12 
Dr. Richardson suggested that a Class 2 designation was adequate. Dr. Bems 
said he had discussed the issue with Dr. Richardson, and they had agreed 
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 quantities of viruses greater than 
the quantities needed for diagnostic purposes. The CDC classification 
is based on use of diagnostic quantities. 
Third, Dr. Nightingale said the wor)dng group had discussed at length the 
role and responsibilities of the IBCs. They noted that a greater burden had 
been placed on the IBCs by the April 21, 1982, revision of the Guidelines. 
The working group discuss^ v^ether RAC should collect information about 
IBC functions. Che suggestion was that a questionnaire be sent to all IBCs. 
Mr. Mitchell conmented that the IBCs have been delegated a great deal of 
responsibility, but RAC has little data on the actual functioning and 
effectiveness of the IBCs. He suggested that some mechanism of specific 
carmunication between RAC and the IBCs should be developed. 
Fourth, Dr. Nightingale noted that the working 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 through the proposed revisions 
of the Guidelines section by section; amendments could then be offered 
in an orderly fashion. He requested a formal motion to adopt the pro- 
posed revised Guidelines as they appeared in the Federal Register of 
May 26, 1982 (tab 1072). Dr. Ahmed so moved, and Dr. Berns seconded the 
motion. Dr. Mason offered an amendment to coiimend 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 "potentiadly harmful polynucleotide" in 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 "potentially harmful polypeptides". 
Dr. Wensink suggested it might be a transposable element. It was agreed 
to leave the language as proposed. 
Dr. Bcdtimore said tJiat a "pharmacologically active agent" is equated with 
a toxin in Section I-B. He questioned that language. It was pointed out 
that the text says "e.g., a toxin or a pharmacologically active agent" 
and does not necessarily equate the two. Also, the text is identical with 
that in the current April 21, 1982, version of the Guidelines. Dr. Bems 
said the working group determined that proposals to clone genes for certain 
biologicedly active polypeptides should be carefully evaluated, as were 
proposals involving toxins. The language of Section III-A-1 and ^pendix 
F have been modified to reflect this intent. Dr. Berns said these sections 
specify the LDSOs that define " biolog icedly active polypeptides." It was 
agreed to leave the language as proposed. 
[ 471 ] 
