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Naphthalene Acetic Acid, its Salts, Ester, and Acetamide; Reregistration Eligibility Decision and Amendment for Low-Risk Pesticide; Notice of Availability
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
[Federal Register: December 5, 2007 (Volume 72, Number 233)]
[Notices]
[Page 68582-68584]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05de07-48]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2006-0507; FRL-8154-6]
Naphthalene Acetic Acid, its Salts, Ester, and Acetamide;
Reregistration Eligibility Decision and Amendment for Low-Risk
Pesticide; Notice of Availability
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: This notice announces the availability of EPA's Reregistration
Eligibility Decision (RED) and Amendment for the pesticide naphthalene
acetic acid, its salts, ester, and acetamide, and opens a public
comment period on these documents, related risk assessments, and other
support documents. EPA has reviewed the low-risk pesticide naphthalene
acetic acid, its salts, ester, and acetamide (also referred to as
naphthalene acetates or NAA) through a modified, streamlined version of
the public participation process that the Agency uses to involve the
public in developing pesticide reregistration and tolerance
reassessment decisions. Through these programs, EPA is ensuring that
all pesticides meet current health and safety standards.
DATES: Comments must be received on or before January 4, 2008.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2006-0507, 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-
2006-0507. 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 (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Mark T. Howard, Special Review and
Reregistration Division (7508P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (703) 308-8172; fax
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
This action is directed to the public in general, and may be of
interest to a wide range of stakeholders including environmental, human
health, and agricultural advocates; the chemical industry; pesticide
users; and members of the public interested in the sale, distribution,
or use of pesticides. Since others also may 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
applicability of this action to a particular entity, 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.
[[Page 68583]]
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?
Under section 4 of the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), EPA is reevaluating existing pesticides to
ensure that they meet current scientific and regulatory standards.
Using a modified, streamlined version of its public participation
process, EPA has completed a RED and an Amendment for the low-risk
naphthalene acetate pesticides under section 4(g)(2)(A) of FIFRA. The
naphthalene acetates are plant growth regulators that mimic the
function of the naturally occurring plant growth hormone, auxin. They
are mainly used on apple and pear trees but also have minor uses on
crops such as olives and cherries. They are also used on a wide variety
of ornamental plants, trees, and shrubs. In its various forms, NAA can
stimulate root growth, thin excess fruit, and prevent premature fruit
drop. EPA has determined that the database to support reregistration is
substantially complete and that products containing naphthalene acetic
acid, its salts, ester, and acetamide will be eligible for
reregistration provided the risks are mitigated either in the manner
described in the RED Amendment or by another means that achieves
equivalent risk reduction. Upon submission of any required product
specific data under section 4(g)(2)(B) of FIFRA and any necessary
changes to the registration and labeling (either to address any
concerns identified in the RED Amendment or as a result of product
specific data), EPA will make a final reregistration decision under
section 4(g)(2)(C) of FIFRA for products containing naphthalene acetates.
With the May 26, 2004 RED signature, EPA concluded that the use of
the naphthalene acetates would have no effect on any endangered or
threatened species or their critical habitat from the uses currently
registered based on its screening-level assessment. However, the Agency
was informed that one very minor use, on olive trees as a chemical
thinning agent, has an approved application rate higher than assessed
in the RED. Based on screening-level ecological and occupational
assessments of the higher use rate, calculated risk quotients (RQs) for
NAA use on olive trees then exceeded the level of concern for
endangered species and one worker exposure scenario exceeds the
occupational level of concern. The Agency performed a refined risk
assessment with additional data, which allowed EPA to characterize the
risks and determine that risks were at an acceptable level. The Agency
is issuing an Amended RED for NAA, which reflects the refined
occupational and ecological assessments.
In addition, certain components of the document, which did not
affect the final regulatory decision, were undergoing final editing at
the time of the RED's signature. These components, including the list
of additional generic data requirements, summary of labeling changes,
appendices, and other relevant information, have been added to the
naphthalene acetic acid, its salts, ester, and acetamide RED Amendment
document. Subsequent to signature, EPA identified some minor errors and
ambiguities in the original RED. Therefore, for the sake of accuracy,
the Agency also has included the appropriate error corrections and
clarifications to the RED Amendment. None of these additions or changes
impacts the decisions described in the NAA RED or its Amendment. These
changes are described in the preamble to the naphthalene acetic acid,
its salts, ester, and acetamide RED Amendment.
EPA is applying the principles of public participation to all
pesticides undergoing reregistration and tolerance reassessment. The
Agency's Pesticide Tolerance Reassessment and Reregistration; Public
Participation Process, published in the Federal Register on May 14,
2004, (69 FR 26819) (FRL-7357-9) explains that in conducting these
programs, the Agency is tailoring its public participation process to
be commensurate with the level of risk, extent of use, complexity of
issues, and degree of public concern associated with each pesticide.
EPA can expeditiously reach decisions for pesticides like the
naphthalene acetates, which pose few risk concerns, and require little
risk mitigation. Once EPA assesses uses and risks for such low risk
pesticides, the Agency may go directly to a decision and prepare a
document summarizing its findings, such as the naphthalene acetic acid,
its salts, ester, and acetamide RED and its Amendment.
The reregistration program is being conducted under congressionally
mandated timeframes, and EPA recognizes the need both to make timely
decisions and to involve the public in finding ways to effectively
mitigate pesticide risks. NAA, however, poses few risks that require
mitigation. The Agency therefore is issuing the naphthalene acetic
acid, its salts, ester, and acetamide RED and Amendment, its risk
assessments, and related support materials simultaneously for public
comment. The comment period is intended to provide an opportunity for
public input and a mechanism for initiating any additional amendments
to the RED. All comments should be submitted using the methods in
ADDRESSES, and must be received by EPA on or before the closing date.
These comments will become part of the Agency Docket for naphthalene
acetic acid, its salts, ester, and acetamide. Comments received after
the close of the comment period will be marked ``late.'' EPA is not
required to consider these late comments.
EPA will carefully consider all comments received by the closing
date and will provide a Response to Comments Memorandum in the Docket
and regulations.gov. If any comment significantly affects the document,
EPA also will publish an amendment to the RED in the Federal Register.
In the absence of substantive comments requiring changes, the
naphthalene acetic acid, its salts, ester, and acetamide RED as amended
will be implemented as it is now presented.
B. What is the Agency's Authority for Taking this Action?
Section 4(g)(2) of FIFRA, as amended, directs that, after
submission of all data concerning a pesticide active ingredient, ``the
Administrator shall determine whether pesticides containing such active
ingredient are eligible for reregistration,'' before calling in product
specific data on individual end-use products and either reregistering
[[Page 68584]]
products or taking other ``appropriate regulatory action.''
List of Subjects
Environmental protection, Pesticides and pests, Naphthalene acetic
acid, Naphthalene acetates, NAA.
Dated: November 21, 2007.
Steven Bradbury,
Director, Special Review and Reregistration Division, Office of
Pesticide Programs.
[FR Doc. E7-23306 Filed 12-4-07; 8:45 am]
BILLING CODE 6560-50-S