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Metaldehyde Reregistration Eligibility Decision; Notice of Availability
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
[Federal Register: August 9, 2006 (Volume 71, Number 153)]
[Notices]
[Page 45551-45554]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09au06-80]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2005-0231; FRL-8067-1]
Metaldehyde 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
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
[[Page 45552]]
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 (703) 305-5805.
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 (703)
305-5805.
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: (703) 308-8019; fax
number: (703) 308-7070; E-mail address: bloom.jill@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
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
[[Page 45553]]
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 theFederal 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.
[[Page 45554]]
Dated: August 2, 2006.
Debra Edwards,
Director, Special Review and Reregistration Division, Office of
Pesticide Programs.
[FR Doc. E6-12896 Filed 8-8-06; 8:45 am]
BILLING CODE 6560-50-S