U N IT ED STATES ENV I RO:\M ENTAL PROTECTIOS AGESCY WASHIN G T ON D .C.. :!0460



### JUN 2 4 2010 OffInOf CHEMICAL SAH.H**A~DPOt.l UT10'"**  I'REVlNTlOS 

### MEMORAN DUM
SU BJECT :

FROM :

THR U: Eva luation of P ublic Interest F inding s fo r th e Co nditional Regis tration of M etr af enone Fungicide f or Con trol of Po wdery M ildew D isease o n G rapes (DP # 3783 76 an d 37 8377). T ara C h andgoyal, Ph
. D ., Pl an t Path o logist B io logical A naly sis Branch B iological and Econom ic Ana lysis D iv ision (7 503 P) Arnet J one s, C hief B i ological Analy sis Branch B iological and E conomic An alysis Div ision (7 5 3 ) TO: Tawanda Maignan , Ri sk Man ager F ungicide Bran ch Reg i stration Div ision ( 7505P) 

### P RODUCT REV IEW PANEL : 

### June 23, 2010 S um mary Th e reg istrant BASF requ ested a conditi onal regi str ation o f m etrafenone f ungicide f or the cont rol of p owdery mil dew d isea s e o n gr ape clai ming it is i n the public int ere st. Th e r egistrant justifie s i t s c ase based o n three cla im s: ( I ) Met rafenone i s a new ac tive ingredient with a new mode of ac ti on agai n st powdery mil dew p at hogen o n grape s, ( 2) Bene fits of m etrafenone incl ude th at i t i s effective agains t powdery m ildew 

### (Uncinula n eca to r) and the growers can u se it i n preventing a nd managi ng re sistance deve lop ment again s t e stablished fungicide s, and (3) C omparative Ri sk s hows that i t is le ss ri sky and has a good environmen ta l and toxico lo gical profil e c ompared to the leadin g/alternative fun gicide s u sed for the c ontrol of powdery m ildew
. B EAD defers to RD , H ED an d EFED to determine i f metr afenone fun gicide i s m ore f avorable than o the r regi stered fun g icide s with re gard to en vironm ental and toxicological ri sk s . A carefu l review o f t he s ubmi tt ed p ublic intere st findin g and ava ilab le in formation s u gges ts tha t metrafe none is effec t ive i n co ntroll ing powdery mild ew d i seases o n grape s . The su bm i tted and ava ilable data s ho w tha t the 

### grape growe r s can effect ively con trol powdery m ildew o n grape s u si ng regi s tered a lternative s. The grape grow ers ca n ro tat e pr esently re g i ste red fung icide s wi thd iff erent m ode s o f ac t ion to preven t/d el ay th e d evel opm ent of re si s tan c e in po wdery m i ldew p at hogen . BEAD beli eve s th at metraf e n o ne i s a wel c ome a dditional fu ngicid e fo r the c ontrol o f pow dery m ilde w o n g rapes . H owever , it d oe s n ot m eet c ri te ria a s pr oposed by the re gis trant an d co n sidered b y B EAD ( 2, 4 , an d 6 as g iven bel o w ) f o r a p ubl ic in terest fi nding
.. 

### Age ncy Pub lic I nter es t F inding P elley F IFRA s ec t i o n 3 (c)(7)(C) a uthoriz es th e i s s uance of a c o nditio nal re g i s tration f or a new pe s ticid e w ith s peci fic re stric t ion s and f or a s p eci fic p e rio d o f tim e . Thi s i nteri m regi s trat ion a ll ows te mporary u se o f a pe st icide w hi le fu ll regi s tr ati on i s bei n g p ursued. A ll th ree o f t he f oll o wing co nditi ons m u st b e m et f o r a c o ndit io n a l regi st ra ti on : I ) i nsufficient tim e h as e laps ed f or th e g eneration o f dat a s in ce the r equi rement fo r th at d ata wa s imp osed ; 2) u s e o f th e p e sti cide w ill n ot c ause unr easonabl e ad ver s e e ffects; and 3 ) u se o f the pe sticide i s in th e public int erest. Th e regi str ati on of a new p e sti cide in gredient i s p re s umed to be in th e pu blic in tere st i f o ne o r m or e of the fo ll owi n g cri te ria ar e ap plicable : 1 ) it i nvolve s a repl a cem ent f or an o ther p esticid e t hat is of con tin u ing ri sk c o nc e rn to the Age ncy ; 2 ) it i n v olve s a u se fo r wh ich a s ec ti o n 1 8 e merge ncy exe mpt ion h as be en gran ted, i f th e b as i s fo r th e e xemp tion w a s the l ac k o f a s uita b le a lterna ti ve; 3) i n vo l ves a us e a gain st a pe st of pu bli c h ealth s ign ific ance; 4 ) There i s a need for the new pe sticide th a t i s n ot be ing m et b y c urrently re gi stered pe sti cide o r n o n -pe s ticidal a lternatives ; 5 ) Th e new pes ticide i s co mparatively le s s ri sky than curre ntly regist ered ; o r 6 ) The benefit s f rom the new pe s ticide are gre at er than th o se fro m currentl y re gis ter ed pe s ticides or n on c hemical pe s t co ntro l m easure s . B EAD r ev iewe rs focus o n item s 2 , 4 and 6
. 

### M et rafe none Fungicide - Ge neral I nformat ion: Th i s i s a new fun gi cide a nd a ll g en e ral inf orm ati o n abou t th is fun g icid e i s fro m th e reg i strant 's s ub miss ion un le ss s tated o therw is e . Th e re g i s trant s tates th at m etra fenone 's m ode o f ac ti o n i s differe nt than th e f un gicide s regi stered f or u se a gain s t grap e p owdery mildew
. It affect s s ev eral s ta ges in th e inf e cti on proce ss of p owdery milde w p ath og en . The r egi strant a l so cla im s th at metraf enone inhibit s s po re ge rmination , inf ection o f plant ti ss ues, an d s ubse qu e nt my ce lial growth. It a l s o reduce s s po ru la ti o n b y pr e v entin g n ormal d evelop ment o f co nid io pho re s and co nidia of powdery mild ew p ath og en. Many o f th e s e cl ai m s h ave be en ve ri fied (O p a ls ki 

### e t a l ., 200 6)
. Th e re gis trant a l s o s tates th at thi s fun gi cide mu st be ap plied be f o re v is ual s ymp to m s of powd ery m ild ew appear . It d oes n ot h ave c u rat iv e pr opertie s an d , th er e for e , it will n o t c o ntrol l a te n t or e stab li shed inf ec tio n s o f po wdery m ild e w. If p owde ry mi ld ew infectio n s are e stablished m etrafe n one s hould be app les in a tank m ix co mbinat ion w ith o the r fun gicides o r fo llowing application o f a curative fung icide
. The Fungici de Re s istance Ac tion Co mm ittee ( F RA C) has cl assified m etrafenone fun gicide as be l o n ging to Be nzo ph enone U 8 gro up of f ungici des w ith Un kn o wn Mo de of Act ion ( http :// v.w w . frac
. int o / fra ci publicatio ni anhan gi FRAC C ODE LIS T.pd O
. 

### R egistrant 's C laims in S ubmitted P ublic Int erest Document:

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### The regis trant h a s mad e seve ral clai m s i n its p ublic intere st d ocument. These are : Registrant's Claim 1: Need Bei ng Me t : P owdery m ildew pathogen c an devastate grap e y ield and qu ality. Me trafenone is a new act ive ing redient wi th a n ew m ode of ac tion tha t mak es it a uniqu e f ungicide having fungicidal prop erties aga inst po wdery m ildew 

### ( Uncinula necator) o n gra pe s. The registran t ha s d ocumented th e effi cacy o f me trafenone and s o me of t he reg istered alternative s i n co ntrolling powdery mild ew o n g rape s in 24 tab le s. Th e regi s trant a lso clai med that BASF and Interregional Research Pro ject N umber 4 (IR A) are d eveloping da ta for ap plying for registration s for u se on other cro ps (s uch as f ruiting vegetab le s, c ucurbit vege tables, p ome fru it s and s to n e fru its) in the Uni ted S tates . BEAD's Response: At le a s t 20 fun gicide s are regis tered for t he cont rol of powdery mi ldew d isease on grape s (app l icant' s s ub m itte d information an d h ttp://npir s.ceris.purduc .cdulhtbi nlpr! i s ts.com , http s: l lpremier.cdm s.netlwebapls/re sults.asp )
. In thi s li s t th ere are fi ve SBI (s terol biosynthe s is i nhibitor) fung icide s ( fe n ari m o l, my clobutanil , propiconazole , teb uconazole and trifl umizole) , f our strobil uri n fungicides (az oxystrobin, k re soxi m-methyl , py raclo stro bin , and tr ifloxystrobin), one anilide f ungicide (boscalid) , o ne qui noline fungicide (qui noxyfen) , o ne benzimidazole (thiop hanate -methyl) , o ne pol yoxin (g lucan s ynt he sis inhibi tor , pol yoxan-D), and man y others (s ulfur , mi neral o ils, p etroleum oi ls , po tassium s al t of f atty ac ids , co pper-ba sed fu ngicides , p otas si um c arbonate s, an d bi ological 

### (Bacillu s s ubtilus, an d 

### Bacillus pum ilus). Th e r esult s of s ub m itte d and ava ilable e fficacy data s how th at m ost of t he regi s tered fun gicide s (SB I f ungicides , s trobilurins , bo sca lid , qu inoxyfen and sulf ur) are hig hly e ffective in contro lling pow dery m ildew o n grape l eave s and f ruits ( UC -IPM
. 2010 , Wilcox , 20 10 ; Wilcox an d Rieg el, 20 06 and 2008; Gubler 

### et al. ,20 08; Psc heidt , 2 009 ; Sc ilder 

### et al. , 2008 ; Trave s 

### e t al ., 2008). T he di fferent f ungici de program s, u si ng a co mbination of th ese f ungicide s, h ave be en recom mended to co ntrol powde ry mil dew on gra pe s (G ubler 

### et al ., 2008)
. Most of th e SB I f ungicides have exc ellent e fficacy and con s i s tently co ntrol p owdery mild ew (U C -IPM , 20 10)
. Si milarly , qu inoxyfen , Pristine (a m ixture o f boscalid and py raclo strobi n) and s ulfur are h ighly effec tiv e in co ntrolling pow de ry m ildew of grape s (U C- IPM, 2 010 , Wilcox an d Riegel , 20 06)
. BEAD ag rees w ith th e regis trant that metrafe none i s a new ac tiv e ingredient with a new mod e o f act ion agai nst powdery mildew pathogen on g rape s. B ased o n publis hed repo rts , BEAD co ncludes th at p re se ntly reg istered alternative s are adequa te in contro lling pow dery mi ldew o n grape s. Th erefore, i t d oes n ot meet t he Criterion 4 of the Age ncy P ublic Intere st Finding Po licy
. Registrant 's Claim 2 : Bene fits: Me traf e non e i s e ffec tive agai nst pow dery mild ew o n grapes provid ing co ntrol l evel s better th an , or as good as, regis tered a lternativ e f ungicides. Me trafenone provid es a new mode of act ion that grower s can use to preve nt an d man age re sistance dev elopment aga in st e s tabli shed fu ngicides
. Its p osition in th e fungicide ma rk e t will offe r c o nsiderable va lue for growers. BEAD's Response: Base d on efficacy da ta s ubmitte d by the reg istrant , B EAD concl ud es tha t metrafenone i s as effec tive a s regi stered f ungicides i n con trolling th e di sease. On grapes six d ifferent gro up o f f ungicides w ith d ifferent m ode s o f ac tion are reg i stered (please see B EAD' s re sponse to cl aim 1 )
. In additio n , co pper, sulfur and others are registered for th e control o f

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### p owdery mild ew . The gra pe growers hav e been u sing d i ff erent fungicide pro grams t o eff ectively co ntrol po wdery m ildew on g rape s and man age th e developme nt o f resistance aga in st re gi st ered f ungicides
. We a gree th at metrafenone ha s a new an d u nique mode of action aga in s t powdery m ildew pathogen o n gra pe s. H owever, th e grape growers have adequate numbe r of registered a lternative s to rotate and manage resi stan ce i n the pa thogen. Th erefore, it doe s n ot m eet th e Criteri o n 6 o f the Age nc y Publ ic Interest Fi nding Policy. Registrant's Claim 3: C o mparat ive Ri sk: M etrafenone i s le s s risky and ha s a goo d e nvironmental and toxico logical profile c ompar ed to t he leading/alt e rnative f ungicides u s ed for the co ntrol o f pow dery mild ew. B EAD's Response : BEAD defers to RD , li ED a nd EF ED to determine i f metrafenone f ungicide i s more favo rable ove r other reg i s tered f ungicide s wi th re gard to e nvironmental and toxicological risks as per Cr iteria 1 an d 5 of the Age ncy Publi c Intere st Finding Po licy
. Economic Con siderations : The data package s ubmitted b y BASF doe s n ot have an y i nformation o n th e eco nomic s of thi s fu ngicide. Genera lly , i n a P ublic Interest Pro posal , ec onomic i nformation i nclude s e xpected m arket p rice, e x pected percent share of th e mark et and an ana ly s i s of th e p rimary co mpetitive pro ducts
. B ASF has p rovided n o inf ormation to d etermine m arket share or mark et p rice to e valuate it s impact o n th e mark et. BEA D Analysis and C onclusions: From t he p ublished report s it a ppears th at powdery m ildew c an b e m anaged very e ffectively u si ng currently regi s tered f ungicides. Th e grape grower s c an rotate presently registered fungicides w ith d if ferent mod e s o f ac tion t o prevent/de lay the d evelopment o f resistance in th e powdery mild ew path ogen . BEAD b elieve s th at m etrafenone i s a we lcome add itional fungicide for th e co ntrol o f p owdery m ildew on grapes . Ho wever , it d oes not m eet any c riteria eva luated b y BEAD f or a pu blic i ntere st fin ding
. BE AD defers to RD w ith re gard t o w hether metrafenone f ulfills other crit eria f or a p ublic interest findin g. References : G ubler , 

### et al. 2008. Gra pe Powdery mild ew . H ow to Man age P ests
- DC P est Ma nagement G uileline s ( htlp :// ipm
. ucdavi s. edu/PMG /r 30 2 l0 031 1.html )
. Acce ssed Ju ne 10 , 20 10 O palski , K S., Tresc h, S. , Kogel , KH ., Grossman K ., Koh le , H an d H uclelhoven , R
. 2 006
. Me trafenone : s t udi es on th e mod e o f act ion o f a nova l ce real pow dery m ildew f ungicide. Pe st M anagement Scie nce 6 2(5): 3 93 -4 0 1. Psc heidt, JW. 2009
. G rape - P owdery Mi ldew
. A n o nli ne gui de to pl ant d isease co ntrol ( http :// ipmne t.or g/pla nt-d is ea s e/di s aca s e . cfin ? R e cordIO

- 5 25). Acce sse d J une 0 9 , 2010

4Sc ilder , AM C , G illett , J M and S ysa l , RW
. 2008
. Evaluation offu ngicid e for c ontro l of powd ery mi ldew and downy mil dew i n w ine g rape s. P lant D i sease Management Report s 4 : SMF03 4
. T ravis, JW , Ha lbrendt , N O and Jarjour
. 2008
. Eva l uation o f sy nthetic and organic a lternative fungic ide s for contr o l o f powdery mildew on g rape s. P lant Dis ease Manag ement Rep ort s 3 : SMF027
. UC-IPM
. 20 10
. Grape

- 2010 F ungicide E fficacy and Treatmen t Timing ( htt p :// i pm.ucda v i s. edu/PMG /r 3 0290 2 11I.hlml). A c cesse d Ju ne 14 , 2 010 Wilcox, W F. S trategies to contro l powdery mildew
. ( http ://wv..W .prac ti calwincr y. com/marapr0 3 / marapr0 3 p16.htm )
. Accessed J une 1 0 , 2010 Wilco x, W F a nd Rie ge l , DG
. 2006
. E valu atio n o f fu ngicide program s for contro l of powdery mi ld ew on Co ncord g rape s. Plan t Disease Manageme nt Reports 1 : S MF006
. Wilcox, W F and R iege l , DO
. 2008
. E valuation o f fu ngicide program s for contro l o f powder y mi ld ew on C hardonnay g rapes. P lant D iseas e Mana gemen t Re port s 4 : S MF046.

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