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Federal Register / Vol. 59, No. 127 / Tuesday, July 5, 1994 / Notices 
DEPARTMENT OF HEALTH AND 
HUMAN SERVICES 
National Institutes of Health 
Recombinant DNA Research: Actions 
Under the Guidelines 
AGENCY: National Institutes of Health. 
PHS, DHHS. 
ACTION: Notice of actions under the 
National Institutes of Health Guidelines 
for Research Involving Recombinant 
DNA Molecules (NIH Guidelines). 
SUMMARY: This notice sets forth four 
actions to be taken by the Director, 
National Institutes of Health (NIH), 
under the May 7, 1986, NIH Guidelines 
(51 FR 16958). 
FOR FURTHER INFORMATION CONTACT: 
Additional information can be obtained 
from Dr. Nelson A. Wivel, Director, 
Office of Recombinant DNA Activities 
(ORDA), Office of Science Policy and 
Technology Transfer, National Institutes 
of-Health, Building 31, room 4B11, 
Bethesda, Maryland 20892, (301) 496- 
9838. 
SUPPLEMENTARY INFORMATION: Today 
four actions are being promulgated 
under the NIH Guidelines. These four 
proposed actions were published for 
comment in the Federal Register 
announcements of August 11. 1987 (52 
FR 29800); April 18. 1988 (53 FR 
12752); December 30, 1988 (53 FR 
53262); April 29. 1991 (56 FR 19776); 
November 9, 1993 (58 FR 59612); and 
February 11, 1994 (59 FR 6702). These 
proposed actions were reviewed and 
recommended for approval by the NIH 
Recombinant DNA Advisory Committee 
(RAC) at its meetings on September 21, 
1987; December 3, 1988; January 30, 
1989; May 30-31, 1991; December 2-3, 
1993; and March 3—4, 1994. 
In accordance with Section IV-C-l-b 
of the NIH Guidelines, these actions 
have been found to comply with the 
NIH Guidelines and to present no 
significant risk to health or the 
environment. 
A revised version of the NIH 
Guidelines is published in a separate 
section of the Federal Register 
following this announcement. These 
revised NIH Guidelines differ from the 
previous version promulgated on May 7, 
1986 (51 FR 16958) by incorporating 
within them the major actions to the 
NIH Guidelines that were promulgated 
on August 24, 1987 (52 FR 31848); July 
29, 1988 (53 FR 28819); October 26, 
1988 (53 FR 43410); March 13. 1989 (54 
FR 10508); March 1, 1990 (55 FR 7438); 
September 12. 1990 (55 FR 37565); July 
18. 1991 (56 FR 33174); October 15. 
1991 (56 FR 51784); November 21, 1991 
(56 FR 58800); January 28. 1992 (57 FR 
3212); April 22. 1992 (57 FR 14774); 
August 26. 1992 (57 FR 38734); 
February 18. 1993 (58 FR 9102); April 
23, 1993 (58 FR 21738); September 13, 
1993 (58 FR 47906); October 18, 1993 
(58 FR 53814); and the changes that are 
promulgated in this announcement. 
I. Background Information and 
Decision on Action Under the NIH 
Guidelines 
A. Amendment to Sections II, III-C, III- 
D, V, Appendices C-I, and G and 
Addition of Appendix P, Physical and 
Biological Containment for 
Recombinant DNA Research Involving 
Plants, and Appendix Q, Physical and 
Biological Containment for 
Recombinant DNA Research Involving 
Animals of the NIH Guidelines 
The NIH Guidelines were originally 
developed to cover research in 
laboratories in which recombinant DNA 
techniques were used. It is recognized 
today that these techniques are being 
used by scientists working with plants 
and large animals, and that procedures 
for containment of these plants and 
animals have not been specifically 
described in the NIH Guidelines. 
Institutional Biosafety Committees 
(IBCs) have requested guidance on the 
containment procedures that should be 
recommended for specific experiments 
with these organisms since they have 
the responsibility of approving such 
experiments under containment 
appropriate for the organisms. The 
principles of biological safety that are 
used to categorize experiments 
involving microorganisms, for example, 
are equally applicable to plants and 
animals. These safety procedures have 
been employed successfully for many 
years and have been recognized for their 
efficacy in biological containment. 
Appendices P and Q are the result of 
several years of meetings and 
discussions involving research scientists 
and representatives from university, 
government, and industrial research 
sectors with expertise in several 
disciplines, including plant genetics, 
plant physiology, plant pathology, 
entomology, animal (including 
arthropod and aquatic species) 
physiology and reproduction, molecular 
biology, veterinary medicine, and 
human biomedical research. The 
Federal agencies involved in the 
development of Appendices P and Q 
include the NIH, the National Science 
Foundation (NSF). and the U.S. 
Department of Agriculture (USDA). 
The process of developing 
Appendices P and Qwas initiated when 
the USDA published an Advanced 
Notice of Proposed USDA Guidelines 
(USDA Guidelines) in the Federal 
Register on June 26, 1986 (51 FR 23367). 
This notice was followed by an 
announcement by the USDA regarding 
its intent to propose new guidelines for 
conducting all phases of research with 
domestic agriculture species, including 
both plants and animals modified 
through the application of genetic 
engineering techniques, in the Federal 
Register on December 9, 1986 (51 FR 
44397). At that time, the NIH Guidelines 
did not include specific descriptions for 
containment conditions for research 
involving recombinant DNA containing 
whole plants and animals. The USDA 
convened a working group composed of 
university, government, and industrial 
scientists on December 13-14, 1986, 
with the purpose of discussing and 
redrafting guidelines for physical and 
biological containment of transgenic 
plant and animal species, and 
associated microorganisms. This 
meeting came to be known as the 
“Arlington House Workshop.” 
Participants of the “Arlington House 
Workshop," including former members 
of the RAC, agreed that the USDA , 
Guidelines should be incorporated into 
the NIH Guidelines. The workshop 
participants noted that merging these 
two documents would offer the distinct 
advantage of providing a single 
comprehensive source of information 
regarding conduct of research involving 
organisms containing recombinant DNA 
and plants and animals exposed to 
microorganisms containing recombinant 
DNA. 
A staff working group representing 
the Office of Recombinant DNA 
Activities. NIH. and the Cooperative 
State Research Service, USDA, held 
meetings during the following six 
months. This working group met with 
the purpose of revising the containment 
section and developing a final 
incorporated document for RAC review, 
approval by the NIH Director, and 
incorporation into the, NIH Guidelines. 
On June 28, 1987, and July 16, 1987, 
the RAC appointed the Working Group 
on Revision of the NIH Guidelines to 
meet and consider the draft documents. 
Appendices P and Q, and minor 
modifications to the NIH Guidelines, 
that would accommodate the proposed 
appendices. Appendices P and Q and 
the proposed revisions to tlie NIH 
Guidelines were published for public 
comment in the Federal Register on 
August 11, 1987 (52 FR 29800). 
Additional re\'isions to Appendices P 
and Q were proposed by the RAC and 
the Agricultural Research Service, 
USDA, at the September 17, 1987, RAC 
meeting. These modifications wore 
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