produce imported into the Philippines can meet standards for food safety,
inspection, labeling, and consumer protection that are at least equal to standards applicable to
such commodities and produce produced in the Philippines.

SEC. 12. National and Local Government Cooperation. —
(a) In General -
(1)Authority - The Administrator shall strengthen and expand food-borne illness surveillance
systems to ~ :

(A) inform and evaluate efforts to prevent food-borne illness; and



(B) enhance the identification and investigation of, and response to, food-borne illness
outbreaks.
(2) Food-Borne Iliness Outbreak- For purposes of this section, the term ‘foodborne illness
outbreak’ means the occurrence of two (2) or more cases of a similar illness resulting from
the ingestion of a common food.
(b) Food-Borne Illness Surveillance Systems - The Administrator, shall enhance food-borne
illness surveillance systems to improve the collection, analysis, reporting, and usefulness of data
on food-borne illnesses by —
(J) coordinating food-borne illness surveillance systems, including complaint systems, in
order to —
(A) produce better information on illnesses associated with foods, including sources and

risk factors for infections by emerging pathogens; and

(B) facilitate sharing of data acquisition and findings on a more timely basis among
governmental agencies, and national and local agencies, and with the public;
(2) augmenting such systems to improve attribution of a food-borne illness outbreak to a
specific food;
(3) developing improved epidemiological tools for obtaining quality exposure data,
microbiological methods for classifying cases and detecting clusters, and improved
tracebacks to rapidly and specifically identify contaminated food products;
(4) expanding capacity of such systems for implementation of fingerprinting strategies for
food-borne infectious agents, inchiding parasites and hepatitis A, in order to increase
pathogen discovery efforts to identify new or rarely documented causes of food-borne illness;
(5) allowing timely public access to de-identified, aggregate surveillance data;
(6) at least annually, publishing current reports on findings from such systems;
(7) exploring establishment of registries for long-term case follow-up to better characterize
ate complications of food-borne illness;
(8) increasing participation in national networks of public health and food regulatory
agencies and laboratories to ~
(A) allow public health officials at the national and local levels to share and accept
laboratory analytic findings; and
(B) identity food-borne illness outbreaks and attribute such outbreaks to specific foods
through submission of standardized molecular subtypes (also known as ‘fingerprints’) of
food-bome illness pathogens to a centralized database; and
(9) establishing a flexible mechanism for rapidly supporting scientific research by academic
centers of excellence, which may include staff representing academic clinical researchers,
food microbiologists, animal and plant disease specialists, ecologists, and other allied

disciplines.



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(c) Improving Local Government Surveillance Capacity - The Administrator, shall improve
capacity for surveillance in the local governments by ~
(1) supporting outbreak investigations with needed specialty expertise, including
epidemiological, microbiological, and environmental expertise, to assist identification of
underlying common sources and contributing factors;
(2) identifying, disseminating, and supporting implementation of model practices at the
national and local level for —
(A) facilitating rapid shipment of clinical isolates from clinical laboratories to local
government public health laboratories to avoid delays in testing;
(B) conducting rapid and more standardized interviewing of cases associated with major
enteric pathogens, including prior to designation of clusters as food-borne illness
outbreaks;
(C) conducting and evaluating rapid and standardized interviews of healthy control
persons;
(D) sharing information on a timely basis —
(i) within public health and food regulatory agencies;
(ii) among such agencies;
iii) with the food industry;
(iv) with healthcare providers; and
(v) with the public;
(3) developing, regularly updating, and disseminating training curricula on food-borne illness
surveillance investigations, including standard sampling methods and laboratory procedures;
(4) integrating new molecular diagnostic tools for parasites into web-based consultation
services for parasitic infections to accelerate the identification of these food-borne infectious
agents;
(5) supporting research to develop and deploy new sub-typing methods for salmonella, E.
coli, campylobacter, and other pathogens, to increase the speed and accuracy of diagnoses;
(6) determining minimum core competencies for public health laboratories, and developing
self-evaluation and proficiency-testing tools for such laboratories;
(7) facilitating regional public health laboratory partnerships to leverage resources, including
‘equipment and physical space, and increase surge capacity;
(8) providing technical assistance, which may include the detailing of officers and employees
of the Administrator, to national and local public health and food regulatory agencies;
(9) partnering with the Food Safety Administration to increase communication, coordination,
and integration of food-borne illness surveillance and outbreak investigation activities; and
(10) developing and periodically updating response and interview procedures so that such
procedures are standardized and tested.



(@ Program Activities - The Administrator shall carry out activities to support core food safety
functions of national and local public health laboratories, including--

(1) establishing fellowships, stipends, and scholarships to address critical workforce
shortages;

(2) training and coordination of national and local personnel;

(3) establishing partnerships between private and public laboratories to facilitate sharing of
positive enteric specimens and improve surge capacity;

(4) strengthening capacity to participate in existing or new food-borne illness surveillance
systems; and

(5) purchasing and maintaining data systems hardware and software and laboratory

equipment.

(©) Plan to Improve Food Safety Capacity at the national and local level -

(1) Goals - The Administrator shall leverage and enhance the food safety capacity and roles
of national and local agencies and integrate national and local agencies as fully as possible
into national food safety efforts, in order to achieve the following goals:
(A) Improve food-borne illness outbreak response and containment.
(B) Improve the contribution of food-borne illness surveillance and investigation to the
prevention of food-borne illness.
(© Strengthen oversight of food safety at the retail level.
(D) Strengthen the capacity of national and local agencies to carry out inspections and
enforce safety standards in food processing establishments, as part of a national strategy
and plan to provide an adequate level of inspection and achieve compliance with safety
standards in such establishments.
(E) Make more effective use of the Nation’s combined food safety resources to reduce
the burden of food-borne illness.
(2) Survey - In preparation for development of the plan required by paragraph (3), the
Administrator shall, not later than one (1) year after the date of enactment of this part,
complete a survey of national and local capacities, and needs for enhancement, with respect
to-
(A) staffing levels and expertise available to perform food safety functions;
(B) laboratory capacity to support surveillance, outbreak response, inspection, and
enforcement activities;
(©) information systems to support data management and sharing of food safety
information among national and local agencies;
() legal authorities of national and local agencies to support the roles of such agencies
in a national food safety system; and

(E) organizational arrangements for managing and coordinating food safety activities.



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(3) Plan - Taking into account the goals established in paragraph (1), results from the survey
required in paragraph (2), and consultations with national and local agencies and other food
safety stakeholders, the Administrator shall, not later than 2 years after the date of enactment
of this part, develop, publish, and begin implementation of a plan that includes the following
elements:
(A) Criteria for assessing the adequacy of national and local capacity to perform food
safety functions as part of a national food safety system.
(B) Priorities for enhancing the capacity of national and local agencies.
(©) Action plans for meeting the highest priority capacity needs, including budget
requirements and financing plans that take into account national and local resources.
(D) Improved coordination and information flow among national and local agencies to
strengthen food-borne illness surveillance, outbreak response, and investigation and to
ensure that agencies at all levels have the information on origins and causes of food-
borne illness that such agencies need to plan preventive measures.
(E) Integration of the inspection and compliance programs in food processing
establishments of the Food Safety Administration .and national and local agencies,
including —
(i joint planning and priority setting to ensure that the collective effort has the
greatest possible impact on achieving compliance with food safety standards and
reducing food-borie illness;
(ii) elimination of barriers to the free flow of information among the Food Safety
Administration and national and local agencies with respect to inspection and
compliance programs and integration of national and local inspection and laboratory
data systems;
(iii) steps to expand, and ensure the vigor and consistency of, national and local
inspection of processing establishments under contract to the Food Safety
Administration; and
(iv) reliance by the Food Safety Administration on national inspection and food
sample analyses in local enforcement activities.
(4) Food Safety Capacity Building Grants - The Administrator shall make grants to national
and local agencies to enhance national and local food safety capacity and programs and
support achievement of the goals established in paragraph (1). In awarding such grants, the
Administrator shall take into account the criteria and priorities established by the
Administrator under paragraph (3).
(5) Report To Congress - Not later than 1 year after the date of enactment of this part, and on
an annual basis thereafter, the Administrator shall submit to Congress a report that describes-
(A) progress made in implementing this section, including any obstacles to such
implementation; and

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(B) any legislative recommendations or additional resources needed for full
implementation.

(8 Service Agreements -
(1) In General - The Administrator may, under agreements entered into with national, or local
agencies, use on a reimbursable basis or otherwise the qualified personnel and services of
those agencies in carrying out this Act.
(2) Training - Agreements with local govemments under this subsection shall provide for
training of local government employees.
(3) Maintenance Of Agreements - The Administrator shall maintain any agreement described
in paragraph (1) that is in effect on the day before the date of the enactment of this Act until
the Administrator evaluates such agreement and determines whether to maintain or substitute
such agreement.
(4) Commissioning - Where necessary and appropriate to fulfill the provisions of this Act or
other food safety law, the Administrator shall, as part of any service agreement, commission
qualified national and local regulatory officials and inspectors to assist the Administrator in
carrying out the food safety law and accord such commissioned officials and inspectors

access to information in possession of the Administrator.

SEC. 13. Imports. -
(@) In General - All imported food under this Act shall meet requirements for food safety,
inspection, labeling, and consumer protection that are at least equal to those applicable to food
grown, manufactured, processed, packed, or held for consumption in the Philippines.
(b) Certification System - Not later than 2 years after the date of the enactment of this Act, the
Administrator shall establish a system under which food products offered for importation into the
Philippines shall be certified by the accredited foreign government in the country of export or by
an accredited certifying agent meeting all applicable standards under this section.
(1) Category 1, 2, and 3 food establishments shall secure certification of products from the
accredited foreign government in the country where the products are produced and must
enter the Philippines through ports designated by the Administrator.
(2) Category 4 and 5 food establishments shall be certified either by ~
(A) the accredited foreign government in the country where the products are produced; or
(B) acertifying agent that has been accredited under subsection (c).
(3) Beginning not later than 5 years after the date of the enactment of this Act, food from
category 4 and 5 food establishments that is not certified by an accredited entity described in
subsection (c) shall not enter the Philippines except through ports of entry that are located in
a metropolitan area with an accredited food testing laboratory.
(©) Certification Standard -



(1) In General - A foreign government or third party agent requesting accreditation to certify
food for entry into the Philippines shall demonstrate, in a manner determined appropriate by
the Administrator, that food produced under the supervision of the foreign government or
third party agent, respectively, can meet standards for food safety, inspection, labeling, and
consumer protection that are at least equal to standards applicable to food produced in the
Philippines.
(2) Request by Foreign Government - Prior to accrediting a foreign government, the
Administrator shall —
(A) review and audit the food safety program of the requesting foreign government
(including all statutes, regulations, and inspection authority); and
(B) determine that the exporting country--
(i) administers a food control program that requires food exporters to implement
hazard control measures for physical, chemical, and biological contaminants;
(ii) ensures sanitary operations of facilities;
(iii) utilizes testing and verification programs; and
(iv) administers an effective enforcement program.
(3) Request by a Certifying Agent - Prior to accrediting a certifying agent, the Administrator
shall —
(A) review the training and qualifications of auditors and other employees used by the
agent;
(B) ensure that any such auditors have completed such training as may be required by the
Administrator for the conduct of food safety inspections; and
(C) conduct reviews of internal systems and such other investigation as the Administrator
deems necessary to determine that the certifying agent is capable of auditing food
establishments -- ,
(i) to assess the adequacy of systems and standards in use; and
(ii) to ensure that food approved by the agent for import to the Philippines meets the
requirements of this Act.
(4) Certification to Accompany Each Shipment - As a condition of accrediting any foreign
government or certifying agent, such government or agent shall agree to issue a written and
electronic certification to accompany each shipment intended for import to the Philippines
from any food establishment which the government or agent certifies, subject to requirements
set forth by the Administrator,
(@ Audits; Inspections - Following any accreditation under subsection (c), the Administrator
may at any time --
(1) conduct an on-site audit of any food establishment registered under section 202, with or
without the certifying agent; or

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(2) require a certifying agent to submit an onsite audit report and any other reports or
documents which the agent requires as part of the audit process, including documentation
that the food establishment is in compliance with registration requirements and prior notice
requirements for food imported to the Philippines.

(©) Limitation - A foreign government or other certifying agent accredited by the Administrator

to certify food for import to the Philippines under this section may certify only the food products

or food categories for importation to the Philippines that are specified in the grant of
accreditation.

(® Withdrawal of Accreditation - The Administrator may withdraw accreditation from a foreign

government or certifying agent--

(1) if food approved by the foreign government or certifying agent is linked to an outbreak of
human illness;

(2) following an investigation and finding by the Administrator that, the programs of the
foreign government, or a foreign food establishment certified by the certifying agent, are no
longer equal to those applied to food grown, manufactured, processed, packed, or held in the
Philippines; or

(3) following a refusal to allow Philippines officials to conduct such audits and investigations
‘as may be necessary to ensure continued compliance with the requirements of this section.

(g) Renewal of Accreditation - The Administrator shall audit foreign governments and certifying

agents whenever needed, but no less than once every 3 years, to ensure the continued compliance

with the requirements set forth in this section. Renewal of accreditation shall occur following
each satisfactory audit.

(b) Required Routine Inspection - The Administrator shall routinely inspect food before or at

entry into the Philippines to ensure ongoing compliance with food safety law and where

appropriate, as part of the audit of any certifying entity.

(i) Enforcement - The Administrator may--

(1) deny importation of food from any foreign country if the government of such country
does not permit Philippines officials to enter the foreign country to conduct such audits and
inspections as may be necessary to fulfill requirements under this section;

(2) deny importation of food from’ any foreign country or foreign food establishment that
does not consent to a timely investigation by the Administration when food from that foreign
country or foreign food establishment is linked to a food-borne illness outbreak or is
otherwise found to be adulterated or misbranded;

(3) promulgate regulations to carry out the purposes of this section, including setting terms
and conditions for the destruction of products that fail to meet the requirements of this Act;
and ,

(A) establish such fees as are necessary to carry out the implementation of the accreditation

and inspection programs required under this section.

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(j) Detention and Seizure - Any food imported for consumption in the Philippines may be
detained, seized, or condemned pursuant to relevant trade policies.

(k) Certifying Agents - Entities eligible for accreditation as a certifying agent under subsection
(©) may include —

(1) a national or local government food authority; or

(2) a foreign or domestic cooperative that aggregates the products of growers or processors

for importation.

() Avoiding Conflicts of Interest with Certifying Agents -

(1) In General - To be eligible for accreditation under subsection (¢), a certifying agent shall
(A) not be owned, managed, or controlled by any person that owns or operates an
establishment whose products are to be certified by such agent;

(B) have procedures to ensure against the use, in carrying out audits of food
establishments under this section, of any officer or employee of such agent that has a
financial conflict of interest regarding an establishment whose products are to be certified
by such agent; and

(C) annually make available to the Secretary, disclosures of the extent to which such
agent, and the officers and employees of such agent, have maintained compliance with
subparagraphs (A) and (B) relating to financial conflicts of interest,

(2) Regulations - The Secretary shall promulgate regulations not later than 18 months after

the date of the enactment of this Act to ensure that there are protections against conflicts of

interest between a certifying agent and the establishments whose products are to be certified
by such agent. Such regulations shall include--
(A) requiring that domestic audits performed under this section be unannounced;
(B) a structure, including timing and public disclosure, for fees paid by food
establishments to certifying agents to decrease the potential for conflicts of interest; and
(C) appropriate limits on financial affiliations between a certifying agent and any person

that owns or operates an establishment whose products are to be certified by such agent.

SEC. 14. Resource Plan. —
(a) In General - The Administrator shall prepare and update annually a resource plan describing
the resources required, in the best professional judgment of the Administrator, to develop and
fully implement the national food safety program established under this Act.
(b) Contents of Plan - The resource plan shall--
(1) describe quantitatively the personnel, financial, and other resources required to carry out

the inspection of food establishments under section 10 and other requirements of this Act;

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(2) allocate inspection resources in a manner reflecting the distribution of risk and
opportunities to reduce risk across the food supply to the extent feasible based on the best
available information, and subject to section 10; and
(3) describe the personnel, facilities, equipment, and other resources needed to carry out
inspection and other oversight activities, at a total resource level equal to at least 50 percent
of the resources required to carry out.inspections in food establishments under section 10 and
food production facilities under this Act
(A) in foreign establishments and production facilities; and
(B) at the point of importation.
(©) Grants - The resource plan shall include recommendations for funding to provide grants to
national and local governments to carry out food safety activities and inspections of food
establishments and food production facilities and include resources to audit such programs.
(@ Submission of Plan - The Administrator shall submit annually to the Committee on
Appropriations of the Senate, the Committee on Appropriations of the House of Representatives,
and other relevant committees of Congress, the resource plan required under this section.

SEC. 15. Accredited Laboratories. —
(a) Establishment of Program - The Administrator shall establish a program for accrediting
laboratories to perform sampling and testing for purposes of this Act. Such program shall
include--
(1) standards for appropriate sampling and analytical procedures;
(2) training and experience qualification levels for individuals who conduct sampling and
analysis;
(3) annual onsite visits to audit the performance of an accredited laboratory; and
(4) such additional requirements as the Administrator determines to be appropriate.
(b) Requirements - To be accredited under this section, a laboratory shall —
(1) prepare and submit an application for accreditation to the Administrator;
(2) meet required tests and standards established by the Administrator; and
(3) comply with such terms and conditions as are determined necessary by the Administrator.
(c) Accrediting Bodies - The Administrator may approve local government agencies or private,
nonprofit entities as accrediting bodies to act on behalf of the Administrator in accrediting
laboratories under this section. The Administrator shall--
(1) in making such approvals —
(A) oversee and review the performance of any accrediting body acting on behalf of the
Administrator to ensure that such accrediting body is in compliance with the
requirements of this section; and
(B) have the right to obtain from an accrediting body acting on behalf of the
Administrator and from any laboratory that may be certified by such a body all records

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and materials that may be necessary for the oversight and review required by
subparagraph (A);
(2) reevaluate accreditation bodies approved under paragraph (1) whenever ~
(A) the Administrator determines a laboratory accredited by the accrediting body is no
longer in compliance with this section;
(B) the Administrator determines the accrediting body is no longer in compliance with
the requirements of this section; or
(C) no less than once every 5 years; and
(3) promptly revoke the approval of any accreditation body found not to be in compliance
with the requirements of this section.
(@ Revocation of Accreditation- The Administrator shall revoke the accreditation of any

laboratory that fails to meet the requirements this section.

TITLE IV--RESEARCH AND EDUCATION
SEC. 16. Public Health Assessment System. —
(a) In General - The Administrator, acting in coordination with the Director of the Centers for
Disease Control and Prevention and with food safety and research programs of the Department
of Agriculture, shall ~
(1) identify on an ongoing basis the priorities for collection of epidemiological data and for
other food safety research and data collection that are most important to implementing the
food safety law and reducing the public health burden of food-borne illness;
(2) have full access for purposes of implementing the food safety Jaw to the applicable data
and data systems of the country;
(3) provide appropriate support and input on the design and implementation by concerned
government agencies of an active surveillance system that provides information on the
incidence and causes of food-borne illness which is timely, detailed, and representative of the
population of the Philippines;
(4) based on data and information obtained from concerned government agencies and other
sources, assess the incidence, distribution, public health impact, and causes of human illness
in the Philippines associated with the consumption of food, and conduct research and
analysis to devise effective and feasible interventions to reduce food-borne illness;
(5) institute DNA matching system and epidemiological system dedicated to food-borne
illness identification, outbreaks, and containment; and
(6) utilize surveillance data created by means of monitoring and statistical studies conducted
as part of its own inspection.
(b) Public Health Sampling-

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(1) In General - Not later than 1 year after the enactment of this Act, the Administrator shall

2 establish guidelines for a sampling system under which the Administrator shall take and
3 analyze samples of food ~
4 (A) to assist the Administrator in carrying out this Act; and
5 (B) to assess the nature, frequency of occurrence, and quantities of contaminants in food.
6 (2) Requirements - The sampling system described in paragraph (1) shall provide —
7 (A) statistically valid monitoring, including market-based studies, on the nature,
8 frequency of occurrence, and quantities of contaminants in food available to consumers;
9 and
10 (B) at the request of the Administrator, such other information, including analysis of
ab monitoring and verification samples, as the Administrator determines may be useful in
12 assessing the occurrence of contaminants in food.
13 (c) Assessment of Health Hazards -
14 (1) In General - Through the surveillance system and analyses referred to in subsection (a)
15 and the sampling system described in subsection (b), the Administrator shall —
16 (A) rank food categories based on the hazard to human health presented by the food
7 category and specific chemical and microbiological hazards associated with foods in
18 those categories;
19 (B) identify appropriate industry and regulatory approaches to minimize hazards in the
20 food supply; and
21 (©) assess the conditions affecting the likelihood that emerging pathogens and diseases,
2 including zoonosis, will affect the safety of the food supply and possible strategies for
23 minimizing the potential risk to public health associated with emerging pathogens and
24 diseases.
25 (2) Components of Analysis- The analysis under subsection (b)(1) may include —
26 (A) a comparison of the safety of commercial processing with the health hazards
27 associated with food that is harvested for recreational or subsistence purposes and
28 prepared non-commercially;
29 (B) a comparison of the safety of food that is domestically processed with the health
30 hazards associated with food that is processed outside the Philippines;
31 (C) a description of contamination originating from handling practices that occur prior to
32 or after the sale of food to consumers; and
33 (D) use of comparative risk assessments.
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35 SEC. 17. Public Education And Advisory System. —
36 (a) Public Education -

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(1) In General - The Administrator, in cooperation with private and public organizations,
including the cooperative extension services and building on the efforts of appropriate
national and local entities, shall establish a national public education program on food safety.
(2) Requirements - The program shall provide —
(A) information to the public regarding national and local standards and best practices,
and promotion of public awareness and understanding of those standards and practices;
(B) information for health professionals —
(i) to improve diagnosis and treatment of food-related illness; and
(ii) to advise individuals at special risk for food-related illnesses; and
(©) such other information or advice, including on safe food handling practices, to
consumers and other persons as the Administrator determines will promote the purposes
of this Act.
(b) Health Advisories - The Administrator, in consultation with other departments and agencies
as the Administrator determines necessary, shall work with the local government units and other
appropriate entities —
(1) to develop and distribute regional and national advisories conceming food safety;
(2) to develop standardized formats for written and broadcast advisories;
(3) to incorporate national and local advisories into the national public education program
established under subsection (a); and
(4) to present prompt, specific information regarding food found to pose a threat to the public
health, including by identifying the retailers and food establishments where such food has

been sold.

SEC. 18. Research. —

(a) In General - The Administrator shall conduct research to carry out this Act, including studies
to-

(1) improve sanitation and food safety practices in the processing of food;

(2) develop improved techniques to monitor and inspect food;

(3) develop efficient, rapid, and sensitive methods to detect contaminants in food:

(4) determine the sources of contamination of contaminated food;

(5) develop food consumption data;

(6) identify ways that animal production techniques could improve the safety of the food

supply;

(7) draw upon research and educational programs that exist at the national and local level;

(8) utilize the DNA matching system and other processes to identify and control pathogens;

(9) address common and emerging zoonotic diseases;

(10) develop methods to reduce or destroy harmful pathogens before, during, and after

processing;

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(11) analyze the incidence of antibiotic resistance as it pertains to the food supply and
develop new methods to reduce the transfer of antibiotic resistance to humans; and
(12) conduct other research that supports the purposes of this Act.

(b) Contract Authority- The Administrator may enter into contracts and agreements with any

university, national or local government agency, or person to carry out this section.

SEC. 19. Working Group on Improving Foodborne Illness Surveillance. —
Not later than 180 days after the date of enactment of this Act, the Administrator shall establish a
diverse working group of experts and stakeholders from national and local food safety and health
agencies, the food industry, consumer organizations, and academia. Such working group shall
provide the Administrator, through at least annual meetings of the working group and an annual
public report, advice and recommendations on an ongoing and regular basis regarding the
improvement of food-borne illness surveillance, including advice and recommendations on--
(a) the priority needs of regulatory agencies, the food industry, and consumers for information
and analysis on food-borne illness and its causes that can be used to prevent food-borne illness;

(b) opportunities to improve the effectiveness of initiatives at the national, and local levels,

including coordination and integration of activities among national agencies, and between the
national and local levels of government;

(©) improvement in the timeliness and depth of access by regulatory and health agencies, the
food industry, academic researchers, and consumers to food-borne illness surveillance data
collected by government agencies at all levels;

(@) key barriers to improvement in food-borne illness surveillance and its utility for preventing
food-borne illness at national and local levels; and

(©) specific actions to reduce barriers to such improvement, implement the working group’s
recommendations, with measurable objectives and timelines, and identification of resource and

staffing needs.

SEC. 20. Food-Borne Illness Health Registry. —
(a) Purpose - The purpose of the registry under subsection (b) is to stimulate research on the
trends, sources, health outcomes, and preventive strategies related to food-borne disease.
(b) Registry - For the purpose described in subsection (a), the Secretary of Health acting through
the Administrator, shall develop and maintain a registry, to be known as the Food-Borne Illness
Health Registry, consisting of data on the trends, sources, health outcomes, and preventive
strategies related to food-borne disease.

CHAPTER V
ENFORCEMENT
SEC. 21. Prohibited Acts. — It is prohibited —



eI Auk oN

(a) to manufacture, introduce, deliver for introduction, or receive in commerce any food that is
adulterated, misbranded, or otherwise unsafe;

(b) to adulterate or misbrand any food in commerce;

(©) for a food establishment or foreign food establishment to fail to register under section 7, or to
operate without a valid registration;

(@) to refuse to permit access to a food establishment or food production facility for the
inspection and copying of a record as required under sections 10(f) and 11(a);

(©) to fail to establish or maintain any record or to make any report as required under sections
10(f) and 11(b);

(8) to refuse to permit entry to or inspection of a food establishment as required under section 10;

(g) to fail to provide to the Administrator the results of testing or sampling of food, equipment,
or material in contact with food, that is positive for any contaminant under section 10(0(1)(B);
(h) to fail to comply with a provision, regulation, or order of the Administrator under sections 6,
8,9, 11, of 13;

(i) to slaughter an animal that is capable for use in whole or in part as human food at a food
establishment processing any food for commerce, except in compliance with the food safety law:
(j) to transfer food in violation of an administrative detention order under section 402 or to
remove or alter a required mark or label identifying the food as detained;

(Kk) to fail to comply with a recall or other order under section 403; or

(I) to otherwise violate the food safety law.

SEC. 22. Food Detention, Seizure, And Condemnation. —
(a) Administrative Detention of Food -
(1) Expanded Authority - The Administrator shall have authority to administratively detain
and seize any food regulated under this Act that the Administrator has reason to believe is
unsafe, is adulterated or misbranded, or otherwise fails to meet the requirements of the food
safety law.
(2) Detention Authority - If, during an inspection conducted in accordance with section 10 or
13, an officer, employee, or government agent making the inspection has reason to believe
that a domestic food, imported food, or food offered for import is unsafe, is adulterated or
misbranded, or otherwise fails to meet the requirements of this the food safety law, the
officer, employee, or agent may order the food detained.
(3) Period of Detention -
(A) In General- A food may be detained under paragraph (1) or (2) for a reasonable
period, not to exceed 20 days, unless a longer period, not to exceed 30 days, is necessary
for the Administrator to institute a seizure action.
(B) Perishable Food- The Administrator shall provide by regulation for procedures to
institute a seizure action on an expedited basis with respect to perishable food.

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(4) Security of Detained Food -

(A) In General - A detention order under this subsection-~

i) may require that the food be labeled or marked as detained; and
(ii) shall require that the food be removed to a secure facility, if appropriate.

(B) Food Subject to an Order - A food subject to a detention order under this subsection

shall not be transferred by any person from the place at which the food is removed, until

released by the Administrator or until the expiration of the detention period applicable

under the order, whichever occurs first.

(C) Delivery Of Food - This subsection does not authorize the delivery of a food in

accordance with execution of a bond while the article is subject to the order.

(©) Condemnation of Food -
(1) In General - After confirming a detention order, the Administrator may order the food
condemned.
(2) Destruction of Food - Any food condemned shall be destroyed under the supervision of
the Administrator.
(3) Release of Food - If the Administrator determines that, through reprocessing, relabeling,
or other action, a detained food can be brought into compliance with this Act, the food may
be released following a determination by the Administrator that the relabeling or other action
as specified by the Administrator has been performed.
(d) Temporary Holds at Ports of Entry -

(1) In General - If an officer or qualified employee of the Administration has reason to
believe that a food is unsafe, is adulterated or misbranded, or otherwise fails to meet the
requirements of this Act, and the officer or qualified employee is unable to inspect, examine,
or investigate the food when the food is offered for import at a port of entry into the
Philippines, the officer or qualified employee shall request the Bureau of Customs to hold the
food at the port of entry for a reasonable period of time, not to exceed 24 hours, to enable the
Administrator to inspect or investigate the food as appropriate.
(2) Removal to Secure Facility - The Administrator shall work in coordination with the
Commissioner of the Bureau of Customs to remove a food held in accordance with paragraph
(1) toa secure facility as appropriate.
(3) Prohibition on Transfer - During the period in which food is held, the food shall not be
transferred by any person from the port of entry into the Philippines, or from the secure
facility to which the food has been removed.
(4) Delivery in Accordance with a Bond - The delivery of the food in accordance with the
execution of a bond while the food is held is not authorized.
(5) Prohibition on Re-export - A food found unfit for human or animal consumption shail be
prohibited from re-export without further processing to remove the contamination and re-
inspection by the Administration.

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SEC. 23. Notification and Recall. -
(a) Notice to Administrator of Violation -
(1) In General - A person that has reason to believe that any food introduced into or in
commerce, or held for sale (whether or not the first sale) after shipment in commerce, may be
in violation of the food safety law shall immediately notify the Administrator of the identity
and location of the food.
(2) Manner of Notification - Notification under paragraph (1) shall be made in such manner
and by such means as the Administrator may require by regulation.
(b) Recall and Consumer Notification -
(1) Voluntary Actions - If the Administrator determines that food is in violation of the food
safety law when introduced into or while in commerce or while held for sale (whether or not
the first sale) after shipment in commerce and that there is a reasonable probability that the
food, if consumed, would present a threat to public health, as determined by the
Administrator, the Administrator shall give the appropriate persons (including the
manufacturers, importers, distributors, or retailers of the food) an opportunity to —
(A) cease distribution of the food;
(B) notify all persons —
(i processing, distributing, or otherwise handling the food to immediately cease such
activities with respect to the food; or
(ii) to which the food has been distributed, transported, or sold, to immediately cease
distribution of the food;
(C) recall the food;
(D) in conjunction with the Administrator, provide notice of the finding of the
Administrator —
(i to consumers to whom the food was, or may have been, distributed; and
(ii) to national and local public health officials; or
(E) take any combination of the measures described in this paragraph, as determined by
the Administrator to be appropriate in the circumstances.
(2) Mandatory Actions - If a person referred to in paragraph (1) refuses to or does not
adequately carry out the actions described in that paragraph within the time period and in the
manner prescribed by the Administrator, the Administrator shall —
(A) have authority to control and possess the food, including ordering the shipment of the
food from the food establishment to the Administrator —
(i) at the expense of the food establishment; or
Gi) in an emergency (as determined by the Admi

trator), at the expense of the
Administration; and
(B) by order, require, as the Administrator determines to be necessary, the person to

immediately ~

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(i) cease distribution of the food; and
i) notify all persons —
() processing, distributing, or otherwise handling the food to immediately cease
such activities with respect to the food; or
(I) if the food has been distributed, transported, or sold, to immediately cease
distribution of the food.
(3) Notification to Consumers by Administrator - The Administrator shall, as the
Administrator determines to be necessary —
(A) provide notice of the finding of the Administrator under paragraph (1) —
(3) to consumers to whom the food was, or may have been, distributed; and
(ii) to national and local public health officials; and
(B) provide notice to the public of the names and addresses of retail locations at which
recalled food products were available for sale.
(4) Non-distribution By Notified Persons - A person that processes, distributes, or otherwise
handles the food, or to which the food has been distributed, transported, or sold, and that is
notified under paragraph (1)(B) or (2)(B) shall immediately cease distribution of the food.
(5) Availability of Records To Administrator - Each person referred to in paragraph (1) that
processed, distributed, or otherwise handled food shall make available to the Administrator
information necessary to carry out this subsection, as determined by the Administrator,
regarding —
(A) persons that processed, distributed, or otherwise handled the food; and
(B) persons to which the food has been transported, sold, distributed, or otherwise
handled.
(©) Informal Hearings on Orders -
(1) In General - The Administrator shall provide any person subject to an order under
subsection (b) with an opportunity for an informal hearing, to be held as soon as practicable
but not later than 2 business days after the issuance of the order.
(2) Scope Of The Hearing - In a hearing under paragraph (1), the Administrator shall
consider the actions required by the order and any reasons why the food that is the subject of
the order should not be recalled.
(@ Post-Hearing Recall Orders -
(1) Amendment of Order - If, after providing an opportunity for an informal hearing under
subsection (c), the Administrator determines that there is a reasonable probability that the
food that is the subject of an order under subsection (b), if consumed, would present a threat
to the public health, the Administrator, as the Administrator determines to be necessary, may
(A) amend the order to require recall of the food or other appropriate action;
(B) specify a timetable in which the recall shall occur;

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(©) require periodic reports to the Administrator describing the progress of the recall; and
(D) provide notice of the recall to consumers to whom the food was, or may have been,
distributed.
(2) Vacation Of Orders - If, after providing an opportunity for an informal hearing under
subsection (c), the Administrator determines that adequate grounds do not exist to continue
the actions required by the order, the Administrator shall vacate the order.
(©) Remedies Not Exclusive - The remedies provided in this section shall be in addition to, and
not exclusive of, other remedies that may be available.

SEC. 24, Injunction Proceedings. —
(a) Jurisdiction - The courts of the Philippines shall have jurisdiction, for cause shown, to
restrain a violation of this Act (or a regulation promulgated thereunder).
(b) Trial - In a case in which violation of an injunction or restraining order issued under this
section also constitutes a violation of the food safety law, trial shall be by the court or, upon

demand of the accused, by a jury.

SEC. 25. Civil and Criminal Penalties. —
(a) Civil Sanctions -
(1) Civil Penalty -
(A) In General - Any person that commits an act that violates the food safety law
(including a regulation promulgated or order issued under the food safety law) may be
assessed a civil penalty by the Administrator of not more than $1,000,000 for each such
act.
(B) Separate Offense - Each act described in subparagraph (A) and each day during
which that act continues shall be considered a separate offense.
(2) Other Requirements ~
(A) Written Order - The civil penalty described in paragraph (1) shall be assessed by the
Administrator by a written order, which shall specify the amount of the penalty and the
basis for the penalty under subparagraph (B) considered by the Administrator.
(B) Amount Of Penalty - Subject to paragraph (1)(A), the amount of the civil penalty
shall be determined by the Administrator, after considering —
(i) the gravity of the violation;
(ii) the degree of culpability of the person;
(iii) the size and type of the business of the person; and
(iv) any history of prior offenses by the person under the food safety law.
(C) Review of Order - The order may be reviewed only in accordance with subsection
©.
(b) Criminal Sanctions -

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(1) Offense Resulting in Serious Hlness - If an adulterated or misbranded food results in
serious illness, the person committing the violation shall be imprisoned for not more than 5
years, with appropriate fines.

(2) Offense Resulting in Death - If an adulterated or misbranded food results in death, the
person committing the violation shall be imprisoned for not more than 10 years, with
appropriate fines.

(c) Remedies Not Exclusive - The remedies provided in this section are in addition to, and not

exclusive of, other remedies that may be available.

SEC. 26. Citizen Civil Actions. -

(a) Civil Actions - A person may commence a civil action against
(1) a person that violates a regulation (including a regulation establishing a performance
standard), order, or other action of the Administrator to ensure the safety of food; or
(2) the Administrator (in his or her capacity as the Administrator), if the Administrator fails
to perform an act or duty to ensure the safety of food that is not discretionary under the food
safety law.

(b) Court - In an action commenced under this section:
(1) In General - The action shall be commenced--

(A) in the case of a civil action against a person, the Philippines municipal trial court for
the city or municipality in which the defendant resides, is found, or has an agent; and
(B) in the case of a civil action against the Administrator, any municipal trial court.
2) Jurisdiction - The court shall have jurisdiction, without regard to the amount in
controversy, or the citizenship of the parties, to enforce a regulation (including a regulation
establishing a performance standard), order, or other action of the Administrator, o to order
the Administrator to perform the act or duty.
(3) Damages - The court may —
(A) award damages, in the amount of damages actually sustained; and
(B) if the court determines it to be in the interest of justice, award the plaintiff the costs of
suit, including reasonable attorney’s fees, reasonable expert witness fees, and penalties.
(©) Remedies Not Exclusive -°The remedies provided for in this section shall be in
addition to, and not exclusive of, other remedies that may be available.

CHAPTER VI. IMPLEMENTATION
SEC. 27. Reorganization Plan. ~
(a) Submission of Plan - Not later than 180 days after the enactment of this Act, the President
shall transmit to the appropriate congressional committees a reorganization plan regarding the
following:

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(1) The transfer of agencies, personnel, assets, and obligations to the Administration pursuant
to this Act.
(2) Any consolidation, reorganization, or streamlining of agencies transferred to the
Administration pursuant to this Act.
(b) Plan Elements - The plan transmitted under subsection (a) shall contain, consistent with this
Act, such elements as the President determines appropriate, including the following:
(1) The timetable for transfer and identification of any functions of agencies designated to be
transferred to the Administration pursuant to this Act that will not be transferred promptly to
the Administration under the plan.
(2) Specification of the steps to be taken by the Administrator to organize the Administration,
including the delegation or assignment of functions transferred to the Administration among
the officers of the Administration in order to permit the Administration to carry out the
functions transferred under the plan.
(3) Specification of the funds available to each agency that will be transferred to the
Administration as a result of transfers under the plan.
(4) Specification of the proposed allocations within the Administration of unexpended funds
transferred in connection with transfers under the plan.
(5) Specification of any proposed disposition of property, facilities, contracts, records, and
other assets and obligations of agencies transferred under the plan.
(6) Specification of the proposed allocations within the Administration of the functions of the
agencies and subdivisions that are not related directly to ensuring the safety of food.
(©) Modification of Plan - The President may, on the basis of consultations with the appropriate
congressional committees, modify or revise any part of the plan until that part of the plan
becomes effective in accordance with subsection (d).
(@ Effective Date -
(1) In General - The reorganization plan described in this section, including any
modifications or revisions of the plan under subsection (c), shall become effective for an
agency on the earlier of —
(A) the date specified in the plan (or the plan as modified pursuant to subsection (c)),
except that such date may not be earlier than 90 days after the date the President has
transmitted the reorganization plan to the appropriate congressional committees pursuant
to subsection (a); or
(B) the end of the 12-month period beginning on the date of the enactment of this Act.
(2) Statutory Construction - Nothing in this subsection may be construed to require the
transfer of functions, personnel, records, balances of appropriations, or other assets of an
agency on a single date.

SEC. 28. Transitional Authorities. —

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(a) Provision of Assistance by Officials - Until the transfer of an agency to the Administration,
any official having authority over or function relating to the agency immediately before the date
of the enactment of this Act shal! provide the Administrator such assistance, including the use of
personnel and assets, as the Administrator may request in preparing for the transfer and
integration of the agency to the Administration.
(b) Services and Personnel - During the transition period, upon the request of the Administrator,
the head of any executive agency may provide services or detail personnel to assist with the
transition,
(©) Acting Officials -
(1) In General - During the transition period, pending the advice and consent of the Senate to
the appointment of an officer required by this Act to be appointed by and with such advice
and consent, the President may designate any officer whose appointment was required to be
made by and with such advice and consent and who was such an officer immediately before
the date of the enactment of this Act (and who continues to be in office) or immediately
before such designation, to act in such office until the same is filled as provided in this Act.
(2) Compensation - While acting pursuant to paragraph (1), such officers shall receive
‘compensation at the higher of--
(A) the rates provided by this Act for the respective offices in which they act; or
(B) the rates provided for the offices held at the time of designation.
(3) Limitation - Nothing in this Act shall be construed to require the advice and consent of
the Senate to the appointment by the President to a position in the Administration of any
officer whose agency is transferred to the Administration pursuant to this Act and whose
duties following such transfer are germane to those performed before such transfer,
(d) Transfer of Personnel, Assets, Obligations, and Function -
(1) In General - The personnel, assets, liabilities, contracts, property, records, and
unexpended balances of appropriations, authorizations, allocations, and other funds that
relate to the functions transferred under subsection (a) from a local agency shall be
transferred to the Administration.
(2) Unexpended Funds - Unexpended funds transferred under this subsection shall be used by
the Administration only for the purposes for which the funds were originally authorized and
appropriated.

SEC. 29. Savings Provisions. —
(a) Completed Administrative Actions - The enactment of this Act or the transfer of functions
under this Act shall not affect any order, determination, rule, regulation, tolerance, guidance,
permit, personnel action, agreement, grant, contract, certificate, license, registration, user fees,
privilege, or other administrative action issued, made, granted, or otherwise in effect or final with

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respect to that agency on the day before the transfer date with respect to the transferred
functions.
(b) Pending Proceedings - Subject to the authority of the Administrator under this Act--
(1) pending proceedings in an agency, including notices of proposed rulemaking, and
applications for licenses, permits, certificates, grants, and financial assistance, shall continue
notwithstanding the enactment of this Act or the transfer of the ageney to the Administration,
unless discontinued or modified under the same terms and conditions and to the same extent
that such discontinuance or modification could have occurred if such enactment or transfer
had not occurred; and
(2) orders issued in such proceedings, and appeals therefrom, and payments made pursuant to
such orders, shall issue in the same manner on the same terms as if this Act had not been
enacted or the agency had not been transferred, and any such order shall continue in effect
until amended, modified, superseded, terminated, set aside, or revoked by an official of the
Philippines or a court of competent jurisdiction, or by operation of law.
(©) Pending Civil Actions - Subject to the authority of the Administrator under this Act, any civil
action commenced with regard to that agency pending before that agency on the day before the
transfer date with respect to the transferred functions shall continue notwithstanding the
enactment of this Act or the transfer of an agency to the Administration.
(@) References -
(1) In General - After the transfer of functions from a local agency under this Act, any
reference in any other national law, Executive order, rule, regulation, directive, document, or

other material to that local agency or the head of that agency in connection with the

administration or enforcement of the food safety law shall be deemed to be a reference to the
Administration or the Administrator, respectively.

(2), Statutory Reporting Requirements - Statutory reporting requirements that applied in
relation to such an agency immediately before the date of the enactment of this Act shall
continue to apply following such transfer if they refer to the agency by name.

SEC. 30. Funding. - The amount necessary for the effective implementation of this Act
shall be charged to the appropriations for the DOH under the current General Appropriations
Act (GAA). Thereafter, such sum as may be necessary for the continued implementation of
this Act shall be included in the annual GAA.

SEC. 31. Implementing Rules. — The Secretary of the DOH shall issue the pertinent rules

with regard to this Act, including but not limited to the application for, termination of,

suspension and lifting of suspension of the Program.

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1 SEC. 32. Separability Clause. — If any provision or part hereof is held invalid or

2 unconstitutional, the remainder of the law or the provision not otherwise affected shall remain

3 valid and subsisting.

4

5 SEC. 33. Repealing Clause. — Any law, presidential decree or issuance, executive order,

6 letter of instruction, administrative order; rule or regulation contrary to, or inconsistent with, the

7 provisions of this Act, is hereby repealed, modified, or amended accordingly.

8

9 SEC. 34. Effectivity Clause. ~ This Act shall take effect fifteen (15) days after its
10 complete publication in the Official Gazette or in at least two (2) newspapers of general
11 circulation.

Approved,

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