Sulfentrazone; Pesticide Tolerances, 54620-54626 [2014-21807]
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Federal Register / Vol. 79, No. 177 / Friday, September 12, 2014 / Rules and Regulations
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2013–0712; FRL–9915–47]
Sulfentrazone; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes a
tolerance for residues of sulfentrazone
in or on apple. The Interregional
Research Project Number 4 (IR–4)
requested these tolerances under the
Federal Food, Drug, and Cosmetic Act
(FFDCA).
SUMMARY:
This regulation is effective
September 12, 2014. Objections and
requests for hearings must be received
on or before November 12, 2014, and
must be filed in accordance with the
instructions provided in 40 CFR part
178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2013–0712, is
available at https://www.regulations.gov
or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket)
in the Environmental Protection Agency
Docket Center (EPA/DC), West William
Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave., NW., Washington,
DC 20460–0001. The Public Reading
Room is open from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding
legal holidays. The telephone number
for the Public Reading Room is (202)
566–1744, and the telephone number for
the OPP Docket is (703) 305–5805.
Please review the visitor instructions
and additional information about the
docket available at https://www.epa.gov/
dockets.
FOR FURTHER INFORMATION CONTACT: Lois
Rossi, Registration Division (7505P),
Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington,
DC 20460–0001; main telephone
number: (703) 305–7090; email address:
RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
DATES:
I. General Information
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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. The following
list of North American Industrial
Classification System (NAICS) codes is
not intended to be exhaustive, but rather
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provides a guide to help readers
determine whether this document
applies to them. Potentially affected
entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
B. How can I get electronic access to
other related information?
You may access a frequently updated
electronic version of EPA’s tolerance
regulations at 40 CFR part 180 through
the Government Printing Office’s e-CFR
site at https://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/
40tab_02.tpl.
C. How can I file an objection or hearing
request?
Under FFDCA section 408(g), 21
U.S.C. 346a, any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. You must file your objection
or request a hearing on this regulation
in accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2013–0712 in the subject line on
the first page of your submission. All
objections and requests for a hearing
must be in writing, and must be
received by the Hearing Clerk on or
before November 12, 2014. Addresses
for mail and hand delivery of objections
and hearing requests are provided in 40
CFR 178.25(b).
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing (excluding
any Confidential Business Information
(CBI)) for inclusion in the public docket.
Information not marked confidential
pursuant to 40 CFR part 2 may be
disclosed publicly by EPA without prior
notice. Submit the non-CBI copy of your
objection or hearing request, identified
by docket ID number EPA–HQ–OPP–
2013–0712, by one of the following
methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the online
instructions for submitting comments.
Do not submit electronically any
information you consider to be CBI or
other information whose disclosure is
restricted by statute.
• Mail: OPP Docket, Environmental
Protection Agency Docket Center (EPA/
DC), (28221T), 1200 Pennsylvania Ave.
NW., Washington, DC 20460–0001.
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• Hand Delivery: To make special
arrangements for hand delivery or
delivery of boxed information, please
follow the instructions at https://
www.epa.gov/dockets/contacts.html.
Additional instructions on commenting
or visiting the docket, along with more
information about dockets generally, is
available at https://www.epa.gov/
dockets.
II. Summary of Petitioned-For
Tolerance
In the Federal Register of December
30, 2013 (78 FR 79359) (FRL–9903–69),
EPA issued a document pursuant to
FFDCA section 408(d)(3), 21 U.S.C.
346a(d)(3), announcing the filing of a
pesticide petition (PP 3E8202) by IR–4,
500 College Road East, Suite 201W,
Princeton, NJ 08540. The petition
requested that 40 CFR 180.498 be
amended by establishing tolerances for
residues of the herbicide sulfentrazone,
(N-[2,4-dichloro-5-[4-(difluoromethyl)4,5-dihydro-3-methyl-5-oxo-1H-1,2,4triazol-1yl]phenyl]methanesulfonamide), and its
metabolite HMS (N-(2,4-dichloro-5-(4(difluoromethyl)-4,5-dihydro-3hydroxymethyl-5-oxo-1H-1,2,4-triazol-1yl)phenyl)methanesulfonamide,
calculated as the stoichiometric
equivalent of sulfentrazone, in or on
apple at 0.15 parts per million (ppm).
That document referenced a summary of
the petition prepared on behalf of IR–4
by FMC Corporation, the registrant,
which is available in the docket,
https://www.regulations.gov. Comments
were received on the notice of filing.
EPA’s response to these comments is
discussed in Unit IV.C.
Based upon review of the data
supporting the petition, EPA has
determined that it is appropriate to
establish the tolerance in or on apple for
the combined residues of the free and
conjugated forms of the herbicide
sulfentrazone, and its metabolites HMS
(N-(2,4-dichloro-5-(4-(difluoromethyl)4,5-dihydro-3-hydroxymethyl-5-oxo-1H1,2,4-triazol-1yl)phenyl)methanesulfonamide) and
DMS (N-(2,4-dichloro-5-(4(difluoromethyl)-4,5-dihydro-5-oxo-1H1,2,4-triazol-1yl)phenyl)methanesulfonamide,
calculated as the stoichiometric
equivalent of sulfentrazone. The reason
for this decision is discussed in Unit
IV.D.
III. Aggregate Risk Assessment and
Determination of Safety
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
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determines that the tolerance is ‘‘safe.’’
Section 408(b)(2)(A)(ii) of 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 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. . . .’’
Consistent with FFDCA section
408(b)(2)(D), and the factors specified in
FFDCA 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
and to make a determination on
aggregate exposure for sulfentrazone
including exposure resulting from the
tolerances established by this action.
EPA’s assessment of exposures and risks
associated with sulfentrazone 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.
Subchronic and chronic toxicity
studies in rats, mice, and dogs identified
the hematopoietic system as the target of
sulfentrazone. Sulfentrazone inhibits
the enzyme protoporphyrinogen oxidase
(PPO) in target plants, and the results of
subchronic and chronic toxicity studies
in mammalian systems are consistent
with PPO inhibition. Disruption of
heme biosynthesis was indicated by
signs of anemia, and decreases in
hematocrit (Hct), hemoglobin (HGB),
and mean corpuscular volume (MCV) in
mice, rats, and dogs at comparable dose
levels from short- through long-term
exposures without a significant increase
in severity.
Sulfentrazone caused developmental
effects when administered via the oral
(rats and rabbits) and dermal (rat only)
routes of exposure. Developmental
effects in rats and rabbits consisted of
reductions in the number of
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implantations in rats, and increases in
early resorptions and reduction in live
fetuses per litter in rats and rabbits.
Surviving rat fetuses exhibited reduced/
delayed skeletal ossifications, and
decreased fetal body weights.
Developmental effects in rats were seen
in the absence of maternal toxicity. In
contrast with the rat studies,
developmental effects in rabbits were
observed at a maternally toxic dose,
where clinical signs of toxicity included
hematuria (red blood cells in urine),
abortions, and decreased body-weight
gains. In the 2-generation reproductive
toxicity study in rats, developmental
effects included an increased duration
of gestation, reduced prenatal viability
(fetal and litter), reduced litter size, and
an increased number of stillborn pups.
Pup body-weight deficits, along with
reduced pup and litter postnatal
survival, were also observed. All of the
offspring effects were reported in the
presence of mild maternal toxicity
(decreased body weight and bodyweight gain, particularly in F1 females).
No systemic toxicity was seen via the
dermal route up to the limit dose in a
28-day dermal toxicity study in adult
non-pregnant rabbits. In a dermal
developmental study in rats, there was
an increased quantitative fetal
susceptibility. While no maternal effects
were observed up to the highest dose
tested, fetal effects were observed at this
dose, and consisted of decreased body
weights, increased incidences of fetal
variations, hypoplastic or wavy ribs,
incompletely ossified lumbar vertebral
arches, incompletely ossified ischia or
pubis, and a reduced number of thoracic
vertebral and rib ossification sites.
In the 26-day inhalation toxicity
study, effects that were considered
treatment related and adverse effects
occurred only at the highest
concentration tested. Systemic effects at
this concentration consisted of
significant reductions in red blood cell
(RBC) parameters including RBC count,
HGB concentrations, Hct, MCV, mean
corpuscular HGB (MCH), and/or
reticulocytes in both sexes. Portal-ofentry effects in this study consisted of
an increased incidence of minimal nasal
respiratory epithelial hyperplasia in
both sexes as well as minimal laryngeal
epithelial attenuation in all test material
exposure groups. The effects on
hematological parameters were
reversible after 28 days of recovery,
while the nasal injury persisted.
In an acute neurotoxicity (ACN) study
in rats, effects consisted of an increased
incidence of clinical signs of toxicity
(staggered gait, splayed hind limbs, and
abdominal gripping), changes in
functional-observation battery (FOB)
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parameters, and decreased motor
activity at a high dose level. Complete
recovery was observed by day 14, and
there was no evidence of
neuropathology. In a rat subchronic
neurotoxicity (SCN) study, clinical signs
of toxicity, increased motor activity,
and/or decreased body weights, bodyweight gain, and food consumption
were also observed with no evidence of
neuropathology. A published, nonguideline developmental toxicity study
in the rat did not conclusively
demonstrate developmental
neurotoxicity and contained several
shortcomings that limit its use for
regulatory purposes, including the lack
of a no-observed-adverse-effect-level
(NOAEL) (DeCastro VL, Destefani CR,
Diniz C, Poli P., 2007, Evaluation of
neurodevelopmental effects on rats
exposed prenatally to sulfentrazone.
Neurotoxicology 28(6):1249–59). The
reported effects involving measures of
physical and reflex development are
likely secondary effects reflective of the
poor general state of the offspring as
reported in the rat 2-generation
reproductive toxicity study at similar
dose levels but with a well-defined
NOAEL.
In the 28-day rat immunotoxicity
study, there were no effects on the
immune system and systemic effects
consisted of reduced body weight, and
increased absolute and relative spleen
weights at the highest dose tested.
Carcinogenicity studies in rats and mice
showed no evidence of increased
incidence of tumor formation due to
treatment with sulfentrazone, and the
EPA has classified sulfentrazone as not
likely to be carcinogenic to humans. The
available mutagenicity studies indicate
that sulfentrazone is weakly clastogenic
in the in vitro mouse lymphoma assay
in the absence of S9 activation. There is
no evidence that sulfentrazone is
mutagenic in bacterial cells or
clastogenic in male or female mice in
vivo.
Specific information on the studies
received and the nature of the adverse
effects caused by sulfentrazone as well
as the NOAEL and the lowest-observedadverse-effect-level (LOAEL) from the
toxicity studies can be found at https://
www.regulations.gov in document:
‘‘Sulfentrazone—Preliminary HumanHealth Risk Assessment for Registration
Review and the Risk Assessment for the
Section 3 Registration Request for a New
Use on Apples’’ at pp. 44–49 in docket
ID number EPA–HQ–OPP–2013–0712.
B. Toxicological Points of Departure/
Levels of Concern
Once a pesticide’s toxicological
profile is determined, EPA identifies
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toxicological points of departure (POD)
and levels of concern to use in
evaluating the risk posed by human
exposure to the pesticide. For hazards
that have a threshold below which there
is no appreciable risk, the toxicological
POD is used as the basis for derivation
of reference values for risk assessment.
PODs are developed based on a careful
analysis of the doses in each
toxicological study to determine the
dose at which the NOAEL and the
LOAEL are identified. Uncertainty/
safety factors are used in conjunction
with the POD to calculate a safe
exposure level—generally referred to as
a population-adjusted dose (PAD) or a
reference dose (RfD)—and a safe margin
of exposure (MOE). For non-threshold
risks, the Agency assumes that any
amount of exposure will lead to some
degree of risk. Thus, the Agency
estimates risk in terms of the probability
of an occurrence of the adverse effect
expected in a lifetime. For more
information on the general principles
EPA uses in risk characterization and a
complete description of the risk
assessment process, see https://
www.epa.gov/pesticides/factsheets/
riskassess.htm.
A summary of the toxicological
endpoints for sulfentrazone used for
human risk assessment is shown in
Table 1 of this unit.
TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR SULFENTRAZONE FOR USE IN HUMAN HEALTH RISK
ASSESSMENT
Point of departure
and
uncertainty/safety
factors
RfD, PAD, LOC for
risk
assessment
Acute dietary (Females 13–49
years of age).
NOAEL = 14 mg/kg/
day.
UFA = 10x
UFH = 10x
FQPA SF = 1x
Acute RfD = 0.14
mg/kg/day.
aPAD = 0.14 mg/kg/
day.
Acute dietary (General population including infants and
children).
NOAEL = 250 mg/
kg/day.
UFA = 10x
UFH = 10x
FQPA SF = 1x
NOAEL = 14 mg/kg/
day.
UFA = 10x
UFH = 10x
FQPA SF = 1x
Acute RfD = 2.5 mg/
kg/day.
aPAD = 2.5 mg/kg/
day.
NOAEL = 14 mg/kg/
day.
UFA = 10x
UFH = 10x
FQPA SF = 1x
Dermal study
NOAEL = 100 mg/
kg/day.
UFA = 10 x
UFH = 10 x
FQPA SF = 1x
Portal-of-entry
NOAEL = 0.256
mg/L, HEC =
0.054 mg/L, HED
= 1.55.
mg/kg/day UFA = 3x
UFH = 10x
FQPA SF = 1x
LOC for MOE = 100
Exposure/scenario
Chronic dietary (All populations)
Incidental oral short- (1 to 30
days) and intermediate-term
(1–6 months).
Dermal short-term (1 to 30
days).
Short-term (1–30 days) inhalation.
Cancer (Oral, dermal, inhalation).
Chronic RfD = 0.14
mg/kg/day.
cPAD = 0.14 mg/kg/
day.
LOC for MOE = 100
LOC for MOE = 30 ..
Study and toxicological effects
2-generation Reproductive Toxicity Study—Rat
Offspring Toxicity LOAEL = 33 (M) and 40 (F) mg/kg/day
based on reduced prenatal viability (fetal & litter), reduced litter size, increased number of stillborn pups, reduced pup
and litter postnatal survival, and decreased pup body weights
throughout lactation.
Acute Neurotoxicity (ACN) Study—Rat
LOAEL = 750 mg/kg/day based on increased incidence of clinical signs and FOB parameters and decreased motor activity.
2-generation Reproductive Toxicity Study—Rat
Offspring Toxicity LOAEL = 33 (M) and 40 (F) mg/kg/day
based on reduced prenatal viability (fetal & litter), reduced litter size, increased number of stillborn pups, reduced pup
and litter postnatal survival, and decreased pup body weights
throughout lactation.
2-Generation Reproductive Toxicity Study—Rat
Offspring LOAEL = 33 mg/kg/day based on decreased pup
body weights and reduced postnatal survival in both generations.
Dermal Developmental Study—Rat
LOAEL = 250 mg/kg/day based on decreased fetal body
weight; increased incidences of fetal skeletal 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.
Portal-of-entry LOAEL = 1.71 mg/L based on an increased incidence of minimal nasal respiratory epithelial hyperplasia in
male and female rats.
Sulfentrazone is classified as not likely to be carcinogenic to humans
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FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day =
milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c =
chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in
sensitivity among members of the human population (intraspecies). HEC = human-equivalent concentration. HED = human-equivalent dose.
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to sulfentrazone, EPA
considered exposure under the
petitioned-for tolerances as well as all
existing sulfentrazone tolerances in 40
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CFR 180.498. EPA assessed dietary
exposures from sulfentrazone in food as
follows:
i. Acute exposure. Quantitative acute
dietary exposure and risk assessments
are performed for a food-use pesticide,
if a toxicological study has indicated the
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possibility of an effect of concern
occurring as a result of a 1-day or single
exposure. Such effects were identified
for sulfentrazone, and EPA performed
separate acute risk assessments for
females 13 to 49 years old and for the
general population, including infants
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and children, based on different
endpoints and acute population
adjusted doses (aPADs). In estimating
acute dietary exposures, EPA used the
Dietary Exposure Evaluation Model,
Food Consumption Intake Database
(DEEM–FCID, ver. 3.16), which
incorporates consumption data from
United States Department of Agriculture
(USDA) National Health and Nutrition
Examination Survey, What We Eat in
America, (NHANES/WWEIA; 2003–
2008). As to residue levels in food, EPA
assumed tolerance-level residues, 100
percent crop treated (PCT), and DEEM
(ver. 7.81) default processing factors.
ii. Chronic exposure. In conducting
the chronic dietary exposure assessment
EPA used DEEM–FCID, ver. 3.16, which
incorporated consumption data from the
USDA’s NHANES/WWEIA; 2003–2008.
As to residue levels in food, EPA
assumed tolerance-level residues, 100
PCT, and DEEM (ver. 7.81) default
processing factors.
iii. Cancer. Based on the data
summarized in Unit III.A., EPA has
concluded that sulfentrazone does not
pose a cancer risk to humans. Therefore,
a dietary exposure assessment for the
purpose of assessing cancer risk is
unnecessary.
iv. Anticipated residue and PCT
information. EPA did not use
anticipated residue and/or PCT
information in the dietary assessment
for sulfentrazone. Tolerance level
residues and/or 100 PCT were assumed
for all food commodities.
2. Dietary exposure from drinking
water. The Agency used screening level
water exposure models in the dietary
exposure analysis and risk assessment
for sulfentrazone in drinking water.
These simulation models take into
account data on the physical, chemical,
and fate/transport characteristics of
sulfentrazone. Further information
regarding EPA drinking water models
used in pesticide exposure assessment
can be found at https://www.epa.gov/
oppefed1/models/water/index.htm.
Based on the Pesticide Root Zone
Model/Exposure Analysis Modeling
System (PRZM/EXAMS) and Pesticide
Root Zone Model Ground Water (PRZM
GW), the estimated drinking water
concentrations (EDWCs) of
sulfentrazone for acute exposures are
estimated to be 37.3 parts per billion
(ppb) for surface water and 134 ppb for
ground water; and for chronic exposures
for non-cancer assessments are
estimated to be 5.3 ppb for surface water
and 98 ppb for ground water.
Modeled estimates of drinking water
concentrations were directly entered
into the dietary exposure model. For
acute dietary risk assessment, the water
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concentration value of 134 ppb was
used to assess the contribution to
drinking water. For chronic dietary risk
assessment, the water concentration of
value 98 ppb was used to assess the
contribution to drinking water.
3. From non-dietary exposure. The
term ‘‘residential exposure’’ is used in
this document to refer to nonoccupational, non-dietary exposure
(e.g., for lawn and garden pest control,
indoor pest control, termiticides, and
flea and tick control on pets).
Sulfentrazone is currently registered for
the following uses that could result in
residential exposures: Residential home
lawns/turf and recreational turf, such as
golf courses. EPA assessed residential
exposures using the following
assumptions: Adults were assessed for
potential short-term dermal and
inhalation handler exposures from
applying sulfentrazone to residential
turf/home lawns and for short-term
postapplication dermal exposure from
contact with treated residential and
recreational turf.
Children, ages 11 < 16 years old and
6 < 11 years old, were assessed for
postapplication dermal exposure from
contact with treated residential and
recreational turf (home lawns and golf
courses). Children, ages 1 < 2 years old,
were assessed for postapplication shortterm dermal and incidental oral
exposures (hand-to-mouth, object-tomouth, and episodic ingestion of
granules), as well as short- and
intermediate-term incidental oral soil
ingestion scenarios from contact with
residential turf/home lawns.
The recommended adult residential
exposure scenario for use in the
aggregate assessment reflects short-term
dermal exposure from applications to
turf via backpack sprayer. The
recommended residential exposure
scenario for use in the combined shortand intermediate-term aggregate
assessment for children ages 1 < 2 years
old reflects dermal and hand-to-mouth
exposures from postapplication
exposure to turf applications. This
combination should be considered a
protective estimate of children’s
exposure to pesticides used on turf
since the incidental oral scenarios are
considered inter-related, likely
occurring interspersed amongst each
other across time; therefore, combining
these scenarios would be overlyconservative because of the conservative
nature of each individual assessment. In
addition, the only potential
intermediate-term exposure is
postapplication soil ingestion which is
significantly less than short-term handto-mouth exposure. Further, this
scenario is considered protective of
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potential post-application exposures to
children, ages 6 < 11 and 11 < 16 years
old, as children 1–2 years old represent
the population subgroup for children
with the greatest exposure, and is
therefore considered protective of other
children population subgroups.
Chronic exposures are not expected
and were not assessed. Finally,
residential handler and/or
postapplication inhalation risk
estimates were not combined with
dermal or oral risk estimates in the
aggregate risk assessment since the
toxicological effects in the inhalation
toxicological study were portal-of-entry
and were different from those seen in
the dermal and oral toxicological
studies. Further information regarding
EPA standard assumptions and generic
inputs for residential exposures may be
found at https://www.epa.gov/pesticides/
trac/science/trac6a05.pdf.
4. Cumulative effects from substances
with a common mechanism of toxicity.
Section 408(b)(2)(D)(v) of 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 has not
found sulfentrazone to share a common
mechanism of toxicity with 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 assumed that
sulfentrazone does not have 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 EPA’s Web site at https://
www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and
Children
1. In general. Section 408(b)(2)(C) of
FFDCA provides that EPA shall apply
an additional tenfold (10X) 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
based on reliable data that a different
margin of safety will be safe for infants
and children. This additional margin of
safety is commonly referred to as the
Food Quality Protection Act Safety
Factor (FQPA SF). In applying this
provision, EPA either retains the default
value of 10X, or uses a different
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additional safety factor when reliable
data available to EPA support the choice
of a different factor.
2. Prenatal and postnatal sensitivity.
There is evidence of increased
quantitative susceptibility following in
utero exposure in the oral and dermal
rat developmental toxicity studies.
Developmental effects, including
decreased fetal body weights and
reduced/delayed skeletal ossifications,
were observed at doses that were not
maternally toxic. In the 2-generation
reproduction study in rats, offspring
effects such as decreased body weights
and decreased litter survival were
observed at a slightly maternally toxic
dose (slightly decreased body weight
gain), indicating possible slightly
increased qualitative susceptibility.
3. Conclusion. EPA has determined
that reliable data show the safety of
infants and children would be
adequately protected if the FQPA SF
were reduced to 1X. That decision is
based on the following findings:
i. The toxicity database for
sulfentrazone is complete.
ii. In the ACN and SCN studies,
observed effects included changes in
motor activity and FOB parameters,
clinical signs, and body-weight
decrements. There is low concern for
neurotoxicity since:
1. Effects were seen at relatively high
doses;
2. Effects occurred in the absence of
neuropathology;
3. There is no evidence of
neurotoxicity in other available studies
in the toxicity database;
4. Effects are well-characterized with
clearly established NOAEL/LOAEL
values; and
5. The selected PODs are protective of
these effects.
iii. There was evidence for increased
quantitative susceptibility following
oral and dermal exposures in the
developmental toxicity studies in rats.
Although developmental toxicity was
observed at lower doses than maternal
toxicity in both studies in the rat, the
concern is low based on the following
considerations:
1. The toxicology database for
assessing pre- and postnatal
susceptibility is complete;
2. There are clear NOAELs and
LOAELs for the developmental effects
observed via both the oral and dermal
routes;
3. The PODs used for assessing
dietary and dermal exposure risks are
based on developmental and/or
offspring toxicity;
4. The portal-of-entry effects seen in
the 26-day inhalation study are
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protective of the developmental toxicity;
and
5. There are no residual uncertainties
for pre- and/or postnatal toxicity.
iv. There are no residual uncertainties
identified in the exposure databases.
The dietary food exposure assessments
were performed based on 100 PCT and
tolerance-level residues. EPA made
conservative (protective) assumptions in
the ground and surface water modeling
used to assess exposure to sulfentrazone
in drinking water. EPA used similarly
conservative assumptions to assess
postapplication exposure of children as
well as incidental oral exposure of
toddlers. These assessments will not
underestimate the exposure and risks
posed by sulfentrazone.
E. Aggregate Risks and Determination of
Safety
EPA determines whether acute and
chronic dietary pesticide exposures are
safe by comparing aggregate exposure
estimates to the acute PAD (aPAD) and
chronic PAD (cPAD). For linear cancer
risks, EPA calculates the lifetime
probability of acquiring cancer given the
estimated aggregate exposure. Short-,
intermediate-, and chronic-term risks
are evaluated by comparing the
estimated aggregate food, water, and
residential exposure to the appropriate
PODs to ensure that an adequate MOE
exists.
1. Acute risk. An acute aggregate risk
assessment takes into account acute
exposure estimates from dietary
consumption of food and drinking
water. Using the exposure assumptions
discussed in this unit for acute
exposure, the acute dietary exposure
from food and water to sulfentrazone
will occupy 6.7% of the aPAD for
females 13–49 years old, and 1.1% of
the aPAD for all infants less than 1 year
old, the population group receiving the
greatest exposure for all populations
other than females 13–49 years old.
2. Chronic risk. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that chronic exposure to sulfentrazone
from food and water will utilize 7.1% of
the cPAD for children 1–2 years old, the
population group receiving the greatest
exposure. Based on the explanation in
Unit III.C.3., regarding residential use
patterns, chronic residential exposure to
residues of sulfentrazone is not
expected.
3. Short-term risk. Short-term
aggregate exposure takes into account
short-term residential exposure plus
chronic exposure to food and water
(considered to be a background
exposure level). Sulfentrazone is
currently registered for uses that could
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result in short-term residential
exposure, and the Agency has
determined that it is appropriate to
aggregate chronic exposure through food
and water with short-term residential
exposures to sulfentrazone.
Using the exposure assumptions
described in this unit for short-term
exposures, EPA has concluded the
combined short-term food, water, and
residential exposures result in an
aggregate MOE of 480 for adults.
Because EPA’s level of concern for
sulfentrazone is a MOE of 100 or below,
this MOE is not of concern.
4. Short- and intermediate-term risk.
Combined short- and intermediate-term
aggregate exposures take into account
short- and intermediate-term residential
exposures plus chronic exposure to food
and water (considered to be a
background exposure level).
Sulfentrazone is currently registered for
uses that could result in short- and
intermediate-term residential exposures,
and the Agency has determined that it
is appropriate to aggregate chronic
exposure through food and water with
short- and intermediate-term residential
exposures to sulfentrazone.
Using the exposure assumptions
described in this unit for combined
short- and intermediate-term exposures,
EPA has concluded that the combined
short- and intermediate-term food,
water, and residential exposures result
in an aggregate MOE of 260 for children
1–2 years old, the population subgroup
for children with the greatest exposure.
Because EPA’s level of concern for
sulfentrazone is a MOE of 100 or below,
this MOEs are not of concern.
5. Aggregate cancer risk for U.S.
population. Based on the lack of
evidence of carcinogenicity in two
adequate rodent carcinogenicity studies,
chemical name is not expected to pose
a cancer risk 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, or to infants and children
from aggregate exposure to
sulfentrazone residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology,
gas chromatography (GC), is available to
enforce the tolerance expression. 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;
email address: residuemethods@
epa.gov.
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Executive Order 12898, entitled
‘‘Federal Actions to Address
In making its tolerance decisions, EPA
Environmental Justice in Minority
seeks to harmonize U.S. tolerances with
Populations and Low-Income
international standards whenever
Populations’’ (59 FR 7629, February 16,
possible, consistent with U.S. food
1994).
safety standards and agricultural
Since tolerances and exemptions that
practices. EPA considers the
are established on the basis of a petition
international maximum residue limits
under FFDCA section 408(d), such as
(MRLs) established by the Codex
the tolerance in this final rule, do not
Alimentarius Commission (Codex), as
require the issuance of a proposed rule,
required by FFDCA section 408(b)(4).
the requirements of the Regulatory
The Codex Alimentarius is a joint
Flexibility Act (RFA) (5 U.S.C. 601 et
United Nations Food and Agriculture
seq.), do not apply.
Organization/World Health
This final rule directly regulates
Organization food standards program,
growers, food processors, food handlers,
and it is recognized as an international
and food retailers, not States or tribes,
food safety standards-setting
nor does this action alter the
organization in trade agreements to
relationships or distribution of power
which the United States is a party. EPA
and responsibilities established by
may establish a tolerance that is
Congress in the preemption provisions
different from a Codex MRL; however,
of FFDCA section 408(n)(4). As such,
FFDCA section 408(b)(4) requires that
the Agency has determined that this
V. Conclusion
EPA explain the reasons for departing
action will not have a substantial direct
from the Codex level.
Therefore, tolerances are established
effect on States or tribal governments,
The Codex has not established a MRL for residues of sulfentrazone, (N-[2,4on the relationship between the national
for sulfentrazone.
dichloro-5-[4-(difluoromethyl)-4,5government and the States or tribal
dihydro-3-methyl-5-oxo-1H-1,2,4C. Response to Comments
governments, or on the distribution of
triazol-1EPA received one comment to the
yl]phenyl]methanesulfonamide), and its power and responsibilities among the
various levels of government or between
Notice of Filing that made a general
metabolites HMS (N-(2,4-dichloro-5-(4the Federal Government and Indian
objection to the presence of any
(difluoromethyl)-4,5-dihydro-3sulfentrazone residues on apple or any
hydroxymethyl-5-oxo-1H-1,2,4-triazol-1- tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
other crop. The Agency understands the yl)phenyl)methanesulfonamide and
‘‘Federalism’’ (64 FR 43255, August 10,
commenter’s concerns and recognizes
DMS (N-(2,4-dichloro-5-(4that some individuals believe that
(difluoromethyl)-4,5-dihydro-5-oxo-1H- 1999) and Executive Order 13175,
entitled ‘‘Consultation and Coordination
pesticides should be banned on
1,2,4-triazol-1with Indian Tribal Governments’’ (65 FR
agricultural crops. However, the existing yl)phenyl)methanesulfonamide,
67249, November 9, 2000) do not apply
legal framework provided by section
calculated as the stoichiometric
to this final rule. In addition, this final
408 of the FFDCA states that tolerances
equivalent of sulfentrazone, in or on
rule does not impose any enforceable
may be set when persons seeking such
apple at 0.15 ppm.
duty or contain any unfunded mandate
tolerances or exemptions have
VI. Statutory and Executive Order
as described under Title II of the
demonstrated that the pesticide meets
Reviews
Unfunded Mandates Reform Act of 1995
the safety standard imposed by that
(UMRA) (2 U.S.C. 1501 et seq.).
This final rule establishes a tolerance
statute. This citizen’s comment appears
under FFDCA section 408(d) in
This action does not involve any
to be directed at the underlying statute
technical standards that would require
and not EPA’s implementation of it; the response to a petition submitted to the
Agency. The Office of Management and
Agency consideration of voluntary
citizen has made no contention that
Budget (OMB) has exempted these types consensus standards pursuant to section
EPA has acted in violation of the
of actions from review under Executive
12(d) of the National Technology
statutory framework. The Agency has
Order 12866, entitled ‘‘Regulatory
Transfer and Advancement Act of 1995
concluded after this assessment, that
Planning and Review’’ (58 FR 51735,
(NTTAA) (15 U.S.C. 272 note).
there is a reasonable certainty that no
October 4, 1993). Because this final rule
harm will result from aggregate human
VII. Congressional Review Act
has been exempted from review under
exposure to sulfentrazone.
Executive Order 12866, this final rule is
Pursuant to the Congressional Review
D. Revisions to Petitioned-For
not subject to Executive Order 13211,
Act (5 U.S.C. 801 et seq.), EPA will
Tolerances
entitled ‘‘Actions Concerning
submit a report containing this rule and
Regulations That Significantly Affect
EPA was petitioned to establish a
other required information to the U.S.
Energy Supply, Distribution, or Use’’ (66 Senate, the U.S. House of
tolerance in or on apple for residues of
FR 28355, May 22, 2001) or Executive
sulfentrazone and its metabolite HMS;
Representatives, and the Comptroller
Order 13045, entitled ‘‘Protection of
however, upon review of the data
General of the United States prior to
Children from Environmental Health
supporting the petition, the Agency has
publication of the rule in the Federal
Risks and Safety Risks’’ (62 FR 19885,
determined that the apple tolerance
Register. This action is not a ‘‘major
April 23, 1997). This final rule does not rule’’ as defined by 5 U.S.C. 804(2).
should be established on the combined
contain any information collections
residues of the free and conjugated
List of Subjects in 40 CFR Part 180
subject to OMB approval under the
forms of sulfentrazone, including its
Environmental protection,
Paperwork Reduction Act (PRA) (44
metabolites HMS (N-(2,4-dichloro-5-(4Administrative practice and procedure,
U.S.C. 3501 et seq.), nor does it require
(difluoromethyl)-4,5-dihydro-3Agricultural commodities, Pesticides
hydroxymethyl-5-oxo-1H-1,2,4-triazol-1- any special considerations under
B. International Residue Limits
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54625
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yl)phenyl)methanesulfonamide) and
DMS (N-(2,4-dichloro-5-(4(difluoromethyl)-4,5-dihydro-5-oxo-1H1,2,4-triazol-1yl)phenyl)methanesulfonamide,
calculated as the stoichiometric
equivalent of sulfentrazone. EPA
previously reviewed metabolism data
and determined that the residues of
concern are the parent compound,
sulfentrazone, and the metabolites HMS
and DMS (free and conjugated) in all
crops except soybean seed, where the
residues of concern are sulfentrazone
and the metabolite HMS. Samples of
raw agricultural and processed
commodities from the apple studies
were analyzed for residues of
sulfentrazone and its metabolites DMS
and HMS, and EPA is establishing an
apple tolerance based upon those
analyses.
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Federal Register / Vol. 79, No. 177 / Friday, September 12, 2014 / Rules and Regulations
and pests, Reporting and recordkeeping
requirements.
Dated: September 4, 2014.
Lois Rossi,
Director, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.498, add alphabetically the
following commodity to the table in
paragraph (a)(2) to read as follows:
■
§ 180.498 Sulfentrazone; tolerances for
residues.
(a) * * *
(2) * * *
Parts per
million
Commodity
Apple .....................................
*
*
*
*
*
*
*
0.15
*
*
*
[FR Doc. 2014–21807 Filed 9–11–14; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF TRANSPORTATION
Office of the Secretary
48 CFR Parts 1201 and 1202
[Docket No. OST–2014–0119]
RIN 2105–AE34
Organization and Delegation of Powers
and Duties in the Transportation
Acquisition Regulation
Office of the Secretary (OST),
Department of Transportation (DOT).
ACTION: Final rule.
AGENCY:
This rule amends the
Transportation Acquisition Regulation
(TAR) to reflect the elevation of the
Research and Innovative Technology
Administration into the Office of the
Secretary, creating the Office of the
Assistant Secretary for Research and
Technology. The amendment to TAR
allows the Assistant Secretary for
Research and Technology to have the
same authority as the former Research
and Innovative Technology
Administrator. The change provides the
Office of the Assistant Secretary for
Research and Technology (formerly the
Research and Innovative Technology
Administration) the same authority as
an Operating Administration, and
mstockstill on DSK4VPTVN1PROD with RULES
SUMMARY:
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provides the Assistant Secretary for
Research and Technology to have the
same authority as a Head of an
Operating Administration.
DATES: This rule is effective September
12, 2014.
FOR FURTHER INFORMATION CONTACT:
Lenita Ahmadi, Office of the Senior
Procurement Executive, M–61, 1200
New Jersey Ave. SE., Washington, DC
20950, (202) 366–4974.
SUPPLEMENTARY INFORMATION: This final
rule reflects changes made in Public
Law 113–76, Division L, Title I—
Department of Transportation, which
states, ‘‘Notwithstanding section 102 of
title 49 and section 5315 of title 5,
United States Code, there shall be an
Assistant Secretary for Research and
Technology within the Office of the
Secretary, appointed by the President
with the advice and consent of the
Senate, to lead such office: Provided
further, that any reference in law,
regulation, judicial proceedings, or
elsewhere to the Research and
Innovative Technology Administration
shall be deemed to be a reference to the
Office of the Assistant Secretary for
Research and Technology of the
Department of Transportation.’’
Accordingly, the Transportation
Acquisition Regulation (TAR) has been
revised to update references of the
Research and Innovative Technology
Administration to references of the
Assistant Secretary for Research and
Technology. This rule also provides for
the Assistant Secretary for Research and
Technology to have the same authority
under TAR as the former Research and
Innovative Technology Administrator.
A. Background
The U.S. Department of
Transportation (DOT) has determined
that changes to TAR are necessary to
implement and align it with the
Consolidated Appropriations Act, 2014.
These changes are necessary in order to
update references to the Research and
Innovative Technology Administration
(RITA) by replacing them with
references to the Office of the Assistant
Secretary for Research and Technology
(OST–R). The changes are also
necessary to ensure that the Assistant
Secretary of OST–R continues to
exercise the same authority under TAR
as the Administrator of the former RITA.
B. Public Participation
This final rule does not impose new
substantive requirements. It simply
updates the CFR to reflect changes made
by other law and represent the current
organizational posture of the
Department with regard to the Office of
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Frm 00060
Fmt 4700
Sfmt 4700
the Assistant Secretary for Research and
Technology. The final rule is ministerial
in nature and relates only to
Departmental management, procedure,
and practice. Therefore, the Department
has determined that notice and
comment are unnecessary and that the
rule is exempt from prior notice and
comment requirements under 5 U.S.C.
553(b)(3)(A). This rule will not have a
substantive impact on the public, as it
is purely organizational. Therefore, the
Department finds that there is good
cause under 5 U.S.C. 553(d)(3) to make
this rule effective less than 30 days after
publication in the Federal Register.
C. Regulatory Analysis and Notices
1. Executive Order 12866 (Regulatory
Planning and Review), Executive Order
13563 (Improving Regulation and
Regulatory Review), and DOT
Regulatory Policies and Procedures
The DOT has considered the impact
of this rulemaking action under
Executive Orders 12866 and 13563
(January 18, 2011, ‘‘Improving
Regulation and Regulatory Review’’),
and the DOT’s regulatory policies and
procedures (44 FR 11034; February 26,
1979). The Department has determined
that this rule is not a significant
regulatory action, and therefore, was not
subject to review by the Office of
Management and Budget under
Executive Order 12866. There are no
costs associated with this rule. The rule
updates references to RITA to reflect its
elevation into the Office of the Secretary
as OST–R.
2. Executive Order 13132 (Federalism)
The Department has analyzed this
final rule under the principals and
criteria contained in Executive Order
13132, dated August 4, 1999, and it has
been determined that it does not have a
substantial direct effect on, or sufficient
federalism implications for, the States,
nor would it limit the policymaking
discretion of the States. Therefore, the
preparation of a Federalism Assessment
is not necessary.
3. Regulatory Flexibility Act
Because no notice of proposed
rulemaking is required for this rule
under the Administrative Procedure
Act, 5 U.S.C. 553, the provisions of the
Regulatory Flexibility Act (Pub. L. 96–
354, 5 U.S.C. 601–612) do not apply.
Even so, DOT has evaluated the effects
of these changes on small entities and
does not believe that this rule would
impose any costs on small entities as it
merely revises and clarifies TAR.
Therefore, I hereby certify that this final
rule does not have a significant
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]]>Agencies
[Federal Register Volume 79, Number 177 (Friday, September 12, 2014)]
[Rules and Regulations]
[Pages 54620-54626]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-21807]
[[Page 54620]]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2013-0712; FRL-9915-47]
Sulfentrazone; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes a tolerance for residues of
sulfentrazone in or on apple. The Interregional Research Project Number
4 (IR-4) requested these tolerances under the Federal Food, Drug, and
Cosmetic Act (FFDCA).
DATES: This regulation is effective September 12, 2014. Objections and
requests for hearings must be received on or before November 12, 2014,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2013-0712, is available at https://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave., NW., Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is (202) 566-1744, and the telephone number for the OPP
Docket is (703) 305-5805. Please review the visitor instructions and
additional information about the docket available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Lois Rossi, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
number: (703) 305-7090; email address: RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at https://www.ecfr.gov/cgi-bin/text-
idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab02.tpl.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2013-0712 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
November 12, 2014. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2013-0712, by one of
the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets/contacts.html. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at https://www.epa.gov/dockets.
II. Summary of Petitioned-For Tolerance
In the Federal Register of December 30, 2013 (78 FR 79359) (FRL-
9903-69), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
3E8202) by IR-4, 500 College Road East, Suite 201W, Princeton, NJ
08540. The petition requested that 40 CFR 180.498 be amended by
establishing tolerances for 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 metabolite HMS
(N-(2,4-dichloro-5-(4-(difluoromethyl)-4,5-dihydro-3- hydroxymethyl-5-
oxo-1H-1,2,4-triazol-1-yl)phenyl)methanesulfonamide, calculated as the
stoichiometric equivalent of sulfentrazone, in or on apple at 0.15
parts per million (ppm). That document referenced a summary of the
petition prepared on behalf of IR-4 by FMC Corporation, the registrant,
which is available in the docket, https://www.regulations.gov. Comments
were received on the notice of filing. EPA's response to these comments
is discussed in Unit IV.C.
Based upon review of the data supporting the petition, EPA has
determined that it is appropriate to establish the tolerance in or on
apple for the combined residues of the free and conjugated forms 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, calculated as the stoichiometric
equivalent of sulfentrazone. The reason for this decision is discussed
in Unit IV.D.
III. Aggregate Risk Assessment and Determination of Safety
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
[[Page 54621]]
determines that the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) of
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
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. . . .''
Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA 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 and to make a
determination on aggregate exposure for sulfentrazone including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with sulfentrazone
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.
Subchronic and chronic toxicity studies in rats, mice, and dogs
identified the hematopoietic system as the target of sulfentrazone.
Sulfentrazone inhibits the enzyme protoporphyrinogen oxidase (PPO) in
target plants, and the results of subchronic and chronic toxicity
studies in mammalian systems are consistent with PPO inhibition.
Disruption of heme biosynthesis was indicated by signs of anemia, and
decreases in hematocrit (Hct), hemoglobin (HGB), and mean corpuscular
volume (MCV) in mice, rats, and dogs at comparable dose levels from
short- through long-term exposures without a significant increase in
severity.
Sulfentrazone caused developmental effects when administered via
the oral (rats and rabbits) and dermal (rat only) routes of exposure.
Developmental effects in rats and rabbits consisted of reductions in
the number of implantations in rats, and increases in early resorptions
and reduction in live fetuses per litter in rats and rabbits. Surviving
rat fetuses exhibited reduced/delayed skeletal ossifications, and
decreased fetal body weights. Developmental effects in rats were seen
in the absence of maternal toxicity. In contrast with the rat studies,
developmental effects in rabbits were observed at a maternally toxic
dose, where clinical signs of toxicity included hematuria (red blood
cells in urine), abortions, and decreased body-weight gains. In the 2-
generation reproductive toxicity study in rats, developmental effects
included an increased duration of gestation, reduced prenatal viability
(fetal and litter), reduced litter size, and an increased number of
stillborn pups. Pup body-weight deficits, along with reduced pup and
litter postnatal survival, were also observed. All of the offspring
effects were reported in the presence of mild maternal toxicity
(decreased body weight and body-weight gain, particularly in
F1 females). No systemic toxicity was seen via the dermal
route up to the limit dose in a 28-day dermal toxicity study in adult
non-pregnant rabbits. In a dermal developmental study in rats, there
was an increased quantitative fetal susceptibility. While no maternal
effects were observed up to the highest dose tested, fetal effects were
observed at this dose, and consisted of decreased body weights,
increased incidences of fetal variations, hypoplastic or wavy ribs,
incompletely ossified lumbar vertebral arches, incompletely ossified
ischia or pubis, and a reduced number of thoracic vertebral and rib
ossification sites.
In the 26-day inhalation toxicity study, effects that were
considered treatment related and adverse effects occurred only at the
highest concentration tested. Systemic effects at this concentration
consisted of significant reductions in red blood cell (RBC) parameters
including RBC count, HGB concentrations, Hct, MCV, mean corpuscular HGB
(MCH), and/or reticulocytes in both sexes. Portal-of-entry effects in
this study consisted of an increased incidence of minimal nasal
respiratory epithelial hyperplasia in both sexes as well as minimal
laryngeal epithelial attenuation in all test material exposure groups.
The effects on hematological parameters were reversible after 28 days
of recovery, while the nasal injury persisted.
In an acute neurotoxicity (ACN) study in rats, effects consisted of
an increased incidence of clinical signs of toxicity (staggered gait,
splayed hind limbs, and abdominal gripping), changes in functional-
observation battery (FOB) parameters, and decreased motor activity at a
high dose level. Complete recovery was observed by day 14, and there
was no evidence of neuropathology. In a rat subchronic neurotoxicity
(SCN) study, clinical signs of toxicity, increased motor activity, and/
or decreased body weights, body-weight gain, and food consumption were
also observed with no evidence of neuropathology. A published, non-
guideline developmental toxicity study in the rat did not conclusively
demonstrate developmental neurotoxicity and contained several
shortcomings that limit its use for regulatory purposes, including the
lack of a no-observed-adverse-effect-level (NOAEL) (DeCastro VL,
Destefani CR, Diniz C, Poli P., 2007, Evaluation of neurodevelopmental
effects on rats exposed prenatally to sulfentrazone. Neurotoxicology
28(6):1249-59). The reported effects involving measures of physical and
reflex development are likely secondary effects reflective of the poor
general state of the offspring as reported in the rat 2-generation
reproductive toxicity study at similar dose levels but with a well-
defined NOAEL.
In the 28-day rat immunotoxicity study, there were no effects on
the immune system and systemic effects consisted of reduced body
weight, and increased absolute and relative spleen weights at the
highest dose tested. Carcinogenicity studies in rats and mice showed no
evidence of increased incidence of tumor formation due to treatment
with sulfentrazone, and the EPA has classified sulfentrazone as not
likely to be carcinogenic to humans. The available mutagenicity studies
indicate that sulfentrazone is weakly clastogenic in the in vitro mouse
lymphoma assay in the absence of S9 activation. There is no evidence
that sulfentrazone is mutagenic in bacterial cells or clastogenic in
male or female mice in vivo.
Specific information on the studies received and the nature of the
adverse effects caused by sulfentrazone as well as the NOAEL and the
lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies
can be found at https://www.regulations.gov in document:
``Sulfentrazone--Preliminary Human-Health Risk Assessment for
Registration Review and the Risk Assessment for the Section 3
Registration Request for a New Use on Apples'' at pp. 44-49 in docket
ID number EPA-HQ-OPP-2013-0712.
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies
[[Page 54622]]
toxicological points of departure (POD) and levels of concern to use in
evaluating the risk posed by human exposure to the pesticide. For
hazards that have a threshold below which there is no appreciable risk,
the toxicological POD is used as the basis for derivation of reference
values for risk assessment. PODs are developed based on a careful
analysis of the doses in each toxicological study to determine the dose
at which the NOAEL and the LOAEL are identified. Uncertainty/safety
factors are used in conjunction with the POD to calculate a safe
exposure level--generally referred to as a population-adjusted dose
(PAD) or a reference dose (RfD)--and a safe margin of exposure (MOE).
For non-threshold risks, the Agency assumes that any amount of exposure
will lead to some degree of risk. Thus, the Agency estimates risk in
terms of the probability of an occurrence of the adverse effect
expected in a lifetime. For more information on the general principles
EPA uses in risk characterization and a complete description of the
risk assessment process, see https://www.epa.gov/pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for sulfentrazone used for
human risk assessment is shown in Table 1 of this unit.
Table 1--Summary of Toxicological Doses and Endpoints for Sulfentrazone for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
Point of departure
Exposure/scenario and uncertainty/ RfD, PAD, LOC for Study and toxicological effects
safety factors risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (Females 13-49 NOAEL = 14 mg/kg/day Acute RfD = 0.14 mg/ 2-generation Reproductive Toxicity
years of age). UFA = 10x........... kg/day. Study--Rat
UFH = 10x........... aPAD = 0.14 mg/kg/ Offspring Toxicity LOAEL = 33 (M)
FQPA SF = 1x........ day. and 40 (F) mg/kg/day based on
reduced prenatal viability (fetal
& litter), reduced litter size,
increased number of stillborn
pups, reduced pup and litter
postnatal survival, and decreased
pup body weights throughout
lactation.
Acute dietary (General population NOAEL = 250 mg/kg/ Acute RfD = 2.5 mg/ Acute Neurotoxicity (ACN) Study--
including infants and children). day. kg/day. Rat
UFA = 10x........... aPAD = 2.5 mg/kg/ LOAEL = 750 mg/kg/day based on
UFH = 10x........... day. increased incidence of clinical
FQPA SF = 1x........ signs and FOB parameters and
decreased motor activity.
Chronic dietary (All populations) NOAEL = 14 mg/kg/day Chronic RfD = 0.14 2-generation Reproductive Toxicity
UFA = 10x........... mg/kg/day. Study--Rat
UFH = 10x........... cPAD = 0.14 mg/kg/ Offspring Toxicity LOAEL = 33 (M)
FQPA SF = 1x........ day. and 40 (F) mg/kg/day based on
reduced prenatal viability (fetal
& litter), reduced litter size,
increased number of stillborn
pups, reduced pup and litter
postnatal survival, and decreased
pup body weights throughout
lactation.
Incidental oral short- (1 to 30 NOAEL = 14 mg/kg/day LOC for MOE = 100.. 2-Generation Reproductive Toxicity
days) and intermediate-term (1-6 UFA = 10x........... Study--Rat
months). UFH = 10x........... Offspring LOAEL = 33 mg/kg/day
FQPA SF = 1x........ based on decreased pup body
weights and reduced postnatal
survival in both generations.
Dermal short-term (1 to 30 days). Dermal study NOAEL = LOC for MOE = 100.. Dermal Developmental Study--Rat
100 mg/kg/day. LOAEL = 250 mg/kg/day based on
UFA = 10 x.......... decreased fetal body weight;
UFH = 10 x.......... increased incidences of fetal
FQPA SF = 1x........ skeletal 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 (1-30 days) inhalation Portal-of-entry LOC for MOE = 30... Portal-of-entry LOAEL = 1.71 mg/L
NOAEL = 0.256 mg/L, based on an increased incidence
HEC = 0.054 mg/L, of minimal nasal respiratory
HED = 1.55. epithelial hyperplasia in male
mg/kg/day UFA = 3x.. and female rats.
UFH = 10x...........
FQPA SF = 1x........
------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation) Sulfentrazone is classified as not likely to be carcinogenic to humans
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
members of the human population (intraspecies). HEC = human-equivalent concentration. HED = human-equivalent
dose.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to sulfentrazone, EPA considered exposure under the
petitioned-for tolerances as well as all existing sulfentrazone
tolerances in 40 CFR 180.498. EPA assessed dietary exposures from
sulfentrazone in food as follows:
i. Acute exposure. Quantitative acute dietary exposure and 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. Such effects were identified
for sulfentrazone, and EPA performed separate acute risk assessments
for females 13 to 49 years old and for the general population,
including infants
[[Page 54623]]
and children, based on different endpoints and acute population
adjusted doses (aPADs). In estimating acute dietary exposures, EPA used
the Dietary Exposure Evaluation Model, Food Consumption Intake Database
(DEEM-FCID, ver. 3.16), which incorporates consumption data from United
States Department of Agriculture (USDA) National Health and Nutrition
Examination Survey, What We Eat in America, (NHANES/WWEIA; 2003-2008).
As to residue levels in food, EPA assumed tolerance-level residues, 100
percent crop treated (PCT), and DEEM (ver. 7.81) default processing
factors.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used DEEM-FCID, ver. 3.16, which incorporated
consumption data from the USDA's NHANES/WWEIA; 2003-2008. As to residue
levels in food, EPA assumed tolerance-level residues, 100 PCT, and DEEM
(ver. 7.81) default processing factors.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that sulfentrazone does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
iv. Anticipated residue and PCT information. EPA did not use
anticipated residue and/or PCT information in the dietary assessment
for sulfentrazone. Tolerance level residues and/or 100 PCT were assumed
for all food commodities.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for sulfentrazone in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of sulfentrazone. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at https://www.epa.gov/oppefed1/models/water/index.htm.
Based on the Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS) and Pesticide Root Zone Model Ground Water (PRZM
GW), the estimated drinking water concentrations (EDWCs) of
sulfentrazone for acute exposures are estimated to be 37.3 parts per
billion (ppb) for surface water and 134 ppb for ground water; and for
chronic exposures for non-cancer assessments are estimated to be 5.3
ppb for surface water and 98 ppb for ground water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 134 ppb was used to assess
the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 98 ppb was used to assess
the contribution to drinking 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
currently registered for the following uses that could result in
residential exposures: Residential home lawns/turf and recreational
turf, such as golf courses. EPA assessed residential exposures using
the following assumptions: Adults were assessed for potential short-
term dermal and inhalation handler exposures from applying
sulfentrazone to residential turf/home lawns and for short-term
postapplication dermal exposure from contact with treated residential
and recreational turf.
Children, ages 11 < 16 years old and 6 < 11 years old, were
assessed for postapplication dermal exposure from contact with treated
residential and recreational turf (home lawns and golf courses).
Children, ages 1 < 2 years old, were assessed for postapplication
short-term dermal and incidental oral exposures (hand-to-mouth, object-
to-mouth, and episodic ingestion of granules), as well as short- and
intermediate-term incidental oral soil ingestion scenarios from contact
with residential turf/home lawns.
The recommended adult residential exposure scenario for use in the
aggregate assessment reflects short-term dermal exposure from
applications to turf via backpack sprayer. The recommended residential
exposure scenario for use in the combined short- and intermediate-term
aggregate assessment for children ages 1 < 2 years old reflects dermal
and hand-to-mouth exposures from postapplication exposure to turf
applications. This combination should be considered a protective
estimate of children's exposure to pesticides used on turf since the
incidental oral scenarios are considered inter-related, likely
occurring interspersed amongst each other across time; therefore,
combining these scenarios would be overly-conservative because of the
conservative nature of each individual assessment. In addition, the
only potential intermediate-term exposure is postapplication soil
ingestion which is significantly less than short-term hand-to-mouth
exposure. Further, this scenario is considered protective of potential
post-application exposures to children, ages 6 < 11 and 11 < 16 years
old, as children 1-2 years old represent the population subgroup for
children with the greatest exposure, and is therefore considered
protective of other children population subgroups.
Chronic exposures are not expected and were not assessed. Finally,
residential handler and/or postapplication inhalation risk estimates
were not combined with dermal or oral risk estimates in the aggregate
risk assessment since the toxicological effects in the inhalation
toxicological study were portal-of-entry and were different from those
seen in the dermal and oral toxicological studies. Further information
regarding EPA standard assumptions and generic inputs for residential
exposures may be found at https://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of 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 has not found
sulfentrazone to share a common mechanism of toxicity with 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 assumed that sulfentrazone does
not have 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 EPA's Web site at https://www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) 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 based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the Food Quality
Protection Act Safety Factor (FQPA SF). In applying this provision, EPA
either retains the default value of 10X, or uses a different
[[Page 54624]]
additional safety factor when reliable data available to EPA support
the choice of a different factor.
2. Prenatal and postnatal sensitivity. There is evidence of
increased quantitative susceptibility following in utero exposure in
the oral and dermal rat developmental toxicity studies. Developmental
effects, including decreased fetal body weights and reduced/delayed
skeletal ossifications, were observed at doses that were not maternally
toxic. In the 2-generation reproduction study in rats, offspring
effects such as decreased body weights and decreased litter survival
were observed at a slightly maternally toxic dose (slightly decreased
body weight gain), indicating possible slightly increased qualitative
susceptibility.
3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
i. The toxicity database for sulfentrazone is complete.
ii. In the ACN and SCN studies, observed effects included changes
in motor activity and FOB parameters, clinical signs, and body-weight
decrements. There is low concern for neurotoxicity since:
1. Effects were seen at relatively high doses;
2. Effects occurred in the absence of neuropathology;
3. There is no evidence of neurotoxicity in other available studies
in the toxicity database;
4. Effects are well-characterized with clearly established NOAEL/
LOAEL values; and
5. The selected PODs are protective of these effects.
iii. There was evidence for increased quantitative susceptibility
following oral and dermal exposures in the developmental toxicity
studies in rats. Although developmental toxicity was observed at lower
doses than maternal toxicity in both studies in the rat, the concern is
low based on the following considerations:
1. The toxicology database for assessing pre- and postnatal
susceptibility is complete;
2. There are clear NOAELs and LOAELs for the developmental effects
observed via both the oral and dermal routes;
3. The PODs used for assessing dietary and dermal exposure risks
are based on developmental and/or offspring toxicity;
4. The portal-of-entry effects seen in the 26-day inhalation study
are protective of the developmental toxicity; and
5. There are no residual uncertainties for pre- and/or postnatal
toxicity.
iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to sulfentrazone in drinking water. EPA used
similarly conservative assumptions to assess postapplication exposure
of children as well as incidental oral exposure of toddlers. These
assessments will not underestimate the exposure and risks posed by
sulfentrazone.
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. Using the exposure assumptions discussed in this unit
for acute exposure, the acute dietary exposure from food and water to
sulfentrazone will occupy 6.7% of the aPAD for females 13-49 years old,
and 1.1% of the aPAD for all infants less than 1 year old, the
population group receiving the greatest exposure for all populations
other than females 13-49 years old.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
sulfentrazone from food and water will utilize 7.1% of the cPAD for
children 1-2 years old, the population group receiving the greatest
exposure. Based on the explanation in Unit III.C.3., regarding
residential use patterns, chronic residential exposure to residues of
sulfentrazone is not expected.
3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). Sulfentrazone
is currently registered for uses that could result in short-term
residential exposure, and the Agency has determined that it is
appropriate to aggregate chronic exposure through food and water with
short-term residential exposures to sulfentrazone.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in an aggregate MOE of 480 for adults.
Because EPA's level of concern for sulfentrazone is a MOE of 100 or
below, this MOE is not of concern.
4. Short- and intermediate-term risk. Combined short- and
intermediate-term aggregate exposures take into account short- and
intermediate-term residential exposures plus chronic exposure to food
and water (considered to be a background exposure level). Sulfentrazone
is currently registered for uses that could result in short- and
intermediate-term residential exposures, and the Agency has determined
that it is appropriate to aggregate chronic exposure through food and
water with short- and intermediate-term residential exposures to
sulfentrazone.
Using the exposure assumptions described in this unit for combined
short- and intermediate-term exposures, EPA has concluded that the
combined short- and intermediate-term food, water, and residential
exposures result in an aggregate MOE of 260 for children 1-2 years old,
the population subgroup for children with the greatest exposure.
Because EPA's level of concern for sulfentrazone is a MOE of 100 or
below, this MOEs are not of concern.
5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, chemical name is not expected to pose a cancer risk 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, or to infants and children from aggregate
exposure to sulfentrazone residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology, gas chromatography (GC), is
available to enforce the tolerance expression. 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; email address: residuemethods@epa.gov.
[[Page 54625]]
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
The Codex has not established a MRL for sulfentrazone.
C. Response to Comments
EPA received one comment to the Notice of Filing that made a
general objection to the presence of any sulfentrazone residues on
apple or any other crop. The Agency understands the commenter's
concerns and recognizes that some individuals believe that pesticides
should be banned on agricultural crops. However, the existing legal
framework provided by section 408 of the FFDCA states that tolerances
may be set when persons seeking such tolerances or exemptions have
demonstrated that the pesticide meets the safety standard imposed by
that statute. This citizen's comment appears to be directed at the
underlying statute and not EPA's implementation of it; the citizen has
made no contention that EPA has acted in violation of the statutory
framework. The Agency has concluded after this assessment, that there
is a reasonable certainty that no harm will result from aggregate human
exposure to sulfentrazone.
D. Revisions to Petitioned-For Tolerances
EPA was petitioned to establish a tolerance in or on apple for
residues of sulfentrazone and its metabolite HMS; however, upon review
of the data supporting the petition, the Agency has determined that the
apple tolerance should be established on the combined residues of the
free and conjugated forms of sulfentrazone, including 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, calculated as the stoichiometric
equivalent of sulfentrazone. EPA previously reviewed metabolism data
and determined that the residues of concern are the parent compound,
sulfentrazone, and the metabolites HMS and DMS (free and conjugated) in
all crops except soybean seed, where the residues of concern are
sulfentrazone and the metabolite HMS. Samples of raw agricultural and
processed commodities from the apple studies were analyzed for residues
of sulfentrazone and its metabolites DMS and HMS, and EPA is
establishing an apple tolerance based upon those analyses.
V. Conclusion
Therefore, tolerances are established for 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 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, calculated as the
stoichiometric equivalent of sulfentrazone, in or on apple at 0.15 ppm.
VI. Statutory and Executive Order Reviews
This final rule establishes a tolerance under FFDCA section 408(d)
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 final rule has
been exempted from review under Executive Order 12866, this final rule
is not subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). 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.), 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).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), 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.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et seq.).
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) (15 U.S.C. 272 note).
VII. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
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
the rule in the Federal Register. This action 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
[[Page 54626]]
and pests, Reporting and recordkeeping requirements.
Dated: September 4, 2014.
Lois Rossi,
Director, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. In Sec. 180.498, add alphabetically the following commodity to the
table in paragraph (a)(2) to read as follows:
Sec. 180.498 Sulfentrazone; tolerances for residues.
(a) * * *
(2) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Apple................................................... 0.15
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 2014-21807 Filed 9-11-14; 8:45 am]
BILLING CODE 6560-50-P
