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Federal Register / Vol. 50, No. 60 / Thursday, March 28, 1985 / Notices 
specific DNA sequences) would alter the 
potential for significant adverse effects. 
3. Evaluation of results of tests 
conducted in contained environments to 
predict the ecological behavior of the 
modified organism relative to that of its 
nonmodified parent. 
D. The Nature of the Test 
Discuss the following specific features 
of the experiment that are designed to 
minimize potential adverse effects of the 
modified organism: 
1. Test site location and area. 
2. Introduction protocols. 
3. Numbers of organisms and their 
expected reproductive capacity. 
4. Emergency procedures for aborting 
the experiment. 
5. Procedures conducted at the 
termination of the experiment. 
II. Proposed Revision of Appendix C 
Dr. Jack J. Manis of the Upjohn 
Company, Kalamazoo, Michigan, has 
proposed that the following kinds of 
experiments be made exempt under 
Section III— D— 5 and the following 
language be included in Appendix C of 
the NIH Guidelines: 
Experiments and processes utilizing 
recombinant DNA containing derivatives of 
Streptomyces fradiac or Streptomyces 
lincolnensis are exempt from the Guidelines 
at all levels of volume scale when the 
recombinant DNA molecules contained in 
these hosts are derived solefy from 
nonpathogenic streptomycetes. The 
nonpathogenicities of the recombinant DNA 
sources are determined by the local 1BC. 
For these exempt laboratory experiments. 
BL1 physical containment conditions are 
recommended. 
For large-scale fermentation experiments 
BI.l-I.S physical containment conditions are 
recommended. However, following review by 
the IBC of appropriate data for a particular 
host-vector system some latitude in the 
application of BLl-LS requirements as 
outlined in Appendix K-Il-A through K-lI-F 
is permitted. 
Exceptions. Experiments described in 
Section III— A which require specific RAC 
review and NIH approval before initiation of 
the experiment. 
Large-scale experiments (e.g., more than 10 
liters of culture) require prior IBC review and 
approval (see Section 1U-B-5). 
Explanation of this proposed 
modification is provided in the 
submission. 
III. Proposed Amendment of Part 111 
In a memorandum dated February 12, 
1985, Dr. Bernard Talbot, Deputy 
Director of the National Institute of 
Allergy and Infectious Diseases, noted 
that under the NIU Guidelines for 
Research Involving Recombinant DNA 
Molecules certain proposals are 
received by NIH for review by the NIH 
Recombinant DNA Advisory Committee 
(RAC) and subsequent NIH approval. 
These include proposals which are 
required to be submitted from 
institutions that receive support for 
recombinant DNA research from NIH, 
and also proposals voluntarily 
submitted by institutions that receive no 
NIH support for recombinant DNA 
research. Recently other Federal 
agencies have made steps toward 
assuming new roles in review of 
recombinant DNA proposals. 
Because of these developments, it 
could now happen that a proposal 
submitted to the NIH for RAC review . 
and NIH approval (either from an 
institution that receives NIH funding for 
recombinant DNA research or 
voluntarily submitted by an institution 
that receives no such support) may be 
also submitted to another Federal 
agency for review. 
Dr. Talbot states: 
In such a case, 1 believe it would be 
advantageous for NIH to have the option of 
deferring to the review and approval by the 
other Federal agency rather than always 
going through review and approval by both 
the other Federal agency and the NIH. In 
order to allow this. I request that the 
following proposed change in the NIH 
Guidelines be issued for public comment, and 
placed on the agenda of the next RAC 
meeting. 1 propose that a new sentence be 
added at the end of Section III— A of the 
Guidelines ("Experiments that Require RAC 
Review and NIH and IBC Approval Before 
Initiation") just before Section II1-A-1 of the 
Guidelines, as follows: "If experiments in this 
category are submitted for review to another 
Federal agency, the submitter shall notify 
ORDA: ORDA may then determine that such 
review serves the same purpose, and based 
on that determination, notify the submitter 
that no RAC review will take place, no NIH 
approval is necessary, and the experiment 
may proceed upon approval from the other 
Federal Agency." 
Additional background information is 
provided in the memorandum. 
IV. Proposed RAC Working Group 
Messrs. Lee Rogers and Jeremy Rifkin 
of the Foundation on Economic Trends, 
Washington. D.C., submitted the 
following letter dated February 28, 1985, 
to NIH: 
We are formally proposing that the 
Recombinant DNA Advisory Committee 
(RAC) of the National Institutes of Health 
(NIH) establish a working subgroup whose 
staled purpose would be to examine potential 
uses of recombinant DNA technology for 
offensive and defensive biological weapons 
systems. In addition, this subgroup will also 
explore current Department of Defense 
(DOD) programs specifically designed to 
develop "defensive" preparedness against 
the threat of genetic engineering warfare by 
aggressor nations or terrorists. It should be 
mude clear that such a study is designed to 
look into the potential as well as actual uses 
of reoombinant DNA technology for military 
purposes regardless of whether such 
experimentation is being conducted at this 
time. The working subgroup on biological 
warfare will make its findings available to 
the RAC, NIH, and interested members of the 
public. The working subgroup may also wish 
to make recommendations regarding future 
oversight of recombinant DNA work in this 
field. 
It is no longer possible to ignore the 
potential military uses of recombinunt DNA 
experimentation in light of the DOD's plan to 
construct an aerosol test laboratory at 
Dugway Proving Ground in Utah. The 
military has stated its intention to use this lab 
to test defenses against biological warfare 
experiments and it furiher stated that it will 
be working with deadly biological pathogens. 
In November 1984, the Secretary of Defense. 
Caspar Weinberger, stated in a letter to 
Senator Jim Sasser: "We continue to obtain 
new evidence that the Soviet Union has 
maintained its offensive biological warfare 
program and that it is exploring genetic 
engineering to expand their program’s scope. 
Consequently, it is essential and urgent that 
we develop and field adequate biological and 
toxin protection." (See enclosed document.) 
In light of these recent developments, it is 
imperative that the RAC begin a thorough 
and comprehensive study of the potential 
uses of recombinant DNA technology for 
military purposes. 
Since its inception. RAC has involved itself 
in every aspect of recombinant DNA 
technology in an effort to develop procedures, 
guidelines, protocols, and ethical standards 
to oversee this research. The only area of 
recombinant DNA experimentation that has 
not yet been rigorously examined is the 
potential military uses. Therefore, I would 
think that this committee would find it helpful 
to explore the potential military uses of 
recombinant DNA technology in order to 
facilitate a better understanding of the 
various issues involved. Moreover, it is 
altogether appropriate for the RAC to engage 
in such a study as the DOD has stated on 
many occasions that it is adhering to the 
guidelines established by this committee and 
the NIH. An independent study by the RAC 
of the military potential or recombinant DNA 
technology can only serve to better inform 
the Executive Branch, Congress and the 
public of the issues involved in this particular 
field. 
Dated: March 11, 1985. 
Anthony S. Fauci, 
Director, National Institute of Allergy and 
Infectious Diseases, National Institutes of 
Health. 
OMB's “Mandatory Information 
Requirements for Federal Assistance 
Program Announcements" (45 FR 39592) 
requires a statement concerning the 
official government programs contained 
in the Catalog of Federal Domestic 
Assistance. Normally NIH lists in its 
announcements the number and title of 
affected individual programs for the 
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