74 



ENVIRONMENTAL 

 DEFENSE FUND 



June 10, 1994 



National Headquarters 

 257 Park Avenue South 

 New York. NY 10010 

 (212)505-2100 

 FiLx: 212-505-2375 



Senator Harry Reid 



Chairman 



Subcommittee on Toxic Substances, Research and Development 



Senate Committee on Environment and Public Works 



456 Dirksen Senate Office Building 



Washington, DC 20510 



Re: Regulation of biotechnology products under the Toxic Substances Control Act, 

 15 U.S.C. 2601 et seq. 



Dear Senator Reid, 



As part of reauthorization of the Toxic Substances Control Act (TSCA), we 

 urge you to consider amendments TSCA which would give the U.S. Environmental 

 Protection Agency (EPA) clear authority for regulation of genetically engineered 

 microorganisms. In the mid-1980' s, rapid growth of the biotechnology industry 

 prompted questions about federal regulation of biotechnology products, and in 

 particular, about regulation of deliberate releases of genetically engineered 

 organisms into the environment. In 1986, the White House Office of Science and 

 Technology Policy issued the "Coordinated Framework for Regulation of 

 Biotechnology," 51 Fed. Reg. 23302, a policy statement explaining how we would 

 "make do with what we have." Rather than create new legislation, the 

 Coordinated Framework applied a patchwork of preexisting statutes to regulation 

 of biotechnology products. 



Under the Coordinated Framework, TSCA is supposed to cover the 

 manufacture and release into the environment of many genetically engineered 

 microorganisms (GEM's). TSCA functions as a catchall statute, covering all 

 corrunercial uses of GEM's that are not pesticides or defined as agricultural pests. 

 EPA has drafted proposed rules for regulation of GEM's under TSCA. The Office 

 of Management and Budget is now reviewing these rules. 



Unfortunately, EPA's authority to regulate GEM's under TSCA is subject to 

 some ambiguity, and has yet to be tested in court. Initially, TSCA was written to 

 regulate "chemical substances and mixtures" in the standard ser\se, with chemical 

 substance defined as any "organic or inorganic substance having a particular 

 molecular identity." Although this definition may be read broadly to encompass 

 GEM's, there are grounds for arguing that it does not. Microorganisms are 

 generally not defined as chemical substances; their chemical composition varies 



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