Document ID: EPA-HQ-OPP-2009-0276-0007
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2010-01-27T05:00Z

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

	OFFICE OF PREVENTION, PESTICIDE

	AND TOXIC SUBSTANCES

  SEQ CHAPTER \h \r 1 MEMORANDUM

Date:   October 30, 2009

SUBJECT:	Triticonazole.  Application for New Seed Treatment Uses on
Cereal Grains (Except Rice) (PP#8F7420).  Amendment to Label and Request
for Removal of Plant Back Interval Restrictions Requirement

PC Code:  125620	DP Barcodes:   DP325956, DP370705

Decision No.:  399231	Registration No.:  7969-xxx

Petition No.:  #8F7420	Regulatory Action:  Section 3 Registration

Risk Assessment Type:  NA	Case No.:  NA

TXR No.:  NA	CAS No.:  131983-72-7

MRID No.:  None	40 CFR:  §180.583

	Ver.Apr.08

From:	Stephen Funk, Senior Science Advisor

Risk Assessment Branch 3

Health Effects Division (7509P)

Through:	Paula Deschamp, Branch Chief

Risk Assessment Branch III

	                    Health Effects Division (7509P)

To:		Shaja Joyner, RM #20

        Fungicide Branch

                    Registration Division (7505P)

	  SEQ CHAPTER \h \r 1 

Background	

The Registration Division has requested HED reevaluation of a BASF Crop
Protection application (PP#8F7420) for new seed treatment uses on Cereal
Grains (Except Rice).  The HED review (A. Acierto,  06/12/2009, D325956,
D353372, D360624): concluded that (1) The label must be modified to
specify a 120-day (4-month) plantback restriction for leafy vegetables,
a 365-day (12-month) plantback restriction for root and tuber
vegetables, and to prohibit the planting of all other crops not listed
on the label; (2) To support a proposed 30-day plantback restriction on
the label, limited field rotational crop data for leafy vegetables, root
and tuber vegetables, foliage of root and tuber vegetables, and a cereal
grain are required; (3)

A revised Section F must be submitted to reflect the tolerance
recommendation of 0.25 ppm for 

the forage, fodder, and straw of cereal grains, group 16 (except rice). 
The individual tolerances 

established for barley hay and straw, and wheat forage, hay and straw in
40 CFR §180.583(a) 

should be deleted when the crop group tolerance is established; (4) A
revised Section F must 

submitted to reflect the tolerance recommendation of 0.01 ppm for cereal
grains, group 15 

(except rice).  The individual tolerances established for barley grain
and wheat grain at 0.05 ppm 

in 40 CFR §180.583(a) should be deleted when the crop group tolerance
is established;  (5) To 

support the reported results for 1,2,4-triazole and the triazole
conjugates, the final report of the 

ongoing storage stability study with free triazole and triazole
conjugates in plant 

must be submitted. 	

In response to conclusions #1 and #2 (above) only, the registrant has
proposed reduction in the 

application rate and reconsideration of the conditional requirement for
limited field rotational 

crop studies and associated plant back restrictions.

Executive Summary

  SEQ CHAPTER \h \r 1 Triticonazole is a systemic triazole fungicide
that is currently registered for seed treatment on barley and wheat for
the control of various seed-borne diseases.  Triticonazole is formulated
as liquid flowable formulations.  The first food/feed use was requested
under PP#9F6051 in 2001 by Aventis Crop Science (EPA Company No. 264);
the Aventis products have since been transferred to BASF (EPA Company
No. 7969).

BASF Crop Protection previously submitted a tolerance petition,
PP#8F7420, and Section 3 request to  register Triticonazole HL Fungicide
(EPA Reg. No. 7969-xxx, a 4.17 lb ai/gal liquid flowable formulation)
for seed treatment uses on cereal grains (except rice) at a maximum rate
of 0.05 lb ai/100 lb seed.

HED RAB3 reviewed the petition and recommended  for the conditional
registration for the requested  seed treatment uses on cereal grain
crops (except rice) and the establishment of tolerances for residues of
the fungicide triticonazole,
(1RS)-(E)-5-[(4-chlorophenyl)methylene]-2,2-dimethyl-1-(1H
-1,2,4-triazol-1-ylmethyl)cyclopentanol, from the treatment of seed
prior to planting in/on (A. Acierto,  06/12/2009, D325956, D353372,
D360624):  

	Grain, cereal, group 15 (except rice)
………………………………...0.01 ppm

	Grain, cereal, forage, fodder, and straw, group 16 (except rice)
……0.25 ppm

RAB 3 also recommended that  upon establishment of the above tolerances
for grain, cereal, group 15 (except rice) and grain, cereal, forage,
fodder, and straw, group 16 (except rice), the existing tolerances
listed in 40 CFR 180 (a) should be removed:  barley, grain; barley, hay;
barley, straw; wheat, forage; wheat, grain; wheat, hay; wheat, straw.

HED recommended for a conditional registration until two deficiencies
were satisfied (A. Acierto,  06/12/2009, D325956, D353372, D360624): 
First,  the adequacy of the additional triazole storage stability data
to support the storage durations of cereal grain forages, fodders and/or
straws, corn kernel plus cob with husk removed (K+CWHR), and sorghum
stalks from the cereal grain field trial studies need to  be determined
when the final results of an ongoing triazole storage stability study
are submitted to the Agency.  According to current Agency policy,
storage stability in the raw agricultural commodity (RAC) can be
translated to the processed commodity. 

Second, limited field rotational crop studies are needed.  The confined
rotational crop study data indicate that residues of triticonazole may
be present at >0.01 ppm in 30-DAT rotated lettuce (0.017 ppm), radish
tops (0.049 ppm) and wheat forage (0.041 ppm), straw (0.133 ppm) and
chaff (0.139 ppm); 120-DAT rotated radish tops (0.016 ppm), and wheat
forage (0.019 ppm), straw (0.150 ppm), and chaff (0.114 ppm); and
365-DAT rotated wheat forage (0.025 ppm), straw (0.086 ppm) and chaff
(0.133 ppm).  Wheat hay was not analyzed but forage and straw were
analyzed, and residues of triticonazole were found in forage and straw.

The originally proposed label for the 4.17 lb/gal FS specifies that
“planting of any crop not listed on the label within 30 days after
planting treated seed is not allowed”.  The results of the submitted
confined rotational crop study do not support this restriction.  The
data from the confined rotational crop study indicate that triticonazole
residues greater than 0.01 ppm were detected at the 30-day PBI.  To
support a 30-day plantback restriction on the label, limited field
rotational crop data for leafy vegetables, root and tuber vegetables,
foliage of root and tuber vegetables, and a cereal grain are required. 
Until the requested data are provided, HED previously concluded that the
label must be modified to specify a 120-day (4-month) plantback
restriction for leafy vegetables, a 365-day (12-month) plantback
restriction for root and tuber vegetables, and prohibit the planting of
all other crops not listed on the label.

The present submission  addresses the second deficiency (rotational crop
requirement) and the associated plant back restrictions on the label. 
The registrant has responded with a request to amend the label to delete
the high  seed treatment rates (0.05 lbs ai/100 lbs seed) for wheat,
barley, rye, and oats and to retain only the 0.005 lbs ai/100 lbs seed
treatment rates for wheat, barley, rye, and oats.  The registrant also
presents an extrapolation of  the new seed treatment rates to equivalent
ground application rates and contends that these rates would not lead to
quantifiable residues (<0.01 ppm)  in  rotational crops at a  30 day
plant back interval.  

The reduction in the application rate by a factor of 10 for the seed
treatment of wheat, rye, barley and oats has no effect on the previous
recommendation of tolerance for cereal grains (except rice).  The
available data support a tolerance level of 0.01 ppm for cereal grains,
group 15 (except rice).  The value of 0.05 ppm proposed by the
petitioner is excessive, when rice is excluded.  Moreover, the 0.01 ppm
level harmonizes with Canada.  A revised Section F must be submitted to
reflect the tolerance recommendation of 0.01 ppm for cereal grains,
group 15 (except rice).  The individual tolerances established for
barley grain and wheat grain at 0.05 ppm in 40 CFR §180.583(a) should
be deleted when the crop group tolerance is established. 

The reduction in the application rate by a factor of 10 for the seed
treatment of wheat, rye, barley and oats does have an effect on the
previous recommendation of tolerance for forage and stover of cereal
grains (except rice).  Residues of triticonazole were  nonquantifiable
in treated field and sweet corn forage and stover, and sorghum forage
and stover.  Quantifiable residues of triticonazole were observed in
treated wheat forage, hay and straw, and rice straw.  Highest residues 
were observed in the wheat feed commodities, where the application rate
was 10X the label specification.   Appropriate tolerance levels were
determined  from the highest residues observed.  The residue data for
rice straw was excluded because the petitioner is not applying for use
on rice.   HED recommends a crop group tolerance of  0.10 ppm based on
the highest observed residue value for wheat feed commodities from the
10X study.  This is in agreement with the petitioner’s proposal and
replaces the previous HED recommendation of  0.25 ppm (A. Acierto, 
06/12/2009, D325956, D353372, D360624)

Further consideration of the confined rotational crop study with the
proposed label change (maximum seed treatment rate reduced from 0.05 to
0.005 lb ai/100 lbs seed) leads to the conclusion that residues are not
anticipated (<0.01 ppm) on rotational crops from use of triticonazole as
a seed treatment under the revised label conditions.  Therefore, limited
field rotational crop studies are not required.  This deficiency from
the previous memo (A. Acierto,  06/12/2009, D325956, D353372, D360624)
is resolved.

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

HED has examined the residue chemistry database for triticonazole and
concludes that 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 conditional registration for the
requested seed treatment uses on cereal grain crops (except rice) and
the establishment of tolerances for residues of the fungicide
triticonazole,
(1RS)-(E)-5-[(4-chlorophenyl)methylene]-2,2-dimethyl-1-(1H
-1,2,4-triazol-1-ylmethyl)cyclopentanol, from the treatment of seed
prior to planting in/on:  

	Grain, cereal, group 15 (except rice)
………………………………...0.01 ppm

	Grain, cereal, forage, fodder, and straw, group 16 (except rice)
……0.10 ppm

Moreover, upon establishment of the above tolerances for grain, cereal,
group 15 (except rice) and grain, cereal, forage, fodder, and straw,
group 16 (except rice), the existing tolerances listed in 40 CFR 180 (a)
should be removed:  barley, grain; barley, hay; barley, straw; wheat,
forage; wheat, grain; wheat, hay; wheat, straw.

A human health risk assessment has been conducted (N. Tsaur et al,
D358614, 08/07/2009).    The changes recommended herein have no effect
on that assessment and it remains valid.

860.1200 Directions for Use

	

		• The previous recommendation for a label change to add various
plant back intervals is 

		   withdrawn.  The existing plantback interval (30 days) for
Triticonazole HL Fungicide is adequate.  This change results from the
proposal to reduce the  maximum application rate for seed treatment to
0.005 lbs. ai/100 lbs seed.

 

860.1550 Proposed Tolerances

	•  A revised Section F must be submitted to reflect the tolerance
recommendation of 0.01 ppm for cereal grains, group 15 (except rice); to
reflect the tolerance recommendation of 0.10 ppm for grain, cereal,
forage, fodder, and straw, group 16 (except rice); and to reflect the
correct commodity definitions as listed in Table 7.

HED recommends conversion of conditional registration to unconditional
registration for the cereal grains (except rice) upon adequate
resolution of data pertaining to storage stability.

Tolerance Expression:

The tolerance expression in 40CFR180§583(a) should be modified to the
following:

“Tolerances are established for residues of the fungicide
triticonazole, including its metabolites 

and degradates, from the treatment of seed prior to planting,  in or on
the commodities in the 

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

measuring only 
5-[(4-chlorophenyl)methylene]-2,2-dimethyl-1-(1H-1,2,4-triazol-1-

ylmethyl)cyclopentanol.”

860.1380 Storage Stability

	•  To support the reported results for 1,2,4-triazole and the
triazole conjugates, the final report of the ongoing storage stability
study with free triazole and triazole conjugates in plant commodities
must be submitted (A. Acierto,  06/12/2009, D325956, D353372, D360624) .

860.1900 Field Accumulation in Rotational Crops

	• The previous deficiency is resolved.   Data from limited field
accumulation studies on rotational crops are not  required, because the
confined rotational crop study shows that quantifiable residues are
unlikely in rotated commodities from use of triticonazole as a seed
treatment for cereal grains (except rice) in accordance with the use
instructions of the revised label for Triticonazole HL Fungicide.   

Background

The chemical structure and nomenclature of triticonazole and
triazole-related metabolites, and the physicochemical properties of the
technical grade of triticonazole are, respectively, presented in Tables
1 and 2. 

Triazole acetic acid or triazolylacetic acid

Table 2.	Physicochemical Properties of Chemical:  Triticonazole.

Parameter	Value	Reference

Melting point/range	140 ºC; PAI displays two crystalline forms melting
at 137 and 141 ºC	BASF document number 2002/1016091 1

pH	Not available

	Density	1.21 g/mL (PAI)	BASF document number 2002/1016091 1

Water solubility	8.4 mg/L at 20 ºC

	Solvent solubility (at 20 ºC)	Hexane		0.12 g/L

Methanol	18.2 g/L

Acetone		74.5 g/L

Toluene		12.6 g/L

Dichloromethane	191 g/L

Ethyl acetate	48.6 g/L

n-Octanol	6.2 g/L

	Vapor pressure	<0.1 x 10-5 PA at 50 ºC

	Dissociation constant, pKa	Does not dissociate

	Octanol/water partition coefficient, Log(KOW)	Log P = 3.29 at 20 ºC

	UV/visible absorption spectrum	Not available

	1 As referenced in MRID 47470203.

860.1200 Directions for Use

A summary of the revised proposed use directions is presented in Table
3.  Information pertaining to the proposed use pattern was obtained from
a September 2009 specimen label submitted for Triticonazole HL Fungicide
Seed Treatment (4.17 lb/gal FS).  The EP is proposed for the control of
various seed-borne diseases in cereal crops except rice.  

Table 3 shows that Triticonazole HL Fungicide Seed Treatment is proposed
for seed treatment on cereal grains (except rice) at a maximum rate of
0.005 lb ai/100 lb seed for oats, rye, barley, and wheat; at 0.01 lbs
ai/100 lbs seed for sweet corn; at 0.050 lbs ai/a00 lbs seed for field
corn, and at 0.020 lbs ai/100 lbs sorghum.  The end-use product
Charter® Fungicide Treatment (EPA Reg. No. 7969-386; accepted
6/27/2007) is currently registered on barley and wheat for preplant seed
treatment at a maximum rate of 0.005 lb ai/100 lb seed.

Table 3.	Summary of Proposed Seed Treatment Use of Triticonazole.

Application Type	Formulation

[EPA Reg. No.]	Seed Treatment 

Application Rate 

(lb ai/100 lb seed)	Maximum 

Seeding Rate 1 

(lb seed planted/A)	Maximum Equivalent 

Field Application Rate,  2

lb ai/A

(kg ai/ha)

Barley

Seed Treatment	4.17 lb/gal FS

[7969-xxx]	0.005 	96	0.0048

(0.0054)

Field Corn and Popcorn (includes seed production)

Seed Treatment	4.17 lb/gal FS

[7969-xxx]	0.005-0.050 	15	0.0075

(0.0084)

Sweet Corn

Seed Treatment	4.17 lb/gal FS

[7969-xxx]	0.010	15	0.0015

(0.0017)

Oats

Seed Treatment	4.17 lb/gal FS

[7969-xxx]	0.005	128	0.0064

(0.0072)

Rye

Seed Treatment	4.17 lb/gal FS

[7969-xxx]	0.005	112	0.056

(0.0063)

Sorghum

Seed Treatment	4.17 lb/gal FS

[7969-xxx]	0.010-0.020	10	0.0020

(0.0022)

Wheat and Triticale

Seed Treatment	4.17 lb/gal FS

[7969-xxx]	0.005	150	0.0075

(0.0084)

General Use Directions and Limitations:  To be applied as a water-based
mixture using standard or mist-type seed treatment application
equipment.  A colorant must be added to identify the treated seed.  The
proposed label does not include water amounts needed to provide the
mixture or slurry rate for optimum coverage, but recommends consulting a
seed-treatment specialist.  The product may be tank-mixed with other
water-based seed treatments.  Use of treated seed for food, feed, or oil
processing is prohibited.  Planting of any crop not listed on the label
within 30 days after planting treated seed is not allowed. 

1  From Science Advisory Council for Exposure, Standard Operating
Procedure, SOP #15, 3/2/04.

2  Calculated by the study reviewer using the maximum seed treatment
rate and maximum seeding rate.

Conclusions.  The revised  submitted label for Triticonazole HL
Fungicide Seed Treatment  reduced the maximum treatment rate for wheat,
oats, barley, and rye by a factor of 10.    The submitted confined
rotational crop study (see below), which was conducted at 14x to 71x 
the proposed maximum equivalent field application rate for cereal
grains, indicates that residues of triticonazole will likely be absent
at >0.01 ppm in 30-DAT rotated lettuce, radish tops and roots,  and
wheat forage, straw and chaff;, and grain   The proposed 30-day
plantback interval for all crops not listed on the label is now
acceptable.   

860.1300 Nature of the Residue - Plants

Residue Chemistry Memo DP# 262566, 6/6/2001, N. Dodd (PP#9F6051)

Residue Chemistry Memo DP# 325956, 353372, 360624; A. Acierto
(PP#8F7420)

860.1300 Nature of the Residue - Livestock

Residue Chemistry Memo DP# 262566, 6/6/2001, N. Dodd (PP#9F6051)

Residue Chemistry Memo DP# 325956, 353372, 360624; A. Acierto
(PP#8F7420)

860.1340 Residue Analytical Methods

Enforcement method

Residue Chemistry Memo DP# 262566, 6/6/2001, N. Dodd (PP#9F6051)

Residue Chemistry Memo DP# 325956, 353372, 360624; A. Acierto
(PP#8F7420)

Data-Collection Method

DER Reference:  47511902.der.doc

Residue Chemistry Memo DP# 325956, 353372, 360624; A. Acierto
(PP#8F7420)

860.1360 Multiresidue Methods

Residue Chemistry Memo DP# 262566, 6/6/2001, N. Dodd (PP#9F6051)

Residue Chemistry Memo DP# 325956, 353372, 360624; A. Acierto
(PP#8F7420)

860.1380 Storage Stability

Storage Stability Study with Triticonazole on Wheat

DER Reference: 45595401.der.doc

Residue Chemistry Memo DP# 262566, 6/6/2001, N. Dodd (PP#9F6051)

Residue Chemistry Memo DP# 325956, 353372, 360624; A. Acierto
(PP#8F7420)

Interim Results of a Storage Stability Data Study with 1,2,4-Triazole
(T), Triazolylalanine (TA), and Triazolylacetic Acid (TAA) In Apples,
Wheat Flour, Peanut Butter, Milk, and Eggs

DER Reference: 	46568301.der.doc

Residue Chemistry Memo DP# 325956, 353372, 360624; A. Acierto
(PP#8F7420)

860.1400 Water, Fish, and Irrigated Crops

There are no proposed uses relevant to this guideline topic.  The
petitioner noted that they are not seeking to register use on rice, a
crop which may be irrigated, at this time.

860.1460 Food Handling

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

860.1480 Meat, Milk, Poultry, and Eggs

Residue Chemistry Memo DP# 262566, 6/6/2001, N. Dodd (PP#9F6051)

Residue Chemistry Memo DP# 325956, 353372, 360624; A. Acierto
(PP#8F7420)

860.1500 Crop Field Trials

DER Reference:  47470203.der.doc

Residue Chemistry Memo DP# 325956, 353372, 360624; A. Acierto
(PP#8F7420)

Wheat, corn, sorghum, and rice crop field trials were previously
reviewed.  The seed treatment application rate for all crop seeds was 
50 g ai/100 kg seed. or 0.05  lbs ai/100 lbs seed.  This is 10x the
revised maximum proposed seed treatment use on  oats, rye, wheat, and
triticale.  The residues found on the mature crop commodities will be
elevated relative to those resulting from use according to the revised
label.  

The summary table of field trial results is repeated below.  Residues of
triticonazole were <0.01 ppm on field corn,  sweet corn, and sorghum 
commodities from treatments at 1X to 5X  the label rate.  The maximum
triticonazole residues on wheat forage, hay, straw, and grain were 0.10
ppm, 0.08 ppm, 0.08 ppm, and <0.01 ppm, respectively,  from treatments
at 10X the label rate.

Table 4.   Summary of Residue Data from Crop Field Trials with
Triticonazole.

Commodity	Applic.

Rate 

g ai/100

 kg seed

(lb ai/100 lbs seed)	DAP (days)	Residue Levels (ppm)1

	n	Min.	Max.	HAFT2	Median

(STMdR)	Mean

(STMR)	Std. 

 Dev. 3 

Proposed Rate on Barley, Oats, Rye, Wheat, and Triticale =  0.0050 lb
ai/100 lb seed

Propsed Rate on Corn (Field and Pop) = 0.050 lb ai/100 lb seed

Proposed Rate on Sweet Corn = 0.010 lb ai/100 lb seed

Proposed Rate on Sorghum = 0.020 lb ai/100 lb seed)

Triticonazole

Wheat, forage	50

(0.05)	35-102	30	<0.01	0.10	0.10	0.02	0.04	0.028

Wheat, hay	50

(0.05)	56-135	30	<0.01	0.08	0.08	0.02	0.03	0.026

Wheat, grain	50

(0.05)	90-177	30	<0.01	<0.01	<0.01	0.01	0.01	NA

Wheat, straw	50

(0.05)	90-177	30	<0.01	0.08	0.08	0.03	0.03	0.024

Corn, forage 4	50

(0.05)	78-155	38	<0.01	<0.01	<0.01	0.01	0.01	NA

Corn, grain	50

(0.05)	112-161	30	<0.01	<0.01	<0.01	0.01	0.01	NA

Corn, stover 4	50

(0.05)	92-176	38	<0.01	<0.01	<0.01	0.01	0.01	NA

Corn, K+CWHR	50

(0.05)	71-114	18	<0.01	<0.01	<0.01	0.01	0.01	NA

Sorghum, forage	50

(0.05)	61-113	24	<0.01	<0.01	<0.01	0.01	0.01	NA

Sorghum, grain	50

(0.05)	90-199	24	<0.01	<0.01	<0.01	0.01	0.01	NA

Sorghum, stover	50

(0.05)	90-199	24	<0.01	<0.01	<0.01	0.01	0.01	NA

Rice, grain	50

(0.05)	114-182	24	<0.01	0.02	0.02	0.01	0.01	0.003

Rice, straw	50

(0.05)	114-182	24	<0.01	0.04	0.04	0.01	0.02	0.009

Triazole (T)

Wheat, forage	50

(0.05)	35-102	30	<0.05	<0.05	<0.05	0.05	0.05	NA

Wheat, hay	50

(0.05)	56-135	30	<0.05	<0.05	<0.05	0.05	0.05	NA

Wheat, grain	50

(0.05)	90-177	30	<0.01	<0.01	<0.01	0.01	0.01	NA

Wheat, straw	50

(0.05)	90-177	30	<0.05	<0.05	<0.05	0.05	0.05	NA

Corn, forage 4	50

(0.50)	78-155	38	<0.05	<0.05	<0.05	0.05	0.05	NA

Corn, grain	50

(0.05)	112-161	30	<0.01	<0.01	<0.01	0.01	0.01	NA

Corn, stover 4	50

(0.05)	92-176	38	<0.05	<0.05	<0.05	0.05	0.05	NA

Corn, K+CWHR	50

(0.05)	71-114	18	<0.01	<0.01	<0.01	0.01	0.01	NA

Sorghum, forage	50

(0.05)	61-113	24	<0.05	<0.05	<0.05	0.05	0.05	NA

Sorghum, grain	50

(0.50)	90-199	24	<0.01	<0.01	<0.01	0.01	0.01	NA

Sorghum, stover	50

(0.05)	90-199	24	<0.05	<0.05	<0.05	0.05	0.05	NA

Rice, grain	50

(0.05)	114-182	24	<0.01	<0.01	<0.01	0.01	0.01	NA

Rice, straw	50

(0.05)	114-182	24	<0.05	<0.05	<0.05	0.05	0.05	NA

Triazolylalanine (TA)

Wheat, forage	50

(0.05)	35-102	30	<0.05	0.12	0.11	0.05	0.05	0.015

Wheat, hay	50

(0.05)	56-135	30	<0.05	0.14	0.13	0.05	0.06	0.021

Wheat, grain	50

(0.05)	90-177	30	<0.05	0.26	0.24	0.06	0.10	0.063

Wheat, straw	50

(0.05)	90-177	30	<0.05	0.07	0.07	0.05	0.05	0.004

Corn, forage 4	50

(0.05)	78-155	38	<0.05	<0.05	<0.05	0.05	0.05	NA

Corn, grain	50

(0.05)	112-161	30	<0.05	0.35	0.31	0.05	0.07	0.065

Corn, stover 4	50

(0.05)	92-176	38	<0.05	<0.05	<0.05	0.05	0.05	NA

Corn, K+CWHR	50

(0.05)	71-114	18	<0.05	0.26	0.24	0.05	0.07	0.061

Sorghum, forage	50

(0.05)	61-113	24	<0.05	0.10	0.08	0.05	0.05	0.010

Sorghum, grain	50

(0.05)	90-199	24	<0.05	0.39	0.38	0.05	0.08	0.091

Sorghum, stover	50

(0.05)	90-199	24	<0.05	0.26	0.25	0.05	0.07	0.057

Rice, grain	50

(0.05)	114-182	24	<0.05	0.29	0.29	0.05	0.07	0.066

Rice, straw	50

(0;05)	114-182	24	<0.05	<0.05	<0.05	0.05	0.05	NA

Triazolyl-acetic acid (TAA)

Wheat, forage	50

(0.05)	35-102	30	<0.05	<0.05	<0.05	0.05	0.05	NA

Wheat, hay	50

(0.05)	56-135	30	<0.05	0.13	0.11	0.05	0.06	0.016

Wheat, grain	50

(0.05)	90-177	30	<0.01	0.20	0.20	0.04	0.05	0.046

Wheat, straw	50

(0.05)	90-177	30	<0.05	0.10	0.10	0.05	0.05	0.011

Corn, forage 4	50

(0.05)	78-155	38	<0.05	<0.05	<0.05	0.05	0.05	NA

Corn, grain	50

(0.05)	112-161	30	<0.01	<0.01	<0.01	0.01	0.01	NA

Corn, stover 4	50

(0.05)	92-176	38	<0.05	<0.05	<0.05	0.05	0.05	NA

Corn, K+CWHR	50

(0.05)	71-114	18	<0.01	<0.01	<0.01	0.01	0.01	NA

Sorghum, forage	50

(0.05)	61-113	24	<0.05	0.07	0.06	0.05	0.05	0.004

Sorghum, grain	50

(0.05)	90-199	24	<0.01	0.37	0.35	0.01	0.04	0.095

Sorghum, stover	50

(0.05	90-199	24	<0.05	<0.05	<0.05	0.05	0.05	NA

Rice, grain	50

(0.05)	114-182	24	<0.01	0.50	0.50	0.03	0.07	0.134

Rice, straw	50

(0.05)	114-182	24	<0.05	0.34	0.34	0.05	0.08	0.082

860.1520 Processed Food and Feed

DER Reference:  47511901.der.doc

Residue Chemistry Memo DP# 325956, 353372, 360624; A. Acierto
(PP#8F7420)

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

Analytical standards for triticonazole are currently available in the
EPA National Pesticide Standards Repository (personal communication with
Dallas Wright, ACB, 2/23/09), expiration date 7/8/2014.  

860.1850 Confined Accumulation in Rotational Crops

DER Reference:  47399201.der.doc

Residue Chemistry Memo DP# 262566, 6/6/2001, N. Dodd (PP#9F6051)

Residue Chemistry Memo DP# 325956, 353372, 360624; A. Acierto
(PP#8F7420)

The results from the previously reviewed confined rotational crop study
are summarized in Table 5 (DP# 262566, 6/6/2001, N. Dodd).   The
application rate to the soil was 120 g ai/ha. (0.107 lb ai/acre) 

Table 5.  Total Radioactive Residues and Triticonazole  in Rotated
Lettuce, Radish, and Wheat Matrices 

Matrix	Plantback Interval (days)	TRR Phenyl Label (ppm)	TRR Triazole
Label (ppm)

	Triticonazole (ppm)

Combustion	Calculated1	Combustion	Calculated1

	Lettuce	30	0.020	0.024	0.065	0.065	0.017

	120	0.014	0.014	0.026	0.025	0.006

	365	0.005	0.004	0.029	0.024	0.003

Radish, roots	30	0.009	0.009	0.099	0.094	0.007

	120	0.006	0.006	0.055	0.056	0..003

	365	0.003	0.003	0.031	0.029	0.002

Radish, tops	30	0.072	0.067	0.279	0.256	0.049

	120	0.052	0.040	0.331	0.286	0.016

	365	0.011	0.009	0.128	0.043	0.003

Wheat, forage	30	0.067	0.042	0.199	0.129	0.041

	120	0.049	0.035	0.155	0.095	0.019

	365	0.029	0.015	0.141	0.107	0.025

Wheat, straw	30	0.209	0.181	0.629	0.580	0.133

	120	0.345	0.298	0.675	0.576	0.150

	365	0.282	0.198	0.520	0.455	0.086

Wheat, chaff	30	0.181	0.174	0.509	0.571	0.139

	120	0.151	0.141	0.848	0.786	0.114

	365	0.106	0.095	0.562	0.549	0.133

Wheat, grain	30	0.008	0.008	0.453	0.948	0.00

	120	0.054	0.053	0.689	0.706	0.00

	365	0.025	0.028	0.682	0.773	0.00

1 Calculated by the summation of extractable and nonextractable
radioactivity; these values were used by the petitioner for all further
calculations.

The application rate used in the confined rotational crop study  is
significantly higher than the equivalent application rate achieved from
the proposed seed treatment rates.  The comparison is given in Table 6.

Table 6.  Equivalent Field Rates from Proposed Label for Triticonazole
Seed Treatment

Crop	Maximum seed treatment rate

(lbs ai/100 lbs seed)	Maximum seeding rate (lb seed/acre)	Maximum
Equivalent Field Application Rate (lbs ai/acre)	Exaggeration Factor from
Confined Rotational Crop1

Field corn	0.050	15	0.0075	14

Sweet corn	0.010	15	0.0015	71

Sorghum	0.020	10	0.0020	54

Wheat	0.005	150	0.0075	14

Barley	0..05	96	0.0048	22

Rye	0.005	112	0.0056	19

Oat	0.005	128	0.0064	17

1 Confined rotational crop application rate (0.107 lb ai/acre) / maximum
equivalent field application rate from seed treatment.

The confined rotational crop study was conducted at a minimum
exaggerated rate of 14X.  Assuming a proportionality between the
concentration of triticonazole in the soil and the triticonazole residue
in the rotated crop commodities, all triticonazole residues on all
commodities would be <0.01 ppm at all plant back intervals with the
exception of wheat straw and wheat chaff.  These commodities might
contain about 0.01 ppm triticonazole at all plant back intervals, e.g.,
0.150 ppm wheat straw at 120 days  / 14 = 0.0107 ppm.    However, given
that a confined study represents the worst possible case, it is likely
that triticonazole residues on wheat chaff and straw would not achieve a
level of 0.01 ppm under field conditions.

Conclusion.  .  The application rate used  in the confined rotational
crop study reflects 14 to  71X  the equivalent per acre rate proposed
for cereal grain crops.   It is unlikely that quantifiable residues of
triticonazole (>0.01 ppm) will be found in rotated crop commodities at
plant back intervals of 30 days or greater when triticonazole is used as
a seed treatment at the label rates proposed.

860.1900 Field Accumulation in Rotational Crops

The proposed label for the 4.17 lb/gal FS specifies that “planting of
any crop not listed on the label within 30 days after planting treated
seed is not allowed”.  The results of the submitted confined
rotational crop study support this restriction.  The data from the
confined rotational crop study indicate that triticonazole residues
greater than 0.01 ppm were detected at the 30-day PBI.   However, when
the exaggerated treatment rate of the confined study (14X minimum) is
taken into consideration, it is likely that triticonazole residues will
be < 0.01 ppm on rotated food commodities.  

Although significant  triticonazole was quantitated at >0.01 ppm in the 
rotated  livestock feed commodities wheat straw, forage,  and chaff 
planted at the 30-, 120- and 365-day PBIs from a confined rotational
crop study conducted at an exaggerated rate of  14X,  the levels of
triticonazole anticipated from 1X treatment are estimated to be <0.01
ppm. . 

Conclusion. Field accumulation in rotational crops studies will not be
required.  The confined study indicates that residues of triticonazole
will be non-quantifiable in rotated crops resulting from the use of
triticonazole as a seed treatment for cereal grains (except rice) used
according to the proposed label application rates.

860.1550 Proposed Tolerances

Tolerances have been established under 40 CFR §180.583(a) for residues
of the fungicide triticonazole,
(1RS)-(E)-5-[(4-chlorophenyl)methylene]-2,2-dimethyl-1-(1H
-1,2,4-triazol-1-ylmethyl)cyclopentanol, from the treatment of seed
prior to planting in/on barley grain, hay and straw, and wheat grain,
forage, hay and straw, each at 0.05 ppm.  HED has previously determined
that triticonazole is the residue of concern in barley and wheat from
seed treatment uses.  This regulatory decision may be extended to
include all crop commodities in the cereal grains crop group.  The
petitioner has not specified the tolerance expression with the proposed
tolerances in Section F of the petition. 

The submitted residue data for field corn grain, sweet corn K+CWHR,
sorghum grain, and wheat grain, which are the representative commodities
of the cereal grain group,  do not support the proposed  tolerance for
the ‘Grain, cereal, group 15 (except rice)’ at 0.05 ppm.  The data
do support a tolerance for ‘Grain, cereal, group 15 (except rice)’
at 0.01 ppm. A revised Section F must be submitted to reflect the
tolerance recommendation of 0.01 ppm for “Grain, cereal, group 15
(except rice)” at 0.01 ppm. The established individual tolerances for
wheat grain and barley grain must be deleted when the crop group
tolerance is established.

The submitted residue data for corn forage and stover, sorghum forage
and stover, and wheat forage, hay, and straw are adequate to determine a
tolerance level for the forage, fodder, and straw of cereal grains crop
group (except rice).  The residues in wheat commodities were highest,
but resulted from a 10X exaggerated rate study.   The HAFT residues
resulting from the study  were used to establish, the tolerance levels
for wheat   forage, wheat hay, and wheat straw.   The data support  the 
proposed  Section F tolerance of  0.10 ppm for  “Grain, cereal,
forage, fodder, and straw, group 16 (except rice).”   The established
individual tolerances for barley hay and straw, and wheat forage, hay
and straw must be deleted when the crop group tolerance is established. 

The considerations for processed commodities and livestock commodities
remain unchanged from the previous review (A. Acierto,  06/12/2009,
D325956, D353372, D360624) 

A summary of the recommended tolerances for the petition is listed in
Table 7

Table 7. 	Tolerance Summary for Triticonazole

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

Established tolerances under 180.583(a)

Barley, grain	0.05	Remove	Barley grain will be covered with the
establishment of the cereal grain, group 15 (except rice) tolerance.

Barley, hay	0.05	Remove	Increase in the tolerance based on residues
resulting from new uses. Barley hay and straw and wheat forage will be
covered with the establishment of the cereal grain group 16 (except
rice) tolerance.

Barley, straw	0.05	Remove

	Wheat, forage	0.05	Remove

	Wheat grain	0.05	Remove	Barley grain will be covered with the
establishment of the cereal grain, group 15 (except rice) tolerance

Wheat, hay	0.05	Remove	Increase in the tolerance based on residues
resulting from new uses. Wheat hay and straw and will be covered with
the establishment of the cereal grain group 16 (except rice) tolerance.

Wheat, straw	0.05	Remove

	Tolerances to be established under 180.583(a)

Grain, cereal, group 15 (except rice)	0.05	0.01	.

Grain, cereal, forage, fodder, and straw, group 16 (except rice)	0.10
0.101	.

1 The only change from the previous tolerance summary  (A. Acierto, 
06/12/2009, D325956, 353372, 360624)  is the replacement of 0.25 with
0.10 ppm.

References

DP#:		262566

Subject:	PP#9F6051.  Triticonazole Seed Treatment on Barley and Wheat. 
Review of Analytical Methods and Residue Data.  First Food Use Review.

From:		N. Dodd

To:		S. Gardner-Jenkins/M. Waller

Dated:		6/6/2001

MRIDs:  	44904515-25, 44995701-06

DP#		325956; 353372; 360624

Subject:	Triticonazole.  Application for New Seed Treatment Uses on
Cereal Grains (Except Rice) (PP#8F7420).  Summary of Analytical
Chemistry and Residue Data..  

From:		A. Acierto

To:		S. Joyner

Dated:		6/12/2009

MRIDs:	47511902; 45595401; 46568301; 47470203; 47511901; 47399201

Template Vers.,ion September 2005

Triticonazole                  Addendum to Summary of Analytical
Chemistry and Residue Data	DP #370705

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