[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
________________________________________________________________________
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