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Subsequent to completion of the human health risk assessment entitled Dimethomorph: Human Health Risk Assessment to Support Amended Use on Grapes, Bulb Vegetables, Leafy Brassica Vegetables, and Leafy Vegetables (D387381, 09/15/11), Health Canada’s Pest M anagement Regulatory Agency (PMRA) informed HED that they had an expansion of the same uses for dimethomorph. HED agreed to harmonize with PMRA in/on bulb vegetables (CG3), leafy vegetable except Brassica (CG 4), Brassica vegetables (CG5) and grapes toler ances. Also, the registrant, BASF Corporation requested further clarification/ explanation on the requirement for crop restrictions in cereal crops and a 7

- month rotational crop restriction for soybeans. Conclusions stated here supersede conclusions fr om the 09/15/11 memorandum.

In order to harmonize MRLs with Canada, Isabelle Piolet of PMRA provided inpu t to the Agency in the form of written correspondence dated October 24, 2011 to Tamue Gibson, EPA.

The residue values were entered into the OECD calculator to determine appropriate tolerance

levels . The revised harmonized tolerances are shown in Table A.1. Additionally, a revised dietary assessment was conducted which included the harmonized tolerances.

BASF Corporation ’s request for clarifica tion was provided to the Agency in the form of written correspondence s dated November 4, 2011 and December 23, 2011 from Charlotte Sansom, Team Leader, to Tamue Gibson, EPA. The Agency reviewed BASF ’s request with respect to residue chemistry data issues and has updated the previously generated residue chemistry chapters (D381813, S.Piper, 9/13/11). In summary, the Agency concluded that provided the registrant is willing to amend the proposed label to specify a 30

- day PBI for cereal grains, then

, toleranc es are needed in rotated cereal grain commodities (forage, hay and straw) and recommended that the following tolerances be established:

Wheat

, forage

................................ ...................... 0.15 ppm Wheat

, hay

................................ ......................... 0.15 ppm Wheat

, straw

................................ ......................... 0.4 ppm

EPA 's Chemistry Science Advisory Council ( ChemSAC ) met on February 29, 20 12 to discuss BASF requests that EPA reduce the 7

- month PBI to 1

- month for soybeans and other legume vegetables and/or establish tolerances for inadvertent residues of dimethomorph in soybean/legume forage, straw, and seed similar to wheat, based on the following experimental observations and results from the confined rotational crop, field accumulation studies, and RAC

studies for lima beans. ChemSAC recommended that the label remain at a 7 month plant back

restriction for soybean o ther legume vegetables. To support a proposed 30

- day plantback restriction on the label, limited field rotational crop data for soybean are required (D398565, S. Piper, 3/ 6 /12).

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Updated Regulatory Recommendation

Provided the registrant submits a re vised Section F (see Table 1 ) , there are no human health risks of concern that would preclude the establishment or revision of tolerances for the residue of dimethomorph under 40 CFR 180.493 as follows:

Grape

................................ ................................ ..... 3.0 ppm Grape

, raisin

................................ .......................... 7.0 ppm

Brassica , head and stem, subgroup 5A

................ 6.0 ppm

Brassica , leafy greens, subgroup 5B

................... 30.0 ppm Leafy Vegetable except Brassica

, group 4..

....... 30.0 ppm

Onion

, bulb subgroup 3

- 07A

................................ 0.6 ppm

Onion , green subgroup 3

- 07B

........................... 15.0 ppm

Under 40 CFR 180.493(d) for indirect or inadve rtent residues of dimethomorph:

Wheat

, forage

................................ ...................... 0.15 ppm

Wheat

, hay

................................ ......................... 0.15 ppm

Wheat

, straw

................................ ......................... 0.4 ppm

Label Recommendations

Section B of the labels should be modified to specify a 30

- day plant

- back restriction for cereal grains, and a 7 month plant

- back rest riction for soybean and other legume vegetables ; all other

crops can be planted 12 months after the last application

.

Chronic Dietary Risk Assessment

An acute endpoint was not selected for dimethomorph; therefore, the Agency conducted only a chronic dietary (food and drinking water) exposure and risk assessment. Based on the revised tolerances and assumed 100% crop treated, the c hronic dietary risks ar e not of concern for the U.S. population and all subpopulations. For food and drinking water, the chronic aggregate dietary risk was calculated at 17 % of the cPAD (chronic population adjusted dose). The exposure estimate for the most highly exposed subpo pulation (children 1

- 2 years) is 2 7 % of the

cPAD. See Table 1.

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Table 1 . Summary of Dietary Exposure and Risk for Dimethomorph

Population Subgroup Acute Dietary Chronic Dietary Cancer

Dietary Exposure (mg/kg/day) %

aPAD Dietary

Exposure (mg/kg/day) % cPAD Dietary Exposure (mg/kg/day) Ris

k

General U.S. Population

N/A 0.01 6520 1 7 %

N/A All Infants (< 1 year old) 0.01 2239 1 2 %

Children 1

- 2 years old 0.026 850 27%

Children 3

- 5 years old 0.023 110 2 3 %

Children 6

- 12 years old 0.01 5989 1 6 %

Youth 13

- 19 years old 0.01 2770 1 3 %

Adults 20

- 49 years old 0.01 6295 1 6 %

Adults 50+ years old 0.01 6350 1 6 %

Females 13

- 49 years old 0.01 6042 1 6 %

The population with the highest exposure is in bold.



### References

DP#: D398565 Subject: Addendum to Dimethomorph. Application for Proposed Amended Use on Grapes

(PP# 0F77 51) and the Section 3 Registration Action on the Bulb Vegetables (PP#0F7800 )

, Leafy Brassica Vegetables (PP#0F7800 ) ; and Leafy Vegetables (PP#0F7816). Summary of Analytical Chemistry and Residue Data.

From: S.Piper

To: T. Gibson, M. Waller

Date: 2 / 07 / 1 2

MRIDs: 47700109, 47700113, 47700114, 47700115, 47700105

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Appendix A. Proposed MRLs for Dimethomorph Residues in Plant Commodities

TABLE A.1. Proposed MRLs for Dimethomorph Residues in Plant Commodities

Crop Group Representative

Crops Formulation/ Use Pattern Maximum

Residues (ppm) Individual

OECD

Calculator

MRL (ppm) Previously

Proposed US

MRL New Proposed

US and

Canadian

MRL

Crop Group 3 Dry bulb onion WP (1.6 kg a.i./ha without adjuvant, 0d PHI) 0.28 0.5 0.6 ppm for all crops of crop subgroup

3

- 07A 0.6 ppm

for all crops of

CG 3

- 07 A SC (0.7 kg a.i./ha with adjuvant, 0d PHI) 0.40 0.6

Green onion WP (1.6 kg a.i./ha without

adjuvant, 0d PHI) 1.22 3 15 ppm for all crops of crop subgroup

3

- 07B 15 ppm

for all crops of

CG 3

- 07 B SC (0.7 kg a.i./ha with adjuvant, 0d PHI) 6.60 15

Crop Group 4 Leaf lettuce WP (1.6 kg a.i./ha without adjuvant, 0d PHI) 9.10 20

2 0 ppm for all crops of crop group 4 A

3 0 ppm

for all crops of

CG 4 SC (0.7 kg a.i./ha with adjuvant, 0d PHI) 10.53 20

Head lettuce WP (1.6 kg a.i./ha without

adjuvant, 0d PHI) 6.50 15

SC (0.7 kg a.i./ha with adjuvant, 0d PHI) 4.10 7

Spinach WP (1.6 kg a.i./ha without

adjuvant, 7d PHI) 10.10 Summary table only provided

and raw data of poor quality;

Use cannot be supported 15 ppm for

leaf petioles

4B SC (0.7 kg a.i./ha with adjuvant, 0d PHI) 11.47 30

Celery WP

- No data

-- Use cannot be supported SC (0.7 kg a.i./ha with adjuvant, 0d PHI) 8.82 15

Crop Group 5 Cabbage WP (1.6 kg a.i./ha without adjuvant, 7d PHI) 0.69 1.5

5.0 ppm for all crops of crop subgroup

5A 6.0 ppm

for all crops subgroup 5A SC (0.7 kg a.i./ha with adjuvant, 0d PHI) 4.61 6

Broccoli WP (1.6 kg a.i./ha without

adjuvant, 7d PHI) 0.52 0.9

SC (0.7 kg a.i./ha with adjuvant, 0d PHI) 2. 62 (1d PHI) 4

Mustard Green WP

- No data

-- Use cannot be supported 30 ppm

for all crops of crop subgroup

5B 3 0 ppm

for all crops of

5B SC (0.7 kg a.i./ha with adjuvant, 0d PHI) 19.25 30

SC (0.7 kg a.i./ha with adjuvant, 4d PHI) 0.42 0.6

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TABLE A.1. Proposed MRLs for Dimethomorph Residues in Plant Commodities

Crop Group Representative

Crops Formulation/ Use Pattern Maximum

Residues (ppm) Individual

OECD

Calculator

MRL (ppm) Previously

Proposed US

MRL New Proposed

US and

Canadian

MRL

Grape SC

- dilute spray (0.9 kg

a.i./ha with adjuvant, 14d

PHI) 1.86 3 4.0 ppm for all crops of crop subgroup

13

- 07F

(already registered

on the Acrobat

WP at a rate of 0.9 kg a.i./ha and a 7d PHI, MRL of 1.5 ppm) 3.0 ppm

for grapes

SC

– concentrated spray (0.9 kg a.i./ha with adjuvant, 14d PHI) 1.83 3

Raisin SC (0.9 kg a.i./ha with

adjuvant, 14d PHI) HAFT x PF = 1.86 x 3.8 = 7.068 ppm 6.0 ppm for

raisins 7 ppm

for raisins

Inadvertent Tolerances (for rotational crops)

Wheat

, forage WP (1. 4 lb a.i.

, 23

- 52 d PHI) 0.06 0.15

-- 0.15 ppm for wheat forage SC (0. 68 kg a.i./ha with adjuvant , 30

- 120 d PHI) 0.03 0.06

--

Wheat

, hay WP (1. 4 lb a.i.

, 23

- 52 d PHI) <0.05 0.15

-- 0.15 ppm for wheat hay SC (0. 68 kg a.i./ha with adjuvant , 30

- 120 d PHI) 0.05 0.15

--

Wheat

, straw WP (1. 4 lb a.i.

, 23

- 52 d PHI) 0.07 0.15

-- 0.4 ppm for

wheat straw SC (0. 68 kg a.i./ha with adjuvant , 30

- 120 d PHI) 0.20 0.4

--