

[Federal Register: July 6, 2007 (Volume 72, Number 129)]
[Notices]               
[Page 37012-37013]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06jy07-66]                         

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2005-0231; FRL-8137-5]

 
Metaldehyde; Amendment and Closure of Reregistration Eligibility 
Decision; Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces EPA's intention to modify certain 
provisions of the 2006 Reregistration Eligibility Decision (RED) for 
the pesticide metaldehyde. EPA is amending the metaldehyde RED in 
response to comments received during the public comment period on the 
RED and new information considered by the Agency after the RED was 
issued. The public comments submitted during the comment period have 
prompted the Agency to reconsider several risk mitigation measures 
discussed in the RED. This reconsideration has resulted in revisions to 
several elements of the risk mitigation program, including product 
labeling.

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: 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.

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. In 
2006, EPA issued a RED for metaldehyde under section 4(g)(2)(A) of 
FIFRA. In response to a notice of availability published in the Federal 
Register on August 9, 2006 (71 FR 45551) (FRL-8067-1), the Agency 
received comments from stakeholders, including a dog owner, 
registrants, government agencies, and users.
    The Agency reviewed these comments and additional information that 
became available after the RED was released, and determined that 
certain changes were warranted to the explanatory text and requirements 
of the RED. These changes are captured in the amendment to the 
metaldehyde RED, which includes the revised label table. These 
documents, and an analysis of the comments received during the public 
comment period on the RED, may be found on the public docket at 
http://www.regulations.gov (use the advanced search for docket ``OPP-2005-

0231''). Changes to the RED made in response to comments and additional 
information are summarized in this Notice.
    Several commenters thought that the precautionary labeling and 
storage restrictions required by the RED for end-use products were 
excessive in length and contained redundant phrases. The Agency has 
reexamined this labeling, and is revising it to be more concise.

[[Page 37013]]

    The phrase, ``metaldehyde can be fatal to children and dogs...if 
ingested'' and its variants in the precautionary statements are being 
revised in response to a comment that fatal poisonings of children have 
not been ascribed to metaldehyde. Because nonlethal incidents in 
children have been recorded, the subject phrase is revised to note that 
metaldehyde may be harmful to children if ingested.
    Also in reference to precautionary labeling, some commenters 
suggested that it is premature to require two poisoning hotline 
numbers, one each for incidents in humans and in domestic animals, or 
to designate that poisoning calls be routed to NPIC. The Agency has 
reexamined its requirements and agrees that its concerns can be 
addressed through the use of a standardized incident handling and data 
collection system, covering both human and domestic animal exposures, 
by entities that the registrants choose for their hotline service.
    Other changes to the precautionary statements were made in response 
to comments on the environmental hazard statements, as detailed in the 
amendment, and can be viewed from the docket.
    The Agency solicited ideas for a graphic warning to be placed on 
the front of residential end-use product labels. The purpose of the 
graphic is to draw attention to the need for keeping children and pets 
out of treated areas from the time the metaldehyde product is applied 
until the applied product is no longer visible. No comments were 
submitted offering alternatives to the graphic suggested by the RED, so 
the RED is now revised to require that the suggested graphic, i.e., a 
red circle with the words ``Children'' and ``Pets'' within the circle 
and with a red bar running diagonally through it, be incorporated onto 
the front of the label.
    The Agency received comments on key general application 
restrictions and repeating language in the Directions for Use portions 
of the labels. The Agency determined that some additional restrictions 
would be added, that the repetition was warranted, and that unusual 
restrictions must be offset from the surrounding text by the use of 
boldface or other contrasting type. The Agency also abbreviated the 
cultural practices language to be more concise. These changes are 
incorporated into the amended label table to the RED.
    One registrant requested that the number of applications allowed on 
blueberries be increased from two per season to three. During 
development of the original mitigation plan, the Agency consulted an 
expert in the field who advised that blueberry growers have a critical 
need for a third application in years of high rainfall and high pest 
pressure. The Agency's restriction to two applications per season was 
made in error and the number of applications is increased to three in 
the amended RED. Three aplications per season is a decrease from the 
assessed five per season.
    Based on comments from stakeholders and additional research 
findings obtained after the RED was released, the Agency has determined 
that the requirement for adding blue dye to metaldehyde pellets will be 
withdrawn. The comments and information led the Agency to conclude that 
the blue-dyed pellets would not with certainty reduce wildlife 
ingestion of metaldehyde formulations, and that the blue color might 
turn out to be attractive to children.
    USDA's Animal and Plant Health Inspection Service commented that 
some use sites the Agency excluded from product labels (such as 
railroad rights-of-way) were essential to the Service's program for 
controlling invasive slug and snail species that threaten plant and 
human health. The Agency is allowing these use sites within a ``Special 
Use Box'' on the labels of products that have been used this way in the 
past or which may be used in this manner. The Special Use Box indicates 
that such applications must only be made in response to Federal and/or 
State mollusk eradication operations.
    The body of the RED is revised in several places to expand on EPA 
findings and correct errors based on comments submitted by the 
registrants. The comparison of costs for metaldehyde and alternatives 
is revised to address the differences in maximum vs. typical 
application rates. A passage describing the potential for exposures 
other than ingestion to cause death in domestic animals is corrected to 
note that while such exposures are possible, they are not known to be 
fatal.
    The metaldehyde RED will be implemented with the changes cited 
above, as detailed in the amendment and the revised label table posted 
on the public docket.

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.''

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: June 26, 2007.
Peter Caulkins,
Acting Director, Special Review and Reregistration Division, Office of 
Pesticide Programs
[FR Doc. E7-12865 Filed 7-5-07; 8:45 am]

BILLING CODE 6560-50-S
