Sulfentrazone; Pesticide Tolerances, 5704-5711 [2011-1898]
Download as PDF
5704
Federal Register / Vol. 76, No. 22 / Wednesday, February 2, 2011 / Rules and Regulations
*
*
*
*
Fruit, citrus, group 10 ...............
*
*
*
*
Grape ........................................
*
*
*
*
Potato1 ......................................
Potato, chips1 ...........................
Potato, granules/flakes1 ............
*
1 No
*
This regulation is effective
February 2, 2011. Objections and
requests for hearings must be received
*
on or before April 4, 2011, and must be
0.03 filed in accordance with the instructions
provided in 40 CFR part 178 (see also
*
0.01 Unit I.C. of the SUPPLEMENTARY
INFORMATION).
Parts per
million
Commodity
*
*
*
1.0
2.0
4.0
*
U.S. registrations.
*
*
*
*
*
(c) Tolerances with regional
registrations. Tolerances with regional
registrations are established for residues
of the herbicide fluazifop-P-butyl,
including its metabolites and
degradates, in or on the following
commodities in the table. Compliance
with the tolerance levels specified in the
table below is to be determined by
measuring only the sum of fluazifop-Pbutyl, butyl(R)-2-[4-[[5(trifluoromethyl)-2pyridinyl]oxy]phenoxy]propanoate, and
the free and conjugated forms of the
resolved isomer of fluazifop, (R)-2-[4[[5-(trifluoromethyl)-2pyridinyl]oxy]phenoxy]propanoic acid,
calculated as the stoichiometric
equivalent of fluazifop, in or on the
commodity.
*
*
*
*
*
[FR Doc. 2011–1779 Filed 2–1–11; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
I. General Information
[EPA–HQ–OPP–2008–0125; FRL–8860–1]
A. Does this action apply to me?
Sulfentrazone; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
tolerances for residues of sulfentrazone
in or on multiple commodities.
Additionally, this regulation deletes
existing tolerances on commodities
superseded by the establishment of crop
subgroups. This regulation also deletes
a time-limited tolerance on bean,
succulent seed without pod (lima bean
and cowpea), as the tolerance expired
on December 31, 2007. Interregional
Research Project Number 4 (IR–4)
requested these tolerances under the
Federal Food, Drug, and Cosmetic Act
(FFDCA).
rmajette on DSK29S0YB1PROD with RULES
SUMMARY:
14:48 Feb 01, 2011
EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2008–0125. All documents in the
docket are listed in the docket index
available at https://www.regulations.gov.
Although listed in the index, some
information is not publicly available,
e.g., Confidential Business Information
(CBI) or other information whose
disclosure is restricted by statute.
Certain other material, such as
copyrighted material, is not placed on
the Internet and will be publicly
available only in hard copy form.
Publicly available docket materials are
available in the electronic docket at
https://www.regulations.gov, or, if only
available in hard copy, at the OPP
Regulatory Public Docket in Rm. S–
4400, One Potomac Yard (South Bldg.),
2777 S. Crystal Dr., Arlington, VA. The
Docket Facility is open from 8:30 a.m.
to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket
Facility telephone number is (703) 305–
5805.
FOR FURTHER INFORMATION CONTACT:
Laura Nollen, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 305–7390; e-mail address:
nollen.laura@epa.gov.
ADDRESSES:
SUPPLEMENTARY INFORMATION:
40 CFR Part 180
VerDate Mar<15>2010
DATES:
Jkt 223001
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. Potentially
affected entities may include, but are
not limited to those engaged in the
following activities:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
This listing is not intended to be
exhaustive, but rather to provide 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
PO 00000
Frm 00026
Fmt 4700
Sfmt 4700
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 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.gpoaccess.gov/ecfr.
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–2008–0125 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 April 4, 2011. 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 that does not
contain any 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 a copy of
your non-CBI objection or hearing
request, identified by docket ID number
EPA–HQ–OPP–2008–0125, by one of
the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the on-line
instructions for submitting comments.
• Mail: Office of Pesticide Programs
(OPP) Regulatory Public Docket (7502P),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001.
• Delivery: OPP Regulatory Public
Docket (7502P), Environmental
Protection Agency, Rm. S–4400, One
Potomac Yard (South Bldg.), 2777 S.
Crystal Dr., Arlington, VA. Deliveries
are only accepted during the Docket
Facility’s normal hours of operation
(8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays).
E:\FR\FM\02FER1.SGM
02FER1
Federal Register / Vol. 76, No. 22 / Wednesday, February 2, 2011 / Rules and Regulations
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
II. Summary of Petitioned-For
pesticide chemical residue, including
Tolerances
all anticipated dietary exposures and all
In the Federal Register of March 12,
other exposures for which there is
2008 (73 FR 13225) (FRL–3854–6), EPA
reliable information.’’ This includes
issued a notice pursuant to section
exposure through drinking water and in
408(d)(3) of FFDCA, 21 U.S.C.
residential settings, but does not include
346a(d)(3), announcing the filing of a
occupational exposure. Section
pesticide petition (PP 7E7308) by IR–4,
408(b)(2)(C) of FFDCA requires EPA to
500 College Road East, Suite 201 W.,
give special consideration to exposure
Princeton, NJ 08540. The petition
of infants and children to the pesticide
requested that 40 CFR 180.498 be
chemical residue in establishing a
amended by establishing tolerances for
tolerance and to ‘‘ensure that there is a
residues of the combined free and
reasonable certainty that no harm will
conjugated residues of the herbicide
result to infants and children from
sulfentrazone, [N-[2,4-dichloro-5-[4aggregate exposure to the pesticide
(difluoromethyl)-4,5-dihydro-3-methylchemical residue. * * *’’
5-oxo-1H-1,2,4-triazol-1Consistent with section 408(b)(2)(D)
yl]phenyl]methanesulfonamide] and its
of FFDCA, and the factors specified in
metabolites HMS [N-(2,4-dichloro-5-(4section 408(b)(2)(D) of FFDCA, EPA has
(difluoromethyl)-4,5-dihydro-3reviewed the available scientific data
hydroxymethyl-5-oxo-1H-1,2,4-triazol-1- and other relevant information in
yl)phenyl)methanesulfonamide] and
support of this action. EPA has
DMS [(N-2,4-dichloro-5-[4sufficient data to assess the hazards of
(difluoromethyl)-4,5-dihydro-5-oxo-1H- and to make a determination on
1,2,4-triazol-1aggregate exposure for sulfentrazone
yl)phenyl)methanesulfonamide] in or on including exposure resulting from the
food commodities Brassica, head and
tolerances established by this action.
stem, subgroup 5A at 0.20 parts per
EPA’s assessment of exposures and risks
million (ppm); Brassica, leafy greens,
associated with sulfentrazone follows.
subgroup 5B at 0.35 ppm; melon,
A. Toxicological Profile
subgroup 9A at 0.10 ppm; vegetable,
EPA has evaluated the available
fruiting, group 8 at 0.05 ppm; okra at
toxicity data and considered its validity,
0.05 ppm; pea, succulent at 0.05 ppm;
completeness, and reliability as well as
flax at 0.05 ppm; strawberry at 0.05
the relationship of the results of the
ppm; and vegetable, tuberous and corn,
studies to human risk. EPA has also
subgroup 1C at 0.15 ppm. That notice
considered available information
referenced a summary of the petition
concerning the variability of the
prepared on behalf of IR–4 by FMC
sensitivities of major identifiable
Corporation, the registrant, which is
subgroups of consumers, including
available in the docket, https://
infants and children.
www.regulations.gov. Comments were
Sulfentrazone has low acute toxicity
received on the notice of filing. EPA’s
via the oral, dermal, and inhalation
response to these comments is
routes of exposure. It is a mild eye
discussed in Unit IV.C.
irritant, but not a dermal irritant or
Based upon review of the data
supporting the petition, EPA has revised sensitizer. Subchronic and chronic
the proposed tolerance levels for several toxicity studies in rats, mice and dogs
commodities. Additionally, the EPA has identified the hematopoietic system as
the target of sulfentrazone.
assessed several additional fruiting
Protoporphyrinogen oxidase inhibition
vegetable commodities in order to
in the mammalian species may result in
establish the revised and expanded
disruption of heme synthesis. In these
fruiting vegetable group 8–10. EPA has
also revised the tolerance expression for studies, disruption of heme synthesis
was observed at about the same dose
all established commodities to be
levels across species except in the case
consistent with current Agency policy.
of mice, where the effects were seen at
The reasons for these changes are
a slightly higher dose. The
explained in Unit IV.D.
hematotoxicity occurred around the
III. Aggregate Risk Assessment and
same dose level for short- through longDetermination of Safety
term exposure without increasing in
Section 408(b)(2)(A)(i) of FFDCA
severity.
In the oral and dermal rat
allows EPA to establish a tolerance (the
developmental toxicity studies,
legal limit for a pesticide chemical
decreased fetal body weights and
residue in or on a food) only if EPA
rmajette on DSK29S0YB1PROD with RULES
Special arrangements should be made
for deliveries of boxed information. The
Docket Facility telephone number is
(703) 305–5805.
VerDate Mar<15>2010
14:48 Feb 01, 2011
Jkt 223001
PO 00000
Frm 00027
Fmt 4700
Sfmt 4700
5705
reduced/delayed skeletal ossifications
were noted at doses that were not
maternally toxic. In rabbits,
developmental effects such as decreased
pup viability were observed at a
maternally toxic dose (clinical signs,
abortions and decreased body weight
gains). In the 2-generation reproduction
study in rats, offspring effects such as
decreased body weights and decreased
litter survival were observed at a
maternally toxic dose (slightly
decreased body weight gain).
In the acute neurotoxicity study, an
increased incidence of clinical signs
(staggered gait, splayed hind limbs, and
abdominal gripping), changes in
functional observation battery (FOB)
parameters, and decreased motor
activity were observed; however,
complete recovery was observed within
14 days and there was no evidence of
neuropathology. In the subchronic
neurotoxicity study, clinical signs of
toxicity, increased motor activity, and/
or decreased body weights, body weight
gain, and food consumption were
observed. There was no evidence of
neuropathology in either study. In a
published, non-guideline
developmental toxicity study in the rat
(de Castro, et al., 2007), several dosedependent effects (delayed ear opening,
decreased grip response and rearing
frequency, and increased surface
righting reflex reaction time) were
reported in pups whose mothers were
treated with sulfentrazone. However,
this study had several shortcomings that
limit its use for regulatory purposes.
Carcinogenicity studies in rats and
mice showed no evidence of increased
incidence of tumor formation due to
treatment with sulfentrazone. Therefore,
the EPA 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; however, the response was
not evident in the presence of S9
activation. Sulfentrazone is neither
mutagenic in bacterial cells, nor
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 no-observed-adverse-effect-level
(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the
toxicity studies can be found at https://
www.regulations.gov in document:
‘‘Sulfentrazone; REVISED Section 3
Registration Request to Add New Uses
on: Brassica, Head and Stem, Subgroup
5A; Brassica, Leafy Greens, Subgroup
5B; Melon, Subgroup 9A; Fruiting
E:\FR\FM\02FER1.SGM
02FER1
5706
Federal Register / Vol. 76, No. 22 / Wednesday, February 2, 2011 / Rules and Regulations
Vegetable, Group 8 and Okra; Pea,
Succulent; Flax; Strawberry; and
Tuberous and Corm Vegetable,
Subgroup 1C. Human-Health Risk
Assessment.’’ pp. 51–56 in docket ID
number EPA–HQ–OPP–2008–0125.
B. Toxicological Points of Departure/
Levels of Concern
Once a pesticide’s toxicological
profile is determined, EPA identifies
toxicological points of departure (POD)
and levels of concern (LOC) 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 the NOAEL and the lowest dose
at which adverse effects of concern are
identified (the LOAEL). 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) (a =
acute, c = chronic) 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.
The doses and toxicological endpoints
selected for several exposure scenarios
including the acute dietary endpoints
for females 13–49 years old, the chronic
dietary endpoint, and the short- and
intermediate-term inhalation endpoint
have been revised since the last risk
assessment based on a re-evaluation of
the toxicology database. The updated
endpoints are protective of
sulfentrazone’s developmental toxicity,
which was the critical effect in the
database and observed via both the oral
and dermal routes of exposure.
The acute dietary endpoint is based
on increased gestation duration,
reduced prenatal viability (fetal and
litter), reduced litter size, increased
number of stillborn pups, reduced
postnatal survival (pups and litter), and
pup body weight deficits throughout
lactation in both generations of offspring
observed in a 2-generation reproductive
toxicity study in rats. The
developmental effects were reported in
the presence of mild maternal toxicity
(slightly decreased body-weight gain,
particularly in F1 females). It has been
EPA’s practice to consider various forms
of developmental toxicity such as
reduced prenatal viability, reduced litter
size, and increased number of stillborn
pups as single-dose effects and,
therefore, relevant for the acute dietary
(females aged 13–49) exposure scenario,
in order to protect against potential
exposure of pregnant females. It should
be noted that the fetal body weight
deficits and retardation in skeletal
development (including decreased
numbers of caudal vertebral and
metacarpal ossification sites) reported in
the oral rat prenatal developmental
toxicity study were also evaluated for
this acute dietary endpoint. However, it
was concluded that such effects are
unlikely due to a single dose event and
are more appropriate for a repeatedexposure scenario. Furthermore, EPA
has not traditionally considered delays
in ossification (and related fetal body
weight deficits) to be single dose effects.
The chronic dietary endpoint is based
on developmental toxicity (decreased
fetal weights and delay in skeletal
ossification) that was observed in the
oral developmental toxicity study in the
rat. This study provides the lowest
NOAEL in the database, and the effects
are similar to those observed in
offspring (decreased body weight) at a
slightly higher dose in the 2-generation
reproduction study in rats. In addition,
choice of the developmental toxicity
study in the rat protects against
exposure of women throughout their
entire lifespan, which includes their
childbearing years.
The short- and intermediate-term
inhalation endpoints are based on
developmental toxicity (decreased fetal
weights, delay in skeletal ossification)
that was observed in the oral
developmental toxicity study in the rat.
An oral study was chosen for this
exposure scenario in the absence of an
inhalation toxicity study. Assuming
100% absorption via the inhalation
route, the oral developmental toxicity
study protects pregnant women who
might be exposed via inhalation against
the critical effect observed in the
sulfentrazone database, developmental
toxicity.
The endpoints for the other exposure
scenarios remain the same. 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
Exposure/scenario
Acute dietary ...........
(Females 13–49
years of age).
rmajette on DSK29S0YB1PROD with RULES
Acute dietary ...........
(General population
including infants
and children).
Chronic dietary (All
populations).
VerDate Mar<15>2010
Point of departure
and uncertainty/
safety factors
NOAEL = 14 milligrams/kilogram/
day (mg/kg/day).
UFA = 10x .............
UFH = 10x .............
FQPA SF = 1x ......
NOAEL = 250 mg/
kg/day.
UFA = 10x .............
UFH = 10x .............
FQPA SF = 1x ......
NOAEL= 10 mg/kg/
day.
UFA = 10x .............
UFH = 10x .............
FQPA SF = 1x ......
14:48 Feb 01, 2011
Jkt 223001
RfD, PAD, LOC for
risk assessment
Study and toxicological effects
Acute RfD = 0.14
mg/kg/day.
aPAD = 0.14 mg/
kg/day.
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 RfD = 2.5
mg/kg/day.
aPAD = 2.5 mg/kg/
day.
Acute-Neurotoxicity Study—Rat, LOAEL = 750 mg/kg/day based on increased
incidence of clinical signs and FOB parameters and decreased motor activity.
Chronic RfD = 0.1
mg/kg/day.
cPAD = 0.1 mg/kg/
day.
Prenatal Developmental Toxicity—Rat, Developmental LOAEL = 25 mg/kg/
day, based upon 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.
PO 00000
Frm 00028
Fmt 4700
Sfmt 4700
E:\FR\FM\02FER1.SGM
02FER1
Federal Register / Vol. 76, No. 22 / Wednesday, February 2, 2011 / Rules and Regulations
5707
TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR SULFENTRAZONE FOR USE IN HUMAN HEALTH RISK
ASSESSMENT—Continued
Exposure/scenario
Incidental oral shortterm (1 to 30
days) and intermediate-term (1 to
6 months).
Dermal short-term (1
to 30 days) and
intermediate-term.
(1 to 6 months) .......
Inhalation short-term
(1 to 30 days).
Point of departure
and uncertainty/
safety factors
NOAEL= 14 mg/kg/
day.
UFA = 10x .............
UFH = 10x .............
FQPA SF = 1x ......
Dermal (or oral)
study NOAEL =
100 mg/kg/day.
UFA = 10x .............
UFH = 10x .............
FQPA SF = 1x ......
Inhalation (or oral)
study NOAEL=
10 mg/kg/day
(inhalation absorption rate =
100%).
UFA = 10x .............
UFH = 10x .............
FQPA SF = 1x ......
RfD, PAD, LOC for
risk assessment
Study and toxicological effects
LOC for MOE =
100.
2-Generation Reproduction Study—Rat, LOAEL = 33 mg/kg/day based on decreased pup body weights during lactation and reduced postnatal survival
in both generations.
LOC for MOE =
100.
Dermal Developmental Study—Rat, LOAEL = 250 mg/kg/day 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.
LOC for MOE =
100.
Prenatal Developmental Toxicity—Rat, Developmental LOAEL = 25 mg/kg/
day, based upon 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.
Sulfentrazone is classified as ‘‘not likely to be carcinogenic to humans.’’
Cancer (Oral, dermal, inhalation).
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population
(intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term study for long-term risk assessment. UFDB = to account
for the absence of data or other data deficiency. FQPA SF = Food Quality Protection Act Safety Factor.
rmajette on DSK29S0YB1PROD with RULES
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. EPA performed
separate acute risk assessments for
females 13–49 years old and for the
general population, including infants
and children, based on different
endpoints and aPADs. In estimating
acute dietary exposure, EPA used food
consumption information from the
United States Department of Agriculture
(USDA) 1994–1996 and 1998
Nationwide Continuing Surveys of Food
Intake by Individuals (CSFII). As to
residue levels in food, EPA used
tolerance-level residues, Dietary
Exposure Evaluation Model (DEEM)TM
(ver. 7.81) default processing factors,
and assumed 100 percent crop treated
(PCT) for all commodities.
VerDate Mar<15>2010
14:48 Feb 01, 2011
Jkt 223001
ii. Chronic exposure. In conducting
the chronic dietary exposure assessment
EPA used the food consumption data
from the USDA 1994–1996 and 1998
CSFII. As to residue levels in food, EPA
used tolerance-level residues, DEEMTM
(ver. 7.81) default processing factors,
and assumed 100 PCT for all
commodities.
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.
PO 00000
Frm 00029
Fmt 4700
Sfmt 4700
Sulfentrazone and 3-carboxylic acid
sulfentrazone are the residues of
concern in drinking water. Therefore,
the First Index Reservoir Screening Tool
(FIRST) model was used to estimate
concentrations of sulfentrazone and 3carboxylic acid sulfentrazone in surface
water, and the Screening Concentration
in Ground Water (SCI–GROW) model
was utilized to estimate concentrations
in ground water. The estimated drinking
water concentrations (EDWCs) of
sulfentrazone and 3-carbyoxylic acid
sulfentrazone for acute exposures are
estimated to be 35.8 parts per billion
(ppb) for surface water and 26.0 ppb for
ground water. For chronic exposures for
non-cancer assessments, EDWCs are
estimated to be 7.8 ppb for surface water
and 26.0 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 35.8 ppb was
used to assess the contribution to
drinking water. For chronic dietary risk
assessment, the water concentration of
value 26.0 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
E:\FR\FM\02FER1.SGM
02FER1
rmajette on DSK29S0YB1PROD with RULES
5708
Federal Register / Vol. 76, No. 22 / Wednesday, February 2, 2011 / Rules and Regulations
flea and tick control on pets).
Sulfentrazone is currently registered for
the following use that could result in
residential exposures: residential home
lawns/turf and recreational turf, such as
golf courses (application by professional
applicators only). EPA assessed
residential exposure using the following
assumptions: Adults were assessed for
potential short-term dermal and
inhalation handler exposure from
applying sulfentrazone to residential
turf/home lawns and for short-term
postapplication dermal exposure from
contact with treated residential and
recreational turf (home lawns and golf
courses). Youths, ages 10–12 years old,
were selected as a representative
population to assess postapplication
dermal exposure from contact with
treated residential and recreational turf
(home lawns and golf courses).
Children, ages 3–6 years old, were
selected as a representative population
to assess for postapplication dermal and
incidental oral (hand-to-mouth, objectto-mouth, soil ingestion and episodic
ingestion of granules) exposure to
residential turf/home lawns. As shortand intermediate-term points of
departure are the same, the short-term
assessment is considered protective of
intermediate-term exposures. For
children, however, while all three
incidental oral exposures were
aggregated for short-term exposures, the
intermediate-term postapplication
exposure scenario included only the soil
ingestion incidental oral pathway, as
this is the only pathway assumed to
potentially result in intermediate-term
exposures. Chronic exposures are not
expected and were not assessed.
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
VerDate Mar<15>2010
14:48 Feb 01, 2011
Jkt 223001
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 (10×) 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
FQPA Safety Factor (SF). In applying
this provision, EPA either retains the
default value of 10×, or uses a different
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.
Additionally, several dose-dependent
effects were observed in rat pups whose
mothers were treated with sulfentrazone
in a published non-guideline rat
developmental toxicity study.
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 except for
immunotoxicity testing. Recent changes
to 40 CFR part 158 require
immunotoxicity testing (OPPTS Test
Guideline 870.7800) for pesticide
registration. However, the existing data
are sufficient for endpoint selection for
exposure/risk assessment scenarios, and
for evaluation of the requirements under
the FQPA. The toxicology database for
sulfentrazone does not show any
evidence of treatment-related effects on
PO 00000
Frm 00030
Fmt 4700
Sfmt 4700
the immune system; the overall weight
of evidence is consistent with this
chemical being a PPO inhibitor resulting
in disruption of heme biosynthesis and
subsequent effects on red blood cell
dysfunction (e.g., anemia). Unlike white
blood cells (leukocytes) which are cells
of the immune system, red blood cells
function to deliver oxygen to body
tissues and are not involved in eliciting
an immune response. Furthermore,
there is no indication in the
sulfentrazone database of any effect on
leukocyte counts (an indicator of
immune function). Thus, the overall
weight of evidence indicates that this
chemical does not directly target the
immune system. Sulfentrazone also
does not belong to a class of chemicals
(e.g., the organotins, heavy metals, or
halogenated aromatic hydrocarbons)
that would be expected to be
immunotoxic. Based on the above
considerations, EPA does not believe
that conducting a functional
immunotoxicity study will result in a
lower point of departure than that
currently used for overall risk
assessment. Therefore, an additional
database UF to account for potential
immunotoxicity does not need to be
applied.
ii. The toxicity database for
sulfentrazone does not trigger the need
for a developmental neurotoxicity
(DNT) study. There are no indications in
any of the studies available that the
nervous system is a target for
sulfentrazone. The FOB findings were
very non-specific signs of toxicity
(perianal staining, colored tears) and
motor activity changes only occurred at
higher doses following acute exposure
with rapid reversibility, also indicating
general toxicity rather than specific
neurotoxicity. The lack of
neuropathological findings further
supports the non-specific nature of the
signs observed. In addition, there is a
literature DNT study available for
sulfentrazone. The only reliable effects
seen in this study involved effects on
physical and reflex development, which
are known to be affected by body
weight. Therefore, these effects are
likely secondary to the effects
(including body weight deficits)
reported in the 2-generation
reproductive toxicity study. EPA
employed an independent statistical
method to evaluate the literature DNT in
an effort to determine if these effects
were consistent with effects observed in
other guideline studies at these same
dose levels. The results of that analysis
indicate that the results of the literature
DNT study are consistent with what was
observed in the rat 2-generation
E:\FR\FM\02FER1.SGM
02FER1
Federal Register / Vol. 76, No. 22 / Wednesday, February 2, 2011 / Rules and Regulations
reproduction study and that the studies
used for risk assessment (NOAEL of 10
mg/kg/day from the developmental
toxicity study in rat and the NOAEL of
14 mg/kg/day from the 2–generation
reproduction study), are protective of
the observations made at ≥25 mg/kg/day
in the literature study for which a
NOAEL was not attained. Based on the
weight of evidence, there is no
uncertainty related to developmental
neurotoxicity.
iii. There is evidence of increased
quantitative susceptibility following in
utero exposure in the oral and dermal
developmental toxicity studies in rats
and possible evidence of slightly
increased qualitative susceptibility of
offspring in the 2-generation rat
reproduction study. However, concern
is low because clear NOAELs have been
identified for the effects noted in these
studies and both of the developmental
toxicity studies have been chosen for
endpoint selection, thereby protecting
the relevant human subpopulations
from the noted effects.
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.
rmajette on DSK29S0YB1PROD with RULES
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 aPAD and 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. Using the exposure
assumptions discussed in this unit for
acute exposure, the acute dietary
exposure from food and water to
sulfentrazone will occupy <1% of the
aPAD for the general population,
including infants and children. For
females 13–49 years old, the acute
dietary exposure to sulfentrazone from
food and water will occupy 2.3% of the
VerDate Mar<15>2010
14:48 Feb 01, 2011
Jkt 223001
applicable aPAD chosen for that
population subgroup.
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 3.6% 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- and intermediate-term risk.
Short- and intermediate-term aggregate
exposure takes into account short- and
intermediate-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- and intermediate-term
residential exposure, and the Agency
has determined that it is appropriate to
aggregate chronic exposure through food
and water with short- and intermediateterm residential exposures to
sulfentrazone.
Using the exposure assumptions
described in this unit for short- and
intermediate-term exposures, EPA has
concluded the combined short- and
intermediate-term food, water, and
residential exposures result in aggregate
MOEs of 310 for the general U.S.
population; 450 for children 1–2 years
old for short-term exposures; and 590
for children 1–2 years old for
intermediate-term exposures. Because
EPA’s level of concern for sulfentrazone
is a MOE of 100 or below, these MOEs
are not of concern.
4. Aggregate cancer risk for U.S.
population. Based on the lack of
evidence of carcinogenicity in two
adequate rodent carcinogenicity studies,
sulfentrazone is not expected to pose a
cancer risk to humans.
5. 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 has been forwarded for
inclusion in the Pesticides Analytical
Manual, Volume II. The method may be
requested from: Chief, Analytical
Chemistry Branch, Environmental
Science Center, 701 Mapes Rd., Ft.
PO 00000
Frm 00031
Fmt 4700
Sfmt 4700
5709
Meade, MD 20755–5350; telephone
number: (410) 305–2905; e-mail
address: residuemethods@epa.gov.
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 U.N.
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.
There are no Codex, Canadian, or
Mexican MRLs established for residues
of sulfentrazone in or on the subject
commodities.
C. Response to Comments
EPA received one comment to the
Notice of Filing that had an objection to
‘‘the manufacture or sale’’ of
sulfentrazone, citing the cruelty of
animal testing as the main source of
opposition. The Agency has received
these same or similar comments from
this commenter on numerous previous
occasions. Please refer to the Federal
Register of 70 FR 1349 (January 7, 2005)
and 70 FR 37683 (June 30, 2005) for the
Agency’s previous responses to these
and other similar comments.
D. Revisions to Petitioned-For
Tolerances
Based upon review of the data
supporting the petition, EPA revised the
proposed tolerances for the following
commodities: Brassica, leafy greens,
subgroup 5B from 0.35 ppm to 0.40
ppm; melon, subgroup 9A from 0.10
ppm to 0.15 ppm; vegetable, fruiting,
group 8 from 0.05 ppm to 0.15 ppm;
okra from 0.05 ppm to 0.15 ppm; pea,
succulent from 0.05 ppm to 0.15 ppm;
flax from 0.05 ppm to 0.15 ppm; and
strawberry from 0.05 ppm to 0.15 ppm.
EPA revised the tolerance levels based
on analysis of the residue field trial data
using the Agency’s Tolerance
Spreadsheet in accordance with the
Agency’s Guidance for Setting Pesticide
Tolerances Based on Field Trial Data.
Additionally, EPA was petitioned for
tolerances on fruiting vegetable group 8
E:\FR\FM\02FER1.SGM
02FER1
5710
Federal Register / Vol. 76, No. 22 / Wednesday, February 2, 2011 / Rules and Regulations
VI. Statutory and Executive Order
Reviews
This final rule establishes tolerances
under section 408(d) of 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 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 section 408(d) of FFDCA, such as
the tolerance in this final rule, do not
require the issuance of a proposed rule,
V. Conclusion
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
Therefore, tolerances are established
for residues of the combined residues of seq.) do not apply.
This final rule directly regulates
free and conjugated forms of
growers, food processors, food handlers,
sulfentrazone (N-[2,4-dichloro-5-[4and food retailers, not States or tribes,
(difluoromethyl)-4,5-dihydro-3-methylnor does this action alter the
5-oxo-1H-1,2,4-triazol-1relationships or distribution of power
yl]phenyl]methanesulfonamide) and its
and responsibilities established by
metabolites HMS (N-(2,4-dichloro-5-(4Congress in the preemption provisions
(difluoromethyl)-4,5-dihydro-3hydroxymethyl-5-oxo-1H-1,2,4-triazol-1- of section 408(n)(4) of FFDCA. As such,
the Agency has determined that this
yl)phenyl)methanesulfonamide) and
action will not have a substantial direct
DMS (N-(2,4-dichloro-5-(4(difluoromethyl)-4,5-dihydro-5-oxo-1H- effect on States or tribal governments,
on the relationship between the national
1,2,4-triazol-1yl)phenyl)methanesulfonamide, in or on government and the States or tribal
Brassica, head and stem, subgroup 5A at governments, or on the distribution of
power and responsibilities among the
0.20 ppm; Brassica, leafy greens,
various levels of government or between
subgroup 5B at 0.40 ppm; melon,
the Federal Government and Indian
subgroup 9A at 0.15 ppm; vegetable,
tribes. Thus, the Agency has determined
fruiting, group 8–10 at 0.15 ppm; pea,
succulent at 0.15 ppm; flax at 0.15 ppm; that Executive Order 13132, entitled
Federalism (64 FR 43255, August 10,
strawberry at 0.15 ppm; and vegetable,
tuberous and corm, subgroup 1C at 0.15 1999) and Executive Order 13175,
entitled Consultation and Coordination
ppm. Additionally, this regulation
deletes existing individual tolerances in with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply
or on cabbage at 0.20 ppm and potato
to this final rule. In addition, this final
at 0.15 ppm, and further deletes the
rule does not impose any enforceable
time-limited tolerance for bean,
duty or contain any unfunded mandate
succulent seed without pod (lima bean
as described under Title II of the
and cowpea) at 0.1 ppm.
rmajette on DSK29S0YB1PROD with RULES
and a separate tolerance on okra. In the
Federal Register of December 8, 2010
(75 FR 76284) (FRL–8853–8), EPA
issued a final rule that revised the crop
grouping regulations. As part of this
action, EPA expanded and revised the
existing fruiting vegetable crop group 8.
Changes to crop group 8 included
adding okra, cocona, African eggplant,
pea eggplant, scarlet eggplant, goji berry,
garden huckleberry, martynia,
naranjilla, roselle, sunberry, bush
tomato, currant tomato, and tree tomato;
creating subgroups; revising the
representative commodities; and
naming the new crop group fruiting
vegetable group 8–10. EPA indicated in
the December 8, 2010 final rule as well
as the earlier January 6, 2010 proposed
rule (75 FR 807) (FRL–8801–2) that, for
existing petitions for which a Notice of
Filing had been published, the Agency
would attempt to conform these
petitions to the rule. Therefore,
consistent with this rule, EPA has
assessed and is establishing a tolerance
on fruiting vegetable group 8–10.
Finally, the EPA has revised the
tolerance expression to clarify (1) that,
as provided in FFDCA section 408(a)(3),
the tolerance covers metabolites and
degradates of sulfentrazone not
specifically mentioned; and (2) that
compliance with the specified tolerance
levels is to be determined by measuring
only the specific compounds mentioned
in the tolerance expression.
VerDate Mar<15>2010
14:48 Feb 01, 2011
Jkt 223001
PO 00000
Frm 00032
Fmt 4700
Sfmt 4700
Unfunded Mandates Reform Act of 1995
(UMRA) (Public Law 104–4).
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).
VII. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report 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: January 14, 2011.
Daniel J. Rosenblatt,
Acting Director, Registration Division, Office
of Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.498 is amended as
follows:
■ i. Revise the introductory text of
paragraph (a)(1);
■ ii. Revise the introductory text of
paragraph (a)(2), remove the entries for
‘‘Cabbage’’ and ‘‘Potato’’ and add
commodities to the table;
■ iii. Revise paragraph (b); and
■ iv. Revise the introductory text of
paragraph (d), to read as follows:
■
§ 180.498 Sulfentrazone; tolerances for
residues.
(a)(1) General. Tolerances are
established for the combined residues of
the free and conjugated forms of
sulfentrazone, including its metabolites
and degradates, in or on the
commodities in the table below.
Compliance with the tolerance levels
E:\FR\FM\02FER1.SGM
02FER1
Federal Register / Vol. 76, No. 22 / Wednesday, February 2, 2011 / Rules and Regulations
specified below is to be determined by
measuring only the sum of
sulfentrazone (N-[2,4-dichloro-5-[4(difluoromethyl)-4,5-dihydro-3-methyl5-oxo-1H-1,2,4-triazol-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 the
following commodities.
*
*
*
*
*
(2) Tolerances are established for the
combined residues of the free and
conjugated forms of sulfentrazone,
including its metabolites and
degradates, in or on the commodities in
the table below. Compliance with the
tolerance levels specified below is to be
determined by measuring only the sum
of sulfentrazone (N-[2,4-dichloro-5-[4(difluoromethyl)-4,5-dihydro-3-methyl5-oxo-1H-1,2,4-triazol-1yl]phenyl]methanesulfonamide) and its
metabolites HMS (N-(2,4-dichloro-5-(4(difluoromethyl)-4,5-dihydro-3hydroxymethyl-5-oxo-1H-1,2,4-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 in or on the
following commodities.
(b) Section 18 emergency exemptions.
Time-limited tolerances are established
for the combined residues of the free
and conjugated forms of sulfentrazone,
including its metabolites and
degradates, in connection with use of
the pesticide under section 18
emergency exemptions granted by EPA.
Parts per
Compliance with the tolerance levels
million
specified below is to be determined by
measuring only the sum of
*
sulfentrazone (N-[2,4-dichloro-5-[4(difluoromethyl)-4,5-dihydro-3-methyl0.20
5-oxo-1H-1,2,4-triazol-10.40 yl]phenyl]methanesulfonamide) and its
metabolites HMS (N-(2,4-dichloro-5-(4(difluoromethyl)-4,5-dihydro-3*
0.15 hydroxymethyl-5-oxo-1H-1,2,4-triazol-1yl)phenyl)methanesulfonamide) and
*
DMS (N-(2,4-dichloro-5-(40.15
0.15 (difluoromethyl)-4,5-dihydro-5-oxo-1H1,2,4-triazol-1*
yl)phenyl)methanesulfonamide,
0.15 calculated as the stoichiometric
equivalent of sulfentrazone in or on the
*
following commodities. These
0.15
tolerances expire and are revoked on the
0.15 dates specified in the following table.
Commodity
*
*
*
*
Brassica, head and stem, subgroup 5A .................................
Brassica, leafy greens, subgroup
5B ............................................
*
*
*
*
Flax .............................................
*
*
*
*
Melon, subgroup 9A ...................
Pea, succulent ............................
*
*
*
*
Strawberry ..................................
*
*
*
*
Vegetable, fruiting, group 8–10 ..
Vegetable, tuberous and corm,
subgroup 1C ...........................
Parts per
million
Commodity
Flax, seed ....................................................................................................................................................
Strawberry ....................................................................................................................................................
rmajette on DSK29S0YB1PROD with RULES
*
*
*
*
*
(d) Indirect or inadvertent residues.
Tolerances are established for
inadvertent and indirect combined
residues of the free and conjugated
forms of sulfentrazone, including its
metabolites and degradates, in or on the
commodities in the table below.
Compliance with the tolerance levels
specified below is to be determined by
measuring only the sum of
sulfentrazone (N-[2,4-dichloro-5-[4(difluoromethyl)-4,5-dihydro-3-methyl5-oxo-1H-1,2,4-triazol-1yl]phenyl]methanesulfonamide) and its
metabolites HMS (N-(2,4-dichloro-5-(4(difluoromethyl)-4,5-dihydro-3hydroxymethyl-5-oxo-1H-1,2,4-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 in or on the
following commodities when present
VerDate Mar<15>2010
14:48 Feb 01, 2011
Jkt 223001
5711
Expiration/
revocation date
0.20
0.60
12/31/13
12/31/13
therein as a result of the application of
sulfentrazone to growing crops.
*
*
*
*
*
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
[FR Doc. 2011–1898 Filed 2–1–11; 8:45 am]
ADDRESSES:
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2009–0796; FRL–8860–2]
Bispyribac-sodium; Pesticide
Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
tolerances for residues of bispyribacsodium in or on fish, freshwater. Valent
U.S.A. Corporation requested these
tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective
February 2, 2011. Objections and
requests for hearings must be received
on or before April 4, 2011, and must be
filed in accordance with the instructions
SUMMARY:
PO 00000
Frm 00033
Fmt 4700
Sfmt 4700
EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2009–0796. All documents in the
docket are listed in the docket index
available at https://www.regulations.gov.
Although listed in the index, some
information is not publicly available,
e.g., Confidential Business Information
(CBI) or other information whose
disclosure is restricted by statute.
Certain other material, such as
copyrighted material, is not placed on
the Internet and will be publicly
available only in hard copy form.
Publicly available docket materials are
available in the electronic docket at
https://www.regulations.gov, or, if only
available in hard copy, at the OPP
Regulatory Public Docket in Rm. S–
4400, One Potomac Yard (South Bldg.),
2777 S. Crystal Dr., Arlington, VA. The
Docket Facility is open from 8:30 a.m.
to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket
Facility telephone number is (703) 305–
5805.
E:\FR\FM\02FER1.SGM
02FER1
Agencies
[Federal Register Volume 76, Number 22 (Wednesday, February 2, 2011)]
[Rules and Regulations]
[Pages 5704-5711]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-1898]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2008-0125; FRL-8860-1]
Sulfentrazone; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of
sulfentrazone in or on multiple commodities. Additionally, this
regulation deletes existing tolerances on commodities superseded by the
establishment of crop subgroups. This regulation also deletes a time-
limited tolerance on bean, succulent seed without pod (lima bean and
cowpea), as the tolerance expired on December 31, 2007. Interregional
Research Project Number 4 (IR-4) requested these tolerances under the
Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective February 2, 2011. Objections and
requests for hearings must be received on or before April 4, 2011, 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: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2008-0125. All documents in the
docket are listed in the docket index available at https://www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at https://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.
FOR FURTHER INFORMATION CONTACT: Laura Nollen, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 305-7390; e-mail address: nollen.laura@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to those
engaged in the following activities:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather to
provide 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 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.gpoaccess.gov/ecfr.
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-2008-0125 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
April 4, 2011. 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 that does not contain any 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 a copy of
your non-CBI objection or hearing request, identified by docket ID
number EPA-HQ-OPP-2008-0125, by one of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
[[Page 5705]]
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is (703) 305-5805.
II. Summary of Petitioned-For Tolerances
In the Federal Register of March 12, 2008 (73 FR 13225) (FRL-3854-
6), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
7E7308) by IR-4, 500 College Road East, Suite 201 W., Princeton, NJ
08540. The petition requested that 40 CFR 180.498 be amended by
establishing tolerances for residues of the combined free and
conjugated residues of the herbicide sulfentrazone, [N-[2,4-dichloro-5-
[4-(difluoromethyl)-4,5-dihydro-3-methyl-5-oxo-1H-1,2,4-triazol-1-
yl]phenyl]methanesulfonamide] and its metabolites 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 Brassica, head
and stem, subgroup 5A at 0.20 parts per million (ppm); Brassica, leafy
greens, subgroup 5B at 0.35 ppm; melon, subgroup 9A at 0.10 ppm;
vegetable, fruiting, group 8 at 0.05 ppm; okra at 0.05 ppm; pea,
succulent at 0.05 ppm; flax at 0.05 ppm; strawberry at 0.05 ppm; and
vegetable, tuberous and corn, subgroup 1C at 0.15 ppm. That notice
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
revised the proposed tolerance levels for several commodities.
Additionally, the EPA has assessed several additional fruiting
vegetable commodities in order to establish the revised and expanded
fruiting vegetable group 8-10. EPA has also revised the tolerance
expression for all established commodities to be consistent with
current Agency policy. The reasons for these changes are explained 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 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 section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of 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 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.
Sulfentrazone has low acute toxicity via the oral, dermal, and
inhalation routes of exposure. It is a mild eye irritant, but not a
dermal irritant or sensitizer. Subchronic and chronic toxicity studies
in rats, mice and dogs identified the hematopoietic system as the
target of sulfentrazone. Protoporphyrinogen oxidase inhibition in the
mammalian species may result in disruption of heme synthesis. In these
studies, disruption of heme synthesis was observed at about the same
dose levels across species except in the case of mice, where the
effects were seen at a slightly higher dose. The hematotoxicity
occurred around the same dose level for short- through long-term
exposure without increasing in severity.
In the oral and dermal rat developmental toxicity studies,
decreased fetal body weights and reduced/delayed skeletal ossifications
were noted at doses that were not maternally toxic. In rabbits,
developmental effects such as decreased pup viability were observed at
a maternally toxic dose (clinical signs, abortions and decreased body
weight gains). In the 2-generation reproduction study in rats,
offspring effects such as decreased body weights and decreased litter
survival were observed at a maternally toxic dose (slightly decreased
body weight gain).
In the acute neurotoxicity study, an increased incidence of
clinical signs (staggered gait, splayed hind limbs, and abdominal
gripping), changes in functional observation battery (FOB) parameters,
and decreased motor activity were observed; however, complete recovery
was observed within 14 days and there was no evidence of
neuropathology. In the subchronic neurotoxicity study, clinical signs
of toxicity, increased motor activity, and/or decreased body weights,
body weight gain, and food consumption were observed. There was no
evidence of neuropathology in either study. In a published, non-
guideline developmental toxicity study in the rat (de Castro, et al.,
2007), several dose-dependent effects (delayed ear opening, decreased
grip response and rearing frequency, and increased surface righting
reflex reaction time) were reported in pups whose mothers were treated
with sulfentrazone. However, this study had several shortcomings that
limit its use for regulatory purposes.
Carcinogenicity studies in rats and mice showed no evidence of
increased incidence of tumor formation due to treatment with
sulfentrazone. Therefore, the EPA 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; however,
the response was not evident in the presence of S9 activation.
Sulfentrazone is neither mutagenic in bacterial cells, nor 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 no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at https://www.regulations.gov in document: ``Sulfentrazone; REVISED Section 3
Registration Request to Add New Uses on: Brassica, Head and Stem,
Subgroup 5A; Brassica, Leafy Greens, Subgroup 5B; Melon, Subgroup 9A;
Fruiting
[[Page 5706]]
Vegetable, Group 8 and Okra; Pea, Succulent; Flax; Strawberry; and
Tuberous and Corm Vegetable, Subgroup 1C. Human-Health Risk
Assessment.'' pp. 51-56 in docket ID number EPA-HQ-OPP-2008-0125.
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern (LOC) 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 the NOAEL and the lowest dose at which adverse
effects of concern are identified (the LOAEL). 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) (a = acute, c = chronic) 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.
The doses and toxicological endpoints selected for several exposure
scenarios including the acute dietary endpoints for females 13-49 years
old, the chronic dietary endpoint, and the short- and intermediate-term
inhalation endpoint have been revised since the last risk assessment
based on a re-evaluation of the toxicology database. The updated
endpoints are protective of sulfentrazone's developmental toxicity,
which was the critical effect in the database and observed via both the
oral and dermal routes of exposure.
The acute dietary endpoint is based on increased gestation
duration, reduced prenatal viability (fetal and litter), reduced litter
size, increased number of stillborn pups, reduced postnatal survival
(pups and litter), and pup body weight deficits throughout lactation in
both generations of offspring observed in a 2-generation reproductive
toxicity study in rats. The developmental effects were reported in the
presence of mild maternal toxicity (slightly decreased body-weight
gain, particularly in F1 females). It has been EPA's
practice to consider various forms of developmental toxicity such as
reduced prenatal viability, reduced litter size, and increased number
of stillborn pups as single-dose effects and, therefore, relevant for
the acute dietary (females aged 13-49) exposure scenario, in order to
protect against potential exposure of pregnant females. It should be
noted that the fetal body weight deficits and retardation in skeletal
development (including decreased numbers of caudal vertebral and
metacarpal ossification sites) reported in the oral rat prenatal
developmental toxicity study were also evaluated for this acute dietary
endpoint. However, it was concluded that such effects are unlikely due
to a single dose event and are more appropriate for a repeated-exposure
scenario. Furthermore, EPA has not traditionally considered delays in
ossification (and related fetal body weight deficits) to be single dose
effects.
The chronic dietary endpoint is based on developmental toxicity
(decreased fetal weights and delay in skeletal ossification) that was
observed in the oral developmental toxicity study in the rat. This
study provides the lowest NOAEL in the database, and the effects are
similar to those observed in offspring (decreased body weight) at a
slightly higher dose in the 2-generation reproduction study in rats. In
addition, choice of the developmental toxicity study in the rat
protects against exposure of women throughout their entire lifespan,
which includes their childbearing years.
The short- and intermediate-term inhalation endpoints are based on
developmental toxicity (decreased fetal weights, delay in skeletal
ossification) that was observed in the oral developmental toxicity
study in the rat. An oral study was chosen for this exposure scenario
in the absence of an inhalation toxicity study. Assuming 100%
absorption via the inhalation route, the oral developmental toxicity
study protects pregnant women who might be exposed via inhalation
against the critical effect observed in the sulfentrazone database,
developmental toxicity.
The endpoints for the other exposure scenarios remain the same. 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 RfD, PAD, LOC for
Exposure/scenario uncertainty/ risk assessment Study and toxicological effects
safety factors
----------------------------------------------------------------------------------------------------------------
Acute dietary................. NOAEL = 14 Acute RfD = 0.14 2-Generation Reproductive Toxicity Study--
(Females 13-49 years of age).. milligrams/ mg/kg/day. Rat, Offspring Toxicity LOAEL= 33 (M) and
kilogram/day (mg/ aPAD = 0.14 mg/kg/ 40 (F) mg/kg/day based on reduced
kg/day). day. prenatal viability (fetal & litter),
UFA = 10x........ reduced litter size, increased number of
UFH = 10x........ stillborn pups, reduced pup and litter
FQPA SF = 1x..... postnatal survival and decreased pup body
weights throughout lactation.
Acute dietary................. NOAEL = 250 mg/kg/ Acute RfD = 2.5 Acute-Neurotoxicity Study--Rat, LOAEL =
(General population including day. mg/kg/day. 750 mg/kg/day based on increased
infants and children). UFA = 10x........ aPAD = 2.5 mg/kg/ incidence of clinical signs and FOB
UFH = 10x........ day. parameters and decreased motor activity.
FQPA SF = 1x.....
Chronic dietary (All NOAEL= 10 mg/kg/ Chronic RfD = 0.1 Prenatal Developmental Toxicity--Rat,
populations). day. mg/kg/day. Developmental LOAEL = 25 mg/kg/day, based
UFA = 10x........ cPAD = 0.1 mg/kg/ upon decreased mean fetal weights, and
UFH = 10x........ day. retardation in skeletal development
FQPA SF = 1x..... evidenced by an increased number of
litters with any variation and by
decreased number of caudal vertebral and
metacarpal ossification sites.
[[Page 5707]]
Incidental oral short-term (1 NOAEL= 14 mg/kg/ LOC for MOE = 100 2-Generation Reproduction Study--Rat,
to 30 days) and intermediate- day. LOAEL = 33 mg/kg/day based on decreased
term (1 to 6 months). UFA = 10x........ pup body weights during lactation and
UFH = 10x........ reduced postnatal survival in both
FQPA SF = 1x..... generations.
Dermal short-term (1 to 30 Dermal (or oral) LOC for MOE = 100 Dermal Developmental Study--Rat, LOAEL =
days) and intermediate-term. study NOAEL = 250 mg/kg/day based on decreased fetal
(1 to 6 months)............... 100 mg/kg/day. body weight; increased incidences of
UFA = 10x........ fetal variations: hypoplastic or wavy
UFH = 10x........ ribs, incompletely ossified lumbar
FQPA SF = 1x..... vertebral arches, and incompletely
ossified ischia or pubes; and reduced
number of thoracic vertebral and rib
ossification sites.
Inhalation short-term (1 to 30 Inhalation (or LOC for MOE = 100 Prenatal Developmental Toxicity--Rat,
days). oral) study Developmental LOAEL = 25 mg/kg/day, based
NOAEL= 10 mg/kg/ upon decreased mean fetal weights, and
day (inhalation retardation in skeletal development
absorption rate evidenced by an increased number of
= 100%). litters with any variation and by
UFA = 10x........ decreased number of caudal vertebral and
UFH = 10x........ metacarpal ossification sites.
FQPA SF = 1x.....
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, Sulfentrazone is classified as ``not likely to be carcinogenic to humans.''
inhalation).
----------------------------------------------------------------------------------------------------------------
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members
of the human population (intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term
study for long-term risk assessment. UFDB = to account for the absence of data or other data deficiency. FQPA
SF = Food Quality Protection Act Safety Factor.
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. EPA performed separate acute risk assessments for
females 13-49 years old and for the general population, including
infants and children, based on different endpoints and aPADs. In
estimating acute dietary exposure, EPA used food consumption
information from the United States Department of Agriculture (USDA)
1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by
Individuals (CSFII). As to residue levels in food, EPA used tolerance-
level residues, Dietary Exposure Evaluation Model (DEEM)\TM\ (ver.
7.81) default processing factors, and assumed 100 percent crop treated
(PCT) for all commodities.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 CSFII. As to residue levels in food, EPA used tolerance-level
residues, DEEM\TM\ (ver. 7.81) default processing factors, and assumed
100 PCT for all commodities.
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.
Sulfentrazone and 3-carboxylic acid sulfentrazone are the residues
of concern in drinking water. Therefore, the First Index Reservoir
Screening Tool (FIRST) model was used to estimate concentrations of
sulfentrazone and 3-carboxylic acid sulfentrazone in surface water, and
the Screening Concentration in Ground Water (SCI-GROW) model was
utilized to estimate concentrations in ground water. The estimated
drinking water concentrations (EDWCs) of sulfentrazone and 3-
carbyoxylic acid sulfentrazone for acute exposures are estimated to be
35.8 parts per billion (ppb) for surface water and 26.0 ppb for ground
water. For chronic exposures for non-cancer assessments, EDWCs are
estimated to be 7.8 ppb for surface water and 26.0 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 35.8 ppb was used to
assess the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 26.0 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
[[Page 5708]]
flea and tick control on pets). Sulfentrazone is currently registered
for the following use that could result in residential exposures:
residential home lawns/turf and recreational turf, such as golf courses
(application by professional applicators only). EPA assessed
residential exposure using the following assumptions: Adults were
assessed for potential short-term dermal and inhalation handler
exposure from applying sulfentrazone to residential turf/home lawns and
for short-term postapplication dermal exposure from contact with
treated residential and recreational turf (home lawns and golf
courses). Youths, ages 10-12 years old, were selected as a
representative population to assess postapplication dermal exposure
from contact with treated residential and recreational turf (home lawns
and golf courses). Children, ages 3-6 years old, were selected as a
representative population to assess for postapplication dermal and
incidental oral (hand-to-mouth, object-to-mouth, soil ingestion and
episodic ingestion of granules) exposure to residential turf/home
lawns. As short- and intermediate-term points of departure are the
same, the short-term assessment is considered protective of
intermediate-term exposures. For children, however, while all three
incidental oral exposures were aggregated for short-term exposures, the
intermediate-term postapplication exposure scenario included only the
soil ingestion incidental oral pathway, as this is the only pathway
assumed to potentially result in intermediate-term exposures. Chronic
exposures are not expected and were not assessed.
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 FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10x, or uses a different 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. Additionally, several dose-dependent effects were
observed in rat pups whose mothers were treated with sulfentrazone in a
published non-guideline rat developmental toxicity study.
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 except for
immunotoxicity testing. Recent changes to 40 CFR part 158 require
immunotoxicity testing (OPPTS Test Guideline 870.7800) for pesticide
registration. However, the existing data are sufficient for endpoint
selection for exposure/risk assessment scenarios, and for evaluation of
the requirements under the FQPA. The toxicology database for
sulfentrazone does not show any evidence of treatment-related effects
on the immune system; the overall weight of evidence is consistent with
this chemical being a PPO inhibitor resulting in disruption of heme
biosynthesis and subsequent effects on red blood cell dysfunction
(e.g., anemia). Unlike white blood cells (leukocytes) which are cells
of the immune system, red blood cells function to deliver oxygen to
body tissues and are not involved in eliciting an immune response.
Furthermore, there is no indication in the sulfentrazone database of
any effect on leukocyte counts (an indicator of immune function). Thus,
the overall weight of evidence indicates that this chemical does not
directly target the immune system. Sulfentrazone also does not belong
to a class of chemicals (e.g., the organotins, heavy metals, or
halogenated aromatic hydrocarbons) that would be expected to be
immunotoxic. Based on the above considerations, EPA does not believe
that conducting a functional immunotoxicity study will result in a
lower point of departure than that currently used for overall risk
assessment. Therefore, an additional database UF to account for
potential immunotoxicity does not need to be applied.
ii. The toxicity database for sulfentrazone does not trigger the
need for a developmental neurotoxicity (DNT) study. There are no
indications in any of the studies available that the nervous system is
a target for sulfentrazone. The FOB findings were very non-specific
signs of toxicity (perianal staining, colored tears) and motor activity
changes only occurred at higher doses following acute exposure with
rapid reversibility, also indicating general toxicity rather than
specific neurotoxicity. The lack of neuropathological findings further
supports the non-specific nature of the signs observed. In addition,
there is a literature DNT study available for sulfentrazone. The only
reliable effects seen in this study involved effects on physical and
reflex development, which are known to be affected by body weight.
Therefore, these effects are likely secondary to the effects (including
body weight deficits) reported in the 2-generation reproductive
toxicity study. EPA employed an independent statistical method to
evaluate the literature DNT in an effort to determine if these effects
were consistent with effects observed in other guideline studies at
these same dose levels. The results of that analysis indicate that the
results of the literature DNT study are consistent with what was
observed in the rat 2-generation
[[Page 5709]]
reproduction study and that the studies used for risk assessment (NOAEL
of 10 mg/kg/day from the developmental toxicity study in rat and the
NOAEL of 14 mg/kg/day from the 2-generation reproduction study), are
protective of the observations made at [gteqt]25 mg/kg/day in the
literature study for which a NOAEL was not attained. Based on the
weight of evidence, there is no uncertainty related to developmental
neurotoxicity.
iii. There is evidence of increased quantitative susceptibility
following in utero exposure in the oral and dermal developmental
toxicity studies in rats and possible evidence of slightly increased
qualitative susceptibility of offspring in the 2-generation rat
reproduction study. However, concern is low because clear NOAELs have
been identified for the effects noted in these studies and both of the
developmental toxicity studies have been chosen for endpoint selection,
thereby protecting the relevant human subpopulations from the noted
effects.
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
aPAD and 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. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to sulfentrazone will occupy <1% of the aPAD for the general
population, including infants and children. For females 13-49 years
old, the acute dietary exposure to sulfentrazone from food and water
will occupy 2.3% of the applicable aPAD chosen for that population
subgroup.
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 3.6% 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- and intermediate-term risk. Short- and intermediate-term
aggregate exposure takes into account short- and intermediate-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- and
intermediate-term residential exposure, 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 short-
and intermediate-term exposures, EPA has concluded the combined short-
and intermediate-term food, water, and residential exposures result in
aggregate MOEs of 310 for the general U.S. population; 450 for children
1-2 years old for short-term exposures; and 590 for children 1-2 years
old for intermediate-term exposures. Because EPA's level of concern for
sulfentrazone is a MOE of 100 or below, these MOEs are not of concern.
4. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, sulfentrazone is not expected to pose a cancer risk to humans.
5. 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 has been
forwarded for inclusion in the Pesticides Analytical Manual, Volume 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
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 U.N. 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. There are no Codex,
Canadian, or Mexican MRLs established for residues of sulfentrazone in
or on the subject commodities.
C. Response to Comments
EPA received one comment to the Notice of Filing that had an
objection to ``the manufacture or sale'' of sulfentrazone, citing the
cruelty of animal testing as the main source of opposition. The Agency
has received these same or similar comments from this commenter on
numerous previous occasions. Please refer to the Federal Register of 70
FR 1349 (January 7, 2005) and 70 FR 37683 (June 30, 2005) for the
Agency's previous responses to these and other similar comments.
D. Revisions to Petitioned-For Tolerances
Based upon review of the data supporting the petition, EPA revised
the proposed tolerances for the following commodities: Brassica, leafy
greens, subgroup 5B from 0.35 ppm to 0.40 ppm; melon, subgroup 9A from
0.10 ppm to 0.15 ppm; vegetable, fruiting, group 8 from 0.05 ppm to
0.15 ppm; okra from 0.05 ppm to 0.15 ppm; pea, succulent from 0.05 ppm
to 0.15 ppm; flax from 0.05 ppm to 0.15 ppm; and strawberry from 0.05
ppm to 0.15 ppm. EPA revised the tolerance levels based on analysis of
the residue field trial data using the Agency's Tolerance Spreadsheet
in accordance with the Agency's Guidance for Setting Pesticide
Tolerances Based on Field Trial Data.
Additionally, EPA was petitioned for tolerances on fruiting
vegetable group 8
[[Page 5710]]
and a separate tolerance on okra. In the Federal Register of December
8, 2010 (75 FR 76284) (FRL-8853-8), EPA issued a final rule that
revised the crop grouping regulations. As part of this action, EPA
expanded and revised the existing fruiting vegetable crop group 8.
Changes to crop group 8 included adding okra, cocona, African eggplant,
pea eggplant, scarlet eggplant, goji berry, garden huckleberry,
martynia, naranjilla, roselle, sunberry, bush tomato, currant tomato,
and tree tomato; creating subgroups; revising the representative
commodities; and naming the new crop group fruiting vegetable group 8-
10. EPA indicated in the December 8, 2010 final rule as well as the
earlier January 6, 2010 proposed rule (75 FR 807) (FRL-8801-2) that,
for existing petitions for which a Notice of Filing had been published,
the Agency would attempt to conform these petitions to the rule.
Therefore, consistent with this rule, EPA has assessed and is
establishing a tolerance on fruiting vegetable group 8-10.
Finally, the EPA has revised the tolerance expression to clarify
(1) that, as provided in FFDCA section 408(a)(3), the tolerance covers
metabolites and degradates of sulfentrazone not specifically mentioned;
and (2) that compliance with the specified tolerance levels is to be
determined by measuring only the specific compounds mentioned in the
tolerance expression.
V. Conclusion
Therefore, tolerances are established for residues of the combined
residues of free and conjugated forms 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, in or on Brassica, head and stem,
subgroup 5A at 0.20 ppm; Brassica, leafy greens, subgroup 5B at 0.40
ppm; melon, subgroup 9A at 0.15 ppm; vegetable, fruiting, group 8-10 at
0.15 ppm; pea, succulent at 0.15 ppm; flax at 0.15 ppm; strawberry at
0.15 ppm; and vegetable, tuberous and corm, subgroup 1C at 0.15 ppm.
Additionally, this regulation deletes existing individual tolerances in
or on cabbage at 0.20 ppm and potato at 0.15 ppm, and further deletes
the time-limited tolerance for bean, succulent seed without pod (lima
bean and cowpea) at 0.1 ppm.
VI. Statutory and Executive Order Reviews
This final rule establishes tolerances under section 408(d) of
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 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 section 408(d) of 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.
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 section 408(n)(4) of FFDCA. 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) (Public Law 104-4).
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).
VII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report 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: January 14, 2011.
Daniel J. Rosenblatt,
Acting Director, Registration Division, 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. Section 180.498 is amended as follows:
0
i. Revise the introductory text of paragraph (a)(1);
0
ii. Revise the introductory text of paragraph (a)(2), remove the
entries for ``Cabbage'' and ``Potato'' and add commodities to the
table;
0
iii. Revise paragraph (b); and
0
iv. Revise the introductory text of paragraph (d), to read as follows:
Sec. 180.498 Sulfentrazone; tolerances for residues.
(a)(1) General. Tolerances are established for the combined
residues of the free and conjugated forms of sulfentrazone, including
its metabolites and degradates, in or on the commodities in the table
below. Compliance with the tolerance levels
[[Page 5711]]
specified below is to be determined by measuring only the sum 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
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
the following commodities.
* * * * *
(2) Tolerances are established for the combined residues of the
free and conjugated forms of sulfentrazone, including its metabolites
and degradates, in or on the commodities in the table below. Compliance
with the tolerance levels specified below is to be determined by
measuring only the sum 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 the following commodities.
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Brassica, head and stem, subgroup 5A........................ 0.20
Brassica, leafy greens, subgroup 5B......................... 0.40
* * * * *
Flax........................................................ 0.15
* * * * *
Melon, subgroup 9A.......................................... 0.15
Pea, succulent.............................................. 0.15
* * * * *
Strawberry.................................................. 0.15
* * * * *
Vegetable, fruiting, group 8-10............................. 0.15
Vegetable, tuberous and corm, subgroup 1C................... 0.15
------------------------------------------------------------------------
(b) Section 18 emergency exemptions. Time-limited tolerances are
established for the combined residues of the free and conjugated forms
of sulfentrazone, including its metabolites and degradates, in
connection with use of the pesticide under section 18 emergency
exemptions granted by EPA. Compliance with the tolerance levels
specified below is to be determined by measuring only the sum 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 the following
commodities. These tolerances expire and are revoked on the dates
specified in the following table.
------------------------------------------------------------------------
Parts per Expiration/
Commodity million revocation date
------------------------------------------------------------------------
Flax, seed........................ 0.20 12/31/13
Strawberry........................ 0.60 12/31/13
------------------------------------------------------------------------
* * * * *
(d) Indirect or inadvertent residues. Tolerances are established
for inadvertent and indirect combined residues of the free and
conjugated forms of sulfentrazone, including its metabolites and
degradates, in or on the commodities in the table below. Compliance
with the tolerance levels specified below is to be determined by
measuring only the sum 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 the following commodities when
present therein as a result of the application of sulfentrazone to
growing crops.
* * * * *
[FR Doc. 2011-1898 Filed 2-1-11; 8:45 am]
BILLING CODE 6560-50-P