FIFTEENTH CONGRESS OF THE REPUBLIC 
) 
OF THE PHILIPPINES 
) 
First Regular Session 
) 
,c P"'24 
It) 
jut t,) 
;..: 
0 •• 
SENl\l:e. 
S.No. 
1471 
/'" / 
Introduced by Senator Miriam Defensor s~;a~~VtD HV' ty" __ ·h. 
EXPLANATORY NOTE 
The Constitution, Article 2, Section 15 provides that: 
The State shall protect and promote the right to health of 
the people and instill health consciousness among them. 
Persons who produce or process food for human consumption have the responsibility to 
prevent or minimize food safety hazards related to their products. They should ensure that all 
fully processed or ready-to-eat food are processed in a sanitary manner in order to eliminate 
human pathogens or other potentially harmful substances likely to cause food-borne illness. 
Hence, this bill seeks to establish a comprehensive program for the purpose of protecting 
human health, by ensuring that the food industry has effective programs in place to assure the 
safety of food products consumed in the Philippines. 
, Lw~ 4h·~~ :2Y~ 
f).fot MIRIAM DEFE~SOR SA-NTIA,O-
I 


FIFTEENTH CONGRESS OF THE REPUBLIC 
) 
OF THE PHILIPPINES 
) 
First Regular Session 
) 
• 
SEN~i7 
S.No. 
1 
1 
~. - f 
10 
JUL 15 P2 :24 
. nf:C"iVFO fI'f . 
Introduced by Senator Miriam Defensor Santiago 
1 
AN ACT 
2 
TO ESTABLISH A COMPREHENSNE PROGRAM TO ENSURE THE SAFETY OF 
3 
FOOD PRODUCTS INTENDED FOR HUMAN CONSUMPTION 
Be it enacted by the Senate and the House of Representatives of the Philippines in 
Congress assembled: 
4 
SECTION 1. Short Title. - This Act shall be known as the "Consumer Food Safety Act." 
5 
SECTION 2. Definitions. - For purposes of this Act: 
6 
(A) The term "contaminants" includes bacteria, chemical contaminants, natural toxins, 
7 
viruses, parasites, and physical hazards that when found on or in food can cause human illness or 
8 
injury. 
9 
(B) The term "facility" shall include any factory, warehouse establishment, or importer 
10 
that handles or processes food. 
11 
(C) The term "process" means the harvesting, preparations, manufacture, and 
12 
transportation of food products. 
13 
(D) the term "Secretary" means the Secretary of Health. 
14 
TITLE I - NATIQNAL FOOD SAFETY PROGRAM 
15 
SECTION 3. Administration of National Program. - (A) IN GENERAL - (1) Persons 
16 
who produce or process food for human consumption have the responsibility to prevent or 
17 
minimize food safety hazards related to their products. The Secretary shall administer a national 
18 
program for the purpose of protecting human health by ensuring that the food industry has 
19 
effective programs in place to assure the safety of food products consumed in the Philippines. 
20 
(2) The program shall -
1 


1 
(a) be based on a comprehensive analysis of the hazards associated with different 
2 
food products and with the harvesting, processing and handling of different food 
3 
products, including the identification and evaluation of -
4 
(i) the severity of the potential health risks; 
5 
(ii) the sources and specific points of potential contamination that may render 
6 
food products unsafe for human consumption; and 
7 
(iii) the potential for persistence, multiplication or concentration of naturally 
8 
occurring or added contaminants in foods and food products; 
9 
(iv) take into consideration the distinctive characteristics of food production 
10 
and processing; 
11 
(v) establish inspectiop and oversight procedures to monitor that facilities are 
12 
utilizing preventive controls to minimize or eliminate identifiable hazards; and 
13 
(vi) require each food processing facility to annually register with the 
14 
Secretary. 
15 
(B) PROGRAM ELEMENTS - The program shall provide for: (1) implementation of a 
16 
national system for the registration and quarterly inspection of facilities and importers. Quarterly 
17 
inspections can be waived by plants that meet the Secretary's standards for exceptional or 
18 
negligible-risk facilities or importers; 
19 
(2) development of a progr;un to oversee the implementation of process controls in 
20 
food processing facilities; 
21 
(3) the establishment and enforcement of health-based standards for (a) substances 
22 
which may contaminate food; and (b) safety and sanitation in the processing and in food 
23 
processing facilities; 
24 
(4) implementation of a sampling program to ensure that industry programs to 
25 
prevent food contamination are effective and that food products meet the standards 
26 
established in paragraph (1); 
27 
(5) implementation of procedures and requirements to ensure the safety of imported 
28 
food products; 
2 


1 
(6) coordination with other agencies in carrying out inspection, enforcement, and 
2 
monitoring; 
3 
(7) implementation of a national surveillance system to access the health risks 
4 
associated with the human consumption of food products, in cooperation with the 
5 
Secretary of Agriculture; 
6 
(8) development of public education and advisory programs; and 
7 
(9) implementation of a research program in furtherance of the purposes of this Act. 
8 
SECTION 4. Registration of Processors and Importers. - (A) IN GENERAL - Any 
9 
facility engaged in processing of food products and any person who imports food products shall 
10 
register with the Secretary. Application for registration shall be made to the Secretary using such 
II 
forms and containing such informatiorr as the Secretary shall prescribe by regulation within 
12 
twenty-four (24) months after the date of enactment of this Act. Upon receipt and review of a 
13 
completed application, the Secretary shall issue to the applicant a certificate of registration unless 
14 
good cause is shown why such applicati~n should be denied. The Secretary shall promptly notify 
15 
any applicant of such denial, include written explanation of the reasons for such denial, and 
16 
provide an opportunity for a hearing or reapplication upon request. 
17 
(B) SUSPENSION OF REGISTRATION -
18 
(1) The registration may be suspended immediately by the Secretary for -
19 
(a) failure to permit aocess for inspection under this Act; 
20 
(b) violation of this Act or regulation issued under this Act, where the Secretary 
21 
determines that such Suspension is likely to prevent a significant risk of adverse 
22 
health consequences; 
23 
(c) conviction of the applicant of registrant of-
24 
(i) any felony other than a felony based upon the acquiring, handling, or 
25 
distribution of adulterated or misbranded food; or 
26 
(ii) more than one violation of any law other than a violation involving any 
27 
fraud in connection with transactions in food. 
3 


I 
(2) Any registration suspended under paragraph (1) may be restricted whenever the 
2 
Secretary determines that suspension is no longer necessary. 
3 
(C) EXEMPTION AUTHORITY - The Secretary may by regulation exempt classes of 
4 
facilities from the requirements of paragraph (A) if the Secretary determines that the registration 
5 
of such facilities or persons is not needed for effective enforcement of this Act. 
6 
SECTION 5. Process Controls To Reduce The Adulteration of Food Products. -
7 
(A) IN GENERAL - The Secretary shall, upon the basis of the best available scientific 
8 
and technological data, prescribe regulations to-
9 
(1) limit the presence of human pathogens and other potentially harmful substances 
lOin food products; 
11 
(2) ensure that all registered facilities implement appropriate measures to control 
12 
and reduce the presence and growth of human pathogens and other potential substances 
13 
on food products; 
14 
(3) ensure that all fully processed or ready-to-eat food products are processed in a 
15 
sanitary manner, using reasonably available techniques and technologies to eliminate any 
16 
human pathogens or other potentially harmful substances likely to cause food-borne 
17 
illness; and 
18 
(4) ensure that food products intended for final processing outside commercial 
19 
establishments are labelled with instructions for handling and preparation for 
20 
consumption which, when adhered to, will destroy any human pathogens or other 
21 
potentially harmful substances likely to cause food-borne illness. 
22 
(B) REG{]LATIONS - The Secretary shall, within one (1) year of the enactment of this 
23 
Act, issue regulations that require all registered facilities to adopt processing controls adequate to 
24 
protect public health and to limit the presence and growth of human pathogens and other 
25 
potentially harmful substances in food products prepared in any registered facility. Such 
26 
regulations shall-
27 
(1) set standards for sanitation; 
28 
(2) set tolerances for biological, chemical and physical hazards as appropriate; 
4 


1 
(3) require process controls to assure that food is safe and that relevant regulatory 
2 
and safety standards are met; 
3 
(4) require record-keeping to'monitor compliance; 
4 
(5) require sampling to assure that processing controls are effective and that 
5 
regulatory standards are being met; and 
6 
(6) provide for agency access to records kept by official establishments and 
7 
submission of copies of such records to the Secretary as tbe Secretary deems appropriate. 
8 
The Secretary may, as the Secretary deems necessary, require any person, finn or 
9 
corporation with responsibility for or control over food ingredients to adopt processing 
10 
controls, where such processing controls are needed to assure the protection of public 
11 
health. 
12 
SECTION 6. Inspections of Processors and Importers. -
(A) NATURE OF 
13 
INSPECTIONS-
14 
(1) The inspection system shall provide for frequent unannounced inspections of 
15 
food processing and importing facilities to detern1ine if such facilities are operated in a 
16 
sanitary manner and if food proqucts are unsafe for human consumption, or adulterated or 
17 
misbranded. Inspection shall include review of processing records and sample. 
18 
(2) Inspections shall be conducted at least quarterly, unless tbe Products detennines 
19 
that the facility, is an exceptional or negligible-risk facility under standards established 
20 
by the Secretary. 
21 
(3) Standards for exceptional or negligible-risk facilities shall consider the hazards 
22 
associated with the type of product being produced; and the facility's history of 
23 
compliance, food safety problems and such other factors as the Secretary may deem 
24 
appropriate. The Secretary shall specify an alternative inspection frequency for each 
25 
facility which is deemed exceptional or negligible risk. Each inspection shall include an 
26 
examination of whether the facility continues to meet the standards for exceptional or 
27 
negligible-risk facilities. 
28 
(B) CONDUCT OF INSPECTIONS -
5 


1 
(1) An inspection under subsection (1) of any domestic, foreign or importing facility 
2 
shall extend to all things therein (including records required to be maintained under 
3 
subsection (5), processes, controls, and premises) that bear on weather, food products are 
4 
in compliance with this Act. Access to records may include the copying of such records. 
5 
(2) In conducting such inspections, officers or employees duly designated by the 
6 
Secretary, upon presenting appropriate credentials to the owner, operator or agent in 
7 
charge, are authorized-
8 
(a) to enter at reasonable times any facility in which persons are engaged in the 
9 
food processing or importing of food products, or to enter any vehicle being used to 
10 
transport or ho ld such food products; 
11 
(b) to inspect in a reasonable manner such facility or vehicle and all pertinent 
12 
equipment, finished and unfinished materials, containers, labelling, processes, 
13 
controls, and premises; and 
14 
(c) to collect and retain samples of food products or ingredients or of any other 
15 
items found during an inspection that may contribute to a finding of whether such 
16 
food products are unsafe for human consumption or adulterated or misbranded. 
17 
(3) Immediately after completion of inspection, the officer or employee making the 
18 
inspection shall give to the owner, operator, or agent in charge a report in writing setting 
19 
forth any conditions or practices observed which indicate that either processing controls 
20 
are inadequate to prevent or minimize food safety hazards or that any food from such 
21 
facility is unsafe for human consumption, or adulterated or misbranded. 
22 
(C) PRODUCT DETENTION AND CONDEMNATION 
23 
(1) If, during an inspection conducted under this section, an officer or employee 
24 
making the inspection has reason to believe that a food product is unsafe for human 
25 
consumption, or adulterated or misbranded, such officer or employee may order the food 
26 
product segregated, impounded, and if objection is not made within 48 hours, 
27 
condemned. If objection is made, such food products that are in perishable form may be 
28 
processed to the extent necessary to prevent spoilage, and a hearing shall be commenced 
29 
expeditiously. 
6 


1 
(2) if the Secretary detennines that, through re-Iabelling or other action, such food 
2 
products can be brought into compliance with this Act, the food may be released 
3 
following a detennination by the Secretary that such re-labelling or other action as 
4 
specified by the Secretary has been perfonned. 
5 
(3) Any food product condemned without objection, or after hearing and judicial 
6 
review, shall be destroyed under s'upervision of the Secretary. 
7 
(D) OFFICIAL MARK - The Secretary shall prescribe by regulation the conditions under 
8 
which any food product shall display an official mark, when needed to facilitate exports, that 
9 
signifies that the food product has been p;rocessed in accordance with standards approved by the 
10 
. Secretary. Such a mark may be subject to a fee. 
11 
(E) MAINTENANCE OF RECORDS - Each facility or person registered under this 
12 
section shall maintain and make available for inspection by the Secretary such records as the 
13 
Secretary may prescribe. Such records shall be maintained for a reasonable period of time as 
14 
detennined by the Secretary. The recdrds shall include, but are not limited to, infonnation 
15 
concerning -
16 
(1) the origin, receipt, delivery, sale, movement, holding, and disposition of food 
17 
products or ingredients; the identity and amount of ingredients used in the food; the 
18 
processing of the food; the results of laboratory, sanitation, or other quality control tests 
19 
perfonned on the food or in the facility; consumer complaints concerning the food or its 
20 
packaging; and 
21 
(2) other matters reasonably related to whether food products may be unsafe for 
22 
human consumption, or adulterated or misbranded. 
23 
SECTION 7. Tolerance for Contaminants in Food. -
24 
(A) TOLERANCES - The Secretary shall establish tolerances limiting the quantity of 
25 
contaminants that, when found in food products, may render such products unsafe for human 
26 
consumption. Contaminants include, but are not limited to bacteria, chemical contaminants, 
27 
natural toxins, viruses and parasites that when found on or in food can cause human illness. Such 
28 
tolerances may include indicators (including indicator organisms) from which it may reasonably 
7 


1 
be inferred that a contaminant is present in a food product. In developing a tolerance, the 
2 
Secretary shall take into account the extent to which consumers may be exposed to such 
3 
contaminant from sources other than food, and the extent to which such contaminant can be 
4 
avoided or minimized in the commercial handling and processing of such food. 
5 
(B) REGULATIONS - (1) The Secretary, after notice and an opportunity for comment, 
6 
shall promulgate regulations to implement paragraph (A) within forty-eight (48) months after the 
7 
date of enactment of this Act. In promulgating such regulations, the Secretary shall establish for 
8 
the contaminants that the Secretary determines are having the greatest public health impact6 as 
9 
early as feasible after implementation of this Act. 
10 
(2) A tolerance established under this section shall be based on -
11 
(a) a scientific analysis of the health risks attributable to the contaminant for which 
12 
the tolerance is established; and 
13 
(b) analysis of the risk for sensitive groups, such as children, elderly, pregnant 
14 
women and the immune compromised. 
15 
(3) The Secretary shall, in a timely manner, issue revisions to the regulations under 
16 
paragraph (A) which take into account new information. 
17 
(C) REPORT - The Secretary shall report to the Congress on the progress of the 
18 
Secretary in establishing tolerances under this section. The report shall include a description of 
19 
the research that has been conducted with respect to such tolerances and the research that must 
20 
be conducted before additional tolerances, a timetable for the establishment of such tolerances, 
21 
and the estimated cost, including costs of research, associated with the establishment of such 
22 
tolerances. The report shall be transmitt<:d on or about the end of 18th month after the date of the 
23 
enactment of this Act, and biennially thereafter during the 6-year period that begins on such date 
24 
of enactment. 
25 
SECTION 8. Imports. - (A) ROLE OF SECRETARY - Within twenty-four (24) months 
26 
after the date of enactment of this Act, the Secretary shall establish and administer a 
27 
comprehensive and efficient system to ensure the safety of food imported into the Philippines. 
28 
The Secretary shall routinely inspect processing facilities in exporting nations and imports at 
8 


1 
ports of entry into the country. The Secretary shall assure the effective operation; through 
2 
verification and other activities, as the Secretary considers necessary. 
3 
(B) IMPORT REQUIREMENTS' - (1) No food product may enter the Philippines, or be 
4 
withdrawn from a warehouse, for consumption in the Philippines if such food product -
5 
(a) appears unsafe for human consumption, or adulterated or misbranded; 
6 
(b) is not marked or labelled as required by regulations for domestic or imported 
7 
articles; or 
8 
(c) does not comply with the requirements of this Section. 
9 
(2) Upon entry for consumption in the Philippines, food products that are not 
10 
prohibited from entry or from withdrawal from a warehouse under paragraph (A) shall be 
11 
deemed to be treated as domestio food products, except that all labelling of such products 
12 
shall clearly identify the country of origin to facilitate the identification of products 
13 
linked to outbreaks of illness. 
14 
(C) INSPECTION OF IMPORTS - (1) Food products that are offered for importation, 
15 
or withdrawn from a warehouse, for consumption in the Philippines, shall be subject to 
16 
examinations inspections, sampling, and such other procedures at the port of entry or in the 
17 
exporting nation by officers or employees duly designated by the Secretary. Such procedures 
18 
shall be conducted with such frequency and in such manner as the Secretary may prescribe by 
19 
regulation. 
20 
(2) Food products from a nation that is certified for such food products under 
21 
subsection (E) (3) shall be subject to random examinations, inspection, sampling, and 
22 
other procedures. Food products !yom a nation that is not certified for such food products 
23 
under subsection (E) (3) shall be subject to such intensified examinations, inspection, 
24 
sampling, and other verification procedures, including inspection in the country of origin, 
25 
as the Secretary determines are necessary to ensure compliance with this Act. 
26 
(D) DETENTION OF IMPORTED FOOD PRODUCT- If during an inspection or other 
27 
verification procedures came out under this section, an officer or employee conducting the 
28 
procedure has reason to believe that a food product is unsafe for human consumption, or 
29 
adulterated or misbranded, such officer or employee may order the food product segregated, 
9 


I 
impounded, and if objection is not made within 48 hours, condemned. If objection is made, such 
2 
food products that are in perishable form may be processed to the extent necessary to prevent 
3 
spoilage, and a hearing shall be commenced expeditiously. The final condemnation or other 
4 
disposition of such food product shall be subject to the provisions of this Act. 
5 
(E) AGREEMENTS WITH FOREIGN NATIONS- (I) The Secretary may enter into an 
6 
agreement with any nation desiring to export food products to the Philippines. Prior to 
7 
concluding such an agreement, the Secretary shall evaluate the food safety program of the 
8 
foreign nation to determine if such program provides at least the same level of protection, with 
9 
respect to food products intended for export to the Philippines, as domestic laws that affect the 
10 
safety of the food supply. In such evaluation, the Secretary shall consider: 
11 
(a) the potential for health, ~anitary, enviromnenta1, or other conditions within the 
12 
foreign nation to adversely affect the safety of food products exported from such nation; 
13 
and 
14 
(b) how well the food safety programs of the foreign nation functions to minimize 
15 
any adverse effects on such safety 
16 
(2) Any agreement under this subsection with a nation desiring to export food products 
17 
to the Philippines shall-
18 
(a) require that the exporting nation sha11-
19 
(i) establish and maintain a food safety system that is adequate to ensure that the 
• 
20 
food products intended for export to the Philippines are safe for human consumption, and 
21 
not adulterated or misbranded; and 
22 
(ii) promptly notify the Secretary of any violations affecting the safety of food 
23 
products exported or intended for export to the Philippines; 
24 
(b) provide for such activities (whether in the exporting nation or at the port of entry 
25 
during importation) by the Secretary, including examinations, inspections, sampling and testing, 
26 
at such stages in the growth or harvest of food, or in the processing or handling of food products, 
27 
as the Secretary considers appropriate to ensure that the food safety program of the exporting 
28 
nation continues to provide at least the same level of protection, with respect to food products 
10 


1 
intended for export to the Philippines, as domestic laws that affect the safety of the food supply; 
2 
and 
3 
(c) provide for reciprocity with respect to the treatment of food imports and exports 
4 
between the Philippines and the exporting nation. 
5 
(3) If the Secretary determines that a nation desiring to export food products to the 
6 
Philippines has a program that provides at least the saline level of protection, with respect to 
7 
food products intended for export to the Philippines, as domestic laws that affect the safety of the 
8 
food supply, the Secretary shall, upon entry into force of an agreement under subsection (E) (I), 
• 
9 
certify the types of food products for which the nation maintains such a program. 
10 
(4) The Secretary shall periodically or for good cause, and not less than once every three 
11 
years, review certifications made under paragraph (3), and shall revoke the certification of any 
12 
nation that the Secretary determines is not maintaining a food safety program that provides at 
13 
least the same level of protection, with respect to food products intended for export to the 
14 
Philippines, as domestic laws that affect the safety ofthe food supply. 
15 
(5) The Secretary shall review and modify, as needed, an agreement made under 
16 
paragraph (1) with any nation whose certification has been revokes under subparagraph (i) of this 
17 
paragraph. 
18 
TITLE II-RESEARCH AND EDUCATION 
19 
SECTION 9. Public Health Assesliment System. - (A) PUBLIC HEALTH SAMPLING-
20 
(1) Within twelve (12) months after the date of enactment of this Act, the Secretary in 
21 
cooperation with the Secretary of Agriculture shall establish guidelines for a sampling system 
22 
under which the Secretary of Agriculture shall take and analyze samples of food products to 
23 
assist the Secretary in carrying out this Act and to more accurately assess the nature, frequency 
24 
of occurrence and amounts of contaminants in food products. 
25 
(2) Such sampling system shall provide-
26 
(a) statistically valid monitoring, including market-basket studies, on the nature, 
27 
frequency of occurrence, and a)llounts of contaminants in food products available to 
28 
consumers; and 
11 


I 
(b) at the request of the Secretary, such other information, including may analysis of 
2 
monitoring and verification samples, as the Secretary determines be useful in assessing 
3 
the occurrence of contaminants in food products. 
4 
(B) ASSESSMENT OF HEALTH HAZARDS - Through the surveillance system referred 
5 
to in subsection (A) (1) and the sampling system described in subsection (A) (2), the Secretary 
6 
shall rank food categories based on their hazard to human health and identify appropriate 
7 
industry and regulatory approaches to minimize hazards in the food supply. Such analysis could 
8 
include-
9 
(I) the safety of commercial harvesting and processing, as compared with the health 
10 
hazards associated with food products that are harvested for recreational or subsistence 
II 
purposes and prepared non-commercially; 
12 
(2) the safety of food products that are domestically harvested and processed, as 
13 
compared with the health hazards associated with food products that are harvested or 
14 
processed outside ofthe Philippines; and 
IS 
(3) contamination originating form handling practices that occur prior to or after the 
16 
sale of food products to consumers . 
• 
17 
SECTION 10. Public Education and Advisory System. -
18 
(A) PUBLIC EDUCATION. - The Secretary, in cooperation with private and public 
19 
organizations, shall design and implement a national public education program on food safety. 
20 
The program shall provide -
21 
(I) information to the public regarding standards and good practice require a 
22 
national public education program on food safety, promotion of public awareness 
23 
understanding, and acceptance of such standards and requirements; 
24 
(2) information to health professionals so that the may improve diagnosis and 
25 
treatment of food-related illness and advise individuals whose health conditions place 
26 
them in particular risk; and 
27 
(3) such other information,or advice to consumers and other persons as the Secretary 
28 
determines will promote the purposes of this Act. 
12 


1 
(B) HEALTH ADVISORIES-The Secretary, in consultation with the Secretary of 
2 
Agriculture and the Secretary of Enviroument and Natural Resources, shall work to-
3 
(1) develop and distribute regional and national advisories concerning food safety; 
4 
and 
5 
(2) develop standardized formats for written and broadcast advisories. 
6 
SECTION 11. Research. - (A) IN GENERAL. - The Secretary shaH conduct research to 
7 
assist in the implementation of this Act, including studies to-
8 
(1) improve sanitation and food safety practices in the processing of food products; 
9 
(2) develop improved techniques for the monitoring of food and inspection of food 
10 
products; 
11 
(3) develop efficient, rapid, and sensitive methods for determining and detecting the 
12 
presence of contaminants in food products; 
13 
(4) determine the sources of contamination of food and food products with 
14 
contaminants; and 
15 
(5) develop consumption date with respect to food products. 
16 
(B) CONTRACT AUTHORITY- The Secretary is authorized to enter into contracts and 
17 
agreements with the University of the Philippines or any state university or any other university, 
18 
other govenunent agencies or other persons to carry out the activities under this Section. 
19 
TITLE III-ENFORCEMENT 
20 
SECTION 12. Notification and Recall. -
(A) NOTICE TO SECRETARY OF 
21 
ADULTERATION OR MISBRANDNG. - Any person (other than a household consumer or 
22 
other individual who is intended consumer of an article of food) that has a reasonable basis for 
23 
believing that any article of food introduced into or in interstate commerce, or held for sale 
• 
24 
(whether or not the first sale) after shipment in interstate commerce, may be adulterated or 
25 
misbranded, or otherwise be in violation of appropriate laws shall immediately notify the 
26 
Secretary, in such marmer and by such means as the Secretary may by regulation prescribe, or 
27 
the identity and location of such article. 
13 


1 
(B) 
RECALL 
AND 
CONSUMER 
NOTIFICATION 
(1) 
VOLUNTARY 
2 
PROCEDURES - If the Secretary finds, upon notification under subsection (A) or othenvise, that 
3 
any article of food is adulterated or misbranded when introduced into or while held for sale 
4 
(whether or not for first sale) after shipment in interstate commerce and there is a reasonable 
5 
probability that such article, if consumed, would present a threat to public health, as determined 
6 
by the Secretary shall provide the appropriate persons (including the manufacturers, importers, 
7 
distributors, or retailers) with an opportunity to -
8 
(a) cease distribution of such articles; 
9 
(b) notify all persons-
10 
(i) producing, manufacturing, packing, processing, preparing, treating, 
11 
packaging, distributing, or holding such article; or 
12 
(ii) to which such article has been distributed, transported, or sold, to 
13 
immediately cease distribution of such article; or 
14 
( c) recall such article; 
15 
(d) provide, in consultation with the Secretary, notice to consumers to whom such 
16 
article was, or may have been, distributed; or 
17 
(e) take any combination of the above measures, as appropriate in the circumstances. 
18 
(2) PRE-HEARING ORDER TO CEASE DISTRIBUTION AND GIVE NOTICE - If 
19 
such person reuses to or does not voluntarily cease distribution, make notification, recall such 
20 
article, or provide notice to consumers, as applicable, within the time and in the manner 
21 
prescribed by the Secretary, the Secretary shall, by order, require, as the Secretary deems 
22 
necessary, such persons to -
23 
(a) immediately cease distribution of such articles; 
24 
(b) immediately notify all persons-
25 
26 
27 
28 
(i) producing, 
man~facturing, packing, processing, preparing, treating, 
packaging, distributing, or holding such article; or 
(ii) to which such article has been distributed, transported, or sold, to 
immediately cease distribution of such article; or 
14 


1 
(iii) immediately take the actions specified in both subparagraphs (B)(1) and (B) 
2 
(2). 
3 
(3) NOTIFICATION OF CONSUMERS BY SECRETARY - The Secretary shall, as the 
4 
Secretary deems necessary, provide notice to consumers to whom such article was, or may have 
5 
been, distributed. 
6 
(4) HEARING ON ORDER - The Secretary shall provide any person subject to an order 
7 
under subsection (b) with an opportunity for a hearing, to be held s soon as possible but not later 
8 
than 2 days after the issuance of the order, on the action ,required by the order and on why the 
9 
article that is the subject of the order should not be recalled. 
10 
(5) POST-HEARING RECALL ORDER-
II 
(a) AMENDMENT OF ORDER - If, after providing opportunity for a hearing 
12 
under subsection (3), the Secretary determines that there is a reasonable probability that 
13 
the article that is the subject of an order under subsection (2), if consumed, presents a 
14 
threat to public health, the Secretary, as the Secretary deems necessary, may-
15 
(i) amend the order to require recall of such article or other appropriate action; 
16 
(ii) specify a timetable in which the recall shall occur; 
17 
(iii) require periodic reports to the Secretary describing the progress of the 
18 
recall; and 
19 
(iv) provide notice to consumers to whom such article was, or may have been, 
20 
distributed. 
21 
(b) VACATION OF ORDER - If, after such a hearing, the Secretary determines that 
22 
the adequate grounds do not exist to continue the actions required by the order, the 
23 
Secretary shall vacate the order. 
24 
(c) REMEDIES NOT EXCLUSIVE - The remedies provided in this section shall be 
25 
in addition to and not exclusive of other remedies that may be available. 
26 
SECTION 13. Civil Penalties.-
27 
(A) IN GENERAL. - (1) ACTS SUBJECT TO PENALTY; PENALTY AMOUNT. -
28 
Any person that commits and act that violates this Act may be assessed a civil penalty by the 
15 


1 
Secretary, subject to review in accordance with the administrative code and - other pertinent 
2 
laws, of not more than One Hundred Thousand Pesos (PlOO,OOO.OO) for such act. Each such act 
, 
3 
and each day during which such act continues shall be a separate offense. 
4 
(2) NOTICE AND HEARING - No penalty shall be assessed by the Secretary under this 
5 
section unless such person is given notice and opportunity for a hearing on the record before the 
6 
Secretary in accordance with laws pertinent to administrative proceedings. 
7 
(3) OTHER REQUIREMENTS - The amount of such civil penalty shall be assessed by 
8 
the Secretary by written order, taking into account the gravity of the violation, degree of 
9 
culpability, size and type of business, and any history of prior offenses; 
10 
(B) COLLECTION ACTIONS - If any person fails to pay an assessment of a civil 
11 
penalty after it has become a final and unappealable order, the Secretary shall refer the matter to 
12 
the Solicitor General, who shall institute a civil action to recover the amount. In such collection 
13 
actins, the validity and appropriateness of the Secretary's order imposing the civil penalty shall 
14 
not be subject to review. 
15 
(C) SECRETARY'S DISCRETION TO PROSECUTE - Nothing in this Act shall be 
16 
construed as requiring the Secretary to report for prosecution, or for the institution of libel or 
17 
injunction proceedings, violations of this Act whenever the Secretary believes that interest will 
18 
be adequately served by assessment of civil penalties. 
19 
SECTION 14. Whistleblower Protection.- (A) IN GENERAL - employee or other person 
20 
may be harassed, prosecuted, held liable or discriminated against in any way because that 
21 
person-
22 
(1) has commenced, caused to be commenced, or is about to commence a the 
23 
public proceeding, testified or is about to testify at a proceeding, or assisted or 
24 
participated or is about to assist or participate in any manner in such a proceeding or in 
25 
any other action to carry out the purposes, actions or responsibilities set forth in this Act; 
26 
(2) is refusing to violate or assist in the violation of a law, rule or regulation. 
27 
SECTION 15. Traceback. - The Secretary may impose on a food product requirements 
28 
for the traceability of such type or class of food product whenever such requirements are 
16 


• 
1 
necessary to assure the protection of the public health. Traceability requirements shall be 
2 
established in accordance with regulations and guidelines issued by the Secretary. 
3 
SECTION 16. Citizen's Civil Action. - Any person may against-
4 
(A) any person who violated any rule, tolerance, order, or ensure the safety of food 
5 
products; or 
6 
(B) the Secretary where there is alleged a failure of the Secretary to perform any act or 
7 
duty to ensure the safety of food products, which is not discretionary. 
8 
TITLE IV-AUTHORIZATION 
9 
SECTION 17. Authorization of Appropriations. -
(A) IN GENERAL-There are 
10 
authorized to be appropriated such sums as may be necessary to carry out the provisions of this 
11 
Act. 
12 
(B) RESEARCH PROGRAM AUTHORIZATION - Of the funds authorized to be 
13 
appropriated under subsection (I), there are authorized to be appropriated such sums as may be 
14 
necessary to carry out the research program authorized by this Act. 
15 
SECTION 18. Separability Clause. - If any provision, or part hereof, is held invalid or 
16 
unconstitutional, the remainder of the law or the provision not otherwise affected shall remain 
17 
valid and subsisting. 
18 
SECTION 19. Repealing Clause. - Any law, presidential decree or issuance, executive 
19 
order, letter of instruction, administrative order, rule or regulation contrary to or inconsistent 
20 
with, the provisions of this Act is hereby repealed, modified or amended accordingly. 
21 
SECTION 20. Effectivity Clause. - This Act shall take effect fifteen (\5) days after its 
22 
publication in at least two (2) newspapers of general circulation. 
Approved, 
17