Document ID: EPA-HQ-OPP-2007-0107-0006
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2008-03-26T04:00Z

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF           

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

MEMORANDUM

Date:		10/1/07

Subject:	Myclobutanil.  Section 3 Requests for Use on Snap Bean, Mint,
Papaya, Gooseberry, Currant, Caneberry, Bell and Non-Bell Pepper, Head
and Leaf Lettuce, and Artichoke.  Summary of Analytical Chemistry and
Residue Data. PP#s: 7E4861, 7E4877, 3E6562, 8E4939, 6E7138, & 7E4866. 

DP Num:  341689	Decision#: 372360

PC Code:  128857	40 CFR:  180.443

MRID:  45596301, 45880301, 45883401, 45908101, 45908201, 45910601, &
46990901-03

	

From:		W. Cutchin, Acting Branch Senior Scientist

		Alternative Risk Integration Assessment Team (ARIA)

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

		Registration Division (RD; 7505P)

Through:	George F. Kramer, Ph.D., Senior Chemist

		Registration Action Branch (RAB1)

		Health Effects Division (HED) (7509P)

To:		Barbara Madden, RM Team 05

		RIMUERB/RD (7505P)

The Interregional Research Project No. 4 (IR-4) has submitted petitions
for the use of myclobutanil
[α-butyl-α-(4-chlorophenyl)-1H-1,2,4-triazole-1-propanenitrile] and
the establishment of permanent tolerances for the combined residues of
myclobutanil and its alcohol metabolite, RH-9090
[α-(3-hydroxybutyl)-α-(4-chlorophenyl)-1H-1,2,4-triazole-1-propanenitr
ile] 6-chloro-3-pyridinyl)methyl]-N-nitro-2-imidazolidinimine, expressed
as the parent, in/on the following raw agricultural commodities (RACs): 

Commodity	Proposed Tolerance

(ppm)

Crop group 8, except tomato	4.5

Okra	4.5

Crop subgroup 4A, except spinach	11

Cilantro	11

Artichoke	0.9

Papaya	2.0

Black sapote	2.0

Canistel	2.0

Mamey sapote	2.0

Mango	2.0

Sapodilla	2.0

Star apple	2.0

In addition, IR-4 has submitted data in support of the requests to
remove the conditions of registration for myclobutanil on bean, snap,
succulent; peppermint and spearmint; gooseberry; currant; and caneberry.

Permanent tolerances are currently established for the combined residues
of myclobutanil and its RH-9090 metabolite (free and bound) in/on a
variety of RACs at levels ranging from 0.02 to 25.0 ppm and in meat,
milk, poultry, and eggs at levels ranging from 0.02 to 1.0 ppm [40 CFR
§180.443(a)].  In addition, tolerances in conjunction with Section 18
registrations have been established for a number of RACs under 40 CFR
§180.443(b).  Tolerances for indirect or inadvertent residues of
myclobutanil have been established for several crop groups under 40 CFR
§180.443(d).

The proposed uses are: snap beans are to be treated with four
applications at 0.125 lb ai/A (0.50 lb ai/A, total rate) with 7 to 8
days retreatment intervals (RTI) and a 0-day PHI; mint is to be treated
with three applications at 0.125 lb ai/A (0.375 lb ai/A, total rate)
with 12 to 15 days RTI and a PHI of 30 days; papayas are to be treated
with eight applications at 0.25 lb ai/A (2.0 lb ai/A, total rate) with
13 to 15 days RTI and a 0-day PHI; gooseberries are to be treated with
eight applications at 0.125 lb ai/A (1.0 lb ai/A, total rate) with 10 to
14 days RTI and a 0-day PHI; currants are to be treated with three
applications at 0.125 ai/A (1.0 lb ai/A, total rate) with applications
at pre-bloom, full bloom and 2 weeks later and a 0-day  PHI; caneberries
are to be treated with four applications at 0.03 to 0.60 lb ai/A (0.25
lb ai/A, total rate) with 10 to 14 days RTI and a 0-day PHI; peppers are
to be treated with four applications at 0.0625 to 0.125 lb ai/A (1.25 lb
ai/A, total rate) with 10 to 14 days RTI and a 0-day PHI;  lettuce is to
be treated with four applications at 0.0625 to 0.125 lb ai/A(1.25 lb
ai/A, total rate) with 10 to 14 days RTI and a 3-day PHI ; and
artichokes are to be treated with six applications at 0.075 to 0.1 lb
ai/A (0.6 lb ai/A, total rate with a14-day RTI and a 3-day PHI. 

The nature of the residue in plants and livestock is adequately
understood.  The residues of concern in plants are myclobutanil and its
metabolite RH-9090 (free and bound).  The residues of concern in
livestock commodities except milk are myclobutanil and its metabolite
RH-9090 (free).  The residues of concern in milk are myclobutanil and
its metabolites RH-9090 (free and bound) and α -(4-chlorophenyl)-
α-(3,4-dihydroxybutyl) -1H-1,2,4-triazole-1-propanenitrile.  An
adequate enforcement method for plant commodities, Rohm and Haas Method
34S-88-10, is available to enforce the proposed tolerances. 
Quantitation is by gas chromatography using nitrogen/ phosphorus
detector (GC/NPD) for myclobutanil and an electron capture detector
(GC/ECD) for the alcohol metabolite.  The methods used for data
collection, are based on the enforcement method and are adequate.  The
lower limit of method validation (LLMV) for both myclobutanil and its
metabolite RH-9090 ranged from 0.01-0.02 ppm in the submitted studies. 
The Food and Drug Administration (FDA) Multiresidue Method (MRM)
database indicates that complete recovery has been obtained for
myclobutanil under Method D and variable recovery has been obtained
under Method A.  The alcohol metabolite, RH-9090, has a variable
recovery under Method A.  There is adequate storage stability data to
support the submitted residue field trials.

None of the raw agricultural commodities of the subject petitions have
associated livestock feed items of regulatory concern; therefore, a
discussion of livestock exposure to myclobutanil is not germane to this
action.

Snap beans received four foliar applications at a single application
rate of 0.121 to 0.127 lb ai/A (0.50 lb ai/A, total rate) with 7 to 8
days between applications and were harvested at PHI of 0 days.  The
results from these trials show that the highest total myclobutanil
residues were 0.40 ppm in samples treated at the seasonal rate of 0.50
lb ai/A and harvested the day of the final application.  The submitted
data supports the removal of the conditional registration.  Since the
additional data does not exceed the established tolerance, no change in
the existing tolerance is required.

 

Mint received three foliar applications at a single application rate of
0.126 to 0.129 lb ai/A (0.382 lb ai/A, total rate) with 12 to 15 days
between applications and were harvested at PHI of 31 days.  The results
from these trials show that the highest total myclobutanil residues were
0.24 ppm in samples treated at the seasonal rate of 0.382 lb ai/A and
harvested at 31 days after the final application.  The submitted data
supports the removal of the conditional registration.  Since the
additional data does not exceed the established tolerance, no change in
the existing tolerance is required

Papayas received eight foliar applications at a single application rate
of 0.23 to 0.26 lb ai/A (seasonal rate of 1.98 to 2.03 lb ai/A) with 13
to 15 days between applications and were harvested at PHI of 0 days. 
The results from these trials show that the highest total myclobutanil
residues were 1.95 ppm on a sample treated at the seasonal rate of 2.0
lb ai/A and harvested the day of the final application.  There is
adequate number and geographic location of residue field trials to
support a tolerance registration on papaya.  In addition, since papaya
is the representative crop for the proposed tropical crop group, the
data also support tolerance for black sapote, canistel, mamey sapote,
mango, sapodilla, and star apple as requested by the petitioner. 
However, the results of the MRL (maximum residue limit) spreadsheet
indicate that the requested tolerances are not appropriate.  A revised
Section F is required for the residues of myclobutanil on papaya,
sapote, canistel, mamey sapote, mango, sapodilla, and star apple at 3.0
ppm. 

Gooseberries received eight foliar applications at a single application
rate of 0.122 to 0.136 lb ai/A (seasonal rate of 1.04 to 1.05 lb ai/A)
with 10 to 14 days between applications and were harvested at PHI of 0
days.  The results from these trials show that the highest total
myclobutanil residues were 0.35 ppm in samples treated at the seasonal
rate of ~1.00 lb ai/A and harvested the day of the final application. 
The submitted data supports the removal of the conditional registration.
 Since the additional data does not exceed the established tolerance, no
change in the existing tolerance is required.

Currants received eight foliar applications at a single application rate
of 0.125 to 0.130 lb ai/A (1.01 lb ai/A, total rate) with 13 and 15 days
between applications and were harvested at PHI of 0 days.  The results
from these trials show that the highest total myclobutanil residues were
1.05 ppm in samples treated at the seasonal rate of ~1.0 lb ai/A and
harvested the day of the final application.  The submitted data supports
the removal of the conditional registration.  Since the additional data
does not exceed the established tolerance, no change in the existing
tolerance is required

Caneberries received four foliar applications at a single application
rate of 0.060 to 0.068 lb ai/A (seasonal rate of 0.244 to 0.257 lb ai/A)
with 10 to 14 days between applications and were harvested at PHI of 0
days.  The results from these trials show that the highest total
myclobutanil residues were 0.62 ppm in samples treated at the seasonal
rate of ~0.25 lb ai/A and harvested the day of the final application. 
The submitted data supports the removal of the conditional registration.
 Since the additional data does not exceed the established tolerance, no
change in the existing tolerance is required

Peppers were treated with four foliar applications at the approximate
rate of 0.125 lb ai/A for a total of approximately 0.50 lb ai/A with
applications at 12 to16-day intervals.  Commercially mature peppers were
collected following the final application, after the test substance had
dried.  The analytical results show that the maximum myclobutanil
residues were 0.19 ppm on bell pepper and 0.14 ppm on non-bell pepper
sampled at the 0-day PHI.  Using both the previously submitted data and
in the current submission there is adequate number and geographic
location of residue field trials to support a tolerance on peppers.  In
addition, the data also support a tolerance for fruiting vegetables
(except cucurbits), crop group 8, except tomato since bell and non-bell
peppers are the representative crop.  The MRL spreadsheet indicates that
the requested tolerances are not appropriate.  In addition, the
requested commodity definition is incorrect.  A revised Section F is
required for the residues of myclobutanil on fruiting vegetables (except
cucurbits), crop group 8, except tomato at 4.0 ppm.

No data have been submitted for the residues of myclobutanil on okra. 
Okra is not currently a member of the fruiting vegetables crop group;
however, a crop group amendment has been submitted to add okra to the
fruiting vegetables crop group.  The previous bell and non-bell pepper
data was used to support an okra tolerance with regional registration
for myclobutanil.   The MRL spreadsheet indicates that the requested
tolerances are not appropriate.  A revised Section F is required for the
residues of myclobutanil on okra at 4.0 ppm.

Lettuce was treated with four foliar applications at the approximate
rate of 0.125 lb ai/A for a total of approximately 0.50 lb ai/A with
applications at 12 to15-day intervals and were collected 2-4 days after
the final application.  In the head lettuce trials, wrapper leaves were
removed from half of the samples.  Maximum myclobutanil residues on head
lettuce at 2-4 day PHI were 1.36 ppm with wrapper leaves and 0.25 ppm
without wrapper leaves. Maximum myclobutanil residues on leaf lettuce at
2-4 day PHI were 4.03 ppm.  Myclobutanil and RH-9090 residues declined
significantly from 0-14 day PHI on leaf lettuce.  There are adequate
number and geographic location of residue field trials on head and leaf
lettuce, the representative crops to support a tolerance on leafy
greens, crop subgroup 4A, except spinach.  The MRL spreadsheet indicates
that the requested tolerances are not appropriate.  In addition, the
commodity definition is incorrect.  A revised Section F is required for
the residues of myclobutanil on leafy greens, crop subgroup 4A, except
spinach at 9.0 ppm.

No data have been submitted for the residues of myclobutanil on
cilantro.  Cilantro is not currently a member of the leafy greens, crop
subgroup 4A, except spinach.  However, since data for parsley has been
determined to be adequate to support tolerances on cilantro and parsley
is a member of crop subgroup 4A, the data for head and leaf lettuce is
adequate to support a tolerance on cilantro.  The MRL spreadsheet
indicates that the requested tolerances are not appropriate.  A revised
Section F is required for the residues of myclobutanil cilantro at 9.0
ppm.

Artichokes were treated with six foliar-directed applications at the
approximate rate of 0.1 lb ai/A for a total of approximately 0.6 lb ai/A
with applications at 12 to 16-day intervals and collected 3 days after
the final application.  The analytical results show that the highest
total myclobutanil residues were 0.60 on treated artichoke samples. 
There is adequate number and geographic location of residue field trials
on artichoke.  The MRL spreadsheet (see attached) indicates that the
requested tolerances are appropriate.  ARIA recommends for the proposed
myclobutanil tolerance of 0.9 ppm on artichokes.

Mint oil is the only processed commodity of regulatory concern in the
subject petitions.  A processing study was previously performed which
demonstrated that myclobutanil residues do not concentrate in mint oil.
No separate tolerance is required for mint oil.

Based on the results of a limited field rotational crop study, it has
been determined that crops listed on a registered label can be rotated
at any time after the last treatment and that all other crops may be
planted 30 days after the last application of a product containing
myclobutanil.  The current rotational crop restrictions are adequate.

Conclusion/Recommendations

Provided a revised Section F is submitted, the residue chemistry
database supports the establishment of permanent tolerances for the
combined residues of myclobutanil and its alcohol metabolite RH-9090
(free and bound) in/on the following RACs:

Commodity	Tolerance

(ppm)

Fruiting vegetables (except cucurbits), crop group 8, except tomato	4.0

Okra	4.0

Leafy greens, crop subgroup 4A, except spinach	9.0

Cilantro	9.0

Artichoke	0.90

Papaya	3.0

Black sapote	3.0

Canistel	3.0

Mamey sapote	3.0

Mango	3.0

Sapodilla	3.0

Star apple	3.0

In addition, the submitted data supports the removal of the conditional
registrations for myclobutanil on bean, snap, succulent; peppermint and
spearmint; gooseberry; currant; and caneberry.  Since the additional
data does not exceed the established tolerances, no change in the
existing tolerances is required.

A human-health risk assessment will be prepared as a separate document.

Residue Chemistry Deficiencies

A revised Section F is required for the residues of myclobutanil on
papaya, sapote, canistel, mamey sapote, mango, sapodilla, and star apple
at 3.0 ppm. 

A revised Section F is required for the residues of myclobutanil on
fruiting vegetables (except cucurbits), crop group 8, except tomato at
4.0 ppm.

A revised Section F is required for the residues of myclobutanil on okra
at 4.0 ppm.

A revised Section F is required for the residues of myclobutanil on
leafy greens, crop subgroup 4A, except spinach at 9.0 ppm.

A revised Section F is required for the residues of myclobutanil on
cilantro at 9.0 ppm.

Background

The nomenclature and physicochemical properties of myclobutanil are
presented in Tables 1 and 2.

Table 1.  Myclobutanil Nomenclature.

Chemical structure

 

Common name	Myclobutanil

Company experimental name	RH-3866

IUPAC name
(RS)-2-(4-chlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)hexanenitrile

CAS name	

 

Common name	Alcohol metabolite

Company experimental name	RH-9090

Table 2.  Physicochemical Properties of the Technical Myclobutanil.

Parameter	Value	Reference

Melting point range	63-68oC	Product Chemistry Review (C.L. Trichilo,
1988) of: 

MRID/Acces. Nos. 00141683, 266121, 256773, and Rohm and Haas Report,
“Revision to: RH-3866 Technical - Physical and Chemical
Characteristics”

pH	The technical material cannot be diluted or dispersed in water.  The
pH of a saturated aqueous solution of this material is about 6-7, the
same as the background value of the water used.

	Density	1.22 g/cc @ 23oC

1.19 g/cc @ 100oC

	Water solubility (20ºC)	(25C) 142 ppm

	Solvent solubility (g/L at 20ºC)	xylene:  >50 g/100g

amyl acetate: >50 g/100g

cyclohexanone: >50 g/100g

DMF: >50 g/100g

methyl ethyl ketone: >50 g/100g

	Vapor pressure at 20ºC	

1.6 X 10-6 torr @ 25oC for pure ai

	Dissociation constant, pKa	The pure ai does not have acidic hydrogens
and is expected to be a very weak base.  Attempts to measure pKa by
titration with acid (HCl) and base (NaOH) failed to detect any
inflection on the titration curve, indicating little or no dissociation.

	Octanol/water partition coefficient Log(KOW)	2.94 @ 25oC for pure ai

	UV/visible absorption spectrum	not available

	

860.1200 Directions for Use

Table 3.  Summary of Proposed Use Patterns.

Crop	Product

(EPA Reg. No.)	#

App.	Application Rate

(lb ai/A)	RTI1 (days)	PHI1 (days)	Restrictions

	Per app.	Per season

	Snap Bean	Rally 40 W

(62719-411)	4	0.125	0.5	7-10	0	Rust: Begin at first observation.

Pod tip rot: Begin at pod development and continue at 7-10 day intervals

Mint	Rally 40 W

(62719-411)	3	0.125	0.375	14-21	30	Begin applications in early spring
when plants break dormancy.

Papaya	Rally 40 W

(62719-411)	8	0.25	2.0	14	0	Do not plant any crop other than those on
the label for 12 months following the last application.

Gooseberry	Rally 40 W

(62719-411	8	0.125	1.0	10-14	0	Anthracnose: Begin at unfolded first leaf
then at 10-14 intervals.

Powdery mildew: Make applications at pre-bloom, full bloom and 2 weeks
later.

Currant	Rally 40 W

(62719-411)	3	0.125	1.0	NA	0	Make applications at pre-bloom, full bloom
and 2 weeks later.

Blackberry & Raspberry	Rally 40 W

(62719-411)	4	0.03-0.06	0.25	10-14	0	Apply at budbreak. Use shorter
interval under heavy disease pressure.

Fruiting vegetables, crop group 8, except tomato and okra	Rally 40 W

(62719-411) NOVA 40W

(62719-411)	4	0.0625 to 0.125	1.25	10-14	0	Apply the lower rate when
plants are small. Increase the rate as plants increase in size. 

Crop subgroup 4A, except spinach	Rally 40 W

(62719-411)

NOVA 40W

(62719-411)	4	0.0625-0.125	1.25	10-14	3	Apply the lower rate when plants
are small. Increase the rate as plants increase in size. 

Artichoke	Rally 40 W

(62719-411)	6	0.075 - 0.1	0.6	14	3	Apply the lower rate when plants are
small. Increase the rate as plants increase in size.

1 RTI = retreatment interval; PHI = preharvest interval; GPA = gallons
per acre.

The label specifies the following rotational crop restrictions:  Fields
treated with myclobutanil can be rotated at any time to crops that are
listed on a registered myclobutanil label immediately after the last
treatment.  Do not plant other crops within 30 days after the last
application of a product containing myclobutanil.

Conclusions:  The proposed use directions are adequate and supported by
the available residue chemistry data.

860.1300 Nature of the Residue - Plants

HED in previous reviews of myclobutanil metabolism in wheat (PP#4G3149,
R. Loranger, 1/9/85), and grapes and apples (PP#7G3479, R. Loranger,
6/16/87).  The residues of concern are myclobutanil
{α-butyl-α-(4-chlorophenyl)-1H-1,2,4-triazole -1-propanenitrile] and
its metabolite [α -(3-hydroxybutyl)- α -(4-chlorophenyl)
-1H-1,2,4-triazole-1-propanenitrile] (free and bound), as specified in
40 CFR 180.443(a). 

860.1300 Nature of the Residue - Livestock

6/89).  The residues of concern in livestock commodities except milk are
myclobutanil
[α-butyl-α-(4-chlorophenyl)-1H-1,2,4-triazole-1-propanenitrile] and
its metabolite α-(3-hydroxybutyl)-
α-(4-chlorophenyl)-1H-1,2,4-triazole-1-propanenitrile (free).  The
residues of concern in milk are myclobutanil [α-butyl- α
-(4-chlorophenyl)-1H -1,2,4-triazole -1-propanenitrile] and its
metabolites, α-(3-hydroxybutyl)- α-(4-chlorophenyl) -1H-1,2,4-triazole
-1-propanenitrile (free and bound) and α -(4-chlorophenyl)-
α-(3,4-dihydroxybutyl) -1H-1,2,4-triazole-1-propanenitrile.

860.1340 Residue Analytical Methods – Plants

Samples were analyzed for residues of myclobutanil and its metabolite
RH-9090 using a Working Method derived from Rohm & Haas Technical Report
Number 34S-88-10, “RH-3866 Total Residue Analytical Method for Apple
and Grape.”  Briefly, samples were extracted with acidified methanol. 
The extract was made basic by adding a sodium hydroxide solution. 
Sodium borohydride was then added; the flask was shaken and allowed to
stand 20 minutes.  The sample was transferred to a separatory funnel. 
Sodium chloride solution was used to rinse the flask and the rinsate was
combined with the sample.  The sample was partitioned with hexane.  The
water-methanol layer from the separatory funnel was then partitioned
twice with dichloromethane, and the combined dichloromethane fractions
were evaporated to dryness.  The residues were dissolved in 1:4 (v/v)
methanol-water, loaded onto a ferric chloride-activated Chelex 100
column, and eluted with 1:1 (v/v) methanol-water.  Sodium chloride was
added to the eluant and it was partitioned three times with
dichloromethane.  Methylene chloride extracts were combined and rotary
evaporated to dryness.  The residues were loaded onto a preconditioned
silica gel column, and the analytes were eluted with acetone-toluene and
evaporated.  Finally, the samples were analyzed for myclobutanil and
RH-9090 by GC/NPD in nitrogen mode (also designated as thermionic
specific detector (GC/TSD)) and GC/ECD, respectively.  The LLMV for both
myclobutanil and its metabolite RH-9090 was 0.01 ppm in lettuce (head
and leaf) and artichoke; 0.02 ppm in pepper (bell and non-bell),
caneberry, gooseberry, and snap bean.  The LLMV for currant was 0.0199
ppm for myclobutanil and 0.0204 ppm for RH9090.  The LLMV for papaya was
0.0199 ppm for myclobutanil and 0.0204 ppm for RH9090.  The LLMV for
mint was 0.019 ppm for myclobutanil and 0.02 for RH9090.

An adequate enforcement method for plant commodities, Rohm and Haas
Method 34S-88-10, is available to enforce the proposed tolerances. 
Quantitation is by GC/NPD for myclobutanil and GC/ECD for the alcohol
metabolite (PP#7F3476, MRID: 40803302, M. Nelson, 4/14/88).  This method
has been submitted for publication in PAM II (PP#7F3476, M. Nelson,
7/18/89).

Conclusions:  The method used for data collection, based on the
enforcement method, 34S-88-10, is adequate.

860.1340 Residue Analytical Methods – Livestock

Enforcement methods for the established tolerances on livestock
commodities are Methods 34S-88-22 (MRID: 408253-01), 34S-88-15 (MRID:
406458-01), 31S-87-02 (MRID:  404813-01), and 34S-88-21 (MRID:
408033-01).  This method has been submitted for publication in PAM II
(PP#7F3476, M.J. Nelson, 7/18/89).

860.1360 Multiresidue Method (MRM)

The FDA Pestrack database (PAM Vol. I, Appendix, date 11/6/90) indicates
that complete recovery has been obtained for myclobutanil under FDA
Multiresidue Method D.  Variable recovery has been obtained under FDA
Multiresidue Method A under special instrument conditions.  The alcohol
metabolite, RH-9090, has a variable recovery under FDA Multiresidue
Method A under special instrument conditions.

The 2/97 FDA PESTDATA database (PAM Volume I, Appendix I) indicates that
residues of myclobutanil are adequately recovered (>80%) using
Multiresidue Method Section 302 (Luke Method; Protocol D), but are not
recovered using Multiresidue Method Sections 303 (Mills, Onley, Gaither
Method; Protocol E, non-fatty foods) or 304 (Mills Method; Protocol E,
fatty foods).  Residues of the metabolite RH-9090 were poorly recovered
(30-55%) using Multiresidue Method Section 302 (Luke Method; Protocol
D); the metabolite is not recovered using Multiresidue Method Sections
303 (Mills, Onley, Gaither Method; Protocol E, non-fatty foods) and 304
(Mills Method; Protocol E, fatty foods).

860.1380 Storage Stability

Snap Bean

MRID: 45596301, W. Cutchin, in process

	The maximum storage interval for field treated snap bean samples in the
study was 233 days.  No freezer storage stability test was conducted
with this study; however, previously submitted storage stability data
indicate that residues were stable for up to 657 days under the
conditions samples were held from harvest to analysis (PP#7E04861, DP
Num: 238454, MRID: 44338201, N. Dodd, 4/24/98).

Mint

MRID: 45880301, W. Cutchin, in process

The maximum storage interval for field treated mint samples in the study
was 297 days.  No freezer storage stability test was conducted with this
study; however, previously submitted storage stability data indicate
that residues were stable under the conditions samples were held for at
least 296 days under frozen conditions (PP# 7E04877, DP Num: 238448,
MRID: 44349601, J. Rowell, 8/3/99).

Papaya

MRID: 45883401, W. Cutchin, in process

The maximum storage interval for field treated papaya samples in the
study was 353 days.  Storage stability samples were fortified with
myclobutanil and RH9090 and analyzed after 378 and 379 days,
respectively.  Recoveries obtained during storage stability testing were
acceptable. 

Gooseberry

PP# 8E4939, DP Num: 242704, MRID: 44462101, J. Rowell, 9/17/99

The maximum storage interval for field treated gooseberry samples in the
study was 292 days.  No freezer storage stability test was conducted
with this study; however, previously submitted storage stability data
indicate that myclobutanil and RH-9090 metabolite are relatively stable
during frozen storage up to 279 days in/on gooseberries (PP# 8E4939, DP
Num: 242704, MRID: 44462101, J. Rowell, 9/17/99).

Currant 

PP# 8E4939, DP Num: 242704, MRID: 44462101, J. Rowell, 9/17/99

The maximum storage interval for field treated currant samples in the
study was 260 days.  No freezer storage stability test was conducted
with this study; however, previously submitted storage stability data
indicate that residues of myclobutanil and its RH-9090 metabolite are
stable during frozen storage for up to 202 days in/on currants (PP#
8E4939, DP Num: 242704, MRID: 44462101, J. Rowell, 9/17/99).

Caneberry

PP# 7E04866, DP Num: 238444, MRID: 44339201 and -02, J. Rowell, 9/17/99)

No freezer storage stability test was conducted with this study;
however, previously submitted storage stability data show that
myclobutanil and RH-9090 metabolite are relatively stable during frozen
storage up to 187 days (~6 months) in/on blackberries and up to 308 days
(~10 months) in/on raspberries (PP# 7E04866, DP Num: 238444, MRID:
44339201 and -02, J. Rowell, 9/17/99).

Bell and Non-Bell Pepper

(PP#:1E6265, DP Num: 275142, MRID: 45334201 and -02, J. Tyler, 6/4/01

The maximum storage interval for field treated pepper samples in the
study was 238 days.  Myclobutanil and RH-9090 have previously been shown
to be sable on bell and non-bell peppers in frozen storage for up to 475
days.474-475 days in/on peppers (bell and non-bell) (PP#:1E6265, DP Num:
275142, MRID: 45334201 and -02, J. Tyler, 6/4/01).

Head and Leaf Lettuce

MRID: 46990902, W. Cutchin, in process

  

The maximum storage interval for field treated samples was 335 days. 
The results of a freezer storage stability study demonstrated that
myclobutanil and RH-9090 residues were stable in leaf lettuce samples
stored frozen 376 days.  

Artichoke

MRID: 46990903, W. Cutchin, in process

  

	The maximum storage interval for field treated artichoke samples in the
study was 583 days.  The results of a freezer storage stability study
demonstrated that myclobutanil and RH-9090 residues were stable in
artichoke samples stored frozen 610 days.

Conclusions:  There is adequate storage stability data to support the
submitted residue field trials.

860.1480 Meat, Milk, Poultry, and Eggs

None of the raw agricultural commodities of the subject petitions have
associated livestock feed items of regulatory concern; therefore, a
discussion of livestock exposure to myclobutanil is not germane to this
action.

860.1500 Crop Field Trials

Snap Bean

MRID: 45596301, W. Cutchin, in process

IR-4 has submitted field trial data for myclobutanil on snap bean.  Two
trials were conducted in NAFTA Regions: 5 (WI; 1 trial) and 10 (CA; 1
trial) during the 2002 growing season.  The number and locations of
field trials are in accordance with OPPTS Guideline 860.1500 and
Directive 98-02; Section 9.  At each test location, snap beans received
four foliar applications at a single application rate of 0.121 to 0.127
lb ai/A (0.50 lb ai/A, total rate) with 7 to 8 days between
applications.  An adjuvant was not added to the spray mixture for all
applications.  Snap beans were harvested at PHI of 0 days.  

The samples were analyzed for myclobutanil and its metabolite, RH 9090,
using Rohm and Haas Analytical Method TR 34S-88-10, titled: “RH-3866
Total Residue Analytical Method for Apple and Grape.”  The LLMV for
snap bean pods was 0.02 ppm for both myclobutanil and RH9090.  The
analytical method has been found suitable for data collection.  Residues
of the chemical have been shown to be stable for the duration of storage
that occurred during the conduct of this study.  The results from these
trials show that the highest total myclobutanil residues were 0.40 ppm
in samples treated at the seasonal rate of 0.50 lb ai/A and harvested
the day of the final application.

Table 4.  Summary of Residue Data from Snap Bean Crop Field Trials with
Myclobutanil.

Commodity	Total Applic.  Rate,

(lb ai/A)	PHI (days)	Residue Levels (ppm)

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

Myclobutanil

Snap Beans	0.5	0	4	0.09	0.38	0.30	0.16	0.19	0.14

RH 9090

Snap Beans	0.5	0	4	<0.02	<0.02	<0.02	<0.02	<0.02	<0.02

* HAFT = Highest Average Field Trial.

Conclusions:  In a previous review HED stated:

	“The geographic representation of the residue data from the submitted
crop field trials (MRID# 44338201) is not adequate.  A total of seven
trials reflecting the proposed maximum use pattern were conducted in
Regions 1 (1 trial), 2 (2 trials), 3 (1 trial), 5 (2 trials), and 11 (1
trial).  The current guidance (OPPTS GLN 860.1500, Tables 1 and 5)
recommends that a minimum of 8 trials should be conducted for the
establishment of a tolerance for snap beans, preferably in Regions 1 (1
trial), 2 (1 trial), 3 (1 trial), 5 (3 trials), 10 (1 trial), and 11 (1
trial).  Therefore, two additional residue trials should be performed,
preferably in Region 10 (1 trial) and Region 5 (1 trial).  Thus, the
crop field trial data support a conditional registration until the
additional data are submitted” (PP# 7E4861, DP Num: 250160, J. Rowell,
10/13/99).

  

	The new snap bean data was submitted to remove the conditional
registration stated above.  The data is adequate in number and
geographic location to satisfy the requirements as requested in the
cited memo.  ARIA recommends that the conditional registration for
myclobutanil on bean, snap, succulent be removed.  Since the additional
data does not exceed the established tolerance, no change in the
existing bean, snap, succulent tolerance is required.

Mint

MRID: 45880301, W. Cutchin, in process

IR-4 has submitted field trial data for myclobutanil on mint.  One trial
was conducted in Washington (NAFTA Region 11) during the 2000 growing
season.  The number and locations of field trials are in accordance with
OPPTS Guideline 860.1500 and Directive 98-02; Section 9.  At the test
location, mint received three foliar applications at a single
application rate of 0.126 to 0.129 lb ai/A (0.382 lb ai/A, total rate)
with 12 to 15 days between applications.  An adjuvant was not added to
the spray mixture for all applications.  Mint samples were harvested at
PHI of 31 days.

The samples were analyzed for myclobutanil and its metabolite, RH 9090,
using Rohm and Haas Analytical Method TR 34S-88-10, titled: “RH-3866
Total Residue Analytical Method for Apple and Grape.”  The analytical
method has been found suitable for data collection.  Residues of the
chemical have been shown to be stable for the duration of storage that
occurred during the conduct of this study.  The results from these
trials show that the highest total myclobutanil residues were 0.24 ppm
in samples treated at the seasonal rate of 0.382 lb ai/A and harvested
at 31 days after the final application.

Table 5.	 Summary of Residue Data from Mint Crop Field Trials with
Myclobutanil.

Commodity	Total Applic. Rate

(lb ai/A)	PHI (days)	Residue Levels (ppm)

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

Myclobutanil

Mint	0.382	31	2	0.10	0.16	0.13	0.13	0.13	NA

RH 9090

Mint	0.382	31	2	0.04	0.08	0.06	0.06	0.13	NA

* HAFT = Highest Average Field Trial.

Conclusions:  In a previous review HED stated:

“The geographic representation of residue data is inadequate.  Four
field trials were performed in Regions 5 (2 trials) and 11 (2 trials). 
The current guidance specifies that a minimum of five trials should be
conducted in the following regions for the establishment of a tolerance
for mint:  Regions 5 (2 trials) and 11 (3 trials) (Residue Chemistry
Test Guidelines, OPPTS 860.1500 Crop Field Trials Table 5).  An
additional mint trial, preferably from Region 11, reflecting the
proposed maximum use pattern, is needed.  HED recommends for conditional
registration until the additional data are submitted” (PP# 7E4877, DP
Num: 238448, MRID: 4434960, J. Rowell, 8/13/99).

The mint data was submitted to remove the conditional registration
stated above.  The data is adequate in number and geographic location to
satisfy the requirements as requested in the cited memo.  ARIA
recommends that the conditional registration for myclobutanil on mint be
removed.  Since the additional data does not exceed the established
tolerances, no change in the existing peppermint and spearmint
tolerances are required.

Papaya

MRID: 45883401, W. Cutchin, in process

IR-4 has submitted field trial data for myclobutanil on papaya.  Four
trials were conducted in Hawaii (NAFTA Region 13) during the 2003
growing season.  The number and locations of field trials are in
accordance with OPPTS Guideline 860.1500 and Directive 98-02; Section 9.
 At each test location, papayas received eight foliar applications at a
single application rate of 0.23 to 0.26 lb ai/A (seasonal rate of 1.98
to 2.03 lb ai/A) with 13 to 15 days between applications.  An adjuvant
was added to the spray mixture for all applications.  Papayas were
harvested at PHI of 0 days.

	The samples were analyzed for myclobutanil and its metabolite, RH 9090,
using Rohm and Haas Analytical Method TR 34S-88-10, titled: “RH-3866
Total Residue Analytical Method for Apple and Grape.”  The LLMV for
papaya was 0.0199 ppm for myclobutanil and 0.0204 ppm for RH9090.The
analytical method has been found suitable for data collection.  Residues
of the chemical have been shown to be stable for the duration of storage
that occurred during the conduct of this study.  The results from these
trials show that the highest total myclobutanil residues were 1.95 ppm
on a sample treated at the seasonal rate of 2.0 lb ai/A and harvested
the day of the final application.

Table 6.  Summary of Residue Data from Papaya Crop Field Trials with
Myclobutanil.

Commodity	Total Applic.  Rate,

(lb ai/A)	PHI (days)	Residue Levels (ppm)

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

Myclobutanil

Papaya	1.982-2.032	0	8	0.42	1.13	1.07	0.77	0.77	0.23

RH 9090	

Papaya	1.982-2.032	0	8	0.24	0.82	0.73	0.60	0.53	0.21

* HAFT = Highest Average Field Trial.

Conclusions:  There is adequate number and geographic location of
residue field trials to support a tolerance registration on papaya.  In
addition, since papaya is the representative crop for the proposed
tropical crop group, the data also support tolerance for black sapote,
canistel, mamey sapote, mango, sapodilla, and star apple as requested by
the petitioner.  However, the results of the MRL spreadsheet (see
attached) indicates that the requested tolerances are not appropriate. 
A revised Section F is required for the residues of myclobutanil on
papaya, sapote, canistel, mamey sapote, mango, sapodilla, and star apple
at 3.0 ppm. 

Gooseberry

MRID: 45908101, W. Cutchin, in process

IR-4 has submitted field trial data for myclobutanil on gooseberry.  Two
trials were conducted in Oregon (NAFTA Region 12; 2trials) during the
2003 growing season. The number and locations of field trials are in
accordance with OPPTS Guideline 860.1500 and Directive 98-02; Section 9.
 At each test location, gooseberries received eight foliar applications
at a single application rate of 0.122 to 0.136 lb ai/A (seasonal rate of
1.04 to 1.05 lb ai/A) with 10 to 14 days between applications.  An
adjuvant was not added to the spray mixture for all applications.
Berries were harvested at PHI of 0 days.

The samples were analyzed for myclobutanil and its metabolite, RH 9090,
using Rohm and Haas Analytical Method TR 34S-88-10, titled: “RH-3866
Total Residue Analytical Method for Apple and Grape.” The analytical
method has been found suitable for data collection.  Residues of the
chemical have been shown to be stable for the duration of storage that
occurred during the conduct of this study.  The results from these
trials show that the highest total myclobutanil residues were 0.35 ppm
in samples treated at the seasonal rate of ~1.00 lb ai/A and harvested
the day of the final application.

Table 7.  Summary of Residue Data from GooseberryCrop Field Trials with
Myclobutanil.

Commodity	Total Applic. Rate,

(lb ai/A)	PHI (days)	Residue Levels (ppm)

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

RH3866

Gooseberry	1.04 to 1.05	0	4	0.23	0.32	0.28	0.30	0.29	0.04

RH9090	

Gooseberry	1.04 to 1.05	0	4	0.03	0.03	0.03	0.03	0.03	NA

* HAFT = Highest Average Field Trial.

Conclusions: In a previous review HED stated:

“Geographic representation of residue data is inadequate.  Only one
trial was conducted (OR).  According to the current guidance (Table 1 of
OPPTS 860.1500), a minimum of three trials should be conducted for the
establishment of a tolerance for gooseberries.  Two additional
gooseberry trial (sic) reflecting the proposed maximum use patterns are
needed.  The database supports a conditional registration until the
necessary residue data are submitted” (PP# 8E4939, DP Num: 242704, J.
Rowell, 9/17/99).

The gooseberry data was submitted to remove the conditional registration
stated above.  The data is adequate in number and geographic location to
satisfy the requirements as requested in the cited memo.  ARIA
recommends that the conditional registration for myclobutanil on
gooseberry be removed.  Since the additional data does not exceed the
established tolerances, no change in the existing gooseberry tolerance
is required.

Currant 

MRID: 45908201, W. Cutchin, in process 

IR-4 has submitted field trial data for myclobutanil on currant.  One
trial was conducted in Washington (NAFTA Region 11) during the 2003
growing season.  The number and locations of field trials are in
accordance with OPPTS Guideline 860.1500 and Directive 98-02; Section 9.
 At the test location, currants received eight foliar applications at a
single application rate of 0.125 to 0.130 lb ai/A (1.01 lb ai/A, total
rate) with 13 and 15 days between applications.  An adjuvant was not
added to the spray mixture for all applications.  Currants were
harvested at PHI of 0 days.

The samples were analyzed for myclobutanil and its metabolite, RH 9090,
using Rohm and Haas Analytical Method TR 34S-88-10, titled: “RH-3866
Total Residue Analytical Method for Apple and Grape.”  The analytical
method has been found suitable for data collection.  Residues of the
chemical have been shown to be stable for the duration of storage that
occurred during the conduct of this study.  The results from these
trials show that the highest total myclobutanil residues were 1.05 ppm
in samples treated at the seasonal rate of ~1.0 lb ai/A and harvested
the day of the final application.

Table 8.  Summary of Residue Data from Currant Crop Field Trials with
Myclobutanil.

Commodity	

Total Applic. Rate,

 (lb ai/A)	

PHI (days)	

Residue Levels (ppm)

	

n	

Min.	

Max.	

HAFT*	

Median	

Mean	

Std. Dev.

Myclobutanil

Currant	

	1.0 to 1.01	

0	

	2	

	0.66	

	0.86	

	0.76	

	0.76	

	0.76	

	NA

RH9090

Currant	

	1.0 to 1.01	

0	

	2	

	0.17	

	0.19	

	0.18	

	0.18	

	0.18	

	NA

* HAFT = Highest Average Field Trial.

Conclusions: In a previous review HED stated:

“The geographic representation of residue data is inadequate.  The
current guidance (OPPTS GLN 860.1500, Table 1) specifies that a minimum
of two trials should be conducted for the establishment of a tolerance
for currants.  The petitioner claims that a total of two trials
reflecting the proposed maximum use pattern were conducted in WA;
however, both were performed in very close proximity to each other using
the same spray solution.  Therefore, the data can only be considered as
two plots from the same trial.  An additional currant trial, preferably
from Region 12, reflecting the proposed maximum use pattern is needed. 
The database supports a conditional registration until the necessary
residue data are submitted” (PP# 8E4939, DP Num: 242704, J. Rowell,
9/17/99).

The current data was submitted to remove the conditional registration
stated above.  The data is adequate in number and geographic location to
satisfy the requirements as requested in the cited memo.  ARIA
recommends that the conditional registration for myclobutanil on currant
be removed.  Since the additional data does not exceed the established
tolerances, no change in the existing currant tolerance is required.

Caneberry

MRID: 45910601, W. Cutchin, in process  

IR-4 has submitted field trial data for myclobutanil on caneberry.  Five
trials were conducted in NAFTA Regions: NJ (Region 2; 1 trial), OR
(Region 11; 2 trials), and CA (Region 10; 2 trials) during the 2003
growing season. The number and locations of field trials are in
accordance with OPPTS Guideline 860.1500 and Directive 98-02; Section 9.
 At each test location, caneberries received four foliar applications at
a single application rate of 0.060 to 0.068 lb ai/A (seasonal rate of
0.244 to 0.257 lb ai/A) with 10 to 14 days between applications.  An
adjuvant was not added to the spray mixture for all applications. 
Caneberries were harvested at PHI of 0 days. 

The samples were analyzed for myclobutanil and its metabolite, RH 9090,
using Rohm and Haas Analytical Method TR 34S-88-10, titled: “RH-3866
Total Residue Analytical Method for Apple and Grape.”  The analytical
method has been found suitable for data collection.  Residues of the
chemical have been shown to be stable for the duration of storage that
occurred during the conduct of this study.  The results from these
trials show that the highest total myclobutanil residues were 0.62 ppm
in samples treated at the seasonal rate of ~0.25 lb ai/A and harvested
the day of the final application.

Table 9.  Summary of Residue Data from Caneberry Crop Field Trials with
Myclobutanil.

Commodity	

Total Applic. Rate,

 (lb ai/A)	

PHI (days)	

Residue Levels (ppm)

	

n	

Min.	

Max.	

HAFT*	

Median	

Mean	

Std. Dev.

Myclobutanil

Caneberry	

0.244 - 0.257	

10 to 14	

	10	

	0.10	

	0.60	

	0.56	

	0.32	

	0.33	

	0.16

RH 9090	

Caneberry	

0.244 - 0.257	

10 to 14	

	10	

	<0.02	

	0.09	

	0.08	

	0.04	

	0.04	

	0.03

* HAFT = Highest Average Field Trial.

Conclusions:  In a previous review HED stated:

“The submitted blackberry and raspberry field residue data are
inadequate to support the establishment of the proposed subgroup
tolerance for caneberries due to inadequate residue data.  Although the
current guidance (OPPTS 860.1500, Tables 1, 3, and 5) specifies that a
minimum of 5 trials should be conducted on any one blackberry or any one
raspberry for the establishment of a tolerance for caneberries, HED is
willing to combine the submitted trials for a total of 6 trials. 
However, of the six trials conducted (4 for blackberries and 2 for
raspberries), only three trials (2 for blackberries in Regions 5 and 12,
and 1 for raspberries in Region 5) were conducted according to the
maximum proposed use patterns.  HED guidance recommends that blackberry
trials be conducted in Regions 2 (1 trial), 6 (1 trial), and 12 (3
trials), and the raspberry trials be conducted in Regions 1 (1 trial), 5
(1 trial), and 12 (3 trials).  Therefore, three additional caneberry
trials reflecting the proposed maximum use patterns are needed and the
following geographic distribution is recommended:  one in Region 1 or 2
and two in Region 12.  The database supports a conditional registration
until the necessary trials are submitted.” (PP# 7E04866, DP Num:
238444, J. Rowell, 9/17/99).

The caneberry data was submitted to remove the conditional registration
stated above.  The data is adequate in number and geographic location to
satisfy the requirements as requested in the cited memo.  ARIA
recommends that the conditional registration for myclobutanil on
caneberry be removed.  Since the additional data does not exceed the
established tolerance, no change in the existing caneberry tolerance is
required.

Bell and Non-Bell Pepper

MRID: 46990901, W. Cutchin, in process  

PP#: 1E6265, DP Num: 275142, MRID: 45334201-02, J. Tyler, 6/4/01

IR-4 has submitted field trial data for myclobutanil on pepper (bell and
non-bell).  Six field trials were conducted in New Jersey (EPA region
2), Florida (EPA Region 3), North Carolina (EPA Region 2), California
(EPA Region 10), and Wisconsin EPA Region 5) during the 2002-growing
season.  Bell peppers were grown in five trials and non-bell peppers
were grown in one trial (Florida).  These data were submitted to
compliment a previously submitted pepper study, IR-4 PR No. 06071,
“Myclobutanil: Magnitude of the Residue on Pepper (Bell &
Non-Bell),” 1997, MRID No. 45334202.  At each trial, peppers were
treated with four foliar applications of Rally 40W, a 40% wettable
powder formulation of myclobutanil  at the approximate rate of 0.125 lb
ai/A for a total of approximately 0.50 lb ai/A.  The applications were
made at 12 to16-day intervals.  The test substance was mixed with water
without any adjuvant.  Commercially mature peppers were collected
following the final application, after the test substance had dried. 

Samples were analyzed for residues of myclobutanil and its metabolite
RH-9090 using the Working Method derived from Rohm & Haas Technical
Report Number 34S-88-10, “RH-3866 Total Residue Analytical Method for
Apple and Grape.”  In this study, the LLMV was 0.02 ppm for both
myclobutanil and its metabolite RH-9090.  The maximum storage interval
for field treated samples was 238 days.  Freezer storage stability data
were not provided; however, myclobutanil and RH-9090 have previously
been shown to be sable on bell and non-bell peppers in frozen storage
for up to 475 days.  The analytical results show that the highest total
myclobutanil residues were 0.19 ppm on bell pepper and 0.14 ppm on
non-bell pepper sampled at the 0-day PHI.  Also, RH-9090 residues were
less than the LLMV of 0.02 ppm in all samples.

Table 10.  Summary of Residue Data from Pepper Crop Field Trials with
Myclobutanil

Commodity	Total Applic. Rate,

 (lb ai/A)	PHI

(days) 	Analyte	Residue Levels (ppm)

n	Min.	Max.	HAFT1	Median	Mean	Std. Dev.

Bell pepper 	0.4935-0.5071	0	Myclobutanil	10	0.02	0.17	0.15	0.07	0.07
0.05

	RH-9090	10	<0.02	<0.02	<0.02	-	-	-

Non-bell pepper	0.4935-0.5071	0	Myclobutanil	2	0.11	0.12	0.11	0.11	0.11
0.00

	RH-9090	2	<0.02	<0.02	<0.02	-	-

	1 HAFT = Highest Average Field Trial.

Conclusions:  A total of 6 field trials on peppers were previously
conducted during the 1997 growing season in Regions 6 (3 trials - 2 bell
and 1 non-bell) and 10 (3 trials - 2 bell and 1 non-bell).  Pepper plots
received 4 foliar applications of myclobutanil at rates of ~0.125 lb.
ai/A (0.5 lb. ai/A/season).  The applications were made at intervals of
13-15 days and mature peppers were collected following the final
application or 1 day later.  In bell peppers, myclobutanil and RH-9090
residues ranges were 0.02- 0.51 ppm and <0.02-0.17 ppm, respectively. 
In the non-bell peppers, myclobutanil and RH-9090 residues ranges were
0.08-2.03 ppm and 0.03-0.39 ppm, respectively.  The previous data was
used to support a tolerance with regional registration for myclobutanil
on peppers (bell and non-bell) to the following states: Texas, Oklahoma,
Arkansas, New Mexico, Colorado, Arizona, Utah, Nevada, and California.  

	Using both the previously submitted data and in the current submission
there is adequate number and geographic location of residue field trials
to support a tolerance with a national registration on peppers.  In
addition, the data also support a tolerance for fruiting vegetables
(except cucurbits), crop group 8, except tomato since bell and non-bell
peppers are the representative crop.  The MRL spreadsheet (see attached)
indicates that the requested tolerances are not appropriate.  The two
commodities, bell and non-bell peppers, were analyzed separately.  The
higher result of the two analyses, bell pepper at 4.0 ppm, is the
appropriate tolerance level.  In addition, the commodity definition is
incorrect.  A revised Section F is required for the residues of
myclobutanil on fruiting vegetables (except cucurbits), crop group 8,
except tomato at 4.0 ppm.

Okra

PP#: 1E6265, DP Num: 275142, MRID: 45334201-02, J. Tyler, 6/4/01

DP Num: 274312, G. Herndon, 4/30/01

	No data have been submitted for the residues of myclobutanil on okra. 
Okra is not currently a member of the fruiting vegetables crop group;
however, IR-4 has submitted a Crop Group amendment to EPA to add okra to
the fruiting vegetables crop group.  HED has previously determined that
field residue data for non-bell peppers is applicable to okra (DP Num:
274312, G. Herndon, 4/30/01).  The previous bell and non-bell pepper
data was used to support an okra tolerance with regional registration
for myclobutanil in the following states: Texas, Oklahoma, Arkansas, New
Mexico, Colorado, Arizona, Utah, Nevada, and California.  

Conclusions:  ARIA concludes that the data for the fruiting vegetables
(except cucurbits) is adequate to support the requested tolerance on
okra.  The MRL spreadsheet for bell and non-bell peppers (see attached)
indicates that the requested tolerances are not appropriate; a tolerance
of 4.0 ppm is required.  A revised Section F is required for the
residues of myclobutanil on okra at 4.0 ppm.

Head and Leaf Lettuce

MRID: 46990902, W. Cutchin, in process

  

IR-4 has submitted field trial data for myclobutanil on lettuce (head
and leaf).  Fourteen field trials including seven head lettuce trials
and seven leaf lettuce trials were conducted in New Hampshire (EPA
Region 1), Florida (EPA Region 3), California (EPA Region 10, four
trials), and Oregon (EPA Region 12) during the 2000-2001 growing season.
 At each trial, lettuce was treated with four foliar applications of
myclobutanil at the approximate rate of 0.125 lb ai/A for a total of
approximately 0.50 lb ai/A.  The foliar applications were made at 12
to15-day intervals.  The test substance was mixed with water without any
adjuvant.  Commercially mature lettuce samples were collected 2-4 days
after the final application.  Leaf lettuce samples for decline
determination were also collected at approximately 0, 7, and 14 days
following the final application in the Florida 00-FL55 and California
00-CA*21 leaf trials.  In the head lettuce trials, wrapper leaves were
removed from half of the samples. 

Samples were analyzed for residues of myclobutanil and its metabolite
RH-9090 using a Working Method derived from Rohm & Haas Technical Report
Number 34S-88-10, “RH-3866 Total Residue Analytical Method for Apple
and Grape.”  In this study, the LLMV was 0.01 ppm for both
myclobutanil and its metabolite RH-9090.  The maximum storage interval
for field treated samples was 335 days.  The results of a freezer
storage stability study demonstrated that myclobutanil and RH-9090
residues were stable in leaf lettuce samples stored frozen 376 days. 
Maximum myclobutanil residues on head lettuce at 2-4 day PHI were 1.36
ppm with wrapper leaves and 0.25 ppm without wrapper leaves. Maximum
myclobutanil residues on leaf lettuce at 2-4 day PHI were 4.03 ppm. 
Myclobutanil and RH-9090 residues declined significantly from 0-14 day
PHI on leaf lettuce.

Table 11.  Summary of Residue Data from Lettuce Crop Field Trials with
Myclobutanil

Commodity	Total Applic. Rate1

 (lb ai/A)	PHI

(days) 	Analyte	Residue Levels (ppm)

n	Min.	Max.	HAFT2	Median	Mean	Std. Dev.

Head lettuce with wrapper leaves 	0.491-0.513	2-4	Myclobutanil	7	0.02
1.33	1.33	0.380	0.510	0.462

	RH-9090	7	0.01	0.09	0.09	0.020	0.031	0.027

Head lettuce without wrapper leaves	0.491-0.513	2-4	Myclobutanil	7	<0.01
0.24	0.24	0.060	0.075	0.082

	RH-9090	7	<0.02	0.01	<0.01	-	-	0.002

Leaf lettuce	

0.499-0.512	0	Myclobutanil	4	0.97	7.40	6.33	3.24	3.71	3.15

	RH-9090	4	0.04	0.28	0.26	0.14	0.15	0.13

2-4	Myclobutanil	14	0.16	3.95	3.93	1.19	1.34	1.26

	RH-9090	14	0.04	0.32	0.30	0.07	0.094	0.087

6-7	Myclobutanil	4	0.15	0.72	0.71	0.46	0.45	0.30

	RH-9090	4	0.04	0.21	0.20	0.12	0.12	0.093

13-14	Myclobutanil	4	0.07	0.29	0.26	0.17	0.17	0.10

	RH-9090	4	0.04	0.16	0.13	0.070	0.085	0.057

1 Four foliar applications of Rally 40W at rate of approximately 0.125
lb ai/A each were applied for a total of approximately 0.50 lb ai/A..

2 HAFT = Highest Average Field Trial.

Conclusions:  There is adequate number and geographic location of
residue field trials on head and leaf lettuce, the representative crops
to support a tolerance on leafy greens, crop subgroup 4A, except
spinach.  The MRL spreadsheet (see attached) indicates that the
requested tolerances are not appropriate.  The two commodities, head
lettuce with wrapper and leaf lettuce, were analyzed separately.  The
higher result of the two analyses, leaf lettuce at 9.0 ppm, is the
appropriate tolerance level.  In addition, the commodity definition is
incorrect.  A revised Section F is required for the residues of
myclobutanil on leafy greens, crop subgroup 4A, except spinach at 9.0
ppm.

Cilantro

No data have been submitted for the residues of myclobutanil on
cilantro.  Cilantro is not currently a member of the leafy greens, crop
subgroup 4A, except spinach.  However, since data for parsley has been
determined to be adequate to support tolerances on cilantro
(Reviewer’s Guide, B. Schneider, 6/14/02) and parsley is a member of
crop subgroup 4A, the data for head and leaf lettuce is adequate to
support a tolerance on cilantro.  

Conclusions:  ARIA concludes that the data for the head and leaf lettuce
(except cucurbits) is adequate to support the requested tolerance on
cilantro.  However, the proposed tolerance is incorrect; ARIA recommends
for the establishment of a tolerance on cilantro at 9.0 ppm. A revised
Section F is required for the residues of myclobutanil on cilantro at
9.0 ppm.

Artichoke

MRID: 46990903, W. Cutchin, in process

IR-4 has submitted field trial data for myclobutanil on artichokes. 
Three field trials were conducted in California (EPA Region 10) in the
1998-growing season.  At each trial, artichokes were treated with six
foliar-directed applications of myclobutanil at the approximate rate of
0.1 lb ai/A for a total of approximately 0.6 lb ai/A.  The foliar
applications were made at 12 to 16-day intervals.  The test substance
was mixed with water without any adjuvant.  Commercially mature
artichoke samples were collected 3 days after the final application.  

Samples were analyzed for residues of myclobutanil and its metabolite
RH-9090 using a Working Method derived from Rohm & Haas Technical Report
Number 34S-88-10, “RH-3866 Total Residue Analytical Method for Apple
and Grape.”  In this study, the LLMV was 0.01 ppm for both
myclobutanil and its metabolite RH-9090.  The maximum storage interval
for field treated samples was 583 days.  The results of a freezer
storage stability study demonstrated that myclobutanil and RH-9090
residues were stable in artichoke samples stored frozen 610 days.  The
analytical results show that the highest total myclobutanil residues
were 0.60 ppm in treated artichoke samples.

Table 12.  Summary of Residue Data from Artichoke Crop Field Trials with
Myclobutanil

Commodity	Total Applic. Rate1

 (lb ai/A)	PHI

(days) 	Analyte	Residue Levels (ppm)

n	Min.	Max.	HAFT2	Median	Mean	Std. Dev.

Artichoke 	0.6	3	Myclobutanil	6	0.24	0.59	0.52	0.44	0.40	0.13

	RH-9090	4	<0.01	0.01	0.01	0.01	0.01	N/A

1 Six foliar applications of Rally 40W at rate of approximately 0.1 lb
ai/A each were applied for a total of approximately 0.6 lb ai/A..

2 HAFT = Highest Average Field Trial.

Conclusions: There is adequate number and geographic location of residue
field trials on artichoke.  The MRL spreadsheet (see attached) indicates
that the requested tolerances are appropriate.  ARIA recommends for the
proposed myclobutanil tolerance of 0.9 ppm on artichokes. 

860.1520 Processed Food and Feed

PP# 7E04877, DP Num: 238448, MRID: 44349601, J. Rowell, 8/3/99

Mint oil is the only processed commodity of regulatory concern in the
subject petitions.  A processing study was previously performed (MRID:
44349601).  The processing study demonstrated that myclobutanil residues
do not concentrate in mint oil.  

Conclusions: No separate tolerance is required for mint oil.

860.1850 and 860.1900 Confined/Field Accumulation in Rotational Crops

PP# 7E4861, DP Num: 308904, MRID: 46034003, J. Tyler, 6/25/05

No confined or field rotational crop data were submitted in conjunction
with the current petitions.  HED has determined, based in the results of
a limited field rotational crop study, that   crops that are listed on a
registered label can be rotated at any time after the last treatment and
that all other crops may be planted 30 days after the last application
of a product containing myclobutanil.

Conclusions:  The proposed label includes the appropriate restrictions. 
The current rotational crop restrictions are adequate.

860.1550 Proposed Tolerances

A summary of the recommended tolerances and the correct commodity
definitions for the proposed uses are listed in Table 13.  The
appropriate tolerance levels were calculated using the methodology
formulated by the NAFTA MRL/Tolerance Harmonization Workgroup for
calculating statistically based pesticide tolerances for plant
commodities based on field trial residue data (see Attachment 2).  The
residue chemistry database supports the establishment of the permanent
tolerances for residues of myclobutanil and it alcohol metabolite (free
and bound) in/on the RACs listed in Table 13.

Table 13.  Tolerance Summary for Myclobutanil.

Commodity	Proposed Tolerance (ppm)	Recommended Tolerance (ppm)	Comments

(correct commodity definition)

Crop group 8, except tomato	4.5	4.0	fruiting vegetables (except
cucurbits), crop group 8, except tomato 

Okra	4.5	4.0

	Crop subgroup 4A, except spinach	11	9.0	leafy greens, crop subgroup 4A,
except spinach.

Cilantro	11	9.0

	Artichoke	0.9	0.90

	Papaya	2.0	3.0

	Black sapote	2.0	3.0

	Canistel	2.0	3.0

	Mamey sapote	2.0	3.0

	Mango	2.0	3.0

	Sapodilla	2.0	3.0

	Star apple	2.0	3.0

	

There are no current Codex, Canadian or Mexican MRLs for residues of
myclobutanil in/on any crops.  Therefore, harmonization is not an issue.
 The International Residue Limit Status (IRLS) Sheet is attached as
Attachment 1.

Attachments

Attachment 1.  IRLS Sheet.

Attachment 2.  Inputs for calculating statistically based pesticide
tolerances.

Attachment 1.  IRLS Sheet.

INTERNATIONAL RESIDUE LIMIT STATUS

Chemical Name:

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Çÿ

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Ff

଀α-butyl-α-(4-chlorophenyl)-1H-1,2,4-triazole-1-propanenitrile]
Common Name:

Myclobutanil	x Proposed tolerance

 Reevaluated tolerance

 Other	Date: 8/28/07

Codex Status (Maximum Residue Limits)	U. S. Tolerances

 No Codex proposal step 6 or above

√No Codex proposal step 6 or above for the crops requested	Petition
Number: 6E7138

DP#s: 336253

Other Identifier:

Residue definition (step 8/CXL):  myclobutanil	Reviewer/Branch: W.
Cutchin

	Residue definition: myclobutanil and its RH-9090 metabolite (free and
bound)

Crop (s)	MRL (mg/kg)	Crop(s) 	Tolerance (ppm)

Crop group 8, except tomato	4.5

Okra	4.5

Crop subgroup 4A, except spinach	11

Cilantro	11

Artichoke	0.9

Papaya	2.0

Limits for Canada	Limits for Mexico

 No Limits

√No Limits for the crops requested	 No Limits

√No Limits for the crops requested

Residue. α-butyl-α-(4-chlorophenyl)-1H-1,2,4-

triazole-1-propanenitrile,including the metabolites

α-(3-hydroxybutyl)-α-(4-chlorophenyl)-1H-1,2,4-

triazole-1-propanenitrile and α-(butyl-3-one)-α-(4-

chlorophenyl)-1H-1,2,4-triazole-1-propanenitrile

	Residue definition:  myclobutanil

Crop(s)	MRL (mg/kg)	Crop(s)	MRL (mg/kg)

	Notes/Special Instructions:  S. Funk, 08/29/2007.

Attachment 2.  MRL Calculator

Papaya

EPA

Myclobut

papaya

0 day

Residues

1.390

0.790

1.950

1.640

0.920

0.850

1.510

1.340

Caneberry

EPA

Myclobut

caneberry

0 day

Residues

0.280

0.290

0.180

0.120

0.620

0.540

0.370

0.490

0.460

0.420

Bell-Pepper

EPA

myclobut

bellpep

0-1 day

residues

0.100

0.120

0.130

0.070

0.160

0.190

0.040

0.040

0.040

0.060

0.590

0.680

0.040

                 

Non-Bell Pepper

EPA

myclobut

nonbell

0-1 day

residues

0.140

0.130

1.230

1.530

2.360

2.420

0.130

0.260

0.110

0.130

Leaf Lettuce

EPA

Myclobut

leaf lett

2-4 day

Residues

3.98

4.03

1.96

1.92

0.540

0.58

1.070

1.96

0.270

0.23

1.430

1.57

0.240

0.28

Head Lettuce with Wrapper Leaf

EPA

Myclobut

head w/lf

2-4 day

Residues

0.35

0.97

0.04

1.36

0.570

0.4

0.100

Head Lettuce without Wrapper Leaf

EPA

Myclobut

head w/o

2-4 day

Residues

0.030

0.110

0.020

0.250

0.100

0.070

0.020

Lettuce: Head w/ Wrapper & Leaf

EPA

Myclobut

lettuce

2-4 day

Residues

0.35

0.97

0.04

1.36

0.57

0.4

0.1

3.98

4.03

1.96

1.92

0.54

0.58

1.07

1.96

0.27

0.23

1.43

1.57

0.24

0.28

Artichoke

Myclobut

artichok

3-day

Residues

0.250

0.26

0.440

0.6

0.440

0.45

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