Docket Number: EPA-HQ-OPP-2006-0111 www.regulations.gov



## Fenoxycarb Proposed Registration Review Final Decision February 2011TABLE OF CONTENTS

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

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

III. PROPOSED REGISTRATIO N REVIEW FINAL 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 R eview Final Decision for fenoxycarb 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 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 fenoxycarb (case 7401). The following tim eline highlights signifi cant events that have occurred during the regist ration review of fenoxycarb:

• August 1, 2007 – Publication of the Fenoxycarb Summary Document

, Scoping

Document, and Problem Formulation Document in the docket (EPA-HQ-OPP2006-0111) for a 60-day public comment period. The Summary Document also included the preliminary work plan.

• December 20, 2007 – Publication of the Fenoxycarb Final Work Plan and the Agency’s response to the public comment s received during the 60-day comment period on the fenoxycarb S ummary Document . Based on the public comments received, the Fenoxycarb Final Work Plan was slightly modified from the Fenoxycarb Preliminary Work Plan.

• August 25, 2010 – Published a Notice of Recei pt of requests to voluntarily cancel certain pesticide registrations containing fenoxycarb in the Federal Register (75 FR 52340) (FRL-8843-1). No comments were received during the 30-day comment period.

• December 30, 2010 – Published the Produc t Cancellation Order for certain pesticide registrations co ntaining fenoxycarb in the Federal Register (75 FR 82387) (FRL-8854-8).

4II. BACKGROUND INFORMATION

Fenoxycarb is an O-ethyl carbamate ester derivative insecticide, miticide, insect growth regulator, sex attractant, or feeding stimulant. It is intended to be used to inhibit metamorphosis of juvenile ins ects to the adult stage. Fenoxycar b’s registered uses are all non-food uses. The registered use pattern is for indoor residen tial settings (flea control), greenhouses, turf (residential/commercial/ornamental), non- bearing orchards, and on outdoor plants. The most recent human health exposure assessments and environmental fate and ecological review o ccurred in the late 1990’s.

After the Final Work Plan was published in December, 2007 as part of the registration review process for fenoxycarb, the technical and end-use product registrants, Syngenta Crop Protection, Inc. and Whitmire Micro-Gen Research Laboratories, Inc. informed the Agency that they were each requesting to voluntarily cancel all of their fenoxycarb product registrations. A Notice of Receipt of requests to voluntarily cancel all pesticide registrations cont aining fenoxycarb published in the Federal Register on August 25, 2010. There were no comments submitted during the 30-day comment period. The Agency then issued the product cancellation order on December 30, 2010 for all fenoxycarb product registrations. (C opies of those documents are included in the docket for this registration review.) As specified in the Cancellation Order, the fenoxycarb technical product and Whitmire Mi cro-Gen Research Laboratories, Inc.’s end-use product were cancelled as of December 30, 2010.

Syngenta Crop Protection, Inc. is prohibited fr om using, selling, or distributing technical fenoxycarb except for:

1. export consistent with FIFRA section 17

2. for proper disposal, or

3. to formulate existing stocks of the technical fenoxycarb into its end-use product effective immediately.

The Syngenta Crop Protection Inc.’s end-us e product is cancelled effective as of December 31, 2012. After December 31, 2012, Syngenta Crop Protection, Inc. is prohibited from selling or distributing its end- use product, except for export consistent with FIFRA section 17 or for proper dis posal. Persons other than Syngenta Crop

Protection, Inc. are allowed to sell, distribute, and use existi ng stocks of the canceled enduse product until supplies 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.

Whitmire Micro-Gen Research Laboratories, Inc. is permitted to sell and distribute existing stocks of its end- use fenoxycarb product until December 31, 2013. Thereafter, Whitmire Micro-Gen Research Laboratories, Inc. is prohibited from selling or distributing its end-use product, except for e xport consistent with FI FRA section 17 or for proper disposal. Persons other than Whitmire Micro-Gen Research Laboratories, Inc. are allowed to sell, distribute, and use existing stocks of the canceled end-use product until

56 supplies 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.

III. PROPOSED REGISTRATION REVIEW FINAL DECISION

As stated in the Fenoxycarb Preliminary Wo rk Plan, the Agency had intended to revise the existing ri sk assessments for fenoxycarb. Ho wever, due to the cancellation order issued affecting all remaining fenoxycar b product registrations in the United States, the Agency has found that it is not nece ssary to conduct new risk assessments for fenoxycarb and is, therefore, issuing a pr oposed decision pursuant to 40 CFR Part 155.53(c)(2) and 40 CFR Part 155.58. The voluntary cancellation of all U.S. fenoxycarb registrations will become effective prior to the previously planned completion dates for the preliminary fenoxycarb risk assessments. Additionally, the sale and distribution of existing stock for the one remaining end use prod uct will end in the same calendar year as the scheduled final registration review decision. The Registration Review Timeline introduced in the fenoxycarb preliminary work plan proposed that the Agency would issue the preliminary risk assessments in mi d-2012, issue the revised risk assessments in late 2012 with a final registration review decision scheduled for 2013.

The Agency does not expect the current risks associated with fenoxycarb use to differ from those identified during the fenoxycar b reregistration process. The existing

stocks sales and distribution deadlines in cluded in the December 30, 2010 cancellation order ensure that fenoxycarb sale, distributi on, and use will decline and eventually cease entirely in the United States in the futu re. During this inte rim period, the Agency believes that existing stocks of fenoxycarb 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 registration review final decision be issued, thus concluding the fenoxycarb regist ration review for the reasons discussed above. The affected product registrations ar e subject to the terms and conditions of the

December 30, 2010 cancellation order.

IV. NEXT STEPS AND TIMELINE

Pursuant to 40 CFR § 155.58, this proposed registration review final decision document is being entered into the fe noxycarb docket (EPA- HQ-OPP-2006-0111). A Federal Register notice will announce the availability of this proposed registration review final decision for fenoxycarb and allo w 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 final decision for fenoxy carb (case 7401), which will be announced in

the Federal Register . The Agency anticipates that the final decision will be issued in

2011.