[Federal Register: March 12, 2010 (Volume 75, Number 48)]
[Notices]
[Page 11877-11878]
[DOCID:fr12mr10-55]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2007-1145; FRL-9126-8]

Review of the Secondary National Ambient Air Quality Standards
for Oxides of Nitrogen and Oxides of Sulfur

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of availability of draft report.

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SUMMARY: On or about March 1, 2010, the Office of Air Quality Planning
and Standards (OAQPS) of EPA is making available a draft report, Policy
Assessment for the Review of the Secondary National Ambient Air Quality
Standards for Oxides of Nitrogen and Oxides of Sulfur: First External
Review Draft. The EPA is releasing this preliminary draft document to
seek early consultation with the Clean Air Scientific Advisory
Committee (CASAC) and to solicit public comment on the overall
structure and framing of key issues and areas of focus that will be
discussed in a future, complete draft policy assessment document.

DATES: Comments should be submitted on or before April 29, 2010.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2007-1145, by one of the following methods:
     www.regulations.gov: Follow the on-line instructions for
submitting comments.
     E-mail: Comments may be sent by electronic mail (e-mail)
to<EMAIL_ADDRESS>Attention Docket ID No. EPA-HQ-OAR-2007-
1145.
     Fax: Fax your comments to<PHONE_NUMBER>, Attention Docket
ID. No. EPA-HQ-OAR-2007-1145.
     Mail: Send your comments to: Air and Radiation Docket and
Information Center, Environmental Protection Agency, Mailcode: 2822T,
1200 Pennsylvania Ave., NW., Washington, DC 20460, Attention Docket ID
No. EPA-HQ-OAR-2007-1145.
     Hand Delivery or Courier: Deliver your comments to: EPA
Docket Center, 1301 Constitution Ave., NW., Room 3334, Washington, DC.
Such deliveries are only accepted during the Docket's normal hours of
operation, and special arrangements should be made for deliveries of
boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-OAR-
2007-1145. The EPA's policy is that all comments received will be
included in the public docket without change and may be made available
online at www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through www.regulations.gov
or e-mail. The www.regulations.gov Web site is an ``anonymous access''
system, which means EPA will not know your identity or contact
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information in the body of your comment and with any disk or CD-ROM you
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viruses.
    Docket: All documents in the docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in www.regulations.gov or in hard copy at the Air Docket in the EPA
Docket Center, EPA West, Room 3334, 1301 Constitution Ave., NW.,
Washington, DC. This Docket Facility is open from 8:30 a.m. to 4:30
p.m. Monday through Friday, excluding legal holidays. The Docket
telephone number is<PHONE_NUMBER>; fax<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Dr. Bryan Hubbell, Office of Air
Quality Planning and Standards (Mailcode C504-02), U.S. Environmental
Protection Agency, Research Triangle Park, NC 27711; e-mail:
<EMAIL_ADDRESS>telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>.

General Information

A. What Should I Consider as I Prepare My Comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
www.regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
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CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for Preparing Your Comments. When submitting comments,
remember to:
     Identify the rulemaking by docket number and other
identifying information (subject heading, Federal Register date and
page number).
     Follow directions--The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
     Explain why you agree or disagree; suggest alternatives
and substitute language for your requested changes.
     Describe any assumptions and provide any technical
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you arrived at your estimate in sufficient detail to allow for it to be
reproduced.
     Provide specific examples to illustrate your concerns, and
suggest alternatives.
     Make sure to submit your comments by the comment period
deadline identified.
    Under section 108(a) of the Clean Air Act (CAA), the Administrator
identifies and lists certain pollutants which ``cause or contribute to
air pollution which may reasonably be anticipated to endanger public
health or welfare.'' The EPA then issues air quality criteria for
listed pollutants, which are commonly referred to as ``criteria
pollutants.'' The air quality criteria are to ``accurately reflect the
latest scientific knowledge useful in indicating the kind and extent of
all identifiable effects on public health or welfare which may be
expected from the presence of [a] pollutant in the ambient air, in
varying

quantities.'' Under section 109 of the CAA, EPA establishes national
ambient air quality standards (NAAQS) for each listed pollutant, with
the NAAQS based on the air quality criteria. Section 109(d) of the CAA
requires periodic review and, if appropriate, revision of existing air
quality criteria. The revised air quality criteria reflect advances in
scientific knowledge on the effects of the pollutant on public health
or welfare. The EPA is also required to periodically review and revise
the NAAQS, if appropriate, based on the revised criteria.
    The EPA is currently conducting a joint review of the existing
secondary (welfare-based) NAAQS for oxides of nitrogen (NOX)
and oxides of sulfur (SOX). Because NOX,
SOX, and their associated transformation products are linked
from an atmospheric chemistry perspective as well as from an
environmental effects perspective, and because of the National Research
Council's 2004 recommendations to consider multiple pollutants in
forming the scientific basis for the NAAQS, EPA has decided to jointly
assess the science, risks, and policies relevant to protecting the
public welfare associated with NOX and SOX. This
is the first time since NAAQS were established in 1971 that a joint
review of these two pollutants has been conducted. Since both the CASAC
and EPA have recognized these interactions historically, and the
science related to these interactions has continued to evolve and grow
to the present day, there is a strong basis for considering them
together.
    As part of this review of the current secondary (welfare-based)
NAAQS for NOX and SOX, EPA's OAQPS staff are
preparing a first draft Policy Assessment. The objective of this
assessment is to evaluate the policy implications of the key scientific
information contained in the document Integrated Science Assessment for
Oxides of Nitrogen and Sulfur-Ecological Criteria (http://
cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid=201485), prepared by EPA's
National Center for Environmental Assessment (NCEA) and the results
from the analyses contained in the Risk and Exposure Assessment for
Review of the Secondary National Ambient Air Quality Standards for
Oxides of Nitrogen and Oxides of Sulfur (http://www.epa.gov/ttn/naaqs/
standards/no2so2sec/cr_rea.html). The first draft Policy Assessment
will be available online at: http://www.epa.gov/ttn/naaqs/standards/
no2so2sec/index.html. This first draft Policy Assessment will be
reviewed by the CASAC during a public meeting to be held April 1 and 2,
2010. Information about this public meeting will be available at http:/
/yosemite.epa.gov/sab/sabpeople.nsf/WebCommittees/CASAC.

    Dated: March 9, 2010.
Mary E. Henigin,
Acting Director, Office of Air Quality Planning and Standards.
[FR Doc. 2010-5576 Filed 3-11-10; 8:45 am]
BILLING CODE 6560-50-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

MEMORANDUM

Date: 11/14/07

Subject:	 Amended Ethalfluralin –Summary of Analytical Chemistry and
Residue Data for Dill and Potato.  Petition Numbers PP# 1E6326 and
2E6360

DP Nums: 306146, 306147, & 333867	Submission: 335258 & 336469

PC Code: 113101	MRID Nos.: 45437501 and 45514401

40 CFR 180.416

From:		J. R. Tomerlin, PhD., Plant Pathologist, ARIA TEAM

		Registration Division/Fungicide Branch (7505P)

Through:		W. Cutchin, Chemist, ARIA Team

		Risk Integration, Minor Use, and Emergency Response Branch

		Registration Division (7505P)

		R. Loranger, PhD., Branch Senior Scientist

		Registration Action Branch 2/Health Effects Division (7509P)

To:		S. Brothers, Risk Manager

		Risk Integration, Minor Use, and Emergency Response Branch

		Registration Division (7505P)

Executive Summary

  SEQ CHAPTER \h \r 1 The Interregional Research Project No. 4 (IR-4)
has submitted petitions for the establishment of permanent tolerances
for residues of ethalfluralin
[N-ethyl-N-(2-methyl-2-propenyl)-2,6-dinitro-4-(trifluoromethyl)-benzena
mine] in/on dill (fresh and dried; PP# 1E6326; CURBIT® EC formulation;
31.5% a.i.) at 0.05 ppm and in/on potato (PP# 2E6360; Sonalan® HFP
formulation; 31.5% a.i.) at 0.05 ppm.  Concurrently, IR-4 is requesting
the inclusion of dill and potato as use sites for these two
ethalfluralin end-use products; CURBIT® EC is registered to Platte
Chemical Company and Sonalan® HFP is registered to DowElanco under
Section 3 of FIFRA.

Ethalfluralin is a preemergence herbicide used to control a variety of
annual grasses and broadleaf weeds on agricultural sites.  The Agency
completed an assessment of the potential human health and environmental
risks associated with the pesticidal use of ethalfluralin in the United
States with the issuance of the Ethalfluralin Reregistration Eligibility
Decision (RED) Document in March 1995.  The RED Document concluded that
the scientific database is adequate to support the reregistration
eligibility of all registered uses of ethalfluralin with the exception
of postemergence and post-transplant applications to cucurbits; the
cucurbit metabolism requirement has since been satisfied.  The
Ethalfluralin RED Document has determined that the uses of ethalfluralin
products labeled and used as specified in the RED Document, will not
cause unreasonable risk to humans or the environment.

In dill, the proposed use pattern is for one broadcast soil-incorporated
application to be made after seeding but before emergence of the dill.
Application rates can be up to a maximum of 4 pints/A (1.5 lbs a.i./A).
In potato, the proposed use pattern is for one broadcast
soil-incorporated application to be made after seeding but before
emergence of potatoes.  Application rates in potato can be up to a
maximum of 2 2/3 pints/A (1.0 lb a.i./A).  No preharvest interval (PHI)
is proposed for either formulation because the proposed use patterns
involve preemergence applications.

Ethalfluralin residues in or on dill (fresh and dry) are less than the
limit of quantitation (LOQ) of 0.05 ppm when ethalfluralin was applied
according to the proposed use patterns.  Likewise, the results from
potato field trials show that ethalfluralin residues were below the
lowest limit of method validation (LLMV) of 0.05 ppm for all treatments
in potato tubers when the test substance was applied according to the
proposed potato use pattern.

After 169 days in storage, storage stability in fresh dill samples was
87% ± 14% recovery.  After 175 days in storage, storage stability in
dried dill samples was 86% ± 3% recovery.  In potato, storage stability
in potato tubers was 94% ± 2% recovery.  A concurrent recovery sample
analyzed with the storage samples resulted in 93% recovery.  Based on
these results in dill and potato matrices, residues were not affected by
freezer storage and accurately represent residue levels in harvested
samples.

Regarding processed potato fractions, there was no evidence of
concentration in any processed potato fraction; however, the lack of
detectable residues in the RAC potato tuber precludes the calculation of
processing factors.

Established tolerances for residues in/on plant (bean, dry, seed;
canola, seed; peanut; pea, dry, seed; safflower, seed; soybean;
sunflower, seed; and vegetable, cucurbit, group 9) are expressed in
terms of ethalfluralin per se [40 CFR §180.416 (a)].  All of these
tolerances are established at 0.05 ppm.  No tolerances are required in
edible livestock commodities.  Adequate enforcement methods are
available for the determination of ethalfluralin residues in/on plant
and animal commodities.

The Agency recommends for the establishment of tolerances of 0.05 ppm in
dill (fresh and dried) and potato, as well as approving the use sites
for ethalfluralin associated with these tolerances.

Residue Chemistry Deficiencies

The processing study is invalid because it was not conducted at an
exaggerated rate, as recommended by Guideline 860.1520.  Consequently,
default processing factors as specified in Guideline 860-1520 should be
used in the assessment of dietary risk.

The potato processing study is invalid because residues were not
detected in the RAC samples.  Consequently, the dietary risk assessment
should employ default processing factors listed in OPPTS Harmonized
Guideline 860-1520.

Background

Ethalfluralin
(N-ethyl-N-(2-methyl-2-propenyl)-2,6-dinitro-4-(trifluoromethyl)
benzenamine), the active ingredient of CURBIT® EC (31.5% a.i.), will
control grass and broadleaf weeds in dill production.  Sonalan® HFP
(31.5% a.i.), another ethalfluralin formulated product, will control
grass and broadleaf weeds in potato production.  Tolerances for
ethalfluralin currently exist for bean, dry, seed; canola, seed; peanut;
pea, dry, seed; safflower, seed; soybean; sunflower, seed; and
vegetable, cucurbit, group 9.  Table 1 summarizes the identity and
nomenclature of the compound and Table 2 summarizes the
physical-chemical properties of ethalfluralin.

TABLE 1.  Test Compound Nomenclature.

Compound	Chemical Structure

Common name	Ethalfluralin

Company experimental name	N/A

IUPAC name
N-ethyl-α,α,α-trifluoro-N-(2-methylallyl)-2,6-dinitro-p-toluidine

CAS name
N-ethyl-N-(2-methyl-2-propenyl)-2,6-dinitro-4-(trifluoromethyl)benzenami
ne

CAS #	5523-68-6

End-use product/(EP)	CURBIT® EC Herbicide (Reg. No. 34704-610) and
Sonalan® HFP Herbicide (Reg. No. 62719-188)

TABLE 2.  Physicochemical Properties of the Technical Grade Test
Compound: Ethalfluralin.

Parameter	Value	Reference

Melting point/range	57ºC	Ethalfluralin RED, EPA 738-R-95-001, March
1995

pH (@ 20°C)	7.68	DP Num: 276090, MRID#’s 45406501 and 45406502

Density (@ 20°C)	1.049 g/ml	DP Num: 276090, MRID #’s 45406501 and
45406502

Water solubility	0.22 ppm @ pH 3

0.21 ppm @ pH 7

0.16 ppm @ pH 11	DP Num: 199662, MRID# 00135194

Solvent solubility (mg/L at 25°C)	> 0.50 in acetone

> 0.50 in acetonitrile

> 0.50 in chloroform

> 0.50 incyclohexanone

> 0.165 in ethyl cellosolve

> 0.250 in heavy aromatic naphtha

> 0.082 in hexane

> 0.082 in methanol

> 0.50 in xylene

> 0.50 in methylene chloride	DP Num: 199662, MRID# 00135194

Vapor pressure (@ 20 - 25°C)	8.538 x 10-6	Texas Risk Reduction Program

Octanol/water partition coefficient Log(KOW)	4.783	Texas Risk Reduction
Program

860.1200  Directions for Use

Table 3 summarizes the proposed use patterns for ethalfluralin in dill
and potato.

TABLE 3.  Summary of Directions for Use of Ethalfluralin.

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

Dill

Soil surface broadcast	CURBIT® EC

[Reg. No. 34704-610]	1.5	1	1.5	91 - 100	Sprinkler irrigation may be used
to incorporate compound into soil

Potato

Soil surface broadcast	Sonalan® HFP

[Reg. No. 62719-188]	1.0	1	1.0	65 - 143

  SEQ CHAPTER \h \r 1 Specimen labels for Platte Chemical Company’s
ethalfluralin end-use product CURBIT® EC and the proposed use pattern
for dill were included in Sections A and B, respectively, of petition
1E6236.  CURBIT® EC is a 31.5% (3 lb a.i./gal) emulsifiable concentrate
(EC; EPA Reg. No. 34704-610).  The proposed use pattern is for one
broadcast soil-incorporated application, to be made after seeding, but
before emergence of the dill.  Application rates can be up to a maximum
of 4 pints/A (1.5 lbs a.i./A).  Specimen labels for Dow AgroSciences’
ethalfluralin end-use product Sonalan® HFP and the proposed use pattern
for potato were included in Sections A and B, respectively, of petition
2E6360.  Sonalan® HFP also is a 31.5% (3 lb a.i./gal) emulsifiable
concentrate (EPA Reg. No. 62719-188).  The proposed use pattern is for
one broadcast soil-incorporated application, to be made after seeding,
but before emergence of potatoes.  Application rates in potato can be up
to a maximum of 2 2/3 pints/A (1.0 lb a.i./A).  No preharvest interval
is proposed for either formulation because the proposed use patterns
involve preemergence applications.

The following rotational crop restrictions appear on the CURBIT® EC
label:

If replanting is required, only crops listed on an ethalfluralin product
label should be replanted;

Sugar beets or red beets should not be planted within 13 months
following application of ethalfluralin at 1.1 lb ai/A; where less than
1.1 lb ai/A was applied, sugar beets or red beets may be planted no
earlier than 8 months after an application and then only if the soil is
moldboard plowed to a depth of at least 12 inches prior to planting;

In the states of CA and AZ, spinach or oats should not be planted within
8 months following application of ethalfluralin at 1.1 lb ai/A or more.

Similar restrictions appear on the Sonalan® HFC label.  However, the
ethalfluralin RED (Ethalfluralin RED, EPA 378-R-95-001, March 1995)
states (p. 17): “Field rotational crop studies are not required since
no residues of concern were found at significant levels in rotational
crops. Furthermore, tolerances for rotational crop commodities and
plantback restrictions need not be established.”  It should be noted
that the Herbicide Handbook (7th Edition, W. H. Ahrens and M. T.
Edwards, Weed Science Society of America, Champaign, IL. 352pp.)
indicates potential for phytotoxicity to sugar beets.  Therefore, ARIA
notes without objection that there are plantback restrictions listed on
the CURBIT® EC and Sonalan® HFP labels, even though such restrictions
are not required for reasons of residue chemistry.

The proposed uses of ethalfluralin on dill using ethalfluralin CURBIT®
EC (31.5% or 3 lb a.i./gal) have been adequately described, as have the
proposed uses of ethalfluralin on potato, using the Sonalan® HFP
formulation.

860.1300 Nature of the Residue - Plants

MRID Nos. 00145955, 00094754, and 43394001 – cited in the
Ethalfluralin RED, EPA 378-R-95-001, March 1995

TXR 0050808, Case 2260, S. Funk, 5/25/95

Ethalfluralin RED, EPA 378-R-95-001, March 1995

DP Num: 212755, MRID No. 43532201, S. Funk, June 1995

  SEQ CHAPTER \h \r 1 The Ethalfluralin RED Document concluded that the
qualitative nature of the residue in beans and peanuts is understood.
The major portion of the radioactivity was characterized as lignin,
cellulose, and protein. The parent, ethalfluralin, was a minor residue.
The terminal residue of concern in plants is ethalfluralin per se; the
current tolerance expression for plants is adequate.  Previously, a
cucurbit metabolism study was considered outstanding and was required
before plant metabolism could be considered fully understood.  A
cucumber study was subsequently submitted and the metabolism data
requirement was determined to be fulfilled.

In 1995, the Metabolism Committee concluded that the residue of concern
for both tolerance and risk assessment purposes is ethalfluralin parent
only.

860.1300 Nature of the Residue - Livestock

Ethalfluralin RED, EPA 378-R-95-001, March 1995

  SEQ CHAPTER \h \r 1 The Ethalfluralin RED Document concluded that the
qualitative nature of the residue in animals is adequately understood
based on acceptable poultry and ruminant metabolism studies.  The
residue of concern in milk, eggs, and animal tissues is ethalfluralin
per se.  However, as a result of the low levels of radiolabeled residues
found with exaggerated (200x) feeding levels, the Agency has waived
requirements for animal feeding studies.  It was also concluded that
residues of ethalfluralin from up to 10x dietary burden would not be
quantifiable (<0.05 ppm).  Therefore, according to 40 CFR §180.6
(a)(3), if it is not possible to determine finite residues with
certainty, and if it is unlikely there are any residues, tolerances need
not be established for eggs, milk, fat, and meat byproducts of cattle,
goats, hogs, horses, poultry, and sheep.  Thus, previous tolerances in
edible livestock commodities have been revoked.

860.1340 Residue Analytical Methods

DP Num: 306146, MRID No. 45437501, J. R. Tomerlin, 2/21/07

DP Num: 306147, MRID No. 45514401, J. R. Tomerlin, 2/21/07

Ethalfluralin RED, EPA 378-R-95-001, March 1995

  SEQ CHAPTER \h \r 1 Adequate residue analytical methods are available
for the purpose of tolerance enforcement.  Two gas chromatograph (GC)
methods, Methods I and II, both with electron capture detection (ECD)
are listed in the Pesticide Analytical Manual (PAM, Vol. II, Section
180.416).  Methods I and II are applicable for the analysis of
ethalfluralin residues in/on plant and animal commodities, respectively.
 The limits of detection (LODs) are 0.01 and <0.01 ppm for methods I and
II, respectively.

Samples of fresh and dried dill and potatoes were analyzed using Residue
Method Number AM-AA-CA-R025-AB-755, Lilly Research Laboratories,
Greenfield, IN (Currently Dow Agrosciences).  For analysis, a 25 g
subsample of the homogenized frozen commodity was shaken with methanol.
After settling, an aliquot was diluted with 5% aqueous sodium chloride
and extracted with methylene chloride.  Decane was added to the combined
organic extracts and the methylene chloride was evaporated under vacuum.
 A Varian Mega Bond Elut® FL cartridge (Florisil) and solid phase
extraction station was used to purify each sample.  The residue was then
chromatographed on Florisil that had been deactivated by the addition of
water.  The column was eluted with 1% ethyl acetate in hexane because
ethalfluralin does not elute from the cartridge using hexane alone.
Decane was added to the hexane eluant; the hexane was removed by rotary
evaporation.  Analysis of duplicate samples from each plot was
accomplished by gas chromatography with a 63Ni electron capture
detection.

The range of recoveries was adequate in both fresh and dried dill.  The
range of concurrent recoveries was adequate, except for one set of fresh
dill fortified at 0.05 ppm.  The LOD was 0.025 ppm; the LOQ was
determined to be 0.05 ppm.  In potatoes, the range of recoveries for
method validation was adequate, although one fortified potato tuber
sample had a recovery of 49%.  Sample response curves demonstrated good
linearity.  The LLMV in potato was determined to be 0.05 ppm.  Sample
response curves demonstrated good linearity for all matrices analyzed.

The methods for enforcement are adequate in light of the tolerance
expression and have passed Agency validation.  The method used in the
dill and potato field trials is suitable for data collection.

860.1360 Multiresidue Methods

  SEQ CHAPTER \h \r 1 The FDA PESTDATA database dated 2005 (PAM Vol. I,
section 180.416) indicates that ethalfluralin is completely recovered
(>80% recovery) using multiresidue method protocols D and E (fatty and
nonfatty).

860.1380 Storage Stability

DP Num: 306146, MRID No. 45437501, J. R. Tomerlin, 2/21/07

DP Num: 306147, MRID No. 45514401, J. R. Tomerlin, 2/21/07

Ethalfluralin RED, EPA 378-R-95-001, March 1995

The Ethalfluralin RED Document reported that storage stability studies
have been conducted using fortified samples of beans (dry), cucumbers,
peanuts, peas (dry), soybean, soybean processed commodities, and
sunflower seed.  Residues of ethalfluralin are stable under frozen
storage conditions (-20ºC) in/on beans (dry), soybean processed
commodities, and sunflower seed for up to 6 months, in/on peas (dry) for
up to 10 months, and in/on cucumbers, peanuts, and soybean for up to 12
months.

A storage stability study was conducted with six subsamples of fresh and
dried dill fractions fortified with ethalfluralin at 0.5 ppm.  After 169
days in storage, three of the six fresh dill samples were extracted and
analyzed, resulting in 87% ± 14% recovery.  After 175 days in storage,
three of six dried samples were extracted and analyzed, resulting in 86%
± 3% recovery.

A storage stability study was conducted with six samples of control
potato tubers fortified with 0.5 ppm ethalfluralin.  After 150 days in
storage, three of the six samples were extracted and analyzed, resulting
in 94% ± 2% recovery.  A concurrent recovery sample analyzed with the
storage samples resulted in 93% recovery.

Based on these results in dill and potato matrices, residues were not
affected by freezer storage and accurately represent residue levels in
harvested samples.

860.1480 Meat, Milk, Poultry, and Eggs

Ethalfluralin RED, EPA 378-R-95-001, March 1995

The data requirements for magnitude of ethalfluralin residue in meat,
milk, poultry, and eggs have been waived.  The results of nature of the
residue studies in poultry and ruminants, using exaggerated feeding
rates (200x) indicate that residues of ethalfluralin at levels 1-10x the
dietary burden will not be quantifiable (<0.05 ppm).  Therefore, it is
not possible to establish with certainty whether finite residues will be
incurred and there is no reasonable expectation of finite residues (40
CFR §180.6).  Tolerances of ethalfluralin for eggs, milk, and fat,
meat, and meat byproducts of cattle, goats, hogs, horses, poultry, and
sheep are not required and previous established tolerances have been
revoked.

860.1500 Crop Field Trials

DP Num: 306146, MRID No. 45437501, J. R. Tomerlin, 2/21/07

DP Num: 306147, MRID No. 45514401, J. R. Tomerlin, 2/21/07

Table 4 summarizes the results of the crop residue field trials for
ethalfluralin in dill and potato.

TABLE 4.  Summary of Residues from the Crop Field Trials with
Ethalfluralin.

Crop Matrix	Applic. Rate

(lb ai/A)	PHI (days)	Residues (ppm)

	Mean	Std. Dev.	HAFT	Min.	Max.

Dill (1.5 lb ai/A total application rate, 91 to 100-day PHI)

Dill, fresh	1.5	91 – 100	< 0.05	< 0.05	< 0.05	< 0.05	< 0.05

Dill, dry	1.5	91 – 100	< 0.05	< 0.05	< 0.05	< 0.05	< 0.05

Potato (1.0 lb ai/A total application rate, 65 to 143-day PHI)

Potato, tuber, fresh	1.0	65 – 143	< 0.05	0	< 0.05	< 0.05	< 0.05

Ethalfluralin residues in or on dill (fresh and dry) were less than the
LOQ of 0.05 ppm when ethalfluralin was applied at approximately 1.5 lb
a.i./A once per season as a preemergence broadcast treatment and
harvested at PHIs of 91- to 100-days, according to the proposed label.

The results from potato field trials show that ethalfluralin residues
were below the LLMV of 0.05 ppm for all treatments in potato tubers when
the test substance was applied at the proposed maximum seasonal
application rate of approximately 1.0 lb a.i./A.  A PHI was not
specified for either proposed use because in both cases the compound is
applied as a preemergence broadcast spray.

Storage stability studies in both dill and potato support the residue
data from the field trials.  Ethalfluralin, the residue of concern, was
the compound analyzed for in both the dill and potato trials.  All
residue values in both commodities were below the LOQ; therefore, a
tolerance at the LOQ of 0.05 ppm is supported in both dill and potato.

860.1520 Processed Food and Feed

DP Num: 306147, MRID No. 45514401, 45514401ppf.der.doc, J. R. Tomerlin,
2/21/07

DP Num: 257274, Contract No. 68-W-99-053 (Dynamac Corporation), 8/31/99

Ethalfluralin formulated as Sonalan® HFP (31.5% a.i.) was applied one
time as a soil surface, preemergence broadcast treatment at the proposed
rate of 1.0 lb a.i./A (1.12 kg a.i./ha), not at an exaggerated rate.  An
adjuvant was not added to the spray mixture.  Mature potato tubers were
harvested 126 days PHI.

Samples of fresh potato tubers and processed fractions were analyzed
using Residue Method Number AM-AA-CA-R025-AB-755, Lilly Research
Laboratories, Greenfield, IN (Currently Dow Agrosciences).  Analysis was
accomplished via GC using a Florasil column.  The lowest limit of method
validation (LLMV) was determined to be 0.05 ppm.  For processed
fractions, method validation was performed concurrently with sample
analyses.  At a fortification of 0.05 ppm, recoveries were 96% ± 1%,
87% ± 3%, 101% ± 4%, and 97% ± 15% in RAC tubers, chips, flakes, and
wet peel, respectively.  In a storage stability study, RAC potato
tubers, chips, flakes and peel were analyzed 150, 125, 126, and 133 days
after processing, after storage at -34°C to -18°C.  Residue values in
all RAC and processed fraction samples were below the LLMV of 0.05 ppm
for applications of 1.0 lb a.i./A (1.12 kg a.i./hectare) and a PHI of
126 days.

The processing study was not conducted at an exaggerated rate, as
recommended by Guideline 860.1520.  Therefore, it is not possible to
calculate a processing factor in any processed potato fraction.
Consequently, default processing factors as specified in Guideline
860-1520 should be used in the assessment of dietary risk.

860.1850 Confined Accumulation in Rotational Crops

Ethalfluralin RED, EPA 378-R-95-001, March 1995

  SEQ CHAPTER \h \r 1 The Ethalfluralin RED reported that no significant
levels of ethalfluralin residues were found in rotational crops from a
confined rotational crop study.  Therefore, tolerances for rotational
crop commodities and plantback restrictions need not be established; no
additional data concerning rotational crops are required.

860.1900 Field Accumulation in Rotational Crops

Field rotational crop studies are not required since no residues of
concern were found at significant levels in rotational crops.
Furthermore, tolerances for rotational crop commodities and plantback
restrictions need not be established.

The following rotational crop restrictions appear on the CURBIT® EC
label:

If replanting is required, only crops listed on an ethalfluralin product
label should be replanted;

Sugar beets or red beets should not be planted within 13 months
following application of ethalfluralin at 1.1 lb ai/A; where less than
1.1 lb ai/A was applied, sugar beets or red beets may be planted no
earlier than 8 months after an application and then only if the soil is
moldboard plowed to a depth of at least 12 inches prior to planting;

In the states of CA and AZ, spinach or oats should not be planted within
8 months following application of ethalfluralin at 1.1 lb ai/A or more.

Similar restrictions appear on the Sonalan® HFC label, although, the
ethalfluralin RED (Ethalfluralin RED, EPA 378-R-95-001, March 1995)
states (p. 17): “Field rotational crop studies are not required since
no residues of concern were found at significant levels in rotational
crops. Furthermore, tolerances for rotational crop commodities and
plantback restrictions need not be established.”  It should be noted
that the Herbicide Handbook (7th Edition, W. H. Ahrens and M. T.
Edwards, Weed Science Society of America, Champaign, IL. 352pp.)
indicates potential for phytotoxicity to sugar beets.  Therefore, ARIA
notes without objection that there are plantback restrictions listed on
the CURBIT® EC and Sonalan® HFP labels, even though such restrictions
are not required for reasons of residue chemistry.

860.1550 Proposed Tolerances

The tolerance expression as stated in 40 CFR 180.416 is ethalfluralin
(N-ethyl-N-(2-methyl-2-propenyl)-2,6-dinitro-4-(trifluoromethyl)-benzena
mine).  As described in the sections 860.1300 and 960.1480, tolerances
of ethalfluralin are not required in edible livestock commodities.
There are currently no Codex, Canadian, or Mexican Maximum Residue
Limits for residues of ethalfluralin on dill or potato, therefore there
are no international harmonization issues associated with this action
(Attachment 1).  Table 5 summarizes recommended tolerances for
ethalfluralin in dill (fresh and dried) and potato.

TABLE 5.  Tolerance Summary for Ethalfluralin.

Commodity	Proposed Tolerance (ppm)	Recommended Tolerance (ppm)	Commodity
definition

Dill, fresh leaves	0.05	0.05	Dill, fresh and dried

Dill, dried leaves	0.05	0.05	Dill, fresh and dried

Potato	0.05	0.05	Potato

Template Version September 2005

ATTACHMENT 1 – MRL STATUS SHEET

INTERNATIONAL RESIDUE LIMIT STATUS

Chemical Name:
N-ethyl-N-(2-methyl-2-propenyl)-2,6-dinitro-4-(trifluoromethyl)-benzenam
ine	Common Name: Ethalfluralin

	 Proposed tolerance

 Reevaluated tolerance

 Other	Date:

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

( No Codex proposal step 6 or above

 No Codex proposal step 6 or above for the crops requested	Petition
Number: 1E6326 and 2E6360

DP Num: 306146 and 106147

Other Identifier:

Residue definition (step 8/CXL):    N/A	Reviewer/Branch: J. R.
Tomerlin/RD-FB (ARIA Team)

	Residue definition: Ethalfluralin

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

Dill, fresh and dried	0.05

Potato	0.05

Limits for Canada	Limits for Mexico

( No Limits

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Residue definition:

N/A	Residue definition:

etalfluralina

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

	Notes/Special Instructions:

S. Funk, 02/23/2007.

Ethalfluralin	Summary of Analytical Chemistry and Residue Data	DP Num:
306146

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