29 July 2010

Select Agent and Toxin List

[Federal Register: July 29, 2010 (Volume 75, Number 145)]
[Proposed Rules]               
[Page 44724-44725]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29jy10-5]                         

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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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[[Page 44724]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

7 CFR Part 331

9 CFR Part 121

[Docket No. APHIS-2009-0070]
RIN 0579-AD09

 
Agricultural Bioterrorism Protection Act of 2002; Biennial Review 
and Republication of the Select Agent and Toxin List; Reorganization 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. In addition, we are soliciting public 
comment on the potential reorganization of the list of select agents 
and toxins based on the relative potential of each select agent or 
toxin to be misused to adversely affect human, plant or animal health. 
Such tiering of the list could allow for the application of different 
security measures for those select agents or toxins which pose a higher 
risk to animal or plant health if they were to be stolen or otherwise 
misused.

DATES: We will consider all comments that we receive on or before 
August 30, 2010.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to (http://
www.regulations.gov/fdmspublic/component/
main?main=DocketDetail&d=APHIS-2009-0070) to submit or view comments.
     Postal Mail/Commercial Delivery: Please send two copies of 
your comment to Docket No. APHIS-2009-0070, Regulatory Analysis and 
Development, PPD, APHIS, Station 3A-03.8, 4700 River Road Unit 118, 
Riverdale, MD 20737-1238. Please state that your comment refers to 
Docket No. APHIS-2009-0070.
    Reading Room: You may read any comments that we receive on this 
docket in our reading room. The reading room 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) 690-2817 before coming.
    Other Information: Additional information about APHIS and its 
programs is available on the Internet at (http://www.aphis.usda.gov).

FOR FURTHER INFORMATION CONTACT: Ms. Aimee M. Hyten, Compliance 
Manager, APHIS Agriculture Select Agent Program, PPQ, APHIS, 4700 River 
Road Unit 2, Riverdale, MD 20737-1236; (301) 734-5281.

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 
both human and animal health, to animal health, to 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 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

[[Page 44725]]

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/fdmspublic/component/
main?main=DocketDetail&d=APHIS-2009-0070).
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    Reorganization of Current List of Select Agents and Toxins
    We are also seeking public comment regarding potential 
reorganization of the list of select agents and toxins. Recent reports 
by the National Academies, the Executive Order 13486 Working Group, and 
the National Science Advisory Board for Biosecurity have recommended 
tiering the list of select agents and toxins based on the relative 
potential of each to be misused. If implemented, such tiering could 
allow for the application of different security measures for those 
select agents or toxins that pose a higher risk to animal or plant 
health if they were to be stolen or otherwise misused.
    For those commenters who believe tiering the list of select agents 
and toxins is advisable, we also welcome recommendations as to what 
criteria should be used to designate high risk select agents and 
toxins. For example, potential tiering of the select agent and toxin 
list could reflect one or more of the following:
     The relative ease with which a particular select agent or 
toxin might be disseminated or transmitted from one animal to another 
or into the environment where it could produce a deleterious effect 
upon animal or plant health;
     The potential for high animal or plant mortality rates;
     The potential for a major animal or plant health impact;
     Select agents or toxins whose misuse might result in 
public panic or other social or economic disruption;
     Select agents or toxins whose use might require Federal, 
State, and/or local officials to take special action in planning for 
major animal or plant health disasters.
    Additionally, we are interested in any potential corresponding 
changes to the security requirements of the current regulations that 
would be necessary to provide appropriate protection of higher tier 
select agents or toxins and whether such changes should be prescriptive 
or performance based.
    At the conclusion of the working group 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. The 
document may also include reorganization of the lists of select agents 
and toxins via tiering of the select agents or toxins themselves and/or 
tiered security requirements.
    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 22nd day of July 2010.

John Ferrell
Deputy Under Secretary for Marketing and Regulatory Programs.
[FR Doc. 2010-18581 Filed 7-28-10; 8:45 am]
BILLING CODE 3410-34-S