4 
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 Administra- 
tive 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 
Secretary of DHEW a description of such activity and assurances 
that he will comply with the requirements under the legislation in 
carrying out such activity. 
Revisions and exemptions 
Revisions in the requirements are to be accomplished by regulation, 
with a public comment period. 
Exemptions may be granted by order of the Secretary, subject to 
any conditions he may prescribe, for activities determined to pose no 
significant risk to health or the environment, or for specific risk assess- 
ment studies supported by the Secretary. 
/ inspection and enforcement 
The Secretary of HEW is given broad inspection authority to en- 
sure that all recombinant DNA activities are conducted according to 
the NIH standards. He may delegate much of this responsibility to 
local (biohazard or biosafety) committees at his discretion. 
The proposed legislation spells out what constitutes a “prohibited 
act” and allows the Secretary to suspend HEW grant funds for 
violations, to impose a civil fine of $5,000, or to seek an injunction 
in the courts to restrain or enjoin activities done in violation of the 
requirements. U.S. district courts shall have jurisdiction over civil 
actions, including those brought for the seizure or destruction of mate- 
rial involved in a violation of the law. 
Effect on State and local requirements 
Under the proposed legislation, a State or local government could 
enact stricter laws which would supersede the requirements of this 
Act if it can be shown that such action is necessary to protect health 
or the environment, taking into account local conditions. That is, 
a State or local government would have to demonstrate that the re- 
quirement under the proposed legislation provide inadequate protec- 
tion of health or the environment in the context of a particular local 
situation. 
Training and studies 
The Secretary would be authorized to conduct and support training 
programs in safety techniques for persons engaged ih tecombinant 
DNA activities and required to conduct and support risk assessment 
studies. 
[Appendix B — 192] 
