THIRTEENTH CONG-SS 
OF THE REPUBLIC 1 
"-A 
[,,'f. ;? 
., I .' 
, 
I 
, . I ,  
I
)
 
OF THE PHIL~PPINES 
1 
First Regular Session 
1 
Introduced by Senator Miriam Defensor Santiago 
,. 
EXPLANATORY NOTE 
The Constitution, Article 2, Section 15 provides: 
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 sanitruy manner in order to eliminate 
human pathogens or other potentially harmfbl substances likely to cause food-borne illness. 
Hence, this bill seeks to establish a comprehensive program for the purpose 
human health, by ensuring that the food industry has effective programs in place 
safety of food products consumed in the Philippines. 


THIRTEENTH CONGRESS OF THE REPUBLIC 
) 
OF THE PHILIPPINES 
) 
*?,$ 
j,ij: 1 ;II 7 ::{: 
First Regular Session 
1 
importer that handles or processes food. 
(3) The term “process” means the commercial harvesting, 
Introduced by Senator Miriam Defensor Santiago 
preparation, 
.. 
. 
, 
AN ACT 
TO ESTABLISH A COMPREHENSIVE PROGRAM TO ENSURE THE SAFETY OF FOOD 
PRODUCTS INTENDED FOR HUMAN CONSUMPTION 
Be it enacted by the Senate and the House of Repvesentatives of the Philippines in 
Congress assembled: 
TITLE I-NATIONAL 
FOOD SAFETY PROGRAM 
SECTION 3. Administvation of National Program. - 
(1) IN GENERAL - 
(a) Persons 
who produce or process food for human consumption have the responsibility to prevent or 
minimize food safety hazards related to their products. The Secretary shall administer a national 
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. 
(b) The program shall- 
__ 


(i) be based on a comprehensive analysis of the hazards associ ted with 
different food products and with the haruesting, processing and handling o different 
food products, including the identification and evaluation of-- 
(aa) the severity of the potential health risks; 
(bb) the sources and specific points of potential contamination that may 
.
.
 
1. 
render food products unsafe for human consumption; and 
(cc) the potential for persistence, multiplication or concentration of naturally 
occurring or added contaminants in foods and food products; 
(dd) take into consideration the distinctive characteristics of food production 
and processing; 
(ee) establish inspection and oversight procedures to monitor that facilities 
are utilizing preventive controls to minimize or eliminate identifiable hazards; and 
(ff) require each food processing facility to annually register with the 
Secretary. 
(2) PROGRAM 
.-. . 
E.LEMENTS-The 
program shall provide for-(a) 
implementation of a 
national system for the registration and quarterly inspection of facilities and importers. Quarterly 
inspections can be waived by plants that meet the Secretary’s standards for exceptional or 
negligible-risk facilities or importers; 
(b) development of a program to oversee the implementation of process controls 
(c) the establishment and enforcement of health-based standards for (i) ubstances 
which may contaminate food; and (ii) safety and sanitation in the proce 1. 
sing and 
in food processing facilities; 
handling of food products; 
.
.
 
(d) implementation of a sampling program to ensure that industry programs to 
prevent food contamination are effective and that food products meet the standards 
established in paragraph (i); 
(e) implementation of procedures and requirements to ensure the safety of 
imported food products; 


(i) implementation of a research program in furtherance of the purpoxs 
Act. 
of this 
,. . 
, 
(aa) any felony other than a felony based upon the acquiring, 
or distribution of adulterated or misbranded food; or 
handling, 
,. 
, 
, 


(b) Any registration suspended under paragraph (a) may be reinstated whenever 
the Secretary determines that suspension is no longer necessary. 
(3) EXEMPTION AUTHORITY-The 
Secretary may by regulation exempt classes of 
facilities from the requirements of paragraph (1) if the Secretary determines that the registration 
of such facilities or persons is not needed for effective enforcement of this Act. 
SECTION 5. Pvo-eess.Controls To Reduce The Adulteration Of Food Pyoduets.- (1) IN 
GENERAL-The 
SecretaIy shall, upon the basis of the best available scientific and 
technological data, prescribe regulations to- 
(a) limit the presence of human pathogens and other potentially harmful 
substances in food products; 
(b) ensure that all registered facilities. implement appropriate measures (to control 
and reduce the presence and growth of human pathogens and other potential 
substances on food products; 
harmful 
. 
. 
(c) ensure that all fully processed or ready-to-eat food products are processed in a 
sanitary manner, using reasonably available techniques and technologies to eliminate any 
human pathogens or other potentially harmful substances likely to cause food-borne 
illness; and 
(d) ensure that food products intended for final processing outside commercial 
establishments are labeled with instructions for handling and preparation for consumption 
which, when adhered to, will destroy any human pathogens or other potentially harmful 
substances likely to cause food-borne illness. 
(2) REGULATIONS-The 
Secretary shall, within one (1) year of the enactment of this 
Act, issue regulations that require all registered facilities to adopt processing controls adequate to 
protect public health and to limit the presence and growth of human pathogens and other 
potentially harmful subztances 
.- . 
in food products prepared in any registered facility. Such 
regulations shall- 
.
I
.
.
 . 
(a) set standards for sanitation; 
(b) set tolerances for biological, chemical and physical hazards as appropriate; 


(c) require process controls to assure that food is safe and that relevant Ieguiatory 
and safety standards are met; 
(d) require record-keeping to monitor compliance; 
(e) require sampling to assure that processing controls are effective and that 
regulatory standards are being met; and 
(f) provide for agency access to records kept by official establishments and 
submission of copies of such records to the Secretav as the Secretary deems 
appropriate. 
The Secretary may, as the Secretary deems necessary, require any person, firm or 
corporation with responsibility for or control over food ingredients to adopt processing controls, 
where such processing controls are needed to assnre the protection of public health. 
SECTION 6. Inspections of Processors and Importers. - (1) NATURE OF 
-. 
INSPECTIONS- 
(a) The inspection system shall provide for frequent unannounced inspections of 
food processing and importing facilities to determine if such facilities are operated in a 
sanitary manner and if food products are unsafe for human consumption, or adulterated or 
misbranded. Inspection shall include review of processing records and sampli 
(b) Inspections shall. be conducted at least quarterly, unless the 
products. 
determines that the facility, is an exceptional or negligible-risk facility under standards 
established by the Secretary. 
(c) Standards for exceptional or negligible-risk facilities shall consider the hazards 
associated with the type of product being produced; and the facility’s history of 
compliance, food safety problems and such other factors as the Secretary may ,deem 
appropriate. The Secretary shall specify an alternative inspection frequency for each 
facility which is deemed exceptional or negligible-risk. Each inspection shall include an 
examination of whether the facility continues to meet the s tmdards for exceptional or 
negligible-risk facilities. 


(2) CONDUCT OF INSPECTIONS- 
(a) An inspection under subsection (a) of any domestic, foreign or importing 
aintained 
facility shall extend to all things therein (including records required to be 
under subsection (e), processes, controls, and premises) that bear on wha i, 
her , food 
products are in compliance with this Act. Access to records may include the copying of 
such records. 
(b) In conducting such inspections, officers or employees duly designated by the 
Secretary, upon presenting appropriate credentials to the owner, operator or agent in 
charge, are authorized- 
(i) to enter at reasonable times any facility in which persons are engaged 
in the food processing or importing of food products, or to enter any vehicle 
being used to transport or hold such food products; 
(ii) to inspect in a reasonable manner such facility or vehicle and all 
pertinent equipment, finished and unfinished materials, containers, labeling, 
processes, controls, and premises; and 
(iii)to collect and retain samples of food products or ingredients or of any 
other items found during an inspection that may contribute to a finding of 
whether such food products are unsafe for human consumption or adulterated 
or misbranded. 
T- 
- ~ .  
(c) Immediately after completion of inspection, the officer or employee making 
the inspection shall give to the owner, operator, or agent in charge a report ,'n writing 
setting forth any conditions or practices observed which indicate that either rocessing 
controls are inadequate to prevent or minimize food safety hazards or that any ood from 
such facility is unsafe for human consumption, or adulterated or misbranded. 
(3) PRODUCT DETENTION AND CONDEWATION- 
I 
(a) If, during an inspection conducted under this section, an officer or employee 
making the inspection has reason to believe that a food product is unsafe for human 
consumption, or adulterated or misbranded, such officer or employee may order the food 
product segregated, impounded, and if objection is not made within 48 hours, 


., 
condemned. If objection is made, such food products that are in perishable form may be 
processed to the extent necessary to prevent spoilage, and a hearing shall be commenced 
expediiously. 
.- . 
(b) if the Secretary determines that, through relabeling or other action, such food 
products can be brought into compliance with this Act, the food may be released 
following a determination by the Secretary that such relabeling or other action as 
specified by the Secretary has been performed. 
I 
(c) Any food product condemned without objection, or after hearing a d judicial 
review, shall be destroyed under supervision of the Secretary. 
1.. 
. .  
(4) OFFICIAL MARK-The 
Secretary shall prescribe by regulation the conditions under 
which any food product shall display an official mark, when needed to facilitate exports, that 
signifies that the food product has been processed in accordance with standards approved by the 
Secretary. Such a mark may be subject to a fee. 
(5) MAINTENANCE OF RECORDS-Each 
facility or person registered under this 
section shall maintain and make available for inspection b y  the S ecretary such records as the 
Secretary may prescribe. Such records shall b e rn aintained for a reasonable period o f t ime as 
determined by the Secretary. The records shall include, but are not limited to, information 
conceming- 
(a) the origin, receipt, delivery, sale, movement, holding, and disposition of food 
products or ingredumts; the identity and amount of ingredients used in the food; the 
processing of the food; the results of laboratory, sanitation, or other quality control tests 
perfo-aed on thefood or in the facility; consumer complaints concerning the food or its 
packaging; and 
(b) other matters reasonably related to whether food products may be unsafe for 
human consumption, or adulterated or misbranded. 
SECTION 7. Tolerance for Contaminants in Food. - (1) TOLERAN ES-The 
Secretary shall establish tolerances limiting the quantity of contaminants that, when found in 
.
.
 . 
food products, may render such products unsafe for human consumption. Contaminan t s include 


enactment of this Act. In promulgating such regulations, the Secretary shall establish 
for the contaminants that the Secretary determines are having the greatest public health 
of enactment. 
:olerances 
impact as 


I
j
 
SECTION 8. Imports.- (1) ROLE OF SECRETARY--Within twenty-four (24) months 
after the date of enactment of this Act, the Secretary shall. establish and administer 
,
,
 a 
comprehensive and efficient system to ensure the safety of food imported into the Philippines. 
The Secretary shall routinely inspect processing facilities in exporting nations and imports at 
ports of entry into the country. The Secretary shall assure the effective operation; through 
,
,
 
i
i
 
I
!
 
I 
i 
1
1
 
1
;
 
l
i
 
~ 
verification and other activities, as the Secretary considers necessary. 
, 
~ 
I
i
 
(2) IMPORT REQUIREMENTS-(a) 
No food product may enter the Philippines, :or be 
regulation. 
1 
:
I
 
i
i
 
withdrawn from a warehouse, for consumption in the Philippines if such food product- 
~ 
~ 
!
I
 
(i) appears unsafe for human consumption, or adulterated or misbranded; 
(ii) is not marked or labeled as required by regulations for dorestic or 
I
:
 
imported articles; or 
I
!
 
~~ 
,
#
 
i
i
 
i 
, , ,. 
!I 1, 
1 
under subsection (5)(c) shall be subject to such intensified examinations, ins e 
I 
sampling, and other verification procedures, including inspection in'the country qf I 
I' 
I 
!i 
II 
11 ! 
1 
as the Secretary determines are necessary to ensure compliance with'this Act, 
: not 
111 be 
lucts 
iucts 
sn, or 
:t to 
1 the 
iures 
ie by 
inder 
and 
lucts 
ions, 
igin, 
'i 


(4) DETENTION OF IMPORTED FOOD PRODUCT-If 
during an inspectio or other 
verification procedure camed out under this section, an officer or employee cond sting the 
procedure has reason to believe that a food product is unsafe for human consumption, or 
adulterated or misbranded, such officer or employee may order the food product segregated, 
impounded, and if objection is not made within 48 hours, condemned. If objection is made, such 
food products that are in perishable form may be processed to the extent necessary to prevent 
spoilage, and a hearing shall be commenced expeditiously. The final condemnation or other 
disposition of such food product shall be subject to the provisions of this Act. 
I 
(5) AGREEMENTS WITH FOREIGN NATIONS-(a) 
The Secretary may enter into an 
agreement with any nation desiring to export food products to the Philippines. Prior to 
concluding such an agreement, the Secretary shall evaluate the food safety program of the 
foreign nation to determine if such program provides at least the same level of protection, with 
respect to food products intended for export to the Philippines, as domestic laws that affect the 
safety of the food supply. In such evaluation, the Secretary shall consider- 
s.. 
(i)'the~ potential for health, sanitary, environmental, or other conditions 
within the foreign nation to adversely affect the safety of food products exported 
from such nation; and 
(ii) how well the food safety programs of the foreign nation functions to 
minimize any adverse effects on such safety 
(b) Any agreement under this subsection with a nation desiring to e 
products to the Philippines shall- 
(i) require that the exporting nation shall- 
(aa) establish and maintain a food safety system that is adequate to 
ensure that the food products intended for export to the Philippines are 
safe €or human consumption, and not adulterated or misbranded; and 
(bb) promptly notify the Secretary of any violations affecting the 
safety of food products exported or intended for export to the Philippines; 
(ii) provide for such activities (whether in the exporting nation or at the 
port of entry during importation) by the Secretary, including examinations, 


inspections, sampling and testing, at such stages in the growth or harvest of food, 
or in the processing or handling of food products, as the Secretary considers 
appropriate to ensure that the food safety program of the exportifig nation 
continues to provide at least the s ame 1 eve1 o f p rotection, with r espe t to food 
products intended for export to the Philippines, as domestic laws that affect the 
safety of the food supply; and 
1 
(iii) provide for reciprocity with respect to the treatment of food imports 
and exports between the Philippines and the exporting nation. 
(c) If the Secretary determines that a nation desiring to export food products to the 
Philippines has a program that provides at least the saline level of protection, with respect 
to food products intended for export to the Philippines, as domestic laws that affect the 
safety of the food supply, the Secretary shall, upon entry into force of an agreement under 
subsection (5)(a), certify the types of food products for which the nation maintains such a 
program. 
(d)(i) The Secretary shall periodically or for good cause, and not less than once 
every three years, review certifications made under paragraph (3), and shall revoke the 
certification of any nation that the Secretary determines is not maintaining a food safety 
progr-ZE that provires at least the same level of protection, with respect to food products 
intended for export to the Philippines, as domestic laws that affect the safety of the food 
.. 
supply. 
(e) The Secretary shall review and modify, as needed, an agreement made under 
paragraph (1) with any nation whose certification has been revokes under subparagraph 
(i) of this paragraph. 
.
,
 
TITLE TI-RESEARCH AND EDUCATION 
SECTION 9. Public Health Assessment System.- (1) PUBLIC HEALTH SmPLNG- 
(a) Within twelve (12) months after the date of enactment of this Act, the 
Secretary in cooperation with the Secretary of Agriculture shall establish guidelines for a 
sampling system under which the Secretary of Agriculture shall take and analyze samples 


of food products-to assist the Secretary in carrying out this Act and to more accurately 
assess the nature, frequency of occurrence and amounts of contaminants in food products. 
@) Such sampling system shall provide- 
(i) s tatistically valid monitoring, including m arket-basket studies, on the 
nature, frequency of occurrence, and amounts of contaminants in food products 
available to consumers; and 
(ii) at the request of the Secretary, such other information, including 
ines may 
1, 
. 
analysis of monitoring and verification samples, as the Secretary dete 
be useful in assessing the occurrence of contaminants in food products. 
(2) ASSESSMENT OF HEALTH HAZARDS-Through 
the surveillance system referred 
to in subsection (1) (a) and the sampling system described in subsection (1) (b), the Secretary 
shall rank food categories based on their hazard to human health and identify appropriate 
industry and regulatory approaches to minimize hazards in the food supply. Such analysis could 
include- 
(a) the safety of commercial harvesting and processing, as compared with the 
health hazards associated with food products that are harvested for recreational or 
subsistence purposes and prepared non-commercially; 
(b) the safety of food products that are domestically harvested and processed, as 
compared with the health hazards associated with food products that are harvested or 
processed outside of the Philippines; and 
-- 
~ 
(c) contamination originating form handling practices that occur prior to or after 
the sale of food products to consumers. 
SECTION 10. Public Education And Advisory System. - 
(1) PUBLIC EDUCATION- 
The Secretary, in cooperation with private and public organizations, shall design and i 
(a) information to the public regarding standards and good practice req 
a national public education program on food safety. The program shall provid- 
and promotion of public awareness understanding, and acceptance of such standards and 
requirements; 


(b) information to health professionals so that the may improve diagnosis and 
treatment of food-related illness and advise individuals whose health conditions place 
them in particular risk; and 
--(c) such ofher information or advice to consumers and other persons as the 
Secretary determines will promote the purposes of this Act. 
(2) HEALTH ADVISORIES-The 
Secretary, in consultation with the Secretary of 
Agriculture and the Secretary of Environment and Natural Resources, shall work to- 
(a) develop and distribute regional and national advisories concerning food 
safety; and 
(b) develop standardized formats for written and broadcast advisories. 
SECTION 11. R e s e u d -  (1) IN GENERAL-The 
Secretary shall conduct research to 
assist in the implementation of this Act, including studies to- 
(a) 
products; 
(b) 
improve sanitation and food safety practices in the processing of food 
develop improved techniques for the monitoring of food and inspection of 
food products; 
(c) 
develop efficient, rapid, and sensitive methods for determining and 
detecting the presence of contaminants in food products; 
(d) 
determine the sources of contamination of food and food products with 
contaminants; and 
(e) 
develop consumption date with respect to food products. 
(2) CONTRACT AUTHORITY-The 
Secretary is authorized to enter into contracts and 
agreements with the University of the Philippines or any state university or any other university, 
other government agencies or other persons to carry out the activities under this Section. 
.-. 
~ 
TITLE 111-ENFORCEMENT 
SECTION 12. Notlfcution and Recall.- 
(1) NOTICE TO SECRET RY OF 
ADULTERATION OR MISBRANDNG-Any 
person (other than a household co sumer or 
1.. 
. 


consumed, would present a threat to public health, as determined by the 
Secretary shall provide the appropriate persons (including the manufacturers, 
Sec:etary, the 
mporters, 


time and in the manner prescribed by the Secretary, the Secretary shall, by order, require, 
as the Secretary deems necessary, such person to- 
(i) immediately cease distribution of such articles; 
(ii) immediately notify all persons- 
(aa) producing, manufacturing, packing, processing, preparing, 
treating, packaging, distributing, or holding such article; or 
(bb) to which such article has been distributed, transported, or sold, 
to immediately cease distribution of such article; or 
(cc) immediately take the actions specified in both subparagraphs 
- 
.- . 
- 
- 
(2)(a) and (2) (b). 
(c) NOTJFICATION OF CONSUMERS BY SECRETARY-The 
Secretary shall, 
as the Secretary deems necessary, provide notice to consumers to whom such article was, 
or may have been, distributed. 
(d) HEARING ON ORDER-The 
Secretary shall provide any person subject to 
an order under subsection (b) with an opportunity for a hearing, to be held s soon as 
possible but not later than 2 days after the issuance of the order, on the action ,required 
by the order and on why the article that is the subject of the order should not be recalled. I 
(e) POST-HEARING RECALL ORDER- 
(i) AMENDMENT OF ORDER-If, 
after providing opportunity for a hearing 
under subsection (c), the Secretary determines that there is a reasonable probability 
that the article that is the subject of an order under subsection (b), if consumed, 
presents a threat to public health, the Secretary, a s  the S ecretary deems necessary, 
may- 
.-- 
~ 
(aa) 
amend the order to require recall of such article or other 
appropriate action; 
(bb) 
(cc) 
specify a timetable in which the recall shall occur; 
require periodic reports to the Secretary describing the progress of 
the recall; and 
- _- 
. 


(dd) 
provide notice to consumers to whom such article was, or may 
have been, distributed. 
(3) VACATION OF ORDER-If, 
after such a hearing, the Secretary determines that the 
adequate grounds do not exist to continue the actions required by the order, the Secretary shall 
vacate the order. 
(4) REMEDIES NOT EXCLUSIVE-The 
remedies provided in this section shall be in 
addition to and not exclusive of other remedies that may be available. 
SECTION 13. Civil PenuZties,- 
(1) IN GENERAL-(a) 
ACTS SUBJECT TO 
PENALTY; PENALTY AMOUNT-Any 
person that commits and act that violates this Act may 
be assessed a civil penalty by the Secretary, subject to review in accordance with the 
administrative code and - other pertinent laws, of not more than One Hundred thousand Pesos 
(PlO0,OOO.OO) for such act. Each such act and each day during which such act continues shall be 
a separate offense. 
~- 
. 
.- - 
(b) NOTICE AND HEARING-No 
penalty shall be assessed by the Secretary 
under this section unless such person is given notice and opportunity for a hearing on the 
record before the Secretary in accordance with laws pertinent to adm nistrative 
proceedings. 
(c) OTHER REQUIREMENTS-The 
amount of such civil penalt shall be 
assessed by the Secretary by written order, taking into account the gravity of the 
violation, degree of culpability, size and type of business, and any history of prior 
offenses; 
(2) COLLECTION ACTIONS-If 
any person fails to pay an assessment of a civil 
penalty after it has become a final and unappealable order, the Secretary shall refer the matter to 
the Solicitor General, who shall institute a civil action to recover the amount. In such collection 
actins, the validity and appropriateness of the Secretary’s order imposing the civil penalty shall 
not be subject to review. 
1 
(3) SECRETARY’S DISCRETION TO PROSECUTE-Nothing 
in this Act shall be 
construed as requiring the Secretary to report for prosecution, or for the institution of libel or 


injunction proceedings, violations of this Act whenever the Secretary believes that 
interest will be adequately served by assessment of civil penalties. 
SECTION 14. Wzistlebloweu Protection.-(1) 
IN GENERAGNo employee or other 
person may be harassed, prosecuted, held liable or discriminated against in any way because that 
person- 
(a) 
has commenced, caused to be commenced, or is about to commence a 
the public 
.. 
. 
, 
proceeding, testified or is about to testify at a proceeding, or assisted or participated or is 
about to assist or participate in any manner in such a proceeding or in any other action to 
carry out the purposes, hctions or responsibilities set forth in this Act; 
(b) 
is refusing to violate or assist in the violation of a law, rule or regulation. 
SECTLON 15. Tvaseback. - 
The Secretary may impose on a food product requirements 
for the traceability of such type or class of food product whenever such requirements are 
necessary to assure the protection of the public health. Traceability requirements shall be 
established in accordance with regulations and guidelines issued by the Secretary. 
SECTION 16. Citizen's Civil Action. - Any person may 
against- 
(1) any person who violated any rule, tolerance, order, or 
ensure the safety of food products; or 
(2) the Secretary where there is alleged a failure of the Secretary to perform any act or 
duty to ensure the safety of food precuts, which is not discretionary. 


TITLE N-AUTHORIZATION 
SECTION 17. Authorization of Appvopviations.-(1) 
IN GENERAL-There 
are 
authorized to be appropriated such sums as may be necessary to carry out the provisi I ns of this 
Act. 
(2) RESEARCH PROGRAM AUTHORIZATION-Of 
the funds autho ized to be 
I 
appropriated under subsection (l), there are authorized to be appropriated such sums as may be 
necessary to carry out the research program authorized by this Act. 
SECTION 18. Separability Clause. - 
If any provision, or part hereof, is held invalid or 
unconstitutional, the remainder of the law or the provision not otherwise affected shall remain 
valid and subsisting. 
SECTION 19. Repealing Clause. - 
Any law, presidential decree or issuance, executive 
order, letter of instruction, administrative order, rule or regulation contrary to or inconsistent 
with, the provisions of this Act is hereby repealed, modified or amended accordingly. 
SECTION 20. Effectivity Clause. - 
This Act shall take effect fifteen (15) days after its 
publication in-at least two-72) -newspapers of general circulation. 
Approved 
I1916