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Malathion; Revised Reregistration Eligibility Decision

Note: EPA no longer updates this information, but it may be useful as a reference or resource.

PDF Version (2 pp, 74K, About PDF)

[Federal Register: June 24, 2009 (Volume 74, Number 120)]
[Notices]
[Page 30083-30084]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24jn09-84]

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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2004-0348; FRL-8424-1]

Malathion; Revised Reregistration Eligibility Decision

AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.

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SUMMARY: This notice announces EPA's decision to modify certain risk
mitigation measures that were specified in the 2006 Reregistration
Eligibility Decision (RED) for the pesticide malathion. EPA conducted
this reassessment of the malathion RED in response to public comments
received during the comment period and to new data submitted by the
technical registrant, Cheminova, Inc. Based on the new information
received, and in a continuing effort to mitigate risk, the Agency has
made certain modifications to the malathion RED.

FOR FURTHER INFORMATION CONTACT: Eric Miederhoff, Special Review and
Reregistration Division (7508P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania

[[Page 30084]]

Ave., NW., Washington, DC 20460-0001; telephone number: (703) 347-8028;
fax number: (703) 308-7070; e-mail address: miederhoff.eric@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, farm worker 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. How Can I Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established a docket for this action under
docket identification (ID) number EPA-HQ-OPP-2004-0348. 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 Office of Pesticide Programs (OPP) Regulatory Public
Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal
Dr., 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.
    2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr.

II. Background

A. What Action is the Agency Taking?

    Section 4 of the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA) directs EPA to reevaluate existing pesticides to ensure
that they meet current scientific and regulatory standards. In 2006,
EPA issued a RED for malathion under section 4(g)(2)(A) of FIFRA. In
response to a notice of availability published in the Federal Register
of November 29, 2006 (71 FR 69114) (FRL-8104-2), the Agency received
substantive public comments and new data from the technical registrant.
The Agency's response to comments is available for viewing in the
public docket. The revised malathion RED reflects changes resulting
from Agency consideration of these comments and the new data received
on provisions of the RED, as well as efforts by the Agency to
appropriately mitigate overall risk. The revised RED for malathion
concludes EPA's reregistration eligibility decision-making process for
this pesticide.
    In response to a Data Call-In issued in October 2004, the Agency
received a special acute and repeat dose comparative cholinesterase
(ChE) assay with malaoxon (the active ChE inhibiting metabolite of
malathion) and malathion in March 2008. The study and post-RED comments
have enabled the Agency to refine several toxicological assumptions for
malathion. If these refined values were to be incorporated into the
human health risk assessments for malathion, the estimate of risk from
exposure to malathion would likely be reduced. Although the human
health risk assessments have not been revised to include the new
toxicity assumptions, the refinements from those used in the RED, which
were sufficient to demonstrate a level of risk below the Agency's level
of concern, confirm that conclusions in the human health risk
assessments were adequately conservative to protect human health.
    The revised malathion RED includes a revised label table that
modifies label language for consumer products, ultra low volume
applications, and the use patterns for a number of specific crops.
Additional revisions include: Updates on the status of two endangered
species assessments that include malathion; clarification of how the
Boll Weevil Eradication Program was considered in the Agency's
residential risk assessments; descriptions of recent studies examining
isomalathion (an impurity present in malathion). A comparison of
reassessed U.S. tolerances (listed in 40 CFR 180.111) relative to
Canada, Mexico, and Codex maximum residue limits has also been added.
Additionally, the Agency has revised the confirmatory data requirements
for malathion, removing the requirement for an aerobic aquatic
metabolism study with malathion and a comparative Che study with
malathion and malaoxon.
    After considering public comments submitted after the 2006 RED was
issued, for a limited number of crops, the Agency has increased the
allowed number of applications per crop cycle from what was proposed
for these crops in the 2006 RED. In the 3 years since the RED was
issued, several comments raised substantive concerns about whether the
proposed use patterns would allow efficacious control of target pests.
The Agency investigated these claims and found that in some cases, an
adjustment to the allowed number of applications was justified.
Although the Agency routinely evaluates the needs of pesticide users
during the development of its REDs, new concerns arise during public
comment periods, particularly for pesticides available for as wide a
variety of applications as malathion. Recent endangered species
assessments conducted both by the Agency and the National Marine and
Fisheries Service which include malathion, are based on the highest use
rates that appear on current, EPA-approved product labels. These labels
have not yet been revised to implement use rate reductions specified by
the malathion RED. The increases to the allowed number of applications
of malathion to certain crops introduced in the revised RED remain,
without exception, reduced from those rates which were utilized in
recent endangered species assessments.

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, Malathion, Pesticides and pests.

    Dated: June 18, 2009.
Peter Caulkins,
Acting Director, Special Review and Reregistration Division, Office of
Pesticide Programs.
[FR Doc. E9-14864 Filed 6-23-09; 8:45 am]
BILLING CODE 6560-50-S

 
 

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