88 
that is needed to resolve this concern of industry is to incorporate some of the 
routine practices for protection of trade secrets, that have long prevailed in 
other governmental agencies, into the regulations governing recombinant DNA 
research. 
Sincerely yours, 
Peteb Barton Hutt. 
See page 73 for letter of Secretary Califano, February 27, 1978, to Senator 
Stevenson. 
U.S. Environmental Protection Agency, 
IF ashington, D.G., December 9, 1977. 
Hon. Adlai E. Stevenson, 
Chairman, Subcommittee on Science, Technology, and Space, Committee on Com • 
merce, Science, and Transportation, U.S. Senate, Washington, D.C. 
Dear Mr. Chairman : I am writing in response to your letter of November 30, 
1977, which focused on various policy issues associated with recombinant DNA 
activities. Your particular concern was the extent to which the Environmental 
Protection Agency (EPA) can regulate the commercial applications of recombi- 
nant DNA research under the authorities contained in the Toxic Substances Con- 
trol Act (TSCA). 
I am in general agreement with your observations concerning the scope of 
TSCA and its application to the commercialization of chemical substances. How- 
ever, I believe that effective regulation of all aspects of recombinant DNA re- 
search — including the commercial applications which may be derived therefrom — 
would be better achieved by the enactment of comprehensive legislation spe- 
cifically addressing itself to the unique policy issues surrounding all recombinant 
DNA activities. 
There are two principal factors underlying this recommendation. First, EPA’s 
administration of TSCA is still in its infancy. The Agency is wrestling with the 
many difficult policy issues involved in the implementation of TSCA, resolution 
of which may take months or perhaps years. This effort will require a great 
commitment of Agency resources, and is critical to the ultimate success of the 
program. Regulation of recombinant DNA activities, however, will require consid- 
eration of additional questions which may not be directly relevant to other as- 
pects of the regulation of toxic chemicals ; resolution of those issues will require 
a significant diversion of Agency energy and expertise. As a matter of overall 
program priorities,, therefore, I believe that regulation of all recombinant DNA 
activities should be placed under some statutory authority other than TSCA. 
Second, any attempt to regulate the commercial applications of recombinant 
DNA research under TSCA may be hampered or obstructed by certain inter- 
pretative and conceptual problems. For instance, although there is a general con- 
sensus 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 defini- 
tion. Practical applications of recombinant DNA technology will utilize several 
generations of organisms which will inherit the implanted genetic information 
via natural biological reproductive processes. If such organisms axe subject to 
TSCA on the grounds that they are a “combination of . . . substances occurring in 
whole or in part as a result of a chemical reaction,” 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. 
Similarly, with respect to products which may be derived from such organisms 
(e.g., enzymes), section 5 of TSCA will require a pre-manufacturing notice only 
ff the product is a- “new chemical substance” or will be put to “a significant new 
use”. New methods (including recombinant DNA technologies) of production of 
ehemical substances included in the inventory published under section 8 of TSCA 
are not per se subject to the notice requirements of section 5. Finally, it should 
be observed that a significant area of application of recombinant DNA research 
Is likely to be in the economical and efficient production of certain drugs or 
pharmaceuticals, which are specifically excluded from the coverage of TSCA. 
I do not believe that these and similar problems should be solved by amend- 
ments to TSCA. As illustrated above, adjustments to particular provisions of 
TSCA to embrace circumstances peculiar to recombinant DNA research may have 
[Appendix B — 347] 
