Final Guidance for Pesticide Registrants on Antimicrobial Pesticide Products With Anthrax-Related Claims, 51467-51468 [E8-20384]

Download as PDF sroberts on PROD1PC70 with NOTICES Federal Register / Vol. 73, No. 171 / Wednesday, September 3, 2008 / Notices Owners and operators must also submit notification date of the initial performance test, and the results of the initial performance test. After the initial recordkeeping and reporting requirements, semiannual reports are required if there has been an exceedance of control device operating parameters. Respondents are also required to maintain records of occurrence and duration of any startup, shutdown, or malfunction, or any period during which the monitoring system is inoperative. Notifications are to inform the Agency or delegated authority when a source becomes subject to the standard. The reviewing authority may then inspect the source to ensure that the pollution control devices are properly installed and operating and that the standards are being met. Performance test reports are required as these are the Agency’s records of a sources’ initial capability to comply with the emission standards and to serve as a record of the operating conditions under which compliance are to be achieved. The information generated by monitoring, recordkeeping and reporting requirements described in this ICR are used by the Agency to ensure that facilities that are affected by the standard continue to operate the control equipment and achieve continuous compliance with the regulation. All reports are sent to the delegated state or local authority. In the event that there is no such delegated authority, the reports are sent directly to the EPA regional office. This information is being collected to assure compliance with 40 CFR part 60, subpart H, as authorized in sections 112 and 114(a) of the Clean Air Act. The required information consists of emissions data and other information that have been determined to be private. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB Control Number. The OMB Control Number for EPA’s regulations listed in 40 CFR part 9 and 48 CFR chapter 15 is identified on the form and/or instrument, if applicable. Burden Statement: The annual public reporting and recordkeeping burden for this collection of information estimated to average 127 hours per response. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose and provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of VerDate Aug<31>2005 22:59 Sep 02, 2008 Jkt 214001 collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information. All existing ways will have to adjust to comply with any previously applicable instructions and requirements that have subsequently changed; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. Respondents/Affected Entities: Sulfuric acid plants. Estimated Number of Respondents: 103. Frequency of Response: Initially, occasionally, and semiannually. Estimated Total Annual Hour Burden: 26,177. Estimated Total Annual Cost: $2,576,771, which includes $463,500 O&M costs and $2,113,271 labor costs. Changes in the Estimates: There is no change in the labor hours or cost in this ICR compared to the previous ICR. This is due to two considerations: (1) The regulations have not changed over the past three years and are not anticipated to change over the next three years; and (2) the growth rate for the industry is very low, negative or non-existent, so there is no significant change in the overall burden. It should be noted that the previous ICR rounded the burden cost up to the nearest one thousand. In this ICR, the exact cost figure is reported which results in an apparent decrease in the cost when, in fact, no decrease has occurred. Since there are no changes in the regulatory requirements and there is no significant industry growth, the labor hours and cost figures in the previous ICR was used in this ICR, and there is no change in burden to industry. Dated: August 27, 2008. Sara Hisel-McCoy, Director, Collection Strategies Division. [FR Doc. E8–20396 Filed 9–2–08; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY [EPA–HQ–OPP–2008–1004; FRL–8378– 9] Final Guidance for Pesticide Registrants on Antimicrobial Pesticide Products With Anthrax-Related Claims Environmental Protection Agency (EPA). ACTION: Notice of availability. AGENCY: PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 51467 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 biodecontamination 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 E:\FR\FM\03SEN1.SGM 03SEN1 51468 Federal Register / Vol. 73, No. 171 / Wednesday, September 3, 2008 / Notices sroberts on PROD1PC70 with NOTICES 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 anthraxrelated 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 VerDate Aug<31>2005 22:59 Sep 02, 2008 Jkt 214001 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 PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 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 ENVIRONMENTAL PROTECTION AGENCY [EPA–HQ–ORD–2008–0200; FRL–8710–3] Board of Scientific Counselors, Water Quality Mid-Cycle Subcommittee Meeting—2008 Environmental Protection Agency (EPA). ACTION: Notice of meeting. AGENCY: SUMMARY: Pursuant to the Federal Advisory Committee Act, Public Law 92–463, the Environmental Protection Agency, Office of Research and Development (ORD), gives notice of a meeting of the Board of Scientific Counselors (BOSC) Water Quality MidCycle Subcommittee. DATES: The meeting will be held on Tuesday, September 23, 2008 from 9 a.m. to 3 p.m. Eastern Standard Time. The meeting may adjourn early if all business is finished. Requests for the draft agenda or for making oral presentations at the conference call will be accepted up to one business day before the meeting. ADDRESSES: The meeting will be held at the Key Bridge Marriott, 1401 Lee Highway, Arlington, Virginia 22209. Submit your comments, identified by Docket ID No. EPA–HQ–ORD–2008– 0200, by one of the following methods: • http://www.regulations.gov: Follow the on-line instructions for submitting comments. • E-mail: Send comments by electronic mail (e-mail) to: ORD.Docket@epa.gov, Attention Docket ID No. EPA–HQ–ORD–2008–0200. • Fax: Fax comments to: (202) 566– 0224, Attention: Docket ID No. EPA– HQ–ORD–2008–0200. • Mail: Send comments by mail to: Board of Scientific Counselors, Water Quality Mid-Cycle Subcommittee—2008 E:\FR\FM\03SEN1.SGM 03SEN1

Agencies

[Federal Register Volume 73, Number 171 (Wednesday, September 3, 2008)]
[Notices]
[Pages 51467-51468]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-20384]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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