8 
SECTION-BY- SECTION SUMMARY OF H.R. 11102 
Title I — Interim Regulation of Recombinant DNA Activities 
Definitions {section 101) 
Section 101 of the bill defines the term “recombinant DNA’’ ex- 
plicitly and operationally as it is done in current NIH Guidelines. 
“Eecombinant DNA activity” is defined as the possession in a State 
of recombinant DNA and any activtiy (including research and trans- 
portation) undertaken for the production of recombinant DNA. 
Extension of the recombinant DNA guidelines ( section 102) 
Section 102(a) of the bill provides for the extension of the require- 
ments of sections II (Containment) and III (Experimental Guide- 
lines) of the NIH Guidelines to all recombinant DNA activities be- 
ginning on the tenth day after the date of enactment and ending 
twenty-four months after such day. Before the expiration of the ten- 
day period the Secretary, of HEW is required to publicize and make 
available the requirements of sections II and III of the Guidelines. 
The Secretary is authorized to amend the requirements, in accord- 
ance with the Administrative Procedure Act, if he determines that 
such an amended requirement would be sufficient for the protection 
of health and the environment. 
Section 102(b) authorizes the Secretary to exempt from the re- 
quirements any recombinant DNA activity which he finds does not 
present a significant risk to health or the environment. 
Section 102(c) requires each individual or entity which is responsi- 
ble for the conduct of any recombinant DNA activity or which will 
be responsible for such an activity to be commenced during the period 
the guidelines are in effect to report to the Secretary such individual’s 
or entity’s name, a description of such activity, an identification of 
the place or places in which such activity is or will be conducted, and 
assurances satisfactory to the Secretary that such activity will be 
carried out in accordance with the requirements of the guidelines. 
Section 102(d) requires the Secretary within 90 days of the date of 
enactment to issue regulations for the administration of the require- 
ments of the proposed legislation. 
Prohibited acts and 'penalties ( section 103) 
Section 103(a) prohibits any person from conducting any recom- 
binant DNA activity in violation of any requirement of section 102 
of the bill ; moving recombinant DNA in violation of an order issued 
under section 105 (c) ( administrative detention) ; or failing or refusing 
to establish or maintain records, make reports or provide information, 
or permit entry to instruction as required by the proposed legislation. 
Section 103(b) provides that any person who violates section 103(a) 
would be liable for a civil penalty of up to $5,000 for each violation. 
Each day such a violation continues would constitute a separate 
violation. 
Section 103(c) authorizes the Secretary, in instances in which a 
person has violated section 103(a) in carrying out a project funded 
by a grant from HEW, to cancel such grant or withhold payments 
under such grant until he determines such person will carry out such 
project in accordance with the requirements of the guidelines. 
[Appendix B — 196] 
