43 
4321. et. seq. (NEPA)). requires in part that all agencies shall 
insure “* * * that presently unquantified environmental amenities 
and values be given appropriate consideration in decisionmaking 
along with economic and technical considerations. * * *” (sec. 102(2) 
(B) ). It has been argued that NEPA requires agencies to protect the 
environment in actions taken, whether or not the authorizing statute 
specifically provides for environmental protection. Thus, once an 
agency has established jurisdiction over a substance for whatever pur- 
pose, then it is automatically obligated in its actions to protect the 
environment. 
The extent to which NEPA imposes an additional substantive duty 
upon each Federal official to protect the environment has not been 
extensive] v litigated. Nonetheless, in three important cases ( Calvert 
Cliffs v. AFC (2 EEC 1770) . Zabel v. Tabb (1 ER 1449), and EDF v. 
Matthews (8 ERC 1879)) the courts have upheld the authority and 
responsibility of agencies to protect the environment, notwithstanding 
an authorizing statute which does not explicitly provide for environ- 
mental protection. 
While the authority of section 361 is broad and arguably could reach 
many, if not all, of the commercial applications of recombinant 
DNA research, it is highly unlikely that the Secretary of HEW will 
use the authority in this manner. In the absence of definitive judicial 
rulings, using section 361 of the Public Health Service Act to safe- 
guard the environment could result in litigation. 
PREVENTION OF HAZARDS 
With the passage of TOSCA in October 1976, Congress established 
the principle that chemical hazards should be controlled before their 
hazards become manifest. The act’s mechanisms for premarket review, 
which were in part patterned after similar provisions in pesticide and 
drug law, provided the first comprehensive means of enabling regu- 
lators to review hazards and take action before a substance reaches the 
channels of commerce. Experience in recent years with such chemical 
disasters as PCB, kepone, PBB, vinyl chloride, and others demon- 
strated that the Nation could no longer afford to act against chemicals 
after the damage was done. In his environmental message of April 1977 
President Carter reiterated this policy and stated emphatically that the 
administration embraces preventive control. The reasoning that re- 
sulted in the preventive control measures in TOSCA and other statutes 
applies as well to commercial products developed with recombinant 
DNA techniques. 
Apart from FIFRA and the FDCA, the only statute explicitly pro- 
viding for premanufacturing review is TOSCA. The premanufactur- 
ing review coverage of TOSCA is broad, excluding only pesticides, 
tobacco and tobacco products, nuclear material, firearms, materials sub- 
ject to FDCA, and mixtures of chemical substances. While other statu- 
tory authorities, like section 361 of the PIIS Act, may also be inter- 
preted to provide this type of authority, the explicit terms of TOSCA 
provide for premanufacture review of new chemical substances and 
significant new uses of existing ones. However, the limitations of 
TOSCA described above relative to the coverage of recombinant DNA 
[Appendix B — 302] 
