GOVPH

In the Philippines, the interest in biosafety, as one of the concerns in the application of modern biotechnology traces its origin from the issues raised by scientists at the University of the Philippines Los Baños (UPLB) and the International Rice Research Institute (IRRI) when their researches started to require the use of modern biotechnology tools.It was the time when recombinant DNA technology or genetic engineering was proving to be a promising tool in the genetic improvement of crops, livestock, and microorganisms. A memorandum of agreement signed by then UPLB Chancellor Raul P. De Guzman and then IRRI Director General M.S. Swaminathan on 12 October, 1987 created a Joint Committee on Biosafety with the following terms of reference:

• Review research proposals submitted by UPLB and IRRI scientists initiating experiments which require special safety requirements 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 modern biotechnology researches at UPLB and IRRI;

• Serve as a clearing house of information on experimental procedures involving recombinant DNA technology; and

• Review from time to time ongoing experiments in modern 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, IRRI, BPI, and PCARRD as follows: UPLB (8)— Professors Reynaldo E. Dela Cruz, Saturnina C. Halos, Bonifacio T. Mercado, Oscar S. Opina, William G. Padolina, Dolores A. Ramirez, Belen M. Rejesus, and Fernando F. Sanchez; IRRI (6) — Drs. Fernando A. Bernardo, Gurdev S. Khush, Tom W. Mew, Mano D.Pathak, Bernard M. Shepard, and Paul S.Teng; BPI (1) —Dr. Salome Del Rosario; and PCARRD (1) —Dr. Dely P. Gapasin. Dr. Ramirez was the chair of the committee.

The first activity of the committee was the formulation of biosafety guidelines. For its take off point, the committee reviewed existing guidelines in several countries, including those of Australia, Japan, United Kingdom, and the US Institute of Health. In addition, the committee paid special attention to the existing quarantine laws of the Philippines, especially those that deal with the introduction of microorganisms, plants, and animals into the country as well as those dealing with the movement of regulated microorganisms, plants and animals within the country. The overriding philosophy was to make use of existing quarantine rules and regulations that would apply to genetically modified organisms (GMOs) and that the guidelines to be drafted should only supplement the Philippine quarantine laws.

Because national and international experiences on recombinant DNA technology in the agricultural sciences were then very limited, the resulting guidelines tended to be quite strict. Furthermore, the guidelines had emphasis on the biosafety of the process/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 hazards that may be poised on humans as well as on the environment, should the GMO be released to the environment. The draft biosafety guidelines recommended that UPLB and IRRI facilitate the creation of a national committee on safety in biological researches and proposed that the biosafety guidelines be adapted nationally.

The draft biosafety guidelines were submitted for review of some scientists of UPLB and IRRI as well as scientists from other countries who were visiting IRRI, e.g. Professor Bruce Holloway from Monash University, Australia, Dr. Hiroyuke Hibino from Japan,

During the period 1988 to 1989, the draft guidelines was presented in several international conferences in India, Indonesia, Thailand, and U.S.A. It was also during this time that some legislators and Senators became interested in the issue of biosafety of GMOs, The committee was invited by both houses of congress because they wanted to legislate biosafety. Both UPLB and IRRI proposed that instead of legislation, adaption of the biosafety guidelines by all R & D institutions be the option.

The move for national adaption of the guidelines was initiated when UPLB and IRRI submitted the guidelines to the National Academy of Science and Technology, Philippines (NAST, PHIL) with the recommendation that the NAST take the lead in the process of getting the guidelines nationally adapted. As its first activity in the process, NAST sponsored public consultations regarding the draft biosafety guidelines in as many places in the country, inviting largely the science communities in Luzon, Visayas and Mindanao. Taking into account 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.DOST, in turn proposed the creation of a National Committee on Biosafety and on 15 October, 1990 then President Corazon C. Aquino promulgated Executive Order 430 creating the National Committee on Biosafety of the Philippines (NCBP). Another round of public consultations regarding the draft biosafety guidelines was undertaken by DOST involving not only the science communities but also the other stakeholders. Again, comments and suggestions were considered in the preparation of the final draft of the Philippines Biosafety Guidelines.

Mandate of the Department of Science and Technology. The Department of Science and Technology (DOST). as the premiere science and technology body in the country, shall take the lead in ensuring that the best available science is utilized and applied in adopting biosafety policies, measures and guidelines, and in making biosafety decisions.The DOST shall ensure that such policies, measures, guidelines and decisions are made on the basis of scientific information that is of the highest quality, multi-disciplinary, peer-reviewed, and consistent with international standards as they evolve. In coordination with other concerned departments and agencies, and consistent with the requirements of transparency and public participation as provided in Sections 6 and 7 of the NBF, it shall exercise such jurisdiction and other powers that it has been conferred with under existing laws. It shall also take the lead in evaluating and monitoring regulated articles intended for contained use.

Mandate of the Department of Agriculture. As the principal agency of the Philippine government responsible for the promotion of agricultural development growth, rural development so as to ensure food security and contribute to poverty alleviation, the Department of Agriculture shall take the lead in addressing biosafety issues related tothe country’s agricultural productivity and food security.In coordination with other concerned departments and agencies, and consistent with the requirements of transparency and public participation as provided in Sections 6 and 7 of the NBF, it shall exercise such jurisdiction and other powers that it has been conferred with under existing laws. It shall also take the lead in evaluating and monitoring plant and plant products derived from the use of modern biotechnology, as provided in Department of Agriculture Administrative Order No. 008, s. 2002.

Mandate of the Department of Environment and Natural Resources. As the primary government agency responsible for the conservation, management, development and proper use of the country’s environment and natural resources, the Department of Environment and Natural Resources (DENR) shall ensure that environmental assessments are done and impacts identified in biosafety decisions. It shall also take the lead in evaluating and monitoring regulated articles intended for bioremediation, the improvement of forest genetic resources, and wildlife genetic resources.

Mandate of the Department of Health. The Department of Health (DOH), as the principal authority on health, shall formulate guidelines in assessing the health impacts posed by modern biotechnology and its applications. The DOH shall also require, review and evaluate results of environmental health impact assessments related to modern biotechnology and its applications. In coordination with other concerned departments and agencies, it shall exercise such jurisdiction and other powers that it has been conferred with under existing laws.It shall also take the lead in evaluating and monitoring processed food derived from or containing genetically modified organisms.

Mandate of Associated Departments and Agencies. In coordination with other concerned departments and agencies, and consistent with the requirements of transparency and public participation as provided in Sections 6 and 7 of the NBF, all other departments and agencies shall exercise such jurisdiction and other powers that it has been conferred with under existing laws. In particular, the following departments and agencies shall participate in biosafety decision making, where appropriate: 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 Department of Interior and Local Government, in relation to biosafety decisions which have an impact on the autonomy of local government units.

The NCBP shall be composed of the following:

• The Secretaries of the Departments of Science and Technology, Agriculture, Health, Environment and Natural Resources, Foreign Affairs, Trade and Industry, and Interior and Local Government or their designated representatives. The DOST Secretary shall be the permanent Chair;

• A biological scientist, physical scientist, environmental scientist, health scientist, and social scientist to be endorsed by the DOST Secretary upon the recommendation of recognized professional and collegial bodies such as the National Academy of Science and Technology (NAST) and the Philippine Social Science Council (PSSC), and appointed by the President, each serving for a term of three (3) years, renewable for another term.

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

• A community representative from the farmers, fisherfolk and indigenous sector appointed by the President from a list submitted bynationally recognized sectoral organizations, serving for a term of three (3) years, renewable for another term;

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

The NCBP shall be the lead body to coordinate and harmonize inter-agency and multi-sector efforts to develop biosafety policies in the country and set scientific, technical and procedural standards on actions by agencies and other sectors to promote biosafety in the Philippines.