Association of Biotechnology Companies 
Post Office Box 3922 1 
Washington, D.C. 20016 
(301)977-0084 
June 25, 1984 
Director 
Office of Recombinant DNA Activities 
Building 31 
Room 3-B-10 
National Institutes of Health 
Bethesda, Maryland 20205 
COMMENTS BY 
THE ASSOCIATION OF BIOTECHNOLOGY COMPANIES (ABC) 
on the Recommendations of the Staff Report, 
"ENVIRONMENTAL IMPLICATIONS OF GENETIC ENGINEERING" 
Subcommittee on Investigations and Oversight 
House Committee on Science and Technology 
Founding Companies: 
Advanced Genetics 
Research Institute (AGRI) 
Oakland, California 
Biotech Research 
Laboratories, Inc. 
Rockville, Maryland 
Cambridge BioScience 
Corporation 
Hopkinton, 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 Ann Liebert, Inc. 
New York City, New York 
National Geno 
Sciences, Inc. 
Southfield, Michigan 
New Brunswick 
Scientific Co., Inc. 
Edison, New Jersey 
Unigene Laboratories, Inc. 
Fairfield, New Jersey 
in response to the Request for Comment published 
49 Federal Register 17682 (April 24, 1984) 
1. 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.... 
Val J. Williams 
Executive Vice President 
Dr. Paul Came 
Consultant, Silver Spring 
Bruce F. Mackler, Esq., Ph D. 
General Counsel 
ABC COMMENT: EPA's authority to regulate organisms as 
"chemical substances" under TSCA is not universally 
recognized. Indeed, in 1977 Administrator Douglas Costle 
advised the Honorable Adlai Stevenson, then Chairman of a 
Senate subcommittee considering RDNA legislation, that, 
"although there is a general consensus that recombinant DNA 
molecules are 'chemical substances' within the meaning of 
section 3 of TSCA, it is not at all clear whether a host 
organism containing recombined DNA molecules fits — or was 
intended to fit — that definition.... If such organisms are 
subject to TSCA ..., the Agency might logically have to 
include all living things in the definition of 'chemical 
substance' — an interpretation which I am confident the 
Congress neither contemplated nor intended." See 
Recombinant DNA Research and its Applications, Oversight 
Report , Subcommittee on Science, Technology and Space Senate 
Committee on Commerce, Science and Transportation, 95th 
Cong., 2d. Sess. August 1978. 
In opposition to EPA's new interpretation of "chemical 
substances," one may point to the language of a related 
environmental protection statute, the Federal Water 
Pollution Control Act (FWPCA) . In that Act, the term 
(726] 
