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Federal Register / Vol. 47, No. 77 / Wednesday, April 21, 1982 / Notices 
1981, “Gottesman" propoal as a 
substitute motion with a commitment to 
continue to review, reorganize, simplify, 
and remove restrictions from the 
Guidelines as expeditiously as possible. 
Dr. Fedoroff seconded the motion. 
Dr. Bems said that the current 
Guidelines are cumbersome and 
complex. The RAC has several options. 
The most signiHcant issue is the 
mandatory nature of the Guidelines. He 
thought having DBCs is good, and 
recommended keeping the RAC. He 
stated a preference for readily 
understandable Guidelines. 
Dr. Mason said RAC has acted 
responsibly in the process of reviewing 
the Guidelines. He supported the need 
for IBCs in both academia and industry. 
Indeed this type of activity should not 
be limited to the recombinant DNA field 
but should be encouraged genetically. 
He feared that RAC, by its endorsement 
for publication of the December 4, 1981, 
proposal, did not convey to the public 
the importance of IBCs. Dr. Mason 
suggested that certain issues should be 
carefully scrutinized, including 
deliberate release or recombinant 
containing organisms into the 
environment and the cloning of genes 
for drug resistance and for certain 
toxins. Dr. Mason expressed the belief 
that the NIH Guidelines ultimately 
should and will become voluntary, but 
suggested they should remain 
mandatory for the time being for at least 
two reasons: (1) More information 
should be collected, particularly in 
regard to some of the areas currently 
prohibited; and (2) the public is not yet 
ready for voluntary guidelines. 
Dr. Goldstein said that he could not 
support the December 4 proposal. He 
said that he supports the December 7 
proposal as it simplifies the Guidelines, 
specifies IBCs, and maintains 
mandatory' Guidelines. He stated that 
haphazard local regulations, varying 
from community to community, and 
hindering the research, will result if 
national oversight is not maintained. He 
felt the December 7, 1981, proposal does 
not deal adequately with large-scale 
work and that area should be reviewed. 
Ms. King noted that at the September 
8-9, 1981, RAC meeting she had not 
supported what became the December 4, 
1981, proposal. She believes the 
December 7, “Gottesman” proposal is 
where the RAC should begin in trying to 
reach a final position. She expressed the 
belief that regulation is justified by 
concerns about safety. Arguments that 
recombinant DNA is no more 
dangerous than other forms of 
biomedical research have been 
advanced. This does not lead Ms. King 
to the conclusion that only a voluntary 
code of conduct is necessary. She 
suggested, rather, that if other research 
areas pose similar risk, then perhaps 
they too should be regulated. She 
favored mandatory Guidelines with 
sanctions and a monitoring system. The 
structure should not yet be dismantled 
nor should it be made voluntary. 
Otherwise a system of fragmented 
regulations at the state and local level 
might develop. 
Mr. Thornton recognized Dr. 
Gottesman who had authored the 
December 7, 1981, proposal. Dr. 
Gottesman said her proposal is based on 
the assessment of risks in the document 
“Evaluation of the Risks Associated 
with Recombinant DNA” (46 FR 59385). 
She noted that that document had been 
generated by the Working Group on 
Revision of the Guidelines during the 
summer of 1981. On the basis of that 
evaluation, she had concluded that there 
are several types of experiments about 
which questions remain or about which 
so little is known that no absolute 
conclusion can be drawn. For these 
types of experiments she felt a 
mandatory record-keeping and oversight 
mechanism is appropriate. 
Dr. Gottesman said her proposal 
requires RAC review and NIH approval 
for certain experiments involving toxin 
genes, drug resistance genes, and 
release into the environment. 
Responsibility for oversight of certain 
other experiments is delegated to the 
IBCs. The types of experiments to be 
reviewed and IBC review procedures 
might be modified by RAC. RAC may 
wish to permit the IBCs greater leeway 
in lowering containment for certain 
experiments. Dr. Gottesman noted that 
her proposal does not alter the status of 
currently exempt experiments. 
Mr. Daloz said that specialists in 
general tend to develop tunnel-vision so 
that their own concerns become 
uppermost in their minds. He noted that 
many laws and guidelines regulate our 
daily lives, and that even if the NIH 
Guidelines were eliminated, other 
agencies might institute guidelines or 
regulations. Mr. Daloz expressed his 
support for the December 7, 1981, 
proposal; he said, in any event, the IBCs 
should be retained. 
Dr. McKinney said he had discussed 
the December 4 and December 7 
proposals with scientists, lawyers, and 
representatives of commercial 
organizations. He said the researchers 
he had spoken with are approximately 
evenly divided in their support of 
mandatory vs. voluntary Guidelines. 
Regarding the current prohibitions. Dr. 
McKinney said many people felt certain 
experiments should be monitored and 
controlled. 
Dr. McKinney said that previously the 
RAC had extricated itself from 
“regulating” large-scale activities. He 
felt the reintroduction of the question of 
how to oversee large-scale work was 
retrogressive; RAC should address 
science issues and avoid reviewing 
large-scale activities per se. Finally, Dr. 
McKinney noted that some 
correspondents mentioned the negative 
effects the Guidelines have had on 
research. He said the committee must 
also take into account the beneficial 
aspects of the review process; in his 
view the benefits far outweigh any 
negative aspects. He said RAC would be 
remiss if it eliminated oversight over 
recombinant DNA research before more 
data are accumulated. 
Mr. Mitchell said he had made a rough 
analysis of the opinions submitted by 
commentators on the proposals. 
According to his estimate, 
approximately half favored the 
December 4 proposal; the other half 
favored either the current Guidelines or 
modest changes therein, or the 
December 7 proposal, 
Mr. Mitchell said the press gives the 
impression that the recombinant DNA 
field is advancing very rapidly. These 
accounts do not support the allegation 
that the Guidelines have inhibited 
research. He suggested that should the 
NIH change the Guidelines 
substantially, RAC would find itself in 
an untenable position; it would forfeit 
the opportunity to "move" the 
technology on a rational basis, and 
uniformity of standards would be lost. 
Mr. Mitchell suggested that adoption of 
the December 4, 1961, proposal would 
destroy some of the scientific 
community's credibility. He said that 
should Congress ever again consider 
national legislation, scientists could no 
longer argue they were following a 
policy of self-regulation. 
Mr. Mitchell said he had attended a 
panel meeting of the California 
legislature’s Committee on Health on 
December 14, 1981. He said these 
legislators, few of whom have a 
scientific background, spoke in terms of 
public perceptions. He questioned how 
many of those legislators would 
understand the scientific arguments or 
attempt to comprehend technical 
presentations. 
Mr. Mitchell said he supported the 
December 7 proposal as it maintains the 
mandatory nature of the Guidelines and 
the requirement for IBCs. Dr. Fedoroff 
said she strongly suppored the 
December 7 proposal, and urged that a 
mechanism for further simplification be 
introduced. 
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