Report from NIH 
2 
Dr. Talbot distributed copies of the proposed First Annual Update of 
the NIH Program to Assess the Risks of Recombinant DNA Research ( Federal 
Register September 17, 1980, pages 61874-61878). Following the public 
comment period it will be finalized and published again in the Federal Register . 
He noted that the NIH Recombinant DNA Advisory Committee (RAC) 
met most recently on September 25-26, 1980. He distributed copies of the 
NIH Director's "Decision Document" accepting most of the recommendations 
made by the RAC at the meeting, accompanied by publication of a "clean copy" 
of the NIH Guidelines for Research Involving Recombinant DNA Molecules 
( Federal Register November 21, 1980, pages 77372-77409). The two major changes in 
the Guidelines, effective November 21, are: 
1. For experiments under 10 liters, for which the containment 
conditions are given in the Guidelines, the previous 
requirement has now been eliminated that a "Memorandum of 
Understanding and Agreement" describing the experiment be 
sent to NIH by the Institutional Biosafety Committee. 
2. For proposed experiments over 10 liters (these have been 
primarily voluntary submissions from industry), the RAC will 
continue to do pre-review of the biological aspects of the 
individual proposal, but will no longer do pre-review of the 
details of physical containment. A Working Group of the RAC, 
including representation from all interested federal agencies, 
will do post-review of the system and advise the RAC on 
possible future changes in the definition of the "P-LS" 
physical containment criteria. 
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