statute could not be used to control manufactur ing where the genetic

Statute could not be used to control manufactur ing

This preview shows page 231 - 233 out of 336 pages.

statute could not be used to control manufactur- ing where the genetic techniques presented on- ly hypothetical risks. However, it should be ap- plicable to large-scale processes using known human toxins, pathogens, or their DNA. The Secretary of Labor is also directed to ac- count for the “urgency of the need” in es- tablishing regulatory priorities. How the De- partment of Labor will view genetic technol- ogies within its scale of priorities remains to be seen. NIOSH, the research organization created by this statute, has been studying rDNA produc- tion methods to determine what risks, if any, are being faced by workers. It has conducted fact-finding inspections of several manufac- turers, and it is planning a joint project with EPA to assess the adequacy of current control technology. In addition, a group established by the Center for Disease Control (CDC) together with NIOSH will be making recommendations on: 1) the medical surveillance of potentially ex- posed workers, 2) the central collection and analysis of medical data for epidemiological pur- poses, and 3) the establishment of an emergency response team. 35 s4/ndustria/ Union Department, AFL-C1O v. American Rtrolellm Institute, 100 S. Ct. 2844,2863, 1980. 3SMinute~ of th e [ndustria] practices Subcommittee of th e Federal Interagency Advisory Committee on Recombinant DNA Research, Dec. 16, 1980, op. cit., p, 6.
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226 . Impacts of Applied Genetics—Micro-Organisms, Plants, and Animals The Toxic Substances Control Act (TSCA) was intended by Congress to fill in the gaps in the other environmental laws. It authorizes EPA to acquire information on “chemical substances” in order to identify and evaluate potential hazards and then to regulate the production, use, distri- bution, and disposal of those substances. A "chemical substance” is defined under sec- tion 3(2) of this Act as “any organic or inorganic substance of a particular molecular identity, ” in- cluding “any combination of such substances oc- curring in whole or in part as a result of a chem- ical reaction or occurring in nature.”* This would include DNA molecules; however, it is unclear if the definition would encompass gene- tically engineered organisms. In promulgating its Inventory Reporting Regulations under TSCA on December 23, 1977, EPA took the fol- lowing position in response to a comment that commercial biological preparations such as yeasts, bacteria, and fungi should not be con- sidered chemical substances: 36 The Administrator disagrees with this com- ment . . . . This definition [of chemical sub- stance] does not exclude life forms which may be manufactured for commercial purposes and nothing in the legislative history would suggest otherwise. However, in a December 9, 1977, letter re- sponding to a Senate inquiry, EPA Administra- tor Douglas M. Costle stated: 37 [A]lthougkt there is a general consensus that re- combinant DNA molecules are “chemical sub- stances” within the meaning of section 3 of TSCA, it is not at all clear whether a host or- ganism containing recombined DNA molecules fits—or was intended to fit—that definition . . . .
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