Docket Number: EPA - HQ - OPP - 20 06 - 0 111

www.regulations.gov



## Fenoxycarb

**Registration Review Final**  **Decision**

**September 201**  **1**2 

## Fenoxycarb **Registration Review Final**  **Decision September,**  **201 1**  **Case Number 7401** 

**Approved by: ______________________**

**Richard P. Keigwin, Jr. Director,**  **Pesticide Re -**  **evaluation Division**  **Date:**

**______________________**3 **TABLE OF CONTENTS I.**  **INTRODUCTION** ................................ ................................ ........................ 4 **II. BACKGROUND**  **INF ORMATION**  ................................ ........................... 5 **III. REGISTRATION REVIEW**  **FINAL DECISION**  ................................ ..... 64

**I. INTRODUCTION**  This document is the Environmental Protection Agency ’s (EPA or the Agency) Registration Review 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 b y 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 generall y 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 pesti cides 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 th e 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 f or fenox yc arb ( c ase 7401 ). The following timeline highlights significant events that have occurred during the registration review of fenoxycarb :  August 1 , 200 7

– Publication of the F enox yc arb Summary Document , Scoping Document, and Problem Formulation Document in the docket (EPA - HQ - OPP 200 6 - 0111 ) for a 60 - day

public comment period. The Summary Document also included the preliminary

work plan.

 December 20, 2007

– Publication of the F enox yc arb Final W ork Plan an d the Agency ’s response to the public comment s received during the 60 - day comment period on the fenox yc arb S ummary Document . Based on the public comments received, the Fenox yc arb Final Work Plan was slightl y modified from the Fenox yc arb Preliminary

Work P lan.

 August 25, 2010

– Published a Notice of Receipt of requests to v oluntaril y c ancel certain p esticide registrations containing fenoxycarb in the Federal Register (75 FR 52340 ) ( FRL - 88 43 - 1 ) . No comments were received during the 30 - day comment period.5

 December 30 , 2010

– Published the Product Cancellation Order for certain pesticide registrations containing fenox yc arb in the Federal Register (75 FR 82387 ) (F RL - 88 54 - 8 ).

 May 4 , 2011

– Publication of the fenox yc arb Registration Review Proposed Final Decision Notice of Availability in the Federal Register (Volume 76, Number 86 , Pages 25340 - 25342 ).

 July 5, 2011

– Closure of the 60 - day public comment period on the proposed decision. No comment was received. **II. BACKGROUND INFORMATION**  Fenox yc arb is an O - ethyl carbamate ester derivative insecticide, miticide, insect growth regulator, sex attractant, and feeding stimulant. Itis intended to be used to inhibit metamorphosis of juvenile insects to the adult stage. Fenox yc arb’s registered uses are all non - food uses. The registered use pattern is for indoor residential settings (flea control), greenhouses, turf (residential/ commercial/o rnamental), non - bearing orchards, and on outdoor plants . The most recent human health exposure assessments and environm ental fate and ecological review occurred in the late 1990’s. After the Final Work Plan was published in December, 2007 as part of the registration review process for fenox yc arb , the technical and end - use product registrant s , Sy ngenta Crop Protection , In c. and Whitmire Micro - Gen Research Laboratories, Inc. informed the Agency

that they were each requesting to voluntaril y cancel all of their fenox ycarb product registrations. A Notice of Receipt of requests to voluntarily cancel all pesticide registrations containing 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 fenox yc arb product registrations. (Copies of those documents are included in the docket for this registration review.) As specified in the Cancellation Order, the fenox ycarb technical product and Whitmire Micro - Gen Research Laboratories, Inc.’s end - use product wer e cancelled as of December 30, 2010 . Sy ngenta Crop Protection, Inc. is prohibited from using, selling, or distributing technical fenox ycarb except for : 1. e xport 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 immediatel y. The Sy ngenta Crop Protection Inc.’s end - use product is cancelled effective as of December 31, 2012. After December 31, 2012, S yngenta Crop Protection, Inc. is prohibited from selling or distributing its end - use product, except for export consistent with FIFRA section 17 or for proper disposal. Persons other than Sy ngenta Crop Protection, Inc. are allowed to sell, distribute, and use exi sting stocks of the canceled end -6

use product until supplies are exhausted, provided that such sale, distribution, and use is consistent with the terms of the previousl y approved labeling on, or that accompanied, the canceled product. Whitmire Micro - Gen Re search 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 produ ct, except for export consistent with FIFRA 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 supplies are exhausted, provided that such sale, distribution, and use is consistent with the terms of the previousl y approved labeling on, or that accompanied, the canceled product. **III. REGISTRATION REVIEW**  **FINAL DECISION**  As stated in the Fenox yc arb Preliminary Work Plan, the Agency had intended to revise the existing risk assessments for fenox yc arb . However, due to the cancellation order issued affecting all remaining fenox yc arb product registrations in the United States, the Agency

found that it is not necessary to conduct new risk assessments for fenox yc arb and , therefore , issued 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. fenox ycarb registrations will become effective prior to the previously pl anned completion dates for the preliminary fenox ycarb risk assessments . Additionally, the sale and distribution of existing stock for the one remaining end use product will end in the same calendar year as the scheduled final registration review decision. The Registration Review Timeline introduced in the fenox ycarb p reliminary w ork pl an proposed that the Agency would issue the preliminary risk assessments in mid - 201 2 , issue the revised risk assessments in late 201 2 with a final registration revi ew decision scheduled for 201 3 . The Agency

does not expect the current risks associated with fenox yc arb use to differ from those identified during the fenox yc arb reregistration process. The existing stocks sales and distribution deadlines included in the December 30, 2010 cancellation order ensure that fenoxycarb sale, distribution, and use will decline and eventually cease entirely in the United States in the future. During this interim period, the Agency believes that existing stocks of fenox yc arb 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 Final Decision , thus concluding the fenox yc arb registration review, for the reasons discussed above. The affected product registrations are subject to the terms and conditions of the December 30, 2010 cancellation order.