• Environmental transport possibilities 
• Potential environmental generation times 
• Potential routes of exposure 
• Methods of monitoring the organism's presence 
and concentration in the environment 
• Methods of controlling or eliminating the 
organism. 
The issue of whether EPA has jurisdiction over 
genetically engineered products may be a moot point. In a 
report published in February, 1984 by the Congressional 
Committee on Science and Technology Sub-Committee on 
Investigation and Oversight, it was stressed that the 
environment implications of genetic engineering are not 
addressed in the current regulatory framework. The NIH 
RAC's ability to adequately evaluate the environmental 
hazards posed by a deliberate release of genetically 
engineered organisms is limited by both its expertise and 
its jurisdiction. A recommendation was made that the EPA 
should proceed with its stated intention to extend its 
authority to include all deliberately released organisms 
not specifically identified as part of the legal 
obligation of another agency. 
The EPA will be issuing a policy statement and 
proposed guidelines on how biotechnology companies may 
comply with section 5 reporting requirements so EPA may 
adequately assess and control risks. The prospect of yet 
another federal agency contributing to the plethora of 
regulations that industry must comply with, is not one 
that everyone will greet with enthusiasm. However, 
industry should accept the EPA's minimal experience with 
bio-engineered products as an opportunity rather than a 
potential stumbling block. It is this area of risk 
assessment and the need for EPA to understand just what if 
any, those risks are, that offers industry another 
opportunity to impact on regulations. To date, industry 
has been relatively satisfied with the method by which the 
Food and Drug Administration has approached its 
responsibilities to regulating biotechnology. Dr. Bruce 
Merchant, head of the National Center for Drugs and 
Biologies' Hybridoma Committee, is Director of the 
Immunohematology Branch in the Office of Biologies at FDA. 
Under his guidance, FDA went to industry before any Points 
to Consider Documents were released on iji vitro or in vivo 
diagnostics concerning human or mouse derived monoclonal 
[ 734 ] 
