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Federal Register / Vol. 47, No. 102 / Wednesday. May 26, 1982 / Notices 
comment, with pubUshed response, 
before final action." 
n. Section IV-E-l-b (renumbered IV- 
C-l-b), Specific Responsibilities of the 
Director, NIH, would read as follows: 
"IV-C-l-b. Specific Responsibilities 
of the Director, NIH. In carrying out 
responsibilities set forth in this Section, 
the Director or a designee shall weigh 
each proposed action, through 
appropriate analysis and consultation, 
to determine that it cpmplies with the 
Guidelines and presents no significant 
risk to health or the environment." 
o. Section IV-E-l-b-{l) (renumbered 
rV-C-l-b-(l)) would be modified to 
read as follows: 
"IV-C-l-b-(l). Major Actions. To 
execute major actions the Director must 
seek the advice of the RAC and provide 
an opportunity for public and Federal 
agency comment. Speciflcally, the 
agenda of the RAC meeting citing the 
major actions will be published in the 
Federal Register at least 30 days before 
the meeting, and the Director will also 
publish the proposed actions in the 
Federal Register for comment at least 30 
days before the meeting. In addition, the 
Director's proposed decision, at his 
discretion, may be published in the 
Federal Register for 30 days of comment 
before Final action is taken. The 
Director's final decision, along with 
response to comments will be published 
in the Federal Register and the 
Recombinant DNA Technical Bulletin. 
The RAC and IBC chairpersons will be 
notified of this decision:" 
p. The order of the subsections under 
Section rV-E-l-b-(l) (renumbered IV- 
C-l-b-(l)) would be modiFied. 
q. Section lV-E-l-b-{2) (renumbered 
IV-C-l-b-(2}) would be modified to 
read: 
"rV-C-l-b-(2). Lesser Actions. To 
execute lesser actions, the Director must 
seek the advice of the RAC. The 
Director's decision will be transmitted to 
the RAC and the IBC chairpersons and 
published in the Recombinant DNA 
Technical Bulletin. " 
r. SecUon IV-E-l-b-(2Hd) 
(renumbered IV-C-l-b^2Hd)) would 
be modified to read as follows: 
"IV-C-l-l>-(2Hd). Revising the 
'Classification of Etiologic Agents' for 
the purposes of these Guidelines (1)." 
s. Section IV-E-l-b-{3) (renumbered 
rV-C-l-b-{3)), would read as follows: 
"IV-C-l-b^3). Other Actions. The 
Director's decision will be transmitted to 
the RAC and IBC chairpersons and 
published in the Recombinant DNA 
Technical Bulletin. " 
t. A new Section IV-C-l-b-(3Hb) 
would be added as follows: 
"rV-C-l-b-(3Hb). Setting 
containment under Section HI-B-l-d 
and Section III-B-3-d." 
The order of subsections of Section 
rV-E-l-b-(3) (renumbered IV-C-l-b- 
(3)] would be modified and the 
subsections renumbered. 
u. Section fV-E-4-b would be deleted. 
Section IV-E-4-b reads as follows: 
"IV-E-4-b. Announcing and 
distributing certified HV2 host-vector 
systems (see Section II-D-3)." 
V. Section IV-F, Compliance, would 
be renumbered to become Section IV-D. 
w. A note would be added to Section 
IV-F-4 which would be renumbered as 
Section IV-D-4 as follows: 
Note. — Other Federal agencies which have 
adopted the NIH Guidelines may have the 
authority to terminate funding to their 
grantees should these grantees not comply 
with the NIH Guidelines." 
5. Section V. Footnotes and 
References. 
a. The title of the Section would be 
amended to read: 
“V. Footnotes and References of 
Sections l-IV ’ 
b. The footnotes and references would 
be rearranged and renumbered. 
Footnotes and references applying to 
Appendices would be moved to relevant 
Appendices. 
c. Reference (1) would be modified to 
read: 
“1. The original reference to 
organisms as Class 1. 2, 3, 4 , or 5 refers 
to the classification in the publication 
Classification of Etiologic Agents on the 
Basis of Hazard, 4th Edition, July 1974, 
U.S. Department of Health, Education 
and Welfare, Public Health Service, 
Center for Disease Control, Office of 
Biosafety, Atlanta, Georgia 30333. 
"The Director, NIH, with advice of the 
Recombinant DNA Advisory Committee, 
may revise the classification for the 
puposes of these Guidelines (see Section 
IV-C-l-b-{2)-{d)). The revised list of 
organisms in each class is reprinted in 
Appendix B of these Guidelines." 
6. Section VI. Voluntary Compliance. 
a. The second paragraph of Section 
Vl-C. Certification of Host-Vector 
Systems, would be deleted. That 
paragraph reads as follows: 
"Institutions not otherwise covered by 
the Guidelines will not be subject to 
Section II-D-3 by complying with these 
procerfures." 
7. Appendix B. Classification of 
Microorganisms on the Basis of Hazard. 
a. The title of the first heading, I, In 
Appendix B would be changed to read: 
“Appendix B-I. Classification of 
Etiologic Agents. [The original reference 
for this classification was the 
publication “Classification of Etiological 
Agents on the Basis of Hazard, ’ 4th 
edition, July 1974, U.S. Department of 
Health. Education and Welfare, Public 
Health Service. Center for Disease 
Control. Office of Biosafety, Atlanta, 
Georgia 30333. For the purposes of these 
Guidelines, this list has been revised by 
NIH.]” 
b. The following organisms would be 
added to the list of Class 2 bacterial 
agents: 
“Aeromonas hydrophila 
Campylobacter fetus 
Campylobacter jejuni 
Edwardsiella tarda 
Yersinia enterocolita ” 
c. The language describing Class 2 E. 
coli would be modified to read: 
“Escherichia coli — all 
enteropathogenic, enterotoxigenic, 
enteroinvasive and strains bearing Kl 
antigen." 
d. Vesicular Stomatitis Virus would be 
added to Class 2 viral agents and 
deleted from Class 3 viral agents. 
e. The following modibcations 
concerning Poxvirus and Rabies Virus 
would be made in Class 2 viral agents: 
"Poxviruses — all types except 
Alas trim. Smallpox, and Whitepox, 
which are Class 5 and Monkey Pox, 
which depending on experiments, is in 
Class 3 or Class 4. 
"Rabies virus — all strains except 
Rabies street virus, which should be 
classified in Class 3." 
f. Alastrim, Smallpox, and Whitepox 
would be reclassitied from Class 3 and 
Class 4 agents to Class 5 agents. 
g. The language including Rabies 
street virus as a Class 3 agent would 
read: 
"Rabies street virus " 
h. The language in Class 4 viral agents 
on Monkey pox would read: 
"Monkey pox, when used for 
transmission or animal inoculation 
experiments [4]." 
i. Descriptive language would be 
added to the Classification of 
Oncogenic Viruses on the Basis of 
Potential Hazard [5] as follows: 
"Appendix B-II-A. Low-Risk 
Oncogenic Viruses. These viruses 
should be treated as Class 2 agents. 
"Appendix B-II-B. Moderate-Risk 
Oncogenic Viruses. These viruses 
should be treated as Class 3 agents." 
j. Class 5 Agents (Appendix B-III) 
would be separated into the following 
categories: 
"Appendix B-IU-A. Animal Disease 
Organisms Which Are Forbidden Entry 
Into the United States by Law. ” 
"Appendix B-IIl-B. Animal Disease 
Organisms and Vectors Which Are 
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