UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

MEMORANDUM 

Date: October 28, 2015 

OFFICE OF 

CHEMICAL SAFETY AND 

POLLUTION PREVENTION 

SUBJECT: Mancozcb: HED Response to Comments on the Registration Review Preliminary Work Plan 

PCCode: 014504; 014601 ;6000 16 DP Barcodc: 042917 1 

Decision No.: 509157 Reeistration No.: NA 

Petition No.: NA Regulatory Action: Registration Review 

Risk Assessment Type: NA Case No.: NA 

T XR No.: NA CAS No.: 8018-01-7 

MRID No.: NA 40 CFR: 180. 176 

FROM: Danette Drew, Chernisl~ jl 

Pete Savoia, Chemist (;;:r ,.,<.-:( '-~ ~ o~­

Risk Assessment Branches V N II 

Health Effects Division (7509P) 

THROUGH: Michael Metzger, Branch Chief 

Risk Assessment Branches V /VII 

Health Effects Division (7509P) 

TO: Steven Snyderman, Chemical Review Manager 

Tracy Perry, Team Leader 

Risk Management and Implementation Branch 3 

Pesticide Re-Evaluation Division (7508P) 

The Mancozeb Task Force has submitted comments on the Mancozeb Pre liminary Work Plan for 

Registration Review (Docket No. EPA-HQ-OPP-20 15-0291) (August, 24, 2015 letter). The Health 

Effect's Division (HED) has considered the following Task Force comments pertaining to the HED 

document titled Mancozeb: Human Health Risk Assessment Scoping Document in Support of 

Registration Review (611120 15, 0425216) and provides the following responses: 

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L Market Basket Survey J ustification 

ln response to the Agency's request for justification that the 1989- 1990 ethylene-bis-dithiocarbarnate 

(EBDC) Market Basket (MB) survey remains relevant for refining mancozeb and other EBDC dietary 

assessments, the Mancozeb Task Force maintains that it still is a usable statistical survey. The Task 

Force reiterates the significance of the survey results and states that EBDC usage has not significantly 

increased. However, specific information has not been provided demonstrating the relevancy of the 

older MB survey for use in current assessments. Given the age of the survey, any changes in 

application techniques, typical rates, handling, storage, and transportation could result in incurring 

different residue levels in food today than those reported in the MB survey. To allow for the 

continued use of the MB survey, specific data must be submitted that illustrate that the survey results 

remain representative of present EBDC usage. This would include providing comparisons (across 

time) of typical rates, EBDC usage totals, application techniques/timing, percent crop treated data, 

commercial practices (handling, storage and transportation), and the capabilities of analytical methods 

to detect residues. In the event that the continued use of the MB survey cannot be justified , the 

Agency will rely on residue data from available controlled studies (fie ld trial & processing studies), 

which will likely result in significantly greater risk estimates, until a new survey can be provided. 

2. "Reach The Decision Makers" Policv Brief 

The Task Force states that the Policy Brief from the May 29, 2014 "Reach the Decision Makers" 

(REACH) meeting on mancozeb is not suitable or reliable for risk assessment purposes associated 

with mancozeb. The Task Force expects that the Agency will complete its review of these studies early 

in the registration review process and will concur that the conclusions in the Policy Brief are incorrect. 

The Agency will review the REACH information as part of the registration review process for 

mancozeb and at that time will evaluate whether that information is suitable for incorporation into the 

human health risk assessment. 

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