Revision of the Guidelines Subcommittee - 06/22/87 
06/22/87 
Dr. McGarrity opened the meeting by introducing those present 
As a background for this session. Dr. McGarrity gave a brief history of the National Institutes of Health (NIH) Guidelines and 
the revision process that had produced the Guidelines to date. He then cited the proposed revisions to the Guidelines for 
recombinant DNA research, which were concerned with: (1) certain experiments that require the approval of Institutional 
Biosafety Committees (IBCs) and the RAC; (2) Appendix L, on the release of certain plants into the environment and Points 
to Consider documents; (3) definition of recombinant DNA activities from the Definitions Subcommittee; and (4) the area of 
vaccine development. He noted that traditional containment coocepts for recombinant DNA products don't work well for 
plants and animals. He stated that the Working Group was dealing with contained research. 
Dr. McGarrity said the proposed revisions will be presented to the RAC on September 21, 1987. Should issues remain 
unresolved after today, the Working Group could reconvene on a later date or the RAC meeting could be delayed. 
Dr. Tolin, was introduced by Dr. McGarrity to provide background, from the USD A point of view, oo the revisions to be 
considered at this meeting. She said that the Department of Agriculture has worked with NIH and organized workshops in 
December, 1986. The Department of Agriculture Science and Education Division proposed Guidelines within the Coordinated 
Framework for the Regulation of Biotechnology and many comments have been received. She cited previously proposed 
Appendices L, M, N, and O and stated that the revisions to the NIH Guidelines considered at this meeting would be 
Appendices P and Q. She mentioned that Drv Talbot and Gartland had been extensively consulted and that they would 
reformat her suggestions to make them consistent with the NTH Guidelines. 
Dr. Tolin stated that containment for plants and animals is currently set by IBCs. The IBCs have made many inquiries to the 
L'SDA and ORDA. Because there are no written guidelines the decisions from the local IBCs have been very inconsistent. 
Dr. Tolin stated that the current proposal has five parts: (1) the addition of six paragraphs to Part II to describe biosafety 
levels; (2) the modification of Pan III to incorporate plants and animals; (3) the minor modification of Appendix G; (4) the 
addition of Appendix P, which details the containment for plants, and; (5) the addition of Appendix Q, which details the 
containment for animals. Dr. Tolin said that Ms. Stacey Frost, L'SDA, had developed a comparative outline of the 
appendices. Dr. Tolin further noted that nooc of experiments covered under these p ropo sa ls require Federal approval, they 
all can be approved at the EBC level. 
Dr. McGarrity suggested that the Working Group discuss general issues before moving into specific proposals on the 
appendices; Dr. Tolin concurred. Dr. Gottesman believed that there were two principal issues: (1) clarification of the 
proposals; (2) shifting classifications of some types of experiments. She preferred to begin with the latter. Dr. Scandalios 
wished to address the inconsistencies of IBCs. Dr. Tolin stated that this was the purpose of the proposals before the 
committee. 
Dr. Korwck stated that Ms. Frost's chart is very useful. He asked whether containment standards were being increased or 
decreased. Dr. Pramer believed that the document from the Environmental Protection Agency (EPA), dated 4/15/87, which 
described physical containment should be discussed. 
Dr. Betz, of the EPA, stated the L’SDA and EPA had a proposal for greenhouse standards to contain genetically engineered 
microorganisms, but not plants or animals. This draft was then taken by the EPA and refined. The EPA Biotechnology 
Science Advisory Committee document for the greenhouse containment remains a draft document; the proposed containment 
levels for greenhouse testing of microorganisms remains under discussion. Dr. Tolin mentioned that the document under 
consideration today deals with recombinant-modified plants as well as with some recombinant-modified microorganisms and 
was developed by the plant and microorganism working groups in December. She cited the P-1 growth conditions for plants 
approved by the RAC in 1984, but never incorporated into the Guidelines. 
Dr. Fedoroff suggested and Dr. Gottesman supported the delegation of these issues to smaller working subgroups, though 
only after general guidance has been supplied. Dr. FedorofT believed that categories of containment were the first 
requirement Dr. Gottesman asked what was in place and bow the EPAs proposals changed it She felt that what required 
change was undear, and requested time to develop personal questions. Dr. Wagner, speaking for the animal investigators. 
Recombinant DNA Research, Volume 13 
