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

Seventeenth Congress
Second Regular Session

7926

HOUSE BILL NO.

Introduced by Representative Sharon S. Garin

EXPLANATORY NOTE

This proposed Bill seeks to establish an Act to expedite the regulatory decision-
making process in biotechnology to help ensure the health and well-being of Filipinos,
promote competitiveness, help reduce hunger and poverty and help mitigate the effects of
climate change. It is time that safe and responsible use of biotechnology is included in the
Philippine tool kit to meet national development goals. The current regulatory regime, which
is based on outdated knowledge and assumptions, must be revised to enable the Philippines to
benefit from products of modem biotechnology without delay. Support is also needed to
accelerate research and development to further ensure the utility and safety of products of
modern biotechnology.

Right now, it takes 65 months or more to complete all requirements for the
commercial release of modern biotechnology products. The cumbersome regulations can no
longer be justified for they effectively discriminate against local public biotech research
institutions which have limited resources to comply with the existing regulations. This
proposed bill will address this concern.

Biotechnology, is also a tool to address poverty, climate change, health issues and
competitiveness, thereby helping ensure the well-being of Filipinos. Recent statistics (2015)
show that poverty incidence in the Philippines averages about 21.6% of the population; and it
is highest among farmers (34.3%). Biotechnology will increase yields and better products,
leading to more income for our farmers.

The Philippines is also one of the countries most heavily affected by climate change.
Around 20 typhoons visit the Philippines annually. The pattern has been that of increasingly
strong typhoons. The damages caused by typhoons Sendong (2011), Pablo (2012) and
Yolanda (2013) to property and agriculture have been estimated to be PI.7 billion, P14
billion and P40 billion, respectively. Biotechnology, will provide climate and weather
resistant crops that will mitigate the effects of these natural disasters.

‘The National Economic and Development Authority (NEDA) has already highlighted
agricultural biotechnology as a priority sector in agriculture with a direct impact on
Ambisyon 2040. Philippine Development Plan 2017-2022 acknowledges through the
Harmonized National R&D Agenda for Agriculture, Aquatic, and Natural Resources 2017-
2022 that biotechnology is “a tool to find solutions to agriculture, fisheries, and forestry
problems”

Since the 1980s, modem biotechnology has developed many useful products. These
include insulin, and corn that is resistant to borers and to a specific herbicide. These GMO


com plants have helped keep livestock and poultry affordable and improved the profitability
of 406,000 small resource poor Filipino farmers.

Release to the public of GMO products in the pipeline has been delayed because of
cumbersome regulations, which are based on knowledge available during the 1980s. Thus
eggplant farmers depend on chemical pesticides (Bt eggplant, a biotech product developed by
the University of the Philippines, markedly reduces this dependence), and some people suffer
from debilitating Vitamin A deficiency (Golden Rice, a biotech product developed jointly by
the International Rice Research Institute and PhilRice, supplies Vitamin A.)

‘The National Academy of Science and Technology of the Philippines states: “when
used properly, GMOs are good for farmers and for the environment. GM foods are safe for
animals and humans.” The US National Academy for Sciences state: “there is no difference
between traditional and biotech crops in terms of risks to human health, not any negative
effects on environment from biotech crops.” The Food and Drug Administration of the
Philippines state that “all food derived from GM crops in the market have met international
food safety standards and are as safe as and as nutritious as the food derived from
conventional crops” Similarly, the World Health Organization (WHO) declares that “no
effects on human health have been shown as a result of the consumption of GM foods.”

The University of Wisconsin in a survey covering 900 studies of GMOs found no
substantial evidence that foods from biotech crops were less safe than foods from non-biotech
crops. The European Commission (Belgium) concludes: “more than 130 research projects,
covering a period of more than 23 years of research, and involving more than 500
independent research groups, show that biotechnology, and in particular GMOs, are no more
risky than conventional breeding technology.” 107 Nobel laureates pointed out to
Greenpeace, the United Nations, and Governments around the world that there has never
been a single verified case of a negative health outcome of consuming foods improved
through biotechnology. In terms of environmental impact, these products have been
consistently found to be less detrimental to the environment and beneficial to global
biodiversity.

‘These observations are reinforced by the change of heart of former critics. Among
these are Bill Nye,"the Science Guy” who earned a well-deserved reputation as an excellent
science communicator. Bill Nye had expressed misgivings about the safety of GMOs. When
taken to task for voicing opinions that were not supported by the data he showed that he is
truly “the Science Guy” by changing his mind after he evaluated the data more closely.
‘Another is Patrick Moore who was one of the founding member of Greenpeace and served as
President of Greenpeace Canada and Director of Greenpeace International. Over time, he
‘came to realize that the facts did not support many of the opposition campaigns to GMOs. He
is now a staunch supporter of Golden Rice and agricultural biotechnology. In the late 1990s,
Mark Lynas actively opposed GMO crops by participating in vandalism of field trials in the
United Kingdom. After realizing that his support for science-based decisions related to
climate change were inconsistent with his rejection of the science of modern crop
improvement, he issued a public apology stating, among other things, that: “My conclusion
here today is very clear: the GM debate is over. It is finished. Over a decade and a half with
three trillion GM meals eaten there has never been a single substantiated case of harm. You
are more likely to get hit by an asteroid than to get hurt by GM food. More to the point,
people have died from choosing organic, but no one has died from eating GM.”



In view of the foregoing, tha passage of this bill is earnestly sought.

si , GARIN
AAI ra Partylist


Seorourens

"1
12
13
14

15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30

31
32

33

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

Seventeenth Congress
Second Regular Session
26

HOUSE BILL NO.

Introduced by Representative Sharon S. Garin

AN ACT
PROMOTING SAFE AND RESPONSIBLE USE OF MODERN BIOTECHNOLOGY
ESTABLISHING THE BIOTECHNOLOGY AUTHORITY OF THE PHILIPPINES
FOR THIS PURPOSE AND APPROPRIATING FUNDS THEREOF

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

SECTION I. Title. ~ This Act shall be known as the “Modern Biotechnology Act of
2018”.

SEC. 2. Declaration of Policy. — It shall be the policy of the State to support safe and
responsible use of modern biotechnology for the development of bio-based industries in
agriculture, agroforestry, food processing, human health and medicine, and processing of
high value commercial products.

SEC. 3. Objectives. — In pursuit of this policy, this Act shall have the following
objectives:

a) Establish a Biotechnology Authority of the Philippines (BioAP) to provide
leadership in biotechnology industry development and rationalize the
regulation of modern biotechnology;

b) Support strong new & existing programs to develop scientific human
resources in educational and research institutions that are dedicated to modern
biotechnology;

©) Establish state-of-the-art facilities for the development of modern
biotechnology, as well as facilities for processing high value products and
medical (pharmaceutical) preparations with modern _ biotechnology
components; and

4) Provide sustained funding for modern biotechnology programs in agriculture,
agroforestry, food processing, health, and manufacturing high value products
for local and international markets.

SEC. 4. Definition of Terms. — As used in this Act:

a) Genetically modified organism (GMO) refers to an organism whose genetic
material has been altered through genetic engineering;

b) Modern biotechnology refers to techniques for modifying genomes for the
production of new bio-based products;


42
43
44

c) Genome is the genetic material containing all the information needed to build
and maintain an organism;

d) Product-based regulatory approach refers to the assessment of the merits of
the endproduct rather than the process used to produce it;

©) Science-based regulatory approach refers to the application of knowledge and
criteria derived from consensus of independent academies of science and
similar scientific bodies, as opposed to opinions of indi

CHAPTER II
THE BIOTECHNOLOGY AUTHORITY OF THE PHILIPPINES

SEC 5. Biotechnology Authority of the Philippines (BioAP) — To implement the
provisions of this Act, the Biotechnology Authority of the Philippines (BioAP) is hereby
established. It shall be attached to function as an agency of the Department of Science and
Technology (DOST).

It shall review existing regulatory bodies & processes with a view to rationalize and
integrate the regulatory decision-making process in consultation with competent national
government agencies.

The National Committee on Biosafety of the Philippines (NCBP) and other modern
biotech regulatory bodies shall henceforth be abolished, and their functions shall be absorbed
by the BioAP.

SEC. 6. Functions of the BioAP — The BioAP shall perform the following functions:

a) Formulate strategies, policies and guidelines for modern biotechnology
programs and projects in the Philippines with priority on agriculture,
agroforestry, health and medicine, and processing high value food and health
products for the local and international markets;

b) Review, improve, and implement biosafety regulations for products of modern
biotechnology and ensure that they are science-based and simplified with a
productbased and not a process-based regulatory approach;

©) Promote capacity building in modern biotechnology in line with international
policies followed by developed countries in educational and R&D institutions
by strengthening biotechnology taking into account the attainment of national
development goals;

4) Support government educational and R&D institutions to develop long-term
programs in modern biotechnology which will serve as basis for sustainable
funding;

©) Lead public information and education programs to highlight the benefits that
can be derived from modern biotechnology;

f) Serve as arbiter of all issues relating to biotechnology, particularly those
involving biosafety of GM‘

2) Absorb and carry out all functions of the National Committee on Biosafety of
the Philippines (NCBP) and other modern biotech regulatory bodies.

SEC. 7. Members — The BioAP shall consist of the following members to be
appointed by the President, upon the recommendation of the Secretary of DOST, for a five-
year term, renewable for another term or more in exceptional cases:



a) The DOST Secretary or a designated Undersecretary;
b) Four members to be recommended by the National Academy of Science and
‘Technology of the Philippines (NASTPhil);
©) Two members to be recommended by the Philippine Chamber of Commerce
andIndustry (PCCI).

SEC. 8. Secretariat - The BioAP shall have a Secretariat headed by an Executive
Director to be appointed by the President of the Philippines upon recommendation by the
DOST Secretary. The Executive Director should have at least 10 years of professional
experience in managing R&D programs.

CHAPTER IIT
BIOSAFETY ASSESSMENT

SEC. 9. Science-based Biosafety Guidelines - The Authority shall ensure that the
goverment formulates and strictly implements science-based biosafety guidelines and
regulations.

SEC. 10. Assessment — Biosafety regulations shall have two stages: (1) biosafety
assessment covering efficacy and safety to the environment, animal and human health, and
(2) commercial competitiveness and related criteria. In all cases, assessment shall be product-
based, and not process-based.

SEC. 11. Product Safety Committees — Each and every public and private R&D
organization shall have a product safety committee. Every one of these committees shall
perform biosafety assessment of all biotechnology and certify that these products to be
submitted for BioAP’s approval shall have passed biosafety assessment in accordance with its
guidelines.

CHAPTER IV
IMPORT AND EXPORT OF GMOS

SEC. 12. International Commitments — In case of conflict between international

‘commitments and the science-based, product-oriented approach, the latter shall prevail.

CHAPTER V
PROHIBITED ACTS AND PENALTIES
SEC. 13. Prohibited Acts — The following acts shall be prohibited and shall be
penalized accordingly:
a) Unauthorized destruction of biotech crops, whether the crops are used for
experimental objectives or for production;

b) Sale or distribution of fake GMO seeds;
©) Any other acts that are inimical to the safe and responsible use of modem
biotechnology and are violative of the regulations set by the BioAP.
SEC. 14. Penalties — For any violation of the provisions of this Act, and regulations
approved by BioAP the following penalties and/or fines shall be imposed:
a) Imprisonment for two (2) years and/or fine of five hundred thousand pesos
(Php500,000) if violation is made by an individual;


b) Fine of ten (10) million pesos (Php 10,000,000) if violation is made by an
institution or organization and/or suspension of privilege to operate within the
Philippines.
Violations of this Act shall not exempt violators from other pertinent laws, rules and
regulations that may have also violated by an individual or an organization.

CHAPTER VI
MISCELLANEOUS PROVISIONS

SEC. 15. Exemption From Taxes and Government Procurement System — Any
donation, contribution, bequest, subsidy, or financial aid to the BioAP or any Department,
SUC, or research center in support of modern biotechnology shall constitute allowable
deductions from taxable income of the donor, and shall be exempt from donor’s tax.

The provisions of Republic No. 9184, otherwise known as the “Government
Procurement Reform Act” shall not apply to the procurement of all items, supplies, materials,
and general support services including consulting services, which may be needed by
departments, agencies, state universities and colleges, government-owned or controlled
corporations, and organizations in the pursuit of any modern biotechnology-related R&D
undertaking, project or activity.

For this purpose, the DOST Secretary shall certify such procurement whether in the
nature of equipment, furniture, as well as trucking, hauling and related or analogous services.
The Office of the DOST Secretary, through BioAP, shall create the guidelines for such
procurements, subject to existing rules and regulations of the Commission on Audit.

CHAPTER VII
IMPLEMENTING PROVISIONS

SEC. 16. Implementing Rules and Regulations ~ Within six (6) months following the
effectivity of this Act, the BioAP shall be activated by the DOST Secretary and BioAP
Executive Director. All members of the BioAP shall work together to produce the IRR within
three months.

SEC. 17. Appropriations — The amount of Five Hundred Million Pesos (P500,000,000)
is hereby allotted to initially implement the provisions of this Act. Thereafter, the funding
needed to fully implement the provisions of this Act shall be included in the annual General
Appropriations Act.

SEC. 18. Separability Clause — If any provision or part of this Act is declared invalid
or unconstitutional, the remaining parts or provisions not affected shall remain in full force
and effect.

SEC. 19. Repealing Clause — All laws, decrees, executive orders, proclamations, rules
and regulations, and issuances, or parts thereof, which are inconsistent with the provisions of
the Act are hereby repealed or amended accordingly.

SEC. 204. Effectivity ~ This Act shall take effect fifteen (15) days after publication in
the Official Gazette or two (2) newspapers of general circulation.

Approved,