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Sulfentrazone (IR-4; FMC). September 24, 2003.
Pesticide Tolerances. Final Rule. Federal Register.


http://www.epa.gov/fedrgstr/EPA-PEST/2003/September/Day-24/p24011.htm


[Federal Register: September 24, 2003 (Volume 68, Number 185)]
[Rules and Regulations]
[Page 55269-55280]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24se03-2]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2003-0270; FRL-7324-5]
 
Sulfentrazone; Pesticide Tolerances

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

-----------------------------------------------------------------------

SUMMARY: This regulation establishes tolerances for combined residues 
of the herbicide sulfentrazone and its metabolites in or on asparagus; 
bean, lima, succulent; cabbage; corn, field, forage; corn, field, 
grain; corn, field, stover; horseradish, roots; pea and bean, dried 
shelled, except soybean, subgroup 6C; peanut; peanut, meal; peppermint, 
tops; potato; spearmint, tops; sugarcane, cane; sugarcane, molasses; 
and sunflower, seed. EPA is also deleting certain sulfentrazone 
tolerances that are no longer needed as result of this action. The 
Interregional Research Project Number 4 and FMC Corporation requested 
these tolerances 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 24, 2003. Objections and 
requests for hearings, identified by docket ID number OPP-2003-0270, 
must be received on or before November 24, 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: Hoyt Jamerson, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703)308-9368; e-mail address: jamerson.hoyt@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be affected by this action if you are an agricultural 
producer, food manufacturer, or pesticide manufacturer. Potentially 
affected categories and entities may include, but are not limited to:
     Crop production (NAICS 111)
     Animal production (NAICS 112)
     Food manufacturing (NAICS 311)
     Pesticide manufacturing (NAICS 32532)

[[Page 55270]]

    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-2003-0270. 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, Exit Disclaimer
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 7, 2003 (68 FR 11096) (FRL-7290-
1), 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 
pesticide petitions (PP 0E6149, 1E6311, 2E6405, 2E6498, and 2E6500) by 
the Interregional Research Project Number 4 (IR-4), and 681 U.S. 
Highway #1 South, North Brunswick, NJ 08902, and PP 0F6116 and 
2F6391 by FMC Corporation, Agricultural Products Group, 1735 Market 
Street, Philadelphia, PA 19103. That notice included a summary of the 
petitions prepared by FMC Corporation, the registrant. There were no 
comments received in response to the notice of filing.
    The petitions requested that 40 CFR 180.498 be amended by 
establishing tolerances for combined residues of the herbicide 
sulfentrazone, [N-(2,4-dichloro-5-(4-(difluoromethyl)-4,5-dihydro-3-
methyl-5-oxo-1H-1,2,4-triazol-1-ylphenylmethansulfonoamide and its 
metabolites HMS (N-(2,4-dichloro-5-(4-(difluoromethyl)-4,5-dihydro-3-
hydroxymethyl-5-oxo-1H-1,2,4-triazol- 1-yl)phenyl)methanesulfonamide) 
and DMS (N-(2,4-dichloro-5-(4-(difluoromethyl)-4,5-dihydro-5-oxo-1H-
1,2,4-triazol-1-yl)phenyl)methanesulfonamide), in or on food 
commodities as follows: Sunflower, seed at 0.2 parts per million (ppm) 
(PP 0E6149); horseradish, roots at 0.2 ppm (PP 1E6311); cabbage at 0.2 
ppm (PP 1E6311); peppermint, tops and spearmint, tops at 0.3 ppm 
(1E6311); potato at 0.1 ppm (PP 2E6405); bean, lima, succulent at 0.15 
ppm (PP 2E6498); asparagus at 0.15 ppm (2E6500); peanut nutmeat and its 
processed parts at 0.2 ppm and sugarcane and its processed parts at 0.1 
ppm (PP 0F6116); corn, field forage at 0.25 ppm (PP 2F6391); corn, 
field stover at 0.35 ppm (PP 2F6391); pea and bean, dried shelled, 
except soybean, subgroup 6C at 0.15 ppm (PP 2F6391). Pesticide 
petitions 0F6116, 2F6391 and 2E6405 were subsequently amended to 
propose tolerances for peanut at 0.20 ppm; peanut, meal at 0.40 ppm; 
sugarcane, cane at 0.15 ppm; sugarcane, molasses at 0.20 ppm; corn, 
field, forage at 0.20 ppm; corn, field, grain at 0.15 ppm; corn, field, 
stover at 0.30 ppm and potato at 0.15 ppm. EPA is also deleting several 
time-limited tolerances established in connection with section 18 
emergency exemption under 40 CFR 180.498(b) that are no longer needed, 
as a result of this action. The deletions to 40 CFR 180.498(b) are as 
follows:
    1. Delete horseradish, roots at 0.1 ppm; replace with horseradish, 
roots at 0.20 ppm.
    2. Delete pea, dry, seed at 0.10 ppm; replace with pea and bean, 
dried shelled, except soybean, subgroup 6C at 0.15 ppm.
    3. Delete potato at 0.10 ppm; potato, granules/flakes at 0.20 ppm; 
and potato, wet peel at 0.15 ppm; replace with potato at 0.15 ppm.
    4. Delete sugarcane at 0.05 ppm; replace with sugarcane, cane 0.15 
ppm and sugarcane, molasses at 0.20 ppm.
    5. Delete sunflower at 0.1 ppm; replace with sunflower, seed at 
0.20 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

[[Page 55271]]

FFDCA, for tolerances for combined residues of sulfentrazone and its 
major metabolites on asparagus at 0.15 ppm; bean, lima, succulent at 
0.15 ppm; cabbage at 0.20 ppm; corn, field, forage at 0.20 ppm; corn, 
field, grain at 0.15 ppm; corn, field, stover at 0.30 ppm; horseradish, 
roots at 0.20 ppm; pea and bean, dried shelled, except soybean, 
subgroup 6C at 0.15 ppm; peanut at 0.20 ppm; peanut, meal at 0.40 ppm; 
peppermint, tops at 0.30 ppm; potato at 0.15 ppm; spearmint, tops at 
0.30 ppm; sugarcane, cane 0.15 ppm; sugarcane, molasses 0.20 ppm; and 
sunflower, seed at 0.20 ppm. EPA's assessment of exposures and risks 
associated with establishing the tolerances 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 sulfentrazone 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          NOAEL = 19.9
                                   toxicity rodents    milligrams/
                                   (rats)              kilogram/day (mg/
                                                       kg/day) for males
                                                       and 23.1 mg/kg/
                                                       day for females
                                                      LOAEL = 65.8 mg/kg/
                                                       day for males and
                                                       78.1 mg/kg/day
                                                       for females based
                                                       on clinical signs
                                                       of anemia
                                                       (reduced
                                                       hematocrit,
                                                       hemoglobin, mean
                                                       cell volume, and
                                                       mean cell
                                                       hemoglobin values
                                                       during treatment)
------------------------------------------------------------------------
870.3100                          90-Day oral         NOAEL = 60 mg/kg/
                                   toxicity rodents    day for males and
                                   (mice)              79.8 mg/kg/day
                                                       for females
                                                      LOAEL = 108.4 mg/
                                                       kg/day for males
                                                       and 143.6 mg/kg/
                                                       day for females
                                                       based on
                                                       decreased body
                                                       weights, body
                                                       weight gains, red
                                                       blood cells,
                                                       hemoglobin,
                                                       hematocrit, and
                                                       severity of
                                                       splenic
                                                       micropathology
                                                       (increased
                                                       incidence and
                                                       severity of
                                                       extramedullary
                                                       hematopoiesis)
------------------------------------------------------------------------
870.3150                          90-Day oral         NOAEL = 28 mg/kg/
                                   toxicity in         day
                                   nonrodents (dogs)  LOAEL = 57 mg/kg/
                                                       day for males and
                                                       73 mg/kg/day for
                                                       females based on
                                                       decreased body
                                                       weights (7-10%)
                                                       and body weight
                                                       gains during
                                                       first 5 weeks of
                                                       study; decreased
                                                       hemoglobin,
                                                       hematocrit, mean
                                                       cell volume, mean
                                                       cell hemoglobin
                                                       and mean cell
                                                       hemoglobin
                                                       concentration,
                                                       and increased
                                                       absolute liver
                                                       weights and
                                                       alkaline
                                                       phosphatase
                                                       levels, and
                                                       microscopic
                                                       changes in the
                                                       liver and spleen
                                                       (pigmented
                                                       sinusoidal
                                                       microphages in
                                                       the liver,
                                                       swollen
                                                       centrilobular
                                                       hepatocytes and
                                                       pigmented
                                                       reticuloendotheli
                                                       al cells in the
                                                       spleen)
------------------------------------------------------------------------
870.3200                          21/28-Day dermal    Systemic and
                                   toxicity            dermal NOAEL =
                                                       1,000 mg/kg/day,
                                                       highest dose
                                                       tested (HDT)
------------------------------------------------------------------------
870.3700                          Prenatal            Maternal
                                   developmental in   NOAEL = 25 mg/kg/
                                   rodents (rats)      day
                                                      LOAEL = 50 mg/kg/
                                                       day based on
                                                       increased
                                                       relative splenic
                                                       extramedullary
                                                       hematopoiesis
                                                      Developmental
                                                      NOAEL = 10 mg/kg/
                                                       day
                                                      LOAEL = 25 mg/kg/
                                                       day based on
                                                       decreased mean
                                                       fetal weights,
                                                       and retardation
                                                       in skeletal
                                                       development
                                                       evidenced by an
                                                       increased number
                                                       of litters with
                                                       any variation and
                                                       by decreased
                                                       number of caudal
                                                       vertebral and
                                                       metacarpal
                                                       ossification
                                                       sites
------------------------------------------------------------------------

[[Page 55272]]

870.3700                          Prenatal            Maternal
                                   developmental in   NOAEL = 250 mg/kg/
                                   rodents (rats)      day
                                                      LOAEL was not
                                                       established.
                                                      Developmental
                                                      NOAEL = 100 mg/kg/
                                                       day
                                                      LOAEL = 250 mg/kg/
                                                       day based on
                                                       decreased fetal
                                                       body weight;
                                                       increased
                                                       incidence of
                                                       fetal variations:
                                                       hypoplastic or
                                                       wavy ribs,
                                                       incompletely
                                                       ossified lumbar
                                                       vertebral arches,
                                                       and incompletely
                                                       ossified ischia
                                                       or pubis; and
                                                       reduced number of
                                                       thoracic
                                                       vertebral and rib
                                                       ossification
                                                       sites
------------------------------------------------------------------------
870.3700                          Prenatal            Maternal
                                   developmental in   NOAEL = 100 mg/kg/
                                   nonrodents          day
                                   (rabbits)          LOAEL = 250 mg/kg/
                                                       day based on
                                                       increased
                                                       abortions,
                                                       clinical signs
                                                       (hematuria and
                                                       decreased feces),
                                                       and reduced body
                                                       weight gain
                                                      Developmental
                                                      NOAEL = 100 mg/kg/
                                                       day
                                                      LOAEL = 250 mg/kg/
                                                       day based on
                                                       increased
                                                       resorptions,
                                                       decreased live
                                                       fetuses per
                                                       litter, and
                                                       decreased fetal
                                                       weights
------------------------------------------------------------------------
870.3800                          2-Generation        Parental/Systemic
                                   reproduction and   NOAEL = 14 mg/kg/
                                   fertility effects   day for males and
                                   (rats)              16 mg/kg/day for
                                                       females
                                                      LOAEL = 33 mg/kg/
                                                       day for males and
                                                       40 mg/kg/day for
                                                       females based on
                                                       decreased
                                                       maternal body
                                                       weight/body
                                                       weight gain
                                                       during gestation
                                                       in both
                                                       generation (P and
                                                       F1) and reduced
                                                       premating body
                                                       weight gain in
                                                       second generation
                                                       (F1) males
                                                      Reproductive
                                                      NOAEL = 14 mg/kg/
                                                       day for males and
                                                       16 mg/kg/day for
                                                       females
                                                      LOAEL = 33 mg/kg/
                                                       day for males and
                                                       40 mg/kg/day for
                                                       females based on
                                                       increased
                                                       duration of
                                                       gestation in
                                                       females and
                                                       degeneration and/
                                                       or atrophy of the
                                                       germinal
                                                       epithelium of the
                                                       testes and
                                                       oligospermia and
                                                       intratubular
                                                       degenerated
                                                       seminal material
                                                       in the epididymis
                                                       of F1 males
                                                      Offspring
                                                      NOAEL = 14 mg/kg/
                                                       day for males and
                                                       16 mg/kg/day for
                                                       females
                                                      LOAEL = 33 mg/kg/
                                                       day for males and
                                                       40 mg/kg/day for
                                                       females based on
                                                       reduced prenatal
                                                       viability (fetal
                                                       and litter),
                                                       reduced litter
                                                       size, increased
                                                       number of
                                                       stillborn pups,
                                                       reduced pup and
                                                       litter postnatal
                                                       survival and
                                                       decreased pup
                                                       body weights
                                                       throughout
                                                       lactation
------------------------------------------------------------------------
870.3800                          Reproduction and    Parental/Systemic
                                   fertility effects  NOAEL = 20 mg/kg/
                                   (rat)               day
                                   Nonguideline       LOAEL = 51 mg/kg/
                                                       day (F1 females)
                                                       based on decrease
                                                       in pre-mating
                                                       body weight gain
                                                       (10%)
                                                      Offspring and
                                                       Reproductive
                                                      NOAEL = 16 mg/kg/
                                                       day
                                                      LOAEL = 40 mg/kg/
                                                       day based on
                                                       reduced gestation
                                                       day 20 fetal
                                                       weights;
                                                       decreased
                                                       postnatal day 0,
                                                       4 and 7 pup
                                                       weights;
                                                       decreased pup
                                                       survival; delayed
                                                       vaginal patency;
                                                       reduced
                                                       epididymal,
                                                       prostate, and
                                                       testicular
                                                       weights
                                                      Additional
                                                       information
                                                       supports the
                                                       conclusions
                                                       reached in the 2-
                                                       generation
                                                       reproduction
                                                       study in rats
------------------------------------------------------------------------

[[Page 55273]]

870.4100                          Chronic toxicity    NOAEL = 24.9 mg/kg/
                                   dogs                day for males and
                                                       29.6 mg/kg/day
                                                       for females
                                                      LOAEL = 61.2 mg/kg/
                                                       day for males and
                                                       61.9 mg/kg/day
                                                       for females based
                                                       on compensated
                                                       normochromic
                                                       microcytosis
------------------------------------------------------------------------
870.4200                          Carcinogenicity     NOAEL = 93.9 mg/kg/
                                   mice                day for males and
                                                       116.9 mg/kg/day
                                                       for females
                                                      LOAEL = 160.5 mg/
                                                       kg/day for males
                                                       and 198.0 mg/kg/
                                                       day for females
                                                       based on dose-
                                                       related decreases
                                                       in hemoglobin and
                                                       hematocrit by
                                                       study termination
                                                      No evidence of
                                                       carcinogenicity
------------------------------------------------------------------------
870.4300                          Combined chronic    NOAEL = 40 mg/kg/
                                   toxicity/           day for males and
                                   carcinogenicity     36.4 mg/kg/day in
                                   rats                females
                                                      LOAEL = 82.2 mg/kg/
                                                       day for males and
                                                       67 mg/kg/day for
                                                       females based on
                                                       dose-related
                                                       decreased body
                                                       weights (11 and
                                                       19%), body weight
                                                       gains (13 and
                                                       26%), food
                                                       consumption (13
                                                       and 19%),
                                                       hemoglobin,
                                                       hematocrit, mean
                                                       cell volume, and
                                                       mean cell
                                                       hemoglobin.
                                                       Increased
                                                       nucleated red
                                                       blood cells and
                                                       reticulocytes in
                                                       bone of females
                                                       at 124.7 mg/kg/
                                                       day
                                                      No evidence of
                                                       carcinogenicity
------------------------------------------------------------------------
870.5100                          Gene mutation       No evidence of
                                                       compound-induced
                                                       cytotoxicity was
                                                       evident in
                                                       Salmonella
                                                       typhimurium
                                                       strains TA1535,
                                                       TA1538, TA1537,
                                                       TA98 and TA100
                                                       either in
                                                       presence or in
                                                       absence of S9
                                                       activation. The
                                                       positive controls
                                                       induced the
                                                       expected
                                                       mutagenic
                                                       responses in the
                                                       appropriate
                                                       tester strain.
                                                      Sulfentrazone was
                                                       considered not
                                                       mutagenic under
                                                       any test
                                                       condition.
------------------------------------------------------------------------
870.5300                          In vitro mammalian  In a forward gene
                                   cell gene           mutation assay,
                                   mutation assay      sulfentrazone at
                                   (mouse lymphoma)    precipitating
                                                       levels was
                                                       equivocally
                                                       positive in the
                                                       absence of S9
                                                       activation. This
                                                       response was not
                                                       repeated at doses
                                                       up to 1,800 [mu]g/
                                                       ml in the
                                                       presence of S9
                                                       activation.
------------------------------------------------------------------------
870.5395                          Mammalian           The test was
                                   erythrocyte         negative in mice
                                   micronucleus test   administered
                                                       single
                                                       intraperitoneal
                                                       doses of 85 to
                                                       340 mg/kg. The
                                                       340 mg/kg dose
                                                       was estimated to
                                                       be approximately
                                                       80% of the LD50.
                                                       No evidence of a
                                                       cytotoxic effect
                                                       on the target
                                                       organ and no
                                                       significant
                                                       increase in the
                                                       frequency of
                                                       micronucleated
                                                       polychromatic
                                                       erythrocytes in
                                                       bone marrow
                                                       cells.
------------------------------------------------------------------------
870.5450                          Dominant lethal     There were no
                                   assay- rodent       significant
                                                       difference from
                                                       negative controls
                                                       in the proportion
                                                       of early dead:
                                                       total implants,
                                                       and (total) dead:
                                                       total implants.
                                                       Based on the
                                                       results,
                                                       sulfentrazone is
                                                       considered
                                                       negative for
                                                       inducing dominant
                                                       lethal mutations
                                                       in pre-meiotic,
                                                       meiotic, and post-
                                                       meiotic germ
                                                       cells of male
                                                       rats under
                                                       conditions of
                                                       this assay up to
                                                       the estimated
                                                       MTD.
------------------------------------------------------------------------
870.6200                          Acute               NOAEL = 250 mg/kg/
                                   neurotoxicity       day
                                   screening battery  LOAEL = 750 mg/kg/
                                                       day based on
                                                       increased
                                                       incidence of
                                                       clinical signs,
                                                       FOB findings, and
                                                       decreased motor
                                                       activity which
                                                       was reversed by
                                                       day 14 postdose.
                                                       No evidence of
                                                       neuropathology at
                                                       any dose tested.
------------------------------------------------------------------------

[[Page 55274]]


870.6200                          Subchronic          NOAEL = 30 mg/kg/
                                   neurotoxicity       day for males and
                                   screening battery   37 mg/kg/day for
                                                       females
                                                      LOAEL = 150 mg/kg/
                                                       day for males and
                                                       180 mg/kg/day for
                                                       females based on
                                                       increased
                                                       incidence of
                                                       clinical signs;
                                                       decreased body
                                                       weight, body
                                                       weight gains, and
                                                       food consumption
                                                       in females; and
                                                       increased motor
                                                       activity in
                                                       females. At 5,000
                                                       ppm, included
                                                       increased
                                                       mortality;
                                                       decreased body
                                                       weights, and body
                                                       weight gains in
                                                       males; decreased
                                                       hindlimb grip
                                                       strength and
                                                       increased tail
                                                       flick latency in
                                                       males at week 8;
                                                       distended
                                                       bladders with red
                                                       fluid and
                                                       enlarged spleen.
                                                      No evidence of
                                                       neuropathology at
                                                       2,500 and 5,000
                                                       ppm.
------------------------------------------------------------------------
870.7485                          Metabolism and      Sulfentrazone
                                   pharmacokinetics    (Phenyl -14C -
                                   (rats)              sulfentrazone)
                                                       was readily
                                                       absorbed and 84
                                                       to 104% of the
                                                       administered dose
                                                       was excreted in
                                                       urine and feces
                                                       within 72 hours.
                                                       There were no
                                                       major sex
                                                       differences in
                                                       the pattern of
                                                       excretion. Almost
                                                       all the
                                                       radioactivity in
                                                       the urine was 3-
                                                       hydroxy-methyl-
                                                       F6285 (84 - 104%
                                                       of the
                                                       administered
                                                       dose). In the
                                                       feces, HMS
                                                       accounted for
                                                       1.26 to 2.55% of
                                                       the administered
                                                       dose. The
                                                       proposed
                                                       metabolic pathway
                                                       appeared to be
                                                       conversion of the
                                                       parent compound
                                                       mainly to 3-
                                                       hydroxymethyl-
                                                       F6285 (excreted
                                                       in the urine). A
                                                       small amount of 3-
                                                       hydroxymethyl-
                                                       F6285 was also
                                                       converted to 3-
                                                       carboxylic acid-
                                                       F6285 (excreted
                                                       in the urine and
                                                       feces).
------------------------------------------------------------------------

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 sulfentrazone used for human risk assessment is shown in 
Table 2 of this unit:

[[Page 55275]]

    Table 2.--Summary of Toxicological Dose and Endpoints for Sulfentrazone for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                                                 FQPA SF* and Level of
          Exposure Scenario               Dose Used in Risk         Concern for Risk     Study and Toxicological
                                            Assessment, UF             Assessment                Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (females 13-50 years of  NOAEL = 25 mg/kg/day     FQPA SF = 1X             Developmental toxicity
 age)                                  UF = 100...............  aPAD = acute RfD/FQPA     study in rats
                                       Acute RfD = 0.25 mg/kg/   SF = 0.25 mg/kg/day.    LOAEL = 50 mg/kg/day
                                        day.                                              based on decreased
                                                                                          live fetuses, and
                                                                                          increased early
                                                                                          resorptions
-----------------------------------------------------------------------------------------
Acute dietary (general population      NOAEL = 250 mg/kg/day    FQPA SF = 1X             Acute neurotoxicity
 including infants and children)       UF = 100...............  aPAD = acute RfD/FQPA     study in rats
                                       Acute RfD = 2.5 mg/kg/    SF = 2.5 mg/kg/day.     LOAEL = 750 mg/kg/day
                                        day.                                              based on increased
                                                                                          incidence of clinical
                                                                                          signs and FOB
                                                                                          parameters and
                                                                                          decreased motor
                                                                                          activity.
-----------------------------------------------------------------------------------------
Chronic dietary (all populations)      NOAEL= 14 mg/kg/day      FQPA SF = 1X             2-Generation
                                       UF = 100...............  cPAD = chronic RfD/FQPA   reproduction study
                                       Chronic RfD = 0.14 mg/    SF = 0.14 mg/kg/day.    LOAEL = 33 mg/kg/day
                                        kg/day.                                           based on decreased
                                                                                          body weight and body
                                                                                          weight gains
-----------------------------------------------------------------------------------------
Short-term (1 to 30 days) and          Offspring                LOC for MOE = 100        2-Generation
 intermediate-term (1 to 6 months)     NOAEL = 14 mg/kg/day...   (Residential)            reproduction study
 incidental oral                                                                         LOAEL = 33 mg/kg/day
                                                                                          based on decreased pup
                                                                                          body weights during
                                                                                          lactation in both
                                                                                          generations
-----------------------------------------------------------------------------------------
Short-term dermal (1 to 30 days),      Dermal study NOAEL= 100  LOC for MOE = 100        Dermal developmental
 intermediate-term dermal (1 to 6       mg/kg/day                (Residential)            study in rats
 months) and long-term dermal (>6      (dermal absorption rate                           LOAEL = 250 mg/kg/day
 months)                                = 10%).                                           based on decreased
                                                                                          fetal body weight;
                                                                                          increased incidences
                                                                                          of fetal variations:
                                                                                          hypoplastic or wavy
                                                                                          ribs, incompletely
                                                                                          ossified lumbar
                                                                                          vertebral arches, and
                                                                                          incompletely ossified
                                                                                          ischia or pubes; and
                                                                                          reduced number of
                                                                                          thoracic vertebral and
                                                                                          rib ossification sites
-----------------------------------------------------------------------------------------
Short-term inhalation (1 to 30 days),  Oral study NOAEL = 14    LOC for MOE = 100        2-Generation
 intermdiate-term inhalation (1 to 6    mg/kg/day (inhalation    (Residential)            reproduction study
 months) and long-term inhalation (>    rate = 100%                                      LOAEL = 33 mg/kg/day
 6 months)                                                                                based on decreased
                                                                                          body weight and body
                                                                                          weight gains
-----------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)      Not applicable           Not applicable           No evidence of
                                                                                          carcinogenicity in
                                                                                          rats and mice
----------------------------------------------------------------------------------------------------------------
*The reference to the 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. Tolerances have been 
established (40 CFR 180.498) for the combined residues of 
sulfentrazone, in or on soybean, seed at 0.05 ppm. Time-limited 
tolerances (set to expire on December 31, 2004) are established in 
connection with section 18 emergency exemptions for bean, succulent 
seed without pod at 0.1; horseradish, roots at 0.1 ppm; chickpea, seed 
at 0.10 ppm; pea, dry, seed 0.10 ppm; potato at 0.10 ppm; potato, wet 
peel at 0.15; flax, seed at 0.20 ppm; potato, granules/flakes at 0.20 
ppm; strawberry at 0.60 ppm. Time-limited tolerances (set to expire on 
December 31, 2005) are established in connection with section 18 
emergency exemptions for sugarcane at 0.05 ppm and sunflower at 0.1 
ppm. Tolerances are also established for indirect or inadvertent 
residues in or on cereal grain (excluding sweet corn). Risk assessments 
were conducted by EPA to assess dietary exposures from sulfentrazone 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. In conducting the acute dietary risk assessment EPA 
used the Dietary Exposure Evaluation Model software with the Food 
Commodity Intake Database (DEEMTM) which incorporates food 
consumption data 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. Separate Tier 
I, acute dietary exposure assessments were performed for females 13 to 
49 years old and for the general U.S. population (including infants and 
children) using tolerance-level residues and 100 percent crop treated 
(PCT).
    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment EPA used the DEEMTM software with the Food 
Commodity Intake Database which incorporates food consumption data as 
reported by respondents in the USDA 1994-1996 and 1998 nationwide CSFII 
and accumulated exposure to the chemical for each commodity. An 
unrefined, Tier I chronic dietary exposure assessment was performed 
using tolerance-level residues and 100 PCT.
    2. Dietary exposure from drinking water. Sulfentrazone and the 
degradate 3-carboxylic acid sulfentrazone are the residues of concern 
for the drinking-water risk assessment. Environmental

[[Page 55276]]

fate data suggest that sulfentrazone and 3-carboxylic acid 
sulfentrazone are persistent and mobile. Based on the structure 
similarity, 3-carboxylic acid sulfentrazone could potentially have 
similar toxicity as the parent.
    The Agency lacks sufficient monitoring exposure data to complete a 
comprehensive dietary exposure analysis and risk assessment for 
sulfentrazone 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 sulfentrazone.
    The Agency uses the FQPA Index Reservoir Screening Tool (FIRST) or 
the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/
EXAMS), to produce estimates of pesticide concentrations in an index 
reservoir. The Screening Concentrations in 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. FIRST and PRZM/EXAMS 
incorporate an index reservoir environment, and both models include 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 unlikely that drinking water concentrations would 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 sulfentrazone, they are 
further discussed in the aggregate risk sections in Unit E.
    Based on the FIRST and SCI-GROW models the EECs of sulfentrazone 
plus its major metabolite 3-carboxylic acid for acute exposures are 
estimated to be 35.8 parts per billion (ppb) for surface water and 26.0 
ppb for ground water. The EECs for chronic exposures are estimated to 
be 7.8 ppb for surface water and 26.0 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). Sulfentrazone is 
proposed for use on use on turf by professional lawn care operators as 
a broadcast spray at a maximum application rate of 0.03 lbs active 
ingredient. Based on the proposed use pattern, potential residential/
non-occupational post-application exposures include the following: 
Short-term oral turfgrass exposure (toddler hand-to-mouth, object-to-
mouth); short-term dermal turfgrass exposure (adult and toddler) and 
short-term dermal golfer exposure (adult and adolescent). Incidental 
ingestion of soil is assumed to be negligible. Exposure over 
intermediate-term (1-6 months) or long-term (chronic, more than 6 
months) exposure is not expected. Homeowner handler exposure is not 
expected since sulfentrazone will be applied by professional lawn care 
operators.
    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 sulfentrazone 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 sulfentrazone 
and any other substances and sulfentrazone 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 sulfentrazone 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://www.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 is evidence of 
increased quantitative susceptibility following in utero exposure in 
the developmental-toxicity studies in rats via the oral and dermal 
routes, and there is evidence for increased qualitative susceptibility 
following prenatal and/or postnatal exposure in the 2-generation 
reproduction study in rats. A Degree of Concern Analysis was performed 
by EPA and it was concluded that concerns are low for the quantitative 
susceptibility of rat fetuses observed following oral and dermal 
exposures, the qualitative susceptibility of rabbit fetuses seen via 
the oral route, and the qualitative susceptibility seen in the 1- and 
2-generation reproduction studies. The conclusion was based on the 
following:
     The dose-response was well characterized.
     There were clear NOAELs and LOAELs for developmental, 
offspring, maternal, and parental toxicities.
     The developmental effects in rabbits and the offspring 
effects in the rats were seen in the presence of maternal and parental 
toxicities, respectively.
     The parental reproductive and offspring effects were 
reproducible between the two reproductive studies.
    3. Conclusion. There is a complete toxicity data base for 
sulfentrazone and

[[Page 55277]]

exposure data are complete or are estimated based on data that 
reasonably accounts for potential exposures. EPA determined that the 
10X safety factor to protect infants and children should be reduced to 
1X for the following reasons:
    1. There are no residual uncertainties for prenatal and/or 
postnatal toxicities via the oral route since the doses selected for 
overall risk assessments would address the concerns for the 
developmental and offspring toxicities seen in the above mentioned 
studies.
    2. There are no residual uncertainties for prenatal and/or 
postnatal toxicities via the dermal route since the dose/endpoint/
study/species of concern was used for dermal-risk assessment.
    3. The toxicology data base is complete.
    4. The dietary (food) exposure assessment utilizes existing and 
proposed tolerance level residues and assumes 100% of crops treated 
with sulfentrazone. The assessment is based on reliable data and is not 
expected to underestimate exposure/risk.
    5. Conservative assumptions are used in the drinking water models. 
The drinking water exposure assessment is not expected to underestimate 
exposure/risk.
    6. The residential exposure assessment is based on conservative 
assumptions and is not expected to underestimate risk.

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, EPA concludes with reasonable certainty that 
exposures to the pesticide in drinking water (when considered along 
with other sources of exposure for which EPA has reliable data) would 
not result in unacceptable levels of aggregate human health risk at 
this time. Because EPA 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, EPA 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 
sulfentrazone will occupy <1% of the aPAD for the U.S. population, <1% 
of the aPAD for females 13 years and older, and <1% of the aPAD for 
children 1 to 2 years old, the population at greatest exposure. In 
addition, there is potential for acute dietary exposure to 
sulfentrazone 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 aPAD, as shown in 
Table 3 of this unit:

                     Table 3.--Aggregate Risk Assessment for Acute Exposure to Sulfentrazone
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                 aPAD (mg/      % aPAD     Water EEC    Water EEC   Acute DWLOC
                                                     kg)         (Food)       (ppb)        (ppb)        (ppb)
----------------------------------------------------------------------------------------------------------------
 U.S. population                                         2.5           <1         35.8           26       87,000
----------------------------------------------------------------------------------------
Children (1 to 2 years old)                              2.5           <1         35.8           26       25,000
----------------------------------------------------------------------------------------
Females (13 to 49 years old)                             2.5           <1         35.8           26       75,000
----------------------------------------------------------------------------------------------------------------

    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
sulfentrazone from food will utilize 1% of the cPAD for the U.S. 
population, 1% of the cPAD for females 13 to 49 years old and 1 % of 
the cPAD for children, 3 to 5 years old, the population at greatest 
exposure. Based on the proposed use pattern for turf grass, chronic 
residential exposure to residues of sulfentrazone is not expected. In 
addition, there is potential for chronic dietary exposure to 
sulfentrazone and its degredate, 3-carboxylic acid sulfentrazone, 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 cPAD, as shown in Table 4 of this unit:

[[Page 55278]]

             Table 4.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Sulfentrazone
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                cPAD mg/kg/     % cPAD     Water EEC    Water EEC     Chronic
                                                     day         (Food)       (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population                                         0.14            1          7.8           26        4,900
----------------------------------------------------------------------------------------
Children (3 to 5 years old)                             0.14            1          7.8           26        1,400
----------------------------------------------------------------------------------------
Females (13 to 49 years old)                            0.14            1          7.8           26        4,200
----------------------------------------------------------------------------------------------------------------

    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).
    Sulfentrazone is proposed for registration for 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 sulfentrazone. 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 
ranging from 6,900 for the U.S. population to 3,200 for children 3 to 5 
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 sulfentrazone in ground water and surface 
water. After calculating DWLOCs and comparing them to the EECs for 
surface water 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 Sulfentrazone
----------------------------------------------------------------------------------------------------------------
                                                               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                                        6,900          100          7.8           26        4,900
----------------------------------------------------------------------------------------
Children (3 to 5 years old)                            3,200          100          7.8           26        1,400
----------------------------------------------------------------------------------------
Females (13 to 49 years)                               7,600          100          7.8           26        4,200
----------------------------------------------------------------------------------------------------------------

    5. Aggregate cancer risk for U.S. population. There is no evidence 
of carcinogenicity to humans based on carcinogenicity studies in male 
and female rats and mice. The Agency concludes that pesticidal uses of 
sulfentrazone are not likely to pose a cancer hazard to humans.
    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 sulfentrazone residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    An adequate enforcement method using gas chromatography (GC) for 
the determination of sulfentrazone, DMS, and HMS residues is available 
for enforcement. The method was forwarded to the Food and Drug 
Administration (FDA) for inclusion in Pesticide Analytical Method 
Volume II (PAM II). 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 established Codex, Canadian or Mexican maximum residue 
limits (MRLs) for residues of sulfentrazone in/on the subject 
commodities. Therefore, no compatibility problems exist for the 
tolerances established by this rule.

V. Conclusion

    Therefore, the tolerance is established for combined residues of 
sulfentrazone and its metabolites HMS (N-(2,4-dichloro-5-(4-
(difluoromethyl)-4,5-dihydro-3-hydroxymethyl-5-oxo-1H-1,2,4-triazol-1-
yl)phenyl)methanesulfonamide) and DMS (N-(2,4-dichloro-5-(4-
(difluoromethyl)-4,5-dihydro-5-oxo-1H-1,2,4-triazol-1-
yl)phenyl)methanesulfonamide, in or on asparagus at 0.15 ppm; bean, 
lima, succulent at 0.15 ppm; cabbage at 0.20 ppm; corn, field, forage 
at 0.20 ppm; corn, field, grain at 0.15 ppm; corn, field, stover at 
0.30 ppm; horseradish, roots at 0.20 ppm; pea and bean, dried shelled, 
except soybean, subgroup 6C at 0.15 ppm; peanut at 0.20 ppm; peanut, 
meal at 0.40 ppm; peppermint, tops at 0.30 ppm; potato at 0.15 ppm; 
spearmint, tops at 0.30 ppm; sugarcane, cane 0.15 ppm; sugarcane, 
molasses 0.20 ppm; and sunflower, seed at 0.20 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 
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

[[Page 55279]]

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-2003-0270 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 
24, 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-2003-0270, 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 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

[[Page 55280]]

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 (59 FR 22951, 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 10, 2003.
Debra Edwards,
Director, Registration Division, 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 180.498 is amended by redesignating existing paragraph (a) 
as (a)(1), by adding paragraph (a)(2), and in the table to paragraph 
(b) by removing the entries ``horseradish, roots''; ``pea, dry, seed''; 
``potato''; ``potato, granules/flakes''; ``potato, wet peel''; 
``sugarcane''; and ``sunflower, seed.''

Sec.  180.498  Sulfentrazone; tolerances for residues.

    (a) General. (1) * * *
    (2) Tolerances are established for combined residues of the 
herbicide sulfentrazone and its metabolites HMS (N-(2,4-dichloro-5-(4-
(difluoromethyl)-4,5-dihydro-3-hydroxymethyl-5-oxo-1H-1,2,4-triazol- 1-
yl)phenyl)methanesulfonamide) and DMS (N-(2,4-dichloro-5-(4-
(difluoromethyl)-4,5-dihydro-5-oxo-1H-1,2,4-triazol-1-
yl)phenyl)methanesulfonamide in or on the following food commodities:

----------------------------------------------------------------------------------------------------------------
                       Commodity                                            Parts per million
----------------------------------------------------------------------------------------------------------------
Asparagus.............................................                                                      0.15
Bean, lima, succulent.................................                                                      0.15
Cabbage...............................................                                                      0.20
Corn, field, forage...................................                                                      0.20
Corn, field, grain....................................                                                      0.15
Corn, field, stover...................................                                                      0.30
Horseradish, roots....................................                                                      0.20
Pea and bean, dried shelled, except soybean, subgroup                                                       0.15
 6C...................................................
Peanut................................................                                                      0.20
Peanut, meal..........................................                                                      0.40
Peppermint, tops......................................                                                      0.30
Potato................................................                                                      0.15
Spearmint, tops.......................................                                                      0.30
Sugarcane, cane.......................................                                                      0.15
Sugarcane, molasses...................................                                                      0.20
Sunflower, seed.......................................                                                      0.20
----------------------------------------------------------------------------------------------------------------

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[FR Doc. 03-24011 Filed 9-23-03; 8:45 am]
BILLING CODE 6560-50-S