Sulfentrazone; Pesticide Tolerances for Emergency Exemptions

Note: EPA no longer updates this information, but it may be useful as a reference or resource.

[Federal Register: August 21, 2002 (Volume 67, Number 162)]
[Rules and Regulations]
[Page 54111-54119]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21au02-11]

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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2002-0176; FRL-7191-5]

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 metabolites 3-hydroxymethyl
sulfentrazone (HMS) and 3-desmethyl sulfentrazone (DMS) in or on flax,
seed; potato; potato, wet peel; and potato, granules/flakes. This
action is in response to EPA's granting of an emergency exemption under
section 18

[[Page 54112]]

of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)
authorizing use of the pesticide on flax and potatoes. This regulation
establishes maximum permissible levels for residues of sulfentrazone in
these food commodities. These tolerances will expire and are revoked on
December 31, 2004.

DATES: This regulation is effective August 21, 2002. Objections and
requests for hearings, identified by docket ID number OPP-2002-0176,
must be received on or before October 21, 2002.

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 ID number -OPP-2002-0176 in the
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Andrew Ertman, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460;
telephone number: (703) 308-9367; e-mail address:
Ertman.Andrew@epamail.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/. A frequently updated electronic
version of 40 CFR part 180 is available at http://www.access.gpo.gov/
nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, a beta site
currently under development.
2. In person. The Agency has established an official record for
this action under docket ID number OPP-2002-0176. 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.

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 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-yl]phenyl]
methanesulfonamide, and its metabolites 3-hydroxymethyl sulfentrazone
(HMS) and 3-desmethyl sulfentrazone (DMS), in or on flax, seed at 0.20
part per million (ppm); potato at 0.10 ppm; potato, wet peel at 0.15
ppm; and potato, granules/flakes at 0.20 ppm. These tolerances will
expire and are revoked on December 31, 2004. 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 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 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 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 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.

[[Page 54113]]

III. Emergency Exemption for Sulfentrzone on Flax and Potatoes and
FFDCA Tolerances

North Dakota submitted a section 18 request for the emergency use
of sulfentrazone on flax to control kochia. EPA reviewed this request
and concluded that the situation was urgent and non-routine.
Colorado and Nebraska submitted section 18 requests for the
emergency use of sulfentrazone on potatoes to control ALS-inhibitor and
triazine-resistant Palmer amaranth, redroot pigweed, common waterhemp.
EPA reviewed these requests and concluded that the situations were
urgent and non-routine. EPA has authorized under FIFRA section 18 the
use of sulfentrazone on flax to control kochia in North Dakota, and on
potatoes for control of ALS-inhibitor and triazine-resistant Palmer
amaranth, redroot pigweed, common waterhemp in Colorado and Nebraska.
After having reviewed these 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 residues of sulfentrazone in or on
flax and potatoes. In doing so, EPA considered the safety standard in
FFDCA section 408(b)(2), and EPA decided that the necessary tolerance
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 exemption 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, 2004, under
FFDCA section 408(l)(5), residues of the pesticide not in excess of the
amounts specified in the tolerances remaining in or on flax, seed;
potato; potato, wet peel; potato, granules/flakes 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 flax and/or potatoes
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 sulfentrzone 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 North Dakota, Colorado and
Nebraska 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 exemption for sulfentrazone, contact the
Agency's Registration Division at the address provided underFOR 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 flax, seed at 0.20 ppm;
potato at 0.10 ppm; potato, wet peel at 0.15 ppm; and potato, granules/
flakes at 0.20 ppm. EPA's assessment of the dietary exposures and risks
associated with establishing the tolerance 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 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 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 factor is
retained due to concerns unique to 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 x 10-6 or one in a million).
Under certain specific circumstances, MOE calculations will be used for
the carcinogenic risk assessment. In this non-linear approach, a
``point of departure'' is identified below which carcinogenic effects
are not expected. The point of departure is typically a NOAEL based on
an endpoint related to cancer effects though it may be a different
value derived from the dose response curve. To estimate risk, a ratio
of the point of departure to exposure (MOE_cancer= point of
departure/exposures) is calculated. A summary of the toxicological
endpoints for sulfentrazone used for human risk assessment is shown in
the following Table 1:

[[Page 54114]]

Table 1.--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 = 10.0 mg/kg/day FQPA SF = 10 aPAD = Developmental study in
age UF = 100 Acute RfD = acute RfD rats
0.10 mg/kg/day. FQPA SF = Developmental LOAEL =
0.01 mg/kg/day......... 25 mg/kg/day based 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 study in rats
2.5 mg/kg/day. FQPA SF LOAEL = 750 mg/kg/day
= 0.25 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 were
reversed by day 14
post dose.
----------------------------------------------------------------------------------------------------------------
Chronic dietary all populations NOAEL= 14.0 mg/kg/day FQPA SF = 10 cPAD = 2-generation
UF = 100 Chronic RfD = chronic RfD reproduction study in
0.14 mg/kg/day. FQPA SF rats
= 0.014 mg/kg/day...... LOAEL = 33/44 mg/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 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 residues of sulfentrazone
on soybean seed. Tolerances are established for inadvertent and
indirect residues of sulfentrazone on cereal grains. Time-limited
tolerances have been established on bean, lima (succulent seed without
pod); cowpeas (without pod); horseradish, roots; sugarcane, cane;
sunflower, seeds; and, sunflower, forage. These time-limited tolerances
have an expiration date of 12/31/02. 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. 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: Tolerance level residues and 100% crop treated
information were used for all commodities (Tier 1). As the acute
analyses were Tier 1 assessments, acute risk estimates are presented at
the 95th percentile.
ii. Chronic exposure. In conducting this chronic dietary risk
assessment the DEEM analysis evaluated the individual food
consumption as reported by respondents in the USDA 1989-1992 nationwide
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 risk assessment 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

[[Page 54115]]

concentrations in surface water and screening concentration in ground
water (SCI-GROW), which predicts pesticide concentrations in ground
water. 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. 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 16 parts per billion (ppb) for
surface water and 16 ppb for ground water. The EECs for chronic
exposures are estimated to be 4 ppb for surface water and 16 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. In general. FFDCA section 408 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 database 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. Developmental toxicity studies--i. 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.
ii. 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.
3. 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.
4. Prenatal and postnatal sensitivity. The toxicological database
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.
5. Conclusion. There is a complete toxicity database for
sulfentrazone and exposure data are complete or are estimated based on
data that reasonably

[[Page 54116]]

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 safety factor 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 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 EPA 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 ground water are less than the
calculated DWLOCs, EPA concludes with reasonable certainty that
exposures to sulfentrazone 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 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, 8%
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 EECs 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/ % aPAD Water EEC Water EEC Acute DWLOC
kg) (Food) (ppb) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
Females, 13-50 years old 0.01 8 16 16 270
U.S. Population 0.25 <1 16 16 8,700
Children (1-6 years old) and all infants (<1 0.25 <1 16 16 2500
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 3% of the cPAD for the U.S.
population, 5% 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 EECs 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
day (Food) (ppb) (ppb) DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population 0.014 4 4.0 16 470
Children (1-6 years old) and all infants (< 1 0.014 8 4.0 16 130
year old)
Females (13-50 years old) 0.014 3 4.0 16 410
Males (13-19 years old) 0.014 4 4.0 16 470
----------------------------------------------------------------------------------------------------------------

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.
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).

[[Page 54117]]

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, PRRIB, 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 maximum residue limits (MRLs) established for
sulfentrazone on either flax or potatoes.

VI. Conclusion

Therefore, the tolerances are established 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
metabolites 3-hydroxymethyl sulfentrazone (HMS) and 3-desmethyl
sulfentrazone (DMS), in or on flax, seed at 0.20 ppm; potato at 0.10
ppm; potato, wet peel at 0.15 ppm; and potato, granules/flakes at 0.20
ppm

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 ID number OPP-2002-0176 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 October
21, 2002.
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 ID number OPP-2002-0176, 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.
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 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit an
electronic copy of your

[[Page 54118]]

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 time limited tolerances 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).
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 FIFRA
section 18 exemption under FFDCA section 408, such as the [tolerances]
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). For these same reasons, the Agency has
determined that this rule does not have any ``tribal implications'' as
described in Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 6,
2000). Executive Order 13175, requires EPA to develop an accountable
process to ensure ``meaningful and timely input by tribal officials in
the development of regulatory policies that have tribal implications.''
``Policies that have tribal implications'' is defined in the Executive
Order to include regulations that have ``substantial direct effects on
one or more Indian tribes, on the relationship between the Federal
Government and the Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.''
This rule will not have substantial direct effects on tribal
governments, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes, as specified in
Executive Order 13175. Thus, Executive Order 13175 does not apply to
this rule.

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.

August 12, 2002.
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 alphabetically adding commodities
to the table in paragraph (b) to read as follows:

Sec. 180.498 Sulfentrazone; tolerances for residues.

* * * * *
(b) * * *

------------------------------------------------------------------------
Expiration/
Commodity Parts per million revocation date
------------------------------------------------------------------------
* * * * *
Flax, seed........................ 0.20 12/31/04

[[Page 54119]]

* * * * *
Potato............................ 0.10 12/31/04
Potato, granules/flakes........... 0.20 12/31/04
Potato, wet peel.................. 0.15 12/31/04
* * * * *
------------------------------------------------------------------------

* * * * *

[FR Doc. 02-20989 Filed 8-20-02; 8:45 am]
BILLING CODE 6560-50-S

Sulfentrazone; Pesticide Tolerances for Emergency Exemptions

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