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

 HYPERLINK "http://www.regulations.gov" www.regulations.gov 

Temephos 

Registration Review Final Decision

September 2011

Temephos 

Registration Review Final Decision

September, 2011

Case Number 0006

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 temephos 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:   HYPERLINK
"http://www.epa.gov/oppsrrd1/registration_review/"
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 timeline
highlights significant events that have occurred during the registration
review of temephos:

June 25, 2008 – Publication of the temephos Summary Document, Scoping
Document, and Problem Formulation  in the temephos docket
(EPA-HQ-OPP-2008-0444) 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 comments 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 registrations containing
temephos in the Federal Register (75 FR 69073) (FRL-8851-5).  The docket
number for the receipt of the voluntary cancellation is
EPA-HQ-OPP-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
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 develop 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) (FRL-8863-4).

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 Supply’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 by the
Cancellation Order.  If the required temephos data are submitted by the
registrant, reviewed, and found acceptable by the Agency prior to
December 30, 2015, the Agency may amend the Cancellation Order for the
affected product registrations.   

II.	BACKGROUND INFORMATION

	Temephos is a non-systemic organophosphate insecticide which is applied
to standing water, shallow ponds, lakes, woodland pools, tidal waters,
marshes, swamps, waters high in organic content, highly polluted water,
catch basins (and similar areas where mosquitoes may breed), stream
margins, 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 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 officials,
personnel of mosquito abatement districts, and other similar government
agencies or personnel under contract to these entities.  The most recent
environmental fate, ecological, and human health risk assessments for
temephos were completed in 1999 in support 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
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.  

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 documents 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 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, 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 decision, 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 by 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 temephos registration review DCI.  

If the required temephos data are submitted by the registrant, reviewed,
and determined to the acceptable by 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 conduct new risk assessments 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
registration review decision would be completed.  The anticipated
registration review 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
reregistration, the Agency specified mitigation measures in the temephos
RED, which are already 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 eventually 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 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
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.

 PAGE   

 PAGE   6 

