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
aInstitute of 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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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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M E S S A G E
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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M E S S A G E
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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M E S S A G E
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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M E S S A G E
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
Page | 16 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.
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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 2006 and Moving Forward Discussion (1st of the Compound, series) Bicutan, Taguig Page | 22
City Oct. 11, Workshop on Relevant Roundtable NAST, DOST 2006 Experiences of Various Discussion (2nd of the Compound, Biosafety System series) Bicutan, Taguig Stakeholders” City Nov. 13, Roundtable discussion on Roundtable DOST Exec. 2006 E.O.514 (3rd 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
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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
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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
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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 Transformation of E. coli with plasmid containing bioluminescent gene and other plasmids/cassettes. Identification, development Genetic analysis of Pseudomonas solanacearum; and/or use of molecular identification of genetic markers for high alcohol production markers for genetic in locally isolated yeast strains; RFLP mapping of rice blast analysis, varietal resistance genes and various QTLs; identification of disease identification, resistance genes by screening activator-tagged mutant rice characterization, marker- population; development of Ac/Ds transposon tagging system aided selection and/or to isolate agronomically important genes; identification of breeding 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. Cloning of genes Genes such as α-amylase, thermophilic gene, poly -3- hydroxybutyrate depolymerase gene and expression in E. coli.
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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.
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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 food trade. In its 26th 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.
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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 harvested from a 600 to 1000 m2 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)
Page | 38 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
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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 enters a new phase. The following is an attempt to summarize these points or concerns1:
• 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.
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