[Federal Register Volume 85, Number 52 (Tuesday, March 17, 2020)]
[Proposed Rules]
[Pages 15078-15079]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-05499]


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 Proposed Rules
                                                 Federal Register
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 This section of the FEDERAL REGISTER contains notices to the public of 
 the proposed issuance of rules and regulations. The purpose of these 
 notices is to give interested persons an opportunity to participate in 
 the rule making prior to the adoption of the final rules.
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  Federal Register / Vol. 85, No. 52 / Tuesday, March 17, 2020 / 
Proposed Rules  

[[Page 15078]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

7 CFR Part 331

9 CFR Part 121

[Docket No. APHIS-2019-0018]
RIN 0579-AE52


Agricultural Bioterrorism Protection Act of 2002; Biennial Review 
and Republication of the Select Agent and Toxin List

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Advance notice of proposed rulemaking and request for comments.

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SUMMARY: In accordance with the Agricultural Bioterrorism Protection 
Act of 2002, we are soliciting public comment regarding the list of 
select agents and toxins that have the potential to pose a severe 
threat to animal or plant health, or to animal or plant products. The 
Act requires the biennial review and republication of the list of 
select agents and toxins and the revision of the list as necessary. 
Accordingly, we are soliciting public comment on the current list of 
select agents and toxins in our regulations and suggestions regarding 
any addition or reduction of the animal or plant pathogens currently on 
the list of select agents.

DATES: We will consider all comments that we receive on or before May 
18, 2020.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2019-0018.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2019-0018, Regulatory Analysis and Development, PPD, 
APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-
1238.
    Supporting documents and any comments we receive on this docket may 
be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2019-
0018 or in our reading room, which is located in room 1141 of the USDA 
South Building, 14th Street and Independence Avenue SW, Washington, DC. 
Normal reading Room hours are 8 a.m. to 4:30 p.m., Monday through 
Friday, except holidays. To be sure someone is there to help you, 
please call (202) 799-7039 before coming.

FOR FURTHER INFORMATION CONTACT: Mrs. Sally Rejas, Program Analyst, 
Agriculture Select Agent Services, Strategy & Policy, VS, APHIS, 4700 
River Road, Riverdale, MD 20716; (301) 851-3384.

SUPPLEMENTARY INFORMATION: 

Background

    The Public Health Security and Bioterrorism Preparedness and 
Response Act of 2002 provides for the regulation of certain biological 
agents and toxins that have the potential to pose a severe threat to 
human, animal, and plant health, or to animal and plant products. The 
Animal and Plant Health Inspection Service (APHIS) has the primary 
responsibility for implementing the provisions of the Act within the 
U.S. Department of Agriculture (USDA). Veterinary Services (VS) select 
agents and toxins, listed in 9 CFR 121.3, are those that have been 
determined to have the potential to pose a severe threat to animal 
health or animal products. Plant Protection and Quarantine (PPQ) select 
agents and toxins, listed in 7 CFR 331.3, are those that have been 
determined to have the potential to pose a severe threat to plant 
health or plant products. Overlap select agents and toxins, listed in 9 
CFR 121.4, are those that have been determined to pose a severe threat 
to public health and safety, to animal health, or to animal products. 
Overlap select agents are subject to regulation by both APHIS and the 
Centers for Disease Control and Prevention (CDC), which has the primary 
responsibility for implementing the provisions of the Act for the 
Department of Health and Human Services.
    Title II, Subtitle B of the Public Health Security and Bioterrorism 
Preparedness and Response Act of 2002 (which is cited as the 
``Agricultural Bioterrorism Protection Act of 2002'' and referred to 
below as the Act), section 212(a), provides, in part, that the 
Secretary of Agriculture (the Secretary) must establish by regulation a 
list of each biological agent and each toxin that the Secretary 
determines has the potential to pose a severe threat to animal or plant 
health, or to animal or plant products.
    In determining whether to include an agent or toxin in the list, 
the Act requires that the following criteria be considered:
     The effect of exposure to the agent or toxin on animal or 
plant health, and on the production and marketability of animal or 
plant products;
     The pathogenicity of the agent or the toxicity of 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 caused by the agent or 
toxin;
     Whether such inclusion would have a substantial negative 
impact on the research and development of solutions for the animal and 
plant disease caused by the agent or toxin and whether the negative 
impact would substantially outweigh the risk posed by the agent or 
toxin to animal or plant health if it is not included on the list 
(added by the 2018 Farm Bill); and
     Any other criteria that the Secretary considers 
appropriate to protect animal or plant health, or animal or plant 
products.
    Paragraph (a)(2) of section 212 of the Act requires the Secretary 
to review and republish the list of select agents and toxins every 2 
years and to revise the list as necessary. To fulfill this statutory 
mandate, PPQ and VS each convene separate interagency working groups in 
order to review the lists of PPQ and VS select agents and toxins, as 
well as any overlap select agents and toxins, and develop 
recommendations regarding possible changes to the list using the five 
criteria for listing found in the Act. In this document, we are asking 
for comments on the current list \1\ of select agents and toxins and on 
any other significant pathogens so as to inform the working groups as 
they begin the biennial review process.
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    \1\ You may view the lists of select agents and toxins on the 
internet at http://www.regulations.gov/#!docketDetail;D=APHIS-2019-
0018.
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    As detailed below, we are considering removing one PPQ select 
agent, one VS select agent, and four overlap select

[[Page 15079]]

agents. CDC is publishing a notice concurrently which also lists the 
overlap agents under consideration. Proposed select agent removals are 
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as follows:

PPQ Select Agents

     Peronosclerospora philippinensis (Peronosclerospora 
sacchari): This agent is only able to survive and reproduce in the host 
plant and requires specific environmental conditions to become 
infectious, for which mitigations exist.

VS Select Agents

     African horse sickness virus: This virus is difficult to 
successfully disseminate and effectively transmit. An effective vaccine 
exists.

Overlap Select Agents

     Bacillus anthracis (Pasteur strain): This agent presents 
little economic or animal health risk due to low mortality rates, low 
virulence, and minimal risk of farm-to-farm transmission due to modern 
production practices (e.g., physical separation of groups of animals on 
farms and robust quarantine protocols in the face of any infection).
     Brucella abortus: This agent presents little economic or 
animal health risk as it is unlikely to result in large-scale 
population introduction due to the high concentration of the agent 
necessary to produce disease as well as modern cattle production 
processes that limit animal-to-animal transmission routes. There is an 
efficacious vaccine, moderate immunity status within vulnerable 
populations, limited farm-to-farm transmission risk, and effective 
quarantine procedures.
     Brucella melitensis: This agent, which primarily affects 
goats and sheep, is of lesser concern because the low farm-to-farm 
transmission risk due to modern production practices limits the chance 
of introduction on a scale large enough to impact domestic production.
     Brucella suis: This agent presents a low to moderate 
animal health risk due to limited farm-to-farm transmission risk as a 
result of modern production practices which reduce the risk of a large-
scale introduction.
     Venezuelan equine encephalitis virus: An effective vaccine 
exists for this agent, which contributes to a high level of immunity 
within vulnerable populations. Furthermore, large-scale production and 
efficient dissemination would be difficult due to the virus' limited 
ability to persist in the environment outside of an infected animal or 
mosquito host.
    At the conclusion of the comment review process, we will publish 
another document in the Federal Register either republishing the lists 
of select agents and toxins in 7 CFR 331.3, 9 CFR 121.3, and 9 CFR 
121.4 or proposing changes to one or more of the lists.
    This action has been determined to be significant for the purposes 
of Executive Order 12866 and, therefore, has been reviewed by the 
Office of Management and Budget.

    Authority:  7 U.S.C. 8401; 7 CFR 2.22, 2.80, 371.3, and 371.4.

    Done in Washington, DC, this 25th day of February 2020.
Greg Ibach,
Under Secretary for Marketing and Regulatory Programs.
[FR Doc. 2020-05499 Filed 3-16-20; 8:45 am]
 BILLING CODE 3410-34-P