Docket Number: EPA - HQ - OPP - 2008 - 0444

www.regulations.gov



## Tem **ephos**

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

**September 2011** 2 

## Tem **ephos Registration Review**  **Final Decision**  **September, 2011**  **Case Number** 

## 0 **00 6** 

**Approved by: ______________________**

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

**______________________**3 **TABLE OF CONTENTS I.**  **INTRODUCTION** ................................ ................................ ........................ 4 **II. BACKGROUND INFORMATION**  ................................ ........................... 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 temephos and is being issued pursuant to 40 CF R § 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 unre asonable 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 pesticid es 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 m arketplace 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 temephos (case 0 00 6 ). The following timeline highlights significant events that have occurred during the r egistration review of temephos :  June 25 , 2008

– Publication of the temephos Summary Document , Scoping Document, and Problem Formulation in the tem ephos docket (EPA - HQ - OPP 200 8 - 044 4) for a 90 - day

public comment period. The Summary Document also inc luded the Preliminary W ork Plan for the registration review of temephos.

 November 7 , 2008

– S ignature of the temephos Final W ork Plan and the Agency ’s re sponse to the public comment s received during the 9 0 - day comment period on the temephos Summary Document . The one comment received did not chang e the work plan set out in the Preliminary Work Plan .  November 10, 2010

– Publication of a Notice of Receipt o f r equests to v oluntarily c ancel all remaining p esticide registrations containing temephos in the Federal Register (75 FR 69073 ) ( FRL - 88 51 - 5 ) . The docket number for the receipt of the voluntary cancellation is EPA - HQ - OPP - 2009 - 1017 . During the 30 - day comm ent period, c omments were received reg arding temephos from the American Mosquito Control Association and the IR - 4 Project. Both organizations emphasized the benefits of temephos as it is used in public health for mosquito control and requested that EPA extend the comment period for these product5 cancellations. The Agency recognizes the role of temephos in mosquito control and has agreed to a 4 - year phase - out of the product registrations to accommodate the public health need and allow registrants time to d evelop replacement products. The current temephos products will not be cancelled until December 30, 2015 .  February

25, 2011

– Publication of the Product Cancellation Order for all remaining pesticide registrations containing temephos in the Federal Register (76 FR 10587 ) (F RL - 88 63 - 4 ) .  May 25, 2011 - Publication of the temephos Registration Review Proposed Final Decision Notice of Availability in the Federal Register (76 FR 25340 - 25342 ).

 July 5 , 2011

– Closure of the 60 - day public comment period on the proposed decision. Value Garden Supply and the IR - 4 Project submitted comments to the docket regarding temephos. As before, the comments emphasized the benefits of temephos as it is used in public health for mosquito control. Also, Value Garden Supply requested to rescind their voluntary cancellation. In response to Value Garden Suppl y’s request to rescind their voluntary cancellation request, the Agency has been in discussions with the registrant about the specific scientific data required to support their temephos product registrations affected b y the Cancellation Order. If the required temephos data are submitted b y the registrant, reviewed, and found acceptable by the Agency

prior to December 30, 2015, the Agency may amend the Cancellation Order fo r the affected product registrations. **II. BACKGROUND INFORMATION**  Temephos is a non - sy stemic organophosphate insecticide which is applie d to standing water, shallow ponds, lakes, woodland pools, tidal waters, marshes, swamps, waters high in organic co ntent, highl y polluted water, catch basins (and similar areas where mosquitoes may

breed), stream margins, and intertidal zones of sandy beaches. Targ et pests include aquatic larvae of mosquitoes, midges, gnats, punkies, and sandflies. Temephos is one of a few organophosphates registered to control mosquito larvae, and is the only organophosphate with any appreciable larvicidal use. There are no crop uses and no residential uses . Temephos is currently labeled for application only by public health offici als, personnel of mosquito abatement districts , and other similar government agencies or personnel under contract to these entities. The mo st recent environmental fate, ecological , and human health risk assessments for tem ephos were completed in 1999 in s upport of the temephos Reregistration Eligibility Decision (RED) , which was completed in July

2001. The temephos registration review Final Work Plan was signed in November 2008 and the registration review data call - in (DCI) was issued in April 2010. In the DCI , the Agency required environmental fate, ecological, and human health data that would have been used to conduct revised ecological and human health risk assessments for the registration review of temephos. In response to the DCI, the technical and end - use product registrant s , Clarke Mosquito Control Company , Inc. and Value Garden Supply ,6

inf ormed the Agency

that they were requesting to voluntarily cancel all of their temephos product registrations . A Notice of Receipt of requests to voluntarily cancel all pesticide registration containing temephos published in the Federal Register on November 10, 2010. The Agency then issued the product cancellation order on February 25, 2011 for all remaining temephos product registrations. Copies of those do cuments are included in the docket for registration review. As specified in the Cancellation Order, registrants are prohibited from selling or distributing existing stocks of products cont aining temephos for all uses as of December 31, 2015 . After Decemb er 31, 2016 , persons other than registrants are prohibited from selling or distributing existing stocks of products containing temephos labeled for all uses. After December 31, 2016, existing stocks of products containing temephos labeled for all uses, already in the hands of users, can be used legall y until they are exhausted, provided that such use complies with the EPA - approved label and labeling of the affected product. However, during the public comment period for the proposed registration review dec ision, Value Garden Supply requested that the Agency rescind their voluntary cancellation. In response to Value Garden Supply’s request, the Agency has been in discussions with the registrant about the specific scientific data required to support their temephos product registrations affected b y the Cancellation Order. In those discussions, the Agency

indicated that the registrant has the option to actively collaborate with IR - 4 to identify possible funding sources to support the data required in the temep hos registration review DCI. If the required temephos data are submitted by the registrant, reviewed, and determined to the acceptable b y the Agency prior to December 30, 2015, the Agency may amend the Cancellation Order for the affected product registrations. If this occurs, the Agency will revisit the registration review process and develop a new registration review schedule for products containing temephos. **III. REGISTRATION REVIEW**  **FINAL DECISION**  As stated in the temephos Preliminary Work Plan , the Agency had intended to revise the existing risk assessments for temephos . However, due to the cancellation order issued affecting all temephos product registrations in the United States, the Agency found that it is not necessary

to c onduct new risk a ssessments for temephos 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 remaining U.S. temephos registrations will become effective the same year as the final registratio n review decision would be completed. The anticipated registration review timeline introduced in the t emephos Preliminary Work Plan changed due to the issuance of the temephos DCI in April 2010. If the temephos registrations had not been voluntarily cancelled, the Agency would issue the preliminary

risk assessments by January 2014 and issue the revised risk assessments7

by July 2014, with a final registration review decision scheduled for completion by May 2015. The Agency

does not expect the current risks associated with temephos use to differ from those identified during the temephos reregistration process. In order to mitigate the risks identified during reregistration, the Agency specified mitigation measures in the temephos RED, which are alre ady in effect on temephos product labels. The existing stocks, sales, and distribution deadlines included in the February 25, 2011 cancellation order ensure that temephos sale, distribution, and use will decline and eventuall y 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 temephos products may be used until depleted without causing unreasonable risk t o 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 temephos registration review for the reasons discussed above. The affected product registrations are subject to the terms and conditions of the February 25, 2011 cancellation order.