42 
treatment microflora, confer nitrogen-fixing capability on food plants, 
or accelerate the production of methane or hydrogen by micro-orga- 
nisms from hydrocarbon sources such as garbage and waste oil. 
TOciCA may be capable of embracing organisms containing recom- 
bined DNA by virtue of the coverage by that act of DNA molecules. 
Section 3(2) defines a chemical substance subject to the act as "any 
organic or inorganic substance of a particular molecular identity/’ 
The definition also includes "any element or uncombined radical." It is 
thus clear that DNA molecules or segments of DNA molecules are 
fully subject to the provisions of TOSCA, including the premanu- 
facturing notice provisions of section 5. 
The authority contained in TOSCA enables the Administrator of 
EPA to extend controls to any “commercial use” of those molecules, 
presumably including their use in organisms. For example, EPA 
would prohibit or limit the commercial "use” of a recombined DNA 
molecule in an organism that would present unreasonable risks to 
health or the environment. While this may provide some authority 
over the organisms themselves, EPA concludes that TOSCA is not 
meant to control organisms directly. EPA would thus not impose re- 
striction on organisms, only on molecules that might be inserted into 
them. EPA does not question the coverage by TOSCA of DNA mole- 
cules or segments of DNA. Nonetheless, in the absence of specific 
authority addressing the recombinant DNA question, EPA has com- 
mitted itself to utilizing the authority under TOSCA to the fullest 
extent necessary to prevent undue risk to health and the environment. 
(See Appendix.) Clarifying the authority to reach organisms utilized 
in recombinant DNA activities would also insure that those persons 
purchasing DNA recombinants from a producer for the purpose of 
further cloning would also be regulated to insure no undue risk to 
health or the environment. 
Section 361 of the Public Health Service Act (42 TJ.S.C. 264) pro- 
vides the Secretary of Health, Education, and Welfare with authority 
to prevent communicable disease. In relevant part, section 361 author- 
izes the Secretary to “* * * make and enforce such regulations as in 
his judgment are necessary to prevent the introduction, transmission, 
or spread of communicable diseases from foreign countries into the 
states or possessions, or from one state or possession into any other 
state or possession * * *” 
Because of' the broad discretion given the Secretary, it has been 
argued that section 361 provides sufficient authority to control the 
commercial applications of recombinant DNA. In fact, the Environ- 
mental Defense Fund and the Natural Resources Defense Council 
petitioned the Secretary of HEW on November 11, 1976, asking him 
to impose control over all recombinant DNA activities under section 
361 of the Public Health Service Act. An important issue in the use 
of section 361 of the Public Health Service Act, or any other statute 
whose primary purpose is to protect public health, is the extent to 
which environmental concerns may also be addressed. While environ- 
mental concerns often manifest themselves as public health problems, 
there are other ecological insults, such as the destruction of wildlife 
habitats or the despoilation of wilderness, whose “public health” 
link is tenuous. The National Environmental Policy Act (42 U.S.C. 
[Appendix B — 301] 
