28 
envirormental releases. He thought the likelihood of an environmental 
problem developing with recombinant DNA containing organisms would be 
reduced if the issues were reviewed by personnel working under the aegis 
of regulatory agencies familiar with the questions . 
Dr. Sharpies said the envirormental sciences are extremely multi- 
disciplinary. She suggested that to have a true peer review system for 
purposes of evaluating, rather them merely discussing proposals which have 
environmental aspects to them, either RAC needs a larger representation 
from seme of the 15 to 20 not necessarily overlapping disciplines which 
comprise the environmental sciences or the burden of deeding with seme of 
these issues should be shifted predominantly elsewhere. Dr. Sharpies said, 
however, the NIH would be ill-advised at this point to precipitously get 
out of dealing with seme of these issues as EPA clearly is not prepared to 
take on the task at this moment and nay not be for years. 
Mr. Mitchell asked if the EPA has advisory groups similar to RAC. 
Dr. Alexander said he is a member of the EPA Science Advisory Board which 
holds public meetings. 
Mr. Mitchell said testimony on environmental issues before the House Sub- 
committee on Science, Research and Technology and the Subcommittee on 
Investigations and Oversight had suggested a paucity of both knowledge 
and test procedures in the environmental area. He asked if his inter- 
pretation of the testimony was correct. Dr. Levin of the EPA's Office of 
Research and Development replied that it was correct. Dr. Levin said that 
there is a lack of knowledge of what exactly happens when a particular 
organism is released into any environmental system; we don't really know 
and probably never will really knew. 
Dr. Levin said EPA is beginning to explore questions pertaining to environ- 
mental release. EPA has held a series of workshops with academia, industry, 
and other government agencies and has also held in-house workshops. He 
said EPA is currently attempting to define biotechnology; for example, 
should protoplast fusion be included? 
Mr. Mitchell asked why EPA had not yet developed the requisite testing 
systems. Dr. Levin replied that establishing test procedures has been diffi- 
cult because of the myriad parameters involved, and also because evaluation 
of chemical hazards had drained EPA's resources. 
Dr. Fedoroff reminded RAC that Appendix L to the Guidelines requires for 
these cases of release to the environment that procedures for assessing 
the spread of organisms must be developed, and the results of the tests 
must be submitted to the EBC and the RAC Plant Working Group. A data 
base wdll be accumulated. She stated that a decade of research has not 
yet revealed any hazards associated w/ith recombinant ENA. She said she 
would not wish to see the Guidelines become laws or regulations in view of 
the feet that the risks are still hypothetical. 
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