4 
Dr. Krause reported that as a follow-uqp to the reoaitnendations of the NIAID 
Woricshop on Recanblnant DNA Risk Assessnent held in Pasadena, California, 
a receipt date of July 1981 had been set for applications solicited to 
examine the fate of biologically active polypeptides in the human intestinal 
tract. In addition, NIAID had intensely advertised to identify a contractor 
to perform insulin autouminity studies. Cnly one propos^Ll was received 
in response to the Request for Proposals (RFP); this propos^d was rated 
unacceptable by the scientific review group. 
Dr. Krause briefly carmented on the U.S. - Japan meeting which was held 
in Hawaii in February 1981. He said the meeting was an outgro%irth of a 
science and technology agreement between the U.S. «md Japan. In the area 
of recombinant DNA that eigreement entails sharing of information on 
Guidelines, risk assessment exrtivities, etc. Fbur RAC members, Drs. Bems, 
Qotteaian and Levine and Mr. "niomton, attended the Hawaii meeting. 
Dr. Krause said there will be a second meeting in November 1981 at the NIH 
deeding with the introduction of recombinant DNA into eukaryotic cells. 
He said the Japanese wish to host a subsequent meeting on yeast genetics. 
He acknowledged Mr. Justin Bloar of the U. S. State Department, currently 
Counselor for Scientific euid Technological Affairs with the U. S. Ehibassy 
in Tokyo, as having been most helpful. 
IV. PRDPC6EI) REVnSICN OF GUIDELINES FOR REOCMBINANr DNA INVOLVING E. OCLI 
K-12 AND S. CEREVISIAE HOgP-VECTOR SYSTE^IS 
Mr. Thornton introduced Dr. Adelberg and asked him to initiate the discus- 
sion on this proposed revision of the Guidelines (tabs 998, 1015/1, 1017). 
Dr. Adelberg said he had originally proposed, at the November 1980 IBC 
Chairpersons' Meeting, that the paperwork associated with experiments 
OCT-rered by Section III-O be eliminated. He said he offered his proposal 
in light of the widely held view that experiments covered by Section III-O 
are "negligible in risk." In response to this request and the level of 
support it had received at the IBC Chairpersons' meeting and at the request 
of the RAC, ORDA had developed the language which appeared in the March 20, 
1981 Federad. Register (46 FR 17994). Dr. Adelberg said he would support 
any of the three published proposed options as adl would reduce unnecessary 
paperwork. He said he personadly favored option B ais this option would 
eliminate paperwork but would require a PI level of containment for Section 
III-O experiments. 
Dr. Gottesman said that RAC, at the January 8-9, 1981 meeting, had indicated 
that diminishing the amount of paperwork associated with experiments covered 
by Section III-O was desirable. She said that currently. Section III-O 
covered experiments employing ^ ooli K-12 and laboratory strain Saccharo- 
myces oerevisiae host-vector systems. She noted that RAC, at the April 1981 
mating, would rwiew a request to include B. subtil is HVl host-vector 
systems under Section III-O. Dr. Qottearan~5riefly reviewed the three 
options. She favored going as far as option A, did not favor option C, and 
was undecided about option B. 
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