8 
Dr. Richardson said that at least one revision, incorporating oomroents, 
and very liJcely two or more additional revised drafts will be prepared, 
and will be subjected to a reasonable review process. He felt that the 
guidelines were philoeophic^dly appropriate for the NIH and the QC; the 
guidelines are only guidelines, th^ are voluntary and hopefully they will 
result in an upgrading of laboratory fmcticns. 
Dr. Richardson said the proposed guidelines were initiated with two purposes 
in mind: 
(1) to modify the current Classification of Etiological Agents on the 
Basis of Hazaund, and 
(2) to use the guidelines ais an "in-house" guidance document for CDC 
staff in the absence of auiy other docvxnent of similar nature. He 
pointed out that had ocment on the guidelines not been solicited, 
the "in-house" CZXT docunent would have become the national standard 
by default. 
Dr. Brill said he supported the concept of guidelines for the handling of 
potentially damgerous organisms. He said, however, that the guidelines will 
beccme "regulations" as many institutions would require investigators to 
abide by them. Dr. Baltimore said that questions of legad liability ensure 
that the guidelines will be in a sense "regulations;" they would legadly 
be regarded as standard practice. Fdr this reason every recommendation in 
the guidelines should be ceurefully considered. 
Dr. Levine noted that the guidelines specify containment levels for 
"activities involving the use or manipulation of large quantities or high 
concentrations of cultures or other nraterials known or suspected of oontain- 
ing the agent." He asked if "large quantities" or "high concentrations" 
had been defined, and if not, who would determine this. Dr. Richardson 
replied that the guidelines in this respect are meant to be interpretive 
and judgemental. CDC vould never propose to set any stated quantity as 
representing a "large quantity" for all microorganisms. Much concern has 
been expressed over this eispect of the guidelines however, and attenpts 
may be nade in the revision to be more descriptive of criteria to be used 
in determining v4^t constitutes a "liurge quantity" or "high concentration" 
of an agent. 
VI. PROPOSAL TO OCNVEPT NIH GUIDELINES INTO A CODE OF STANDARD PRACTICE AND TO 
BmXS RKXH<BfcEP gBWTAIWBff LEVHS POft 
Mr. Thornton said he would recognize Dr. Nightingale who had requested 
an opportunity to present her views on the proposeil (tabs 994, 1015/11, 
1017) offered by Drs. Baltimore £md Catipbell. 
Dr. Nightingale said it had been apparent for some time that the conmittee 
perceived a need for a reassessment of the purpx>se of the Guidelines. The 
propoe^d from Drs. Bedtimore and Campbell is a serious attempt to meet 
[ 97 ] 
