A Report for the

National
Committee on
Biosafety of the
Philippines (NCBP)

BIOSAFETY REGULATIONS IN
THE PHILIPPINES:
A Review of the First Fifteen Years,
Preparing for the Next Fifteen

Submitted by
The National Academy on Science and Technology (NAST)

© 2009 by the National Academy on Science and Technology (NAST),

Department of Science and Technology (DOST),
National Committee on Biosafety of the Philippines (NCBP),
and the Program for Biosafety Systems (PBS).
All rights reserved.
 Prepared for the
National Academy of Science and Technology
by:

Acd. Evelyn Mae Tecson Mendozaa, PhD

Roberta N. Garciaa, PhD
Maridon Sahagunb, MS
Antonio C. Laurenaa, PhD

aInstituteof Plant Breeding, Crop Science Cluster, College of

Agriculture, University of the Philippines Los Baños, College, Laguna
4031; and
bPhilippine Council for Advanced Science and Technology Research

and Development (PCASTRD)-Department of Science and Technology,

Bicutan, Metro Manila.

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 TABLE OF CONTENTS

Glossary of Terms 5
Acronyms 5
List of Boxes 6
List of Figures 6
List of Tables 6
Messages of the former NCBP Chairmen 7-10
Introduction 11
Historical Background 12
The NCBP—Structure, Mandates and Procedures 13
Organizational Structure 14
Mandates 15
Procedure of Submission and Review 16
Development and Strengthening of the Philippine
Biosafety System 18
Biosafety Guidelines for Contained Facility Tests 18
Guidelines on Planned Release of GMOs 18
Guidelines on Commercialization 19
Strengthening the Capability of the NCBP,
Regulatory Agencies and the IBCs 20
Transparency and Public Participation 21
Summary of Proposals Submitted to NCBP and
NCBP Actions in the Past Fifteen Years 24
Defining Moments in NCBP History 29
NCBP Guidelines and International Biosafety
Guidelines 31
Difficulties and Limitations 31
Assessment of NCBP Guidelines and Practices 31
Very Strict Guidelines and Equally Strict
Implementation 32

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 Page

Difficult and Long Application Process 33

New Products of Modern Biotechnology and Potential
Challenges 35
New Biotechnology Products Now Available in
Other Countries 37
New Biotechnology Products under Development 37
New Regulatory Challenges 39
The New National Biosafety Framework under EO 514 40
Introduction 40
Salient Features 40
Composition and mandates of the new NCBP 42
Implementing Rules and Regulations 43
Concerns about the New NBF 43
Other Issues and Concerns 45
Adventitious Presence of GMOs 45
Labeling of Products Containing GMO 45
Recommendations 45
Acknowledgments 47
References 48

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 GLOSSARY OF TERMS

“Biosafety” is 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 acceptable and
manageable levels.

“Genetically modified organisms” or GMO refers to any living organism that possesses a novel
combination of genetic material obtained through the use of modern biotechnology. GMO also
refers to living modified organism as defined by the Cartagena Protocol on Biosafety.

“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;
or (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 selection.

“Recombinant DNA” is a DNA molecule into which a foreign DNA has been inserted.

“Risk assessment” refers to the procedure that identifies, evaluates and predicts the occurrence of
possible hazards to human and animal health and the environment and designs mitigating
measures to avert or minimize these hazards.

“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.

“Transgenic” means an organism whose cells, including the germline cells, contain foreign DNA.

Definitions obtained from: Philippine Biosafety Guidelines Series 1 and 3, EO 514 and the
Cartagena Protocol.

ACRONYMS
APHIS, Animal and Plant Health Inspection Service
AVRDC, Asian Vegetable Research and Development Center
BPI, Bureau of Plant Industry
BSC, Biosafety Committee
CBD, Convention on Biological Diversity
DA, Department of Agriculture
DENR, Department of Environment and Natural Resources
DOE, Department of Energy
DOH, Department of Health
DOST, Department of Science and Technology
EO, Executive Order
FAO, Food and Agricultural Organization
GRAS, Generally Regarded as Safe
IBC, Institutional Biosafety Committee
IRRI, International Rice Research Institute
NAST, National Academy of Science and Technology Philippines
NBF, National Biosafety Framework
NCBP, National Committee on Biosafety of the Philippines
NEPA, National Environmental Policy Act
NGO, Nongovernment organizations

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PCASTRD, Philippine Council for Advanced Science and Technology Research and
Development
STRP, Scientific and Technical Review Panel
UPLB, University of the Philippines Los Baños
US DA, United States Department of Agriculture
US FDA, United States Food and Drug Administration
US NAS, United States National Academy of Sciences
US NRC, United States National Research Council, an organization of the US NAS
WHO, World Health Organization (of the United Nations)

LIST OF BOXES

Number Page
1 Roundtable Discussions Sponsored by the NCBP-NAST 11
2 List of NCBP Chairs (1990–2008) 18
3 Policy Statement of President Gloria M. Arroyo 20

LIST OF FIGURES
Number Page
1 Organizational structure of the NCBP. 14
2 Distribution of submitted proposals by type of proponent. 27
3 New traits and strategies for the biotechnology generations. 36

LIST OF TABLES
Number Page
1 Number of public consultations/seminars sponsored by NCBP, training by 21
NCBP members and secretariat and activities participated in by NCBP as
resource persons.
2 Summary of research proposals submitted to NCBP and its actions from 25
1991–2006.
3 Number of research proposals submitted to the NCBP by various 26
institutions from 1991–2006.
4 Topics of proposals submitted to the NCBP for approval (1991-2007). 27
5 Length of time for NCBP to take action on biosafety proposals. 34
6 Summary of new traits and organisms which may pose new challenges to 38
biosafety regulations.

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 MESSAGE

It is a pleasure writing a message for this book: “Biosafety Regulations in the Philippines”.
The book chronicles NCBP’s creation and development as a regulatory body and projects its role in
meeting the challenges in the next fifteen years.

In the 1980s, efforts in recombinant DNA technology work in leading laboratory centers
around the world were already making significant progress in the development of crop resistance
against major pests and diseases. In the 1990s, advanced transgenic lines of crops were already at
the field-testing stage in lead countries. By the end of the decade, commercial releases of
outstanding transgenic varieties of maize, soybeans and cotton were already being made in the
U.S. Commercial releases were allowable only after the transgenic varieties had undergone and
passed a series of rigid biosafety evaluations. Once the floodgates opened, rapid spread in the
growing of transgenic crops in other countries, notably Brazil and Argentina, and the use of their
products for food and feed worldwide became inevitable.

With these international developments, concerns began developing in the Philippines

about the need to have a central authority that can deal with issues concerning the entry of GMOs
and exotic materials that may likely pose a hazard to human health and the environment. After
undertaking a thorough preparatory groundwork by the science community in Los Baños and the
National Academy of Science and Technology (NAST), the efforts culminated in the signing of
Executive Order 430 by then President Corazon C. Aquino on October 15, 1990, creating the
National Committee on Biosafety of the Philippines (NCBP).

As Undersecretary for R&D at DOST at the time, I became personally involved in the
whole affair of organization of the NCBP. This included the drafting of an executive order, the
choice of the first line-up of people who would constitute the membership of the NCBP, the setting
up of a functional “command center” at the DOST, the conduct of a continuing series of national
consultations and publication of the first set of regulatory rules in 1991.

I am pleased to say that the NCBP has lived up to its

name in effectively carrying out its mandate. With time, the
NCBP has matured as an organization, with some facets of its
authority decentralized and given to the quarantine agencies
of the DA. The newly released varieties in the Philippines
have proven their worth in terms of increased yield
advantage and high degree of resistance to pests in the
regions where they have been commercialized and, thus,
have assured the farmers of higher profitability.

I have high hopes for the continued success of the

NCBP, even as it faces greater challenges in the years ahead.

Ricardo M. Lantican, Ph.D.

NCBP Chairman
(October 1990 – December 1992)

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 MESSAGE

The emergence of modern biotechnology, including the powerful tools of analyzing

and modifying genes, has generated considerable interest among scientists and the
public. The scientists engaged in research in modern biotechnology are committed to the
responsible use of these tools so that they should benefit mankind. It is in this spirit that
the regulatory framework for genetic modification and related activities were formulated
and adopted.

While there is much public discussion about the benefits derived from research in
modern biotechnology, there is no doubt that the assurance of a scientifically credible
and functional regulatory framework lends assurance to the public that the activities are
done within the boundaries that are scientifically defensible and responsible.

The Philippines is one of the Asian countries that established this regulatory
framework at the very early stage of enhanced global activity in modern biotechnology
research. This biosafety regulatory framework is globally recognized as scientifically
rigorous but functional. This same framework is also a testament to the workings of the
collective expertise that has not only formulated the guidelines but also implemented the
same.

There is no doubt that more and more activities in modern biotechnology in the
Philippines will be reviewed through the lens of this regulatory framework and guidelines
and that the high standards of scientific scrutiny will continue to be maintained.

William G. Padolina, Ph.D.

NCBP Chairman
(January 1993 – December 1994)

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 MESSAGE

This review of biosafety regulations in the Philippines, drawn primarily

from the experience of NCBP’s first fifteen years and synthesized from the
roundtable discussions sponsored by NCBP-NAST, cannot be more timely. Even
more so with the “new” NCBP under the National Biosafety Framework.
Likewise, with new biotechnologies under development come new regulatory
challenges.

The experience of the past, together with the challenges of the present do
require a revisit of the existing NCBP guidelines and their implementing
mechanisms “to ensure the safe use of the products of modern biotechnology in
the Philippines”.

As one of the former chairmen of the NCBP, I would like to express my

deep appreciation to the leadership and staff of the NCBP and the NAST for
undertaking this review with a view to plan and better meet the needs of the
various stakeholders involved in the science-based risk assessment of modern
biotechnology.

Rogelio A. Panlasigui, Ph.D.

NCBP Chairman
(April 1999 – December 2005)

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 MESSAGE

The book, “Biosafety Regulations in the Philippines,” documents the milestones

as well as the struggles from the time the National Committee on Biosafety of the
Philippines was established in 1990 on the basis of Executive Order No. 430
signed by President Corazon C. Aquino.

The aim of E0 430 was to put in place a regulatory framework that will ensure an
adequate level of protection for the safe transfer, handling, and use of genetically
modified organisms resulting from modern applications of biotechnology. At that
time, we knew little about the impact of GMOs on an environment’s biodiversity
and the possible risks on human and animal health, especially in cases of
transboundary movement.

Today, the spirit of the original framework lives on, but as this book describes in
its pages, our knowledge and understanding of the possible risks posed by
GMOs have been greatly enhanced to such a degree that many of the strict
standards originally set in place for field releases have been amended and, in
some cases, relaxed. We will continually evaluate the soundness of our
regulatory measures in conjunction with the influx of new knowledge, techniques,
and tools deployed for biotechnology research, for it is imperative that as
scientific horizons expand, so too must the ethical and social dimensions that
govern them. We at the NCBP shall ensure that biotechnology activities
undertaken in the Philippines are done in a manner that prevents or reduces the
risks to the country’s ecological integrity.

Estrella F. Alabastro, Ph.D.

NCBP Chairperson
(Jan. 1995 – Nov. 1998 and Jan. 2006–present)

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 Introduction

In 1990, the first biosafety system in the developing world was established in the
Philippines by Executive Order No. 430. Designated to implement the biosafety system was the
National Committee on Biosafety of the Philippines (NCBP) with the principal responsibility of
identifying and evaluating potential hazards in genetic engineering experiments or in the
introduction of genetically modified organisms into the country. The NCBP is also mandated to
formulate and review national policies and guidelines on biosafety.

Fifteen years after its establishment, the NCBP has thought it best to look back and draw
lessons from its experiences and to plan for the next fifteen years with the other stakeholders in the
biosafety system. In September 2006, the NCBP requested the National Academy of Science and
Technology to conduct round table discussions with experts and stakeholders in the biosafety
system with the following objectives:

(a) Discuss the development of the biosafety system in the Philippines from 1990–2005,
taking into account parallel developments in the international arena;
(b) Review the current state of knowledge (global and domestic) on modern biotechnology
and biosafety;
(c) Document relevant experiences of various biosafety system stakeholders from 1990–
2005;
(d) Identify potential challenges to the current biosafety system in the next fifteen years;
and
(e) Explore possible institutional responses to future challenges to the biosafety system,
with focus on probable developments from 2005–2020.

Thus, from September 2006 to July 2007, five round table discussions to address these
points were held (Box 1).

This monograph synthesizes the proceedings of the five round table discussion activities,
relevant documents and literature and related seminars sponsored by other organizations to
address the objectives earlier cited.

Box 1. Roundtable Discussions Sponsored by NCBP-NAST

RTD 1. The National Committee on Biosafety of the Philippines: Looking Back and Moving
Forward. Speaker: Atty. Jose Maria A. Ochave, Member, NCBP. September 7, 2006.

RTD 2. Workshop on Relevant Experiences of Various Biosafety System Stakeholders. Speaker:

Dr. Dolores A. Ramirez, National Scientist and Vice Chair, NCBP. October 11, 2006.

RTD 3. The New National Biosafety Framework: EO 514. Resource Person: Dr. Reynaldo V.
Ebora, Executive Director, Philippine Council for Advanced Science and Technology
Research and Development (PCASTRD), DOST. November 13, 2006.

RTD 4. Biosafety Procedures for Plant Producing Pharmaceutical Products and Transgenic
Animals. Speaker: Dr. Flerida A. Cariño, Member, NCBP. December 5, 2006.

RTD 5. Animal Biotechnology and New Uses of Transgenic Crops. Speakers: Dr. Val Giddings
and Dr. Hector Quemada. July 23, 2007.

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 Historical Background

The regulation of researches and products of modern biotechnology traces its origin to the
concerns of scientists in the early 1970s of the far-reaching implications of the ability to manipulate
the DNA through recombinant DNA techniques. Responding to a letter from participants at the
1973 Gordon Conference on Nucleic Acids, the US National Academy of Sciences (NAS)
established a committee to evaluate the safety of research on recombinant DNA. This committee
recommended a moratorium on recombinant DNA experiments as well as invited the National
Institutes of Health (NIH) to establish a committee to oversee the evaluation of potential biological
and ecological hazards and devise guidelines for working with recombinant DNA. Thus, the
February 1975 International Conference on Recombinant DNA Molecules (often referred to as the
Asilomar Conference) was held where participants debated on the safety and ethical issues of
recombinant DNA research work and legal liabilities of injuries that might arise from such research.
The Asilomar Conference resulted in the drafting of a statement of principles that outlined a
proposed set of standards and the agreement of researchers to strictly control their own research
until the safety of the new recombinant DNA technology could be properly ensured. Further, the
NIH through the Recombinant DNA Advisory Committee (RAC) developed the first guidelines for
such research in 1976 for use in NIH-funded research. In 1978 the guidelines were revised
considering the experience with contained applications of recombinant DNA that showed that the
risks feared to be associated with the new technology were overestimated or nonexistent. The
standards for containment were relaxed and responsibility for administration of recombinant DNA
experiments was decentralized and simplified.

As research expanded from laboratory to large scale operations and/or to field testing, the
scope of the guidelines also expanded. The guidelines also became binding to all institutions that
obtained federal funds. The RAC, which also became a multidisciplinary committee, served as the
model for the formation of biotechnology advisory groups for federal regulatory agencies such as
those in the Environmental Protection Agency and the US Department of Agriculture (US NRC,
1989).

In the Philippines, interest in biosafety started when researches at the University of the
Philippines Los Baños (UPLB) and at the International Rice Research Institute (IRRI) started to
require the use of modern biotechnology tools and the scientists themselves raised issues of
concerns. National Scientist DA Ramirez (2007), who was the chairperson of the original committee
that developed the biosafety guidelines at Los Baños, recalled that then UPLB Chancellor Raul P.
de Guzman and IRRI Director General M.S. Swaminathan created a Joint Committee on Biosafety
on October 12, 1987, with the following terms of reference:
• Review research proposals submitted by UPLB and IRRI scientists initiating experiments
which require special safety arrangements and recommend either approval or rejection by
the head of the institution;
• Consult with countries with biosafety regulations in place in order to be able to formulate
and introduce appropriate guidelines for biotechnology researches at UPLB and IRRI;
• Provide guidelines for experimental protocols in cases when a proposed experiment is
considered to be potentially beneficial;
• Serve as a clearing house of information on experimental procedures involving
recombinant DNA technology; and
• Review from time to time ongoing experiments in biotechnology, particularly those
involving fungal, bacterial, and viral pathogens, insect pests, and recombinant DNA to
ensure that the highest standards of safety are maintained.

The Committee was composed of scientists from UPLB (8), IRRI (6), the Department of
Agriculture Bureau of Plant Industry (DA BPI) (1), and Department of Science and Technology
Philippine Council for Agriculture Resources Research and Development (DOST PCARRD) (1).
[Number enclosed in parentheses refers to number of participating scientists.]

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 As its first activity, the committee reviewed existing guidelines in several countries,
including those of Australia, Japan, United Kingdom and the United States. The committee also
paid special attention to the existing quarantine laws of the country, especially those that deal with
the introduction of microorganisms, plants and animals into the country as well as those that deal
with movement of regulated microorganisms, plants and animals within the country with the end in
view that the guidelines to be drafted would supplement and make use of existing quarantine rules
and regulations.

The draft guidelines focused on the biosafety of the process and procedures rather than
the products, without losing sight of the biosafety concerns on the efficacy of gene transfer, the
effects of transformation on the host, and the possible hazards on humans and the environment
should the GMO be released to the environment. The committee submitted the draft guidelines with
a strong recommendation that UPLB and IRRI facilitate the creation of a national committee on
safety in biological researches and further proposed that the biosafety guidelines be adopted
nationally.

From 1988 to 1989, the draft guidelines were reviewed by other scientists in IRRI and
UPLB, and were presented in several international conferences in India, Indonesia, Thailand and
the U.S.A. The country’s House of Representatives and the Senate also invited the committee to
study the possibility of legislating the biosafety system. However, both UPLB and IRRI proposed
that instead of legislation, adoption of the biosafety guidelines by all R & D institutions be the
option.

The draft guidelines were then submitted to the National Academy of Science and
Technology (NAST) with the recommendation that the NAST take the lead in the process of getting
the guidelines nationally adopted. NAST conducted public consultations regarding the draft
guidelines throughout the country, inviting primarily the science communities. Considering the
comments and suggestions gathered during the consultations and in consultation with the UPLB-
IRRI committee, NAST prepared the second to the final draft of the Philippine biosafety guidelines.
This was submitted to the Department of Science and Technology (DOST) for implementation. The
DOST proposed the creation of a national committee on biosafety to then President Corazon C.
Aquino who on October 15, 1990 promulgated Executive Order No. 430 which established the
National Committee on Biosafety of the Philippines (NCBP). DOST undertook another round of
public consultations regarding the draft guidelines involving the scientific communities and other
stakeholders. The outputs from these consultations were considered in preparing the final version
of the Philippine Biosafety Guidelines released in 1990.

The NCBP—Structure, Mandates and Procedures

Organizational Structure

The NCBP is an interdepartmental, multi-disciplinary, technical committee that consists of

the Department of Agriculture (DA), Department of Environment and Natural Resources (DENR),
Department of Health (DOH) and the Department of Science and Technology (Fig. 1).

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 Biosafety Organizational Structure
In the Philippines

NCBP

DA
SECRETARIAT

DENR

STRP
DOH

DOST
IBC’s

Fig. 1. Organizational Structure of the NCBP.

The DOST Undersecretary for R & D serves as Chair of the NCBP and the members
include the ex-officio members who are representatives of DA, DENR, and DOH who are
designated by their respective Secretaries, four scientists with specialization in the biological
sciences, environmental sciences, physical sciences, and social sciences, and two community
representatives. The DOST’s Office of the Undersecretary for R & D serves as the Secretariat of
the NCBP with the member departments providing additional staff support as the need arises.

The Institutional Biosafety Committees (IBCs) are required to be established in institutions

involved in genetic engineering and/or hazardous biological work and are tasked to evaluate and
monitor the biosafety aspects of their biological researches. The IBC shall be composed of at least
five members— at least three scientists with expertise in biotechnology or related fields and have
the capacity to assess and monitor properly any work involving GMOs and potentially harmful and
exotic species (PHES) and two community representatives who are not affiliated with the institution
and shall represent the interest of the surrounding community with respect to health and protection
of the environment as stated in the Philippine Biosafety Guidelines (NCBP 1991). The list of
nominees for IBC membership of an institution has to be approved by the NCBP. Minimum
requirement is the submission of the curriculum vitae of the nominees for review by the NCBP.

The NCBP creates a Scientific and Technical Review Panel (STRP) when needed to
conduct a scientific review or evaluation of biosafety proposals independent of the NCBP. Members
of the STRP are experts in fields relevant to the proposal being evaluated.

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Mandates
The NCBP was mandated by EO 430 (1990) to be the lead national body to:
(1) identify and evaluate potential hazards involved in initiating genetic engineering
experiments or the introduction of new species and genetically modified organisms,
and recommend measures to minimize risks;
(2) formulate, review or amend national policies and guidelines on biosafety, such as
the safe conduct of work on genetic engineering, pests and their genetic materials,
for the protection of public health, environment, and personnel, and supervise the
implementation thereof;
(3) formulate, review or amend national policies and guidelines in risk assessment of
work in biotechnology and supervise the implementation thereof;
(4) develop working arrangement with government quarantine services and institutions
in the evaluation, monitoring, and review of projects vis-à-vis adherence to national
policies and guidelines on biosafety;
(5) assist in the development of technical expertise, facilities and other resources for
quarantine services and risk assessments;
(6) recommend the development and promotion of research programs to establish risk
assessment protocols and assessment of long-term environmental effects of
biological research covered by these guidelines;
(7) hold public deliberations on proposed national policies, guidelines and other
biosafety issues;
(8) provide assistance in the formulation, amendment of pertinent laws, rules and
regulations; and
(9) call upon the assistance of any government agency, department, office, bureau
including government-owned and/or controlled corporations.

The NCBP reviews proposals on modern biotechnology applications for the benefit of the
final approving bodies (agencies which have regulatory functions on specific areas such as the
Department of Agriculture’s Bureau of Plant Industry or the Department of Health or the
Department of Environment and Natural Resources which are official members of the NCBP). It
communicates with proponents thru the IBC, to ensure that it has the best information for a rigorous
review of the technical aspects of the safety of the biotechnology applications. The NCBP’s actions
of “approval” or “disapproval” of biotechnology applications is restricted to “research and
development, technical aspects (whether or not, on the basis of existing science, safety risk are
considered acceptable); scientific advice (i.e., it is directed to pertinent line agencies to provide
them a basis for acting on proposed applications; its action (“approved” or “disapproved”) is not a
final permission to do the application; its action does not preclude any other requirements of laws
or by line agencies; final permission is to be granted by appropriate line agencies” (NCBP
http://www.ncbp.dost.gov.ph).

While permits are granted by the regulatory line agencies (e.g., DA BPI for permit to
import, quarantine of plants etc.), it is the NCBP’s mandate to supervise the implementation of all
its decisions. This supervisory function can be regarded as the regulatory function vested in NCBP
by EO 430. However, it was the contention of Atty. Jose Ma. Ochave, a member of the NCBP, that
the NCBP does not have a regulatory function (Ochave, 2007). He further noted that these
mandate issues were extensively discussed within the NCBP (Ochave, 2007) and commented that
it is to the credit of the public institutions and industry that the authority of the NCBP to regulate or
to disapprove a project was never challenged or contested. But perhaps, the general public
recognized and accepted that EO 430 created the NCBP to be the lead national body in charge of
biosafety assessment and the supervision of activities monitored by the line agencies.

From 1990 to 2002, the NCBP’s scope of mandate included research and development in
the laboratory, screenhouse and in the field. When the DA Administrative Order No. 8 was
approved on April 3, 2002, regulation of field testing of biotech crops became the responsibility of
the DA BPI and this became operational in July 2003.

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 Under EO 430, NCBP’s responsibilities cover both genetically modified organisms and
Potentially Harmful Exotic Species (PHES). However, legally, the regulation of exotic species
belongs to the Plant Quarantine Service of BPI and the Bureau of Animal Industry (BAI) for plants
and animals, respectively. Thus, similar with its policy on GMOs, the NCBP works with the
concerned line agency in dealing with applications for the use or importation of PHES.

On the other hand, DOST adopted a policy decision that it will not fund or continue to fund
any project that involves PHES or GMO in it if the proponent fails to have the project go through the
biosafety regulatory process under the NCBP.

In the case of the IBC, its powers and functions, according to the guidelines published by
the NCBP (1991), are as follows:
(1) Review genetic manipulation work conducted at, or sponsored by the institution and
recommend research
proposals for approval
by the NCBP;
(2) Review regularly work
with potential risks that
are being conducted at
the institution to ensure
that the guidelines are
being fulfilled;
(3) Formulate and adopt
emergency plans
covering accidental spills
and personnel
contamination;
(4) Report immediately to
the appropriate official
and to the NCBP any
significant problems
with/or violations of the
guidelines and any
significant research-
related accidents or illnesses; and
(5) Perform such other functions as may be delegated by the NCBP.

Procedure of Submission and Review

For contained facility
research. A researcher who intends to
work with GMOs or PHES in the
laboratory, screenhouse or greenhouse
should prepare a biosafety proposal
following the guidelines of the NCBP and
submit this to its IBC. The IBC reviews the
proposal in terms of format and content.
Usually, the IBC invites the proponents to
its meeting where questions and
clarifications can be raised for the
proponent to answer. The IBC also
inspects facilities and/or sites which need
approval. Afterwards, the proponent
resubmits the revised biosafety proposal
with a letter which lists the questions from
the IBC and the corresponding answers

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by the proponent. To further facilitate the review, the proponent attaches copies of scientific papers
and other documents which may be required by the IBC and NCBP. If the proponent has satisfied
all the IBC’s requirements, the IBC then endorses the biosafety proposal to the NCBP. The NCBP
requires 12 copies of the proposal which should be received by its office at the DOST, Office of the
Undersecretary for R & D, by 15th of the month, to be considered in the regular monthly meeting of
the NCBP. The electronic copy of the proposal in two forms, full proposal and proposal with
confidential business information (CBI)-deleted version, should also be submitted. Other required
documents are the curriculum vitae of the project leader and researchers involved in the project,
Gannt chart of activities and copy each of relevant scientific literature, data generated from
confined tests and others.

It is the NCBP’s policy to make sure that CBIs are kept confidential. The STRP members
are provided copies of project proposals after they have agreed in writing to maintain and respect
the confidentiality of information provided and approved by the NCBP as CBI.

While the NCBP has a complement of scientists from different disciplines and regulators
from the different departments, if needed, it also forms Scientific and Technical Review Panels
(STRP) which conduct a scientific evaluation of the proposal independent of the NCBP. The NCBP
and the STRP will then discuss any point or issue on which they disagree. Thus, a biosafety
proposal would have been evaluated by three bodies, the IBC, NCBP and the STRP, by the time it
gets approved (or disapproved). According to the Philippine Biosafety Guidelines (1991), the NCBP
will require nine (9) weeks from receipt of the complete proposal to conduct its assessment of
contained experiments.

For field tests. For proposed planned release of GMOs and PHES, the process and time
required for biosafety assessment differ. In this case, additional requirements of public information
consist of posting of an NCBP-approved information sheet in at least three (3) conspicuous places
in the barangay of the test site for at least three weeks, plus the publication once a week for two
consecutive weeks in a newspaper of general circulation. The STRP is also given 30 days to
submit its recommendations to the NCBP after receipt of the proposal.

The NCBP bases its evaluation on the following: (a) the project proposal, including
amendments and attachments; (b) IBC assessment; (c) comments and recommendations of the
STRP; (d) public comments; and (e) other documents and information deemed relevant by the
NCBP (NCBP 1998).

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 Development and Strengthening of the
Philippine Biosafety System
Biosafety Guidelines for Contained Facility Tests

After the constitution of the NCBP in 1990, the draft biosafety guidelines were subjected to
another round of consultation and scrutiny and then adopted as the Philippine Biosafety Guidelines
Series 1 (1990) and published in 1991.

This green book, as it is often referred to, contains the EO 430, information on the NCBP
and IBC functions, procedures for evaluation by the NCBP and IBC, the application form which lists
all the questions that the proponent needs to
address, descriptions of physical containment
facilities, glossary of terms and references. This
Series 1 focuses on biosafety regulation in
contained facilities. National Scientist Ricardo M.
Lantican, then the DOST Undersecretary for R &
D, was the first Chair of the NCBP. Box 2 shows
the list of the Chairs of the NCBP from 1991 to
date.
The first application for experiments
involving GMOs under containment was on
transformation of Indica rice submitted by Dr.
Francisco J. Zapata of IRRI in 1991.

Box 2. List of NCBP Chairs (1990–2008)

Dr. Ricardo M. Lantican, October 1990 – December 1992

Dr. William G. Padolina, January 1993 – December 1994
Dr. Estrella F. Alabastro, January 1995 – November 1998
Dr. Raymundo S. Punongbayan, December 1998 – March 1999
Dr. Rogelio A. Panlasigui, April 1999 – December 2005
Dr. Estrella F. Alabastro, January 2006 – to date

Guidelines on Planned Release of GMOs

The evolution of the Philippine biosafety system is a reflection of the growth and
development of genetic engineering R & D activities in the country, starting from laboratory
experiments, to greenhouse experiments to limited field tests and multilocation tests. The Philippine
Biosafety Guidelines (NCBP 1991) had a section (Chapter III) on movement and field releases of
regulated materials. However, the NCBP decided to develop new guidelines for the planned
release of GMOs, in anticipation of the current local researches that will eventually be released and
tested outside of containment, taking into account the experience of other countries in regulating
field testing involving GMOs and the local experience and resources. The NCBP subjected the new
guidelines to a series of public consultations around the country in 1996–1998. In September 8,
1998, the NCBP Series No. 3 Guidelines on Planned Release of Genetically Modified
Organisms (GMO) and Potentially Harmful Exotic Species (PHES) was issued. The NCBP
planned to issue a second edition of the 1991 Guideline and split it into two—Biosafety Guidelines

Page | 18
for Small-Scale Laboratory Work and Biosafety Guidelines for Large-Scale Contained Work and
Glasshouse Trials. However, this did not materialize, thus, the lack of a series No. 2.

Pioneer Hi-Bred Phils., Inc. and Cargill Phils. Inc. submitted the first two applications for
limited field tests in September and October 1998, respectively, for efficacy verification of
transgenic
corn against
Asiatic corn
borer. These
were
approved in
August 1999.
Cargill Phils.
Inc. (which
later became
Monsanto
Philippines)
proceeded to
conduct the
first field trial
of Bt corn
MON 810 in
General
Santos City in
December
1999, which
culminated in
the first
harvest of a
GMO in the
country in
March 2000.
The NCBP approved and monitored nine field tests involving GMOs up to 2003. The last
field test supervised by NCBP was the project on seed production research involving Bt 11
submitted by Syngenta Philippines Inc. which was approved in October 2003.

Guidelines on Commercialization

With the multilocation field trials of Bt corn conducted by two private companies in July
2001-May 2002 (Monsanto Philippines) and June 2002-July 2003 (Pioneer Hi-Bred Philippines)
and their products nearing commercialization, the need for the next level of risk assessment that
will include short and long term effects on the environment and the ecology, and on human health
became apparent. The Department of Agriculture developed guidelines for the commercialization of
plant products derived from modern biotechnology and subjected these to country-wide public
consultations twice, once under the term of then DA Secretary Edgardo J. Angara and again,
during the term of Secretary Leonardo Q. Montemayor. On July 16, 2001, President Gloria
Macapagal-Arroyo approved the “Policy Statement on Modern Biotechnology” (Box 3) submitted to
the President by Secretary Montemayor based on a draft substantially agreed upon by Secretaries
Estrella F. Alabastro, Leonardo Montemayor, Manuel Dayrit, Angelito Sarmiento and Teresita
Deles.

Page | 19
 Box 3. Policy Statement on Modern Biotechnology of
President Gloria M. Arroyo (July 16, 2001)

“We shall promote the safe and responsible use of modern biotechnology and its
products as one of several means to achieve and sustain food security, equitable
access to health services, sustainable and safe environment, and industry development.

“We shall ensure that all technologies that we promote, including modern
biotechnology, will provide farmers and fisherfolks the opportunity to increase their
over-all productivity and income; enhance the welfare of consumers; promote
efficiency, competitiveness, and improved quality standards of local industries – all
within the paramount objective of attaining safely and sustainable development,
including its human, social and environmental aspects.

“The Departments of Agriculture, Science and Technology, Health, Environment and

Natural Resources, Trade and Industry, and other concerned agencies are hereby
directed to address the current issues associated with the local and global dimensions
and trends of modern biotechnology, including its potential health, environmental and
social impacts. Towards this end, they shall conduct public consultations with
representatives from civil society, government and business; formulate departmental
directives and regulations on the access to and use of the products of modern
biotechnology, coordinate activities and programs on research, development and
application; and allocate appropriate resources for the upgrading of capacities and
capabilities to effectively regulate the technology and its products, including but not
limited to product testing and labeling.”

On April 3, 2002, the Department of Agriculture issued its Administrative Order No.
8 Series of 2002 “Rules and Regulations for the Importation and Release into the
Environment of Plants and Plant Products Derived from the Use of Modern Biotechnology.”

Atty. Ochave describes AO 8 as a consolidation and distillation of NCBP’s experiences in

GMO regulation (Ochave, 2007). He further describes AO 8 as a formalization of an already
existing arrangement between the Bureau of Plant Industry of DA and the NCBP. Prior to AO 8,
BPI was already very much involved in GM regulation, being the principal agency that was actually
monitoring the experiments. Its staff has undergone extensive training as well as obtained actual
experience in the Bt corn field trials. With the AO 8, field trials up to deregulation for
commercialization would now be handled by the DA BPI after the proponent has obtained a
certification of completion for its contained facility testing. AO 8 also ensures that socio-economic
considerations are included in the decision-making process.

Strengthening the Capability of the NCBP, Regulatory Agencies and

the IBCs
Strengthening the national biosafety system meant parallel and concomitant building of
the capability of the regulatory agencies and the NCBP. In the early 1990s, guidelines on biosafety
from other countries such as the United States, Canada, United Kingdom, Australia and Japan,
were already available for the study of the NCBP members and secretariat. In addition, study visits,
consultations and training on various aspects of the regulatory system in Australia, the United
States, Japan and some of the countries in the European Union, were undertaken by the NCBP.
The training continues even as experience in the regulation of research and products of modern

Page | 20
biotechnology has accumulated since the technology is also evolving and more new products are
being developed (Table 1). NCBP has also been involved in training IBC members and staff of the
regulatory groups in the Department of Agriculture, Department of Health and Department of
Environment and Natural Resources. It
is also a policy of the NCBP to
recommend IBC members for relevant
training when such opportunities are
available.

Transparency and Public Participation

The adoption and implementation of the National Biosafety System of the country as
embodied in EO 430 has been accompanied by a policy of maximum public information and public
participation within legal limits. After EO 430 was promulgated by President Corazon C. Aquino in
October 1990, the biosafety guidelines were subjected to public consultations before they were
adopted and released in 1991 as the Philippine Biosafety Guidelines Series 1 (1990). The NCBP
Series No. 3 Guidelines on Planned Release of Genetically Modified Organisms (GMO) and
Potentially Harmful Exotic Species (PHES) was released in 1998 after a series of consultations.

Table 1. Number of public consultations/seminars sponsored by NCBP, training of

NCBP members and secretariat and activities participated in by NCBP
members as resource persons.

Year Training of NCBP Public consultations Symposia,

members and staff or seminars conferences etc
sponsored by NCBP participated in by
NCBP members and
staff as resource
persons
1993 2 2
1994
1995 1
1996 9
1997 2 1 4
1998 1 3 2
1999 2 12
2000 2 30
2001 2 1 26
2002 1 20
2003 13
2004 4 29

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 2005 4 17
2006 4 4 22
Source: Annual Reports of the NCBP from 1993 to 2006.

ACTIVITIES CONDUCTED/ORGANIZED BY THE NCBP

Date Title Short Description of Venue Category

activity (IEC or
Training)
April 26, Seminar-Workshop on Capacity-building DOST, Bicutan,
2007 GMO Regulation for program for IBC Taguig City
Institutional Biosafety members to refresh
Committees (IBCs) their skills in doing
Risk Assessment and
Risk management

May 10- Workshop on the For the Lagos del Sol,

11, 2007 formulation of the IRR of EO implementation of Caliraya Lake,
514 Executive Order No. Cavinti, Laguna
514

July 18- Capacity Building on Capacity Building ERDB-DENR Training-

19, 2007 Biosafety Assessment and Auditorium Workshop
Monitoring of Environmental
Impacts of GMOs
Sept. 13- Capacity Enhancement on Capacity Building ERDB-DENR Training-
15, 2007 Selection of Indicator Auditorium, Workshop
Species and Determination
of Appropriate End Points
for GMOs Risk Assessment
and Post Market Monitoring
July 23, Animal Biotechnology and Roundtable Sofitel Philippine
2007 New Uses of Transgenic Discussion Plaza Manila,
Crops (5th of the series) Pasay City
Dec. 20 BCH User’s training cum Orientation on how to ASTI Training
2007 meeting use the BCH as well Room, ASTI,
as to test the Q.C.
systems
development done
for the Philippine
BCH website
Feb. 23- Lecture on the Philippine IBC Orientation Benguet State IEC
26, 2006 Biosafety Regulation of Program University (BSU),
GMOs to members of the La Trinidad,
BSU-IBC, staff and officials Benguet
and LGUs Province

Feb. 17, Lecture on the Philippine IBC Orientation PhilRice, Muñoz,

2006 Biosafety Guidelines to Program Nueva Ecija
members of the IBCs of
PhilRice and Central Luzon
State University (CLSU)
Sept. 7, The NCBP: Looking Back Roundtable NAST, DOST
st
2006 and Moving Forward Discussion (1 of the Compound,
series) Bicutan, Taguig

Page | 22
 City
Oct. 11, Workshop on Relevant Roundtable NAST, DOST
nd
2006 Experiences of Various Discussion (2 of the Compound,
Biosafety System series) Bicutan, Taguig
Stakeholders” City
Nov. 13, Roundtable discussion on Roundtable DOST Exec.
rd
2006 E.O.514 (3 of the series) Discussion (3rd of Lounge, DOST,
the series) Bicutan, Taguig
City

Dec. 5, Biosafety Procedures for Roundtable DOST Exec.

2006 Plants Producing Discussion (4th of the Lounge, DOST,
Pharmaceutical Products series) Bicutan, Taguig
and Transgenic Animals City
Jan. 20, Echo-seminar on the Apacible
2005 international Conference
conference/training Room,
attended by the NCBP Department of
member/Secretariat Agriculture,
Quezon City
Feb. 19, Lecture/presentation on the Ecosystems
2005 genetics and sexual Research and
reproduction of papaya Development
Bureau (ERDB),
Los Baños,
Laguna
Nov. 25, Lecture on Environmental DOST, Bicutan,
1998 Assessment of Transgenic Taguig
Crops
(Dr. Shantharam of USDA)
Nov. 11, Lecture on Biotechnology: PCARRD, Los
1998 Prospects and Challenges Baños, Laguna

Feb. 10, Visayas-wide public Southeastern

1998 consultation on the University, Cebu
guidelines for field release City
of GMOs and PHEs
Feb. 12, Public consultation on the Cagayan de Oro
1998 Guidelines for field release City
of genetically manipulated
organisms
and potentially harmful
exotic species
Nov. 19, Public Consultations on the Bahay Kalinaw,
1997 Planned Release UP Diliman, Q.C.
Guidelines on GMOs and
PHES
July 11, Seminar-Dialogues on the Davao City
1996 existing regulations on work
Sept. 24- involving the use of Benguet
25, 1996 pathogenic microorganisms
Oct.6-7, Legaspi
1996
Oct. 17- Cebu
18, 1996

Page | 23
Oct. 23- Tacloban
24, 1996
Nov. 11- Cagayan de Oro
12, 1996
Nov. 28- Zamboanga,
29, 1996
May and Seminar-Dialogue on the Dissemination of the Cebu and Davao
August implementation of the first provisions of the
1993 edition of the Philippine biosafety guidelines
Biosafety Guidelines and identify
problems and
institutional
constraints in relation
to compliance with
the guidelines

Institutions applying for field testing or planned release of a GMO in the environment are
required to notify and invite the public to give comments on the proposed activity. The Public
information sheet approved by the NCBP must be posted for at least three weeks in three
conspicuous places in the barangay where the test site is to be conducted. In addition, the
information sheet must also be published in a newspaper of general circulation in the areas where
the test site is located. All comments are to be addressed to the NCBP which will collate the
comments and forward them to the concerned IBC which in turn relays the comments to the
proponent for appropriate response.

To ensure transparency in its actions, the NCBP established a website

(http://www.ncbp.dost.gov.ph/) in 2006. The website contains information on various applications
from private and public institutions engaged in R & D involving recombinant DNA technology or
PHES. Various information can also be obtained from the website such as the annual reports of
NCBP from 1993 to 2006, the biosafety guidelines, Executive Orders and state policies on
biotechnology of the Philippine government among others. In addition, specific queries regarding
proposals can be submitted to the NCBP, which should include the request to the applicant and the
purpose for which the request is being made. The NCBP can only provide information that is not
confidential business information (CBI) as it is duty bound under the law to make sure that CBIs are
kept confidential. Disclosure can only be made with the consent of the applicant.

Summary of Proposals Submitted to NCBP and Actions taken in the

Past Fifteen Years
The NCBP received a total of 227 applications, 217 applications for contained facility
testing and 10 for field testing in the past 15 years (Table 2). A total of 193 were approved, one was
not approved and 33 were withdrawn or not completed by their proponents. Eleven of the 33
proposals were returned to proponents as they did not fall under the jurisdiction of the NCBP.
Of the 217 proposals for contained facility, 32 came from industry, 5 from a private
university, 79 from public universities, 29 from government research institutions, and 72 from an
international research organization.
A total of 192 proposals involved handling or conducting GMOs and 35 involved PHES.

Based on interviews with various stakeholders, withdrawal of proposals or failure to

complete the proposals could be attributed to any or several of the following: (a) lack of funding, (b)
lack of facilities, (c) proponent has left institution, (d) proponent has realized weakness(es) in
proposal, and (e) inability of proponent to comply with NCBP’s requirements, address its questions
or failure to provide additional information or documents. Some of the proposals were also not
within the purview of the NCBP and were thus returned to the proponents. Thus, only one proposal

Page | 24
was eventually disapproved. This number could have been larger if all or most of the 32 proposals
withdrawn or not completed were actually completed.

Table 3 shows the number of proposals submitted to NCBP by different institutions from
1991 to 2006 with the largest number of proposals (27) in 1999 and 2003. Figure 2, on the other
hand, shows the distribution of submitted proposals by type of institution. Public universities and
international organization submitted 33% and 32%, respectively, followed by industry (18%) and
government R & D institutes (15%).

Table 2. Summary of research proposals submitted to NCBP and its actions from
1991–2006.

Industry Private Public Gov’t Int’l

Univ. Univ. Research Research TOTAL
Inst. Inst.
Contained
facility tests
Involving 12 5 70 24 72 183
GMOs
Involving 20 - 9 5 0 34
PHES
Total 32 5 79 29 72 217
Field tests
Involving 8 - - 1 - 9
GMOs
Involving - - - 1 - 1
PHES
Total 8 - - 2 - 10
Approved 27 5 67 24 70 193
Not approved - - - 1 - 1
Withdrawn or 13 - 12 6 2 33
incomplete
Total 40 5 79 31 72 227

Page | 25
Table 3. Number of research proposals submitted to the NCBP by various
institutions from 1991 – 2006.

Year Proponent/s
Public Private
Industry
Univ Univ Int'l Org Gov't R&D Inst TOTAL

1991 1 3 4
1992 3 3 6
1993 2 4 7 13
1994 4 3 9 1 17
1995 1 1 8 2 12
1996 5 9 5 1 20

1997 2 6 4 3 15

1998 5 6 4 2 17

1999 7 12 5 3 27

2000 4 8 3 3 18

2001 1 3 4 4 12

2002 1 5 1 1 8
2003 5 7 4 5 6 27
2004 3 1 2 1 7

2005 4 4 2 10
2006 7 5 2 14
TOTAL 40 79 5 72 31 227

Page | 26
 Gov't R&D Inst Industry
14% 18%

Int'l Org Public Univ

32% Private Univ 34%
2%

Figure 2. Distribution of submitted proposals by type of proponent

Table 4 shows the topics of different proposals submitted to the NCBP for approval. The
topics range from transformation experiments in E. coli for class laboratory experiments, to cloning
of genes and expression in E. coli, to development and use of molecular markers for genetic
analysis, species/varietal identification, characterization and applications in selection and breeding.
Development of transgenic crops covers rice, corn, papaya, mango, banana, and sweet potato for
various traits including better agronomic traits, greater pest resistance, higher nutrients, better shelf
life etc. Several transgenic crops were imported for efficacy testing. Proposals on vaccine
development using both traditional and modern biotechnology were among those approved for
implementation. Applications for testing of imported and local biological control agents,
phytochemicals for anticarcinogenic property and anti-tuberculosis compounds from marine
organisms were also submitted to the NCBP.

Table 4. Topics of proposals submitted to the NCBP for approval (1991-2007).

Areas of study Topics of submitted proposals

Class experiments
Identification, development
and/or use of molecular
markers for genetic
analysis, varietal
identification,
characterization, marker-
aided selection and/or
breeding
Cloning of genes
Transformation of E. coli with plasmid containing
bioluminescent gene and other plasmids/cassettes.
Genetic analysis of Pseudomonas solanacearum;
identification of genetic markers for high alcohol production
in locally isolated yeast strains; RFLP mapping of rice blast
resistance genes and various QTLs; identification of disease
resistance genes by screening activator-tagged mutant rice
population; development of Ac/Ds transposon tagging system
to isolate agronomically important genes; identification of
genes conferring broad spectrum disease resistance in rice;
marker-aided transfer of bacterial leaf blight and rice tungro
disease resistance genes in rice; development of DNA-based
procedures for GM plants.
Genes such as α-amylase, thermophilic gene, poly -3-
hydroxybutyrate depolymerase gene and expression in E.
coli.

Page | 27
 Development of transgenic Optimization of transformation conditions; development of
crops transgenic rice for the following traits: resistance to various
pests such rice ragged stunt virus, bacterial blight, brown
plant hopper, using various genes such as proteinase
inhibitor gene, Bt gene, lectin gene; early flowering trait;
dwarf trait; iron fortification using ferritin gene and iron
transport related genes; provitamin A; using artificial micro
RNAs and validation of gene silencing; drought and salinity
tolerance;
Introgression of genes for Vitamin A from Golden Rice to
Philippine elite varieties; introgression of papaya ring spot
virus (PRSV) resistance into transgenic papaya with delayed
ripening trait.
Corn with insect resistance; papaya and mango with delayed
ripening trait using ACC synthase and ACC oxidase; papaya
with PRSV resistance using biolistic and Agrobacterium
delivery; banana with bunchy top and banana bract virus
resistance; sweet potato with resistance to sweetpotato
feathery mottle virus;
Efficacy testing Testing of imported seeds of transgenic crops for efficacy of
traits, eg., Bt corn, glyphosate-tolerant corn, rice plants
against bacterial blight disease
Field testing Bt corn hybrids from various private companies.
Vaccine/Antibody Vaccine for foot and mouth disease development; generation
development of humanized single gene-encoded antibodies for anti-tumor
applications; developing gene expression systems for
recombinant antibody production; development of
recombinant vaccines against influenza.
Biological control Use of Metarhizium for biological control of Locusta
migratoria manilensis in Central Luzon; release of
parasitoids; odor control of sanitary landfill using bio-
enzymes; evaluation of insect pathogens on insect pests of
different crops; formulations of indigenous fungi to control
weedy Enchinochloa species.
Others Test of anti-TB compounds from marine organisms; binding
of Bt to midgut receptors of Asiatic corn borer;
antigenotoxicity of phytochemicals using green fluorescent
protein; antioxidant assay of phytochemicals using luminous
bacteria.
Source: NCBP website; Note, this table is not meant to be exhaustive. Please refer to the
NCBP website for more information.

Page | 28
Defining Moments in NCBP History

Several events in NCBP history were identified by Ochave (2007) as defining moments as
these changed how NCBP saw itself and how it would operate in the future. These are: (1) the Bt
corn experience, (2) the issuance of the DA-AO No. 8 Series of 2002, (3) the issuance of EO No.
514 in 2006, and (4) the ratification of the Cartagena Protocol on Biosafety.

NCBP inspection of field test Proposed field test site for Bt

Sites for Bt corn, Tigaon, corn, Bgy. Maltana,
Camarines Tampakan,
Sur South Cotabato

The Bt corn experience. The first greenhouse evaluation of Bt corn in the Philippines
was approved in September 1997 with the Institute of Plant Breeding as the major proponent and
CIMMYT and Cargill Philippines as collaborators. The experiment aimed at testing the efficacy of
the Bt corn lines from CIMMYT and from Monsanto against the Asiatic corn borer. Applications for
limited field tests were submitted by Pioneer Hi-Bred Phils. Inc. and Cargill Phils Inc. in September
and October 1998, respectively, and were approved in August 1999. The first field tests of Bt corn
ensued in December 1999 to March 2000 under the supervision of the NCBP. Multilocation field
trials of Bt corn followed in Ilocos Norte, Pangasinan, and Isabela in Northern Luzon, in the Bicol
Region and in Bukidnon, Misamis Oriental, South Cotabato, Sultan Kudarat and other provinces in
Mindanao.
Why then is the Bt corn experience considered a defining moment for NCBP? This phase
in the NCBP history is characterized by: (a) encounters with the anti-biotech groups, (b)
participation in congressional hearings, and (c) involvement in a court case brought by the anti-
biotech group to the Supreme Court. These actually compelled the NCBP members and other
scientists to come out and explain what biotechnology is before the various stakeholders and the
general public all throughout the Philippines. It also made NCBP recognize that biotechnology
involves multiple stakeholders and not only the proponents. Table 1 shows that the frequency of
NCBP members being invited to various fora and conferences as resource persons or speakers
started to increase in 1999, peaked in 2000 and again in 2004.

The issuance of DA AO No. 8. As discussed earlier, with DA AO No. 8 series of 2002,

field tests and eventual commercial propagation of biotech crops would be handled by the
Department of Agriculture’s Bureau of Plant Industry starting July 2003. Thus, DA AO 8 redefined
the NCBP’s tasks to focus on contained facility R & D involving genetically modified organisms.

Page | 29
However, NCBP continued to review and formulate policies on biotechnology as well as review and
modify the science-based risk assessment of protocols to be used by the regulatory agencies
implementing the commercial guidelines. All applications for field tests received before July 1, 2003
remained under the supervision of the NCBP until their completion (2004 NCBP Annual Report).

Promulgation of EO No. 514. EO No.

514 (2006) established the National Biosafety
Framework which many expressed was
essentially a description of the regulatory
framework that was already in existence. EO
No. 514 formally identified the national
competent authorities to be in charge of
regulation of modern biotech activities for the
purposes of complying with the provision of the
Cartagena Protocol on Biosafety. Thus, under
EO No. 514, there will be a new super NCBP
and each department will have its own biosafety
committee. It identified the DOST to be
responsible for contained use experiments and
the DA BPI for the regulation of field testing and
commercialization of biotech crops. When the
implementing rules and regulations of the new
EO are approved and implemented, the present
NCBP under EO 430 will cease to exist.

Ratification of the Cartagena Protocol on Biosafety.

The Cartagena Protocol on Biosafety (Protocol) to the
Convention on Biological Diversity which was adopted in
January 2000 in Montreal, Canada and was ratified by
more than 130 countries in 2003. The Philippines signed
the Protocol on May 24, 2000. The protocol originated
from the 1992 Convention on Biological Diversity (CBD)
during which modern biotechnology was recognized “as
having a great potential for the promotion of human well
being, particularly in meeting critical needs for food,
agriculture and health care.” At the same time, it also
recognized “the need to protect human health and the
environment from the possible adverse effects of the products of modern biotechnology”
(Cartagena Protocol, 2000; http://www.cbd.int/biosafety/protocol.shtml). Article 4 of the Protocol
states that “(it)…shall apply to the transboundary movement, transit, handling and use of all living
modified organisms that may have adverse effects on the conservation and sustainable use of
biological diversity, taking also into account risks to human health.”

For the past 15 years, the Philippine biosafety system has been based on voluntary
disclosure and therefore, the regulation has applied only on those who have submitted applications
to the NCBP. With the Cartagena Protocol on Biosafety, it will be mandatory for importing or
exporting entities to declare the presence of a GMO in the product for transit, which may then be
subject to biosafety regulation.

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NCBP Guidelines and International Biosafety Guidelines
As discussed earlier, the Cartagena Protocol on Biosafety covers “the transboundary
movement, transit, handling and use of all living modified organisms that may have adverse effects
on the conservation and sustainable use of biological diversity, taking also into account risks to
human health” (Cartagena Protocol, 2000). EO 514 created “The National Biosafety Framework
(NBF),” and is a combination of policy, legal, administrative and technical instruments that
addresses the objective of the Cartagena Protocol on Biosafety. (EO 514 will be further discussed
on pp. 43-50 of this report).

The Codex Alimentarius Commission implements the Joint FAO/WHO Food Standards
Programme. Its major purpose is to protect the health of consumers and ensure fair practices in the
th
food trade. In its 26 session in 2003, the Codex Alimentarius Commission adopted the Principles
and Guidelines on foods derived from biotechnology. These provide the overarching principles on
the risk analysis of foods derived from modern biotechnology and guidelines for food safety
assessment of foods derived from recombinant DNA plants and microorganisms. The Codex
Alimentarius standards are not binding to countries but are intended to guide and promote the
establishment of definitions and requirements for foods, to assist in their harmonization and thus to
facilitate international trade (http://www.codexalimentarius.net).

The NCBP guidelines are in consonance with both the provisions of the Cartagena
Protocol on Biosafety and the guidelines of Codex Alimentarius.

Difficulties and Limitations

The members of the NCBP have primary positions in other government and private
institutions, and as such they serve in the NCBP in a part-time capacity. This nature of their
appointments limits the frequency of their meetings to evaluate biosafety proposals due to difficulty
of finding a common time among the members. In the United States, Australia and New Zealand,
and other industrialized countries, the agencies in charge of biosafety regulations have full time
scientist- and nonscientist staff.
It has also been observed that some of the IBCs pass on to the NCBP issues or questions
that should have been decided upon at their level. There have been reports on the lack of
commitment and/or knowledge on their responsibilities of some IBC members which had caused
attendant delay on the approval of biosafety proposals. Seminar-workshops for the IBC members
to enhance their capabilities in evaluating biosafety proposals have been proposed.

Assessment of NCBP Guidelines and Practices

From the open fora following the seminars
and workshops, the impressions and perceptions of
various stakeholders from academic institutions,
private industry sector, NGO and government on
the NCBP guidelines and practices were obtained
and can be summarized as follows: (1) In general,
strict NCBP guidelines and their equally strict
implementation and (2) difficult and long application
process.

Page | 31
Very Strict Guidelines and Equally Strict Implementation
The stakeholders were in agreement that the NCBP guidelines were very stringent and
their implementation was also very strict. However, the stakeholders accepted these requirements
because they acknowledged the mandate of NCBP to ensure the safe use of the products of
modern biotechnology in the Philippines.

There are four transgenic events of corn already released for commercial use in the
country. However, bringing these products to the market has been difficult and involved significant
resources on the part of the industry or the company partly because of these stringent biosafety
regulations and partly because of the efforts of some NGOs campaigning against the introduction
and cultivation of biotech crops. Industry has to contend with numerous dialogues and sometimes
confrontations between government regulators, scientists and technology developers on one side
and the local government units, other scientists and some NGOs on the other side.

Some of the points raised by stakeholders to illustrate the stringency of the guidelines are
as follows:
(a) The required 500 meters isolation distance for
corn translates to roughly 100 hectares of monitored area
which requires frequent scouting of surrounding fields to
ensure that the farmer(s) around has planted his field at least
21 days before or after the planting or arrangements have to
be made with surrounding farmers involving some kind of
compensation so that nobody plants his corn crop within 21
days from the planting of the Bt corn.
(b) The current policy is that a GM crop has to
undergo greenhouse trial before it is allowed to be field
tested. From the point of view of an industry practitioner, the
data generated for a transgenic event in its country of origin should be considered as basis of
approval for field testing. Further, the current policy
should be applicable only if the event has not been
commercialized in other parts of the world. This required
greenhouse testing will have a large impact on costs
especially for the public sector. While the private sector
may afford the extra costs of greenhouse testing,
applicants from government institutions may be burdened
by this requirement.

(c) One requirement for the

field trials is that the site should be
secured against stray animals and
unauthorized entry. During the first field
trials, companies put up extra security
measures including a 24-hour security
measure costing substantial amount of
money, to protect the field from
unauthorized entry and possible
vandalism. Not only one but as many
as three fences were put up.

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Nonetheless, there were cases when plants were still uprooted and destroyed despite the strict
security measures.
(d) Another point raised was the requirement for
public information which is mandatory for field release trials.
There are three layers of public information dissemination.
First is the public consultation or public seminar given in
places/areas where the field trials will be conducted.
Sometimes, one or two public seminars are not sufficient
especially when the community is not very receptive and
has been “educated” and/or agitated earlier by the anti-
biotech groups. Thus, more public consultations need to be
conducted to be able to explain the basis of the technology
and the reason for conducting those trials. This process
requires a lot of time and resources. The second level
involves the posting of Public Information Sheets (PIS) in
the community where the trial will be conducted, and the third level is publishing the PIS for 2
consecutive weeks in a daily newspaper with national circulation. The question is “Is it possible to
harmonize the three levels into just one?”
(e) Another issue raised was the handling of the harvest after the trial is completed. It is
required that immediately after harvest, plant materials should be heat killed, plowed under or
buried in pits in the site. For corn, ears and kernels should be heat-killed, and the vegetative plant
part be collected and plowed under or buried at the designated spot in the site. Boiling the ears
2
harvested from a 600 to 1000 m experimental area is difficult especially in the area where water is
not readily available.
(f) Additional requirements of the NCBP were
thought to be outside the biosafety regimen. An example is
the determination of herbicide residue in the soil and plant
parts required by the NCBP for a proposal which aimed to
evaluate efficacy of the biotech crop against insect pest and
to be commercialized as insect resistant strain. The
proponent opined that the herbicide residue determination
is not a biosafety issue for the transgenic crop but rather
should be covered in the registration of that particular
herbicide for agricultural use with the Fertilizer and
Pesticide Authority.

Difficult and Long Application Process

During the first few years of NCBP’s operations, the initial perception by the academe and
industry stakeholders was that the preparation of biosafety proposals was an additional work or
requirement in R & D. Earlier, projects did not have to undergo close scrutiny and rigorous
assessment for biosafety. Thus, the academe perceived the biosafety requirement from NCBP as a
delay in the approval of research proposals by the funding agencies, consequently, also a delay in
the implementation of the research projects, and eventually in the commercialization of GM
products.
The NCBP biosafety application form contains questions, which may seem redundant and
require detailed answers. These are questions on assessing the risk from the gene level to that of
product, possibility of escape, crossing with wild relatives, gene flow, and food safety in terms of
toxic or allergenic constituents or through secondary effect. Often times, the answers would require
references in the scientific literature; copies of some of the key references are also provided the
NCBP for ease in accessing such materials. The stakeholders also pointed out that the difficulties
encountered during the initial years were mainly due to unfamiliarity with the format and types of
questions and not knowing the responses to the questions indicated in the application. Through
years of experience, the biosafety proposal writing has become easier for those who have
submitted proposals before. The NCBP has also provided a template of the proposal in electronic

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form which can be accomplished easily by the proponent. These forms are now downloadable from
the NCBP website.
Further, it was observed that the NCBP conducted deliberations in a very protracted
manner. If any member of the NCBP raised serious questions, correctly or not, this held back the
decision and discussions on the question were pursued until the issue has been properly
addressed.
During the first years, the industry sector also reported that it took a while before NCBP
approved proposals. For example, the first greenhouse testing of Bt corn was approved almost a
year after submission of the proposal. Likewise, the field testing proposal took a long time before it
was approved. Simultaneous with the approval process are conduct by the anti-GMO advocates of
a very strong campaign against Bt corn. Also, the proponents and the NCBP members as well had
to attend congressional hearings to give light to the issues and concerns raised on the proposal for
field testing of Bt corn and to brief the senators and congressmen on biotechnology. Through the
years, the speed of the approval process has improved.
An analysis of available data (http://www.ncbp.dost.gov.ph/) showed that 33% of the total
proposals took NCBP less than one month to approve, 25% took one month and 12% took two
months (Table 5). Three per cent took 8 to 12 months for the NCBP to take action

Table 5. Length of time for NCBP to take action on biosafety proposals.

Length of time from Number of proposals %
submission to approval
(months)
<1 56 33
1 42 25
2 21 12
3 16 9
4 9 5
5 5 3
6 4 2
7 13 8
8 1 0.6
9 - -
10 2 1.2
11 - -
12 2 1.2
>12 - -
Total 171
Source: NCBP website

In the case of applications for field testing, the first application for limited field test by
Cargill Phils took 10 months for approval. The first application for limited field test of Pioneer Hi-
bred Phils took 11 months. However, in the case of Pioneer, they had to change the site and their
request was approved in 7 months. Six proposals, which include that from Syngenta, Phils., the
latest private company to test its GM product in the country, took 5–7 months. The shortest time for
approval was 4 months which was given for the multilocation field trials of Pioneer Hi-bred Phils in
2002. This only shows that with the increasing experience of both proponent and the NCBP, the
time it took for an application to be processed and decided upon became shorter. The longest time
for approval was for the application of the Philippine Coconut Authority to field release the Stem-
Galling Fly Procecidochares connexa for the control of Chromolaena odorata, which took 2 years.

During the seminar series, members of the NCBP admitted to the long evaluation process
in the early years which they ascribed primarily to the fact that the members meet only once a
month. The delay in action on a proposal could be due to missing information which could be
research data or a cited reference or question(s) on a technical matter regarding the proposal
which would need a clarification or an answer from the proponent. In cases where additional

Page | 34
information is requested, the clock stops and counting resumes once the requested information is
submitted. The information, however minor, is still needed to complete the evaluation process. In
some cases, a member of the committee is delegated to review the completeness the information
and if found sufficient, the application is then considered as approved without waiting for the next
monthly meeting of the NCBP. If a consensus is not possible, the proposal/issue is put in a vote to
avoid long protracted discussions.

The stakeholders are one in saying that the stringency of the biosafety regulations in the
Philippine is understandable considering that they were developed when biotech crops were just
beginning to be commercialized in the US. In addition, they believe that the major reason why the
country has successfully commercialized food biotech crops is because of due diligence on the part
of the NCBP and the strict compliance of the proponents with the biosafety guidelines.

With the current experiences gained and lessons learned in the field testing and
commercialization of biotech products in the Philippines, revisiting the NCBP guidelines and their
implementation is very timely in order to focus on the more important aspects of biosafety
regulation taking into account the scientific data generated from the latest scientific research and
other pertinent information obtained in the past 15 years.

X`

 New Products of Modern Biotechnology and Potential Challenges

In the past fifteen years, the NCBP has reviewed plant products of modern biotechnology
which belong to the first and second waves of biotechnology products with agronomic or input traits
and quality traits, respectively (Figure 3). Among the technologies the NCBP has evaluated are the
insect resistant Bt corn of different events, herbicide resistant corn, bacterial blight resistant rice,
and ringspot virus resistant papaya, which fall under the first wave of biotechnology generation,
papaya with delayed ripening trait and Golden Rice which fall under the second wave of
biotechnology generation. Many more biotech products are under field and or clinical testing in
other countries and which fall under the new generations or waves of biotechnology—production of
pharmaceuticals or industrials in plants and animals and production of renewable resources
involving metabolic pathway engineering (biofuels, nitrogen-use efficient crops, water-use efficient
crops, etc.).

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 What new traits and new biotechnologies are currently available in other countries but not
in the Philippines? What new traits, new gene strategies, new crops and new biotechnologies are
expected to go through the biosafety regulatory system in the next fifteen years? This section aims
to identify new technologies, new gene strategies and challenges which the NCBP will have to
prepare and be ready for.

Figure 3. New traits and strategies for

the biotechnology generations.

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  New Biotechnology Products Now Available in Other Countrie0073
There are new biotech
products approved and available in
other countries and which will
eventually be introduced in the
country. Among these are the
ornamental crops such as blue
carnation and blue rose, the
ornamental fish GloFish®, and the
transgenic and knockout mice.

The blue carnation flowers

developed by Florigene Pty
(http://www.florigene.com.au/) are
produced in farms in Colombia and
http://upload.wikimedia.org/wikipedia/commons/f/f2/GloFish.jpg
Ecuador and are widely available in
the North America and South GloFish: the first genetically modified animal to be sold as a pet.
America, Australia, Japan and in
Europe. Florigene, which is owned by Suntory of Japan, has also announced the development of a
blue rose which is expected to be released in a few years. The blue carnation could be brought in
by individuals or imported by hotels without knowing the biosafety requirement for such a
commodity.
For three years now, transgenic ornamental zebra fish called GloFish®
(http://www.glofish.com/) have been available in the United States. These aquarium zebra fish are
available in three different colors, red, orange and green, and soon in rainbow colors, and were
developed by injecting genes for fluorescing proteins with appropriate promoters from jellyfish and
sea anemone to eggs of zebra fish.
Transgenic mice and knockout mice are commercially available as test animals.
Transgenic mouse is produced by the injection of a foreign DNA in the pronucleus of fertilized
ovum of a mouse to test the effects of overexpressing or misexpressing native or foreign genes at
specific times of locations in the animal. A knockout mouse is a mouse that has had the function of
one or more of its genes made non-functional or deleted.

Efforts should be made to ensure that concerned stakeholders and regulatory agencies
are informed about these biotech products which have not been approved for importation into the
country.

 New Biotechnology Products under Development

Table 6 shows new traits and organisms which pose new challenges to biosafety
regulators in the near future.
Plants. For food and agriculture, to address the problem
of water scarcity, efforts are ongoing to improve important traits
such as water use efficiency and tolerance to drought, salt
tolerance, cold tolerance and pest resistance. Researches on
improving the nutritional content of food crops also continue to help
meet the nutritional requirements of humans and animals. This
includes the enhancement of macro-nutrients like protein,
carbohydrate, fats and fiber, of micro-nutrients such as vitamins
and minerals, phytochemicals as well as the reduction of anti-
nutrients such as allergens, trypsin inhibitor, phytate etc.

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 Table 6. Summary of new traits and organisms which may pose new
challenges to biosafety regulations.

Plants
Improved traits against abiotic stresses (Drought tolerance, salt/cold tolerance, high aluminum
soils)
Improved quality (higher level of nutrient in plant, better postharvest quality, reduced level of anti-
nutrients)
Production of novel product in plant (pharmaceuticals or industrials)
Metabolic (pathway) engineering [nitrogen use efficiency; C3 to C4; minimal water use; annual to
perennial; production of biofuels]
Use in bioremediation

Microorganisms
Cellulosic ethanol production
Bioremediation

Animals
Production of novel product in milk of animal (pharmaceuticals or industrials)
Improved traits (faster growth rate, more efficient nutrient use, better nutritional content, disease
resistance)

Plants are also now considered as major sources of renewable fuels. Sugarcane and corn
are presently commercial sources of bioethanol. Other potential crops are sorghum, soybean,
canola, switchgrass (Panicum virgatum) and poplar. In the United States, based on the
recommendation of the National Research Council, the US Department of Energy is focusing
research on bioenergy crops and metabolic engineering of plant biochemical pathways to produce
key enzymes (NRC 2006). The US DOE’s roadmap includes the breeding of biomass crops which
grow better on marginal lands, be more drought- and pest-tolerant, and be more cost effective, with
characteristics that make them more easily be converted to ethanol. Moreover, the US DOE aims
to develop biology-based options to convert cellulosic materials to ethanol in biorefineries and
reduce waste by-products (US DOE, 2006).

Researches in the laboratory and field stages to produce pharmaceuticals and industrials
in plants are currently being conducted in advanced countries. In 2002, 20 federal permits for such
GE plants were issued in 14 states governing 34 field sites for a total of 130 acres. In 2003–2004,
there were 13 applications, consisting of the production of antigens, antibodies, growth factors,
hormones, enzymes, blood proteins and collagen to address cancer, HIV, heart disease, diabetes,
Alzheimer’s disease, kidney disease, cystic fibrosis, multiple sclerosis, spinal cord injuries, hepatitis
C, chronic obstructive pulmonary disease, obesity and arthritis. Crops which are used in this area
of development are corn, soybean, rice, tomato, barley, safflower, peas and tobacco.

Plants are also potential extractors of pollutants such as heavy metals and can thus be
used in bioremediation.

Animals. In the use of animals as factories for pharmaceuticals, the most advanced
product is ATryn®, an anti-clotting drug produced by GTC Biotherapeutics in Massachusetts. This
is the first health product produced in the milk of a transgenic animal (goat) which was approved for
use in the European Union by the European Medicines Agency in 2006. This is the first time that
any therapeutic protein produced in a transgenic animal had been approved anywhere in the world.
ATryn® has also been designated by the US Food and Drug Administration to be a fast track
product which entitles the product to an accelerated FDA review for the hereditary antithrombin
deficiency indication. Another company, Pharming NV Group, has two products in late stage
development - Rhucin® (recombinant human C1 inhibitor) for hereditary angioedema and human
lactoferrin for use in food products (GRAS notification under review by US FDA). Two other
products, a tissue sealant (rTS) and recombinant human fibrinogen (rhFIB) and collagen (rhCOL)

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are for intermediate products of medical and aesthetic applications. These products are produced
in the milk of transgenic cows or rabbits.

On the other hand, various animals have been improved by genetic engineering to
improve their growth rates (fish such as flounder, salmon and tilapia (Aquabounty Technologies
http://www.aquabounty.com/)), nutrient use efficiency (EnviroTM pigs which are able to degrade
phytate in their feed resulting in release of phosphorus; this also results in their manure having 75%
less phosphorus, (http://www.uoguelph.ca/mediarel/archives/000404.html)), greater nutritional
content (pork with omega-3 fatty acid) and disease-resistance (BSE-free cattle).

New Regulatory Challenges

The new challenges to regulatory agencies that will be brought about by these new
developments are: (a) unfamiliar traits, (b) several traits introduced, (c) new proteins, (d) new
phenotypes and/or ecological impact, and (e) field test and production confinement issues.

In the past years, heated debates have centered on two technologies, transgenic fish
(salmon, flounder and tilapia) which grow faster than their conventional counterparts and the
production of pharmaceuticals or industrials in food or feed crops. For transgenic fish, the concern
revolves on the possibility of the transgenic fish, salmon for example, escaping into the wild and
because of its greater growth rate, the transgenic salmon could outgrow and outbreed the native
salmon. On the other hand, based on the theory put forward by Muir and Howard (1996), if the
offspring of the transgenic fish has lower viability as with the transgenic Medaka, a fast breeding
Japanese fish, the release of the transgenic fish in the wild could lead to the extinction of the
species.

For the production of pharmaceuticals or industrials in crops, the major concern is the
possibility of mixing of the pharma crop with the food or feed crop either in the field or during
processing. Dr. Thomas Lumpkin, former Director General of the Asian Vegetable Research and
Development Center (AVRDC) based in Taiwan, stated that “The unpredictability of nature and
human behavior makes the possibility of absolute confinement, under current approaches,
unrealistic, especially under field conditions” (2003). He further recommended a moratorium on the
use of food crops to produce non-food products and that governments should support the
development of non-food carrier organisms such as castorbean or tobacco which can be used by
pharmaceutical and chemical companies for synthesis of pharmaceutical and industrial products.
The US Department of Agriculture’s APHIS has recently released its “Draft Guidance for APHIS
Permits for Field Testing or Movement of Organisms with Pharmaceutical or Industrial
Intent” (USDA APHIS, 2007). This draft guidance includes changes reflecting increased stringency
of conditions required to handle these regulated materials. The US FDA and the US DA also jointly
released a draft “Guidance for Industry: Drugs, Biologics, and Medical Devices Derived from
Bioengineered Plants for Use in Humans and Animals” which outlines the important scientific
questions and information that the proponent should address, points to demonstrate the safety and
effectiveness of products from bioengineered pharmaceutical plants, and points to consider in
addressing environmental issues and confinement measures (US FDA & USDA, 2007).

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 The New National Biosafety Framework under EO 514
Introduction
On March 17, 2006, the Office of the President promulgated Executive Order No. 514
establishing the National Biosafety Framework (NBF), prescribing the guidelines for its
implementation, strengthening the National Committee on Biosafety of the Philippines, and for
other purposes.
The National Biosafety Framework (NBF) is a combination of policy, legal, administrative
and technical instruments developed to attain the objective of the Cartagena Protocol on Biosafety
which the Philippines signed on May 24, 2000, ratified on October 5, 2006 and entered into force
on January 3, 2007. The Protocol aims to “contribute in ensuring an adequate level of protection in
the safe transfer, handling, and use of living modified organisms (LMOs) resulting from modern
biotechnology that may have adverse effects on the conservation and sustainable use of biological
diversity.”
The NBF can be considered as an expansion of the present National Committee on
Biosafety of the Philippines (NCBP), which since 1987 has played a pioneering and important role
in developing and establishing the current biosafety system in the country and has been
acknowledged as a model system for the developing countries.
Biosafety guidelines and protocols were already in place with the issuance in 1990 of
Executive Order No. 430 creating the NCBP. The same EO establishes institutional biosafety
committees which enable agencies undertaking biotechnology research to put up and comply with
biosafety regulations established by the NCBP. The Department of Agriculture also issued
Administrative Order No. 8 to set in place policies on the importation and release of plants and
plant products derived from modern biotechnology.
The formulation of the NBF drew from the wealth of experience of the NCBP and other
agencies involved in biosafety regulation in the country. It also considered the inputs from multi-
stakeholder consultations/workshops participated in by key players in biosafety-related concerns.
Inventories on the current uses of modern biotechnology, existing legal instruments, capacity-
building activities, and expertise within the country were conducted in the process of crafting the
NBF.

Salient Features

The NBF, as adopted and operationalized by EO 514, covers all activities relating 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. Its
objectives are as follows: (1) to strengthen the existing science-based determination of biosafety;
(2) to 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) to serve as guidelines for implementing international
obligations on biosafety.
The NBF describes the roles, mandates, jurisdiction and powers of various departments
and agencies in relation to biosafety and biotechnology. It also prescribes the institutional
arrangements to be followed for a manageable biosafety decision-making system in the country.
The Framework also stipulated the following principles and guidelines that should govern
biosafety decisions:
1) Standard of Precaution – In accordance with Article 10 (par. 6) and Article 11 (par. 8)
of the Cartagena Protocol on Biosafety, the lack of scientific certainty or consensus

Page | 40
 due to insufficient relevant scientific information and knowledge regarding the extent
of the potential adverse effects of a genetically modified organism on the environment
shall not prevent government departments and agencies from taking the appropriate
decision to avoid or minimize potential or adverse effects.
2) Risk Assessment – Risk assessment shall be mandatory and central in making
biosafety decisions. It shall identify and evaluate the risks to human health and the
environment, and if applicable, to animal health. Risk assessments shall be carried
out to determine whether a regulated article poses significant risks to human health
and the environment. Their conduct by concerned departments and agencies shall be
in accordance with the policies and standards on risk assessment issued by the
NCBP.
3) Role of Environmental Impact Assessment – The application of Environmental Impact
Assessment to biosafety decisions shall be determined by concerned departments
and agencies subject to the requirements of law and standards set by the NCBP.
Where applicable and under the coordination of the NCBP, concerned departments
and agencies shall issue joint guidelines on the matter.
4) Socio-economic, Ethical, Cultural and Other Considerations – Consistent with Article
26 of the Cartagena Protocol, concerned departments and agencies may take into
account socio-economic considerations arising from the impact of regulated articles
on the conservation and sustainable use of biological diversity, especially with regard
to the value of biological diversity to indigenous and local communities.
5) Decisions under the Cartagena Protocol – Competent national authorities may
choose to adopt Articles 7 to 13 of the Cartagena Protocol or issue their own
respective rules and regulations that are consistent with the Protocol. In all cases,
decisions under the NBF shall fall within the timeframes required under the Cartagena
Protocol.
6) Monitoring and Enforcement – Concerned departments and agencies shall monitor
compliance to the conditions attached to approvals and authorizations in a manner
that is transparent, and in coordination with other agencies, including local
government units, and other stakeholders.

The NBF recognizes the right of the public and relevant stakeholders to information
related to biosafety decisions. As such, concerned departments and agencies shall, subject to
reasonable limitations to protect confidential information, disclose all information on such
applications in a prompt and timely manner. The public and relevant stakeholders shall have
access to all biosafety decisions such as summary of the application, results of risk assessment
and other assessments done.
Conduct of meaningful, responsible and accountable public awareness, education, and
public participation shall be promoted and facilitated under the NBF. Public participation shall apply
to all stages of biosafety decision-making process. The following minimum requirements for public
participation shall be followed: 1) notice to all concerned stakeholders; 2) adequate and reasonable
timeframes; 3) public consultations such as formal hearings or solicitation of public comments; 4)
written submissions, and 5) consideration of public concerns in the decision-making process.
To ensure proper implementation of the NBF, the need to strengthen the capacities of
various sectors is recognized. Thus, the design, adoption and implementation of a capacity-building
program supported by adequate financial resources are integral components of the NBF.
In cases of violation of laws, rules and regulations related to biosafety, the following
remedies shall apply: administrative remedies, criminal liability, civil liability, and international legal
norms on liability and compensation, including those developed and adopted under the Cartagena
Protocol on Biosafety.

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Composition and mandate of the new NCBP

The new NCBP. Under the NBF, the composition and functions of the NCBP have been
expanded. The composition of the NCBP includes the secretaries of the Departments of Science
and Technology, Health, Environment and Natural Resources, Foreign Affairs, Trade and Industry,
and Interior and Local Governments or their designated representatives constitute the NCBP. The
DOST Secretary shall serve as the permanent NCBP Chair. Also members of the NCBP must
include a consumer representative, a community representative from the farmers, fisher folk or
indigenous sector, a representative from industry, a biological scientist, physical scientist,
environmental scientist, health scientist, and social scientist.
The NCBP is the lead body in implementing the
NBF. It shall spearhead coordination and harmonization of
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. The NCBP
Secretariat also serves as the country’s focal point for
Biosafety Clearing House (BCH).

Under the NBF, the new NCBP has multi-faceted

roles and shall perform biosafety policy, accountability,
scientific, and capacity-building functions.
The NBF shall be reviewed periodically to identify
gaps and lessons learned from its implementation and
incorporate new information that may lead to its improvement. The NCBP shall initiate and lead
such review every five years, unless new developments require an earlier review.
The mandate of DOST. The DOST, as the premiere S & T body in the country, shall lead
in ensuring that the best available science is used and applied in the adoption of biosafety policies,
measures and guidelines, and in making biosafety decisions. DOST shall be in charge of
evaluating and monitoring regulated articles for contained use.
The mandate of DA. The DA, as the agency primarily responsible for the promotion of
agricultural development growth and rural development to ensure food security and contribute to
poverty alleviation, shall be in charge of addressing biosafety issues related to the country’s
agricultural productivity and food security. It shall take the lead in evaluating and monitoring plant
and plant products derived from the use of modern biotechnology, as provided by DA AO No. 8,
series of 2002.
The mandate of DENR. The DENR, as the agency primary responsible for the
conservation, management, development and proper use of the country’s environment and natural
resources, shall ensure that environmental assessments are done and impacts identified in
biosafety decisions. It shall also be in charge of evaluating and monitoring regulated articles
intended for bioremediation, the improvement of forest and wildlife genetic resources.
The mandate of DOH. As the principal authority on health, the DOH shall formulate
guidelines in assessing impacts on health posed by modern biotechnology and its applications. It
shall be in charge of evaluating and monitoring processed food derived from or containing GMO.

The mandate of associated Departments and Agencies. Where appropriate, the

associated Departments and Agencies shall participate in biosafety decision making: the
Department of Foreign Affairs in promoting and protecting Philippine interests on biosafety in
bilateral, regional and multilateral forums; the Department of Trade and Industry in relation to
biosafety decisions which have an impact on trade, intellectual property rights, investments and
consumer welfare and protection; the National Commission on Indigenous Peoples, in relation to
biosafety decisions which have a specific impact on indigenous peoples and communities; and the

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Department of Interior and Local Government, in relation to biosafety decisions which have an
impact on the autonomy of local government units.
Thus, the DOST, DA, DENR and DOH shall have biosafety committees (BSC) similar to
the present NCBP to handle the evaluation of biosafety proposals and monitoring of approved
projects.

Implementing Rules and Regulations/Procedural Manual

The Implementing Rules and Regulations (IRR) of EO 514 are being formulated by an
Inter-Agency Technical Working Committee created by NCBP by virtue of DOST Special Order No.
307 dated August 8, 2006. A comprehensive procedural manual is also being prepared and will be
subjected to consultation with concerned agencies.

Concerns about the New NBF

During the open fora of various RTDs, one of the most contentious issues was the new
NBF. Some of the concerns raised were: (a) the size and composition of the new NCBP, (b)
requirements for environmental impact assessment, (c) financial and technical resources, (d)
implementing rules and regulations, and (e) the role of local government.

Size and composition of the new NCBP. Under the new NBF, the new NCBP will have
15 members including the Secretaries of Science and Technology, Agriculture, Health,
Environment and Natural Resources, Foreign Affairs, Trade and Industry, and Interior and Local
Government or their designated representatives, a consumer representative, a representative from
the farmers, fisher folk and indigenous sector, a representative from industry, and five scientists,
one each from the biological, physical, environmental, health and social sciences, compared with
the present NCBP with 10 members. Concerns were raised on how this superbody could work
efficiently, if at all, considering its size and composition. There were apprehensions that the
process of evaluating proposals will be prolonged. It was explained that the new NCBP will be
tasked primarily with policy making. The working groups will be at the different concerned agencies
or departments. For example, a working group at the DOST will be tasked to handle the evaluation
and monitoring of researches involving GMOs in contained facilities. On the other hand, the DA will
have its own working group which will be tasked to handle the importation, field testing and
commercialization of agricultural products derived by modern biotechnology.

Requirements for environmental impact assessment. Another hotly discussed issue

was the perceived requirement for environmental impact assessment (EIA) in biosafety
evaluations. The EIA can take many years to conduct and cost millions of pesos and could
therefore delay field tests and discourage proponents. However, according to EO 514 (2006)
“…The application of the EIA System to biosafety decisions shall be determined by concerned
departments and agencies subject to the requirements of law and the standards set by the NCBP.
Where applicable and under the coordination of the NCBP, concerned departments and agencies
shall issue joint guidelines on the matter.” Thus, EO 514 does not impose a mandatory EIA, but
the requirement of an EIA for a particular project will be evaluated and determined by the
concerned department.
It was clarified that under the present practice of the NCBP, the confinement afforded by
the screenhouse and/or contained fields already provides a means to prevent or minimize any
adverse environmental impact and, thus, an environmental impact assessment may not be
required. Similarly, according to the USDA APHIS National Environmental Policy Act (NEPA),
confined field tests may not be required to have an environmental assessment because “the means
through which adverse environmental impacts may be avoided or minimized have been built into
the confinement and containment actions themselves” (APHIS NEPA
http://www.aphis.usda.gov/ppd/es/statutes.html). However, an environmental assessment may be
required when a confined field test involves new species, organisms or novel modifications that
raise new issues. APHIS itself determines if a proposal is excluded from an environmental
assessment or if an EIA or an environmental impact statement is required.

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 Financial and technical resources. According to EO 514, the involved departments
(DOST, DA, DENR, and DOH) will first
allocate from their budgets such amount
needed to support the operations of the NCBP
and its Secretariat. After one year, the funding
requirement shall be included in the General
Appropriations Bill submitted to Congress.
However, there were concerns on the difficulty
of getting the departments to share resources,
as was the experience with the EO 430
implementation, the operational costs of which
have been shouldered by the DOST since
1990.

Implementing rules and

regulations (IRR). The IRR of the NBP is
being formulated by a technical working group composed of representatives from the agencies
involved and headed by the Executive Director of PCASTRD. The challenge to the working group is
to prepare a set of IRR which will be clearly understood by all stakeholders to prevent conflicting
interpretations of EO 514.

Role of local government. According to Section I of the NBF, the state policies as
delineated in the Philippine Constitution shall guide in the implementation of the NBF. One of these
is regarding Local Autonomy and states: “The territorial and political subdivisions shall enjoy local
autonomy (Article 10, Section 2).” The role of local government in the implementation of the NBF is
not well defined. The present practice is that the local community including the barangay officials is
briefed regarding the field testing. The posting of the public information sheet is also signed by the
barangay captain. The barangay captain and other local government officials should therefore have
some understanding of the technology and the issues involved. The NBF recognizes the need for
capacity building of various sectors to ensure its proper implementation. These sectors include
policy makers, regulatory agencies, local government units, the research community and the
general public involved in performing various tasks related to the NBF implementation (Section 8.1
of the NBF).

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 Other Issues and Concerns

Adventitious Presence of GMOs

Adventitious presence refers to the unintentional and accidental commingling of trace
amounts of one type of seed, grain or food product with another. The adventitious presence of
biotech seeds, which have not been officially approved for importation, in imported grains is,
therefore, an unavoidable reality. This has been discussed at various fora and is an issue which the
new NCBP has to contend with.

Labeling of Products Containing GMO

The issue of labeling products containing GMO was raised during one of the fora.
However, this was not discussed at length since this issue is not considered a biosafety issue.

Recommendations

Among this monograph’s aims is to identify concerns that the NCBP should address as it
1
enters a new phase. The following is an attempt to summarize these points or concerns :

• With the experiences and knowledge gained from the past 15 years, the new NCBP and/or the
different departmental biosafety committees (BSC) should consider modifying the present
rules/guidelines on the following aspects:

o Transfer of regulation of laboratory experiments in educational institutions to the

IBCs. It is expected that the number of experiments for laboratory courses and for
theses in universities will increase with the increased interests in modern
biotechnology and funding support from government agencies. The IBCs of these
universities should already prepare to conduct and be responsible for the biosafety
assessment and monitoring of such activities at their level. Guidelines should be
prepared on how and when the IBCs should report to the DOST-BSC on such
activities.
o Exclusion or exemption from biosafety regulation of researches on the development
of molecular markers and their applications including selection and breeding of non-
transgenic plants.
o Further testing of events which have been previously approved for screenhouse and
field testing can be done by notification. As experience in handling of GMOs and
confidence in the safety of GMOs to health and environment increase and with
expected increase in number of screenhouse and field tests, the DA-BSC should
consider allowing proponents to just notify it about further tests of events which have
been previously approved for screenhouse testing. At this time, regulation of field
tests is handled by the DA BPI. The monitoring of such activities shall be handled by
the proponent’s IBC.
o Review of requirements for field testing such as distance from non-transgenic plants,
security measures and public information. Locally derived scientific data from various
field trials of GMOs and those from other countries, should now be carefully studied to
re-determine the appropriate isolation distance between transgenic and non-

1
For clarity, new NCBP will refer to the superbody in charge of policy making, and the departmental
biosafety committees (BSC) will be referred to as such, e.g., DOST-Biosafety Committee or DOST-BSC,
DA-BSC, etc.

Page | 45
 transgenic crops. Similarly, requirements for security and public information should be
reviewed on the basis of local and international experience.
o Events which have been tested in screenhouses in the country of origin can be
considered for direct field testing.

• Considering that technology and policy evolve,

o Continuous capacity building program for members of the NCBP and department-
BSCs as well as members of the secretariat scientist.
o The training of IBC members should be strengthened and be continuous; their
minimum qualification standards for members of IBC should be prescribed.

• To further strengthen transparency of the biosafety regulatory process:

o the website of the NCBP should be continuously updated and should be linked with
the other biosafety regulatory units in the different Departments
o the basis for the decision of the department-BSCs and other regulatory units should
be posted in the NCBP website; the present NCBP website gives little information on
the proposals, specifically the basis for their approval or rejection. In contrast, the
decisions prepared by the USDA APHIS or the EPA as published in the US Federal
Register are clear, substantial and provide the scientific basis for their decisions.

• Considering that the present NCBP receives an average of 14 proposals per year which is
expected to increase given the fast pace of development in this field, the department-BSC, i.e.
the DOST-BSC, should have a complement of full time scientists and non-scientist-staff.

• Coordination and cooperation between and among the biosafety committees of the different
regulatory agencies need to be strengthened and should be built on the relationships already
nurtured during the past 15 years. In the United States, the USDA APHIS and the EPA work
harmoniously in the risk assessment of biosafety proposals. They also coordinate with the US
FDA for food safety assessment.

• Considering that new products of modern biotechnology pose new challenges,

o The NCBP and the department-BSCs have to continuously build their capability to do
risk assessment.
o The NCBP and/or the department-BSCs should enhance its public participation
activities by conducting regular briefings among stakeholders, generate comments
and address issues and concerns posed by the new wave of biotechnology products.
• The new biosafety units in the regulatory agencies including the DOST’s should be prepared to
comply with the Cartagena Protocol through capacity building and the general public be
regularly informed and updated on this and related matters.

• The immediate challenge faced by the new NCBP will be the smooth transition from the “old”
to the “new” NCBP and this will entail careful and detailed planning for all concerned agencies.

• Should continuously build their capabilities in the field of risk assessment and risk
management as well as on human and environmental health safety.

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 Acknowledgments

We are grateful for the insightful comments and suggestions on the draft
report by National Scientist Gelia T. Castillo, Acd. Lediviña V. Cariño, National
Scientist Lourdes J. Cruz and Acd. Asuncion K. Raymundo. We deeply
appreciate the various information and clarification provided by National Scientist
Dolores A. Ramirez. We thank all the resource persons and participants of the
five Round Table Discussions. Our thanks also to Misses Julieta Fe L. Estacio,
Luningning E. Samarita, Charyl C. Apuyan, Virginia Francia O. Gavica, Rowena
V. Briones, Reihvelle A. Perez, Ms. Irma Brul, Mr. Ferdinand C. Gutlay, and Mr.
Francefe Pacis, for their able assistance.
We greatly acknowledge the financial support given by the Department of
Science and Technology (DOST) and the Program for Biosafety Systems (PBS)
for this publication.

Page | 47
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