The Role of the Public and Federal Advisory Committees in Providing

Chapter 5

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The Role of the Public and Federal Advisory Committees in Providing Advice to the Government on Agricultural Science Policy Alvin L. Young and Daniel D. Jones* Office of Agricultural Biotechnology, U.S. Department of Agriculture, Room 1001, Rosslyn Plaza East, Washington, DC 20250-2200

Advisory committees have played an important role in shaping programs and policies of the Federal government from the earliest days of the United States. Today, an average of 1,000 advisory committees with more than 20,000 members advise the President and the Executive Branch on such issues as genetic engineering, agricultural research priorities, standards for organically produced foods, and the safety of food ingredients. With the expertise from advisory committee members, Federal officials and the Nation have access to information and advice on a broad range of issues affecting Federal policies and programs. The public, in turn, is afforded an opportunity to participate actively in the Federal government's decisionmaking process. The development of agricultural biotechnology comes at a critical juncture for United States agriculture. Competition for world markets is growing more and more intense. At the same time, U.S. producers and processors must meet the challenge of new environmental policies. Continued Federal investment in agricultural research is mandatory if the U.S. is to maintain its agricultural standing. Many recent breakthroughs have resulted from the Federal investment in research on genetics, molecular biology, and cell culture. Indeed, the genetic modification of plants, animals, and microbes, often through advances in biotechnology, is becoming increasingly important in agricultural research and production. This has raised issues of health, safety, and the environment that face both the scientific community and public policy makers. For example, a 1987 National Academy of Sciences report concluded that "the scientific community urgently needs to provide guidance to both investigators and *The authors are the Director and Deputy Director, respectively, of the USD A Office of Agricultural Biotechnology. The views presented are those of the authors and do not necessarily represent official policy or interpretations of the USD A . This chapter not subject to U.S. copyright Published 1995 American Chemical Society

Engel et al.; Genetically Modified Foods ACS Symposium Series; American Chemical Society: Washington, DC, 1995.


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regulators in evaluating planned introductions of modified organisms from an ecological perspective" (1). One mechanism that has proven to be useful both in organizing input from the scientific community and in building public confidence in scientific research is the Federal advisory committee mechanism. With the expertise from advisory committee members, Federal officials and the Nation have access to information and advice on a range of scientific and other issues affecting Federal policies and programs. The public, in turn, is afforded an opportunity to participate actively in the Federal government's decisionmaking process. The United States Department of Agriculture (USDA) plays a number of roles in agricultural biotechnology, supporting and encouraging various initiatives and ensuring that biotechnology is developed safely. Ten USDA agencies participate in biotechnology activities -- the Agricultural Research Service, Cooperative State Research Education and Extension Service, Extension Service, Forest Service, Animal and Plant Health Inspection Service, food Safety and Inspection Service, Agricultural Marketing Service, Economic Research Service, National Agricultural Library, and The Foreign Agricultural Service. Scientific Advice for Agriculture USDA strongly supports basic and applied research in biotechnology, allocating $180 million for the effort in Fiscal Year 1994. Some $30 million additional funds were allocated in providing facilities and equipment at universities and Federal laboratories and in the maintenance of repositories and data bases. Decisions on research priorities and special projects and initiatives require the best advice from the agricultural and environmental communities and from the general public. In order to secure the very best scientific advice for the Department on agricultural biotechnology research and related issues, USDA established a scientific advisory committee in 1987 called the Agricultural Biotechnology Research Advisory Committee (ABRAC). The A B R A C was modeled in part after the National Institutes of Health Recombinant D N A Advisory Committee (NIH-RAC) which reviewed recombinant D N A research primarily in medicine and the health sciences. The A B R A C differs from the NIH-RAC in that it embodies expertise and experience specific to the agricultural research community. Purpose of the ABRAC The purpose of the A B R A C is to provide advice to the Secretary of Agriculture on policies, programs, operations, and activities associated with the conduct of agricultural biotechnology research. This includes administrative and procedural measures designed to promote the safety, effectiveness, and public acceptance of agricultural biotechnology research. The A B R A C oversees the review of proposed research projects, evaluates the adequacy of draft proposals used by USDA in preparing environmental assessments of research projects, recommends necessary revisions to research guidelines and protocols, and advises other Federal and State agencies on agriculturally related research projects. It can also provide information to and



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maintain cognizance of institutional biosafety committees (IBC's) to assure the availability of essential personnel to carry out oversight of agriculturally related biotechnology functions. The A B R A C , when it is asked to do so, can also help to strengthen the scientific basis and credibility of actions taken by regulatory agencies within USDA. The A B R A C is cited for consultation by the Secretary in the 1990 Farm Bill, Section 1668, on Biotechnology Risk Assessment Research. As a result of this legislation, the USDA administers a small biotechnology risk assessment research program funded at a level of one percent of the Department's total expenditures on biotechnology research. In Fiscal Year 1994, the amount of funding for the biotechnology risk assessment research program was approximately $1.7 million. Composition of the ABRAC The A B R A C consists of 15 members drawn from academia, industry, and government with knowledge in such fields as animal/veterinary science, fisheries science, plant science, forestry, microbiology, food science, environmental science and policy, laws and regulations, and bioethics. The rotating membership of the A B R A C provides an opportunity for changing the mix of experts on the Committee to accommodate the evolution of issues facing USDA. For example, the A B R A C now includes experts in fisheries science and food science that were lacking in the first A B R A C . The appointment of A B R A C working groups also provides the flexibility to recruit experts outside the A B R A C to address biotechnology issues as they emerge and evolve. For example, an A B R A C Transgenic Animal Working Group included molecular biologists and animal scientists from outside the A B R A C . Because the A B R A C is a Federal advisory committee, transcripts and minutes of meetings are prepared. The minutes are published and their availability to the public is announced. Accomplishments of the ABRAC A B R A C accomplishments include the review of individual research proposals involving questions of biosafety, the development of guidelines and performance standards for research with genetically modified organisms, and, in response to a specific request, the development of recommendations for the food safety evaluation of transgenic livestock. The A B R A C reviewed several individual research proposals for biosafety including proposals involving transgenic carp, transgenic catfish, and genetically modified strains of Rhizobium and Brucella. Several of these proposals, because of potential impacts on the environment, involved the preparation of environmental assessments under the National Environmental Policy Act. For example, the A B R A C advised the former USDA Cooperative State Research Service (CSRS), which funded extramural research, on two controversial proposals for studies of transgenic fish in outdoor research ponds. Based on A B R A C recommendations and appropriate environmental assessments, CSRS approved studies for transgenic carp in 1990 and transgenic catfish in 1992.



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In 1991-92, the A B R A C recommended to USD A a set of practices and procedures for the safe conduct of research involving the planned introduction into the environment of certain genetically modified organisms (2). The guidelines established principles for assessing the safety of research with specific organisms and designing confinement measures to promote safety. The guidelines were intended to aid researchers and institutions in the design of safe experiments conducted outside contained facilities. The A B R A C also provided eight specific examples to illustrate how the guidelines would be applied to different modified organisms; these were cattle, carp, pine, rapeseed, fruit fly, a parasitic wasp, and two species of bacteria, Pseudomonas fluorescens, and Clavibacter xyli. The A B R A C is currently working with the aquatic research community and state and Federal agencies on the development of standards of confinement for outdoor research on genetically modified fish and shellfish. The A B R A C , when requested, has also assisted regulatory agencies by providing scientific advice on specific issues or proposals facing them. For example, the Food Safety and Inspection Service consulted the A B R A C on its proposed policies for both transgenic animals and non-transgenic animals from transgenic experiments. These consultations resulted in Federal Register notices concerning transgenic animals (3) and non-transgenic animals from transgenic experiments (4). The USD A Animal and Plant Health Inspection Service has also worked with the A B R A C on the scientific basis for performance standards for field testing of selected crops. Public Acceptance of Scientific Research Public acceptance of biotechnology research as well as the products of biotechnology is emerging as a critical issue for the 1990's. One of the greatest strengths of the A B R A C is the broadly based and open process that it provides for surfacing special interest concerns about biotechnology and examining them in a public forum and in the light of scientific knowledge. Thus, A B R A C is the primary mechanism the Department uses to promote dialogue with the public and forge a public policy consensus on controversial issues pertaining to the development of agricultural biotechnology. One area which exemplifies the A B R A C s role in promoting public acceptance of biotechnology research is research on genetically modified fish and shellfish. Environmental and other interest groups have repeatedly called for improved procedures and standards for research on genetically modified organisms in aquaculture research. This could also reduce the need for resource-intensive, case-by-case evaluations of the safety of research proposals in the future. The A B R A C has been involved in a broad-based effort including the aquatic research community, the aquaculture industry, and Federal and state government agencies to develop generic standards for assuring the safety and environmental friendliness of aquatic research with genetically modified fish and shellfish. This broad-based approach was adopted to include as many stakeholders in the process as possible and to increase the likelihood of general acceptance of the standards. The A B R A C therefore formed a Working Group on Aquatic Biotechnology and Environmental Safety which included aquaculture and aquatic research experts



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from outside the A B R A C . The Working Group met in conjunction with a workshop for scientists, business people, government officials, and other interest groups at the University of Minnesota in 1993. Workshop participants drafted performance standards to help scientists with the ecological risk assessment of research involving genetically modified fish, crustaceans, and molluscs. Final A B R A C recommendations on scientific protocols to help assure the environmental safety for outdoor research on modified fish and shellfish are expected in the near future. A B R A C also plays a significant role in promoting international dialogue on biosafety issues. The Committee provided an external review mechanism for the Organization for Economic Cooperation and Development's document on the safety of large-scale testing of crop plants. Biosafety Results of Field Tests A meeting of the A B R A C was held in tandem with the 3rd International Symposium on the Biosafety Results of Field Tests of Genetically Modified Plants and Microorganisms in late November, 1994 in Monterey, California. Questions about the ecological effects of field testing were discussed, especially in those countries where large-acreage field tests are in progress with less oversight than in the U.S. The A B R A C has environmental science and policy expertise to address most questions relating to environmental impacts of agricultural field tests. Some of the relevant questions discussed at the November meeting included: ο

Are field testing risks scale-dependent?

ο

Can small-scale results be extrapolated to larger scale?

ο

What are the long-term effects, if any, of agricultural field testing?

ο

Are there unique risks when testing genetically modified organisms in natural centers of diversity?

ο

Are there unresolved issues regarding the possible generation of new viral pathogens from transgenic plants?

Organic Foods and Biotechnology Another issue which may become important for USDA in the future is the possible use of biotechnology in the production of organic foods. USDA, under the 1990 Farm Bill, administers a National Organic Standards Board which is addressing a broad range of questions concerning definitions and standards for organic foods. One of these questions is whether recombinant D N A techniques can be used in the production of foods which are represented to the public as organically produced. The A B R A C , if requested, could serve as a supplementary source of expertise in biotechnology to address scientific aspects of organic standard questions and to develop recommendations for the USDA if needed.


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Food Safety and Public Acceptance The safety of emerging food products of biotechnology is a critical concern of special interest groups and the public. Recombinant chymosin, bovine somatotropin, and the F L A V R SAVR tomato are the first of many food products of biotechnology, some controversial, to enter the food supply. USDA has a strong interest in encouraging public acceptance of any new food products that are safe, wholesome, and properly labeled. A B R A C is beginning to address the acceptance to the public of the use of genetically modified organisms in agricultural research and production. The A B R A C provides a useful public forum in which concerns about the definition and safety of new food products, especially those regulated by USDA, can be raised and discussed in a scientific setting. Issues include: ο

Do transgenic animals expressing human proteins for pharmaceutical use pose unique risks or other problems when presented for entry into the human food chain?

ο

Does classical toxicology offer a useful perspective in assessing the safety of whole food products produced by biotechnology?

Societal/Bioethical Aspects of Biotechnology In 1993, the A B R A C held a meeting in tandem with a conference on the societal issues of food biotechnology (5). While this conference was timely and informative, food biotechnology issues have not gone away and they may arise again in connection with societal impacts of specific new products of biotechnology, acceptance by the public and food service professionals, and impacts on rural economies. The A B R A C can bring logical, philosophical, and bioethical expertise to bear on many of these issues and make a strong contribution to the societal acceptance of new products and technologies. Future Issues In addition to the issues described above, other issues in agricultural biotechnology have been considered for possible A B R A C attention. Specific issues in plant science included management of resistance to biopesticides, spontaneous assembly of infectious agents from molecular subunits, production of pharmaceuticals in plants and animals, and the use and effects of synthetic sequences in plants, animals, and microorganisms. Broader issues included risk management and risk communication in agricultural biotechnology, public attitudes and perceptions, support for biomonitoring databases, and trade constraints to the movement of genetically engineered crops and foods. How many of these issues are placed on the A B R A C agenda will depend in part on resources available to the Committee and on the changing mix of biotechnology issues facing the Department of Agriculture.


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Literature Cited 1.


2.

3.

4.

5.

National Academy of Sciences Committee on the Introduction of Genetically Engineered Organisms into the Environment, Introduction of Recombinant DNA-Engineered Organisms into the Environment: Key Issues, National Academy Press, Washington, D.C., 1987 . Agricultural Biotechnology Research Advisory Committee, Supplement to Minutes: Guidelines for Research Involving Planned Introduction into the Environment of Genetically Modified Organisms, Document No. 91-04, U.S. Department of Agriculture, Washington, D.C., 1992. Food Safety and Inspection Service, "Update on Livestock and Poultry Connected With Biotechnology Research," Federal Register , 59, (52), p. 12582, March 17, 1994. Food Safety and Inspection Service, "Livestock and Poultry Connected with Biotechnology Research," Federal Register, 56, (249), p. 67054, December 27, 1991. Symbol, Substance, and Science: The Societal Issues of Food Biotechnology, Conference Proceedings, June 28-29, 1993, Burke, W.S., Ed., North Carolina Biotechnology Center, Research Triangle Park, North Carolina.

R E C E I V E D June 7, 1995


The Role of the Public and Federal Advisory Committees in Providing

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