APPENDIX J 
361 does not apply to plants, animals, or the general environment. It was 
the conclusion of the Subcommittee that Section 361 lacked the requisite 
authority to meet all of the requirements set for the regulation of this 
research . 
The Subcommittee also considered the authority of the CDC to license 
and control the operation of clinical laboratories under Section 353 of 
the PHS Act, but this provision was not considered to be applicable to 
research laboratories . 
Other authorities of EPA under the Clean Air Act, the Federal Water 
Pollution Control Act, and the Resource Conservation and Recovery Act 
of 1976 were considered briefly and thought only to apply, if at all, to 
isolated aspects of recombinant DNA research. The authorities of the Food 
and Drug Administration (FDA) were also reviewed, but it was concluded that 
recombinant DNA research has not yet reached the stage of commercial appli- 
cation that comes under the FDA's jurisdiction. The regulatory powers 
of the U.S. Department of Agriculture (USDA) were also reviewed and found 
applicable solely to nonhuman animals and plants. 
In summary, the group concluded that no single legal authority, or 
combination of authorities, currently exists which would clearly reach 
all recombinant DNA research in a manner deemed necessary by the Committee. 
Although there is existing authority that might be broadly interpreted to 
cover most of the research at issue, it was generally agreed that 
regulatory actions taken on the basis of any such interpretation would 
probably be subject to legal challenge. 
After completing an analysis of existing legislation, the Sub- 
committee on February 8, 1977, considered elements which might be 
Appendix J — 10 
