20 
DNA actiVfty. Similftriy, a' standard should not remain in effect which 
is too lenient, siiri^y b^auSOTof a lack of information concerning 
potential hazards. 
In ordfer to ass6ss'the limits Of* the actual risks posed by recombinant 
DNA activitieSj the Secretary is encouraged by the Committee to 
permit exemptions (as authorized under paragraph (1)) from 
sections II and III of the NIH Guidelines, including the list of pro- 
hibited experiments, and conduct, under very high physical contain- 
ment if necessary (P-4, or P-3 if judged to be of lower risk) , experi- 
ments ' designed to elicit the worst-case scenarios which are the basis 
for much of the stringency in 'the current NiH Guidelines. That is, 
using an appropriate animal system, it would be desirable to deter- 
mine just to what extent pathogenic strains of E. Coli or other orga- 
nisms capable of accepting E. coli plasmids could be made more 
pathogenic by the deliberate addition of a variety of recombinant 
DNA’s. Similar experiments should be done with modified animal 
and plant viruses, as should experiments to test the persistence of 
organisms containing recombinant DNA in competition with natural 
organisms in a variety of ecological settings. 
Such studies, many of which are now prohibited under the NIH 
Guidelines, would be of immense value in bringing into perspective 
just how great the potential hazards from recombinant DNA work 
may be and how probable the occurrence of an ilhtoward event may be. 
SECTION 108 RELATIONSHIP TO OTHER FEDERAL LAWS 
108(a) Regulation of recombinant DNA activities u/roder other Fed- 
eral laws 
The Recombinant DNA Act does not abridge the authority of 
any Executive Agency to regulate recombinant DNA activities under 
any other statute. It is the committee’s intent that the Department 
of Health, Education, and Welfare be the lead regulatory agency, 
and that there not be more than one set of requirements or regula- 
tions governing the same recombinant DNA activity. However, there 
are activities peripheral to the recombinant DNA activities covered 
by the Recombinant DNA Act, which dthei’ agencies would be ex- 
pected to regulate, such as the purity of products manufactured by 
recombinant DNA techniques to be sold as drugs, biologicals or food, 
occupational safety in manufacturing plants, agricultural products 
of recombinant DNA containing organisms, or the transportation of 
potentially hazardous biological material. 
108(b) Relationship to the Occupational Safety, amd Health Act of 
1970 
Neither the safety requirements ‘ specified in section 102(a) nor 
any personnel safety standards or requirements which the Secretary 
may prescribe under section 102 ( d) shall be considered to be exercis- 
ing statutory authority under the Occupational Health and Safety 
Act. That is, the prescription and enforcement of occupational health 
and safety standards as required by the Occupational Health and 
Safety Act are in no way supplanted or superseded by any provision 
of the Recombinant DNA Act. 
[Appendix B — 159] 
