06-5837. Formetanate Hydrochloride Interim Reregistration Eligibility Decision; Notice of Availability

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

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 [phone].

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 [phone].

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: [phone]; fax number: [phone]; e-mail address: [e-mail].

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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.

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 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.