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



[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Pesticides; Draft Guidance for Pesticide Registrants on 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: http://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 
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.htm.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://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: 


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 
    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 
    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 

    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]