Cyprodinil Summary of Analytical Chemistry and Residue Data DP#: 402158

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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

OFFICE OF CHEMICAL SAFETY

AND POLLUTION PREVENTION

MEMORANDUM

Date: May 29, 2012

SUBJECT: Cyprodinil. Codex Harmonization Issues with the IR-4 Request for Expansions 

of Existing Crop Group/Representative Commodity Uses to Numerous Crop 

Subgroups.

PC Code: 288202 DP Barcode: 402158

Decision No.: 447576 Registration Nos.: 100-828, 100-953, and 100-1317

Petition No.: 1E7854 Regulatory Action: Amended Section 3

Risk Assessment Type: NA Case No.: 7025

TXR No.: NA CAS No.: 121552-61-2

MRID No.: NA 40 CFR: 180.532

 

FROM: Thurston G. Morton, Chemist

Risk Assessment Branch 4

Health Effects Division (7509P)

THROUGH: Elissa Reaves, PhD., Branch Chief

Risk Assessment Branch 4

Health Effects Division (7509P)

TO: Laura Nollen/Barbara Madden

Risk Integration, Minor Use & Emergency Response Branch

Registration Division (7505P)
Cyprodinil Summary of Analytical Chemistry and Residue Data DP#: 402158

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Executive Summary

HED has been asked to further explain the Codex harmonization issues with regards to 

cyprodinil for PP#1E7854. Following are the crop subgroups which needed further explanation 

on Codex harmonization.

Summary of US and International Tolerances and Maximum Residue Limits 

Commodity1 Tolerance (ppm) /Maximum Residue Limit (mg/kg)

US Codex

Onion, bulb subgroup 3-07A 0.60 0.3 onion, bulb

Caneberry subgroup 13-07A 10 0.5 raspberries, red, black

Small fruit vine climbing subgroup 

13-07F, except fuzzy kiwifruit 2.0 3 grapes5 dried grapes (=currants, raisins and sultanas)

Vegetable, leafy, except brassica, 

subgroup 04A 50

10 lettuce, head, lettuce, leaf

Fruit, pome, group 11-10 1.7 0.05 apple

1 pear

For all crop groups/subgroups except grape (which is the representative commodity for Small 

fruit vine climbing subgroup 13-07F, except fuzzy kiwifruit); the maximum residue in the 

magnitude of the residue studies submitted to the US for support in establishment of tolerances 

was greater than the Codex MRL. For Small fruit vine climbing subgroup 13-07F, except fuzzy

kiwifruit; the agency will harmonize and set a tolerance at 3.0 ppm. Along with the 

establishment of the tolerance for Small fruit vine climbing subgroup 13-07F, except fuzzy

kiwifruit; the tolerance for grape will be revoked. The tolerance for grape, raisin will be 

increased from 3.0 to 5.0 ppm to harmonize with Codex.

The registrant will need to submit a revised Section F stating the following:

Small fruit vine climbing subgroup 13-07F, except fuzzy kiwifruit.........3.0 ppm

Grape, raisin..........................................................................5.0 ppm

In addition, the acute dietary exposure analysis was revised to incorporate the proposed increase 

in tolerances for grape and raisin. The chronic dietary exposure analysis did not need reanalyzed 

since average residues were used. A summary of the revised acute dietary exposure is 

summarized below.

Summary of Acute Dietary Exposure and Risk for Cyprodinil Harmonizing with Codex on Grape and 

Raisin

Population Subgroup aPAD (mg/kg/day) Acute (95th Percentile)

Exposure (mg/kg/day) %aPAD

General U.S. Population

2.0

0.097703 4.9

All Infants (< 1 year old) 0.110128 5.5

Children 1-2 years old 0.164214 8.2

Children 3-5 years old 0.137890 6.9

Children 6-12 years old 0.099019 5.0

Youth 13-19 years old 0.080767 4.0

Adults 20-49 years old 0.093475 4.7

Adults 50+ years old 0.086108 4.3

Females 13-49 years old 0.099964 5.0