94 
prior to tlie date on which patent applications directed to the work are filed. 
Causing this uneasiness will be the possibility that a litigation opponent might 
allege years in the future that the disclosure constituted a publication, a public 
use or an offer for sale. The key fact is not the outcome of such an allegation 
but the present fear of the future possibility. Since a governmental regulatory 
program presupposes the disclosure of information about intended research 
before that research is undertaken and therefore well before any patent applica- 
tions based on the outcome of the research are filed, the patent laws in their 
present embodiment are not ideally structured to mesh with a recombinant 
DNA regulatory program. 
If in the recombinant DNA area the needs of the government regulatory 
function could be satisfied by an early and confidential disclosure of informa- 
tion, then a statute so providing should be considered. The difficulty probably 
lies in assuring that information submitted in confidence remains confidential 
throughout the regulatory process. 
Time constraints force us to stop at this point. If we can be of further help 
in the future, please do not hesitate to contact us. 
Sincerely yours, 
Stephen D. Kahn. 
Alan D. Gilliland. 
Natubal Resoubces Defense Council, Inc., New Yoke, N.Y. 
Re regulation of recombinant DNA under existing statutory authorities. 
Date: December 2, 1977. 
Memorandum to: Senator Adlai E. Stevenson, Chairman, Subcommittee on 
Science, Technology and Space. 
From: Marcia J. Cleveland, Staff Attorney, Natural Resources Defense 
Council, Inc. 
INTBODUCTION 
This memorandum reviews existing statutory authority which might be 
used to regulate recombinant DNA activities to determine whether they are 
adequate, and if not, to identify significant omissions. It discussed the Toxic 
Substances Control Act (TSCA; 15 U.S.C. §§2601, ff.) ; the Food, Drug and 
Cosmetic Act (FDCA; 21 U.S.C. §§301 ff.) ; the Federal Insecticide, Fungicide 
and Rodenticide Act (FIFRA; 7 U.S.C. §§ 136 ff.) ; the Occupational Safety and 
Health Act (OSHA; 29 U.S.C. §§ 651 ff.) ; the Clean Air Act (CAA; 42 U.S.C. 
§§1857, ff.) ; the Federal Water Pollution Control Act (FWPCA; 33 U.S.C. 
§§1251, ff.) ; the Public Health Services Act (PHSA; 42 U.S.C. § 264); and 
the National Environmental Policy Act (NEPA; 42 U.S.C. §§ 4321, ff.). 
This memorandum concludes that existing authorities are -not adequate. In 
addition to specific gaps in each statute, they share some common shortcomings. 
None of the regulatory statutes (TSCA, FDCA, FIFRA, OSHA, CAA, FWPCA 
and PHSA) is designed to prevent environmental damage and health hazards 
which are as poorly understood as those posed by recombinant DNA. The pre- 
market testing statutes (TSCA, FDCA, and FIFRA) are better designed to deal 
with incomplete scientific information than the pollution control statutes (OSHA. 
CAA, and FWPCA), but even the testing statutes are of limited value when we 
know so little about the hazards to be tested for that we cannot have standard- 
ized tests, like bioassays for cancer, which dependably evaluate those hazards. 
Only NEPA, which requires federal agencies to evaluate environmental impacts 
regardless of the amount of information available, cau be applied to recombinant 
technology in spite of the present state of our knowledge. None of the statutes 
except NEPA requires technology assessment of recombinant DNA, and NEPA 
provides only partial review because it applies only to federal actions. Finally, 
none of the existing statutes provides adequate regulation of research activities. 
AUTHORITY NECESSARY FOB EFFECTIVE REGULATION OF RECOMBINANT DNA 
This evaluation of existing statutory authority is based on what the Natural 
Resources Defense Council believes to be essential elements of a regulatory pro- 
gram for recombinant DNA. Such a program must be designed to prevent release 
of recombinant organisms into the environment and provide a means for society 
[Appendix B — 353] 
