80 FR 10627 - Agricultural Bioterrorism Protection Act of 2002; Biennial Review and Republication of the Select Agent and Toxin List

DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service

Federal Register Volume 80, Issue 39 (February 27, 2015)

Page Range		10627-10627
FR Document		2015-04180

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.

Federal Register, Volume 80 Issue 39 (Friday, February 27, 2015)

[Federal Register Volume 80, Number 39 (Friday, February 27, 2015)]
[Proposed Rules]
[Page 10627]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-04180]


========================================================================
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.

========================================================================


Federal Register / Vol. 80, No. 39 / Friday, February 27, 2015 / 
Proposed Rules

[[Page 10627]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

7 CFR Part 331

9 CFR Part 121

[Docket No. APHIS-2014-0095]
RIN 0579-AE08


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.

-----------------------------------------------------------------------

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 April 
28, 2015.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2014-0095.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2014-0095, 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-2014-
0095 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: Dr. Charles L. Divan, Unit Director, 
Agricultural Select Agent Services, APHIS, 4700 River Road Unit 2, 
Riverdale, MD 20737-1231; (301) 851-3300.

SUPPLEMENTARY INFORMATION: 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, 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 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; 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 four 
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.
---------------------------------------------------------------------------

    \1\ You may view the lists of select agents and toxins on the 
Internet at http://www.selectagents.gov/SelectAgentsandToxinsList.html.
---------------------------------------------------------------------------

    This action has been determined to be not significant for the 
purposes of Executive Order 12866 and, therefore, has not 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 23rd day of February 2015.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2015-04180 Filed 2-26-15; 8:45 am]
BILLING CODE 3410-34-P

10627

Proposed Rules Federal Register
Vol. 80, No. 39

Friday, February 27, 2015

This section of the FEDERAL REGISTER may be viewed at http:// Secretary determines has the potential
contains notices to the public of the proposed www.regulations.gov/ to pose a severe threat to animal or plant
issuance of rules and regulations. The #!docketDetail;D=APHIS-2014-0095 or health, or to animal or plant products.
purpose of these notices is to give interested in our reading room, which is located in In determining whether to include an
persons an opportunity to participate in the Room 1141 of the USDA South
rule making prior to the adoption of the final agent or toxin in the list, the Act
Building, 14th Street and Independence requires that the following criteria be
rules.
Avenue SW., Washington, DC. Normal considered:
reading room hours are 8 a.m. to 4:30 • The effect of exposure to the agent
DEPARTMENT OF AGRICULTURE p.m., Monday through Friday, except or toxin on animal or plant health, and
holidays. To be sure someone is there to on the production and marketability of
Animal and Plant Health Inspection help you, please call (202) 799–7039 animal or plant products;
Service before coming.
• The pathogenicity of the agent or
FOR FURTHER INFORMATION CONTACT: Dr. the toxin and the methods by which the
7 CFR Part 331 Charles L. Divan, Unit Director, agent or toxin is transferred to animals
Agricultural Select Agent Services, or plants;
9 CFR Part 121 APHIS, 4700 River Road Unit 2,
• The availability and effectiveness of
Riverdale, MD 20737–1231; (301) 851–
[Docket No. APHIS–2014–0095] pharmacotherapies and prophylaxis to
3300.
RIN 0579–AE08 treat and prevent any illness caused by
SUPPLEMENTARY INFORMATION: The
the agent or toxin; and
Public Health Security and Bioterrorism
Agricultural Bioterrorism Protection • Any other criteria that the Secretary
Preparedness and Response Act of 2002
Act of 2002; Biennial Review and considers appropriate to protect animal
provides for the regulation of certain
Republication of the Select Agent and or plant health, or animal or plant
biological agents and toxins that have
Toxin List products.
the potential to pose a severe threat to
AGENCY: Animal and Plant Health human, animal, and plant health, or to Paragraph (a)(2) of section 212 of the
Inspection Service, USDA. animal and plant products. The Animal Act requires the Secretary to review and
and Plant Health Inspection Service republish the list of select agents and
ACTION: Advance notice of proposed
(APHIS) has the primary responsibility toxins every 2 years and to revise the
rulemaking and request for comments.
for implementing the provisions of the list as necessary. To fulfill this statutory
SUMMARY: In accordance with the Act within the U.S. Department of mandate, PPQ and VS each convene
Agricultural Bioterrorism Protection Act Agriculture (USDA). Veterinary Services separate interagency working groups in
of 2002, we are soliciting public (VS) select agents and toxins, listed in order to review the lists of PPQ and VS
comment regarding the list of select 9 CFR 121.3, are those that have been select agents and toxins, as well as any
agents and toxins that have the potential determined to have the potential to pose overlap select agents and toxins, and
to pose a severe threat to animal or plant a severe threat to animal health or develop recommendations regarding
health, or to animal or plant products. animal products. Plant Protection and possible changes to the list using the
The Act requires the biennial review Quarantine (PPQ) select agents and four criteria for listing found in the Act.
and republication of the list of select toxins, listed in 7 CFR 331.3, are those In this document, we are asking for
agents and toxins and the revision of the that have been determined to have the comments on the current list 1 of select
list as necessary. Accordingly, we are potential to pose a severe threat to plant agents and toxins and on any other
soliciting public comment on the health or plant products. Overlap select significant pathogens so as to inform the
current list of select agents and toxins agents and toxins, listed in 9 CFR 121.4, working groups as they begin the
in our regulations and suggestions are those that have been determined to biennial review process.
regarding any addition or reduction of pose a severe threat to public health and This action has been determined to be
the animal or plant pathogens currently safety, to animal health, or to animal not significant for the purposes of
on the list of select agents. products. Overlap select agents are Executive Order 12866 and, therefore,
DATES: We will consider all comments subject to regulation by both APHIS and has not been reviewed by the Office of
that we receive on or before April 28, the Centers for Disease Control and Management and Budget.
2015. Prevention, which has the primary Authority: 7 U.S.C. 8401; 7 CFR 2.22, 2.80,
ADDRESSES: You may submit comments responsibility for implementing the 371.3, and 371.4.
by either of the following methods: provisions of the Act for the Department Done in Washington, DC, this 23rd day of
• Federal eRulemaking Portal: Go to of Health and Human Services. February 2015.
http://www.regulations.gov/ Title II, Subtitle B of the Public Health Kevin Shea,
#!docketDetail;D=APHIS-2014-0095. Security and Bioterrorism Preparedness Administrator, Animal and Plant Health
• Postal Mail/Commercial Delivery:
tkelley on DSK3SPTVN1PROD with PROPOSALS

and Response Act of 2002 (which is Inspection Service.
Send your comment to Docket No. cited as the ‘‘Agricultural Bioterrorism [FR Doc. 2015–04180 Filed 2–26–15; 8:45 am]
APHIS–2014–0095, Regulatory Analysis Protection Act of 2002’’ and referred to
BILLING CODE 3410–34–P
and Development, PPD, APHIS, Station below as the Act), section 212(a),
3A–03.8, 4700 River Road Unit 118, provides, in part, that the Secretary of 1 You may view the lists of select agents and
Riverdale, MD 20737–1238. Agriculture (the Secretary) must toxins on the Internet at http://
Supporting documents and any establish by regulation a list of each www.selectagents.gov/
comments we receive on this docket biological agent and each toxin that the SelectAgentsandToxinsList.html.

VerDate Sep<11>2014 16:15 Feb 26, 2015 Jkt 235001 PO 00000 Frm 00001 Fmt 4702 Sfmt 9990 E:\FR\FM\27FEP1.SGM 27FEP1

Document Created: 2015-12-18 13:14:30
Document Modified: 2015-12-18 13:14:30

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Proposed Rules
Action		Advance notice of proposed rulemaking and request for comments.
Dates		We will consider all comments that we receive on or before April 28, 2015.
Contact		Dr. Charles L. Divan, Unit Director, Agricultural Select Agent Services, APHIS, 4700 River Road Unit 2, Riverdale, MD 20737-1231; (301) 851-3300.
FR Citation		80 FR 10627
RIN Number		0579-AE08
CFR Citation		7 CFR 331 9 CFR 121

80 FR 10627 - Agricultural Bioterrorism Protection Act of 2002; Biennial Review and Republication of the Select Agent and Toxin List

DEPARTMENT OF AGRICULTUREAnimal and Plant Health Inspection Service

Federal Register Volume 80, Issue 39 (February 27, 2015)

DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service