E7-21468. Pesticides; Draft Guidance for Pesticide Registrants on Label Statements Regarding Third-Party Endorsements and Cause Marketing Claims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: 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 [phone].

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 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 [phone].

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: [e-mail].

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, 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.