E7-12865. Metaldehyde; Amendment and Closure of Reregistration Eligibility Decision; Notice of Availability

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

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: [phone]; fax number: [phone]; 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 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.

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