Federal Register / Vol. 49, No. 227 / Friday, November 23, 1984 / Notices 
46257 
recommendation and the Guidelines will 
be modified as published for public 
comment in the Federal Register of 
April 24, 1984, with the addition of the 
word “infected” in Appendix G-U-C-3- 
a, and minor editorial changes. 
II. Summary of Actions 
Amendment of Appendix G of the 
Guidelines, Physical Containment 
In order to modify Appendix G so that 
the description of containment levels 
corresponds to the language of the 
guidelines for research with etiologic 
agents entitled Biosafety in 
Microbiological and Biomedical 
Laboratories, the following 
modifications are introduced into the 
NIG Guidelines for Research Involving 
Recombinant DNA Molecules: 
1. Section II, Containment 
a. In Section II, wherever the terms 
“PI, P2, P3, P4” appear the term “BLl" 
(for Biosafety Level 1) is substituted 
for the term "Pi:" the term “BL2" (for 
Biosafety Level 2) is substituted for 
“P2;” the term “BL3” (for Biosafety Level 
3) is substituted for "P3;" and the term 
“BL4” (for Biosafety Level 4) is 
substituted for “P4." 
b. The fourth sentence of the first 
paragraph of Section IL Containment, is 
deleted. That sentence read 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 is 
substituted for the fourth sentence of the 
first paragraph of Section IL 
Containment: 
‘Tour 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 IB, Guidelines for Covered 
Experiments 
In Section UL wherever the terms “Pl, 
P2, P3, and P4" appear the term “BLT’is 
substituted for the term Pi;” the term 
"BL2“ is substituted for “P2;" the term 
"BL3”is substituted for “P3;" and the 
term “BL4“ is substituted for “P4.“ 
3. Section IV, Roles and Responsibilities 
a. In Section IV, wherever the terms 
“Pl. P2, P3, and P4" appear the term 
“BLl" is substituted for the term “Pl;“ 
the term "BL2" is substituted for “P2;" 
the term "BL3" is substituted for “P3;“ 
and the term "BL4" is substituted for 
“P4." 
b. Section IV-C-4, Other NIH 
Components, is modified to read as 
follows: 
“IV-C-4. Other NIH Components. 
Other NIH components shall be 
responsible for certifying maximum 
containment level (BL4) facilities, 
inspecting them periodically, and 
inspecting other recombinant DNA 
facilities as deemed necessary.” 
4. Appendix C, Exemptions Under III-D- 
5 
The second paragraphs of Appendix 
C-IL Experiments Involving E coli K-12 
Host-Vector Systems, Appendix C-III, 
Experiments Involving S acch aromyces 
cerevisiae Host-Vector Systems are 
modified to read as follows: 
“For these exempt experiments BLl 
containment conditions are 
recommended.” 
5. Appendix D, Actions Taken Under 
Guidelines 
In Appendix D, whenever the terms 
“Pl, P2, P3, P4" appears the term “BLl” 
is substituted for the term “Pl;" the term 
"BL2" is substituted for “P2;" the term 
"BL3" is substituted for “P3;" and the 
term “BL4” is substituted for “P4.“ 
6. Appendix F, Containment Conditions 
for Cloning of Genes Coding for the 
Biosynthesis of Molecules Toxic for 
Vertebrates 
In Appendix F, whenever, the terms 
“Pl, P2, P3, P4" appear the term "BLl" is 
substituted for the term “Pl;" the term 
“BL2" is substituted for “P2;" the term 
“BL3” is substituted for “P3;“ and the 
term “BL4" is substituted for “P4.” 
7. Appendix G, Physical Containment 
a. The fourth sentence of the second 
paragraph of Appendix G-I. Standard 
Practices and Training, is 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, is 
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-IL Physical 
Containment Levels, wherever the terms 
"Pl, P2, P3, P4" appears the term “BLl” 
is substituted for the term “Pl;" the term 
"BL2" is substituted for "P2;” the term 
"BL3” is substituted for “P3;“ and the 
term “BL4" is substituted for “P4." 
d. The third sentence of the second 
paragraph of Appendix G-U, Physical 
Containment Levels, is 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 
12 ]" 
e. The fourth sentence of the second 
paragraph of Appendix G-U, Physical 
Containment Levels, is 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, Pl Level, is 
deleted and the following language is 
substituted for Appendix G-II-A: 
“Appendix G-II-A. Biosafety Level 1 
(BLl) [13]. 
"Appendix G-II-A-1. Standard 
Microbiological Practices. 
"Appendix G-II-A-l-a. Access to the 
laboratory is limited or restricted at the 
discretion of the laboratory director 
when experiments are in progress. 
"Appendix G-Ii-A-l-b. Work 
surfaces are decontaminated once a day 
and after any spill of viable materiaL 
“Appendix G-U-A-l-c. All 
contaminated liquid or solid wastes are 
decontaminated before disposaL 
“Appendix G-U-A-l-d. Mechanical 
pipetting devices are used; mouth 
pipetting is prohibited. 
"Appendix G-U-A-l-e. Eating, 
drinking, smoking, and applying 
cosmetics are not permitted in the work 
area. Food may be stored in cabinets or 
refrigerators designated and used for 
this purpose only. 
"Appendix G-II-A-l-t Persons wash 
their hands after they handle materials 
involving organisms containing 
recombinant DNA molecules, and 
animals, and before leaving the 
laboratory. 
“Appendix G-II-A-l-g. All 
procedures are performed carefully to 
minimize the creation of aerosols. 
“Appendix G-II-A-l-h. It is 
recommended that laboratory coats, 
gowns, or uniforms be worn to prevent 
contamination or soiling of street 
clothes. 
“Appendix G-U-A-2. Special 
Practices. 
“Appendix G-lI-A-2— a. 
Contamination materials that are to be 
decontaminated at a site away from the 
laboratory are placed in a durable 
leadproof container which is closed 
before being removed from the 
laboratory. 
"Appendix G-II-A-2-b. An insect and 
rodent control program is in effect. 
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