Mandipropamid Summary of Analytical Chemistry and Residue Data DP Barcode D409363

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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, DC 20460

OFFICE OF CHEMICAL SAFETY AND

POLLUTION PREVENTION

MEMORANDUM

DATE: 27 August 2013

SUBJECT: Mandipropamid. Petition to Establish Permanent Tolerances (and Section 3 

Registration) for Residues Resulting from Use of the Fungicide on Basil, 

Succulent Beans, Cowpea Forage, Ginseng and Greenhouse Tomatoes; to Update 

Fruiting Vegetables Group 8 to Group 8-10; to Extend the Tolerance in Grapes to 

Subgroup 13-07F, the Tolerance in Dry Bulb Onions to Subgroup 3-07A, and the 

Tolerance in Green Onions to Subgroup 3-07B. Summary of Analytical 

Chemistry and Residue Data. 

PC Code: 036602 DP Barcode: D409363

Decision Number: 472747 Registration Number: 100-1254

Petition: 2E8126 Regulatory Action: Section 3

Risk Assessment Type: NA Case Number: 7058

TXR Number: NA CAS Number: 374726-62-2

MRID Numbers: 48992001-04 40 CFR: §180.637

FROM: William T. Drew, Chemist

Risk Assessment Branch II (RAB2)

Health Effects Division (HED), 7509P

THRU: Dennis McNeilly, Chemist

Michael A. Doherty, PhD, Senior Chemist

RAB2/HED, 7509P

TO: Barbara Madden and Laura Nollen, RM Team 5

Risk Integration, Minor Use, and Emergency Response Branch (RIMUERB)

Registration Division (RD), 7505P
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Table of Contents

1.0 Executive Summary.............................................................................................................. 4

2.0 Regulatory Recommendations.............................................................................................. 7

2.1 Data Deficiencies/Data Needs .......................................................................................... 8

2.2 Tolerance Considerations.................................................................................................. 8

2.2.1 Enforcement Analytical Method/Multiresidue Methods.......................................... 8

2.2.2 Recommended Tolerances........................................................................................ 9

2.2.3 Revisions to Petitioned-For Tolerances.................................................................... 9

2.2.4 International Harmonization ..................................................................................... 9

2.3 Label Recommendations................................................................................................ 10

2.4 Submittal of Analytical Reference Standards (860.1650) ............................................. 10

3.0 Chemical Identity............................................................................................................... 11

3.1 Nomenclature................................................................................................................. 11

3.2 Physicochemical Characteristics.................................................................................... 12

3.3 Pesticide Use Pattern/Directions for Use (860.1200) .................................................... 12

4.0 Metabolite/Degradate Residue Profile............................................................................... 13

4.1 Nature of the Residue..................................................................................................... 13

4.1.1 Summary of Plant and/or Livestock Metabolism (860.1300)................................. 14

4.1.2 Summary of Confined Rotational Crops (860.l850)............................................... 14

4.1.3 Summary of Rat Metabolism.................................................................................. 15

4.1.4 Summary of Environmental Degradation ............................................................... 15

5.0 Residue Profile................................................................................................................... 16

5.1 Residue Analytical Methods (860.1340) ...................................................................... 16

5.1.1 Data Collection Methods ........................................................................................ 16

5.1.2 Multi-Residue Methods (860.1360)........................................................................ 21

5.1.3 Tolerance Enforcement Methods............................................................................ 21

5.2 Storage Stability (860.1380).......................................................................................... 21

5.3 Residue Data .................................................................................................................. 24

5.3.1 Crop Field Trials (860.1500) .................................................................................. 24

5.3.2 Field Rotational Crops (860.1900) ......................................................................... 27

5.3.3 Processed Food and Feed (860.1520)..................................................................... 27
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5.3.4 Meat, Milk, Poultry and Eggs (860.1480) .............................................................. 28

5.3.5. Food Handling (860.1460)...................................................................................... 28

5.3.6 Water, Fish and Irrigated Crops (860.1400)........................................................... 28

5.4 Food Residue Profile...................................................................................................... 28

6.0 Tolerance Derivation ......................................................................................................... 29

References..................................................................................................................................... 30

Attachment 1: International Residue Limit Status....................................................................... 32

Attachment 2: OECD MRL (Tolerance) Assessment Calculations............................................. 33
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1.0 Executive Summary

Mandipropamid (with CAS name 4-chloro-N-[2-[3-methoxy-4-(2-propynyloxy)phenyl]ethyl]-α-

(2-propynyloxy)benzeneacetamide, and CAS number 374726-62-2) is a fungicide in the 

mandelamide class developed by Syngenta Crop Protection for the control of foliar oomycete 

pathogens in a range of crops including Plasmopara viticola in grapes, Phytophthora infestans in 

potatoes and tomatoes, and Pseudoperonospora cubensis in cucurbits. The previous residue 

chemistry summary document for mandipropamid was completed in conjunction with its 

registration for use on hops and tobacco (D348229, D352322; D. Rate; 11 December 2008). 

Permanent tolerances are established for residues of mandipropamid in or on a variety of plant 

commodities, at levels ranging from 0.03 ppm in wet potato peels, to 50 ppm in dried hops cones 

(40CFR §180.637[a]). Time-limited tolerances (associated with Section 18 emergency

exemptions) are established for residues of mandipropamid in fresh and dried basil (40CFR 

§180. 637[b]); these tolerances expire on 31 December 2015. 

The Interregional Research Project Number 4 (IR-4) has submitted a petition requesting new 

uses on basil, ginseng, succulent beans, and greenhouse tomatoes. In conjunction with the 

requested new uses, IR-4 has proposed the establishment of permanent tolerances for residues of 

mandipropamid in/on the following raw agricultural commodities (RACs) and dried basil, at the 

tolerance levels listed: 

Basil, fresh............................................................30 ppm

Basil, dried.........................................................200 ppm

Bean, succulent...................................................0.90 ppm

Ginseng.............................................................0.3 ppm

Cowpea, forage.....................................................15 ppm

Vegetable, fruiting, group 8-10...................................1.0 ppm

Fruit, small, vine climbing, subgroup 13-07F, 

except fuzzy kiwifruit..............................................2.0 ppm

Onion, bulb, subgroup 3-07A.....................................0.1 ppm

Onion, green, subgroup 3-07B....................................7.0 ppm

The proposed tolerances in fresh and dried basil, succulent beans, ginseng, and cowpea forage 

are based on crop field trial data entered into the Organization for Economic Development and 

Cooperation’s (OECD’s) tolerance calculation procedure. Upon establishment of the permanent 

tolerances in fresh and dried basil (40CFR §180.637[a]), the time-limited tolerances in fresh and 

dried basil (40CFR §180.637[b]) would be removed. 

The proposed tolerance in fruiting vegetables (group 8-10) is based on updating the current 

tolerance in fruiting vegetables (group 8). The tolerance of 1.0 ppm would match the existing 

Codex (bell and non-bell peppers) and Canadian (tomatoes, okra, eggplant and peppers) 
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maximum residue limits (MRLs). Upon establishment of the tolerance in group 8-10, the 

existing tolerances in group 8 and okra would be removed. 

The proposed tolerance in small vine climbing fruits except fuzzy kiwifruit (subgroup 13-07F) is 

based upon existing data for grapes (the representative commodity for the subgroup), and 

increasing the current tolerance (1.4 ppm) to harmonize with the existing Codex MRL in grapes. 

Upon establishment of the tolerance in subgroup 13-07F, the existing tolerance in grapes would 

be removed. 

The proposed tolerance in bulb onions (subgroup 3-07A) is based upon existing data for dry bulb 

onions (the representative commodity for the subgroup), and increasing the current tolerance

(0.05 ppm) to harmonize with the existing Codex MRL in bulb onions. Upon establishment of 

the tolerance in subgroup 3-07A, the existing tolerance in dry bulb onions would be removed. 

The proposed tolerance in green onions (subgroup 3-07B) is based upon existing data for green 

onions (the representative commodity for the subgroup), and increasing the current tolerance (4

ppm) to harmonize with the existing Codex MRL in spring onions. Upon establishment of the 

tolerance in subgroup 3-07B, the existing tolerance in green onions would be removed. 

This summary document addresses the data submitted in support of the proposed tolerances for 

residues of mandipropamid in the various commodities listed above. 

Crop Field Trials: To support the requested uses, field trials were conducted on basil (along 

with 2 greenhouse trials), ginseng, and snap beans, and greenhouse trials were conducted on 

tomatoes. 

IR-4 has submitted basil field and greenhouse trial data with mandipropamid. Four field trials 

were conducted in Canada and the US in North American Free Trade Agreement (NAFTA) 

Growing Zones 2 (1 trial in NC), 5A (1 trial in WI), 10 (1 trial in CA) and 11 (1 trial in BC) 

during the 2009 growing season, and two greenhouse trials were conducted in the US in Zones 2 

(1 trial in MD) and 3 (1 trial in FL) during the 2009 and 2010 growing seasons. Following 4 

foliar directed applications of the Revus 2.08SC formulation, containing 2.08 pounds of active 

ingredient per gallon (lb ai/gal), at a total seasonal rate of 0.520-0.528 lb ai per acre (lb ai/A), to 

basil plants (stems and leaves) harvested at a pre-harvest interval (PHI) of 1 day, mandipropamid 

residues ranged from 3.5 ppm to 19 ppm in fresh basil, and 36 ppm to 91 ppm in dried basil 

grown in the field and greenhouse. The adequate basil field trial data support a tolerance of 30 

ppm in fresh basil, and a tolerance of 200 ppm in dried basil. 

Four ginseng field trials were conducted in Canada and the US in NAFTA Growing Zones 5A (3 

trials in WI) and 11 (1 trial in BC) during the 2008 growing season. Following 4 foliar broadcast

applications of the Revus 2.08SC formulation, at a total seasonal rate of 0.521-0.547 lb ai/A, to 

ginseng plants harvested at a PHI of 2 days, mandipropamid residues ranged from 0.0222 ppm to 

0.167 ppm in dried ginseng roots. There were no quantifiable residues (<0.005 ppm) of 
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metabolite SYN500003 in any of the dried root samples. The adequate ginseng field trial data 

support a tolerance of 0.30 ppm in dried ginseng roots. 

Ten snap bean field trials were conducted in the US in NAFTA Growing Zones 1 (1 trial in NY), 

2 (1 trial in MD and 1 trial in GA), 3 (1 trial in FL), 5 (1 trial in OH), 5A (1 trial in MI and 1 trial 

in WI), 10 (2 trials in CA) and 11 (1 trial in WA) during the 2010 growing season. Following 4 

foliar broadcast or directed applications of the Revus 2.08SC formulation, at a total seasonal rate 

of 0.490-0.540 lb ai/A, to snap bean plants harvested at a PHI of 1 day, mandipropamid residues 

ranged from 0.0858 ppm to 0.761 ppm in pods with seed, and 1.24 ppm to 9.84 ppm in plants 

with pods. The adequate snap bean field trial data support a tolerance of 0.90 ppm in snap beans. 

The submitted snap bean data do not support the proposed tolerances in all succulent beans or

cowpea forage (see Section 2.1, below). 

Four tomato greenhouse trials were conducted in the US in NAFTA Growing Zones 2 (1 trial in 

MD), 4 (1 trial in AR), 5 (1 trial in WI) and 10 (1 trial in CA) during the 2010 growing season. 

Following 4 (5 at trial site 10-AR05) foliar broadcast or directed applications of the Revus 

2.08SC formulation, at a total seasonal rate of 0.480-0.651 lb ai/A, to tomato plants harvested at 

a PHI of 1 day, mandipropamid residues ranged from 0.045 ppm to 0.339 ppm in tomato fruit. 

The adequate greenhouse trial data support the proposed use on greenhouse tomatoes, at a 

tolerance of 0.60 ppm (based on the OECD tolerance calculation procedure), which is covered by 

the proposed tolerance of 1.0 ppm in fruiting vegetables group 8-10. 

Processing Studies: Because there are no processed commodities for ginseng or succulent beans, 

processing studies are not required for these RACs. The processed commodity for basil is dried 

basil, samples of which were produced at the field trial sites, and subsequently analyzed along 

with the fresh basil samples. A processing study is not needed for tomatoes, as this requirement 

was addressed in a previous summary document (D328534, D337543; D. McNeilly; 28 August 

2007). 

Residue Analytical Methods: There is an adequate enforcement method available for the 

quantitation of mandipropamid in plant commodities. The Food and Drug Administration (FDA)

multiresidue methods are not adequate for determining residues of mandipropamid. 

Storage Stability: Adequate storage stability data are available to support the storage durations 

and conditions of samples from the submitted field trial studies. 

Meat, Milk, Poultry and Eggs: Because the proposed tolerance in cowpea forage cannot be 

established at this time, the current action for the proposed new uses will not result in the need 

for tolerances in livestock commodities (see Section 2.1, below). 

MRL Harmonization: Neither Codex nor Canada’s Pest Management Regulatory Agency

(PMRA) have established MRLs for mandipropamid in any of the commodities associated with 

the proposed new uses. As such, there are no harmonization issues associated with Codex for the 
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proposed new uses in the current action. However, PMRA and EPA are jointly reviewing the 

basil, ginseng and snap bean data in the current action; EPA and PMRA are harmonized on the 

recommended tolerances/MRLs in fresh basil, dried basil, and ginseng. PMRA is establishing an 

MRL in edible-podded beans at 0.9 ppm, while HED is recommending for a tolerance in snap 

beans at 0.90 ppm. Although the tolerance/MRL level is harmonized, HED cannot harmonize 

with PMRA on the commodity definition, as the submitted snap bean data do not support use on 

all succulent beans, since no data were submitted for a succulent shelled bean, and do not meet

the requirements of subgroup 6A, since no data were submitted for an edible-podded pea. 

Both the current tolerance in group 8 (1.0 ppm) and the proposed tolerance in group 8-10 (1.0

ppm) are harmonized with the Codex (bell and non-bell peppers) and PMRA (tomatoes, okra, 

eggplant and peppers) MRLs. The proposed tolerance of 2.0 ppm in subgroup 13-07F, translated 

from grape data, would be harmonized with the Codex MRL in grapes, but would no longer be 

harmonized with PMRA’s MRL of 1.4 mg/kg in grapes. The proposed tolerance of 0.1 ppm in 

subgroup 3-07A, translated from dry bulb onion data, would be harmonized with the Codex 

MRL in bulb onions, but would no longer be harmonized with PMRA’s MRL of 0.05 ppm in 

various bulb onions. The proposed tolerance of 7.0 ppm in subgroup 3-07B, translated from 

green onion data, would be harmonized with the Codex MRL in spring onions, but would no 

longer be harmonized with PMRA’s MRL of 4 ppm in various green onions. 

2.0 Regulatory Recommendations

HED has examined the residue chemistry database for mandipropamid. Pending submission of a 

revised Section F (to propose tolerance levels in accordance with those recommended by HED, 

and to correct some of the commodity definitions), there are no residue chemistry issues that 

would preclude establishing tolerances in the requested basil and ginseng commodities, and in 

the updated/expanded crop groups and subgroups. However, the submitted snap bean data do 

not support the proposed tolerances in succulent beans or cowpea forage (see Section 2.1, 

below). The recommended tolerances are listed in Table 2.2.2, below. 

Note to RD: Concurrent with the establishment of permanent tolerances in fresh and dried basil 

(40CFR §180.637[a]), the paragraph referring to, and the table containing, the time-limited 

tolerances in fresh and dried basil (40CFR §180.637[b]) should be removed, and replaced with 

“[Reserved]”. 

Concurrent with the establishment of the tolerance in group 8-10, the existing tolerances in group 

8 and okra should be removed (40CFR §180.637[a]). 

Concurrent with the establishment of the tolerance in subgroup 13-07F, the existing tolerance in 

grapes should be removed (40CFR §180.637[a]). 
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Concurrent with the establishment of the tolerance in subgroup 3-07A, the existing tolerance in 

dry bulb onions should be removed (40CFR §180.637[a]). 

Concurrent with the establishment of the tolerance in subgroup 3-07B, the existing tolerance in 

green onions should be removed (40CFR §180.637[a]). 

Note to RD: According to HED’s Interim Guidance on Tolerance Expressions (S. Knizner; 27 

May 2009), the tolerance expression for mandipropamid cited in 40CFR §180.637[a] should be 

revised to state: 

Tolerances are established for residues of mandipropamid, including its 

metabolites and degradates, in or on the commodities listed in the table below. 

Compliance with the tolerance levels specified below is to be determined by 

measuring only mandipropamid (4-chloro-N-[2-[3-methoxy-4-(2-

propynyloxy)phenyl]ethyl]-α-(2-propynyloxy)benzeneacetamide) in or on the 

commodity. 

2.1 Data Deficiencies/Data Needs

HED’s Chemistry Science Advisory Council (ChemSAC) has determined that the submitted 

snap bean data do not support the proposed tolerances in succulent beans and cowpea forage

(ChemSAC meeting; 17 July 2013). Additional field trial data on a succulent shelled bean 

cultivar (such as lima beans) would be necessary in order to establish a tolerance in all succulent 

beans. Because of the possibility of detectable residues occurring in dairy cattle commodities 

(fat, milk and liver) arising from the feeding of treated cowpea forage, the concurrent 

establishment of mandipropamid tolerances at the limit of quantitation (LOQ) in those 

commodities would be necessary. However, with no validated analytical method for enforcing 

tolerances in livestock commodities, it is not possible to establish tolerances in them. Ergo, the 

proposed tolerance in cowpea forage cannot be established until a validated method for 

determining mandipropamid residues in livestock (cattle) commodities is available. Also, if uses 

on additional significant livestock feed items are requested in any future petition, a livestock 

feeding study will be required. 

2.2 Tolerance Considerations

2.2.1 Enforcement Analytical Method/Multiresidue Methods

There is an adequate enforcement method available for the quantitation of mandipropamid in 

plant commodities. Method RAM 415/01, using high performance liquid chromatography with 

tandem mass spectrometric detection (LC/MS/MS), has been adequately validated by an 

independent laboratory. It has a validated LOQ of 0.01 ppm. An acceptable confirmatory

method is also available. 
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The FDA Multiresidue methods are not adequate for determining residues of mandipropamid. 

2.2.2 Recommended Tolerances

TABLE 2.2.2 Tolerance Summary for Mandipropamid.

Commodity as Proposed by 

Registrant

Proposed 

Tolerance (ppm)

Recommended 

Tolerance (ppm)

Comments; Correct Commodity

Definition

Basil, fresh 30 30 Basil, fresh leaves

Basil, dried 200 200 Basil, dried leaves

Bean, succulent 0.90 None Field trial data on a succulent 

shelled bean cultivar is needed. 

Bean, snap None 0.90 The snap bean field trials support 

the establishment of this tolerance. 

Ginseng 0.3 0.30

Cowpea, forage 15 None A validated method for residues in 

cattle commodities is needed. 

Vegetable, fruiting, group 8-10 1.0 1.0

Fruit, small, vine climbing, subgroup 

13-07F, except fuzzy kiwifruit

2.0 2.0 Fruit, small, vine climbing, except 

fuzzy kiwifruit, subgroup 13-07F

Onion, bulb, subgroup 3-07A 0.1 0.10

Onion, green, subgroup 3-07B 7.0 7.0

2.2.3 Revisions to Petitioned-For Tolerances

Instead of the proposed tolerance in ginseng (0.3 ppm), HED recommends establishing the 

tolerance at 0.30 ppm, in order to avoid the situation where a field sample containing residues 

significantly above the tolerance (0.34 ppm, for example) would be considered non-violative. 

For the same reason, HED recommends that the proposed tolerance of 0.1 ppm in bulb onions 

(subgroup 3-07A) be revised to 0.10 ppm. 

For the reasons discussed in Section 2.1 (above), the proposed tolerances in succulent beans and 

cowpea forage cannot be established. However, the snap bean field trials support a tolerance of 

0.90 ppm in snap beans. 

2.2.4 International Harmonization

Neither Codex nor PMRA have established MRLs for mandipropamid in any of the commodities 

associated with the proposed new uses. As such, there are no harmonization issues associated 

with Codex for the proposed new uses in the current action. However, PMRA and EPA are 

jointly reviewing the basil, ginseng and snap bean data in the current action; EPA and PMRA are 

harmonized on the recommended tolerances/MRLs in fresh basil, dried basil, and ginseng. 

PMRA is establishing an MRL in edible-podded beans at 0.9 ppm, while HED is recommending 

for a tolerance in snap beans at 0.90 ppm. Although the tolerance/MRL level is harmonized, 

HED cannot harmonize with PMRA on the commodity definition, as the submitted snap bean 

data do not support use on all succulent beans, since no data were submitted for a succulent 
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shelled bean, and do not meet the requirements of subgroup 6A, since no data were submitted for 

an edible-podded pea. 

Both the current tolerance in group 8 (1.0 ppm) and the proposed tolerance in group 8-10 (1.0 

ppm) are harmonized with the Codex (bell and non-bell peppers) and PMRA (tomatoes, okras 

and peppers) MRLs. The proposed tolerance of 2.0 ppm in subgroup 13-07F, translated from 

grape data, would be harmonized with the Codex MRL in grapes, but would no longer be 

harmonized with PMRA’s MRL of 1.4 mg/kg in grapes. The proposed tolerance of 0.1 ppm in 

subgroup 3-07A, translated from dry bulb onion data, would be harmonized with the Codex 

MRL in bulb onions, but would no longer be harmonized with PMRA’s MRL of 0.05 ppm in 

various bulb onions. The proposed tolerance of 7.0 ppm in subgroup 3-07B, translated from 

green onion data, would be harmonized with the Codex MRL in spring onions, but would no 

longer be harmonized with PMRA’s MRL of 4 ppm in various green onions. 

2.3 Label Recommendations

Because the submitted snap bean data do not support the proposed use on all succulent beans, the 

label section containing directions for the requested use on succulent beans (“Bean, succulent”) 

should instead refer only to snap beans (“Bean, snap”), and the listing of all other succulent bean 

commodities should be deleted from the proposed label. The requested use on greenhouse 

tomatoes listed in the proposed label is supported by the submitted greenhouse trial data.

2.4 Submittal of Analytical Reference Standards (860.1650)

The analytical standard for mandipropamid, with an expiration date of 30 July 2016, is 

currently available in the EPA’s National Pesticide Standards Repository (NPSR), per Email

communication from Theresa Cole of the Biological and Economic Analysis Division’s 

(BEAD’s) Analytical Chemistry Branch (ACB) on 25 June 2013. The registrant is required to 

maintain reasonable amounts of the analytical reference standard for mandipropamid. The 

mandipropamid metabolite, SYN 500003, is not in stock. However, as this metabolite is not 

included in the tolerance expression, it is not required to be stocked in the NPSR. When 

necessary, a new reference standard, or updated certificate of analysis (COA), should be sent to 

the ACB, which is located at Fort Meade, MD. It should be sent to the attention of either 

Theresa Cole or Thuy Nguyen at the address listed below, along with a letter of transmittal. 

Please note that the full 9-digit ZIP Code is required, or the mail will be returned to the 

registrant. 

USEPA

National Pesticide Standards Repository

Analytical Chemistry Branch/BEAD/OPP

701 Mapes Road

Fort George G. Meade, MD 20755-5350
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The letter of transmittal should include the assay of the standard, name of the analytical method 

used, a statement of principal impurities, purification procedures employed, storage 

requirements, and special precautions for safe handling. Replacement of standards may be 

required periodically if supplies are exhausted, if the standards expire, or if decomposition 

occurs during storage. Material Safety Data Sheets (MSDSs) must accompany all analytical 

standards as specified by the Occupational Safety and Health Administration (OSHA) in 

29CFR§1910.1200. 

3.0 Chemical Identity

Mandipropamid is a mandelamide and belongs to the chemical family of the carboxylic acid 

amides (CAA) or, more specifically, the mandelic acid amides. It was developed by Syngenta 

for the control of foliar oomycete pathogens in a range of crops including Plasmopara viticola in 

grapes, Phytophthora infestans in potatoes and tomatoes, and Pseudoperonospora cubensis in 

cucurbits. Mandipropamid is also used on leafy vegetables to control downy mildew (Bremia 

lactucae) and blue mold (Peronospora effuse). The biochemical mode of action of 

mandipropamid is not fully known. However, preliminary results indicate that it inhibits the 

biosynthesis of phospholipids (phosphatidyl choline, lecithin). Based on a review of its 

chemistry, resistance profile, and toxicological attributes, mandipropamid is mechanistically 

unique, and its mode of action is different from other fungicides, including those within the CAA 

group. The chemical structure and nomenclature of mandipropamid are listed in Table 3.1, and 

its physicochemical properties are presented in Table 3.2 (below). 

3.1 Nomenclature

TABLE 3.1 Mandipropamid Nomenclature.

Compound

Common name Mandipropamid

Company experimental name NOA 446510

Molecular formula C23H22ClNO4

Molecular weight 411.88

IUPAC name (RS)-2-(4-chloro-phenyl)-N-[2-(3-methoxy-4-prop-2-ynyloxy-phenyl)-ethyl]-2-

prop-2-ynyloxy-acetamide

CAS name 4-chloro-N-[2-[3-methoxy-4-(2-propynyloxy)phenyl]ethyl]-α-(2-propynyloxy)-

benzeneacetamide

Cl

O

HC

O

N

H

O

CH3

O

CH
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TABLE 3.1 Mandipropamid Nomenclature.

CAS registry number 374726-62-2

End-use product (EP) Revus 2.08SC Fungicide (2.08 lb ai/gal; EPA Registration #100-1254)

3.2 Physicochemical Characteristics

TABLE 3.2 Physicochemical Properties of Mandipropamid.

Parameter Value Reference

Melting point/range (oC) 96.4-97.3 MRID #46800006 (100-

REIR.doc; S. Mathur; 22 

May 2007)

pH (at 25oC in a 1% aqueous dispersion) 6-8

Density (g/cm3at 22oC) 1.24

Water solubility (mg/L at 25oC) 4.2

Solvent solubility (g/L at 25oC) n-hexane 0.042

n-octanol 4.8

toluene 29

methanol 66

ethyl acetate 120

acetone 300

dichloromethane 400

Vapor pressure (Pa [mm Hg] at 25oC) <9.4 x 10-7[<7.1 x 10-9]

Dissociation constant, pKa No dissociation in the pH range of 1 to 12

Octanol/water partition coefficient (Log 

[KOW] at 25oC)

3.3

UV/visible absorption spectrum Molar absorption coefficients for the 

absorbance maximums were: 

Neutral solution

20,144 L/mol cm at 223 nm

2,724 L/mol cm at 276 nm

Acidic solution

20,313 L/mol cm at 223 nm

2,845 L/mol cm at 276 nm

Basic solution

19,414 L/mol cm at 223 nm

2,864 L/mol cm at 276 nm

Mandipropamid is a solid under ambient conditions, and has very low volatility. The compound 

has a relatively low solubility in water, and moderate to high solubility in organic solvents. Its 

octanol/water partition coefficient suggests that accumulation of mandipropamid in fatty tissues 

is possible. 

3.3 Pesticide Use Pattern/Directions for Use (860.1200)

IR-4 has requested that new Section 3 uses of the fungicide mandipropamid be added to the label 

for Revus 2.08SC (EPA Registration #100-1254). The proposed new uses would be for the 

treatment of basil, ginseng, succulent beans, and greenhouse tomatoes. Revus 2.08SC is a 

suspension concentrate (SC) formulation containing 23.3% ai by weight, which is equivalent to
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2.08 lb ai/gal. An example of the proposed label for Revus 2.08SC was provided, and the

proposed use directions therein are summarized in Table 3.3, below. 

TABLE 3.3 Summary of Proposed Directions for Use of Mandipropamid. 

Application Type; 

Equipment1

Use 

Rate

(lb ai/A)

Max. Uses 

Per Season

Max. Seasonal 

Use Rate

(lb ai/A)

PHI2

(Days)

Use Directions, Application Timing, 

and Limitations3

Basil

Foliar; any ground 

or aerial equipment.

0.09 -

0.13

4 0.52 1 RTI4of 7-10 days. 

Ginseng

Foliar; any ground 

or aerial equipment.

0.09 -

0.13

4 0.52 2 RTI of 7-10 days. 

Succulent Beans

Foliar; any ground 

or aerial equipment.

0.09 -

0.13

4 0.52 1 RTI of 7-10 days. 

Greenhouse Tomatoes

Foliar; any ground 

or aerial equipment.

0.09 -

0.13

4 0.52 1 RTI of 7-10 days. May be applied via 

chemigation. 

1. For ground application, apply in a minimum of 10 gallons of water per acre (GPA), unless specified otherwise on 

the label. Do not apply through any ultra-low volume (ULV) spray system. For aerial application, use only 

on crops where aerial applications are indicated. Apply in a minimum of 5 GPA, unless specified 

otherwise on this label. Do not apply through any ULV spray system. For chemigation, use only on crops 

where chemigation is specified on the label. Apply no more than 2 sequential applications unless otherwise 

stated in the crop-specific section. Do not use in transplant production. 

2. PHI = Pre-Harvest Interval. 

3. Begin applications prior to disease development. Use the shorter interval and/or higher rates under high pressure, 

or when conditions are conducive to disease. The addition of a spreading/penetrating type adjuvant such as 

a non-ionic based surfactant (NIS) or crop oil concentrate (COC) or blend is recommended. 

4. RTI = Re-Treatment Interval. 

Conclusions: The proposed use directions for application to basil, ginseng, succulent beans, and 

greenhouse tomatoes are sufficient to allow for evaluation of the submitted residue data relative 

to the proposed use patterns. However, as the submitted snap bean data do not support the 

proposed use on succulent beans, the label section containing directions for use on succulent 

beans (“Bean, succulent”) should instead refer to snap beans (“Bean, snap”), and the listing of all 

other succulent bean commodities in that section should be deleted. 

4.0 Metabolite/Degradate Residue Profile

4.1 Nature of the Residue

D328534, D337543; D. McNeilly; 28 August 2007

The nature of the residue in plants, rotational crops, and ruminants is adequately understood. For 

the purposes of tolerance enforcement and risk assessment, the terminal residue of concern 

(ROC) in primary crops, rotational crops, and ruminants is the parent mandipropamid, with the 
Mandipropamid Summary of Analytical Chemistry and Residue Data DP Barcode D409363

Page 14 of 38

exception of root and tuber vegetables, where the metabolite SYN 500003 is included for risk 

assessment. 

4.1.1 Summary of Plant and/or Livestock Metabolism (860.1300)

Data have been submitted and reviewed depicting the metabolism/degradation of mandipropamid

in numerous crops and the environment. HED has determined the plant and livestock ROCs for 

purposes of tolerance enforcement and risk assessment; see Table 4.1.1, below. 

Table 4.1.1 Summary of Mandipropamid Metabolites and Degradates to be included in the Risk 

Assessment and Tolerance Expression.

Matrix Residues Included in Risk 

Assessment

Residues Included in 

Tolerance Expression

Plants Primary crops (except root and tuber 

vegetables)

Mandipropamid Mandipropamid

Root and tuber vegetables Mandipropamid and SYN 500003 Mandipropamid

Rotational crops Not applicable Mandipropamid*

Livestock Ruminants Not applicable Not applicable

Poultry Not applicable Not applicable

Drinking water Mandipropamid, SYN 504851 and 

SYN 500003

Not applicable

*Although the parent compound is a ROC in rotational crops, tolerances are not needed for the present uses, based 

on the absence of residues in the field rotational crop study following the 30 day plant-back interval (PBI) 

stipulated on the label.

Conclusions: The nature of the residue in plants and animals has been adequately delineated. 

4.1.2 Summary of Confined Rotational Crops (860.l850)

D328534, D337543; D. McNeilly; 28 August 2007

An acceptable confined rotational crop study was reviewed in Petitions #6F7057 and #7F7184. 

In this study, the extent and nature of the residue uptake by crops planted 29, 58, 120, and/or 365 

days post-application in soil treated with [chlorophenyl14C]-mandipropamid or [methoxyphenyl14C]-mandipropamid at 0.806-0.832 lb ai/A was determined. Total radioactive residues 

accumulated at ≥0.01 ppm in all rotated crop matrices except radish roots and tops planted at the 

120-day PBI, and lettuce, wheat forage, and wheat grain (chlorophenyl label only) planted at the 

365-day PBI. The distribution and nature of the residue in the rotated crops was similar between 

the two radiolabels. The parent mandipropamid was identified at low levels. Unchanged parent 

was detected at a level greater than 0.01 ppm only in wheat straw (≤0.023 ppm), but was less 

than 0.01 ppm in lettuce, radish root, radish top, wheat forage, and wheat grain. Two other 

residue components, CGA 380778 and NOA 458422, were also detected at low levels. 

Metabolite CGA 380778 was identified at ≤0.006 ppm in lettuce, radish roots and tops, wheat 

forage, and wheat straw. Metabolite NOA 458422 was identified only in wheat straw at 0.008-

0.016 ppm. 
Mandipropamid Summary of Analytical Chemistry and Residue Data DP Barcode D409363

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The study results showed that mandipropamid is extensively metabolized in rotational crops via 

pathways similar to that in primary crops. The principal metabolic routes include the removal of 

either or both of the propargyl side chains to generate the corresponding alcohol or phenol 

functionalities. Extensive metabolism may occur, yielding small carbon units, followed by

incorporation into natural plant constituents (such as cellulose, glucose, proteins, pectins and 

lignin) or, alternatively, some radioactive components may become covalently bound to 

macromolecules in the plant. 

4.1.3 Summary of Rat Metabolism

Risk Assessment Document D365918; D. Rate; 8 June 2009 (PP#8F7342)

In rat metabolism studies, [14C]-mandipropamid, as single oral or repeated oral methoxy or 

methoxy/chloro radiolabels, was administered to Wistar-derived rats. To examine biliary

excretion, bile duct cannulation was performed. After 48 hours, absorption was 67-74% at 3 

mg/kg, and 30-45% at 300 mg/kg. Blood Tmax at 3 mg/kg was 8.5 hours for males, and 4.5 hours 

for females; at 300 mg/kg it was 24 hours for males, and 10 hours for females. The rate of 

resorption was greater in females; the extent and rate of absorption was greater in the low dose 

animals. Recoveries at 168 hours were 88-99%, with most being eliminated by 48 hours. 

Excluding the females dosed at 3 mg/kg, most of the radioactivity was excreted in the feces; in 

the 3-mg/kg females, feces and urine were similar. Elimination after 48 hours in bile was high at 

3 mg/kg (55-73%), but was 22-28% at 300 mg/kg. Liver had the highest concentration at all 

measurements. More radioactivity was found in plasma than in whole blood. Identified 

compounds were 66-94% of the administered dose in each group (168 hours). The parent and 

the following metabolites were ≥5% at 3 and/or 300 mg/kg: NOA 458422, NOA 458422 

glucuronide, SYN 534133 and CGA 380778. Differences in metabolic profile were due to sex, 

dose and radiolabel position. Each unknown compound was less than 5%. Major metabolic 

transformations involved loss of one or both propargyl groups, followed by glucuronidation and

O-demethylation. 

4.1.4 Summary of Environmental Degradation

EFED Memo; D382369; C. Wendel; 26 July 2011

The major route of dissipation is degradation under aerobic aquatic conditions. Mandipropamid 

appears to be stable to hydrolysis in the environmental pH range of 5-9, but is susceptible to 

photolysis in soil and water. The environmental photolysis half-lives of mandipropamid at pH 7 

in aqueous solutions were estimated at 0.63-1.1 days. The soil photolysis half-life of 

mandipropamid was estimated at 16.4-23.9 days. Based on its vapor pressure and Henry’s Law 

constant, volatilization from water and soil are not expected to be important environmental fate 

processes.

The linear biodegradation half-life of mandipropamid in six European soils, and one US soil,

ranged from approximately 26 to 103 days under aerobic conditions. Under anaerobic 

conditions, the rate of biodegradation appears to be much slower. Mandipropamid degraded 
Mandipropamid Summary of Analytical Chemistry and Residue Data DP Barcode D409363

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with a linear half-life of 151 days in a silt loam soil from Switzerland maintained under 

anaerobic conditions. The aerobic aquatic degradation half-lives of mandipropamid were 17.8-

18.5 days in two river water/silt loam sediment systems from England and Germany. Acceptable 

anaerobic aquatic degradation data have not been submitted. 

Terrestrial field dissipation studies on mandipropamid were conducted in California (sandy loam 

soil), New York (loamy sandy soil), and Georgia (sandy loam soil). The field dissipation halflives of mandipropamid were 75.3 days (California site), l00.5 days (New York), and 81.5 days 

(Georgia). These studies confirm the persistence of mandipropamid in the environment. 

Mandipropamid is moderately mobile, and some of its metabolites are mobile to highly mobile in 

soils, and therefore have the potential to leach into ground water. Mandipropamid can reach 

surface waters via spray drift and rainfall events that cause runoff. 

5.0 Residue Profile

5.1 Residue Analytical Methods (860.1340)

5.1.1 Data Collection Methods

MRIDs #48992001 to -04

Basil: Residues of mandipropamid in treated and control samples of basil were determined using 

a working method derived from reference method RAM 415/01, titled NOA446510: Validation 

of Residue Analytical Method RAM 415/01 for the Determination of Residue in Crops. Method 

RAM 415/01 was previously reviewed, and deemed acceptable for both data collection and 

tolerance enforcement. The modifications included a change in the volume of the subsample 

from 10 mL to 5 mL, which was diluted to 10 mL with acetonitrile (ACN)/water (1:4, v/v). 

Further dilutions were made with ACN/water (1:1, v/v), and the SPE cleanup step was replaced 

with an on-line cleanup step. 

Briefly, samples were extracted by homogenization with ACN/water. Extracts were centrifuged,

and aliquots were diluted with ACN/water. Residues of mandipropamid were determined via

LC/MS/MS coupled with on-line cleanup. 

The reported limit of detection (LOD) and limit of LOQ were 0.0013 ppm and 0.0038 ppm, 

respectively, for fresh basil, and 0.0028 ppm and 0.0085 ppm, respectively, for dried basil. The 

lowest level of method validation (LLMV) was 0.01 ppm for fresh and dried basil. Given that 

the LLMV was 0.01 ppm for mandipropamid, the LOQ of the method will be set at 0.01 ppm for 

mandipropamid in fresh and dried basil. The analytical method was validated prior to sample 

analysis. The method validation recoveries at spiking levels of 0.01 ppm (LOQ), 0.10 ppm (10X

LOQ), 1.0 ppm (100X LOQ) and 20 ppm (2000X LOQ) mandipropamid ranged from 92-102%, 

91-98%, 96-100% and 100-105%, respectively from fresh basil. The method validation 
Mandipropamid Summary of Analytical Chemistry and Residue Data DP Barcode D409363

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recoveries at spiking levels of 0.01 ppm (LOQ) and 0.10 ppm (10X LOQ), 1.0 ppm (100X LOQ) 

and 100 ppm (10000X LOQ) mandipropamid ranged from 83-104%, 93-106%, 95-100% and 98-

100%, respectively from dried basil. The method suitability was also verified concurrently with 

sample analysis. Concurrent recoveries ranged from 93-103% and 95-116% from fresh basil 

spiked with 1.0 ppm (100X LOQ) and 10 ppm (1000X LOQ) mandipropamid, respectively, and 

ranged from 88-112% and 97-103% from dried basil spiked with 1.0 ppm (100X LOQ) and 10 

ppm (1000X LOQ) mandipropamid, respectively. All recoveries were within the generally

recognized acceptable range of 70 to 120%. Therefore, the working method is adequate for the 

determination of residues of mandipropamid in fresh and dried basil samples (see Tables 5.1.1.1

and 5.1.1.2). 

TABLE 5.1.1.1 Summary of Method Validation Recoveries of Mandipropamid from Basil

Matrix Spike Level (ppm) Sample Size (n) Recoveries (%) Mean ± Std. Dev. (%)

Fresh basil 0.01 6 94, 94, 95, 92, 92, 102 95 ± 4

0.10 3 91, 98, 96 95 ± 4

1.0 3 96, 96, 100 97 ± 2

20 3 105, 100, 100 102 ± 3

Dried basil 0.01 6 98, 104, 98, 83, 85, 88 93 ± 8

0.10 3 93, 106, 103 101 ± 7

1.0 3 97, 95, 100 97 ± 3

100 3 100, 100, 98 99 ± 1

TABLE 5.1.1.2 Summary of Concurrent Recoveries of Mandipropamid from Basil

Matrix Spike Level (ppm) Sample Size (n) Recoveries (%) Mean ± Std. Dev. (%)

Fresh basil 1.0 4 103, 97, 94, 93 97 ± 5

10 3 116, 95, 108 106 ± 11

Dried basil 1.0 4 105, 112, 95, 88 100 ± 11

10 2 97, 103 100

Ginseng: Residues of mandipropamid and metabolite SYN500003 in treated and control 

samples of ginseng were determined using a working method derived from method RAM 

415/01, titled NOA446510: Validation of Residue Analytical Method RAM 415/01 for the 

Determination of Residue in Crops, and GRM001.01A, titled Mandipropamid (NOA446510): 

Method for the Determination of Residues of SYN500003 in Potato Tubers and Process Potato 

Commodities. Final Determination by LC-MS/MS. Method RAM 415/01 was previously 

reviewed, and deemed acceptable as a data gathering and enforcement method. Method 

GRM001.01A was not previously reviewed, but is similar to method GRM001.01B, which was 

previously deemed adequate for data gathering purposes. The modifications include a change in 

the volume of the subsample from 10 mL to 5 mL, which was diluted to 10 mL with ACN/water 

(1:4, v/v). Further dilutions were made with ACN/water (1:1, v/v), and the SPE cleanup step 

was replaced with an on-line cleanup step for the analysis of parent only. 

Briefly, residues of mandipropamid and metabolite SYN500003 were extracted with ACN/water 

in a tissumizer. Extracts were analyzed for mandipropamid residues by LC-MS/MS coupled 
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with online cleanup. For the analysis of residues of metabolite SYN500003, an aliquot was 

cleaned up by SPE prior to analysis by LC/MS/MS in combination with online cleanup. 

The reported LOD and LOQ were 0.0072 ppm and 0.022 ppm, respectively, for mandipropamid, 

and 0.0019 ppm and 0.0056 ppm, respectively, for metabolite SYN500003. The LLMV was 

0.01 ppm for mandipropamid, and 0.005 ppm for metabolite SYN500003. Given that the LLMV 

was 0.01 ppm for mandipropamid, and 0.005 ppm for metabolite SYN500003, the LOQ of the 

method will be set at 0.01 ppm for mandipropamid, and 0.005 ppm for metabolite SYN500003. 

The analytical method was validated prior to sample analysis. The method validation recoveries 

at spiking levels of 0.01 ppm (LOQ), 0.10 ppm (10X LOQ) and 1.0 ppm (100X LOQ) 

mandipropamid ranged from 72-113%, 89-98% and 95-99%, respectively. The method 

validation recoveries at spiking levels of 0.005 ppm (LOQ) and 0.10 ppm (20X LOQ) metabolite 

SYN500003 ranged from 84-116% and 85-97%, respectively. The method suitability was also 

verified concurrently with sample analysis. Concurrent recoveries ranged from 103-108% from

ginseng roots spiked with 0.10 ppm mandipropamid, and ranged from 102-127% from ginseng 

roots spiked with 0.10 ppm of metabolite SYN500003. All recoveries were within the generally 

recognized acceptable range of 70 to 120%, with the exception of two concurrent recoveries of 

121% and 127% from ginseng roots spiked with 0.10 ppm of metabolite SYN500003. 

Therefore, the working method is adequate for the determination of residues of mandipropamid 

and metabolite SYN500003 in ginseng roots (see Tables 5.1.1.3 and 5.1.1.4). 

TABLE 5.1.1.3 Summary of Method Validation Recoveries of Mandipropamid from Ginseng.

Matrix Spike Level (ppm) Sample Size (n) Recoveries (%) Mean ± Std. Dev. (%)

Mandipropamid

Ginseng roots 0.01 6 73, 74, 72, 113, 112, 112 93 ± 22

0.10 3 98, 96, 89 94 ± 5

1.0 3 99, 97, 95 97 ± 2

Metabolite SYN500003

Ginseng roots 0.005 6 107, 116, 99, 108, 99, 84 102 ± 11

0.10 3 97, 85, 90 91 ± 6

TABLE 5.1.1.4 Summary of Concurrent Recoveries of Mandipropamid from Ginseng.

Matrix Spike Level (ppm) Sample Size (n) Recoveries (%) Mean ± Std. Dev. (%)

Mandipropamid

Ginseng roots 0.10 4 104, 103, 105, 108 105 ± 2

Metabolite SYN500003

Ginseng roots 0.10 4 116, 127, 102, 121 117 ± 11

Snap beans: Residues of mandipropamid in treated and control samples of snap beans were 

determined using a working method based on method RAM 415/01, titled NOA446510: 

Validation of Residue Analytical Method RAM 415/01 for the Determination of Residue in 

Crops. The modifications included a change in the volume of the subsample from 10 mL to 5 

mL, which was diluted to 10 mL with ACN/water (1:4, v/v). Further dilutions were made with 

ACN/water (1:1, v/v), and the SPE cleanup step was replaced with an on-line cleanup step. This 
Mandipropamid Summary of Analytical Chemistry and Residue Data DP Barcode D409363

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method was previously reviewed, and deemed acceptable for data gathering and enforcement 

purposes. 

Briefly, samples are extracted by homogenization with ACN/water. Extracts are centrifuged and 

aliquots are diluted with ACN/water. Residues of mandipropamid are determined by high 

performance liquid chromatography with tandem quadrupole mass spectrometric detection 

(LC/MS/MS) coupled with on-line cleanup.

The reported LOD and LOQ were 0.00165 ppm and 0.00495 ppm, respectively, for pods with 

seeds, and 0.00122 ppm and 0.00365 ppm, respectively, for plants with pods. The LLMV was 

0.01 ppm for pods with seeds and plants with pods. Given that the LLMV was 0.01 ppm for 

mandipropamid in pods with seeds and plants with pods, the LOQ of the method will be set at 

0.01 ppm. The analytical method was validated prior to sample analysis. The method validation 

mean recoveries at spiking levels of 0.01 ppm (LOQ), 0.10 ppm (10X LOQ) and 1.0 ppm (100X

LOQ) mandipropamid were 102 ± 5% (n = 6), 102 ± 4% (n = 3) and 101 ± 3% (n = 3), 

respectively, from pods with seeds. The method validation mean recoveries at spiking levels of 

0.01 ppm (LOQ), 0.10 ppm (10X LOQ), 1.0 ppm (100X LOQ) and 20 ppm (2000X LOQ) 

mandipropamid were 102 ± 4% (n = 4), 99 ± 3% (n = 3), 94 ± 1% (n = 3) and 101 ± 4% (n = 3), 

respectively, from plants with pods. The method suitability was also verified concurrently with 

sample analysis. Concurrent mean recoveries were 94 ± 9% (n = 10) from pods with seeds 

spiked at 0.10 ppm, and were 99% (n = 2) and 104 ± 12% (n = 8) from plants with pods spiked at 

0.10 ppm and 1.0 ppm, respectively. All method validation and concurrent recoveries were 

within the generally recognized acceptable range (70 to 120%) with the exception of one 

concurrent recovery of 124% from plants with pods at a spiking level of 1.0 ppm. As such, 

method RAM 415/01 is adequate for the determination of residues of mandipropamid in snap 

beans (see Tables 5.1.1.5 and 5.1.1.6). 

TABLE 5.1.1.5 Summary of Method Validation Recoveries of Mandipropamid from Snap Beans.

Matrix Spike Level (ppm) Sample Size (n) Recoveries (%) Mean ± Std. Dev. (%)

Pods with seed 0.01 6 99, 104, 110, 98, 98, 100 102 ± 5

0.10 3 106, 102, 99 102 ± 4

1.0 3 99, 105, 100 101 ± 3

Plants with pods 0.01 6 103, 103, 107, 100, 99, 97 102 ± 4

0.10 3 97, 102, 99 99 ± 3

1.0 3 95, 95, 93 94 ± 1

20 3 105, 101, 98 101 ± 4

TABLE 5.1.1.6 Summary of Concurrent Recoveries of Mandipropamid from Snap Beans.

Matrix Spike Level

(ppm)

Sample 

Size (n)

Recoveries

(%)

Mean ± Std. Dev.

(%)

Pods with seed 0.10 10 102, 94, 79, 101, 84, 85, 100, 107, 93, 91 94 ± 9

Plants with pods 0.10 2 103, 95 99

1.0 8 104, 124, 98, 101, 111, 102, 83, 107 104 ± 12
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Greenhouse tomatoes: Residues of mandipropamid in treated and control samples of tomatoes 

were determined using a working method derived from reference method RAM 415/01, titled 

NOA446510: Validation of Residue Analytical Method RAM 415/01 for the Determination of 

Residue in Crops. Method RAM 415/01 was previously reviewed, and deemed acceptable for 

both data collection and tolerance enforcement. The modifications included a change in the 

volume of the subsample from 10 mL to 5 mL, which was diluted to 10 mL with acetonitrile

(ACN)/water (1:4, v/v). Further dilutions were made with ACN/water (1:1, v/v), and the SPE 

cleanup step was replaced with an on-line cleanup step. 

Briefly, samples were extracted by homogenization with ACN/water. Extracts were centrifuged, 

and aliquots were diluted with ACN/water. Residues of mandipropamid were determined via 

LC/MS/MS coupled with on-line cleanup. 

The reported LOD and limit of LOQ were 0.019 ppm and 0.056 ppm, respectively, for tomatoes. 

The LLMV was 0.01 ppm for tomatoes. Given that the LLMV was 0.01 ppm for 

mandipropamid, the LOQ of the method will be set at 0.01 ppm for mandipropamid in tomatoes. 

The analytical method was validated prior to sample analysis. The method validation recoveries 

at spiking levels of 0.01 ppm (LOQ), 0.10 ppm (10X LOQ) and 1.0 ppm (100X LOQ) 

mandipropamid ranged from 94-107%, 89-94%, and 86-91%, respectively, from tomatoes. The 

method suitability was also verified concurrently with sample analysis. Concurrent recoveries 

ranged from 87-101% from tomatoes spiked with 0.10 ppm (10X LOQ) mandipropamid. All 

recoveries were within the generally recognized acceptable range of 70 to 120%. Therefore, the 

working method is adequate for the determination of residues of mandipropamid in tomatoes

(see Tables 5.1.1.7 and 5.1.1.8). 

TABLE 5.1.1.7 Summary of Method Validation Recoveries of Mandipropamid from Tomatoes.

Matrix Spike Level (ppm) Sample Size (n) Recoveries (%) Mean ± Std. Dev. (%)

Tomato fruit 0.01 6 102, 96, 94, 106, 104, 107 101 ± 6

0.10 3 89, 89, 94 90 ± 3

1.0 3 88, 91, 86 88 ± 3

TABLE 5.1.1.8 Summary of Concurrent Recoveries of Mandipropamid from Tomatoes.

Matrix Spike Level (ppm) Sample Size (n) Recoveries (%) Mean ± Std. Dev. (%)

Tomato fruit 0.10 5 101, 87, 94, 87 92 ± 7

Conclusions: Adequate method validation data have been submitted on the LC/MS/MS method 

used for the determination of mandipropamid residues in the various commodities. No 

additional data are required in support of this data collection method. 
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5.1.2 Multi-Residue Methods (860.1360)

D328534, D337543; D. McNeilly; 28 August 2007

Multiresidue method testing data for mandipropamid were submitted. The study was performed 

according to the FDA Multi-Residue Method Test guidelines in PAM Vol. I. Mandipropamid 

was tested only through Protocol C (Section 302). It was not tested under Protocols A, B, D, E, 

F or G. The petitioner simply stated these protocols were not applicable without further 

explanation. 

Mandipropamid was tested according to Protocol C using GLC systems DG5, DG13, DG17 and 

DG 18. No significant responses were obtained with GLC systems DG5 and DG17, and low or 

multiple peak responses were achieved with GLC systems DG13 and DG18. Further testing 

with mandipropamid was therefore terminated. 

Conclusions: Mandipropamid was tested under Protocol C which appears to be the only 

appropriate protocol to evaluate given the results achieved using that protocol. The FDA 

Multiresidue methods do not appear to be adequate for determining residues of mandipropamid. 

These data were forwarded to the US FDA for further evaluation. 

5.1.3 Tolerance Enforcement Methods

D328534, D337543; D. McNeilly; 28 August 2007

D348229, D352322, D. Rate; 11 December 2008

There is an adequate enforcement method for determination of mandipropamid in plant 

commodities. LC/MS/MS method RAM 415/01, which was previously submitted under 

Petitions #6F7057 and #7F7184, has a validated method LOQ of 0.01 ppm. Method 415/01 has 

been adequately validated by an independent laboratory and was forwarded to ACB/BEAD for a 

petition method validation. The ACB concluded (D336257; C. Stafford; 15 August 2007),

without conducting a laboratory trial, that the method appears to meet OCSPP Residue 

Chemistry Test Guideline 860.1340 for an acceptable tolerance enforcement method, with the 

exception of the general requirement for a confirmatory method since only one MS/MS ion 

transition was documented. The ACB recommended that the petitioner provide an alternate 

chromatographic column and/or mobile-phase combination to add an additional degree of 

specificity, and further reduce the possibility of false positive residues. An acceptable 

confirmatory method is available. 

5.2 Storage Stability (860.1380)

MRIDs #48992001 to -04

Basil: Sample storage conditions and durations are reported in Table 5.2.1, below. Treated fresh 

and dried basil samples were stored frozen (<-20oC/<-4oF) for up to 723 days and 671 days, 

respectively, from harvest to extraction. All samples were analyzed within 9 days of extraction. 

The freezer storage stability of residues of mandipropamid fresh and dried basil samples from 
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this study was demonstrated concurrently with the sample analysis (see Table 5.2.2.). Untreated 

fresh and dried basil were spiked with 1.0 ppm of mandipropamid. The corrected mean recovery

of mandipropamid from fresh and dried basil samples stored frozen for 700 days was 87 ± 8% 

and 115 ± 0%, respectively. The concurrent recoveries of mandipropamid from freshly fortified 

samples of fresh and dried basil spiked at 1.0 ppm were 105% and 85%, respectively. The 

demonstrated storage stability interval of mandipropamid in dried basil covers the actual storage 

duration, and is only slightly shorter than the actual storage duration for fresh basil. As such, 

there are no concerns with the stability of mandipropamid residues in fresh and dried basil 

samples from this study. 

TABLE 5.2.1 Summary of Storage Conditions. 

Matrix Storage Temperature

(°C/°F)

Actual Storage 

Duration (Days)*

Interval of Demonstrated 

Storage Stability (Days)

Fresh basil <-20/<-4 723 700

Dried basil <-20/<-4 671 700

* Storage duration between harvest and extraction. Samples were analyzed within 9 days of extraction.

TABLE 5.2.2 Stability of Residues of Mandipropamid Following Frozen Storage.

Matrix Storage 

Temperature

(°C/°F)

Spiking 

Level

(ppm)

Storage 

Interval

(Days)

Concurrent 

Recovery 

(%)

Recoveries

(%)

Mean 

Recovery ± 

Std. Dev. (%)

Corrected*

Mean Recovery 

± Std. Dev. (%)

Fresh basil <-20/<-4 1.0 700 105 82, 95, 98 92 ± 9 87 ± 8

Dried basil <-20/<-4 1.0 700 85 98, 98, 98 98 ± 0 115 ± 0

* Corrected for concurrent recovery. Mean of recoveries from three stored samples, divided by the recovery from 

the freshly fortified sample, multiplied by 100%. 

Ginseng: Treated ginseng root samples were stored frozen (<-20oC/<-4oF) for up to 939 days 

from harvest to extraction (see Table 5.2.3). All samples were analyzed within 11 days of 

extraction. The freezer storage stability of residues of mandipropamid and metabolite 

SYN500003 in ginseng root samples from this study was demonstrated concurrently with the 

sample analysis (see Table 5.2.4). Untreated ginseng root samples were spiked with 0.10 ppm of 

mandipropamid and metabolite SYN500003. The corrected mean recoveries of mandipropamid 

and metabolite SYN500003 from ginseng root samples stored frozen for 922 days were 107 ± 

12% and 119 ± 10%, respectively. The concurrent recoveries of mandipropamid and metabolite 

SYN500003 from a freshly fortified sample spiked at 0.10 ppm were 99% and 84%, 

respectively. The demonstrated storage stability interval of mandipropamid in ginseng is similar 

to the actual storage duration. Therefore, there are no concerns with the stability of 

mandipropamid residues in ginseng root samples from this study. 

TABLE 5.2.3 Summary of Storage Conditions. 

Matrix Storage Temperature

(°C/°F)

Actual Storage Duration 

(Days)*

Interval of Demonstrated 

Storage Stability (Days)

Ginseng roots <-20/<-4 939 922

* Storage duration between harvest and extraction. Samples were analyzed within 11 days of extraction. 
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TABLE 5.2.4 Stability of Residues of Mandipropamid and Metabolite SYN500003 in Ginseng Roots 

Following Frozen Storage. 

Matrix Storage 

Temperature

(°C/°F)

Spiking 

Level

(ppm)

Storage 

Interval

(Days)

Concurrent 

Recovery 

(%)

Recoveries

(%)

Mean 

Recovery ± 

Std. Dev. (%)

Corrected*

Mean Recovery 

± Std. Dev. (%)

Mandipropamid

Ginseng 

roots

<-20/<-4 0.10 922 99 96, 102, 119 106 ± 12 107 ± 12

Metabolite SYN500003

Ginseng 

roots

<-20/<-4 0.10 922 84 90, 105, 105 100 ± 9 119 ± 10

* Corrected for concurrent recovery. Mean of recoveries from three stored samples, divided by the recovery from 

the freshly fortified sample, multiplied by 100%. 

Snap beans: Treated snap bean samples were stored frozen (<-20oC/<-4oF) for up to 359 days 

from harvest to extraction (see Table 5.2.5). All samples were analyzed within 21 days of 

extraction. The freezer storage stability of residues in snap bean samples from this study was 

demonstrated concurrently with the sample analysis. Untreated snap bean samples (pods with 

seed and plants with pods) were spiked with 0.10 ppm of mandipropamid (see Table 5.2.6). The 

corrected mean recoveries from pods with seed and plants with pod samples stored frozen for 

357 days were 86 ± 3% and 92 ± 2%, respectively. The concurrent recoveries of mandipropamid 

from freshly fortified samples spiked at 0.10 ppm were 107% from pods with seed, and 103% 

from plants with pods. The demonstrated storage stability interval of mandipropamid in snap 

beans is almost the same (2 days shorter) as the actual storage duration. Therefore, there are no 

concerns with the stability of mandipropamid residues in snap bean samples from this study. 

TABLE 5.2.5 Summary of Storage Conditions. 

Matrix Storage Temperature

(°C/°F)

Actual Storage Duration 

(Days)*

Interval of Demonstrated 

Storage Stability (Days)

Pods with seed <-20/<-4 359 357

Plants with pods

* Storage duration between harvest and extraction. Samples were analyzed within 21 days of extraction.

TABLE 5.2.6 Stability of Mandipropamid Residues in Snap Beans Following Frozen Storage.

Matrix Storage 

Temperature

(°C/°F)

Spiking 

Level

(ppm)

Storage 

Interval

(Days)

Concurrent 

Recovery 

(%)

Recoveries

(%)

Mean 

Recovery ± 

Std. Dev. (%)

Corrected*

Mean Recovery

± Std. Dev. (%)

Pods with 

seed

<-20/<-4 0.1 357 107 91, 90, 95 92 ± 3 86 ± 3

Plants 

with pods

103 94, 93, 97 95 ± 2 92 ± 2

* Corrected for concurrent recovery. Mean of recoveries from three stored samples, divided by the recovery from

the freshly fortified sample, multiplied by 100%. 

Greenhouse tomatoes: Treated tomato fruit samples were stored frozen (<-20oC/<-4oF) for up to 

352 days from harvest to extraction (see Table 5.2.7). All samples were analyzed within 4 days 
Mandipropamid Summary of Analytical Chemistry and Residue Data DP Barcode D409363

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of extraction. The freezer storage stability of residues in tomato samples from this study was 

demonstrated concurrently with the sample analysis. Untreated tomato samples were spiked 

with 0.103 ppm of mandipropamid (see Table 5.2.8). The corrected mean recovery from tomato 

fruit stored frozen for 358 days was 91 ± 4%. The concurrent recovery of mandipropamid from 

a freshly fortified tomato sample spiked at 0.10 ppm was 90%. The demonstrated storage 

stability interval of mandipropamid in tomato fruit covers the actual storage duration. Therefore, 

there are no concerns with the stability of mandipropamid residues in tomato fruit samples from 

this study. 

TABLE 5.2.3 Summary of Storage Conditions. 

Matrix Storage Temperature

(°C/°F)

Actual Storage Duration 

(Days)*

Interval of Demonstrated 

Storage Stability (Days)

Tomato fruit <-20/<-4 352 358

* Storage duration between harvest and extraction. Samples were analyzed within 4 days of extraction. 

TABLE 5.2.4 Stability of Residues of Mandipropamid in Tomato Fruit Following Frozen Storage. 

Matrix Storage 

Temperature

(°C/°F)

Spiking 

Level

(ppm)

Storage 

Interval

(Days)

Concurrent 

Recovery 

(%)

Recoveries

(%)

Mean 

Recovery ± 

Std. Dev. (%)

Corrected*

Mean Recovery 

± Std. Dev. (%)

Tomato 

fruit

<-20/<-4 0.103 358 90 83, 85, 78 82 ± 4 91 ± 4

* Corrected for concurrent recovery. Mean of recoveries from three stored samples, divided by the recovery from 

the freshly fortified sample, multiplied by 100%. 

Conclusions: There are no storage stability issues associated with any of the field trial studies. 

Therefore, no corrections for potential decline during storage are needed in reviewing the residue 

studies submitted for the various commodities. 

5.3 Residue Data

5.3.1 Crop Field Trials (860.1500)

MRIDs #48992001 to -04

Basil: IR-4 submitted field and greenhouse trial data for mandipropamid in basil (fresh and 

dried). A total of 4 field trials were conducted in Canada and the US in Zones 2 (1 trial in NC), 

5A (1 trial in WI), 10 (1 trial in CA) and 11 (1 trial in BC) during the 2009 growing season, and 

a total of 2 greenhouse trials were conducted in the US in Zones 2 (1 trial in MD) and 3 (1 trial in 

FL) during the 2009 and 2010 growing seasons. Two trials (in 2 separate greenhouses) were 

required to support the proposed use expansion to greenhouse basil; the growing regions in 

which these were conducted were not specified by OCSPP Residue Chemistry Test Guideline 

860.1500. 

At each trial site, mandipropamid formulated as Revus 2.08SC was applied as 4 foliar directed 

applications at a rate of 0.128-0.139 lb ai/A, with re-treatment intervals (RTIs) of 6 to 8 days, for 

a total seasonal rate of 0.520-0.528 lb ai/A. All applications included a non-ionic surfactant 
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(NIS) in the spray mixture. Fresh basil (stems and leaves) was harvested at a PHI of 1 day. At 

one trial site, fresh basil samples (stems and leaves) were harvested at PHIs of 3, 7 and 11 days 

to assess residue decline. Samples of fresh basil (stems and leaves) used for drying were also 

collected at a PHI of 1 day, and dried for up to 3 days according to local commercial practices. 

The results from this study indicated that mandipropamid residues ranged from 3.5 ppm to 19 

ppm in fresh basil, and ranged from 36 ppm to 91 ppm in dried basil, grown in the field and 

greenhouse (see Table 5.3.1.1, below). The residue decline data indicated that residues of 

mandipropamid in fresh basil decreased with increasing PHIs. 

TABLE 5.3.1.1 Summary of Residue Data from Basil Field and Greenhouse Trials with Mandipropamid. 

Basil 

Commodity

Total Use 

Rate

(lb ai/A)

PHI 

(Days)

Residue Levels (ppm)

n Min. Max. LAFT* HAFT* Median Mean Std. Dev.

Fresh stems 

and leaves

0.520-

0.528

1 1213.5 19 - - 9.0 9.3 4.8

6

2

- - 3.6 19 8.8 9.4 5.0

Dried stems 

and leaves

0.520-

0.528

1 6

1,2 36 91 - - 63 63 20

* LAFT = Lowest Average Field Trial; HAFT = Highest Average Field Trial. 

1. n = total number of samples. 

2. n = total number of field trials. 

Ginseng: IR-4 submitted field trial data for mandipropamid in ginseng. A total of 4 trials were 

conducted in Canada and the US in Zones 5A (3 trials in WI) and 11 (1 trial in BC) during the 

2008 growing season. At each trial site, mandipropamid formulated as Revus 2.08SC was 

applied as 4 foliar broadcast applications at a rate of 0.129-0.141 lb ai/A, with RTIs of 6 to 9 

days, for a total seasonal rate of 0.521-0.547 lb ai/A. All applications included an NIS in the 

spray mixture. Ginseng roots were harvested at a PHI of 2 days. At one trial site, additional 

samples of ginseng roots were harvested at PHIs of 0, 7, 15 and 21 days to assess residue 

decline. The roots were dried for up to 19 days in commercial facilities simulating commercial 

practices. 

The results from this study indicated that mandipropamid residues ranged from 0.0222 ppm to 

0.167 ppm in dried ginseng root samples (see Table 5.3.1.2, below). Results also showed that 

there were no quantifiable residues (<0.005 ppm) of metabolite SYN500003 in dried roots. The 

residue decline data indicated that residues of mandipropamid in dried roots remained fairly 

stable between PHIs of 0 and 21 days. 
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TABLE 5.3.1.2 Summary of Residue Data from Ginseng Field Trials with Mandipropamid. 

Commodity Total 

Use Rate

(lb ai/A)

PHI 

(Days)

Residue Levels (ppm)

n Min. Max. LAFT* HAFT* Median Mean Std. Dev.

Mandipropamid

Ginseng

roots

0.521-

0.547

2 8

1

0.0222 0.167 - - 0.0586 0.0717 0.0551

4

2

- - 0.0271 0.119 0.0705 0.0718 0.0475

Metabolite SYN500003

Ginseng

roots

0.521-

0.547

2 8

1

<0.005 <0.005 - - <0.005 <0.005 -

4

2

- - <0.005 <0.005 <0.005 <0.005 -

* LAFT = Lowest Average Field Trial; HAFT = Highest Average Field Trial. 

1. n = total number of samples. 

2. n = total number of field trials. 

Snap beans: IR-4 submitted field trial data for mandipropamid in snap beans. A total of 10 

trials were conducted in the US in Zones 1 (1 trial in NY), 2 (1 trial in MD and 1 trial in GA), 3 

(1 trial in FL), 5 (1 trial in OH), 5A (1 trial in MI and 1 trial in WI), 10 (2 trials in CA) and 11 (1 

trial in WA) during the 2010 growing season. At each trial site, mandipropamid formulated as 

Revus 2.08 SC was applied as 4 foliar (broadcast or directed) applications at a rate of 0.094-

0.138 lb ai/A, with RTIs of 6 to 8 days, for a total seasonal rate of 0.490-0.540 lb ai/A. All 

applications included an NIS or a crop oil concentrate (COC) in the spray mixture. Snap beans 

(pods with seed and plants with pods) were harvested at a PHI of 1 day. At one trial site, snap 

beans were harvested at PHIs of 3, 7 and 10 days to assess residue decline. 

The results from this study indicated that mandipropamid residues ranged from 0.0858 ppm to 

0.761 ppm in pods with seed, and 1.24 ppm to 9.84 ppm in plants with pods (see Table 5.3.1.3, 

below). Results from the residue decline study indicated that residues decreased over time. 

TABLE 5.3.1.3 Summary of Residue Data from Snap Bean Field Trials with Mandipropamid. 

Commodity Total 

Use Rate

(lb ai/A)

PHI 

(Days)

Residue Levels (ppm)

n Min. Max. LAFT* HAFT* Median Mean Std. Dev.

Pods with 

seed

0.490-

0.540

1 2010.0858 0.761 - - 0.210 0.256 0.175

102- - 0.10 0.58 0.220 0.256 0.164

Plants with 

pods

0.490-

0.540

1 2011.24 9.84 - - 4.15 4.14 2.34

102- - 1.27 9.27 4.35 4.14 2.36

* LAFT = Lowest Average Field Trial; HAFT = Highest Average Field Trial. 

1. n = total number of samples. 

2. n = total number of field trials. 

Greenhouse tomatoes: IR-4 submitted greenhouse trial data for mandipropamid in tomatoes 

grown in greenhouses. A total of 4 greenhouse trials were conducted in the US in Zones 2 (1 

trial in MD), 4 (1 trial in AR), 5 (1 trial in WI) and 10 (1 trial in CA), during the 2010 growing 

season. At each trial site, mandipropamid formulated as Revus 2.08 SC was applied as 4 foliar 

(broadcast or directed) applications (5 at trial site 10-AR05) at a rate of 0.120-0.136 lb ai/A, with 

RTIs of 6 to 8 days, for a total seasonal rate of 0.480-0.651 lb ai/A. The fifth application was 
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made at trial site 10-AR05 in order to obtain commercial-size tomatoes at the proposed 1-day

PHI. All applications included an NIS in the spray mixture. The applications were made starting 

22 days before harvest, except at trial site 10-AR05, where the first application was made 30 

days prior to harvest. Commercially mature tomatoes (large and small-sized varieties) were 

harvested at a PHI of 1 day. 

The results from this study indicated that mandipropamid residues ranged from 0.045 ppm to 

0.339 ppm in tomato fruit (see Table 5.3.1.4, below). 

TABLE 5.3.1.4 Summary of Residue Data from Tomato Greenhouse Trials with Mandipropamid. 

Commodity Total 

Use Rate

(lb ai/A)

PHI 

(Days)

Residue Levels (ppm)

n Min. Max. LAFT* HAFT* Median Mean Std. Dev.

Tomato fruit 0.480-

0.651

1 8

1

0.045 0.339 - - 0.147 0.168 0.101

4

2

- - 0.059 0.289 0.115 0.168 0.105

* LAFT = Lowest Average Field Trial; HAFT = Highest Average Field Trial. 

1. n = total number of samples. 

2. n = total number of field trials. 

Conclusions: The submitted crop field trial data are adequate, and support the establishment of 

permanent tolerances in basil (field and greenhouse), ginseng and snap beans, as listed in Table 

6.0 (see Section 6.0, below). The submitted greenhouse trial data are adequate to support the 

requested use on greenhouse tomatoes. Additional field trial data on a succulent shelled bean 

cultivar (such as lima beans) would be necessary in order to establish the proposed tolerance in 

all succulent beans. 

5.3.2 Field Rotational Crops (860.1900)

D328534, D337543; D. McNeilly; 28 August 2007

An adequate limited field rotational crop study was reviewed in Petitions #6F7057 and #7F7184. 

Mandipropamid residues were below the LOQ (<0.01 ppm) in all samples of rotated radish roots, 

radish tops, spinach leaves, fall wheat forage, spring wheat forage, wheat hay, wheat grain, and 

wheat straw planted at the 28/31-day and 61-day PBIs. HED has determined that the rotational 

crop restriction on the label which states “[d]o not plant any crop which is not registered for use 

with mandipropamid for a period of 30 days after the last application” is appropriate. Given the 

label restriction, tolerances in rotational crops are not needed. 

5.3.3 Processed Food and Feed (860.1520)

Because there are no processed commodities for ginseng or succulent beans, processing studies 

are not required for these RACs. The processed commodity for basil is dried basil, samples of 

which were produced at the field trial sites, and subsequently analyzed along with the fresh basil 

samples. A processing study is not needed for tomatoes, as this requirement was addressed in a 

previous summary document (D328534, D337543; D. McNeilly; 28 August 2007). 
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5.3.4 Meat, Milk, Poultry and Eggs (860.1480)

D328534, D337543; D. McNeilly; 28 August 2007

The only significant livestock feed item associated with the proposed new uses is cowpea forage, 

which is not fed to beef cattle, swine nor poultry. It is fed to dairy cattle at up to 20% of the diet 

in select locations, or as seasonally available. At the proposed tolerance level of 15 ppm, the 

calculated dietary burden to dairy cattle is 10 ppm (the contribution to dietary burden from the 

only current feed items, potato culls and processed waste, is negligible at 0.025 ppm). 

No livestock feeding studies were submitted with this petition. An acceptable ruminant 

metabolism study is available. Goats were dosed with radiolabeled mandipropamid at 30-36 

ppm (3-3.6X the dietary burden to dairy cattle) in the feed for 7 consecutive days. The parent 

compound was identified only in fat (0.013-0.019 ppm), milk (0.013 ppm), and liver (0.004-

0.007 ppm). Based on the highest detected residue of 0.019 ppm in goat fat, anticipated residues 

from feeding cowpea forage containing mandipropamid at the recommended tolerance level of 

15 ppm would be roughly 0.006 ppm. HED’s ChemSAC determined that it is not possible to 

establish a tolerance in cowpea forage, as the potential for finite residues in cattle commodities 

(fat, milk and liver) exists. Establishing a tolerance in cowpea forage would necessitate the 

concurrent establishment of tolerances at the LOQ in cattle fat, milk and liver, which would 

require a suitable method for the enforcement of tolerances in these commodities. However, 

with no validated method for enforcing tolerances in cattle commodities, it is not possible to 

establish tolerances in them (minutes from ChemSAC meeting of 17 July 2013). 

Conclusions: The proposed tolerance in cowpea forage cannot be established until a validated 

method for determining mandipropamid residues in livestock (cattle) commodities is available. 

Also, if uses on additional significant livestock feed items are requested in any future petition, a 

livestock feeding study will be required. 

5.3.5 Food Handling (860.1460)

There are no proposed uses that are relevant to this guideline topic.

5.3.6 Water, Fish and Irrigated Crops (860.1400)

There are no proposed uses that are relevant to this guideline topic

5.4 Food Residue Profile

Residues of mandipropamid are expected to occur at low (up to 0.10 ppm in bulb onions) to high 

levels (up to 200 ppm in dried basil) from the new uses proposed in the current action. 
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6.0 Tolerance Derivation

Instead of the proposed tolerance in ginseng (0.3 ppm), HED recommends establishing the 

tolerance at 0.30 ppm, in order to avoid the situation where a field sample containing residues 

significantly above the tolerance (0.34 ppm, for example) would be considered non-violative. 

For the same reason, HED recommends that the proposed tolerance of 0.1 ppm in bulb onions 

(subgroup 3-07A) be revised to 0.10 ppm. 

The recommended tolerances in fresh and dried basil, snap beans, and ginseng are based on crop 

field trial data entered into OECD’s tolerance calculation procedure. Upon establishment of the 

permanent tolerances in fresh and dried basil (40CFR §180.637[a]), the time-limited tolerances 

in fresh and dried basil (40CFR §180.637[b]) should be removed. 

The recommended tolerance in fruiting vegetables (group 8-10) is based on updating the current 

tolerance in fruiting vegetables (group 8). The tolerance of 1.0 ppm would match the existing 

Codex (bell and non-bell peppers) and PMRA (tomatoes, okras and peppers) MRLs. Upon 

establishment of the tolerance in group 8-10, the tolerances in group 8 and okra should be 

removed. 

The recommended tolerance in small vine climbing fruits except fuzzy kiwifruit (subgroup 13-

07F) is based upon expanding the current tolerance in grapes (1.4 ppm), and raising the US 

tolerance to harmonize with the existing Codex MRL in grapes. Upon establishment of the 

tolerance in subgroup 13-07F, the tolerance in grapes should be removed. 

The recommended tolerance in bulb onions (subgroup 3-07A) is based upon expanding the 

current tolerance in dry bulb onions (0.05 ppm), and raising the US tolerance to harmonize with 

the existing Codex MRL in bulb onions. Upon establishment of the tolerance in subgroup 3-

07A, the tolerance in dry bulb onions should be removed. 

The recommended tolerance in green onions (subgroup 3-07B) is based upon expanding the 

current tolerance in green onions (4 ppm), and raising the US tolerance to harmonize with the 

existing Codex MRL in spring onions. Upon establishment of the tolerance in subgroup 3-07B, 

the tolerance in green onions should be removed. 

The rationales for the establishment (or not) and concurrent removal of tolerances associated 

with the current action are listed in Table 6.0, below. 

An International Residue Limit Status sheet is appended as Attachment 1. Data sets and results 

from the OECD tolerance calculation procedure for the various commodities are appended as 

Attachment 2. 
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TABLE 6.0 Tolerance Recommendations for Mandipropamid. 

Commodity Existing

Tolerance (ppm)

Recommended 

Tolerance (ppm)

Rationale

40CFR §180.637[a]

Basil, fresh leaves None 30 Based on submitted crop field trial data. 

Basil, dried leaves None 200

Bean, succulent None None Field trial data on a succulent shelled bean 

cultivar is needed. 

Bean, snap None 0.90 Based on submitted crop field trial data. 

Ginseng None 0.30

Cowpea, forage None None A validated method for residues in cattle 

commodities is needed. 

Vegetable, fruiting, group 8-

10

None 1.0 Updated from fruiting vegetables group 8.

Fruit, small, vine climbing, 

except fuzzy kiwifruit, 

subgroup 13-07F

None 2.0 Translated from grape data, and 

harmonized with Codex MRL in grapes. 

Onion, bulb, subgroup 3-07A None 0.10 Translated from bulb onion data, and 

harmonized with Codex MRL in bulb 

onions. 

Onion, green, subgroup 3-

07B

None 7.0 Translated from green onion data, and 

harmonized with Codex MRL in spring 

onions. 

Vegetable, fruiting, group 8 1.0 None Remove; updated to group 8-10 tolerance. 

Okra 1.0 None Remove; covered by group 8-10 tolerance. 

Grape 1.4 None Remove; covered by subgroup 13-07F 

tolerance. 

Onion, dry bulb 0.05 None Remove; updated to subgroup 3-07A 

tolerance.

Onion, green 4 None Remove; updated to subgroup 3-07B

tolerance.

40CFR §180.637[b]

Basil, dried 240 None Remove time-limited tolerances, establish 

Basil, fresh 20 None permanent tolerances under 180.637[a]. 

References

Mandipropamid. Section 3 Registration Request to Register New Uses on Hops and Tobacco 

and Confirmatory Residue Analytical Method for Determination of Residues in Crop Matrices. 

Summary of Analytical Chemistry and Residue Data.; D348229, D352322, D. Rate; 11 

December 2008. 
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Mandipropamid. Request to Register New Food/Feed Uses on Head and Stem Brassica, Leafy 

Brassica Greens, Cucurbit Vegetables, Fruiting Vegetables, Leafy Vegetables (except Brassica), 

Tuberous and Corm Vegetables, Grapes, and Onions (Dry Bulb and Green). Summary of 

Analytical Chemistry and Residue Data. Petition Numbers 6F7057 and 7F7184.; D328534, 

D337543; D. McNeilly; 28 August 2007. 

Ecological Risk Assessment for the Mandipropamid Section 3 New Use on Outdoor/Non-food 

Ornamentals and Listed Vegetables Grown for Transplant and Retail Sale to Consumers; 

D382369; C. Wendel; 26 July 2011. 

Minutes from ChemSAC meeting; 17 July 2013. 

Attachments

Attachment 1: International Residue Limit Status sheet. 

Attachment 2: OECD MRL (tolerance) assessment calculations. 
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Attachment 1: International Residue Limit Status. 

Mandipropamid (PC Code 036602)

Summary of US Tolerances and International Maximum Residue Limits.

Residue Definitions

US (40CFR §180.637) Canada Codex

Plants: Mandipropamid (4-chloro-N-

[2-[3-methoxy-4-(2-

propynyloxy)phenyl] ethyl]-α-(2-

propynyloxy)- benzeneacetamide). 

Mandipropamid (4-chloro-N-[2-[3-

methoxy-4-(2-propynyloxy) phenyl]ethyl]-

α-(2-propynyloxy)- benzeneacetamide). 

Mandipropamid. 

Commodity2 Tolerance 

(ppm)3

Commodity MRL 

(mg/kg)

Commodity MRL4

(mg/kg)

Basil, fresh leaves 30

Basil, dried leaves 200

Bean, succulent 0.90

Ginseng 0.30

Cowpea, forage 15

Vegetable, fruiting, 

group 8-10

1.0 Bell peppers, eggplants, groundcherries, non-bell peppers, 

okras, pepinos, pepper hybrids, 

tomatillos, tomatoes

1 Bell peppers, 

non-bell peppers

1

Dried chili 

peppers

10

Tomatoes 0.3

Fruit, small, vine 

climbing, except fuzzy 

kiwifruit, subgroup 

13-07F

2.0 Grapes 1.4 Grapes 2

Onion, bulb, subgroup 

3-07A

0.10 Chinese onions, daylilies, dry 

bulb onions, fritillaria, bulbs, 

garlic, great-headed garlic, lilies, 

pearl onions, potato onions, 

serpent garlic, shallot bulbs

0.05 Bulb onions 0.1

Onion, green, subgroup 

3-07B

7.0 Beltsville bunching onions, 

elegans hosta, fresh Chinese 

chive leaves, fresh chive leaves), 

fresh onions, fritillaria leaves, 

green onions, kurrats, lady's 

leek, leeks, macrostem onions, 

shallot leaves, tree onion tops, 

Welsh onion tops, wild leeks

4 Spring onions 7

Completed: M. Negussie, 27 June 2013. 

1. Mexico adopts US tolerances, and/or Codex MRLs, for its export purposes. 

2. Includes only commodities of interest for this action. 

3. Tolerance values are those recommended by HED, not those proposed by the petitioner. 

4. * = absent at the LOQ. Po = post-harvest treatment, such as treatment of stored grains. PoP = processed postharvest treated commodity, such as a processed commodity of post-harvest treated stored wheat. (Fat) = to 

be measured in the fat portion of the sample. MRLs indicated as “proposed” have not been finalized by the 

CCPR and the CAC. 
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Attachment 2: OECD MRL (Tolerance) Assessment Calculations. 

Basil, Dried

Residues (ppm)

63.000

36.000

62.000

91.000

48.000

78.000

Mandipropamid

Basil, dried

Canada/USA

0.52 lb ai/A

Total number of data (n) 6

Percentage of censored data 0%

Number of non-censored data 6

Lowest residue 36.000

Highest residue 91.000

Median residue 62.500

Mean 63.000

Standard deviation (SD) 19.819

Correction factor for censoring (CF) 1.000

Proposed MRL estimate

- Highest residue 91.000

- Mean + 4 SD 142.277

- CF x 3 Mean 189.000

Unrounded MRL 189.000

Rounded MRL 200
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Basil, Fresh

Residues (ppm)

6.500

19.000

8.500

9.000

3.600

9.600

Mandipropamid

Basil, fresh

Canada/USA

0.52 lb ai/A

Total number of data (n) 6

Percentage of censored data 0%

Number of non-censored data 6

Lowest residue 3.600

Highest residue 19.000

Median residue 8.750

Mean 9.367

Standard deviation (SD) 5.200

Correction factor for censoring (CF) 1.000

Proposed MRL estimate

- Highest residue 19.000

- Mean + 4 SD 30.168

- CF x 3 Mean 28.100

Unrounded MRL 30.168

Rounded MRL 30
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Ginseng

Residues (ppm)

0.119

0.106

0.035

0.027

Mandipropamid

Ginseng

Canada/USA

0.52 lb ai/A

Total number of data (n) 4

Percentage of censored data 0%

Number of non-censored data 4

Lowest residue 0.027

Highest residue 0.119

Median residue 0.070

Mean 0.072

Standard deviation (SD) 0.047

Correction factor for censoring (CF) 1.000

Proposed MRL estimate

- Highest residue 0.119

- Mean + 4 SD 0.262

- CF x 3 Mean 0.215

Unrounded MRL 0.262

Rounded MRL 0.3
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Snap Bean, Pods with Seed (for Succulent Bean)

Residues (ppm)

0.100

0.191

0.114

0.248

0.399

0.130

0.113

0.580

0.429

0.254

Mandipropamid

Snap beans (pods with seed)

USA

0.52 lb ai/A

Total number of data (n) 10

Percentage of censored data 0%

Number of non-censored data 10

Lowest residue 0.100

Highest residue 0.580

Median residue 0.220

Mean 0.256

Standard deviation (SD) 0.163

Correction factor for censoring (CF) 1.000

Proposed MRL estimate

- Highest residue 0.580

- Mean + 4 SD 0.910

- CF x 3 Mean 0.767

Unrounded MRL 0.910

Rounded MRL 0.9
Mandipropamid Summary of Analytical Chemistry and Residue Data DP Barcode D409363

Page 37 of 38

Snap Bean, Plants with Pods (for Cowpea Forage)

Residues (ppm)

1.360

3.320

4.200

4.490

9.270

2.210

1.270

5.030

5.740

4.540

Mandipropamid

Snap beans (plants with pods)

USA

0.52 lb ai/A

Total number of data (n) 10

Percentage of censored data 0%

Number of non-censored data 10

Lowest residue 1.270

Highest residue 9.270

Median residue 4.345

Mean 4.143

Standard deviation (SD) 2.364

Correction factor for censoring (CF) 1.000

Proposed MRL estimate

- Highest residue 9.270

- Mean + 4 SD 13.601

- CF x 3 Mean 12.429

Unrounded MRL 13.601

Rounded MRL 15
Mandipropamid Summary of Analytical Chemistry and Residue Data DP Barcode D409363

Page 38 of 38

Greenhouse Tomato

Residues (ppm)

0.059

0.289

0.219

0.104

Mandipropamid

Greenhouse Tomato

USA

0.52 lb ai/A

Total number of data (n) 4

Percentage of censored data 0%

Number of non-censored data 4

Lowest residue 0.059

Highest residue 0.289

Median residue 0.162

Mean 0.168

Standard deviation (SD) 0.105

Correction factor for censoring (CF) 1.000

Proposed MRL estimate

- Highest residue 0.289

- Mean + 4 SD 0.589

- CF x 3 Mean 0.503

Unrounded MRL 0.589

Rounded MRL 0.6