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Pesticides; Draft Guidance for Pesticide Registrants on Label Statements Regarding Third-Party Endorsements and Cause Marketing Claims
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
[Federal Register: October 31, 2007 (Volume 72, Number 210)]
[Notices]
[Page 61638-61640]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31oc07-64]
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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Pesticides; Draft Guidance for Pesticide Registrants on Label Statements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.
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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: http://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
http://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
http://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 http://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