Federal Register / Vol. 49. No. 184 / Thursday, September 20, 1984 / Notices 
37017 
grants that any such experimentation using 
private funds shall be grounds for the 
immediate suspension of all NIM 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 
guidelines 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 
and outlawed on the same grounds, i.e„ that 
such an intrusion violates the telos of each 
species and is to be condemned as morally 
reprehensible. 
As to non-mammalian species, the same 
principle of species integrity ought to apply. 
Therefore, I am proposing that in addition to 
the adoption of the above amendment to the 
NIH guidelines, the RAC immediately 
establish a working sub-group whose purpose 
will be to propose any additional protocols or 
guidelines that might be necessary to ensure 
compliance with the spirit of the above 
amendment in regard to the protection of the 
gem line of all species. 
On August 23, 1984, Mr. Rifkin 
submitted an additional letter to NIH: 
I am submitting an additional item for 
placement on the agenda for the October 29, 
1984 meeting of the Recombinant DNA 
Advisory Committee of the National 
Institutes of Health. The following 
amendment to the NIH guidelines should be 
raised for discussion and debate along with 
the proposed amendment which I forwarded 
to you in my letter dated August 21, 1984. I 
would like this enclosed amendment to be 
considered first on the agenda and the 
amendment in my August 21 letter to be 
considered second. 
The amendment shall read as follows: 
The National Institutes of Health prohibits 
any experimentation involving the transfer of 
a genetic trait from a human being into the 
germ line of another mammalian species. The 
National Institutes of Health also prohibits 
any experimentation involving the transfer of 
a genetic trait from any mammalian species 
into the germ line of a human being. 
Furthermore, the National Institutes of Health 
considers any such experimentation 
involving the transfer of genetic traits 
between animal and human germ lines to be 
morally and ethically unacceptable. 
Thank you for your time and consideration 
on this matter. 
OMD'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 
its announcements the number and title of 
affected individual programs for the guidance 
of the public. Because the guidance in this 
notice covers not only virtually every NIH 
program but also essentially every federal 
research program in which DNA recombinant 
molecule techniques could be used, it has 
been determined to be not cost effective or in 
the public interest to attempt to list these 
programs. Such a list would likely require 
several additional pages. In addition, NIH 
could not be certain that every federal 
program would be included as many federal 
agencies, as well as private organizations, 
both national and international, have elected 
to follow the NIH Guidelines. In lieu of the 
individual program listing, NIH invites 
readers to direct questions to the information 
address above about whether individual 
programs listed in the Catalog of Federal 
Domestic Assistance are affected. 
Dated: September 10, 1984. 
Bernard Talbot, M.D., Ph.D., 
Acting Director. National Institute of Allergy 
and Infectious Diseases. National Institutes of 
Health. 
[FR Doc. 64-24912 Filed 9-19-64; 8:45 «m| 
BILLING CODE 4140-01-44 
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