Policy Statement

Date: August 13, 2014

Subject: FSAP Policy Statement: Laboratory work with the regulated full-length genomes of regulated Risk Group 3 and 4 (RG3 and RG4) agents at one containment level lower than the infectious virus without RNA inactivation

The Federal Select Agent Program (FSAP) is a collaboration between the Center for Disease Control and Prevention (CDC), Division of Select Agents and Toxins (DSAT) and the Animal and Plant Health Inspection Service (APHIS) Agriculture Select Agent Services (AgSAS) to regulate the possession, use, and transfer of biological agents listed in 7 C.F.R. Part 331, 9 C.F.R. Part 121, and 42 C.F.R. Part 73 (select agents and toxins). The FSAP administers the select agents and toxins regulations in close coordination with the Federal Bureau of Investigation’s Criminal Justice Information Services (CJIS).

Authority:
For biological agents and toxins determined by HHS to have the potential to pose a severe threat to public health and safety (select agents and toxins), the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (42 U.S.C. 262a) directs the promulgation of regulations to establish and enforce safety procedures for the possession and use of select agents and toxins, including measures to ensure proper training and appropriate skills to handle such agents and toxins. 42 U.S.C. § 262a(c)

For biological agents and toxins determined by USDA to have the potential to pose a severe threat to animal health or animal products (select agents and toxins), the Agricultural Bioterrorism Act of 2002 (7 U.S.C. 8401) directs the promulgation of regulations to establish and enforce safety procedures for the possession and use of such select agents and toxins, including measures to ensure proper training and appropriate skills to handle such select agents and toxins. (7 U.S.C. 8401(c))

Zoonotic select agents and toxins are regulated by both HHS and USDA. See 42 CFR 73.4 and 9 CFR 121.4.

Federal regulations require that for entities that possess select agents and toxins their “biosafety and containment procedures must be sufficient to contain the select agent or toxin (e.g., physical structure and features of the entity, and operational and procedural safeguards).” See 42 CFR 73.12(b), 9 CFR 121.12(b).

Policy Statement:
The FSAP received recommendations from a group of Federal subject matter experts (SME) regarding working safely with regulated genomes at lower containment if certain conditions are met. Based upon the SME recommendations it is the policy of the FSAP that a registered entity can perform laboratory work with the regulated full-length genomes of regulated Risk Group 3 and 41 (RG32 and RG43) agents at one containment level lower than the infectious virus without RNA inactivation (i.e., the viral RNA has not been degraded with RNase or otherwise treated or denatured to render it incapable of producing infectious virus).

Note:Regardless of the biosafety level used, the full length genomes capable of producing infectious virus are regulated. For a list of viruses whose genomes are subject to the regulations please see the Guidance on the Regulation of Select Agent & Toxin Nucleic Acids.

If working with regulated genomic material from a Tier 1 positive strand RNA virus (currently only Foot-and-mouth disease virus), lower containment laboratories would still have to maintain the Tier 1 requirements. To work with regulated RG3 and RG4 (+) ssRNA genomic material in laboratories one containment level lower than the level required for the infectious virus, the following additional safety practices must be in place:

  • The genomic material must be free of infectious virus before removing the genomic material from the laboratory designated to work with the live virus.
  • Work must be performed inside a biosafety cabinet (BSC) or equivalent containment device.
  • No concurrent work with mammalian cell culture or in vitro translation experiments are conducted in the same laboratory.
  • No concurrent transfection work or in vitro translation reagents are used or stored in the same laboratory.
  • Personal protective equipment (PPE) must afford adequate mucosal membrane protection to avoid the risk of auto-inoculation and include the following:
    • Disposable or suite-dedicated lab coats.
    • Protective eyewear or face shield.
    • Gloves (latex, vinyl, nitrile, etc.) are chosen to resist those chemicals and or solvents used in cloning procedures.
  • Avoid glassware – plastic ware is recommended.
  • Avoid sharps, including needles and syringes.

This policy statement is effective August 13, 2014.

This policy statement will be provided to the Responsible Official via SAgram for each registered entity on or before the effective date; and to the Responsible Official for each newly registered entity during the registration process.

Any question concerning this policy may be addressed by contacting the Federal Select Agent Program at lrsat@cdc.gov or AgSAS@aphis.usda.gov.

null
Robbin S. Weyant, PhD, RBP (ABSA)
Captain, USPHS (Ret.)
Director, Division of Select Agents and Toxins
Department of Health and Human Services
Centers for Disease Control and Prevention
null
Freeda E. Isaac, DVM
Director, Agriculture Select Agent Services
United States Department of Agriculture
Animal and Plant Health Inspection Service
1. NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules, Appendix B.
2. Agents that are associated with serious or lethal human disease for which preventive or therapeutic interventions may be available (high individual risk but low community risk)
3. Agents that are likely to cause serious or lethal human disease for which preventive or therapeutic interventions are not usually available (high individual risk and high community risk)