[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