Document ID: EPA-HQ-OPP-2009-0797-0006
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2010-08-04T04:00Z

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

	OFFICE OF PREVENTION, PESTICIDE

	AND TOXIC SUBSTANCES

  SEQ CHAPTER \h \r 1 MEMORANDUM

Date:  03/03/2010.

SUBJECT:	Halosulfuron-methyl.  Application for Section 3 Registration of
Sandea® Herbicide (EPA Reg. No. 81880-18) and GWN-3061 Herbicide (EPA
Reg. No. 81880-2) to Add New Uses on:  Pea and Bean, Succulent Shelled,
Subgroup 6B; Vegetable, Tuberous and Corm, Subgroup 1C; Rhubarb;
Bushberry Subgroup 13-07B; Pea and Bean, Dried Shelled, Except Soybean,
Subgroup 6C; Apple; and Okra.  Summary of Analytical Chemistry and
Residue Data.

PC Code:  128721	DP Barcode:  D367058

Decision No.:  414896	Registration Nos.:  81880-18 and 81880-2

Petition No.:  9E7577	Regulatory Action:  Section 3 Registration

Risk Assessment Type:  NA	Case No.:  NA

TXR No.:  NA	CAS No.:  100784-20-1

MRID Nos.:  47772101 through 47772106	40 CFR:  §180.479

	

FROM:	  SEQ CHAPTER \h \r 1 Debra Rate, Ph.D., Biologist

	Alternative Risk Integration and Assessment (ARIA) Team

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

	Registration Division (RD; 7505P)

THROUGH:	Steve Funk, Senior Scientist

		Risk Assessment Branch III (RABIII)

Health Effects Division (HED; 7509P)

		

TO:		Whang Phang, Ph.D., Toxicologist  SEQ CHAPTER \h \r 1   SEQ CHAPTER
\h \r 1 

		RABIII/HED (7509P)

		Barbara Madden

		Minor Use Team

		RIMUERB/RD (7505P)

  SEQ CHAPTER \h \r 1 This document was originally prepared under
contract by Dynamac Corporation.  The document has been reviewed by
ARIA/HED and revised to reflect current Office of Pesticide Programs
(OPP) policies.

Executive Summary

Halosulfuron-methyl is a selective herbicide belonging to the
sulfonylurea group of herbicides.  Its mode of action includes the
inhibition of a specific plant enzyme, acetolacetate synthase. 
Halosulfuron-methyl is registered for the pre- and postemergence control
of annual broadleaf weeds and nutsedges in selected crops, as well as
residential turf grass and ornamentals.  Halosulfuron-methyl is sold in
the U.S. as a dry flowable/water-dispersible granule formulation.

The petitioner, Interregional Research Project No. 4 (IR-4), has
proposed new uses of halosulfuron-methyl on:  apple; bushberry Subgroup
13-07B; okra; succulent-shelled pea and bean Subgroup 6B; dried shelled
pea and bean, except soybean, Subgroup 6C; rhubarb; and tuberous and
corm vegetable Subgroup 1C.  In conjunction with the requested amended
use, IR-4 has submitted a petition, PP#9E7577, to propose the
establishment of permanent tolerances for residues of the herbicide
halosulfuron-methyl (methyl
3-chloro-5-[[[[(4,6-dimethoxy-2-pyrimidinyl)amino]carbonyl]amino]sulfony
l]-1-methyl-1H-pyrazole-4-carboxylate) in/on the following raw
agricultural commodities:

Pea and bean, succulent shelled, Subgroup 6B 	0.05 ppm

Vegetable, tuberous and corm, Subgroup 1C 	0.05 ppm

Rhubarb 	0.05 ppm

Pea and bean, dried shelled, except soybean, Subgroup 6C 	0.05 ppm

Apple 	0.05 ppm

Okra 	0.05 ppm

Bushberry, Subgroup 13-07B 	0.05 ppm

-0.094 lb ai/A depending on the crop.  Only ground equipment in ≥15
gal/A of water may be used for applications; certain crops require the
addition of non-ionic surfactants in the spray mixture for enhanced
control.  The proposed preharvest intervals (PHIs) range from 14 to 60
days. 

Permanent tolerances are established under §180.479(a)(1) for residues
of halosulfuron-methyl and its metabolites and degradates determined as
3-chloro-1-methyl-5-sulfamoylpyrazole-4-carboxylic acid, expressed as
halosulfuron-methyl equivalent in/on the meat byproducts of cattle,
goat, hog, horse, and sheep at 0.1 ppm.  Tolerances are established
under §180.479(a)(2) for residues of halosulfuron-methyl in/on a
variety of field, fruit, and vegetable crop commodities, at levels
ranging from 0.05 to 2.0 ppm.  A time-limited tolerance for sweet potato
established under §180.479(b) has expired (expiration data 12/31/2008).

The nature of the residue in plants is adequately understood based on
acceptable metabolism studies with corn, sugarcane, and soybean treated
both pre- and postemergence.  The terminal residue of concern in plants
is halosulfuron-methyl.

The nature of the residue in ruminants is adequately understood based on
an acceptable goat metabolism study.  The residue of concern in
ruminants is halosulfuron-methyl; however, because the approved
enforcement method for livestock commodities quantifies the parent
compound and metabolites containing the 3-chlorosulfonamide moiety
(3-CSA) by converting residues to 3-CSA, tolerances for residues in
livestock commodities are expressed in terms of halosulfuron-methyl and
its metabolites determined as 3-CSA, expressed as halosulfuron-methyl
equivalents.  There are no poultry feedstuffs associated with the
recommended tolerances and crop uses addressed in this action. 
Therefore, a discussion of the metabolism of halosulfuron-methyl in
poultry and hogs is not germane to this petition.

Adequate analytical methods are available for the enforcement of
tolerances for residues of halosulfuron-methyl in plants (Method
RES-109-97-4), and for residues of halosulfuron-methyl and its 3-CSA
metabolites in livestock commodities (Method RES-046-93).  The plant
method determines halosulfuron-methyl as its rearrangement ester (RRE),
and the livestock method converts residues of halosulfuron-methyl and
metabolites containing the 3-CSA moiety to 3-CSA for determination. 
Samples from the submitted field trial and processing studies were
analyzed for residues of halosulfuron-methyl using a modified version of
the plant enforcement method with a petitioner-validated limit of
quantitation (LOQ) of 0.05 ppm.  A Biological and Economic Analysis
Division (BEAD/EPA) method validation for Method RES-109-97-4 (MRID
44495801) in rice straw, sugar cane, milo grain, field corn grain,
cotton gin byproducts, and almond nutmeats indicated an LOQ of 0.05 ppm
(DP#250584, G. Jeffrey Herndon, 10/28/1998).

Residues of halosulfuron-methyl and 3-CSA are not adequately recovered
by FDA Multiresidue Method protocols.

Adequate storage stability data are available to support the storage
conditions and durations of samples collected from the magnitude of the
residue and processing studies on apples, blueberry, dry bean seed,
succulent pea seed, potato tuber, potato processed commodities, and
rhubarb.  As residues of halosulfuron-methyl were found to be stable in
tested crop matrices, storage stability corrections need not be applied
to the recommended tolerances for halosulfuron-methyl residues for these
commodities.

An adequate dairy cattle feeding study is available.  Based on the
re-evaluation of the feeding study relative to the re-calculated dietary
burdens of 0.468 ppm for beef cattle and 0.825 ppm for dairy cattle,
ARIA concludes that tolerances for residues of halosulfuron-methyl need
not be established for milk or meat, and fat of cattle, goat, hog,
horse, and sheep.  The established tolerance of 0.1 ppm for the meat
byproducts of cattle, goat, hog, horse, and sheep are adequate for this
registration action.  The petitioner should note that if additional uses
are proposed in the future which would result in an increase in the
dietary burdens, ARIA/HED will re-assess the adequacy of established
animal tolerances.  

Residues of halosulfuron-methyl were below the lowest limit of method
validation (LLMV; <0.05 ppm) in/on all commodity samples treated with
the test formulation according to the conditions and parameters used in
magnitude of the residue studies.  The Agency’s tolerance spreadsheet
was not used for tolerance assessment.

The submitted field trial data on apples and blueberries (the latter is
a representative commodity of Crop Subgroup 13-07B) did not reflect the
use of a nonionic surfactant as recommended on the proposed label.  The
data will support a tolerance of 0.05 ppm for apple.  The data will
support a tolerance of 0.05 ppm for the bushberry Subgroup 13-07B
provided the label for Sandea® Herbicide is amended to remove the
instructions pertaining to the use of a non-ionic surfactant.  If it is
IR-4’s intention to add a nonionic surfactant when Sandea® Herbicide
is applied to bushberry Subghroup 13-07B, then additional field trial
data are required which include the use of an adjuvant.  In the case of
apples, the herbicide is applied to the orchard floor, and addition of a
surfactant will have no effect on residues on the apples.

No residue data were submitted to support the proposed use on okra.  The
ChemSAC meeting of 10/18/2006 has recommended the inclusion of okra in
Crop Group 8 (Fruiting Vegetables).  The ChemSAC has also determined
that a separate tolerance for okra should be listed in the appropriate
section of the CFR entry until the new crop group regulation is
published.  The available field trial data for Fruiting Vegetables will
be translated to okra.  ARIA recommends a tolerance of 0.05 ppm for
residues of halosulfuron-methyl in/on okra.

The representative crops of Subgroup 6B are two commodities of: (1) any
succulent shelled cultivar of bean (Phaseolus spp.) or (2) immature
soybean seed (Glycine max) or (3) any Vigna spp. and garden pea (Pisum
spp.).  The submitted field trial data for succulent peas were conducted
at exaggerated rates (1.4X or 2.8X), and the collected samples did not
reflect the proposed 30-day PHI (the earliest PHI tested was 55 days). 
The available data for succulent beans, previously submitted under
PP#1E06322 (DP#278587, A. Acierto, 6/15/2002) to support the established
individual tolerance of 0.05 ppm, also do not reflect the proposed use
on Subgroup 6B because these data represent foliar application whereas
the new proposed use pattern is for preemergence soil application.  ARIA
will not require additional data on succulent peas since treatment at 1X
will likely result in residues below 0.05 ppm, even when harvested at a
PHI of 30-days.  Also, ARIA will not require additional data on
succulent beans since soil treatment will likely result in residues
below 0.05 ppm.  ARIA recommends for the proposed tolerance of 0.05 ppm
for the Subgroup 6B (Pea and Bean, Succulent Shelled) pending a label
revision to prohibit applications to legumes grown for livestock feeds
because no residue data are available for cowpea forage and hay. 
Concomitant with the establishment of a tolerance for Subgroup 6B, the
individual tolerance for ‘bean, snap, succulent’ should be revoked.

The representative commodities of Subgroup 6C are any one dried cultivar
of bean (Phaseolus spp.) and any one dried cultivar of pea (Pisum spp.) 
The submitted residue data for dry beans reflect a single foliar
broadcast application conducted at ~1.6X the proposed application rate
per crop cycle (or ~0.8X the proposed total application rate per year),
the use of a nonionic surfactant, and the treated samples were collected
approximating the proposed 30-day PHI.  Additional data for dry beans
were submitted under PP#1E06322 (DP#278587, A. Acierto, 6/15/2002) to
support the established individual tolerance of 0.05 ppm.  These data
represent a single application of Permit 75 WG Herbicide at 0.032 lb
ai/A made 0 to 6 days after planting and an 86- to 113-day PHI.  ARIA is
unable to recommend for the proposed use and tolerance of 0.05 ppm for
Crop Subgroup 6C (dried shelled bean (except soybean) and pea) because
residue data on dried pea including the forages and hay of field pea
cultivars are required.  When adequate residue data for dried peas
become available, the petitioner may again request a tolerance for
Subgroup 6C.

The submitted field trial data on rhubarb were generated using slightly
exaggerated rates of ~2.0-2.1X.  ARIA will not require additional data
on rhubarb since treatment at 1X will likely result in residues below
0.05 ppm.  The available data will support the proposed tolerance of
0.05 ppm for rhubarb.

The submitted field trial data on potato, the representative commodity
of Crop Subgroup 1C, do not fully conform to the OPPTS 860.1500
guideline as only 14 trials were conducted whereas the guideline
requires a minimum of 16 trials to support a subgroup tolerance.  In
addition, the potato data were generated using exaggerated rates of
~2.0-2.1X.  At this exaggerated rate all potato residues were <0.05 ppm.
 Therefore, ARIA will not require additional data on potatoes since
additional trials at a 1X rate will likely result in residues below 0.05
ppm.  The available data will support the proposed tolerance of 0.05 ppm
for Crop Subgroup 1C.

To fulfill the requirements for an apple processing data, a trial site
was treated at ~5.1X the proposed maximum seasonal rate to generate
samples for processing; however, as residues were nondetectable in any
apple fruit samples, processing was not initiated.  These data are
adequate to conclude that an additional apple processing study and
tolerances for apple processed commodities are not required for this
action.

The submitted processing data for potato are acceptable.  Residues of
halosulfuron-methyl were nonquantifiable (<0.05 ppm) in/on potato tubers
following treatments at 2X the proposed seasonal rate.  Residues were
also nonquantifiable in processed potato granules/flakes, chips, and wet
peel.  The Agency would have preferred that a trial with an exaggerated
rate equal to or higher than the maximum theoretical concentration
factor of 5X for potato have been conducted.  However, because of
phytotoxicity limitations as reported in the magnitude of the residue
trials, a new potato processing study will not be required.  Based on
these data, tolerances for potato processed commodities are not needed.

Adequate confined and limited field rotational crop data are available. 
HED previously concluded that the residue of concern in rotational crops
is halosulfuron-methyl.  Based on the absence of the parent compound in
the confined studies and in the limited field rotational crop studies,
with the exception of one forage sample, HED previously concluded that
rotational crop tolerances and restrictions are not required for
halosulfuron-methyl.

There are no Codex, Canadian, or Mexican maximum residue limits (MRLs)
established for residues of halosulfuron-methyl in crop or livestock
commodities.

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

ARIA has examined the residue chemistry database for halosulfuron-methyl
and evaluated the adequacy of study submissions associated with the
current action.  Pending submission of a revised Section B (see
requirements under Directions for Use), a revised Section F (see
requirements under crop field trials) and the submission of standards
for the 3-CSA (3-chlorosulfonamide acid) metabolite and the RRE of
halosulfuron-methyl (see requirements under Submittal of Analytical
Reference Standards), there are no residue chemistry data gaps that
would preclude ARIA from recommending for registration for the following
requested crops and/or crop subgroups.  ARIA recommends for the
establishment of tolerances for residues of the herbicide
halosulfuron-methyl in/on the following raw agricultural commodities
and/or crop subgroups:

Pea and bean, succulent shelled, Subgroup 6B 	0.05 ppm

Vegetable, tuberous and corm, Subgroup 1C 	0.05 ppm

Rhubarb 	0.05 ppm

Apple 	0.05 ppm

Okra 	0.05 ppm

Bushberry Subgroup 13-07B 	0.05 ppm

A human health risk assessment is forthcoming.  

Full unconditional registration for the recommended crop/crop subgroup
uses (listed above) will be issued following adequate resolution of the
data gaps listed below.

860.1200 Directions for Use

●	For Crop Subgroup 6B (pea and bean, succulent shelled), the label(s)
should be amended to prohibit applications to legumes grown for
livestock feeds because no residue data are available for cowpea forage
and hay.

●	For Crop Subgroup 13-07B (bushberry), the label(s) should be amended
to remove the instructions pertaining to the use of a non-ionic
surfactant.  If it is IR-4’s intention to add a nonionic surfactant
when Sandea® Herbicide is applied to these crops, then additional field
trial data are required.

For Crop Subgroup 6C (dried pea and bean (except soybean)), the labels
should be amended to remove the use directions for Crop Subgroup 6C.  

860.1500 Crop Field Tri污൳

●	Prior to granting a registration on Crop Subgroup 6C (dried shelled
pea and bean (except soybean)), data on dried pea including the forages
and hay of field pea cultivars are required from a minimum of five field
trials.  The requested field trials should reflect total application
rates of 0.047 lb ai/A per crop cycle or 0.094 lb ai/A per year, a
minimum 30-day PHI, and the incorporation of a non-ionic surfactant in
the spray mixture.  A revised Section F should be submitted removing the
request for Crop Subgroup 6C (dried shelled pea and bean (except
soybean)).

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

●	Analytical reference standards for the 3-CSA (3-chlorosulfonamide
acid) metabolite and the RRE of halosulfuron-methyl must be submitted to
the EPA National Pesticide Standards Repository.

Modification to the Tolerance Expression as per HED’s Interim Guidance
on Tolerance Expressions (S. Knizner, 5/27/2009)

40 CFR§180.479(a)(1):

Tolerances are established for residues of halosulfuron-methyl, methyl
5-[(4,6-dimethoxy-2-pyrimidiny)amino]carbonylaminosulfonyl]-3-chloro-1-m
ethyl-1H-pyrazole-4-carboxylate, including its metabolites and
degradates, in or on the commodities in the table below.  Compliance
with the tolerance levels specified below is to be determined by
measuring only those halosulfuron-methyl residues containing the
3-chlorosulfonamide (3-CSA) moiety, expressed as the stoichiometric
equivalent of halosulfuron-methyl, in or on the commodity.

40 CFR§180.479(a)(2):

Tolerances are established for residues of halosulfuron-methyl, methyl
5-[(4,6-dimethoxy-2-pyrimidiny)amino]carbonylaminosulfonyl]-3-chloro-1-m
ethyl-1H-pyrazole-4-carboxylate, including its metabolites and
degradates, in or on the commodities in the table below.  Compliance
with the tolerance levels specified below is to be determined by
measuring only halosulfuron-methyl.

Background

The chemical structures and nomenclatures of halosulfuron-methyl and the
3-CSA moiety are presented in Table 1.  The physicochemical properties
of the technical grade of halosulfuron-methyl are presented in Table 2.

Table 1.	Halosulfuron-methyl Nomenclature.

Chemical structure	

Common name	halosulfuron-methyl

Company experimental name	MON 12000, NC-319

IUPAC name	methyl
3-chloro-5-(4,6-dimethoxypyrimidin-2-ylcarbamoylsulfamoyl)-1-methylpyraz
ole-4-carboxylate

CAS name	methyl
3-chloro-5-[[[[(4,6-dimethoxy-2-pyrimidinyl)amino]carbonyl]amino]sulfony
l]-1-methyl-1H-pyrazole-4-carboxylate

CAS registry number	100784-20-1

End-use product (EP)	75% WG (SANDEA Herbicide; EPA Reg. No. 81880-18)

75% WG (GWN-3061 Herbicide; EPA Reg. No. 81880-2)

Chemical structure of

3-chlorosulfonamide moiety (3-CSA)	

3-chloro-1-methyl-5-sulfamoyl-1H-pyrazole-4-carboxylic acid

Table 2.	Physicochemical Properties of Halosulfuron-methyl.

Parameter	Value	Reference

Melting range	175.5-177.2ºC	MRID 42139403; DP#s 173627 & 180565,
7/30/92, G.J. Herndon

pH	4.11 at 25ºC (1% w/v slurry)

	Density	1.618 g/mL at 25ºC

	Water solubility at 20ºC	pH 5	0.0015 g/100 mL

pH 7	0.165 g/100 mL

pH 9	0.747 g/100 mL

	Solvent solubility at 20ºC	methanol	0.1616 g/100 mL

n-hexane	0.001278 g/100 mL

	Vapor pressure	<1 x 10-7 mm Hg at 25ºC

	Dissociation constant, Ka	3.61 x 10-4 at 22.4ºC

	Octanol/water partition coefficient, Log(KOW) at 23ºC	1.67 at pH 5

-0.0186 at pH 7

-0.542 at pH 9

	UV/visible absorption spectrum	Not available

	

860.1200 Directions for Use

The end-use products (EPs) relevant to this registration action are
Sandea® Herbicide (EPA Reg. No. 81880-18) and GWN-3061 Herbicide (EPA
Reg. No. 81880-2).  Both products are currently registered to Gowan
Company and are classified as WG formulations containing 75%
halosulfuron-methyl.  IR-4 requests that the product labels of these EPs
be amended to include the proposed new crop uses.  The petitioner is
proposing to add the following crops to the Sandea® Herbicide label: 
apple, bushberry Subgroup 13-07B, okra, succulent shelled pea and bean
Subgroup 6B, dried shelled pea and bean (except soybean) Subgroup 6C,
rhubarb, and tuberous and corm vegetables Subgroup 1C.  The petitioner
is also proposing to amend the product label for GWN-3061 Herbicide to
add uses on dried shell pea and bean (except soybean) Subgroup 6C.

The proposed use pattern information is presented in Table 3. 
Supplemental labels (dated 4/13/2009) for both EPs were provided, along
with a copy of the current accepted master label for Sandea® Herbicide,
(undated).  In addition, a description of the proposed uses
corresponding to Section B for both EPs was also included in the
submission.

Table 3.	Summary of Directions for Use of Halosulfuron-Methyl.

Applic. Timing, Type, and
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(≥15 gal/A)	75% WG

[81880-18]	0.023-0.047	Not specified

(NS)	0.094	14	Single or sequential applications may be made on each side
of the tree row.  Use of a non-ionic surfactant (NIS) is recommended. 
Application to trees established less than one year is prohibited.

Apple; West of the Rocky Mts.

Broadcast to orchard floor; Ground

(≥15 gal/A)	75% WG

[81880-18]	0.035-0.094	NS	0.094	14	Single or sequential applications may
be made on each side of the tree row.  Use of an NIS or a penetrating
type surfactant is recommended.  Application to trees established less
than one year is prohibited.

Bushberry Subgroup 13-07B

Soil broadcast; Ground

(≥15 gal/A)	75% WG

[81880-18]	0.023-0.047	NS	0.094	14	Single or sequential applications may
be made on each side of the row with a minimum retreatment interval
(RTI) of 45 days for sequential applications.  Use of an NIS is
recommended.  Application to plants established less than one year is
prohibited.

Fruiting Vegetables Group Including But Not Limited to Eggplant, Okra,
Pepper, and Tomato

Row middle/furrow applications; Ground

(≥15 gal/A; ≥20 gal/A for okra from Section B)	75% WG

[81880-18]	0.023-0.047	NS	0.094	30	Applications are to be made between
rows of direct-seeded or transplanted fruiting vegetables.

Pea and Bean, Succulent Shelled, Subgroup 6B 1

[Any succulent shelled cultivar of bean (Phaseolus, spp.), or immature
soybean seed (Glycine max), or any Vigna spp., and garden pea (Pisum,
spp.)] 

Preemergence; Soil broadcast; Ground

(≥15 gal/A)	75% WG

[81880-18]	0.023	1	0.023	30	Timing is after planting but before crop
emergence.

Pea and Bean (Except Soybean), Dried Shelled, Subgroup 6C 1; East of the
Rocky Mts.

Postemergence; Broadcast or directed; Ground

(≥15 gal/A)	75% WG

[81880-2]

[81880-18]	0.023-0.031	1	0.047 (per crop cycle)

0.094 (per year)	30	Application is to be made when plants have 2 to 4
trifoliate leaves, but before flowering.  An NIS is to be used. 
Directed sprays are recommended.

Pea and Bean (Except Soybean), Dried Shelled, Subgroup 6C; West of the
Rocky Mts.

Postemergence; Broadcast; Ground

(≥15 gal/A)	75% WG

[81880-2]

[81880-18]	0.023-0.047	1	0.047 (per crop cycle)

0.094 (per year)	30	Application is to be made when plants have 2 to 4
trifoliate leaves, but before flowering.  An NIS is to be used. 
Directed sprays are recommended.

Rhubarb

Dormant;

Broadcast;  Ground

(≥15 gal/A)	75% WG

[81880-18]	0.023-0.047	1	0.047	60	Application is to be made as close as
possible to breaking of dormancy.  An NIS is to be used if labeled weeds
have emerged.

Tuberous and Corm Vegetables, Subgroup 1C

[Arracacha; arrowroot; artichoke, Chinese; artichoke, Jerusalem; canna,
edible; cassava, bitter and sweet; chayote (root); chufa; dasheen
(taro); ginger; leren; potato; sweet potato; tanier; turmeric; yam bean;
yam, true]

Preemergence; Soil broadcast;  Ground

(≥15 gal/A)	75% WG

[81880-18]	0.023-0.047	2	0.047	45	First application is to be made after
planting but prior to crop emergence; if necessary, a second application
may be made 45 days before harvest.  If a second application is made, an
NIS should be used in the second application.

Postemergence

Foliar broadcast

Ground

(≥15 gal/A)

1  Individual crop uses of Sandea® Herbicide (EPA Reg. No. 81880-18)
are currently registered on succulent beans and dry beans; the
petitioner now requests uses on Subgroups 6B and 6C.  The EP, GWN-3061
Herbicide (EPA Reg. No. 81880-2), is also currently registered on
soybeans.

The master label for Sandea® Herbicide includes the following
additional directions:  (1) ground applications are to be made in a
minimum of 15 gal/A of water; (2) air assisted (airblast) field crop
sprayers are prohibited; and (3) application through any type of
irrigation system is prohibited.  The label also includes the following
statement pertaining to adjuvant use:  “Unless otherwise stated, a
nonionic surfactant (NIS) is recommended in the spray solution for
postemergence applications or for preemergence applications where
susceptible weeds are present prior to crop emergence.”

Plantback restrictions are also specified on the master label for a
number of crops, ranging from 0 months for sugarcane and
insecticide-/imidazolidone- resistant field corn to 36 months for sugar
beet in ND, MN, and the Red River Valley, strawberries (6 months for
annual FL transplants), and crops not specifically listed.  HED
previously determined that rotational crop tolerances/restrictions are
not needed for halosulfuron-methyl.  The restrictions appear to have
been established for protection of the rotated crops from residual
herbicidal activity.

Conclusions.  The submitted labels for Sandea® Herbicide (EPA Reg. No.
81880-18) and GWN-3061 Herbicide (EPA Reg. No. 81880-2) are adequate to
allow evaluation of the residue data relative to the proposed uses. 
However, the petitioner is required to i) amend the proposed use
directions of Sandea® Herbicide (EPA Reg. No. 81880-18) on Crop
Subgroup 6B to prohibit applications to legumes grown for livestock
feeds because no residue data are available for cowpea forage and hay;
ii) amend the proposed use directions of Sandea® Herbicide (EPA Reg.
No. 81880-18) on Crop Subgroup 13-07B (bushberry) to remove the
instructions pertaining to the use of a non-ionic surfactant; iii)
remove the use directions from both labels for Crop Subgroup 6C (dried
pea and bean (except soybean)).  Additional recommendations pertaining
to label amendments maybe found in the respective ‘Magnitude of the
Residue’ section and summarized in the ‘List of Deficiency’
section.

860.1300 Nature of the Residue - Plants

DP#251007, M. Doherty, 12/10/1998

Metabolism Committee decision, G. Herndon , 5/21/1996

DP#198361, G. Otakie, 7/21/1994

DP#s173627 & 180565, G. Herndon, 7/30/1992

The nature of the residue in plants is adequately understood based on
acceptable metabolism studies reflecting pre- and postemergence modes of
applications on corn, sugarcane, and soybean.  The metabolism of
halosulfuron-methyl was similar in the three tested crops but dependent
on the mode of application.  When halosulfuron-methyl was applied
preemergence, initial breakdown of the herbicide in the soil and
preferential uptake of the pyrazole moieties resulted in the primary
residue being 3-CSA, which has been determined to be less toxic than the
parent.  With a postemergence application, the major residue was the
parent compound with minimal translocation of the herbicide in the
plant, except in grain where the major residue was 3-CSA. 

  SEQ CHAPTER \h \r 1 Based on the very low toxicity of the metabolite
3-CSA, relatively low toxicity of the parent compound, and low residue
levels of both parent compound and the 3-CSA metabolite, HED has
previously determined that the residue of concern in plants is the
parent compound, halosulfuron-methyl.

860.1300 Nature of the Residue - Livestock

DP#223801, 11/17/1998, M. Doherty

Metabolism Committee decision, G. Herndon, 5/21/1996

DP#204062, G. Herndon, 6/22/1994

DP#184435, G. Herndon, 1/15/1993

DP#181023, G. Herndon, 11/12/1992 

DP#s173627 & 180565, G. Herndon, 7/30/1992

An acceptable goat metabolism study was previously submitted and
reviewed in conjunction with petitions for uses on corn and sorghum.  In
goat milk and tissues, the major extractable residue was the parent;
acid hydrolysis released bound or conjugated residues of aminopyrimidine
and 3-CSA.  HED has previously determined that the residue of concern in
ruminants is halosulfuron-methyl; however, because the approved
enforcement method for livestock commodities quantifies the parent
compound and metabolites containing the 3-CSA moiety by converting
residues to 3-CSA, tolerances for residues in livestock commodities are
expressed in terms of halosulfuron-methyl and its metabolites determined
as 3-CSA, expressed as halosulfuron-methyl equivalents.  

There are no poultry feedstuffs associated with the recommended
tolerances and crop uses addressed in this action.  Therefore, a
discussion of the metabolism of halosulfuron-methyl in poultry is not
germane to this petition.

860.1340 Residue Analytical Methods

DP#250584, G. Herndon, 10/28/1998 

DP#214890, G. Herndon, 5/3/1995 

DP#202131, G. Herndon, 10/4/1994

Plants

Enforcement method:  An adequate analytical method is available for
enforcement of tolerances for halosulfuron-methyl residues in plants. 
The GC method quantifies halosulfuron-methyl as its rearrangement ester
(1-H-pyrazole-4-carboxylic acid,
3-chloro-5-[(4,6-dimethoxy-2-pyrimidinyl)amino]-1-methyl, methyl ester)
using thermionic-specific detection (TSD, nitrogen specific).  Monsanto
Analytical Method RES-109-97-4 (MRID 44495801) has been validated as an
enforcement method by the Analytical Chemistry Branch (ACB)/BEAD.  The
LOQ on rice straw, sugarcane, milo grain, field corn grain, cotton gin
byproducts, and almond nutmeats was estimated to be 0.05 ppm (DP#250584,
G. Herndon, 10/28/1998).  

 

Rearrangement ester (RRE) of halosulfuron-methyl

Data collection methods:  Samples collected from the field trial and
processing studies associated with this action were analyzed for
residues of halosulfuron-methyl using the available tolerance
enforcement method, Method RES-109-97-4, with minor modifications. 
Briefly, samples were extracted with acetonitrile (ACN)/water, filtered,
and partitioned with dichloromethane (DCM).  The DCM extract was
evaporated to dryness and redissolved in 15% methanol/DCM for clean-up
through a Florisil solid phase extraction (SPE) cartridge.  The eluate
was mixed with 0.5 M potassium carbonate to convert halosulfuron-methyl
residues to the RRE.  The reaction mixture was then extracted with DCM,
and the DCM extract was evaporated to dryness; residues were
reconstituted in ethyl acetate for further clean-up through a silica SPE
column.  The eluate was evaporated to dryness and redissolved in 50%
ethyl acetate/isooctane for analysis by gas chromatography with nitrogen
phosphorus detection (GC/NPD).  Residues were expressed in terms of
halosulfuron-methyl.  The GC/NPD method was adequate for data collection
based on acceptable method validation and concurrent method recoveries. 
The LLMV was 0.05 ppm.

Conclusions.  The residue analytical methods data are adequate to
satisfy data requirements for the subject action.  An acceptable residue
analytical method is available for tolerance enforcement purposes for
residues in/on crop commodities.  Residues of halosulfuron-methyl in/on
the crop commodities from the magnitude of the residue studies were
determined using an acceptable data collection method.

Livestock

Enforcement method:  An adequate analytical method is available for
enforcement of tolerances for secondary residues of halosulfuron-methyl
in livestock commodities.  Monsanto Analytical Method RES-046-93
quantifies halosulfuron-methyl and metabolites containing the 3-CSA
moiety, expressed as parent equivalents.  Residues of
halosulfuron-methyl and 3-chlorosulfonamide ester are hydrolyzed to
3-CSA, which is extracted with ACN/DCM and then methylated with
trimethylsilyl-diazomethane.  The methyl ester is analyzed by GC with
electron-capture detection (ECD) after cleanup with an alumina/carbon
column.  The petitioner-validated LOQ was 0.01 ppm.  The method has been
validated as an enforcement method by the Analytical Chemistry Branch
(ACB)/BEAD at an LOQ of 0.01 ppm in milk and liver (D. Swineford,
4/28/1995).

860.1360 Multiresidue Methods

DP# 189198, G.Herndon, 3/8/1994

Adequate multiresidue method data for halosulfuron-methyl and 3-CSA were
submitted previously in conjunction with PP#3F4193.  Residues of
halosulfuron-methyl and 3-CSA are not recoverable by the FDA
Multiresidue Protocols A through E.  The results have been forwarded to
FDA.

860.1380 Storage Stability

The storage durations and conditions of crop samples from the submitted
magnitude of the residue and processing studies are presented in Table
4.

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

Matrix 	Storage Temperature  (°C)	Actual Storage Duration	Interval of
Demonstrated 

Storage Stability for Halosulfuron-methyl 1

Apple fruit	≤-4 at the field sites

≤-8 at the analytical facility	78-110 days

(2.6-3.6 months)	Up to 104 days (3.4 months) in/on frozen apple fruit

Blueberry fruit	≤-2 at the field sites

≤-20 at the analytical facility	76-125 days

(2.5-4.1 months)	Up to 146 or 175 days (4.8 or 5.7 months) in/on frozen
blueberry fruit

Dry bean seed	≤-10 at the field sites

≤-12 at the analytical facility	293-328 days

(9.6-10.8 months)	Up to 326 days (10.7 months) in/on frozen bean seed

Succulent pea seed	≤-10 at the field sites (on blue ice at the GA
site)

≤-20 at the analytical facility	64-222 days

(2.1-7.3 months)	Up to 242 days (8.0 months) in/on frozen pea seed

Potato tuber	≤-2 at the field sites

≤-20 at the analytical facility	114-279 days

(3.7-9.2 months)	Up to 284 days (9.3 months) in/on frozen potato tuber

Potato tuber (RAC)	≤-20 at the analytical facility	246 days

(8.1 months)	Up to 284 days (9.3 months), 302 days (9.9 months), 297
days (9.8 months), and 288 days (9.5 months) in/on frozen potato tuber,
flakes/granules, chips, and wet peel, respectively

Potato granules/flakes	Shipped directly to processor at ambient
temperature

≤-12 at the processing facility

≤-20 at the analytical facility	296-300 days

(9.7-9.9 months)

	Potato chips

292 days

(9.6 months)

	Potato wet peel

244-251 days

(8.0-8.2 months)

	Rhubarb petiole	≤-5 at the field sites

<-20 at the analytical facility	113-165 days

(3.7-5.4 months)	Up to 169 or 233 days (5.6 or 7.7 months) in/on frozen
rhubarb petiole

1  Storage stability determined from concurrent field trial samples.

To support the current apple, blueberry, dry bean, succulent pea,
potato, and rhubarb field trial and potato processing data, storage
stability studies were conducted in conjunction with the field trials
and processing study.  For each crop, control samples of the respective
matrices were fortified with halosulfuron-methyl at 0.5 ppm and placed
in storage under the same frozen conditions as the treated samples.  No
zero-day analyses were conducted on the fortified samples placed into
storage.  Rather, triplicate stored samples were analyzed along with a
control sample and freshly fortified samples at an interval reflecting
the maximum storage intervals from the field trials.  Average corrected
recoveries of halosulfuron-methyl following frozen storage were 96% from
apple after 104 days, 93% for blueberry after 175 days, 95% from dry
bean seed after 326 days, 102% for succulent pea seed after 242 days,
99% from potato tuber after 284 days, 98-115% from potato processed
commodities after 288-302 days, and 90% from rhubarb after 233 days. 
Although no 0-day analysis was conducted, the data indicate that
halosulfuro-methyl is stable under frozen storage conditions for up to
3.4 months in apple, 5.7 months in blueberry, 10.7 months in dry bean
seed, 8.0 months in succulent pea seed, 9.3 months in potato tuber,
9.5-9.9 months in potato processed commodities, and 7.7 months in
rhubarb.

Conclusions.  Adequate storage stability data are available to support
the storage conditions and durations of samples collected from the
magnitude of the residue and processing studies on apples, blueberry,
dry bean seed, succulent pea seed, potato tuber, potato processed
commodities, and rhubarb.  As residues of halosulfuron-methyl were found
stable in tested crop matrices, storage stability corrections need not
be applied to the recommended tolerances for halosulfuron-methyl
residues for these commodities.

860.1400 Water, Fish, and Irrigated Crops

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

860.1460 Food Handling

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

860.1480 Meat, Milk, Poultry, and Eggs

DP#s189198 & 198051, G. Herndon, 3/8/1994 

DP#s173627 & 180565, G. Herndon, 7/30/1992 

The livestock feedstuffs associated with the proposed uses are wet apple
pomace and potato culls and processed waste.  The feedstuffs derived
from registered uses include those commodities derived from alfalfa,
almond, corn, cotton, dry and snap beans, rice, sorghum, soybean, and
sugarcane.  The dietary burdens of halosulfuron-methyl to beef and dairy
cattle resulting from the proposed and registered uses are presented in
Table 5a.  There are no poultry and swine feedstuffs associated with the
proposed uses.  The dietary burdens were re-calculated according to the
Agency guidance on constructing maximum reasonably balanced diets (June
30, 2008) and used the proposed and existing tolerances for feedstuffs. 
The calculated dietary burdens are 0.468 ppm for beef cattle and 0.825
ppm for dairy cattle. 

Table 5a.   Calculation of Dietary Burdens of Halosulfuron-methyl
Residues to Livestock.

Feedstuff	Type1	% Dry Matter2	% Diet2	Recommended Tolerance (ppm)
Dietary Contribution (ppm)3

Beef Cattle

Alfalfa, hay	R	89	15	2.0	0.337

Potato, processed waste	CC	15	30	0.05	0.100

Corn, field, grain	CC	88	50	0.05	0.028

Soybean, meal	PC	92	5	0.05	0.003

TOTAL BURDEN	--	--	100	--	0.468

Dairy Cattle

Alfalfa, forage	R	35	20	1.0	0.571

Corn, field, stover	R	83	15	0.80	0.145

Corn, field, forage	R	40	10	0.20	0.050

Potato, processed waste	CC	15	10	0.05	0.033

Corn, field, grain	CC	88	35	0.05	0.020

Cotton, meal	PC	89	10	0.05	0.006

TOTAL BURDEN	--	--	100	--	0.825

1  R:  Roughage; CC:  Carbohydrate concentrate; PC:  Protein
concentrate.

2  OPPTS 860.1000 Table 1 Feedstuffs (June 2008).

3  Contribution = ([tolerance /% DM] X % diet) for beef and dairy
cattle; contribution = ([tolerance] X % diet) for poultry and swine. 

An adequate dairy cattle feeding study was reported in PP#3F4193 (DP#s
189198 and 198051, G. Herndon, 3/8/1994).  Halosulfuron-methyl (MON
1200)   SEQ CHAPTER \h \r 1 was administered in gelatin capsules to
lactating dairy cattle (four animals/dose group) once daily for 28
consecutive days at 3 dose levels (roughly equivalent to 0.5, 1.5, and 5
ppm in the daily diet on a dry weight basis).  Four control animals were
given untreated capsules.  Milk samples were collected from each a.m.
and p.m. milking from Day 1 until the day of sacrifice.  Within 12 hours
after the last dose of test material, the animals were sacrificed, and
samples of liver, kidney, fat, and muscle were collected, finely ground,
and frozen until analysis.  The samples were analyzed either by Method
RES-021-92 (milk samples) or Method RES-027-92 (meat matrices).  Both
methods convert halosulfuron-methyl (MON 12000), MON 12000 acid,
des-methyl MON 12000, and chlorosulfonamide ester to a single
chemophore, chlorosulfonamide acid.  Prior to sample analysis, the
performance of the methods was tested using both unlabeled MON 12000
fortifications as well as the radiolabeled goat milk and liver samples
obtained from the carbon-14 goat metabolism study.  Adequate storage
stability of MON 12000 in the various matrices was shown to cover the
storage interval of the samples.  No residues were detected in the
controls above the 0.01 ppm detection limit.  The results of the cattle
feeding study are shown in Table 5b.

Table 5b.   Maximum Residues in Dairy Cattle Tissues and Milk.

Dose

(ppm)	Maximum Residue (ppm) 1

	Whole Milk	Raw Cream	Raw Skim Milk	Muscle	Fat	Liver	Kidney

0.5	NA 2	NA	NA	NA	NA	0.01	0.02

1.5	NA	NA	NA	<0.01	<0.01	0.04	0.11

5.0	<0.01	<0.01	<0.01	<0.01	<0.01	0.11	0.24

1  Total CSA, expressed as MON 12000 equivalents.

2  NA – not analyzed.

  SEQ CHAPTER \h \r 1 No detectable residues (<0.01 ppm) were found in
milk, muscle, and fat of cattle at feeding levels of 0.5, 1.5, and 5.0
ppm.  Detectable residues were found in liver and kidney at all feeding
levels.

Conclusions.  The livestock feedstuffs derived from registered and
proposed uses would not significantly increase the dietary burdens of
halosulfuron-methyl to beef and dairy cattle provided the petitioner
amends the proposed use directions of Sandea® Herbicide on Crop
Subgroup 6B to prohibit applications to legumes grown for livestock
feeds.  The available dairy cattle feeding study is adequate, and ARIA
continues to conclude that tolerances for halosulfuron-methyl residues
of concern need not be established for the milk, meat, and fat of
cattle, goat, hog, horse, and sheep.  The established tolerance of 0.1
ppm for the meat byproducts of cattle, goat, hog, horse, and sheep
remain adequate.  There are no poultry and swine feedstuffs associated
with the recommended tolerances and crop uses.  The petitioner should
note that if additional uses are proposed in the future which would
result in an increase in the dietary burdens, ARIA/HED will re-assess
the adequacy of established animal tolerances.

860.1500 Crop Field Trials

DER References:	47772101.der.doc (Succulent Pea)

		47772102.de1.doc (Potato)

		47772103.der.doc (Rhubarb)

		47772104.der.doc (Blueberry)

	47772105.der.doc (Dry Bean)

	47772106.der.doc (Apple)

IR-4 has submitted magnitude of the residue studies on apples,
blueberry, dry bean, succulent pea, potato, and rhubarb.    SEQ CHAPTER
\h \r 1 The results from these field trials are discussed below and the
residue data are summarized in Table 6.  As all residues in/on treated
commodity samples were below the LLMV (<0.05 ppm) when the test
formulation was applied to the crops according to the conditions and
parameters used in the field trials, the Agency’s tolerance
spreadsheet was not used for tolerance assessments and recommendations.

Table 6.   Summary of Residue Data from Crop Field Trials with
Halosulfuron-methyl.

Crop Matrix	Total Applic. Rate

(lb ai/A)	PHI (days)	Residues of Halosulfuron-methyl (ppm)

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

Apple

(proposed use = 0.094 lb ai/A total application rate, 14-day PHI)

Apple (fruit)	0.092-0.104	13-14	26	<0.05	<0.05	<0.05	0.05	0.05	--

Bushberry Subgroup 13-07B

(proposed use = 0.094 lb ai/A total application rate, 14-day PHI)

Blueberry (fruit)	0.093-0.099	13-14	12	<0.05	<0.05	<0.05	0.05	0.05	--

Okra

(proposed use = 0.094 lb ai/A total application rate, 30-day PHI)

Okra 	No okra data were submitted.

Pea and Bean, Succulent Shelled, Subgroup 6B

(proposed use = 0.023 lb ai/A total application rate, 30-day PHI)

Pea seed	0.032	55-68	4	<0.05	<0.05	<0.05	0.05	0.05	--

	0.060-0.070	55-72; 1662	18	<0.05	<0.05	<0.05	0.05	0.05	--

Pea seed in pods	0.065-0.066	69-77	6	<0.05	<0.05	<0.05	0.05	0.05	--

Pea and Bean (Except Soybean), Dried Shelled, Subgroup 6C

(proposed use = 0.047 lb ai/A total application rate per crop cycle and
0.094 lb ai/A total application rate per year, 30-day PHI)

Dry bean seed	0.061-0.075	27-31	24	<0.05	<0.05	<0.05	0.05	0.05	--

Rhubarb

(proposed use = 0.047 lb ai/A total application rate, 60-day PHI)

Rhubarb petiole	0.093-0.101	61-78	8	<0.05	<0.05	<0.05	0.05	0.05	--

Tuberous and Corm Vegetables, Subgroup 1C

(proposed use = 0.047 lb ai/A total application rate, 45-day PHI)

Potato tuber	0.094-0.103	42-46	28	<0.05	<0.05	<0.05	0.05	0.05	--

1  HAFT = highest average field trial result.

2  Includes one trial (2 samples) harvested at a 166-day PHI.

Apple

IR-4 has submitted field trial data for halosulfuron-methyl with apple
from 13 field trials conducted in the United States in Zones 1 (NY; 3
trials), 2 (NJ, NC; 2 trials), 5 (MI; 2 trials), 9 (CO; 1 trial), 10
(CA; 1 trial), and 11 (ID, WA; 4 trials) during the 2006 growing season.
 At each trial site, two broadcast applications of a 75% WG formulation
of halosulfuron-methyl were made to the orchard floor during the
fruiting growth stages, at 0.044-0.053 lb ai/A/application, with a 13-
to 15-day retreatment interval (RTI), for a total rate of 0.092-0.104 lb
ai/A (~1X the proposed maximum seasonal rate).  Applications were made
using ground equipment in spray volumes of 15-36 gal/A, without an
adjuvant.  Samples of commercially mature apple fruit were collected at
a 13- to 14-day PHI.  An additional plot was established at the NJ site
using a total seasonal rate of 0.484 lb ai/A, to generate samples for
processing; however, as residues were nondetectable in any apple fruit
sample, processing was not initiated.

Samples of apple fruit were analyzed for residues of halosulfuron-methyl
as its rearrangement ester using the available tolerance enforcement
method, Method RES-109-97-4, with modifications.  The gas chromatography
method with nitrogen-phosphorus detection (GC/NPD) is adequate for data
collection based on acceptable method validation and concurrent method
recoveries.  The LLMV for halosulfuron-methyl in apple was 0.05 ppm.

The maximum storage duration for apple fruit samples was 110 days (3.6
months).  To support sample storage conditions and durations, storage
stability data were generated concurrently with the field trial study. 
These data demonstrate that residues of halosulfuron-methyl are stable
in/on fortified apple fruit stored frozen for up to 104 days (3.4
months).

Residues of halosulfuron-methyl were below the LLMV (<0.05 ppm) in/on
all samples of apple fruit harvested 13 or 14 days following the second
of two broadcast applications of the 75% WG formulation of
halosulfuron-methyl at a total seasonal rate of 0.092-0.104 lb ai/A.

Conclusions:  The submitted field trial data for halosulfuron-methyl on
apples are adequate with regard to the number and location of field
trials.  The application rate and PHI reflect the proposed use pattern,
and the data are supported by concurrent storage stability data. 
Although the apple data did not reflect the use of a nonionic surfactant
as recommended on the proposed label, this is not an issue as the
application is directed to the orchard floor and presence/absence of
surfactant is not expected to change the residue level on the apple
fruit.  The available data will support the proposed tolerance of 0.05
ppm for apple.  

Bushberry Subgroup 13-07B

IR-4 has submitted field trial data for halosulfuron-methyl with
blueberry as a representative of the Crop Subgroup 13-07B, bushberry. 
Six blueberry trials were conducted in the United States in Zones 1 (ME;
1 trial), 2 (NJ and NC; 2 trials), 5 (MI; 2 trials), and 12 (OR; 1
trial), during the 2006 growing season.  At each trial location, a
single soil broadcast application of a 75% WG formulation of
halosulfuron-methyl was made during the crops’ fruiting growth stage
at a rate of 0.093-0.099 lb ai/A (~1X the proposed maximum rate). 
Applications were made to either side of each plant row using ground
equipment in spray volumes of ~16-23 gal/A except for the OR trial where
a spray volume of 62 gal/A was used; no adjuvant was included in any of
the spray volumes.  Samples of commercially mature blueberry fruit were
collected at a 13- or 14-day PHI.

Samples of blueberry fruit were analyzed for residues of
halosulfuron-methyl as its rearrangement ester using the available
tolerance enforcement method, Method RES-109-97-4, with modifications. 
The GC/NPD is adequate for data collection based on acceptable method
validation and concurrent method recoveries.  The LLMV for
halosulfuron-methyl in blueberry fruit was 0.05 ppm.

The maximum storage duration for blueberry samples was 125 days (4.1
months).  To support sample storage conditions and durations, storage
stability study data were generated concurrently with the field trial
study.  These data demonstrate that residues of halosulfuron-methyl are
stable in/on fortified blueberry fruit stored frozen for up to 175 days
(5.7 months).

Residues of halosulfuron-methyl were below the LLMV (<0.05 ppm) in/on
all samples of blueberry harvested 13 or 14 days following a single soil
broadcast application of the 75% WG formulation of halosulfuron-methyl
at 0.093-0.099 lb ai/A.

Conclusions:  The submitted field trial data for halosulfuron-methyl on
blueberries, the representative commodity of Crop Subgroup 13-07B, are
adequate with regard to the number and location of field trials. 
Although the number of field trials is a 25% reduction of the OPPTS
860.1500 guidance, this number is considered sufficient, for
halosulfuron-methyl, to support the Subgroup 13-07B tolerance based on
the lack of quantifiable residues.  The application rate and PHI reflect
the proposed use pattern, and the data are supported by concurrent
storage stability data.  However, the blueberry data did not reflect the
use of a nonionic surfactant as recommended on the proposed label.  The
blueberry data will support and ARIA recommends for the proposed
tolerance of 0.05 ppm for the bushberry Subgroup 13-07B provided the
label for Sandea® Herbicide is amended to remove the instructions
pertaining to the use of a non-ionic surfactant on crops belonging to
the Subgroup 13-07B.  If it is IR-4’s intention to add a nonionic
surfactant when Sandea® Herbicide is applied on Subgroup 13-07B, then
additional field trial data are required.  Although the spray is
directed to the rows between blueberry bushes, there is a finite
possibility of the spray contacting the bushes, and the presence/absence
of surfactant might impact the residue on the blueberries.

Okra

DP#267423, A. Acierto, 4/25/2002

No residue data were submitted to support the proposed use on okra. 
Okra was listed by the petitioner in its proposed labels as part of the
fruiting vegetables crop group.  The ChemSAC meeting of 10/18/2006 has
recommended the inclusion of okra in Crop Group 8 (fruiting vegetables).
 The ChemSAC has also determined that a separate tolerance for okra
should be listed in the appropriate section of the CFR entry until the
new crop group regulation is published.

A tolerance of 0.05 ppm for residues of halosulfuron-methyl has been
established on the fruiting vegetable Crop Group 8 based on field trial
data for tomato and pepper (DP#267423, A. Acierto, 4/25/2002).  The
available field trial data for fruiting vegetables will be translated to
okra.  ARIA recommends for the establishment of a tolerance of 0.05 ppm
for residues of halosulfuron-methyl in/on okra.  This recommendation is
identical to the level proposed by the petitioner.

Pea and Bean, Succulent Shelled, Subgroup 6B

DP#278587, A. Acierto, 6/15/2002

IR-4 has submitted field trial data for halosulfuron-methyl on succulent
shelled and edible podded peas from 12 field trials conducted in the
United States during the 2003-2004 growing seasons.  Nine trials on
succulent shelled peas were conducted in Zones 2 (GA and SC; 2 trials),
5 (OH and WI; 4 trials), 11 (WA; 2 trials), and 12 (OR; 1 trial).  Three
trials on edible podded pea were conducted in Zones 1 (NY; 1 trial) and
10 (CA; 2 trials).  Each trial site consisted of one untreated plot and
two treated plots.  Each treated plot received a single postplant
preemergence broadcast soil application of a 75% WG formulation of
halosulfuron-methyl at ~0.032 lb ai/A (Treatment Plot 2; ~1.4X the
maximum proposed rate) or ~0.064 lb ai/A (Treatment Plot 3; ~2.8X).  All
applications were made using ground equipment in 20-38 GPA spray
volumes, without an adjuvant.  Samples of commercially mature pea seed
were collected at a 55- to 77-day PHI; however, at one trial, peas were
collected at a 166-day PHI.

Samples of succulent pea seed, with and without pods, were analyzed for
residues of halosulfuron-methyl as its RRE using the available tolerance
enforcement method, Method RES-109-97-4, with modifications.  The GC/NPD
is adequate for data collection based on acceptable method validation
and concurrent method recoveries.  The LLMV for halosulfuron-methyl was
0.05 ppm.

The maximum storage duration for pea seed samples was 222 days (7.3
months).  To support sample storage conditions and durations, a
concurrent storage stability study was conducted with the field trial
study.  These data demonstrate that residues of halosulfuron-methyl are
stable in/on fortified pea seed stored frozen for up to 242 days (8.0
months).

  

Residues of halosulfuron-methyl were below the LLMV (<0.05 ppm) in/on
all samples of peas (succulent shelled and edible podded) harvested
55-166 days following a single preemergence broadcast application of the
75% WG formulation of halosulfuron-methyl, made to the soil at a rate of
 0.060-0.070 lb ai/A (Treatment Plot 3).  Residues were also below the
LLMV (<0.05 ppm in/on samples of pea seeds treated at 0.032 lb ai/A
(Treatment Plot 2).  Varying degrees of phytotoxicity were reported at
all but three of the test sites.  The petitioner reported phytotoxic
effects resulting in plant stunting/thinning or chlorosis at the NY, OH,
SC, WI, and WA trial sites, and one CA trial site.  No phytotoxic
effects were noted at the three remaining trials.  Although
phytotoxicity appears to be attributed to the test substance
application, these instances of phytotoxicity did not have an adverse
impact on the residue trials.

Conclusions:  The representative crops of Subgroup 6B are two
commodities of: (1) any succulent shelled cultivar of bean (Phaseolus
spp.) or (2) immature soybean seed (Glycine max) or (3) any Vigna spp.
and garden pea (Pisum spp.).  The submitted field trial data for
succulent peas do not fully support the proposed use pattern because the
trials were conducted at exaggerated rates (1.4X or 2.8X) and the
collected samples did not reflect the proposed 30-day PHI (the earliest
PHI tested was 55 days).  The available data for succulent beans,
previously submitted under PP#1E06322 (DP#278587, A. Acierto, 6/15/2002)
to support the established individual tolerance of 0.05 ppm, also do not
reflect the proposed use on Subgroup 6B because these data represent
foliar application whereas the new proposed use pattern is for
preemergence soil application.  

ARIA will not require additional data on succulent peas since treatment
at 1X will likely result in residues below 0.05 ppm, even when harvested
at a PHI of 30-days.  ARIA will also not require additional data on
succulent beans since soil treatment will likely result in residues
below 0.05 ppm.  ARIA recommends for the proposed tolerance of 0.05 ppm
for the Subgroup 6B (pea and bean, succulent shelled).  Concomitant with
the establishment of a tolerance for Subgroup 6B, the individual
tolerance for ‘bean, snap, succulent’ should be revoked.

Pea and Bean (Except Soybean), Dried Shelled, Subgroup 6C

DP# 278587, A. Acierto, 6/15/2002 

IR-4 has submitted field trial data for halosulfuron-methyl with dry
bean as a representative of the Crop Subgroup 6C dried shelled bean
(except soybean) and pea.  Twelve field trials were conducted in the
United States with dry bean in Zones 1 (NY; 1 trial), 5 (ND, SD, and WI;
5 trials), 7 (NE and ND; 2 trials), 8 or 9 (CO; 2 trials), 10 (CA; 1
trial), and 11 (WA; 1 trial) during the 2005 growing season.  At each
trial site, a single foliar broadcast postemergence application of a 75%
WG formulation of halosulfuron-methyl was made during the crop’s
blooming or fruiting growth stage at 0.061-0.075 lb ai/A (~1.3-1.6X the
proposed application rate per crop cycle and ~0.6-0.8X the proposed
total application rate per year).  Applications were made using ground
equipment in spray volumes of ~18-35 gal/A; an NIS was added as an
adjuvant.  Samples of commercially mature dry bean seed were collected
at a 27- to 31-day PHI.

Samples of dry bean seed were analyzed for residues of
halosulfuron-methyl as its RRE using the available tolerance enforcement
method, Method RES-109-97-4, with modifications.  The GC/NPD is adequate
for data collection based on acceptable method validation and concurrent
method recoveries.  The LLMV for halosulfuron-methyl in dry bean seed
was 0.05 ppm.

The maximum storage duration for dry bean seed samples was 328 days
(10.8 months).  To support sample storage conditions and durations,
storage stability study data were generated concurrently with the field
trial study.  These data demonstrate that residues of
halosulfuron-methyl are stable in/on fortified dry bean seed stored
frozen for up to 326 days (10.7 months).

Residues of halosulfuron-methyl were below the LLMV (<0.05 ppm) in/on
all samples of dry bean seed harvested 27 to 31 days following a single
foliar broadcast postemergence application of the 75% WG formulation of
halosulfuron-methyl at 0.061-0.075 lb ai/A.

Conclusions:  The representative commodities of Subgroup 6C are any one
dried cultivar of bean (Phaseolus spp.) and any one dried cultivar of
pea (Pisum spp.)  The submitted residue data for dry bean are adequate
with regard to geographic representation of data; the data are supported
by concurrent storage stability data.  The dry bean data from the
current submission reflect a single foliar broadcast application
conducted at ~1.6X the proposed application rate per crop cycle (or
~0.8X the proposed total application rate per year), the use of a
nonionic surfactant, and the treated samples were collected
approximating the proposed 30-day PHI.  Additional data for dry beans
were submitted under PP#1E06322 (DP#278587, A. Acierto, 6/15/2002) to
support the established individual tolerance of 0.05 ppm.  These data
represent a single application of Permit 75 WG Herbicide at 0.032 lb
ai/A made 0 to 6 days after planting and a 86- to 113-day PHI.

ARIA is unable to recommend for the proposed tolerance of 0.05 ppm for
Crop Subgroup 6C (Dried Shelled Bean (Except Soybean) and Pea) at this
time because residue data on dried pea including the forages and hay of
field pea cultivars are required.  When adequate residue data for dried
peas become available, the petitioner may again request a tolerance for
Subgroup 6C.  A revised Section F should be submitted removing the
request for Crop Subgroup 6C (dried shelled pea and bean (except
soybean)).

Rhubarb

IR-4 has submitted field trial data for halosulfuron-methyl on rhubarb
from four field trials conducted in the United States in Zones 5 (MI; 1
trial) and 12 (OR; 3 trials) during the 2006 growing season.  At each
trial location, a single soil broadcast application of a 75% WG
formulation of halosulfuron-methyl was made at the end of plant
dormancy, at a rate of 0.093-0.101 lb ai/A (~2.0-2.1X the proposed
rate).  Applications were made using ground equipment in spray volumes
of ~20-32 gal/A; an NIS was added as an adjuvant.  Samples of rhubarb
petiole (stalk plus leaf) were collected at a 61- to 78-day PHI.

Samples of rhubarb petiole were analyzed for residues of
halosulfuron-methyl as its RRE using the available tolerance enforcement
method, Method RES-109-97-4, with modifications.  The GC/NPD is adequate
for data collection based on acceptable method validation and concurrent
method recoveries.  The LLMV for halosulfuron-methyl in rhubarb was 0.05
ppm.

The maximum storage duration for rhubarb petiole samples was 165 days
(5.4 months).  To support sample storage conditions and durations, a
concurrent storage stability study was conducted with the field trial
study.  These data demonstrate that residues of halosulfuron-methyl are
stable in/on fortified rhubarb stored frozen for up to 233 days (7.7
months).  

Residues of halosulfuron-methyl were below the LLMV (<0.05 ppm) in/on
all samples of rhubarb petiole harvested 61 to 78 days following a
single soil broadcast application of the 75% WG formulation of
halosulfuron-methyl at 0.093-0.101 lb ai/A.

Conclusions:  The submitted field trial data for halosulfuron-methyl on
rhubarb are adequate with regard to the number and location of field
trials.  The data also reflect the use of nonionic surfactant as
recommended on the proposed label, samples were collected at appropriate
PHI, and are supported by concurrent storage stability data.  However,
the rhubarb data were generated using slightly exaggerated rates of
~2.0-2.1X.  ARIA will not require additional data on rhubarb since
treatment at 1X will likely result in residues below 0.05 ppm.  The
available data will support the proposed tolerance of 0.05 ppm for
rhubarb.

Tuberous and Corm Vegetables, Subgroup 1C

IR-4 has submitted field trial data for halosulfuron-methyl with potato
as a representative of the Crop Subgroup 1C tuberous and corm
vegetables.  Fourteen potato trials were conducted in the United States
in Zones 1 (ME and NY; 2 trials), 2 (NJ; 1 trial), 3 (FL; 1 trial), 5
(ND and WI; 3 trials), 9 (CO; 1 trial), 10 (CA; 1 trial), and 11 (ID and
WA; 5 trials), during the 2004 growing season.  At each test location,
two broadcast applications of a 75% WG formulation of
halosulfuron-methyl were made at 0.046-0.052 lb ai/A/application for a
total seasonal rate of 0.094-0.10 lb ai/A (~2.0-2.1X the proposed
maximum seasonal rate).  The first application was made to bare soil;
the second was made as a foliar application 27 to 96 days later when the
plants were in a vegetative to post bloom growth stage.  Applications
were made using ground equipment in spray volumes of ~12-32 gal/A.  The
first application did not include an adjuvant, but the second included a
non-ionic surfactant.  Samples of commercially mature potato tuber were
collected at a 42- to 46-day PHI.  At one WA site, additional bulk
samples of potato tuber were collected for processing.

Samples of potato tuber were analyzed for residues of
halosulfuron-methyl as its RRE using the available tolerance enforcement
method, Method RES-109-97-4, with modifications.  The GC/NPD is adequate
for data collection based on acceptable method validation and concurrent
method recoveries.  The LLMV for halosulfuron-methyl was 0.05 ppm.

The maximum storage duration for potato tuber samples was 279 days (9.2
months).  To support sample storage conditions and durations, storage
stability study data were generated concurrently with the field trial
study.  These data demonstrate that residues of halosulfuron-methyl are
stable in/on fortified potato tuber stored frozen for up to 284 days
(9.3 months).

Residues of halosulfuron-methyl were below the LLMV (<0.05 ppm) in/on
all samples of potato tuber harvested 42 to 46 days following the second
of two broadcast applications (soil followed by foliar) of the 75% WG
formulation of halosulfuron-methyl, made during fruiting with a total
seasonal rate of 0.094-0.103 lb ai/A.  Varying degrees of phytotoxicity
(i.e., stunting, some chlorosis, slight browning of leaf edge) following
application of halosulfuron-methyl were reported at some of the test
sites (CA, CO, ND, and WI).  No phytotoxic effects were noted at the
remaining trials.  Although phytotoxicity appears to be attributed to
the test substance application, these instances of phytotoxicity did not
have an adverse impact on the residue trials.

Conclusions:  The submitted field trial data for halosulfuron-methyl on
potato, the representative commodity of Crop Subgroup 1C, reflect the
use of a nonionic surfactant as recommended on the proposed label and
approximate the proposed PHI.  The data are also supported by concurrent
storage stability data.  However, the number and location of field
trials do not fully conform to the OPPTS 860.1500 guideline as only 14
trials were conducted whereas the guideline requires a minimum of 16
trials to support a tolerance on Crop Group 1C.  In addition, the potato
data were generated using slightly exaggerated rates of ~2.0-2.1X.  ARIA
will not require additional data on potatoes since additional trials at
a 1X rate will likely result in residues below 0.05 ppm.  The available
data will support the proposed use pattern and ARIA recommends for a
tolerance of 0.05 ppm for Crop Subgroup 1C.

860.1520 Processed Food and Feed

Apple

DER References:  47772106.der.doc

An additional plot was established at the NJ site using a total seasonal
rate of 0.484 lb ai/A (~5.1X the proposed maximum seasonal rate), to
generate samples for processing; however, as residues were nondetectable
in any apple fruit sample, a processing study was not initiated.  

Conclusions.  These data are adequate to conclude that additional apple
processing study and tolerances for apple processed commodities are not
required for this action.

Potato

DER Reference:  47772102.de2

In a single crop field trial conducted in WA during the 2004 growing
season, two broadcast applications of a 75% WG formulation of
halosulfuron-methyl, were made to bare soil and then to potato plants at
the vegetative/fruiting growth stage, at 0.049-0.050 lb
ai/A/application, with a 95-day RTI, for a total rate of 0.099 lb ai/A
(2X the proposed maximum seasonal rate).  Applications were made using
ground equipment in a spray volume of ~18 gal/A, with an NIS included in
the second application as an adjuvant.  Mature potato tuber was
harvested at a 42-day PHI and processed into granules/flakes, chips, and
wet peel using procedures simulating commercial practices.

Samples of potato tuber, granules/flakes, chips, and wet peel were
analyzed for residues of halosulfuron-methyl as its RRE using the
available tolerance enforcement method, Method RES-109-97-4, with
modifications.  The GC/NPD is adequate for data collection based on
acceptable method validation and concurrent method recoveries.  The LLMV
for halosulfuron-methyl was 0.05 ppm in all potato matrices.

The maximum storage durations of samples from harvest/processing to
analysis were 246 days (8.1 months) for potato tuber and 251-300 days
(8.2-9.9 months) for potato granules/flakes, chips, and wet peel.  To
support sample storage conditions and durations, a concurrent storage
stability study was conducted with the processing study.  These data
demonstrate that residues of halosulfuron-methyl are stable for up to
284 days (9.3 months), 302 days (9.9 months), 297 days (9.8 months), and
288 days (9.5 months) in/on frozen potato tuber, flakes/granules, chips,
and wet peel, respectively.  However, zero-day data were not provided.

The results of the potato processing study are summarized in Table 7. 
Residues of halosulfuron-methyl were nonquantifiable (<0.05 ppm) in/on
potato tuber harvested 42 days following the second of two broadcast
applications of the 75% WG formulation of halosulfuron-methyl, made to
soil and at the vegetative/fruiting growth stage at a total rate of
0.099 lb ai/A.  Residues were also nonquantifiable in processed potato
granules/flakes, chips, and wet peel, therefore, processing factors
could not be calculated.

Theoretical concentration factors based on loss of water (860.1520,
Table 2) are 4.7X for potato granules/flakes and, based on separation
into components, 4.0X for potato processed waste (860.1520, Table 3). 
The maximum theoretical concentration factor for potato is 5X (860.1520,
Table 1).

Table 7.   Residue Data from Potato Processing Study with
Halosulfuron-methyl.

RAC	Processed Commodity	Total Rate

(lb ai/A) 	PHI 

(days)	Residues (ppm)1	Processing Factor

Potato	Tuber (RAC)	0.099	42	ND, ND	--

	Flakes/granules

	ND, ND	Not calculated2

	Chips

	ND, ND

Wet peel

	ND, ND

	1  ND = Not detected.  Residues reported below the LOD (<0.0089 ppm
in/on tuber; <0.0129 ppm in flakes/granules; <0.0307 ppm in chips; and
<0.0402 ppm in wet peel).

2  Not calculated because residues were reported blow the LLMV (<0.05
ppm) in both the RAC and the processed commodity.

Conclusions.  The submitted processing data for potato are acceptable. 
Residues of halosulfuron-methyl were nonquantifiable (<0.05 ppm) in/on
potato tubers following treatments at 2X the proposed seasonal rate. 
Residues were also nonquantifiable in processed potato granules/flakes,
chips, and wet peel.  The Agency would have preferred that a trial with
an exaggerated rate equal to or higher than the maximum theoretical
concentration factor of 5X for potato have been conducted.  However,
because of phytotoxicity limitations as reported in the magnitude of the
residue trials, a new potato processing study will not be required. 
Based on these data, tolerances for potato processed commodities are not
needed.

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

DP#250584, G. Herndon, 10/28/1998 

An analytical standard is currently available in the EPA National
Pesticide Standards Repository for halosulfuron-methyl (expiration
6/14/2013); however, a standard is not available for its 3-CSA
(3-chlorosulfonamide acid) metabolite (personal communication with
Dallas Wright, ACB, 2/23/2009).  ARIA notes that a standard for the RRE
of halosulfuron-methyl is also required in support of the tolerance
enforcement method for plant commodities.  Analytical reference
standards of the 3-CSA metabolite and the RRE must be supplied and
supplies replenished as requested by the Repository.  The reference
standards should be sent to the Analytical Chemistry Lab, which is
located at Fort Meade, to the attention of Theresa Cole at the following
address:

	USEPA

	National Pesticide Standards Repository/Analytical Chemistry Branch/OPP

	701 Mapes Road

	Fort George G. Meade, MD  20755-5350

(Note that the mail will be returned if the extended zip code is not
used.)

860.1850 and 860.1900 Confined/Field Accumulation in Rotational Crops

DP#225273, G.J. Herndon, 10/29/1998

Metabolism Committee decision, G. Herndon , 5/21/1996

DP#192510, G. Kramer, 8/30/1993

DP#s 188144 and 188814, G. Herndon, 3/11/1993

 

Acceptable confined rotational and limited field rotational crop studies
were previously submitted.  The results of both studies indicate that
metabolites containing the pyrazole moiety may accumulate in harvested
crops planted at intervals greater than one year.  The confined
rotational crop study, conducted at 0.19 lb ai/A, indicated that no
measurable residues of halosulfuron-methyl were detected in any
rotational crop commodities of wheat, soybean, radish and lettuce at any
plantback interval (30, 120, and 360 days after treatment).  The limited
field rotational crop study, conducted at 0.22 lb ai/A in a split
(preplant + postemergence) application, with rotated crops of winter
wheat, spring wheat, soybean, sugar beet, and leaf lettuce indicated
that no measurable residues of halosulfuron-methyl were detected in any
field rotational crop samples, except in one spring wheat forage sample
at 0.090 ppm (364-day plantback interval).

HED previously concluded that the residue of concern in rotational crops
is halosulfuron-methyl.  Based on the absence of the parent compound in
the confined studies and in the limited field rotational crop studies,
with the exception of one forage sample, HED previously concluded that
rotational crop tolerances and restrictions are not required for
halosulfuron-methyl.

Conclusion.  The proposed uses on okra, pea and bean (succulent shelled
and dried), tuberous and corm vegetables, and rhubarb are not expected
to alter HED’s earlier assessment regarding the potential for
inadvertent residues in rotatable crops addressed in this registration
action.  No additional data are required.  

860.1550 Proposed Tolerances

Halosulfuron-methyl tolerances for plant commodities have been
established in 40 CFR §180.479(a)(2) and are expressed in terms of
halosulfuron-methyl, methyl
3-chloro-5-[[[[(4,6-dimethoxy-2-pyrimidinyl)amino] carbonyl] amino]
sulfonyl]-1-methyl-1 H -pyrazole-4-carboxylate.  The proposed tolerance
expression is consistent with the halosulfuron-methyl tolerances
established in 40 CFR §180.479(a)(2) and reflect the residues of
concern as previously determined by HED.

Halosulfuron-methyl tolerances for livestock commodities are listed in
40 CFR §180.479(a)(1) and are expressed in terms of   SEQ CHAPTER \h \r
1 halosulfuron-methyl and its metabolites determined as
3-chloro-1-methyl-5-sulfamoylpyrazole-4-carboxylic acid (also referred
to as 3-CSA, expressed as parent equivalents).  

Residues of halosulfuron-methyl were below the LLMV (<0.05 ppm) when the
test formulation was applied to the proposed crops according to the
conditions and parameters used in the field trials.  The Agency’s
tolerance spreadsheet was not used for tolerance assessments and
recommendations.

For apples, the submitted data will support a RAC tolerance of 0.05 ppm.
 

For blueberries, the submitted data will support a tolerance of 0.05 ppm
for Crop Subgroup 13-07B (bushberry) provided the label for Sandea®
Herbicide is amended to remove the instructions pertaining to the use of
a non-ionic surfactant.  If it is IR-4’s intention to add a nonionic
surfactant when Sandea® Herbicide is applied on Subgroup 13-07B, then
additional field trial data are required.

For okra, the available field trial data for fruiting vegetables will be
translated to okra.  The ChemSAC meeting of 10/18/2006 has recommended
the inclusion of okra in Crop Group 8 (fruiting vegetables).  The
ChemSAC has also determined that a separate tolerance for okra should be
listed in the appropriate section of the CFR entry until the new crop
group regulation is published.  The translated data support a tolerance
of 0.05 ppm in/on okra.

For Crop Subgroup 6B (pea and bean, succulent shelled), ARIA recommends
a tolerance of 0.05 ppm, provided the proposed labels on Crop Subgroup
6B is amended to prohibit applications to legumes grown for livestock
feeds.  Concomitant with the establishment of a tolerance for Subgroup
6B, the individual tolerance for ‘bean, snap, succulent’ should be
revoked.

Because data are required for dried pea including the forages and hay of
field pea cultivars for Crop Subgroup 6C (dried shelled bean (except
soybean) and pea), ARIA is unable to recommend for a registration and
tolerance.  When adequate residue data for dried peas become available,
the petitioner may again request a tolerance for Subgroup 6C.

For rhubarb, the submitted data will support a RAC tolerance of 0.05
ppm.

For potatoes, the submitted data will support a tolerance for Crop
Subgroup 1C (tuberous and corm vegetables) at 0.05 ppm.

The apple and potato processing data indicate that tolerances are not
needed for the processed commodities of these crops.  

Tolerances for halosulfuron residues of concern need not be established
for the milk, meat, and fat of cattle, goat, hog, horse, and sheep as a
result of the proposed uses.  The established tolerance of 0.1 ppm for
the meat byproducts of cattle, goat, hog, horse, and sheep remain
adequate.  There are no poultry and swine feedstuffs associated with the
recommended tolerances and crop uses.  The petitioner should note that
if additional uses are proposed in the future which would result in an
increase in the dietary burdens, ARIA/HED will re-assess the adequacy of
established animal tolerances.

Table 8 presents the proposed/recommended tolerance level and the
corrected commodity definition.

There are no Codex, Canadian, or Mexican maximum residue limits (MRLs)
established for residues of halosulfuron-methy in crop or livestock
commodities.  An International Residue Limit (IRL) form is appended to
this Summary Document and follows this section.

Table 8.    Tolerance Summary for Halosulfuron-Methyl.

Commodity (as Defined in Section F)	Proposed Tolerance (ppm)	Recommended
Tolerance (ppm)	Comments; Correct Commodity Definition

PEA AND BEAN, SUCCULENT SHELLED, SUBGROUP 6B	0.05	0.05	ARIA recommends a
label revision to prohibit applications to legumes grown for livestock
feeds because no residue data are available for cowpea forage and hay.

Pea and bean, succulent shelled, subgroup 6B

VEGETABLE TUBEROUS AND CORM, SUBGROUP 1C	0.05	0.05	Vegetable, tuberous
and corm, subgroup 1C

RHUBARB	0.05	0.05	Rhubarb

PEA AND BEAN, DRIED SHELLED, EXCEPT SOYBEAN, SUBGROUP 6C	0.05	None
Revised Section F.  When adequate residue data for dried peas become
available, the petitioner may again request a tolerance for Subgroup 6C.

Pea and bean, dried shelled, except soybean, subgroup 6C

APPLE	0.05	0.05	The proposed label should be amended to remove the
instructions pertaining to the use of a non-ionic surfactant.

Apple

OKRA	0.05	0.05	The recommended tolerance is based on translation of data
from fruiting vegetables.

Okra

BUSHBERRY SUBGROUP 13-07B	0.05	0.05	The proposed label should be amended
to remove the instructions pertaining to the use of a non-ionic
surfactant.

Bushberry subgroup 13-07B

References

DP#s:		173627 & 180565

Subject:	PP#2G4073.  Temporary Tolerance Petition and Experimental Use
Permit for Use of MON 12000 (Permit®) on Corn; 000524-EUP-TO. 
Evaluation of Analytical Method and Residue Data. 

From:  		G. Herndon

To:		J. Miller/D. Kenny and A. Kocialski

Dated:		7/30/1992

MRIDs:	42139400-08

DP#:		181023

Subject:	000524-EUP-TA.  Experimental Use Permit for Use of MON 12000
and MON 13900 Together as MON 12041 (Battalion®) on Corn; Evaluation of
Analytical Method and Residue Data.  CBTS#:  10295.

From:  		G. Herndon

To:		J. Miller/D. Kenny and A. Kocialski

Dated:		11/12/1992

MRIDs:	42396202 and 42396203

DP#s:		184435

Subject:	PP#2G4073.  Temporary Tolerance Petition and Experimental Use
Permit for Use of MON 12000
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Subject:	  SEQ CHAPTER \h \r 1 PP#2G4073.  Temporary Tolerance Petition
and Experimental Use Permit for Use of MON 12000 (Permit®) on Corn;
000524-EUP-TO.  Amendment of 2/10/93 Addressing Analytical Method and
Proposed Label Deficiencies.  Impact of the Confined Rotational Crop
Study Results (EFGWB) on this EUP Request.   CBTS#: 11374 and 11451. 
SEQ CHAPTER \h \r 1 

From:  		  SEQ CHAPTER \h \r 1 G. Herndon 

To:		J. Miller/D. Kenny and   SEQ CHAPTER \h \r 1 A. Kocialski

Dated:		3/11/1993

MRIDs:	None

DP#:		192510

Subject:	  SEQ CHAPTER \h \r 1 ID# 000524-UAT.  Review of limited field
rotational study of MON 12000
[3-chloro-5-[[[[(4,6-dimethoxy-2-pyrimidinyl)amino]carbonyl]amino]-sulfo
nyl]-1-methyl-1H-pyrazole-4-carboxylic acid, methyl ester].  Case
023936.  CBTS# 12079.

From:  		  SEQ CHAPTER \h \r 1 G. Kramer

To:		J. Miller

Dated:		8/30/1993

MRIDs:	42812104

DP#s:		189198, 198051, 189189, 189178, 189183 & 189195

Subject:	PP#3F04193.  Permanent Tolerance Request for Use of MON 12000
(Halosulfuron) on Field Corn and Grain Sorghum (Milo).  Evaluation of
Analytical Method and Residue Data.

From:  		G. Herndon

To:		J. Miller/D. Kenny and A. Kocialski

Dated:		3/8/1994

MRIDs:	42661401-07, 43042601-02

DP#:		204062

Subject:	  SEQ CHAPTER \h \r 1 PP#3F04193.   Section 3 Registration and
Permanent Tolerance Request for Use of MON 12000 (Halosulfuron) on Field
Corn and Grain Sorghum (Milo).  Submission Received 2/24/93 Addressing
Deficiencies in the Nature of the Residue in Plants and Animals.  CBTS#
13817, 13861.

From:  		G. Herndon

To:		J. Miller/D. Kenny and A. Kocialski

Dated:		6/22/1994

MRIDs:	42678001-03

DP#:		198361

Subject:	  SEQ CHAPTER \h \r 1 PP#4G04279 and 524-EUP-74 - EUP and
Temporary Tolerance Request for the New Chemical MON 12000 on Sugarcane
and Sorghum.  CBTS No. 13092.

From:  		G. Otakie

To:		J. Miller/D. Kenny and A. Kocialski

Dated:		7/21/1994

MRIDs:	42991201-02

DP#:		202131

Subject:	  SEQ CHAPTER \h \r 1 PP#3F04193.  Section 3 Registration and
Permanent Tolerance Request for Use of MON 12000 (Halosulfuron) on Field
Corn and Grain Sorghum (Milo).  Submission Received 3/29/94 Addressing
Deficiencies in the Regulatory Enforcement Method for Animal Products
and the Proposed Section F.  CBTS# 13568

From:  		G. Herndon

To:		J. Miller/D. Kenny and A. Kocialski

Dated:		10/4/1994

MRIDs:	43195001 and 43177501

DP#:		214890

Subject:	  SEQ CHAPTER \h \r 1   SEQ CHAPTER \h \r 1 PP#3F04193. 
Halosulfuron (MON 12000) on Animal Commodities.  Results of the Petition
Method Validation Request.  CBTS# 15480.

From:  		G. Herndon

To:		J. Miller/D. Kenny and J. Smith  SEQ CHAPTER \h \r 1 

Dated:		5/3/1995

MRIDs:	43195001

DP#:		None

Subject:	  SEQ CHAPTER \h \r 1 Halosulfuron (MON 12000).  The HED
Metabolism Committee Meeting Held on May 20, 1996.

From:  		G. Herndon

To:		  SEQ CHAPTER \h \r 1 HED Metabolism Committee

Dated:		5/21/1996

MRIDs:	None

DP#:		250584

Subject:	PP#6F4620 and 8F4937.  Halosulfuron-methyl on Various
Commodities.  Results of the Petition Method Validation Request for the
Proposed Enforcement Method.

From:  		G. Herndon

To:		V. Walters/ J. Tompkins

Dated:		10/28/1998

MRIDs:	44495801 and 44555901

DP#:		225273

Subject:	Halosulfuron.  Revised Section F Proposing Deletion of Existing
Rotational Crop Tolerances.

From:  		G. Herndon

To:		V. Walters/ J. Tompkins

Dated:		10/29/1998

MRIDs:	None

DP#:		223801

Subject:	PP6F4661.  Section 3 Registration and Request for Permanent
Tolerances for Halosulfuron-methyl on Sweet Corn and Popcorn. 
Evaluation of Analytical Methods and Residue Data.

From:  		M. Doherty

To:		J. Tompkins/V. Walters

Dated:		11/17/1998

MRIDs:	43918501

DP#:		251007

Subject:	PP8F4937.  Request for Permanent Tolerances for
Halosulfuron-methyl on Cotton, Rice, Pistachio Nuts, and Tree Nut Crop
Group (Crop Group 14 as listed in 40 CFR 180.41).  Evaluation of
Metabolism of Halosulfuron-methyl in Soybean.

From:  		M. Doherty

To:		J. Tompkins/V. Walters

Dated:		12/10/1998

MRIDs:	44689501

DP#:		267423

Subject:	  SEQ CHAPTER \h \r 1 PP# 0F06169.  Halosulfuron-methyl on
Fruiting Vegetables (Except Cucurbits) Crop Group 8/  Review of
Analytical Methods and Magnitude of Residue Data.

From:  		A. Acierto

To:		  SEQ CHAPTER \h \r 1 J. Tompkins/V. Walters

Dated:		4/25/2002

MRIDs:	45117501, 45117502

DP#:		278587

Subject:	  SEQ CHAPTER \h \r 1 PP# 1E06322.  Halosulfuron-methyl on
Bean, Dry and Bean, Snap.  Magnitude of Residue Data.

From:  		A. Acierto

To:		  SEQ CHAPTER \h \r 1 R. Forrest/S. Brothers

Dated:		6/15/2002

MRIDs:	45427801, 45427802

  SEQ CHAPTER \h \r 1 Attachments:  

International Residue Limit Status sheet



INTERNATIONAL RESIDUE LIMIT STATUS

Chemical Name:  methyl
5-[(4,6-dimethoxy-2-pyrimidinyl)amino]carbonylaminosulfonyl-3-chloro-1-m
ethyl-1H-pyrazole-4-carboxylate	Common Name:

Halosulfuron-methyl

	X   Proposed tolerance

□    Reevaluated tolerance

□    Other	Date:  10/2009

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

X No Codex proposal step 6 or above

□ No Codex proposal step 6 or above for the crops requested	Petition
Number:  PP#9E7577

DP#:  367058

Other Identifier:  

Residue definition (step 8/CXL): N/A	Reviewer/Branch:  P. Deschamp, N.
Dodd/RAB3

	Residue definition:  halosulfuron-methyl

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

Pea and bean, succulent shelled, Subgroup 6B	0.05

Vegetable, tuberous and corm, Subgroup
䌱〇〮ܵ܇切畨慢扲〇〮ܵ܇倇慥愠摮戠慥Ɱ搠楲摥猠敨
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□ No Limits for the crops requested	X No Limits

□ No Limits for the crops requested

Residue definition:  N/A

	Residue definition:  N/A

Mexico defers to Codex MRLs or US tolerances for its export purposes.

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

	Notes/Special Instructions:

S. Funk, 10/15/2009.

Page   PAGE  1  of   NUMPAGES  34 

Halosulfuron-methyl	Summary of Analytical Chemistry and Residue Data
DP#367058