[Federal Register Volume 79, Number 177 (Friday, September 12, 2014)]
[Rules and Regulations]
[Pages 54620-54626]
[FR Doc No: 2014-21807]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2013-0712; FRL-9915-47]

Sulfentrazone; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes a tolerance for residues of
sulfentrazone in or on apple. The Interregional Research Project Number
4 (IR-4) requested these tolerances under the Federal Food, Drug, and
Cosmetic Act (FFDCA).

DATES: This regulation is effective September 12, 2014. Objections and
requests for hearings must be received on or before November 12, 2014,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2013-0712, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave., NW., Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<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: Lois Rossi, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main 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.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-
idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab02.tpl.

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2013-0712 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
November 12, 2014. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2013-0712, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html. 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 December 30, 2013 (78 FR 79359) (FRL-
9903-69), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
3E8202) by IR-4, 500 College Road East, Suite 201W, Princeton, NJ
08540. The petition requested that 40 CFR 180.498 be amended by
establishing tolerances for residues of the herbicide sulfentrazone,
(N-[2,4-dichloro-5-[4-(difluoromethyl)-4,5-dihydro-3-methyl-5-oxo-1H-
1,2,4-triazol-1-yl]phenyl]methanesulfonamide), and its metabolite HMS
(N-(2,4-dichloro-5-(4-(difluoromethyl)-4,5-dihydro-3- hydroxymethyl-5-
oxo-1H-1,2,4-triazol-1-yl)phenyl)methanesulfonamide, calculated as the
stoichiometric equivalent of sulfentrazone, in or on apple at 0.15
parts per million (ppm). That document referenced a summary of the
petition prepared on behalf of IR-4 by FMC Corporation, the registrant,
which is available in the docket, http://www.regulations.gov. Comments
were received on the notice of filing. EPA's response to these comments
is discussed in Unit IV.C.
    Based upon review of the data supporting the petition, EPA has
determined that it is appropriate to establish the tolerance in or on
apple for the combined residues of the free and conjugated forms of the
herbicide sulfentrazone, and its metabolites HMS (N-(2,4-dichloro-5-(4-
(difluoromethyl)-4,5-dihydro-3-hydroxymethyl-5-oxo-1H-1,2,4-triazol-1-
yl)phenyl)methanesulfonamide) and DMS (N-(2,4-dichloro-5-(4-
(difluoromethyl)-4,5-dihydro-5-oxo-1H-1,2,4-triazol-1-
yl)phenyl)methanesulfonamide, calculated as the stoichiometric
equivalent of sulfentrazone. The reason for this decision is discussed
in Unit IV.D.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA

determines that the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) of
FFDCA defines ``safe'' to mean that ``there is a reasonable certainty
that no harm will result from aggregate exposure to the pesticide
chemical residue, including all anticipated dietary exposures and all
other exposures for which there is reliable information.'' This
includes exposure through drinking water and in residential settings,
but does not include occupational exposure. Section 408(b)(2)(C) of
FFDCA requires EPA to give special consideration to exposure of infants
and children to the pesticide chemical residue in establishing a
tolerance and to ``ensure that there is a reasonable certainty that no
harm will result to infants and children from aggregate exposure to the
pesticide chemical residue. . . .''
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for sulfentrazone including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with sulfentrazone
follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
    Subchronic and chronic toxicity studies in rats, mice, and dogs
identified the hematopoietic system as the target of sulfentrazone.
Sulfentrazone inhibits the enzyme protoporphyrinogen oxidase (PPO) in
target plants, and the results of subchronic and chronic toxicity
studies in mammalian systems are consistent with PPO inhibition.
Disruption of heme biosynthesis was indicated by signs of anemia, and
decreases in hematocrit (Hct), hemoglobin (HGB), and mean corpuscular
volume (MCV) in mice, rats, and dogs at comparable dose levels from
short- through long-term exposures without a significant increase in
severity.
    Sulfentrazone caused developmental effects when administered via
the oral (rats and rabbits) and dermal (rat only) routes of exposure.
Developmental effects in rats and rabbits consisted of reductions in
the number of implantations in rats, and increases in early resorptions
and reduction in live fetuses per litter in rats and rabbits. Surviving
rat fetuses exhibited reduced/delayed skeletal ossifications, and
decreased fetal body weights. Developmental effects in rats were seen
in the absence of maternal toxicity. In contrast with the rat studies,
developmental effects in rabbits were observed at a maternally toxic
dose, where clinical signs of toxicity included hematuria (red blood
cells in urine), abortions, and decreased body-weight gains. In the 2-
generation reproductive toxicity study in rats, developmental effects
included an increased duration of gestation, reduced prenatal viability
(fetal and litter), reduced litter size, and an increased number of
stillborn pups. Pup body-weight deficits, along with reduced pup and
litter postnatal survival, were also observed. All of the offspring
effects were reported in the presence of mild maternal toxicity
(decreased body weight and body-weight gain, particularly in
F1 females). No systemic toxicity was seen via the dermal
route up to the limit dose in a 28-day dermal toxicity study in adult
non-pregnant rabbits. In a dermal developmental study in rats, there
was an increased quantitative fetal susceptibility. While no maternal
effects were observed up to the highest dose tested, fetal effects were
observed at this dose, and consisted of decreased body weights,
increased incidences of fetal variations, hypoplastic or wavy ribs,
incompletely ossified lumbar vertebral arches, incompletely ossified
ischia or pubis, and a reduced number of thoracic vertebral and rib
ossification sites.
    In the 26-day inhalation toxicity study, effects that were
considered treatment related and adverse effects occurred only at the
highest concentration tested. Systemic effects at this concentration
consisted of significant reductions in red blood cell (RBC) parameters
including RBC count, HGB concentrations, Hct, MCV, mean corpuscular HGB
(MCH), and/or reticulocytes in both sexes. Portal-of-entry effects in
this study consisted of an increased incidence of minimal nasal
respiratory epithelial hyperplasia in both sexes as well as minimal
laryngeal epithelial attenuation in all test material exposure groups.
The effects on hematological parameters were reversible after 28 days
of recovery, while the nasal injury persisted.
    In an acute neurotoxicity (ACN) study in rats, effects consisted of
an increased incidence of clinical signs of toxicity (staggered gait,
splayed hind limbs, and abdominal gripping), changes in functional-
observation battery (FOB) parameters, and decreased motor activity at a
high dose level. Complete recovery was observed by day 14, and there
was no evidence of neuropathology. In a rat subchronic neurotoxicity
(SCN) study, clinical signs of toxicity, increased motor activity, and/
or decreased body weights, body-weight gain, and food consumption were
also observed with no evidence of neuropathology. A published, non-
guideline developmental toxicity study in the rat did not conclusively
demonstrate developmental neurotoxicity and contained several
shortcomings that limit its use for regulatory purposes, including the
lack of a no-observed-adverse-effect-level (NOAEL) (DeCastro VL,
Destefani CR, Diniz C, Poli P., 2007, Evaluation of neurodevelopmental
effects on rats exposed prenatally to sulfentrazone. Neurotoxicology
28(6):1249-59). The reported effects involving measures of physical and
reflex development are likely secondary effects reflective of the poor
general state of the offspring as reported in the rat 2-generation
reproductive toxicity study at similar dose levels but with a well-
defined NOAEL.
    In the 28-day rat immunotoxicity study, there were no effects on
the immune system and systemic effects consisted of reduced body
weight, and increased absolute and relative spleen weights at the
highest dose tested. Carcinogenicity studies in rats and mice showed no
evidence of increased incidence of tumor formation due to treatment
with sulfentrazone, and the EPA has classified sulfentrazone as not
likely to be carcinogenic to humans. The available mutagenicity studies
indicate that sulfentrazone is weakly clastogenic in the in vitro mouse
lymphoma assay in the absence of S9 activation. There is no evidence
that sulfentrazone is mutagenic in bacterial cells or clastogenic in
male or female mice in vivo.
    Specific information on the studies received and the nature of the
adverse effects caused by sulfentrazone as well as the NOAEL and the
lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies
can be found at http://www.regulations.gov in document:
``Sulfentrazone--Preliminary Human-Health Risk Assessment for
Registration Review and the Risk Assessment for the Section 3
Registration Request for a New Use on Apples'' at pp. 44-49 in docket
ID number EPA-HQ-OPP-2013-0712.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies

toxicological points of departure (POD) and levels of concern to use in
evaluating the risk posed by human exposure to the pesticide. For
hazards that have a threshold below which there is no appreciable risk,
the toxicological POD is used as the basis for derivation of reference
values for risk assessment. PODs are developed based on a careful
analysis of the doses in each toxicological study to determine the dose
at which the NOAEL and the LOAEL are identified. Uncertainty/safety
factors are used in conjunction with the POD to calculate a safe
exposure level--generally referred to as a population-adjusted dose
(PAD) or a reference dose (RfD)--and a safe margin of exposure (MOE).
For non-threshold risks, the Agency assumes that any amount of exposure
will lead to some degree of risk. Thus, the Agency estimates risk in
terms of the probability of an occurrence of the adverse effect
expected in a lifetime. For more information on the general principles
EPA uses in risk characterization and a complete description of the
risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for sulfentrazone used for
human risk assessment is shown in Table 1 of this unit.

 Table 1--Summary of Toxicological Doses and Endpoints for Sulfentrazone for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                    Point of departure
        Exposure/scenario            and  uncertainty/    RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk  assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (Females 13-49       NOAEL = 14 mg/kg/day  Acute RfD = 0.14 mg/ 2-generation Reproductive Toxicity
 years of age).                    UFA = 10x...........   kg/day.              Study--Rat
                                   UFH = 10x...........  aPAD = 0.14 mg/kg/   Offspring Toxicity LOAEL = 33 (M)
                                   FQPA SF = 1x........   day.                 and 40 (F) mg/kg/day based on
                                                                               reduced prenatal viability (fetal
                                                                               & litter), reduced litter size,
                                                                               increased number of stillborn
                                                                               pups, reduced pup and litter
                                                                               postnatal survival, and decreased
                                                                               pup body weights throughout
                                                                               lactation.
Acute dietary (General population  NOAEL = 250 mg/kg/    Acute RfD = 2.5 mg/  Acute Neurotoxicity (ACN) Study--
 including infants and children).   day.                  kg/day.              Rat
                                   UFA = 10x...........  aPAD = 2.5 mg/kg/    LOAEL = 750 mg/kg/day based on
                                   UFH = 10x...........   day.                 increased incidence of clinical
                                   FQPA SF = 1x........                        signs and FOB parameters and
                                                                               decreased motor activity.
Chronic dietary (All populations)  NOAEL = 14 mg/kg/day  Chronic RfD = 0.14   2-generation Reproductive Toxicity
                                   UFA = 10x...........   mg/kg/day.           Study--Rat
                                   UFH = 10x...........  cPAD = 0.14 mg/kg/   Offspring Toxicity LOAEL = 33 (M)
                                   FQPA SF = 1x........   day.                 and 40 (F) mg/kg/day based on
                                                                               reduced prenatal viability (fetal
                                                                               & litter), reduced litter size,
                                                                               increased number of stillborn
                                                                               pups, reduced pup and litter
                                                                               postnatal survival, and decreased
                                                                               pup body weights throughout
                                                                               lactation.
Incidental oral short- (1 to 30    NOAEL = 14 mg/kg/day  LOC for MOE = 100..  2-Generation Reproductive Toxicity
 days) and intermediate-term (1-6  UFA = 10x...........                        Study--Rat
 months).                          UFH = 10x...........                       Offspring LOAEL = 33 mg/kg/day
                                   FQPA SF = 1x........                        based on decreased pup body
                                                                               weights and reduced postnatal
                                                                               survival in both generations.
Dermal short-term (1 to 30 days).  Dermal study NOAEL =  LOC for MOE = 100..  Dermal Developmental Study--Rat
                                    100 mg/kg/day.                            LOAEL = 250 mg/kg/day based on
                                   UFA = 10 x..........                        decreased fetal body weight;
                                   UFH = 10 x..........                        increased incidences of fetal
                                   FQPA SF = 1x........                        skeletal variations: hypoplastic
                                                                               or wavy ribs, incompletely
                                                                               ossified lumbar vertebral arches,
                                                                               and incompletely ossified ischia
                                                                               or pubes; and reduced number of
                                                                               thoracic vertebral and rib
                                                                               ossification sites.
Short-term (1-30 days) inhalation  Portal-of-entry       LOC for MOE = 30...  Portal-of-entry LOAEL = 1.71 mg/L
                                    NOAEL = 0.256 mg/L,                        based on an increased incidence
                                    HEC = 0.054 mg/L,                          of minimal nasal respiratory
                                    HED = 1.55.                                epithelial hyperplasia in male
                                   mg/kg/day UFA = 3x..                        and female rats.
                                   UFH = 10x...........
                                   FQPA SF = 1x........
                                  ------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)  Sulfentrazone is classified as not likely to be carcinogenic to humans
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
  members of the human population (intraspecies). HEC = human-equivalent concentration. HED = human-equivalent
  dose.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to sulfentrazone, EPA considered exposure under the
petitioned-for tolerances as well as all existing sulfentrazone
tolerances in 40 CFR 180.498. EPA assessed dietary exposures from
sulfentrazone in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure. Such effects were identified
for sulfentrazone, and EPA performed separate acute risk assessments
for females 13 to 49 years old and for the general population,
including infants

and children, based on different endpoints and acute population
adjusted doses (aPADs). In estimating acute dietary exposures, EPA used
the Dietary Exposure Evaluation Model, Food Consumption Intake Database
(DEEM-FCID, ver. 3.16), which incorporates consumption data from United
States Department of Agriculture (USDA) National Health and Nutrition
Examination Survey, What We Eat in America, (NHANES/WWEIA; 2003-2008).
As to residue levels in food, EPA assumed tolerance-level residues, 100
percent crop treated (PCT), and DEEM (ver. 7.81) default processing
factors.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used DEEM-FCID, ver. 3.16, which incorporated
consumption data from the USDA's NHANES/WWEIA; 2003-2008. As to residue
levels in food, EPA assumed tolerance-level residues, 100 PCT, and DEEM
(ver. 7.81) default processing factors.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that sulfentrazone does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
    iv. Anticipated residue and PCT information. EPA did not use
anticipated residue and/or PCT information in the dietary assessment
for sulfentrazone. Tolerance level residues and/or 100 PCT were assumed
for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for sulfentrazone in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of sulfentrazone. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS) and Pesticide Root Zone Model Ground Water (PRZM
GW), the estimated drinking water concentrations (EDWCs) of
sulfentrazone for acute exposures are estimated to be 37.3 parts per
billion (ppb) for surface water and 134 ppb for ground water; and for
chronic exposures for non-cancer assessments are estimated to be 5.3
ppb for surface water and 98 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 134 ppb was used to assess
the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 98 ppb was used to assess
the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). Sulfentrazone is
currently registered for the following uses that could result in
residential exposures: Residential home lawns/turf and recreational
turf, such as golf courses. EPA assessed residential exposures using
the following assumptions: Adults were assessed for potential short-
term dermal and inhalation handler exposures from applying
sulfentrazone to residential turf/home lawns and for short-term
postapplication dermal exposure from contact with treated residential
and recreational turf.
    Children, ages 11 < 16 years old and 6 < 11 years old, were
assessed for postapplication dermal exposure from contact with treated
residential and recreational turf (home lawns and golf courses).
Children, ages 1 < 2 years old, were assessed for postapplication
short-term dermal and incidental oral exposures (hand-to-mouth, object-
to-mouth, and episodic ingestion of granules), as well as short- and
intermediate-term incidental oral soil ingestion scenarios from contact
with residential turf/home lawns.
    The recommended adult residential exposure scenario for use in the
aggregate assessment reflects short-term dermal exposure from
applications to turf via backpack sprayer. The recommended residential
exposure scenario for use in the combined short- and intermediate-term
aggregate assessment for children ages 1 < 2 years old reflects dermal
and hand-to-mouth exposures from postapplication exposure to turf
applications. This combination should be considered a protective
estimate of children's exposure to pesticides used on turf since the
incidental oral scenarios are considered inter-related, likely
occurring interspersed amongst each other across time; therefore,
combining these scenarios would be overly-conservative because of the
conservative nature of each individual assessment. In addition, the
only potential intermediate-term exposure is postapplication soil
ingestion which is significantly less than short-term hand-to-mouth
exposure. Further, this scenario is considered protective of potential
post-application exposures to children, ages 6 < 11 and 11 < 16 years
old, as children 1-2 years old represent the population subgroup for
children with the greatest exposure, and is therefore considered
protective of other children population subgroups.
    Chronic exposures are not expected and were not assessed. Finally,
residential handler and/or postapplication inhalation risk estimates
were not combined with dermal or oral risk estimates in the aggregate
risk assessment since the toxicological effects in the inhalation
toxicological study were portal-of-entry and were different from those
seen in the dermal and oral toxicological studies. Further information
regarding EPA standard assumptions and generic inputs for residential
exposures may be found at 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 Food Quality
Protection Act Safety Factor (FQPA 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. That decision is based on the following
findings:
    i. The toxicity database for sulfentrazone is complete.
    ii. In the ACN and SCN studies, observed effects included changes
in motor activity and FOB parameters, clinical signs, and body-weight
decrements. There is low concern for neurotoxicity since:
    1. Effects were seen at relatively high doses;
    2. Effects occurred in the absence of neuropathology;
    3. There is no evidence of neurotoxicity in other available studies
in the toxicity database;
    4. Effects are well-characterized with clearly established NOAEL/
LOAEL values; and
    5. The selected PODs are protective of these effects.
    iii. There was evidence for increased quantitative susceptibility
following oral and dermal exposures in the developmental toxicity
studies in rats. Although developmental toxicity was observed at lower
doses than maternal toxicity in both studies in the rat, the concern is
low based on the following considerations:
    1. The toxicology database for assessing pre- and postnatal
susceptibility is complete;
    2. There are clear NOAELs and LOAELs for the developmental effects
observed via both the oral and dermal routes;
    3. The PODs used for assessing dietary and dermal exposure risks
are based on developmental and/or offspring toxicity;
    4. The portal-of-entry effects seen in the 26-day inhalation study
are protective of the developmental toxicity; and
    5. There are no residual uncertainties for pre- and/or postnatal
toxicity.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to sulfentrazone in drinking water. EPA used
similarly conservative assumptions to assess postapplication exposure
of children as well as incidental oral exposure of toddlers. These
assessments will not underestimate the exposure and risks posed by
sulfentrazone.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. Using the exposure assumptions discussed in this unit
for acute exposure, the acute dietary exposure from food and water to
sulfentrazone will occupy 6.7% of the aPAD for females 13-49 years old,
and 1.1% of the aPAD for all infants less than 1 year old, the
population group receiving the greatest exposure for all populations
other than females 13-49 years old.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
sulfentrazone from food and water will utilize 7.1% of the cPAD for
children 1-2 years old, the population group receiving the greatest
exposure. Based on the explanation in Unit III.C.3., regarding
residential use patterns, chronic residential exposure to residues of
sulfentrazone is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). Sulfentrazone
is currently registered for uses that could result in short-term
residential exposure, and the Agency has determined that it is
appropriate to aggregate chronic exposure through food and water with
short-term residential exposures to sulfentrazone.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in an aggregate MOE of 480 for adults.
Because EPA's level of concern for sulfentrazone is a MOE of 100 or
below, this MOE is not of concern.
    4. Short- and intermediate-term risk. Combined short- and
intermediate-term aggregate exposures take into account short- and
intermediate-term residential exposures plus chronic exposure to food
and water (considered to be a background exposure level). Sulfentrazone
is currently registered for uses that could result in short- and
intermediate-term residential exposures, and the Agency has determined
that it is appropriate to aggregate chronic exposure through food and
water with short- and intermediate-term residential exposures to
sulfentrazone.
    Using the exposure assumptions described in this unit for combined
short- and intermediate-term exposures, EPA has concluded that the
combined short- and intermediate-term food, water, and residential
exposures result in an aggregate MOE of 260 for children 1-2 years old,
the population subgroup for children with the greatest exposure.
Because EPA's level of concern for sulfentrazone is a MOE of 100 or
below, this MOEs are not of concern.
    5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, chemical name is not expected to pose a cancer risk to humans.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to sulfentrazone residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology, gas chromatography (GC), is
available to enforce the tolerance expression. The method may be
requested from: Chief, Analytical Chemistry Branch, Environmental
Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone
number:<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.
    The Codex has not established a MRL for sulfentrazone.

C. Response to Comments

    EPA received one comment to the Notice of Filing that made a
general objection to the presence of any sulfentrazone residues on
apple or any other crop. The Agency understands the commenter's
concerns and recognizes that some individuals believe that pesticides
should be banned on agricultural crops. However, the existing legal
framework provided by section 408 of the FFDCA states that tolerances
may be set when persons seeking such tolerances or exemptions have
demonstrated that the pesticide meets the safety standard imposed by
that statute. This citizen's comment appears to be directed at the
underlying statute and not EPA's implementation of it; the citizen has
made no contention that EPA has acted in violation of the statutory
framework. The Agency has concluded after this assessment, that there
is a reasonable certainty that no harm will result from aggregate human
exposure to sulfentrazone.

D. Revisions to Petitioned-For Tolerances

    EPA was petitioned to establish a tolerance in or on apple for
residues of sulfentrazone and its metabolite HMS; however, upon review
of the data supporting the petition, the Agency has determined that the
apple tolerance should be established on the combined residues of the
free and conjugated forms of sulfentrazone, including its metabolites
HMS (N-(2,4-dichloro-5-(4-(difluoromethyl)-4,5-dihydro-3-hydroxymethyl-
5-oxo-1H-1,2,4-triazol-1-yl)phenyl)methanesulfonamide) and DMS (N-(2,4-
dichloro-5-(4-(difluoromethyl)-4,5-dihydro-5-oxo-1H-1,2,4-triazol-1-
yl)phenyl)methanesulfonamide, calculated as the stoichiometric
equivalent of sulfentrazone. EPA previously reviewed metabolism data
and determined that the residues of concern are the parent compound,
sulfentrazone, and the metabolites HMS and DMS (free and conjugated) in
all crops except soybean seed, where the residues of concern are
sulfentrazone and the metabolite HMS. Samples of raw agricultural and
processed commodities from the apple studies were analyzed for residues
of sulfentrazone and its metabolites DMS and HMS, and EPA is
establishing an apple tolerance based upon those analyses.

V. Conclusion

    Therefore, tolerances are established for residues of
sulfentrazone, (N-[2,4-dichloro-5-[4-(difluoromethyl)-4,5-dihydro-3-
methyl-5-oxo-1H-1,2,4-triazol-1-yl]phenyl]methanesulfonamide), and its
metabolites HMS (N-(2,4-dichloro-5-(4-(difluoromethyl)-4,5-dihydro-3-
hydroxymethyl-5-oxo-1H-1,2,4-triazol-1- yl)phenyl)methanesulfonamide
and DMS (N-(2,4-dichloro-5-(4-(difluoromethyl)-4,5-dihydro-5-oxo-1H-
1,2,4-triazol-1-yl)phenyl)methanesulfonamide, calculated as the
stoichiometric equivalent of sulfentrazone, in or on apple at 0.15 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this final rule has
been exempted from review under Executive Order 12866, this final rule
is not subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This final rule does not contain
any information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping requirements.

    Dated: September 4, 2014.
Lois Rossi,
Director, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.498, add alphabetically the following commodity to the
table in paragraph (a)(2) to read as follows:

Sec.  180.498  Sulfentrazone; tolerances for residues.

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

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Apple...................................................            0.15

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

* * * * *
[FR Doc. 2014-21807 Filed 9-11-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 99 (Wednesday, May 22, 2019)]
[Notices]
[Page 23554]
[FR Doc No: 2019-10693]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER19-1871-000]

Titus Power, LLC; Supplemental Notice That Initial Market-Based
Rate Filing Includes Request for Blanket Section 204 Authorization

    This is a supplemental notice in the above-referenced proceeding of
Titus Power, LLC's application for market-based rate authority, with an
accompanying rate tariff, noting that such application includes a
request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is June 5, 2019.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE, Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
eSubscription link on the website that enables subscribers to receive
email notification when a document is added to a subscribed docket(s).
For assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.

    Dated: May 16, 2019.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2019-10693 Filed 5-21-19; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 119 (Monday, June 22, 2015)]
[Notices]
[Pages 35681-35682]
[FR Doc No: 2015-15381]

=======================================================================
-----------------------------------------------------------------------

SECURITIES AND EXCHANGE COMMISSION

[ File No. 500-1]

 In the Matter of China Organic Fertilizer, Inc., Order of
Suspension of Trading

June 18, 2015.
    It appears to the Securities and Exchange Commission
(``Commission'') that there is a lack of current and accurate
information concerning the securities of China Organic Fertilizer, Inc.
(``CHOR'' \1\) (CIK No. 1081944), a revoked Nevada corporation whose
principal place of business is listed as Beijing, China because it is
delinquent in its periodic filings with the Commission, having not
filed any periodic reports since it filed a Form 10-Q for the period
ended March 31, 2011. As of June 10, 2015, CHOR's common stock was
quoted on OTC Link (previously ``Pink Sheets'') operated by OTC Markets
Group Inc. On May 12, 2014, the Commission's Division of Corporation
Finance sent a delinquency letter to CHOR at the address shown in its
then-most recent filing in the Commission's EDGAR system requesting
compliance with its periodic filing requirements, which CHOR failed to
receive because the letter was not deliverable as addressed. CHOR thus
failed to maintain a valid address on file with the Commission as
required by Commission rules (Rule 301 of Regulation S-T, 17 CFR
232.301 and Section 5.4 of EDGAR Filer Manual). To

date, CHOR has failed to cure its delinquencies.
---------------------------------------------------------------------------

    \1\ The short form of the issuer's name is also its ticker
symbol.
---------------------------------------------------------------------------

    The Commission is of the opinion that the public interest and the
protection of investors require a suspension of trading in the
securities of the above-listed company. Therefore, it is ordered,
pursuant to Section 12(k) of the Securities Exchange Act of 1934, that
trading in the securities of the above-listed company is suspended for
the period from 9:30 a.m. EDT on June 18, 2015, through 11:59 p.m. EDT
on July 1, 2015.

    By the Commission.
Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2015-15381 Filed 6-18-15; 4:15 pm]
BILLING CODE 8011-01-P


[Federal Register Volume 81, Number 89 (Monday, May 9, 2016)]
[Notices]
[Pages 28091-28092]
[FR Doc No: 2016-10898]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2016-0281]

Information Collection Request[s] to Office of Management and
Budget; OMB Control Number: 1625-new

AGENCY: Coast Guard, DHS.

ACTION: Sixty-day notice requesting comments.

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

SUMMARY: In compliance with the Paperwork Reduction Act of 1995, the
U.S. Coast Guard intends to submit an Information Collection Request
(ICR) to the Office of Management and Budget (OMB), Office of
Information and Regulatory Affairs (OIRA), requesting approval of a new
collection of information: 1625-new, Maritime Transportation System
Recovery Essential Elements of Information. Our ICR describes the
information we seek to collect from the public. Before submitting this
ICR to OIRA, the Coast Guard is inviting comments as described below.

DATES: Comments must reach the Coast Guard on or before July 8, 2016.

ADDRESSES: You may submit comments identified by Coast Guard docket
number [USCG-2016-0281] to the Coast Guard using the Federal
eRulemaking Portal at http://www.regulations.gov. See the ``Public
participation and request for comments'' portion of the SUPPLEMENTARY
INFORMATION section for further instructions on submitting comments.
    A copy of the ICR is available through the docket on the Internet
at http://www.regulations.gov. Additionally, copies are available from:
COMMANDANT (CG-612), ATTN: PAPERWORK REDUCTION ACT MANAGER, U.S. COAST
GUARD, 2703 MARTIN LUTHER KING JR. AVE. SE., STOP 7710, WASHINGTON, DC
20593-7710.

FOR FURTHER INFORMATION CONTACT: Contact Mr. Anthony Smith, Office of
Information Management, telephone<PHONE_NUMBER>, or fax<PHONE_NUMBER>,
for questions on these documents.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    This Notice relies on the authority of the Paperwork Reduction Act
of 1995; 44 U.S.C. Chapter 35, as amended. An ICR is an application to
OIRA seeking the approval, extension, or renewal of a Coast Guard
collection of information (Collection). The ICR contains information
describing the Collection's purpose, the Collection's likely burden on
the affected public, an explanation of the necessity of the Collection,
and other important information describing the Collection. There is one
ICR for each Collection.
    The Coast Guard invites comments on whether this ICR should be
granted based on the Collection being necessary for the proper
performance of

Departmental functions. In particular, the Coast Guard would appreciate
comments addressing: (1) The practical utility of the Collection; (2)
the accuracy of the estimated burden of the Collection; (3) ways to
enhance the quality, utility, and clarity of information subject to the
Collection; and (4) ways to minimize the burden of the Collection on
respondents, including the use of automated collection techniques or
other forms of information technology. In response to your comments, we
may revise this ICR or decide not to seek approval for the Collection.
We will consider all comments and material received during the comment
period.
    We encourage you to respond to this request by submitting comments
and related materials. Comments must contain the OMB Control Number of
the ICR and the docket number of this request, [USCG-2016-0281], and
must be received by July 8, 2016.

Submitting Comments

    We encourage you to submit comments through the Federal eRulemaking
Portal at http://www.regulations.gov. If your material cannot be
submitted using http://www.regulations.gov, contact the person in the
FOR FURTHER INFORMATION CONTACT section of this document for alternate
instructions. Documents mentioned in this notice, and all public
comments, are in our online docket at http://www.regulations.gov and
can be viewed by following that Web site's instructions. Additionally,
if you go to the online docket and sign up for email alerts, you will
be notified when comments are posted.
    We accept anonymous comments. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided. For more about privacy and the
docket, you may review a Privacy Act notice regarding the Federal
Docket Management System in the March 24, 2005, issue of the Federal
Register (70 FR 15086).

Information Collection Request

    Title: Maritime Transportation System Recovery Essential Elements
of Information.
    OMB Control Number: 1625-new.
    Summary: This information collection captures data on facilities,
vessels and shared transportation infrastructure prior to a port
disruption to be able to characterize the port in its normal fully
functioning condition.
    Need: 33 U.S.C. 1225, 46 U.S.C. 70103, and 50 U.S.C. 191 require
the U.S. Coast Guard to take action to prevent damage to, or the
destruction of, bridges, other structures, on or in navigable waters or
shore area adjacent; to minimize damage from and respond to a
transportation security incident; and to safeguard against destruction
of vessels, harbors, ports and waterfront facilities in the United
States and all territorial waters during a national emergency. To be
prepared to execute these responsibilities, the U.S. Coast Guard needs
to establish the normal fully functioning condition of a port prior to
a port disruption. Then, following a port disruption, the U.S. Coast
Guard may be able to compare the normal port condition to the disrupted
port condition, enabling the Marine Transportation System Recovery Unit
(MTSRU) to assist in prioritizing recovery efforts, and gauge the
effectiveness of the response.
    Forms: CG-11410, Marine Transportation System Recovery Essential
Elements of Information and CG-11410A, Marine Transportation System
Recovery Facility Status.
    Respondents: Owners or operators of U.S. waterfront facilities.
    Frequency: On occasion.
    Hour Burden Estimate: This is a new information collection. The
estimated burden is 2,250 hours a year.

    Authority: The Paperwork Reduction Act of 1995; 44 U.S.C.
Chapter 35, as amended.

    Dated: April 29, 2016.
Thomas P. Michelli,
U.S. Coast Guard, Deputy Chief Information Officer.
[FR Doc. 2016-10898 Filed 5-6-16; 8:45 am]
BILLING CODE 9110-04-P