7 
modified; the term "donor" designates the source of the reccmbinant DMA; and 
the term "modi fieri" designates the genetically modified organism. 
Dr. Pirone asked if it was reasonable to request in Section II-B-3-d of the 
subgroup document that the investigator document the "means and sensitivity 
of the techniques by which the presence or the absence of the microorganism 
will be assessed in the final construction to be released." Dr. Vidaver felt 
such a data requirement should be included in a working group document; she 
cited the use of Agrobacterium tumefaciens to modify plants as an example of a 
procedure in which the continuing presence of the microorganism vector would 
be a consideration. 
Dr. Amtzen called the attention of the working group to Section II of the EPA 
draft document, Points to Consider in the Preparation of TSCA Premanufacture 
Notices for Genetically Engineered Microorganisms , (Attachment VII) . He felt 
seme material in this document was relevant to the working group discussion. 
He questioned whether the working group should be concerned about overlap 
between EPA documents and working group documents. Dr. McGarrity said EPA had 
distributed these documents to the working group to solicit comment and to 
participate in the working group effort. 
Dr. Gartland said a number of biotechnology efforts are currently being pursued 
in several government agencies. He said the various agencies may borrew material 
frart each other even though each agency's efforts are independent; EPA may incor- 
porate portions of any document developed by the RAC Working Group on Release 
into the Ehvirorment into EPA documents just as the working group may borrow 
portions of the EPA documents. 
Dr. McGarrity called the attention of the working group to the sibgrcup preliminary 
draft document (Attachment IV) and asked for further comments on the document. 
Dr. Lacy thought the title of the subgroup draft document, "Points to Consider 
for Submission Involving Release of Microorganisms Containing Reccmbinant DNA 
Molecules into the Ehvirorment," was slightly prejudicial. He suggested the 
title of a working group document should refer to "environmental applications." 
Dr. Miller said FDA prefers "environmental or agricultural applications . " 
Dr. Clowes did not think the title of a working group document should specifically 
refer to agricultural applications; agricultural applications are one aspect of 
environmental applications. Dr. Tolin suggested seme reference to agricultural 
applications might be made in the preamble rather than in the title of a working 
group document. 
Dr. McGarrity noted that the NIH Guidelines refer to "release into the environ- 
ment" and said the language of a working group document should agree with the 
languaqe of the NIH Guidelines. Dr. Miller suggested the language of the NIH 
Guidelines might be changed to refer to environmental applications. Dr. Tolin 
suggested the title of a working group document might refer to "experiments 
under Section III-A-2 of the Guidelines." Dr. Prarner thought such a title 
would be too bureaucratic . 
[17] 
