### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WAS HIN G TON , D.C. 20460



### MEMORANDUM Date: Octob e r 28, 2015 OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION



### SUBJECT : 

### Mancozcb : HED Response to Co mments on the Registration Review P reliminary W o rk Pl an

P CCo d e: 014504 ; 014601 ;6 000 16 DP Barcodc: 04 2 917 1 Dec is io n No.: 509157 R ee is tration No.: NA P et iti o n No.: NA Regulat ory Action: Re g istration Review Ri sk Assessme nt Type : NA Case No.: NA T XR No.: NA CAS No.: 8018-01-7 MR ID No.: NA 40 C FR : 18 0. 176


### F ROM : Danette Drew ,**Chernisl ~**  

## jl Pete Savoia, C hemist (;;:r ,.,<.-:(**'-~ ~** **o~­** 

### Ri sk A ssess ment Branches V 

### N II He alth Effects D ivision (7509P)


### THROUGH : Michael Metzger , Branch C hief Ri sk Assessment Branche s V / VI I Health Effec ts Division ( 7509P )


### TO: Steven Snyder man , Chemica l Rev iew Manager Tracy P e rry , Team Leader Ri s k M an age ment and Implement ation Branch 3 Pe s ticid e Re -Evaluation Di v is io n (7508 P)

The Mancozeb Task Force ha s s ubmitted comment s on the Mancozeb Pre li m inary Work P lan for Re g is tration Revi ew (Docket No. E PA-HQ-OPP- 20 15-0291) (August , 24, 2015 le tter). The H ealth E ffect's Division ( HED ) h as co n sidered th e following Task Force comments pertaining to the HED document titled 

### Mancoz eb: Human Health Ris k Assessment Scoping Do c um en t in Support of R egistr ation R ev i ew (61 1 1

20 15, 0425216 ) and provides the following re sp o n ses:

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## L Ma rket Bas k et S u rvey J u st ifi cati on l n response to th e Age nc y's r eq uest for justification that the 1989

- 1 990 ethylene-bis-dithiocarbarnate (E BDC ) Market Ba sket (MB) survey remains relevant for refining mancozeb and other EBDC dietary assessments , the Mancozeb Task Force maintain s that it still is a u sab le s tati s tical s urvey . The Task Force reiterates the s ignificance of the s urv ey results and s ta tes that EBDC usa ge has not s i g nificantl y increased. Ho wever, specific information has not been provided demonstrating the relevancy of the o lder MB s urvey for u se in current assessments. Given the age of the s urvey , any changes in app licati o n techniques , typical rates , handling , storage, and transportat ion cou ld res ult in incurring different residue leve ls 

### in food today th a n those reported in the MB survey. To allow for the continued use of the MB survey, speci fi c data mu st be submitted that illustrate that the survey results remain representative of p resent EBDC usage . Th is wo ul d include provid i ng comparisons (across time) of typical rates, E BD C u sage to tal s, application techniques/ timin g, percent crop treated data , commercial practi ces (handlin g, storage and transportation) , and the capabil itie s of analytical method s to detect residues. In the event that the continued u se of th e MB survey cannot be just i fied , the Agency will rel y on re s idue data from available controlled stud i es ( fi e ld trial & processing stud ies), whic h will likel y res ult in signi ficantl y g r e ater risk est imates, until a new survey can be provided.

2. "Reach The Deci s ion Makers" Pol i cv B r ief The Task Fo r ce states that th e Pol icy Bri ef from the May 29 , 2014 "Reach the D ec ision Makers" (REAC H ) meetin g on manc ozeb is not sui tabl e or reliable for risk assessment purposes associated w ith mancozeb. The Task Force expects that the Agency will comple te its review of these studies early in the r egistration rev iew proc ess and will concur that the conclusions in the Policy Brief are incorre ct. The Agency will re v iew the REACH information as part of the regi s tration review process for mancozeb and at that time will evaluate whether that information i s suitable for incorporation into th e human hea lth risk assessment.

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