Association of Biotechnology Companies 
Post Office Box 39221 
Washington, D.C. 20016 
(301)977-0084 
For Information Contact: Val J. Williams, Executive Vice President 
ABC DIALOG COLUMN 
( Genetic Engineering News , July/August Issues) 
EPA and Genetic Engineering 
Under the Toxic Substances Control Act (TSCA) the EPA 
is turning its interests for the first time to the area of 
biotechnology products. 
In an article entitled "Biotechnology, The Need to 
Regulate," in the journal Pollution Engineering , December, 
1983, Don R. Clay, the Office Director for the Office of 
Toxic Substances, discussed the EPA's official interest in 
Genetic Engineering. The EPA is concerned with the 
prospect of life forms being sold, distributed and used in 
an open environment without regard to environmental 
consequences. "We intend to see that all modified life 
forms, whose owners intend to put them to commercial use 
are environmentally compatible and benign. In short, we 
intend to review and, if necessary, regulate the 
commercial products of biotechnology which fall under the 
authorities of Federal Insecticide, Fungicide and 
Rodenticide Act (FIFRA) and the Toxic Substances Control 
Act (TSCA)." 
The most significant section of TSCA which can be 
applied to genetic engineering organisms is section 5. 
This section requires companies to notify the agency prior 
to the manufacture of new substances (in this case, 
genetically engineered DNA and RNA) to alert EPA to 
problems before the organism enters the environment. As 
published in Pesticide and Toxic Chemical News , 26 
October, 1983, the pre-manuf acture notification (PMN) 
information that the EPA will most likely require under 
TSCA will include the following: 
• The organism's ability to survive in all 
environments into which it might be introduced 
• The organism's ability to reproduce in nature 
Founding Company 
Advanced Genetics 
Research Institute (A GW) 
Oakland. California 
Biotech Research 
Laboratories, Inc 
Rockville. Maryland 
Cambridge Bio Science 
Corporation 
H op k inton, Massachusetts 
Cellular Products. Inc 
Buffalo. New York 
Centocor 
Malvern. Pennsylvania 
Diagnostic, Inc 
St Paul. Minnesota 
Immuno Modulator 
Laboratories. Inc (IMl) 
Houston. Texas 
Interferon Sciences. Inc 
New Brunswick. New Jersey 
Mary A nr jeoert. Inc 
New York City. New Yo ri 
National Geno 
Sciences. Inc 
Southfield, Michigan 
New Brunswick 
Scientific Co.. Inc 
Edison. New Jersey 
Umgene Laboratories. Inc 
Fairfield, New Jersey 
Val J Williams 
Executive Vice President 
Dr Paul Came 
Consultant. Silver Spring 
Bruce F Mackler, Esq . Pf 
General Counsel 
MACKLER 6-19-84 
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