Document ID: EPA-HQ-OPP-2006-0490-0001
Agency: epa
Document Type: Notice
Title: Phytophthora Palmivora (MWV) and Methyl Salicylate; Reregistration Eligibility Decision; Notice of Availability
Posted Date: 2006-06-28T13:03:21Z

[Federal Register: June 28, 2006 (Volume 71, Number 124)]
[Notices]               
[Page 36789-36792]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28jn06-79]                         

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2006-0490; FRL-8072-5]

 
Phytophthora Palmivora (MWV) and Methyl Salicylate; 
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 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.

[[Page 36790]]

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 (703) 305-5805.
    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 (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Shanaz Bacchus for Phytophthora 
palmivora (telephone number: (703) 308-8097) and Richard King 
(telephone number: (703) 308-8052) for Methyl salicylate, Biopesticides 
and Pollution Prevention Division (7511P), Environmental Protection 
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; fax 
number: (703) 308-7026; e-mail addresses: 
bacchus.shanaz@epa.gov, and king.richard@epa.gov.>

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

[[Page 36791]]

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.

[[Page 36792]]

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.
[FR Doc. 06-5855 Filed 6-27-06; 8:45 am]

BILLING CODE 6560-50-S