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 

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TABLE OF CONTENTS 

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

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

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

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

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I. INTRODUCTION 

This document is the Environmental Protection Agency’s (EPA or the Agency) Proposed 

Registration Review Decision for butylate 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 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 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 assess risk evolves and as policies and practices change, all 

registered pesticides continue to meet the statutory 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 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 

butylate (case 0071). The following timeline highlights significant events that have 

occurred during the registration 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 Cancel Products for Non-Payment of Year 

2010 Registration Maintenance Fees issued to the butylate technical 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 Tri-Ag., Inc., canceling their 

butylate registrations. 

• July 28, 2010 – Publication of a notice of Cancelation of Pesticides for NonPayment of Year 2010 Registration Maintenance 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, for the last butylate registration, in the 

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Federal Register (76 FR 4692, FRL-8856-9). No comments were received during 

the 30-day comment period. 

• March 23, 2011 – Publication of a Product Cancelation Order, for the last butylate 

registration in the Federal Register (76 FR 16417, FRL-8867-9). 

II. BACKGROUND INFORMATION 

Butylate is a thiocarbamate, soil-incorporated 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 registrant, 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 technical registrant, Tri-Ag., Inc., to sell and 

distribute their two butylate products (EPA Reg. Nos. 73637-3, 73637-4) until January 

15, 2011. Persons other than the technical registrant may continue to legally distribute or 

sell existing stocks of these pesticide products until 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 the Agency that they were requesting to 

voluntarily cancel the last butylate product registration (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 registered 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 end-use registrant may continue to sell, 

distribute, and use this butylate product until existing stocks are exhausted, provided that 

such sale, distribution, and use is consistent with the terms of the previously approved 

labeling on, or that accompanied, the canceled product. 

Copies of the afore mentioned cancelation notices are included in the docket for this 

registration review. 

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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 assessments for butylate. However, due to the 

cancelation orders issued affecting all butylate product registrations 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 decision 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 effective date of cancelation for the last butylate product registered 

for use in the U.S. was March 23, 2011. The registration review timeline 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 butylate 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 sales and distribution deadlines 

included in the July 14, 2010 and the March 23, 2011 cancelation orders ensure that 

butylate sale, distribution, and use will decline and then cease entirely in the United 

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 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 issued, 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 availability of this proposed registration review decision for 

butylate 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 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.