2 
issues raised. Dr. Fredrickson also noted that prior to the release 
of the guidelines, meetings were held with representatives from 
other government departments and agencies, private industry, and 
congressional staff. 
Following Dr. Fredrickson's remarks. Dr. William Gartland, Acting 
Director, Office of Recombinant DNA Activities, NIH, summarized 
the substance of the NIH guidelines and his Off ice 's actions to 
implement them. Dr. Gartland defined recombinant DNA research 
as that research involving molecules that consist of different 
segments of DNA which have been joined together in cell free 
systems and which have the capacity to infect and replicate in 
some host cell, either autonomously or as an Integrated part of 
the host genome. He described the two types of containment 
procedures used in the guidelines. The physical containment is a 
system to prevent the escape of organisms containing recombinant 
DNA molecules. Biological containment, on the other hand, is a 
system whereby organisms used in these experiments are crippled so 
that in the event of their escape from the laboratory the likelihood 
for their survival is minimal. Dr. Gartland then briefly reviewed 
the categories of experiments that are forbidden under the guidelines 
and those that are permitted under restrictive conditions. 
Finally, he summarized the roles and responsibilities of the 
investigators, their institutions, and the NIH in ensuring effective 
administration of the guidelines. 
Following Dr. Gartland's comments Dr. Joseph Perpich, Associate 
Director for Program Planning and Evaluation, NIH reviewed NIH 
activities after the release of the guidelines in June. These 
activities included publication of the guidelines in the Federal 
Register on July 7 and publication of the draft environmental impact 
statement for this research in the Federal Register on 
September 7. Further, the NIH, in August, published a volume 
containing the transcript of the public hearing held on the proposed 
guidelines, the correspondence received by the Director, NIH, on this 
matter and relevant meetings held prior to the release of the 
guidelines in June. Dr. Perpich also briefly reviewed •'he creation of 
the Interagency Committee. In a letter to President Ford, 
Senators Kennedy and Javits recommended executive action to extend 
the scope of the NIH guidelines to the rest of the public and 
private sectors and in response President Ford recommended the 
creation of an Interagency Committee to review these and other 
important policy matters pertaining to this research. Following up 
on their letters, the Senate Health Subcommittee under the chairman- 
ship of Senator Kennedy conducted oversight hearings on September 22 
that focused on the need to extend the NIH guidelines to the public 
and private sectors with a mechanism to ensure compliance. 
Dr. Fredrickson testified for the Administration and agreed that 
the Interagency Committee would review these matters and come forth 
with appropriate recommendations. In conclusion. Dr. Perpich also 
noted that the NIH is reviewing Institutional Patent Agreements 
between DHEW and academic institutions to determine an appropriate 
U69] 
