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Notification of
Exclusion
The Public Health
Security and Bioterrorism Preparedness and Response Act of 2002 requires
the United States Department of Health and Human Services (HHS) and the
United States Department of Agriculture (USDA) to establish regulations
regarding the possession, use, and transfer of select biological agents and
toxins. In accordance with the Act, HHS and USDA published new regulations
in the Federal Register on December 13, 2002 (67 FR 76886-76905 and 67 FR
76908-76938, respectively). The HHS regulations are set out in 42 CFR Part
73 and the USDA regulations are set out in 7 CFR Part 331 and 9 CFR Part
121.
The regulations in 42 CFR Part 73 and 9 CFR Part 121 establish a procedure
by which an attenuated strain of a select biological agent or toxin that
does not pose a severe threat to public health and safety, animal health, or
animal products may be excluded from the list of select biological agents
and toxins.
HHS has received requests for exclusions for Yersinia pestis strains,
Bacillus anthracis strains, Francisella tularensis subspecies
novicida and Francisella tularensis subspecies holartica
LVS.
USDA has received requests for exclusions for Bacillus anthracis
Sterne strain and Francisella tularensis subspecies holartica
LVS.
Based upon consultations with subject matter experts and a review of
relevant published studies and information provided by the entities
requesting the exclusions, HHS and USDA have determined that the following
attenuated strains are not subject to the requirements of 42 CFR Part 73 and
9 CFR Part 121 if used in basic or applied research, as positive controls,
for diagnostic assay development, or for the development of vaccines and
therapeutics.
However, an individual or entity that possesses, uses, or transfers an
excluded attenuated strain will be subject to the regulations if there is
any reintroduction of factor(s) associated with virulence or other
manipulations that modify the attenuation such that virulence is restored or
enhanced.
Attenuated strains of
HHS select agents and toxins excluded:
-
Coccidioides posadasii ∆chs5 strain. (effective 10-14-2003)
Background
- Conotoxins
specifically excluded are: the class of sodium channel antagonist
μ-conotoxins, including GIIIA; the class of calcium channel antagonist ω-conotoxins,
including GVIA, GVII, MVIIA, MVIIC, and their analogs or synthetic
derivatives; the class of NMDA-antagonist conantokins, including con-G,
con-R, con-T and their analogs or synthetic derivatives; and the putative
neurotensin agonist, contulakin-G and its synthetic derivatives.
(effective 4-29-2003)
Background
- Yersinia pestis
strains which are Pgm- due to a deletion of a 102-kb region of
the chromosome termed the pgm locus (i.e., ∆pgm).
Examples are Y. pestis strain E.V. or various substrains such as
EV 76. (effective 3-14-2003)
Background
- Yersinia pestis
strains (e.g., Tjiwidej S and CDC A1122) devoid of the 75 kb low-calcium
response (Lcr) virulence plasmid. (effective 2-27-2003)
Background
Attenuated strains of
Overlap select agents and toxins excluded:
- Bacillus anthracis
strains devoid of both plasmids pX01 and pX02. (effective 2-27-2003)
Background
- Bacillus anthracis
strains devoid of the plasmid pX02 (e.g., Bacillus anthracis Sterne,
pX01+pX02-). (effective 2-27-2003)
Background
- Brucella abortus
Strain 19. (effective 6-12-2003)
Background
- Brucella abortus
strain RB51 (vaccine strain). (effective 5-7-2003)
Background
-
Coxiella burnetii Phase II, Nine Mile Strain, plaque purified
clone 4 (effective 10-15-2003)
Background
- Francisella
tularensis subspecies novicida (also referred to as
Francisella novicida) strain, Utah 112 (ATCC 15482). (effective
2-27-2003)
Background
- Francisella
tularensis subspecies holartica LVS (live vaccine strain;
includes NDBR 101 lots, TSI-GSD lots, and ATCC 29684). (effective
2-27-2003)
Background
- Francisella
tularensis ATCC 6223 (also known as strain B38). (effective 4-14-2003)
Background
- Venezuelan Equine
Encephalitis (VEE) virus vaccine candidate strain V3526. (effective
5-5-2003)
Background
Compiled background list
Notifications of
Exclusions for USDA-only agents are located at:
http://www.aphis.usda.gov/vs/ncie/bta.html.
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