UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON D .C ., 2 0460 

### MAR 

# n 5 2 010 OFFICE Of PREVE NTION, PESTICIDES AND T OXIC SUBSTANCES MEMORA NDUM S UBJ ECT :
F ROM : 

### Revi ew of a L abel Amendment Re quest for A zinphos -methyl, including Pub lic Comments (DP # 373559) 

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### ~{ Do nald Atwood, E ntomologist
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# ..o/IV I 

## 3 -4

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# :}o David Bras sard , Senior Entomo logi st 

## D , lJN\AI N ikhil M a llampalli , Entomologi st 

# A N I;{**Ji.t~** 

# 3 / 't /z 0 I 0 Bio log ical Ana ly sis Branch Stephen Smeannan , E conomist T J W yatt, Senior Eco nom ist 

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conomic Ana l ysis Branch Bi ologica l and Economic Ana ly sis Di vision ( 7503P) T U RU: 

### Arnet Jone s, Chief 

### Biologic a l Ana lysis Branch Timoth y Kiely , C hief 

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# VV\ :Y-P Eco nomic Analy sis Branch

### "J**,-~** Bio logical and E conomic Analy sis Di Vi sion (750 3P) ,



### T O: Thoma s Harri s In sectic ide and Rode nticide Branc h Regi stration D iv ision (7505P) 

### Katie W eyrauch, Chemica l Rev iew Manag e r Marga ret R ice , C hief Risk Mana gement and Impl ementa tion Branch 2 

### P

esticide R e -eva luati on D ivision ( 7508P)
BE AD P roduct Review Panel date : March 3, 2010

P age 1 of 17

### Summary Un der the ca ncellat ion agr eement for azi nphos-methyl (AZM ), E PA an d th e r egistrant agreed to a detailed ph ase-out sc hedule for several f rui t c rop s, including ap ples , b lueberries, c herries, and pears. Under th e p hase-out , seasonal ap plication ra tes are reduced i n stage s, begi nning in 2009, w ith u s e of AZ M f ully canc e lled after th e 2 012 growing seaso n. In 2 009 , the regis trant s ubmitted an applica tion for a labe l ame ndment th at wo uld m aintain seaso nal application rates at th e 2009 level t hr o u g h th e p hase-o u t p eriod o n the ground s that i mpacts to grower s wi ll b e sizeab le
. B EAD eva luated th e reg is tran t' s s ubmi ss ion and com ment s f rom univers ity e xtension pe rsonnel, individual grower s and growe r a ssocia tions received in r e s ponse to th e app lication
. T he i nformation and data sub mitted gene rally support the co nclusions of the asse ssme nt s evaluating the i mpac t o f ca ncelling AZM, whic h were co nducted by BEAD i n 2005
. As th e s easona l ra tes are lowered , thes e i mpact s have b egu n to mani fest the mselves. However, no ne of the information or data s ubmitt ed prov ides co mpelling evide nce th at B EAD's 20 05 as sess ment s underestimated t he i mpact s of cance lling AZM , mu ch less undere stimate th e impact s of a l ower seaso nal ap plication rate . Many co mmen ts n oted th at th e rates p ermitted un der th e final yea rs of th e p hase-out wou ld limi t grower s to a s i ng le ap plication o f A ZM p er seaso n. In fact , fro m a b iologica l and e cono mi c p erspe c tive, th e s tep-wi se r e duction in s eas onal ap plication rates was d e si gned to e ncourage , and even re quire, ad option of alternative co ntrol regime s w hile al so pr oviding a " safety n et" for growe rs un accustomed to new prod ucts. D elaying the se red uctions wou ld d i scourage grower s fro m t rying new pes t co ntrol regimes and wou ld l ikely re sult in mo re u ncertainty abo ut th e b e st p e s t manag emen t p ractice s to adopt w hen AZ M i s fu lly wit hdrawn in 2 012
. 

### Background A s p art of the re -evaluation o f az inpho s -methy l (A ZM), EPA an d th e registrant ag reed to a deta iled p hase-out s c h ed ule for s evera l f ruit cro ps , including ap ples , bl ueberrie s, c he rri es, an d pear s. Under the p hase-out, annua l maxi mum app lication amo unts are to be reduced i n s tages, beg inning i n 2009 , and aeria l a pp li catio n is to be p rohibited i n b lueberrie s after 2 009
. A ll reg istration s of thi s c he mica l are to b e termina ted as o f Se ptember 30 , 2012. Thi s agree ment wa s forma lized o n A ZM p roduct label s. In J une 2009, the regi st rant for A ZM, M akhteshim Agan N ort h A merica (MA NA), s ubm i tted an application to am e nd the label s to m aintain p revious label rates through the end of t he comm e nt p eriod. MANA also s ubmitted a d e tailed p aper (MA NA, 2009) i n s upport of th e application , w hich desc ribed th e i mpacts o f cance lling AZM use in th e c rops. Th e paper pr esen t s research in ke y AZM usi ng regions (Wa s hington and M ichigan) , and make s th e general arg ument that reduction s i n ap plication rate s (and t he eli mination of aeria l applica tion in b lueb erries) s hould be dela yed i n o rder to avo id signi ficant y ield lo s ses in a ll th e c rops involve d
. In a Ju ly 2 009 noti ce in the F ed e ra l Regi ster, E PA solici ted publi c co mment on MA NA's app lication wi th an e mphasi s on obtaining data th at wo uld s how w hether or n ot the impacts on agr iculture and agric ultural p roduc ti on wou ld be s ubstant ia ll y m ore s evere tha n th ose de scri bed i n se veral asse ssments co nducted i n 2005. T hese doc ument s are located in dock e t E PA

- HQ

OPP -200 5 -006 1 at www.regulations.go v , and are as fo llow s: Page 2 of 1 7• 2005 Grower Impact A ssessment of Az inpho s - methy l Use o n B lueberries (lowb u sh and highbu sh)
. Do cument ID 

### # EP A -H Q-OPP-2005-006 1-00 33.
• 20 05 G rower Impact Assess ment of Az inphos-methy l Use o n T art C herries. Do cumen t ID # EPA-HQ-OPP -2 005-0061-004 1.
• 200 5 G rower Impact Assess ment of A zinphos-methyl U se o n S weet C herries. Document ID # EP A -H Q-OPP-200 5 -0061-0036.
• 20 05 G rower Impact Assess ment o f A zinphos

- methyl Us e o n App les . Document ID # EP A -HQ -O PP-2005-006 1 -0043.
• 2005 Assess ment f or A zinphos

- methyl Use in P ear Production in the U nite d S tates . D ocumen t ID # EPA

- llQ -O PP

- 2005-0061

- 00 39.
• Initia l Ex amination of Max imum R esidue Leve l s o n Ex ported Fruit for S elected In secticide A lternatives to Az inphos-methy I. D ocument I D # EPA-HQ -O PP-2005-0061

- 014 2. In th is m emo, B EA D r esponds to and eva luates th e M ANA p aper and o ther co mments sub mitted i n s upport o f th e application. Fo r eac h crop, B EAD ex plains the co nditions o f the phase-out and s ummarizes th e co nclusions of th e 2 005 i mpact ass essment. BEA D ou t l ines t he key iss ues raised b y th e MANA s ubmission and pub li c c omments regarding th e i mpacts of fo llowing th e c onditions o f th e phase - out. B EAD th en e valuates th e co mments and any s upporting data to d etermine i f impacts are like l y to b e s ubstantially diff erent t han previously es timated. If th ere were r easons t o be lieve imp acts are g reater than w ere ant icip ated at th e t ime o f the decision, EPA m ay wis h to revisit th e s chedu led r ate r e duc t io n s. Blueb erry ( Hi gh bush varieties o nly) Through 2009 , hi ghbush b lueberry growers co uld u se AZM at a rat e of 1 .5 I bs ac tiv e ingr edient ( a.i .) p er ac re per yea r . Mu ltiple applications were a llo wed a nd app lications co uld be mad e b oth ae rially and by grou nd eq uipment. B eginning i n 2010 and c ontinuing th rough th e e nd o f t he ph ase-out in 2 0 12, aerial a pplications are pr ohibited an d the ap plication rat e i s l im ite d to 0.75 lb s a.i
. per acr e p er year . 

### Summary of BEAD ' s 2 005 impact assessment B EAD concl uded that h ighbush blu eberry growers in th e No rth Ce ntral reg ion (p ri mari ly Mic higan) w ould have to u se mo re treatments o f a set o f alt ernative insecticides to s ubstitute f or the ave rage o f approxima tely 2 spray s o f AZM th ey had recently b een usi ng. A l ikel y se t o f in secticides is comp rised of tebufenozide , e sf envalerate , and a mi ticide to c ontrol s eco ndary pe sts ass ociated w ith t he use o f s yn thet ic p yrethroids. S imilarly, growers i n the ot her m a jo r b lu eberry p roducing r egion , th e E astern US (represented by N e w J ersey i n B EAD's assess ment, s ince th at i s the l arges t production area), w ould a lso ha ve to u se m ultiple a lternatives to ac hieve acceptable co ntrol o f the tar get p ests. In bot h reg ions, BEAD e xpected th at p est m anagement co s ts wo uld rise , whi le yield and qu ality l osse s wo u l d occ ur at th e approximately the s ame l evel as was es timated i n BEAD 's 2 001 ass essment , i. e ., 1 -2% yield and 1 -2% qualit y l osse s . The refore, for bo th regions , l osses r anging from $5 1 to $1 16 p er acre at the grower l evel ( in t erms o f r eturns above varia b le c osts pe r acr e) we re p redicted, ranging be tween 5 and 1 4 % o f n et Pag e 3 o f 1 7operating re turns. (Net o perating re turns d o not acco unt fo r th e fixed c osts o f produ ction and m ay und erestimate th e im pact o n gro wer s' inc ome, part icularl y s mall producers w ho ha ve fe wer ac reage i n pro d uction a cross w hich to s pread fix ed co s t s. ) A t th e reg ional l evel a ggregate losses o f ap proximately $ 2.3 million w ere ex pected. BEA D al so n oted th at a lternatives co uld interfere w ith bi ological co ntrol and that u s e o f so me alternative s mi ght not b e f easible b ecau s e so me co untries imp ortin g U .S. blu eberries h ad n ot s et M ax imum Re s idue Leve l s (MRL s) f or th ese pe sticid es. MRLs se t ma ximum re sidue l evels p ermitted o n imp orted co mmodities a nd i f MRLs ha ve not b een es t ab li s h e d , an y de tected residue s w ould lead to rej ection o f ent ire s hipment s. BE AD d id n ot qu antify the imp act of th e s e po tential exp ort restriction s b ecause th ey depend on indiv idual mark eting s trategies, wh ich can c hange wi th pri ces and exc hange rates . K

ey I s sues Ra ise d by AJANA Su bmission M ANA ( 2009) request s that the seas onal ra te b e s et at 1 .0 lb a. i. p er ac re p er year a nd th at aerial application s b e all owed t hrough th e ph ase o ut. T he request sta tes th at , despite co ntinuing re s earch, a lternative program s rem ain le s s reliable and more c ostly th an A ZM an d th at g round a

pplications are ofte n in fea sible due to w et c ondition s. F urther, the re quest asse rted that th e prohibition o f ae rial applications wo uld d isproportionally af fect s mall pr oducers. The reque st d is cus s e s re cent re se arch co nducted i nto alt ernat ive s to A ZM. In th is w ork , a tran sitional pro gram u sed tebufenozide w ith two ap plication s o f A ZM. A n alt ernative pro gram u sed t ebufenozide w ith two application s of es fenva lerate
. An "a dvanced IPM " pro gram u sed methox yf enoxide , s p i net o ram , an d acet amiprid, a ll o f w hich we re reg istered o n thi s c rop after 2 005
. The req uest in dicat es th at a ll thr ee programs pr ovide e quiv alent co ntrol o f th e p rimary fruit worm p e sts alth ough it is no ted th at th e e sfenvalerate-based pr ogram has b e en s ho wn to r e sult in mit e probl em s , p robably beca use p opul ation s o f b eneficial art hropod pr edators a re re duced
. The A ZM-based program costs about $40 /acre . Th e e sfe nvalerate -based pro gram cos ts $SS -60/a cre d ue to i ncreased u se o f mi ticides and the a dvanced IPM program co s ts about $ 110/ac re . M ANA' s requ est ad apts B EAD' s 2 00S an aly sis to es timate th at the se pr ogram s result in lo s ses o f S -12% o f g rowers ' n et o perati ng r evenue co mpared to an AZ M regime. M ANA further note s th at use o f p yrethroid s have b een implicated i n th e appearance o f s econdary p est s s uch as Putnam sca le and g all m idge
. In a ddition , th e r eque st n otes th at insecticide s lik e te bu fenozide and m ethox yf enozide act b y int erf ering w ith th e in se c t's b iochem ical growth regul ator s. Research c ited in th e request s ho ws that , a s re sult of thi s mode of ac tion , th e timing o f ap plications o ft hese c hemicals is mu ch more c ritical than for A Z M , which can mak e c ontrol more var iable
. M ANA a lso pr esents dat a f rom a r eport b y I saacs (unda ted) , s howing that 2 ,23 0 ac re s o f M ichigan blueb erries we re tr eat ed at a nnual rates o f more than 0 .7 Slb s a.i .lac re. Thi s co mpri ses a pproximately 1 7 % o f th e total M ichigan bl ueberry a creage tr eated w ith A Z M that ye ar. T he or iginal source o f the se d ata i s a 2007 s urvey by U SDA-NASS of M ichigan blu eberry g rowers Fi nally, M ANA no tes th at so me o f t he c he micals in th e a dvanced IPM program c annot b e u sed o n blueb erries b o und f or th e ex port m ark et b e cause importing c ountri es h ave no t ye t esta blished Ma ximum Res idu e Lev el s (MRL s ) f or th ese p e s ticide s . Page 4 o f 1 7Regardin g th e impact o f pr ohib iting ae rial a pplications, M ANA s tates that s mall farm s ar e l ess likel y than large farm s to in vest in s pray e quipment an d are thu s more reli ant o n cus tom applicato rs. MANA p resents d ata fro m the 2 007 US DA -NASS s urvey th at s how 2 8 farm s o f l ess than 3 0 ac res a erially appli ed AZM whil e onl y thr ee farm s w ith m ore than 100 ac res applied AZM b y a ir. E ighteen farm s of betw een 3 0 and 1 00 acr es ap plied AZM b y air. MANA th er ef ore c oncludes that th e prohibiti on o n a erial a pp lications w ill ha ve a di sp roportionate impact o n s mall fann ers. Othe r Comments A num ber o f co mments w ere s ubmitted to E PA that pro vided t estim onials to th e va lue o f A ZM an d/or reiterated p oint s rai sed in the MANA s ubmission w hile s upporting co ntinued rate s o f 1 .5 lb s a .i.lacre /ye ar (A nthony, 20 09; Ka mphui s, 20 09 ; Lau tensleger, 200 9; Ma slyn, 20 09; Ny e, 2 009). O ther c omment s s upported an annu al rate o f2.0 lb s a.i .lacre , cl aiming 1 .5 Ib s a .i .lacre w as insufficient (H artm ann , D ., 200 9; Hartm ann, P ., 200 9; Hartmann , S. , 2 009; T rinka, 2 009). A s ubmission from a c rop du sting s ervice in V an Bur en Co unty, M ichigan, indicated that th e serv ice treat s about 1 500 acre s o f blu eberry w ith AZM e ach ye ar, cov ering 1 30 blueberry fa rms ( Helms, 200 9). H elms s tates th at alternatives ha ve h igher ap plication c osts, in ad dition to hi gher d irect costs , but did not i ndicate h ow much m ore e xpensive application cos ts m ay b e. It s hould be noted tha t the MANA s ubmission o n b lueb erry d raws h eavily f rom a report b y I saacs (unda ted), s ummarizing th e r esults o f th e US DAINASS s urvey o f M ichigan blu eb erry growe rs. BEAD Resp onse to C omments B EAD appreciates th e d ata s ubmitted and th e int ense re search a ctivity und ertaken in response to th e AZM pha se-out. BEA D's 200 5 ass essm ent o f th e c ancellation o f AZM indicated th at the imp acts to in dividual gro wers c ould be high . T he inf orm ation pr esented i n th e MANA s ubmission largely s upports BE AD 's findings but d oes not indi cate that th e impa cts ar e s ubstantially great er than e stimated. The a lternative s pray program s describ ed i n the M ANA re quest we re f ound to p rovid e f ruitw orm cont rol equi valent t o that re sulting from a c onventional s pray program th at includ ed A ZM
. It w as noted, h owever, that a lternative c hemistries may b e mo re se ns itive to timing o f application than i s AZM. It was du e t o th is se nsitivity th at B EAD eva luated a y ield loss o f 1 -2% and a s hift in qualit y f rom fre sh to pro cessed f ruit o f ano ther 1- 2%. The a dditional c osts n oted i n M ANA' s s ubmission are si milar to tho se u sed i n B EAD 's 20 05 a ssessment a nd the r e sult s th at g rowers c ould f ace losses o f7 -12% o f net o perating revenue are w ithin th e bound s o f BEAD 's re sult s. In it s 2 005 ass essment, BE AD m entioned that there ex is ted the poss ibility that minor p ests might b e come more s erious a s th ey are rel eased f rom the l ong-lasting b road-spectrum con trol o ffered by AZM
. So me co mments indi cated that thi s h as h appened in s ome blueberry fie lds. Fo r e xample , th e MANA requ est s tates that Putnam sca le and gall m idge h ave been s een m ore o ften,

Pa ge 5 of 1 7p robably as a res ult of i ncreased p yrethroid u se . H owever, th e co mments did n ot c haracterize the g eographical e xtent or quantif y the e ffects on yi eld an d/or qua lit y. BEAD i s al so aw are o f th e probl em o f acceptance o f so me alternat ive pesticides in i mporting co untries , du e to a lac k o f es tablished M aximum Re sidue Levels (MRLS). B EAD recognizes that thi s s ituation co mp l icates grow e rs' pe st co ntrol d ecisions and increases the management burd en. Ho wever, thi s fact or was also re cognized in the 2 005 assess ments. B EAD h as a lso acknowledged that aeri al ap plications ma y be n eeded w hen c onditions are not f

avorab l e f or ground app l ications. M ANA cl aims that an ae rial proh ibition would hav e a di sproportionate e ffect o n s ma ll f arms co mpared to large f arms, b ased o n s urvey re sults from 2007 , s howing m ore farm s o f 30 ac res o r le ss applyi ng AZM b y ai r th an l ar ger f arms (MANA, 20 09). Ho wever, as s hown in T able I , th e 2007 Ce nsus of Ag riculture ( USDA NASS, 20 08) s hows that ther e a re man y mo re s mall f arms produ cing blu eberry than large f arms. Proportionately, f arms of l ess t han 3 0 ac res app ly AZ M b y air n o more f requently than d o farm s o f mor e than 100 ac res. M id-range farms a ppear to rely more heavily on ae rial app l ications than do s mall o r large fa rms. Tab le 1. 2 007 Aerial An li cation o f AZM bv Blu eb errv Fa rm Size F arm S ize # A pp lyin g AZM by 

### # of F arms I 0/ 0 o f Fa rms Ai r Apply ing AZM by Air Mo re than 100 acres 3 5 0 6.0 3 0 to 9 9 acres 1 8 5 0

- 127 14 .2

- 36. 0 Less th an 3 0 acres 28 6 63

- 740 3. 8 - 4 .2 To tal 4 9 840 5. 8 So urce : MANA, 2 009 (Ta ble 7): USDA NASS , 20 08 I The Census of Agricu lture pr ovides data on 

### farm s of 25 a cres or l ess and on 

### f arms be tween 25 and 1 00 a cres. B EAD impact asse ss ments are co nducted o n a per- acre b asis. Impac ts are me asured rel ative to net op erating cos ts , w hich do not include fi xed co sts. Thu s , impacts as a p roportion o f grower income could be und erstated f or s mall p roducers, wh o have f ewer ac res ove r whi ch to spread their fi xed costs. However , BEAD's es timated i mpacts are mor e r epresentative o f m id-range farm s. As s hown i n Ta ble 2 o f MANA's s ubmission, b lueberr y ac reage h as increased s ubstantially between 2 004 and 20 0S. Further, th e s ubmission ind icates th at th e gr oss va lue of producti on per acre h as a lso i ncreased s ubstantially , f rom about $ 6,200/acre in 2004, to ov er $S,90 0 / acre i n 200S
. Thi s wo uld s uggest th at n et o perating r evenue is a lso i ncreasing, w hich w ould tend to reduce the im pact o f c ancelling AZM as a prop ortion of grower r evenue. BEA D ac know ledges th at a s the ph ase-out ta kes e ffect and s easona l rates are reduced, s ome growers w ill begin to fe el th e i mpacts o ft he loss o f AZM. Thi s i s no t un expected. H owever , give n MANA's s ubmission and th e associa ted co mments, B EAD co ncludes that the e xtent o f th e impa cts i s unl ikely to be s ubstantially greater than was e stimated i n 2005. Page 6 o f 1 7

### Tart and Sweet Ch er ry U nder the phase-out to dat e, tart and s weet cherry grow ers had been able to us e A ZM at a rate o f l.5lb s acti ve ingredient (a.i .) per acre per year. Multiple application s are allow ed
. Beginning in 2010 and continuing through th e end of th e phase- out in 201 2, the application rat e i s limited to 0 .75 lbs a.i
. per acr e p er year. 

### S ummary o f BEAD 's 200 5 impact assessments Tart C herry Ba sed on the availability of efficaciou s alternative s to A ZM to control plum curc ulio and cherry fruit fly in tart cherrie s , BEAD believed that the b enefit s deri ved fr om the u se of A ZM w ere likely to be s mall. In the ab sence of A ZM, grower s would m ost likely u se pho smet to maintain th e local, s tate, and federal mandated z ero toleranc e for th ese p ests. B EAD conclud ed that use o f pho smet would lik ely rai se pr odu ction c osts b y ar ound $10 to $25 per a cre. Thi s co uld a mount to tw o to f our p ercent of a grow er's net cash returns (gr oss re venue minu s operating cos ts). However , BE AD al so noted at th e time that recent increa ses in the price of tart cherrie s may mean that the benefit s of AZM a s a perc ent o f net ca sh return s w ould be s maller. B EAD also noted th at MRL s were not y et in place for all the likely alternati ves at the time o f as sessments, whi ch could affect produ cers targeting e xport markets
. Sw eet C herry G iven th e availabl e alternative s a nd e fficacy data , B EAD c oncluded that grower-level (per acre ) i mpacts o f the lo ss of A ZM for e astern s weet ch erry grow ers could be a s hi gh a s 1 1 % lo ss in net cash return s, while in W ashington s uch lo sses ar e approxim ately 2%
. It appeare d that effectiv e new pest c ontrol altern atives ( such a s thiamethoxam, multiple s prays o f sy nthetic p yrethroid s, and s pinosad) exi sted , and that should allo w grower s to m eet th e s tringent qualit y s tandards required b y the s weet cherry market. Ho weve r, BE AD al so concluded that incre ases in production c osts w ere p ot entiall y si gnificant f or indi vidual gro wer s, at least in the eas tern U.S. C alculated lo sses reflected the increased pr oduction co sts in c urred b y the need to appl y multiple treatment s of s ome alternati ves or the much higher co sts of othe r material s. D EAD al so noted that MRL s were not yet in place for all the likely alternativ es a t the time of a sses sment s which could aff ect producer s targ eting export mar ket s . 

### K

ey I ssues Ra ised by MA NA S ubmission M ANA (2009) requ ests that th e se asonal rate remain at 1 .5 lb s a.i
. per acr e per ye ar. The reque st indicate s that , de spite c ontinuing r esearch, alt ernati ve program s remain less reli able and more cos tly than A ZM
. MAN A's requ est includ ed di scus sion o f research condu cted in Michigan between 2004 and 2008 in vol ving 40 tri als o f v arious p est co ntrol s trategies that do not rel y o n organopho sphate ( OP) or sy nthetic p yrethroid pe sticide s. The se trial s appear to have been conducted on tart cherry , but ma y b e applicabl e to s weet c herry as w ell. Th e reque st s tates th ese s trategies failed in 1 3 trial s ,


### Page 7 of 17including e ight fai lure s of control for the p lum curculio , four fai lure s due to fruit fly , and on e failure due to the J apanese b eetle. AZM

- treated trial s h ad no in sect con trol f ailures. MA NA did not define w hat c onstituted a fai lure in th ese tria l s. According to th e s ubmission, pho smet i s a v al uable late- s ea s on tool in tart cherry, but i s not an acceptable earl y and mid- season alternative to AZM due to a s h orter period of re sidua l activity and does not penetrate th e fruit to ki ll larvae befor e the y develop
. Further , MA NA po int s out that pho smet i s ph ytotoxic to s weet cherry. MA NA al so po int s o ut that the non-OP s trategies that wer e s tudie d are mo re e xpensive than A ZM by mor e t han $5 0 per acre. M ANA adapt s B EAD' s 2005 ana l ysis to es t i mate that thes e program s re sult in lo ss e s i n tart c herr y o f 13% of grower s' net operating revenue c ompared to an AZM re gime
. MANA note s that the W a shington State University's 20 09 C rop Pro tec ti on G uide recom mend s AZ M, at a rate o f O
. 75 1bs a.i. per acre , for co ntrol of th e western c herry fruit fl y, the primary pe st in we stern s weet cherry prod uction. T he 2010 se asona l rate for AZM wo uld li mit grower s to a s ing le application , but two ap pli cations are oft en nece ssary beca u se th e in sect e merges over an e ight wee k period
. T he re searc h cited by M ANA indic ates th at c onventiona lly- treated orch ards main tain higher div ersity of be ne fic ia l i n sects than do orchard s treated with a lternati ve s trategies. MAN A concludes that a rate of 0 .75 lb s a .i. p er acre per ye ar wi ll limit grower s to a sin g le app licatio n of A ZM, w hich w ill b e i nadequate to main tain a s afety n et in c ase an alt e rnati ve s trategy fai ls. MA NA al so note s tha t MRL s for man y alternati ves h ave not b een e stablis hed by co untrie s repre s enting i mportant export market s. Other Comments S everal co mmenters expre ssed s upport f or the reque sted label am endment s, w ithout providing additio nal data o r in formation (A nthony, 2 009; Masl yn, 200 9; N ye, 2009)
. H ubbell (2009) expre ssed opp o sition to the e ntire pha se -out of A ZM. Kors o n (2009a) no ted th at proce ssors h ave z ero tole rance for c herry fruit fl y and p lum c urcu l io i n tart c herry and that there i s n o m ethod for identify i ng and s ort i ng inf ested f ruit prior to de livery by th e grow e r to t he processor. He s tated that the C herry Marketing Institute had tested s evera l alterna ti ves but n one pro vided excellent control of th e two ke y pest s and that pho smet doe s not contro l pl um c urc ulio. No data w ere s ubmitted, how ever. Korson (2009b) and W ill et (2009 ) p ointed out that MRL s hav e n ot been es tablished f o r a ll potent ial AZM alte rnative s in all e xport de stinatio n s and that w here MRL s h ave b een e s tabli s hed the y may be lo w er than toleranc es a llowed in the U .S. Wha lon (2009) provid ed th e mos t ex ten sive co mment s, w hich co vered both s weet and tart cherry
. S evera l oth er com me nt s rei terat ed th e basic co nclu sions ofW halon ' s re searc h (Fo x, 2009; N uge n t, 2 009; Pet erson , 2009)
. Dr. Wha len's comment s make s evera l poi nt s about both the be nefits and ri sks o f A ZM, an d B EAD will f ocus o n l y on tho se that are rele vant to the Page 8 of 1 7i mpacts o f th e AZ M ph aseout. In h i s i ntroductory s tatements, D r . W halon asse rts that E PA 's esti mates o f t he imp act of ca ncelling A ZM "severely m isrepr es ented and un derestimated th e economic im pact s th e lo ss of AZM will ha ve on the i ndu stry .... th e proces se d c herry indu stry received a p retty poo r dete rmination of th e eco nomic i mpact s of th i s d eci s ion ." Wha lon makes th e fo llow ing po ints , b ased o n hi s re searc h o n p e s t control i n cherry o rchard s at Mic higan Sta te University : • Co sts of p est co ntrol u sing " reduced ris k" an d non-O P a lternatives are typ ically around $55 per acre more t han pe s t co ntrol c os t s in a c o nventio nal s ys te m. • Phos met h as sig nifican tly lo we r effi cacy that AZM.
• Research t rials over th e last s ix yea rs h ave s hown m ore "fai lures ' i n fiel ds treated w ith re duced r isk a lternatives s uch a s t hiamethoxa m , spi nosyn, and indoxac arb , a s c ompared to fie lds tr eated with A ZM. Fa ilure is defi ned a s any d e tect i o n of o ne of th e key p ests, especially p lum c urculio a nd che rry f ruit fl y, or a s ituatio n w here the grower r esorted to an application o f AZM or p hosmet. Whalon concludes tha t there are n o s uitable and effec tive pest icide s ava ilable to rep lace AZM. BEAD Re sponse to Comments BEAD appreciate s th e i nformation on those ex port m arkets of key im portance for che rry growers. MRL s fo r t hese mar kets a re bei ng tracke d b y th e Agency and it a ppears th at th ere are level s esta blished for s ome, but not all, A ZM alternative s in many coun trie s importi ng U .S. c herrie s. BEAD n oted th i s concern for th e fe asib ility o f u s ing so me a lternatives b y grower s targe ting th e ex port m arket but was n ot ab le to q uantify the impact. The com ment s prov ide no bas i s to qu antify th e impact s n ow . B EAD 's 2005 imp act as sessme nt es timated th at c o s t s to tart c herry growe rs o f cancelli ng A ZM co uld r ange from $ 10 to $25 p er acre depe nding on t he alternatives th at cou ld be ut ilized. T his esti mate is less than h alf the co st increases estimated b y D r . W halon. However, B EAD n otes t hat th e p e s t con trol reg imes s tudied by D r . Wha lon do not include a ll po tential alternative s i dentified b y B EAD. T he red uced ri s k and o rganophosphate alternativ e co m pound s, for exam ple , do not i nclude eit her p hosmet or syn thetic pyrethroids. B EAD' s 2 005 as sess ment ac know ledged that phosmet was l e s s ef fective than AZM an d m ay require multiple applications and th at s y nt he t ic py rethroid s may r educe pop ulations o f be neficial in sec t s. However, rece nt s tud ies o n c herry fruit fly control i n tart cherrie s s h owed that a lternative s s uc h as fe np ropat hrin and phosmet p rovided 1 00% i nfestation-f ree f ruit at h arve s t (TNR C, 2009). Dr. Wha lon 's s u bmiss i o n s tates th at s o me grow ers u s ed pho smet instead of A ZM for p e st co ntrol w hen tr ial s ' failed.' P ho smet and synthetic p yrethroids may have d i sadva ntages re lative to AZ M , b ut failure to in clude the m as possib le contro l measures o veresti mates the impact s of th e l o ss of AZM
. B EAD' s 20 05 i mpact assess ment fou nd tha t the pro cessed s wee t c herry indus try typical of Mic higan prod uction wo uld be face g reater i mpact s than wo uld the production of fre sh swee t c herry i n the Paci fic N o rth west and C a li fornia. The 2005 asses smen t fo und tha t cos ts to Mic higan s wee t cherry growe rs co uld range fro m $20 to $ 60 p er ac re depe nding o n th e a lternatives tha t co uld be utilized
. B EAD notes th at cos t i ncreases e st imate d by D r. W halon fall wi thin t he s e bo unds. A s not ed above , th e pest co ntro l regi m es studied b y D r. Whalon do n ot includ e the use of s ynthetic pyrethro id s. Page 9 o f 1 7R eg arding Dr. Whalon 's comment s o n the f ailure s o f AZ M a lternatives in r esearch tr ials , B EAD highli ght s two c a vea ts a s to th e utility o f th e inf ormati on a s it wa s de scrib ed: 1) A lack o f inf o nn at io n o n th e exac t d etail s o f th e " paired co mparison s" b etw e en A ZM and th e reduced ri sk alt e rnative s mean s th at B EA D c annot u se the d ata to see i f the 200 5 a ss e ss m e nt o f the utilit y o f lik ely c ombination s o f s uc h a lternative s al ong with oth er conv e ntional m aterials ( s uch as lambda- c yhal othrin , a s ynthe t ic p yr ethroid) w as s ig ni fic an tly in correct. 2) Ba s ed o n th e inform ation p rovided in th e co mme nt , it i s n ot po s sibl e to ex trapolate from th e numb er o f failure s s e e n in re se arch tr ial s of redu c ed ri sk m aterial s to th e lar ger gr ower co mmunity i n a r easonable mann er . F or e x am ple, h ow ca n th e re sults be u s ed to d et ermine th e freque ncy o f s uch f ailur e s in co mmercial production , e sp eciall y w here c omb in ati on s of redu ced ri sk and co nv e ntional in se cticide s a re li kely to be us ed ? B EA D n ote s th at t he d ata o n inc i dent s of failure s in c ommercial ch erry p roduction w ith li kely co mbination s o f AZ M alt e rnative s do not acco unt f o r th e co ntinued avai lability o f AZ M, alb eit at a reduc ed s eas onal rate, unt il 2 0 12 . N o thing in Dr
. Whalon ' s co mment s u gges ts that the c urrent rate i s i nadeq uate to s e rve a s a re s cue treatme nt in cas e of s im i lar incident s . M ore g en er ally , B EAD d oes not s ee ho w the c omments re cei v ed for thi s c rop s ig nifi c antly a lter it s e arlier co nclu s ion s. 

### Appl e U nd e r th e ph as e-out , apple g rower s ma y c urrentl y u se AZM at a rat e o f 3. 0 lb s a ctive in gredient (a .i .) p er ac re p er ye ar . M ultiple application s are allo wed. In 2 010, the rate i s limited to 2
. 0 Ibs a . i , p er a cre per y ear and , in 2 011 and 2 012 , th e appl i c ati o n r ate is limit ed t o 1.5 lb s a .i. p er acre p er yea r . 

### Su mmary of BEAD 's 2 005 impact assess ment N atio nally, B E AD c onclude d th at the impact s dep end upon th e alt ernative pe s t m anagement s cenario co n s idered
. L o ss e s a s a proporti on of net o f o perating re venues ( gro ss r evenue minu s op erating e xpenses , bu t n ot acc ounting f or fi xed c ost s) f or apple acre s tr eated with A ZM c ould range from 5 % to 18% o r $ 63-24 3 per a cre . E xtrapol atin g to th e nat ional level , losses c ould ran ge f rom $ 1 7
. 7 milli on to $ 68 m illion
. T he upper rang e rep re sents a sc e n ar i o in w hich f our applications o f ph o smet replac e thr e e A ZM application s and includ ed b oth i ncrea ses i n c ontrol c o s ts and yield a nd qualit y impa cts. The lo w e r rang e o fl oss w a s e s timate d fr om a s c e nar io w here a co mbination o f thi a cl op rid , n o valur on, and ac etarniprid wo uld r eplace A ZM. U nd e r a third sce nario, w here phe romon e mat ing di srupti on p lu s a s in g le (v resc ue ' ' ) appli cation o f A ZM are e mplo ye d in pla ce of thre e AZM ap pl ic ation s, l os s e s w ere e s timated to b e ab out $ 155 p er a cre o r $ 4 3.8 milli on n ationally and represent 12 % o f an a ve rage g row e r 's revenu e s n et o f o p e rating re ve nu e s.

P age 1 0 o f 1 7Regiona lly, the Western grower s we re expec ted to rea lize great er reductio n s in net revenue pri marily becau se operating co sts are hi gher, and y ield and qua lity i mpa cts ha ve great er impac t on fres h market apples in the West th an in the East. Eff ective n e w alternative s u nder the seco nd and third sce narios give growe rs more treatment opt ion s and c ou ld be u sefu l for resis tance managemen t w he n ro tated wi th p ho smet. However, p er acre application c osts are muc h hig her than with pho smet or wi th A ZM
. B EAD a lso n oted th at MRL s were n ot yet in p lace for all the li kely alternative s at the time of as sessme nt s, w hich influences the feasi bility of u se o n app le s targeting ex port markets
. Key I ssues Ra is ed b y AlANA Submission M ANA reque sts that th e s easo na l rate be s et at 2 .0 lb s a .i
. p er acre per year th rough the end of th e phase -out period. The reque st is intended to prov ide g rowe rs w ith a " saf ety ne t " to u se AZM to dea l with hea vy infe s tations or failure s of other s trategies
. The MANA s ubmission s ummar i zes research con ducted i n the Eas tern United States o n vario us alternati ve pest contr o l s trategies that do no t re ly on organo pho sp hate , s yn thetic pyret hroid, or carbamate in sect icide s. A ccordi ng to the sub mi ss ion , insec t pe st damage was at acce ptably low levels w ith no s tatist i cally s i g ni ficant d ifferen ces betwee n the A ZM -treated b lock s and b lock s emp loying alternative s trateg i es. However , th e c os t s of the alternati ve s trategies are greater th an wi th AZM , ran g ing fro m $58 to $ 188 per acre mor e, where the u pper b ound emplo ys p heromo ne mat ing dis ruption. MANA adapt s B EAD' s 2005 analy sis to es timate th at th ese program s re su lt i n l osse s of6 -18% of growers ' net operating revenue compared to an AZM re g im e. T he ad ded cos t s do not i nclude th e increase i n managemen t t ime re quired for alternative s trategies th at require more preci se app lication timi ng . MANA a lso n otes tha t orchard s u si ng AZM a lte rnati ves e xper ience an i ncrease in s econdary pests including s pider m ite s, San J o s e s cal e, and woo ly app l e ap h id s. In 2005 , BEAD e s timated that , without AZM, grower s i n th e We ste rn United States wou ld re ly o n phosmet
. app l ying 

### it more frequently and i ncurring some lo ss i n f ruit qua lity , o r use a co mbination ofthiacloprid , no va luron and ac etamiprid
. MANA claims tha t pho s met i s not an e ffective a lternative for AZM beca u se o f a s hort residual and low er e ffi cacy. MA NA al so cl aims that thiaclo prid, nova luron and acetamiprid are not v iable opt ions b eca u se th ese prod uct s de stroy be neficial in sec ts and result in s e rious disru ption s of m ite controL Mo reo ver , MR L s h ave no t bee n es tablished i n all countrie s for the se in secticid es. Furthe r , th e s ubm i ssion s tates that Wa shi ngton State University o nly recomme nd s AZM at a ra te of 1.0 l b 

### a. i.Z acre, for the con trol ofthe gre en f ruitworm
. A reduction in the s easona l rate to 1.5 lbs a.i Jacre wo uld preclude growers w ith infe stations of green fruitwonn fro m u si ng A ZM later in the s eason for control of the grape mea lybug or the cod ling m o th
.



### Pag e 1 1 of 17O ther Comments Several comm enters expre ssed s upport fo r th e requ ested lab el amendments , without providing additional data or information ( Anthony , 2009 ; Donohoe , 2009 ; Drake , 2009 ; Girardin , 2009 ; Mas1 yn, 2 009; N ye , 20 09; Sharp , 2009)
. Hubbell (2009) expressed opposition to the entire pha se-out of A ZM. A comm ent from the N orthwest Horti cultural Co uncil Willet (2009) s tates that two A ZM applicati ons are " most appropriat e" for control of " an entire g eneration of c odling moth" in the Pacifi c N orthwest. He al so attached a table s howing M RLs for A ZM and mo st of its alternative s in s everal apple e xport market s, and as serts that the lack o fMRL s for all alternatives in " key market s" (und efined) will prevent their u se. Se etin (2009 ) reiterates the importance of two AZM application s, and the MRL s ituation. He al so provided inform ation on th e change in pri ces for proc essing appl es, s howing a decrea se from over $ 13 to $ 7.50 per hundredweight. He conclude s, therefore , th at the impact s o f cancelling A ZM would be about t wice that e stimated by BE AD in 2005
. BEAD Re sponse to C omments B EAD notes that M ANA' s e stimated impact to grower s of6-18 % of n et op erating r evenue i s in keeping w ith BE AD' s 2005 es timates of impact of 5-22 % of net op erating revenue . B EAD also notes that the 20 05 a s sessment accounted for a loss in qualit y due to le sser pe st control with AZM alt ernatives while th e data s ubmitted by MA NA indicate that th ere i s no diff erence in efficac y bet ween A ZM and the alternative s. Impa cts appear to be s olely a fun ction o f in creased p est c ontrol c osts. B EAD acknowledge s the drop in the pric e impa cts o n proc essing apple s in 2 009 du e to the current economic downturn noted by S eetin ( 2009). Howe ver, in 2005, BE AD e stimated the price for processed apples at $136 p er ton or $6 .80 per hundr ed weight. Thi s i s b elow the 2009 average proce ssing price of $7.50. Thus, the e stimate BEAD made in 2005 of the impact o f the cancellation of A ZM remain s r elevant. B EAD acknowled ged the MRL is sues in the 2005 as sessment. BEAD not es that th ere ar e additional MRL s now e stablish ed for the t op two e xport market s (Mexico and C anada), which tog ether accounted for approximat ely 40% of the apple export market based (Smeannan and Mallampalli , 2006 ). It a ppears th at there are now 4 additional alternati ves that w ere not available wh en th e MRL as se ssment w as c onducted i n 2006 and that there are no w MRL s e stablished in major mark ets s uch as Hong Kong that w ere not identified in 2006
. B EAD al so note s that none o fthe c ommenters pro vided new data on the comparati ve efficacy or c ost o f new er chemi stries in appl e p roduction. 

### In s um, BEAD c annot identify in these c omments c ompelling n ew data to make th e c ase that pr evious a ssessments underestimated the i mpacts of c ancelling A ZM nor the impact s of a lower s easonal application rate .
Page 12 o f 17

### Pear U nder the ph ase-out , p ear g rowers i n 2 009 an d 2010 c an u se AZM at a rate o f 2.0 I b s a ctive i ngredient ( a.i.) p er a cre p er year , reduced f rom 3.0 lb s a .i
. per acre p er yea r i n 20 08. M ultiple ap plications are a llowed. In 2 011 a nd 2 012 , th e year ly ra te is lim ited to 1.5 lb s a. i. pe r ac re p er year . Summa ry of BEAD 's 2005 impact a ss essment BEAD's con clusion was that no y ield o r qu alit y l o s ses we re to b e exp ec ted i f AZM was not ava ilable for u se o n p ears. BEAD noted t hat a lternative pes t co ntrol sce nario s (phos met o r a cet amipri d a nd me thoxy fenozide) are m ore ex pensive th an A ZM. N at i o nal ly, th ese inc reased co ntrol c osts were estimated to d ecrea s e th e val ue of production by les s th an 1 

### % fo r pe ar g rowers . Reg ionally , B EAD co ncluded tha t the Pa cific N o rthw es t wo uld expe rience th e grea test losse s wit h a red uction in per ac re n et revenu es f rom 1 .5% t o 1 .6 % i f AZ M i s not avai lable
. In addition, B EAD s tated th at effe ctive new alternat ives wou ld g ive growe rs m ore treatment op tions and co uld b e use ful for resistance man ag ement w hen ro tated w ith p hosmet , the pr imary a lternative to AZM
. B EAD a lso not ed th at M RLs were n ot ye t i n p lace f or a ll th e l ikely a lternative s at th e t ime o f assess ments . Key Is sues Raised by MANA Submission M ANA r equest s th at th e seaso nal r ate r emain at 2
. 0 lb s a.i. per acre p er year thr ough t he e nd of t he p hase-out p eriod
. T he re quest i s i ntended t o prov ide g rowers with a "s afe t y n et " to u s e A ZM to d eal w ith h eavy inf estation s o r fa ilures of o ther s trategies. M ANA s tates th at , i n 2005 , B EAD es timated th at, w ithout AZM, growe rs i n the W estern U n ite d S tate s w ould re ly o n p hosmet, ap plying it m ore frequently, or use a co mbination of th ia cl op rid , novaluron a nd acetam iprid. [BEAD a ctuall y f ound th at a combination of m ethox yf enozide and ace timiprid was a likely alternative fo r AZM
. ] MANA cla ims that ph osmet is not an effective a lternative f or A ZM beca use ofa s hort residual an d lower e fficacy
. Further , MANA q uestions w hy qu ality lo ss e s we re n ot p rojected f or p ears as th ey were for apples
. MANA also clai ms that thiaclop rid , novaluron an d ace tamiprid are not v iable o ptions b ecause these p roduct s d e s troy be neficial in sects and res ult in se rious d isruptions o f m ite co ntrol. Mo reover , MRL s h ave n ot bee n es tablished i n all c ountries fo r th ese in sec ticide s, part icula rly C ana da and M ex ico , w hich are th e m ajor mar ket s . A ccording to t he s ubmission , Was hington State U niver s ity recom mends A ZM for the co ntrol of c odling m oth and gra pe m ealybug in p ear prod uction. Th e schedu led ra te reduc ti o n wo uld l imit AZM to a s ingle, l ate-season a pplication , pr imarily as a reserve i n ca se of co dling m oth co ntrol. Ph eromone m ating di s ruption and other alternative s are no t effective aga inst the g rape m ealybug
. MANA a lso an ticipates dam age i n Eas tern pear orchards, whic h canno t ea sily use phero mone trea tments due to s mall an d fragmented ac reage .


### Pa ge 13 o f 17Oth er Co mments T wo commenters expre ssed suppo rt for the reque sted label amendment s, without pro viding additional data o r inf ormation (Anthon y, 2009 ; Ma slyn, 2 009) . Willet ( 2009) reiterates the N orthwest Horticultural Council's po sition on apple that two AZ M application s i s " mo s t appr opriate " in order to control " an entire generation of codling moth " in pea rs as well. He al so atta ched a table s howing MRL s for AZ M and mo st of its a lternatives in s everal p ear e xport mark ets, and a s serts that the lack o fMRLs for all alternati ves in "ke y market s, " which are not de fined, will pr event their u se . B EAD R esponse to Comm ents B EAD acknowledged in th e 2005 a sses sment that ph o smet is not a s eff ective as A ZM due to a s horter residu al period
. A s a re sult, BE AD conclud ed that an additional applicati on o f pho smet would ha ve to be mad e to compen sate, re sulting in higher chemi cal c ontrol co sts , but e quivalent pe st control. M ANA has not s ubmitted data to the contrary . In fact, the data s ubmitted by MANA on apple s uggests that equ ivalent efficacy can b e achi eved, such that no los s in y ield or qu ality would b e ex pected for apple
. That i s, BE AD ma y ha ve o vere stimated th e impact of canc elling AZ M on appl e , but it di d not und ere stimate the impact of canc ellation on pear . BE AD a cknowle dges th at outbreaks of s econdary pe sts, s uch a s mite s, ma y occa sionally occur with the us e o f so me A ZM alternati ves. M ANA did not li st thi s as a con straint for two out of the three mo st likel y alt ernati ves cit ed in BE AD' s a ssessment, pho smet and methox yfenozide. N or did M ANA includ e o r cite data verifying such outbreak s that w ould enable BE AD to verify or quanti fy th e freque ncy or ma gnitude of thi s c onstraint. B EAD' s se arch o f th e available literature revealed on e r ef erence which s ummarized the re sults o f20 field trial s c onducted ov er a five ye ar period inv estigating th e e ffects o f a cetamiprid , thiacl oprid , pho smet, and azinpho s-meth yl on s pider mit e an d predatory mite population s (Be er s e t a l ., 20 05)
. T his s tudy reported th at multiple (4 to 8) application s o f acetamipri d, clothianidin , and thi acloprid re sulted in s pider mite p opulation s above th e economic threshold of 5 mite s per l eaf in 4 3%, 17 % , and 11 % of th e compari sons re sp ectively
. Azinpho s-methyl application s re sulted in s pider mite p opulation s abo ve th e economi c thr eshold in 2% of th e c ompari sons and pho smet treatment s ne ver re sulted in s pider mit e population s highe r than th ose i n the control plot s. BE AD a cknowledges that gro wers experiencing s econdary outbreak s of s pider mite s ma y hav e to appl y a n acaricide to a void y ield lo sses , which would in crease the impact s f elt b y the c ancellation of AZM
. As re gards th e point made b y Will ett (2009 ) on the need f or MRL s, BE AD note s that th ere a re ne w MRL s now e stabl ished for the tw o e xport market s id entified by MA NA as accountin g for about 75 % of th e p ear e xport (MA NA 2009)
. BE AD 's 2 005 a sses sment addre ssed thi s i ssue qualitati vely, indicating t hat g rowers tar geting the export market would not find alternative s lacking MR Ls to b e feasible altern atives. B EAD a lso notes that neither c omment pro vided ne w data on the c omparative efficacy or co st o f newer chemi stries in pear pr oduction. 

### Page 140f1 7In s um, B EAD c annot ide ntify in the se comm ents c ompe llin g new d ata to m ake the case that previ ous ass essments und ere stim ated th e i mpact s of c ancellin g AZM o n pear p ro ducers not the impacts o f a lower s easona l ap plicat ion rate . Refe rence s Anth ony , A
. 2009
. G eneral Co mment. M ichigan S tate Horticultura l Soc iety
. A vailable at w,.. v ... reg ulations.gov
. docket E PA-HQ-OPP-20 09 -0365, d ocument 000 9
. B eers EH, J
. B runner , J
. Dun ley , M
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