100 
fore, the Supreme Court has simply stated that “to obtain a patent for a product 
made from raw material, it must possess a new or distinctive form, quaiit.v. or 
property.” American Fruit Growers, Inc. v. Brodex Co., 2S3 U.S. 1, S U.S.P.Q. 
131 (1931). (A thorough discussion of the patent laws is outside the scope of 
this paper, but for a very good introduction to patent law, see, Peter D. Rosen- 
berg, Patent Laic Fundamentals (New York, 1975).) 
Generally speaking, as the law now stands, regulation of scientific research 
or its products must be predicated on some legitimate governmental interest 
such as receipt of federal funding or on a federaL power such as Congress's 
power to regulate interstate commerce. Although legislation may bring within 
its regulatory ambit all persons engaged in an activity which affects commerce 
(see. e.g. OSHA, 29 U.S.C. 652 (5) i, it is doubtful whether such regulatory 
authority would extend to private recombinant DXA research conducted by a 
private individual with very few. if any research associates in a small, local 
facility. On the other hand, there is no doubt that DXA research may be reg- 
ulated to some extent (and probably insofar as use of its products are concerned) 
in research facilities receiving federal funds. Should the patent laws be con- 
strued as encompassing the products of genetic research, then federal regulation 
of DXA research could be predicated on still another federal power. 
The Toxic Substances Control Act, effective since October 1970. gives author- 
ity to the Environmental Protection Agency (EPA) to ban or restrict the manu- 
facture, processing, distribution, commercial use or disposal of chemical 
substances and mixtures which will present "an unreasonable risk of injury to 
health or the environment.” 15 U.S.C. 2001. Of the laws we have analyzed, this 
Act presently has the greatest potential for regulation of DXA research prod- 
ucts. Initially however, to be subject to the Act a “processor” of chemical sub- 
stances or mixtures must be involved in an activity which affects interstate 
trade, traffic or transportation. 15 U.S.C. 2002 (3) (4). As noted previously, the 
private, independent researcher conducting an entirely local research activity 
may not be within the Act's regulatory scope. 
Providing this threshold condition is met the Act applies, where there is an 
unreasonable risk, to the production of a "chemical substance.” i.e. “any organic 
or inorganic substance of a particular identity” which occurs in nature or as a 
result of a chemical reaction. Any combination of chemical substances which 
does not occur in nature or as the result of a chemical reaction, i.e. a “mixture.” 
is also subject to the regulatory provisions of the Act provided that “there is a 
reasonable basis to conclude” that the activity “presents or will present an un- 
reasonable risk of injury to health or the environment.” 15 U.S.C. 2605(a). Thus, 
the EPxV may not restrict or ban such chemical substances or mixtures unless 
the risk is unreasonable. In making that determination the Administrator of 
the EPA must consider and publish a statement, with respect to the effects and 
magnitude of the exposure of the substance or mixture, the benefits of its uses 
and the availability of substitutes and “the reasonably ascertainable economic 
consequences of the rule, after consideration of the effect on the national econ- 
omy. small business, technological innovation, the environment, and public 
health.” 15 U.S.C. 2605(c) (1) (A)-(D). 
Three key provisions serve to effectuate the EPxVs regulatory authority under 
the Act and are potential methods of regulating DXA products somehow involved 
in or affecting interstate commerce. First, EPA may require the testing of any 
chemical substance or mixture if there is potential for an unreasonable risk of 
injury. 15 U.S.C. 2603(a) (1) (A) (i). The Senate Conference Report indicates 
that testing may be required wherever “there is a basis for concern.” S. Rept. 
94-1302, 94th Cong., 2d Sess., at 61. Furthermore, testing may be required if there 
is insufficient data on which to base a prediction as to the dangers of such sub- 
stances. 15 U.S.C. 2603(a) (1) (A) (ii) (iii). 
The Act also provides for a pre-market review mechanism. Notice to EPA is 
required prior to the manufacture or processing of any “new chemical substance,” 
but such notice is not required for “mixtures” unless the mixture contains a new 
chemical substance or is a “significant new use” of an existing chemical substance. 
15 U.S.C. 2604 (A mixture is a combination of chemical substances where the 
combination does not occur in nature or does not result from a chemical reaction. ) 
X'or does the pre-market notification requirement apply to the production of 
“small quantities” of chemicals to be used solely for research and develonment. 
though persons workina with such chemicals must be notified of any risks to 
their health. 15 U.S.C. 2604(h) (3). Furthermore, to come under the provisions, 
[Appendix B — 359] 
