Federal Register / Vol. 46. No. 233 / Friday, December 4, 1981 / Notices 
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containment levels at least as high as those 
recommended for non-recombinant DNA 
experiments. If there is clear evidence that 
the donor DNA will significantly change the 
pathogenicity of the host, the containment 
level appropriate to the anticipated change 
will be applied. Otherwise, all experiments 
may be earned out under conditions of Pt or 
Pl-LS physical containment.' " 
5. The following admonition would be 
added: 
"No experiments should be performed 
which involve deliberate transfer of a drug 
resistance trait to microorganisms that are 
not known to acquire it naturally, if such 
acquisition could compromise the use of a 
drug to control disease agents in human or 
veterinary medicine or agriculture." 
6. Accept the fourth section of the 
Baltimore-Campbell proposal, as 
follows: 
"Part W of the NIH Guidelines shall be 
eliminated, with the following 
exceptions: 
"(a) Those definitions listed in Part IV-C 
which may be needed to clarify 
statements made elsewhere in the 
Guidelines shall be retained. 
"(b) Those portions of Part I'V-E defining 
the composition of RAC and prescribing 
rules for RAC procedures shall be 
retained. 
"(c) The following statement shall be 
added: 
"Each institution conducting or sponsoring 
recombinant DNA research should take 
responsbility for monitoring its own activities 
in this area. Any unusual events that might 
be associated with the use of recombinant 
DNA molecules should be reported to the 
Director, NIH." 
7. Accept the fifth section of the 
Baltimore-Campbell proposal with 
deletion of the words "submitted in 
support of requests for exceptions from 
the prohibitions,” as follows: 
"Section 'VI of the Guidelines will be 
eliminated, except for those portions of 
Section VI-F relevant to the protection of 
proprietary information.” 
Dr. Berns seconded the motion. 
Dr. Saginor suggested an amendment 
10 Dr. Harris’ motion in the form of a 
policy statement that there is a 
continuing need for the RAC and 
applicable recombinant DNA guidelines. 
The purpose of the amendment was to 
indicate that the Adelberg-Zinder 
proposal is not being accepted. Dr. 
Harris agreed to the amendment. 
Ms. King said she wanted the RAC to 
vote on replacing parts 1 and 6 of the 
Baltimore motion with wording from the 
Working Group proposal. It was 
suggested that votes be on one part at a 
time. Ms. King then moved to replace 
the first part of Dr. B 'ltimore’s motion 
with the first section of the Working 
Group’s proposal as follows: 
"Section I-A of the Guidelines would be 
amended to read as follows; 
"I-A. Purpose. The purpose of these 
Guidelines is to specify standard 
practices for constructing and handling 
(i) recombinant DNA molecules and (ii) 
organisms and viruses containing 
recombinant DNA molecules." 
The motion was seconded by Dr. 
Goldstein. Ms. King stated that she 
favors retention of limited Guidelines 
that require IBC review, and she favors 
an oversight function for the RAC; she 
does not support self-regulation. Dr. 
Baltimore did not accept Ms. King’s 
proposed amedment. Dr. Bems pointed 
out that the substitution Ms. King was 
proposing did not make much difference. 
The real point of contention in the RAC 
concerned part six of Dr. Baltimore’s 
motion. 
Ms. King withdrew her previous 
motion and then moved to delete part 
six of Dr. Baltimore’s motion. If her 
motion were accepted, this would leave 
intact Part IV of the Guidelines. It was 
pointed out that the Working Group had 
proposed a change in Part IV dealing 
with IBC membership. Ms. King said 
that if her motion passed, then another 
perfecting motion could be introduced 
dealing with IBC membership. Dr. Harris 
seconded. The motion failed to carry by 
a vote of nine in favor, twelve opposed, 
with no abstentions. 
Dr. Fedoroff noted that the motion as 
it stands would eliminate all 
prohibitions including the prohibition 
against deliberate release into the 
environment. Dr. Baltimore suggested 
that if the RAC wished, a statement 
regarding deliberate release could be 
included with the admonition on drug 
resistance. Dr. Bems said that in his 
view the recommendation that 
experiments be conducted under Pi 
containment precludes deliberate 
release into the environment. 
Dr. Maas then moved to add the 
current prohibition on the cloning of 
certain toxins to the admonition on drug 
resistance. Dr. Goldstein seconded. Dr. 
Gottesman said that the cloning of 
toxins is an example of an area of 
concern. She noted that the RAC 
Working Group on Toxins recommended 
at the last RAC meeting prohibition of 
cloning of certain toxin genes and that 
other experiments involving cloning of 
toxin genes should proceed only in E. 
coli K-12 in the absence of special 
review by ORDA. Dr. Baltimore agreed 
to accept addition of the wording 
regarding toxins currently in Section I- 
D-2 to the admonition on drug 
resistance and to retain Appendix G of 
the current Guidelines. 
Dr. Ahmed moved that a working 
group be appointed to study the 
prohibitions and report back to the RAC. 
Dr. Goldstein seconded the motion. Dr. 
Mason disagreed, noting that at the last 
meeting a working group had been 
appointed to report on revision of the 
Guidelines. They had reported, and now 
the RAC was working through the 
proposal to prepare material for public 
comment. The motion failed to carry by 
a vote of three in favor, fourteen 
opposed, with three abstentions. 
Mr. Thornton recognized Dr. Susan 
Wright. She said the RAC was short- 
circuiting long and detailed discussions 
it should have on all the critical issues. 
She asked RAC members to 
acknowledge ties that they might have 
with genetic engineering companies. She 
said there should be discussion of why 
the working group had decided to 
eliminate public members on IBCs. She 
expressed concern about the currently 
prohibited experiments and large-scale 
experiments. She cited a report she had 
submitted, prepared for the Commission 
of the European Communities, entitled 
“Hazards Involved in the Industrial Use 
of Micro-organisms.” She said that 
change of phenotype due to mutation 
and discharge of waste into the 
environment are important issues among 
many others that need to be considered 
before a decision is reached. 
Dr. Fedoroff said that there should be 
flexibility to have a group look at and 
approve specific experiments which are 
otherwise admonished against. Dr. 
Baltimore said investigators wishing to 
do such experiments could come to the 
local IBC or the RAC to discuss 
conditions under which such 
experiments could be done. 
Dr. Bems said that at a meeting of the 
Large Scale Review Working Group on 
September 9, 1981, none of the members 
thought that the large-scale prohibition 
should be retained. 
Mr. Thornton recognized Ms. Claire 
Nader who said that the RAC should 
look at the assumptions behind the 
recommendations such as that all 
corporations will do the right thing, and 
that the technology is safe. She said that 
there were no experts on corporate 
behavior, or law enforcement, or anti- 
trust questions on the RAC. She said the 
RAC should have on it people who want 
to talk about risks. She criticized the 
way in which the RAC was proceeding. 
Dr. Nightingale said that a working 
group on the prohibitions was appointed 
over a year ago and that the prohibitions 
have been discussed extensively before 
this meeting. Dr. Gottesman said that it 
was peculiar to be concerned about the 
prohibitions and at the same time 
recommending that the entire system 
become voluntary. She said that perhaps 
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