Document ID: EPA-HQ-OPP-2006-1004-0009
Agency: epa
Document Type: Notice
Title: Final Guidance for Pesticide Registrants on Antimicrobial Pesticide Products With Anthrax-Related Claims
Posted Date: 2008-09-03T04:00Z

[Federal Register: September 3, 2008 (Volume 73, Number 171)]
[Notices]               
[Page 51467-51468]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03se08-62]                         

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2008-1004; FRL-8378-9]

 
Final 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 a Pesticide 
Registration Notice (PR Notice) entitled ``Antimicrobial Pesticide 
Products With Anthrax-Related Claims.'' This PR Notice was issued by 
the Agency on [insert date PR Notice is signed by the OD] and is 
identified as PR Notice 2008-2. PR Notices are issued by the EPA's 
Office of Pesticide Programs (EPA/OPP) to inform pesticide registrants 
and other interested persons about important policies, procedures, and 
registration related decisions, and serve to provide guidance to 
pesticide registrants and OPP personnel. This particular PR Notice 
provides guidance pertaining to applications of registration for 
antimicrobial products that would make labeling claims to inactivate 
Bacillus anthracis (anthrax) spores (hereafter referred to as 
``anthrax-related products'').

FOR FURTHER INFORMATION CONTACT: Jeff Kempter, Antimicrobials Division 
(7510P), 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. 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-OPP-2008-1004. 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

[[Page 51468]]

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 final PR Notice provides guidance pertaining to applications 
for registration of antimicrobial products that would make labeling 
claims to ``inactivate Bacillus anthracis (anthrax) spores'' (hereafter 
referred to as ``anthrax-related products''). This guidance should help 
the United States be prepared to respond to incidents involving anthrax 
spores by assuring that anthrax-related products are registered, that 
they bear appropriate labeling, and that they are effective when used 
as directed. In addition, this guidance will help protect public health 
from the potential risks of anthrax spores by limiting the use of 
anthrax-related products to those who are properly trained and 
determined to be competent in their use.
    In summary, this PR notice specifies that in order for a product to 
qualify for a claim of inactivating anthrax spores, an anthrax-related 
product should be: (a) supported by specific sporicidal efficacy 
studies that are acceptable to EPA and (b) subject to specific terms 
and conditions of registration that limit the use of these products to 
certain 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.
    In October 2001, when several letters containing Bacillus anthracis 
(anthrax) spores were introduced into the U.S. Postal Service mail 
system, no antimicrobial products were specifically registered for 
inactivating the spores of this particular pathogen. Since that time, 
EPA/OPP has developed guidance on the terms and conditions of 
registration for the labeling of these products that will limit their 
use to certain persons, as described below. In addition, the EPA/OPP 
has developed guidance on laboratory efficacy test methods for 
demonstrating the effectiveness of antimicrobial products for 
inactivating anthrax spores on inanimate surfaces. Such efficacy 
testing guidance will be issued separately from this PR Notice. It is 
EPA's intent that registrants will follow the efficacy testing guidance 
and this PR Notice when applying for registration of anthrax-related 
products, and that such products, when registered, will be made 
available to trained and competent civilian and military personnel who 
respond to incidents involving anthrax spores.
    The information collection activities associated with the 
activities described in this PR Notice are already approved by the 
Office of Management and Budget (OMB) under the Paperwork Reduction Act 
(PRA), 44 U.S.C. 3501 et seq. The corresponding Information Collection 
Request (ICR) document for the training of pesticide applicators has 
been assigned EPA ICR number 0155.09 and is approved under OMB control 
number 2070-0029. The ICR document for the pesticide application 
process has been assigned EPA ICR number 0277.13, and is approved under 
OMB control number 2070-0060. The total estimated respondent paperwork 
burden associated with the training and certification of a pesticide 
applicator is an annual average of 3.1 burden hours. The annual average 
reporting and recordkeeping burden for a registration applicant 
respondent is estimated to range from 14 hours to 646 hours, depending 
upon the type of activity. For ``Type A'' activities, which include new 
active ingredients and new uses, the estimated annual applicant burden 
average is 194 hours per application. For ``Type B'' activities, which 
include amendments and notifications, the estimated annual applicant 
burden average is 14 hours per application. The respondent burden 
estimate for ``Type C'' reduced risk products is an average of 646 
hours per product. A copy of the most recent version of EPA ICR 
0155.09 is available under Docket ID No. EPA-HQ-OPP-2003-0357, 
and a copy of the most recent version of EPA ICR 0277.13 is 
available under Docket ID No. EPA-HQ-OPP-2004-0419. Both dockets may be 
accessed at www.regulations.gov.

III. Do PR Notices Contain Binding Requirements?

    The PR Notice discussed in this notice is intended to provide 
general guidance to pesticide applicants and registrants. While the 
requirements in the statutes and Agency regulations are binding on EPA, 
registrants, and applicants, this PR Notice is not binding on either 
EPA or any outside parties, and EPA may depart from the guidance where 
circumstances warrant and without prior notice. Likewise, pesticide 
applicants and registrants may assert that the guidance is not 
appropriate generally or not applicable to a specific pesticide or 
situation. Pesticide applicants and registrants may propose 
alternatives to the recommendations described in the PR Notice, and the 
Agency will assess them for appropriateness on a case-by-case basis and 
will respond in writing.

List of Subjects

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

    Dated: August 26, 2008.
Debra Edwards,
Director, Office of Pesticide Programs.
[FR Doc. E8-20384 Filed 9-2-08; 8:45 am]

BILLING CODE 6560-50-S