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To Regulate or Not to Regulate

Forum: To Rationalize U.S. Biotech Regs

"NBIAP News Report." U.S. Department of Agriculture (June 1994)

In the 12 May 1994 issue of Bio/Technology, pages 441-442, Dr. Henry Miller, formerly head of the Biotechnology Policy Office at the Food and Drug Administration (FDA) and now a visiting scholar at Stanford University's Hoover Institution, takes a position he has often expressed previously: that regulatory red tape is strangling progress in biotechnology, and the regulatory process must be rationalized so that it is based on real risks and "is consistent from agency to agency."

To accomplish this rationalization, Dr. Miller proposes among other actions: 1) the elimination of the biotechnology offices at the FDA, the Environmental Protection Agency (EPA), and the National Institutes of Health (NIH), because biotechnology is just a set of tools and not a coherent group of products that requires oversight; 2) taking the NIH out of the business of duplicating the FDA's and local review boards evaluation of gene-therapy protocols; and 3) eliminating the USDA's "unnecessary and meddlesome" Agricultural Biotechnology Research Advisory Committee (ABRAC) and its Office of Agriculture Biotechnology (OAB).

Dr. Miller states that both ABRAC and OAB have big budgets but no functions and have been trying for years to create regulatory responsibilities by overseeing transgenic animal research "on a case-by-case, every-case basis." He maintains that this is a category of research for which there has not been a perceived need for regulation.

Dr. Miller is certainly entitled to express his view that less regulation is best for biotechnology. However, as long as the American public and the scientific community demonstrate some concern about the safety of the research and development of the products of biotechnology, it seems unlikely that the Administration or Congress would approve the virtual elimination of federal oversight as proposed by Dr. Miller.

Without question, biotechnology is a powerful new tool for modifying living organisms to benefit humankind. However, all of the questions about the risk to the environment and public health arising from the use of this technology to produce new food, medical, and environmental remediation products are not answered. Until such time that all safety issues are resolved, appropriate government oversight is needed.

In his recommendations about the U.S. Department of Agriculture's OAB and ABRAC, Dr. Miller is simply in error in his contention that these organizations have big budgets and no function. In fact, their budgets and staffs are very modest, only $50,000 in 1994 for ABRAC for example. Both organizations provide essential services for the Department of Agriculture in the area of agricultural biotechnology. OAB has a coordinating role for biotechnology programs and activities in the Department and provides staff support to the USDA's Biotechnology Council and the ABRAC. The function of ABRAC is to advise the Secretary of Agriculture with respect to policies, programs, operations, and activities associated with the conduct of agricultural biotechnology research.

The most uninformed charge that Dr. Miller makes is that OAB and ABRAC have tried to stake out a claim to regulate animals on a "case-by-case, every-case basis." In fact, the few cases that ABRAC has considered were brought to the Committee because they posed difficult scientific questions or, as in the case of transgenic fish, did not fall under the purview of a regulatory agency within the Federal Coordinated Framework for the Regulation of Biotechnology. In the fish case, another Agency within Agriculture asked for assistance in preparing an environmental assessment of a federally funded research project involving transgenic fish in an outdoor tank. The use of experts and open ABRAC meetings insured that the research proceeded in a safe way. Both OAB and ABRAC are currently working with the aquatic research community to develop voluntary performance standards for research with genetically modified aquatic organisms.

ABRAC has also developed guidelines for agricultural biotechnology research and responded to other USDA regulatory agency requests for scientific advice. In short, ABRAC provides a means to tap a broad range of scientific expertise to deal with biotechnology research issues, and to do it through meetings open to the public.

People of good will can argue all day about the merits of the existing Coordinated Framework as an effective regulatory mechanism for biotechnology products, and most will admit to its shortcomings. However, the mechanism is working, and this administration hasn't yet displayed an inclination to abandon it. One can only hope that in his article Dr. Miller is using the shock tactic of making extreme proposals in order to stimulate a serious dialogue about the effectiveness of biotechnology regulation as it exists today. If so, his proposals might be helpful in the long run.


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