House bill to regulate biotechnology debated The unexplained inaction on the part of the Reagan Administration to complete a policy for regulating genetic engineering products may be pushing Congress to pass legislation to fill the void. A joint hearing of two House subcommittees this month highlighted the frustration and confusion surrounding biotechnology for both government and industry. The purpose of the hearing was to air views on H.R. 4452, the Biotechnology Science Coordination Act of 1986, introduced by House Committee on Science & Technology chairman Don Fuqua (D.-Fla.). The bill focuses on developing a consistent approach to regulating biotechnology products in which useful applications of genetic engineering can be developed while protecting human health and the environment. Although that is the goal of the Administration, the results so far have not demonstrated that consistent approach. For example, tests of a swine vaccine made of a genetically altered live virus were approved, but proper procedures were not followed in granting that approval (C&EN, April 14, page 4). Chairing the hearing was Rep. James H. Scheuer (D.-N.Y.), head of the Subcommittee on Natural Resources, Agriculture Research & Environment, who was joined by the chairman of the Subcommittee on Science, Research & Technology, Harold L. Volkmer (D.-Mo.). Both wanted to know when the Administration will announce its own regulations on biotechnology. Spokesmen for the White House Office of Science & Technology Policy, which is marshaling the various agency regulations into a governmentwide policy, did not have an answer. The policy had been promised by January 1986, but has yet to be delivered. The individual agencies involved, particularly the Environmental Protection Agency and the Department of Agriculture, have completed their portions. The holdup apparently is at the White House itself. A fundamental issue is whether new legislation to regulate the products of biotechnology is needed.
Many involved with biotechnology think not. For instance, both the Industrial Biotechnology Association and the Association of Biotechnology Companies, organizations representing firms doing biotechnology research and development, do not believe new legislation is needed. Jeffrey N. Gibbs, general counsel for ABC, says that's because "we fear the act could severely jeopardize the ability of the biotechnology industry to maintain its present level of creativity and productivity. Few companies have the financial and regulatory resources to take a new product to market under the regulatory scheme contemplated in the proposed legislation." Representatives of the Administration also oppose new legislation. John A. Moore, assistant administrator for pesticides and toxic substances for EPA, told the panels that the laws EPA already has are sufficient and that "EPA does not believe there is any scientific justification for singling out genetically engineered organisms for special legislative action." Similarly, USDA assistant secretary for science and education Orville G. Bentley says his department does not support the bill either. The variety of existing statutes within USDA provide "ample authority to meet the needs of our biotechnology program and we plan to closely monitor the imple-
Bentley: ample authority to meet needs
mentation of our biotechnology policy in the context of these statutes," Bentley says. With the exception of organizations that want very strict government control over the use and release of biotechnology products, support for the bill outside government is equivocal. Judith A. Hautala, managing director of technology operations at Genex Corp., testified on behalf of the American Chemical Society. She said that ACS supports the purpose of the bill—consistent and practical regulation of biotechnology—but recommends some changes. These include defining a genetically engineered organism to include "material derived from pathogenic organisms and organisms whose pathogenicity has not yet been determined." ACS further says the law should apply only to release of "live" organisms and not dead organisms that might be used as delivery systems. The complicated permitting system developed in the bill is another point of concern. A proposed three-tiered setup for organisms regulated by EPA would include organisms used in noncontained systems for manufacturing that had been developed for intentional release, contained intermediate organisms that would not be released, and organisms that would be released for research purposes. ACS believes a more flexible, case-bycase system would be better, and that no permit is necessary for organisms used solely as contained intermediates. These concerns were also expressed by the president of the American Society for Microbiology, Moselio Schaechter. Regardless of Congress' intentions on biotechnology regulations, it will wait until the Administration has completed its revised policy before taking any action. It's possible, but not likely, that the matrix of regulations and guidelines the Administration produces will convince critics that it is serious about genetic engineering regulation. In the meantime, biotechnology companies are trying to move forward under the existing rules, hoping no drastic changes are in the works that will force them to start all over again. David Hanson, Washington June 16, 1986 C&EN
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