Module IV: Biotechnology and Biosafety

In general terms, the biosafety management strategy begins with identifying the key players and soliciting their early participation in the review process, building an atmosphere of openness, and educating decisionmakers about the key role of the biosafety system in building public acceptance and minimizing health and safety risks.

The first task is to define the overall framework of the biosafety system. What are the objectives of the system? What is the scope of oversight, e.g., agriculture, medicine, etc.? What products will require review, and where are the boundaries, e.g., on new products derived from already-approved products? Who are the participants and what are their rights and responsibilities? Who ultimately holds decisionmaking authority? How will decisions be implemented, e.g., through new laws, or by using existing legislation?

Faculty asserted that biosafety guidelines, in order to be effective, must be:

• Science-based (to evaluate risks);
• Flexible (to incorporate new knowledge); and
• Transparent (to allow the public to review and evaluate procedures).

Costs

Developing an effective biosafety system may well require substantial training, e.g., to raise awareness of policymakers, introduce ethical and safety issues to researchers, increase the technical capacities of biosafety reviewers, and to promote regional harmonization of standards. There is currently a limited pool of people qualified to evaluate the safety of GM organisms. Of the people who have relevant expertise, many are private sector firms or researchers who might have a conflict of interest with the review committee’s mandate. Finding the appropriate people to serve on biosafety review committees, and training them if necessary, is therefore one of the greatest initial challenges facing policymakers.

Training and education are not the only costs of the biosafety system. Other costs include the administration of the system; the establishment of public relations mechanisms; the loss of productivity represented, for example, by the participation of scientists who could otherwise be conducting research; the organization of meetings and consultation with experts; access to and collection and dissemination of information; and performance of public outreach. Who should pay for these necessary services? Recommended strategies include pooling resources among agencies; charging application fees for submitting GM organisms for approval; capitalizing on investments by, for example, offering incentives to keep trained people in the country; and taking an anticipatory rather than a reactive approach to biosafety issues.

Information and Risk Assessment

Another difficulty is simply the knowledge gap. There are many unknowns in this area, particularly pertaining to the long-term effects of GM organisms on human health, biodiversity, ecosystem balances, and other environmental effects. Therefore the process of information collection and reporting during laboratory and field testing is essential to building the store of human knowledge in these areas. Whether testing leads to commercialization of products, given these uncertainties, is a question that can only be resolved by the application of rigorous science and risk assessment in combination with informed public policy, ideally driven by democratic processes in which many voices are heard.

While science plays an essential role in providing decisionmakers with physical facts, the ongoing process of review, evaluation, and decision is not simply a matter of calculation based on scientific inputs. The process necessarily involves value judgements as well. For example, there is no such thing as a zero-risk option for biotechnology (or for anything else); every possible decision, including the decision not to adopt any biotechnology, involves some measure of risk. Therefore risk assessment is not a process of determining a risk-free direction. Rather, it is a process of balancing risks against benefits, determining types and acceptable levels of risk for any given decision, and minimizing the likelihood and extent of negative impacts through the management of risk, e.g., through preventive and prepared-response measures.

The information gathering and decisionmaking processes must be transparent precisely because these evaluations do involve value judgements; the question of whose values are represented must be dealt with democratically if a stable, just, and effective system is to be implemented. National committees on biosafety should have broad representation of stakeholders--not just "experts" but concerned lay people as well.

In order for information to be useful, people must have access to it and the capacity to use it in a meaningful way. This principle applies both to the technical people involved in scientific reviews and to the public at large. Thus an information strategy is needed in order to deliver useful information to those who need it. Information costs should be budgeted, open communications lines should be established, and future needs should be anticipated.

Where does the information come from? A variety of sources can be used. Faculty stressed the importance of building local capacity to perform reviews of biotechnology, rather than relying exclusively on foreign experts and their reviews. Nations should have the capability of determining their own priorities, in order to handle imported goods properly and regulate products generated by in-country research, whether conducted by foreign or local researchers. Outside expertise may also be tapped as appropriate, understanding and factoring in any inherent biases of the information sources. Expertise in genetic research exists in Africa; it needs to be enhanced and better organized for the task of biosafety management.

Measures of Success

Measures of success include guidelines that clearly define objectives, responsibilities, and procedures; people who are knowledgeable, well trained, and confident; reviews that are based on sound science and are realistic about risks and benefits; and an evaluation system that actively seeks and uses feedback. In addition, decisions made by national biosafety committees should have substance and legal weight, so that compliance is the norm and progress occurs, i.e., it is not necessary to revisit the same issues over and over again. Finally, a good measure of success is a system in which all stakeholders are actively involved, including NGOs and the public, and in which periodic reviews of decisions and outcomes are made.

The role of the public bears special mention, as it was the topic of a good deal of discussion among participants. There is a tendency among some scientists and policymakers to view the public as a troublesome and ignorant entity that simply needs to be educated about the benefits of biotechnology. This tendency can be seen in recommendations that stress public relations and education, i.e., an outward flow of information, while overlooking the importance of actual public participation in the policy dialogue, i.e., a corresponding inward flow. Several participants objected to this omission. It may be conceded that there are many misconceptions about biotechnology among the general public, and that greater educational and outreach efforts are necessary. However, it is not true that all public concern can be written off as ignorance; there are legitimate concerns that must be respected and addressed. For people to trust the system that is supposed to protect them, they must feel that it truly represents their interests. Genuine democratic participation is the most effective way of ensuring public acceptance and informed policy, and as such is one of the key measures of a successful biosafety system.