Document ID: EPA-HQ-OPP-2006-1004-0001
Agency: epa
Document Type: Notice
Title: Pesticides; Draft Guidance for Pesticide Registrants on Antimicrobial Pesticide Products With Anthrax-Related Claims
Posted Date: 2007-06-06T04:00Z

[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Pesticides; Draft Guidance for Pesticide Registrants on 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