Docket Number: EPA

- HQ

- OPP

- 200 8

- 0 723

www.regulations.gov



## Meth ida thion

Registration Review Final Decision

September 20103 TABLE OF CONTENTS

I. INTRODUCTION

................................ ................................ ........................ 4

II. BACKGROUND INFORMATION

................................ ........................... 5

III. REGISTRATION REVIEW FINAL DECISION

................................ ..... 54

I. INTRODUCTION

This document is the Environmental Protection Agency’s (EPA or the Agency) Registration Review Final Decision for meth ida thion and is being issued pursuant to 40 CFR § 155.57 and § 155.58. A registration review decision is the Agency’s determination whether a pesticide meets, or does not meet, the standard for registration in the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).

FIFRA, as amended by the Food Quality Protection A ct (FQPA) of 1996, mandated the continuous review of existing pesticides. All pesticides distributed or sold in the United States must generally be registered by EPA, based on scientific data showing that they will not cause unreasonable risks to human he alth or the environment when used as directed on product labeling. The registration review program is intended to make sure that, as the ability to assess risk evolves and as policies and practices change, all registered pesticides continue to meet the st atutory standard of no unreasonable adverse effects to human health or the environment. Through the registration review program, the Agency periodically reevaluates pesticides to make sure that as change occurs, products in the marketplace can be safely u sed. 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 Sectio n 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 meth ida thion (case 0 034 ). The following timeline highlights significant events that have occurred during the r egistration review of methidathion :

March 1 8 , 2009

– Publication of the meth ida thion Summary Document

, Scoping Document, and Problem Formulation Document in the docket ( EPA

- HQ

- OPP

200 8

- 0 723 ) for a 60

- day public comment period. The Summary Document also included the preliminary work plan. August 28, 2009

– Publication of the meth ida thion Final Work Plan and the Agency’s response to the public comment s received during the 60

- day comment period on the meth ida thion Summary Document

. The comments received did not change the work plan set out in the preliminary work plan. April 7 , 20 10

– Published a Notice of Receipt of r equests to v oluntarily c ancel all

p esticide r egistration s containing meth ida thion in the Federal Register (75 FR 17735) ( FRL

- 88 19

- 1 )

. No comments were received during the 30

- day comment period.

Ju ne 2 , 2010

– Published the Product Cancellation Order for all pesticide registrations containing methidathion in th e Federal Registe r (75 FR 30824) (F RL

- 88 28

- 4 )

. July 28, 2010

- Publication of the methidathion Registration Review Proposed

Final Decision Notice of Availability in the Federal Register (75 FR 44253).5 September 27, 2010

– Closure of the 60

- day public comme nt period on the proposed decision. One comment was received. The comment did not change the proposed registration review final decision for methidathion.

II. BACKGROUND INFORMATION

Methidathion is a non

- systemic, organophosphate (OP) used as an

insec ticide/acaricide on a wide variety of terrestrial food and feed crops and terrestrial

non

- food crops with the majority of use occurring on almonds, artichokes, and oranges

. The pesticide acts through inhibition of acetylcholinesterase and is used to contr ol a broad range of insects and mites. There are no residential uses. Meth ida thion was the subject of a n April 200 2 Interim Reregistration Eligibility Decision (IRED), and in July 2006, the Reregistration Eligibility Decision (RED) for meth ida thion was f inalized upon completion of the Organophosphate (OP) Cumulative Risk Assessment. The most recent

human health assessment and ecological risk assessment for meth ida thion w ere completed in 2002 in support of the IRED.

After the Final Work Plan was publish ed in August 2009 as part of the registration review process for meth ida thion , the technical and end

- use product registrant s
, Gowan Company and Syngenta Crop Protection informed the Agency that they were each requesting to voluntarily cancel all of their m eth ida thion product registrations. A Notice of Receipt of r equests to v oluntarily c ancel all p esticide

r egistrations containing methidathion published in the Federal Register on April 7, 2010

. There were no comments submitted during the 30

- day comment pe riod. T he Agency

then issued the product cancellation order on June 2, 2010 for all meth ida thion product registra tions. (Copies of those documents are included in the docket for this registration review.) As specified in the Cancellation Order, r egistr ants are prohibited from selling or distributing end

- use products containing methidathion as of December 31, 2012. All sale

and distribution of end

- use products containing methidathion by persons other than the registrants will be prohibited as of Decembe r 31

, 2014

. After December 31, 2014, existing stocks of products containing methidathion labeled for all uses, already in the hands of users can be used legally until they are exhausted, provided that the use complies with the EPA approved label and label ing of the affected product.

III. REGISTRATION REVIEW FINAL DECISION

As stated in the Preliminary Work Plan for methidathion , the Agency had intended to revise the existing risk assessments for methidathion . However, due to the

cancellation order issue d affecting all methidathion product registrations in the United States, the Agency has found that it is not necessary to conduct new risk assessments for

methidathion 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.

methidathion registrations will become effective prior to the previously planned completion dates for the revised methidathion risk assessments

. The Registration Review

Timeline introduced in the methidathion p reliminary w ork pl an proposed that the Agency6

would issue the preliminary risk assessments in December 2013, issue the revised risk

assessments in J u ne 201 4 with a final registration review decision scheduled for 2015.

The Agency does not e xpect the current risks associated with methidathion use to differ from those identified during the methidathion reregistration process. In order to mitigate the risks identified in the RED, the Agency specified mitigation measures in the RED, which are a lready in effect on methidathion product labels. The existing stocks

sales and distribution deadlines included in the Ju ne 2 , 2010 cancellation order ensure

that methidathion sale, distribution, and use will decline and eventually cease entirely in

the Un ited States in the future. 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 methidathion products may be used until depleted without causing unreasonabl e risk to

human health and the environment. Pursuant to 40 CFR § 155.57 and 155.58, the Agency is issuing the Registration Review Final Decision , thus concluding the methidathion registration review, for the reasons discussed above. The affected product registrations are subject to the terms and conditions of the Ju ne 2 , 2010 cancellation

order.