Pesticides; Draft Guidance for Pesticide Registrants on Label Statements Regarding Third-Party Endorsements and Cause Marketing Claims, 61638-61640 [E7-21468]
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Federal Register / Vol. 72, No. 210 / Wednesday, October 31, 2007 / Notices
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.
rwilkins on PROD1PC63 with NOTICES
II. What Action is the Agency Taking?
EPA is printing notice of the filing of
a pesticide petition received under
section 408 of the Federal Food, Drug,
and Cosmetic Act (FFDCA), 21 U.S.C.
346a, proposing the establishment or
modification of regulations in 40 CFR
part 180 for residues of pesticide
chemicals in or on various food
commodities. EPA has determined that
the pesticide petition described in this
notice contains data or information
regarding the elements set forth in
FFDCA section 408(d)(2); however, EPA
has not fully evaluated the sufficiency
of the submitted data at this time or
whether the data supports granting of
the pesticide petition. Additional data
may be needed before EPA rules on this
pesticide petition.
Pursuant to 40 CFR 180.7(f), a
summary of the petition included in this
notice, prepared by the petitioner, is
included in a docket EPA has created
for this rulemaking. The docket for this
petition is available on-line at https://
www.regulations.gov.
New Tolerance
PP 6F7057. Syngenta Crop Protection,
410 Swing Road, P.O. Box 18300,
Greensboro, NC 27419, proposes to
establish a tolerance for residues of the
fungicide mandipropamid,
benzeneacetamide, 4-chloro-N-[2-[3methoxy-4-(2-propynyloxy)
phenyl]ethyl]-alpha-(2-propynyloxy) in
or on food commodities Brassica, Head
and Stem, Subgroup 5A at 3 parts per
million (ppm); Brassica, Head and Stem,
Subgroup 5B at 30 ppm; Cucurbit
Vegetables, Group 9 at 0.3 ppm; Fruiting
Vegetables, Group 8 at 1 ppm; Tuberous
and Corm Vegetables, Subgroup 1C at
0.01 ppm; Grapes at 2 ppm; Raisins at
4 ppm; Onions, dry bulb at 0.05 ppm;
Onions, green at 4 ppm; and Tomato,
paste at 1.3 ppm. The analytical method
involves extraction of mandipropamid
residues from crop samples by
homogenization with acetonitrile:water
(80:20 v/v). Extracts are centrifuged and
aliquots diluted with water prior to
being cleaned-up using polymeric solidphase extraction cartridges. Residues of
mandipropamid are quantified using
high performance liquid
chromatography with mass
spectrometric detection (LC-MS/MS).
This method has been successfully
validated at an independent facility and
therefore, suitable for use as the
VerDate Aug<31>2005
17:45 Oct 30, 2007
Jkt 214001
enforcement method for the
determination of residues of
mandipropamid in crops. The multiresidue method was not successful at
determining residues of
mandipropamid.
List of Subjects
Environmental protection,
Agricultural commodities, Feed
additives, Food additives, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: October 19, 2007.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
[FR Doc. E7–21436 Filed 10–30–07; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPP–2007–1008; FRL–8152–6]
Pesticides; Draft Guidance for
Pesticide Registrants on Label
Statements Regarding Third-Party
Endorsements and Cause Marketing
Claims
Environmental Protection
Agency (EPA).
ACTION: Notice of availability.
AGENCY:
SUMMARY: The Agency is announcing
the availability of and seeking public
comment on a draft Pesticide
Registration Notice (PR Notice) entitled
‘‘Label Statements Regarding ThirdParty Endorsements & Cause Marketing
Claims.’’ PR Notices are issued by the
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 provides guidance to the
registrant concerning the Agency’s
framework for evaluating label
statements regarding third-party
endorsements and cause marketing
claims, in which registrants and other
interested parties may wish to comment.
DATES: Comments must be received on
or before December 31, 2007.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPP–2007–1008, by
one of the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the on-line
instructions for submitting comments.
• Mail: Office of Pesticide Programs
(OPP) Regulatory Public Docket (7502P),
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001.
• Delivery: OPP Regulatory Public
Docket (7502P), Environmental
Protection Agency, Rm. S–4400, One
Potomac Yard (South Bldg.), 2777 S.
Crystal Dr., Arlington, VA. Deliveries
are only accepted during the Docket’s
normal hours of operation (8:30 a.m. to
4 p.m., Monday through Friday,
excluding legal holidays). Special
arrangements should be made for
deliveries of boxed information. The
Docket Facility telephone number is
(703) 305–5805.
Instructions: Direct your comments to
docket ID number EPA–HQ–OPP–2007–
1008. EPA’s policy is that all comments
received will be included in the docket
without change and may be made
available on-line at https://
www.regulations.gov, including any
personal information provided, unless
the comment includes information
claimed to be Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
Do not submit information that you
consider to be CBI or otherwise
protected through regulations.gov or email. The regulations.gov website 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 e-mail comment directly
to EPA without going through
regulations.gov, your e-mail address
will be automatically captured and
included as part of the comment that is
placed in the docket and made available
on the Internet. If you submit an
electronic comment, EPA recommends
that you include your name and other
contact information in the body of your
comment and with any disk or CD-ROM
you submit. If EPA cannot read your
comment due to technical difficulties
and cannot contact you for clarification,
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.
Docket: All documents in the docket
are listed in the docket index available
in regulations.gov. To access the
electronic docket, go to https://
www.regulations.gov, select ‘‘Advanced
Search,’’ then ‘‘Docket Search.’’ Insert
the docket ID number where indicated
and select the ‘‘Submit’’ button. Follow
the instructions on the regulations.gov
website to view the docket index or
access available documents. Although
listed in the index, some information is
not publicly available, e.g., CBI or other
information whose disclosure is
E:\FR\FM\31OCN1.SGM
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Federal Register / Vol. 72, No. 210 / Wednesday, October 31, 2007 / Notices
restricted by statute. Certain other
material, such as copyrighted material,
is not placed on the Internet and will be
publicly available only in hard copy
form. Publicly available docket
materials are available either in the
electronic docket at https://
www.regulations.gov, or, if only
available in hard copy, at the 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 from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal
holidays. The Docket Facility telephone
number is (703) 305–5805.
FOR FURTHER INFORMATION CONTACT:
Nicole Zinn, Immdediate Office (7510P),
Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
703-308-7076; fax number: 703-3084776; e-mail address:
zinn.nicole@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 register products under the Federal
Insecticide, Fungicide, and Rodenticide
Act (FIFRA). 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.
rwilkins on PROD1PC63 with NOTICES
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 e-mail. 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.
VerDate Aug<31>2005
17:45 Oct 30, 2007
Jkt 214001
See Unit III below for a list of
questions that the Agency would like
the public to address.
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.
II. Background
A. What Action is the Agency Taking?
The Agency is announcing the
issuance of a draft Pesticide Registration
Notice [PR-2007-xx] that describes the
Agency’s framework for evaluating label
statements regarding third-party
endorsements and cause marketing
claims. This draft Notice contains a
description of the Agency’s framework
for evaluating proposed statements and
graphic material to appear on pesticide
labeling regarding third-party
endorsements or a relationship between
the pesticide registrant and a charity
(‘‘cause marketing claims’’). The draft
Notice identifies factors EPA may
consider in reviewing applications for
registration or amended registration
with labeling that contains either thirdparty endorsements or cause marketing
claims.
The Notice also identifies the types of
discussion and information that
applicants could provide to support
EPA review of such applications. These
items may include a mock label,
documentation of the third-party
endorsement or information to
substantiate the truthfulness of the
cause marketing claim, and a discussion
of potential consumer impacts,
including consumer market research
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
61639
when appropriate. In some cases, EPA
could approve a proposed label
statement but conditionally require the
registrant to provide additional
information to assess whether adverse
consequences resulted from the addition
of the label statement.
B. Why is the Agency Taking this
Action?
In January 2006, The Clorox Company
(Clorox) contacted EPA about adding
cause marketing language to some of
their pesticide labels. The proposed
language described a philanthropic
relationship between Clorox and the
American Red Cross (Red Cross). In
March 2006, EPA met with Clorox and
Red Cross officials to discuss adding a
cause marketing claim to a pesticide
label. Clorox described the partnership
agreement they had entered into with
the Red Cross, discussed what cause
marketing language they were currently
using on non-pesticide products, and
presented a label mock-up. In this
meeting, EPA expressed concern that
consumers could understand the Red
Cross symbol on the label as an implied
safety claim. Clorox provided an
additional presentation in July 2006
which included a toxicology profile of
bleach; a National Capital Area Poison
Control Center presentation regarding
incidents involving bleach; and
information that the labeling would not
alter consumer behavior in ways that
could lead to misuse.
After review of the information
described above, EPA approved Red
Cross ‘‘cause marketing’’ language on
Clorox label products. In particular, the
Agency decision relied on EPA’s
expectation that consumers will not
interpret the Red Cross symbol on labels
to mean that the product is safe, which
was based on data from consumer
survey research. The decision also
relied on an assessment of the likely
health consequences were the products
to be misused as a result of the presence
of the cause marketing labeling and
consideration of whether such labeling
would alter consumer behavior in ways
that could lead to misuse. EPA
concluded that the available
information was sufficient to support a
conclusion that the product bearing the
cause marketing language would not be
‘‘misbranded’’ under FIFRA.
After EPA’s decision became widely
known, a number of organizations, such
as the Association of American Pest
Control Officials, Beyond Pesticides,
Pesticide Action Network North
America, Center for Environmental
Health, American Bird Conservancy,
Pesticide Education Project, Strategic
Counsel on Corporate Accountability,
E:\FR\FM\31OCN1.SGM
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61640
Federal Register / Vol. 72, No. 210 / Wednesday, October 31, 2007 / Notices
rwilkins on PROD1PC63 with NOTICES
Environmental Health Fund, The
Endocrine Disruption Exchange, and
Northwest Coalition for Alternatives to
Pesticides, as well as Attorneys General
in six states, have petitioned the Agency
to rescind this decision because they
believe the use of the Red Cross symbol
implies an endorsement of the product
and/or its safety. In April 2007, the
Minnesota Department of Agriculture
prohibited Clorox products with the Red
Cross charity labels from being
distributed in Minnesota.
This topic was discussed by the
Pesticide Program Dialogue Committee
(PPDC) in May 2007. The PPDC,
established under the Federal Advisory
Committee Act, consists of a diverse
group of stakeholders and provides an
opportunity for feedback to the
pesticide program on various pesticide
regulatory, policy and program
implementation issues. The Agency
explained at the May 2007 session the
basis for the decision and that the use
of the labeling approved for the Clorox
products was neither false nor
misleading. In order to expand the
discussion of these issues to a wider
audience, and to provide a focus for
comments, the Agency developed a
framework and guidelines for evaluating
these types of labeling proposals. This
draft guidance contains a high standard
for approval. At a minimum, the label
of a registered product must be effective
in providing both use instructions and
necessary safety information.
III. Questions
The Agency requests public input for
a number of questions about the
proposed evaluation process for label
statements regarding third-party
endorsements and cause marketing
claims.
1. Are there other standards in FIFRA,
besides the misbranding standards sec.
2(q) and the unreasonable adverse
effects standards in secs. 3(c)(5) and
3(c)(7), that the Agency should use in
deciding whether to approve third-party
endorsements or cause marketing
claims?
2. Under what circumstances could
the use of a label statement containing
a third-party endorsement or cause
marketing claim affect a consumer’s
assumptions about efficacy or safety?
3. EPA is seeking to ensure that its
decisions whether to approve thirdparty endorsements or cause marketing
claims have a sound basis. Please
suggest how EPA might judge whether
or not to request additional information
to assess the impacts of a claim on
consumers.
4. Please comment on what additional
types of information EPA should request
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17:45 Oct 30, 2007
Jkt 214001
to assess the impacts of a claim on
consumers’ assumptions about efficacy
or safety or about whether a claim
detracts from other information
presented on the label.
5. What, if any, restrictions should
there be on the types of organizations
that can participate in third-party
endorsement or cause marketing claims
on labels?
6. What, if any, restrictions should
there be on the types of symbols that
can be used on labels, in order to
minimize the potential impact of
consumers’ assumptions about efficacy
or safety?
7. How should the Agency evaluate
whether label statements containing a
third-party endorsement or cause
marketing claim detract from other
information presented on the label?
8. How should the Agency maximize
the effectiveness of disclaimer language
when it is used to mitigate the potential
for misunderstandings?
9. Are there other factors the Agency
should consider when evaluating thirdparty endorsements or cause marketing
claims on labels?
10. Please identify and explain why
any particular population groups may
be more vulnerable to adverse impacts
or more likely to misunderstand label
statements regarding third party
endorsements or cause marketing
claims.
11. What kind of public participation
process, if any, is appropriate when the
Agency evaluates a specific proposed
label statement regarding a third party
endorsement or a cause marketing
claim?
12. Should the Agency consider
imposing a time limitation with regard
to approval and use of the third party
endorsement label that is granted?
13.One proposal is that registrants
could use a hang tag, wrap around,
shrink wrap or other approach to
display cause marketing language or a
third-party endorsement. Please
comment on this proposal.
14. Under what circumstances, if any,
should the contents of an application to
add a third-party endorsement or cause
marketing claim to the label of a
registered product be treated as
Confidential Business Information
(CBI)? What information should be
required to support a claim of CBI?
IV. Do PR Notices Contain Binding
Requirements?
The PR Notice discussed in this
notice is intended to provide guidance
to EPA personnel and decision makers
and to pesticide registrants. While the
requirements in the statutes and Agency
regulations are binding on EPA and the
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
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.
List of Subjects
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests.
Dated: October 17, 2007.
Debra Edwards,
Director, Office of Pesticide Programs.
[FR Doc. E7–21468 Filed 10–30–07; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPPT–2007–1067; FRL–8155–2]
Certain New Chemicals; Receipt and
Status Information
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
SUMMARY: Section 5 of the Toxic
Substances Control Act (TSCA) requires
any person who intends to manufacture
(defined by statute to include import) a
new chemical (i.e., a chemical not on
the TSCA Inventory) to notify EPA and
comply with the statutory provisions
pertaining to the manufacture of new
chemicals. Under sections 5(d)(2) and
5(d)(3) of TSCA, EPA is required to
publish a notice of receipt of a
premanufacture notice (PMN) or an
application for a test marketing
exemption (TME), and to publish
periodic status reports on the chemicals
under review and the receipt of notices
of commencement to manufacture those
chemicals. This status report, which
covers the period from September 10,
2007 to October 5, 2007, consists of the
PMNs and TMEs, both pending or
expired, and the notices of
commencement to manufacture a new
chemical that the Agency has received
under TSCA section 5 during this time
period.
DATES: Comments identified by the
specific PMN number or TME number,
must be received on or before November
30, 2007.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPPT–2007–1067, by
one of the following methods.
E:\FR\FM\31OCN1.SGM
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]]>Agencies
[Federal Register Volume 72, Number 210 (Wednesday, October 31, 2007)]
[Notices]
[Pages 61638-61640]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-21468]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2007-1008; FRL-8152-6]
Pesticides; Draft Guidance for Pesticide Registrants on Label
Statements Regarding Third-Party Endorsements and Cause Marketing
Claims
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Agency is announcing the availability of and seeking
public comment on a draft Pesticide Registration Notice (PR Notice)
entitled ``Label Statements Regarding Third-Party Endorsements & Cause
Marketing Claims.'' PR Notices are issued by the 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 provides guidance to the
registrant concerning the Agency's framework for evaluating label
statements regarding third-party endorsements and cause marketing
claims, in which registrants and other interested parties may wish to
comment.
DATES: Comments must be received on or before December 31, 2007.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2007-1008, by one of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is (703) 305-5805.
Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2007-1008. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
https://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website 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 e-
mail comment directly to EPA without going through regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, 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.
Docket: All documents in the docket are listed in the docket index
available in regulations.gov. To access the electronic docket, go to
https://www.regulations.gov, select ``Advanced Search,'' then ``Docket
Search.'' Insert the docket ID number where indicated and select the
``Submit'' button. Follow the instructions on the regulations.gov
website to view the docket index or access available documents.
Although listed in the index, some information is not publicly
available, e.g., CBI or other information whose disclosure is
[[Page 61639]]
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either in the electronic docket at https://
www.regulations.gov, or, if only available in hard copy, at the 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 from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.
FOR FURTHER INFORMATION CONTACT: Nicole Zinn, Immdediate Office
(7510P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: 703-308-7076; fax number: 703-308-4776; e-mail address:
zinn.nicole@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 register
products under the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA). 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. 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 e-mail. 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.
See Unit III below for a list of questions that the Agency would
like the public to address.
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.
II. Background
A. What Action is the Agency Taking?
The Agency is announcing the issuance of a draft Pesticide
Registration Notice [PR-2007-xx] that describes the Agency's framework
for evaluating label statements regarding third-party endorsements and
cause marketing claims. This draft Notice contains a description of the
Agency's framework for evaluating proposed statements and graphic
material to appear on pesticide labeling regarding third-party
endorsements or a relationship between the pesticide registrant and a
charity (``cause marketing claims''). The draft Notice identifies
factors EPA may consider in reviewing applications for registration or
amended registration with labeling that contains either third-party
endorsements or cause marketing claims.
The Notice also identifies the types of discussion and information
that applicants could provide to support EPA review of such
applications. These items may include a mock label, documentation of
the third-party endorsement or information to substantiate the
truthfulness of the cause marketing claim, and a discussion of
potential consumer impacts, including consumer market research when
appropriate. In some cases, EPA could approve a proposed label
statement but conditionally require the registrant to provide
additional information to assess whether adverse consequences resulted
from the addition of the label statement.
B. Why is the Agency Taking this Action?
In January 2006, The Clorox Company (Clorox) contacted EPA about
adding cause marketing language to some of their pesticide labels. The
proposed language described a philanthropic relationship between Clorox
and the American Red Cross (Red Cross). In March 2006, EPA met with
Clorox and Red Cross officials to discuss adding a cause marketing
claim to a pesticide label. Clorox described the partnership agreement
they had entered into with the Red Cross, discussed what cause
marketing language they were currently using on non-pesticide products,
and presented a label mock-up. In this meeting, EPA expressed concern
that consumers could understand the Red Cross symbol on the label as an
implied safety claim. Clorox provided an additional presentation in
July 2006 which included a toxicology profile of bleach; a National
Capital Area Poison Control Center presentation regarding incidents
involving bleach; and information that the labeling would not alter
consumer behavior in ways that could lead to misuse.
After review of the information described above, EPA approved Red
Cross ``cause marketing'' language on Clorox label products. In
particular, the Agency decision relied on EPA's expectation that
consumers will not interpret the Red Cross symbol on labels to mean
that the product is safe, which was based on data from consumer survey
research. The decision also relied on an assessment of the likely
health consequences were the products to be misused as a result of the
presence of the cause marketing labeling and consideration of whether
such labeling would alter consumer behavior in ways that could lead to
misuse. EPA concluded that the available information was sufficient to
support a conclusion that the product bearing the cause marketing
language would not be ``misbranded'' under FIFRA.
After EPA's decision became widely known, a number of
organizations, such as the Association of American Pest Control
Officials, Beyond Pesticides, Pesticide Action Network North America,
Center for Environmental Health, American Bird Conservancy, Pesticide
Education Project, Strategic Counsel on Corporate Accountability,
[[Page 61640]]
Environmental Health Fund, The Endocrine Disruption Exchange, and
Northwest Coalition for Alternatives to Pesticides, as well as
Attorneys General in six states, have petitioned the Agency to rescind
this decision because they believe the use of the Red Cross symbol
implies an endorsement of the product and/or its safety. In April 2007,
the Minnesota Department of Agriculture prohibited Clorox products with
the Red Cross charity labels from being distributed in Minnesota.
This topic was discussed by the Pesticide Program Dialogue
Committee (PPDC) in May 2007. The PPDC, established under the Federal
Advisory Committee Act, consists of a diverse group of stakeholders and
provides an opportunity for feedback to the pesticide program on
various pesticide regulatory, policy and program implementation issues.
The Agency explained at the May 2007 session the basis for the decision
and that the use of the labeling approved for the Clorox products was
neither false nor misleading. In order to expand the discussion of
these issues to a wider audience, and to provide a focus for comments,
the Agency developed a framework and guidelines for evaluating these
types of labeling proposals. This draft guidance contains a high
standard for approval. At a minimum, the label of a registered product
must be effective in providing both use instructions and necessary
safety information.
III. Questions
The Agency requests public input for a number of questions about
the proposed evaluation process for label statements regarding third-
party endorsements and cause marketing claims.
1. Are there other standards in FIFRA, besides the misbranding
standards sec. 2(q) and the unreasonable adverse effects standards in
secs. 3(c)(5) and 3(c)(7), that the Agency should use in deciding
whether to approve third-party endorsements or cause marketing claims?
2. Under what circumstances could the use of a label statement
containing a third-party endorsement or cause marketing claim affect a
consumer's assumptions about efficacy or safety?
3. EPA is seeking to ensure that its decisions whether to approve
third-party endorsements or cause marketing claims have a sound basis.
Please suggest how EPA might judge whether or not to request additional
information to assess the impacts of a claim on consumers.
4. Please comment on what additional types of information EPA
should request to assess the impacts of a claim on consumers'
assumptions about efficacy or safety or about whether a claim detracts
from other information presented on the label.
5. What, if any, restrictions should there be on the types of
organizations that can participate in third-party endorsement or cause
marketing claims on labels?
6. What, if any, restrictions should there be on the types of
symbols that can be used on labels, in order to minimize the potential
impact of consumers' assumptions about efficacy or safety?
7. How should the Agency evaluate whether label statements
containing a third-party endorsement or cause marketing claim detract
from other information presented on the label?
8. How should the Agency maximize the effectiveness of disclaimer
language when it is used to mitigate the potential for
misunderstandings?
9. Are there other factors the Agency should consider when
evaluating third-party endorsements or cause marketing claims on
labels?
10. Please identify and explain why any particular population
groups may be more vulnerable to adverse impacts or more likely to
misunderstand label statements regarding third party endorsements or
cause marketing claims.
11. What kind of public participation process, if any, is
appropriate when the Agency evaluates a specific proposed label
statement regarding a third party endorsement or a cause marketing
claim?
12. Should the Agency consider imposing a time limitation with
regard to approval and use of the third party endorsement label that is
granted?
13.One proposal is that registrants could use a hang tag, wrap
around, shrink wrap or other approach to display cause marketing
language or a third-party endorsement. Please comment on this proposal.
14. Under what circumstances, if any, should the contents of an
application to add a third-party endorsement or cause marketing claim
to the label of a registered product be treated as Confidential
Business Information (CBI)? What information should be required to
support a claim of CBI?
IV. Do PR Notices Contain Binding Requirements?
The PR Notice discussed in this notice is intended to provide
guidance to EPA personnel and decision makers 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.
List of Subjects
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests.
Dated: October 17, 2007.
Debra Edwards,
Director, Office of Pesticide Programs.
[FR Doc. E7-21468 Filed 10-30-07; 8:45 am]
BILLING CODE 6560-50-S
