Federal Register / Vol. 50, No. 47 / Monday. March 11, 1985 / Notices 
9767 
Dr. Utndy said RAC is saying it is 
unconscionable to prohibit exploring 
this avenue of research. I le asked Mr. 
Rifkin if there are any examples in 
history where a social problem has been 
successfully solved before the 
technology was developed to address 
the problem. 
Mr. Rifkin said the Iroquois nation of 
North America had a civilized and 
advanced culture. These people 
followed a specific procedure whenever 
they considered some environmental, 
social, or cultural change. They asked in 
the deliberation process what effect the 
proposed change would have seven 
generations in the future. In some cases, 
the Iroquois decided the particular 
change would have more costs than 
benefits and decided not to implement 
it. 
Mr. Rifkin said genetic engineering is 
one approach to the future; it is not the 
only approach. He emphasized that 
there are other approaches to solving 
problems. He offered as an example 
attempts to deal with heart and lung 
diseases and cancer. He said these 
diseases have an environmental 
component as well as a genetic 
component. Mr. Rifkin said he would be 
thrilled if NIH money were spent 
studying how the environment triggers 
genetic diseases rather than on research 
on gene transfers. 
Mr. Mitchell asked Dr. Bowman 
whether environmental factors are a 
cause of cystic fibrosis. Dr. Bowman 
said environmental factors are not a 
cause; cystic fibrosis is a genetic illness 
Dr. Gottesman said Mr. Rifkin's 
characterization of RAC's activities as 
always giving the go-ahead is untrue as 
RAC has often turned down requests to 
proceed. Dr. Gottesman asked Mr. Rifkin 
to be honest and accurate in his 
portrayal of RAC and RAC’s activities, 
and of the question currently before 
RAC. In this instance, a single gene will 
be moved from one organism to another; 
all sheep are not about to be turned into 
giant sheep nor are people with bat 
wings going to be created. 
Mr. Richard Pollack identified himself 
as having been associated for a two 
year period with Sandia Laboratories as 
a consultant to the Nuclear Regulatory 
Commission (NRC), as having served 
with the NRC on the Three Mile Island 
investigation, and as being “close" to 
Mr. Rifkin. 
Mr. Pollack said Mr. Rifkin was 
asking: 
... if the basic question of the 
environmental impact . . . has been ignored 
by this committee . . . What kind of rood 
are we moving down? . . . with such a 
powerful tool with such great consequences, 
not to have that kind of basic methodology to 
assure the public is very disconcerting, 
whether on a concrete issue or on a less 
abstract issue. . . . 
Dr. Fox asked why others seem to 
think there is an ethical issue to be 
discussed. He said. “Surely there is not 
some dialectical tension here that 
cannot be reconciled, that somewhere 
between us is meaning and substance to 
the reality around us.” 
Dr. McKinney reminded the 
proponents of what their proposal 
entailed; a complete prohibition of 
certain types of research. He then called 
the question. 
By a vote of nineteen in favor, two 
opposed, and one abstention, the RAC 
agreed to close debate. 
Dr. Gottesman then repeated the 
language of her modified motion: 
That RAC reject the amendments proposed 
by Mr. Rifkin and published in the Federal 
Register of September 20, 19&4, Section II. 
Both the importance of this class of 
experiments in current scientific research and 
the long-term possibilities for treatment of 
human and animal disease and the 
development of more efficient food sources 
make it a moral imperative that we Strongly 
oppose the blanket prohibition of this class of 
experiments. 
By a vote of twenty-two in favor, none 
opposed, and no abstentions, the RAC 
approved Dr. Gottesman's motion. 
Mr. Mitchell suggested that a 
document be prepared to set forth the 
statements and concerns of the RAC 
and others. Dr. Gottesman said the 
minutes of the RAC meeting could form 
the basis of that document. 
I-B-4. Decision 
On the basis of the RAC 
recommendation and the large public 
response opposing Mr. Rifkin’s proposal. 
I reject the proposed amendments to the 
NIH Guidelines and endorse RAC's 
statement affirming the importance of 
this class of experiments in current 
scientific research and the long-term 
possibilities for treatment of human and 
animal disease and the development of 
more efficient food sources. 
II. Change in the Nil! Guidelines 
A new third paragraph is added to 
Appendix A, Exemptions under section 
IU-D-4. to immediately precede “Sublist 
A," to read as follows: 
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. 1st Edition (March 
1984). U.S. Department of Health and Human 
Services, Public Health Service, Centers for 
Disease Control. Atlanta, Ceorgia 30333, and 
National Institutes of Health, Bethesda, 
Maryland. 20205). 
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 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: March 1. 1985. 
James B. Wyngaarden, 
Director, National Institutes of Health. 
(KR Doc. 5582 Filed 3-8-85: 8:45 am) 
BILL m<3 coot 4140-01-M 
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