Docket Number: EPA-HQ-OPP-2009-0054 www.regulations.gov



## Disulfoton Registration Review Decision January 2010TABLE OF CONTENTS

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

II. BACKGROUND INFORMATION ...........................................................5

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

3I. INTRODUCTION

This document is the Environmental Prot ection Agency’s (EPA or the Agency) Registration Review Decision for disulfoton and is being issued pursuant to 40 CFR § 155.57 and § 155.58. A registration review deci sion 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 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, the 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 disulfoton (case 0102). The following time line highlights significan t events that have occurred during the registra tion review of disulfoton:

• March 16, 2009 – Publica tion of the disulfoton Summary Document

, Scoping Document, and Problem Formulation Document in the docket (EPA-HQ-OPP2009-0054) for a 60-day public comment period. The Summary Document also included the preliminary work plan.

• July 22, 2009 – Published a Notice of Recei pt of Requests to Voluntarily Cancel Certain Pesticide Registrations for disulfoton in the Federal Register . No comments were received during a 30-day comment period.

• September 23, 2009 – Published a Product Ca ncellation Order for disulfoton in

the Federal Register

.

• October 1, 2009 – Publica tion of the disulfoton Final Work Plan and the Agency’s response to a public comment received during the 60-day comment period on the disulfoton Summary Document

.

• October 23, 2009 – Publication of the disulfoton Registration Review Proposed

Decision in the docket and initiation of a 60-day comment period.

• December 22, 2009 – Closure of the 60-day public comment period on the proposed decision. No comments were received.

4II. BACKGROUND INFORMATION

Disulfoton is an organophosphate insectic ide registered for use on asparagus, beans, broccoli, Brussels sprouts, cabbage, cauliflower, cotton, coffee beans, lettuce, radish grown for seed, Christmas trees, East er lilies, and residential ornamentals. Disulfoton was the subject of a July 2002 In terim Reregistration Eligibility Decision (IRED), and in July 2006, the Reregistration Eligibility Decision (RED) for disulfoton was finalized upon completion of the Organophosphate (OP) Cumulative Risk Assessment. In 2008, the Disulfoton RED wa s amended in response to public comments received on the Agency’s reregistration d ecision. The Disulfoton RED Addendum is the Agency’s most recent assessment of the human health and ecologica l risk of disulfoton

use.

At the beginning of the registration re view process for disulfoton in 2009, the technical product registrant and end-use pr oduct registrant, Bayer (Bayer CropScience, Bayer Environmental Science, and Bayer Adva nced), and the only ot her end-use product registrant, AMVAC Chemical Co., informed th e Agency that they were requesting to voluntarily cancel all of their disulfoton produc t registrations. Following publication of a Federal Register notice announcing receipt of those requests and the end of the public comment period, the Agency issued the product cancellation order on September 23, 2009 for all disulfoton product registrations. (C opies of those notices are included in the docket for this registration review.) Exis ting stocks provisions included in the order allow registrants to sell and distribute the ma jority of disulfoton products (EPA Reg. Nos. 264-723, 264-734, 5481-8989, and 432-1286, CA050010, CA810044, CA840192, NC860005, NC880001, NC920011, OR040030, OR050024, TX860007, WA040015, WA040028, WA920026) until December 31, 2010. The techni cal registrant may sell and distribute the last two disulfoton produc ts (EPA Reg. Nos. 264-725 and 72155-49) until June 30, 2011. Persons other than the registrant may continue to sell , distribute, and use disulfoton products until exha usted, 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. REGISTRATION REVIEW DECISION

As stated in the Preliminary Work Plan for disulfoton, the Agency had intended to revise the existing risk assessments for disu lfoton. However, due to the cancellation order issued affecting all disulfoton product re gistrations in the United States, the Agency has found that it is not necessary to conduct new risk assessments for disulfoton and is, therefore, issuing a decisi on pursuant to 40 CFR Part 155.53(c)(2) and 40 CFR Part 155.58. The voluntary cancellation of U.S. disu lfoton registrations will become effective prior to the previously planned completi on dates for the revised disulfoton risk

assessments. The effective date of the end of the existing stocks pr ovision included in the

cancellation of the last disulfot on products registered for use in the U.S. is June 30, 2011. The Registration Review Timeline introduced in the disulfoton Preliminary Work Plan proposed that the Agency would complete th e revised risk assessments in October 2013

and issue a decision in 2015.

56 The Agency does not expect the current risks associated with disulfoton use to

differ from those identified dur ing the disulfoton reregistrati on process. In order to mitigate the risks identified in the RED, the Agency specified mitigation measures in the RED, which are already in effect on disulfot on product labels. The existing stocks sales

and distribution deadlines incl uded in the September 23, 2009 cancellation order ensure that disulfoton sale, distribution, and use w ill decline and then cease entirely in the United States in the future. During this pe riod, given the mitigation measures that are specified in the RED and are currently in pl ace, the Agency has determined that existing stocks of disulfoton products may be used until depleted without causing unreasonable risk to human health and the environment. Pursuant to 40 CFR § 155.57 and 155.58, the Agency is issuing the Registration Review Decision , thus concluding the disulfoton registration review, for the reasons discussed above. The affected product registrations are subject to the terms and conditions of the September 23, 2009 cancellation order.