[Federal Register Volume 76, Number 196 (Tuesday, October 11, 2011)]
[Notices]
[Pages 62816-62817]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-26224]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Office of Biotechnology Activities; Recombinant DNA Research:
Action Under the NIH Guidelines for Research Involving Recombinant DNA
Molecules (NIH Guidelines)
AGENCY: National Institutes of Health (NIH), Public Health Services
(PHS), Department of Health and Human Services, (DHHS).
ACTION: Notice of Final Action under the NIH Guidelines.
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SUMMARY: The Office of Biotechnology Activities (OBA) is updating
Appendix B of the NIH Guidelines to specify the risk group (RG)
classification for several common attenuated strains of bacteria and
viruses that are frequently used in recombinant DNA research. OBA is
also specifying the risk group for several viruses not previously
listed in Appendix B. In addition, a reference to Appendix B will be
added to Section II-A of the NIH Guidelines, which addresses the risk
assessment for research with recombinant DNA.
Background: The NIH Guidelines provide guidance to investigators
and local Institutional Biosafety Committees (IBCs) for setting
containment for recombinant DNA research. Section II-A, Risk
Assessment, instructs investigators and IBCs to make an initial risk
assessment based on the RG of the agent (see Appendix B, Classification
of Human Etiologic Agents on the Basis of Hazard). The RG of the agent
often correlates with the minimum containment level required for
experiments subject to the NIH Guidelines.
The classification of agents into various RG categories is based
largely on their ability to cause human disease and the availability of
treatments for that disease. For the most part, the organisms listed in
Appendix B are wild-type, non-attenuated strains and a distinction is
not made between the RG classification for the wild-type organism and a
corresponding attenuated strain. A few attenuated strains are
classified in Appendix B at a lower RG than that of the wild-type
organism. However, there are a number of well-established attenuated
strains commonly employed in research that are not specifically listed
and thus by default are included in the same RG as the wild-type
organism. Therefore, the biosafety level (BL) specified for research
subject to the NIH Guidelines may be identical for experimentation with
either the attenuated or the wild-type strain.
OBA has conducted an evaluation of certain attenuated strains,
focusing on those for which a risk assessment had been undertaken and
containment recommendations determined in the Centers for Disease
Control and Prevention (CDC)/NIH publication Biosafety in
Microbiological and Biomedical Laboratories (BMBL) (5th edition). In
addition, the NIH Recombinant DNA Advisory Committee (RAC) discussed
the appropriate containment for two attenuated strains of Yersinia
pestis (lcr(-) and pgm(-) mutants) at its meeting
on June 16, 2010. (A webcast of that discussion is available at http://oba.od.nih.gov/rdna_rac/rac_past_meetings_2010.html.)
Specifying the risk groups for attenuated strains in Appendix B of
the NIH Guidelines will lead to more uniform containment
recommendations that are commensurate with the biosafety risk. In
addition, OBA has identified several RG3 viruses that are not currently
specified in Appendix B or are a member of a family of viruses
otherwise classified as RG2. Therefore, Appendix B is being updated to
address these viruses as well.
OBA consulted the NIH RAC as well as other subject matter experts
from NIH, CDC, and academia. These proposed changes were published in
the Federal Register (76 FR 44339) on July 25, 2011, and one comment
was received. This comment, from the American Biological Safety
Association (ABSA), suggested that ``OBA should consider adding
additional information to Section II-A-3 covering the assignment of
Risk Group to commonly used attenuated strains.'' Section II-A of the
NIH Guidelines provides a framework for conducting a comprehensive risk
assessment. These proposed changes to Appendix B and ABSA's comment
were discussed at the September 13, 2011, meeting of the RAC. OBA and
the RAC appreciated ABSA's comments and will add a reference to
Appendix B to the last sentence of the first paragraph of Section II-A-
3. The last sentence of the first paragraph of Section II-A-3 currently
reads: ``Certain attenuated strains or strains that have been
demonstrated to have irreversibly lost known virulence factors may
qualify for a reduction of the containment level compared to the Risk
Group assigned to the parent strain (see Section V-B, Footnotes and
References of Sections I-IV).'' It will be amended to read:
Certain attenuated strains or strains that have been demonstrated
to have irreversibly lost known virulence factors may qualify for a
reduction of the containment level compared to the Risk Group assigned
to the parent strain (see Appendix B, Classification of Human Etiologic
Agents on the Basis of Hazard and Section V-B, Footnotes and References
of Sections I-IV).
In addition to the change to the first paragraph of Section II-A-3,
the following additions will be made to Appendix B-II-A. Risk Group 2
(RG2)--Bacterial Agents Including Chlamydia:
Coxiella burnetii, Nine Mile strain, plaque purified, clone 4.
*Francisella tularensis subspecies novicida (also referred to as
Francisella novicida) strain, Utah 112.
*Francisella tularensis subspecies holartica LVS.
*Francisella tularensis biovar tularensis strain ATCC 6223 (also known
as strain B38).
Yersinia pestis pgm(-) (lacking the 102 kb pigmentation
locus).
Yersinia pestis lcr(-) (lacking the LCR plasmid).
The following footnote will be added regarding research with
attenuated strains of Francisella:
*For research involving high concentrations, BL3 practices should be
considered (See Appendix G-II-C-2).
The following changes/additions will be made to Appendix B-II-D
Risk Group 2 (RG2)--Viruses:
Alphaviruses (Togaviruses)--Group A Arboviruses:
``Venezuelan equine encephalomyelitis vaccine strain TC-83'' will
be changed to:
Venezuelan equine encephalomyelitis vaccine strains TC-83 and
V3526.
Alphaviruses (Togaviruses)--Group A Arboviruses:
Add: Chikungunya vaccine strain 181/25.
Arenaviruses:
Add: Junin virus candid 1 vaccine strain.
Flaviviruses (Togaviruses)--Group B Arboviruses:
Add: Japanese encephalitis virus strain SA 14-14-2.
Rhabdoviruses:
``Vesicular stomatitis virus--laboratory adapted strains including
VSV--Indiana, San Juan, and Glasgow'' will be changed to:
Vesicular stomatitis virus non-exotic strains: VSV--Indiana 1
serotype strains (e.g. Glasgow, Mudd-Summers, Orsay, San Juan) and
VSV--New Jersey serotype strains (e.g. Ogden, Hazelhurst).
The following additions will be made to Appendix B-III-D Risk Group
3 (RG3)--Viruses and Prions:
Add: Coronaviruses:
Add: SARS-associated coronavirus
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(SARS--CoV).
Alphaviruses (Togaviruses)--Group A Arboviruses:
Add: Chikungunya.
Flaviviruses (Togaviruses)--Group B Arboviruses:
Add: West Nile virus (WNV).
Dated: October 3, 2011.
Jacqueline Corrigan-Curay,
Acting Director, Office of Biotechnology Activities, National
Institutes of Health.
[FR Doc. 2011-26224 Filed 10-7-11; 8:45 am]
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