Federal Register / Vol. 49, No. 50 / Tuesday, April 24, 1934 / Notices 
17G75 
facilities, experience, precautions, 
emergency plan anti references. 
Appendices to the proposal will lie 
reviewed in the portion of the RAC 
meeting closed to the public because 
those Appendices contain trade secrets 
(the processes for construction and 
testing of the organisms containing 
recombinant DNA) and/or confidential 
commercial information (certain 
detailed information about the conduct 
of the experiment) the disclosure of 
which would cause Advanced Genetics 
Sciences, Inc., substantial competitive 
harm. 
VI. Proposal to Amend Appendix G of 
the Guidelines, Physical Containment 
The booklet. Classification of 
Etiologic Agents on the Basis of Hazard 
(U.S. Department of Health. Education, 
and Welfare, Public Health Service, 
Centers for Disease Control, Office of 
Biosafety, Atlanta, Georgia 30333), has 
served since 1969 as a general reference 
for labortory activities utilizing 
infectious agents. The fourth edition of 
that booklet (July 1974) was included in 
the 1978 version of the National 
Institutues of Health (NIH) Guidelines 
lor Research Involving Recombinant 
DNA 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 
laboratory 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 has 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." 
In order to effect this change, the 
following modifications of the 
Guidelines are proposed: 
1. Section II, Containment. 
a. In Section II, wherever the terms 
"Pi, P2, P3, P4" appear the term "BLl” 
(for Biosafety Level 1) would be 
substituted for the term "Pi;" the term 
"BL2" (for Biosafety Level 2) would be 
substituted for "P2;” the term "BL3" (for 
Biosafety Level 3) would be substituted 
for "P3;" and the term "BI/4" (for 
Biosafety Level 4) would be substituted 
for “P4." 
b. The fourth sentence of the first 
paragraph of Section II, Containment, 
would be deleted. That sentence reads 
as follows: 
Four levels of physical containment, which 
are designated as Pi, P2. P3, and P4 are 
described in Appendix G. 
c. The following language would be 
substituted for the fourth sentence of the 
first paragraph of Section II, 
Containment: 
Four biosafety levels are described in 
Appendix G. These biosafety levels consist of 
combinations of laboratory practices and 
techniques, safety equipment and laboratory 
facilities appropriate for the operations 
performed and the hazard posed by agents 
and for the laboratory function and activity. 
2. Section III, Guidelines for Covered 
Experiments. 
In Section III, wherever the terms "Pi, 
P2, P3, P4” appear the term "BLl" would 
be substituted for the term “Pi;" the 
term "BL2" would be substituted for 
"P2;" the term “BL3" would be 
substituted for "P3;" and the term “BL4" 
would be substituted for "P4." 
3. Section IV, Roles and 
Responsibilities. 
a. In Section IV, wherever the terms 
“PI, P2, P3, P4" appear the term "BLl" 
would be substituted for the term "Pi;" 
the term "BL2" would be substituted for 
"P2;" the term “BL3” would be 
substituted for "P3;" and the term "BL4" 
would be substituted for “P4." 
b. Section IV-C-4, Other NIH 
Components, would be modified to read 
as follows: 
IV-C— 4. Other NIH Components. Other 
NIH components shall be responsible for 
certifying maximum containment (BIA) 
facilities, inspecting them periodically, and 
inspecting other recombinant DNA facilities 
as deemed necessary. 
4. Appendix C, Exemptions Under III- 
0-5. 
The second paragraph of Appendix C- 
II, Experiments Involving E. coli K-12 
Host-Vector Systems, Appendix C— III, 
Experiments Involving Saccharomyces 
cere vis iae Host-Vector Systems, and 
Appendix C-IV, Experiments Involving 
Bacillus subtilis Host- Vector Systems 
would be modified to read as follows: 
For the exempt experiments BLl 
containment conditions are recommended. 
5. Appendix F, Containment 
Conditions for Cloning of Genes Coding 
for the Biosynthesis of Molecules Toxic 
for Vertebrates. 
In Appendix F, wherever the terms 
"Pi, P2, P3, P4" appear the term “BLl" 
would be substituted for the term “Pi;" 
the term "BL2" would be substituted for 
"P2;" the term "RL3" would be 
substituted for "I V J;" and the term "BI A" 
would be substituted for "P4." 
0. Appendix G, Physical Containment. 
a. The fourth sentence ofthe second 
paragraph of Appendix G-4, Standard 
Practices and Training, would be 
modified to read: 
If a research group is working with a 
known pathogen for which there is an 
effective vaccine, the vaccine should be 
available to all workers. 
b. The third paragraph of Appendix 
G-I, Standard Practices and Training, 
would be modified to read: 
The "Laboratory Safety Monograph" and 
"Biosafety in Microbiological and Biomedical 
Laboratories” [2] booklets describe practices, 
equipment, and facilities in detail. 
c. In Appendix G-II, Physical 
Containment Levels, wherever the terms 
“PI, P2, P3, P4" appear the term "BLl" 
would be substituted for the term "FT;" 
the term "BL2" would be substituted for 
"P2;" the term "BL3" would be 
substituted for "P3;" and term “BL4" 
would be substituted for "P4." 
d. The third sentence of the second 
paragraph of Appendix G-II, Physical 
Containment Levels, would be footnoted 
and would read as follows: 
It should be emphasized that the 
descriptions and assignments of physical 
containment detailed below are based on 
existing approaches to containment of 
pathogenic organisms (2). 
e. The fourth sentence of the second 
paragraph of Appendix G-II, Physical 
Containment Levels, currently reads as 
follows: 
For example, the “Classification of 
Etiologic Agents on the Basis of Hazard" [2] 
prepared by the Centers for Disease Control 
describes four general levels which roughly 
correspond to our description for Pi, P2, P3 
and P4; and the Notional Cancer Institute 
describes three levels for research on 
oncogenic viruses which roughly correspond 
to our P2, P3, and P4 levels (3). 
This sentence would be modified to 
read: 
The National Cancer Institute describes 
three levels for research on oncogenic viruses 
which roughly correspond to our BL2, BL3, 
and BL4 levels (3). 
f. Appendix G-II-A, Pi Level, would 
be deleted and the following language 
would be substituted for Appendix G-II- 
A: 
Appendix G-II-A. Biosafety Level 1 (BLl) 
1131- 
Appendix G-II-A-1. Standard 
Microbiological Practices. 
Appendix G-II-A-l-a. Access to the 
laboratory is limited or restricted at the 
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