Document ID: EPA-HQ-OPP-2011-0394-0005
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2012-08-17T04:00Z

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

	OFFICE OF CHEMICAL SAFETY

	AND POLLUTION PREVENTION

  SEQ CHAPTER \h \r 1 MEMORANDUM

Date:   May 3, 2012

SUBJECT:	Cyprodinil.  Amended Use. Expansions of Existing Crop
Group/Representative Commodity Uses to Numerous Crop Subgroups, Adding
Use on Leafy Petiole Subgroup 4B, and Adding Use on the Remaining Crops
in Fruiting Vegetables Group 8-10.  Summary of Analytical Chemistry and
Residue Data. 

PC Code:  288202	DP Barcode:  389554 & 391680

Decision No.:  447576 & 448809	Registration Nos.:  100-828, 100-953, and
100-1317

Petition No.:  1E7854 & 1E7869	Regulatory Action:  Amended Section 3

Risk Assessment Type:  NA	Case No.: 7025

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

MRID No.:  48437401 – 05; 48478501	40 CFR:  180.532

		              									

FROM:		Thurston G. Morton, Chemist

	Risk Assessment Branch 4

	Health Effects Division (7509P)

THROUGH:	Susan V. Hummel, Chemist, Senior Scientist

				Elissa Reaves, PhD., Branch Chief

	Risk Assessment Branch 4

		Health Effects Division (7509P)

			

TO:			Rebecca Daiss, Risk Assessor

	Risk Assessment Branch 4

				Health Effects Division (7509P)

 				

				and

				Lisa Jones/Shaja Joyner, RM20

				Fungicide Branch

Registration Division (7505P)	  SEQ CHAPTER \h \r 1   SEQ CHAPTER \h \r
1 

		

Executive Summary

Under PP#1E7854, Interregional Research Project No. 4 (hereafter
referred to as IR-4), on behalf of the Agricultural Experiment Stations,
is requesting the establishment of tolerances for residues of cyprodinil
[4-cyclopropyl-6-methyl-N-phenyl-2-pyrimidinamin] in/on the following
raw agricultural commodities:

Onion, bulb subgroup 3-07A…..	0.6 ppm

Onion, green subgroup 3-07B	4.0 ppm

Caneberry  subgroup 13-07A………………………………….10 ppm

Bushberry subgroup 13-07B	………3.0 ppm

Small fruit vine climbing subgroup 13-07F, except fuzzy
kiwifruit…..2.0 ppm

Low growing berry subgroup 13-07G, except cranberry	5.0 ppm

Dragon fruit 	2.0 ppm

Fruit, pome, group 11-10	1.7 ppm

Vegetable, fruiting, group 8-10	1.3 ppm

Vegetable, leafy, except brassica, subgroup 04A……………...	40 ppm

In addition, IR-4 is requesting to amend the currently established
tolerance for residues of cyprodinil in/on Citrus oil by decreasing it
to 60 ppm. 

Citrus
oil………………………………………………………	60
ppm

In addition, IR-4 is requesting the removal of the currently established
tolerances for residues of cyprodinil in/on Onion, bulb (0.6 ppm);
Onion, green (4.0 ppm); Caneberry subgroup 13A (10.0 ppm); Bushberry
subgroup 13B (3.0 ppm); Juneberry (3.0 ppm); Lingonberry (3.0 ppm);
Salal (3.0ppm); Grape (2.0 ppm); Strawberry (5.0 ppm); Fruit, pome (1.7
ppm); Tomatilla (0.45 ppm); Tomato (0.45 ppm); and Leafy greens subgroup
4A, except spinach (30 ppm).

™ Fungicide (EPA Reg. No. 100-953), a 37.5% water dispersible granule
(WDG) formulation of cyprodinil; Vanguard™ WG (EPA Reg. No. 100-828),
a 75% water dispersible granule (WDG) formulation; and Inspire Super ™
Fungicide (EPA Reg. No. 100-1317), a 2.09 lb ai/gallon emulsifiable
concentrate to the remaining fruiting vegetable crops and to spinach. 
In support of this new use, IR-4 has submitted new pepper and spinach
magnitude of the residue data for cyprodinil using the WDG formulation
of cyprodinil at the proposed use rate.

™ WG (EPA Reg. No. 100-828), Switch 62.5 WG™ Fungicide (EPA Reg. No.
100-953), and Inspire Super ™ Fungicide (EPA Reg. No. 100-1317) to
expand currently registered foliar uses for bulb vegetables, fruiting
vegetables, berry and small fruits, dragon fruit, pome fruits, and leafy
vegetables to include the additional commodities specified under the
following new crop groups/subgroups, respectively:  Onion, bulb subgroup
3-07A, Onion, green subgroup 3-07B, Caneberry  subgroup 13-07A,
Bushberry subgroup 13-07B, Small fruit vine climbing subgroup 13-07F,
except fuzzy kiwifruit, Dragon fruit, Vegetable, fruiting, group 8-10,
Vegetable, leafy, except brassica, subgroup 04A, Pome Fruits Group
11-10, and Low growing Berry Subgroup 13-07G, Except Cranberry.  No
amendments to the use patterns (i.e., maximum use rates, retreatment
intervals, preharvest intervals, use of adjuvants, etc.) on the subject
crops have been proposed.  No new residue chemistry data were submitted
to support these uses.  Instead the petitioner wishes to rely on
previously submitted residue chemistry data which support the currently
registered uses of cyprodinil.

 

One of the products (EPA Reg. No. 100-1317) addressed herein contains a
second active ingredient (difenoconazole) and another product (EPA Reg.
No. 100-953) contains fludioxonil.  Difenoconazole and fludioxonil are
addressed under separate reviews.  The subject review addresses the
proposed uses and supporting data for cyprodinil only.  

Under PP#1E7869, Syngenta Crop Protection, Inc, is requesting the
establishment of tolerances for residues of cyprodinil
[4-cyclopropyl-6-methyl-N-phenyl-2-pyrimidinamin] in/on the following
raw agricultural commodities:

Leafy petiole subgroup 04B	30 ppm

Syngenta Crop Protection, Inc. is requesting a Section 3 request for the
use of Vangard®WG Fungicide (EPA Reg. No. 100-828) and Switch 62.5
WG™ Fungicide (EPA Reg. No. 100-953) on the leafy petiole subgroup
04B.  In support of this new use, Syngenta has submitted celery
magnitude of the residue data for cyprodinil using the WDG formulation
of cyprodinil at the proposed use rate.

Note:  This review only addresses the proposed uses for cyprodinil only.
Related issues for co-ingredient fludioxonil in Switch 62.5 WG™
Fungicide (EPA Reg. No. 100-953) will be discussed in a separate memo.

Cyprodinil was applied in four applications of Switch 62.5 WG™ at a
rate of approximately 0.5 lb cyprodinil a.i./A per application with a
6-8 day retreatment interval (RTI) for a maximum seasonal rate of 2.2 lb
a.i./A to celery.  Celery samples were harvested at a PHI of 0 days.   

 

The nature of cyprodinil residues in plants is understood based on
adequate metabolism studies on apple, peach, potato, tomato, and wheat. 
Only residues of parent cyprodinil need to be included in the tolerance
expression and considered for risk assessment for plant commodities.

The nature of cyprodinil residues in ruminants is also understood based
on an adequate goat metabolism study.  The residues of concern in
ruminants are cyprodinil and its hydroxylated metabolite CGA-304075
(free and conjugated).  No poultry metabolism study is available, but
HED has concluded that none is required for this action since there are
no poultry feed stuffs associated with the proposed new use of
cyprodinil on leafy petiole group 4B.

Adequate HPLC/UV methods (Methods AG-631 and AG-631B) are available for
enforcing tolerances of cyprodinil in/on plant commodities.  The limits
of quantitation (LOQ) for the plant methods range from 0.01 to 0.05 ppm
depending on the commodity.  An adequate LC/MS method (GRM010.01A) is
also available for enforcing tolerances of cyprodinil residues in
livestock commodities.  The method LOQ for this method is 0.02 ppm for
the combined residues of cyprodinil and its metabolite CGA-304075 (free
and conjugated), expressed as parent. 

In the submitted field trial study, residues of cyprodinil in/on
spinach, pepper, and lemon were determined with a method using high
performance liquid chromatography with a tandem mass spectrometer
(LC/MS/MS), which is a modified version of the HPLC/UV Syngenta Method
AG-631B, “Analytical Method for the Determination of Residues of
CGA-219417 in Crops by High Performance Liquid Chromatography with
Column Switching.”  Syngenta Methods AG-631 and AG-631B are the
current tolerance enforcement methods for determining cyprodinil in
plant commodities.  In the submitted field trial study for celery,
residues were analyzed by using a high performance liquid chromatography
method with tandem mass spectrometric detection (LC/MS/MS), Syngenta
method AG-597B.  This method is actually the current tolerance
enforcement method for fludioxonil in plant commodities and was modified
by NCL to enable simultaneous extraction of both cyprodinil and
fludioxinil from celery obviating Syngenta Method AG-631B which is the
current tolerance enforcement method for determining cyprodinil in plant
commodities.

Peppers, spinach, lemon, lemon dried pulp, lemon juice, lemon oil, and
celery samples were stored frozen (-20°C ± 10°C) for up to 9, 22,
3.5, 4.8, 5.6, 10.3, and 7.2 months before analysis, respectively. 
Demonstrated storage stability for the submitted field trial samples
include 9 months for peppers, 5.8 months for dried lemon pulp, 5.9
months for lemon juice, and 10.6 months for lemon oil.  The stability of
cyprodinil has been demonstrated in a variety of other crops, including
mustard greens for 20 months and grape, wine, apple, wheat (ear and
stalk), strawberry, and potato for up to 2 years (D233182, G. Kramer,
02/20/98; D288706, T. Bloem ,7/24/03).  Therefore, the submitted field
trial data are supported by acceptable storage stability data.

The HAFT residue level of cyprodinil in bell peppers, non-bell peppers,
and spinach resulting from four applications for a seasonal rate of 1.3
lb cyprodinil a.i./A was 0.682,  0.668, and 32.1 ppm,  respectively.
Maximum residue levels of cyprodinil were 0.697 ppm in bell pepper,
0.818 ppm in non-bell pepper, and 37 ppm in spinach.  There are an
adequate number of bell pepper, non-bell pepper, and spinach field
trials with acceptable field trial from representative geographical
locations.  The trials were conducted with Switch 62.5WG to support the
requested crop group tolerance, for a 0-day PHI.  No adjuvant or
surfactant was used in the bell pepper or non-bell pepper field trials. 
Non-ionic surfactant or a crop oil concentrate were used in the spinach
field trials.

The HAFT residue level of cyprodinil in celery resulting from four
applications for a seasonal rate of 2.2 lb cyprodinil a.i./A was 17ppm.
Maximum residue levels of cyprodinil were 17 ppm in celery.  There are
an adequate number of celery field trials with acceptable field trial
from representative geographical locations.  The trials were conducted
with Switch 62.5WG to support the requested crop group tolerance, for a
0-day PHI.  Non-ionic surfactant or a crop oil concentrate were used in
the spinach field trials.

The OECD Maximum Residue Limit Calculator was used to determine
appropriate tolerance levels.  A tolerance level of 50 ppm for
Vegetable, leafy, except brassica, subgroup 4A and a tolerance of 1.5
ppm for the Vegetable, fruiting, group 8-10 is appropriate to cover the
proposed amended uses of cyprodinil.  Note that these tolerance levels
are different than those proposed by the registrant.  This is due to
calculating the MRLs with the OECD MRL calculator and harmonizing with
proposed Canadian MRLs.

There are currently established Codex maximum residue limits (MRLs) for
residues of cyprodinil in/on eggplant (0.2 mg/kg), peppers, sweet (0.5
mg/kg), and tomato (0.5 mg/kg).  Neither Codex nor Canada has MRLs for
the leafy petioles crop group.

It is not possible to harmonize with Codex MRLs for residues of
cyprodinil in/on eggplant, peppers, and tomato.  It is not possible to
harmonize with Codex and Canadian MRLs for residues of cyprodinil in/on
these commodities because the US is recommending the establishment of a
fruiting vegetable group 8 tolerance at 1.5 ppm, and removal of the
existing 0.45 ppm tolerance in/on tomato and tomatillo, along with the
1.0 ppm tolerance on tomato paste.  Canada will be establishing an MRL
on the fruiting vegetable crop group also.

There are no tolerances established in Mexico.  

  SEQ CHAPTER \h \r 1 Regulatory Recommendations and Residue Chemistry
Deficiencies

HED has examined the residue chemistry database for cyprodinil.  With
regards to cyprodinil for PP#1E7854, pending submission of a revised
Section B (see requirements under Directions for Use) and a revised
Section F (see requirements under Proposed Tolerances), there are no
residue chemistry issues that would preclude granting amended 
registrations for Vanguard™ WG (EPA Reg. No. 100-828), Switch 62.5
WG™ Fungicide (EPA Reg. No. 100-953), and Inspire Super ™ Fungicide
(EPA Reg. No. 100-1317) to expand currently registered foliar uses for
bulb vegetables, fruiting vegetables, berry and small fruits, dragon
fruit, pome fruits, and leafy vegetables to include the additional
commodities specified under the following new crop groups/subgroups,
respectively:  Onion, bulb subgroup 3-07A, Onion, green subgroup 3-07B,
Caneberry  subgroup 13-07A, Bushberry subgroup 13-07B, Small fruit vine
climbing subgroup 13-07F, except fuzzy kiwifruit, Dragon fruit,
Vegetable, fruiting, group 8-10, Vegetable, leafy, except brassica,
subgroup 04A, Pome Fruits Group 11-10, and Low growing Berry Subgroup
13-07G, Except Cranberry or establishment of tolerances for residues of
cyprodinil only in/on the following commodities:

Onion, bulb, subgroup 3-07A…..	0.6 ppm

Onion, green, subgroup 3-07B	4.0 ppm

Caneberry  subgroup 13-07A………………………………….10 ppm

Bushberry subgroup 13-07B	………3.0 ppm

Fruit, small vine climbing, except fuzzy kiwifruit, subgroup 13-07F,
…..2.0 ppm

Berry, low growing subgroup 13-07G, except cranberry	5.0 ppm

Dragon fruit 	2.0 ppm

Fruit, pome, group 11-10	1.7 ppm

Vegetable, fruiting, group 8-10	1.5 ppm

Vegetable, leafy, except brassica, subgroup 4A……………...	50 ppm

Citrus,
oil………………………...…………………………….60
ppm

The approved amended registrations for Vanguard™ WG (EPA Reg. No.
100-828), Switch 62.5 WG™ Fungicide (EPA Reg. No. 100-953), and
Inspire Super ™ Fungicide (EPA Reg. No. 100-1317) are limited to
expansions to add the commodities specified under the new crop
groups/subgroups and do not include substantive changes to currently
registered use patterns (i.e., maximum use rates, retreatment intervals,
preharvest intervals, use of adjuvants, etc.).  

™ Fungicide (EPA Reg. No. 100-953) to permit a new use on leafy
petioles subgroup 4B or establishing a tolerance for residues of
cyprodinil only in/on the following commodities:

		Leaf petioles subgroup 4B…………………………30 ppm

A human health risk assessment is forthcoming.

Notes to PM:

1.  A tolerance of 60 ppm was listed for citrus oil in the Notice of
Filing but a tolerance of 100 ppm was listed in Section F of the
petition.

  

2.  Use information was taken from Section B of the petition.  

Tolerances should be revised, as needed, to reflect the correct
commodity definitions as specified in Table 8.  

These recommendations are made concerning cyprodinil only.  Issues
concerning co-ingredient difenoconazole or fludioxonil will be discussed
in a separate memo.

A human heath risk assessment is forthcoming.	

 

Background

Cyprodinil is an anilino-pyrimidine fungicide used to control various
plant diseases on a wide variety of fruit, nut, vegetable and herb
crops.  Tolerances for residues of cyprodinil have been established
in/on a variety of crop commodities at levels ranging from 0.02-340 ppm
[40 CFR §180.532].  Tolerances have also been established at 0.02 ppm
for cyprodinil residues in meat byproducts of cattle, goats, horses, and
sheep.  No tolerance is established for poultry byproducts.  

The chemical structure, nomenclature, and physicochemical properties of
the technical grade of cyprodinil are presented in Tables 1 and 2.

 

Table 1.	Cyprodinil Nomenclature.

Compound	

Common name	Cyprodinil

Company experimental name	CGA219417

IUPAC name	(4-cyclopropyl-6-methyl –pyrimidin-2-yl)-phenyl-amine

CAS name	2-pyrimidinamine, 4-cyclopropyl-6-methyl-N-phenyl-

CAS registry number	121552-61-2

End-use product (EP)	75% water-dispersible granule formulation
(Vangard® WG Fungicide; EPA Reg. No. 100-828); a multiple active
ingredient (MAI) end-use product (Inspire Super ™ Fungicide; EPA Reg.
No. 100-1317) formulated as an emulsion [oil] in water (EW), containing
8.4% difenoconazole and 24.1% cyprodinil

Table 2.	Physicochemical Properties of Technical Grade of Cyprodinil.

Parameter	Value	Reference

Melting point/range	75.9 C	DP#s 345970 and 345182, W. Cutchin, 6/4/08

pH	9.5 at 25 C (1% aqueous dispersion)

	Density	1.21 g/cm3 at 20 C

	Water solubility (mg/L at 25 C)	pH 7.6		16

  SEQ CHAPTER \h \r 1 pH 5		20

pH 7		13

pH 9		15

	Solvent solubility (g/L at 25 C)	ethanol		160

acetone		610

toluene		460

n-octanol		160

n-hexane		30

	Vapor pressure	3.8 x 10-6 mm Hg at 25 C

	Dissociation constant, pKa	4.44 at 20 C

	Octanol/water partition coefficient, Log(KOW) at 25 C	3.9 at pH 5

4.0 at pH 7

4.0 at pH 9

	UV/visible absorption spectrum

(molar absorption coefficients for the absorbance maximum)	29,200
l/mol∙cm at 270.8 nm (neutral)

29,200 l/mol∙cm at 251.6 nm (acidic)

29,200 l/mol∙cm at 316.8 nm (acidic)

28,400 l/mol∙cm at 270.8 nm (basic)

	

860.1200  Directions for Use

Table 3.	Summary of Proposed Directions for Use of Cyprodinil

Applic. Timing, Type, and Equip.	Formulation

[EPA Reg. No.]	Applic. Rate 

(lb ai/A)	Max. No. Applic. per Season	Max. Seasonal Applic. Rate

(lb ai/A)	PHI

(days)	Use Directions and Limitations

Spinach

Broadcast foliar

Ground/Aerial/Chemigation	   Vangard WG

75% WDG

 [100-828]	0.114	4	0.34	0	A minimum retreatment interval (RTI) of 7 days
is proposed.  

Broadcast foliar

Ground Only	Switch 62.5WG

37.5% WDG

 [100-953]	0.33	4 implied	1.31	0	A minimum retreatment interval (RTI) of
7-10 days is proposed.

Celery

Broadcast foliar

Ground/Aerial/Chemigation	Vangard WG

75% WDG

 [100-828]	0.33	2 by aerial

4 implied	1.3	0	A minimum retreatment interval (RTI) of 7-10 days is
proposed.

Broadcast foliar

Ground Only	Switch 62.5WG

37.5% WDG

 [100-953]	0.33	4 implied	1.31	0	A minimum retreatment interval (RTI) of
7-10 days is proposed.

Pepper

Broadcast foliar

Ground/Aerial/Chemigation	Vangard WG

75% WDG

 [100-828]	0.33	2 by aerial

4 implied	1.3	0	A minimum retreatment interval (RTI) of 7-10 days is
proposed.

Broadcast foliar

Ground Only	Switch 62.5WG

37.5% WDG

 [100-953]

	0.33

	4 implied

	1.31	0	A minimum retreatment interval (RTI) of 7-10 days is proposed.

Broadcast foliar

Ground/Aerial/Chemigation	Inspire Super

2.09 lb/gal EW

[100-1317]	0.33	2 by aerial

4 implied	1.3	0	A minimum retreatment interval (RTI) of 7-10 days is
proposed.

Conclusions.  The proposed use directions are sufficient to allow for
evaluation of the available residue data.  The submitted field trials
for spinach and celery used adjuvants, while the field trials for
peppers did not.  Thus, a revised section B must be submitted
prohibiting the use of adjuvants for peppers.  In addition, no pepper
field trials were conducted with the Inspire Super EW formulation. 
Therefore, peppers must be removed from the label for Inspire Super.

860.1300 Nature of the Residue - Plants

DP# 219794, G. Kramer, 2/13/96 

DP# 233182, G. Kramer, 2/20/98 

MARC Decision Memo, DP# 243198, G. Kramer, 3/11/98

The nature of the residue in plants is adequately understood based on
acceptable metabolism studies on apple, peach, potato, tomato, and
wheat.  These studies indicated that cyprodinil is metabolized primarily
by hydroxylation followed by sugar conjugation.  Cleavage of the amino
bridge, opening of the pyrimidine ring, opening of the cyclopropyl ring
and formation of thiolactic acid conjugates are minor pathways. 
Incorporation into starch was observed in potato tubers and wheat grain.
 The MARC reviewed these studies and determined that the residue of
concern, for purposes of tolerance enforcement and risk assessment, is
cyprodinil. 

860.1300 Nature of the Residue - Livestock

DP# 233182, G. Kramer, 2/20/98 

MARC Decision Memo, DP# 243198, G. Kramer, 3/11/98

DP# 345970 and 345182, G. Kramer, 6/4/08

DP# 362486, J. Stokes, 9/15/09

The nature of the residue in ruminants is adequately understood based on
acceptable lactating goat metabolism studies using [14C-phenyl] and
[14C-pyrimidinyl] cyprodinil.  The metabolism of cyprodinil in ruminants
proceeds predominantly via hydroxylation followed by conjugation with
sulfuric and glucuronic acid.  Breakdown of the pyrimidinyl ring was
seen only in the liver and resulted in Metabolite L1.  Cleavage of the
amino bridge between the phenyl and the pyrimidinyl rings was only a
minor reaction as indicated by the small amounts of CGA 249287 found in
the liver and kidneys of goats dosed with [14C-pyrimidinyl]cyprodinil.

HED originally concluded that were no cyprodinil metabolites of
toxicological or regulatory concern in ruminant milk and tissues based
on the dietary burden associated with the registered cyprodinil uses at
that time (362486, J. Stokes, 09/15/09; 378920, B. Cropp-Kohlligian,
10/27/10).  However, HED noted that if future uses significantly
increase the potential livestock dietary burden, then a new cyprodinil
feeding study would be required in which residues of cyprodinil and CGA
304075 (both free and conjugated) are determined.  ARIA subsequently has
concluded that the residues of concern for both risk assessment and the
tolerance definition should include the combined residues of cyprodinil
and metabolite CGA-304075 (free and conjugated), expressed in parent
equivalents.

A poultry metabolism for cyprodinil has not been submitted and none has
been requested since the potential dietary exposure of poultry to
cyprodinil residues is extremely low (estimated at 0.005 ppm based on
canola meal consumption).  Since there are no poultry feedstuffs
associated with the proposed amended uses of cyprodinil on tree nuts,
then at this time a poultry metabolism study is not needed and the uses
cannot be considered “Category 3 for poultry.  However, if future crop
are added that produce poultry feedstuffs, then HED may require a study.

860.1340 Residue Analytical Methods

Enforcement methods.  Adequate HPLC/UV methods with column switching
(Syngenta Methods AG-631 and AG-631B) are available for enforcing
tolerances of cyprodinil on plant commodities.  The LOQs for these
methods range from 0.01 to 0.05 ppm depending on the plant commodities. 
Method AG-631B also contains procedures for confirmatory analysis by
GC/NPD.  

An adequate HPLC/MS method (GRM010.01A) is also available for enforcing
tolerances in livestock commodities.  This method determines residues of
both parent and the metabolite CGA-304075 (free and conjugated),
expressed as parent.  The LOQ is 0.01 ppm for each analyte for a
combined LOQ of 0.02 ppm.

Data collection methods.   In the submitted field trial study, residues
of cyprodinil in/on spinach, pepper, and lemon were determined with a
method using high performance liquid chromatography with a tandem mass
spectrometer (LC/MS/MS), which is a modified version of the HPLC/UV
Syngenta Method AG-631B, “Analytical Method for the Determination of
Residues of CGA-219417 in Crops by High Performance Liquid
Chromatography with Column Switching.”  Syngenta Methods AG-631 and
AG-631B are the current tolerance enforcement methods for determining
cyprodinil in plant commodities.  In the submitted field trial study for
celery, residues were analyzed by using a high performance liquid
chromatography method with tandem mass spectrometric detection
(LC/MS/MS), Syngenta method AG-597B.  This method is actually the
current tolerance enforcement method for fludioxonil in plant
commodities and was modified by NCL to enable simultaneous extraction of
both cyprodinil and fludioxinil from celery obviating Syngenta Method
AG-631B which is the current tolerance enforcement method for
determining cyprodinil in plant commodities.  To further verify the
suitability of the method for analysis of cyprodinil, a side-by-side
comparison of the extraction solutions used in Methods AG-597B
(acetonitrile:water, 90:10, v/v) and AG-631B (methanol:water, 80:20,
v/v) was conducted to determine the relative performance of the two
methods and to provide bridging data to support Method AG-597B modified
for LC/MS/MS.  The ACN/water extraction provided acceptable recoveries
(84.2-85.2%) of cyprodinil at the 0.05 and 25 ppm fortification levels. 
In addition, the ACN/water extraction procedure extracted more incurred
residues of cyprodinil with less variability than the methanol/water
extraction procedure (i.e., 1.1 and 5.4% RSD for cyprodinil).  

For method AG-631B, residues of cyprodinil were extracted with
methanol:water (8:2, v/v), filtered, and acidified with dilute HCl. 
Residues were then cleaned-up by elution through a SPE column with
ammoniated methanol.  Residues were concentrated, reconstituted with
0.1% ammonium acetate, and analyzed by LC/MS/MS using a Phenomenex
Synergi 4 micron Polar-RP 80A column (75 x 2.00 mm) and a
multi-component mobile phase (Component A was 0.1% ammonium acetate in
water and Component B was 90/10 acetonitrile:water plus 0.1% ammonium
acetate) with gradient elution.  The m/z 226.1→93.1 ion transition was
used for detection and quantitation of cyprodinil.  Residues were
quantified using external standards. The validated LOQ was 0.01 ppm for
almond and pecan; the LOD was not reported. For method AG-597B, residues
of cyprodinil were extracted with acetonitrile (ACN):water (90:10, v:v)
by shaking at room temperature.  An aliquot of each extract was
centrifuged and filtered.  An aliquot of the filtered extract was
diluted 1:5 with 0.1% acetic acid in water and vortex mixed and then
analyzed by LC/MS/MS.

 

Both methods was validated in conjunction with the analysis of field
trial samples.  Control samples of peppers were fortified with
cyprodinil at 0.01-2.1 ppm.  Recoveries ranged from 71-112.  Control
samples of spinach were fortified with cyprodinil at 0.02-51 ppm. 
Recoveries ranged from 73-113.  Control samples of lemon, lemon dried
pulp, lemon juice, and lemon oil were fortified with cyprodinil at 0.02
ppm, 0.01-2 ppm, 0.01-2.0 ppm, and 0.02-51 ppm, respectively. 
Recoveries ranged from 73-117.Control samples of celery were fortified
with cyprodinil at 0.05-0.5 ppm.  Recoveries ranged from 85-107.

Conclusions.  Adequate HPLC/UV methods are available for enforcing the
proposed new uses.  

All residues of cyprodinil were determined using an adequate LC/MS/MS
method.  The LC/MS/MS method LOQ for residues of cyprodinil in/on
peppers, spinach, lemon, lemon dried pulp, lemon juice, lemon oil, and
celery is 0.01, 0.02, 0.02, 0.01, 0.01, 0.02, and 0.05 ppm,
respectively.

860.1360 Multiresidue Methods

Data are available depicting the recovery of cyprodinil and its
metabolite CGA-232449 through FDA Multiresidue method testing protocols
(C through E).  Acceptable recoveries were obtained for cyprodinil in
apple fortified at 0.50 ppm using Protocol D.  These data were forwarded
to FDA (G. Kramer, 11/28/1995).

860.1380 Storage Stability

DER 47161101-7, W. Cutchin,, 04/18/08)

Peppers, spinach, lemon, lemon dried pulp, lemon juice, lemon oil, and
celery samples were stored frozen (-20°C ± 10°C) for up to 9, 22.
3.5, 4.8, 5.6, 10.3, and 7.2 months before analysis, respectively. 
Demonstrated storage stability for the submitted field trial samples
include 9 months for peppers, 5.8 months for dried lemon pulp, 5.9
months for lemon juice, and 10.6 months for lemon oil.  The stability of
cyprodinil has been demonstrated in a variety of other crops, including
mustard greens for 20 months and grape, wine, apple, wheat (ear and
stalk), strawberry, and potato for up to 2 years (D233182, G. Kramer,
02/20/98; D288706, T. Bloem ,7/24/03).  Therefore, the submitted field
trial data are supported by acceptable storage stability data.  

860.1400 Water, Fish, and Irrigated Crops

The proposed uses are not relevant to this guideline.

860.1460 Food Handling

The proposed uses are not relevant to this guideline.

860.1480 Meat, Milk, Poultry, and Eggs

DP#s 345970 and 345182, W. Cutchin, 6/4/08

DP# 362484, J. Stokes, 9/15/09

DP# 378920, B. Cropp-Kohilligian, 10/27/10

Adequate cattle feeding studies are available for cyprodinil, and
tolerances for cyprodinil residues in livestock commodities were
assessed in conjunction with petitions for tolerances on various plant
commodities (DP#s 345970, 345182, and 378920).  Using the Agency’s
most recent guidance on constructing reasonably balanced livestock diets
the maximum reasonably dietary burdens (MRDBs) of livestock for
cyprodinil residues were calculated to be 0.88 ppm for beef cattle, 1.2
ppm for dairy cattle, and 0.005 ppm for poultry and swine.  Based on
these MDBs, tolerances for residues of cyprodinil and free and
conjugated CGA-304075, expressed in parent equivalents, were required on
meat byproducts of cattle, goats, horses, and sheep at 0.02 ppm (LOQ).  

Based on the proposed modified use pattern of cyprodinil on almond and
consequently a proposed increase in the established almond hull 8.0 ppm
tolerance to 20 ppm, HED recalculated the dietary burden using almond
hull in place of wet apple pomace.  The dietary contribution from the
almond hulls alone did not increase the total dietary burden.  However,
this proposed amended use on almonds was withdrawn and the increased
tolerance for almond hulls did not occur.

Conclusions.  The proposed new uses do not contain any livestock feed
stuffs, therefore, HED has determined that the currently established
0.02 ppm tolerance levels for meat byproducts of cattle, goats, horses,
and sheep are adequate. 

860.1500 Crop Field Trials – Peppers, Spinach, & Celery 

MRID #s 48437401, 48437402, 48437403, & 48478501

  SEQ CHAPTER \h \r 1 The results from the field trials are summarized
below  SEQ CHAPTER \h \r 1 .

TABLE 4	Summary of Residue Data from Pepper Field and Greenhouse Trials
with Cyprodinil.

Commodity	Total App. Rate (lb ai/A)

[g a.i./ha]	PHI (days)	Residue Levels (ppm)1

	n	Sample

Min.	Sample

Max.	LAFT2	HAFT2	Median	Mean	Std. Dev.

Field Trials

Bell Pepper	1.302-1.417

[1459.0-1588.3]	0	18	0.023	0.697	0.036	0.682	0.149	0.201	0.191

Nonbell Pepper	1.308-1.339

[1466.1-1500.8]	0	10	0.119	0.818	0.169	0.668	0.225	0.318	0.209

Greenhouse Trials

Bell Pepper	1.304-1.315

[1461.6-1473.9]	0	8	0.04	0.32	0.08	0.27	0.21	0.20	0.09

Nonbell Pepper	1.327

[1487.4]	0	2	0.58	0.60	0.59	0.59	0.59	0.59	--

1  n = no. of samples.  

2  LAFT = lowest-average-field-trial; HAFT =
highest-average-field-trial.

TABLE 5	Summary of Per Trial Average Residue Data from Crop Field Trials
with Cyprodinil.

Commodity	Total App. Rate (lb ai/A)

[g a.i./ha]	PHI (days)	Residue Levels (ppm)1

	n	Sample

Min.	Sample

Max.	LAFT2	HAFT2	Median	Mean	Std. Dev.

Spinach	1.300-1.367

[1457.1-1532.2]	0	22	4.58	36.9	5.64	32.1	10.3	11.8	7.36

1  Except for sample min/max, values reflect per trial averages; n = no.
of samples.  

2  LAFT = lowest-average-field-trial; HAFT =
highest-average-field-trial.

TABLE 6	Summary of Per Trial Average Residue Data from Crop Field Trials
with Cyprodinil.

Commodity	Total App. Rate (lb ai/A)	PHI (days)	Residue Levels (ppm)1

	n	Sample

Min.	Sample

Max.	LAFT2	HAFT2	Median	Mean	Std. Dev.

Celery	2.16-2.23	0	8	3.2	17	3.5	17	8.5	8.7	4.5

1  Except for sample min/max, values reflect per trial averages; n = no.
of field trials.  

2  LAFT = lowest-average-field-trial; HAFT =
highest-average-field-trial.

Following four foliar applications of the MAI product formulation at a
total rate of 1.302-1.417 lb cyprodonil/A (1459.0-1588.3 g
cyprodinil/ha), residues of cyprodinil (and per trial averages) in/on
bell and nonbell peppers, respectively, at a 0-day PHI were 0.023-0.697
ppm and 0.119-0.818 ppm (0.036-0.682 ppm and 0.169-0.668 ppm) from the
field trials and 0.04-0.32 ppm and 0.58-0.60 ppm (0.08-0.27 ppm and 0.59
ppm) from the greenhouse trials.

Residue decline data show that cyprodinil decreases in field bell
peppers and greenhouse bell peppers with increasing pre-harvest
intervals.

Residues of cyprodinil (and per trial averages) were 4.58 -36.9  ppm
(5.64-32.1 ppm) in/on spinach samples harvested 0 days following the
last of four foliar broadcast applications of the MAI product
formulation at a total seasonal rate of 1.300-1.367 lb cyprodonil/A
(1457.1-1532.2 g cyprodinil/ha).

Residue decline data show that cyprodinil decreases in spinach with
increasing pre-harvest intervals.

Residues of cyprodinil (and per trial averages) were 3.2 -17 (3.5-17)
ppm in/on celery samples harvested 0 days following the last of four
foliar broadcast applications of the WG MAI product formulation (37.5%
cyprodinil and 25% fludioxonil) at a total seasonal rate of 2.16-2.23 lb
ai/A (cyprodinil). 

Residue decline data show that cyprodinil decreases in celery with
increasing pre-harvest intervals.

Conclusion: The data adequately support the requested crop group
tolerance and proposed use patterns.  

860.1520 Processed Food and Feed 

MRID #s 48437404 and 48437405

The results from the lemon processing study are summarized below  SEQ
CHAPTER \h \r 1 .

Table 7	Residue Data from Lemon Processing Study with Cyprodinil.

RAC	Processed Commodity	Total Rate

(lb ai/A)	PHI 

(days)	Residues (ppm)1	Processing Factor2

Lemon	Lemon (RAC)	0.336 	0	0.185

0.214

(0.200)	--

	Dried Pulp

	0.578

0.639

(0.609)	3x

	Juice

	<0.01

<0.01

(<0.01)	<0.05x

	Oil

	34.6

35.2

32.5

(34.1)	171x

LOQ (LLMV) was 0.01 ppm for lemon dried pulp and lemon juice, and 0.02
ppm for lemon oil. Average residues are bolded and reported in
parenthesis.

Processing Factor = [Measured residue for analyte in the processed
fraction] / [Measured residue for analyte in the RAC].  

Residues of cyprodinil concentrated in dried lemon pulp and oil, but did
not concentrate in lemon juice.

Conclusion:  The submitted lemon processing study is adequate.  The
tolerance for citrus oil can be decreased to 60 ppm (0.34 ppm x 171= 58
ppm).

860.1550 Harmonization with Codex

There are currently established Codex maximum residue limits (MRLs) for
residues of cyprodinil in/on eggplant (0.2 mg/kg), peppers, sweet (0.5
mg/kg), and tomato (0.5 mg/kg).  Neither Codex or Canada have MRLs for
the leafy petioles crop group.

It is not possible to harmonize with Codex MRLs for residues of
cyprodinil in/on eggplant, peppers, and tomato.  It is not possible to
harmonize with Codex and Canadian MRLs for residues of cyprodinil in/on
these commodities because the US is recommending the establishment of a
fruiting vegetable group 8 tolerance at 1.5 ppm, and removal of the
existing 0.45 ppm tolerance in/on tomato and tomatillo, along with the
1.0 ppm tolerance on tomato paste.  Canada is proposing a fruiting
vegetable crop group 8-10 MRL and an MRL for the Vegetable, leafy,
except brassica, subgroup 4A.

  SEQ CHAPTER \h \r 1 860.1650 Submittal of Analytical Reference
Standards

Analytical standards for cyprodinil (expiration date 9/30/2012) and
CGA-304075 (expiration date 8/31/2012) are currently available in the
EPA National Pesticide Standards Repository (email communication with T.
Cole, ACB, 09/xx/2011).  

860.1850/1900 Confined and Field Accumulation in Rotational Crops

DP# D257898, S. Levy, 2/8/2000

DP# D326346, W. Wassell, 10/18/2006

Adequate confined and limited field rotational crop studies are
available and were conducted at 2.2x and 1.5x the current maximum use
rate for rotated crops (1.3 lb ai/A).  On the basis of these studies,
the HED requested a field rotational crop study which also monitored for
residues of CGA-232449, NOA-422054, CGA-249287, and CGA-263208.  

In the subsequent field accumulation study, cyprodinil (WDG) was applied
to mustard greens at four test sites in CA (2 tests) and NY (2 tests) as
four broadcast foliar applications at 0.328 lb ai/A/application at 7-day
retreatment intervals for a total of 1.31 lb ai/A (1x rate).  The
primary mustard greens crop was destroyed and removed 7 days after the
final application, and rotational crops of wheat, lettuce and garden
beets were planted at PBIs of 27 to 32 days.  Samples of lettuce, garden
beet roots and tops, and wheat forage, hay, straw and grain were
collected from each test at the appropriate stage of maturity.  All
samples were analyzed for residues of parent and each metabolite
(CGA-232449, NOA-422054, CGA-249287, and CGA-263208) using an adequate
HPLC/MS method (Method 2213-01), which has a validated LOQ of 0.05 ppm
for parent and each metabolite.  

As residues of parent and each metabolite were <LOQ in/on all lettuce,
garden beet and wheat RAC samples, HED concluded that rotational crop
tolerances are not currently required.

860.1550 Proposed Tolerances

The Agency has determined that the residue of concern in plant
commodities for the tolerance expression is only cyprodinil.  
Tolerances have been established for residues of cyprodinil in/on a
variety of crop commodities, at levels ranging from 0.02 ppm in/on
almond to 340 ppm in citrus oil [40 CFR §180.532(a)].  Tolerances have
also been established at 0.02 ppm for cyprodinil and its metabolite
CGA-304075 residues in meat byproducts of cattle, goats, horses and
sheep.  

Table 8. 	Tolerance Summary for Cyprodinil

Commodity	Established/Proposed Tolerance (ppm)	Recommended Tolerance
(ppm)	Comments; Correct Commodity Definition

Tolerances Proposed Under PP#1E7854

Onion, bulb subgroup 3-07A	0.6	0.6	Onion, bulb, subgroup 3-07A

Onion, bulb subgroup 3-07B	4.0	4.0	Onion, green, subgroup 3-07B

Caneberry subgroup 13-07A	10.0	10	---

Bushberry subgroup 13-07B	3.0	3.0	---

Small fruit vine climbing subgroup 13-07F, except fuzzy kiwifruit	2.0
2.0	Fruit, small vine climbing, except fuzzy kiwifruit, subgroup 13-07F

Low growing berry subgroup 13-07G, except cranberry	5.0	5.0	Berry, low
growing, subgroup 13-07G

Vegetable, fruiting, group 8-10	1.3	1.5	---

Vegetable, leafy, except Brassica, subgroup 04A	40	50	Vegetable, leafy,
except brassica, subgroup 4A

Fruit, pome, group 11-10	1.7	1.7	---

Dragonfruit	2.0	2.0	Dragon fruit

	Tolerances That Need Amended Under PP#1E7854

Citrus, oil	100 ppm Section F

60 ppm NOF	60	---

	Tolerances That Need Removed Under PP#1E7854

Onion, bulb	0.60

Onion, green	4.0

Caneberry subgroup 13A	10

Bushberry subgroup 13B	3.0

Grape	2.0

Strawberry	5.0

Tomato	0.45

	Tolerances Proposed Under PP#1E7869

Leafy petioles subgroup 04B	30	30	Leaf petiole subgroup 4B

References

DP Numbers:	378920

Subject:		Cyprodinil.  Cyprodinil.  Amended Use and Amended Tolerance
Petition for Pome Fruit.  Summary of Analytical Chemistry and Residue
Data. 

From:		B. Cropp-Kohlligian

To:		L. Jones

Dated:		10/27/10

MRID(s):	47644301

DP Numbers:	362486

Subject:		Cyprodinil.  Petition for Tolerance on Canola Seed Imported
from Canada.  Summary of Analytical Chemistry and Residue Data.  

From:		J. Stokes

To:		L. Jones

Dated:		09/15/09

MRID(s):	47644301

DP Numbers:	345970 and 345182

Subject:		Cyprodinil.  Section 3 Requests for Uses on Tomato, Avocado,
Herbs, Root Vegetables, Leaves of Root and Tuber Vegetables, Lemon,
Lime, Cucurbits, Kiwifruit, Green and Dry Bulb Onions, and Strawberries.
 Registrant’s Response to Conditional Registration on Carrots and
Brassica Vegetables and Livestock Feeding Study.  Summary of Analytical
Chemistry and Residue Data.  

From:		W. Cutchin

To:		W. Cutchin/B. Madden

Dated:		06/04/08

MRID(s):	47161101-47161107 and 47169305-47169311

DP Number:	326346

Subject:		Registration:  100-953; PP#8E05012; Cyprodinil on Onions. 
Review of Revised Label, Field Accumulation in Rotational Crops, Storage
Stability, and Analytical Methods Data Requested as Conditions of
Registration.

From:	W. Wassell

To:	L. Jones/M. Waller

Dated:	10/18/06

MRID(s):	46078901, 46078903, 46165901

DP Number:	288706, 288708, 288710, and 288773

Subject:		Cyprodinil (PC Code 288202).  Section 3 Registration for
Application of Cyprodinil to Lychee, Longan, Spanish Lime, Rambutan, and
Pulasan (ID# - 2E06447); Brassica Leafy Greens Crop Subgroup, Head and
Stem Brassica Crop Subgroup, and Turnip Greens (ID# - 2E06485); Carrot
(ID# - 2E06461); and Herb Crop Subgroup (ID# - 3E06529).  Summary of
Residue Chemistry Data. 

From:		T. Bloem

To:		R. Forrest

Dated:		07/24/03

MRID(s):	45682401, 45721502, 45726101, 45726102, 45795301, 45795302, and
45839801

DP Number:	257898

Subject:	PP# 8E05012.  Cyprodinil in/on Strawberries and Bulb Vegetables
(Crop Group 3).  Evaluation of Residue Data and Analytical Methods.  

From:	S. Levy

To:	R. Forrest/S. Brothers

Dated:	02/08/00

MRID(s):	44615602, 44615601, 44867312, 44867314

DP Numbers:	243198

Subject:	Cyprodinil.  HED Metabolism Assessment Review Committee Meeting
of 02/10/98.

From:	G. Kramer

To:	HED MARC Members

Dated:	03/11/98

MRID(s):	None

DP Numbers:	233561, 233562, 233928, 233182, 239674, and 236086

Subject:	PP# 6F04656. New Chemical- Cyprodinil (i.e., Vangard®) in/on
Stone Fruit, Pome Fruit, Almonds and Grapes. Evaluation of Residue Data
and Analytical Methods.  

From:	G. Kramer

To:	M. Waller/T. Ellwanger

Dated:	02/20/98

MRID(s):	44186401, 44186404 and 44186410 thru 44186420; 43908402,
43908403 and 43908438 thru 43908445; 44382601; and 44275401 and 44275402

DP Number:	219794

Subject:	PP#s 5G04553.  New Chemical – Cyprodinil and Propiconazole in
or on Stone Fruit.  Evaluation of Residue Data and Analytical Methods.

From:	G. Kramer

To:	C. Welch/ K. Whitby

Dated:	02/13/96

MRID(s):	43709001 through 43709004, 43709048 through 43709055, and
43737603

DP Number:	None

Subject:	Multiresidue Method Testing Data for Cyprodinil and CGA-232449

From:	G. Kramer

To:	B. McMahon, FDA

Dated:	11/28/95

MRID(s):	43709050

  SEQ CHAPTER \h \r 1 Attachments:  

Appendix I - International Tolerances

Appendix II – Tolerance Assessment Calculations

F.	DOCUMENT TRACKING

RDI:  SHummel 05/3/12

Petition Number: 1E7854 & 1E7869

DP#: 389554 & 391680

PC Code: 288202

Template Version September 2005 

Appendix I.  International Tolerances

Cyprodinil (PC Code 288202; 03/06/12)

Summary of US and International Tolerances and Maximum Residue Limits 

Residue Definition: 

US	Canada	Mexico2	Codex

40 CFR 180.532:

Plant/Livestock: Sum of cyprodinil
4-cyclopropyl-6-methyl-N-phenyl-2-pyrimidinamine and free and conjugated
CGA-304075 4-(4-cyclopropyl-6-methyl-pyrimidin-2-ylamino)-phenol,
calculated as the stoichiometric equivalent of cyprodinil.
4-cyclopropyl-6-methyl-N-phenyl -2- pyrimidinamine

Cyprodinil

The residue is fat soluble.

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

	US	Canada	Mexico2	Codex

Onion, bulb subgroup 3-07A		0.60

	0.3 onion, bulb

Onion, green subgroup 3-07B	4.0	4.0 green onions

Caneberry  subgroup 13-07A	10	6.2  blackberries, loganberries, 
raspberries

0.5 raspberries, red, black

Bushberry subgroup 13-07B	3.0	2.0 blueberries, currants, elderberries,
gooseberries, huckleberries, lingonberries, salal berries, saskatoon
berries (juneberries)

Small fruit vine climbing subgroup 13-07F, except fuzzy kiwifruit	2.0
2.0 gooseberries, grape

3.0 raisins

3 grapes

5 dried grapes (=currants, raisins and sultanas)

Low growing berry subgroup 13-07G, except cranberry	5.0	2.0 blueberries,
 lingonberries

 3.5 strawberries

2 strawberry

Dragon fruit	2.0

	Fruit, pome, group 11-10	1.7	0.1 pome fruit  

0.05 apple

1 pear

Vegetable, fruiting, group 8-10	1.5

	0.2 eggplant

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leaves, dock, edible leaved chrysanthemum, endives, fresh chervil
leaves,  fresh parsley leaves, garden cress, garden purslane , garland
chrysanthemum, head lettuce, leaf lettuce, orach leaves, radicchio,
upland cress, winter purslane

10 lettuce, head, lettuce, leaf

Citrus oil	60

	Leafy petioles subgroup 04B	30

	Completed: M. Negussie; 03/08/12

1 Includes only commodities of interest for this action.  Tolerance
values should be the HED recommendations and not those proposed by the
applicant.

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

Appendix II.  Tolerance Assessment Calculations.

For each of the crops listed below, the OECD MRL Calculator User Guide
(SOP), along with the tolerance spreadsheet, was used for calculating
recommended tolerances.  As specified in the SOP, the tolerance
calculation is in the region of the 95th percentile of the underlying
residue distribution, and is more likely to overestimate rather than
underestimate the 95th percentile.  The rounding procedures specified in
the SOP were also used.  The OECD tolerance spreadsheet does not require
the use of maximum-likelihood estimation (MLE) procedures for values
<LOQ.

Using the OECD MRL Calculator, the recommended tolerances are 50 ppm for
spinach, 1.0 ppm for peppers and 30 ppm for celery.    



Cyprodinil

Spinach

US/PMRA

0 day PHI

 	 

Total number of data (n)	11

Percentage of censored data	0%

Number of non-censored data	11

Lowest residue	5.640

Highest residue	32.100

Median residue	10.700

Mean	11.773

Standard deviation (SD)	7.319

Correction factor for censoring (CF)	1.000

 	 

Proposed MRL estimate	 

 	 

- Highest residue	32.100

- Mean + 4 SD	41.050

- CF x 3 Mean	35.318

Unrounded MRL	41.050

 	 

Rounded MRL	50

 	 

 

 

Residues (mg/kg)	n

5.64	1

6.08	1

6.59	1

8.26	1

9.63	1

10.7	1

11.4	1

11.9	1

13	1

14.2	1

32.1	1

Cyprodinil

Bell Pepper

US

0-day PHI

 	 

Total number of data (n)	13

Percentage of censored data	0%

Number of non-censored data	13

Lowest residue	0.036

Highest residue	0.682

Median residue	0.189

Mean	0.200

Standard deviation (SD)	0.165

Correction factor for censoring (CF)	1.000

 	 

Proposed MRL estimate	 

 	 

- Highest residue	0.682

- Mean + 4 SD	0.860

- CF x 3 Mean	0.601

Unrounded MRL	0.860

 	 

Rounded MRL	0.9

 	 

 

 

Residues (mg/kg)	n

0.0358	1

0.0383	1

0.08	1

0.1	1

0.134	1

0.152	1

0.189	1

0.21	1

0.23	1

0.234	1

0.248	1

0.27	1

0.682	1

Cyprodinil

Non-bell Pepper

US

0-day PHI

 	 

Total number of data (n)	6

Percentage of censored data	0%

Number of non-censored data	6

Lowest residue	0.169

Highest residue	0.668

Median residue	0.275

Mean	0.363

Standard deviation (SD)	0.211

Correction factor for censoring (CF)	1.000

 	 

Proposed MRL estimate	 

 	 

- Highest residue	0.668

- Mean + 4 SD	1.209

- CF x 3 Mean	1.090

Unrounded MRL	1.209

 	 

Rounded MRL	1.5

 	 

 High uncertainty of MRL estimate.

[Small dataset]

Residues (mg/kg)	n

0.169	1

0.202	1

0.273	1

0.277	1

0.59	1

0.668	1

Cyprodinil

Leafy Petioles - Celery

US

0 day PHI

 	 

Total number of data (n)	8

Percentage of censored data	0%

Number of non-censored data	8

Lowest residue	3.500

Highest residue	16.500

Median residue	8.450

Mean	8.656

Standard deviation (SD)	4.472

Correction factor for censoring (CF)	1.000

 	 

Proposed MRL estimate	 

 	 

- Highest residue	16.500

- Mean + 4 SD	26.544

- CF x 3 Mean	25.969

Unrounded MRL	26.544

 	 

Rounded MRL	30

 	 

 

 

Residues (mg/kg)	n

3.5	1

3.6	1

5.95	1

7.2	1

9.7	1

10.8	1

12	1

16.5	1

Cyprodinil	Summary of Analytical Chemistry and Residue Data	DP#:  389554
& D391680

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