[Federal Register Volume 75, Number 96 (Wednesday, May 19, 2010)]
[Notices]
[Pages 28012-28014]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-11977]
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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Pesticides; Draft Guidance for Pesticide Registrants on False or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