3 
(5) Establishes a study commission to evaluate Federal policy 
on activities involving genetic manipulation as well as the long 
term applications of gene splicing technology. 
The interim controls and the study commission are established for 
2 years. The Committee anticipates that within 1 to 1 Vfc years after 
enactment, the appropriate Congressional subcommittees would exer- 
cise their oversight responsibilities to assess the current need for uni- 
form standards and the performance of DHEW in administering the 
NIH standards to all parties. Based upon the performance of the 
Department and the current state of the art, appropriate legislation 
will be developed as needed. 
SUMMARY OF THE LEGISLATION 
Scope of legislation 
The safety standards cited in this act, as well as any administra- 
tive requirements or regulations promulgated by the Secretary, 
would cover any activities (including research, transportation or com- 
mercial activities) involving recombinant DNA molecules which are 
addressed in section III of the NIH Guidelines, unless specifically 
exempted under this act. They would, therefore, apply to all private 
and governmental entities engaged in such activities. 
Only activities involving recombinant DNA molecules which are 
formed by joining DNA segments outside of living cells are included 
in Title I of this Act, which establishes interim regulation of re- 
combinant DNA activities. However, the scope of the study commis- 
sion as set forth in title II, includes all types of genetic manipulation. 
This act expires 2 years from the date of enactment. 
Administrative responsibility 
The responsibility for implementing the Recombinant DNA Act 
would rest entirely with the Secretary of Health, Education, and Wel- 
fare. However, the legislation would not affect the authority of any 
other Federal agency which has jurisdiction over certain activities 
which are in some way relevant to recombinant DNA, Specifically, no 
portion of the Occupational Safety and Health Act would be super- 
ceded by the Recombinant DNA Act. Where appropriate, other Fed- 
eral agencies would be expected to cooperate with DHEW in carry- 
ing out is responsibilities under this Act. 
Extension of the Safety Requirements of the NIH Guidelines to All 
Public and Private Entities 
The standards described in section II (Containment) and section 
III (experimental guidelines) of the current NIH Guidelines would 
apply to all public and private recombinant DNA activities. As sec- 
tion IV (roles and responsibilities) is intimately tied to the NIH 
granting process, it is inappropriate as a general provision. Thus, 
under the proposed legislation the Secretary of Health, Education 
and Welfare is to promulgate administrative regulations within 90 
days of enactment, without regard to the provisions of the Adminis- 
trative Procedures Act. 
Registration of activities 
The proposed legislation would require each individual or entity 
engaged in a recombinant DNA activity to report in writing to the 
[Appendix B — 133] 
