[Federal Register Volume 74, Number 120 (Wednesday, June 24, 2009)]
[Notices]
[Pages 30083-30084]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-14864]


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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: [email protected].

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