Summary: USDA/APHIS 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 animal or plant health, or to animal or plant products. This is the final rule of the third biannual review that is required due to regulations created by the Agricultural Bioterrorism Protection Act of 2002. DHHS/CDC 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.” Regulations 7 CFR Part 331 and 9 CFR Part 121 govern the select agents regulated by APHIS, including the Plant Protection and Quarantine select agents (PPQ, for the plant agents and toxins listed in 7 CFR 331.3), Veterinary Services select agents (VS, for the animal agents and toxins listed in 9 CFR 121.3), or ‘‘overlap select agents and toxins’’ (for the agents and toxins listed in both 9 CFR 121.4 and 42 CFR 73.4). The current list of select agents and toxins is available here. Use of select agents found on both APHIS and the CDC select agent lists are subject to both agency regulations and oversight.
1. Modification of select agent and toxin list
a. Exclusion of current PPQ agents: Any subspecies of Ralstonia solanacearum except race 3, biovar 2 and all subspecies of Sclerophthora rayssiae except var. zeae, and Xylella fastidiosa, citrus variegated chlorosis (CVC) strain.
b. Exclusion of current VS agents: 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 leuropneumonia), 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.
c. The current select agent and toxin list is: African horse sickness virus, African swine fever virus, Avian influenza virus, Classical swine fever virus, Foot-and-mouth disease virus, Goat pox virus, Lumpy skin disease virus, Mycoplasma capricolum, Mycoplasma mycoides, Newcastle disease virus, Peste des petits ruminants virus, Rinderpest virus, Sheep pox virus, and Swine vesicular disease virus
d. The current Plant Protection and Quarantine select agents list is: Peronosclerospora philippinensis (Peronosclerospora sacchari), Phoma glycinicola (formerly Pyrenochaeta glycines), Ralstonia solanacearum, Rathayibacter toxicus, Sclerophthora rayssiae, Synchytrium endobioticum, and Xanthomonas oryzae
2. Tiering of the select agent and toxin lists:
a. Tier 1 select agents and toxins:
i. PPQ select agents and toxins: None.
ii. VS select agents and toxins: Foot and-mouth disease virus and Rinderpest virus.
iii. VS/HHS overlap select agents and toxins: Bacillus anthracis, Burkholderia mallei, and 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.
Background: To be considered for placement on the Select agents or toxins list, certain criteria must be considered:
- The effect of exposure to the agent or the toxin on animal and plant health, and on the production and marketability of animal or plant products;
- The pathogenicity of the agent or the toxin and the methods by which the agent or toxin is transferred to animals or plants;
- The availability and effectiveness of pharmacotherapies and prophylaxis to treat and prevent any illness or disease caused by the agent or toxin; and
- Any other criteria that the Secretary considers appropriate to protect animal or plant health, or animal or plant products.
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”. Criteria for which all select agents are judged can be found in the Federal Register final rule notice in the “B. Tiering of Select Agents and Toxins” section.
Effective Dates: There will be a “phase-in” approach for the new regulations to be in effect:
Sixty days from the publication (December 4th,2012): 7 CFR 331.1 through 331.10, 331.13, and 331.16 through 331.20 and 9 CFR 121.1 through 121.10, 121.13, 121.16, 121.17, and 121.20.
One hundred and eighty days (April 3rd, 2012): 7 CFR 331.11, 331.12, 331.14, and 331.15 and 9 CFR 121.11, 121.12, 121.13, 121.14, and 121.15.
Cost of Regulations: APHIS believes that there will be minimal cost for the information protection portions of the regulations to take effect, as most institutions have demonstrated this ability, as determined through site inspections. Most likely, institutions with Select Agents and toxins identified as Tier 1 will be require increased compliance costs, presumable through pre-access suitability reviews and enrollment in an occupational health and safety program (total cost $2.8 – $4.4 million, $9,600 – $15,100 per entity). Now that the regulations have shortened the FBI-conducted background check valid period from 5 to 3 years, the cost of the program (borne by the government) will increase 67%, working out to cost $1.96 million over the next five years ($432,000 annually). Software updates could cost $2 million per year ($5,500 / entity).
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.