Pesticides; Draft Guidance for Pesticide Registrants on Antimicrobial Pesticide Products With Mold-Related Label Claims; Notice of Availability, 74003-74004 [2012-30023]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Pesticides; Draft Guidance for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