Report of the Biotechnology Science Advisory Committee of the U.S. Environmental Protection Agency / the Committee.

  • United States. Environmental Protection Agency. Biotechnology Science Advisory Committee.
Date:
1987
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Licence: Public Domain Mark

Credit: Report of the Biotechnology Science Advisory Committee of the U.S. Environmental Protection Agency / the Committee. Source: Wellcome Collection.

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    industry although the NIH had developed a system of voluntary compliance for institutions not receiving government funds. e The NIH does not have any special system for pro- tecting confidential business information. e As the number of proposed applications increased there was concern that the number of applications would be large and place a large burden on NIH. Therefore, in the spring of 1984, the government formed an interagency working group under the White House Cabinet Council on Natural Resources and the En- vironment (the Cabinet Council Working Group has since been reorganized under the Domestic Policy Council). It was the consensus of the group that various agencies (United States Department of Agriculture [USDA], Food and Drug Administration [FDA] and EPA) have the necessary authority to regulate the products of biotech- nology under existing statutes; and the government con- structed a coordinated regulatory framework of several agencies (USDA, EPA, FDA, NIH and National Science Foundation) to regulate biotechnology* Two EPA statutes are currently applied to biotech- nology products among those statutes believed to invest EPA with the authority to regulate products of biotech- nology. The statutes used at this time to regulate biotech- nology products are: e The Federal Insecticide, Fungicide and Rodenticide Act (FIFRA)? which creates a regulatory framework under which EPA regulates the sale and distribution of pesticides. FIFRA gives EPA oversight responsibility over microbial pest control agents whether or not these agents are genetically engineered. e The Toxic Substances Control Act (TSCA)'® auth- orizes EPA to acquire information on ‘‘chemical sub- stances’’ and ‘‘mixtures’’ of chemical substances in order to identify potential hazards and exposures. TSCA gives EPA jurisdiction over the manufacturing, processing, distribution, use and disposal of all chemicals in com- merce or intended for entry into commerce that are not specifically covered by other regulatory authorities. TSCA’s applicability to regulating microbial biotech- nology products is based on the interpretation that microbes are chemical substances under TSCA. In the June 26, 1986, Federal Register’, EPA detailed the applicability of TSCA and FIFRA to certain living microorganisms. That Federal Register also: e made certain policies immediately effective and others voluntary. The policies which are currently volun- tary will be made effective by rulemaking. e indicated that a definition of release will be devel- oped through the rulemaking process. In the interim, the Agency is relying on a definition of release that focuses on containment; i.e., procedures that are not ‘‘contained’’ as defined in the document are considered ‘‘release.’’ At this time, three rules must be promulgated under TSCA in order to fully implement EPA’s biotechnology policy. A definition of ‘‘release into the environment’’ is needed to circumscribe the scope of these three rules. These rules are: e In order to require that a Premanufacture Notice (PMN) review be conducted prior to the release of any microorganism covered by the policy, the Agency will amend the section 5 rule so that environmental releases in the course of ‘‘research and development?’ will not be exempt from PMN review. e Under section 5(a)(2) of TSCA, EPA will issue a significant new use rule (SNUR) which will cover certain microorganisms which are pathogens or have been deliberately altered to contain DNA from pathogens. En- vironmental uses of these organisms would be considered “‘significant new uses.”’ e EPA will issue a rule under section 8(a) of TSCA to require reporting of information about organisms and uses. This will provide a mechanism of monitoring the industry and ensuring an increasing base of information with which to assess and modify regulatory decisions. This rule would cover environmental uses. In addition to the need for a definition of release to ful- ly implement the TSCA statutes, enforcement of the biotechnology policy under FIFRA also depends on a definition of ‘‘release’’ to the environment. Applicability of Definition A definition of release is needed to permit both the Agen- cy and industry to determine whether a particular use of a microbial product constitutes a release to the envi- ronment. The definition of release will apply to environmental applications of microbial pesticides under FIFRA and to environmental releases of microorganisms subject to TSCA. Under TSCA, all microorganisms produced for en- vironmental, industrial, or consumer uses are potential- ly regulable with the exception of microorganisms used as foods, food additives, drugs, cosmetics, medical de- vices, and pesticides and microorganisms used to produce foods, food additives, drugs, cosmetics, and medical devices. It is not possible to list all the applications that could be subject to TSCA because many will undoubtedly be developed in the future. Examples of the types of microorganisms that would be subject to TSCA include microorganisms used in con- version of biomass for energy, pollutant degradation, sewage treatment, enhanced oil recovery, fossil fuel desulfurization processes, and certain non-food and non- pesticidal agricultural applications such as nitrogen fixation. Microorganisms used in the production of a chemical end product are subject to TSCA if the end product is a chemical substance used for a purpose other than as a food, food additive, drug, cosmetic, or medical device. Under FIFRA, uses of pesticides which would be regulated include pesticides used on agricultural plants, grain fumigants, and insect sprays. The definition of environmental release will determine, to a large extent, the scope of coverage of EPA regulatory policies.