The HHS and APHIS published regulatory changes to the select agent and toxin rules in the October 5, 2012 Federal Register (see links above). The final rule changes implement the findings of the third biennial review of the select agent and toxin lists, designate a subset of the list of select agents and toxins as Tier 1 based on their risk to be deliberately misused, and change security requirements for entities possessing Tier 1 select agents and toxins.
Highlights of the DHHS changes include:
- The following viruses are added to the HHS select agent list “based on scientific data related to their significant public health risk”: SARS-CoV, Lujo and Chapare viruses
- The following agents are removed from the list of HHS and overlap select agents and toxins: Herpes B virus, Clostridium perfringens epsilon toxin, Coccidioides posadasii/Coccidioides immitis, Eastern Equine Encephalitis virus (South American type only), Flexal virus, West African clade of Monkeypox virus, Rickettsia rickettsii, the non-short, paralytic alpha conotoxins containing the following amino acid sequence, CCX2, PACGX3, X4, X5, X6, CX7, Shigatoxins, Shiga-like ribosome inactivating proteins, Staphylococcal Enterotoxins L(non-A, non-B, non-C, non-D, and non-E subtypes and Tick-borne encephalitis complex viruses (Central European subtype)
- The following agent would no longer be considered an overlap select agent: Venezuelan Equine Encephalitis Virus (subtypes ID and IE)
- Executive Order 13546 directed HHS to designate a subset of the select agent and toxin list as Tier 1, a category that presents the greatest risk of deliberate misuse with the greatest potential for mass casualties or devastating effects to the economy, critical infrastructure or public confidence. There are eight (8) HHS Tier 1 select agents and toxins: Ebola virus, Francisella tularensis, Marburg virus, Variola major virus, Variola minor virus, Yersinia pestis, Botulinum neurotoxin, Botulinum neurotoxin producing species of Clostridium; and three (3) Tier 1 Overlap select agents and toxins: Bacillus anthracis, Burkholderia mallei, and Burkholderia pseudomallei
- There are changes in the rules for physical security for entities possessing Tier 1 select agents and toxins, including requirements for pre-access assessments and monitoring of personnel with access to Tier 1 agents and toxins
- There are miscellaneous revisions to the regulations concerning security, training, biosafety and incident response
- The effective date for amendments to 73.1, 73.3-73.6, 73.9. 73.10, 73.13, 73.16, 73.17 and 73.20 is December 4, 2012.The remaining provisions of the final rule are effective April 3, 2013.
Highlights of the APHIS changes include:
- The following agents would no longer be considered PPQ select agents or toxins, or would be excluded from compliance with the select agent regulations: Any subspecies of Ralstonia olanacearum except race 3, biovar 2 and all subspecies of Sclerophthora rayssiae except var. zeae, and Xylella fastidiosa, citrus variegated chlorosis (CVC) strain.
- The following agents would no longer be considered VS select agents or toxins, or would be excluded from compliance with the select agent regulations: Any low pathogenic strains of avian influenza virus, any strain of Newcastle disease virus which does not meet the criteria for virulent Newcastle disease virus, all subspecies Mycoplasma capricolum except subspecies capripneumoniae (contagious caprine pleuropneumonia), and all subspecies Mycoplasma mycoides except subspecies mycoides small colony (Mmm SC) (contagious bovine pleuropneumonia), Akabane virus; Bluetongue virus (exotic), Bovine spongiform encephalopathy agent; Camel pox virus; Ehrlichia ruminantium (Heartwater); Japanese encephalitis virus; Malignant catarrhal fever virus (Alcelaphine herpesvirus type 1); Menangle virus; and Vesicular stomatitis virus (exotic): Indiana subtypes VSV-IN2, VSV-IN3.
- The following agent would no longer be considered a VS/Department of Health and Human Services (HHS) overlap select agent: Venezuelan Equine Encephalitis Virus (subtypes ID and IE).
- Tiering of the select agent and toxin lists:
- Tier 1 select agents and toxins: PPQ select agents and toxins: None.
- VS select agents and toxins: Foot-and-mouth disease virus and Rinderpest virus.
- VS/HHS overlap select agents and toxins: Bacillus anthracis, Burkholderia mallei, and Burkholderia pseudomallei.
- Establishes physical security standards for entities possessing Tier 1 select agents and toxins, including the requirement to conduct pre-access assessments and ongoing monitoring of personnel with access to Tier 1 agents and toxins;
- Miscellaneous revisions to the regulations to clarify regulatory language concerning security, training, biosafety, and incident response.