Document ID: EPA-HQ-OPP-2007-0106-0005
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2007-09-19T04:00Z

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF           

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

MEMORANDUM

	Date:	02/AUG/2007

	Subject:	Pendimethalin.  Petitions for Tolerances on Brassica Head and
Stem Vegetables, Subgroup 5A, Asparagus, Grape and Artichoke.  Summary
of Analytical Chemistry and Residue Data.  Petition Number 6E7129.

DP Num:	340343	Decision Number:	371520

PC Code:	108501	MRID Nos.:	46963501, 46963502, 46963503, 46963504,
46963505

40 CFR 180.	361

Chemical Class:	Dinitroaniline Herbicide

	From:	Debra Rate, Ph.D., Biologist

		Alternative Risk Integration and Assessment (ARIA)

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

		Registration Division (RD) (7505P)

	Through:	William Cutchin, Acting Branch Senior Scientist

		ARIA

		RIMUERB/RD (7505P)

William T. Drew, Chemist

	Registration Action Branch 2

	Health Effects Division (7509P)

To:  D. Rosenblatt/B. Madden PM-5

RIMUERB/RD (7505P)

Executive Summary 

Pendimethalin is a preemergent and early postemergent dinitroaniline
herbicide which acts as a microtubule disruptor by inhibiting cell
division and cell elongation in plants.  Pendimethalin was developed for
the control of most annual grasses and certain broadleaf weeds. 
Tolerances are currently established for the combined residues of the
herbicide pendimethalin [N-
(1-ethylpropyl)-3,4-dimethyl-2,6-dinitrobenzenamine] and its metabolite
4-[(1-ethylpropyl)amino]-2-methyl-3,5-dinitrobenzyl alcohol in or on
various plant commodities at levels ranging from 0.1 to 4 ppm (40 CFR
§180.361[a]).  

Interregional Research Project No. 4 (IR-4) has submitted petitions
supporting the use of pendimethalin, formulated as a emulsifiable
concentrate (EC) containing 37.4% active ingredient (ai), pendimethalin
(Prowl® 3.3 EC, EPA Reg. No. 241-337) and an aqueous capsule suspension
(CS) formulation containing 38.7% pendimethalin (Prowl® H20, EPA Reg.
No. 241-418) on asparagus, artichoke, Brassica head and stem vegetables,
and grape.  The proposed use on asparagus, is for a single broadcast
application prior to spear emergence at up to 4.0 lb ai/A, with a 14-day
PHI.  For artichoke, the proposed use is for a single pre-transplant
soil application, at up to 4.0 lb ai/A, with a 200 day PHI.  For
Brassica head and stem vegetables, subgroup 5A, the proposed use is for
a single foliar application at transplant at up to 1.0 lb ai/A, with a
PHI of 108 days.  For grape, the proposed use is a single soil directed
application up to 6.0 lb ai/A, with a PHI of 100 days.  In conjunction
with the above uses, the petitioners are proposing the following
permanent tolerances for pendimethalin:

Brassica, head and stem, subgroup 5A	0.05 ppm

Artichoke, globe	0.05 ppm

Asparagus	0.1 ppm

Grape	0.05 ppm

The nature of the residue in plants is understood, based on adequate
studies conducted with [14-C]-pendimethalin in potatoes and sweet corn. 
The results of these studies are supported by additional studies
conducted on cotton, dry bean, lima bean, peanut, red table beet, rice,
snap bean, soybean, sugarcane and wheat.  The residues of concern in
plant commodities are pendimethalin per se and its 3,5-dinitrobenzyl
alcohol metabolite; the chemical names and structures of pendimethalin
and its 3,5-dinitrobenzyl alcohol metabolite are depicted in Appendix I.
 The current tolerance expression for pendimethalin in 40 CFR §180.361
is in terms of the combined residues of pendimethalin and its
3,5-dinitroenzyl alcohol metabolite; it is noted that the
3,5-dinitrobenzyl alcohol metabolite is also known by the company
designated name, CL202,347 and will be predominately referred to as
CL202,347 in this memorandum.  The proposed tolerance expression, from
IR-4 is consistent with 40 CFR §180.361.  

The nature of the residue in animals is adequately understood.  Data
from the goat metabolism study, along with data from a poultry
metabolism study indicate that there is no reasonable expectation of
finite residues (pendimethalin, Goat Metabolite 6, and CL202,347) in
meat milk, poultry, nor eggs (40 CFR §180.361(a)(3)) as a result of the
proposed new uses.

There are adequate crop residue analytical methods for tolerance
enforcement and data collection.  Methods I through IV in the Pesticide
Analytical Manual (PAM) Volume II are gas chromatography with electron
capture detection (GC/ECD) methods having a limit of quantitation (LOQ)
of 0.050 ppm each for the parent compound and CL202,347.  Currently, all
pendimethalin tolerances for RACs are established at the combined LOQ
(or lowest level of method validation (LLMV)) of 0.10 ppm.  A
confirmatory gas chromatography with mass spectroscopy (GC/MS) method
has been submitted with a petition on carrots, and has been found
adequate to determine the combined residues of pendimethalin and
CL202,347.  Methods used for analysis of samples from the current
petition were analyzed using a method of gas chromatography with
nitrogen-phosphorus detection (GC/NPD).  These methods are adequate for
data collection, based on acceptable method recoveries obtained during
sample analysis.  

Adequate storage stability data were provided in conjunction with the
field trials.  These studies indicate that combined pendimethalin
residues are stable in frozen storage (≤-17(C) for intervals of up to
112 days in broccoli, 258 days in cabbage, 101 days in asparagus, 196
days in artichoke and 387 days in grape.  Together with earlier storage
stability data on a wide variety of plant commodities, the new storage
stability data support the sample storage durations and conditions used
in the submitted field trials.

The new field trials on asparagus, artichoke, broccoli, and grape are
adequate and support the proposed uses.  An adequate number of tests
were conducted on each proposed crop in the appropriate regions, and
samples were analyzed for the residues of concern using an adequate
method.

In the three artichoke field trials conducted during 1999, pendimethalin
(EC) was applied as one pre-transplant broadcast soil application made
at a rate of approximately 4.0 lb ai/A (4.48 kg ai/ha).  Trial results
show that all pendimethalin residues were below the LLMV (<0.05 ppm)
in/on 200-226-day PHI artichoke samples.  

In the six asparagus field trials conducted during 1998, pendimethalin
(EC) was applied as one broadcast application made to soil prior to
spear emergence at a rate of approximately 4.0 lb ai/A (4.48 kg ai/ha). 
No adjuvants or additives were added to the spray mixture for any of the
above applications.  Asparagus was harvested 14-days after the
application.  Pendimethalin was found at residue levels of 0.055 and
0.062 ppm at the Prosser, WA site (.98-WA*48) only.  Residues at the
other trial sites were below the LLMV (<0.05 ppm) in/on 14-day PHI
asparagus samples.  No CL202,347 residues were found above the LLMV on
any samples.

In the six broccoli field trials conducted during 1998, pendimethalin
(EC) was applied as one broadcast application made after transplanting
at a target rate of 1.0 lb ai/A (1.12 kg ai/ha).  No adjuvants or
additives were added to the spray mixture for any of the above
applications.  Trial results show that all pendimethalin residues were
below the LOQ (<0.05 ppm) in/on broccoli samples treated at a 58-99-day
PHI.  

In the seven cabbage field trials conducted during 1997/1998,
pendimethalin (EC) was applied as one broadcast application made 72
hours after transplanting or at the 2-4 leaf stage at a rate of
approximately 1.0 lb ai/A (1.12 kg ai/ha).  No adjuvants or additives
were added to the spray mixture for any of the above applications. 
Trial results show that all pendimethalin residues were below the LLMV
(<0.05 ppm) in/on 70-108-day PHI cabbage samples.  

In the nine grape field trials conducted during 1995, pendimethalin (EC)
was applied as one broadcast soil application made during the
vegetative/fruiting stage at a rate of approximately 6.0 lb ai/A (6.73
kg ai/ha).  An additional trial was conducted at one site in California
(95-CA64) at an application rate of 12.0 lb ai/A (13.46 kg ai/ha) for
the collection of samples for processing into raisins and juice.  No
adjuvants or additives were added to the spray mixture for any of the
above applications.  Trial results show that all pendimethalin and
CL202,347 residues were below the LLMV (<0.05 ppm) in/on 87-100 day PHI
grape samples.  

Adequate processing studies with pendimethalin on grapes are not
available.  The submitted study (2X application rate) resulted in no
residues in/on the RAC and processed commodities (raisins and grape
juice), therefore a study with an application rate of at least 5X is
required. 

Adequate confined rotational crop studies are available to support the
uses on crops that can be rotated (broccoli, asparagus, artichoke and
cabbage).  Based on the results of the confined accumulation studies,
ARIA concludes that the current rotational crop plant-back intervals
(PBIs) are acceptable and that field trials and tolerances for rotated
crops are not necessary.  

As requested in the previous Residue Chemistry Summary Document (DP Num:
271502, W. Drew, 12/JUL/2006), field accumulation in rotational crops
(860.1900) are required to determine the uptake by rotational crops due
to the increased rate of application (4.0 lb ai/A).

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

No major deficiencies were noted in the subject petitions that would
preclude establishing permanent tolerances for pendimethalin on the
proposed commodities; provided that the petitioner addresses the
deficiencies noted below.  The available r  SEQ CHAPTER \h \r 1 esidue
data support   SEQ CHAPTER \h \r 1 establishing permanent tolerances for
pendimethalin residues at 0.15 ppm in/on asparagus, at 0.1 ppm in/on
brassic head and stem vegetables, globe artichoke, and grape.  In
addition, due to the deficiency in the submitted processing study,
tolerances should be set at 0.50 ppm for grapes and 0.15 ppm for grape
juice, based on default processing factors.    SEQ CHAPTER \h \r 1 A
summary of the proposed and recommended tolerances, along with the
correct commodity definitions for the requested commodities, are
presented in Table 7.  

1.  Section F of the petition must be revised to reflect the recommended
tolerance levels and correct commodity definitions listed in Table 7.

2.  860.1200 Directions for Use:

(a) The product label must be amended to restrict use to a single
application for each of the proposed crops.

(b) As previously requested by HED (DP Num: 329627, W. Drew,
12/JUL/2006), ARIA concludes that the registrant should impose PBIs of
90-days for rotated cereal grain crops, and 270-days for all other
rotated crops, until limited field rotational crop studies (OPPTS
860.1900) have been conducted in order to determine if tolerances for
residues of pendimethalin in rotational crops are needed.  

860.1520 Processed Food and Feed:

To remove the tolerances of 0.15 ppm for grape juice or 0.50 ppm for
raisins, the petitioner must submit a study using at least 5X the
application rate or show that the use of such a high rate is phytotoxic
to the plants and cannot be successfully completed.

 

860.1900 Field Accumulation in Rotational Crops:

HED has previously requested a limited field accumulation study (OPPTS
860.1900) to determine the amount of pesticide residue uptake into
rotational crops.  The limited field trials should reflect the maximum
label use rate of 4.0 lb ai/A for rotated crops, and should be conducted
on a representative crop (as defined in 40CFR §180.41), at two trial
sites per crop, for the following three crop groups:  

	(1) root and tuber vegetables, 

	(2) leafy vegetables, and 

	(3) small grains (wheat, barley, oats, rye), 

for a total of six trials.  The six trials should be conducted on crops
which the petitioner intends to have as rotational crops on the label. 
Samples should be analyzed for pendimethalin and its 3,5-dinitrobenzyl
alcohol metabolite.  

Background

Pendimethalin is a preemergent and early postemergent dinitroaniline
herbicide.  Its proposed mode of action is the inhibition of seedling
growth.  Pendimethalin was developed for the control of most annual
grasses and certain broadleaf weeds.  The nomenclature and
physicochemical properties of pendimethalin are presented below in
Tables 1 and 2.  The chemical names and structures of pendimethalin and
its 3,5-dinitrobenzyl alcohol metabolite (CL202,347) are also depicted
in Appendix I.

TABLE 1.  Test Compound Nomenclature

Common name	Pendimethalin

Chemical Class	Dinitroaniline Herbicides

IUPAC name	N-(1-ethylpropyl)-2,6-dinitro-3,4-xylidine

CAS name	N-(1-ethylpropyl)-3,4-dimethyl-2,6-dinitrobenzenamine

CAS #	40487-42-1

End-use product/EP	Prowl 3.3EC Herbicide (EPA Reg. No. 241-337), Prowl®
H20 (EPA Reg. No. 241-418)

Chemical Structure	

 

TABLE 2.  Physicochemical Properties of the Technical Grade Test
Compound

Parameter	Valuea

Molecular Weight	281.3

Melting point	57.7-58ºC

Boiling point	330ºC

Vapor pressure	1.94 x 10-3 Pa @ 25°C

Henry’s Law Constant	2.728 x 10-3 KPa x m3/mol

Density 	0.85 g/cm3 @ 25°C

Vapor pressure	1.2x 10-5 Pa @ 25°C

Log10 KOW (Log P)	5.2 @ pH 7

Solubility	0.54 mg/L @ 20°C in water (pH 4)

0.33 mg/L @ 20°C in water (pH 7)

0.44 mg/L @ 20°C in water (pH 10)

48.9 g/L @ 20°C in n-hexane

66.08 mg/L @ 20°C in n-octanol

>800 g/L @ 20°C in ethyl acetate

>800 g/L @ 20°C in xylene

>800 g/L @ 20°C in acetone

>800 g/L @ 20°C in dichloromethane

Dissociation Constant	pKa = 2.8

aEuropean Commission Health & Consumer Protection Directorate-General,
Directorate E – Pendimethalin 7477/ VI/98-final, 13 January 2000 ( 
HYPERLINK
"http://ec.europa.eu/food/plant/protection/evaluation/existactive/list1-
35_en.pdf" 
http://ec.europa.eu/food/plant/protection/evaluation/existactive/list1-3
5_en.pdf )

860.1200 Direction for Use

IR-4 is proposing   SEQ CHAPTER \h \r 1 new uses of pendimethalin for
broadleaf weed control in asparagus, artichoke, Brassica head and stem
vegetables, subgroup 5A and grape.  The formulations being proposed for
these uses include a 37.4% EC formulation (Prowl® 3.3 EC, EPA Reg. No.
241-377) and a 38.7% aqueous capsule suspension (Prowl® H20, EPA Reg.
No. 241-418).  These formulations are currently registered to BASF
Corporation, LLC for use on a wide variety of fruit, field and vegetable
crops.

IR-4 provided example labels containing the use directions for the other
crops.  IR-4 also provided summaries of the proposed use directions in
Section B of their petition.  The use directions summarized in Table 3
were obtained from the Section B provided by IR-4.  

Table 3.	Summary of Directions for Use of Pendimethalin. 

Applic. Timing, Type, and Equip.	Formulation

(EPA Reg. No.)	Applic. Rate 

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

(lb ai/A)	PHI

(days)	Use Directions and Limitations 

Artichoke 

Apply as a broadcast spray directed to the soil surface 1-2 days prior
to transplanting.	Prowl® 3.3 EC 

(241-377)	9.7 pints/A

(4.0 lb ai/A)	1	9.7 pints/A

(4.0 lb ai/A)	200	Do not feed forage or graze livestock in treated
fields.

Most effective when incorporated in the weed germination zone by
rainfall or irrigation with 7 days of application.

Apply as a broadcast spray directed to the soil surface 1-2 days prior
to transplanting.	Prowl® H20 (241-418)	8.2 pints/A

(4.0 lb ai/A)	1	8.2 pints/A

(4.0 lb ai/A)	200	Do not feed forage or graze livestock in treated
fields.

Most effective when incorporated in the weed germination zone by
rainfall or irrigation with 7 days of application.

Asparagus

Apply as soil directed broadcast spray at least 14 days before harvest,
prior to spear emergence.	Prowl® 3.3 EC 

(241-377)	9.7 pints/A

(4.0 lb ai/A)	1	9.7 pints/A

(4.0 lb ai/A)	14 	Do not feed forage or graze livestock in treated
fields.

Most effective when incorporated in the weed germination zone by
rainfall or irrigation with 7 days of application.

Apply as soil directed broadcast spray at least 14 days before harvest,
prior to spear emergence.	Prowl® H20 (241-418)	8.2 pints/A

(4.0 lb ai/A)	1	8.2 pints/A

(4.0 lb ai/A)	14	Do not feed forage or graze livestock in treated
fields.

Most effective when incorporated in the weed germination zone by
rainfall or irrigation with 7 days of application.

Brassica Head and Stem Vegetables

Apply as broadcast foliar spray to 2-4 leaf vegetable transplants at 1
to 3 days after transplanting or of dierect seeded plants.	Prowl® 3.3
EC 

(241-377)	2.4 pints/A

(1.0 lb ai/A)	1	2.4 pints/A

(1.0 lb ai/A)	60 broccoli, 70 cabbage	Do not feed forage or graze
livestock in treated fields.

Most effective when incorporated in the weed germination zone by
rainfall or irrigation with 7 days of application.

Apply as broadcast foliar spray to 2-4 leaf vegetable transplants at 1
to 3 days after transplanting or of dierect seeded plants.	Prowl® H20
(241-418)	2.1 pints/A

(1.0 lb ai/A)	1	2.1 pints/A

(1.0 lb ai/A)	60 broccoli, 70 cabbage	Do not feed forage or graze
livestock in treated fields. 

Most effective when incorporated in the weed germination zone by
rainfall or irrigation with 7 days of application.

Grape

Apply as a soil directed broadcast spray underneath the canopy of grape
vines at least 90 days before the harvest.	Prowl® 3.3 EC 

(241-377)	14.5 pints/A

(6.0 lb ai/A)	1	14.5 pints/A

(6.0 lb ai/A)	90	Do not feed forage or graze livestock in treated
fields. 

Most effective when incorporated in the weed germination zone by
rainfall or irrigation with 7 days of application.

Apply as a soil directed broadcast spray underneath the canopy of grape
vines at least 90 days before the harvest.	Prowl® H20 (241-418)	12.3
pints/A

(6.0 lb ai/A)	1	12.3 pints/A

(6.0 lb ai/A)	90	Do not feed forage or graze livestock in treated
fields. 

Most effective when incorporated in the weed germination zone by
rainfall or irrigation with 7 days of application.

Conclusions:  The available labels and Section B are adequate for
evaluation of the field trial data.  Based on the available field trial
data, the following revisions should also be made to the proposed labels
for both Prowl® 3.3 EC and Prowl® H20:

1.  The use on each crop should be restricted to a single application
per season. 

860-1300 Nature of the Residue – Plants.

DP Num: 271502, W. Drew, 12/JUL/2006

DP Num: 221531, B. Cropp-Kohlligian, 08/DEC/1995

46407601.der, W. Drew, 12/JUL/2006

The nature of the residue in plants is   SEQ CHAPTER \h \r 1 understood,
based on adequate studies conducted with [14C]-pendimethalin on potatoes
and sweet corn.  The results of these studies are supported by
additional corn, cotton, dry bean, lima bean, peanut, potato, red table
beet, rice, snap bean, soybean, sugarcane, and wheat metabolism data. 
The residues of concern in plant commodities are pendimethalin per se
and its 3,5-dinitrobenzyl alcohol metabolite.  The current tolerance
expression for pendimethalin in 40 CFR §180.361specifies the combined
residues of pendimethalin and its 3,5-dinitrobenzyl alcohol metabolite. 
The proposed tolerance expression in the subject petitions is adequate
and consistent with 40 CFR §180.361.

860.1300 Nature of the Residue – Livestock.

DP Num: 271502, W. Drew, 12/JUL/2006

46407601.der; W. Drew (12/JUL/2006)

DP Num: 183220, Paula Deschamp, 24/SEP/1993

The nature of the residue in animals is adequately understood. 
Resolution of the residue characterization issue for goat kidney seems
to be pending.  Data from a goat metabolism study along with data from a
poultry metabolism study indicate that there is no reasonable
expectation of finite residues (pendimethalin, Goat Metabolite 6, and
the 3,5-dinitrobenzyl alcohol metabolite) in meat, milk, poultry and
eggs (40CFR §180.6[a][3]).  Tolerances for pendimethalin residues of
concern in livestock commodities are not needed for the purpose of
evaluating the petitions discussed in this document.  

860.1340 Residue Analytical Methods.

DP Num: 238470, W. Cutchin, 02/AUG/1999

The PAM VII lists four gas chromatography, with electron capture
detection (GC/ECD), methods for the determination of pendimethalin
residues of concern in plant commodities.  Methods I and III determine
residues of the parent, whereas Methods II and IV determine residues of
CL202,347.  The LOQ (or LLMV) of each method is 0.05 ppm.  An adequate
confirmatory GC/MS method was submitted with a petition on carrots, to
determine residues of pendimethalin and CL202,347.  

	

Data-Collection Methods:

The data-collection method, used by IR-4, for the analysis of samples
from the various field, processing and storage stability studies is a  
SEQ CHAPTER \h \r 1 gas chromatography with nitrogen/phosphorus
detection (GC/NPD) method entitled either:  

(1) Herbicide,Pendimethalin (CL 92,553):  Determination of CL 92,553 and
CL

202,347 (Metabolite) Residues in Grape (American Cyanamid Company
M1623), or

	

(2) Pendimethalin (CL 92,553):  Determination of CL 92,553 and CL202,347

(Metabolite) Residues in Alfalfa Green Forage, Alfalfa Seed, Alfalfa Hay
and Processed Meal, SOP M1930.01

Using these methods, residues were extracted with methanol and filtered.
 A 1% dodecane in methanol solution was added, and then concentrated. 
After evaporation, residues were partitioned into hexane, concentrated,
then cleaned up using a Florisil column eluted with 10% ethyl
acetate/hexane for pendimethalin and 20% ethyl acetate/hexane for CL
202,347.  A 1% dodecane in ethyl acetate solution was added to each
fraction.  Residues were then determined via GC/NPD using an external
standard.  The LOQ or LLMV was 0.050 ppm for both pendimethalin and
CL202,347.  The GC/NPD method is adequate for data collection, based on
acceptable method recoveries obtained during sample analysis.  

Conclusions:  Adequate methods are available for tolerance enforcement
and data collection.    SEQ CHAPTER \h \r 1 Methods I through IV in the
PAM VII are GC/ECD methods with LOQs of 0.050 ppm each for the parent
and its CL202,347.  Currently, all pendimethalin tolerances for RACs are
established at the combined LOQ of 0.10 ppm.  A confirmatory GC/MS
method was submitted with a petition on carrots, and found adequate to
determine residues of pendimethalin and CL202,347.  Methods used for
data collection were GC/NPD.  This method is adequate for data
collection, based on acceptable method recoveries obtained during sample
analysis.  

860.1360 Multiresidue Methods

DP Num: 271502, W. Drew, 12/JUL/2006

  SEQ CHAPTER \h \r 1 Multiresidue method testing data for pendimethalin
and its 3,5-dinitrobenzyl alcohol metabolite (CL202,347) have been
previously submitted, and forwarded to FDA.  The FDA PESTDATA database,
date January 1994 (PAM Volume I, Appendix1), indicates that
pendimethalin is completely recovered (>80%) by Multiresidue Methods
Sections 302 (Luke method; Protocol D) and 303 (Mills, Onley, Gaither
method; Protocol E, nonfatty), and partially recovered (50-80%) by
Multiresidue Method Section 304 (Mills fatty food method; Protocol E,
fatty).  Recovery data for CL202,347 were not reported.

860.1380 Storage Stability

In conjunction with each of the new field trials, concurrent storage
stability studies were also conducted using control samples of each
commodity fortified with pendimethalin and CL202,347 at 0.05 or 0.5 ppm
and stored under conditions similar to the field trial samples
(≤-17ºC).  These studies indicated that combined pendimethalin
residues are stable at <-17ºC for at least the following intervals: 112
days in broccoli, 258 days in cabbage, 101 days in asparagus and 387
days in grape.  The actual duration of sample storage from the new crop
field trials are presented in Table 4.  No residue decline was observed
in the submitted storage stability studies.  

Table 4.	Summary of Storage Conditions and Intervals of Samples from
Crop Field Trials.  

Matrix 	Analytes	Storage Temperature  (°C)	Actual Storage Duration

(Days)	Interval of Demonstrated

Storage Stability (Days)

Artichoke, globe	Pendimethalin/CL202,347	<-17	196	204

Asparagus	Pendimethalin/CL202,347	<-17	92	101

Broccoli	Pendimethalin/CL202,347	NR1	112	NR

Cabbage	Pendimethalin/CL202,347	<-17	142	258

Grape	Pendimethalin/CL202,347	-20 ± 6	344-402	387

Raisins	Pendimethalin/CL202,347	-20 ± 6	415	418

1 NR = Not Reported

Conclusions:  The available storage stability data are adequate and
support the sample storage durations incurred in the submitted field
trials.  

860.1400 Water, Fish, and Irrigated Crops

This guideline requirement is not relevant to the current petition as no
aquatic uses are being proposed.

860.1460 Food Handling

This guideline requirement is not relevant to the current petition as no
food handling uses are being proposed for pendimethalin. 

860.1480 Meat, Milk, Poultry, and Eggs

This guideline requirement is not relevant to the current petition as
none of the proposed crops are livestock feed items.

860.1500 Crop Field Trials

46963501.der.doc, J. Sullivan, 25/MAY/2007

46963502.der.doc, J. Sullivan, 25/MAY/2007

46963503.der.doc, J. Sullivan, 25/MAY/2007

46963504.der.doc, J. Sullivan, 25/MAY/2007

IR-4 has submitted new field trial data on asparagus, artichoke,
broccoli, cabbage, and grapes.  The broccoli and cabbage data will be
used to support a use on the Brassica head and stem vegetables, subgroup
5A.  The results from these studies are discussed below and summarized
in Table 5.    SEQ CHAPTER \h \r 1 

Table 5.	Summary of Residue Data from Crop Field Trials with
Pendimethalin (EC).

Crop matrix	PHI (days)	Total Applic. Rate  lb ai/A  (kg ai/ha)	Analyte
Residue Levels (ppm) 1

n	Min.	Max.	HAFT2	Mean	Std. Dev.

	Asparagus (proposed use = 4.0 lb ai/A total application rate, 14-day
PHI)

Asparagus	14	3.85 - 4.38

(4.316–4.910)	Pendimethalin	12	<0.050	0.062	0.059	0.051	0.004

3.85 - 4.38

(4.316–4.910)	CL202,347	12	<0.050	<0.050	<0.050	<0.050	---

	Combined	12	<0.100	0.112	0.110	0.101	---

Asparagus	7	3.85 - 4.38

(4.316–4.910)	Pendimethalin	2	0.144	0.185	0.165	0.165	0.029

3.85 - 4.38

(4.316–4.910)	CL202,347	2	<0.050	<0.050	<0.050	<0.050	---

	Combined	2	0.149	0.235	0.215	0.215

	Asparagus	21	3.85 - 4.38

(4.316–4.910)	Pendimethalin	2	<0.050	<0.050	<0.050	<0.050	---

3.85 - 4.38

(4.316–4.910)	CL202,347	2	<0.050	<0.050	<0.050	<0.050	---

	Combined	2	<0.100	<0.100	<0.100	<0.100	---

Artichoke (proposed use = 4.0 lb ai/A total application rate, 200-day
PHI)

Artichoke	200-206 

	4.18-5.73

(4.67–6.42)	Pendimethalin	6	<0.050	<0.050	<0.050	<0.050	---

	CL202,347	6	<0.050	<0.050	<0.050	<0.050	---

	Combined	6	<0.100	<0.100	<0.100	<0.100	---

	Brassica head and stem vegetables, subgroup 5A (proposed use = 1.0 lb
ai/A total application rate, 60-day PHI for broccoli, 70-day PHI for
cabbage)

Broccoli	58-99	0.99 – 1.03

(1.109-1.154)	Pendimethalin	12	<0.050	<0.050	<0.050	<0.050	---

	CL202,347	12	<0.050	<0.050	<0.050	<0.050	---

	Combined	12	<0.100	<0.100	<0.100	<0.100	---

Cabbage head with wrapper leaves	70-108	0.99 – 1.03

(1.109-1.154)	Pendimethalin	7	<0.050	<0.050	<0.050	<0.050	---

	CL202,347	7	<0.050	<0.050	<0.050	<0.050	---

	Combined	7	<0.100	<0.100	<0.100	<0.100	---

Cabbage head without wrapper leaves	70-108	0.99 – 1.03

(1.109-1.154)	Pendimethalin	7	<0.050	<0.050	<0.050	<0.050	---

7	<0.050	<0.050	<0.050	<0.050	---

	CL202,347

	Combined	7	<0.100	<0.100	<0.100	<0.100	---

Grape (proposed use = 6.0 lb ai/A total application rate, 90-day PHI)

Grape

	87 - 100	5.74–11.95 (6.43–13.40)	Pendimethalin	18	<0.050	<0.050
<0.050	<0.050	---

	CL202,347	18	<0.050	<0.050	<0.050	<0.050	---

	Combined	18	<0.100	<0.100	<0.100	<0.100	---

1	LLMV is 0.05 ppm for all matrices and both analytes (pendimethalin,
CL202,347).  

2	HAFT = Highest Average Field Trial.

Asparagus:  IR-4 has submitted field trial data for pendimethalin on
asparagus.  Six supervised crop field trials were conducted with
asparagus in EPA growing Regions 1 (NY, 1 trial), 5 (MI, 2 trials), 10
(CA, 2 trials) and 11 (WA, 1 trial).  In all trials, one broadcast
application of Prowl 3.3EC (37.4% pendimethalin) was made to soil prior
to spear emergence at a rate of approximately 4.0 lb ai/A (4.48 kg
ai/ha).  No adjuvants or additives were added to the spray mixture for
any of the above applications.  Asparagus was harvested 14-days after
the application in all trial sites except at the Prosser, WA site
(98-WA*48), where trials were conducted using 7-, 14-, and 21-day PHIs. 
Pendimethalin was found at residue levels of 0.144 and 0.185 ppm (7-day
PHI samples), 0.055 and 062 ppm (14-day PHI samples), and <LLMV (21-day
PHI samples) at the Prosser, WA site (98-WA*48) only.  Residues at the
other trial sites were below the LLMV (<0.05 ppm) in/on 14-day PHI and
21-day PHI asparagus samples.  No CL202,347 residues were found above
the LLMV on any samples.  Residue decline data were collected, and
pendimethalin residues decreased from 0.185 ppm at day 7 (no t = 0 data
was provided) to 0.062 at day 14 to <LOQ at 21 days after application. 
Asparagus was stored frozen for a maximum of 92 days at <-17ºC.

Asparagus samples were extracted with methanol, partitioned into hexane,
concentrated to approximately 2 mL using a Turbovap system, and cleaned
up with Florisil SPE.  Quantitation was accomplished by GC/NPD.  Samples
of control asparagus were fortified at 0.05 ppm and 0.50 ppm.  The LLMV
was reported as 0.05 ppm for both pendimethalin and CL202,347.  The
limit of detection (LOD) was 0.007/0.0097 ppm (pendimethalin/CL202,347)
and the LOQ was 0.021/0.029 ppm (pendimethalin/CL202,347), calculated as
3 times the LOD for asparagus.  

Artichoke:  IR-4 has submitted field trial data for pendimethalin on
artichoke.  Three supervised crop field trials were conducted with
artichoke in EPA growing Region 10 (CA).  In all trials, one
pre-transplant broadcast soil application of Prowl 3.3EC (37.4%
pendimethalin) was made at a rate of approximately 4.0 lb ai/A (4.48 kg
ai/ha).  No adjuvants or additives were added to the spray mixture for
any of the above applications.  In all trials, artichoke was harvested
200-226 days after the application.  Trial results show that all
pendimethalin residues were below the LLMV (<0.05 ppm) in/on 200-226-day
PHI artichoke samples.  No residue decline data were collected. 
Artichoke was stored frozen for a maximum of 196 days at <-20ºC.  

Artichoke samples were extracted with methanol, partitioned into hexane,
concentrated to approximately 2 mL using a Turbovap system, and cleaned
up with Florisil SPE.  Quantitation was accomplished by GC/NPD.  Samples
of control artichoke were fortified at 0.05 ppm and 0.50 ppm.  The LLMV
was reported as 0.05 ppm for both pendimethalin and CL202,347.  The LOD
was 0.006/0.018 ppm (pendimethalin/CL202,347) and the LOQ was 0.02/0.05
ppm (pendimethalin/CL202,347), calculated as three times the LOD for
artichoke.

Brassica Head and Stem Vegetables, Subgroup 5A

Broccoli:  IR-4 has submitted field trial data for pendimethalin on
broccoli.  Six supervised crop field trials were conducted with broccoli
in EPA growing Regions 6 (TX, 1 trial), 10 (CA, 4 trials), and 12 (OR ,
1 trial) during the 1998 growing season. In all trials, one broadcast
application of Prowl 3.3EC (37.4% pendimethalin) was made after
transplanting at a target rate of 1.0 lb ai/A (1.12 kg ai/ha).  No
adjuvants or additives were added to the spray mixture for any of the
above applications.  In all trials, broccoli was harvested 58-99 days
after the application.  Trial results show that all pendimethalin
residues were below the LOQ (<0.05 ppm) in/on broccoli samples treated
at a 58-99-day PHI.  No residue decline data were collected.  Broccoli
was stored frozen for a maximum of 112 days at <-20 C.  

Broccoli samples were extracted with methanol, partitioned into hexane,
concentrated to approximately 2 mL using a Turbovap system, and cleaned
up with Florisil SPE.  Quantitation was accomplished by GC/NPD.  Samples
of control broccoli were fortified at 0.05 ppm and 0.50 ppm.  The LLMV
was reported as 0.05 ppm.  The LOD was 0.02 ppm and the LOQ was 0.06 ppm
(calculated as 3 times the LOD) for broccoli.

Cabbage:  IR-4 has submitted field trial data for pendimethalin on
cabbage.  Seven supervised crop field trials were conducted with cabbage
in EPA growing Regions 1 (NY, 1 trial), 6 (TX, 1 trial), 2 (SC, 1
trials), 5 (OH and WI, 2 trials), 3 (FL, 1 trial), and 10 (CA, 1 trial).
 In all trials, one broadcast application of Prowl 3.3EC (37.4%
pendimethalin) was made 72 hours after transplanting or at the 2-4 leaf
stage at a rate of approximately 1.0 lb ai/A (1.12 kg ai/ha).  No
adjuvants or additives were added to the spray mixture for any of the
above applications.  In all trials, cabbage was harvested 70-108 days
after the application.  Trial results show that all pendimethalin
residues were below the LLMV (<0.05 ppm) in/on 70-108-day PHI cabbage
samples.  No residue decline data were collected.  Cabbage was stored
frozen for a maximum of 142 days at <-20 ºC.  Frozen storage stability
samples were fortified at 0.50 ppm with pendimethalin and CL202,347 and
stored for 258 days.  

Cabbage samples were extracted with methanol, partitioned into hexane,
concentrated to approximately 2 mL using a Turbovap system, and cleaned
up with Florisil SPE.  Quantitation was accomplished by GC/NPD.  Samples
of control cabbage were fortified at 0.05 ppm and 0.50 ppm.  The LLMV
was reported as 0.05 ppm for both pendimethalin and CL202,347.  The LOD
was 0.016/0.031 ppm (pendimethalin/CL202,347) and the LOQ was 0.05/0.09
ppm (pendimethalin/CL202,347), calculated as 3 times the LOD for
cabbage.  

Grape:  IR-4 has submitted field trial data for pendimethalin on grape. 
Nine supervised crop field trials were conducted with grape in EPA
growing Regions 1 (NY, 1 trial), 2 (NJ, 1 trial), 11 (WA, 2 trials), and
5 (CA, 5 trials).  In all trials, one broadcast soil application of
Prowl 3.3EC (37.4% pendimethalin) was made during the
vegetative/fruiting stage at a rate of approximately 6.0 lb ai/A (6.73
kg ai/ha).  An additional trial was conducted at one site in California
(.95-CA64) at an application rate of 12.0 lb ai/A (13.46 kg ai/ha) for
the collection of samples for processing into raisins and juice
(46963504.de2.doc).  No adjuvants or additives were added to the spray
mixture for any of the above applications.  Nine trials (twelve
requested) were conducted because no quantifiable crop residues were
expected.  One trial each was conducted in NAFTA Regions 1 and 2 rather
than the requested two trials in NAFTA Region 1.  In addition, two
trials were conducted in NAFTA Region 11 rather than one trial in NAFTA
Region 11 and one trial in NAFTA Region 12.  Grapes were harvested
87-100 days after the application at all trial sites.  A minimum of 4
pounds of grapes were collected per RAC sample.  Trial results show that
all pendimethalin and CL202,347 residues were below the LLMV (<0.05 ppm)
in/on 87-100 day PHI grape samples.  No residue decline data were
collected.  Grapes were stored frozen for a maximum of 402 days at –20
± 6 ºC.  

Grape samples were extracted with methanol, while raisin samples were
extracted with 1:1 methanol:water.  After extraction, aliquots were
partitioned into hexane, concentrated to approximately 2 mL using a
Turbovap system, and cleaned up with a small disposable Florisil SPE
column.  Pendamethalin was eluted from the column with hexane/methylene
chloride (50/50) and CL202,347 was eluted with methylene chloride. 
Quantitation was accomplished by fused silica GC/NPD.  Samples of grape
RAC were fortified at 0.05 ppm and 0.50 ppm for method validation
studies and 0.50 ppm for concurrent recovery studies.  The LLMV was
reported as 0.05 ppm for both pendimethalin and CL202,347.  

Conclusions:  The available asparagus, artichoke, broccoli, cabbage, and
grape field trials are adequate and support the proposed use patterns. 
An adequate number of tests were conducted on each crop in the
appropriate geographical regions.  Samples were analyzed for the
residues of concern (pendimethalin and CL202,347) using an adequate
method, and sample storage conditions and durations were supported by
the available/submitted storage stability data.  As residues were <LOQ
(or LLMV) (0.05 ppm) in/on all commodities, except asparagus, the data
support a tolerance of 0.10 ppm for the combined pendimethalin residues
(pendimethalin and CL202,347) in/on the following commodities:
artichoke, globe; Brassica head and stem vegetables, subgroup 5A; and
grapes.  Asparagus residues were greater than the LLMV in two of the 12
samples and therefore the recommended tolerance (0.15 ppm) was
calculated using the MLE and MRL spreadsheet calculators (See Appendix
II).  

The petitioner must submit a revised Section F to adjust the proposed
tolerances to match the recommended tolerance and commodity definitions
as presented in Table 7.

860.1520 Processed Food and Feed

Grape is the only crop associated with the current petition for which a
processing study is required.  A grape processing study has been
submitted with the current petition (PP#6E7129).  All residues of
pendimethalin and CL202,347 were below the LLMV (<0.050 ppm) when
treated at 12.0 lb ai/A (2X rate).  

Table 6.	Residue Data from the Grape Processing Study with Pendimethalin
and CL 202,347 

RAC	Processed Commodity	Total Rate1

(lb ai/A) 

(kg ai/ha)	PHI (days)	Residues (ppm)	Processing Factor2

Sample 1	Sample 2

	Pendimethalin 	Fruit, Grape	11.95 

(13.40)	98	<0.050	<0.050	--

Pendimethalin 	Raisins	11.95 

(13.40)	98	<0.050	<0.050	NC3

Pendimethalin 	Juice	11.95 

(13.40)	98	<0.050	<0.050	NC

CL 202,347	Fruit, Grape	11.95 

(13.40)	98	<0.050	<0.050	--

CL 202,347	Raisins	11.95 

(13.40)	98	<0.050	<0.050	NC

CL 202,347	Juice	11.95 

(13.40)	98	<0.050	<0.050	NC

1Applied at 2X rate

2Residues did not concentrate from grapes to the processed raisins or
juice fractions.

3NC = Not Calculated

Conclusions:  The submitted grape processing study is not adequate.  The
submitted study (2X application rate) resulted in no residues in/on the
RAC and processed commodities (raisins and grape juice), therefore a
study with an application rate of at least 5X is required.  Due to this
deficiency in the submitted processing study, tolerances should be set
at 0.50 ppm for grapes and 0.15 ppm for grape juice, based on default
processing factors.

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

Analytical reference standards for pendimethalin and its
3,5-dinitrobenzyl alcohol metabolite (CL202,347) are currently available
at the EPA National Pesticide Standards Repository.  

860.1850/860.1900 Confined and Field Accumulation in Rotational Crops

DP Num: 271502, W. Drew, 12/JUL/2006

DP Num: 223184, B. Cropp-Kohlligian, 13/MAY/1996

An acceptable confined rotational crop study with pendimethalin is
available and was reviewed by HED (DP Num: 223184, B. Cropp-Kohlligian,
13/MAY/1996).  The results indicate that the TRR in representative crop
matrices (mature wheat straw, wheat grain, lettuce plants, radish tops,
and radish roots) will exceed 0.01 ppm when planted 90 and/or 270 DAT of
soil with radiolabeled pendimethalin at a nominal rate of 2.0 lb ai/A,
and that these radioactive residues in rotated crops will be extensively
metabolized.  Furthermore, the petitioner indicated that only
radioactive residues of pendimethalin per se exceeded 0.01 ppm in any of
the mature RACs studied, and that radioactive residues of pendimethalin
per se were below 0.01 ppm in lettuce plants, radish tops, and radish
roots at 270 DAT, as well as in wheat straw and grain at 90 DAT.  Based
on the study results, HED had concluded that the petitioner should
impose plant-back intervals (PBIs) of 90-days for rotated cereal grain
crops, and 270-days for all other rotated crops, until limited field
rotational crop studies (OPPTS 860.1900) have been conducted in order to
determine if tolerances for residues of pendimethalin in rotational
crops are needed.  

Conclusions:  The maximum application rate which may be applied to
rotated food/feed crops (excluding crops grown for seed) is 4.0 lb ai/A.
 HED will not require a new confined rotational crop study reflecting
treatment at 4.0 lb ai/A because pendimethalin is typically applied
pre-emergence or early post-emergence to crops, and the nature of the
residues in rotational crops would likely be similar to primary crops. 
However, as a result of the increase in application rate, HED has
previously requested a limited field accumulation study (OPPTS 860.1900)
to determine the amount of pesticide residue uptake into rotational
crops.

The limited field trials should reflect the maximum label use rate of
4.0 lb ai/A, and should be conducted on a representative crop (as
defined in 40CFR §180.41), at two trial sites per crop, for the
following three crop groups:  

	(1) root and tuber vegetables, 

	(2) leafy vegetables, and 

	(3) small grains (wheat, barley, oats, rye), 

for a total of six trials.  The six trials should be conducted on crops
which the petitioner intends to have as rotational crops on the label. 
Samples should be analyzed for pendimethalin and its 3,5-dinitrobenzyl
alcohol metabolite.  The trials may be distributed at the petitioner’s
discretion among the representative crops showing uptake.  In addition,
some of the six trials could be conducted using other crops that are
typically involved in crop rotation, such as alfalfa and soybeans.  HED
and/or ARIA will assess the adequacy of the proposed rotational crop
restrictions when the requested data have been submitted and evaluated.

860.1550 Proposed Tolerances

The Residue Chemistry Chapter for the Pendimethalin RED concluded that
the residues of concern in plants are pendimethalin   SEQ CHAPTER \h \r
1 [N-(1-ethylpropyl)-3,4-dimethyl-2,6-dinitrobenzenamine] and its
metabolite, 4-[(1-ethylpropyl)amino]-2-methyl-3,5-dinitrobenzyl alcohol
(CL202,347).  The chemical names and structures of pendimethalin and
CL202,347 are depicted in Appendix I. The proposed tolerance expression
is consistent with 40CFR §180.361.  

A summary of tolerance assessments, following ARIA’s review of
submitted field and processing studies, is presented in Table 7.  ARIA
recommends tolerances of 0.1 ppm for the commodities listed in Table 7
which were not entered in a Tolerance/MRL Harmonization Spreadsheet (all
proposed commodities except asparagus), because all of the samples
treated at the proposed 1X application rate bore residues below the
method LLMV (or LOQ) (<0.050 ppm) for each analyte.  Following
application at 1X, the combined residues were <0.1 ppm in all samples of
artichoke (n = 6 samples), broccoli (n = 12), cabbage (n = 7) and grape
(n = 18).  The residues observed in all but two samples of asparagus (n
= 12) treated at 1X were also <0.050 ppm for each analyte.  The proposed
tolerance for asparagus was calculated using the maximum limit estimator
(MLE) and the maximum residue limit (MRL) spreadsheet.  Without ignoring
lognormality, a value of 0.15 ppm was recommended for asparagus using
the 95th percentile of EU method I.  ARIA also recommends establishing
tolerances for grape, raisin at 0.50 ppm and grape, juice at 0.15 ppm
due to inadequate grape processing studies.

There are currently no Canadian , Mexico or Codex maximum residue limits
(MRLs) for pendimethalin on the proposed commodities.  An International
Residue Limit Status sheet is appended at the end of this document in
Appendix II.  

Pendimethalin tolerances are not required for milk, meat, poultry, nor
eggs for the purpose of evaluating the subject IR-4 petition.  

Pending submission of a revised Section F to reflect appropriate
tolerance levels, there are adequate residue data to support the
establishment of pendimethalin tolerances on artichoke, globe;
asparagus; Brassica head and stem vegetables, subgroup 5A; and grape.

Table 7.	Tolerance Summary for Pendimethalin.

Commodity	Proposed Tolerance (ppm)	Recommended Tolerance (ppm)
Comments1;

Correct Commodity Definition

Brassica, head and stem, subgroup 5A	0.05	0.1	Adequate field trial data
are available.  All combined residues were <0.1 ppm.

Artichoke, globe	0.05	0.1	Adequate field trial data are available.  All
combined residues were <0.1 ppm.

Asparagus	0.1	0.15	Adequate asparagus field trial data are available and
the tolerance was calculated using the MLE and MRL spreadsheets.

Grape	0.05	0.1	Adequate grape field trial data are available.  All
residues in the field studies were below the combined residue LLMV (<0.1
ppm).

Grape, juice	--	0.15	Adequate grape processing studies were not
provided.  The study must use an application rate of at least 5X or the
petitioner may show that the exaggerated rate is phytotoxic to the crop.
 Once adequate studies have been reviewed, the tolerance may be revised
or withdrawn.

Grape, raisin 	--	0.50

	1 MLE = Maximum Limit Estimater; MRL = Maximum Residue Limit

References

  SEQ CHAPTER \h \r 1 DP Num:	238470

Subject:	PP#6E4603.  Request for the Use of Pendimethalin on Carrots. 
Revised Section B and F; Confirmatory Method.  Amendments of 8/26/96 and
6/30/97.

From:		W. Cutchin

  SEQ CHAPTER \h \r 1 DP Num:	271502

Subject:	Pendimethalin.  IR-4 Tolerance Petitions   SEQ CHAPTER \h \r 1
Requesting Section 3 Registration for Food Uses of the Herbicide on
Fruiting Vegetables (PP#0E6175), Pome Fruit and Juneberry (PP#2E6450),
Stone Fruit (PP#2E6464), Pomegranate (PP#2E6449), Green Onion
(PP#5E6927), Strawberry (PP#5E6928), and Pistachio (PP#0E6083).  BASF
Corporation Tolerance Petition   SEQ CHAPTER \h \r 1 Requesting Section
3 Registration for Food Uses of the Herbicide on Wheat (PP#4F6870). 
Summary of Analytical Chemistry and Residue Data.

From:		W. Drew

To:		J.Tompkins and C. Bien

Dated:		12/JUL/2006

MRID(s):	44983303, 45134201- 45134203, 45660101-45660102, 45660201,
45682501-45682503, 46391002, 46391004-46391010, 46407601, 46407602,
46525101, 46525201

  SEQ CHAPTER \h \r 1 DP Num:	223184

Subject:	Pendimethalin Re-registration.  Confined rotational crop study.

From:		B. Cropp-Kohlligian

To:		Walter Waldrop/Jane Mitchell 

Dated:		13/MAY/1996

MRID(s):	43918601

  SEQ CHAPTER \h \r 1 DP Num:	221531

Subject:	Product and Residue Chemistry Chapters for the Pendimethalin
Re-registration Eligibility Decision.

From:		B. Cropp-Kohlligian

To:		Lois Rossi, Chief

Dated:		08/DEC/1995

MRID(s):	None

  SEQ CHAPTER \h \r 1 DP Num:	183220

Subject:	Product and Residue Chemistry Chapters for the Pendimethalin
Re-registration Eligibility Decision.

From:		P. Deschamp

To:		Lois Rossi/Terri Stowe

Dated:		24/SEP/1993

MRID(s):	42467802, 42471902, 42471903 and 42471901

  SEQ CHAPTER \h \r 1 Attachments:  

Appendix I: Structures of Residues of Concern 

Appendix II: Tolerance Calculations 

Appendix III: International Residue Limits Status 

Appendix I:

Chemical Name And Structure of Pendimethalin and its 3,5-Dinitro-Benzyl
Alcohol Metabolite.  

Pendimethalin

                   	3,5-Dinitro-Benzyl Alcohol Metabolite

                   

Chemical Name:  N-(1-ethylpropyl)-3,4-dimethyl-2,6-dinitrobenzenamine

Company Experimental Name:  CL 92,553	Chemical Name: 
4-[(1-ethylpropyl)amino]-2-methyl-3,5-dinitrobenzyl alcohol

Company Experimental Name:  CL 202,347

Appendix II

Tolerance assessment calculations.

The Agency’s Guidance for Setting Pesticide Tolerances Based on Field
Trial Data was utilized for determining appropriate tolerance levels on
asparagus, as not all of the residue values were below the LLMV
(LOQ)(<0.050 ppm).  However, the tolerance spreadsheet was not used to
calculate tolerances for artichoke, globe; broccoli; cabbage; and grape
as all residues were <LLMV (LOQ) in/on the samples from these crops.

 

The residue values used to calculate the asparagus tolerances are
provided in Table II-1.  These values were estimated values for the
residues below the LLMV (<0.050 ppm).  These estimated values (in
addition to the actual residue values) were used in the MRL spreadsheet
to calculate the recommended tolerance.  Visual inspection of the
lognormal probability plot (Figure II-1) indicates that the
“estimated” dataset is reasonably lognormal, and the result from the
approximate Shapiro-Francia test statistic (Figure II-2) confirms this
assumption.  Therefore, the Log Normal method was used to calculate
tolerances of 0.15 ppm for asparagus.  

Table II-1:

Regulator:	EPA 

Chemical:	Pendimethalin

Crop:	Asparagus

PHI:	14 Days

App. Rate:

	Submitter:

Residues

	0.105

	0.112

	0.073

	0.077

	0.080

	0.082

	0.085

	0.087

	0.089

	0.091

	0.094

	0.097

Figure II-1:

Figure II-2:

Appendix III:

INTERNATIONAL RESIDUE LIMIT STATUS

Chemical Name:  N-(1-ethylpropyl)-3,4-dimethyl-2,6-dinitrobenzenamine
Common Name:

Pendimethalin	X Recommended Tolerances

 Reevaluated tolerance

  Other	Date: 26/JUN/2007

Codex Status (Maximum Residue Limits)	US Tolerances

( No Codex proposal step 6 or above

 No Codex proposal step 6 or above for the crops requested	Petition
Numbers:  6E7129 

DP Num:  34034

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 PAGE   

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Pendimethalin	Summary of Analytical Chemistry and Residue Data	DPNum:
340343

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