12 
Dr. Levin of the EPA said his agency was examining some aspects of deliberate 
release of microorganisms into the environment. These data will be shared 
with the RAC. He pointed out that interpreting these experiments requires 
expertise in population genetics and population biology. He said questions 
such as the following have to be considered: (1) what happens if genetic 
drift occurs; and (2) what happens if in the process of altering a plasmid, 
the rate at which it is transmitted is changed? Dr. Levin pointed out 
that the outcome of the introduction of an organism with a novel genotype 
into the environment cannot be predicted. 
Dr. Fedoroff said she supported the letter from Dr. Gill (tab 1094) 
stating that the experiments proposed by Dr. Murphy, Cloning and Expression 
of DNA Coding for Diphtheria Toxin , should not be included in the annual 
update as Section II-G. These experiments would not provide general risk 
assessment information. Dr. Holmes agreed. Dr. Fedoroff moved that Section 
II-G be deleted from the proposed update. Dr. Holmes seconded Dr. Fedoroff's 
motion. He said RAC's approval for the experiment to proceed at P4 contain- 
ment, as was given to Dr. Murphy, did not reflect RAC support of the experi- 
mental goal; rather it indicated RAC's judgment that P4 could safely contain 
the experiment. He thought the use of the words "on the reccmmendation of 
the RAC" in the draft risk assessment plan gave the erroneous appearance 
that RAC was encouraging the work. Dr. Talbot said that Dr. Murphy's 
proposal will be reviewed for scientific merit by an NIH study section. 
A decision will then be made on whether or not to allow the experiment to 
proceed in the NIH P4 facility. 
By a vote of thirteen in favor, one opposed, and six abstentions, the RAC 
recommended Section II-G be deleted from the second annual update. 
V. CPC -NIH GUIDELINES AND NCr REVISION OF ONCOGENIC VIRUS GUIDELINES 
Dr. Barkley, Director of the NIH Division of Safety and Chairman of the RAC 
Working Group on Classification of Microorganisms, reported on the revision 
of the CDC (Centers for Disease Control) - NIH guide to microorganisms, 
entitled "Biosafety in Microbiological and Biomedical Laboratories" 
which will be distributed for comment. The guide covers pathogens which: 
(1) are documented hazards to laboratory personnel, (2) pose a high 
potential risk to laboratory personnel, or (3) may produce diseases of 
grave consequence should infection occur. Dr. Barkley said the document 
also refines the four classes of safeguards, PI through P4, that were 
first developed for the Nlli Guidelines for Research Involving Recombinant 
DNA Molecules. Et. Berns said this version represents a major effort by 
Dr. Barkley and collaborators who have done a terrific job. Dr. Barkley 
said that after reviewing the comments received on the draft, it is hoped 
that a final document will be reo3y soon after September 1, 1983. 
Dr. Barkley then reported on the status of revision of the National Cancer 
Institute (NCI) Safety Standards for Research Involving Oicogenic Viruses. 
These standards, issued in 1974, specify three levels of control: low, 
moderate, and high. The high level, equivalent to P4 containment, is 
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