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sulfentrazone (Authority) Pesticide Tolerances for Emergency Exemptions 11/00


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[Federal Register: November 9, 2000 (Volume 65, Number 218)]
[Rules and Regulations]
[Page 67272-67280]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09no00-14]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301074; FRL-6751-7]
RIN 2070-AB78


Sulfentrazone; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION:  Final rule.

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SUMMARY:  This regulation establishes time-limited tolerances for
combined residues of sulfentrazone N-[2,4-dichloro-5-[4-
(difluoromethyl)-4,5-dihydro-3-methyl-5-oxo-1H-1,2,4-triazol-1-
yl]phenyl]methanesulfonamide and its major metabolite 3-hydroxymethyl
sulfentrazone N-[2,4-dichloro-5-[4-(difluoromethyl)-4,5-dihydro-3-
hydroxymethyl-5-oxo-1H-1,2,4-triazol-1-yl]phenyl]methanesulfonamide in
or on horseradish and sugarcane. This action is in response to EPA's
granting of emergency exemptions under section 18 of the Federal
Insecticide, Fungicide, and Rodenticide Act authorizing use of the
pesticide on horseradish and sugarcane. This regulation establishes a
maximum permissible level for combined residues of sulfentrazone in
these food commodities. The tolerances will expire and are revoked on
December 31, 2002.

DATES:  This regulation is effective November 9, 2000. Objections and
requests for hearings, identified by docket control number OPP-301074,
must be received by EPA on or before January 8, 2001.

ADDRESSES:  Written objections and hearing requests may be submitted by
mail, in person, or by courier. Please follow the detailed instructions
for each method as provided in Unit VII. of the SUPPLEMENTARY
INFORMATION. To ensure proper receipt by EPA, your objections and
hearing requests must identify docket control number OPP-301074 in the
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT:  By mail: Meredith Laws, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460;
telephone number: 703 305-9366; and e-mail address:
laws.meredith@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does This Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected categories and entities may include, but are not
limited to:

------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS codes         potentially
                                                      affected  entities
------------------------------------------------------------------------
Industry                          111                 Crop production
  ..............................  112                 Animal production
                                  311                 Food manufacturing
  ..............................  32532               Pesticide
                                                       manufacturing
------------------------------------------------------------------------

    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 the table could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether or not this action might apply to certain entities. If you have
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 Additional Information, Including Copies of This
Document and Other Related Documents?

    1. Electronically.You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, from the EPA Internet Home Page at http://www.epa.gov/.
To access this document, on the Home Page select ``Laws and
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the
entry for this document under the ``Federal Register--Environmental
Documents.'' You can also go directly to the Federal Register listings
at http://www.epa.gov/fedrgstr/.
    2. In person. The Agency has established an official record for
this action under docket control number OPP-301074. The official record
consists of the documents specifically referenced in this action, and
other information related to this action, including any information
claimed as Confidential Business Information (CBI). This official
record includes the documents that are physically located in the
docket, as well as the documents that are referenced in those
documents. The public version of the official record does not include
any information claimed as CBI. The public version of the official
record, which includes printed, paper versions of any electronic
comments submitted during an applicable comment period is available for
inspection in the Public Information and Records Integrity Branch
(PIRIB), Rm. 119, Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA,
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The PIRIB telephone number is (703) 305-5805.

[[Page 67273]]

II. Background and Statutory Findings

     EPA, on its own initiative, in accordance with sections 408(e) and
408 (l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 346a, is establishing a tolerance for combined residues of the
herbicide sulfentrazone, in or on horseradish and sugarcane at 0.1 and
0.05 part per million (ppm) respectively. These tolerances will expire
and are revoked on December 31, 2002. EPA will publish a document in
the Federal Register to remove the revoked tolerance from the Code of
Federal Regulations.
    Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under section 18
of FIFRA. Such tolerances can be established without providing notice
or period for public comment. EPA does not intend for its actions on
section 18 related tolerances to set binding precedents for the
application of section 408 and the new safety standard to other
tolerances and exemptions. Section 408(e) of the FFDCA allows EPA to
establish a tolerance or an exemption from the requirement of a
tolerance on its own initiative, i.e., without having received any
petition from an outside party.
     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) 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)
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. . . . ''
    Section 18 of the FIFRA authorizes EPA to exempt any Federal or
State agency from any provision of FIFRA, if EPA determines that
``emergency conditions exist which require such exemption.'' This
provision was not amended by the Food Quality Protection Act (FQPA).
EPA has established regulations governing such emergency exemptions in
40 CFR part 166.

III. Emergency Exemptions for Sulfentrazone on Horseradish and
Sugarcane and FFDCA Tolerances

    Illinois submitted a section 18 request for the emergency use of
sulfentrazone on horseradish to control annual broadleaf weeds. EPA
reviewed the request and concluded that the situation was urgent and
nonroutine because heavy rains, urbanization, and drainage canal
problems led to flooding of fields during the spring of 1999 resulting
in significant problems with yellow nutsedge and broadleaf weeds.
    Louisiana submitted a section 18 request for the emergency use of
sulfentrazone to control morning glories infesting sugarcane fields.
EPA agrees that morning glory infestations may create emergency
conditions for growers since the registered alternative herbicide is
ineffective against late season infestations when used on a higher
yielding sugarcane variety. Due to this variety's earlier lay-by, late
season applications of soil herbicides are not possible. Additionally,
morning glory vines can cause indirect economic costs to growers by
disabling combine-type harvesters.
    EPA has authorized under FIFRA section 18 the use of sulfentrazone
on horseradish and sugarcane for control of annual broadleaf weeds in
Illinois and morning glories in Louisiana, respectively. After having
reviewed the submissions, EPA concurs that emergency conditions exist
for these States.
    As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by the combined residues of sulfentrazone
in or on horseradish and sugarcane. In doing so, EPA considered the
safety standard in FFDCA section 408(b)(2), and EPA decided that the
necessary tolerances under FFDCA section 408(l)(6) would be consistent
with the safety standard and with FIFRA section 18. Consistent with the
need to move quickly on the emergency exemptions in order to address an
urgent non-routine situation and to ensure that the resulting food is
safe and lawful, EPA is issuing these tolerances without notice and
opportunity for public comment as provided in section 408(l)(6).
Although these tolerances will expire and are revoked on December 31,
2002, under FFDCA section 408(l)(5), residues of the pesticide not in
excess of the amounts specified in the tolerances remaining in or on
horseradish and sugarcane after that date will not be unlawful,
provided the pesticide is applied in a manner that was lawful under
FIFRA, and the residues do not exceed a level that was authorized by
these tolerances at the time of that application. EPA will take action
to revoke these tolerances earlier if any experience with, scientific
data on, or other relevant information on this pesticide indicate that
the residues are not safe.
    Because these tolerances are being approved under emergency
conditions, EPA has not made any decisions about whether sulfentrazone
meets EPA's registration requirements for use on horseradish or on
sugarcane or whether permanent tolerances for these uses would be
appropriate. Under these circumstances, EPA does not believe that these
tolerances serve as a basis for registration of sulfentrazone by a
State for special local needs under FIFRA section 24(c). Nor do these
tolerances serve as the basis for any State other than Illinois and
Louisiana to use this pesticide on these crops under section 18 of
FIFRA without following all provisions of EPA's regulations
implementing section 18 as identified in 40 CFR part 166. For
additional information regarding the emergency exemptions for
sulfentrazone, contact the Agency's Registration Division at the
address provided under FOR FURTHER INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

    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 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) .
    Consistent with section 408(b)(2)(D), 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
sulfentrazone and to make a determination on aggregate exposure,
consistent with section 408(b)(2), for time-limited tolerances for
combined residues of sulfentrazone in or on horseradish and sugarcane
at 0.1 and 0.05 ppm, respectively. EPA's assessment of the dietary
exposures and risks associated with establishing these tolerances
follows.

A. 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

[[Page 67274]]

used to estimate the toxicological endpoint. 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 intra species 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 factor 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 Safety Factor.
    For non-dietary risk assessments (other than cancer) the UF is used
to determine the level of concern (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 x10-6 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
the following Table 1:

    Table 1.--Summary of Toxicological Doses 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 = 10.0 mg/kg/day   FQPA SF = 10 aPAD =      Rat Developmental LOAEL
 age                                    UF = 100 Acute RfD =     acute RfD/FQPA SF =      = 25 mg/kg/day based
                                        0.10 mg/kg/day           0.01 mg/kg/day           on decreased fetal
                                                                                          weight and retarded
                                                                                          skeletal development
                                                                                          as evidenced by an
                                                                                          increased number of
                                                                                          litters with any
                                                                                          variation and by
                                                                                          decreased numbers of
                                                                                          caudal vertebral and
                                                                                          metacarpal
                                                                                          ossification sites.
----------------------------------------------------------------------------------------------------------------

Acute Dietary general population       NOAEL = 250 mg/kg/day    FQPA SF = 10 aPAD =      Acute Neurotoxicity
 including infants and children         UF = 100 Acute RfD =     acute RfD/FQPA SF =      Study in Rats LOAEL =
                                        2.5 mg/kg/day            0.25 mg/kg/day           750 mg/kg/day based on
                                                                                          increased incidences
                                                                                          of clinical signs
                                                                                          abdominal gripping,
                                                                                          abdominogenital
                                                                                          staining, and/or
                                                                                          reddish- brown
                                                                                          staining under the
                                                                                          cage, FOB findings,
                                                                                          and decreased motor
                                                                                          activity which was
                                                                                          reversed by Day 14
                                                                                          postdose. There was no
                                                                                          evidence of
                                                                                          neuropathology at the
                                                                                          highest dose tested
                                                                                          (2,000 mg/kg/day).
----------------------------------------------------------------------------------------------------------------

[[Page 67275]]

Chronic Dietary all populations        NOAEL= 14.0 mg/kg/day    FQPA SF = 10 cPAD =      2-Gen. Repro. Study in
                                        UF = 100 Chronic RfD =   chronic RfD/FQPA SF =    Rats LOAEL = 33/44 mg/
                                        0.14 mg/kg/day           0.014 mg/kg/day          kg/day in males and
                                                                                          females, respectively
                                                                                          based on 1) decreased
                                                                                          maternal body weight
                                                                                          and/or body weight
                                                                                          gain during gestation
                                                                                          in both P and F1
                                                                                          generations, 2)
                                                                                          reduced premating body
                                                                                          weight gains in the
                                                                                          second generation (F1
                                                                                          adults), 3) increased
                                                                                          duration of gestation
                                                                                          in both F1 and F2
                                                                                          dams, 4) reduced
                                                                                          prenatal viability
                                                                                          (fetal and litter), 5)
                                                                                          reduced litter size,
                                                                                          6) increased number of
                                                                                          stillborn pups, 7)
                                                                                          reduced pup and litter
                                                                                          postnatal survival,
                                                                                          and 8) decreased pup
                                                                                          body weights
                                                                                          throughout gestation.
                                                                                          In males, effects
                                                                                          included decreased
                                                                                          fertility in F1
                                                                                          generation and/or
                                                                                          atrophy of the
                                                                                          germinal epithelium of
                                                                                          the testes,
                                                                                          oligospermia and
                                                                                          intratubular
                                                                                          degeneration of the
                                                                                          seminal product in the
                                                                                          epididymis.

----------------------------------------------------------------------------------------------------------------
 *The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns unique
  to the FQPA.

B. 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 a variety of raw agricultural commodities. A
permanent tolerance has been established for soybean, seed at 0.05 ppm.
Time-limited tolerances have been established for cowpeas, lima beans,
and sunflowers, with an expiration date of 12/30/00. 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 one day
or single exposure. The Dietary Exposure Evaluation Model (DEEM )
analysis evaluated the individual food consumption as reported by
respondents in the USDA 1989-1992 nationwide Continuing Surveys of Food
Intake by Individuals (CSFII) and accumulated exposure to the chemical
for each commodity. The following assumptions were made for the acute
exposure assessments: Two acute doses and endpoints were selected, one
for the females 13+ years old population subgroup and another for the
U.S. population and other subgroups (excluding females 13+ years old).
Therefore, acute dietary exposure analyses were performed using two
separate endpoints. Tolerance level residues and 100% crop treated were
used for all commodities (Tier 1). As the acute analyses were Tier 1
assessments, acute risk estimates are shown at the 95th percentile.
    ii. Chronic exposure. In conducting this chronic dietary risk
assessment the Dietary Exposure Evaluation Model (DEEM ) analysis
evaluated the individual food consumption as reported by respondents in
the USDA 1989-1992 nationwide Continuing Surveys of Food Intake by
Individuals (CSFII) and accumulated exposure to the chemical for each
commodity. The following assumptions were made for the chronic exposure
assessments: Tolerance level residues and 100% crop treated information
were used for all commodities (Tier 1).
    iii. Cancer. Sulfentrazone has been classified as a ``Group E''
chemical (not likely to be carcinogenic to humans via relevant routes
of exposure). Therefore, no cancer dietary exposure risk analysis was
performed.
    2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for 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 Generic Estimated Environmental Concentration
(GENEEC) or the Pesticide Root Zone/Exposure Analysis Modeling System
(PRZM/EXAMS) to estimate pesticide concentrations in surface water and
SCI-GROW, which predicts pesticide concentrations in groundwater. In
general, EPA will use GENEEC (a tier 1 model) before using PRZM/EXAMS
(a tier 2 model) for a screening-level assessment for surface water.
The GENEEC model is a subset of the PRZM/EXAMS model that uses a
specific high-end runoff scenario for pesticides.

[[Page 67276]]

 GENEEC incorporates a farm pond scenario, while PRZM/EXAMS incorporate
an index reservoir environment in place of the previous pond scenario.
The PRZM/EXAMS model includes a percent crop area factor as an
adjustment to account for the maximum percent crop coverage within a
watershed or drainage basin.
    None of these models include consideration of the impact processing
(mixing, dilution, or treatment) of raw water for distribution as
drinking water would likely have on the removal of pesticides from the
source water. The primary use of these models by the Agency at this
stage is to provide a coarse screen for sorting out pesticides for
which it is highly unlikely that drinking water concentrations would
ever exceed human health levels of concern.
    Since the models used are considered to be screening tools in the
risk assessment process, the Agency does not use estimated
environmental concentrations (EECs) from these models to quantify
drinking water exposure and risk as a %RfD or %PAD. Instead drinking
water levels of comparison (DWLOCs) are calculated and used as a point
of comparison against the model estimates of a pesticide's
concentration in water. DWLOCs are theoretical upper limits on a
pesticide's concentration in drinking water in light of total aggregate
exposure to a pesticide in food, and from residential uses. Since
DWLOCs address total aggregate exposure to sulfentrazone they are
further discussed in the aggregate risk sections below.
    Based on the GENEEC and SCI-GROW models the EECs of sulfentrazone
for acute exposures are estimated to be 12.5 parts per billion (ppb)
for surface water and 21.8 ppb for ground water. The EECs for chronic
exposures are estimated to be 12.0 ppb for surface water and 10.2 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 not registered for use on any sites that would
result in residential exposure.
    4.  Cumulative exposure to substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) 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 or how to include this pesticide in a cumulative risk
assessment. Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity,
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 final rule
for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

C. Safety Factor for Infants and Children

    1. Safety factor for infants and children-- i. In general. FFDCA
section 408 provides that EPA shall apply an additional ten-fold 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 margin of exposure (MOE) analysis or through
using uncertainty (safety) factors in calculating a dose level that
poses no appreciable risk to humans.
    ii. Developmental toxicity studies-- a. Rats. In the oral
developmental study in rats, the maternal (systemic) NOAEL was 25 mg/
kg/day, based on increased spleen weights and splenic extramedullary
hematopoiesis at the LOAEL of 50 mg/kg/day. The developmental (fetal)
NOAEL was 10 mg/kg/day, based on decreased mean fetal weight and
retardation in skeletal development as evidenced by increased numbers
of litters with any variation and by decreased numbers of caudal
vertebral and metacarpal ossification sites at the LOAEL of 25 mg/kg/
day.
    In the dermal developmental study in rats, the maternal (systemic)
NOAEL was 250 mg/kg/day and a LOAEL was not determined. The
developmental (fetal) NOAEL was 100 mg/kg/day, based on decreased fetal
weight and increased fetal variations (hypoplastic or wavy ribs,
incompletely ossified lumbar vertebral arches, incompletely ossified
ischia or pubes, and reduced numbers of thoracic vertebral and rib
ossification sites) at the LOAEL of 250 mg/kg/day.
    b. Rabbits. In the oral developmental toxicity study in rabbits,
the maternal (systemic) NOAEL was 100 mg/kg/day, based on increased
abortions, clinical signs (decreased feces and hematuria), and reduced
body weight gain during gestation at the LOAEL of 250 mg/kg/day. The
developmental (pup) NOAEL was 100 mg/kg/day, based on increased
resorptions, decreased live fetuses per litter, and decreased fetal
weight at the LOAEL of 250 mg/kg/day.
    iii. Reproductive toxicity study-- Rats. In the 2-generation
reproductive toxicity study in rats, the maternal (systemic) NOAEL was
14/16 mg/kg/day in males and females, respectively, based on decreased
maternal body weight and/or body weight gain during gestation in both P
and F1 generations, and reduced premating body weight gains in the
second generation (F1 adults) at the LOAEL of 33/44 mg/kg/day for males
and females, respectively. The developmental (pup) NOAEL was 14/16 mg/
kg/day based on 1) reduced prenatal viability (fetal and litter), 2)
reduced litter size, 3) increased number of stillborn pups, 4) reduced
pup and litter postnatal survival, and 5) decreased pup body weights
throughout lactation at the LOAEL of 33/44 mg/kg/day. The reproductive
NOAEL was 14/16 mg/kg/day, based on 1) increased duration of gestation
in both F1 and F2 dams, 2) decreased fertility in F1 generation
(males), and/or 3) atrophy of the germinal epithelium of the testes,
oligospermia and intratubular degeneration of the seminal product in
the epididymis at the LOAEL of 33/44 mg/kg/day.
    iv. Prenatal and postnatal sensitivity. The toxicological data base
for evaluating prenatal and postnatal toxicity for sulfentrazone is
complete with respect to current data requirements. Based on the
developmental and reproductive toxicity studies discussed above for
sulfentrazone there appears to be prenatal and postnatal sensitivity.
    v. Conclusion. There is a complete toxicity data base for
sulfentrazone and 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
retained. For acute dietary analysis, the FQPA SF was retained and is
applicable to the U.S. population and all subgroups due to the
increased susceptibility observed in the prenatal developmental
studies. For chronic dietary analysis, the

[[Page 67277]]

FQPA safety factor was retained and is applicable for all populations
due to the qualitative increased susceptibility observed in the 2-
generation reproduction study.

D. 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 + chronic non-dietary, non-occupational 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: 2L/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 groundwater are less than the
calculated DWLOCs, OPP concludes with reasonable certainty that
exposures to sulfentrazone in drinking water (when considered along
with other sources of exposure for which OPP has reliable data) would
not result in unacceptable levels of aggregate human health risk at
this time. Because OPP considers the aggregate risk resulting from
multiple exposure pathways associated with a pesticide's uses, levels
of comparison in drinking water may vary as those uses change. If new
uses are added in the future, OPP will reassess the potential impacts
of sulfentrazone on 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, 6% of
the aPAD for females 13 years and older, 1% of the aPAD for all infants
(1 year old) and 1% of the aPAD for children (1-6 years old). In
addition, despite the potential for acute dietary exposure to
sulfentrazone in drinking water, after calculating DWLOCs and comparing
them to conservative model estimated environmental concentrations of
sulfentrazone in surface and ground water, EPA does not expect the
aggregate exposure to exceed 100% of the aPAD, as shown in the
following Table 2.

                     Table 2.--Aggregate Risk Assessment for Acute Exposure to Sulfentrazone
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
           Population Subgroup                aPAD (mg/kg)       % aPAD     Water EEC    Water EEC   Acute DWLOC
                                                                 (Food)       (ppb)        (ppb)        (ppb)
----------------------------------------------------------------------------------------------------------------
Females, 13-50 years old                                0.01            6         12.5         21.8          284
----------------------------------------------------------------------------------------------------------------
U.S. population (including infants and                  0.25            1         12.5         21.8        8,700
 children)
----------------------------------------------------------------------------------------------------------------
Children (1-6 years old) and all infants                0.25            1         12.5         21.8         2484
 (1 year old)
----------------------------------------------------------------------------------------------------------------

    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 2% of the cPAD for the U.S.
population, 4% of the cPAD for all infants ( 1 year old) and 6 % of the
cPAD for children (1-6 years old). There are no residential uses for
sulfentrazone that result in chronic residential exposure to
sulfentrazone. In addition, despite the potential for chronic dietary
exposure to sulfentrazone in drinking water, after calculating DWLOCs
and comparing them to conservative model estimated environmental
concentrations of sulfentrazone in surface and ground water, EPA does
not expect the aggregate exposure to exceed 100% of the cPAD, as shown
in the following Table 3:

             Table 3.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Sulfentrazone
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
           Population Subgroup                cPAD (mg/kg)       % cPAD     Water EEC    Water EEC     Chronic
                                                                 (Food)       (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S Population                                         0.014            2          4.0         10.2          478
----------------------------------------------------------------------------------------------------------------
Children (1-6 years old)                               0.014            6          4.0         10.2          132
----------------------------------------------------------------------------------------------------------------
Children (Females 13-50 years old)                     0.014            2          4.0         10.2          412
----------------------------------------------------------------------------------------------------------------
Males (13-19 years old)                                0.014            3          4.0         10.2          477
----------------------------------------------------------------------------------------------------------------

    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 not registered for use on any sites that would
result in residential exposure. Therefore, the aggregate risk is the
sum of the risk from food and water, which were previously addressed.

[[Page 67278]]

    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account non-dietary, non-occupational exposure plus chronic
exposure to food and water (considered to be a background exposure
level).
    Sulfentrazone is not registered for use on any sites that would
result in residential exposure. Therefore, the aggregate risk is the
sum of the risk from food and water, which were previously addressed.
    5. Aggregate cancer risk for U.S. population. Because sulfentrazone
is not a carcinogen, a cancer aggregate risk assessment was not
conducted.
    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.

V. Other Considerations

A. Analytical Enforcement Methodology

    An analytical methodology for the determination of sulfentrazone,
3-desmethyl sulfentrazone, and 3-hydroxymethyl sulfentrazone residues
in/on various matrices was submitted with a petition for a
sulfentrazone tolerance on soybeans. A petition method validation (PMV)
was successfully completed by the Agency's Analytical Chemistry
Laboratory. The Limit of Quantitation (LOQ) and Minimum Detection Limit
(MDL) were determined to be 0.05 ppm and 0.005-0.025 ppm, respectively.
EPA concluded that the method is suitable for enforcement purposes.
    Adequate enforcement methodology (example - gas chromotography) is
available to enforce the tolerance expression. The method may be
requested from: Calvin Furlow, PIRIB, IRSD (7502C), Office of Pesticide
Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW,
Washington, DC 20460; telephone number: (703) 305-5229; e-mail address:
furlow.calvin@epa.gov.

B. International Residue Limits

    There are no Codex, Canandian or Mexican residue limits for
sulfentrazone on horseradish and sugarcane. Therefore, no compatibility
problems exist for the proposed tolerances.

C. Conditions

    Rotational field trial data for wheat, corn, rice and sorghum were
submitted in support of a petition for a sulfentrazone tolerance on
soybeans. Permanent tolerances have been established on cereal grains
(excluding sweet corn) when planted in rotation with the primary crop
soybeans. The suggested rotational crop restrictions on the Section 18
labels pertaining to these emergencies are the same as those on the
label for soybeans. Therefore, additional rotational crop data are not
necessary for this action.

VI. Conclusion

    Therefore, the tolerances are established for combined residues of
sulfentrazone, in or on horseradish and sugarcane at 0.1 and 0.05 ppm,
respectively.

VII. 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 of 1996, EPA will continue to use those
procedures, with appropriate adjustments, until the necessary
modifications can be made. The new section 408(g) 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), as was provided in the old FFDCA sections 408 and 409.
However, the period for filing objections is now 60 days, rather than
30 days.

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

    You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket control number OPP-301074 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 January
8, 2001.
    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 (1900),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460. You may also deliver your request to the Office
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW.,
Washington, DC 20460. 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 (202) 260-4865.
    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.
    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.
    3. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VII.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.2. Mail your
copies, identified by the docket control number OPP-301074, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental

[[Page 67279]]

Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
In person or by courier, bring a copy to the location of the PIRIB
described in Unit I.B.2. 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 file format 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).

VIII. Regulatory Assessment Requirements

    This final rule establishes a time-limited tolerance under FFDCA
section 408. 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).
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 prior consultation
as specified by Executive Order 13084, entitled Consultation and
Coordination with Indian Tribal Governments (63 FR 27655, May 19,
1998); special considerations as required by Executive Order 12898,
entitled Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994);
or require 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 FIFRA
section 18 petition under FFDCA section 408, such as the tolerance/
exemption 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
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 FFDCA section 408(n)(4).

IX. Submission to Congress and the Comptroller General

    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: October 25, 2000.

Peter Caulkins,

Acting 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), (346a) and 371.

    2. Section 180.498 is amended by alphabetically adding the
commodities to the table in paragraph (b) to read as follows:

Sec. 180.498   Sulfentrazone; tolerances for residues.

* * * * *
    (b)* * *

----------------------------------------------------------------------------------------------------------------
                           Commodity                             Parts per million   Expiration/Revocation Date
----------------------------------------------------------------------------------------------------------------
     *                *                *                *                *                *                *
Horseradish, Roots.............................................                0.1                      12/31/02
     *                *                *                *                *                *                *
Sugarcane......................................................               0.05                      12/31/02
     *                *                *                *                *                *                *
----------------------------------------------------------------------------------------------------------------

[[Page 67280]]

* * * * *

[FR Doc. 00-28714 Filed 11-8-00; 8:45 am]
BILLING CODE 6560-50-S
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Last Modified: 10/19/2000
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