Docket Number: EPA-HQ-OPP-2008-0444 www.regulations.gov



## Temephos Proposed Registration Review Final Decision

March 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 temephos and is being issued pursuant to 40 CFR § 155.57 and § 155.58. A registrati on review decision is the Agency’s determination whether a pesticide meets, or doe s 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 temephos (case 0006). The following timelin e highlights significant events that have occurred during the registra tion review of temephos:

• June 25, 2008 – Publication of the temephos Summary Document

, Scoping

Document, and Problem Formulation in the temephos docket (EPA-HQ-OPP2008-0444) for a 90-day public comment period. The Summary Document also

included the Preliminary Work Plan for the registration review of temephos.

• November 7, 2008 – Signature of the temephos Final Work Plan and the Agency’s response to the public comment s received during the 90-day comment period on the temephos Summary Document . The one comment received did not change the work plan set out in the Preliminary Work Plan

.

• November 10, 2010 – Publication of a Notice of Receipt of requests to voluntarily cancel all remaining pesticide regist rations containing temephos in the Federal

Register (75 FR 69073) (FRL-8851-5). The doc ket number for the receipt of the voluntary cancellation is EPA-HQ-O PP-2009-1017. During the 30-day comment period, comments were received regarding 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 product

4cancellations. However, the Agency rec ognizes the role of temephos in mosquito control and has agreed to a 4-year ph ase-out of the product registrations to accommodate this need and allow registrants time to develop replacement products. The current temephos products would not be cancelled until December 30, 2015. For these reasons, the Agency did not extend the comment period.

• February 25, 2011 – Publication of th e Product Cancellation Order for all remaining pesticide registrati ons containing temephos in the Federal Register (76 FR 10587) (FRL-8863-4).

II. BACKGROUND INFORMATION

Temephos is a non-systemic organophosphate insecticide which is applied to standing water, shallow ponds, lakes, woodla nd pools, tidal waters, marshes, swamps, waters high in organic content, highly pollu ted water, catch basins (and similar areas where mosquitoes may breed), stream margin s, and intertidal zones of sandy beaches. Target pests include aquatic larvae of mosquitoes, midges, gnats, punkies, and sandflies. Temephos is one of a few organophosphates regist ered to control mos quito larvae, and is the only organophosphate with any appreciable larvicidal use. There are no crop uses and no residential uses. Temephos is curren tly labeled for applic ation only by public health officials, personnel of mosquito abat ement districts, and ot her similar government agencies or personnel under contract to thes e entities. The most recent environmental fate, ecological, and human health risk asse ssments for temephos were completed in 1999 in support of the temephos Reregistration Eligibility Decision (RED), which was completed in July 2001.

After the Final Work Plan was signed in November 2008 as part of the registration review process for temephos, the technical and end-use product registrants, Clarke Mosquito Control Company, Inc. and Value Garden Supply, informed the Agency that they were requesting to voluntarily cancel all of their temephos product registrations. These were the last remaining products regi stered in the U.S. containing temephos. A Notice of Receipt of requests to voluntarily cancel all pesticide registrations containing temephos published in the Federal Register on November 10, 2010.

The Agency then issued the product can cellation order on February 25, 2011 for all remaining temephos product registrations. Copies of those documents are included in the docket for this registration review. As sp ecified in the Cancellation Order, registrants are prohibited from selling or distributi ng existing stocks of products containing temephos for all uses as of December 31, 2015. After December 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 legally until they are exhausted, provi ded that such use complies with the EPAapproved label and labeling of the affected product.

56 III. PROPOSED REGISTRATION REVIEW FINAL DECISION

As stated in the temephos Preliminary Work Plan , the Agency had intended to revise the existing risk assessments for temephos. Howeve r, due to the cancellation order issued affecting all temephos product registra tions in the United States, the Agency has found that it is not necessary to conduct new risk assessments for temephos and is, therefore, issuing a proposed decision pursuant to 40 CFR Part 155.53(c)(2) and 40 CFR Part 155.58. The voluntary cancellation of all re maining U.S. temephos registrations will become effective the same year as the fi nal registration review decision would be completed. The anticipated registration re view timeline introduced in the temephos 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 assessments 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 reregi stration, the Agency specified mitigation measures in the temephos RED, which are al ready in effect on temephos product labels. The existing stocks, sales, and distributi on deadlines included in the February 25, 2011 cancellation order ensure that temephos sa le, distribution, and use will decline and eventually cease entirely in the United States in the future. During this period, given the mitigation measures that are specified in th e RED and are currently in place, the Agency believes that existing stocks of temephos products 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 teme phos registration review for th e reasons discussed above. The affected product registrations are subject to the terms a nd conditions of the February

25, 2011 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 temephos docket (EPA-HQ-OPP-2008-0444). A Federal Register notice will announce the availability of this proposed registration review final decision for temephos 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 final d ecision for temephos, Case 0006, which will be announced in

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

mid 2011.