06-5855. Phytophthora Palmivora (MWV) and Methyl Salicylate; 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 Phytophthora palmivora (MWV) and methyl salicylate, and opens a public comment period on this document. The Agency's risk assessments and other related documents also are available in the Phytophthora palmivora MWV and methyl salicylate Docket. Phytophthora palmivora MWV is expected to control milk weed vine in citrus groves in certain counties of Florida. Methyl salicylate is a biochemical insect and animal repellent. EPA has reviewed Phytophthora palmivora MWV and methyl salicylate 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 July 28, 2006.

ADDRESSES:

Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2006-0490, 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-2006-0490. 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 Facility telephone number is [phone].

FOR FURTHER INFORMATION CONTACT:

Shanaz Bacchus for Phytophthora palmivora (telephone number: [phone]) and Richard King (telephone number: [phone]) for Methyl salicylate, Biopesticides and Pollution Prevention Division (7511P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; fax number: [phone]; e-mail addresses: [e-mail], and [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 has completed a Reregistration Eligibility Decision (RED) for the pesticides, Phytophthora palmivora MWV and methyl salicylate under section 4(g)(2)(A) of FIFRA.

Below is a summary of each case:

1. Phytophthora palmivora. MWV- Case 4105 (PC Code 111301). Phytophthora palmivora MWV is a fungus that controls milk weed vine in citrus groves by attacking their roots. It is a plant pathogen that is very specific for this target plant pest and occurs naturally in Florida in the counties for which it is labeled. The active ingredient, P. palmivora, was registered in 1981 by Abbott Laboratories but was transferred on April 29, 2000, to Valent BioSciences Corporation who still holds the registration. Valent's label for Devine Biological Herbicide indicates that the product is for use on citrus groves in Florida only and “do not use in Clay, Gulf, Liberty, or Gadsden counties.” It is to be applied approximately once every two years. It is considered in Toxicity Category IV based on acute toxicology tests in mammalian systems as described in the RED. No hypersensitivity incidents have been reported in association with the use of this pesticide. This fungal active ingredient is not expected to harm human adults, infants and children via dietary, non-dietary, aggregate, occupational, residential and cumulative exposures. The exemption from tolerance was reassessed and the database complies with the Food Quality Protection Act of 1996. The pesticide is not to be used in counties where susceptible endangered species are found. No harm is expected to human health and the environment including birds, beneficial insects, aquatic and other non-target terrestrial organisms, and wildlife. There is a “not likely to adversely affect” (NLAA) endangered species determination when the labeling excludes applications in counties where endangered plants may be found.

2. Methyl salicylate. Case 4080 (PC Code 076601). Methyl salicylate is a biochemical insect and animal repellant. Methyl salicylate was first registered in 1972 for use as an animal repellent in impregnated twist tabs hung on plants to repel dogs and cats from flower gardens. In 1996, the Agency registered methyl salicylate as an insect repellent to be used as a constituent of food and feed packaging material to repel insects in stored commodities (e.g. Indian meal moths). This registration is considered to be a “food use”, since it entails use in stored food commodities which necessitated the establishment of an exemption from the requirements of a tolerance (Refer to 40 CFR 180.1189). The active ingredient methyl salicylate is considered to be a low toxicity biochemical (toxicity categories III and IV) as described in the RED on the basis of toxicological mammalian tests for acute oral, dermal effects and primary eye and skin irritations. No reported incidents of hypersensitivity have been reported to the Agency. In fact, methyl salicylate has a long history of use in consumer products as a counterirritant and as an analgesic in the treatment and temporary management of aching and painful muscles and joints. Methyl salicylate is also used in suntan lotions as an UV-absorber, and in perfumery as a modifier of blossom fragrances. Because of its use patterns, as twist tabs in flower gardens and a constituent of food packaging, methyl salicylate is not expected to harm aquatic or terrestrial non-target birds, fish, beneficial insects or plants or the environment. The data base supporting the RED complies with the Food Quality Protection Act of 1996. No harm is expected to human adults, infants, and children from dietary, non-dietary, aggregate, residential and occupational and cumulative exposure when this biochemical pesticide is used as labeled.

EPA has determined that the data base to support reregistration is substantially complete and that products containing Phytophthora palmivora MWV and methyl salicylate are eligible for reregistration depending on their specific uses, provided the risks are mitigated either in the manner described in the RED or by another means that achieves equivalent risk reduction. 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 RED or as a result of product specific data), EPA will make a final reregistration decision under section 4(g)(2)(C) for products containing Phytophthora palmivora MWV and methyl salicylate.

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 Phytophthora palmivora MWV and methyl salicylate exemptions from tolerances included in this notice.

Although the Phytophthora palmivora MWV and Methyl salicylate REDs were signed on March 1, 2006, and September 22, 2005, respectively, certain components of the document, which did not affect the final regulatory decision, were undergoing final editing at that time. These components, including the list of additional generic data requirements, summary of labeling changes, appendices, and other relevant information, have been added to the Phytophthora palmivora MWV and methyl salicylate RED document. In addition, subsequent to signature, EPA identified several minor errors and ambiguities in the document. Therefore, for the sake of accuracy, the Agency also has included the appropriate error corrections, amendments, and clarifications. None of these additions or changes alter the conclusions documented in the March 1, 2006, Phytophthora palmivora MWV and September 22, 2005, methyl salicylate RED. All of these changes are described in detail in an errata memorandum which is included in the public docket for Phytophthora palmivora MWV and methyl salicylate

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, Phytophthora palmivora MWV and methyl salicylate was reviewed through the full 6-Phase or modified 4-Phase process. Through this process, EPA worked extensively with stakeholders and the public to reach the regulatory decisions for Phytophthora palmivora MWV and methyl salicylate.

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 Phytophthora palmivora MWV and methyl salicylate 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 Phytophthora palmivora MWV and methyl salicylate. 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 RED in the Federal Register. In the absence of substantive comments requiring changes, the Phytophthora palmivora MWV and methyl salicylate 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 Agency review is to be completed by August 3, 2006. EPA has reviewed and made the requisite safety finding for the exemptions from tolerances for the following pesticides: Phytophthora palmivora MWV and the biochemical pesticide methyl salicylate included in this notice. The exemptions from tolerances for these two biopesticides comply with the requirements of FQPA.

List of Subjects

• Environmental protection
• Pesticides and pests

Dated: June 16, 2006.

Janet L. Andersen,

Director, Biopesticides and Pollution Prevention Division, Office of Pesticide Programs.