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Federal Register / Vol. 46, No. 233 / Friday. December 4, 1981 / Notices 
Dr. Nightingale said that she agrees 
with most of what Dr. Baltimore said. In 
order to implement sound public policy 
there are three basic ingredients; 
knowledge base, commitment of 
leadership, and appropriate social 
strategy. She said that in this case there 
is much agreement on the knowledge 
base and that there is need for change 
and the direction of that change. There 
is more disagreement on the appropriate 
social strategy. Having Federal 
involvement is one method of tempering 
local extremism. 
Ms. King noted that the Baltimore- 
Campbell proposal would put industry 
and academia on an equal footing. She 
said that the RAC shorild consider a 
special meeting and public hearing on 
the proposed changes. 
Dr. Cottesman noted that the current 
Guidelines are flexible and that the vast 
majority of experiments done today are 
exempt. She feels that there are 
scientific reasons for having a group 
other than the principal investigator 
look at the experiments still covered by 
the Guidelines; they should be reviewed 
by IBCs. She said that the critical issues 
in Part IV of the Guidelines are IBC 
prereview and compliance. She said that 
the Working Group’s proposal does not 
involve an immense administrative 
burden. 
Dr. Goldstein said that he also shares 
concerns about the scientific issues. He 
noted the number of new companies 
becoming involved in recombinant DNA 
research. 
Dr. Brill stated that at a recent public 
meeting regarding a genetic engineering 
company in Madison. Wisconsin, no 
concerns were expressed about use of 
recombinant DNA technology 
Dr. McKinney said that the handling 
of the prohibitions is an important issue 
They could perhaps be changed to 
cautionary advisories He also said that 
j citation of CDC and USDA guidelines 
needs to be considered. He preferred 
that NIH retain some form of guidance 
over recombinant DNA research. 
With regard to the proposed revision 
I of the CDC guidelines. Dr. Bems said 
that he expects great improvement in 
the document in the near future. He had 
discussed proposed revisions of the NIH 
Guidelines at a recent Gordon 
conference; most scientists there did not 
favor complete abolition of the 
Guidelines and favored instead 
something like the Baltimore-Campbell 
proposal. He also cited his local 
^ Congressman's concern about the 
potential for increasing public concern 
’ about recombinant DNA technology. It 
IS important in the Guidelines revision 
that public confidence be maintained. 
Dr. Zinder said that the public trusts 
academic researchers, but not industry. 
Dr. Gottesman stressed that under the 
Working Group's proposal, the IBC 
would make the decision on 
containment using the CDC document 
only as guidance. Dr. Goldstein said that 
how the IBCs use and interpret the COC 
guidelines should be made more explicit, 
so that there are uniform standards. 
Dr. McGarrity said that he is 
comfortable in accepting voluntary 
guidelines. He felt that the Working 
Croup's background report is excellent 
and that perhaps an abridged version 
could be published for educating the 
general public. 
Dr. Holmes said that he supports 
retaining the current prohibition dealing 
with the introduction of drug resistance 
traits. He said that to make the 
Guidelines voluntary would be a 
mistake and could invite legislation. 
Dr. Baltimore said that the concern 
raised in the Boston area is not a unique 
situation and that activities at the 
Federal level are still important. He said 
that since there are differences in the 
science done at different institutions it is 
not suprising, and not relevant to the 
present discussion, that different IBCs in 
California operate differently. Dr. 
Baltimore emphasized his view that IBC 
prereview is a serious obstruction of 
science, which results in scientific 
momentum being lost. 
Dr. McKinney pointed out that the 
NIH could still choose to mandate 
guidelines even if the RAC recommends 
otherwise. He suggested that reference 
to CDC and USDA guidelines not be 
incorporated into the body of the text of 
the revised guidelines; rather they could 
be cited as references. 
Ms. King suggested that the RAC 
should structure the issues on which it 
wants public comment such as 
treatment of prohibitions and the 
voluntary vs. mandatory nature of the 
guidelines. Dr. Talbot pointed out that 
the RAC could follow Ms. King's 
suggestion and present issues for public 
comment. The alternative would be for 
the RAC to accept the Working Group 
proposal, the Baltimore-Campbell 
proposal, or an amalgam of the two. 
Following the meeting. NIH staff could 
then develop a new version of the 
Guidelines based on the RAC proposal 
and put this out for public comment 
Dr. Harris then moved to accept the 
report of the Working Group so that 
discussion could proceed to consider the 
report section by section. Dr. Mason 
seconded the motion. There followed 
discussion of the effect of such a motion. 
Dr. Ahmed praised the report of the 
Working Group. He favored publication 
for public comment of a series of 
different options. Dr. Mason expressed 
concern about eliminating all of the 
prohibitions. Dr. Saginor suggested that 
the RAC might first consider the 
Adelberg-Zinder minority proposal to 
abolish the Guidelines. Dr. McKirmey 
said that he considered the Working 
Group's recommendations as too 
cursory. Dr. Gottesman responded that 
the Working Group had considered the 
issues in-depth at two meetings and had 
prepared a report on its evalution of the 
risks associated with recombinant DNA 
research. The RAC could change or 
elaborate on the recommendations 
before seeking public comment. Dr. 
Zinder said that the recommendations of 
the Working Croup were adopted 
unanimously except for those 
concerning Part IV of the Guidelines. 
Dr. Baltimore, in the interests of 
providing a forum for RAC discussion of 
the points of difference between the 
various proposals, moved a seven part 
motion as a substitute for Dr. Harris’ 
motion: 
1. Accept the first section of the 
Baltimore-Campbell proposal, as 
follows: 
“Section i-A of the NIH Guidelines will bt 
replaced with the following: 
■|-A. Purpose. The purpose of these 
Guidelines is to specify standard practices 
for constructing and handling (i) recombinant 
DNA molecules and (li) organisms and 
viruses containing recombinant DNA 
molecules. Adherence to these standards by 
all laboratories using recombinant DNA is 
recommended.' ’’ 
2. Accept the second section of the 
Baltimore-Campbell proposal, as 
follows: 
"Part 1-C of the NIH Guidelines shall be 
eliminated.” 
3. Accept the second section of the 
Working Croup proposal, as follows; 
"Section l-D of the Guidelines. 
Prohibitions, would be eliminated.” 
4. Accept the third section of the 
Working Croup report modified by 
removing references to CDC Guidelines 
and USDA Regulations and treating 
these references in a footnote, as 
follows: 
“Part 111 of the Guidelines would be 
replaced with the following language: 
‘Part in discusses experiments covered by 
the Guidelines. The reader should first 
consult Part I, where exempt experiments are 
listed. 
‘Where recommended physical 
containment levels applicable to non- 
recombinant DNA experiments exist for 
either the host or the vector,* recombinant 
DNA experiments should be carried out at 
'Such as those specified by CDC Guidelines or 
the USDA Quarantine Regulations. 
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