[Federal Register Volume 77, Number 134 (Thursday, July 12, 2012)]
[Rules and Regulations]
[Pages 41081-41088]
[FR Doc No: 2012-17020]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2011-0758; FRL-9353-8]

Sulfentrazone; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
sulfentrazone in or on multiple commodities which are identified and
discussed later in this document. Interregional Research Project Number
4 (IR-4) and FMC requested these tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective July 12, 2012. Objections and
requests for hearings must be received on or before September 10, 2012,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2011-0758 is available at http://www.regulations.gov or at the OPP Docket in the Environmental
Protection Agency Docket Center (EPA/DC), located in EPA West, Rm.
3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Andrew Ertman, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
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 http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2011-0758 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
September 10, 2012. 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-2011-0758, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting
comments. Do not submit electronically any information you consider to
be Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection
Agency Docket Center (EPA/DC), Mail Code: 28221T, 1200 Pennsylvania
Ave. NW., Washington, DC 20460-0001.
     Hand Delivery: To make special arrangements for
hand delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.htm.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of October 5, 2011 (76 FR 61647) (FRL-8890-
5), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21 U.S.C.
346a(d)(3), announcing the filing of a pesticide petition (PP 1E7890)
by (IR-4), Rutgers, The State University of New Jersey, 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 herbicide sulfentrazone (N-[2,4-dichloro-5-[4-(difluoromethyl)-
4,5-dihydro-3-methyl-5-oxo-1H-1,2,4-triazol-1-
yl]phenyl]methanesulfonamide) and its metabolites 3-
hydroxymethylsulfentrazone (N-[2,4-dichloro-5-[4-(difluoromethyl)-4,5-
dihydro-3-hydroxymethyl-5-oxo-1H-1,2,4-triazol-1-
yl]phenyl]methanesulfonamide) and 3-desmethyl sulfentrazone (N-[2,4-
dichloro-5-[4-(difluoromethyl)-4,5-dihydro-5-oxo-1H-1,2,4-triazol-1-
yl]phenyl]methanesulfonamide), in or on rhubarb at 0.2 parts per
million (ppm); turnip, roots at 0.2 ppm; turnip, tops at 0.7 ppm; and
sunflower subgroup 20B at 0.2 ppm; ``Tolerances with regional
registrations'' in or on wheat, forage at 0.45 ppm (Pacific Northwest
only); wheat, hay at 0.20 ppm (Pacific Northwest only); wheat, grain at
0.20 ppm (Pacific Northwest only); wheat, straw at 1.4 ppm (Pacific
Northwest only); and cowpea, succulent at 0.15 ppm (Tennessee only). In
addition, the petition requested to amend the current tolerances in 40
CFR 180.498 in or on bean, lima, succulent at 0.15 ppm by removing the
tolerance from the table in Section (a)(2) and adding the tolerance to
Section (c) Tolerances with regional registrations. Upon approval of
the aforementioned tolerance on the sunflower subgroup 20B, the
petition additionally proposed to remove the established tolerance in
or on the raw agricultural commodity sunflower, seed at 0.2 ppm. That
notice referenced a summary of the petition prepared by FMC, the
registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the
notice of filing.
    In the Federal Register of July 6, 2011 (76 FR 39358) (FRL-8875-6),
EPA issued a notice pursuant to FFDCA section 408(d)(3), 21 U.S.C.
346a(d)(3), announcing the filing of a pesticide petition (PP 1F7838)
by FMC Corporation, 1735 Market St., Philadelphia, PA 19103. The
petition requested that 40 CFR 180.498 be amended by establishing
tolerances for residues of the herbicide sulfentrazone (N-[2,4-
dichloro-5-[4-(difluoromethyl)-4,5-dihydro-3-methyl-5-oxo-1H-1,2,4-
triazol-1-yl]phenyl]methanesulfonamide) and its metabolites 3-
hydroxymethylsulfentrazone (N-[2,4-dichloro-5-[4-(difluoromethyl)-4,5-
dihydro-3-hydroxymethyl-5-oxo-1H-1,2,4-triazol-1-
yl]phenyl]methanesulfonamide) and 3-desmethyl sulfentrazone (N-[2,4-
dichloro-5-[4-(difluoromethyl)-4,5-dihydro-5-oxo-1H-1,2,4-triazol-1-
yl]phenyl]methanesulfonamide), in or on crop group 10-10 citrus fruit
at 0.15 ppm; crop group 13-07 berry and small fruit at 0.15 ppm; crop
group 14 tree nut and pistachio at 0.15 ppm; and crop group 18 non-
grass animal feed (forage, fodder, straw, and hay): Alfalfa, forage at
5 ppm; alfalfa, hay at 20 ppm; alfalfa, seed at 3 ppm; clover, forage
at 5 ppm; clover, hay at 20 ppm; and clover, seed at 3 ppm. That notice
referenced a summary of the petition prepared by FMC, the registrant,
which is available in the docket, http://www.regulations.gov. A comment
was received on the notice of filing. EPA's response to this comment is
discussed in Unit IV.C.
    Based upon review of the data supporting the petition, EPA has
modified the tolerance levels for some commodities and is not
establishing tolerances on alfalfa forage, hay, and seed and clover
forage, hay, and seed. 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 FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for sulfentrazone including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with sulfentrazone
follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
    Based on the results of acute toxicity studies in rats,
sulfentrazone was classified as having 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. A published, non-guideline
developmental toxicity study in the rat (de Castro, et al., 2007)
failed to demonstrate conclusively developmental neurotoxicity and
contains several shortcomings that limit its use for regulatory
purposes. Further, the reported offspring effects involving measures of
physical and reflex development are likely secondary effects reflective
of the poor general state of the offspring, as reported in the rat 2-
generation reproductive toxicity study at similar dose levels.
    No systemic toxicity was seen via the dermal route up to the limit
dose in a 28-day dermal toxicity study in rabbits.
    Preliminary review of a recently submitted 28-day rat
immunotoxicity study suggests that sulfentrazone does not directly
target the immune system; and, there is no evidence of immunotoxicity
in the rest of the toxicity database for sulfentrazone.
    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 http://www.regulations.gov in the document titled
``Sulfentrazone: Human-Health Risk Assessment for the Establishment of
Sulfentrazone Tolerances in/on: Rhubarb, Turnip Roots and Tops,
Sunflower Subgroup 20B, Succulent Cowpea, Succulent Lima Bean,
Succulent Vegetable Soybean, Wheat (Spring), Citrus Fruit Group 10-10,
Low-Growing Berry Group 13-07, Tree Nut Group 14, Pistachios, and Crop
Group 18 Nongrass Animal Feeds,'' pp. 45-49 in docket ID number EPA-HQ-
OPP-2011-0758.

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 which no adverse effects are observed (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) 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 http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for sulfentrazone used for
human risk assessment is shown in the following table:

  Table--Summary of Toxicological Doses and Endpoints for Sulfentrazone for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (Females 13-49       NOAEL = 14 mg/kg/day  Acute RfD = 0.14 mg/ 2-Generation Reproductive Toxicity
 years of age).                    UFA = 10X...........   kg/day               Study--Rat Offspring Toxicity
                                   UFH = 10X...........  aPAD = 0.14 mg/kg/    LOAEL = 33 (M) and 40 (F) mg/kg/
                                   FQPA SF = 1X........   day.                 day based on reduced prenatal
                                                                               viability (fetal & litter),
                                                                               reduced litter size, increased
                                                                               number of stillborn pups, reduced
                                                                               pup and litter postnatal
                                                                               survival, and decreased pup body
                                                                               weights throughout lactation.
Acute dietary (General population  NOAEL = 250 mg/kg/    Acute RfD = 2.5 mg/  Acute Neurotoxicity Study--Rat
 including infants and children).   day                   kg/day               LOAEL = 750 mg/kg/day based on
                                   UFA = 10X...........  aPAD = 2.5 mg/kg/     increased incidence of clinical
                                   UFH = 10X...........   day.                 signs and FOB parameters and
                                   FQPA SF = 1X........                        decreased motor activity.

Chronic dietary (All populations)  NOAEL = 14 mg/kg/day  Chronic RfD = 0.14   2-Generation Reproductive Toxicity
                                   UFA = 10X...........   mg/kg/day            Study--Rat Offspring Toxicity
                                   UFH = 10X...........  cPAD = 0.14 mg/kg/    LOAEL = 33 (M) and 40 (F) mg/kg/
                                   FQPA SF = 1X........   day.                 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.
Short- (1-30 days) and             NOAEL = 14 mg/kg/day  LOC for MOE = 100    2-Generation Reproduction Study--
 Intermediate-Term (1-6 months)    UFA = 10X...........                        Rat Offspring LOAEL = 33 mg/kg/
 Incidental Oral.                  UFH = 10X...........                        day based on decreased pup body
                                   FQPA SF = 1X........                        weights and reduced postnatal
                                                                               survival in both generations.
Short-Term Dermal (1-30 days)....  Dermal study          LOC for MOE = 100    Dermal Developmental Study--Rat
                                   NOAEL = 100 mg/kg/                          LOAEL = 250 mg/kg/day based on
                                    day (dermal                                decreased fetal body weight;
                                    absorption rate =                          increased incidences of fetal
                                    100%).                                     skeletal variations: Hypoplastic
                                   UFA = 10X...........                        or wavy ribs, incompletely
                                   UFH = 10X...........                        ossified lumbar vertebral arches,
                                   FQPA SF = 1X........                        and incompletely ossified ischia
                                                                               or pubes; and reduced number of
                                                                               thoracic vertebral and rib
                                                                               ossification sites.
Short-Term Inhalation (1-30 days)  Inhalation (or oral)  LOC for MOE = 1000   Prenatal Developmental Toxicity--
                                    study                                      Rat Developmental LOAEL = 25 mg/
                                   NOAEL = 10 mg/kg/day                        kg/day, based upon decreased mean
                                    (inhalation                                fetal weights, and retardation in
                                    absorption rate =                          skeletal development evidenced by
                                    100%).                                     an increased number of litters
                                   UFA = 10X...........                        with any variation and by
                                   UFH = 10X...........                        decreased number of caudal
                                   FQPA SF = 10X.......                        vertebral and metacarpal
                                                                               ossification sites.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFDB = to account for the absence of data or other
  data deficiency. UFH = potential variation in sensitivity among members of the human population
  (intraspecies). M = male. F = female. FOB = functional observation battery.

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 to 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 DEEMTM
(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, 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 or PCT information in the dietary assessment for
sulfentrazone. Tolerance level residues and 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 http://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 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. 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 post-application dermal exposure from contact with treated
residential and recreational turf home lawns and golf courses. For
adult handlers, dermal and inhalation exposures were aggregated for the
short-term assessment. Because the level of concern for dermal
exposures (MOEs less than 100) and inhalation exposure (MOEs less than
1,000) are different, a total aggregate risk index (ARI) approach was
used for adult handlers instead of the MOE approach. ARIs of less than
1 indicate risks are not of concern. Children, ages 11 < 16 years old
and 6 < 11 years old, were assessed for post-application dermal
exposure from contact with treated residential and recreational turf
(home lawns and golf courses). Children, ages 1 < 2 years old, were
assessed for post-application dermal and incidental oral (hand-to-
mouth, object-to-mouth, soil ingestion and episodic ingestion of
granules) exposure to residential turf/home lawns.
    For the short-term exposure duration, the post-application exposure
scenarios that were combined for children 1 < 2 years old are the
dermal and hand-to-mouth scenarios. This combination should be
considered a protective estimate of children's exposure to pesticides
used on turf. For the intermediate-term exposure duration, the only
potential post-application exposure scenario is soil ingestion. 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 http://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 http://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.
    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 for all scenarios except for inhalation
exposure, where a 10X FQPA SF factor has been retained due to the lack
of an appropriate inhalation study. That decision is based on the
following findings:
    i. The toxicity database for sulfentrazone is complete with the
exception of a 28-day inhalation study in rats. A 10X FQPA SF has been
retained for inhalation exposure scenarios due to this data gap.
    ii. There is no indication that sulfentrazone is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional safety factors to account for neurotoxicity.
    iii. There is evidence of increased quantitative susceptibility
following in utero exposure in the oral and dermal developmental
toxicity studies in rat 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
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.

    1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to sulfentrazone will occupy 3.2% of the aPAD for females 13-49 years
old, the population group receiving the greatest exposure.
    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 4.2% of the cPAD for
children 1-2 years old, the population group receiving the greatest
exposure. Based on the explanation in Unit III.C.3., regarding
residential use patterns, chronic residential exposure to residues of
sulfentrazone is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
    Sulfentrazone is currently registered for uses that could result in
short-term residential exposure, and the Agency has determined that it
is appropriate to aggregate chronic exposure through food and water
with short-term residential exposures to sulfentrazone.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in an aggregate MOE of 280 for
children 1-2 years old, and an ARI of 3.9 for the general U.S.
population and adult males. Because EPA's level of concern for
sulfentrazone is an MOE of 100 or below and/or and ARI of 1 or below,
this MOE and ARI are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account 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
intermediate-term residential exposure, and the Agency has determined
that it is appropriate to aggregate chronic exposure through food and
water with intermediate-term residential exposures to sulfentrazone.
    Using the exposure assumptions described in this unit for
intermediate-term exposures, EPA has concluded that the combined
intermediate-term food, water, and residential exposures result in an
aggregate MOE of 2,400 for children 1-2 years old, the only population
subgroup of concern. Because EPA's level of concern for sulfentrazone
is an MOE of 100 or below, this MOE is not of concern.
    5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, sulfentrazone is not expected to pose a cancer risk to humans.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population or to infants and children from aggregate
exposure to sulfentrazone residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography (GC)) is
available to enforce the tolerance expression. The method 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:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    There are no Codex MRLs established for sulfentrazone on the
subject crops in this rule.

C. Response to Comments

    A comment was received objecting generally to the use of this
chemical stating that the ``* * * product should [sic] not be approved
to be manufactured or sold anywhere on earth * * *'' The Agency
understands the commenter's concerns and recognizes that some
individuals believe that pesticides should be banned on agricultural
crops. However, the existing legal framework provided by section 408 of
the FFDCA states that tolerances may be set when persons seeking such
tolerances or exemptions have demonstrated that the pesticide meets the
safety standard imposed by that statute. This comment appears to be
directed at the underlying statute and not EPA's implementation of it;
the commenter has made no contention that EPA has acted in violation of
the statutory framework.

D. Revisions to Petitioned-For Tolerances

    The tolerances proposed in the petitions have been revised as
follows: the rhubarb tolerance is being set at 0.15 ppm instead of 0.2
ppm; the turnip root tolerance is being set at 0.15 ppm instead of 0.2
ppm; the turnip top tolerance is being set at 0.60 ppm instead of 0.7
ppm; the wheat forage tolerance is being set at 0.50 ppm instead of
0.45 ppm; the wheat hay tolerance is being set at 0.30 instead of 0.20
ppm; the wheat grain tolerance is being set at 0.15 ppm instead of 0.20
ppm; the wheat straw tolerance is being set at 1.5 ppm instead of 1.4
ppm. EPA revised the tolerance levels based on analysis of the residue
field trial data and by using the organization for economic cooperation
and development (OECD) tolerance calculation procedures.
    Tolerances are not being established at this time for alfalfa
forage, hay, and seed and clover forage, hay, and seed due to the need
for additional residue data and a ruminant feeding study.

V. Conclusion

    Therefore, tolerances are established for residues of
sulfentrazone, (N-[2,4-dichloro-5-[4-(difluoromethyl)-4,5-dihydro-3-
methyl-5-oxo-1H-1,2,4-triazol-1-yl]phenyl]methanesulfonamide) and its
metabolites 3-hydroxymethylsulfentrazone (N-[2,4-dichloro-5-[4-
(difluoromethyl)-4,5-dihydro-3-hydroxymethyl-5-oxo-1H-1,2,4-triazol-1-
yl]phenyl]methanesulfonamide) and 3-desmethyl sulfentrazone (N-[2,4-
dichloro-5-[4-(difluoromethyl)-4,5-dihydro-5-oxo-1H-1,2,4-triazol-1-
yl]phenyl]methanesulfonamide), in section 180.498(a)(2) in or on
rhubarb at 0.15 ppm; turnip roots at 0.15 ppm; turnip tops at 0.60 ppm;
sunflower subgroup 20B at 0.20 ppm; citrus fruit group 10-10 at 0.15
ppm; low growing berry group 13-07 at 0.15 ppm; tree nut group 14 at
0.15 ppm; pistachio at 0.15 ppm; and section 180.498 (c) tolerances

with regional registrations for wheat forage at 0.50 ppm; wheat hay at
0.30 ppm; wheat grain at 0.15 ppm; wheat straw at 1.5 ppm; and cowpea,
succulent at 0.15 ppm.
    In addition, the following tolerances are being removed as
unnecessary in section 180.498(a)(2), sunflower seed, and strawberry,
and in section 180.498(b), flax seed and strawberry.
    Lastly, the tolerance for ``bean, lima, succulent'' is being moved
from section 180.498(a)(2) to section 180.498(c).

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this final rule has
been exempted from review under Executive Order 12866, this final rule
is not subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This final rule does not contain
any information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Pub. L. 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: July 3, 2012.
Lois Rossi,
Director, Registration Division, Office 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 by:
0
i. In the table to paragraph (a)(2), remove the entries for ``bean,
lima, succulent,'' ``sunflower, seed,'' and ``strawberry'', and add
alphabetically new entries as shown below.
0
ii. Revise paragraphs (b) and (c).
    The added and revised text read as follows:

Sec.  180.498  Sulfentrazone; tolerances for residues.

    (a) * * *
    (2) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------

                                * * * * *
Berry, low growing, group 13-07...........................          0.15

                                * * * * *
Fruit, citrus, group 10-10................................          0.15

                                * * * * *
Nut, tree, group 14.......................................          0.15

                                * * * * *
Pistachio.................................................          0.15
Rhubarb...................................................          0.15

                                * * * * *
Sunflower subgroup 20B....................................          0.20
Turnip, roots.............................................          0.15
Turnip, tops..............................................          0.60

                                * * * * *
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved].
    (c) Tolerances with regional registrations. Tolerances with
regional registration 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
------------------------------------------------------------------------
Bean, lima, succulent....................................           0.15
Cowpea, succulent........................................           0.15
Wheat, forage............................................           0.50
Wheat, grain.............................................           0.15
Wheat, hay...............................................           0.30
Wheat, straw.............................................           1.5
------------------------------------------------------------------------

* * * * *
[FR Doc. 2012-17020 Filed 7-11-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 33 (Tuesday, February 19, 2019)]
[Notices]
[Page 4800]
[FR Doc No: 2019-02637]

-----------------------------------------------------------------------

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP19-116-001.
    Applicants: DTE Midstream Appalachia, LLC.
    Description: Compliance filing Compliance Filing--Non-Redacted
Transportation Service Agreement to be effective 12/18/2018.
    Filed Date: 2/11/19.
    Accession Number: 20190211-5176.
    Comments Due: 5 p.m. ET 2/25/19.

    Docket Numbers: RP19-647-000.
    Applicants: Trunkline Gas Company, LLC.
    Description: Sec.  4(d) Rate Filing: Housekeeping Filing on 2-11-19
to be effective 3/14/2019.
    Filed Date: 2/11/19.
    Accession Number: 20190211-5033.
    Comments Due: 5 p.m. ET 2/25/19.

    Docket Numbers: RP19-648-000.
    Applicants: Trunkline Gas Company, LLC.
    Description: Sec.  4(d) Rate Filing: Housekeeping Filing--Orig.
Vol. 1-A on 2-11-19 to be effective 3/14/2019.
    Filed Date: 2/11/19.
    Accession Number: 20190211-5034.
    Comments Due: 5 p.m. ET 2/25/19.

    Docket Numbers: RP19-649-000.
    Applicants: Panhandle Eastern Pipe Line Company, LP.
    Description: Sec.  4(d) Rate Filing: Housekeeping Filing on 2-11-19
to be effective 3/14/2019.
    Filed Date: 2/11/19.
    Accession Number: 20190211-5035.
    Comments Due: 5 p.m. ET 2/25/19.

    Docket Numbers: RP19-650-000.
    Applicants: Southwest Gas Storage Company.
    Description: Sec.  4(d) Rate Filing: Housekeeping Filing on 2-11-19
to be effective 2/11/2019.
    Filed Date: 2/11/19.
    Accession Number: 20190211-5036.
    Comments Due: 5 p.m. ET 2/25/19.

    Docket Numbers: RP19-651-000.
    Applicants: Viking Gas Transmission Company.
    Description: Sec.  4(d) Rate Filing: Gas Quality to be effective 3/
14/2019.
    Filed Date: 2/11/19.
    Accession Number: 20190211-5093.
    Comments Due: 5 p.m. ET 2/25/19.

    Docket Numbers: RP19-652-000.
    Applicants: Great Lakes Gas Transmission Limited Partnership.
    Description: Sec.  4(d) Rate Filing: FSA Pressure Commitment &
TCPlus Cleanup to be effective 3/13/2019.
    Filed Date: 2/11/19.
    Accession Number: 20190211-5177.
    Comments Due: 5 p.m. ET 2/25/19.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: February 12, 2019.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2019-02637 Filed 2-15-19; 8:45 am]
 BILLING CODE 6717-01-P