Republic of the Philippines
HOUSE OF REPRESENTATIVES
Quezon City

EIGHTEENTH CONGRESS
First Regular Session

House BILLNo. 6411

Introduced By Representative ALLAN BENEDICT S. REYES

EXPLANATORY NOTE

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

Over the last decade, there is a growing concern about 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, 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.

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.

It 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 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
fegulatory 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. “t
JA

HON. ALLAN BENEDICT S. REYES
Representative Lore
3" District, Quezon City

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Republic of the Philippines
HOUSE OF REPRESENTATIVES,
Quezon City

EIGHTEENTH CONGRESS
First Regular Session

HOUSE BILL NO. bald

Introduced By Representative ALLAN BENEDICT S. REYES

Sooranawne

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AN ACT TO BE KNOWN AS “THE PHILIPPINE GENETICALLY MODIFIED
ORGANISN (GMO) LABELING ACT, THE RIGHT-TO-KNOW-ACT” REQUIRING
THE MANDATORY LABELING AND REGULATION OF FOOD WHICH ARE 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 House of Representatives of the Philippines in
Congress assembled

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 undertaking the 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 (GMOs) or are produced by genetic
engineering 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
labeling.

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b)

°)

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SECTION 3. Definition of Terms.

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.

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.

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

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

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

Derivative — Refers to products derived from processing GMO crops, such as but not
limited to, extracts, oil, syrup, powder, flour, etc.

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.

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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.

j) 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:

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;

. 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;

|. 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 person 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 like rice, corn 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).

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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;

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;

“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 sides 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;

|. 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 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;

. 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 c of this Act shall be printed on a tag
that will correspondingly identify the specific item being sold; and

The labeling line shall be as follows:

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

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

3) 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;

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4) 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.

5)

6)

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 Drug Administration Head — Ex-Officio Chairman

b. Department of Agriculture — Ex-Officio

c. Department of Trade and Industry — Ex-Officio

d. Department of Environment and Natural Resources — Ex-Officio
e. Two (2) representatives Academic Sector - Members

f. Two (2) representatives Consumer Sector - Members

g. Two (2) representatives Peasant Sector - Members

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) — There 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:

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1. 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;

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

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

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

5. To conduct motu propio investigations against violators;

6. To act immediately on all verified reports of violations;

7. To issue subpoena duces tecum and ad testificandum to any parties
in the complaint;

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

9. 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;

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

11. To 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;

12. To validate the label annually from the date of approval;

13. 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;

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;

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3. The salaries of the Director and Assistant Director shall be
commensurate to the promulgated rates for civil service;

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, scrutinize 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) and 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%) 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. The accruing funds, including

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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 Clause. — This Act shall take effect fifteen (15) days after

its publication the Official Gazette or in the two (2) national newspaper of general
circulation.

Approved,

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