[Federal Register Volume 80, Number 210 (Friday, October 30, 2015)]
[Rules and Regulations]
[Pages 66795-66801]
[FR Doc No: 2015-27788]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0607; FRL-9934-88]

Metaflumizone; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for the combined
residues of the insecticide metaflumizone in or on the raw agricultural
commodities citrus (crop group 10-10) at 0.04 parts per million (ppm);
pome fruit (crop group 11-10) at 0.04 ppm; stone fruit (crop group 12-
12) at 0.04 ppm; and tree nut (crop group 14-12) at 0.04 ppm. BASF
Corporation requested these tolerances under the Federal Food, Drug,
and Cosmetic Act (FFDCA).

DATES: This regulation is effective October 30, 2015. Objections and
requests for hearings must be received on or before December 29, 2015,
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-2014-0607, 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: Susan Lewis, 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), e.g., agricultural
workers; greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS code 112), e.g., cattle ranchers
and farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS code 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS code 32532), e.g.,
agricultural workers; commercial applicators; farmers; greenhouse,
nursery, and floriculture workers; residential users.

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

    You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Printing Office's e-CFR cite at http://www.ecfr.gov/cgi-bin/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-2014-0607 in the subject line on the first
page of your submission. All requests must be in writing, and must be
received by the Hearing Clerk on or before December 29, 2015. 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-2014-0607, 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. Background and Statutory Findings

    In the Federal Register of December 17, 2014 (79 FR 75107) (FRL-
9918-90), 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
#4F8286) by BASF Corporation, P.O. Box 13528, Research Triangle Park,
NC 27709. The petition requested that 40 CFR 180.657 be amended by
establishing a tolerance for the combined residues of the

insecticide metaflumizone (2-[2-(4-cyanophenyl)-1-[3-
(trifluoromethyl)phenyl]ethylidene]-N-[4-(trifluoromethoxy)phenyl]
hydrazinecarboxamide; E and Z isomers) and its metabolite 4-{2-oxo-2-
[3-(trifluoromethyl)phenyl]ethyl{time} -benzonitrile, in or on the raw
agricultural commodities citrus (crop group 10-10) at 0.04 ppm; pome
fruit (crop group 11-10) at 0.04 ppm; stone fruit (crop group 12-12) at
0.04 ppm; and tree nut (crop group 14-12) at 0.04 ppm. In addition,
that petition requested removal of the existing tolerances for
metaflumizone in or on fruit, citrus group 10 at 0.04 ppm and nut,
tree, group 14 at 0.04 ppm upon establishment of the petitioned-for
tolerances. That document included a summary of the petition prepared
by BASF Corporation, the registrant. There were no substantive comments
received in response to the notice of filing.

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), EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with FFDCA
section 408(b)(2), for a tolerance for metaflumizone, including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with establishing
the tolerance 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.
    Hematotoxicity (toxicity of the blood) was the primary toxic effect
of concern following subchronic or chronic oral exposures to
metaflumizone. Splenic extramedullary hematopoiesis, increased
hemosiderin, and anemia were the most common hematotoxic effects
reported after repeated oral dosing with metaflumizone. Chronic oral
(gavage) exposures to dogs resulted in slight decreases in mean
corpuscular hemoglobin concentration and total hemoglobin, leading to
increased plasma bilirubin, increased urinary urobilinogen, and
increased hemosiderin in the liver. In a chronic toxicity/
carcinogenicity study in mice, anemia was observed in the form of
increased hemosiderin in the spleen, increased mean absolute
reticulocyte count, decreased mean corpuscular volume, and mean
corpuscular hemoglobin.
    The postulated pesticidal mode of action of metaflumizone involves
inhibition of sodium channels in target insect species; however, in
mammals (rats), there were only clinical signs of neurotoxicity (i.e.,
piloerection and body temperature variations) with no neuropathology in
the presence of systemic toxicity (e.g., recumbency and poor general
state) following acute or repeated exposures. Similarly, several immune
system organs seem to be affected following metaflumizone
administration via the oral, dermal, and inhalation routes (e.g., the
presence of macrophages in the thymus, lymphocyte necrosis in the
mesenteric lymph nodes, and diffuse atrophy of the mandibular);
however, there was no evidence of any functional deficits at the
highest dose tested in a recently submitted and reviewed guideline
immunotoxicity study. Therefore, the clinical neurotoxicity signs and
the effects on the immune system organs following metaflumizone
administration are likely to be secondary to the hematotoxic effects.
    Metaflumizone induced an increased incidence of a missing
subclavian artery at a relatively high dose that also caused severe
maternal toxicity (e.g., late term abortions) in the developmental
toxicity study in rabbits. There was no evidence (quantitative or
qualitative) of increased susceptibility following in utero exposures
to rats or rabbit and following pre- and post natal exposures. There
was no evidence that metaflumizone is genotoxic and carcinogenicity
studies with mice and rabbits were negative.
    Specific information on the studies received and the nature of the
adverse effects caused by metaflumizone 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 entitled, ``Metaflumizone: Human
Health Risk Assessment in Support of Section 3 Registrations for
Application of Metaflumizone to Pome Fruit (crop group (CG) 11-10) and
Stone Fruit (CG 12-12); Updating the CG Designation for Citrus to 10-10
and Tree Nuts to 14-12; and Permitting Aerial Application to Citrus
Fruits, Grapes, Tree Nuts, and Nurseries Containing Field-/Container-
Grown Nonbearing Stone and Pome Fruit Trees'' in docket ID number EPA-
HQ-OPP-2014-0607.

B. Toxicological Endpoints of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern (LOCs) 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 metaflumizone used for
human risk assessment is provided below:

    i. Acute Dietary Endpoint (General population including infants and
children). An acute dietary endpoint was not established for this
population group since an endpoint of concern (effect) attributable to
a single dose was not identified in the database. Studies considered
for this endpoint included the acute neurotoxicity study for which a
LOAEL was not observed.
    ii. Acute Dietary Endpoint (Females 13-49 years old). This endpoint
was established based on a developmental effect observed in the rabbit
developmental toxicity study that can be potentially due to a single
dose of metaflumizone. This effect consisted of an increased incidence
of an absent subclavian artery in the offspring at the LOAEL of 300
milligram/kilogram (mg/kg) body weight/day (bw/day) metaflumizone
(NOAEL = 100 mg/kg bw/day). The rat developmental toxicity study was
also considered for this endpoint; however, no developmental effects
were observed in this study at the highest dose tested of 120 mg/kg bw/
day metaflumizone. A combined uncertainty factor (UF) of 300 was
applied to account for interspecies (10x) and intraspecies (10x)
extrapolation. A Food Quality Protection Act (FQPA) safety factor (SF)
of 3x was retained because the rabbit developmental toxicity study was
performed via oral gavage dosing. In an absorption study submitted by
the petitioner, dietary exposures (which are more relevant for human
exposures) exhibited an approximately 2-fold greater absorption into
the systemic circulation than oral gavage dosing and, thus, can
potentially lead to toxicity at 2-fold lower levels of exposure. Thus,
aPAD for females 13-49 years old is estimated to be 0.33 mg/kg bw/day.
    iii. Chronic Dietary Endpoint. This endpoint was established based
on results of a chronic toxicity study with dogs via capsule
administration. The effects at the LOAEL of 30 mg/kg bw/day (NOAEL = 12
mg/kg bw/day), consisted of reduced general health condition, slight to
severe ataxia, recumbency, and severe salivation, decreases in mean
cell hemoglobin concentration (MCHC) and total hemoglobin (Hb) and
increased bilirubin, increased urobilinogen, and increased hemosiderin
in the liver. A combined UF of 300 was applied to account for
interspecies (10x) and intraspecies (10x) extrapolation and an FQPA SF
of 3x was retained for the higher absorption observed in dietary
exposures to metaflumizone (see above). Thus, the chronic population
adjusted dose (cPAD) is estimated to be 0.040 mg/kg bw/day.
    iv. Incidental Oral (Short- and Intermediate-Term). This endpoint
was selected on the basis of the maternal effects observed in the rat
two-generation reproductive toxicity study at the LOAEL of 50 mg/kg bw/
day metaflumizone (NOAEL = 20 mg/kg bw/day). Maternal toxicity
consisted of poor general health and body weight deficits which were
also associated with improper nursing behavior. Similar effects were
also noted in a developmental neurotoxicity study (gavage, range
finding) also considered for this endpoint. In this study, poor
maternal health was also observed at the LOAEL of 120 mg/kg bw/day
metaflumizone (NOAEL = 80 mg/kg bw/day). Both studies considered for
this endpoint achieved a clear maternal NOAEL for the offspring
effects, but the NOAEL of 20 mg/kg bw/day for the 2-generation
reproductive toxicity study is considered more protective. A combined
UF of 300 was applied to account for interspecies (10x) and
intraspecies (10x) extrapolation, and an FQPA SF of 3x to account for
the 2-fold greater absorption observed in dietary versus oral gavage
exposures (see above). The LOC is 300.
    v. Dermal (Short- and Intermediate-Term). This endpoint was based
on a rat 90-day dermal toxicity study in which deficits in body weight,
body-weight gain, and food consumption (in males and females);
anogenital smearing; increased macrophages in the thymus; lymphocyte
necrosis in the mesenteric lymph nodes; diffuse atrophy of the
mandibular lymph node; and increased hemosiderin in the liver (females
only) were observed at the LOAEL of 300 mg/kg bw/day (NOAEL = 100 mg/kg
bw/day). The LOC, for both occupational and residential exposure is
100, based on a combined UF of 100 for interspecies (10x) and in
intraspecies (10x) extrapolation. The FQPA SF is reduced to 1x for this
exposure scenario because there is no residual uncertainty concerning
potential effects on infants and children.
    vi. Inhalation (Short- and Intermediate-Term). There is a 28-day
inhalation study that is adequate for both exposure durations. There
was no NOAEL identified for female rats. At the LOAEL of 0.10
milligrams per Liter (mg/L) metaflumizone (NOAEL = 0.03 mg/L),
histopathology of the nasal tissues, lungs, thymus, prostate, and
adrenal cortex was observed in males. The LOAEL of 0.03 mg/L identified
in females resulted in lymphocyte necrosis in the mesenteric lymph
node.
    The methods and dosimetry equations described in EPA's reference
concentration (RfC) guidance (1994) are suited for calculating human-
equivalent concentrations (HECs) based on the inhalation toxicity point
of departure (NOAEL, LOAEL, or Benchmark Dose Lower Confidence Limit
(BMDL)) for use in MOE calculations. The regional-deposited-dose ratio
(RDDR), which accounts for the particulate diameter (mass median
aerodynamic diameter (MMAD) and geometric standard deviation ([sigma]g)
of aerosols), can be used to estimate the different dose fractions
deposited along the respiratory tract. The RDDR accounts for
interspecies differences in ventilation and respiratory-tract surface
areas. Thus, the RDDR can be used to adjust an observed inhalation
particulate exposure of an animal to the predicted inhalation exposure
for a human. For the subchronic inhalation toxicity study with
metaflumizone, an RDDR was estimated at 2.81 based on systemic effects
(lymphocyte necrosis in the mesenteric lymph node) in females at the
LOAEL of 0.03 mg/L (no NOAEL established), and a MMAD of 1.7 micrometer
([mu]m) and [sigma]g of 2.7.
    For this action with metaflumizone, residential and occupational
handler scenarios are being assessed. For residential handler
scenarios, 2-hr/day inhalation exposures are assumed. Adjustment to
shorter exposure scenarios relative to the animal toxicity study
duration (e.g., 2 hr. residential exposures) should only be made if
there is time-course information that would support a shorter time-
frame. Since there is no such information available for metaflumizone,
the unadjusted animal POD was used to assess the shorter duration
residential handler exposures. Thus, the HEC equals the LOAEL from the
study, and was calculated to be 0.084 mg/L. The FQPA SF of 10x is being
retained for lack of a NOAEL for females in the study. The standard
interspecies extrapolation UF can be reduced from 10x to 3x due to the
HEC calculation accounting for pharmacokinetic (not pharmacodynamic)
interspecies differences. The intraspecies UF remains at 10x.
Therefore, the LOC for this scenario is 300, which includes the FQPA SF
of 10x, interspecies (3x), and intraspecies (10x) extrapolation.

C. Exposure Assessment

    1. Dietary Exposure from Food and Feed Uses. Tolerances have been
established in (40 CFR 180.657) for the residues of metaflumizone, in
or on a variety of raw agricultural commodities. Risk assessments were
conducted by EPA to assess dietary exposures from metaflumizone 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 metaflumizone. In estimating acute dietary exposure, EPA used food
consumption information from the United States Department of
Agriculture (USDA) National Health and Nutrition Examination Survey,
What We Eat in America (NHANES/WWEIA). This dietary survey was
conducted from 2003 to 2008. As to residue levels in food, EPA assumed
tolerance-level residues. It was further assumed that 100% of crops
with the requested uses of metaflumizone were treated.
    ii. Chronic Exposure. In conducting the chronic dietary exposure
assessment, EPA used the food consumption data from the USDA NHANES/
WWEIA. As to residue levels in food, EPA assumed tolerance-level
residues. It was further assumed that 100% of crops with the requested
uses of metaflumizone were treated.
    iii. Cancer. EPA has concluded that metaflumizone 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 Percent Crop Treated (PCT) Information.
EPA did not use anticipated residue or PCT information in the dietary
assessment for metaflumizone. 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 metaflumizone in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of metaflumizone. 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 Screening Concentration in Ground Water (SCI-
GROW) models, the estimated drinking water concentrations (EDWCs) of
metaflumizone for acute exposures are estimated to be 1.03 parts per
billion (ppb) for surface water and 1.09 x 10-\12\ ppb for
ground water. The EDWCs of metaflumizone for chronic exposures for non-
cancer chronic assessments are estimated to be 0.487 ppb for surface
water and 1.09 x 10-\12\ 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 1.03 ppb was used to
assess the contribution of drinking water. For chronic dietary risk
assessment, the water concentration value of 0.487 ppb was used to
assess the contribution of 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). Metaflumizone is
currently registered for the following uses that could result in
residential exposures: As a fire ant bait for application to lawns,
landscapes, golf courses, and other non-cropland area; and as a fly
bait for use around industrial buildings, commercial facilities,
agricultural structures/premises, and recreational facilities/areas.
    EPA assessed residential exposure using the following assumptions:
Fire ant bait applications to home lawns are expected to result in
short-term, residential handler exposure to adults. Fire ant bait
applications to lawns and golf-courses are expected to result in short-
term, post-application dermal exposure to adults, children 11 to <16
years old, and children 1 to <2 years old, and incident oral exposure
for children 1 to <2 years old. For the fly bait product, residential
handler exposure is not expected, because the product is applied by
commercial handlers. The fly bait product is expected to result in
short-term, post-application dermal exposure to adults, children 11 to
<16 years old, and children 1 to <2 years old, and incident oral
exposure for children 1 to <2 years old.
    For residential handlers, dermal and inhalation exposures are
combined since the endpoints are similar for these routes. For children
(1- to <2-year-olds), post-application hand-to-mouth and dermal
exposures are combined. Since the LOCs for the dermal, inhalation and
incidental oral routes are not the same (dermal LOC = 100, inhalation
LOC = 300, and incidental oral LOC = 300), these routes were combined
using the aggregate risk index approach. 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.''
    Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to metaflumizone and any
other substances and metaflumizone does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action; therefore, EPA has not assumed that metaflumizone has
a common mechanism of toxicity with other substances. For information
regarding EPA's efforts to determine which chemicals have a common
mechanism of toxicity and to evaluate the cumulative effects of such
chemicals, see the policy statements released by EPA's Office of
Pesticide Programs concerning common mechanism determinations and
procedures for cumulating effects from substances found to have a
common mechanism on EPA's Web site at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply
an additional ten-fold margin of safety for infants and children in the
case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base on toxicity and exposure
unless EPA determines based on reliable data that a different margin of
safety will be safe for infants and children. Margins of safety are
incorporated into EPA risk assessments either directly through use of a
MOE analysis or through using uncertainty (safety) factors in
calculating a dose level that poses no appreciable risk to humans. In
applying this provision, EPA either retains the default value of 10X
when reliable data do not support the choice of a different factor, or,
if reliable data are available, EPA uses a different additional safety
factor value based on the use of traditional uncertainty factors and/or
special FQPA SFs, as appropriate.
    2. Prenatal and Postnatal Sensitivity. There is no evidence for
increased qualitative or quantitative sensitivity/susceptibility
resulting from pre- and/or postnatal exposures. In the rat prenatal
development toxicity study, there was no offspring toxicity reported at
any

dose tested whereas in the rabbit study a maltransformation based on an
absent subclavian artery was noted to occur only in the presence of
severe maternal toxicity. Similarly, offspring mortality in the 2-
generation reproductive toxicity occurred only in the presence of a
poor maternal health state. Thus, there is no evidence for increased
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 from 10x to 3x for all oral exposure scenarios;
retained at 10x for inhalation exposure scenarios; and reduced to 1x
for dermal exposures. That decision is based on the following findings:
    i. The toxicological database for metaflumizone is adequate for
risk assessment and FQPA SF evaluation. Several studies are available
for evaluating the safety of metaflumizone, although differences in
dose administration and a missing NOAEL warrant retention of various
FQPA safety factors in this instance.
    Dietary exposures exhibited an approximately 2-fold greater
absorption into the systemic circulation as compared to oral gavage
and, thus, can potentially lead to toxicity at 2-fold lower levels of
exposure. Applying an FQPA SF of 3x for all oral exposure scenarios is
adequate to protect against any greater toxicity that might occur in
dietary exposures (absorption was noted to be 2-fold greater in dietary
versus oral gavage studies).
    The FQPA SF of 10x is being retained for inhalation exposure
scenarios for the use of a LOAEL instead of a NOAEL (no NOAEL achieved)
for histopathological lesions consisting of lymphocyte necrosis in the
mesenteric lymph node. The FQPA SF of 10x is adequate because the
effect (lymphocyte necrosis) is considered minimal to slight and does
not exhibit a strong dose dependence.
    The FQPA SF for dermal exposure scenarios is being reduced from 10x
to 1x since there is a route-specific study with a clear NOAEL.
    ii. There is no indication that metaflumizone directly affects the
nervous system. Clinical signs indicative of neurotoxicity were
observed in several studies; however, these signs were generally
observed in the presence of poor animal health (e.g., reduced general
health condition, loss of body weight, or death). In addition, no
neuropathology was observed in any study with metaflumizone. There is
no need for a developmental neurotoxicity study or additional
uncertainty factors to account for neurotoxicity.
    iii. There are no residual concerns or uncertainties for increased
sensitivity/susceptibility in developing animals resulting from pre-
and/or postnatal exposure.
    iv. There are no residual uncertainties identified in the exposure
databases.

The dietary analyses assumed tolerance-level residues, 100 PCT, and
modeled drinking water estimates. EPA made conservative (protective)
assumptions in the ground and surface water modeling used to assess
exposure to metaflumizone in drinking water. EPA used similarly
conservative assumptions to assess post-application exposure of
children as well as incidental oral exposure of toddlers. These
assessments will not underestimate the exposure and risks posed by
metaflumizone.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
aPAD and cPAD. For linear cancer risks, EPA calculates the lifetime
probability of acquiring cancer given the estimated aggregate exposure.
Short-, intermediate-, and chronic-term risks are evaluated by
comparing the estimated aggregate food, water, and residential exposure
to the appropriate PODs to ensure that an adequate MOE exists. Based on
the proposed/registered uses and since inhalation, dermal, and
incidental oral exposures can be combined, aggregate acute (dietary),
short-term (dietary, incidental oral, and/or dermal), and chronic
(dietary) assessments were conducted.
    1. Acute Risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute aggregate exposure assessment
consists of exposure from only food and water. The acute dietary
exposure assessment for females 13-49 years old was 1.6% of the aPAD
and therefore, does not exceed EPA's LOC.
    2. Chronic Risk. Since there are no registered/proposed uses that
result in chronic residential exposure, the chronic aggregate exposure
assessment consists of exposure from only food and water. The chronic
dietary exposure estimate was <=7.2% the cPAD and therefore, does not
exceed EPA's LOC.
    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). Metaflumizone
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 metaflumizone. Since the LOC and
toxicological points of departure for the short-term dermal and oral
routes of exposure differ, the aggregate risk index method was used to
determine aggregate risk (aggregate risk indices >1 are not a risk of
concern).
    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 aggregate risk indices of 42 for
the general population, and 22 for children 1-2 years old. Because
EPA's LOC for metaflumizone is an aggregate risk index less than 1, the
aggregate risks 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). Metaflumizone is not currently registered for uses that could
result in intermediate-term residential exposure; however, since the
PODs for the short- and intermediate-term durations are the same for
metaflumizone, the short-term aggregate assessment is protective of
intermediate-term exposures.
    5. Aggregate Cancer Risk for U.S. Population. As discussed in Unit
III.A., EPA does not expect metaflumizone 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, and to infants and children from aggregate
exposure to metaflumizone residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    EPA previously reviewed method validation and independent
laboratory validation (ILV) studies for the BASF high-performance
liquid chromatography (HPLC)/mass spectrometry (MS)/MS analytical
method 531/0 and forwarded the method to FDA for tolerance enforcement
(46264221.der; D308394, T. Bloem, 30-Nov-2005; D328915, T. Bloem, 17-
May-2006). It is noted that following method validation, BASF
incorporated several minor modifications to method 531/0 with this
revised method specified as 531/1 (method 531/1 is the current
enforcement method). Based on the similarities of the proposed crops to
that currently registered and since the grape, citrus, and tree nut
residue samples

were analyzed using a method very similar to the current enforcement
method and since adequate validation data were submitted, EPA concludes
that the current enforcement method is suitable for enforcement of the
tolerances recommended herein. The limit of quantitation (LOQ) is 0.01
ppm for metaflumizone (E and Z isomers) and 0.018 ppm for M320I04
(expressed in parent equivalents).
    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.
    Codex MRLs are not established in/on the relevant crops for
metaflumizone; therefore, harmonization is not an issue for this
petition.

V. Conclusion

    Therefore, the tolerance is established for the combined residues
of the insecticide metaflumizone (2-[2-(4-cyanophenyl)-1-[3-
(trifluoromethyl)phenyl]ethylidene]-N-[4-(trifluoromethoxy)phenyl]
hydrazinecarboxamide; E and Z isomers), in or on the following raw
agricultural commodities: Fruit, citrus, group 10-10 at 0.04 ppm;
fruit, pome, group 11-10 at 0.04 ppm; fruit, stone, group 12-12 at 0.04
ppm; and nut, tree, group 14-12 at 0.04 ppm. The existing tolerances
for fruit, citrus, group 10 at 0.04 ppm and for nut, tree, group 14 at
0.04 ppm are removed because they are superseded by the tolerances
being established in this action.

VI. Statutory and Executive Order Reviews

    This action 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 action has been
exempted from review under Executive Order 12866, this action 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 action 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 tolerances 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 action 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 action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(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 (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: October 21, 2015.
G. Jeffrey Herndon,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. Section 180.657 is amended as follows:
0
a. Remove the entries for ``Fruit, citrus, group 10'' and ``Nut, tree,
group 14'' from the table in paragraph (a).
0
b. Add alphabetically the following list of commodities to the table in
paragraph (a).
    The additions read as follows:

Sec.  [emsp14]180.657  Metaflumizone; tolerances for residues.

    (a) * * *

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

                                * * * * *
Fruit, citrus, group 10-10.................................         0.04
Fruit, pome, group 11-10...................................         0.04
Fruit, stone, group 12-12..................................         0.04

                                * * * * *
Nut, tree, group 14-12.....................................         0.04

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

* * * * *
[FR Doc. 2015-27788 Filed 10-29-15; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: October 24, 2008 (Volume 73, Number 207)]
[Notices]
[Page 63465]
[DOCID:fr24oc08-60]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[P-13282-000]

Renaissance Ketchikan Group LLC; Notice of Application for
Preliminary Permit Accepted for Filing and Soliciting Comments, Motions
To Intervene, and Protests

October 17, 2008.
    On August 20, 2008, Renaissance Ketchikan Group (RKG) LLC filed an
application, pursuant to section 4(f) of the Federal Power Act (FPA),
to study the feasibility of RKG Hydroelectric Project. The proposed
project would be located on the Ward Cove, Ward Creek, and Connell Lake
in Ketchikan Borough, Alaska. RKG owns all of the lands to be occupied
by the proposed project and the majority of required infrastructure is
in place. No lands of the United States are within the proposed project
boundary.
    The proposed project would use: (1) The existing Connell Lake Dam,
(2) an existing penstock, (3) an existing building would be remodeled
to become the powerhouse, (4) a switchyard, and (5) appurtenant
facilities. The proposed project would have a total installed capacity
of 865 kilowatts and an average annual generation of 7.46 gigawatt-
hours of power, which RKG would initially utilize onsite and later sell
to Ketchikan Public Utility.
    Applicant Contact: Jerry Jenkins, Manager, 3695 S. Jojoba Way,
Chandler, AZ 85248,<PHONE_NUMBER>.
    FERC Contact: Jake Tung,<PHONE_NUMBER>.
    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance of this notice.
Comments, motions to intervene, notices of intent, and competing
applications may be filed electronically via the Internet. See 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
under the ``e-Filing'' link. If unable to be filed electronically,
documents may be paper-filed. To paper-file, an original and eight
copies should be mailed to: Kimberly D. Bose, Secretary, Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426. For
more information on how to submit these types of filings please go to
the Commission's Web site located at http://www.ferc.gov/filing-
comments.asp. More information about this project can be viewed or
printed on the ``eLibrary'' link of the Commission's Web site at http:/
/www.ferc.gov/docs-filing/elibrary.asp. Enter the docket number (P-
13282) in the docket number field to access the document. For
assistance, call toll-free 1-866-208-3372.

Kimberly D. Bose,
Secretary.
[FR Doc. E8-25339 Filed 10-23-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 201 (Thursday, October 19, 2023)]
[Notices]
[Pages 72083-72084]
[FR Doc No: 2023-23011]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-1005]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Focus Groups and
Interviews as Used by the Food and Drug Administration

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995 (PRA).

DATES: Submit written comments (including recommendations) on the
collection of information by November 20, 2023.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0497. Also include the FDA docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Focus Groups and Interviews as Used by the Food and Drug Administration

OMB Control No. 0910-0497--Extension

    FDA conducts focus groups and in-depth individual interviews on a
variety of topics involving FDA-regulated products, including drugs,
biologics, devices, food, tobacco products, and veterinary medicine.
    Focus groups are an important role in gathering information because
they allow for a better understanding of consumers' attitudes, beliefs,
motivations, and feelings than do quantitative studies and encourages
interaction between participants.
    Individual interviews allow for a more comprehensive, in-depth
information exchange where more insights are likely to be collected.
    Both focus groups and in-depth individual interviews serve the
narrowly defined need for direct and informal opinion on a specific
topic and, as a qualitative research tool, have three major purposes:
     To obtain consumer information that is useful for
developing variables and measures for quantitative studies,
     To better understand consumers' attitudes and emotions in
response to topics and concepts, and
     To further explore findings obtained from quantitative
studies.
    FDA will use findings to test and refine ideas but will generally
conduct further research before making important decisions, such as
adopting new policies and allocating or redirecting significant
resources to support these policies.
    Respondents to this collection of information will include members
of the general public, healthcare professionals, the industry, and
other stakeholders who are related to a product under FDA's
jurisdiction. Inclusion and exclusion criteria will vary depending on
the research topic.
    In the Federal Register of April 11, 2023 (88 FR 21680), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Three comments were received, two in support
of the information collection, and one that did not address the
elements of the PRA.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
                              Activity                                  Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Focus groups and individual in-depth interviews....................          12,000                1           12,000             1.75           21,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The estimated burden for the information collection reflects an
overall increase of 5,600 hours and a corresponding increase of 3,200
responses. We have added individual in-depth interviews as a method of
information gathering. In addition, we are consolidating ICR 0910-0677,
``Focus Groups About Drug Products as Used by the Food and Drug
Administration'' into this request for extension.

    Dated: October 13, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-23011 Filed 10-18-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 86, Number 153 (Thursday, August 12, 2021)]
[Notices]
[Pages 44382-44385]
[FR Doc No: 2021-17217]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2021-0002; Internal Agency Docket No. FEMA-B-2158]

Changes in Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency, Department of Homeland
Security.

ACTION: Notice.

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SUMMARY: This notice lists communities where the addition or
modification of Base Flood Elevations (BFEs), base flood depths,
Special Flood Hazard Area (SFHA) boundaries or zone designations, or
the regulatory floodway (hereinafter referred to as flood hazard
determinations), as shown on the Flood Insurance Rate Maps (FIRMs), and
where applicable, in the supporting Flood Insurance Study (FIS)
reports, prepared by the Federal Emergency Management Agency (FEMA) for
each community, is appropriate because of new scientific or technical
data. The FIRM, and where applicable, portions of the FIS report, have
been revised to reflect these flood hazard determinations through
issuance of a Letter of Map Revision (LOMR), in accordance with Federal
Regulations. The LOMR will be used by insurance agents and others to
calculate appropriate flood insurance premium rates for new buildings
and the contents of those buildings. For rating purposes, the currently
effective community number is shown in the table below and must be used
for all new policies and renewals.

DATES: These flood hazard determinations will be finalized on the dates
listed in the table below and revise the FIRM panels and FIS report in
effect prior to this determination for the listed communities.
    From the date of the second publication of notification of these
changes in a newspaper of local circulation, any person has 90 days in
which to request through the community that the Deputy Associate
Administrator for Insurance and Mitigation reconsider the changes. The
flood hazard determination information may be changed during the 90-day
period.

ADDRESSES: The affected communities are listed in the table below.
Revised flood hazard information for each community is available for
inspection at both the online location and the respective community map
repository address listed in the table below. Additionally, the current
effective FIRM and FIS report for each community are accessible online
through the FEMA Map Service Center at https://msc.fema.gov for
comparison.
    Submit comments and/or appeals to the Chief Executive Officer of
the community as listed in the table below.

FOR FURTHER INFORMATION CONTACT: Rick Sacbibit, Chief, Engineering
Services Branch, Federal Insurance and Mitigation Administration, FEMA,
400 C Street SW, Washington, DC 20472,<PHONE_NUMBER>, or (email)
<EMAIL_ADDRESS>or visit the FEMA Mapping and Insurance
eXchange (FMIX) online at https://www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION: The specific flood hazard determinations are
not described for each community in this notice. However, the online
location and local community map repository address where the flood
hazard determination information is available for inspection is
provided.
    Any request for reconsideration of flood hazard determinations must
be submitted to the Chief Executive Officer of the community as listed
in the table below.
    The modifications are made pursuant to section 201 of the Flood
Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance
with the National Flood Insurance Act of 1968, 42 U.S.C. 4001 et seq.,
and with 44 CFR part 65.
    The FIRM and FIS report are the basis of the floodplain management
measures that the community is required either to adopt or to show
evidence of having in effect in order to qualify or remain qualified
for participation in the National Flood Insurance Program (NFIP).
    These flood hazard determinations, together with the floodplain
management criteria required by 44 CFR 60.3, are the minimum that are
required. They should not be construed to mean that the community must
change any existing ordinances that are more stringent in their
floodplain management requirements. The community may at any time enact
stricter requirements of its own or pursuant to policies established by
other Federal, State, or regional entities. The flood hazard
determinations are in accordance with 44 CFR 65.4.
    The affected communities are listed in the following table. Flood
hazard determination information for each community is available for
inspection at both the online location and the respective community map
repository address listed in the table below.

Additionally, the current effective FIRM and FIS report for each
community are accessible online through the FEMA Map Service Center at
https://msc.fema.gov for comparison.

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

Michael M. Grimm,
Assistant Administrator for Risk Management, Department of Homeland
Security, Federal Emergency Management Agency.

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                     Location and  case     Chief executive  officer of                                  Online location of  letter of  map                           Community
         State and county                   No.                      community              Community map  repository                 revision                Date of  modification      No.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Alaska: Anchorage................  Municipality of        The Honorable Austin Quinn-     Municipality of Anchorage,     https://msc.fema.gov/portal/        Nov. 5, 2021..........       020005
                                    Anchorage (20-10-      Davidson, Mayor, Municipality   4700 South Bargaw Street,      advanceSearch.
                                    0848P).                of Anchorage, 632 West 6th      Anchorage, AK 99507.
                                                           Avenue, Suite 840, Anchorage,
                                                           AK 99501.
Arizona:
    Maricopa.....................  City of Surprise (21-  The Honorable Skip Hall,        Public Works Department,       https://msc.fema.gov/portal/        Nov. 5, 2021..........       040053
                                    09-0673P).             Mayor, City of Surprise,        Engineering Development        advanceSearch.
                                                           16000 North Civic Center        Services, 16000 North Civic
                                                           Plaza, Surprise, AZ 85374.      Center Plaza, Surprise, AZ
                                                                                85374.
    Pinal........................  Unincorporated Areas   The Honorable Stephen Q.        Pinal County, Engineering      https://msc.fema.gov/portal/        Oct. 22, 2021.........       040077
                                    of Pinal County (21-   Miller, Chairman, Board of      Division, 31 North Pinal       advanceSearch.
                                    09-0194P).             Supervisors, Pinal County,      Street Building F, Florence,
                                                           P.O. Box 827, Florence, AZ      AZ 85132.
                                                           85132.
California:
    Riverside....................  Unincorporated Areas   The Honorable Karen Spiegel,    Riverside County, Flood        https://msc.fema.gov/portal/        Nov. 26, 2021.........       060245
                                    of Riverside County    Chair, Board of Supervisors,    Control and Water              advanceSearch.
                                    (21-09-0016P).         Riverside County, 4080 Lemon    Conservation District, 1995
                                                           Street, 5th Floor, Riverside,   Market Street, Riverside, CA
                                                           CA 92502.                       92501.
    San Joaquin..................  City of Lathrop (20-   The Honorable Sonny Dhaliwal,   Community Development          https://msc.fema.gov/portal/        Nov. 18, 2021.........       060738
                                    09-0630P).             Mayor, City of Lathrop, 390     Department, Planning           advanceSearch.
                                                           Towne Centre Drive, Lathrop,    Division, 390 Towne Centre
                                                           CA 95330.                       Drive, Lathrop, CA 95330.
    Ventura......................  City of Simi Valley    The Honorable Keith L.          City Hall, 2929 Tapo Canyon    https://msc.fema.gov/portal/        Nov. 8, 2021..........       060421
                                    (21-09-0281P).         Mashburn, Mayor, City of Simi   Road, Simi Valley, CA 93063.   advanceSearch.
                                                           Valley, 2929 Tapo Canyon
                                                           Road, Simi Valley, CA 93063.
    Ventura......................  Unincorporated Areas   The Honorable Linda Parks,      Ventura County, Public Works   https://msc.fema.gov/portal/        Oct. 21, 2021.........       060413
                                    of Ventura County      Chair, Board of Supervisors,    Agency, 800 South Victoria     advanceSearch.
                                    (20-09-1626P).         Ventura County, 800 South       Avenue, Ventura, CA 93009.
                                                           Victoria Avenue, Ventura, CA
                                                           93009.
Colorado:........................  Unincorporated Areas   Mr. Mark Arndt, District 1      Morgan County, Planning and    https://msc.fema.gov/portal/        Oct. 22, 2021.........       080129
Morgan...........................   of Morgan County (21-  Commissioner, Morgan County,    Zoning Department, 218 West    advanceSearch.
                                    08-0019P).             P.O. Box 596, Fort Morgan, CO   Kiowa Avenue, Fort Morgan,
                                                           80701.                          CO 80701.
Idaho:
    Ada..........................  City of Eagle (20-10-  The Honorable Jason Pierce,     City Hall, 660 East Civic      https://msc.fema.gov/portal/        Oct. 14, 2021.........       160003
                                    1292P).                Mayor, City of Eagle, 660       Lane, Eagle, ID 83616.         advanceSearch.
                                                           East Civic Lane, Eagle, ID
                                                           83616.
    Ada..........................  City of Star (20-10-   The Honorable Trevor Chadwick,  City Hall, 10769 West State    https://msc.fema.gov/portal/        Oct. 14, 2021.........       160236
                                    1292P).                Mayor, City of Star, City       Street, Star, ID 83669.        advanceSearch.
                                                           Hall, 10769 West State
                                                           Street, Star, ID 83669.
    Ada..........................  Unincorporated Areas   Mr. Rod Beck, Chairman, Ada     Ada County, Courthouse, 200    https://msc.fema.gov/portal/        Oct. 14, 2021.........       160001
                                    of Ada County (20-10-  County, Board of                West Front Street, Boise, ID   advanceSearch.
                                    1292P).                Commissioners, 200 West Front   83702.
                                                           Street, Boise, ID 83702.
    Illinois: Will...............  Village of             The Honorable Mary Alexander-   Village Hall, 375 West         https://msc.fema.gov/portal/        Oct. 28, 2021.........       170812
                                    Bolingbrook (21-05-    Basta, Mayor, Village of        Briarcliff Road,               advanceSearch.
                                    0627P).                Bolingbrook, 375 West           Bolingbrook, IL 60440.
                                                           Briarcliff Road, Bolingbrook,
                                                           IL 60440.
Florida:

    Duval........................  City of Jacksonville   The Honorable Lenny Curry,      City Hall, 117 West Duval      https://msc.fema.gov/portal/        Oct. 14, 2021.........       120077
                                    (21-04-0683P).         Mayor, City of Jacksonville,    Street, Room 100,              advanceSearch.
                                                           City Hall at St. James          Jacksonville, FL 32202.
                                                           Building, 117 West Duval
                                                           Street, Suite 400,
                                                           Jacksonville, FL 32202.
    St. Johns....................  Unincorporated Areas   Mr. Jeremiah Ray Blocker,       St. Johns County,              https://msc.fema.gov/portal/        Nov. 29, 2021.........       125147
                                    of St. Johns County    Chair, St. Johns County,        Administration Building,       advanceSearch.
                                    (20-04-5575P).         Board of County                 4020 Lewis Speedway, St.
                                                           Commissioners, 500 San          Augustine, FL 32084.
                                                           Sebastian View, St.
                                                           Augustine, FL 32084.
    St. Johns....................  Unincorporated Areas   Mr. Jeremiah Ray Blocker,       St. Johns County,              https://msc.fema.gov/portal/        Oct. 14, 2021.........       125147
                                    of St. Johns County    Chair, St. Johns County,        Administration Building,       advanceSearch.
                                    (21-04-0683P).         Board of County                 4020 Lewis Speedway, St.
                                                           Commissioners, 500 San          Augustine, FL 32084.
                                                           Sebastian View, St.
                                                           Augustine, FL 32084.
Iowa: Story......................  City of Ames (21-07-   The Honorable John Haila,       City Hall, 515 Clark Avenue,   https://msc.fema.gov/portal/        Oct. 21, 2021.........       190254
                                    0024P).                Mayor, City of Ames, 515        Ames, IA 50010.                advanceSearch.
                                                           Clark Avenue, Ames, IA 50010.
Kansas: Shawnee..................  City of Topeka (21-07- The Honorable Michelle De La    Engineering Division, 620      https://msc.fema.gov/portal/        Oct. 12, 2021.........       205187
                                    0131P).                Isla, Mayor, City of Topeka,    Southeast Madison Street,      advanceSearch.
                                                           215 Southeast 7th Street,       Topeka, KS 66603.
                                                           Room 350, Topeka, KS 66603.
Michigan:
    Oakland......................  City of Farmington     The Honorable Vicki Barnett,    City Hall, 31555 Eleven Mile   https://msc.fema.gov/portal/        Oct. 22, 2021.........       260172
                                    Hills (20-05-4934P).   Mayor, City of Farmington       Road, Farmington Hills, MI     advanceSearch.
                                                           Hills, 31555 West Eleven Mile   48336.
                                                           Road, Farmington Hills, MI
                                                           48336.
    Oakland......................  City of Novi (20-05-   The Honorable Bob Gatt, Mayor,  Civic Center, 45175 Ten Mile   https://msc.fema.gov/portal/        Oct. 22, 2021.........       260175
                                    4934P).                City of Novi, Civic Center,     Road, Novi, MI 48375.          advanceSearch.
                                                           45175 Ten Mile Road, Novi, MI
                                                           48375.
    Wayne........................  Charter Township of    Mr. Andrew Linko, Supervisor,   Charter Township Offices,      https://msc.fema.gov/portal/        Nov. 18, 2021.........       260218
                                    Brownstown (21-05-     Charter Township of             21313 Telegraph Road,          advanceSearch.
                                    2424P).                Brownstown, Township Hall,      Brownstone, MI 48183.
                                                           21313 Telegraph Road,
                                                           Brownstown, MI 48183.
Minnesota:
    Marshall.....................  City of Oslo (21-05-   The Honorable Erika Martens,    City Hall, 107 3rd Avenue      https://msc.fema.gov/portal/        Nov. 5, 2021..........       270272
                                    2364P).                Mayor, City of Oslo, City       East, Oslo, MN 56744.          advanceSearch.
                                                           Hall, P.O. Box 187, Oslo, MN
                                                           56744.
    Marshall.....................  Unincorporated Areas   Mr. Rolland Miller,             Marshall County, Courthouse,   https://msc.fema.gov/portal/        Nov. 5, 2021..........       270638
                                    of Marshall County     Chairperson, Marshall County,   208 East Colvin Avenue,        advanceSearch.
                                    (21-05-2364P).         Board of Commissioners, 26817   Warren, MN 56762.
                                                           420th Avenue Northwest,
                                                           Warren, MN 56762.
Nevada:
    Clark........................  City of Henderson (21- The Honorable Debra March,      Public Works Department, 240   https://msc.fema.gov/portal/        Nov. 3, 2021..........       320005
                                    09-0246P).             Mayor, City of Henderson, 240   South Water Street,            advanceSearch.
                                                           South Water Street,             Henderson, NV 89015.
                                                           Henderson, NV 89015.
    Clark........................  Unincorporated Areas   The Honorable Marilyn           Office of the Director of      https://msc.fema.gov/portal/        Nov. 3, 2021..........       320003
                                    of Clark County (21-   Kirkpatrick, Chair, Board of    Public Works, 500 South        advanceSearch.
                                    09-0246P).             Commissioners, Clark County,    Grand Central Parkway, 2nd
                                                           500 South Grand Central         Floor, Las Vegas, NV 89155.
                                                           Parkway, 6th Floor, Las
                                                           Vegas, NV 89155.
    Washoe.......................  Unincorporated Areas   The Honorable Bob Lucey,        Washoe County, Administration  https://msc.fema.gov/portal/        Nov. 10, 2021.........       320019
                                    of Washoe County (21-  Chairman, Board of              Building, Department of        advanceSearch.
                                    09-0392P).             Commissioners, Washoe County,   Public Works, 1001 East 9th
                                                           1001 East 9th Street, Reno,     Street, Reno, NV 89512.
                                                           NV 89512.

New Jersey: Passaic..............  Borough of Pompton     The Honorable Michael Serra,    Municipal Building, 25 Lenox   https://msc.fema.gov/portal/        Oct. 25, 2021.........       345528
                                    Lakes (21-02-0381P).   Mayor, Borough of Pompton       Avenue, Pompton Lakes, NJ      advanceSearch.
                                                           Lakes, 25 Lenox Avenue,         07442.
                                                           Pompton Lakes, NJ 07442.
Texas: Dallas....................  Town of Highland Park  The Honorable Margo Goodwin,    Engineering Department, 4700   https://msc.fema.gov/portal/        Nov. 22, 2021.........       480178
                                    (21-06-0509P).         Mayor, Town of Highland Park,   Drexel Drive, Highland Park,   advanceSearch.
                                                           4700 Drexel Drive, Highland     TX 75205.
                                                           Park, TX 75205.
Virginia: Albemarle..............  Unincorporated Areas   Mr. Jeff Richardson, Albemarle  Albemarle County, Department   https://msc.fema.gov/portal/        Nov. 5, 2021..........       510006
                                    of Albemarle County    County, Executive, 401          of Community Development,      advanceSearch.
                                    (21-03-0174P).         McIntire Road,                  401 McIntire Road,
                                                           Charlottesville, VA 22902.      Charlottesville, VA 22902.
Wisconsin: Crawford..............  City of Prairie du     The Honorable Dave Hemmer,      City Hall, 214 East Blackhawk  https://msc.fema.gov/portal/        Oct. 28, 2021.........       555573
                                    Chien (21-05-1223P).   Mayor, City of Prairie du       Avenue, Prairie du Chien, WI   advanceSearch.
                                                           Chien, 214 East Blackhawk       53821.
                                                           Avenue, Prairie du Chien, WI
                                                           53821.
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[FR Doc. 2021-17217 Filed 8-11-21; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register Volume 82, Number 59 (Wednesday, March 29, 2017)]
[Notices]
[Page 15522]
[FR Doc No: 2017-06158]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following electric
corporate filings:

    Docket Numbers: EC17-97-000.
    Applicants: HA Wind V LLC, Morgan Stanley Wind LLC.
    Description: Application for Approval Under Section 203 of the
Federal Power Act of Morgan Stanley Wind LLC, et al.
    Filed Date: 3/22/17.
    Accession Number: 20170322-5029.
    Comments Due: 5 p.m. ET 4/12/17.

    Take notice that the Commission received the following exempt
wholesale generator filings:

    Docket Numbers: EG17-82-000.
    Applicants: PPA Grand Johanna LLC.
    Description: Self-Certification of Exempt Wholesale Generator
Status of PPA Grand Johanna LLC.
    Filed Date: 3/21/17.
    Accession Number: 20170321-5213.
    Comments Due: 5 p.m. ET 4/11/17.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER15-1456-003; ER11-4634-002; ER17-436-001; ER17-
437-001; ER16-999-004; ER15-1457-003.
    Applicants: Beaver Falls, L.L.C., Greenleaf Energy Unit 1 LLC,
Hazleton Generation LLC, Marcus Hook Energy, L.P., Marcus Hook 50,
L.P., Syracuse, L.L.C.
    Description: Supplement to December 1, 2016 Notice of Change in
Status of Beaver Falls, L.L.C., et. al.
    Filed Date: 3/21/17.
    Accession Number: 20170321-5230.
    Comments Due: 5 p.m. ET 4/11/17.

    Docket Numbers: ER17-862-001.
    Applicants: Bethel Wind Farm LLC.
    Description: Tariff Amendment: Additional Amendment of Bethel Wind
Farm MBR Tariff to be effective 1/28/2017.
    Filed Date: 3/21/17.
    Accession Number: 20170321-5188.
    Comments Due: 5 p.m. ET 4/11/17.

    Docket Numbers: ER17-913-002.
    Applicants: Consolidated Edison Company of New York, Inc.
    Description: Tariff Amendment: Amendment #2 PASNY RY 1 filing to be
effective 2/1/2017.
    Filed Date: 3/22/17.
    Accession Number: 20170322-5069.
    Comments Due: 5 p.m. ET 4/12/17.

    Docket Numbers: ER17-1285-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Sec.  205(d) Rate Filing: 2017-03-22 Reorganization of
Attachment X Generator Interconnection Procedures to be effective 3/23/
2017.
    Filed Date: 3/22/17.
    Accession Number: 20170322-5141.
    Comments Due: 5 p.m. ET 4/12/17.

    Docket Numbers: ER17-1286-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Queue Position AB2-109,
Original Service Agreement No. 4654 to be effective 12/31/9998.
    Filed Date: 3/22/17.
    Accession Number: 20170322-5144.
    Comments Due: 5 p.m. ET 4/12/17.

    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: March 22, 2017.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2017-06158 Filed 3-28-17; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 136 (Monday, July 18, 2022)]
[Notices]
[Pages 42794-42795]
[FR Doc No: 2022-15224]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2019-0278]

Hours of Service of Drivers: Application for Exemption; Harris
Companies, Inc. (Harris)

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of final disposition; denial of exemption.

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

SUMMARY: FMCSA announces its decision to deny the Harris Companies,
Inc. (Harris) application for exemption from the electronic logging
device (ELD) rule for all its employees who are required to prepare
records of duty status (RODS). This includes elevator technicians,
electricians, other general laborers, and welders who operate
commercial motor vehicles (CMVs) in interstate commerce. FMCSA has
analyzed the exemption application and the public comments and
determined that the applicant has not demonstrated that it would likely
achieve a level of safety that is equivalent to, or greater than, the
level that would be achieved absent the requested exemption.

FOR FURTHER INFORMATION CONTACT: Mr. Richard Clemente, FMCSA Driver and
Carrier Operations Division: Telephone:<PHONE_NUMBER> or
[email protected]. If you have questions on viewing or submitting material
to the docket, contact Dockets Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Public Participation

Viewing Comments and Documents

    To view comments, as well as documents mentioned in this notice as
being available in the docket, go to www.regulations.gov and insert the
docket number, ``FMCSA-2020-0171 in the ``Keyword'' box and click
``Search.'' Next, click the ``Open Docket Folder'' button and choose
the document to review. If you do not have access to the internet, you
may view the docket online by visiting Dockets operations in Room W12-
140 on the ground floor of the DOT West Building, 1200 New Jersey
Avenue SE, Washington, DC 20590, between 9 a.m. and 5 p.m., e.t.,
Monday through Friday, except Federal holidays. To be sure someone is
there to help you, please call<PHONE_NUMBER> or<PHONE_NUMBER> before
visiting Dockets Operations.

II. Legal Basis

    FMCSA has authority under 49 U.S.C. 31136(e) and 31315 to grant
exemptions from certain Federal Motor Carrier Safety Regulations. FMCSA
must publish a notice of each exemption request in the Federal Register
(49 CFR 381.315(a)). The Agency must provide the public an opportunity
to inspect the information relevant to the application, including any
safety analyses that have been conducted. The Agency must also provide
an opportunity for public comment on the request.
    The Agency reviews safety analyses and public comments submitted
and determines whether granting the exemption would likely achieve a
level of safety equivalent to, or greater than, the level that would be
achieved by the current regulation (49 CFR 381.305). The Agency's
decision must be published in the Federal Register (49 CFR 381.315(b))
with the reasons for denying or granting the application and, if
granted, the name of the person or class of persons receiving the
exemption, and the regulatory provision from which the exemption is
granted. The notice must also specify the effective period (up to five
years) and explain the terms and conditions of the exemption. The
exemption may be renewed (49 CFR 381.300(b)).

III. Request for Exemption

    Harris, a family-owned and operated company comprised of an
elevator division and an electric division, applied for an exemption
from the use of ELDs required under 49 CFR 395.8. The exemption would
cover the company's 14 elevator technicians and electricians and seven
general laborers and welders who operate CMVs. The company currently
uses electronic devices to document hours of service (HOS). However,
given internet connectivity issues affecting operation of its ELDs,
Harris requested the exemption to allow it to resume the use of paper
RODS.

IV. Public Comments

    On December 13, 2019, FMCSA published notice of the Harris
application for exemption and requested public comment (84 FR 68287).
The Agency received three comments, two opposing and one supporting the
exemption request. The Commercial

Vehicle Safety Alliance (CVSA) opposed this exemption, describing it as
``both unjustified and impractical.'' The CVSA noted that, ``if
granted, this exemption would negatively impact safety and place an
excessive burden on the enforcement community. The Federal HOS
requirements exist to help prevent and manage driver fatigue.'' Mr.
Michael Millard also opposed the request, stating that ``[the] Harris
Companies application for an exception from ELDs is most likely based
on its small size and its thoughts on an added expense for installing
ELDs.'' In response to an opposing commenter, Harris filed a comment in
favor of its own application. Harris' comment
    emphasized the inability of its current ELDs to operate properly in
rural areas with little to no internet connection.

V. Method To Ensure an Equivalent or Greater Level of Safety

    To ensure an equivalent level of safety, Harris offered company
safety policies and procedures. Harris referenced several ongoing
company training programs to ensure compliance with the various Federal
Motor Carrier Safety Regulations. These training programs include
general safety and compliance policies, vehicle operating policies, HOS
training and compliance, drug and alcohol testing procedures, and risk
management services. In addition, Harris offered the continuous use of
paper RODS for recording and tracking their drivers' HOS compliance.

VI. FMCSA Response and Decision

    FMCSA has evaluated the Harris application for exemption and the
public comments submitted. When the Agency adopted the ELD rule in
2015, as mandated by Congress, it determined that ELDs would improve
CMV safety and reduce the overall paperwork burden for both motor
carriers and drivers. ELDs have led to improved compliance with the
applicable HOS rules. Harris has failed to provide a sufficient
analysis of the safety impacts of the requested exemption or adequate
countermeasures to ensure that the exemption would likely achieve a
level of safety equivalent to, or greater than, the level that would be
achieved by the current regulations. For these reasons, FMCSA denies
the request for exemption.

Robin Hutcheson,
Deputy Administrator.
[FR Doc. 2022-15224 Filed 7-15-22; 8:45 am]
BILLING CODE 4910-EX-P