Document ID: EPA-HQ-OPP-2010-0282-0001
Agency: epa
Document Type: Notice
Title: Pesticides: Draft Guidance for Pesticide Registrants on False or Misleading Pesticide Product Brand Names
Posted Date: 2010-05-19T04:00Z

[Federal Register: May 19, 2010 (Volume 75, Number 96)]
[Notices]               
[Page 28012-28014]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19my10-54]                         

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2010-0282; FRL-8824-8]

 
Pesticides; Draft Guidance for Pesticide Registrants on False or 
Misleading Pesticide Product Brand Names

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 ``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

[[Page 28013]]

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 (703) 305-5805.
    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 (703) 305-5805.

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: (703) 305-5448; fax number: (703) 308-6467; e-mail address: 
kempter.carlton@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 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

[[Page 28014]]

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.

[FR Doc. 2010-11977 Filed 5-18-10; 8:45 am]
BILLING CODE 6560-50-S