Document ID: EPA-HQ-OPP-2005-0231-0011
Agency: epa
Document Type: Notice
Title: Metaldehyde Reregistration Eligibility Decision; Notice of Availability
Posted Date: 2006-08-09T14:17:18Z

[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