Public Input

The general public cannot have confidence in official statements that assert "this GM crop is safe to grow and safe to eat" if they feel deliberately excluded from the decision making. Needless to say, opponents of biotechnology are aware of this, too, and easily raise suspicion and fears by claiming that the public has no voice in decisions regarding the use of GM technology. Furthermore, perceptions that biosafety reviews are inadequate, that deliberations are conducted behind closed doors, and that private sector interests are strongly influential seriously undermine the credibility of biosafety reviewers and competent authorities.

With few exceptions, technical biosafety reviews are primarily scientific evaluations conducted by a small group of specialists and, usually, government officials. Final decisions about consumers' use of GMOs, however, must necessarily consider both safety and nonsafety (e.g., socioeconomic, trade, equity) issues. It is at this point that public input should become a factor in decision making.

Public participation in biosafety decision making, specifically addressed in Article 23 of the Cartagena Protocol, typically is achieved through mechanisms to solicit public comment on proposed activities and pending decisions on GMO market releases and deliver it to decision makers. National biosafety officials may use normal government communications channels to announce such events and call for public comment. In a few cases, even proposed field tests are open for public comment. Regulatory officials may place notifications and contact information in local newspapers and on radio programs or conduct local informational meetings. Public meetings are especially useful in that they allow diverse points of view to be heard. The discussions sensitize scientists and regulators to public concerns and at the same time provide an opportunity for the public to obtain accurate information. (See section six, "Communicating about Risk and Biosafety.") A few countries (e.g., the Philippines and the United Kingdom) have instituted direct public involvement in biosafety assessment of GMOs by including representatives of the general public on their national biosafety committees. These committee members may or may not have a technical background.

Terms of Reference for Biosafety Committees

Groups best work together when members have a common understanding of the group's purpose, scope of subject matter, and mode of operation. Ideally, such information for national biosafety committees is specified in formal or informal terms of reference. Although few committees in developing countries have written terms of reference (and many in developed countries lack them as well), they can be instrumental in setting up a functional and effective biosafety committee and serve to coordinate its operations within the larger national regulatory framework.

Terms of reference (principles of operation) are often the first level of guidance for a biosafety committee. They may be articulated within national regulations, guidelines, rules for implementation, or as a separate document. They may address a range of topics, several of which are listed in the box below. Usually, terms of reference establish how the committee is to function, the boundaries of activity in which it may be involved, and the expec tations for its deliberations and output. The choice of topics to include and the language used to describe them will reflect the regulatory framework and the perspectives of those drafting the terms. In practice, the list would be longer, perhaps including such additional topics as document management and record keeping, committee procedures, handling of confidential business information, review procedures, member confidentiality, use of external

The terms provided for each topic are examples of how each topic could be addressed; many other approaches are possible.

PURPOSE

a. The National Biosafety Committee (NBC) is constituted to conduct scientific reviews of applications to import, field test, produce, and/or place on the market genetically modified organisms (GMOs).

b. The NBC is the competent authority for determining the acceptability of a GMO intended for local consumption as food, feed or fiber, export or trade, production of industrial or pharmaceutical products, or any other applications, on the basis of a scientific evaluation of risks, benefits, and comparison of these with those of their conventional counterparts.

c. The Biosafety Advisory Group serves in an expert capacity to evaluate the potential risks of GMOs to human health and the environment and make recommendations to the Ministry of the Environment regarding their use and distribution.

AUTHORITY

a. The NBC is constituted under authority of the Minister of

Agriculture as assigned in the Agricultural Products Use Act of 1999.

b. In accordance with Environmental Protection Directive 86-041, as amended on 3 June 1991, the Council for the Environment will establish, maintain, and provide support to an NBC.

APPOINTMENT

a. Members of the NBC will be appointed by the Deputy Minister of the Environment upon recommendation by the Secretary of the National Council of Environmental Affairs.

b. The Director of Agricultural Development and Trade will receive nominations for membership annually. After formal screening, selected individuals will be invited to sit on the committee for a term of 5 years.

c. Members are appointed by the Deputy Director of Agricultural Research and Development. In addition, the President may at any time appoint an additional member or members of his/her own choosing.

MEMBERSHIP

a. The committee is composed of scientists having expertise in relevant scientific disciplines, including molecular biol-

or ad hoc advisors, and dealing with conflicts of interest. Each country or committee must formulate its own terms of reference according to its bio-safety objectives, regulatory infrastructure, human resources, and similar contributing factors.

Note that some of the sample terms of reference are overly restrictive. An example is "Scope of Review: The committee's primary responsibility is to conduct a safety assessment of applications to field test or commercialize GMOs. Risks are to be identified, their magnitude estimated, and their potential negative consequences described." The wording confines reviewers to look only at risk. No balancing consideration is to be given to potential benefits or positive consequences.

In other cases, the terms are very broad. An example is "Membership: The committee is composed of scientists having expertise in relevant sci-

ogy, plant breeding, genetics, plant pathology, agronomy, weed science, ecology, and others.

b. Members include the Deputy Minister of Agriculture, Director of the National Council for Science and Technology, the Minister's science advisor, representatives of the Ministries of Environment, Health, Production and Trade, and scientists having expertise in disciplines.

SCOPE OF REVIEW

a. Biosafety reviews will focus on scientific issues related to environmental impacts of the proposed activity. Analyses will be based on scientific data provided by the applicant or by outside sources.

b. The NBC evaluation will focus on the potential risks and potential benefits of a particular GMO in light of the known risks and benefits of the nonmodified conventional variety.

c. The committee's primary responsibility is to conduct a risk assessment of applications to field test or commercialize GMOs. Risks are to be identified, their magnitude estimated, and their potential consequences described.

d. The Biosafety Advisory Board Review will, in the course of its assessment, consider the necessity for developing the GM variety, its relevance to national needs and priorities, and comparative advantages/disadvantages over non-GM varieties.

e. The NBC will not comment on the proposed experimental design or choice of scientific methods except where concerns are raised that safety could be compromised.

f. Nonsafety concerns (e.g., socioeconomic impact) will be referred to an auxiliary body established for that purpose or to the decision-making authority for independent evaluation.

POSTREVIEW RESPONSIBILITIES

a. The committee will be responsible for establishing a follow-up monitoring program for compliance with regulatory decisions and any constraints therein. This may be accomplished through submission by the applicant of annual reports or a final report, site visits by NBC member(s) or their representative(s), or as otherwise deemed sufficient by the committee.

b. After completion of each review, the committee or an appointed spokesperson will be available to the Deputy Minister of Agriculture to respond to follow-up questions or additional analyses as deemed necessary.

entific disciplines, including molecular biology, plant breeding, genetics, plant pathology, agronomy, weed science, ecology, and others." This term leaves open who makes the appointments, by what process, the number of members, and their length of service. Both strong and weak examples are given as a way to stimulate discussions of the merits, drawbacks, and, most importantly, the implications of each.

Additional terms of reference may address topics such as committee procedures, use of external or ad hoc advisors, record keeping, handling of confidential business information, and dealing with conflicts of interest.

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