4 
also beginning to constitute a ccrrmittee to review proposals involving environ- 
mental release of modified organisms. 
Dr. Jane Pussier of the EPA added that the December 31, 1984, Federal Register 
contained EPA's policy position; EPA is awaiting ccmment on this announcement. 
Dr. Tolin of the USDA said TJSDA is awaiting canments on USDA's policy statement 
published in the December 31, 1984, Federal Register . She said USDA is evaluating 
vhether it will establish a RAC-like review body. 
Dr. Miller of FDA said the FDA position statement in the December 31, 1984, 
Federal Register is self-explanatory. The FDA is considering several alternative 
methods of obtaining scientific input in FDA decisions. An FDA review ccnmittee 
vhich resembles the RAC may be instituted or the review ccnmittee may resemble 
other FDA advisory carmittees. Alternatively, the FDA review ccnmittee may 
have a structure somewhat like RAC and somewhat like other FDA advisory committees . 
Dr. Sharpies asked if an interagency coordinating ccnmittee would also be 
instituted. Dr. Oartland replied that the December 31, 1984, Federal Register 
proposes the establishment of a Biotechnology Science Board; however, the 
Cabinet Council Working Group is currently filling the function of an interagency 
coordinating ccnmittee. 
POINTS TO CONSIDER FOR SUBMISSIONS INVOLVING TESTING IN THE ENVIRONMENT OF 
MICROORGANISMS DERIVED BY RECOMBINANT DNA TECHNIQUES 
Dr. Gartland said in the future, proposals involving field testing of modified 
microorganisms may be reviewed by agencies other than the NIH. The working 
group should, however, continue developing this points to consider document 
for several reasons: (1) the document the working group develops may be 
useful to any other agency reviewing field tests of genetically modified 
microorganisms; and (2) a system of dual review in vhich a proposal maybe 
submitted to more than one ccmmittee for review is being proposed. The RAC 
may be asked to review proposals involving field testing of modified micro- 
organisms, and this document would be useful in such reviews. 
Dr. McGarrity reviewed the history of the development of the points to consider 
document. At the October 5, 1984, meeting of the Working Group on Release 
into the Environment, the working group constructed a draft document based on 
portions of a subgroup document developed by Drs. Lacy, Milewski, Pirone, 
Tolin, and Vidaver and portions of the EPA document entitled Points to Consider 
in the Preparation of TSCA Premanufacturing Notices for Genetically-Engineered" 
Microorganisms vhich the EPA had sent to the working group to elicit carmerrt and 
to provide information. Dr. McGarrity said the working group had subsequently 
met on October 30, 1984, to continue to develop the document. The document 
(Attachments II and III) the working group will discuss at the February 11, 
1985, meeting is the current draft version of the points to consider. 
Dr. McGarrity said this draft document contains a Section V (Attachment III) 
dealing with risk analysis written by Drs. Tolin and Lacy. He suggested the 
working group begin by discussing this portion of the document. 
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