9760 
Federal Register / Vol, 50, No. 47 / Monday, March 11, 1905 / Notices 
DEPARTMENT OF HEALTH AND 
HUMAN SERVICES 
National Institutes of Health 
Recombinant DNA Research; Actions 
Under Guidelines 
agency: National Institutes of Health, 
j PHS, HHS. 
action: Notice of Actions Under NIH 
i Guidelines for Research Involving 
Recombinant DNA Molecules. 
summary: This notice sets for actions 
taken by the Director, National 
Institutes of Health (NIH), under the 
November 1984 NIH Guidelines for 
Research Involving Recombinant DNA 
Molecules (49 FR 46266, November 23, 
1984. 
j EFFECTIVE date: March 11, 1985. 
FOR FURTHER INFORMATION CONTACT 
Additional information can be obtained 
from Dr. William J. Gartland, Office of 
Recombinant DNA Activities (ORDA), 
National Institutes of Health, Bethesda, 
Maryland 20205, (301) 496-6051. 
SUPPLEMENTARY INFORMATION: One 
change in the NIH Guidelines for 
Research Involving Recombinant DNA 
Molecules is being promulgated today. 
This proposed change was published for 
comment in the Federal Register of 
September 20, 1984 (49 FR 37016), and 
reviewed and recommended for 
approval by the Recombinant DNA 
Advisory Committee (RAC) at its 
meeting on October 29, 1984. In 
accordance with section IV-C-l-b of 
the NIH Guidelines, this action has been 
found to comply with the NIH 
Guidelines and to present no significant 
risk to health or the environment. 
The decision on a second proposal 
published for comment in the Federal 
Register of September 20, 1984 (49 FR 
37016), and reviewed and recommended 
for disapproval by the RAC at its 
meeting on October 29, 1984, is also 
described in this announcement. 
Part I of this announcement provides 
background information on the 
proposals. Part II gives the change in the 
NIH Guidelines effective today. 
I-A. Proposed Amendment of Section 
III— D of the NIH Guidelines 
In a letter dated August 21, 1984, Mr. 
C. Searle Wadley and Dr. John H. Keene 
of Abbott Laboratories, North Chicago, 
Illinois, proposed that the following 
sentence be added to Section III— D of 
the NIH Guidelines: 
Although these experiments are exempt, it 
is recommended that they be performed at 
the appropriate biosafety level for the host or 
recombinant organism (for biosafety levels 
see "Biosafety in Microbiological and 
Biomedical Laboratories"). 
In support of their proposal, Mr. 
Wadley and Dr. Keene stated it would 
be advisable to recommend appropriate 
biosafety levels be considered for those 
recombinant experiments that are 
exempt from the NIH Guidelines. 
This proposed amendment was 
published for public comment in the 
September 20, 1984, Federal Register (49 
FR 37016). No comments were received 
on this proposal. The RAC discussed 
this proposed modification of the NIH 
Guidelines at its October 29, 1984, 
meeting. 
Several RAC members endorsed the 
addition of the proposed language to the 
NIH Guidelines. However, RAC 
recommended the proposed language be 
added to the introductory language of 
Appendix A, Exemptions Under Section 
III-D-4, rather than Section III— D. In 
addition, RAC suggested the reference 
to the booklet “Biosafety in 
Microbiological and Biomedical 
Laboratories" be added to the proposed 
language. A motion to this effect was 
accepted by the RAC by a vote of 
twenty-two in favor, none opposed, and 
no abstentions. 
I accept this recommendation, and 
Appendix A of the NIH Guidelines will 
be so modified. 
I-B. Proposed Addition of Prohibited 
Experiments to the NIH Guidelines. 
Mr. Jeremy Rifkin of the Foundation 
on Economic Trends, Washington, D.C., 
proposed that the NIH Guidelines for 
Research Involving Recombinant DNA 
Molecules be amended to prohibit any 
experimentation involving the transfer 
of a genetic trait from one mammalian 
species into the germline of another 
unrelated mammalian species. 
The description of the review of Mr. 
Rifkin’s proposal is organized as 
follows: 
I— B— 1. Description of the Proposal 
I-B-2. Comments on the Proposal in 
Response to the September 20, 1984, 
Federal Register Notice 
I-B-3. The Draft Minutes of the Relevant Part 
of the October 29, 1984, RAC Meeting 
I-B-4. Decision 
I-B-l. Description of the Proposal 
Mr. Rifkin submitted the following 
letter dated August 21, 1984, to the NIH: 
I am formally requesting that the following 
item be placed on the agenda for the October 
29, 1984 meeting of the Recombinant DNA 
Advisory Committee of the National 
Institutes of Health. 
It has come to our attention that the 
National Institutes of Health and the National 
Science Foundation are helping to fund 
specific experiments by Dr. Ralph Brinster of 
the University of Pennsylvania in which 
human genes regulating growth hormone is 
being injected into sheep and pig embryos 
with the express purpose of incorporating 
these human genes permanently into the germ 
line fo these other mammalian species. These 
experiments are currently being conducted, in 
part, with the assistance and cooperation of 
the USDA at its agricultural experimental 
station at Beltsville, Maryland. 
If successful, these experiments would 
represent the second time in history that a 
segment of the genetic make-up of homo- 
sapiens has been permanently transferred 
into the genetic make-up of another species. 
The Brinster team has already successfully 
transferred the human growth hormone gene 
into the germ line of mice. Thus, a dramatic 
new technological threshold has been 
crossed, making it imperative that the Federal 
Government act immediately and 
expeditiously to establish a policy in regard 
to such experimentation. 
Therefor®, I am proposing the following 
amendment to the NIH guidelines for 
recombinant DNA experimentaion: 
The NIH prohibits any experimentation 
involving the transfer of a genetic trait from 
one mammalian species into the germ line of 
another unrelated mammalian species. 
'Unrelated' shall be defined as any two 
species that cannot mate and produce one 
generation of offspring either in the wild or 
under pre-existing domestic breeding 
programs. 
This NIH guideline shall encompass all 
mammalian species, including homo-sapiens 
Upon adoption of this guideline by the NIH, 
said agency shall immediately discontinue 
funding any current experimental research 
involving the transfer of genetic traits from 
one mammalian species into the germ line of 
another unrelated mammalian species and 
shall instruct all institutions receiving NIH 
grants that any such experimentation using 
private funds shall be grounds for the 
immediate suspension of all NIH research 
grants to the institution. This amendment 
shall also cover all private companies who 
are signatories of license agreements with 
NIH funded institutions where said 
agreements contain clauses requiring the 
licensee to adhere to the NIH guidelines 
involving recombinant DNA experimentation. 
The intent of this amendment to the NIH 
guideline is to protect the biological integrity 
of every mammalian species. Existing Federal 
policy, as reflected in many Federal statutes, 
protects the Integrity and well being of 
species. The crossing of species borders and 
the incorporation of genetic traits from one 
species directly into the germ line of another 
species represents a fundamental assault on 
the principle of species integrity and violates 
the right of every species to exist as a 
separate, identifiable creature. 
Certainly most human beings would 
condemn any attempt to introduce animal 
genes permanently into the germ line of 
homo-sapiens. We would abhor any such 
experiment as a gross and unconscionable 
violation of our telos as a species. In like 
manner this amendment establishes the 
principle that similar experiments between 
all other mammalian species be condemned 
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