





                   







Metofluthrin Final Work Plan





Registration  Review

Case Number 7445









December, 2013





































Approved by:	 S1?& 	p 	

Richard P. Keigwin, Jr.

Director

Pesticide  Re-evaluation Division







                                                                        
                        



Date:



INTRODUCTION



This is the Environmental Protection Agency's  (EPA or the Agency) Final
Work Plan (FWP) for the registration review of metofluthrin. This work
plan addresses public comments received concerning the Preliminary Work
Plan (PWP), which was posted in the metofluthrin registration review
docket (EPA-HQ-OPP-2012-0105).  Metofluthrin is a Type 1 synthetic 
pyrethroid  insect repellent and insecticide  with products registered
for use in residential and commercial  areas, including  barns. stables.
and kennels.  There are a number of products containing  metofluthrin as
the sole active ingredient  that are registered for use as repellents
for adult mosquitoes.  These products are an impregnated paper repellent
strip. a battery-operated personal outdoor  insect repellent fan, an
impregnated  fiberglass  ring heated  by a candle, and a recently 
registered

battery-operated  automated  mister.  Metotluthrin also is co-formulated
 with piperonyl  butoxide

and clothianidin,  and registered  for use to kill .bed  bugs. There 
are no registered food/feed  uses.



The Agency is implementing the registration review program pursuant to
Section 3(g) of the Federal

Insecticide, Fungicide, and Rodenticide Act (FIFRA), and will review
each registered pesticide every 15 years to determine whether it
continues to meet the FIFRA standard for registration. Changes in
science, public policy, and pesticide use practices occur over time. 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. The
public phase

of registration review begins when the initial docket is opened for each
case. Information on this program is provided on the Agency's  website.
1



The FWP begins with any updates since the PWP was issued.  Next is a
summary of substantive comments received during the public comment
period for the PWP concerning anticipated data needs, expected risk
assessments, or the estimated timeline identified in the PWP, and a
summary of the Agency's  responses to those comments.  This section is
followed by registration review planned data needs, risk assessments
expected to be conducted, and the projected registration review timeline
for metofluthrin.  Lastly, there is a discussion of next steps.



 UPDATES SINCE THE PWP WAS ISSUED



There are no additional updates on metofluthrin since the PWP.





































                                                     1     HYPERLINK
http://www.epa.gov/opp.srrd1/registration_review/ 
http://www.epa.gov/opp.srrd 1/registration_review/

SUMMARY OF COMMENTS  AND AGENCY RESPONSES



During the 60-day public comment period on the Metofluthrin Preliminary
Work Plan, this opened on June 6, 2013 and closed on August 26, 2013,
the Agency received 4 public comments. Comments were submitted by the
San Francisco Bay Regional Water Quality Control Board, the Central
Valley Regional Water Quality Control Board, and the California
Stormwater Quality Association.



The comments do not address the timeline described in the PWP, but they
do address the planned ecological and human health risk assessments and
data requirements.  In the PWP, EPA also solicited comments on the
specif ic topics of environmental justice, water quality concerns, and
trade irritants, but no comments or information were received on those
issues.



This section does not capture every comment made on the PWP nor all the
Agency's  responses.  A full listing of all publ ic comments and EPA
responses in their entirety are located in the docket,
EPA-HQ-OPP-2012-0105.  Those public comments and Agency responses
related to the anticipated ecological risk assessment or data needs can
be found in the Summary of Public Comments Received on the Preliminary
Ecological Risk Assessment and Endangered Species Effects Determination
Conducted for the Registration Review of Metojluthrin.



Comments submitted by all three organizations; the San Francisco Bay
Regional Water Quality Control Board, the Central Valley Regional Water
Quality Control Board, and the California Stormwater Quality Association
in EPA-HQ-OPP-2012-0105.



1 .  Comment:  The data and modeling required of other pyrethroids
undergoing registration review should also be required for metofluthrin;
metofluthrin's environmental risk assessment should include a
quantitative assessment of the same level of rigor as the risk
assessments for all other pyrethroids; and that all pyrethroids should
be reviewed together as a group.



Response:  The Environmental Fate and Effects Division plans to review
and respond to these comments at the same time that the Health Effects
Division responds to comments received on the human health risk
assessment during the next phase of registration review, currently
scheduled for June 2014



 PLANNED DATA NEEDS



The Agency does not anticipate requiring any additional data at this
time, although the Agency intends to revisit the human incident data
base for incidents associated with the use of metofluthrin prior to
releasing its preliminary human health risk assessment.

DE MINIMIS DETERMINATION



The Science Policy C<mncil/Risk Management Forum De Minimis Subgroup
determined  which metofluthrin met the criteria for the EPA's de minimis
policy for registration review.  As part of the registration review
process, the Agency selected metofluthrin as a de minimis candidate due
to its low potential for ecological risk and exposure and effects to
non-target organisms. The most recent ecological and environmental fate
risk assessment was completed April 16, 2013. These risk assessments are
contained in Registration Review:  Preliminary Ecological Risk
Assessment and Endangered Species Effects Determinationfor Metofluthrin.
 Also see De Minimis Subgroup Opinion on Meto.fluthrin located in the
metofluthrin docket. The Agency has not made a determination that the
human health risks associated with the use of metofluthrin meet
appropriate de minimis criteria.



RISK  ASSESSMENTS FOR  REGISTRATION REVIEW



Table 1 below summarizes  the planned registration review risk
assessments based on the EFED Problem Formulation and HED Scoping
Document and the planned assessments have not changed from what was
included in the PWP.







 Table 2: Planned Risk Assessments for the MetofluthrinRegistration
Review Type of Risk Assessment Conduct? Notes Ecolosrlcal and
Environmental Fate Comprehensive ecological

(species to be assessed

include terrestrial and aquatic organisms), including endangered
speciesNThe Agency has concluded that there are no risks

of concern to li sted and non-listed species assoc iated with the
current uses of metofluthrin, so a new assessment  will not be needed
for registration review.IncidentsWill check for

updatesThere are no ecological incidents reported for metotluthri n. 
Any new incident information becoming avai lable during registration
review  wi II  be

considered .Human HealthDietaryFoodNThere are no proposed or currently
registered food

uses for metofluthrin. so a food-only dietary

assessment i s not needed.Drinking waterNDrinking water exposure is not
expected based on

the indoor and limited outdoor uses of metotluthrin, so a revised
drinking water assessment  is not expected to

be needed.OccupationalHandlers (mixers, loaders,

applicators)NBased on the fi ndings from the current assessment,

an updated assessment is not expected to be needed.Post-applicationNA
quanti tative occupational post-application

expos ure assess ment has not been conducted and i s

not expected to be needed for registration revie w.ResidentialHandlers 
N	Based on the f i ndings from the current assessment, new residential
handler assessments are not expected to be needed.

Post-application	N 	Based on the findings  from the cunent assessme nt,
the Agency does not expect that new residential  po:-.t - a pplication 
risk assessments wil l   be needed.

Other

Aggregate	N 	Because there are no di etary risk concern   t<.H

rnerofl ut hri n . an aggregate assessment  is not ex pected

to be needed.

Cumulative	N 	A Tolerances	N 	There  are no food  uses for metotluthrin,
 so tolerances are not needed.

Incidents 	Will check for 	A limited  number of human health  incidents 
have updates 	been reported for metotluthrin.    Because  metotluthrin

is a relatively  new pesticide,  the incident  data will be re-assessed 
as the Agency  approaches   its registration

review decision.







TIMELINE



EPA has created the following estimated   timeline for the completion of
the metofluthrin registration review  in Table 2 below.





 Table 2:  Registration Review for Metofluthrin Registration Review
Timeline Activities Estimated Date Opening  the Docket Open Docket and
60-day  Public Comment Period 2013-June-Completed Close Public Comment
2013-August- Completed Case Development Final Work Plan
2013-December-Completed 60-day Public Comment Period for Draft Risk
Assessments1 2014-April-June Registration Review Decision 60-day  Public
Comment Period for Proposed  Registration Review

Decision2014-0ctober-DecemberRegistration Review Decision and Begin
Post-Decision Follow-u_Q_2015Total (years)2 years











                                                     2 The regulations
governing Registration Review generally require the Agency to provide a
public comment period of at least 30 calendar days for draft risk
assessments; see 40 CFR Part 155.53(c).  For conventional pesticides,
the Agency plans to provide a 60 calendar day public comment period
generally for draft risk assessments.

 NEXT STEPS





As noted previously. the Agency will review the human health incident
data and develop its Human Health Risk Assessment for metofluthrin.  The
Agency will review and respond to comments during the next phase of
registration review, currently scheduled for J u ne 2014.  The Agency
then will develop its proposed decision for the registration review of
metofluthrin.

