APRIL 27-28-MINUTES OF MEETING 
9 
F. The RAC endorsed retention in the Guidelines of the specification 
in the description of a P3 laooratory or an autoclave "within the 
building, and preferably within the controlled laboratory area." 
G. This issue proposes alternative wording of the second sentence 
of the definition of HVl. The definition of HVl was discussed 
a number of times on both days of the RAC meeting; discussion 
of specific cases requesting interpretation of the 1976 
Guidelines in regard to using hosts other than EL coli K-12 
led the RAC also to consider how these specific cases would 
be treated in the proposed revised Guidelines, i.e., would 
they meet the definition of HVl? 
The RAC, rather than rewording the second sentence of the 
definition of HVl as proposed in Question G of Attachment II, 
preferred instead to delete this sentence. The definition 
would thus read: "a. HVl . A host-vector system which provides 
a moderate level of containment." 
Other rewording (to change seme of the language just preceding 
the definition of HVl, where biological containment in general 
is discussed) was proposed but not adopted by the RAC. 
Throughout the discussion it became apparent that some host-vector 
systems might not meet the criteria for HVl but still might be 
considered by the RAC as safe systems provided they are used 
under specified containment levels. The proposed revised Guide- 
lines do not discuss this possibility. Therefore, there was 
strong endorsement for inserting into the Guidelines language 
which would permit this and other flexibility, i.e., a general 
flexibility clause. 
H. The RAC, by a vote of 11 to 1, rejected the suggestion in 
Attachment II of deleting the requirement for HV3 that "the 
relevant genotypic and phenotypic traits of such HV3 systems 
have been independently confirmed," i.e., the RAC wishes to 
retain this requirement. 
I. The RAC expressed willingness to review requests from the private 
sector (e.g., for interpretations and exceptions frem the Guide- 
lines and certification of new host-vector systems). Some members 
did not really wish to be involved with proprietary data but 
agreed reluctantly. Dr. Stetten felt that NIH should undertake 
to review EK2 host-vector systems only if they would be made 
freely available to other investigators; if a system is truly 
safer, then not sharing it with others is wrong. Other committee 
members agreed. 
[ 525 ] 
