Document ID: EPA-HQ-OPP-2006-0111-0015
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2011-11-17T05:00Z

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

                                  Fenoxycarb
                      Registration Review Final Decision
                                September 2011
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                  Fenoxycarb
                      Registration Review Final Decision
                                September, 2011
                                       
                                       
                               Case Number 7401
                                       
                                       
                                       
                                       
                                       
                                       
                                       

Approved by: ______________________
		Richard P. Keigwin, Jr.
		Director, Pesticide Re-evaluation Division

Date:		______________________

                                       
                                       
                               TABLE OF CONTENTS
                                       
I.	INTRODUCTION	4

II.	BACKGROUND INFORMATION	5

III.	REGISTRATION REVIEW FINAL DECISION	6

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 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 fenoxycarb (case 7401).  The following timeline highlights significant events that have occurred during the registration review of fenoxycarb:

   * August 1, 2007  -  Publication of the Fenoxycarb Summary Document, Scoping Document, and Problem Formulation Document in the docket (EPA-HQ-OPP-2006-0111) 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 comments received during the 60-day comment period on the fenoxycarb Summary 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 Receipt 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 Product Cancellation Order for certain pesticide registrations containing fenoxycarb in the Federal Register (75 FR 82387) (FRL-8854-8).
   
   * May 4 , 2011  -  Publication of the fenoxycarb 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

	Fenoxycarb is an O-ethyl carbamate ester derivative insecticide, miticide, insect growth regulator, sex attractant, and feeding stimulant. It is intended to be used to inhibit metamorphosis of juvenile insects to the adult stage. Fenoxycarb's registered uses are all non-food uses. The registered use pattern is for indoor residential 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 occurred 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 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 fenoxycarb product registrations.  (Copies of those documents are included in the docket for this registration review.)  As specified in the Cancellation Order, the fenoxycarb technical product and Whitmire Micro-Gen Research Laboratories, Inc.'s end-use product were cancelled as of December 30, 2010. 
	
Syngenta Crop Protection, Inc. is prohibited from 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-use 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 disposal. Persons other than Syngenta Crop Protection, 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 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 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 previously approved labeling on, or that accompanied, the canceled product.
 
III.	REGISTRATION REVIEW FINAL DECISION

	As stated in the Fenoxycarb Preliminary Work Plan, the Agency had intended to revise the existing risk assessments for fenoxycarb.  However, due to the cancellation order issued affecting all remaining fenoxycarb product registrations in the United States, the Agency found that it is not necessary to conduct new risk assessments for fenoxycarb 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. 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 product 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 mid-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 fenoxycarb 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 fenoxycarb 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 fenoxycarb 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.