a>
EX

” Reckiven
bun 27 SEP 2016 ©

Republic of the Philippines
HOUSE OF REPRESENTATIVES
Quezon City
SEVENTEENTH CONGRESS.

First Regular Sessi
HOUSE BILL NO. ves 8

Introduced by Representative Divina Grace C. Yu

EXPLANATORY NOTE

There is a rapid expansion of the use of modern biotechnology not only for scientific
research but also for products for commercial releases and purposes. However, concerns
were raised over modern biotechnology’s potential impacts on the environment, particularly
‘on biological diversity, on human health, and on social and cultural well-being, In order to
lessen or to totally prevent these adverse potential impacts, the Cartagena Protocol on
Biosafety to the United Nations Convention on Biological Diversity which the Philippines is a
signatory, was entered into force on 11 September 2003.

To enhance the existing biosafety framework to better respond to the challenges
presented by further advances in modern biotechnology and to comply with the
administrative requirements of the Cartagena Protocol on Biosafety, Executive Order No.
514, dated 17 March 2006 was issued and established the National Biosafety Framework and
strengthened the existing National Committee on Biosafety of the Philippines.

Significantly, the United Nation (UN) General Assembly, during the tenth meeting of
the Conference of Parties to the CBD in Nagoya Japan on October of 2010, recommended for
the UN to declare 2011-2020 as the Decade on Biodiversity. Consistent with such
declaration, former President Benigno C. Aquino IIT issued Proclamation No. 178 which
declared the years 2011-2020 as the National Decade on Biodiversity in the Philippines. The
Proclamation likewise “enjoined all branches and agencies of the government,
including government-owned and controlled corporations, local government units,
and state universities and colleges to initiate activities to promote biodiversity
conservation, in cooperation with the private sector, community organizations and
non-government organizations.”

It is therefore imperative to institutionalize the National Biosafety Framework and
the National Committee on Biosafety (NCMB) to fully implement and realize the country’s
role and undertaking under the Cartagena Protocol and the United Nations declaration of
Decade on Biodiversity.

In view hereof, approval of this bill is earnestly sought and recommeded.

DIVINA GRACEC.

1|



Republic of the Philippines
HOUSE OF REPRESENTATIVES
Quezon City
SEVENTEENTH CONGRESS

First Regular Sexi
HOUSE BILL nooo 8

Introduced by Representative Divina Grace C. Yu

AN ACT
STRENGTHENING THE NATIONAL BIOSAFETY FRAMEWORK AND
INSTITUTIONALIZING THE NATIONAL COMMITTEE ON BIOSAFETY OF THE
PHILIPPINES, APPROPRIATING FUNDS THEREFOR AND FOR OTHER
PURPOSES.

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

ARTICLE I
DECLARATION OF POLICY AND FRAMEWORK

SECTION 1.Title. This Act shall be known as the “National Commission on
Biosafety of the Philippines Act of 2016”

SEC. 2.Declaration of Policy. Itis the policy of the state to protect and promote
the right to health of the people and instil health consciousness among them. The protection
and advancement of the right of the people to a balanced and healthful ecology in accord
with the rhythm and harmony of nature is likewise declared by the State. To fulfill these, the
State is mandated to promote the safe and responsible use of modern biotechnology and its
produets as one of the several means to achieve and sustain food security, equitable access to
health services, sustainable and safe environment and industry development.

SEC, 3.National Biosafety Framework (NBF). There is hereby instituted in
this Act a National Biosafety Framework with the following scope and objectives:

3.1. Scope. The NBF shall apply to the development, adoption and
implementation of all biosafety policies, measures and guidelines and in making biosafety
decisions concerning the research, development, handling and use, transboundary
movement, release into the environment and management of regulated articles.

3.2 Objectives. The NBF shall have the following objectives:
1 Strengthen the science-based determination of

biosafety to ensure the safe and responsible use of
modern biotechnology so that the Philippines and its

21


citizens can benefit from its application while avoiding
or minimizing the risks associated with it;

3.2.2 Enhance the decision-making system on the application
of products of modern biotechnology to make it more
efficient, predictable, effective, balanced, culturally-
appropriate, ethical, transparent and participatory; and

3.2.3 Serve as guidelines for implementing international
obligations on biosafety.

SEC. 4.Definition of Terms. For purposes of this Act, the following terms shall
mean:

4.1 “Biosafety” - refers to a condition in which the probability of harm, injury
and damage resulting from the intentional and unintentional introduction
and/or use of a regulated article is within the acceptable and manageable
levels;

4.2 “Biosafety Clearing House” — refers to an information exchange
mechanism established by the Cartagena Protocol on Biosafety to assist
parties in the implementation of its provisions and to facilitate sharing and
exchange of scientific, technical, environmental and legal information on, and
experience with, regulated articles;

43 “Biosafety Decisions” - refers to the development, adoption and
implementation of all biosafety policies, measures and guidelines and in
making decisions concerning the research, development, handling and use,
transboundary movement, release into the environment and management of
regulated articles;

4.4 “Contained use” - means any operation undertaken within a facility,
installation or other physical structure, which involves genetically modified
organisms that are controlled by specific measures that effectively limit their
contract with, and their impact on, the external environment

4.5 “Genetically modified organism” also refers to “living modified
organism’ under the Cartagena Protocol on Biosafety refers to any living
organism that possesses a novel combination of genetic material obtained
through the use of modern technology;

4.6 “Handling and use” ~ means the process by which regulated articles are
moved, carried, transported, delivered, stored or worked with;

4.7 “Hazard” ~ refers to traits inherent to or activities of a regulated article that,
may cause harm to human or animal health or to the environment;

4.8 “Management” ~ means measures adopted after the release of regulated
articles to ensure their safe use and, in cases of commercial release, shall also
include product monitoring and product identification;

4.9 “Modern Biotechnology” - means the application of: a) in vitro nucleic
acid techniques, including recombinant deoxyribonucleic acid (DNA) or direct,
injection of nucleic acid into cells or organelles; b) fusion of cells beyond the
taxonomic family, that overcome natural physiological reproductive or
recombination barriers and that are not techniques used in traditional
breeding or selectior

410 “Product identification” refers to information on the presence of
a regulated article in a particular product, as implemented by concerned

3|P



departments and agencies through import and export documents, unique
identification system, or similar applicable approaches such as product
labeling;

4a “Produet Monitoring”- refers to any post-commercialization
‘measure that provides data on thefate and effects of the regulatedarticle, in
order to confirmeompliance with _regulatoryrequirements, collect
informationnecessary for controlling andmanaging potentially adversepublie
health or environmentalsituations, assess environmentalquality and detect
unexpected orpotentially damaging effects onhuman and animal health and
theenvironment. Product monitoringhelps reduce uncertaintyremaining from
risk assessment,confirm conclusions _withadditional data and
provideinformational feedback on systemstatus or conditions;

412 “Regulated article”- refers to agenetically modified organism and

4.13 refers to the combinationof the likelihood that an
adverseconsequence of a biohazardousactivity or trait will occur and
themagnitude of such aconsequence;

414 “Risk assessment” -refers to theprocedure that identifies,
evaluatesand predicts the occurrence ofpossible hazards to human andanimal
health and the environmentand designs mitigating measuresto avert or
minimize thesehazards;

4.45 “Risk management”- refers toappropriate mechanisms,measures
and strategies to identified in the risk assessment including those conditions
imposed by concerned departments or agencies;

416 “Transboundary movement” - means the movement of a
regulated article from another country to the Philippines; and
417. “Transformation event”- means one instance of entry, stable

integration and expression of an introduced gene into a cell which then
develops into a functional organism expressing the introduced gene.

ARTICLE IT
‘THE NATIONAL COMMISSION ON BIOSAFETY

SEC. 5. The National Commission on Biosafety of the Philippines
(NCBP).To support the above stated policy, the National Committee on Biosafety of the
Philippines is hereby institutionalized and shall be known as the “National Commission
on Biosafety of the Philippines (NCBP)"under the Department of Science and
‘Technology. The NCBP shall be the lead body to coordinate and harmonize inter-agency and
multi-sector efforts to develop biosafety policies in the country and set scientific, technical
and procedural standards on actions by agencies and other sectors to promote biosafety in
the Philippines; oversee the implementation of the NBF; act as a clearing house for biosafety
matters; and coordinate and harmonize the efforts of all concerned agencies and
departments in this regard.

‘The operationalization of the NCBP in the implementation of the NBF shall be guided
by the following principles:

4iP



1. Policy on Modern Biotechnology. The NBF shall be implemented in the
context of the overall policy of the Philippines on modern biotechnology, to wit: The
state shall promote the safe and responsible use of modern biotechnology and its
products as one of the several means to achieve and sustain food security, equitable
access to health services, sustainable and safe environment and industry
development;

2, Policy on Sustainable Development. The overall policy of the Philippines on
sustainable development, as laid down in Philippine Agenda 21, shall equally guide
the implementation of the NBF;

3. A Balanced Approach. A balanced approach, which recognizes both the
potential benefits and risks, shall guide the implementation of the NBF. This shall be
based on the recognition that modern biotechnology has significant potential for
human well-being if developed and used with adequate safety measures for the
environment and human health. Such approach recognizes both the potential
benefits and risks of moder biotechnology to human health, agricultural
productivity, food security, the livelihoods of the poor, biological diversity and the
environment;

4.A Scientific Approach. The implementation of the NBF shall be based on the
best available science and knowledge. Such science and knowledge shall be of the
highest quality, multi-disciplinary, peer reviewed, and consistent with international
standards as they evolve.

5. Socio-economic, Cultural and Ethical Consideration. The socio-economic,
ethical and cultural benefits and risks, of modern biotechnology to the Philippines
and its citizens, and in particular on small farmers, indigenous people, women, small
and medium enterprises and the domestic scientific, community, shall be taken in to
account in implementing the NBF;

6. Using Precaution. In accordance with principle 15 of the Rio Declaration of
1992 and the relevant provisions of the Cartagena Protocol on Biosafety, in particular
Articles 1, 10 (par. 6) and 11 (par.8), the precautionary approach shall guide biosafety
decisions. The principles and elements of this approach shall hereby
implementedthrough the decision making system in the NBF;

7. Transparency and Public Participation. Decision taken under the NBF shall
be arrived at in a transparent and participatory manner. Biosafety issues are best
handled with the participation of all relevant stakeholders and organizations. They
shall have appropriate access to information and the opportunity to participate
responsibly and in accountable manner in biosafety decision making-processes;

8. Consensus Building. In making biosafety decisions, all concerned government
departments and agencies shall exert all efforts to find consensus among all relevant
stakeholders using well-accepted methods such as negotiation, mediation, and other
appropriate dispute resolution processes. Such consensus, to be achieved in a
transparent and participatory manner, shall be based on the best available science
and knowledge and shall not compromise public safety and welfare;

5?


9. Principle of Subsidiarity. As provided by law and where competence exists, all
levels of government, including local government units, shall participate in
implementing the NBF;

10. Availability of Remedies. Effective access to judicial and administrative
proceedings, including redress and remedy, shall be available in accordance with
Philippine law;

11, International Obligations and Cooperations. In accordance with
international law, the NBF shall be implemented in a manner consistent with and
mutually supportive of the international obligations of the Philippines, in particular
its obligations under international trade and environmental law. Multilateral,
regional and bilateral cooperation in implementing the NBF, in particular its sections
on capacity building and financial resources shall be encouraged;

12.Efficient Administration and Timely Decision Making. The NBF decision
making process shall be conducted in an efficient, coordinated, effective, predictable,
cost-effective and timely manner. Undue delay shall be avoided without
compromising transparency, public participation, public safety, and public welfare;
and

13.Publie interest and welfare. In cases of conflict in applying these principles,
the principle of protecting publie interest and welfare shall always prevail. No section
or provision in the Framework shall be construed as to limit the legal authority and
mandate of heads of departments and agencies to consider the national interest and
public welfare in making biosafety decisions.

SEC. 6. Composition of the NCBP. The NCBP shall be headed by the Secretary of
the Department of Science and Technology (DOST) as the permanent Chairperson.

The NCBP members shall be the following:

‘The Secretary of the Department of Agriculture;

‘The Secretary of the Department of Health;

‘The Secretary of the Department of Environment and Natural Resources;

‘The Secretary of Foreign Affairs

‘The Secretary of the Department of Trade and Industry

‘The Secretary of the Interior and Local Government

A Consumer representative appointed by the President from a list submitted
by nationally recognized consumer organizations, serving for a term of three
(3) years, renewable for another term;

h. A representative from industry appointed by the President from a list
submitted by the Secretary of Trade and Industry, serving for a term of three
(3) years, renewable for another term; and

A biological scientist, physical scientist, environmental scientist, health
scientist, and social scientist to be endorsed by the DOST Secretary upon the
recommendation of recognized professional and collegial bodies such as the
National Academy of Science and Technology (NAST), The National Research
Council of the Philippines (NRCP) and the Philippine Social Science Council

6|Page

emeaoge



(PSSC), and appointed by the President, each serving for a term of three (3)
years, renewable for another term

SEC. 7. NCBP Executive Committee and Technical Working Groups. The
NCBP may create an Executive Committee and Technical Working Groups as it deems

necessary and appropriate.

SEC. 8. NCBP Secretariat. The NCBP shall create a Secretariat that shall be based
in the DOST. All other concerned agencies may be called upon to participate in the functions

of the Secretariat.

SEC. 9. Powers and Functions of the NCBP. As the lead body in implementing
the NBF, the NCBP shall have the following powers and functions:

9.1 Biosafety Policy functions:

9.1.1 Assist concerned departments and agencies in formulating,
reviewing, or amending their respective policies, measures and
guidelines on biosafety;

9.1.2 Hold public deliberations on proposed national policies,
guidelines, and other biosafety issues;

9.1.3 Provide assistance in the formulation, amendment of pertinent
laws, rules and regulations;

9.1.4 In coordination with concerned departments and agencies and
consistent with the requirements of transparency and public
participation as provided in Sections 6 and 7 of the NBF, shall
take the lead in periodically reviewing the NBF;

9.15 Issue detailed guidelines on the conduct of socioeconomic
impact evaluation of biosafety decisions; and

9.1.6 Propose to Congress necessary and appropriate legislation.

9.2Accountability Functions:

9.2.1 Monitor the implementation of the NBF by concerned
departments and agencies;

9.2.2 Ensure coordination among competent national authorities
that have shared mandates;

9.2.3 Ensure that NCBPguidelines, and the principlesand processes
established in this Framework are complied with by concerned
departments and agencies; and

9.2.4 Review procedures for accountability in biosafety decision~

making by competent national authorities, with particular
emphasis on ensuring independence and impartiality in such
decisions.

9.3 Scientific Functions:

934

Facilitate the study and evaluation of biosafety research and
control and minimize the concomitant risks and hazards

71


9.3.2

9.33

934

9.35

9.3.6

93.7

93.8

9.3.9

associated with the deliberate release of regulated articles in
the environment;

Identify and evaluate potential hazards involved in modern
biotechnological experiments or the introduction of regulated
articles and recommend measures to minimize risks;
Recommend the development and promotion of research
programs to establish risk assessment protocols and
assessment of long-term environmental effects of regulated
articles;

Develop working arrangements with the government
quarantine services and institutions in the evaluation,
monitoring, and review of projects vis-ivis adherence to
national policies and guidelines on biosafety;

Review and develop guidelines in the risk assessment of
regulated articles for contained use;

Assist other agencies in developing risk assessment guidelines
and procedures of regulated articles for field trials and
commercial release;

Review the appointment of the members of the Institutional
Biosafety Committees created _byinstitutions engaged
inactivities involving regulatedarticles, uponrecommendation
by theirrespective heads ofinstitutions;

Publish the results of internaldeliberations and agencyreviews
of the NCBP;

Hold discussions on thecomparative ecological,economic and
socialimpacts of alternativeapproaches to attain the
purposes/objectives of the proposed genetic modification
products and/or services; and

9.3.10 Perform such functions as may be requested by concerned

departments and agencies.

0.4 Capacity Building Functions:

4k

9.4.2

Assist in the development of technical expertise, facilities, and
other resources for quarantine services and risk assessments;
and

Take the lead in developing and implementing a national
capacity-building program for biosafety.

SEC. 10.Public Information. The NCBP shall promote and facilitate public
awareness, education and participation, includingaccess to information, and also requires
mandatory public consultation anddisclosure of results of decisions to the public in the

decision-making process.

SEC. 11.Community Participation Agreements. - Agreements may be forged
between the communities where these areas of biodiversity can be found and any public or
private agency for the conduct of biodiversity prospecting activities within their areas of
jurisdiction. Any responsible local government unit, duly-accredited people's organization
non-government organization-or private corporate entity may take the initiative in

8]


organizing the communities concerned to enable them to participate in biodiversity
agreements.

‘The consent of the communities concerned shall be secured before any biodiversity
prospecting activities may be conducted to attain the purposes of this Act.

SEC. 12.Respect to the Indigenous Cultural Communities. - The customs,
beliefs and practices of the indigenous cultural communities with respect to biodiversity
shall be given primary consideration and respect in the conduct of biodiversity prospecting
activities in accordance with the provisions of this Act.

The customary use of these biological resources shall be promoted and encouraged in
accordance with the cultural practices which are compatible with conservation or sustainable
use requirements,

SEC. 13.Implementing Rules and Regulations. The DOST, DA, DOH, DENR,
DTI, DFA, DILG with the participation of the representatives from the consumer and
industry sector and other stakeholders, shall formulate the IRR for the effective
implementation of this Act. The DOST Secretary shall chair the drafting committee. The IRR
shall be issued within ninety (90) days after the effectivity of this Act. Copies of the IRR shall
be submitted to the Committees on Science and Technology of both Houses of Congress
within thirty (30) days after its promulgation, as well as to other appropriate agencies as may
be required by law.

SEC. 14.Funding-The DOST, DENR, DA and DOH shall allocate funds from their
present budgets for the initial implementation of this Act. Thereafter, the funding
requirements shall be included in the budget of DOST of the year following the enactment of
this Act.

SEC. 15.Separability Clause. If any provision of this Act shall be held
unconstitutional or invalid, the other provisions not otherwise affected shall remain in full
force and effect.

SEC. 16.Effectivity. This Act shall take effect after fifteen (15) days following the
date of its publication in the Official Gazette or in two (2) newspapers of general circulation
whichever comes earlier.

Approved.

91