Trifloxyfulfuron-sodium (Syngenta). Sept 17, 2003. Pesticide tolerance. Final Rule. Federal Register.

FLUORIDE ACTION NETWORK PESTICIDE PROJECT

Trifloxysulfuron-sodium (Syngenta). September 17, 2003. Pesticide Tolerance. Final Rule. Federal Register.

http://www.epa.gov/fedrgstr/EPA-PEST/2003/September/Day-17/

[Federal Register: September 17, 2003 (Volume 68, Number 180)]
[Rules and Regulations]
[Page 54377-54386]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17se03-11]

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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2003-0286; FRL-7325-1]

Trifloxysulfuron; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of
trifloxysulfuron in or on almond; almond, hulls; fruit, citrus, group
10; cotton, undelinted seed; cotton, gin byproducts; sugarcane; and
tomato. Syngenta Crop Protection, Inc. requested this tolerance under
the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the
Food Quality Protection Act of 1996 (FQPA).

DATES: This regulation is effective September 17, 2003. Objections and
requests for hearings, identified by docket ID number OPP-2003-0286,
must be received on or before November 17, 2003.

ADDRESSES: Written objections and hearing requests may be submitted
electronically, by mail, or through hand delivery/courier. Follow the
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY
INFORMATION.

FOR FURTHER INFORMATION CONTACT: Jim Tompkins, Registration Division
(7505C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW.,Washington, DC 20460-0001; telephone
number: (703) 305-5697; e-mail address: tompkins.jim@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
¥ Crop production (NAICS 111)
¥ Animal production (NAICS 112)
¥ Food manufacturing (NAICS 311)
¥ Pesticide manufacturing (NAICS 32532)
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.

B. How Can I Get Copies of This Document and Other Related Information?

1. Docket. EPA has established an official public docket for this
action under docket identification (ID) number OPP-2003-0286. The
official public docket consists of the documents specifically
referenced in this action, any public comments received, and other
information related to this action. Although a part of the official
docket, the public docket does not include Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. The official public docket is the collection of materials
that is available for public viewing at the Public Information and
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2,
1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The docket telephone number is (703) 305-5805.
2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr/. A frequently updated
electronic version of 40 CFR part 180 is available at http://www.access.
gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html,
a beta site currently under development. To access the OPPTS Harmonized
Guidelines referenced in this document, go directly to the guidelines
at http://www.epa.gov/opptsfrs/home/guidelin.htm.
An electronic version of the public docket is available through
EPA's electronic public docket and comment system, EPA Dockets. You may
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public
comments, access the index listing of the contents of the official
public docket, and to access those documents in the public docket that
are available electronically. Although not all docket materials may be
available electronically, you may still access any of the publicly
available docket materials through the docket facility identified in
Unit I.B.1. Once in the system, select ``search,'' then key in the
appropriate docket ID number.

II. Background and Statutory Findings

In the Federal Register of March 21, 2003 (68 FR 13924) (FRL-7296-
6), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C.
346a, as amended by FQPA (Public Law 104-170), announcing the filing of
a pesticide petition (PP 1F6280) by Syngenta Crop Protection, Inc.,
Greensboro, NC 27419. That notice included a summary of the petition
prepared by Syngenta Crop Protection, Inc., the registrant. There were
no comments received in response to the notice of filing.
The petition requested that 40 CFR 180 be amended by establishing a
tolerance for residues of the herbicide trifloxysulfuron-sodium, [N-
[[(4,6-dimethoxy-2-pyrimidinyl)amino)carbonyl]-3-(2,2,2-
trifluoroethoxy)-2-pyridinesulfonamide), in or on sugarcane at 0.01
part per million (ppm); cottonseed at 0.05 ppm; cotton byproducts at
1.0 ppm; citrus at 0.01 ppm; almond hulls at 0.01 ppm; almond nut meat
at 0.01 ppm; and tomatoes at 0.01 ppm.
During the course of the review The Agency determined that based on
available data and current commodity vocabulary that tolerances should
be established for residues of the herbicide trifloxysulfuron N-[[4,6-
dimethoxy-2-pyrimidinyl)amino)carbonyl]-3-2,2,2-trifluoroethoxy)-2-
pyridinesulfonamide in or on the commodities almond at 0.02 ppm;
almond, hulls at 0.01 ppm; fruit, citrus, group 10 at 0.03 ppm; cotton,
undelinted seed at 0.05 ppm; cotton, gin

[[Page 54378]]

byproducts at 1.0 ppm; sugarcane at 0.01 ppm, and tomato at 0.01 ppm.
Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of the FFDCA defines ``safe'' to mean that ``there is
a reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of the FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of the FFDCA and a complete
description of the risk assessment process, see the final rule on
Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-
5754-7).

III. Aggregate Risk Assessment and Determination of Safety

Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed
the available scientific data and other relevant information in support
of this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2) of the FFDCA, for a tolerance for residues of
trifloxysulfuron on almond at 0.02 ppm; almond, hulls at 0.01 ppm;
fruit, citrus, group 10 at 0.03 ppm; cotton, undelinted seed at 0.05
ppm; cotton gin byproducts at 1.0 ppm; sugarcane at 0.01 ppm; and
tomato at 0.01 ppm. EPAs assessment of exposures and risks associated
with establishing the tolerance follows.

A. Toxicological Profile

EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The nature of the toxic effects caused by trifloxysulfuron
are discussed in Table 1 of this unit as well as the no observed
adverse effect level (NOAEL) and the lowest observed adverse effect
level (LOAEL) from the toxicity studies reviewed.

Table 1.-- Subchronic, Chronic, and Other Toxicity
----------------------------------------------------------------------------------------------------------------
Guideline No. Study Type Results
----------------------------------------------------------------------------------------------------------------
870.3100 90-Day oral toxicity NOAEL: 507/549 milligrams/kilogram/day (mg/
rodents (rats) kg/day) Male/Female (M/F)
LOAEL: 1052/1128 mg/kg/day (M/F): M =
decreased body weight, decreased body
weight gain, equivocal increased
testicular atrophy at end of recovery
phase; F = decreased body weight,
decreased body weight gain, equivocal
slightly increased histopathology in liver
(single cell necrosis, focal necrosis,
inflammation, hepatocellular hypertrophy).
----------------------------------------------------------------------------------------------------------------
870.3100 90-Day oral toxicity NOAEL: 1,023/1,507 mg/kg/day (M/F)
rodents (mice) LOAEL: >1,023/>1,507 mg/kg/day (M/F): M =
not attained; F = not attained.
----------------------------------------------------------------------------------------------------------------
870.3150 90-Day oral toxicity in NOAEL: 19.8/19.6 mg/kg/day (M/F)
nonrodents (dogs) LOAEL: 164.2/167.3 mg/kg/day (M/F): M =
decreased body weight gain (20%), slight
hematological effects, clinical chemistry
changes suggesting hepatotoxicity,
decreased thymus weight, thymic atrophy,
increased glycogen in liver, hemorrhage in
mesenteric lymph nodes; F = decreased body
weight gain (44%), anemia with
extramedullary hematopoiesis in liver/
spleen and myeloidhyperplasia in bone
marrow, clinical chemistry changes
suggesting hepatotoxicity, decrease thymus
weight, thymic atrophy and hyaline tubular
change in kidney.
----------------------------------------------------------------------------------------------------------------
870.3200 21/28-Day dermal toxicity NOAEL: 1,000/100 mg/kg/day (M/F)
(rats) LOAEL: >1,000/1,000 mg/kg/day(M/F): M = not
attained; F = decreased body weight gain.
No dermal irritation M/F.
----------------------------------------------------------------------------------------------------------------
870.3700 Prenatal developmental in Maternal NOAEL: 300 mg/kg/day
rodents (rats) Maternal LOAEL: 1,000 mg/kg/day based on
decreased food consumption during
treatment, decreased body weight gain
during post-treatment.
Developmental NOAEL: 300 mg/kg/day
Developmental LOAEL: 1,000 mg/kg/day based
on slight decrease in fetal weight,
increased skeletal anomalies,increased
poor/absent skeletal ossification.
----------------------------------------------------------------------------------------------------------------
870.3700 Prenatal developmental in Maternal NOAEL: 100 mg/kg/day
nonrodents (rabbit) Maternal LOAEL: 250 mg/kg/day based on
increased mortality, increased vaginal/
anal bleeding.
Developmental NOAEL: 50 mg/kg/day
Developmental LOAEL: 100 mg/kg/day based on
abnormally shaped heart (one fetus at 100
mg/kg/day and 3 fetuses from 2 litters at
250 mg/kg/day).
----------------------------------------------------------------------------------------------------------------

[[Page 54379]]

870.3800 Reproduction and fertility Parental systemic NOAEL: 78.8/83.5 mg/kg/
effects (rat) day (M/F)
Parental systemic LOAEL: 631/676 mg/kg/day
(M/F) based on decreased body weight and
gain as well as decreased food
consumption.
Offspring systemic NOAEL: 78.8/83.5 mg/kg/
day (M/F)
Offspring systemic LOAEL: 631/676 mg/kg/day
(M/F): decreased pup weight and weight
gain, decreased spleen weight, thymus
weight and increased vaginal patency.
Reproductive NOAEL: 968/1,030 mg/kg/day (M/
F)
Reproductive LOAEL: >968/1,030 (M/F)
----------------------------------------------------------------------------------------------------------------
870.4100 Chronic toxicity rodents See 870.4300
(rat)
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870.4100 Chronic toxicity dogs NOAEL: 51.1/45.3 mg/kg/day (M/F)
LOAEL: 123/121 mg/kg/day (M/F): M = gray-
white foci in lungs, fibrous thickening of
lung pleura, equivocal decreased body
weight gain; F = equivocal increased
incidence and severity of chronic urinary
bladder inflammation.
----------------------------------------------------------------------------------------------------------------
870.4200 Carcinogenicity rats See 870.4300
----------------------------------------------------------------------------------------------------------------
870.4200 Carcinogenicity mice NOAEL: 854/112 mg/kg/day (M/F)
LOAEL: >854/818 mg/kg/day (M/F): M = not
determined; F = decreased body weight,
body weight gain and food consumption.
Negative for carcinogenicity in M and F.
----------------------------------------------------------------------------------------------------------------
870.4300 Chronic feeding/ NOAEL: 82.6/23.7 mg/kg/day (M/F)
carcinogenicity rats LOAEL: 429/99.3 mg/kg/day (M/F): M =
decreased body weight and gains, decreased
food consumption and increased Leydig cell
hyperplasia in testes; F = increased
tubular atrophy in kidneys. At 500 mg/kg/
day decreased body weight, body weight
gain, food consumption and increased
tubular atrophy in kidneys. Negative for
carcinogenicity in M and F.
----------------------------------------------------------------------------------------------------------------
870.5100 Gene mutation bacterial Negative without and with S-9 activation.
reverse mutation assay
(S. typhimurium/E. coli)
----------------------------------------------------------------------------------------------------------------
870.5300 In vitro mammalian cell Negative without and with S-9 activation.
forward gene mutation
assay (CHO cells/HGPRT
locus)
----------------------------------------------------------------------------------------------------------------
870.5375 In vitro mammalian Negative without and with S-9 activation.
cytogenetics assay in CHO
cells
----------------------------------------------------------------------------------------------------------------
870.5395 Cytogenetics - mammalian Negative at single oral doses up to 5,000
erythrocyte micronucleus mg/kg.
test in the mouse
----------------------------------------------------------------------------------------------------------------
870.5500 In vitro unscheduled DNA Negative response up to 250 [mu]g/mL.
synthesis (primary rat Cytotoxicity at £=15.63 [mu]g/
hepatocytes) mL.
----------------------------------------------------------------------------------------------------------------
870.6200 Acute neurotoxicity NOAEL: <2,000 mg/kg/day (M/F)
screening battery (rat) LOAEL: 2,000 mg/kg/day (M/F): M and F =
decreased motor activity on day 1,
histopathological lesions in nervous
system tissues.
----------------------------------------------------------------------------------------------------------------
870.6200 Acute neurotoxicity NOAEL: 2,000/600 mg/kg/day (M/F)
screening battery (rat) LOAEL: >2,000/2,000 mg/kg/day (M/F): M =
not attained; F = decreased motor activity
on day 1.
----------------------------------------------------------------------------------------------------------------
870.6200 Subchronic neurotoxicity NOAEL: 112/553 mg/kg/day (M/F)
screening battery (rat) LOAEL: 472/1,128 mg/kg/day (M/F): M =
decreased body weight, body weight gain
and food consumption.; F = decreased body
weight.
----------------------------------------------------------------------------------------------------------------

[[Page 54380]]

870.6300 Developmental No study performed. Not Required.
neurotoxicity (rat)
----------------------------------------------------------------------------------------------------------------
870.7485 Metabolism and Rapidly absorbed and exceted. Most (>87%)
pharmacokinetics (rat) of the administered dose (AD) was excreted
within 24 hours. After 7 days, very little
(<=0.3% of AD) remained in the tissues.
Urine was the primary route of excretion
in males (50-61% of AD) and in females (70-
80% of AD). Unchanged parent in males (11-
20% of AD) and in females (37-47% of AD)
was excreted almost entirely in the urine
and only trace amounts were found in the
feces. With the exception of the parent,
the metabolite profile was similar between
the urine and feces. The 2 primary
metabolites in both urine and feces were
Metabolite J (desmethyl parent, up to 26%
of AD) and Metabolite K (5'hydroxy-
pyrimidine of parent, up to 19% of AD).
Other metabolites were Metabolites X, N,
F, A and D, each up to 8.2% of the AD in
males and up to 4.7% of the AD in females.
Several minor metabolites were also
identified as Metabolite Q, Metabolite P,
guanidine, CGA-382997 and CGA-368732 (each
<=4.4% of the AD).
----------------------------------------------------------------------------------------------------------------
870.7485 Biliary metabolism (rat) In bile duct cannulated rats, absorption
was 84-88% of the Administered Dose (AD)
at 48 hours. Nearly all of the AD was
excreted within 48 hours. Excretion in
urine ranged from 58-76%, in bile from 5-
27%, and in feces was about 6% of the AD.
There was no evidence for an enterohepatic
circulation. Biotransformation was similar
to that in the conventional rat metabolism
study. The metabolite profiles in urine,
bile fluid and feces were all similar.
----------------------------------------------------------------------------------------------------------------
870.7600 Dermal penetration (rat) No study performed. Not Required.
----------------------------------------------------------------------------------------------------------------

B. Toxicological Endpoints

The dose at which no adverse effects are observed (the NOAEL) from
the toxicology study identified as appropriate for use in risk
assessment is used to estimate the toxicological level of concern
(LOC). However, the lowest dose at which adverse effects of concern are
identified (the LOAEL) is sometimes used for risk assessment if no
NOAEL was achieved in the toxicology study selected. An uncertainty
factor (UF) is applied to reflect uncertainties inherent in the
extrapolation from laboratory animal data to humans and in the
variations in sensitivity among members of the human population as well
as other unknowns. An UF of 100 is routinely used, 10X to account for
interspecies differences and 10X for intraspecies differences.
For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference dose (acute RfD or
chronic RfD) where the RfD is equal to the NOAEL divided by the
appropriate UF (RfD = NOAEL/UF). Where an additional safety factors
(SF) is retained due to concerns unique to the FQPA, this additional
factor is applied to the RfD by dividing the RfD by such additional
factor. The acute or chronic Population Adjusted Dose (aPAD or cPAD) is
a modification of the RfD to accommodate this type of FQPA SF.
For non-dietary risk assessments (other than cancer) the UF is used
to determine the LOC. For example, when 100 is the appropriate UF (10X
to account for interspecies differences and 10X for intraspecies
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and
compared to the LOC.
The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify carcinogenic risk. The Q*
approach assumes that any amount of exposure will lead to some degree
of cancer risk. A Q* is calculated and used to estimate risk which
represents a probability of occurrence of additional cancer cases
(e.g., risk is expressed as 1 x 10-6 or one in a million).
Under certain specific circumstances, MOE calculations will be used for
the carcinogenic risk assessment. In this non-linear approach, a
``point of departure'' is identified below which carcinogenic effects
are not expected. The point of departure is typically a NOAEL based on
an endpoint related to cancer effects though it may be a different
value derived from the dose response curve. To estimate risk, a ratio
of the point of departure to exposure (MOE_cancer = point of
departure/exposures) is calculated. A summary of the toxicological
endpoints for trifloxysulfuron used for human risk assessment is shown
in Table 2 of this unit:

[[Page 54381]]

Table 2.--Summary of Toxicological Dose and Endpoints for Trifloxysulfuron for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
Special FQPA SF* and
Exposure Scenario Dose Used in Risk Level of Concern for Study and Toxicological
Assessment, UF Risk Assessment Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (females 13-49) Developmental NOAEL = Special FQPA SF = 1 Developmental Toxicity
50 mg/kg/dayUF = 100 aPAD = Study in Rabbits.
Acute RfD =0.5 mg/kg... acute RfD/Special FQPA Developmental LOAEL =
SF = 0.5 mg/kg. 100 mg/kg/day based on
increased incidence of
abnormal shaped hearts
in fetuses.
-----------------------------------------------------------------------------------------
Acute dietary (general population) NOAEL = 600 mg/kg UF = Special FQPA SF = 1 Acute Neurotoxicity
100 aPAD = Studies in Rats.
Acute RfD =6.0 mg/kg... acute RfD/Special FQPA LOAEL = 2,000 mg/kg
SF = 6.0 mg/kg. based on decreased
motor activity on day
1 and
histopathological
lesions in nervous
system tissues of
males and females.
-----------------------------------------------------------------------------------------
Chronic dietary (all populations) NOAEL= 23.7 mg/kg/day Special FQPA SF = 1 Combined Chronic
UF = 100 cPAD = Toxicity/
Chronic RfD = 0.237 mg/ chronic RfD/Special Carcinogenicity Study
kg/day. FQPA SF = 0.237 mg/kg/ in Rats.
day. LOAEL = 99.3 mg/kg/day
based on increased
tubular atrophy in the
kidneys of females
(developing after 12
months).
-----------------------------------------------------------------------------------------
Incidental oral short-term (1 - 30 Offspring NOAEL = 78.8/ Residential LOC for MOE 2-Generation
days) 83.5 (M/F) mg/kg/day = 100 Reproduction Study in
Rats.
Offspring LOAEL = 631/
676 (M/F) mg/kg/day
based on decreased pup
body weights on day
21.
-----------------------------------------------------------------------------------------
Dermal short-term (1 - 30 days) Dermal study Residential LOC for MOE 28-Day Dermal Toxicity
Systemic NOAEL= 100 mg/ = 100 Study in Rats.
kg/day. Systemic LOAEL = 1,000
mg/kg/day based on
decreased body weight
gain in females.
-----------------------------------------------------------------------------------------
Inhalation short-term (1 - 30 days) Oral study Residential LOC for MOE Developmental Toxicity
NOAEL= 50 mg/kg/day = 100 Study in Rabbits.
(inhalation absorption LOAEL = 100 mg/kg/day
factor = 100%). based on increased
incidence of abnormal
shaped hearts in
fetuses.
-----------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation) Classification: Not Likely to be carcinogenic to humans
----------------------------------------------------------------------------------------------------------------
*The reference to the Special FQPA SF refers to any additional SF retained due to concerns unique to the FQPA.

C. Exposure Assessment

1. Dietary exposure from food and feed uses. No tolerances have
been previously established for trifloxysulfuron. Tolerances being
established under Sec. 180.591 include almond; almond hulls; cotton,
undelinted seed; cotton, gin byproducts; fruit, citrus, Group 10;
sugarcane, and tomato. No tolerances are required for meat, milk,
poultry or eggs. Risk assessments were conducted by EPA to assess
dietary exposures from trifloxysulfuron in food as follows:
i. Acute exposure. Acute dietary risk assessments are performed for
a food-use pesticide if a toxicological study has indicated the
possibility of an effect of concern occurring as a result of a 1-day or
single exposure. The Dietary Exposure Evaluation Model
(DEEMTM) analysis evaluated the individual food consumption
as reported by respondents in the United States Department of
Agriculture (USDA) 1994-1996 and 1998 nationwide Continuing Surveys of
Food Intake by Individuals (CSFII) and accumulated exposure to the
chemical for each commodity. The following assumptions were made for
the acute exposure assessments: 100% of the crops from registered uses
are treated and that residues of trifloxysulfuron are at tolerance
levels. Anticipated residues were not used.
ii. Chronic exposure. In conducting this chronic dietary risk
assessment the DEEMTM analysis evaluated the individual food
consumption as reported by respondents in the USDA 1994-1996 and 1998
nationwide CSFII and accumulated exposure to the chemical for each
commodity. The following assumptions were made for the chronic exposure
assessments: 100% of the crops from registered uses are treated and
that residues of trifloxysulfuron are at tolerance levels. Anticipated
residues were not used.
iii. Cancer. Trifloxysulfuron has been classified as ``not likely
to be carcinogenic in humans.'' Therefore a quantitative assessment of
aggregate cancer risk was not performed.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for trifloxysulfuron in drinking
water. Because the Agency does not have comprehensive monitoring data,
drinking water concentration estimates are made by reliance on
simulation or modeling taking into account data on the physical
characteristics of trifloxysulfuron.
The Agency uses the First Index Reservoir Screening Tool (FIRST) or
the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS),
to produce estimates of pesticide concentrations in an index reservoir.
The Screening Concentrations in

[[Page 54382]]

Ground Water (SCI-GROW) model is used to predict pesticide
concentrations in shallow ground water. For a screening-level
assessment for surface water EPA will use FIRST (a Tier 1 model) before
using PRZM/EXAMS (a Tier 2 model). The FIRST model is a subset of the
PRZM/EXAMS model that uses a specific high-end runoff scenario for
pesticides. While both FIRST and PRZM/EXAMS incorporate an index
reservoir environment, the PRZM/EXAMS model includes a percent crop
area factor as an adjustment to account for the maximum percent crop
coverage within a watershed or drainage basin.
None of these models include consideration of the impact processing
(mixing, dilution, or treatment) of raw water for distribution as
drinking water would likely have on the removal of pesticides from the
source water. The primary use of these models by the Agency at this
stage is to provide a coarse screen for sorting out pesticides for
which it is highly unlikely that drinking water concentrations would
ever exceed human health levels of concern.
Since the models used are considered to be screening tools in the
risk assessment process, the Agency does not use estimated
environmental concentrations (EECs) from these models to quantify
drinking water exposure and risk as a %RfD or %PAD. Instead drinking
water levels of comparison (DWLOCs) are calculated and used as a point
of comparison against the model estimates of a pesticide's
concentration in water. DWLOCs are theoretical upper limits on a
pesticide's concentration in drinking water in light of total aggregate
exposure to a pesticide in food, and from residential uses. Since
DWLOCs address total aggregate exposure to trfloxysulfuron they are
further discussed in the aggregate risk sections Unit E.
Based on the PRZM/EXAMS and SCI-GROW models the EECs of
trifloxysulfuron and its metabolites of concern for acute exposures are
estimated to be 6.47 parts per billion (ppb) for surface water and
0.054 ppb for ground water. The EECs for chronic exposures are
estimated to be 0.52 ppb for surface water and 0.054 ppb for ground
water.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
Trifloxysulfuron will be registered for use on the following non-
dietary sites: Turf--golfcourses. The risk assessment was conducted
using the following exposure assumptions: The Agency has examined the
potential postapplication exposure to individuals over 12 years of age
from the proposed use of trifloxysulfuron on golf courses. Duration of
such exposure is anticipated to be short-term. The short-term dermal
post-application exposure for golfing was estimated to be 0.0005 mg/kg/
day. The estimate assumes that 18 holes of golf are played in 4 hours,
that there are 0.015 [mu]g ai/cm2 of turf, that the transfer
coefficient for turf is 500 cm2/hour, and that the average
golfer weighs 60 kg. Transfer coefficients are based on surrogate data,
from chlorothalonil and chlorpyrifos, describing actual, median-value
exposures to golfers.
The vapor pressure of trifloxysulfuron is very low and, therefore,
inhalation exposure to trifloxysulfuron vapor is not expected to occur.
The Agency has not assessed inhalation exposure to trifloxysulfuron due
to residential activities.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
EPA does not have, at this time, available data to determine
whether trifloxysulfuron has a common mechanism of toxicity with other
substances. Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity, EPA
has not made a common mechanism of toxicity finding as to
trifloxysulfuron and any other substances and trifloxysulfuron does not
appear to produce a toxic metabolite produced by other substances. For
the purposes of this tolerance action, therefore, EPA has not assumed
that trifloxysulfuron has a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see the policy statements
released by EPA's Office of Pesticide Programs concerning common
mechanism determinations and procedures for cumulating effects from
substances found to have a common mechanism on EPA's website at
http://epa.gov/pesticides/cumulative/.

D. Safety Factor for Infants and Children

1. In general. Section 408 of the FFDCA provides that EPA shall
apply an additional tenfold margin of safety for infants and children
in the case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base on toxicity and exposure
unless EPA determines that a different margin of safety will be safe
for infants and children. Margins of safety are incorporated into EPA
risk assessments either directly through use of a MOE analysis or
through using uncertainty (safety) factors in calculating a dose level
that poses no appreciable risk to humans.
2. Prenatal and postnatal sensitivity. There was no evidence of
increased quantitative or qualitative susceptibility in the
developmental toxicity study in rats or in the 2-generation
reproduction study in rats. In the developmental toxicity study in
rabbits, there was an increase in quantitative susceptibility based
upon the presence of abnormally shaped heart in one fetus at 100 mg/kg/
day. Three additional fetuses from two litters at 250 mg/kg/day also
had abnormally shaped hearts. The degree of concern for this finding
was low because there was a clear NOAEL for this effect, only 1 fetus
had the effect at the LOAEL, and this effect was used as a
toxicological endpoint in appropriate risk assessments. There are no
residual uncertainties for prenatal and/or postnatal toxicity.
3. Conclusion. There is a complete toxicity data base for
trifloxysulfuron and exposure data are complete or are estimated based
on data that reasonably accounts for potential exposures. EPA
determined that the 10X SF to protect infants and children should be
reduced to 1X. This determination was based on the following:
¥ The toxicological data base is complete for FQPA
assessment.
¥ There was no evidence of increased quantitative or
qualitative susceptibility in the developmental toxicity study in rats.
At the limit dose, maternal effects were decreased food consumption
during treatment and decreased body weight gain during post-treatment.
The only fetal findings noted at the limit dose were a slight decrease
in fetal body weights, and an increase in minimal skeletal findings and
poor/absent skeletal ossification.
¥ There was evidence of increased quantitative susceptibility
in the developmental toxicity study in rabbits. The maternal NOAEL was
100 mg/kg/day based on increased mortality and

[[Page 54383]]

increased vaginal/anal bleeding at the LOAEL of 250 mg/kg/day. The
developmental NOAEL was 50 mg/kg/day based on an increased incidence of
abnormally shaped hearts at the LOAEL of 100 mg/kg/day (one fetus at
100 mg/kg/day). Three additional fetuses from two litters at 250 mg/kg/
day also had abnormally shaped hearts. In historical control data
provided by the registrant, there were no reported instances of
abnormally shaped hearts. The degree of concern is low for the
quantitative evidence of susceptibility seen in the rabbit
developmental study because there was a clear NOAEL for this effect,
only one fetus had the effect at the LOAEL, this effect was used as a
toxicological endpoint in appropriate risk assessments.
¥ There was no evidence of increased quantitative or
qualitative susceptibility in the 2-generation reproduction study in
rats.
¥ There are no residual uncertainties for prenatal and/or
postnatal toxicity.
¥ A developmental neurotoxicity study in rats is not
required.
¥ The acute and chronic dietary food exposure assessments
assumed tolerance level residue data and 100% crop treated. The acute
and chronic risk assessments will not underestimate exposure or risk
since the exposures are based on reliable data derived from studies
designed to produce worst-case residues.
¥ The dietary drinking water assessment used concentration
values generated by model and associated modeling parameters which are
designed to provide conservative, health protective, high-end estimates
of water concentrations which will not likely be exceeded. Furthermore,
EPA used a highly conservative technique to estimate concentrations of
non-parent residues of concern.
¥ The non-dietary exposure assessment will not underestimate
postapplication exposure to golfers resulting from the use of
trifloxysulfuron-sodium on golf course turf.

E. Aggregate Risks and Determination of Safety

To estimate total aggregate exposure to a pesticide from food,
drinking water, and residential uses, the Agency calculates DWLOCs
which are used as a point of comparison against the model estimates of
a pesticide's concentration in water EECs. DWLOC values are not
regulatory standards for drinking water. DWLOCs are theoretical upper
limits on a pesticide's concentration in drinking water in light of
total aggregate exposure to a pesticide in food and residential uses.
In calculating a DWLOC, the Agency determines how much of the
acceptable exposure (i.e., the PAD) is available for exposure through
drinking water e.g., allowable chronic water exposure (mg/kg/day) =
cPAD - (average food + residential exposure). This allowable exposure
through drinking water is used to calculate a DWLOC.
A DWLOC will vary depending on the toxic endpoint, drinking water
consumption, and body weights. Default body weights and consumption
values as used by the USEPA Office of Water are used to calculate
DWLOCs: 2 liter (L)/70 kg (adult male), 2L/60 kg (adult female), and
1L/10 kg (child). Default body weights and drinking water consumption
values vary on an individual basis. This variation will be taken into
account in more refined screening-level and quantitative drinking water
exposure assessments. Different populations will have different DWLOCs.
Generally, a DWLOC is calculated for each type of risk assessment used:
Acute, short-term, intermediate-term, chronic, and cancer.
When EECs for surface water and ground water are less than the
calculated DWLOCs, OPP concludes with reasonable certainty that
exposures to the pesticide in drinking water (when considered along
with other sources of exposure for which OPP has reliable data) would
not result in unacceptable levels of aggregate human health risk at
this time. Because OPP considers the aggregate risk resulting from
multiple exposure pathways associated with a pesticide's uses, levels
of comparison in drinking water may vary as those uses change. If new
uses are added in the future, OPP will reassess the potential impacts
of residues of the pesticide in drinking water as a part of the
aggregate risk assessment process.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food to
trifloxysulfuron will occupy <1% of the aPAD for the U.S. population,
<1% of the aPAD for females 13-49 years, <1% of the aPAD for all
infants > 1 year old and <1% of the aPAD for children 1-12 year old. In
addition, there is potential for acute dietary exposure to
trifloxysulfuron in drinking water. After calculating DWLOCs and
comparing them to the EECs for surface and ground water, EPA does not
expect the aggregate exposure to exceed 100% of the aPAD, as shown in
Table 3 of this unit:

Table 3.--Aggregate Risk Assessment for Acute Exposure to Trifloxysulfuron
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup aPAD (mg/ % aPAD Water EEC Water EEC Acute DWLOC
kg) (Food) (ppb) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population 6.0 <1 6.47 0.054 210,000
----------------------------------------------------------------------------------------
All infants < 1 year old 6.0 <1 6.47 0.054 60,000
----------------------------------------------------------------------------------------
Children 1-2 year old 6.0 <1 6.47 0.054 60,000
----------------------------------------------------------------------------------------
Females 13-49 years old 0.05 <1 6.47 0.054 15,000
----------------------------------------------------------------------------------------------------------------

2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
trifloxysulfuron from food will utilize <1% of the cPAD for the U.S.
population, <1% of the cPAD for females 13-49 years, <1% of the cPAD
for all infants > 1 year old and <1% of the cPAD for children 1-2 years
old. Based the use pattern, chronic residential exposure to residues of
trifloxysulfuron is not expected. In addition, there is potential for
chronic dietary exposure to trifloxysulfuron in drinking water. After
calculating DWLOCs and comparing them to the EECs for surface water and
ground water, EPA does not expect the aggregate exposure to exceed 100%
of the cPAD, as shown in Table 4 of this unit:

[[Page 54384]]

Table 4.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Trifloxysulfuron
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup cPAD mg/kg/ % cPAD Water EEC Water EEC Chronic
day (Food) (ppb) (ppb) DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population 0.237 <1 0.52 0.054 8300
----------------------------------------------------------------------------------------
All infants < 1 year old 0.237 <1 0.52 0.054 2,400
----------------------------------------------------------------------------------------
Children 1-2 years old 0.237 <1 0.52 0.054 2,400
----------------------------------------------------------------------------------------
Females 13-49 years old 0.237 <1 0.52 0.054 7,100
----------------------------------------------------------------------------------------------------------------

3. Short-term risk. Short-term aggregate exposure takes into
account residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
Trifloxysulfuron is proposed for a use that could result in short-
term residential exposure and the Agency has determined that it is
appropriate to aggregate chronic food and water and short-term
exposures for trifloxysulfuron.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food and residential exposures
aggregated result in aggregate MOEs of 20,000 for all affected
populations including the general U. S. population, youth 13-19 years
old, adults 20-49 years old, and females 13-49 years old. These
aggregate MOEs do not exceed the Agency's level of concern for
aggregate exposure to food and residential uses. In addition, short-
term DWLOCs were calculated and compared to the EECs for chronic
exposure of trifloxysulfuron in ground and surface water. After
calculating DWLOCs and comparing them to the EECs for surface and
ground water, EPA does not expect short-term aggregate exposure to
exceed the Agency's level of concern, as shown in Table 5 of this unit:

Table 5.--Aggregate Risk Assessment for Short-Term Exposure to Trifloxysulfuron
----------------------------------------------------------------------------------------------------------------
Aggregate
Aggregate Level of Surface Ground Short-Term
Population Subgroup MOE (Food + Concern Water EEC Water EEC DWLOC (ppb)
Residential) (LOC) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
U. S. population 170,000 100 0.52 0.054 28,000
----------------------------------------------------------------------------------------
Youth 13-19 years old 170,000 100 0.52 0.054 24,000
----------------------------------------------------------------------------------------
Adults 20-49 years old 180,000 100 0.52 0.054 28,000
----------------------------------------------------------------------------------------
Females 13-49 years old 180,000 100 0.52 0.054 24,000
----------------------------------------------------------------------------------------------------------------

4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
Trifloxysulfuron is not registered for use any sites that would
result in any intermediate residential exposure. Therefore, the
aggregate risk has not been assessed for intermediate scenarios.
5. Aggregate cancer risk for U.S. population. Trifloxysulfuron has
been classified as ``not likely to be carcinogenic to humans.''
Therefore, no cancer risk is expected.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, and to infants and children from aggregate
exposure to trifloxysulfuron residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

Adequate enforcement methodology high performance liquid
chromatography/ultravoilet (HPLC/UV) is available to enforce the
tolerance expression. The method may be requested from: Chief,
Analytical Chemistry Branch, Environmental Science Center, 701 Mapes
Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail
address: residuemethods@epa.gov.

B. International Residue Limits

There are no Canadian, Mexican, or Codex maximum residue limits
(MRLs) established for trifloxysulfuron. Therefore, international
harmonization is not an issue with the proposed uses.

C. Conditions

No conditions are required to support these tolerances.

V. Conclusion

Therefore, the tolerance is established for residues of
trifloxysulfuron, N-[[4,6-dimethoxy-2-pyrimidinyl)amino]carbonyl]-3-
(2,2,2-trifluoroethoxy)-2-pyridinesulfonamide, in or on almond at 0.02
ppm; almond, hulls at 0.01 ppm; fruit, citrus, group 10 at 0.03 ppm;
cotton, undelinted seed at 0.05 ppm; cotton, gin byproducts at 1.0 ppm;
sugarcane at 0.01 ppm, and tomato at 0.01 ppm.

VI. Objections and Hearing Requests

Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. Although the procedures in those
regulations require some modification to reflect the amendments made to
the FFDCA by the FQPA, EPA will continue to use those procedures, with

[[Page 54385]]

appropriate adjustments, until the necessary modifications can be made.
The new section 408(g) of the FFDCA provides essentially the same
process for persons to ``object'' to a regulation for an exemption from
the requirement of a tolerance issued by EPA under new section 408(d)
of FFDCA, as was provided in the old sections 408 and 409 of the FFDCA.
However, the period for filing objections is now 60 days, rather than
30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket ID number OPP-2003-0286 in the subject line on the
first page of your submission. All requests must be in writing, and
must be mailed or delivered to the Hearing Clerk on or before November
17, 2003.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900C),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. You may also deliver your request to the
Office of the Hearing Clerk in Rm. 104, Crystal Mall #2, 1921
Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is
open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Office of the Hearing Clerk is
(703) 603-0061.
2. Tolerance fee payment. If you file an objection or request a
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must
mail the fee to: EPA Headquarters Accounting Operations Branch, Office
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please
identify the fee submission by labeling it ``Tolerance Petition Fees.''
EPA is authorized to waive any fee requirement ``when in the
judgement of the Administrator such a waiver or refund is equitable and
not contrary to the purpose of this subsection.'' For additional
information regarding the waiver of these fees, you may contact James
Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov,
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
3. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VI.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in Unit I.B.1. Mail your
copies, identified by docket ID number OPP-2003-0286. to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the
PIRIB described in Unit I.B.1. You may also send an electronic copy of
your request via e-mail to: opp-docket@epa.gov. Please use an ASCII
file format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit an
electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).

VII. Statutory and Executive Order Reviews

This final rule establishes a tolerance under section 408(d) of the
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this rule has been
exempted from review under Executive Order 12866 due to its lack of
significance, this rule is not subject to Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does
not contain any information collections subject to OMB approval under
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose
any enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
104-4). Nor does it require any special considerations under Executive
Order 12898, entitled Federal Actions to Address Environmental Justice
in Minority Populations and Low-Income Populations (59 FR 7629,
February 16, 1994); or OMB review or any Agency action under Executive
Order 13045, entitled Protection of Children from Environmental Health
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does
not involve any technical standards that would require Agency
consideration of voluntary consensus standards pursuant to section
12(d) of the National Technology Transfer and Advancement Act of 1995
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are established on the basis of a
petition under section 408(d) of the FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. In addition, the Agency has determined that this
action will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various

[[Page 54386]]

levels of government, as specified in Executive Order 13132, entitled
Federalism(64 FR 43255, August 10, 1999). Executive Order 13132
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by State and local officials in the development of
regulatory policies that have federalism implications.'' ``Policies
that have federalism implications'' is defined in the Executive Order
to include regulations that have ``substantial direct effects on the
States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government.'' This final rule directly regulates
growers, food processors, food handlers and food retailers, not States.
This action does not alter the relationships or distribution of power
and responsibilities established by Congress in the preemption
provisions of section 408(n)(4) of the FFDCA. For these same reasons,
the Agency has determined that this rule does not have any ``tribal
implications'' as described in Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments
(65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by tribal officials in the development of regulatory policies that have
tribal implications.'' ``Policies that have tribal implications'' is
defined in the Executive Order to include regulations that have
``substantial direct effects on one or more Indian tribes, on the
relationship between the Federal Government and the Indian tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian tribes.'' This rule will not have substantial
direct effects on tribal governments, on the relationship between the
Federal Government and Indian tribes, or on the distribution of power
and responsibilities between the Federal Government and Indian tribes,
as specified in Executive Order 13175. Thus, Executive Order 13175 does
not apply to this rule.

VIII. Congressional Review Act

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this final rule in the Federal Register. This final
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

Dated: September 4, 2003.
James Jones,
Director, Office of Pesticide Programs.

¥ Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

¥ 1. The authority citation for part 180 continues to read as follows:

Authority: 21 U.S.C. 321(q), 346(a) and 371.

¥ 2. Section 180.591 is added to read as follows:

Sec. 180.591 Trifloxysulfuron; tolerances for residues

(a) General. Tolerances are established for residues of the
herbicide trifloxysulfuron, N-[[(4,6-dimethoxy-2-
pyrimidinyl)amino]carbonyl]-3-(2,2,2-trifluoroethoxy)-2-
pyridinesulfonamide in or on the following raw agricultural
commodities.

--------------------------------------------------------------------------
Commodity Parts per million
--------------------------------------------------------------------------
Almond................................................ 0.02
Almond, hulls......................................... 0.01
Fruit, citrus, Group 10............................... 0.03
Cotton, undelinted seed............................... 0.05
Cotton, gin byproducts................................ 1.0
Sugarcane............................................. 0.01
Tomato................................................ 0.01
--------------------------------------------------------------------------

(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]

[FR Doc. 03-23428 Filed 9-16-03; 8:45am]
BILLING CODE 6560-50-S