99 
only applies to recombinant activities regulated or funded by the federal gov- 
ernment. Because the federal government’s authority to reach private recom- 
binant activities is limited, the value of NEPA as a vehicle for evaluating the 
consequences of recombinant technology is also limited. 
The Library of Congress, 
Congressional Research Service, 
Washington, D.C., December 7, 10 77. 
To : Senate Committee on Commerce, Science, and Transportation, Subcommittee 
on Science, Technology, and Space. 
From : American Law Division. 
Subject : Regulation Under Current Law of the Products of Recombinant DXA 
Research. 
In response to your request for a determination as to whether products of 
recombinant DNA research may be regulated under current federal statutes, 
we have analyzed the following laws : 
1. The Patent Laws (Title 35) ; 
2. Toxic Substances Control Act (15 U.S.C. 2601 et seq.) ; 
3. Marine Protection, Research and Sanctuaries Act (33 U.S.C. 1401 et 
seq.) ; 
4. Federal Water Pollution Control Act (33 U.S.C. 1251 et seq.) ; 
5. Solid Waste Disposal Act (42 U.S.C. 3251 et seq.) ; 
6. Federal Hazardous Substances Act (15 U.S.C. 1261 et seq.) ; 
7. Hazardous Materials Transportation Control Act (18 U.S.C. S34 et 
seq.) ; 
8. Occupational Safety and Health Act (29 U.S.C. 631 et seq.) ; 
9. National Environmental Policy Act (42 U.S.C. 4321 et seq.) ; 
10. Public Health Service Act (42 U.S.C. 201 et seq.) ; 
11. Federal Food, Drug and Cosmetic Act (21 U.S.C. 301 et seq.) ; 
12. Consumer Product Safety Act (15 U.S.C. 2051 et seq.). 
In brief, comprehensive regulation of the products resulting from recombinant 
DNA research techniques does not appear feasible under current laws. At best, 
regulation will be piecemeal and dependent on the uses for which those products 
are intended. Regulation will be dispersed throughout several federal agencies, 
where the research activities involved come under the respective department 
or agency mandate and it will be limited by the purposes enumerated in the ap- 
propriate authorizing legislation. 
There has been very recent, rather curious development that could have far- 
reaching effects in the realm of genetic experimentation. In an October decision, 
the United States Court of Customs and Patent Appeals, as a matter of first 
impression, held that a biologically pure culture of a micro-organism, that ap- 
parently did not exist as a biologically pure culture naturally, was a “manu- 
facture” within the meaning of the patent statutes. Thus, the fact that the 
claimed invention was alive did not remove it from the category of patentable 
things. Two judges dissented from the. court’s decision and whether the decision 
will stand upon appeal is a matter of speculation. If it should, then the patent 
laws may offer the most wide-reaching means of regulating the uses to which 
DNA research products may be put. See, Application of Bergy , U.S. Court of 
Customs and Patent Appeals, October 6, 1977. 
The Constitution confers upon Congress the power to secure authors and in- 
ventors, for periods of limited duration, the exclusive right to their writings 
and discoveries. This power is implemented by legislation which vests an in- 
ventor with the right to exclusive use of his invention provided he has perfected 
his right by proceeding in the manner required by law. (The patent laws may 
be found in Title 35 of the U.S. Code.) 
Ultimately, the decision as to whether new life forms may be patented is a 
matter for Congress. The Constitution does not spell out the subject matters 
which are proper ones for patent protection. The exercise of the patent power 
is a permissive one and Congress may restrict or enlarge the granting of patent 
rights by specifying Categories of discoveries or inventions appropriate for 
patent protection. 
In Application of Bergy the court found a new genetic composition to fall 
within the statutorily recognized category of “manufacture” or an “article of 
manufacture.” While new life forms have not been treated as patentable hereto- 
[ Appendix B — 358] 
