172 
The question is that if industry would like to start commercializing 
it, and there will be definitions developed, rules and regulations by EPA 
on this, the question is they have to provide certain premarket tests — pro- 
tocols and guidelines will be also provided by EPA. Nothing has ever been 
discussed, as far as I know, in the Office of Toxic Substances in the EPA, 
as far as I am aware of, to seriously address the question of premarket 
testing for recombinant DNA work. I mean, I am involved in that process 
myself as an outsider. It is a very important question you raise here. 
Then the other question you raise is after the thing gets out into the 
environment, when does the Water Act come into play, the Clean Air Act, the 
Hazardous Substances Act, all these other acts, including the Food and Drug 
Act, as you mentioned. 
DR. FREDRICKSON: These matters have been the subject of considerable 
discussion in the Interagency Committee, as you can well imagine, where all 
of these Federal agencies are mingling. 
DR. AHMED: The Interagency Committee could perhaps address this. 
DR. FREDRICKSON: I wonder if I might remind the Committee that we have 
six more witnesses scheduled. 
Dr. Ginsberg. 
DR. GINSBERG: I wanted to pursue something that you brought up, and 
that was I was concerned about the general statement you made about the local 
biohazard — institutional biohazards committees being unable to judge the 
quality of the data. Is this not the statement you made? I was wondering 
what you would want them to be able to judge better, and on what basis you 
made that statement. 
MS. PFUND: Well, for one thing, some of the weaknesses of the function- 
ing of the institutional biohazards committees, which Leslie has mentioned, 
including the UCSF experience and the Harvard experience, just decrease my 
confidence in the system as it is now run. And since, in lowering contain- 
ment, the investigator — to apply for a lower containment level — the invest- 
igator has to show that he has characterized his clone or he has purified 
his DNA. That implies that there is going to be a standard applied to his 
data, and someone will make a judgment as to where the cutoff point is. I 
am just saying that perhaps because some institutional biohazards committees 
do have a predominance of people doing the research, which gives them a high 
level of expertise, but also a special interest in the proceedings, that we 
need to expand the basis of decision-making to include a broader array of, 
say, workers or nonprofessional lab personnel. 
DR. GINSBERG: Would this give the Committee a better ability to judge 
the quality of data? I mean, would a union representative be able to judge 
the quality of recombinant DNA research data? 
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