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Guidelines for Handling Exempt Strains of Select Agents

The United States Department of Health and Human Services (HHS) and the United States Department of Agriculture (USDA) have established regulations for the possession, use and transfer of select agents and toxins (see 42 CFR Part 73, 7 CFR Part 331 and 9 CFR Part 121). These regulations have also established a procedure by which an attenuated strain of a select agent that does not pose a severe threat to public health and safety, animal health, or animal products may be excluded from the requirements of the regulations when used for specific purposes. Please note that if an excluded attenuated strain is manipulated in such a way that virulence is restored or enhanced, or if factors associated with virulence are reintroduced, it will then be subject to the regulations. Because of the nature of these exempt strains and the potential for them to be manipulated for use as a biological weapon, the Office of Environmental Health and Safety/Office of Radiation, Chemical and Biological Safety (EHS/ORCBS) has implemented the containment and security requirements outlined in Appendix J for handling exempt strains of select agents.

The containment and security requirements apply to the following exempt strains of select agents:

• Bacillus anthracis strains devoid of both plasmids pX01 and pX02
• Bacillus anthracis strains devoid of the plasmid pX02 (e.g., Bacillus anthracis Sterne, pX01 + pX02 - )
• Brucella abortus strain RB51 (vaccine strain)
• Brucella abortus strain 19
• Coxiella burnetii Phase II, Nine Mile Strain, plaque purified clone 4
• Francisella tularensis subspecies novicida (also referred to as Francisella novicida ) strain, Utah 112 (ATCC 15482)
• Francisella tularensis subspecies holartica LVS (live vaccine strain; includes NDBR 101 lots, TSI-GSD lots, and ATCC 29684)
• Francisella tularensis ATCC 6223 (also known as strain B38)
• Rift Valley fever virus, MP-12 vaccine strain
• Venezuelan equine encephalitis virus, TC-83 strain
• Venezuelan equine encephalitis virus vaccine candidate strain V3526
• Highly pathogenic avian influenza virus, recombinant vaccine reference strains of the H5N1 and H5N3 subtypes
• Japanese encephalitis virus, SA-14-14-2 strain

Guidelines for the Use of Exempt Levels of Select Agent Toxins

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