2010-11977. Pesticides; Draft Guidance for Pesticide Registrants on False or Misleading Pesticide Product Brand Names

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 “False or Misleading Pesticide Product Brand Names.” 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 applicants, registrants and distributors concerning pesticide product brand names that may be false or misleading, either by themselves or in association with particular company names or trademarks.

DATES:

Comments must be received on or before June 18, 2010.

ADDRESSES:

Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2010-0282, 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 Facility’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-2010-0282. 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 at http://www.regulations.gov. 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:

Jeff Kempter, Antimicrobials Division (7510P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: [phone]; fax number: [phone]; 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 are required to register pesticides. 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.

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. What Guidance Does this PR Notice Provide?

This draft PR Notice provides guidance to applicants, registrants and distributors on pesticide product brand names that may be false or misleading, either by themselves or in association with particular company names or trademarks. The Agency previously announced the availability of this draft PR Notice for public comment (67 FR 14941; FRL-6809-9) on March 28, 2002 and received comments from 28 parties (EPA docket ID number EPA-HQ-OPP-2002-0084). The Agency has reviewed those comments, made appropriate changes to the draft PR Notice, and written responses to the comments (see the Responses to Comments document posted to the docket ID number EPA-HQ-OPP-2010-0282).

The revised draft PR Notice clarifies how statutory and regulatory provisions that prohibit pesticide labeling from being false or misleading apply to product brand names. Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) sections 12(a)(1)(E) and 2(q)(1)(A), and 40 CFR 156.10(b)(2) and 40 CFR 156.10(a)(5), products with brand names that, in a false or misleading manner, state or imply safety, efficacy or comparative claims, or are otherwise false or misleading in any particular, are considered to be misbranded and may not be sold or distributed.

The revised, draft PR Notice explains the statutory and regulatory requirements that a pesticide product brand name, either by itself or containing or located in close proximity to a company name or trademark, not be false or misleading. The draft PR Notice provides examples of potentially false or misleading product brand names. Finally, the draft PR Notice states that the Agency will be applying these regulations as interpreted in this notice when evaluating applications for new products or brand names, reviewing notifications for alternate or changed brand names, reviewing applications for registration, or conducting registration reviews. The draft PR Notice encourages applicants and registrants to review their product names in light of its guidance, and, if warranted, take corrective action within two years of the issuance of the final PR Notice. The draft PR Notice explains that after the final implementation date, EPA may consider the guidance in the final PR Notice when determining whether a product is misbranded under FIFRA.

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 statute 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 and applicants may assert that the guidance is not appropriate categorically or not applicable to a specific pesticide or situation.

List of Subjects

• Environmental protection
• Administrative practice and procedure
• Agricultural commodities
• Pesticides and pests

Dated: May 12, 2010.

Steven Bradbury,

Acting Director, Office of Pesticide Programs.