Summary: HHS/NIH/CDC is amending and republishing the list of select agents and toxins and their governing regulations that have the potential to pose a severe threat to human health. This is the current final rule determined by a review that is required due to regulations created by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. USDA/APHIS has also recently updated their guidance. The select agent list is being reorganized, to reflect the relative potential of each agent for misuse/intentional release. In addition, a tier system will be established for the most dangerous agents, Tier 1. A “Tier 1” select agent should meet the criteria established in Executive Order 13546 which requires the designation of a “subset of the Select Agent List (Tier 1) that presents the greatest risk of deliberate misuse with most significant potential for mass casualties or devastating effects to the economy, critical infrastructure, or public confidence.” Regulation 42 CFR Part 73 governs the select agents enforced by HHS. The current list of select agents and toxins is available here (for both the USDA and HHS). Use of select agents found on both HHS and the CDC select agent lists are subject to both agency regulations and oversight.
1. Modification of HHS select agent and toxin list
a. Adding: Chapare virus, Lujo virus, and SARS-associated coronavirus (SARS-CoV)
b. Removing: Cercopithecine Herpesvirus 1 (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 1 C = Cysteine residues (indicated in bold) are all present as disulfides, with the 1st and 3rd Cysteine, and the 2nd and 4th Cysteine forming specific disulfide bridges; The consensus sequence includes known toxins a-MI and a-GI (shown above) as well as a-GIA, Ac1.1a, a-CnIA, a-CnIB; X1 = any amino acid(s) or Des-X; X2 = asparagine or Histidine; P = Proline; A = Alanine; G = Glycine; X3 = Arginine or Lysine; X4 = Asparagine, Histidine, Lysine, Arginine, Tyrosine, Phenylalanine or Tryptophan; X5 = Tyrosine, Phenylalanine, or Tryptophan; X6 = Serine, Threonine, Glutamate, Aspartate, Glutamine, or Asparagine; X7 = Any amino acid(s) or Des X; and ‘‘Des X’’ = ‘‘an amino acid does not have to be present at this position.’’ For example if a peptide sequence were XCCHPA then the related peptide CCHPA would be designated as Des-X. X1CCX2PACGX3X4X5X6CX7, 1 Shigatoxins, Shiga-like ribosome inactivating proteins, Staphylococcal Enterotoxins (non-A, non-B, non-C, non- D, and non-E subtypes), and Tick-borne encephalitis complex viruses (Central European subtype).
c. Removing Overlap agent: Venezuelan Equine Encephalitis Virus (subtypes ID and IE).
2. Tiering of the select agent and toxin lists:
a. Tier 1 select agents and toxins:
i. Ebola virus
ii. Francisella tularensis
iii. Marburg virus
iv. Variola major virus
v. Variola minor virus
vi. Yersinia pestis
vii. Botulinum neurotoxin
viii. Botulinum neurotoxin producing species of Clostridium
b. VS/HHS overlap select agents and toxins:
i. Bacillus anthracis
ii. Burkholderia mallei
iii. Burkholderia pseudomallei
3. Establishing 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. Of note, those agents/toxins not selected for Tier 1 status do not have a lessened health risk as compared to previous regulations.
4. Miscellaneous revisions to the regulations to clarify regulatory language concerning security, training, biosafety, and incident response.
Effective Dates: The amendments to §§ 73.1, 73.3 through 73.6, 73.9, 73.10, 73.13, 73.16, 73.17, and 73.20, of Title 42, Code of Federal Regulations are effective December 4, 2012. The remaining provisions to this final rule are effective April 3, 2013.
Applicability Dates: By December 4, 2012, all entities that possess SARS, Chapare, and Lujo viruses must provide notice to CDC regarding their possession of these viruses, and by April 3, 2013, all previously unregistered entities must meet all of the requirements of this part.
For further insight into the new regulations, there will be a Select Agent Program Workshop webinar taking place November 16th, 2012, from 9 AM to 5 PM (EST). This event is hosted by the DHHS, USDA, and FBI.