Pesticides; Draft Guidance for Pesticide Registrants on Antimicrobial Pesticide Products With Mold-Related Label Claims; Notice of Availability, 74003-74004 [2012-30023]

Download as PDF Federal Register / Vol. 77, No. 239 / Wednesday, December 12, 2012 / Notices interview is expected to last approximately one hour in duration. Total estimated burden: 250 hours (per year). Burden is defined at 5 CFR 1320.03(b) Total estimated cost: $4,900 (per year), includes $0 annualized capital or operation & maintenance costs. Changes in Estimates: Not applicable. This is a new information collection. Dated: November 26, 2012. James E. Woolford, Director, Office of Superfund Remediation and Technology Innovation. [FR Doc. 2012–29981 Filed 12–11–12; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY [EPA–HQ–OPP–2010–0539; FRL–9362–3] Pesticides; Draft Guidance for Pesticide Registrants on Antimicrobial Pesticide Products With Mold-Related Label Claims; Notice of Availability SUPPLEMENTARY INFORMATION: Environmental Protection Agency (EPA). ACTION: Notice. AGENCY: mstockstill on DSK4VPTVN1PROD with I. General Information A. Does this action apply to me? The Agency is announcing the availability of and seeking public comment on a draft Pesticide Registration Notice (PR Notice) titled ‘‘Guidance on Antimicrobial Pesticide Products with Mold-Related Label Claims.’’ PR Notices are issued by EPA’s Office of Pesticide Programs (OPP) to inform pesticide registrants and other interested persons about important policies, procedures, and registrationrelated decisions, and serve to provide guidance to pesticide registrants and OPP personnel. This particular draft PR Notice, once final, will provide guidance to the registrant concerning product performance (efficacy) data and labeling for ‘‘mold-related’’ pesticide products. EPA believes that the label improvements described in this draft document, once final, will provide consumers better product information with which to make an informed choice in selecting mold-related products that best suit their needs and thereby help improve protection of public health. DATES: Comments must be received on or before February 11, 2013. ADDRESSES: Submit your comments, identified by docket identification (ID) number EPA–HQ–OPP–2010–0539, by one of the following methods: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be SUMMARY: VerDate Mar<15>2010 15:48 Dec 11, 2012 Jkt 229001 Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. • Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/ DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 20460–0001. • Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at https:// www.epa.gov/dockets/contacts.htm. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at https://www.epa.gov/dockets. 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; email address: kempter.carlton@epa.gov. You may be potentially affected by this action if you are required to submit data under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) or are required to register pesticides. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include: • Producers of pesticide products (NAICS 32532). • Producers of antimicrobial pesticides (NAICS 32561). 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 email. 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 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 PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 74003 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. C. How can I get copies of this document and other related information? A copy of the draft PR notice is available in the docket, identified by docket identification (ID) number EPA– HQ–OPP–2010–0539. II. What guidance does this PR notice provide? This draft PR Notice, once final, will provide guidance to the registrant concerning product performance (efficacy) data and labeling for ‘‘moldrelated’’ pesticide products. Moldrelated pesticides are antimicrobial pesticides that bear a label claim to inhibit or destroy mold or mildew growth on hard, nonporous and porous surfaces in indoor environments (hereinafter referred to as ‘‘mold-related pesticides’’). ‘‘Fungicides’’ are antimicrobial pesticides that destroy fungi (including yeasts) and fungal spores pathogenic to humans. ‘‘Fungistats’’ are antimicrobial pesticides intended for aesthetic or cosmetic purposes and only inhibit fungal growth. This guidance, once final, will explain when the Agency expects to require applicants or registrants to submit efficacy data in support of the registration of mold-related pesticides. In accordance with 40 CFR part 161, E:\FR\FM\12DEN1.SGM 12DEN1 74004 Federal Register / Vol. 77, No. 239 / Wednesday, December 12, 2012 / Notices EPA pursuant to FIFRA requires the submission of efficacy data for fungicides. EPA also requires the submission of efficacy data when any specific species of fungus is listed on the label of fungicides, or when ‘‘residual’’ or ‘‘prevention’’ claims are made for fungicides. For fungistats, registrants must conduct efficacy studies but are not required under 40 CFR part 161 to submit them to EPA except upon request. This guidance, once final, will also describe appropriate label language for fungicides and fungistats, and for products used for mold remediation, on nonporous and porous surfaces, for residual activity, for mold prevention, and in heating, ventilation, air conditioning and refrigeration systems. All of these recommended label changes are designed to improve protection of public health through proper use of mold-related pesticides. III. Do PR notices contain binding requirements? The PR Notice discussed in this notice is intended to provide guidance to EPA personnel and decisionmakers 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 either EPA or 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. Authority: Sections 2 through 34 of FIFRA (7 U.S.C. 136–136y). List of Subjects Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests. Dated: November 29, 2012. Steven Bradbury, Director, Office of Pesticide Programs. [FR Doc. 2012–30023 Filed 12–11–12; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY mstockstill on DSK4VPTVN1PROD with [EPA–HQ–ORD–2012–0892; FRL–9761–4] Human Studies Review Board; Notification of a Public Meeting Environmental Protection Agency (EPA). ACTION: Notice. AGENCY: VerDate Mar<15>2010 15:48 Dec 11, 2012 Jkt 229001 The EPA Office of the Science Advisor announces a public meeting of the Human Studies Review Board to advise the Agency on the EPA scientific and ethical reviews of research with human subjects. DATES: This public meeting will be held on January 17, 2013, from approximately 1:00 p.m. to approximately 4:30 p.m. Eastern Time. Comments may be submitted on or before noon (Eastern Time) on Thursday, January 10, 2013. ADDRESSES: Submit your written comments, identified by Docket ID No. EPA–HQ–ORD–2012–0892, by one of the following methods: Internet: https://www.regulations.gov: Follow the online instructions for submitting comments. Email: ORD.Docket@epa.gov. Mail: The EPA Docket Center EPA/ DC, ORD Docket, Mail code: 28221T, 1200 Pennsylvania Avenue NW., Washington, DC 20460. Hand Delivery: The EPA/DC Public Reading Room is located in the EPA Headquarters Library, Room Number 3334 in the EPA West Building, at 1301 Constitution Avenue NW., Washington, DC 20460. The hours of operation are 8:30 a.m. to 4:30 p.m. Eastern Time, Monday through Friday, excluding federal holidays. Please call (202) 566– 1744 or email the ORD Docket at ord.docket@epa.gov for instructions. Updates to Public Reading Room access are available on the Web site https:// www.epa.gov/epahome/dockets.htm. Instructions: Direct your comments to Docket ID No. EPA–HQ–ORD–2012– 0892. The Agency’s policy is that all comments received will be included in the public docket without change and may be made available online at https://www.regulations.gov, including any personal information provided, unless the comment includes information claimed to be Confidential Business Information or other information the disclosure of which is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through https:// www.regulations.gov or email. The https://www.regulations.gov Web site 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 email comment directly to the EPA without going through https://www.regulations.gov, your email address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, the EPA SUMMARY: PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 recommends that you include your name and other contact information in the body of your comment and with any electronic storage media you submit. If the EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, the 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. FOR FURTHER INFORMATION CONTACT: Any member of the public who wishes to receive further information should contact Jim Downing at telephone number (202) 564–2468; fax: (202) 564– 2070; email address: downing.jim@epa.gov or Lu-Ann Kleibacker on telephone number (202) 564–7189; fax (202) 564–2070; email address kleibacker.lu-ann@epa.gov; mailing address Environmental Protection Agency, Office of the Science Advisor, Mail code 8105R, 1200 Pennsylvania Avenue NW., Washington, DC 20460. General information concerning the EPA HSRB can be found on the EPA Web site at https:// www.epa.gov/osa/hsrb/. SUPPLEMENTARY INFORMATION: Location: The meeting will be held at the EPA Conference Center—Lobby Level, One Potomac Yard (South Building), 2777 S. Crystal Drive, Arlington, VA 22202. Meeting access: Seating at the meeting will be on a first-come basis. To request accommodation of a disability, please contact the persons listed under FOR FURTHER INFORMATION CONTACT at least ten business days prior to the meeting using the information under FOR FURTHER INFORMATION CONTACT, so that appropriate arrangements can be made. Procedures for providing public input: Interested members of the public may submit relevant written or oral comments for the HSRB to consider during the advisory process. Additional information concerning submission of relevant written or oral comments is provided in Section I, ‘‘Public Meeting’’ under subsection D. ‘‘How May I Participate in this Meeting?’’ of this notice. I. Public Meeting A. Does this action apply to me? This action is directed to the public in general. This Notice may, however, be of particular interest to persons who conduct or assess human studies, especially studies on substances regulated by the EPA, or to persons who are, or may be required to conduct testing of chemical substances under the Federal Food, Drug, and Cosmetic Act E:\FR\FM\12DEN1.SGM 12DEN1

Agencies

[Federal Register Volume 77, Number 239 (Wednesday, December 12, 2012)]
[Notices]
[Pages 74003-74004]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-30023]


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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2010-0539; FRL-9362-3]


Pesticides; Draft Guidance for Pesticide Registrants on 
Antimicrobial Pesticide Products With Mold-Related Label Claims; Notice 
of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Agency is announcing the availability of and seeking 
public comment on a draft Pesticide Registration Notice (PR Notice) 
titled ``Guidance on Antimicrobial Pesticide Products with Mold-Related 
Label Claims.'' PR Notices are issued by EPA's Office of Pesticide 
Programs (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 draft PR Notice, once final, will 
provide guidance to the registrant concerning product performance 
(efficacy) data and labeling for ``mold-related'' pesticide products. 
EPA believes that the label improvements described in this draft 
document, once final, will provide consumers better product information 
with which to make an informed choice in selecting mold-related 
products that best suit their needs and thereby help improve protection 
of public health.

DATES: Comments must be received on or before February 11, 2013.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2010-0539, by one of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at https://www.epa.gov/dockets/contacts.htm.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://www.epa.gov/dockets.

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; email address: 
kempter.carlton@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are required 
to submit data under the Federal Insecticide, Fungicide, and 
Rodenticide Act (FIFRA) or are required to register pesticides. The 
following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Producers of pesticide products (NAICS 32532).
     Producers of antimicrobial pesticides (NAICS 32561).

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 email. 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 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.

C. How can I get copies of this document and other related information?

    A copy of the draft PR notice is available in the docket, 
identified by docket identification (ID) number EPA-HQ-OPP-2010-0539.

II. What guidance does this PR notice provide?

    This draft PR Notice, once final, will provide guidance to the 
registrant concerning product performance (efficacy) data and labeling 
for ``mold-related'' pesticide products. Mold-related pesticides are 
antimicrobial pesticides that bear a label claim to inhibit or destroy 
mold or mildew growth on hard, nonporous and porous surfaces in indoor 
environments (hereinafter referred to as ``mold-related pesticides''). 
``Fungicides'' are antimicrobial pesticides that destroy fungi 
(including yeasts) and fungal spores pathogenic to humans. 
``Fungistats'' are antimicrobial pesticides intended for aesthetic or 
cosmetic purposes and only inhibit fungal growth.
    This guidance, once final, will explain when the Agency expects to 
require applicants or registrants to submit efficacy data in support of 
the registration of mold-related pesticides. In accordance with 40 CFR 
part 161,

[[Page 74004]]

EPA pursuant to FIFRA requires the submission of efficacy data for 
fungicides. EPA also requires the submission of efficacy data when any 
specific species of fungus is listed on the label of fungicides, or 
when ``residual'' or ``prevention'' claims are made for fungicides. For 
fungistats, registrants must conduct efficacy studies but are not 
required under 40 CFR part 161 to submit them to EPA except upon 
request.
    This guidance, once final, will also describe appropriate label 
language for fungicides and fungistats, and for products used for mold 
remediation, on nonporous and porous surfaces, for residual activity, 
for mold prevention, and in heating, ventilation, air conditioning and 
refrigeration systems. All of these recommended label changes are 
designed to improve protection of public health through proper use of 
mold-related pesticides.

III. Do PR notices contain binding requirements?

    The PR Notice discussed in this notice is intended to provide 
guidance to EPA personnel and decisionmakers 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 either EPA or 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.

    Authority: Sections 2 through 34 of FIFRA (7 U.S.C. 136-136y).

List of Subjects

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

    Dated: November 29, 2012.
Steven Bradbury,
Director, Office of Pesticide Programs.
[FR Doc. 2012-30023 Filed 12-11-12; 8:45 am]
BILLING CODE 6560-50-P
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