Federal Regiater / Vol. 47, No. 167 / Friday. August 27, 1682 / Notices 
38041 
below 20 percent when this specialist is 
appointed and the oniversity woald 
have to appoint another non-affiliated 
member, llie specification that at least 
two members shall not be a^iliated with 
the institution should remain m the 
Guidelines to ensure community 
representation. It was felt that in a 
twenty member committee, two public 
members would provide adequate 
representation for the community. 
Members of the working group could not 
envisage IBCs larger than 20 members 
functioning smoothly. In addition, it was 
noted that ORDA reviews IBC 
membership for comidiance and would 
be alert to cases in which an institution 
might attempt to dilute community 
representation by, for example, 
af^inting a 50 member committee. 
The working group also considered 
the language of current Section IV-D-2- 
b. A discussion ensued regarding 
representation on the IBC from the 
laboratory technical staff. If the term 
“nondoctoral" was deleted, postdoctoral 
associates might also be appointed to 
the IBC. Other members of the working 
group pointed out that technicians are. 
indeed, those most likely to be 
performing recombinant DNA 
experiments and those having the least 
“competitive” pressures exerted on 
them. Although technicians do 
experience certain types of pressures, 
many on the working group felt they 
would be among the best 
“watchpersons.” 
The working group also recommended 
a number of ad^tional changes in the 
Guidelines. The reconnnendations of the 
working group, with minor modifications 
introduced by NIH staff were 
summarized in a Federal Register 
amiouncemmit on May 26, 1982 (47 FR 
23110). The proposed revised 
Guidelines, incorporating the changes, 
were printed in their entirety in the 
same Federal Register aimouncement. 
Several addition^ proposed changes 
were also published for comment. 
On )une 28, 1982, the RAC reviewed 
the proposed revised Guidelines and the 
one letter of comment received on the 
proposed revtsirms. Part 0 of this 
announcement contains the draft 
minutes of the relevant portion of the 
June 28, 1982, RAC meeting. Part 111 
gives the response of the Director, 
National Institute of Allergy and 
Infectious Diseases, to the RAC 
recommendations. 
n. Draft Minutes of Relevant Portions of 
June 28, 1982, Meeting of the 
Recombinant DNA Advisory Committee 
Dr. Nightingale began discussion of 
the modifications (tabs 1071, 1072, 1074) 
to the Guidehnes proposed by the 
Working Group on Revision of the 
Guidelines. She recalled to the 
committee that the RAC at its February 
8-9, 1982 meeting, recomended that the 
NIH accept a proposed modification of 
the NIH Guidelines for Resecnch 
Involving Recombinant DNA Molecules. 
In recommending this modification to 
the NIH. the committee recommended 
that a working group be formed to 
further simplify and modify the 
document. The NIH, following this 
recommendation, promulgated the 
Revised Guidelines on April 21, 1982. An 
ad hoc Working Group on Revision of 
the Guidelines was formed and 
convened for a meeting on April 19, 
1982, to further modify the document 
promulgated on April 21, 1982. Dr. 
Nightingale said the working group 
attempted to clarify and simplify, 
wherever possible, the structure and 
language of the Guidelines, to suggest 
changes apprc^riate in light of available 
data, and to reconunend future activities 
in the area of guideline review and 
revision. 
Dr. Nightingale then indicated four 
major proposed modifications offered by 
this working group. First, the working 
group had suggested the presentatron of 
the Guidelines be rearranged primarily 
by placing the description of physical 
and biological containment into 
appencfices. Second, the working group 
recommended that the RAC and NIH 
adopt for the Guidelines a revised 
version of the 1974 GDC Classification 
of Etiologic Agents on the Basis of 
Hazard. Hie working group also 
suggested that the RAC assume 
responsibility for regularly updating the 
listing. Dr. Nightingale explained that 
the original 1976 Guidelhies used the 
Classification of Etiologic Agents on the 
Basis of Hazard, 4th Edition, July 1974, 
U.S. Department of Health, Education, 
and Welfare, Public Health Service, 
Center for disease Contnd (CDC), as the 
reference source for classi^ation of 
micro o rganisms for the purposes of the 
Guidelines. At the present time, die CDC 
and the NIH are engaged in an effort to 
revise this classification. The working 
-groupi however, feh that this revised, 
version might not serve the purposes of 
the Guidelines as well as the original 
1974 version as revised. This is the only 
proposal of the working group that 
received a tetter of comment, and Dr. 
Bems said he wished to reply to an 
issue raised by Dr. John Richardson of 
the CDC in a letter of June 10, 1982 (tab 
1074), concerning the proposed revision 
of Appendix B for the purposes of the 
NIH Guidelines. Dr. Bems said the 
proposed revised classification would 
classify Rabies street virus as a Gass 3 
agent for all procedures. Dr. Richardson 
suggested that a Class 2 designation was 
adequate. Dr. Bems said be had 
discussed the issue with Dr. Richardson 
and they had ag|-eed that a Class 3 
specification for Rabies street virus was 
more appropriate for the purposes of the 
NIH Guidelines: investigators following 
the NIH Guidelines would more 
probably be using chemical quanUties of 
viruses, rather than the quantities 
needed for diagnostic purposes on 
which the CDC classification was baaed. 
Third, Dr. Nightingale said the 
working group had ^scussed at length 
the role and responsibilities of the IBCs. 
They noted that a greater burden bad 
been placed on the IBCs by the April 21, 
1982, revision of the Guidelines. Hie 
working group discussed whether RAC 
should collect information about IBC 
functions. One suggestion was that a 
questionnaire be sent to all IBCs. 
Mr. Mitchell commented that the IBCs 
have been delegated a great deal of 
responsibility, but RAC has little data 
on the actual fimctioning and 
effectiveness of the IBCs. He suggested 
that some mechanism of specific 
communication between RAC and the 
IBCs should be developed. 
Fourdi, Dr. bfightingale noted that the 
woiidng group suggested an ongoing 
process of review and revision of the 
Guidelines; such a process should occur 
with some regular periodicity, perhaps 
once a year. 
Mr. Thornton suggested that RAC 
proceed dtrough die proposed revisions 
of the Guidehnes section by section; 
amendments could then be offered in an 
ordeiiy fashion. He requested a formal 
motion to adopt the proposed revised 
Guidelines as they appeared in the 
Federal Register of May 26, 1982 (tab 
1072}. Dr. ^med so moved, and Dr. 
Bems seconded the motion. Dr. Mason 
offered an amendment to commend the 
working group for its outstanding efforts 
in generating the proposed document. 
Dr. Ahmed accepted the amendment as 
did Dr. Bems. 
Beginning with Section I of the 
Guidelines, Dr. Baltimore questioned the 
words “potentially harmful 
polynucleotide” hi the second paragraph 
of Section I-B, Definition of 
Recombinant DNA Molecules. He asked 
how synthetic DNA segments could 
yield "potentially harmful 
polynucleotides” other than being 
translated to "potentiaUy harmful 
polypeptides”. Dr. Wensink suggested ft 
might be a transposable element. It was 
agreed to leave &e leinguage as 
proposed. 
Dr. Baltimore said that a 
“pharmacologically active agent” is 
equated with a toxin in Section I-B. He 
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