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Federal Register / Vol. 49, No. 80 / Tuesday, April 24, 1984 / Notices 
DEPARTMENT OF HEALTH AND 
HUMAN SERVICES 
Request for Public Comment on the 
Recommendations Offered In the 
Report "The Environmental 
Implications of Genetic Engineering” 
AGENCY: National Institutes of Health, 
PHS, DHHS. 
action: Request for public comment. 
summary: This notice publishes for 
public comment the recommendations of 
the report ‘The Environmental 
Implications of Genetic Engineering" 
prepared by the staff of the 
Subcommittee on Investigations and 
Oversight of the Committee on Science 
and Technology of the U.S. House of 
Representatives. 
dates: Comments received by May 29 
will be reproduced and distributed to 
the NIH Recombinant DNA Advisory 
Committee (RAC) for consideration at 
its next meeting on June 1, 1984. 
address: Written comments and 
recommendations should be submitted 
to the Director, Office of Recombinant 
DNA Activities, Building 31, Room 3B10, 
National Institutes of Health, Bethesda, 
Maryland 20205. All comments received 
in timely response to this notice will be 
considered and will be available for 
public inspection in the above office on 
weekdays between the hours of 8:30 
a.m. and 5:00 p.m. 
FOR FURTHER INFORMATION CONTACT: 
Single copies of the report “The 
Environmental Implications of Genetic 
Engineering” and additional information 
may be obtained from the Office of 
Recombinant DNA Activities, National 
Institutes of Health, Bethesda, Maryland 
20205, (301) 496-6051. 
SUPPLEMENTARY information: On June 
22, 1983, the House Subcommittee on 
Investigations and Oversight and the 
House Subcommittee on Science, 
Research, and Technology held a joint 
hearing to examine implications of 
deliberately introducing genetically 
engineered organisms into the 
environment. 
The report "The Environmental 
Implications of Genetic Engineering" by 
the staff of the Subcommittee on 
Investigations and Oversight is based on 
these hearings. The report which was 
issued in February 1984 presents a 
summary of the staff review together 
with several recommendations. 
Recommendations Offered by the 
Report, “The Environmental 
Implications of Genetic Engineering." 
The report, “The Environmental 
Implications of Genetic Engineering," 
states that it addresses: 
* * * the deliberate release of all 
"genetically engineered" organises and not 
just those created through recombinant DNA 
techniques. While much of the discussion in 
the report involves recombinant DNA 
technology — the actually (sic) cutting and 
splicing of genes — "genetic engineering," 
encompasses far more than that particular 
technology. It is intended to include as 
concerns about the potential environmental 
effects of genetically engineered organisms 
created by other techniques — such as 
protoplast fusion (the fusing together of two 
unwalled cells), chemical mutation, and other 
procedures — as about the possible impacts of 
organisms created by recombinant DNA 
technology described by the RAC in their 
charter. 
Generally, the conclusions of the 
report are: 
(1) The potential environmental risks 
associated with the deliberate release of 
genetically engineered organisms are best 
described as "low probability of high 
consequence risks:" that is, while there is 
only a small possibility of occurrence, the 
damage that could occur is great. 
(2) Predicting the specific type, magnitude 
or probability of environmental effects 
associated with deliberate release will be 
extremely difficult at the present time. 
(3) The current regulatory framework does 
not guarantee that adequate consideration 
will be given to potential environmental 
effec's of a deliberate release. 
The report offers several 
recommendations, certain of which 
pertain to the NIH and its Recombinant 
DNA Advisory Committee (RAC). The 
NIH publishes these recommendations 
in order to solicit comment; the NIH is 
particularly interested in comments on 
NIH's appropriate future role and the 
steps to be taken before promulgating 
any changes from the current role. The 
recommendations listed in the report 
‘The Environmental Implications of 
Genetic Engineering" are: 
(1) The EPA should proceed with its stated 
Intention to extend its authority to include all 
deliberately released organisms not 
specifically identified as part of the legal 
obligation of another agency. In view of 
EPA's stated conclusion that the Toxic 
Substances Control Act (TSCA) does provide 
it with authority to oversee deliberate 
releases and the fact that Congress intended 
TSCA to be "gap filling" legislation, no 
additional legislation or clarifying 
amendments are needed at this time. EPA 
should, however, establish formal 
communications and agreements with other 
agencies to ensure that gaps and 
redundancies in the regulatory structure do 
not occur. A major goal should be to permit 
research and commercialization to proceed 
with minimum interference while adequately 
addressing environmental and public health 
concerns. 
(2) Until such time as EPA's regulations are 
promulgated, an interagency task force 
should be established to review all proposals 
for deliberate releases. EPA should take the 
initiative in organizing this panel. The panel 
should be comprised of representatives from 
EPA, the U.S. Department of Agriculture . 
(USDA), NIH, and any other appropriate 
federal agency or entity directly Involved 
from either the scientific or regulatory 
perspective. The panel should establish an 
environmentally oriented risk/benefit 
assessment program to evaluate current 
proposals for deliberate releases. The panel 
should also develop a uniform set of 
guidelines to govern deliberate releases. The 
panel should, moreover, serve the function of 
educating the public about the potential risks 
and benefits associated with this aspect of 
biotechnology. Consideration should be given 
to making this panel a permanent oversight 
body even after EPA has promulgated 
regulations to ensure that the broadest 
possible expertise is brought to bear in 
overseeing the technology. 
(3) No deliberate release should be 
permitted by EPA, NIH, USDA, or any other 
federal agency until the potential 
environmental effects of the particular 
release have been considered by the 
interagency review panel. The panel shall 
consider the effects of any environmental 
release, regardless of size or Intent. Each 
agency should evaluate proposals for 
deliberate releases according to a uniform set 
of guidelines to be developed by the 
interagency task force. It is recognized that 
initially decisions may be made on the basis 
of Incomplete data. 
(4) The task force should consider the need 
for oversight of research scale releases and, if 
appropriate, develop guidelines for reviewing 
proposals for such releases. The task force 
should prepare a report containing its 
conclusions on this matter within 90 days of 
its establishment. The report should be made 
available to the Subcommittee. 
(5) The NIH should cease its practice of 
evaluating and approving proposals for 
deliberate release from commercial 
biotechnology companies. The NIH should 
review proposals only from parties engaged 
In NIH-sponsored research, and refer 
requests from industry to the appropriate 
agency. 
(6) The NIH and USDA should revise the 
membership of their respective Recombinant 
DNA Advisory Committees (RAC) to include 
Individuals specifically trained in ecology 
and the environmental sciences. 
(7) The General Accounting Office should 
review the activities of USDA in overseeing 
biotechnology and evaluate the agency's 
authority to regulate deliberate releases 
under all relevant statutes, regulations, and 
executive orders. 
Dated: April 17, 1984. 
Richard M. Krause, M.D., 
Director, National Institute of Allergy ana 
Infectious Diseases, National Institutes of 
Health. 
OMB's "Mandatory Information 
Requirements for Federal Assistance Program 
Announcements” (45 FR 39592) requires a 
statement concerning the offical government 
programs contained in the Catalog of Federal 
Domestic Assistance. Normally NIH lists in 
i 1 8 announcements the number and title of 
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