Baylor College of Medicine 
DEPARTMENT OF VIROLOGY AND EPIDEMIOLOGY 
Division of Biochemical Virology* 713 790-4507 
Texas Medical Center 
Houston, Texas 77030 
May 25, 1984 
Director 
Office of Recombinant DNA Activities 
Building 31, Room 3B10 
National Institutes of Health 
Bethesda, Maryland 20205 
Dear Sir: 
The following comments are submitted in response to the recommendations 
listed in the report, "The Environmental Implications of Genetic Engineering," 
published in the Federal Register, Vol. 49, No. 80, Tuesday, April 24, 1984: 
(1) There appears to be no need for EPA to "extend its authority to 
include all deliberately released organisms not specifically identified 
as part of the legal obligation of another agency." For example, the NIH 
guidelines on recombinant DNA research list procedures for dealing with 
deliberate release (Section III-A, June, 1983) and describe approved 
experiments in this category (Appendices D and L) . It is felt that USDA 
and FDA, for example, also have regulations pertaining to deliberate release 
of organisms. 
(2) If there are specific projects not covered by guidelines of 
existing agencies, then the proposed "interagency task force" could make 
recommendations to the appropriate agency which has authority for approval 
or disapproval of proposed projects. Procedures for consideration of 
comments already exist; for example, see Paragraph III-A of "Guidelines 
for Research Involving Recombinant DNA Molecules." Agencies such as 
NIH and USDA have adequate expertise for dealing with questions related 
to deliberate release into the environment of organisms. 
(3) Deliberate releases should be the decisions of the appropriate 
agency, under its own procedures. The interagency task force could make 
recommendations based on its own uniform guidelines. For example, for 
recombinant DNA molecules, NIH could notify the interagency task force 
of proposed research and request comments during the 30-day period of 
publication in the Federal Register. Incidentally, there exists now a 
Federal Interagency Advisory Committee on Recombinant DNA Research (see 
Appendix J) . 
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