7 
number of people would constitute an executive group. Dr. Scandalios said only 
4 or 5 people can easily be handled by a conference call. He noted that these 
4 or 5 people would have full RAC power so how individuals are selected to 
review proposals is very important. Dr. Gottesman said that a group of 6 
might be reasonable; four experts, and two lay members. The RAC chairman 
should be part of every group. ORDA would rotate the members of the group. 
Should a RAC member express a desire to serve on the executive subcommittee 
reviewing a particular proposal, the member is automatically appointed to that 
subcommittee. 
Dr. Gartland said that a similar procedure had been attempted in 1976 with the 
Host-\fector Subcommittee. This had not worked well. Dr. Martin said the ques- 
tions currently facing the RAC are highly complex; he felt the current procedure 
should be followed, i.e., full RAC review, except for certain proposals in the 
agricultural area. The working group agreed. 
Other Questions. 
Dr. Tolin said that several investigators had questioned her on the Guidelines 
concerning the construction of "shuttle" vectors. These shuttle vectors are 
frequently constructed with ENA from 4 or 5 different species. Dr. Gottesman 
said that while protocols detailing the construction of these shuttle vectors 
may be complicated, the Guidelines specify that each piece of DNA must be 
evaluated. She saw no need to suggest modifying the Guidelines regarding the 
construction of shuttle vectors. She suggested that a statement on how to 
proceed might be included in any "condensation" of the Guidelines. 
Dr. Martin questioned the specification in Appendix G-II-D-2-a on P4 contain- 
ment. That Section specifies that "Experimental procedures involving organisms 
that require P4 level physical containment shall be conducted in (i) a Class 
III cabinet system or in (ii) Class I or Class II cabinets that are located in 
a specially designed area in which all personnel are required to wear one 
piece positive- pressure isolation suits." Dr. Martin said the specification 
requiring use of the Class III glove box is meant to protect the investigator 
against contamination by aerosol. He said the use of the Class III glove box, 
however, does not afford protection when infection by the organism being studied 
does not occur with aerosol exposure. This is the case with the Eh coli K-12 
host-vector systems. He suggested the language of G-II-D-2-a be amended to 
include a statement that "in those situations where an aerosol will not be 
generated or when illness is not caused by aerosol exposure, the research must 
be conducted in the P4 facility, but options for working outside the glove box 
may be available." Dr. Martin stressed that the P4 facility itself protects the 
environment, while the Class III glove box protects the investigator. 
Dr. Gottesman asked if a contaminated investigator might carry the organism 
from the P4 facility into the community. Dr. Martin replied that use of P2 
or P3 containment procedures in the P4 facility protects the community. He 
argued that automatic assignment of experiments to the glove box ties up NIH 
staff, since all manipulations are more difficult to perform in the glo/e box. 
Dr. Nightingale asked if Dr. Martin felt the local IBC ought to have the autho- 
rity to set containment in the P4 facility on a case-by-case basis. Dr. Martin 
rv4j 
