UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON D

. C

. , 20460 OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENT I ON


### MEMORANDUM

SUBJECT: F RO M :

THRU:

TO: Nove mber 16 , 2015 PC Co de: 014504 DP Barcode: 429170 Review of Public Re s pon se to Mancozeb Problem Formulation A llen Vau g han , Entomologist 

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# / JL-- Environm e nt a l Risk Branch S 

### 1{r"I' ( E n viro nm e nt a l Fate and Effec t s Di visio n (7S07 P ) Mah S h am im , Branch Chief E nvironm e ntal Risk Branch S Environm e ntal Fate and Effec t s Di v is ion (7S 07P) Tracy P e rr y , Team Le ader , RMIB 3 P es ticid e Re - evaluation Di vis io n (7S08 P )

EFED has re v iewed the co mm ents recei ved from th e Mancozeb T ask Force and the Ph ys ic ian s Committee for Res p o n sib le M edicine. The Mancozeb Task Force h as com m en ted on iss ue s related to requirement s fo r addit ional hon ey be e t es tin g currentl y requi red for outdoor use c hemicals. The Ph ys ic ians Committee has cited ex is te nce of an alternative te s t ( O EC D 223) for oral tox i city to birds , and reco mm ends that thi s m e thod be used to fulfill the 8S0.2 l 00 FIFRA data requirement. The Commi ttee al so cites a publi s he d source for avian di e tary data on mancozeb. EFED ha s r es p o nded below to the indi v idual comments. 

### Mancozeb Task Force co mment regarding requireme nt s for additional hone y bee ac ute a nd c hronic toxicity te s tin g: The Task Force believ es th a t the Agency s hould reco n s ider th e need for th e pollinator studies id ent ifi ed in the Prelim in ary Work Plan. Manco ze b ex hibits ve r y lo w toxi c ity in honey bees. In a laboratory s tud y cond ucted by the U ni ve rs ity of Californ ia-River side in wh ich Mancozeb ( in the fo rm of Dithane M4S ) was applied directl y onto adult honey bees , very li tt le tox icity was observe d. The E P A categorizes pesticides as "Tox ic to bees" if they cause g reate r than 50% mortality in adult bees exposed up to 11 mic rograms per bee, which tech ni cally spea king me ans that the LOSO is le ss th an 11 micro grams/bee
. In thi s study , the contact LOSO for Mancozeb was re p orted as greate r than 178 .87 mi crogram s/bee , the highest dose t este d. In a subsequent rep ort by the s ame authors , honeybees exposed to Dith a ne M-4S at 193.38 mi c rog ra m s/be e (at a nomin a l purity of 80 % a. i. , that is e quivalent to l S4. 7 mi crog ram s manc ozeb acti ve in g redient) ex p e ri e nced only 3
.7% m o rtality , no different from random variati on in control bees.Confirm ing the fi ndin gs of the laboratory studies , Atki n s et al. published a summary of 120 honey bee field and lab o rato r y s tud ies conducted by th e Un iversity of Ca li fornia Ri vers id e from 1950 to 1971 on nea rl y 60 pesticide formulat i o n s , o ne of which was Di thane M -45. Th e conc lu s i o n o f the review was that Di than e M-45 ca n be co nside red "Relatively nontox ic " a nd "Ca n be used around bees wi th a minimum of in jury." 

### EF ED Re s pon se: The Man cozeb Task Force has c ited a number of studies s h owing that mancozeb is relatively nontoxic to adult bees in acute contact studi es. However. acute toxicity testing with adult bees does not necessarily reflec t potential toxic ity to developing larvae or chronic toxicity to ad ult bees. In order to co ndu c t Tier I assess ment of pollinator risk, chronic effec t s to adults and la rva l b ees are cons i d e red. The reg i strant may w i s h to consu lt the Offic e of Pes ticide P rogram s Gu idance for Assess in g Pest ic id e Ri s k s to Bee s implemented June 23, 2014 r egard ing determinati o n fo r testing need s and assess m e nt of exposure p o te nti a l c urrently used by the Age ncy . 

### Ph ys ici an s Co mmittee for Res p o ns ibl e M edi c in e co mm e nt reg ardin g av ia n ac ute o ra l toxici ty tes tin g re quir e m e nt 850.2100 . We reconunend that OEC D Test G uideline 223, Av ia n Acu te Oral Toxici ty Tes t , be used as the protoco l instead of EPA Gu id e l ine 850
. 2 10 0 in th e interest of reducin g the numbers of animals u se d b y up to 61 

### %. W e also refer the regi s trant to the " Gu idance for C l a ss ify in g Stu dies Co nducted Using the OECD Test Guideline 223 (TG223) (A cute Av ian Oral Se quent ial Do se Stu d y)" available o n th e Age n cy's website. 

### EFE D Res p o ns e : Fo r s tu d ies with bobwhite quail and mallard , the Agency will accept testing under OECD Guideline 223. EFED generall y recommends against the u se of OECD 223 for passerine species , as this guideline has not been tested or va lidated for passer ines. 

### Ph ys ici a ns C om mittee fo r Res pon s ibl e M ed icin e c omment regardin g av i a n di e tary toxici ty tes tin g requir e ment 8 5 0. 2200. We fo und the following data which ma y fulfill th e Agency ' s n ee d s wi th ou t add itional testing.

" Man cozeb i s slightly toxic to b ird s, with reported d ietary LC50 values in bobwhite quail and mallard ducklings of g reater than 1 0,000 ppm. The I 0 -d ay dietary LC50 values of 6400 ppm a nd 3200 ppm are reported for mallard ducks a nd Japanese quail , respectively. " 

### EFE D Re s pon s e : The data cited by the Committee are from a secondary so urc e (summary docume n t)
. The docum e nt pro v ide s on l y the toxicity values, and doe s not pro v ide the detail e d information n ecessary to a ll ow val i dation of th e data.