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.

Proposed Rules Federal Register

10627 

Vol. 80, No. 39 

Friday, February 27, 2015 

1 You may view the lists of select agents and 

toxins on the Internet at http://

www.selectagents.gov/

SelectAgentsandToxinsList.html. 

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. 

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 


tkelley on DSK3SPTVN1PROD with PROPOSALS