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

SIXTEENTH CONGRESS
First Regular Session

HOUSE BILL NO._ 4352

Introduced by Representative LEAH S. PAQUIZ of ANG NARS Party — List

EXPLANATORY NOTE

It is a Constitutional guaranty that the State shall protect and promote the health of the
people, instill in them a consciousness about healthy living, and ensure that every citizen live
ina balanced and healthful ecology in accord with the rhythm and harmony of nature.

Over the last decade, there is a growing and alarming concern on the possible health
hazards from genetically modified crops and its derivatives that are directly and indirectly
consumed by people as food and beverage. In the Philippines, local ordinances banning the
planting of Genetically Modified Organisms (GMOs), like in Bohol, Mindoro, Benguet, and
Negros, have been enacted after the local government saw the possible negative effects of
GMOs on the environment and on the health of the people

‘To stress the need for the Philippines to protect its citizens from the possible harm of
GMOs, the Court of Appeals in its Decision dated 17 May 2013 enjoined the government
through the Environmental Management Bureau of the Department of Environment and
Natural Resources, Bureau of Plant Industry of the Department of Agriculture, and other
government and private respondents, to cease and desist from conducting field trials of a
proprietary GMO crop, bacillus thuringiensis (bt) eggplant or more known as bt Talong, for
eventual commercialization and direct human consumption. Prominent members of Congress,
academe and cause-oriented groups led the filing of the petition for a Writ of Kalikasan, The
said ruling was later on AFFIRMED by the Court of Appeals and further declared that:

“Xxx XXX xxx _ field trials of bt talong could not be
declared by this Court as safe to human health and to our
ecology, with full scientific certainty, it being an alteration
of an otherwise natural state of affairs in our ecology.”

Internationally, a number of nations, more particularly those from the European Union,
has banned or restricted the planting and the entry of genetically modified organisms (GMOs)
into their food system, To date, 64 countries around the world have imposed mandatory
labeling of food and beverages that contain ingredients from GMO crops. GMO corn, soya,
canola, and their derivatives, among other GMO crops, are used as feeds for livestock or


ingredients for processed foods, and eventually become an integral component of processed
and fresh food for human consumption.

Tt is thus imperative to address the dangers brought about by GMOs through appropriate
regulation, awareness campaign, and mandatory labeling of food and beverages and from
where and how they have been derived to assure safety in the public’s consumption as
mandated by Section 12 , Article XIII of the Constitution, to wit:

The State shall establish and maintain an effective food

and_drug regulatory system and undertake appropriate
health, manpower development, and research, responsive to
the country’s health needs and problems.

Hence, the filing of this urgent health measure is earnestly sought.

REP. BEAH S. PAQUIZ
ANG NARS Party-list


N

Voausw

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

SIXTEENTH CONGRESS
First Regular Session

HOUSE BILL NO. 4352

Introduced by Representative LEAH S. PAQUIZ of ANG NARS Party ~ List

AN ACT TO BE KNOWN AS “THE PHILIPPINE GENETICALLY MODIFIED
ORGANISM (GMO) LABELING ACT, THE RIGHT-TO-KNOW-ACT” REQUIRI
THE MANDATORY LABELING AND REGULATION OF FOOD WHICH ARI
GMOs OR CONTAINING SUBSTANCES DERIVED FROM GMOs AND THOSE
PRODUCED BY GENETIC ENGINEERING TECHNOLOGIES, PROVIDING
FUNDS THEREFOR AND FOR OTHER PURPOSES

Be it enacted by the Senate and the House of Representative of the Republic of the

Philippine: ‘ong bled:

SECTION 1. Short Title - This Act shall be known as, “THE PHILIPPINE GMO
LABELING AND REGULATION ACT, THE RIGHT-TO-KNOW ACT”,

SECTION 2. Declaration of Policy — It is hereby declared that the State shall protect and
promote the right to health of the people and instill health consciousness among them. It shall
also protect and advance the right of the people to a balanced and healthy ecology, as it is the
duty of the State to inform and warn the people of the health and environmental risks of
Genetically Modified Organisms or GMOs.

The State further guarantees the establishment and maintenance of an effective food and
drug regulatory system and undertake appropriate health, manpower development, and
research, responsive to the country's health needs and problems

To this end, the state recognizes the rights of the consumers and general public on their right

to know whether the food, food products and their derivatives (processed or not) and
agricultural products like rice, corn and vegetables, among others, contain genetically modified
organisms (GMO) or are produced by genetically engineered technologies (GET). Thus, the
State shall endeavor to provide Filipinos with safe and healthy food and agricultural products
that will not jeopardize their health and place the environment at risk as a result of
developments in food manufacturing that utilizes the process and products of genetic
engineering technologies through an efficient and effective regulation and labelling.


1
2
3
4
5
6
7
8

9
10
orm
12
13
14
15
16
7
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42

43
44

45
46

SECTION 3. Definition of Terms —

a) Genetically Modified Organism (GMO) ~ Living organisms whose genetic make-up
were manipulated in a laboratory by non-natural means such as genetic engineering
technologies in order to incorporate genes from different species that normally will not
reproduce with each other. An example of this is a corn plant whose genes were inserted
with a gene from a bacterium such as the Bacillus thuringiensis or Bt that acts as a
pesticide to kill corn borers.

b) Genetic Engineering (GE) -- The process of inserting a foreign gene into a host
organism to achieve a trait not normally held by that organism, such as the ability to
produce its own pesticides, or to be immune to certain herbicides,

©) Genetically Modified Food (GM Food) ~ Processed food that contain GMOs, or
products derived from them, fresh meat and edible plants that are modified through
genetic engineering.

d) Genetically Modified Crops (GM Crops) ~ Refer to agricultural crops like, but not
limited to Bt Com, Round Up-Ready (RR) soya, RR canola, Bt cotton, etc., which
contain genes of other organisms inserted in their own genes thru genetic engineering,

e) Genetically Modified Feed (GM Feed) ~ Any agricultural crop like corn, soya, etc, that
are genetically modified and used as feed for the livestock indust

f) Livestock ~ Any animal, bird, fish, etc, that are raised as an industry for human
consumption.

g) Derivative ~ Refers to products derived from processing GMO crops, such as but not
limited to, extracts, oil, syrup, powder, flour, ete.

h) Food —In addition to Republic Act 9711 or the Food and Drug Administration Act of
2009's definition of food, it is any natural and processed food intended for human.
consumption that includes agricultural crops like rice, corn, vegetables, among others;
beverages, whether natural or processed; and any substance, whether natural or
processed which has been used as an ingredient in the manufacture, preparation or
treatment of food,

i) Processed Food — Any food that has undergone any procedure that has changed it and
made it different from its natural state. Examples of these procedures are preserving,
packaging, irradiation, pasteurization, fortifying, genetically modifying, etc.

i) Threshold Level -- the percentage limit of traceable GMO contained in all food, crops,
feeds and derivatives

SECTION 4. Coverage and Scope ~ The following persons, whether natural or juridical, are
covered by this Act:

a. Any person who are involved in the development, production and/or sale of GMO
agricultural crops, GMO marine products and other unnatural substances obtained by


genetic engineering technologies, as defined by this Act, that are intended for
propagation and commercialization;

b. Any person who are involved in the propagation, planting, marketing and/or sale of
the items, in whole or in part, as stated in Section 4.a. and defined by this Act;

©. Any person who are involved in the manufacture and processing of derivatives, as
defined by this Act, that are sourced from the items as stated in Section 4.a. and defined
by this Act;

4. Any person who are involved in the marketing and sale of derivatives, as defined by
this Act;

€. Any person who are involved in the production, marketing, distribution and/or sale of
food and beverage that are sourced from the items as stated in Section 4.a, and defined
by this Act; and

£ Any persons who are involved in importing or bringing in Genetically Modified food,
crops, animals, feeds and derivatives, as defined by this Act, into the Philippines

SECTION 5. Mandatory Labeling of Food, Food Products and their Derivatives and
Agricultural Products like rice, corn and vegetables, among others, that contain GMOs
All food, food products that have been processed and their derivatives and agricultural products
such as but not limited to rice, com and vegetables, among others, containing genetically
modified organisms or GMOs, as well as those produced by genetic engineering technologies
shall be labeled in accordance with the provisions of this Act and the existing regulations issued
by the Department of Health, through the Food and Drug Administration (FDA):

a. For the regulation and mandatory labeling of processed food and beverages containing
GMO as defined by this Act, the Department of Health, through the FDA, will be the
implementing agency;

b, For the regulation and mandatory labeling of genetically modified crops, livestock and
marine products, some of which have been specifically approved by Philippine
government in the past for commercialization in the Philippines, and as defined by this
Act, the Department of Agriculture, in collaboration with the FDA, will be the
implementing agency;

c, “THIS PRODUCT CONTAINS GENETICALLY MODIFIED ORGANISM? or
“THIS PRODUCT CONTAINS GMO” shall be permanently printed as a stand-
alone, conspicuous label in the front and back of the general packaging materials like
boxes, sacks, etc., containing the bulk of the food, beverages and all other items, and
individual packaging materials of the items as proportioned by the producer. The size
of the printed label shall not be less than five (5) percent of the total volume area of the
container,

d. In the case of GMO agricultural crops, livestock and marine products, as defined by
this Act whose cultivation/propagation is ongoing, the same label as stated by Section
5, subsection c of this Act shall be printed on the front side of a tag, banner, or any other
medium where the label can be printed. The size of the tag, or a corresponding

3


combination of number and volume thereof, shall not be less than one-half (0.5) square
meter per hectare of the total area of the cultivation/propagation. The size of the tag
shall also be same even if the area is less than one (1) hectare. The size of the label on
the tag shall not be less than forty percent of the size of the tag;

e. In the case of GMO agricultural crops, livestock and marine products, as defined by
this Act, that are retailed and displayed as a mass -- like rice, corn, soya beans,
vegetables, fish, meat, etc. ~ the same label as mandated by Section 5, subsection ¢ of
this Act shall be printed on a tag that will correspondingly identify the specific item
being sold; and

f. The labeling line shall be as follows:

1)
2)

3

4

5

6)

The producers of seeds for GMO crops shall label their products so that
the farmers will be informed,

Farmers who plant GMO crops shall tag their fields and label their
containers so that their buyers will be informed;

Buyers of GMO crops, who will sell the same as a mass product, should
tag and label so that the consuming public will be informed;

Buyers and processors of GMO crops for the production of derivatives
as defined by this Act shall label their products so that their food and
beverage-processor buyers will be informed;

Food and beverage processors who use GMO crop derivatives as defined
by this Act shall label their products so that the consuming public will
be informed; and

Importers of GMO-containing processed or whole food into the
Philippines, including derivatives, all defined by this Act, shall secure
prior clearance from the Authority created by this Act for the effective
administration of the labeling mandate of this Act.

SECTION 6. Threshold level -- The tolerance level is nine-tenth (0.9) percent. Above the
threshold level, a food is regarded as genetically modified, Hence, must be properly labeled.
‘The threshold of nine-tenth (0.9) percent still allows for some unintended contamination of
food with GM ingredients.

SECTION 7. Institutional Mechanism — There is hereby created an office to be called the
GMO CROP, FOOD AND BEVERAGE LABELING COUNCIL (COUNCIL) that will be
attached to the Department of Health, thru the FDA, and chaired by the same agency. With the
mandate to oversee and coordinate the implementation of this Act, supervise the Authority, the
institution of a continuous information and education campaign on GMOs to be led and
undertaken by its sectoral members and propose policies to Congress for the improvement of
this Act, the Council shall be composed by the following:

a, Food and Drugs Administration Head — Ex-Officio Chairman
b. Department of Agriculture Representative - Ex-Officio

c. Department of Trade and Industry Representative - Ex-Officio

d. Department of Environment and Natural Resources Representative - Ex-Officio

e. two (2) representatives Academic Sector — Members
two (2) representatives Consumer Sector — Members

g. two (2) representatives Peasant Sector


13

14
15
16
7
18
19
20
21
22
23
24
25
26
2.
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43

h. two (2) representatives Health Advocacy Sector ~Members
i, two (2) representatives Business Sector - Members

The sectoral members of the Council shall be selected by the FDA through a nomination
process from the respective sector.

SECTION 8, Accreditation of Scientific Laboratories ~ All scientific laboratories operating
in the Philippines, as well as those located abroad, shall secure prior accreditation to be
recognized as lawful and competent entities that are able to conduct analyses of GMO presence
in food, beverages and other items as defined by this Act.

SECTION 9, GMO Crop, Food and Beverage Labeling and Regulation Authority (Authority)

Thete is hereby created an office to be called the GMO CROP, FOOD AND BEVERAGE
LABELING AND REGULATION AUTHORITY that will be attached to the Department of
Health, thru the FDA.

a) Functions:

Wy

Even without prior notice, to visit within the Philippines the offices, facilities,
or farms, etc,, of all the entities involved in all the articles defined and cited by
this Act;

To enlist and secure the assistance of any government agency, including the
police, in the performance of its functions;

‘After due process, to establish the evidence and culpability of the violators of
this Act;

With warranted evidence, to file the case against the violators before the court
of law;

To conduct motu propio investigations against violators;

To act immediately on verified complaints concerning any violation of the
provisions of this Act;

To issue subpoena duces tecum and_ ad testifancandum to any parties in the
complaint;

To conduct regular research on GMOs and track the uses of the same in the food
chain;

To maintain a database of its research and other documents. It shall post in its
website all the labeled articles in the Philippines by virtue of this Act. It shall
also post all the articles and products all over the world that are equally labeled,
including the identification and tracking of derivatives of GMO crops as defined
by this Act;

. After due process, to collect all the imposable penalties and fines from the

‘iolators;

‘0 regulate and approve all the applications for the label as defined and
mandated by this Act. The label becomes lawful when it is accompanied by the
logo of this Authority;

To validate the label annually from the date of approval;

To collect a nominal fee annually for the application, processing, validation,
approval and administration of the label. The fee shall be determined and
approved by the Council;



wavansenr

cu
12
13
14
15
16
wv
18
19
20
21
22
23
24
25

26
27
28
29
30
31
32

33
34
35
36
37
38

39
40
4a
42

43

14. Prior to importation, to verify and impose a clearing mechanism on all processed
and whole food importations into the Philippines and collect a nominal fee
therefor. The fee shall be determined and approved by the Council;

15. To accredit scientific laboratories and collect a nominal fee therefrom, The fee
shall be determined and approved by the Council; and

16, To acquire the necessary competence by hiring expertise and purchasing
scientific equipment to ascertain the presence of GMO in all the products and
articles as defined by this Act, This shall be determined and approved by the
Council

b) Officers, Staff and Domicile:

1. The Authority will be headed by a Director, The Director reports directly to the
head of the FDA, who is also the chair of the Council;

2. The Authority shall have an Assistant Director, who reports directly to the
Director, to act as the officer-in-charge in the absence or incapacity of the
Director;

3, The salaries of the Director and Assistant Director shall be commensurate to the
promulgated rates for civil servi

4. ‘The employment of the Director and Assistant Director shall be processed,
scrutinized and recommended for approval by the Council. The Secretary of
Health shall approve the said recommended employment and administer the
oath of office;

5, The Authority shall have an initial three (3) administrative staff. Upon
justification for any additional staff at any given time, the Council will process,
‘crutinize and approve the same; and

6. The office of the Authority shall be located in FDA.

SECTION 10, Inapplicability of Regulation-Making Exemptions ~ Due to the urgent and
extreme public necessity and the need to keep the public adequately protected and to preserve
the right of the consumers to choose, the power of the Secretaries of Trade and Industry, and
Health to make exemptions to the regulations as specified in the Consumer Act of the
Philippines and the FDA Act is hereby rendered inapplicable unless it can be shown that public
order, public health and public safety are not placed in jeopardy with its exemption, actual
application and implementation

SECTION 11. Penalties Any person who knowingly distribute GMO plants, food, food
products and their derivatives and agricultural products such as rice, corn and vegetables,
among others, containing or derived from GMOs without the proper label shall be subject to a
fine per improper label of not less than five hundred thousand pesos (P500,000.00),
imprisonment ranging from six years and one day to twelve years and/or revocation of license
to operate upon the discretion of the court.

SECTION 12. Funding ~ For the effective implementation of this Act, there is hereby
appropriated an initial fund of ten million pesos (Php 10,000,000.00) for the administration and
operation of the Council and the Authority, of which the Council shall be funded with two
million pesos (Php 2,000,000.00) and the rest consists the fund for the Authority.

The total initial fund of ten million pesos (Php 10,000,000,00) shared by the Council and
Authority, which shall be rated by future Congressional appropriations at twenty percent (20%)

6


for the Council and eighty percent (80%) for the Authority, shall be sourced initially, during
the first fiscal year of the effectivity of this Act, from the funds of the Department of Health
and Department of Agriculture at five million pesos (Php 5,000,000.00) each.

‘The succeeding, combined funding requirement of the Council and Authority, rated at 20:80
percent, respectively, shall be determined and approved by the Council. The two bodies shall
submit to Congress their budget proposals for final approval and appropriation

To augment the funds of the Council and Authority for the purpose of implementing this Act,
the monetary penalties, imposable fees and all other monies and resources collected by the
Authority shall always remain in the coffers of the respective bodies for the sole purpose of the
effective implementation of this Act subject to rules and regulations of the Commission on
Audit, The accruing funds, including the annual appropriated budget therefor, shall build the
competency, capability and efficiency of the Council and Authority in the implementation of
this Act,

And where the two bodies have sufficiently generated their own funds, determined through
annual audited reports to Congress, they shall momentarily cease from proposing for
appropriated funds until their own funds can last

SECTION 13. Implementing Rules and Regulations — The Council and the Authority, with
the participation of the appropriate government agency and in consultation with the concerned
business and industry representatives, government agencies, civil society organizations and
people’s organizations, shall promulgate the necessary regulations for the effective
implementation of this Act within six (6) months from the date of the passage of this Act.

SECTION 14, Repealing Clause ~ All laws, decrees, orders, rules and regulations, policies,
programs or parts thereof, that are inconsistent with any of the provisions of this Act, are hereby
repealed, amended or modified accordingly.

SECTION 15. Separability Clause ~ If for any reason, any section or provisions of this Act is
declared to be unconstitutional or invalid, the other sections or provisions hereof, which are
not affected hereby, shall continue in full force and effect.

SECTION 16, Effectivity ~ This Act shall take effect fifteen (15) days following its publication
in the Official Gazette or in two (2) newspaper of general circulation.

Approved.