4 
lead to a major revision of the Guidelines. The Working Group met on June 1 
and July 9, 1981. The Working Gtoup prepared a proposal for revising the 
Guidelines and a sonnary of its actions (Attachment III). In addition, 
the Working Group prepared a docianent entitled "Evaluation of the Risks 
Associated with Re<X3mbin£mt CNA Research." minority reports were prepared 
by several members of the Working Gtoup (Attachment IV). The Working Group 
report (tab 1042), the minority reports, and letters of comment (tabs 1020, 
1040, 1045, 1046) were distributed to RAC members prior to the September 1981 
meeting. 
Mr. Thomton as)ced Dr. Gottesnan to introduce the Working Group's report. 
Dr. Gottesnan reviewed the highlights of the report. She noted that the 
revision of the Guidelines prcmulgated on July 1, 1981, already exenpts 
many experiments in three major hret-vector systems. The Baltimore-Campbell 
proposad (Attachment II) would convert mandatory Guidelines to a voluntary 
code of good practice and would set as containment levels those appropriate 
for the org^mism being used. The Working Group considered various approaches; 
the majority supported a proposal (Attachment III) which adopts the contain- 
ment provisions of the Badtimore-Campbell proposad but retains the mandatory 
aspect of the Guidelines. The {proposal has not yet been published ais a 
proposed najor auction in the Fe^ral Register . The RAC may wish to modify 
the proposal before its fontal publication in the Federal Register for public 
comment. 
Dr. Gottesran noted that the badcground docunent discusses basic assumptions. 
It is difficult to imagine hazards resulting from random combinations of DMA. 
Furthermore, deliberate combinations will not be harmful in most cases. How- 
ever, there are still some questions about certain experiments. The issue 
is how to dead with the latter experiments. The proposed of the Working 
Group would retain IBC prereview so that there is a level of review beyond 
the investigator. Dr. Gottesran then reviewed the main points of the Working 
Group proposal. The proposed containment levels are very similar to those of 
the Badtimore-Campbell proposal, i.e., containment would be largely based on 
the pathogenicity of the h^t. For adl non-exempt experiments, at least the 
PI level wxdd be recommended. The Working Group proposal eliminates refers 
enoe to biological containment in Part III of the Guidelines. The Working 
Group proposal adso adds an admonition which reads as follows: 
"If there is clear evidence that the donor DMA will significantly 
change the pathogenicy of the host, the containment level 
appropriate to the anticipated change will be applied." 
Vtiile the Baltimore-Campbell proposal would be a voluntary code of practice, 
the working Group proposal retains IBC prereview of covered experiments and 
retains Section IV-G of the Guidelines which discusses possible penalties for 
failing to follow the Guidelines. However, the Working Group recommends 
eliminating nembership requirements for IBCs currently specified- in Section 
( 195 ) 
