Federal Register / Vol. 50, No. 47 / Monday, March 11, 1985 / Notices 
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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 
germ 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. 1 
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. 
I-B-2. Comments on the Proposal in 
Response to the September 20, 1984, 
Federal Register Notice 
These proposed actions were 
published in the September 20, 1984 (49 
FR 37016), Federal Register for public 
'comment. 
Prior to the October 29, 1984, RAC 
meeting, 360 letters containing 434 
signatures were received by the NIH. 
Three hundred and fifty-nine letters 
with 433 signatures opposed Mr. Rifkin's 
proposed actions. One letter with one 
signature supported the proposal. 
A total of 297 letters containing 313 
signatures opposing Mr. Rifkin's 
proposal were received from the general 
public. These letters can be divided by 
geographical area as follows: 129 letters 
with 133 signatures from Elizabethtown, 
Kentucky; 47 letters with 52 signatures 
from Athens, Ohio; 24 letters with 24 
signatures from Louisville, Kentucky; 26 
letters with 29 signatures from 
Nelsonville, Ohio; 15 letters with 16 
signatures from Zanesville, Ohio; 14 
letters with 14 signatures from New 
Marshfield, Ohio; 10 letters with 10 
signatures from Rockbridge, Ohio; 5 
letters with 5 signatures from Akron, 
Onio; 3 letters with 4 signatures from 
Albany. Ohio; 4 letters with 4 signatures 
from West Point, Kentucky, 2 letters 
with 3 signatures from The Plains, Ohio; 
2 letters with 2 signatures from Logan, 
Ohio; 2 letters with 2 signatures from 
Rineysville, Kentucky; 2 letters with 2 
signatures from Seminole, Florida; 2 
letters with 2 signatures from 
Anchorage, Kentucky; 1 letter with 2 
signatures from Lancaster, Kentucky; 
and 1 letter with 1 signature each from; 
Radcliff, Kentucky; Jefferson, Kentucky; 
Hodgenville, Kentucky; Nashport, Ohio; 
Crey8ville, Ohio; Mount Perry, Ohio; 
Durham, North Carolina; Salem, 
Indiana; and St. Petersburg, Florida. 
Comments typical of the letters 
received from this segment of the 
population can be seen in the letters 
from Ms. Charlene Thompson of 
Elizabeth, Kentucky, Mr. James E. Bee of 
Zanesville, Ohio, Ms. Barbara Walence 
of New Marshfield, Ohio, Mr. H. Erick 
Layton of Durham, North Carolina, Ms. 
Jeannie Clark of Elizabethtown, 
Kentucky, and Mrs. Bonnie C. Vail of 
Athens, Ohio. 
Ms. Charlene Thompson wrote: 
I am strongly urging the committee to 
overrule the proposed amendment. * * * 
Mr. James E. Bee wrote: 
I am very concerned that Mr. Rifkin's 
proposal does not take into consideration the 
discontinuance of important medical research 
relative to genetic disorders, cancer and other 
diseases. 
Ms. Barbara Walence wrote: 
If this procedure is prohibited, you are 
limiting the search for a cure for this genetic 
problem. 
Mr. H. Erick Layton wrote: 
Please act to establish a wise and humane 
policy. * * * 
Ms. Jeannie Clark wrote: 
I feel we, as caring people, need to help 
those less blessed than we that are bom with 
good health. One way to help I feel is through 
research so I come before you and ask you to 
overrule the proposed amendment. * * * 
Mrs. Bonnie C. Vail wrote: 
I am saddened to think that all medical 
research would be delayed or prohibited. 
Thirty-three letters with 80 signatures 
were received from scientists and 
researchers opposed to Mr. Rifkin’s 
proposal. The following types of 
arguments were offered by this group. 
Dr. Finnie A. Murray of Ohio 
University wrote: 
It is apparent that Mr. Rifkin believes that 
introduction of a gene derived from one 
species into the genome of another species 
violates some essential essence of the 
species, what he calls the species 'border'. It 
is a misconception that one or a few genes 
are sufficient to violate the integrity of a 
species. Individuals within species possess 
only a portion of the gene pool of the species, 
and the gene pool is dynamically evolving, 
with loss and gain of genetic variation. 
Introduction of 'new' genetic material into a 
species can be argued to be beneficial to the 
ability of the species to compete and survive, 
because it is the limit in genetic variation 
within a species that determines its long-term 
survivability. An individual within a species 
is not the definition of that species, it is only 
a representative of that species. 
Dr. Roy D. Schmickel of the University 
of Pennsylvania wrote: 
The use of interspecies constructs has 
proven to be extremely useful and permits a 
careful analysis of small differences between 
species. The work by Ralph Brinster here at 
the University of Pennsylvania has been 
extraordinary in its productivity and 
represents one of the most fruitful avenues of 
investigation of hormone action. Only when a 
gene is injected into germ cells can the effect 
of the gene be seen in an entire organism, and 
only when a human gene has been injected 
into another mammal can we ethically study 
the embyrological action of a human gene. 
When we consider the enormous number of 
diseases that are caused by hormonal 
deficiencies or abnormalities, it is imperative 
that we continue this type of study of 
hormonal genes. It is not d|Jficult to look 
ahead slightly to see the enormous impact 
that such experiments will have in helping us 
understand ways to prevent developmental 
birth defects. 
Dr. Ira Herskowitz of the University of 
California, San Francisco, wrote: 
DNA transfer from humans or other 
mammals into non-human mammals makes it 
possible to address fundamental questions in 
developmental biology concerned with gene 
expression. In addition such transfer 
experiments make it possible to address 
fundamental questions concerned with 
carcinogenesis. Information gleaned from 
these experiments is certain to provide 
important new insights into disease 
processes both in humans and in other 
mammals. The end result will be a literal 
strengthening of species, a deeper 
understanding that will improve the ability of 
these species to combat disease. 
Dr. Oliver Smithies of the University 
of Wisconsin-Madison wrote: 
In all my studies I am constantly made 
aware of the great commonality of genetic 
material. Mammalian species that have no 
possible means of breeding at the present 
time have features in their genomes of 
remarkable similarity. Nowhere do I find 
evidence supporting any inviolate principle of 
species integrity. Indeed, there is increasing 
evidence that genetic material can be 
transferred from one species to another by 
viral and other microbial agents. Such 
transfers, although infrequent, appear to be 
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