[Federal Register Volume 67, Number 162 (Wednesday, August 21, 2002)]
[Rules and Regulations]
[Pages 54111-54119]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-20989]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2002-0176; FRL-7191-5]


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 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: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected 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 (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:

[[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: 
[email protected].

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 [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    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: [email protected]. Please use an ASCII file 
format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your

[[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