•Jn:ied States 
Opartment of 
Agriculture 
Animal and 
Plant Health 
Inspection Service 
Washington, D C. 
20250 
January 29, 1987 
Dr. William Gartland, Director 
Office of Recombinant DNA Activities 
Building 31, Room 3B10 
National Institutes of Health 
Bethesda, Maryland 20892 
Dear Dr. Gartland: 
We wish to take this opportunity to respond to "Recombinant DNA Research: 
Proposed Actions Under NIH Guidelines" which appeared in the Federal Register 
on December 19, 1986, (51 FR 45650-52). 
We support the proposed deletion of the current language in Section III-A and 
favor the proposed addition of the described paragraph at the end of Section 
I-A of the Guidelines. While the proposed change would continue the National 
Institutes of Health (NIH) review requirement for experiments covered by 
Section III-A of the Guidelines, it would eliminate NIH review for all other 
DNA experiments because the review would be conducted by another Federal 
agency. Such a change would be consistent with the development of regulatory 
authority in Federal agencies in response to the expanding commercialization 
of products derived from biotechnological procedures. This proposed change 
would also help eliminate possible confusion about the agency to which an 
experiment should be submitted for review and approval. 
In Section III-A of the current Guidelines, experiments which require specific 
NIH-Recombinant DNA Advisory Committee (NIH-RAC) review and approval by both 
NIH and the Institutional Biosafety Committee (IBC) may be submitted to 
another Federal agency. If the NIH Office of Recombinant DNA Activities 
(ORDA) determines that such reviews serve the same purpose, NIH approval is 
unnecessary and the proposed experiment may be Initiated with approval from 
the other Federal agency. At the present time, there are no provisions or 
requirements for the transfer of such information between the NIH and another 
Federal regulatory agency. Because the review by another Federal agency 
serves the same purpose as that currently conducted by NIH, it would be 
redundant to require overlapping reviews. Each regulatory Federal agency may 
also require unique criteria not normally required by NIH. 
Currently, the NIH Guidelines provide the conditions under which only plants 
containing recombinant DNA molecules may be released in the environment. The 
RAC Working Group on Definitions, at their meeting on December 5, 1986, 
recommended the establishment of new appendices, similar to Appendix L 
"Release Into the Environment of Certain Plants" which would be written to 
include conditions of release for animals, microorganisms other than vaccines 
Recombinant DNA Research, Volume 1 1 
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APHIS • Protecting American Agriculture 
