[Federal Register: July 24, 2003 (Volume 68, Number 142)]
[Proposed Rules]               
[Page 43660-43661]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24jy03-30]                         

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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 43660]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

7 CFR Part 331

[Docket 03-070-1]

 
Public Meetings; Listing of Biological Agents and Toxins

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice of public meetings.

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SUMMARY: This is to notify individuals and entities possessing, using, 
or transferring biological agents and toxins listed in 7 CFR 331.3, as 
well as other interested parties, that the Animal and Plant Health 
Inspection Service will hold a series of public meetings to provide a 
forum for discussion of the criteria used to determine whether an agent 
has the potential to pose a severe threat to plant health or products.

DATES: We will consider all comments that we receive on or before 
September 8, 2003.
    Three public meetings are scheduled for August 2003. They will be 
held on August 12, 2003, from 5:30 to 8:30 p.m. in Charlotte, NC; on 
August 19, 2003, from 9 a.m. to 3 p.m. in Riverdale, MD; and on August 
21, 2003, from 9 a.m. to 3 p.m. in Sacramento, CA.

ADDRESSES: If you cannot attend the meetings and wish to submit 
comments, you may submit comments by postal mail/commercial delivery or 
by e-mail. If you use postal mail/commercial delivery, please send four 
copies of your comment (an original and three copies) to: Docket No. 
03-070-1, Regulatory Analysis and Development, PPD, APHIS, Station 
3C71, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state 
that your comment refers to Docket No. 03-070-1. If you use e-mail, 
address your comment to regulations@aphis.usda.gov. Your comment must 
be contained in the body of your message; do not send attached files. 
Please include your name and address in your message and ``Docket No. 
03-070-1'' on the subject line.
    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.
    APHIS documents published in the Federal Register, and related 
information, including the names of organizations and individuals who 
have commented on APHIS dockets, are available on the Internet at 
http://www.aphis.usda.gov/ppd/rad/webrepor.html.
    The public meetings will be held at the following locations:
    1. Charlotte, NC. The Charlotte Convention Center, 510 South 
College Street, Room 217AB, Charlotte, NC 28202.
    2. Riverdale, MD. The USDA Center at Riverside, 4700 River Road, 
Riverdale, MD 20737. Travel directions to the USDA Center at Riverside 
are available on the Internet at http://www.aphis.usda.gov/ppq/direct.html.
 Picture identification is required to gain access to the 
building. Parking is available next to the building for a $2.25 fee 
(please have quarters or $1 bills available). The nearest Metro station 
is the College Park station on the Green Line, which is within walking 
distance.
    3. Sacramento, CA. The John E. Moss Federal Building, General 
Services Administration, 650 Capital Mall, 1st Floor Conference Center, 
Stanford Room, Sacramento, CA 95814.

FOR FURTHER INFORMATION CONTACT: Dr. Michael J. Firko, Assistant 
Director, Plant Health Programs, USDA, APHIS, PPQ, 4700 River Road Unit 
137, Riverdale, MD 20737-1236; (301) 734-8758.

SUPPLEMENTARY INFORMATION: On June 12, 2002, the President signed into 
law the Public Health Security and Bioterrorism Preparedness and 
Response Act of 2002 (Pub. L. 107-188). Title II of Public Law 107-188, 
``Enhancing Controls on Dangerous Biological Agents and Toxins'' 
(sections 201 through 231), provides for the regulation of certain 
biological agents and toxins by the Department of Health and Human 
Services (subtitle A, sections 201-204) and the Department of 
Agriculture (subtitle B, sections 211-213), and provides for 
interagency coordination between the two departments regarding overlap 
agents and toxins (subtitle C, section 221). For the Department of 
Health and Human Services, the Centers for Disease Control and 
Prevention (CDC) has been designated as the agency with primary 
responsibility for implementing the provisions of the Act; the Animal 
and Plant Health Inspection Service (APHIS) is the agency fulfilling 
that role for the Department of Agriculture (USDA).
    In subtitle B (which is cited as the ``Agricultural Bioterrorism 
Protection Act of 2002,'' 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 she 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 on the list, the Act requires the 
Secretary to consider:
    1. 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;
    2. 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;
    3. The availability and effectiveness of pharmacotherapies and 
prophylaxis to treat and prevent any illness caused by the agent or 
toxin; and
    4. Any other criteria that the Secretary considers appropriate to 
protect animal or plant health, or animal or plant products.
    In accordance with these statutory requirements, on August 12, 
2002, we published in the Federal Register (67 FR 52383-52389, Docket 
No. 02-082-1) an interim rule that established the initial lists of 
biological agents and toxins. To accomplish this, we established new 
parts in the Code of Federal Regulations (CFR), one part in the plant-
related provisions of title 7, chapter III, and one part in the animal-
related provisions of title 9, chapter I. Then, on December 13, 2002, 
we published in the Federal Register (67 FR 76908-76938, Docket No. 02-
088-1) an interim rule that amended the initial

[[Page 43661]]

lists of biological agents and toxins in both 7 CFR 331.3 and 9 CFR 
121.3.
    The Act requires that the lists of biological agents and toxins be 
reviewed and republished biennially, or more often as needed, and 
revised as necessary. In addition, the Act requires that, when 
determining whether to include an agent or toxin, the Secretary shall 
consult with appropriate Federal departments and agencies and with 
scientific experts representing appropriate professional groups.
    In preparation for the biennial review of the list required by the 
Agricultural Bioterrorism Protection Act of 2002, APHIS' Plant 
Protection and Quarantine program intends to reevaluate and further 
develop the criteria used to determine whether an agent has the 
potential to pose a severe threat to plant health or products. 
Accordingly, we are holding a series of public meetings to provide a 
forum for discussion of the criteria that should be used.
    The meetings will be held on August 12, 2003, from 5:30 to 8:30 
p.m. in Charlotte, NC; on August 19, 2003, from 9 a.m. to 3 p.m. in 
Riverdale, MD; and on August 21, 2003, from 9 a.m. to 3 p.m. in 
Sacramento, CA. Information regarding the meetings may be obtained from 
the person listed under FOR FURTHER INFORMATION CONTACT.

Written Comments

    If you cannot attend the meeting, you may submit written comments 
on the topics outlined in this notice. To submit written comments, 
please follow the instructions listed under the heading ADDRESSES near 
the beginning of this document.

    Done in Washington, DC, this 21st day of July, 2003.

Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 03-18951 Filed 7-23-03; 8:45 am]

BILLING CODE 3410-34-P