[Federal Register Volume 68, Number 180 (Wednesday, September 17, 2003)]
[Rules and Regulations]
[Pages 54377-54386]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-23428]


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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: [email protected].

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:
    [sbull] Crop production (NAICS 111)
    [sbull] Animal production (NAICS 112)
    [sbull] Food manufacturing (NAICS 311)
    [sbull] 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)
----------------------------------------------------------------------------------------------------------------
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 (MOEcancer = 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:
    [sbull] The toxicological data base is complete for FQPA 
assessment.
    [sbull] 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.
    [sbull] 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.
    [sbull] There was no evidence of increased quantitative or 
qualitative susceptibility in the 2-generation reproduction study in 
rats.
    [sbull] There are no residual uncertainties for prenatal and/or 
postnatal toxicity.
    [sbull] A developmental neurotoxicity study in rats is not 
required.
    [sbull] 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.
    [sbull] 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.
    [sbull] 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: [email protected].

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 [email protected], 
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: [email protected]. 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.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

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

0
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