Revision of the Guidelines Subcommittee - 06 / 22/87 
06 / 22/87 
stated that the containment levels had to be examined in light of the experiments that were currently being performed or 
which will be performed in the near future. Dr. Korwek said that the terms needed clear definitions from a legalistic point of 
view. 
Dr. Tolin pointed out that Appendices P and Q were separate, but developed in parallel. Therefore one shouldn't go too far 
with one without considering the other. Dr. Miller said that both Appendices P and Q were relevant to insects, but have 
relied on different approaches of control. Dr. Gottesman gave her overall impressions of the two sections so that the 
subgroups would have a common ground. She stated that whole animals and plants, under Section III-&4-a of the NIH 
Guidelines, require approval by IBCs, which set containment standards under Section III-B-4-b. She felt that Biosafety Level 
(BL) 1 required clarification. She asked if the IBCs needed more specific advice. Self-cloning and tissue culture experiments 
were already exempt. In addition, neither pathogenic microorganisms that are tested on whole animals nor plant pathogens 
are addressed in the current NIH Guidelines. She asked if the Department of Agriculture's proposal offers specifications and 
whether it raises or lowers containment of experiments. 
Dr. Federoff stated that there was already a significant amount of experience worldwide and more plant experiments should be 
added to the exemption list of the NIH Guidelines. Dr. LaSalle stated that it was extremely important that veterinary biologic 
vaccine developers not be hampered by the new additions. After all, he said, they have been working successfully for 78 years 
without RAC help. Dr. Shibley said that the Working Group needed to consider new terms and regulatory requirements in 
light of existing legislation. He stated that one can't focus solely on the research side, since there are other considerations. 
The working group then broke into two subgroups, with Dr. Fedoroff chairing the plant group and Dr. McGarrity the animal 
group. 
The Working Group returned to plenary session. Dr. McGarrity gave the animal group points of discussion. Fust, in the 
absence of vectors, transgenic animals present a low hazard and should form a separate subdivision. Second, defective viruses 
are not addressed in the current NIH Guidelines. Cases with less than two-thirds and greater than two-thirds of the viral 
genome must be addressed. In the BL2-N, there is concern about restrictions on the decontamination of animal wastes. BL3- 
N appears too restrictive. On the other hand, BL4-N is not restrictive enough. 
Dr. Fedoroff summarized for the plant group. She believed that the Working Group needed to define categories differently. 
She suggested that all plants except weeds, as a class of experiments, be exempt from the NIH Guidelines. Any disarmed 
vector, including these based on plant toxins, could be permissible, because genes that generate toxins are covered elsewhere. 
Dr. Gottesman stated that the animal group would propose no significant changes in containment levels, though the plant 
group appears prepared to do so. She was uncertain what the procedure for 'Virus rescue* would entail. Dr. Fedoroff read 
the proposed definition for ’disarmed* viruses. Dr. Hughes believed that this would be difficult to define within the virology 
community. A long discussion regarding 'disarmed viruses* ensued. 
The Working Group took a lunch break. 
After lunch, a summation of the plant group discussions was given by Dr. Fedoroff. She stated that they had made some 
significant changes based on the philosophy that containment should be risk based as opposed to process based. That is, the 
containment level should be determined by the perceived risk posed by the organism, not by the fact that it contained 
recombinant DNA They had defined three levels of containment BL1-P, BL2-P, and BL3-P. First, BL1-P, the exempt 
categoiy, should include all organisms that pose no threat to the environment or human health. BL2-P was for experiments 
which require prior IBC notification. The third level would cover exotic organisms. There was discussion within the working 
group that four levels, as in the USDA guidelines, would be appropriate. If so, the BL3-P would be divided, with the most 
contained level being equivalent to BL-4 facilities. This latter containment would be prohibitively expensive and was felt to be 
rarely needed. Dr. S. Hughes then brought up the matter of *a-box-within-a-box* in relationship to green houses. To be 
completely analogous to BL-4, one would need *a-box-within-a-box*, but this is not practical for greenhouses with glass 
windows. Does one then require perimeter fencing etc.? There was some sentiment for elimination of containment equivalent 
to BL-4 because of the practical considerations. 
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Recombinant DNA Research, Volume 13 
