6 
called for the vote on the motion to approve the minutes of the February 6, 
1984, RAC meeting as amended. By a vote of sixteen in favor, none opposed, 
and no abstentions, the motion carried. 
III. AMENDMENT OF APPENDIX G - PHYSICAL CONTAINMENT 
Dr. McKinney explained the history of the proposal (tab 1156/VI, 1171) to 
amend Appendix G, Physical Containment , of the Guidelines. 
The booklet, Classification of Etiologic Agents on the Basis of Hazard 
(U.S. Department of Health, Education, and Welfare, Public Health Service, 
Center for Disease Control, Office of Biosafety, Atlanta, Georgia 30333), 
has served since 1969 as a general reference for laboratory activities uti- 
lizing infectious agents. The fourth edition of that booklet (July 1974) 
was incorporated in the 1978 revision of the National Institutes of Health 
(NIH) Guidelines for Research Involving Recombinant ENA Molecules and has 
since been a part of those Guidelines as Appendix B. 
Now an Interagency Working Group constituted by the Centers for Disease 
Control (CDC) and the NIH has prepared a new set of guidelines for labora- 
tory research with etiologic agents. These new guidelines are entitled 
Biosafety in Microbiological and Biomedical Laboratories . The CDC/NIH 
guidelines designate four categories of biosafety levels for laboratory 
operation: Biosafety Levels 1, 2, 3, and 4. These levels are comparable 
to the PI, P2, P3, and P4 containment levels described in the NIH Guidelines 
for Research Involving Recombinant DNA Molecules. 
The CDC/NIH Interagency Working Group proposed that RAC consider recommending 
a revision of the description of the P levels in the NIH Guidelines so that 
these descriptions would correspond to the biosafety levels set forth in 
the document Biosafety in Microbiological and Biomedical Laboratories . 
Dr. McKinney said the P-levels of physical containment described in the NIH 
Guidelines were the first clear def initial of practices, procedures, and 
facility corditions promulgated for microbiological research. Dr. McKinney 
said the P-levels have served well; however, these designations have been 
extended into a number of areas where they are inappropriate. Dr. McKinney 
felt institution of a common language corresponding to the biosafety levels 
set forth in the document Biosafety in Microbiological and Biomedical 
Laboratories would aid in eliminating the resultant confusion from these 
areas. He anticipated that common language describing biosafety levels 
could be implemented in general rmicrobiology laboratories, in recombinant 
ENA laboratories, and in laboratories dealing with oncogenic viruses. 
Dr. McKinney said the language proposed in the April 24, 1984, Federal 
Register would not substantively change Appendix G of the Guidelines. 
Dr. Barkley of the NIH Division of Safety said Biosafety Level 2 (BL2) 
differs from P2 in six major ways: (1) BL2 specifically gives responsibil- 
ity to the laboratory director for establishing a laboratory access policy; 
(2) BL2 recognizes the problem of skin contamination; (3) BL2 expands the 
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