antibodies. In this manner, issues that might have led to 
an adversarial role between FDA and industry were 
discussed, and in most cases resolved, before any official 
documents were released for comments. 
Biotechnology relies on two general techniques for 
manufacturing products; genetic engineering, involving 
recombinant DNA techniques and hybridoma technology, which 
encompasses the production of immortal cell lines either 
by cell fusion, transfection or vital transformation. To 
intelligently assess the environmental implications of 
genetic engineering, and to judge whether sufficient 
safeguards are in place through existing regulations or if 
new regulations and modification in PMN are necessary, - 
EPA personnel require the same expertise that has been 
developing within the FDA. The ease and facility with 
which EPA incorporates an understanding of biotechnology 
and all of its implications, within its organizational 
structure will reflect directly upon industry and its 
efforts to move products based on genetic engineering into 
the market place. 
Because EPA only recently made the decision to 
proceed under TSCA, its activities in this area are at a 
early stage. This is an opportunity for industry to have 
an input into the EPA that in the long run may strengthen 
its ability to bring bio-engineered products to the market 
place. Trade associations such as ABC have collective 
expertise concerning the scientific principals, risks and 
current safeguards that are considered to be effective by 
research and industrial scientists and can serve as 
educational resources to the EPA. Before the issue of 
regulations can be addressed, it is in industry's interest 
to make sure that EPA personnel have a sound understanding 
of the principals and rationales governing recombinant DNA 
technology and the immortalization of newly engineered 
cells. With an understanding of the nature of the 
organisms that are being manipulated and safety 
regulations and equipment that are encompassed during 
production stages, EPA will be able to meet its 
responsibilities for regulation, in a manner consistent 
with industry's efforts to introduce genetically 
engineered products to the market place in an efficient 
and least costly manner. 
Joan Rener, Ph.D., Chairperson 
ABC Subcommittee on EPA Issues; 
Director, Hybridoma Technology 
Services, Hazleton Biotechnologies 
Corporation, Vienna, Virginia 
[ 735 ] 
