Docket Number: EPA-HQ-OPP-2008-0842 www.regulations.gov



## Methamidophos Proposed Registration Review Decision February 20103 TABLE OF CONTENTS

I. INTRODUCTION ........................................................................................4

II. BACKGROUND INFORMATION ...........................................................4

III. PROPOSED REGISTRATION REVIEW DECISION ...........................5

IV. NEXT STEPS AND TIMELINE ................................................................64 I. INTRODUCTION

This document is the Environmental Prot ection Agency’s (EPA or the Agency) Proposed Registration Review Decision for methamidophos and is being issued pursuant to 40 CFR § 155.57 and § 155.58. A registrati on review decision is the Agency’s determination whether a pesticide meets, or doe s not meet, the standard for registration in the Federal Insecticide, Fungicide , and Rodenticide Act (FIFRA).

FIFRA, as amended by the Food Qual ity Protection Act (FQPA) of 1996, mandated the continuous review of existing pestic ides. All pesticides distributed or sold in the United States must generally be re gistered by EPA, base d on scientific data showing that they will not cause unreasonable risks to human health or the environment when used as directed on product labeling. The registration review program is intended to make sure that, as the ability to asse ss risk evolves and as policies and practices change, all registered pesticides continue to meet the statutory standard of no

unreasonable adverse effects to human hea lth or the environment. Through the registration review program, th e Agency periodically reevaluate s pesticides to make sure that as change occurs, products in the mark etplace can be safely used. Information on this program is provided at: http://www.epa.gov/oppsrrd1/registration_review/

.

In 2006, the Agency implemented the Registration Review program pursuant to FIFRA Section 3(g), and will review each registered pesticide every 15 years to

determine whether it continues to meet the FIFRA standard for registration.

Pursuant to 40 CFR § 155.50, the Agency formally initiated registration review for methamidophos (case 0043). The following ti meline highlights signif icant events that have occurred during the registra tion review of methamidophos:

• December 17, 2008 – Publication of the Methamidophos Summary Document

, Scoping Document, and Problem Formulation Document in the docket (EPA-HQOPP-2008-0842) for a 90-day public comment period. The Summary Document also included the preliminary work plan.

• May 13, 2009 – Publication of the methamidophos Final Work Plan

.

• July 22, 2009 – Publication of a Notice of Receipt of Requests to Voluntarily Cancel Certain Pesticide Regist rations for methamidophos in the Federal Register . No comments were received during a 30-day comment period.

• September 23, 2009 – Publication of a Product Cancellation Order for methamidophos in the Federal Register

.

II. BACKGROUND INFORMATION

Methamidophos is a restricted use organophosphate insecticide, which in 2009 was registered for use on potato, cotton, tomato, and alfalfa grown for seed. Methamidophos was the subject of a July 2002 Interim Reregist ration Eligibility Decision (IRED), and in July 2006, the Rere gistration Eligibility Decision (RED) for5 methamidophos was finalized upon completi on of the Organophosphate (OP) Cumulative Risk Assessment. The Methamidophos RED is the Agency’s most recent comprehensive assessment of the human health, and eco logical risk of methamidophos use. Additionally, in July 2007, EPA completed an endangered species assessment that evaluated the California red-legged frog’s exposure to methamidophos.

On May 20, 2009, pursuant to a voluntary request by Bayer CropScience

, EPA published

an order in the Federal Register to terminate all methamidophos use on cotton as of September 30, 2009

. Existing stocks for use on cotton may be sold and distributed by persons other than the regist rant until July 31, 2010. Existing stocks labeled for use on cotton may be used until September 30, 2011, provided that such use complies with the EPA-approved labels and labeling of the products.

In 2009, the sole methamidophos registra nt, Bayer CropScience, informed the Agency that they were requesting to vol untarily cancel all of their remaining methamidophos product registrati ons. Following publication of a Federal Register notice announcing receipt of those requests and the completion of the corresponding public comment period, the Agency issued the product cancellation order on September 23, 2009 for all methamidophos product registrations (copies of t hose notices are included in the docket for this registration review). All methamidophos product cancellations became effective on December 31, 2009. Existing stocks provisions included in the order allowed Bayer CropScience to sell and dist ribute methamidophos products, excluding products cancelled by the cotton use termin ation referred to above, until December 31, 2010. Persons other than the registrant may c ontinue to sell, dist ribute, and use these methamidophos products until exhausted, provided that such sale, distribution, and use is consistent with the terms of the previously approved labeling on, or that accompanied, the canceled products.

III. PROPOSED REGISTRATION REVIEW DECISION

As stated in the Preliminary Work Plan for methamidophos, the Agency had intended to revise the existing risk assessmen ts for methamidophos. However, due to the cancellation order issued affecting all metham idophos product registra tions in the United States, the Agency has found that it is not n ecessary to conduct new risk assessments for methamidophos and is, therefore, issuing a proposed decision pursuant to 40 CFR Part 155.53(c)(2) and 40 CFR Part 155.58. The voluntary cancellation of all U.S. methamidophos registrations has occurred pr ior to the previously planned completion dates for the revised methamidophos risk assess ments. The effective date of cancellation for methamidophos products registered for use in the U.S. was December 31, 2009. The Registration Review Timeline introduced in the methamidophos Preliminary Work Plan proposed that the Agency would complete the revised risk assessments by December

2013 and issue a decision in 2015.

The Agency does not expect the current ri sks associated with methamidophos use to differ from those identified during the meth amidophos reregistration process. In order to mitigate the risks identified in the RED, the Agency specified mitigation measures in6 the RED, which are already in effect on methamidophos prod uct labels. The existing

stocks sales and distribution deadlines included in the Se ptember 23, 2009 cancellation order ensure that methamidophos sale, distri bution, and use will decline and then cease entirely in the United States in the futu re. During this period, given the mitigation measures that are specified in the RED and are currently in place, the Agency believes that existing stocks of methamidophos pr oducts may be used until depleted without causing unreasonable risk to human health a nd the environment. Pursuant to 40 CFR § 155.57 and 155.58, the Agency proposes that the re gistration review de cision be issued, thus concluding the methamidophos registration review, for the reasons discussed above. The affected product registrations are subj ect to the terms and conditions of the September 23, 2009 cancellation order.

IV. NEXT STEPS AND TIMELINE

Pursuant to 40 CFR § 155.58, this pr oposed registration review decision document is being entered into the me thamidophos docket (EPA-HQ-OPP-2008-0842).

A Federal Register notice will announce the availabil ity of this proposed registration review decision for methamidophos and allow a 60-day comment period. If there are no significant comments or additional information submitted to the docket during the comment period that leads the Agency to change its decision, EPA will issue a registration review decision for methami dophos, Case 0043, which will be announced in

the Federal Register . The Agency anticipates that a de cision will be issued in 2010. In addition, the Agency will propose to revoke a ll tolerances resulting from methamidophos

use in a timeframe that will allow fo r the exhaustion of existing stocks.