15 
provision legally establishes inclusion of all private and governmental 
recombinant DNA activities within the legal jurisdiction of the United 
States under the Recombinant DNA Act. 
(5) Secretary 
The term “Secretary” means the Secretary of Health, Education, 
and Welfare. 
SECTION 102. EXTENSION OF THE RECOMBINANT DNA GUIDELINES 
102(a). Safety requirements 
The committee recognizes the difficult and time-consuming task un- 
dertaken by the National Institutes of Health in carefully consider- 
ing the technical details of all anticipated recombinant DNA activi- 
ties, reviewing all available data in order to assess the possible risk 
posed by each particular activity, and in developing explicit physical 
and biological containment requirements and experimental guidelines 
for the conduct of research and other activities involving recombinant 
DNA molecules. It is the consensus of the scientific community that 
these safety guidelines represent an appropriate response to the un- 
certainties presented by genetically modified organisms, and that they 
provide a substantial margin of safety to both workers and the public. 
Therefore, paragraph (1) specifies that beginning on the tenth 
day after enactment, all recombinant DNA activities must be carried 
out in accordance with the safety requirements described in section II 
(“Containment”) and section III (“Experimental Guidelines”) of 
the NIH Guidelines, unless exempted from these requirements by the 
Secretary as specified elsewhere in this act (section 102(b) or section 
107 (a) (2) ). The 10-day period after the day of enactment is included 
to allow time to provide notice to the public that such requirements 
will be in effect, as required by paragraph (3). The Secretary must 
publish the requirements in the Federal Register before the expira- 
tion of the 10-day period. These provisions are to remain in effect for 
a 2-year period; Congressional action would be required to extend 
them beyond the 2-year period. 
Under the proposed legislation, sections II and III of the NIH 
Guidelines in effect at the date of enactment would become the safety 
standards for the conduct of any recombinant DNA activity. That is, 
if the expected revisions in the guidelines are put into effect before 
the legislation is signed into law, then it is sections II and III of the 
revised NIH Guidelines which apply. 
Paragraph (2) specifies that after the date of enactment, the Sec- 
retary may revise the above requirements by regulation. Such regu- 
lations must be promulgated in accordance with the Administrative 
Procedure Act (section 553 of title 5, United States Coda), requiring 
the publication of proposed changes and a public comment period. It 
is recognized by the committee that, while not required by law to do 
so, NIH has published all proposed revisions of the guidelines in the 
Federal Register, and has, in addition to a public comment period, 
held public hearings on the proposed revisions. The committee com- 
mends the efforts of NIH to inform the public of its actions regarding 
recombinant DNA policy and to enable the public to participate in 
H. Rapt. 95-1005 3 
[Appendix B — 145] 
