Attachment VII - Page 1 
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 
WASHINGTON. D.C. 20460 
may 3 1 e® 4 
SUBJECT: Request for Working Group Comments on an EPA Draft 
Document: "Points To Consider In The Preparation Of 
TSCA Premanufacture Notices For Genetically Engineered 
Microorganisms" 
TO: 
FROM: 
Gerard J. McGarrity, Ph.D. 
Chair, Recombinant DNA Advisory Committee 
Working Group on Release into the Environment 
John R. Fowle , III. Ph.D. 
Environmental Protection Agency 
Representative to the Working Group 
EPA would appreciate any comments by the Environmental 
Release Working Group representatives on the attached draft 
document. This material was modelled after the FDA approach of 
providing general guidance to drug manufacturers, in the form of 
"points to consider." Its purpose is to provide broad points to 
consider in preparing premanufacture notices for genetically 
engineered organisms which may be reviewed under the Toxic 
Substances Control Act. It is intended to be used flexibly and 
to evolve over time. Thus, EPA's purpose in developing this 
guidance is similar to an immediate goal of this Working Group, 
that is, to develop general guidelines for evaluating genetically 
engineered organisms proposed for release into the environment. 
In addition to soliciting your help and comments on this draft, 
we hope that it may be useful to the Working Group's efforts. 
The Agency intends to solicit wide public comment on a later 
draft of this document by publishing it as background material to 
EPA's planned Federal Register notice, and perhaps in other 
forums which would insure its wide review. 
Please note that the attached document is a draft prepared 
by the Office of Toxic Substances staff, and should not be 
considered an official EPA document. 
We hope that it will be of interest and assistance to the 
Working Group, and we look forward to your comments. 
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