1 

# Metofluthrin Final Work Plan Registration Review Case Number 7445
December , 2013

Approve d by: 

# S1 ?

& 

# p Richard P. K e igwi n , J r. Director Pesticide Re
- evaluation Division
Date:2



### INTRODUCTION This i s 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 p o sted in the metofluthrin registration review docket (EPA
- HQ
- OPP
- 2012
- 0105). Metofluthrin i s a Ty pe 1 synthe t i c pyrethroid in sect repellent and insecticide with products registered for use in r esidential and commercial area s , including barns. stable s . and kennel s. There are a number of products contain ing metofluthri n a s the sole active ingredient that are registered for u se as repellents for adult mosqu itoe s . Th e se products are an impregn ated paper repellent strip. a battery
- operated personal outdoor insect repellent fan, an imp r egnat ed fiberglass ring heated by a candle, and a recently re g is t er e d battery
- operated automated mister. Metotluthrin also is co - formulated with piperonyl butoxide and clothianidin, and registered for u se to kill
. be d bug s . There are no registered food/feed u se s . The Agency is implementing the registration review program pursuant to Section 3(g) of the Federal Insecticide, Fu

ngicide, and Rodenticide Act (FIFRA), and will review each re g istered pesticide every 15 ye ars to determine whether it continues to meet the FIFRA standard for registration. Changes in science, public polic y , and pesticide use practices occur over time. The registration review program i s 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 st a tutory standa rd. The pu

b l i c ph ase of registration review begins when the initial docket is opened for each cas e . Information on th i s program is pro v ided 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 need s , expected risk asse s sme n t s , or the estimated timeline identified in the PWP, and a summary of the Agency's respons e s to those comments. This section i s followed by registration review planned data needs, risk assessments expected to be conducted, and the projected registration review timeline for metofluthrin. La stly , there is a discussion of next step s . 

### UPDATES SI

NCE THE PWP WAS ISSUED There are no additional updates on metofluthrin s ince the PWP.

1 htt p ://www. epa.gov/opp.srrd 1/registratio n

_review/3

**SUMMARY OF**  **COMMENTS AND**  **AGENCY RESPONSES**  During the 60
- day publ i c commen t period on the Metofluthrin Preliminary Work Plan, this opened on June 6, 2013 and closed on August 26, 2013, the Agency received 4 public co mments. C omments were s ubmi tted by th e San Francisco Bay Re gi on a l Water Qu a l ity Control Board, the C e ntral Valley Regional Water Qua li t y Control Board, and the California Stormwater Quality Asso c iation. The comm e

nt s do n ot address the timeline described in the PWP , but they do address the planned ecological and human h ealth risk assessments and data requirements. In the PWP, EPA also solicit e d comments on the speci f

i c topics of environmental justice, water quality concerns, and trade irritant s, but no comments or information were received on those i ssues. This section does not capt ure eve ry comment mad e on the PWP nor a ll the Agency's responses. A full listing of all pub l i c comments and EPA responses in their entirety are located in the docke t , **EP A** **- HQ**  **- OPP**  **- 2012**  **- 010**  **5 .**  Those public comments and Agency responses related to the anticipated ecological risk assessment or data n eeds 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. **C o** **mments 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 -**  **OP P** **- 2** **012 -**  **0105.** 1
. Comment: The data and modeling required of o t h er pyrethroids undergoing registrat ion re view s hould also be requ i red for metofluthrin; metofluthrin's environm ental risk assessment should include a quantitative assessment of the same level of rigor as the risk assessments for all other py rethroids; and that all pyrethroids should be review e d together as a g

r oup. Response: The Environmen tal Fate and Effects Division plans to review and respond to th ese comments at the same time that the Health Effects Division re spond s to comments received on the human he a

l th risk assessment during the n ext phase of registration review, currently sche d uled for June 2 0 14 **PLANNED DATA**  **NEEDS** The Agency does not an ticipate requiring any ad d iti on al data at this time, a l though th e Agency intends to re visit the human incident data base for incidents associated with the use of metofluthrin prior to releasing its preliminary human health risk assessm e nt.4

DE MINIMIS DETERMINATI O N 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 co ntained in Registration Review: Preliminary Ecological Risk Assessment and Endangered Species Effects Determinationfor Metofluthrin. Also see De Minimis Subgroup Opinion on Meto.fluthrin loc a t ed 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 criteri a . RISK ASSESSMENTS FOR REGISTRA TION REVIEW Table 1 below su

m mariz e s the plann ed r e gi s t ration review risk assessm e n ts based on the EFED Problem Formulation and HED Scoping Document and the planned assessments have not changed from w h a t was included in the PWP.

Tab l e 2 : Planned Risk Assessments for the MetofluthrinRegistration Review Ty pe of Risk Assessment Conduct? Notes E c olosrlcal and En v i ronmental F ate Comprehensive ecological (species to be assessed include terrestrial and aquatic organisms), including endangered spe c i es N The Agency has concluded that there a r e no risks of concern to li sted and non - listed species ass oc iated with the curr

ent uses of metofluthrin, so a new a sse ssment will not be needed for registration review. Incidents Will check for updates There are no ecological incidents reported for

metotluthri n. Any new incident information becoming avai lab l e during registration r eview w i II be consid e r e d
. Human Hea l th D ietary Food N There are no prop o sed or currently registered food uses for metofluthrin. so a food
- only dietary assessment i s not needed. Drinking water N Drinking water e xposure is not expect ed based on the in door and limited outdoor uses of metotluthrin, s o a revi sed drinking water as s essment is n ot expected to be needed. Occupational Hand lers (mixers, loaders, ap p l icators ) N Based on th e f i nding s from the current asse ss ment , an updated ass e

s s ment is not e xpected to be n e e ded. Post
- application N A quant i tative occupational p os t - application e xp o s ure ass e s s ment has not been conducted and i s not expected to be n e

eded f o r reg i s tratio n r

e vi e w . Residential5

Handlers N Based on the f i ndings from th e current a s s essment , new residential h andler a s s essment s are not expected to b e n ee d ed. Pos t - ap p lication N Based on the finding s from the cunent asse ss me nt , the Agency does not expect that new res idential p o : - . t a pplication ri sk a sse ss ment s wil l be needed. Other Aggregate N Becau se there ar e n o di e ta

ry ri s k c o n c ern 

### t<.H rnerofl ut hri n . an aggre g ate a sses sment i s not e x pected to be needed. Cumulative N A · new cumulative r i sk assessment that includes metofluthrin is n

ot eXQected to be n e ed ed. Tolerances N There are no food u ses for metotluthrin, so tolerances are not needed. Incidents Will check for A limited number of human health incidents h ave updates been reported for metotluthrin. Because metotluthrin

is a relatively new pesticide, the incident data will be re - assessed 

### as the Agency approaches it s registration review decision.
**TIMEL I**  **NE** EPA has created the following estimated tim e line for the completion of the metofluthrin registration revi ew in Table 2 below.
**Ta b**  **l e**  **2: Registration**  **Review for**  **Metofluthrin Registration**  **Review T** **i meline** 

**Activities Estimated**  **Date** Opening the Docket Open Docket and 60
- day Public Comment Period 2 0 1 3
- J une - Completed Close Public Comment 2013
- August
- Comp l eted Case Development Final Work Plan 2 0 13
- December
- Completed 60
- day Public Comment Period for Draft Risk Assessment s 1 2014
- April
- June Registration Review Decision 60
- day Public Comment Period for Proposed Registration Review Decision 2 0 14
- 0ctober
- December Registration Review Decision and Begin Post
- Decision Follow
-u_Q_ 2015 Total (years ) 2 years

2 The regulations governing Registration Review gen erall y 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 convention a l pesticide s , the Agency plans to provide a 60 c a l endar day public comment period generally for draft risk assessment s .6

**NEXT STEPS**  As noted previously. the Agency will review the h u man health incident data and develop i ts Human Health Risk Assessment for metofluthrin. The Agency will review and re spond to comments during the next ph a se of regi stration re v iew , currently s c

heduled for J u ne 2014. The Agency then wi ll develop its proposed decision for the regi s tr ati o n review of metofluthrin.