07/16/87 
The Working Group then took a lunch break. 
After the lunch break, Dr. McGarrity presented the recommendations of the Animal Subgroup. 
The Subgroup found that Biosafety Level 3-N of proposed Appendix Q of the NIH Guidelines as 
too restrictive, and should be eased. In addition, Appendix B of the NIH Guidelines required an 
overhaul; in particular, retroviruses were of concern. The Subgroup recommended adding a 
page of definitions and a reference to the NIH Biosafety Manual.^ He noted that the NIH 
Recombinant DNA Advisory Committee must look at viral vectors and attenuation. 
Dr. Fedoroff presented the recommendations and observations of the Plant Subgroup. While the 
four levels of containment should be retained, the requirements for the containment levels should 
become somewhat less stringent; some biological containment should be added. The Subgroup 
had spent most of its time on tables for the containment levels, and recommended that the 
lowest level should require notification to an Institutional Biosafety Committee without being 
excessively onerous. In addition, the format of the NIH Guidelines should be rewritten, perhaps 
in tabular form. She noted that guidelines for transportation have not been discussed. Dr. 
Korwek suggested that the Working Group request that the National Research Council develop 
a more comprehensive list. Dr. Fedoroff suggested that the Office of Recombinant DNA Activities 
of NIH assemble a group of plant pathologists in order to develop a list. Dr. Tolin said she would 
ask specialists at the next American Pathologist meeting to investigate the problem. 
Dr. Fedoroff argued that these suggestions will not solve the entire problem. Principles must be 
developed. Dr. Tolin asked if the Working Group had been adequately helpful. Dr. Hardy 
proposed that each member of the Working Group give one or two examples for each category 
in the list for containment levels. Dr. Bittle asked if the Department of Agriculture should sponsor 
the compilation of a new list. Dr. Tolin cited a workshop on plant pathogens that took place ten 
years ago. Dr. McGarrity stated that both plant and animal experiments require classification. 
Dr. Stephen Hughes mentioned that some lists of animal pathogens are available. He suggested 
that the Working Group send the entire document to the RAC, and announce and publish it in 
the Federal Register as soon as possible. 
Dr. Fedoroff suggested that a motion be made to recommend that a manual be written that would 
offer guidance to Institutional Biosafety Committees on: (1) the category in which a given 
organism belongs; (2) the appropriate containment level for the organism. The Working Group 
should also seek as broad a request as is appropriate for the National Research Council to hold 
a workshop on animals and plants. 
Dr. Scandalios argued that some basic, general guidelines should be provided, so that 
researchers would be able to classify organisms themselves. He believed that the full RAC 
should pick the most appropriate body. The Working Group required additional input to help 
Institutional Biosafety Committees determine the proper category for a given organism. Because 
the Working Group lacks the required expertise, input for the characterization of the relevant 
2 Biosafety in Microbial and Biomedical Laboratories, 2nd Edition, (May 1988), U.S. 
Department of Health and Human Services, Centers for Disease Control, Atlanta, Georgia 30333, 
and National Institutes of Health, Bethesda, Maryland 20892. 
Recombinant DNA Research, Volume 13 
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