49 
the Food, Drug and Cosmetic Act, and the Toxic Substances Control 
Act. With respect to commercial activities beyond the research stage, 
however, the likelihood of overlapping regulation is much greater. The 
subcommittee urges close coordination among the relevant executive 
.agencies; memoranda of understanding or Executive oi’ders may be 
appropriate methods of sorting out their responsibilities. The execu- 
tive branch should begin at once to make these determinations. To the 
extent that reorganization of the executive branch consolidates juris- 
diction over matters of health, safety, and environmental protection, 
authority over commercial applications of recombinant DNA should 
also be consolidated. 
The subcommittee further recognizes that certain agencies may need 
to acquire expertise in recombinant DXA techniques and additional 
personnel and other resources. For example, the Environmental Pro- 
tection Agency will likely assume much of the burden for screening 
and controlling recombinant DNA molecules and their uses. Depend- 
ing upon how rapidly the technology is developed, EPA should be 
given additional funds and manpower as necessary to administer the 
program. 
Finally, existing statutory authorities should be used to the maxi- 
mum extent feasible. There is broad discretion in several statutes, in- 
cludir g section 361 of the Public Health Service Act and the plant and 
anima, quarantine laws, to protect public health and, to an uncertain 
degree, the environment. Careful consideration should be given to us- 
ing those authorities to remedy weaknesses in other Federal laws more 
directly related to recombinant DNA applications. It is particularly 
important that recombinant DNA orgamsms intended to be released 
into the environment be subject to premanufacturing review and cer- 
tification that they pose no significant risk. If authority to accomplish 
this is questionable or extensive litigation likely, Congress should 
consider amendments to the relevant statutes. The executive branch 
should make these determinations as soon as possible and propose 
^appropriate legislation to Congress. 
[Appendix B — 308] 
