269 
not believe that NIH can function — and cor 
promoter and also the regulator — as the pe 
ments and at the same time regulate them, 
to be passed in Congress, there should be 
these two arms of the HEW's function as a 
Government. I am hoping that Mr. Hutt wil 
views on this issue. But it is very impor 
of interest be kept uppermost in our minds 
in the future. 
rect me if I am wrong — as both the 
ople who, at NIH, do such experi- 
And if such legislation were ever 
adequate measures made to separate 
line agency of the United States 
1 expand on that. He has some 
tant that the question of conflict 
so that we don't make any errors 
The question of credibility also goes to the process — both at the local 
level, to the biohazards committees, and to the avenues suggested by many 
witnesses for making this process as open as possible. I endorse most of 
those . 
The other process is pee 
scientific level; that it be 
used in terms of assessing sc 
is a different matter; but if 
scientific information to beg 
policy on it? I think that i 
debating on this morning. 
r review--and peer review is basically at the 
as rigorous as possible, that high standards 
ientific data. How you derive policy on that 
you can't even rely upon the credibility of 
in with, how can you really develop credible 
s really the heart of the issue that we were 
be 
the 
In terms of the ways you implement the Guidelines, you ought to develop 
procedures for monitoring and inspection that are as rigorous and credible 
as possible; and in this respect I agree with many of the suggestions made 
by several speakers about increasing the ability for the local biohazards 
committees to both monitor this performance at the local level and have some 
kind of an inspection program. 
I have one very specific point to bring out today which was glossed 
over, I think, yesterday, and that has to do with shipment. In your revised 
Guidelines, I looked at the section on page 49600, and it is perhaps the 
shortest section in the entire Guidelines. I would have liked to have heard 
the gentleman from the Department of Transportation talk on this. However, 
all we have in your Guidelines is some mention of other codes that pertain 
to this whole area. Now, it seems to me reasonable that if you were to 
have experiments conducted under different containment levels, that that 
particular type of logic should apply to shipment too, because you obviously 
provide a weak link in your entire containment procedures if you had loose 
application of similar guidelines. I am not sure how well the U.S. Postal 
Office is in matters of control, but I would submit that I would not neces- 
sarily want to trust everything I have to the Postal Service. So I would 
caution you about taking that as a major way of dealing with the shipment 
quest ion. 
Finally, on the question of risk assessment, I am in general agreement 
that exemptions should be given to those experiments where the Director feels 
it is warranted. I also agree that a more comprehensive program ought to be 
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