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Senator Harry Reid , 



June 10, 1994 

 Page 2 



constantly as their metabolic processes occiir. TSCA's definition somewhat better 

 fits genetically engineered DNA molecules (e.g. molecules altered via recombinant 

 DNA techniques) which are inserted into microorganisms, but genetic material is 

 still subject to evolutionary change (which in the case of short-lived 

 microorganisms can be rapid). If EPA is to regulate GEM's under TSCA, this 

 statute needs to be amended so that it applies unambiguously to GEM's and 

 EPA's regulatory program is not vulnerable to legal clullenge. 



Under the Coordinated Framework, research and development involving 

 deliberate releases of genetically engineered organisms into the environment, as 

 well as commercial activities, are to be regulated. (Laboratory research and other 

 "contained" research is generally subject only to guidelines for good practices.) 

 Regulation of releases of organisms used in research and development is proper 

 and necessary. Unlike chemicals, which can only become diluted and degraded, 

 organisms can survive and reproduce . Thus releases of even small numbers of 

 organisms can result in large, permanent populations. 



Reflecting TSCA's primary focus on commercial manufacture of chemicals, 

 the statute exempts small quantities of chemicals used for scientific research and 

 analysis from regulation, with small quantities defined by rule. EPA intends to 

 define as zero the quantity of living GEM's that can be purposefully released into 

 the environment. EPA's authority to promulgate this necessary rule would be 

 strengthened if TSCA was amended to explicitly cover experimental releases of 

 GEM's into the environment. 



Thank you for your consideration. 



Sincerely, 



Rebecca Goldburg, Ph.D. j 

 Senior Scientist 



