Document ID: EPA-HQ-OPP-2011-0394-0007
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2012-08-17T04:00Z

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

	OFFICE OF CHEMICAL SAFETY

	AND POLLUTION PREVENTION

  SEQ CHAPTER \h \r 1 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)	  SEQ CHAPTER \h \r 1   SEQ CHAPTER \h
\r 1 

		

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
grapes

5 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

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

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