

[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
