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Sulfentrazone (IR-4; FMC). September
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Pesticide Tolerances. Final Rule. Federal Register.
http://www.epa.gov/fedrgstr/EPA-PEST/2003/September/Day-24/p24011.htm
[Federal Register: September 24, 2003 (Volume 68, Number 185)]
[Rules and Regulations]
[Page 55269-55280]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24se03-2]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2003-0270; FRL-7324-5]
Sulfentrazone; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for combined residues
of the herbicide sulfentrazone and its metabolites in or on asparagus;
bean, lima, succulent; cabbage; corn, field, forage; corn, field,
grain; corn, field, stover; horseradish, roots; pea and bean, dried
shelled, except soybean, subgroup 6C; peanut; peanut, meal; peppermint,
tops; potato; spearmint, tops; sugarcane, cane; sugarcane, molasses;
and sunflower, seed. EPA is also deleting certain sulfentrazone
tolerances that are no longer needed as result of this action. The
Interregional Research Project Number 4 and FMC Corporation requested
these tolerances under the Federal Food, Drug, and Cosmetic Act
(FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA).
DATES: This regulation is effective September 24, 2003. Objections and
requests for hearings, identified by docket ID number OPP-2003-0270,
must be received on or before November 24, 2003.
ADDRESSES: Written objections and hearing requests may be submitted
electronically, by mail, or through hand delivery/courier. Follow the
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY
INFORMATION.
FOR FURTHER INFORMATION CONTACT: Hoyt Jamerson, Registration Division
(7505C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703)308-9368; e-mail address: jamerson.hoyt@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be affected by this action if you are an agricultural
producer, food manufacturer, or pesticide manufacturer. Potentially
affected categories and entities may include, but are not limited to:
¥ Crop production (NAICS 111)
¥ Animal production (NAICS 112)
¥ Food manufacturing (NAICS 311)
¥ Pesticide manufacturing (NAICS 32532)
[[Page 55270]]
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Get Copies of this Document and Other Related Information?
1. Docket. EPA has established an official public docket for this
action under docket identification (ID) number OPP-2003-0270. The
official public docket consists of the documents specifically
referenced in this action, any public comments received, and other
information related to this action. Although a part of the official
docket, the public docket does not include Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. The official public docket is the collection of materials
that is available for public viewing at the Public Information and
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2,
1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The docket telephone number is (703) 305-5805.
2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr/. A frequently updated
electronic version of 40 CFR part 180 is available at http://www.access.
gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, 
a beta site currently under development. To access the OPPTS Harmonized
Guidelines referenced in this document, go directly to the guidelines
at http://www.epa.gov/opptsfrs/home/guidelin.htm.
An electronic version of the public docket is available through
EPA's electronic public docket and comment system, EPA Dockets. You may
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public
comments, access the index listing of the contents of the official
public docket, and to access those documents in the public docket that
are available electronically. Although not all docket materials may be
available electronically, you may still access any of the publicly
available docket materials through the docket facility identified in
Unit I.B.1. Once in the system, select ``search,'' then key in the
appropriate docket ID number.
II. Background and Statutory Findings
In the Federal Register of March 7, 2003 (68 FR 11096) (FRL-7290-
1), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C.
346a, as amended by FQPA (Public Law 104-170), announcing the filing of
pesticide petitions (PP 0E6149, 1E6311, 2E6405, 2E6498, and 2E6500) by
the Interregional Research Project Number 4 (IR-4), and 681 U.S.
Highway #1 South, North Brunswick, NJ 08902, and PP 0F6116 and
2F6391 by FMC Corporation, Agricultural Products Group, 1735 Market
Street, Philadelphia, PA 19103. That notice included a summary of the
petitions prepared by FMC Corporation, the registrant. There were no
comments received in response to the notice of filing.
The petitions requested that 40 CFR 180.498 be amended by
establishing tolerances for combined residues of the herbicide
sulfentrazone, [N-(2,4-dichloro-5-(4-(difluoromethyl)-4,5-dihydro-3-
methyl-5-oxo-1H-1,2,4-triazol-1-ylphenylmethansulfonoamide and its
metabolites HMS (N-(2,4-dichloro-5-(4-(difluoromethyl)-4,5-dihydro-3-
hydroxymethyl-5-oxo-1H-1,2,4-triazol- 1-yl)phenyl)methanesulfonamide)
and DMS (N-(2,4-dichloro-5-(4-(difluoromethyl)-4,5-dihydro-5-oxo-1H-
1,2,4-triazol-1-yl)phenyl)methanesulfonamide), in or on food
commodities as follows: Sunflower, seed at 0.2 parts per million (ppm)
(PP 0E6149); horseradish, roots at 0.2 ppm (PP 1E6311); cabbage at 0.2
ppm (PP 1E6311); peppermint, tops and spearmint, tops at 0.3 ppm
(1E6311); potato at 0.1 ppm (PP 2E6405); bean, lima, succulent at 0.15
ppm (PP 2E6498); asparagus at 0.15 ppm (2E6500); peanut nutmeat and its
processed parts at 0.2 ppm and sugarcane and its processed parts at 0.1
ppm (PP 0F6116); corn, field forage at 0.25 ppm (PP 2F6391); corn,
field stover at 0.35 ppm (PP 2F6391); pea and bean, dried shelled,
except soybean, subgroup 6C at 0.15 ppm (PP 2F6391). Pesticide
petitions 0F6116, 2F6391 and 2E6405 were subsequently amended to
propose tolerances for peanut at 0.20 ppm; peanut, meal at 0.40 ppm;
sugarcane, cane at 0.15 ppm; sugarcane, molasses at 0.20 ppm; corn,
field, forage at 0.20 ppm; corn, field, grain at 0.15 ppm; corn, field,
stover at 0.30 ppm and potato at 0.15 ppm. EPA is also deleting several
time-limited tolerances established in connection with section 18
emergency exemption under 40 CFR 180.498(b) that are no longer needed,
as a result of this action. The deletions to 40 CFR 180.498(b) are as
follows:
1. Delete horseradish, roots at 0.1 ppm; replace with horseradish,
roots at 0.20 ppm.
2. Delete pea, dry, seed at 0.10 ppm; replace with pea and bean,
dried shelled, except soybean, subgroup 6C at 0.15 ppm.
3. Delete potato at 0.10 ppm; potato, granules/flakes at 0.20 ppm;
and potato, wet peel at 0.15 ppm; replace with potato at 0.15 ppm.
4. Delete sugarcane at 0.05 ppm; replace with sugarcane, cane 0.15
ppm and sugarcane, molasses at 0.20 ppm.
5. Delete sunflower at 0.1 ppm; replace with sunflower, seed at
0.20 ppm.
Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of the FFDCA defines ``safe'' to mean that ``there is
a reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of the FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of the FFDCA and a complete
description of the risk assessment process, see the final rule on
Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-
5754-7).
III. Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed
the available scientific data and other relevant information in support
of this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2) of the
[[Page 55271]]
FFDCA, for tolerances for combined residues of sulfentrazone and its
major metabolites on asparagus at 0.15 ppm; bean, lima, succulent at
0.15 ppm; cabbage at 0.20 ppm; corn, field, forage at 0.20 ppm; corn,
field, grain at 0.15 ppm; corn, field, stover at 0.30 ppm; horseradish,
roots at 0.20 ppm; pea and bean, dried shelled, except soybean,
subgroup 6C at 0.15 ppm; peanut at 0.20 ppm; peanut, meal at 0.40 ppm;
peppermint, tops at 0.30 ppm; potato at 0.15 ppm; spearmint, tops at
0.30 ppm; sugarcane, cane 0.15 ppm; sugarcane, molasses 0.20 ppm; and
sunflower, seed at 0.20 ppm. EPA's assessment of exposures and risks
associated with establishing the tolerances follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The nature of the toxic effects caused by sulfentrazone are
discussed in Table 1 of this unit as well as the no observed adverse
effect level (NOAEL) and the lowest observed adverse effect level
(LOAEL) from the toxicity studies reviewed.
Table 1.--Subchronic, Chronic, and Other Toxicity
------------------------------------------------------------------------
Guideline No. Study Type Results
------------------------------------------------------------------------
870.3100 90-Day oral NOAEL = 19.9
toxicity rodents milligrams/
(rats) kilogram/day (mg/
kg/day) for males
and 23.1 mg/kg/
day for females
LOAEL = 65.8 mg/kg/
day for males and
78.1 mg/kg/day
for females based
on clinical signs
of anemia
(reduced
hematocrit,
hemoglobin, mean
cell volume, and
mean cell
hemoglobin values
during treatment)
------------------------------------------------------------------------
870.3100 90-Day oral NOAEL = 60 mg/kg/
toxicity rodents day for males and
(mice) 79.8 mg/kg/day
for females
LOAEL = 108.4 mg/
kg/day for males
and 143.6 mg/kg/
day for females
based on
decreased body
weights, body
weight gains, red
blood cells,
hemoglobin,
hematocrit, and
severity of
splenic
micropathology
(increased
incidence and
severity of
extramedullary
hematopoiesis)
------------------------------------------------------------------------
870.3150 90-Day oral NOAEL = 28 mg/kg/
toxicity in day
nonrodents (dogs) LOAEL = 57 mg/kg/
day for males and
73 mg/kg/day for
females based on
decreased body
weights (7-10%)
and body weight
gains during
first 5 weeks of
study; decreased
hemoglobin,
hematocrit, mean
cell volume, mean
cell hemoglobin
and mean cell
hemoglobin
concentration,
and increased
absolute liver
weights and
alkaline
phosphatase
levels, and
microscopic
changes in the
liver and spleen
(pigmented
sinusoidal
microphages in
the liver,
swollen
centrilobular
hepatocytes and
pigmented
reticuloendotheli
al cells in the
spleen)
------------------------------------------------------------------------
870.3200 21/28-Day dermal Systemic and
toxicity dermal NOAEL =
1,000 mg/kg/day,
highest dose
tested (HDT)
------------------------------------------------------------------------
870.3700 Prenatal Maternal
developmental in NOAEL = 25 mg/kg/
rodents (rats) day
LOAEL = 50 mg/kg/
day based on
increased
relative splenic
extramedullary
hematopoiesis
Developmental
NOAEL = 10 mg/kg/
day
LOAEL = 25 mg/kg/
day based on
decreased mean
fetal weights,
and retardation
in skeletal
development
evidenced by an
increased number
of litters with
any variation and
by decreased
number of caudal
vertebral and
metacarpal
ossification
sites
------------------------------------------------------------------------
[[Page 55272]]
870.3700 Prenatal Maternal
developmental in NOAEL = 250 mg/kg/
rodents (rats) day
LOAEL was not
established.
Developmental
NOAEL = 100 mg/kg/
day
LOAEL = 250 mg/kg/
day based on
decreased fetal
body weight;
increased
incidence of
fetal variations:
hypoplastic or
wavy ribs,
incompletely
ossified lumbar
vertebral arches,
and incompletely
ossified ischia
or pubis; and
reduced number of
thoracic
vertebral and rib
ossification
sites
------------------------------------------------------------------------
870.3700 Prenatal Maternal
developmental in NOAEL = 100 mg/kg/
nonrodents day
(rabbits) LOAEL = 250 mg/kg/
day based on
increased
abortions,
clinical signs
(hematuria and
decreased feces),
and reduced body
weight gain
Developmental
NOAEL = 100 mg/kg/
day
LOAEL = 250 mg/kg/
day based on
increased
resorptions,
decreased live
fetuses per
litter, and
decreased fetal
weights
------------------------------------------------------------------------
870.3800 2-Generation Parental/Systemic
reproduction and NOAEL = 14 mg/kg/
fertility effects day for males and
(rats) 16 mg/kg/day for
females
LOAEL = 33 mg/kg/
day for males and
40 mg/kg/day for
females based on
decreased
maternal body
weight/body
weight gain
during gestation
in both
generation (P and
F1) and reduced
premating body
weight gain in
second generation
(F1) males
Reproductive
NOAEL = 14 mg/kg/
day for males and
16 mg/kg/day for
females
LOAEL = 33 mg/kg/
day for males and
40 mg/kg/day for
females based on
increased
duration of
gestation in
females and
degeneration and/
or atrophy of the
germinal
epithelium of the
testes and
oligospermia and
intratubular
degenerated
seminal material
in the epididymis
of F1 males
Offspring
NOAEL = 14 mg/kg/
day for males and
16 mg/kg/day for
females
LOAEL = 33 mg/kg/
day for males and
40 mg/kg/day for
females based on
reduced prenatal
viability (fetal
and litter),
reduced litter
size, increased
number of
stillborn pups,
reduced pup and
litter postnatal
survival and
decreased pup
body weights
throughout
lactation
------------------------------------------------------------------------
870.3800 Reproduction and Parental/Systemic
fertility effects NOAEL = 20 mg/kg/
(rat) day
Nonguideline LOAEL = 51 mg/kg/
day (F1 females)
based on decrease
in pre-mating
body weight gain
(10%)
Offspring and
Reproductive
NOAEL = 16 mg/kg/
day
LOAEL = 40 mg/kg/
day based on
reduced gestation
day 20 fetal
weights;
decreased
postnatal day 0,
4 and 7 pup
weights;
decreased pup
survival; delayed
vaginal patency;
reduced
epididymal,
prostate, and
testicular
weights
Additional
information
supports the
conclusions
reached in the 2-
generation
reproduction
study in rats
------------------------------------------------------------------------
[[Page 55273]]
870.4100 Chronic toxicity NOAEL = 24.9 mg/kg/
dogs day for males and
29.6 mg/kg/day
for females
LOAEL = 61.2 mg/kg/
day for males and
61.9 mg/kg/day
for females based
on compensated
normochromic
microcytosis
------------------------------------------------------------------------
870.4200 Carcinogenicity NOAEL = 93.9 mg/kg/
mice day for males and
116.9 mg/kg/day
for females
LOAEL = 160.5 mg/
kg/day for males
and 198.0 mg/kg/
day for females
based on dose-
related decreases
in hemoglobin and
hematocrit by
study termination
No evidence of
carcinogenicity
------------------------------------------------------------------------
870.4300 Combined chronic NOAEL = 40 mg/kg/
toxicity/ day for males and
carcinogenicity 36.4 mg/kg/day in
rats females
LOAEL = 82.2 mg/kg/
day for males and
67 mg/kg/day for
females based on
dose-related
decreased body
weights (11 and
19%), body weight
gains (13 and
26%), food
consumption (13
and 19%),
hemoglobin,
hematocrit, mean
cell volume, and
mean cell
hemoglobin.
Increased
nucleated red
blood cells and
reticulocytes in
bone of females
at 124.7 mg/kg/
day
No evidence of
carcinogenicity
------------------------------------------------------------------------
870.5100 Gene mutation No evidence of
compound-induced
cytotoxicity was
evident in
Salmonella
typhimurium
strains TA1535,
TA1538, TA1537,
TA98 and TA100
either in
presence or in
absence of S9
activation. The
positive controls
induced the
expected
mutagenic
responses in the
appropriate
tester strain.
Sulfentrazone was
considered not
mutagenic under
any test
condition.
------------------------------------------------------------------------
870.5300 In vitro mammalian In a forward gene
cell gene mutation assay,
mutation assay sulfentrazone at
(mouse lymphoma) precipitating
levels was
equivocally
positive in the
absence of S9
activation. This
response was not
repeated at doses
up to 1,800 [mu]g/
ml in the
presence of S9
activation.
------------------------------------------------------------------------
870.5395 Mammalian The test was
erythrocyte negative in mice
micronucleus test administered
single
intraperitoneal
doses of 85 to
340 mg/kg. The
340 mg/kg dose
was estimated to
be approximately
80% of the LD50.
No evidence of a
cytotoxic effect
on the target
organ and no
significant
increase in the
frequency of
micronucleated
polychromatic
erythrocytes in
bone marrow
cells.
------------------------------------------------------------------------
870.5450 Dominant lethal There were no
assay- rodent significant
difference from
negative controls
in the proportion
of early dead:
total implants,
and (total) dead:
total implants.
Based on the
results,
sulfentrazone is
considered
negative for
inducing dominant
lethal mutations
in pre-meiotic,
meiotic, and post-
meiotic germ
cells of male
rats under
conditions of
this assay up to
the estimated
MTD.
------------------------------------------------------------------------
870.6200 Acute NOAEL = 250 mg/kg/
neurotoxicity day
screening battery LOAEL = 750 mg/kg/
day based on
increased
incidence of
clinical signs,
FOB findings, and
decreased motor
activity which
was reversed by
day 14 postdose.
No evidence of
neuropathology at
any dose tested.
------------------------------------------------------------------------
[[Page 55274]]
870.6200 Subchronic NOAEL = 30 mg/kg/
neurotoxicity day for males and
screening battery 37 mg/kg/day for
females
LOAEL = 150 mg/kg/
day for males and
180 mg/kg/day for
females based on
increased
incidence of
clinical signs;
decreased body
weight, body
weight gains, and
food consumption
in females; and
increased motor
activity in
females. At 5,000
ppm, included
increased
mortality;
decreased body
weights, and body
weight gains in
males; decreased
hindlimb grip
strength and
increased tail
flick latency in
males at week 8;
distended
bladders with red
fluid and
enlarged spleen.
No evidence of
neuropathology at
2,500 and 5,000
ppm.
------------------------------------------------------------------------
870.7485 Metabolism and Sulfentrazone
pharmacokinetics (Phenyl -14C -
(rats) sulfentrazone)
was readily
absorbed and 84
to 104% of the
administered dose
was excreted in
urine and feces
within 72 hours.
There were no
major sex
differences in
the pattern of
excretion. Almost
all the
radioactivity in
the urine was 3-
hydroxy-methyl-
F6285 (84 - 104%
of the
administered
dose). In the
feces, HMS
accounted for
1.26 to 2.55% of
the administered
dose. The
proposed
metabolic pathway
appeared to be
conversion of the
parent compound
mainly to 3-
hydroxymethyl-
F6285 (excreted
in the urine). A
small amount of 3-
hydroxymethyl-
F6285 was also
converted to 3-
carboxylic acid-
F6285 (excreted
in the urine and
feces).
------------------------------------------------------------------------
B. Toxicological Endpoints
The dose at which no adverse effects are observed (the NOAEL) from
the toxicology study identified as appropriate for use in risk
assessment is used to estimate the toxicological level of concern
(LOC). However, the lowest dose at which adverse effects of concern are
identified (the LOAEL) is sometimes used for risk assessment if no
NOAEL was achieved in the toxicology study selected. An uncertainty
factor (UF) is applied to reflect uncertainties inherent in the
extrapolation from laboratory animal data to humans and in the
variations in sensitivity among members of the human population as well
as other unknowns. An UF of 100 is routinely used, 10X to account for
interspecies differences and 10X for intraspecies differences.
For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference dose (acute RfD or
chronic RfD) where the RfD is equal to the NOAEL divided by the
appropriate UF (RfD = NOAEL/UF). Where an additional safety factors
(SF) is retained due to concerns unique to the FQPA, this additional
factor is applied to the RfD by dividing the RfD by such additional
factor. The acute or chronic Population Adjusted Dose (aPAD or cPAD) is
a modification of the RfD to accommodate this type of FQPA SF.
For non-dietary risk assessments (other than cancer) the UF is used
to determine the LOC. For example, when 100 is the appropriate UF (10X
to account for interspecies differences and 10X for intraspecies
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and
compared to the LOC.
The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify carcinogenic risk. The Q*
approach assumes that any amount of exposure will lead to some degree
of cancer risk. A Q* is calculated and used to estimate risk which
represents a probability of occurrence of additional cancer cases
(e.g., risk is expressed as 1 x 10-6 or one in a million).
Under certain specific circumstances, MOE calculations will be used for
the carcinogenic risk assessment. In this non-linear approach, a
``point of departure'' is identified below which carcinogenic effects
are not expected. The point of departure is typically a NOAEL based on
an endpoint related to cancer effects though it may be a different
value derived from the dose response curve. To estimate risk, a ratio
of the point of departure to exposure (MOEcancer = point of
departure/exposures) is calculated. A summary of the toxicological
endpoints for sulfentrazone used for human risk assessment is shown in
Table 2 of this unit:
[[Page 55275]]
Table 2.--Summary of Toxicological Dose and Endpoints for Sulfentrazone for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
FQPA SF* and Level of
Exposure Scenario Dose Used in Risk Concern for Risk Study and Toxicological
Assessment, UF Assessment Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (females 13-50 years of NOAEL = 25 mg/kg/day FQPA SF = 1X Developmental toxicity
age) UF = 100............... aPAD = acute RfD/FQPA study in rats
Acute RfD = 0.25 mg/kg/ SF = 0.25 mg/kg/day. LOAEL = 50 mg/kg/day
day. based on decreased
live fetuses, and
increased early
resorptions
-----------------------------------------------------------------------------------------
Acute dietary (general population NOAEL = 250 mg/kg/day FQPA SF = 1X Acute neurotoxicity
including infants and children) UF = 100............... aPAD = acute RfD/FQPA study in rats
Acute RfD = 2.5 mg/kg/ SF = 2.5 mg/kg/day. LOAEL = 750 mg/kg/day
day. based on increased
incidence of clinical
signs and FOB
parameters and
decreased motor
activity.
-----------------------------------------------------------------------------------------
Chronic dietary (all populations) NOAEL= 14 mg/kg/day FQPA SF = 1X 2-Generation
UF = 100............... cPAD = chronic RfD/FQPA reproduction study
Chronic RfD = 0.14 mg/ SF = 0.14 mg/kg/day. LOAEL = 33 mg/kg/day
kg/day. based on decreased
body weight and body
weight gains
-----------------------------------------------------------------------------------------
Short-term (1 to 30 days) and Offspring LOC for MOE = 100 2-Generation
intermediate-term (1 to 6 months) NOAEL = 14 mg/kg/day... (Residential) reproduction study
incidental oral LOAEL = 33 mg/kg/day
based on decreased pup
body weights during
lactation in both
generations
-----------------------------------------------------------------------------------------
Short-term dermal (1 to 30 days), Dermal study NOAEL= 100 LOC for MOE = 100 Dermal developmental
intermediate-term dermal (1 to 6 mg/kg/day (Residential) study in rats
months) and long-term dermal (>6 (dermal absorption rate LOAEL = 250 mg/kg/day
months) = 10%). based on decreased
fetal body weight;
increased incidences
of fetal variations:
hypoplastic or wavy
ribs, incompletely
ossified lumbar
vertebral arches, and
incompletely ossified
ischia or pubes; and
reduced number of
thoracic vertebral and
rib ossification sites
-----------------------------------------------------------------------------------------
Short-term inhalation (1 to 30 days), Oral study NOAEL = 14 LOC for MOE = 100 2-Generation
intermdiate-term inhalation (1 to 6 mg/kg/day (inhalation (Residential) reproduction study
months) and long-term inhalation (> rate = 100% LOAEL = 33 mg/kg/day
6 months) based on decreased
body weight and body
weight gains
-----------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation) Not applicable Not applicable No evidence of
carcinogenicity in
rats and mice
----------------------------------------------------------------------------------------------------------------
*The reference to the FQPA SF refers to any additional SF retained due to concerns unique to the FQPA.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.498) for the combined residues of
sulfentrazone, in or on soybean, seed at 0.05 ppm. Time-limited
tolerances (set to expire on December 31, 2004) are established in
connection with section 18 emergency exemptions for bean, succulent
seed without pod at 0.1; horseradish, roots at 0.1 ppm; chickpea, seed
at 0.10 ppm; pea, dry, seed 0.10 ppm; potato at 0.10 ppm; potato, wet
peel at 0.15; flax, seed at 0.20 ppm; potato, granules/flakes at 0.20
ppm; strawberry at 0.60 ppm. Time-limited tolerances (set to expire on
December 31, 2005) are established in connection with section 18
emergency exemptions for sugarcane at 0.05 ppm and sunflower at 0.1
ppm. Tolerances are also established for indirect or inadvertent
residues in or on cereal grain (excluding sweet corn). Risk assessments
were conducted by EPA to assess dietary exposures from sulfentrazone in
food as follows:
i. Acute exposure. Acute dietary risk assessments are performed for
a food-use pesticide if a toxicological study has indicated the
possibility of an effect of concern occurring as a result of a 1-day or
single exposure. In conducting the acute dietary risk assessment EPA
used the Dietary Exposure Evaluation Model software with the Food
Commodity Intake Database (DEEMTM) which incorporates food
consumption data as reported by respondents in the United States
Department of Agriculture (USDA) 1994-1996 and 1998 nationwide
Continuing Surveys of Food Intake by Individuals (CSFII) and
accumulated exposure to the chemical for each commodity. Separate Tier
I, acute dietary exposure assessments were performed for females 13 to
49 years old and for the general U.S. population (including infants and
children) using tolerance-level residues and 100 percent crop treated
(PCT).
ii. Chronic exposure. In conducting this chronic dietary risk
assessment EPA used the DEEMTM software with the Food
Commodity Intake Database which incorporates food consumption data as
reported by respondents in the USDA 1994-1996 and 1998 nationwide CSFII
and accumulated exposure to the chemical for each commodity. An
unrefined, Tier I chronic dietary exposure assessment was performed
using tolerance-level residues and 100 PCT.
2. Dietary exposure from drinking water. Sulfentrazone and the
degradate 3-carboxylic acid sulfentrazone are the residues of concern
for the drinking-water risk assessment. Environmental
[[Page 55276]]
fate data suggest that sulfentrazone and 3-carboxylic acid
sulfentrazone are persistent and mobile. Based on the structure
similarity, 3-carboxylic acid sulfentrazone could potentially have
similar toxicity as the parent.
The Agency lacks sufficient monitoring exposure data to complete a
comprehensive dietary exposure analysis and risk assessment for
sulfentrazone in drinking water. Because the Agency does not have
comprehensive monitoring data, drinking water concentration estimates
are made by reliance on simulation or modeling taking into account data
on the physical characteristics of sulfentrazone.
The Agency uses the FQPA Index Reservoir Screening Tool (FIRST) or
the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/
EXAMS), to produce estimates of pesticide concentrations in an index
reservoir. The Screening Concentrations in Ground Water (SCI-GROW)
model is used to predict pesticide concentrations in shallow ground
water. For a screening-level assessment for surface water EPA will use
FIRST (a Tier 1 model) before using PRZM/EXAMS (a Tier 2 model). The
FIRST model is a subset of the PRZM/EXAMS model that uses a specific
high-end runoff scenario for pesticides. FIRST and PRZM/EXAMS
incorporate an index reservoir environment, and both models include a
percent crop area factor as an adjustment to account for the maximum
percent crop coverage within a watershed or drainage basin.
None of these models include consideration of the impact processing
(mixing, dilution, or treatment) of raw water for distribution as
drinking water would likely have on the removal of pesticides from the
source water. The primary use of these models by the Agency at this
stage is to provide a coarse screen for sorting out pesticides for
which it is unlikely that drinking water concentrations would exceed
human health levels of concern.
Since the models used are considered to be screening tools in the
risk assessment process, the Agency does not use estimated
environmental concentrations (EECs) from these models to quantify
drinking water exposure and risk as a %RfD or %PAD. Instead drinking
water levels of comparison (DWLOCs) are calculated and used as a point
of comparison against the model estimates of a pesticide's
concentration in water. DWLOCs are theoretical upper limits on a
pesticide's concentration in drinking water in light of total aggregate
exposure to a pesticide in food, and from residential uses. Since
DWLOCs address total aggregate exposure to sulfentrazone, they are
further discussed in the aggregate risk sections in Unit E.
Based on the FIRST and SCI-GROW models the EECs of sulfentrazone
plus its major metabolite 3-carboxylic acid for acute exposures are
estimated to be 35.8 parts per billion (ppb) for surface water and 26.0
ppb for ground water. The EECs for chronic exposures are estimated to
be 7.8 ppb for surface water and 26.0 ppb for ground water.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). Sulfentrazone is
proposed for use on use on turf by professional lawn care operators as
a broadcast spray at a maximum application rate of 0.03 lbs active
ingredient. Based on the proposed use pattern, potential residential/
non-occupational post-application exposures include the following:
Short-term oral turfgrass exposure (toddler hand-to-mouth, object-to-
mouth); short-term dermal turfgrass exposure (adult and toddler) and
short-term dermal golfer exposure (adult and adolescent). Incidental
ingestion of soil is assumed to be negligible. Exposure over
intermediate-term (1-6 months) or long-term (chronic, more than 6
months) exposure is not expected. Homeowner handler exposure is not
expected since sulfentrazone will be applied by professional lawn care
operators.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
EPA does not have, at this time, available data to determine
whether sulfentrazone has a common mechanism of toxicity with other
substances. Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity, EPA
has not made a common mechanism of toxicity finding as to sulfentrazone
and any other substances and sulfentrazone does not appear to produce a
toxic metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has not assumed that sulfentrazone has
a common mechanism of toxicity with other substances. For information
regarding EPA's efforts to determine which chemicals have a common
mechanism of toxicity and to evaluate the cumulative effects of such
chemicals, see the policy statements released by EPA's Office of
Pesticide Programs concerning common mechanism determinations and
procedures for cumulating effects from substances found to have a
common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative/.
D. Safety Factor for Infants and Children
1. In general. Section 408 of the FFDCA provides that EPA shall
apply an additional tenfold margin of safety for infants and children
in the case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base on toxicity and exposure
unless EPA determines that a different margin of safety will be safe
for infants and children. Margins of safety are incorporated into EPA
risk assessments either directly through use of a MOE analysis or
through using uncertainty (safety) factors in calculating a dose level
that poses no appreciable risk to humans.
2. Prenatal and postnatal sensitivity. There is evidence of
increased quantitative susceptibility following in utero exposure in
the developmental-toxicity studies in rats via the oral and dermal
routes, and there is evidence for increased qualitative susceptibility
following prenatal and/or postnatal exposure in the 2-generation
reproduction study in rats. A Degree of Concern Analysis was performed
by EPA and it was concluded that concerns are low for the quantitative
susceptibility of rat fetuses observed following oral and dermal
exposures, the qualitative susceptibility of rabbit fetuses seen via
the oral route, and the qualitative susceptibility seen in the 1- and
2-generation reproduction studies. The conclusion was based on the
following:
¥ The dose-response was well characterized.
¥ There were clear NOAELs and LOAELs for developmental,
offspring, maternal, and parental toxicities.
¥ The developmental effects in rabbits and the offspring
effects in the rats were seen in the presence of maternal and parental
toxicities, respectively.
¥ The parental reproductive and offspring effects were
reproducible between the two reproductive studies.
3. Conclusion. There is a complete toxicity data base for
sulfentrazone and
[[Page 55277]]
exposure data are complete or are estimated based on data that
reasonably accounts for potential exposures. EPA determined that the
10X safety factor to protect infants and children should be reduced to
1X for the following reasons:
1. There are no residual uncertainties for prenatal and/or
postnatal toxicities via the oral route since the doses selected for
overall risk assessments would address the concerns for the
developmental and offspring toxicities seen in the above mentioned
studies.
2. There are no residual uncertainties for prenatal and/or
postnatal toxicities via the dermal route since the dose/endpoint/
study/species of concern was used for dermal-risk assessment.
3. The toxicology data base is complete.
4. The dietary (food) exposure assessment utilizes existing and
proposed tolerance level residues and assumes 100% of crops treated
with sulfentrazone. The assessment is based on reliable data and is not
expected to underestimate exposure/risk.
5. Conservative assumptions are used in the drinking water models.
The drinking water exposure assessment is not expected to underestimate
exposure/risk.
6. The residential exposure assessment is based on conservative
assumptions and is not expected to underestimate risk.
E. Aggregate Risks and Determination of Safety
To estimate total aggregate exposure to a pesticide from food,
drinking water, and residential uses, the Agency calculates DWLOCs
which are used as a point of comparison against the model estimates of
a pesticide's concentration in water (EECs). DWLOC values are not
regulatory standards for drinking water. DWLOCs are theoretical upper
limits on a pesticide's concentration in drinking water in light of
total aggregate exposure to a pesticide in food and residential uses.
In calculating a DWLOC, the Agency determines how much of the
acceptable exposure (i.e., the PAD) is available for exposure through
drinking water e.g., allowable chronic water exposure (mg/kg/day) =
cPAD - (average food + residential exposure). This allowable exposure
through drinking water is used to calculate a DWLOC.
A DWLOC will vary depending on the toxic endpoint, drinking water
consumption, and body weights. Default body weights and consumption
values as used by the USEPA Office of Water are used to calculate
DWLOCs: 2 liter (L)/70 kg (adult male), 2L/60 kg (adult female), and
1L/10 kg (child). Default body weights and drinking water consumption
values vary on an individual basis. This variation will be taken into
account in more refined screening-level and quantitative drinking water
exposure assessments. Different populations will have different DWLOCs.
Generally, a DWLOC is calculated for each type of risk assessment used:
Acute, short-term, intermediate-term, chronic, and cancer.
When EECs for surface water and ground water are less than the
calculated DWLOCs, EPA concludes with reasonable certainty that
exposures to the pesticide in drinking water (when considered along
with other sources of exposure for which EPA has reliable data) would
not result in unacceptable levels of aggregate human health risk at
this time. Because EPA considers the aggregate risk resulting from
multiple exposure pathways associated with a pesticide's uses, levels
of comparison in drinking water may vary as those uses change. If new
uses are added in the future, EPA will reassess the potential impacts
of residues of the pesticide in drinking water as a part of the
aggregate risk assessment process.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food to
sulfentrazone will occupy <1% of the aPAD for the U.S. population, <1%
of the aPAD for females 13 years and older, and <1% of the aPAD for
children 1 to 2 years old, the population at greatest exposure. In
addition, there is potential for acute dietary exposure to
sulfentrazone in drinking water. After calculating DWLOCs and comparing
them to the EECs for surface water and ground water, EPA does not
expect the aggregate exposure to exceed 100% of the aPAD, as shown in
Table 3 of this unit:
Table 3.--Aggregate Risk Assessment for Acute Exposure to Sulfentrazone
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup aPAD (mg/ % aPAD Water EEC Water EEC Acute DWLOC
kg) (Food) (ppb) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population 2.5 <1 35.8 26 87,000
----------------------------------------------------------------------------------------
Children (1 to 2 years old) 2.5 <1 35.8 26 25,000
----------------------------------------------------------------------------------------
Females (13 to 49 years old) 2.5 <1 35.8 26 75,000
----------------------------------------------------------------------------------------------------------------
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
sulfentrazone from food will utilize 1% of the cPAD for the U.S.
population, 1% of the cPAD for females 13 to 49 years old and 1 % of
the cPAD for children, 3 to 5 years old, the population at greatest
exposure. Based on the proposed use pattern for turf grass, chronic
residential exposure to residues of sulfentrazone is not expected. In
addition, there is potential for chronic dietary exposure to
sulfentrazone and its degredate, 3-carboxylic acid sulfentrazone, in
drinking water. After calculating DWLOCs and comparing them to the EECs
for surface and ground water, EPA does not expect the aggregate
exposure to exceed 100% of the cPAD, as shown in Table 4 of this unit:
[[Page 55278]]
Table 4.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Sulfentrazone
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup cPAD mg/kg/ % cPAD Water EEC Water EEC Chronic
day (Food) (ppb) (ppb) DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population 0.14 1 7.8 26 4,900
----------------------------------------------------------------------------------------
Children (3 to 5 years old) 0.14 1 7.8 26 1,400
----------------------------------------------------------------------------------------
Females (13 to 49 years old) 0.14 1 7.8 26 4,200
----------------------------------------------------------------------------------------------------------------
3. Short-term risk. Short-term aggregate exposure takes into
account residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
Sulfentrazone is proposed for registration for use that could
result in short-term residential exposure and the Agency has determined
that it is appropriate to aggregate chronic food and water and short-
term exposures for sulfentrazone. Using the exposure assumptions
described in this unit for short-term exposures, EPA has concluded that
food and residential exposures aggregated result in aggregate MOEs
ranging from 6,900 for the U.S. population to 3,200 for children 3 to 5
years old. These aggregate MOEs do not exceed the Agency's level of
concern for aggregate exposure to food and residential uses. In
addition, short-term DWLOCs were calculated and compared to the EECs
for chronic exposure of sulfentrazone in ground water and surface
water. After calculating DWLOCs and comparing them to the EECs for
surface water and ground water, EPA does not expect short-term
aggregate exposure to exceed the Agency's level of concern, as shown in
Table 5 of this unit:
Table 5.--Aggregate Risk Assessment for Short-Term Exposure to Sulfentrazone
----------------------------------------------------------------------------------------------------------------
Aggregate
Aggregate Level of Surface Ground Short-Term
Population Subgroup MOE (Food + Concern Water EEC Water EEC DWLOC (ppb)
Residential) (LOC) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population 6,900 100 7.8 26 4,900
----------------------------------------------------------------------------------------
Children (3 to 5 years old) 3,200 100 7.8 26 1,400
----------------------------------------------------------------------------------------
Females (13 to 49 years) 7,600 100 7.8 26 4,200
----------------------------------------------------------------------------------------------------------------
5. Aggregate cancer risk for U.S. population. There is no evidence
of carcinogenicity to humans based on carcinogenicity studies in male
and female rats and mice. The Agency concludes that pesticidal uses of
sulfentrazone are not likely to pose a cancer hazard to humans.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, and to infants and children from aggregate
exposure to sulfentrazone residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
An adequate enforcement method using gas chromatography (GC) for
the determination of sulfentrazone, DMS, and HMS residues is available
for enforcement. The method was forwarded to the Food and Drug
Administration (FDA) for inclusion in Pesticide Analytical Method
Volume II (PAM II). The method may be requested from: Chief, Analytical
Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft.
Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail address:
residuemethods@epa.gov.
B. International Residue Limits
There are no established Codex, Canadian or Mexican maximum residue
limits (MRLs) for residues of sulfentrazone in/on the subject
commodities. Therefore, no compatibility problems exist for the
tolerances established by this rule.
V. Conclusion
Therefore, the tolerance is established for combined residues of
sulfentrazone and its metabolites HMS (N-(2,4-dichloro-5-(4-
(difluoromethyl)-4,5-dihydro-3-hydroxymethyl-5-oxo-1H-1,2,4-triazol-1-
yl)phenyl)methanesulfonamide) and DMS (N-(2,4-dichloro-5-(4-
(difluoromethyl)-4,5-dihydro-5-oxo-1H-1,2,4-triazol-1-
yl)phenyl)methanesulfonamide, in or on asparagus at 0.15 ppm; bean,
lima, succulent at 0.15 ppm; cabbage at 0.20 ppm; corn, field, forage
at 0.20 ppm; corn, field, grain at 0.15 ppm; corn, field, stover at
0.30 ppm; horseradish, roots at 0.20 ppm; pea and bean, dried shelled,
except soybean, subgroup 6C at 0.15 ppm; peanut at 0.20 ppm; peanut,
meal at 0.40 ppm; peppermint, tops at 0.30 ppm; potato at 0.15 ppm;
spearmint, tops at 0.30 ppm; sugarcane, cane 0.15 ppm; sugarcane,
molasses 0.20 ppm; and sunflower, seed at 0.20 ppm.
VI. Objections and Hearing Requests
Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. Although the procedures in those
regulations require some modification to reflect the amendments made to
the FFDCA by the FQPA, EPA will continue to use those procedures, with
appropriate adjustments, until the necessary modifications can be made.
The new section 408(g) of the FFDCA provides essentially the same
process for persons to ``object'' to a regulation for an exemption from
the requirement of a tolerance issued by EPA under new section 408(d)
of FFDCA, as was provided in the old sections 408 and 409 of the FFDCA.
However, the period
[[Page 55279]]
for filing objections is now 60 days, rather than 30 days.
A. What Do I Need to Do to File an Objection or Request a Hearing?
You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket ID number OPP-2003-0270 in the subject line on the
first page of your submission. All requests must be in writing, and
must be mailed or delivered to the Hearing Clerk on or before November
24, 2003.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900C),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. You may also deliver your request to the
Office of the Hearing Clerk in Rm. 104, Crystal Mall #2, 1921
Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is
open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Office of the Hearing Clerk is
(703) 603-0061.
2. Tolerance fee payment. If you file an objection or request a
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must
mail the fee to: EPA Headquarters Accounting Operations Branch, Office
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please
identify the fee submission by labeling it ``Tolerance Petition Fees.''
EPA is authorized to waive any fee requirement ``when in the
judgement of the Administrator such a waiver or refund is equitable and
not contrary to the purpose of this subsection.'' For additional
information regarding the waiver of these fees, you may contact James
Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov,
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
3. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VI.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in Unit I.B.1. Mail your
copies, identified by docket ID number OPP-2003-0270, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the
PIRIB described in Unit I.B.1. You may also send an electronic copy of
your request via e-mail to: opp-docket@epa.gov. Please use an ASCII
file format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit an
electronic copy of your request at many Federal Depository Libraries.
B. When Will the Agency Grant a Request for a Hearing?
A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).
VII. Statutory and Executive Order Reviews
This final rule establishes a tolerance under section 408(d) of the
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this rule has been
exempted from review under Executive Order 12866 due to its lack of
significance, this rule is not subject to Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does
not contain any information collections subject to OMB approval under
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose
any enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
104-4). Nor does it require any special considerations under Executive
Order 12898, entitled Federal Actions to Address Environmental Justice
in Minority Populations and Low-Income Populations (59 FR 7629,
February 16, 1994); or OMB review or any Agency action under Executive
Order 13045, entitled Protection of Children from Environmental Health
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does
not involve any technical standards that would require Agency
consideration of voluntary consensus standards pursuant to section
12(d) of the National Technology Transfer and Advancement Act of 1995
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are established on the basis of a
petition under section 408(d) of the FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. In addition, the Agency has determined that this
action will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled
Federalism(64 FR 43255, August 10, 1999). Executive Order 13132
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by State and local officials in the
[[Page 55280]]
development of regulatory policies that have federalism implications.''
``Policies that have federalism implications'' is defined in the
Executive Order to include regulations that have ``substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.'' This final
rule directly regulates growers, food processors, food handlers and
food retailers, not States. This action does not alter the
relationships or distribution of power and responsibilities established
by Congress in the preemption provisions of section 408(n)(4) of the
FFDCA. For these same reasons, the Agency has determined that this rule
does not have any ``tribal implications'' as described in Executive
Order 13175, entitled Consultation and Coordination with Indian Tribal
Governments (59 FR 22951, November 6, 2000). Executive Order 13175,
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by tribal officials in the development of regulatory
policies that have tribal implications.'' ``Policies that have tribal
implications'' is defined in the Executive Order to include regulations
that have ``substantial direct effects on one or more Indian tribes, on
the relationship between the Federal Government and the Indian tribes,
or on the distribution of power and responsibilities between the
Federal Government and Indian tribes.'' This rule will not have
substantial direct effects on tribal governments, on the relationship
between the Federal Government and Indian tribes, or on the
distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified in Executive Order 13175.
Thus, Executive Order 13175 does not apply to this rule.
VIII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this final rule in the Federal Register. This final
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: September 10, 2003.
Debra Edwards,
Director, Registration Division, Office of Pesticide Programs.
¥ Therefore, 40 CFR chapter I is amended as follows:
PART 180--AMENDED
¥ 1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346(a) and 371.
¥ 2. Section 180.498 is amended by redesignating existing paragraph (a)
as (a)(1), by adding paragraph (a)(2), and in the table to paragraph
(b) by removing the entries ``horseradish, roots''; ``pea, dry, seed'';
``potato''; ``potato, granules/flakes''; ``potato, wet peel'';
``sugarcane''; and ``sunflower, seed.''
Sec. 180.498 Sulfentrazone; tolerances for residues.
(a) General. (1) * * *
(2) Tolerances are established for combined residues of the
herbicide sulfentrazone and its metabolites HMS (N-(2,4-dichloro-5-(4-
(difluoromethyl)-4,5-dihydro-3-hydroxymethyl-5-oxo-1H-1,2,4-triazol- 1-
yl)phenyl)methanesulfonamide) and DMS (N-(2,4-dichloro-5-(4-
(difluoromethyl)-4,5-dihydro-5-oxo-1H-1,2,4-triazol-1-
yl)phenyl)methanesulfonamide in or on the following food commodities:
----------------------------------------------------------------------------------------------------------------
Commodity Parts per million
----------------------------------------------------------------------------------------------------------------
Asparagus............................................. 0.15
Bean, lima, succulent................................. 0.15
Cabbage............................................... 0.20
Corn, field, forage................................... 0.20
Corn, field, grain.................................... 0.15
Corn, field, stover................................... 0.30
Horseradish, roots.................................... 0.20
Pea and bean, dried shelled, except soybean, subgroup 0.15
6C...................................................
Peanut................................................ 0.20
Peanut, meal.......................................... 0.40
Peppermint, tops...................................... 0.30
Potato................................................ 0.15
Spearmint, tops....................................... 0.30
Sugarcane, cane....................................... 0.15
Sugarcane, molasses................................... 0.20
Sunflower, seed....................................... 0.20
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[FR Doc. 03-24011 Filed 9-23-03; 8:45 am]
BILLING CODE 6560-50-S