Docket Number: EPA-HQ-OPP-2008-0882 www.regulations.gov



## Butylate Proposed Registration Review Decision July 2011

## Butylate Proposed Registration Review Decision July 2011

Case Number 0071

Approved by:

__________________________________ Richard P. Keigwin, Jr. Director, Pesticide Re-evaluation Division

____________________ _______________ Date

2TABLE OF CONTENTS

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

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

III. PROPOSED REGISTRATION REVIEW DECISION ...........................6

IV. NEXT STEPS AND TIMELINE ................................................................6

3I. INTRODUCTION

This document is the Environmental Prot ection Agency’s (EPA or the Agency) Proposed Registration Review Decision for butylate and is being i ssued 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 Pr otection Act (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 h ealth or the environment when used as directed on product labeling. Th e registration review program is intended to make sure that, as the ability to assess risk evolve s and as policies and practices change, all registered pesticides continue to meet th e statutory standard of no unreasonable adverse

effects to human health or the environmen t. Through the registration review program, the Agency periodically reevaluates pesticid es to make sure that as change occurs, products in the marketplace can be safely use d. 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 register ed pesticide every 15 years to determine

whether it continues to meet the FIFRA standard for registration.

Pursuant to 40 CFR § 155.50, the Agency form ally initiated registration review for butylate (case 0071). The following timeline hi ghlights significant events that have occurred during the registra tion review of butylate:

• June 24, 2009 – Publication of the butylate Summary Document

, Scoping

Document , and Problem Formulation Document in the docket (EPA-HQ-OPP2008-0882) for a 60-day public comment period. The Summary Document also included the preliminary work plan. No comments or information were received during the 60-day comment period on the butylate Summary Document

.

• October 23, 2009 – Publication of the butylate Final Work Plan (FWP).

• February 26, 2010 – Notice of Intent to Ca ncel Products for Non-Payment of Year 2010 Registration Maintenance Fees issued to the butylate tec hnical registrant, Tri-Ag., Inc., for their butylate registrations.

• July 14, 2010 – Cancelation Order for Non-Payment of Year 2010 Registration

Maintenance Fees issued to the technical registrant Tr i-Ag., Inc., canceling their butylate registrations.

• July 28, 2010 – Publication of a notice ofCancelation of Pesticides for NonPayment of Year 2010 Registration Main tenance Fees, for butylate products registered by Tri-Ag., Inc., in the Federal Register (75 FR 44240, FRL-8835-2).

• January 26, 2011 – Publication of a notice of Receipt of Requests to Voluntarily Cancel Certain Pesticide Registrations, fo r the last butylate registration, in the

4Federal Register (76 FR 4692, FRL-8856-9). No comments were received during the 30-day comment period.

• March 23, 2011 – Publication of a Product Ca ncelation Order, fo r the last butylate registration in the Federal Register (76 FR 16417, FRL-8867-9).

II. BACKGROUND INFORMATION

Butylate is a thiocarbamate, soil-incorporat ed herbicide that was registered for use on field corn, pop corn and sweet corn. Butylate was the subject of a 1993 Reregistration Eligibility Decision (RED) and a 2001 Report of the Food Quality Protection Act (FQPA) Tolerance Reassessment Progress and Risk Management Decision (TRED)

.

On July 14, 2010, pursuant to Section 4(i)(5 )(G) of FIFRA, the Agency issued a

cancelation order to the sole technical re gistrant, Tri-Ag., Inc., canceling their two butylate registrations (EPA Reg. Nos. 73637-3, 73637-4) for non-payment of the annual registration maintenance fees, which were due by January 15, 2010. Existing stocks provisions included in the order allowed the t echnical registrant, Tri- Ag., Inc., to sell and distribute their two butylate products (E PA Reg. Nos. 73637-3, 73637-4) until January 15, 2011. Persons other than the t echnical registrant may conti nue to legally distribute or sell existing stocks of these pesticide products un til their supply is exhausted, provided that such further sale and use comply with the EPA-approved labels and labeling of the affected products.

In February 2011, the remaining butylate end- use product registrant, Arysta Lifescience North America, LLC (Arysta), informed th e Agency that they were requesting to voluntarily cancel the last butylate product registrati on (EPA Reg. No. 66330-264). Following publication of a Federal Register notice announcing receipt of this request and the completion of the corresponding public comment period, the Agency issued the product cancelation order on March 23, 2011 for the remaining butylate product registration. This order terminated the last butylate product regist ered for use in the United States. Existing stocks provisions included in the order allow the end-use registrant, Arysta, to sell and distribute the butylate product (EPA Reg. No. 66330-264) until March 23, 2012. Persons other than the en d-use registrant may continue to sell, distribute, and use this butylate product unt il existing stocks are e xhausted, provided that such sale, distribution, and use is consistent with the term s of the previously approved labeling on, or that accompanied, the canceled product.

Copies of the afore mentioned cancelation no tices are included in the docket for this registration review.

56 III. PROPOSED REGISTRATION REVIEW DECISION

As stated in the Final Work Plan for butylate, the Agency had intended to revise the ecological and human health risk assessmen ts for butylate. However, due to the

cancelation orders issued aff ecting all butylate product regist rations in the United States, the Agency has found that it is not necessary to conduct new risk assessments for butylate and is, therefore, issuing a proposed deci sion pursuant to 40 CFR Part 155.53(c)(2) and 40 CFR Part 155.58. The voluntary cancelation of the last U.S. butylate registration will become effective prior to the previously planned completion dates for the revised butylate

risk assessments. The effectiv e date of cancelation for the la st butylate product registered for use in the U.S. was March 23, 2011. The re gistration review time line in the butylate

Final Work Plan scheduled the release of the preliminary risk assessments by March 2014 and a registration review decision in 2015.

The Agency does not expect the current risks associated with butylate use to differ from those identified during the butylat e reregistration process. In order to mitigate the risks identified in the RED, the Agency specified mitigation measures, which are already in effect on butylate product labels . The existing stocks sale s and distribution deadlines included in the July 14, 2010 and the Marc h 23, 2011 cancelation orders ensure that butylate sale, distribution, and use will d ecline and then cease entirely in the United States in the future. During this period, give n the mitigation measures that are specified in the RED and are currently in place, the Ag ency believes that existing stocks of butylate 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 proposes that the registration review decision be issue d, thus concluding the butylate registration review, for the reasons discussed above. The affected product registrations are subject to the terms and conditions of the July 14, 2010 and the March 23, 2011 cancelation orders.

IV. NEXT STEPS AND TIMELINE

Pursuant to 40 CFR § 155.58, this proposed registration review decision document is being entered into the butylate docket (EPA-HQ-OPP-2008-0882). A Federal Register

notice will announce the availabi lity of this proposed regi stration review decision for butylate and allow a 60-day comment period. If there are no si gnificant comments or

additional information submitted to the docke t during the comment period that leads the Agency to change its decision, EPA will issue a registration review decision for butylate, case 0071, which will be announced in the Federal Register . The Agency anticipates that a decision will be issued in October 2011. In addition, the Agency will propose to revoke all butylate tolerances in a timeframe that will allow for the exhaustion of existing stocks.