11 
Dr. Holmes said the Risk Assessment Subcommittee agreed designing risk 
assessment experiments to address general issues raised in _he ASPE 
memorandum would be very difficult. The experiments currently being sub- 
mitted to RAC for evaluation should continue to be reviewed on a case-by- 
case basis. 
Dr. McGarrity suggested the Risk Assessment Subcommittee respond directly 
to the ASPE memorandum without first submitting their response to RAC for 
review. The subcommittee could simply report to RAC at the next meeting. 
Dr. McKinney agreed. He said the Assistant Secretary for Health did not 
stipulate the full RAC should consider these issues but rather asked that 
they be reviewed by the RAC Risk Assessment Subcommittee. 
Dr. Sharpies said the information generated by the Risk Assessment Subcom- 
mittee should, however, be available to RAC. 
V. ADDITIONAL ANNOUNCEMENTS 
Mr. Mitchell said RAC's charter was renewed by the Secretary, HHS, in June 
1984. A revision was introduced into the charter at that renewal: RAC 
members may serve after the expiration of their terms intil their successors 
have been appointed. Mr. Mitchell said the terms of six RAC members, 
Drs. Holmes, Fedoroff, McGarrity, McKinney, Levine, and Scandal ios , expired 
in June 1984. These members have kindly consented to continue to serve 
until successors have been appointed . 
VI. PROPOSED AMENDMENT OF SECTION III-D OF THE NIH GUIDELINES 
Mr. Mitchell asked Dr. McKinney to present this proposal to amend the NIH 
Guidelines (tabs 1181, 1186/1). Dr. McKinney said Mr. C. Searle Wadley 
and Dr. John H. Keene of Abbott l aboratories. North Chicago, Illinois, in 
a letter dated August 21, 1984, proposed the following sentence be added 
to Section III-D of the NIH Guidelines: 
"Although these experiments are exempt, it is recommended that they be 
performed at the appropriate biosafety level for the host or recombinant 
organism (for biosafety levels see 'Biosafety in Microbiological and 
Bicmedical Laboratories ' ) . " 
Dr. Lardy felt this language stated the obvious but was not opposed to 
including it in the NIH Guidelines. Drs. Holmes and Levine also concurred. 
Dr. McKinney said he felt the language would more appropriately be included 
as a new last paragraph of the narrative section of Appendix A. Ear. McGarrity 
agreed with Ear. McKinney's analysis. He felt the authors' intent could be 
met by including the proposed language in Appendix A. 
Dr. McKinney moved the proposed language be included as a new third para- 
graph of the narrative portion of Appendix A of the NIH Guidelines. He also 
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