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Federal Register / Vol. 49. No. 80 / Tuesday, April 24, 1984 / Notices 
16. Biosafety Level 3 is applicable to 
clincial, diagnostic, teaching, research, or 
production facilities In which work is done 
with Indigenous or exotic agents which may 
cause serious or potentially lethal disease as 
result of exposure by the Inhalation route. 
Laboratory personnel have specific training 
in handling pathogenic and potentially lethal 
agents and are supervised by competent 
scientists who are experienced in working 
with these agents. All procedures involving 
the manipulation of infectious material are 
conducted within biological safety cabinets 
or other physical containment devices or by 
personnel wearing appropriate personal 
protective clothing and devices. The 
laboratory has special engineering and design 
features. It is recognized, however, that many 
existing facilities may not have all the facility 
safeguards recommended for Biosafety Level 
3 (e.g., access zone, sealed penetrations, and 
directional airflow, etc.). In those 
circumstances, acceptable safety may be 
achieved for routine or repetitive operations 
(e.g., diagnostic procedures involving the 
propagation of an agent for identification, 
typing, and susceptibility testing) in 
laboratories where facility features satisfy 
Biosafety Level 2 recommendations provided 
the recommended 'Standard Microbiological 
Practices,' 'Special Practices,’ and 
'Containment Equipment’ for Biosafety Level 
3 are rigorously followed. The decision to 
implement this modification of Biosafety 
Level 3 recommendations should be made 
only by the laboratory director (See 
Appendix G-Ul-2). 
7. Appendix H, Shipment. 
a. 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. Appendix H-III of Appendix H, 
Shipment, would be modified to read as 
follows: 
Appendix H-III. Information on packaging 
and labeling of etiologic agents is shown in 
Figures 1, 2, and 3. Additional information on 
packaging and shipment is given in the 
'Laboratory Safety Monograph — A 
Supplement to the NIH Guidelines for 
Rec ombinant DNA Research,' available from 
Office of Recombinant DNA Activities and in 
'Biosafety in Microbiological and Biomedical 
Laboratories (see Appendix G — III— 2).’ 
8. Appendix K. Physical Containment 
for Large-Scale Uses of Organisms 
Containing Recombinant DNA 
Molecules. 
a. 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 the term 
“P2;" the term "BL3" would be 
substituted for the term "P3;" and the 
term “BL4" would be substituted for 
"P4.” 
b. Wherever the terms "Pl-LS, P2-LS, 
P3-LS, P4-LS" appear, the term "BLl- 
LS" (for Biosafety Level 1 — Large-Scale) 
Dated: April 12, 1984. 
Richard M. Krause, M.D., 
Director, Notional Institute of Allergy and 
Infectious Diseases, National Institutes of 
Health. 
OMB's “Mandatory Information 
Requirements for Federal Assistance Program 
Announcements" (45 FR 39592) requires a 
statement concerning the official government 
programs contained in the Catalog of Federal 
Domestic Assistance. Normally NIH lists in 
its announcements the number and title of 
affected individual programs for the guidance 
of the public. Because the guidance in this 
notice covers not only virtually every federal 
research program in which DNA recombinant 
would be substituted for the term "Pl- 
LS;" the term "BL2-LS” would be 
substituted for “P2-LS;" and the term 
“BL3-LS” would be substituted for "P3- 
LS.” 
9. Section III— B— 5 would be modified 
so as to correctly indicate the location of 
the Physical Containment for Large- 
Scale Uses of Organisms Containing 
Recombinant DNA Molecules in the 
Guidelines. That section would read as 
follows: 
III— B— 5. Experiments Involving More than 
10 Liters of Culture. The appropriate 
containment will be decided by the IBC. 
Where appropriate, the large-scale 
containment recommendations of the NIH 
should be used (Appendix K). 
molecule techniques could be used, it has 
been determined to be not cost effective or in 
the public interest to attempt to list these 
programs. Such a list would likely require 
several additional pages. In addition, NIH 
could not be certain that every federal 
program would be included as many federal 
agencies, as well as private organizations, 
both national and international, have elected 
to follow the NIH Guidelines. In lieu of the 
individual program listing, NIH invites 
readers to direct questions to the information 
address above about whether individual 
programs listed in the Catalog of Federal 
Domestic Assistance are affected. 
(FR Doe. S4-10667 Filed 4-23-04; W5 am| 
BILUNG CODE 4HO-01-M 
Table I.— Possible Combinations of Containment Safeguards 
Classification of experiment 
Alternate combinations of physical and biological 
containment 
Physical containment 
Biological 1 
containment 
Physical containment 
Laboratory 
facilities 
specified for 
Laboratory 
practices 
specified for 
Contain- 
ment 
equipment 
specified lor 
Biological 
containment 
BL3 .... - . 
HV2 
BL3 
BL3 
BL3 
HV2 
BL3 .... 
HV2 
BL3 
BL3 
BL4 
HV1 
BL3 .. 
HV1 
M3 
BL3 
BL3 
HV1 
BL3 .. 
HV1 
BL3 
BL3 
BL2 
HV2 
BL4 
HV1 
BL4 
BL4 
BL4 
HV1 
BL4 
HV1 
BL4 
•814 
BL3 
HV2 
1 See Appendix I for description of bk>k>gical containment 
• In this case gloves shaH be worn in addition to clothing specified In Appeodta G-ll-2-e. 
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