78 
The Environmental Protection Agency has expressed a number of concerns 
in a report by its study group on recombinant DNA. The report was unani- 
mously endorsed by EPA's Scientific Advisory Board on the original Guide- 
lines. I choose three suggestions from the report. There are many. 
The report suggests, for example, that organisms to be used in any re- 
combinant DNA activities, and organisms with new genotypes that are created 
by these activities, must be labeled so that their source and environmental 
fate may be traced in case of accidental release. Further, the report 
suggests that each individual in a laboratory working on recombinant DNA 
should be certified, as suggested by Dr. Jonathan King, as to his knowledge 
of handling pathogenic materials and familiarity with standards of safety 
for a clinical laboratory. 
Further, the study group agreed that there is an urgent need for plan- 
ning for possible accidental discharges of harmful recombinant DNA materials 
inasmuch as no containment facility is perfect. As part of the planning 
for a capability for an immediate response to such a discharge, an inter- 
disciplinary team of individuals should be designated to help eliminate 
the harmful discharge. 
This document was made available to the Recombinant DNA Advisory Com- 
mittee last spring, so we are forced to question why we have not seen 
evidence of consideration of this and other critiques by this Committee in 
setting up the Guidelines and perhaps incorporating some of these sugges- 
tions into the proposed revisions. 
We believe that the failure to address these questions and many others 
reflects the unavoidable bias of an agency whose function is the promotion 
of biomedical research. Since it is imperative in our view that policy for 
a technology which will affect all sectors of society be developed by repre- 
sentatives of these sectors, we believe that only an independent, broadly 
based commission can democratically provide for that essential policy-making 
function. This would of course include guideline decisions. 
If the public is to be adequately protected, we feel it essential that 
the preceding points and those we made earlier be addressed. 
DR. FREDRICKSON: Thank you, Ms. Simring. Are there any questions or 
comments on Ms. Simring' s presentation? 
Ms. Simring has, in the opening part of her remarks, referred to the 
absence of an Environmental Impact Statement on the proposed revisions. I 
think for clarification I should reiterate that these are proposed revisions 
and it is the purpose of this hearing to determine which of those proposals 
or what others that are related to them should actually be made in the Guide 
lines, and of course, until that is decided there could not be any Environ- 
mental Impact Statement on their impact. 
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