E6-12896. Metaldehyde Reregistration Eligibility Decision; Notice of Availability

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

This notice announces the availability of EPA's Reregistration Eligibility Decision (RED) for the pesticide metaldehyde, and opens a public comment period on this document. The Agency's risk assessments and other related documents also are available in the metaldehyde Docket. Metaldehyde is a molluscicide used to control snails and slugs on a wide variety of sites, including turf, ornamentals, berries, citrus, and vegetables. EPA has reviewed metaldehyde 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 October 10, 2006.

ADDRESSES:

Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2005-0231, 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-2005-0231. 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 http://www.regulations.gov or E-mail. The Federal http://www.regulations.gov Web site 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 http://www.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 Bldg.), 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 Facility telephone number is [phone].

FOR FURTHER INFORMATION CONTACT:

Jill Bloom, 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].

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 http://www.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 has completed a Reregistration Eligibility Decision (RED) for the pesticide metaldehyde under section 4(g)(2)(A) of FIFRA. Metaldehyde is a molluscicide used to control snails and slugs on a wide variety of sites, including turf, ornamentals, berries, citrus, and vegetables. EPA has determined that the data base to support reregistration is substantially complete. The technical registrant of metaldehyde, Lonza, elected not to support many uses through the development of residue and other data. Of the uses Lonza is supporting, turf and dichondra lawns are not eligible for reregistration, mainly based on the risks these residential uses pose to domestic animals, which may be poisoned by ingesting metaldehyde pellets intended as snail and slug baits. The uses of metaldehyde that are eligible for reregistration are: Ornamentals, citrus, cole crops, several leafy greens (including lettuce and spinach), tomato, strawberry, berries (including blackberry, blueberry, currant, elderberry, gooseberry, and raspberries), artichoke, and grass grown for seed. To mitigate the risks associated with the eligible uses of metaldehyde, the Agency is requiring that the registrants implement a number of measures aimed at reducing exposures to domestic animals and wildlife, mainly through reduced numbers of applications and reduced application rates, and product labeling and reformulation. In addition, the Agency is requiring that the registrants undertake a comprehensive incident monitoring program, data from which will be used by the Agency to determine whether these risk mitigation measures adequately reduce numbers and severity of poisoning incidents for domestic animals. Upon submission of any required generic and product-specific data pursuant to the RED, and any necessary changes to metaldehyde registrations and product labeling (either to address concerns identified in the RED or resulting from the use of product-specific data), EPA will make a final reregistration decision under section 4(g)(2)(C) for products containing metaldehyde.

EPA must review tolerances and tolerance exemptions that were in effect when the Food Quality Protection Act (FQPA) was enacted in August 1996, to ensure that these existing pesticide residue limits for food and feed commodities meet the safety standard established by the new law. Tolerances are considered reassessed once the safety finding has been made or a revocation occurs. EPA has reviewed and made the requisite safety finding for the sole existing metaldehyde tolerance.

Although the metaldehyde RED was signed on July 27, 2006, certain components of the document, which did not affect the final regulatory decision, are undergoing final editing at this time. These components, including the list of additional generic data requirements, summary of labeling changes, appendices, and other relevant information, will be added to the metaldehyde RED when they are complete. None of these additions will alter the conclusions documented in the July 27, 2006 metaldehyde RED.

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, metaldehyde was reviewed through the modified 4-Phase process. Through this process, EPA worked extensively with stakeholders and the public to reach the regulatory decisions for metaldehyde.

The reregistration program is being conducted under Congressionally mandated time frames, and EPA recognizes the need both to make timely decisions and to involve the public. The Agency is issuing the metaldehyde RED 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 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 metaldehyde. Comments received after the close of the comment period will be marked “late.” EPA is not required to consider these late comments.-

In particular, during the 60-day comment period following the publication of this Notice, the Agency is soliciting input on several of the mitigation measures required by the RED. -

The Agency is specifically seeking public comment on how the directions on home and garden product labels to exclude children and domestic animals from treated areas may be enhanced. As an example, the RED requires that these product labels include a graphic representing the prohibition for allowing children and domestic animals access to treated areas (e.g., the words “Children and Pets” within a red circle with a red bar running diagonally through the circle). The formulators of metaldehyde products have commented that they believe a “Children and Pets” graphic of this nature could be misleading to consumers. Comments on this feature in particular are requested.

In addition, the Agency seeks public comment on a requirement that all metaldehyde granular products be formulated with a bright blue pigment, which anecdotal evidence suggests may deter ingestion by animals. Some registrants have expressed concern that the blue color could attract children who might mistake the granules for candy. The Agency is soliciting input on this issue and data on the potential effect of the blue color on ingestion of such material by animals. The registrants are also concerned that the blue color in granules could transfer to produce or the containers in which harvested produce is transported, reducing the marketability of the produce. The Agency believes that the soil-applied baits should have little likelihood of transferring color to plants, but is seeking public comment on experience with the pigmented formulations in agricultural sites, where they are already used.

The Agency is also seeking input on a prohibition of use for metaldehyde in strawberries grown as annuals. The annual growth pattern is typically associated with lower populations of slugs which may do little economic damage to the fruits. The Agency seeks information to be able to confirm or refute that the use of metaldehyde on strawberries grown as annuals is not necessary.-

The Agency will carefully consider all comments received by the closing date and subsequently will post a Response to Comments Memorandum to the metaldehyde Docket. If any comment significantly affects the reregistration decision, EPA also will publish an amendment to the RED in the Federal Register. In the absence of substantive comments requiring changes, the metaldehyde RED 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 products or taking other “appropriate regulatory action.”

Section 408(q) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(q), requires EPA to review tolerances and exemptions for pesticide residues in effect as of August 2, 1996, to determine whether the tolerance or exemption meets the requirements of section 408(b)(2) or (c)(2) of FFDCA. This review is to be completed by August 3, 2006.

List of Subjects

• Environmental protection
• Pesticides and pests

Dated: August 2, 2006.

Debra Edwards,

Director, Special Review and Reregistration Division, Office of Pesticide Programs.