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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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This page last reviewed March 16, 2004

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