Federal Register / Vol. 47, No. 77 / Wednesday, April 21, 1982 / Notices 
17169 
Dr. Saginor said that the recombinant 
DNA issue could easily become a 
political football; the Guidelines have 
restrained politicians from using this as 
an issue. He added that the RAC as a 
central committee providing a forum for 
discussion is necessary. He supported 
the December 7, 1981, proposal. 
Dr. Irving Johnson oi Eli Lilly and 
Company said Eli Lilly had commented 
favorably on both the December 4 and 
the December 7 proposals, although he 
had reservations about both proposals. 
He said the December 4 proposal 
provides no "trackability''. The 
December 7 proposal, while it simplifies 
the Guidelines, perpetuates unnecessary 
bookkeeping. He said that Eli Lilly and 
Company recommends mandatory 
retention of IBCs which should be 
required to report problems to the RAC. 
Dr. Johnson pointed out that 
representatives of regulatory agencies_ 
are on the Interagency Recombinant 
DNA Committee and have liaison 
representatives to the RAC. These 
representatives are there to monitor 
events and suggest appropriate action to 
their agencies. For a company involved 
in interestate commerce such as Eli Lilly 
and Company, these agencies represent 
regulations which are mandatory and 
not voluntary. 
Dr. Johnson said he had attended the 
November 1981 hearings of the 
California legislature's Committee on 
Health and had detected little concern 
over risk at that hearing. Concerns were 
expressed, however, over moral and 
ethical problems. Dr. Johnson expressed 
concern about again raising the issue of 
large-scale work and cited the safety of 
large-scale equipment. He proposed 
amending the December 4 . 1981, 
proposal to require retention of IBCs. 
Dr. McCarrity said that he has 
concluded that recombinant DNA 
research presents no hazards beyond 
those normally associated with 
microbiological research. This is not to 
say there are no problems in other areas 
of biomedical research: however, these 
hazards have been adequately handled. 
He stated that it is time to stop the 
discriminatory treatment of recombinant 
DNA research. He favored the 
December 4 , 1981, proposal with some 
modifications. 
Dr. Holmes said he favored retaining 
mandatory Guidelines and the 
requirement for IBCs. He rejected the 
argument that recombinant DNA 
activities should not require oversight 
because other areas of microbiological 
or biomedical research do not have 
special oversight. He said he would 
support the December 7, 1981 proposal 
with the addition of a recommendation 
that IBCs also review non-recombinant 
DNA research that is similar to research 
covered by Section III of the Guidelines. 
Dr. Baltimore reiterated his belief that 
recombinant DNA research is no more 
hazardous than experiments in the 
mainstream of biomedical research. He 
felt this was the judgement of a majority 
of the scientific community, and that the 
December 4, 1981. proposal reflects this 
consensus. He said fear of local 
regulation or fear of leaving industry 
with no code for legal protection were 
not reasons for maintaining mandatory 
Guidelines. Adoption of the December 4, 
1981, proposal would send a message to 
States and localities that the RAC 
concludes that regulations are not 
necessary. Finally. Dr. Baltimore said 
that the CDC "Classirication of 
Etiological Agents on the Basis of 
Hazard" is not appropriate for use in 
classifying recombinant DNA 
experiments. 
Dr. Lewis of the National Science 
Foundation suggested greater flexibility 
in IBC speciHcations might be desirable. 
Dr. Landy said that he supported the 
original Baltimore-Campbell proposal, 
and subsequently the December 4 , 1981, 
proposal, as the only intellectually 
honest recognition of the relationship 
between the unestablished potential risk 
in recombinant DNA research, and 
known risk in other areas of research 
which are not regulated. In attempting to 
rationalize support for greater controls 
over recombinant DNA research than 
over work with known pathogens. Dr. 
Landy said the training, procedures and 
restraints applied by the select group of 
investigators studying pathogens would 
not necessarily have been followed by 
all those now using recombinant DNA 
techniques. 
Dr. Cottesman concurred with Dr. 
Landy's rationalization and added that 
investigators studying pathogens know 
the properties of these organisms; 
recombinant organisms might express 
unexpected properties. 
Dr. Maas said he saw no logic in 
having guidelines for one type of 
experimental procedure, which is 
rapidly becoming a very commonly 
employed technique, and having no 
regulations for other types of more 
dangerous procedures, such as work 
with chemical carcinogens. 
Dr. Cottesman said that mandatory 
guidelines are not necessarily 
synonomous with bureaucracy. She 
noted that the December 7. 1981. 
proposal no longer requires RAC review 
and NIH approval for large-scale 
procedures; rather it specifies that large- 
scale experiments be approved by the 
IBC. She said the definition of large- 
scale might be revised. Dr. Cottesman 
agreed with Dr. Baltimore that the CDC 
Classification of Etiological Agents in 
not perfect, but she said the alternative 
in the December 4 proposal of "use 
whatever you have and figure it out 
yourself is not better. If RAC cannot 
fmd a better mechanism than the CD(^ 
classification. IBCs and Pis individually 
will not be able to make better 
decisions. 
Ms. King said that the central issue is 
mandatory vs. voluntary guidelines. She 
said she was concerned with questions 
of process. She referred to Dr. 
Baltimore's statement that only a 
minority of scientists believe there may 
be some safety concerns with respect to 
recombinant DNA research. She said the 
public cannot ascertain whether that 
statement is accurate. The RAC did not 
cross-examine those who submitted 
written comments. Ms. King said RAC 
members should be aware of what she 
considers to be defects in process, and 
therefore err on the side of caution in 
deciding between the December 4 and 
December 7 proposals. 
Dr. Nightingale praised the more 
extensive attempts to solicit conunents 
on these proposals than had occurred in 
the past. As a result of this, the 
comments received were more varied 
than in the past. However, she felt it 
was only one small step in really 
assessing what the public feels. 
Referring back to Dr. Baltimore's 
statement. Dr. Nightingale said that 
disagreement does exist within the 
scientific community on whether there 
are unique risks of recombinant DNA 
research. She said that a major issue is 
voluntary vs. mandatory IBCs. She said 
that the December 7, 1981, proposal 
could be simplified and reorganized to 
make it easier to read and less 
cumbersome. She suggested that Section 
III-C could be eliminated; that the 
criteria for defining large-scale could be 
revised to emphasize inoculum size 
rather than volume: that Section IV 
could be simplified and reorganized; 
that the bureaucracy within IBCs could 
be greatly simplified; that the section 
dealing with whole or defective viruses 
could be simplified; that Section lIl-B-2- 
a and Section III-B-2-b dealing with 
etiological agents could be combined; 
and that all work in nonpathogens could 
be performed at PI containment. She 
viewed the December 7, 1981, proposal 
as a first, very positive step towards 
reducing complexity and restrictions. 
Dr. Levine attempted to address the 
question of why recombinant DNA 
research is singled out for special 
consideration while other biomedical 
research, using inherently much more 
dangerous organisms, is not. He said the 
answer is in the historical context. Work 
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