Page 33 of Attachment E 
In the next section, Dr. Emmett Barkley from the NIH discussed 
changes in the “ Physical Containment" requirements. He explained 
that many of these changes had come about after a /omt meeting 
sponsored by NIH and the European Molecular Biological Organization 
in which physical containment procedures were discussed in depth and 
an attempt was made to harmonize containment procedures used in 
foreign countries and the United States. There was not much discussion 
in this section except tor Dr. Barkley's explanation (after queries) of (1) 
why it is unnecessary to filter air exhausting from P3 laboratories (with 
the exception of that coming from biological containment cabinets) and 
(2) why it is unnecessary to require that every P3 laboratory have an 
autoclave within the restricted area. 
In the next segment of the meeting, Dr. Susan Gottesman explained 
the changes in the “ Biological Containment" section. The major in- 
novation in this section is the introduction of the HV terminology (host- 
virus). This was done in order to allow for the development of host vector 
systems in addition to that utilizing E. coli K-12. The RAC considered 
that this was an important and necessary change. The requirements that 
all new HV systems be certified by the RAC will insure that there will be 
a constant surveillance of the types of systems to be used. 
Some of the most heated and important discussions of the entire 
meeting took place in the discussion in the next two sections; changes 
in the “ Experimental Guidelines" and " Roles and Responsibilities". It 
became apparent after presentations by Dr. John Tooze of the European 
Molecular Biology Organization and various representatives from the 
plant virus fields that the Experimental Guidelines outlined for animal 
virus studies and for plant and plant virus studies are still unnecessarily 
restrictive. John Tooze made the statement that in the opinion of many 
European animal virologists, and of those in EMBO, the NIH Guidelines 
for animal viruses were strongly influenced by what he considered 
“political" considerations. Several members of the Advisory Committee 
expressed consternation at this fact. They believed that the Guidelines 
should reflect a true scientific evaluation rather than political con- 
siderations. I believe that Dr. Fredrickson is considering sponsoring a 
meeting of European and American animal virologists in the near future 
in order to rectify this situation. It is hoped that this meeting can come 
up with recommendations which will be consistent with the best 
scientific evaluations of possible hazard. An important bit of in- 
formation that was revealed at the meeting and had significant impact 
was the inability of the animal virus groups in the United States to 
perform any animal virus risk assessment experiments. This ability 
arises from the severe restrictions placed on these experiments by the 
Guidelines. John Tooze announced that the same risk assessment 
experiments that have been planned for at least 2 years in the United 
States (but not yet initiated) are now being carried out in Europe. It was 
the general agreement that the problems with the “ Experimental 
Guidelines" relative to plants and plant viruses stem from the fact that 
these fields are not adequately represented in the RAC and attempts will 
be made to rectify this situation as well. 
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