60 
Guidelines even came into existence, many of which claim to be complying 
with the specifications as written by the National Sanitation Foundation, 
but many of which in fact really don’t, or if they did in an ideal situa- 
tion, after installation turned out not to comply with the specifications. 
I am wondering if you planned or considered at all requiring some sort 
of certification of the design specifications of these biological safety 
cabinets for, say, a P2 or P3 facility or authorization to be used as such 
by local biohazards committees. 
DR. BARKLEY: We are getting into the area of roles and responsibili- 
ties, where the local biohazards committees certify that those measures for 
physical containment are there and are operational. The Guidelines do de- 
fine what a Class II biological safety cabinet is. So my statement would 
be that yes, they should comply in the certification, and should be there 
whether it is needed at P2 or P4 . There is an effort continuing with the 
National Sanitation Foundation to develop a means of certifying certifiers 
so that there would be greater consistency in how this might be done through- 
out the country. But the standards of the National Sanitation Foundation are 
appropriate. They can be achieved on equipment that is on the market today. 
If the systems do not comply with those performance requirements, I would 
recommend that they not be used for anything other than sterile assembly, but 
certainly not for containment. 
MR. BEATY: I guess my comment then, since the intent of what I was 
suggesting is present in the Guidelines, or the proposed Guidelines is 
perhaps that it can be made explicitly clear to local biohazards committees 
that this is their role, that they have to require a certification. The 
word "certification" isn't actually mentioned. 
DR. BARKLEY: All right. And I will see that the Appendix D explicitly 
defines the certification procedures even more thoroughly than it does now. 
DR. FREDRICKSON: Dr. Shaw. 
DR. SHAW: I have a very general question. Is there data on how many 
PI, P2, P3, and P4 labs have been approved by local committees, or certi- 
fied, or whatever? 
DR. FREDRICKSON: In the Environmental Impact Statement, that informa- 
tion is available, and more up-to-date information can be obtained. 
DR. AHMED: But there aren't any P4? 
DR. FREDRICKSON: There are no P4 laboratories in this country — or, 
to our knowledge, abroad at this time — working on recombinant DNA. 
We have time for one more question from the Committee. 
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