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Formetanate Hydrochloride Interim Reregistration Eligibility Decision; Notice of Availability
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
[Federal Register: June 28, 2006 (Volume 71, Number 124)]
[Notices]
[Page 36784-36786]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28jn06-76]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2004-0032; FRL-8064-2]
Formetanate Hydrochloride Interim Reregistration Eligibility
Decision; Notice of Availability
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: This notice announces the availability of EPA's Interim
Reregistration Eligibility Decision (IRED) for the N-methyl carbamate
pesticide formetanate hydrochloride (formetanate HCl), and opens a
public comment period on this document. The Agency's risk assessments
and other related documents also are available in the formetanate HCl
Docket. Formetanate HCl, a miticide/insecticide, is used on orchard
crops and alfalfa grown for seed. EPA has reviewed formetanate HCl
through 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 August 28, 2006.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2004-0032, 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
Building), 2777 S. Crystal Drive, 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 telephone number is (703) 305-5805.
Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2004-0032. 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 Federal 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.
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
Building), 2777 S. Crystal Drive, 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 telephone number is (703)
305-5805.
FOR FURTHER INFORMATION CONTACT: Demson Fuller, Special Review and
Reregistration Division (7508P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (703) 308-8062; fax
number: (703) 308-7070; e-mail address: fuller.demson@epa.gov.
SUPPLEMENTARY INFORMATION:
[[Page 36785]]
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.
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. EPA
completed an IRED for the N-methyl carbamate pesticide formetanate HCl
on March 15, 2006, and is now issuing this document for public comment.
Formetanate HCl, a miticide/insecticide, is used on orchard crops and
alfalfa grown for seed. The formetanate HCl IRED presents the Agency's
conclusions on the risks posed by exposure to formetanate HCl alone;
however, section 408(b)(2)(D)(v) of the Federal Food, Drug and Cosmetic
Act (FFDCA) directs the Agency also to consider available information
on the cumulative risk from substances sharing a common mechanism of
toxicity. Because the N-methyl carbamate pesticides share a common
mechanism of toxicity, the Agency will evaluate the cumulative risk
posed by this group before making final reregistration eligibility
decisions on individual N-methyl carbamates.
During the pendency of the N-methyl carbamate cumulative
assessment, the Agency is proceeding with risk assessments and interim
risk management for individual N-methyl carbamate pesticides. While EPA
has not yet completed its cumulative risk assessment for the N-methyl
carbamates, cumulative risks of these chemicals will be considered in
the future. At that time, the Agency's final tolerance reassessment and
reregistration decisions for formetanate HCl and the other N-methyl
carbamates will be issued. Upon submission of any required product
specific data under section 4(g) (2) (B) and any necessary changes to
the registration and labeling (either to address concerns identified in
the IRED or as a result of product specific data), and after assessing
N-methyl carbamate cumulative risks, EPA will make a final
reregistration decision under section 4(g) (2) (C) for products
containing formetanate HCl. When the Agency finalizes decisions for
formetanate HCl and other N-methyl carbamate pesticides, further risk
mitigation may be required for formetanate HCl.
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, EPA 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.
Due to its uses, risks, and other factors, formetanate HCl was reviewed
through the modified 4 phase public participation process. Through this
process, EPA worked extensively with stakeholders and the public to
reach the regulatory decisions for formetanate HCl.
The reregistration program is being conducted under Congressionally
mandated time frames, and EPA recognizes the need both to make timely
reregistration decisions and to involve the public. The Agency is
issuing the formetanate HCl IRED for public comment. This comment
period is intended to provide an additional opportunity for public
input and a mechanism for initiating any necessary amendments to the
IRED. 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 formetanate HCl.
Comments received after the close of the comment period will be marked
``late.'' EPA is not required to consider these late comments.
The Agency 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 IRED in the Federal
Register. In the absence of substantive comments requiring changes, the
risk management decisions reflected in the formetanate HCl IRED will be
implemented as presented. These decisions may be supplemented by
further risk mitigation measures when EPA considers its cumulative
assessment of the N-methyl carbamate pesticides.
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
[[Page 36786]]
eligible for reregistration,'' before calling in product specific data
on individual end-use products and either reregistering products or
taking other ``appropriate regulatory action.''
List of Subjects
Environmental protection, Pesticides and pests.
Dated: June 20, 2006.
Debra Edwards,
Director, Special Review and Reregistration Division, Office of
Pesticide Programs.
[FR Doc. 06-5837 Filed 6-27-06; 8:45 am]
BILLING CODE 6560-50-S