[Federal Register Volume 71, Number 124 (Wednesday, June 28, 2006)]
[Notices]
[Pages 36789-36792]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-5855]
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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: [email protected], and
[email protected].>
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