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Pesticides; Draft Guidance for Pesticide Registrants on Antimicrobial Pesticide Products With Anthrax-Related Claims

Note: EPA no longer updates this information, but it may be useful as a reference or resource.




[Federal Register: June 6, 2007 (Volume 72, Number 108)]
[Notices]
[Page 31325-31326]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06jn07-89]

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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2006-1004; FRL-8113-5]

Pesticides; Draft Guidance for Pesticide Registrants on
Antimicrobial Pesticide Products With Anthrax-Related Claims

AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of availability.

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SUMMARY: The Agency is announcing the availability of, and seeking
public comment on, a draft Pesticide Registration Notice entitled,
``Guidance for Antimicrobial Pesticide Products With Anthrax-Related
Claims.'' PR notices are issued by the Office of Pesticide Programs
(OPP) to inform pesticide registrants and other interested persons
about important policies, procedures, and registration related
decisions. This particular notice would, once final, provide guidance
to prospective applicants of antimicrobial products that make labeling
claims to inactivate Bacillus anthracis (anthrax) spores (hereafter
referred to as ``anthrax-related products'').

DATES: Comments must be received on or before September 4, 2007.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2006-1004, by one of the following methods:
    • Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
    • Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
    • Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is (703) 305-5805.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2006-1004. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The Federal regulations.gov website is an ``anonymous access''
system, which means EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an e-mail comment directly to EPA without going through
regulations.gov, your e-mail address will be automatically captured and
included as part of the comment that is placed in the docket and made
available on the Internet. If you submit an electronic comment, EPA
recommends that you include your name and other contact information. If
EPA cannot read your comment due to technical difficulties and cannot
contact you for clarification, EPA may not be able to consider your
comment. Electronic files should avoid the use of special characters,
any form of encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index.
Although listed in the index, some information is not publicly
available, e.g., CBI or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either in the electronic docket at http://www.regulations.gov
, or, if only available in hard copy, at the OPP
Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.),
2777 S. Crystal Dr., Arlington, VA. The hours of operation of this
Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.

FOR FURTHER INFORMATION CONTACT: Jeff Kempter, Antimicrobials Division,
Office of Pesticide Programs, Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(703) 305-5448; fax number: (703) 308-6467; e-mail address: 
kempter.carlton@epa.gov.


SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me

    This action is directed to the public in general. Although this
action may be of particular interest to those persons who are required
to register pesticides and federal, state, and local government
agencies and private institutions or organizations who are interested
in bio-decontamination chemicals. Since other entities may also be
interested, the Agency has not attempted to describe all the specific
entities that may be affected by this action. If you have any questions
regarding the information in this notice, consult the person listed
under FOR FURTHER INFORMATION CONTACT.

B. What Should I Consider as I Prepare My Comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD ROM that you mail to EPA, mark the outside of the

[[Page 31326]]

disk or CD ROM as CBI and then identify electronically within the disk
or CD ROM the specific information that is claimed as CBI. In addition
to one complete version of the comment that includes information
claimed as CBI, a copy of the comment that does not contain the
information claimed as CBI must be submitted for inclusion in the
public docket. Information so marked will not be disclosed except in
accordance with procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.

B. How Can I Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established a docket for this action under
docket identification (ID) number EPA-HQ-OPPT-2006-1004. Publicly
available docket materials are available either in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the Office of Pesticide Programs (OPP) Regulatory Public
Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal
Dr., Arlington, VA. The hours of operation of this Docket Facility are
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The Docket facility telephone number is (703) 305-5805.
    2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr.

II. What Guidance Does this PR Notice Provide?

    This draft PR Notice provides guidance to the registrant concerning
antimicrobial products that make labeling claims to ``inactivate
Bacillus anthracis (anthrax) spores'' (hereafter referred to as
``anthrax-related products''). In summary, this notice specifies that
in order for a product to qualify for a claim of inactivating anthrax
spores, an anthrax-related product should be:
    1. Supported by specific sporicidal efficacy studies that are
acceptable to EPA; and
    2. Subject to specific terms and conditions of registration that
limit the use of these products to certain trained persons. Prospective
applicants are encouraged to follow the guidance in this notice and
consult with EPA prior to applying for registration or amendment of a
product when seeking such a claim. This guidance should help the United
States be better prepared to respond to the intentional, accidental or
natural introduction of anthrax spores by helping to assure that
anthrax-related products bear appropriate labeling and are effective
when used as directed.
    In October 2001, when several letters containing Bacillus anthracis
(anthrax) spores were introduced into the U.S. Postal Service mail
system causing extensive contamination to dozens of buildings, no
antimicrobial products were specifically registered for inactivating
this particular pathogen. Since that time, the EPA has conducted
extensive research and coordinated across the federal government to
determine which efficacy test methods would be appropriate for
demonstrating the effectiveness of antimicrobial products for
inactivating B. anthracis spores. Guidance on acceptable efficacy test
methods will be made available in a separate document. EPA's Office of
Pesticide Programs has also developed guidance on the terms and
conditions of registration for the labeling of these products. EPA
intends to limit the use of these products to certain groups of trained
persons. This notice is aimed primarily at applicants and registrants,
but may also be of interest to other federal, state, and local
government agencies, academic institutions, and other interested
parties.

III. Do PR Notices Contain Binding Requirements?

    The PR Notice discussed in this notice is intended to provide
guidance to EPA personnel and to pesticide registrants. While the
requirements in the statutes and Agency regulations are binding on EPA
and the applicants, this PR Notice is not binding on pesticide
registrants, and EPA may depart from the guidance where circumstances
warrant and without prior notice. Likewise, pesticide registrants may
assert that the guidance is not appropriate generally or not applicable
to a specific pesticide or situation.

List of Subjects

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Decontamination.

    Dated: May 21, 2007.
Debra Edwards,
Director, Office of Pesticide Programs.
[FR Doc. E7-10694 Filed 6-5-07; 8:45 am]

BILLING CODE 6560-50-S

 
 

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