[Federal Register Volume 80, Number 151 (Thursday, August 6, 2015)]
[Rules and Regulations]
[Pages 46816-46822]
[FR Doc No: 2015-18825]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0441; FRL-9930-99]

Fluazifop-P-Butyl; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation amends a tolerance for residues of fluazifop-
P-butyl in or on sweet potato, roots. Syngenta Crop Protection
requested this tolerance under the Federal Food, Drug, and Cosmetic Act
(FFDCA).

DATES: This regulation is effective August 6, 2015. Objections and
requests for hearings must be received on or before October 5, 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-2014-0441, 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).
     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/Title40/40tab_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-2014-0441 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
October 5, 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-2014-0441, 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 September 5, 2014 (79 FR 53009) (FRL-
9914-98), 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
4F8262) by Syngenta Crop Protection, P.O. Box 18300, Greensboro, NC
27419-8300. The petition requested that 40 CFR 180.411 be amended by
amending the established tolerance for residues of the herbicide
fluazifop-P-butyl in or on sweet potato, roots from 0.05 parts per
million (ppm) to 1.5 ppm. That document referenced a summary of the
petition prepared by Syngenta, the registrant, which is available in
the docket, http://www.regulations.gov. No FFDCA-related comments were
received on 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), 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 fluazifop-P-butyl including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with fluazifop-P-
butyl 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.
    Fluazifop-P-butyl is the R enantiomer of fluazifop-butyl [(R,S)-2-
(4-((5-(trifluoromethyl)-2-pyridinyl)oxy)phenoxy)propanoic acid, butyl
ester]. The toxicology database for fluazifop-P-butyl consists of
studies conducted using fluazifop-butyl (racemic mixture) and its
enriched R-isomer, fluazifop-P-butyl. Comparison studies have shown
similar toxicities from both compounds. Metabolism studies have been
conducted in the rat with fluazifop-butyl, and absorption, excretion,
and confirmatory metabolism studies in the dog with fluazifop-butyl,
and hamster with fluazifop-P-butyl. Comparative metabolism studies in
the rat show that both fluazifop-P-butyl and fluazifop-butyl mixed
isomers are rapidly hydrolyzed to fluazifop acid and the [S] enantiomer
is rapidly converted to the [R] enantiomer in the blood, yielding
similar toxicities. In vivo, the S-isomer quickly converts to the R-
isomer.
    Oral dog and female rat studies show similar results, while male
rats show greater toxicity. Fluazifop-butyl is rapidly absorbed through
the gut after oral dosing and the ester linkage is hydrolyzed to
produce the fluazifop acid in the blood. No parent fluazifop-ester was
detected in plasma at any time. Male rats show similar fluazifop acid
excretion to the female, but excretion is slower, because fluazifop is
excreted in the bile and results in a higher percentage in the feces.
    The liver and kidney are its target organs expressed for the most
part as liver toxicity in the presence of peroxisome proliferation and
exacerbation of age-related kidney toxicity. These data are reasonably
consistent among the rat with fluazifop-butyl and fluazifop-P-butyl,
dog with fluazifop-butyl, and hamster with fluazifop-P-butyl.
Fluazifop-P-butyl shows similar toxicity by both the inhalation and
oral routes.
    Although the liver and kidney were the organs most consistently
affected, other findings were used as endpoints for selection of the
points of departure. A rat developmental study exhibiting diaphragmatic
hernia effects was used as the basis to select the acute dietary
endpoint for females 13-49 years of age. The short-term incidental oral
and children's dermal endpoints were selected based upon a maternal
body weight gain decrement exhibited in the developmental toxicity
studies performed on rats. The chronic dietary (all populations),
intermediate-term dermal and inhalation, as well as the intermediate-
term incidental oral endpoints, were selected from the 2-generation
reproduction study in rats. This study was significant in exhibiting
decreased testes and epididymal weights in males, along with decreased
uterine and pituitary weights in females. In regard to the short-term
dermal for adults and inhalation endpoints used in this assessment, the
developmental toxicity studies performed on rats were used as the basis
for endpoint selection. These studies were notable in exhibiting
decreased fetal weights, as well as hydroureter and delayed
ossification effects. An additional endpoint was chosen that was
specific for short-term dermal exposure to children, as a developmental
effect is generally protective of pregnant women and fetuses. In this
case, the maternal toxicity (body weight gain decrement) was chosen to
be protective of children.
    Indications of possible neurotoxicity were observed in the acute
neurotoxicity study, including clinical signs indicative of toxicity
(reduced activity, decreased rearing, hunched posture and/or
piloerection), decreased body temperature, and decreased motor activity
(total distance and number of rearings). No signs of neurotoxicity were
observed in the subchronic neurotoxicity test at doses up to 70 mg/kg/
day in males and 328 mg/kg/day in females. There was no observed
immunotoxicity resulting from fluazifop-P-butyl exposure in the
submitted study. There was no carcinogenicity observed in acceptable
studies in the rat with fluazifop-butyl or in the hamster for
fluazifop-P-butyl. The hamster was selected for cancer study, because
liver peroxisome proliferation more closely resembled what was found
for human liver cells. There was no mutagenicity observed for
fluazifop-butyl or fluazifop-P-butyl.

    In a dermal absorption and pharmacokinetic study in humans, most of
the applied dose appeared to be in the stratum corneum and easily
removed (the unrecovered test material was speculated to be in the
outer layers of the skin). Peak plasma levels were shown to occur 24 to
31 hours after application in these men. The one half-life for
excretion was about 18 hours. Specific information on the studies
received and the nature of the adverse effects caused by fluazifop-P-
butyl 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 document ``Fluazifop-P-
Butyl. Human-Health Risk Assessment for Sweet Potato Label Amendment
and Resulting Tolerance Increase.'' at pages 28-36 in docket ID number
EPA-HQ-OPP-2014-0441.

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 no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for fluazifop-P-butyl used
for human risk assessment is shown in Table 1 of this unit.

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                                    Point of departure
        Exposure/scenario            and  uncertainty/    RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
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Acute dietary (Females 13-49       NOAEL = 50 mg/kg/day  Acute RfD = 0.50 mg/ MRIDs: 00088857, 92067047,
 years of age).                    UFA = 10x...........   kg/day.              00088858, 92067048, Rat
                                   UFH = 10x...........                        developmental.
                                   FQPA SF = 1x........                       Developmental LOAEL = 200 mg/kg/
                                                                               day based on diaphragmatic
                                                                               hernia.
Acute dietary (General population  ....................  ...................  An appropriate endpoint for the
 including infants and children).                                              general population attributable
                                                                               to a single dose was not
                                                                               identified in the available
                                                                               studies.
Chronic dietary (All populations)  NOAEL = 0.74 mg/kg/   Chronic RfD = cPAD   MRIDs: 00088859, 92067050, Rat
                                    day.                  = 0.0074 mg/kg/day.  reproduction study; reproductive
                                   UFA = 10x...........                       LOAEL = 5.8 mg/kg/day based on
                                   UFH = 10x...........                        decreased testes and epididymal
                                   FQPA SF = 1x........                        weights.
Incidental oral short-term (1 to   NOAEL = 100 mg/kg/    Residential LOC for  MRIDs: 46082913, 46158401, Rat
 30 days).                          day.                  MOE = 100.           developmental study; maternal
                                   UFA = 10x...........                       LOAEL = 300 mg/kg/day based on
                                   UFH = 10x...........                        maternal body weight gain
                                   FQPA SF = 1x........                        decrement during GD 7-16.
Dermal short-term (1 to 30 days:   NOAEL = 100 mg/kg/    Residential LOC for  MRIDs: 46082913, 46158401, Rat
 Children).                         day.                  MOE = 100.           developmental study; maternal.
                                   DAF= 9% (low                               LOAEL = 300 mg/kg/day based on
                                    exposure) or 2%                            maternal body weight gain
                                    (high exposure)..                          decrement during GD 7-16.
                                   UFA = 10x...........
                                   UFH = 10x...........
                                   FQPA SF = 1x........
Dermal short-term (1 to 30 days:   NOAEL = 2.0 mg/kg/    Residential LOC for  MRIDs: 46082903, 46082013, Rat
 Adults).                           day.                  MOE = 100.           developmental study;
                                   DAF = 9% (low                               Developmental
                                    exposure) or 2%                           LOAEL = 5.0 mg/kg/day based on
                                    (high exposure)..                          fetal weight decrement,
                                   UFA = 10x...........                        hydroureter, and delayed
                                   UFH = 10x...........                        ossification.
                                   FQPA SF = 1x........
Inhalation short-term (1 to 30     Inhalation (or oral)  Residential LOC for  MRIDs: 46082903, 46082013, Rat
 days).                             study NOAEL = 2.0     MOE = 100.           developmental study;
                                    mg/kg/day                                  Developmental
                                    (inhalation                               LOAEL = 5.0 mg/kg/day based on
                                    absorption rate =                          fetal weight decrement,
                                    100%).                                     hydroureter, and delayed
                                   UFA = 10x...........                        ossification.
                                   UFH = 10x...........
                                   FQPA SF = 1x........
                                  ------------------------------------------------------------------------------

Cancer (Oral, dermal, inhalation)                     Not likely to be carcinogenic to humans.
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Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data
  and used to mark the beginning of extrapolation to determine risk associated with lower environmentally
  relevant human exposures. NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect
  level. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential
  variation in sensitivity among members of the human population (intraspecies). UFL = use of a LOAEL to
  extrapolate a NOAEL. UFS = use of a short-term study for long-term risk assessment. UFDB = to account for the
  absence of key data (i.e., lack of a critical study). FQPA SF = FQPA Safety Factor. PAD = population adjusted
  dose (a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC = level of concern. N/A =
  not applicable. DAF = dermal absorption factor.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to fluazifop-P-butyl, EPA considered exposure under the
petitioned-for tolerance as well as all existing fluazifop-P-butyl
tolerances in 40 CFR 180.411. EPA assessed dietary exposures from
fluazifop-P-butyl 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 fluazifop-P-butyl. In estimating acute dietary exposure, EPA used
food consumption information from the United States Department of
Agriculture (USDA) 2003-2008 National Health and Nutrition Survey/What
We Eat in America (NHANES/WWEIA) database. The acute dietary analysis
was conducted using 100% crop treated assumptions and tolerance-level
residues, adjusted as appropriate using factors from the metabolism
studies, to account for residues of concern not measured by the
analytical method.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment, EPA used the food consumption data from the USDA 2003-2008
NHANES/WWEIA database. As to residue levels in food, the chronic
dietary analysis was conducted assuming mean residue levels from crop
field trials with a ratio adjustment for additional metabolites of
concern, average percent crop treated estimates, and experimentally-
determined processing factors.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that fluazifop-P-butyl 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.
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and
information on the anticipated residue levels of pesticide residues in
food and the actual levels of pesticide residues that have been
measured in food. If EPA relies on such information, EPA must require
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after
the tolerance is established, modified, or left in effect,
demonstrating that the levels in food are not above the levels
anticipated. For the present action, EPA will issue such data call-ins
as are required by FFDCA section 408(b)(2)(E) and authorized under
FFDCA section 408(f)(1). Data will be required to be submitted no later
than 5 years from the date of issuance of these tolerances.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only if:
     Condition a: The data used are reliable and provide a
valid basis to show what percentage of the food derived from such crop
is likely to contain the pesticide residue.
     Condition b: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
     Condition c: Data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area. In addition, the
Agency must provide for periodic evaluation of any estimates used. To
provide for the periodic evaluation of the estimate of PCT as required
by FFDCA section 408(b)(2)(F), EPA may require registrants to submit
data on PCT.
    The Agency estimated the PCT for existing uses as follows: For the
acute dietary analysis, 100 PCT was assumed for all crops. The
following average percent crop treated estimates were used in the
chronic dietary risk assessments for the following crops that are
currently registered for fluazifop-P-butyl: Apricots, 2.5%; asparagus,
2.5%; carrots, 15%; cherries, 1%; cotton, 1%; dry beans/peas. 1%;
garlic, 10%; grapefruit, 15%; grapes, 2.5%; nectarines, 1%; onions,
10%; oranges, 2.5%; peaches, 2.5%; peanuts, 1%; pecans, 1%; peppers,
2.5%; plums, 2.5%; potatoes, 1%; prunes, 2.5%; soybeans, 2.5%; and
sugar beets, 1%; 100 PCT was assumed for sweet potatoes and all other
registered crops not listed above.
    To determine PCT values, EPA uses available data from United States
Department of Agriculture/National Agricultural Statistics Service
(USDA/NASS), proprietary market surveys, and the National Pesticide Use
Database for each chemical/crop combination from the most recent 6-7
years. EPA uses an average PCT for chronic dietary risk analysis. The
average PCT figure for each existing use is derived by combining
available public and private market survey data for that use, averaging
across all observations, and rounding to the nearest 5%, except for
those situations in which the average PCT is less than one. In those
cases, 1% is used as the average PCT and 2.5% is used as the maximum
PCT. EPA uses a maximum PCT for acute dietary risk analysis. The
maximum PCT figure is the highest observed maximum value reported
within the recent 6 years of available public and private market survey
data for the existing use and rounded up to the nearest multiple of 5%.
    The Agency believes that the three conditions discussed in Unit
III.C.1.iv. have been met. With respect to Condition a, PCT estimates
are derived from Federal and private market survey data, which are
reliable and have a valid basis. The Agency is reasonably certain that
the percentage of the food treated is not likely to be an
underestimation. As to Conditions b and c, regional consumption
information and consumption information for significant subpopulations
is taken into account

through EPA's computer-based model for evaluating the exposure of
significant subpopulations including several regional groups. Use of
this consumption information in EPA's risk assessment process ensures
that EPA's exposure estimate does not understate exposure for any
significant subpopulation group and allows the Agency to be reasonably
certain that no regional population is exposed to residue levels higher
than those estimated by the Agency. Other than the data available
through national food consumption surveys, EPA does not have available
reliable information on the regional consumption of food to which
fluazifop-P-butyl may be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for fluazifop-P-butyl in drinking water. These simulation
models take into account data on the physical, chemical, and fate/
transport characteristics of fluazifop-P-butyl. 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.
    Estimated drinking water concentrations (EDWCs) in ground water
were modeled using Tier I SCIGROW (version 2.3) and surface water EDWCs
were modeled using Tier II PRZM (Pesticide Root Zone Model) and EXAMS
(Exposure Analysis Modeling System). Modeled estimates of drinking
water concentrations were directly entered into the dietary exposure
model. For the acute dietary risk assessment, the surface water
concentration value of 33.4 ppb was used to assess the contribution
from drinking water. For the chronic dietary risk assessment, the
surface water concentration value of 6.6 ppb was used to assess the
contribution from 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).
    Fluazifop-P-butyl is currently registered for the following uses
that could result in residential exposures: Non-agricultural outdoor
buildings, building foundations, curbs, driveways, fencerows, non-
agricultural areas (wildlife refuge), non-crop areas, ornamentals
(lawns, flowering shrubs, flowering plants, gardens, ground covers,
plants, trees, turf, and woody shrubs), patios, pathways, rights-of-
way, sidewalks, and storage yards. EPA assessed residential exposure
using the following assumptions. For handlers, there is a potential for
short-term inhalation and dermal exposure. Residential handler exposure
scenarios include handwand, hose and sprayer, backpack, sprinkler can,
and RTU hose end sprayer.
    There is also the potential for short-term post-application
exposure for dermal exposure to all groups: Adult and child (1 to <2
years) turf-high contact; adult and youth (11-16 years) mowing; adult,
child (6 to <11 years) and youth (11-16 years) golfing; adult and child
(6 to <11 years) garden. Two separate dermal absorption values were
used: 9% is used for assessing dermal exposures while golfing or mowing
a lawn, since these are representative of low exposure activities
(i.e., the Agency assumes that 9% of dermal exposures will be
absorbed), whereas 2% is used for assessing dermal exposures from high-
contact lawn activities, since these are representative of high-
exposure activities (i.e., the Agency assumes that 2% of dermal
exposures will be absorbed). In addition, there is potential for short-
term post-application incidental oral exposure for children (1 to <2
years). Chemical-specific dislodgeable foliar residue (DFR) data are
available and were used for the residential post application exposure
assessment for gardens. Since Turf Transferable Residue (TTR) data are
not available for fluazifop-P-butyl, default TTR values were used for
the residential post application exposure assessment for turf. Given
the conservatisms associated with default TTR values and the potential
compounding nature of conservatisms in the turf assessment, EPA is able
to rely upon the calculated exposure estimates with confidence that
exposure is not being underestimated. 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
fluazifop-P-butyl to share a common mechanism of toxicity with any
other substances, and fluazifop-P-butyl does not appear to produce a
toxic metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that fluazifop-P-butyl
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 (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. No increased offspring
sensitivity over parent was seen in the rabbit pre-natal developmental
studies or the rat post-natal reproduction study, and no evidence of
neurotoxicity was observed. Several rat developmental toxicity studies
conducted on both fluazifop-butyl and fluazifop-P-butyl indicate fetal
effects (ranging from delayed ossification, fetal weight decrements,
increased incidence of small fetuses, cervical arches and centrum in
fetuses and litters at levels from 5 to 20 mg/kg/day to diaphragmatic
hernia at 200 mg/kg/day) in the absence of maternal toxicity.
    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 assessing potential prenatal and
postnatal toxicity of fluazifop-P-butyl to infants and children is
complete.
    ii. As there is limited indication of developmental neurotoxicity
resulting from exposure to fluazifop-P-butyl with the current data
sets, there is no need for a developmental neurotoxicity study. There
were no developmental or central nervous system malformations seen in
any of the developmental toxicity studies with rats or rabbits and

no evidence of neurotoxicity or neuropathology in adult animals in the
available studies. The toxicological significance of the marginal
increases in brain weights at high doses is unknown in the absence of
corroborative histopathological lesions. EPA therefore concludes that
there is not a concern for developmental neurotoxicity resulting from
exposure to fluazifop-butyl or fluazifop-P-butyl.
    iii. While there was quantitative evidence of increased
susceptibility in the fetuses of rats exposed in utero to fluazifop-
butyl and fluazifop-P-butyl, EPA concludes that there is no residual
uncertainty for prenatal or postnatal toxicity that would warrant an
additional 10X safety factor. The available studies clearly identify
well-defined NOAELs and LOAELs that are consistent across the five
developmental rat toxicity studies. In addition, the Agency has
selected, based on these studies, a developmental endpoint of concern
(diaphragmatic hernia) for assessing acute dietary risk. As this
endpoint is relevant to single exposures, the acute risk assessment
based on this endpoint will be protective of any fetal effects
resulting from a single exposure. Further, the Agency has selected,
based these studies, a developmental endpoint of concern (delayed
ossifications) for repeat exposure scenarios, which will be protective
of any developmental effects in those scenarios.
    iv. There are no residual uncertainties identified in the exposure
databases. There is an adequate toxicity database for fluazifop-P-butyl
and exposure data are complete. The dietary and residential assessments
are based on reliable data and will not underestimate exposure/risk.
EPA made conservative (protective) assumptions in the ground and
surface water modeling used to assess exposure to fluazifop-P-butyl in
drinking water. EPA used similarly conservative assumptions to assess
post application exposure of children as well as incidental oral
exposure of toddlers. Although EPA has required additional data on
transferable residues from treated turf for fluazifop-P-butyl, EPA is
confident that it has not underestimated turf exposure due to the
conservativeness of the default turf transfer value and conservative
assumptions in the short-term turf assessment procedures (e.g.,
assuming residues do not degrade over the thirty day assessment period
and assuming high-end activities on turf for every day of the
assessment period). The additional data on transferable turf residues
have been required in case refinement of exposure assessments is needed
in the future and to further EPA's general understanding of the
availability of turf transferable pesticide residues. These assessments
will not underestimate the exposure and risks posed by fluazifop-P-
butyl.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to fluazifop will occupy 14% of the aPAD for females 13-49 years old,
the only relevant population subgroup for the acute dietary endpoint.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
fluazifop-P-butyl from food and water will utilize 64% 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
fluazifop-P-butyl 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). Fluazifop-P-
butyl 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 Fluazifop-P-butyl.
    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 MOEs of 210 for adults
and 3100 for children. Because EPA's level of concern for fluazifop-P-
butyl is a MOE of 100 or below, these MOEs 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).
    An intermediate-term adverse effect was identified; however,
fluazifop-P-butyl is not registered for any use patterns that would
result in intermediate-term residential exposure. Intermediate-term
risk is assessed based on intermediate-term residential exposure plus
chronic dietary exposure. Because there is no intermediate-term
residential exposure and chronic dietary exposure has already been
assessed under the appropriately protective cPAD (which is at least as
protective as the POD used to assess intermediate-term risk), no
further assessment of intermediate-term risk is necessary, and EPA
relies on the chronic dietary risk assessment for evaluating
intermediate-term risk for fluazifop-P-butyl.
    5. Aggregate cancer risk for U.S. population. Fluazifop-P-butyl has
been classified as ``Not likely to be carcinogenic to humans'';
therefore, EPA concludes that fluazifop-P-butyl will not pose a cancer
risk.
    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 fluazifop-P-butyl residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (High Performance Liquid
Chromatography/Ultra-Violet Spectrometry (HPLC/UV)) is available to
enforce the tolerance expression. The method is available in Pesticide
Analytical Methods (PAM), Volume II: Method I for animal tissues and
milk and Method II for crops. The stated detection limits are 0.02-0.05
ppm for crops, 0.01 ppm for milk, and 0.02 ppm for animal tissues.
Improved enforcement methods based on liquid chromatography and tandem
mass spectroscopy, LC/MS/MS, are available as Method GRM044.01A and
Method GRM044.02A. Both of these methods have been validated at 0.01
ppm on a wide variety of crop matrices.

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 fluazifop-P-butyl.

V. Conclusion

    Therefore, the tolerance is amended for residues of fluazifop-P-
butyl in or on sweet potato, roots from 0.05 ppm to 1.5 ppm.

VI. Statutory and Executive Order Reviews

    This action amends 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 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 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 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: July 23, 2015.
Susan Lewis,
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. In Sec.  180.411, revise the commodity ``Sweet potato, roots'' in
the table in paragraph (a) to read as follows:

Sec.  180.411  Fluazifop-P-butyl; tolerances for residues.

    (a) * * *

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

                                * * * * *
Sweet potato, roots..........................................       1.5
------------------------------------------------------------------------

* * * * *
[FR Doc. 2015-18825 Filed 8-5-15; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 32 (Thursday, February 15, 2018)]
[Notices]
[Pages 6855-6856]
[FR Doc No: 2018-03130]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2016-E-2501 and FDA-2016-E-2502]

Determination of Regulatory Review Period for Purposes of Patent
Extension; ADDYI

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for ADDYI and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of an application to the
Director of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of a patent which claims that human drug
product.

DATES: Anyone with knowledge that any of the dates as published (in the
SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by April
16, 2018. Furthermore, any interested person may petition FDA for a
determination regarding whether the applicant for extension acted with
due diligence during the regulatory review period by August 14, 2018.
See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before April 16, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of April 16, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of April 16, 2018. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket Nos.
FDA-2016-E-2501 and FDA-2016-E-2502 for ``Determination of Regulatory
Review Period for Purposes of Patent Extension; ADDYI.'' Received
comments, those filed in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with Sec.  10.20 (21 CFR 10.20) and
other applicable disclosure law. For more information about FDA's
posting of comments to public dockets, see 80 FR 56469, September 18,
2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants

permission to market the drug product. Although only a portion of a
regulatory review period may count toward the actual amount of
extension that the Director of USPTO may award (for example, half the
testing phase must be subtracted as well as any time that may have
occurred before the patent was issued), FDA's determination of the
length of a regulatory review period for a human drug product will
include all of the testing phase and approval phase as specified in 35
U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product ADDYI
(flibanserin). ADDYI is indicated for the treatment of premenopausal
women with acquired, generalized hypoactive sexual desire disorder as
characterized by low sexual desire that causes a marked distress or
interpersonal difficulty and is NOT due to: (1) A co-existing medical
or psychiatric condition, (2) problems within the relationship, or (3)
the effects of a medication or other drug substance. Subsequent to this
approval, the USPTO received patent term restoration applications for
ADDYI (U.S. Patent Nos. 7,151,103 and 7,420,057) from Sprout
Pharmaceuticals, Inc., and the USPTO requested FDA's assistance in
determining the patents' eligibility for patent term restoration. In a
letter dated September 23, 2016, FDA advised the USPTO that this human
drug product had undergone a regulatory review period and that the
approval of ADDYI represented the first permitted commercial marketing
or use of the product. Thereafter, the USPTO requested that FDA
determine the product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
ADDYI is 6,852 days. Of this time, 4,730 days occurred during the
testing phase and 2,122 days occurred during the approval phase. These
periods of time were derived from the following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective:
November 15, 1996. FDA has verified Sprout Pharmaceuticals, Inc. claims
that November 15, 1996, is the date the investigational new drug
application became effective.
    2. The date the application was initially submitted with respect to
the human drug product under section 505 of the FD&C Act: October 27,
2009. FDA has verified the applicant's claims that the new drug
application (NDA) for ADDYI (NDA 22-526) was initially submitted on
October 27, 2009.
    3. The date the application was approved: August 18, 2015. FDA has
verified the applicant's claims that NDA 22-526 was approved on August
18, 2015.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its applications for patent extension,
this applicant seeks 5 years of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: Must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: February 9, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-03130 Filed 2-14-18; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 99 (Thursday, May 22, 2014)]
[Notices]
[Page 29449]
[FR Doc No: C1-2014-09450]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2014-0002; Internal Agency Docket No. FEMA-B-1404]

Proposed Flood Hazard Determinations

Correction

    In notice document 2014-09450 beginning on page 23005 in the issue
of Friday, April 25, 2014 make the following correction:
    On page 23007, in the table, under the heading Davidson County,
Tennessee, and Incorporated Areas, in the Community Map Repository
Address column, the second entry should read ``City Hall, 698 Thompson
Lane, Berry Hill, TN 37204''.
[FR Doc. C1-2014-09450 Filed 5-21-14; 8:45 am]
BILLING CODE 1505-01-D


[Federal Register Volume 88, Number 70 (Wednesday, April 12, 2023)]
[Notices]
[Pages 22022-22023]
[FR Doc No: 2023-07669]

=======================================================================
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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following Complaints
and Compliance filings in EL Dockets:

    Docket Numbers: EL23-54-000.
    Applicants: Aurora Generation, LLC, et al. v. PJM Interconnection,
L.L.C.
    Description: Complaint of Aurora Generation, LLC, et al. v. PJM
Interconnection, L.L.C.
    Filed Date: 4/4/23.
    Accession Number: 20230404-5201.
    Comment Date: 5 p.m. ET 5/4/23

    Docket Numbers: EL23-55-000.
    Applicants: Coalition of PJM Capacity Resources v. PJM
Interconnection, L.L.C.
    Description: Complaint of Coalition of PJM Capacity Resources v.
PJM Interconnection, L.L.C.
    Filed Date: 4/4/23.
    Accession Number: 20230404-5249.
    Comment Date: 5 p.m. ET 5/4/23.

    Docket Numbers: EL23-56-000.
    Applicants: Talen Energy Marketing, LLC v. PJM Interconnection,
L.L.C.
    Description: Complaint of Talen Energy Marketing, LLC v. PJM
Interconnection, L.L.C.
    Filed Date: 4/5/23.
    Accession Number: 20230405-5177.
    Comment Date: 5 p.m. ET 5/5/23.

    Docket Numbers: EL23-57-000.
    Applicants: Lee County Generating Station, LLC v. PJM
Interconnection, L.L.C.
    Description: Complaint of Lee County Generating Station, LLC v. PJM
Interconnection, L.L.C.
    Filed Date: 4/5/23.
    Accession Number: 20230405-5179.
    Comment Date: 5 p.m. ET 5/5/23.

    Docket Numbers: EL23-58-000.
    Applicants: SunEnergy1, LLC v. PJM Interconnection, L.L.C.
    Description: Complaint of SunEnergy1, LLC v. PJM Interconnection,
L.L.C.
    Filed Date: 4/5/23.
    Accession Number: 20230405-5181.
    Comment Date: 5 p.m. ET 5/5/23.

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

    Docket Numbers: ER23-425-002.
    Applicants: PJM Interconnection, L.L.C.
    Description: Tariff Amendment: Amendment of Amended WMPA, SA No.
6062; Queue No. AG1-253 Docket No. ER23-425 to be effective 1/14/2023.
    Filed Date: 4/6/23.
    Accession Number: 20230406-5069.
    Comment Date: 5 p.m. ET 4/27/23.

    Docket Numbers: ER23-1074-001.
    Applicants: Evergy Metro, Inc.
    Description: Tariff Amendment: Amendment Reflecting Transfer of
Ownership of Certain Interconnection Equipment to be effective 2/10/
2023.
    Filed Date: 4/6/23.
    Accession Number: 20230406-5098.
    Comment Date: 5 p.m. ET 4/27/23.

    Docket Numbers: ER23-1238-001.
    Applicants: ORNI 36 LLC.
    Description: Tariff Amendment: Amendment to be effective 3/4/2023.
    Filed Date: 4/6/23.
    Accession Number: 20230406-5169.
    Comment Date: 5 p.m. ET 4/27/23.

    Docket Numbers: ER23-1239-001.
    Applicants: USG Nevada LLC.
    Description: Tariff Amendment: Amendment to be effective 3/4/2023.
    Filed Date: 4/6/23.
    Accession Number: 20230406-5182.
    Comment Date: 5 p.m. ET 4/27/23.

    Docket Numbers: ER23-1578-000.
    Applicants: Liberty Utilities (Granite State Electric) Corp.
    Description: Sec.  205(d) Rate Filing: Borderline Sales Rate Sheet
Update Effective March 2023 w/Notice Waiver to be effective 3/1/2023.
    Filed Date: 4/6/23.
    Accession Number: 20230406-5017.
    Comment Date: 5 p.m. ET 4/27/23.

    Docket Numbers: ER23-1579-000.
    Applicants: Pacific Gas & Electric Company.
    Description: Notice of Termination of Service Agreement No. 10
under Pacific Gas and Electric Company's FERC Electric Tariff Volume
No. 4.
    Filed Date: 3/28/23.
    Accession Number: 20230328-5304.
    Comment Date: 5 p.m. ET 4/18/23.

    Docket Numbers: ER23-1580-000.
    Applicants: Midcontinent Independent System Operator, Inc.,
MidAmerican Energy Company.
    Description: Sec.  205(d) Rate Filing: Midcontinent Independent
System Operator, Inc. submits tariff filing per 35.13(a)(2)(iii: 2023-
04-06_SA 4032 MidAmerican-Lost Island Wind E&P (J1270) to be effective
3/21/2023.

    Filed Date: 4/6/23.
    Accession Number: 20230406-5031.
    Comment Date: 5 p.m. ET 4/27/23.

    Docket Numbers: ER23-1581-000.
    Applicants: ISO New England Inc., Eversource Energy Service Company
(as agent),Versant Power, New England Power Pool Participants
Committee.
    Description: Sec.  205(d) Rate Filing: ISO New England Inc. submits
tariff filing per 35.13(a)(2)(iii: ISO-NE/NEPOOL; Sunset CNRIS Timeout
Rules to be effective 6/5/2023.
    Filed Date: 4/6/23.
    Accession Number: 20230406-5039.
    Comment Date: 5 p.m. ET 4/27/23.

    Docket Numbers: ER23-1582-000.
    Applicants: Crooked Lake Solar, LLC.
    Description: Baseline eTariff Filing: Market-Based Rate Application
to be effective 6/6/2023.
    Filed Date: 4/6/23.
    Accession Number: 20230406-5066.
    Comment Date: 5 p.m. ET 4/27/23.

    Docket Numbers: ER23-1583-000.
    Applicants: Indiana Crossroads Wind Farm II LLC.
    Description: Baseline eTariff Filing: Market-Based Rate Application
to be effective 6/6/2023.
    Filed Date: 4/6/23.
    Accession Number: 20230406-5073.
    Comment Date: 5 p.m. ET 4/27/23.

    Docket Numbers: ER23-1584-000.
    Applicants: Pearl River Solar Park LLC.
    Description: Baseline eTariff Filing: Market-Based Rate Application
to be effective 6/6/2023.
    Filed Date: 4/6/23.
    Accession Number: 20230406-5079.
    Comment Date: 5 p.m. ET 4/27/23.

    Docket Numbers: ER23-1585-000.
    Applicants: Riverstart Solar Park III LLC.
    Description: Baseline eTariff Filing: Market-Based Rate Application
to be effective 6/6/2023.
    Filed Date: 4/6/23.
    Accession Number: 20230406-5080.
    Comment Date: 5 p.m. ET 4/27/23.

    Docket Numbers: ER23-1586-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Original NSA, Service
Agreement No. 6851; Queue No. AE1-020 to be effective 3/7/2023.
    Filed Date: 4/6/23.
    Accession Number: 20230406-5101.
    Comment Date: 5 p.m. ET 4/27/23.

    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by 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: April 6, 2023.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2023-07669 Filed 4-11-23; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 183 (Friday, September 22, 2023)]
[Notices]
[Pages 65388-65389]
[FR Doc No: 2023-20575]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2003-0004; FRL-11389-01-OCSPP]

Access to Confidential Business Information by Eastern Research
Group (ERG) and Its Subcontractors

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: EPA has authorized the following contractor and subcontractors
to access information which has been submitted to EPA under all
sections of the Toxic Substances Control Act (TSCA), some of which may
be claimed or determined to be confidential business information (CBI):
Eastern Research Group Inc. (ERG) of Lexington, MA/Chantilly, VA and
its subcontractors as listed in Unit III.

DATES: Access will occur no sooner than September 29, 2023.

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPPT-2003-0004, is available at
https://www.regulations.gov. Additional instructions on accessing the
docket, along with more information about dockets generally, is
available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT:
    For technical information contact: Colby Lintner, Program
Management and Operations Division (7407M), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number:
(202) 564-8182; email address: [email protected] or Adam Schwoerer;
telephone number:<PHONE_NUMBER>; email address:
[email protected].
    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. Does this action apply to me?

    This action is directed to the public in general. This action may,
however, be of interest to all who manufacture, process, or distribute
industrial chemicals. Because other entities may also be interested,
the Agency has not attempted to describe all the specific entities that
may be affected by this action.

II. What is the Agency's authority for taking this action?

    This notice is provided pursuant to section 14 of the Toxic
Substances Control Act (TSCA), 15 U.S.C. 2601 et seq., and EPA
implementing regulations in 40 CFR part 2.

III. What action is the Agency taking?

    Under EPA contract number 68HERC23D0006, Eastern Research Group
(ERG) and its subcontractors as identified in this unit will provide
support for Chemical Screening, Review, and Evaluation of New,
Existing, and Safer Choice Chemical Substances in accordance with the
Performance Work Statement which are vital to Agency personnel to make
informed decisions on environmental issues and other information that
maybe claimed as TSCA CBI in accordance with the TSCA Security Manual.
    In accordance with 40 CFR 2.306(j), EPA has determined that to
perform successfully the duties specified under EPA contract number
68HERC23D0006, the contractor and its subcontractors will require
access to information that may contain CBI submitted under all sections
of TSCA. As such, personnel of the contractor and its subcontractors
will be given access to information that may be claimed or determined
to be CBI information submitted to EPA under all sections of TSCA.
    EPA is issuing this notice to inform all submitters of information
under all sections of TSCA that EPA will provide the herein identified
contractor and its subcontractors with access to the CBI

materials on a need-to-know basis only. All access to TSCA CBI under
this contract will take place at EPA Headquarters, and/or at the
following facilities of the contractor and/or subcontractors:
     Eastern Research Group (ERG), located at 110 Hartwell
Ave., Lexington, MA 02421 and 14555 Avion Parkway, Suite 200,
Chantilly, VA;
     Avanti Corporation, located at 5695 King Centre Dr., #301,
Alexandria, VA 22315;
     Kathleen Wolf, located at 22319 43rd Dr. SE, Bothell, WA
98021;
     Lopez Environmental, located at 413 Patton Ave.,
Piscataway, NJ 08854;
     Northwest Green Chemistry/Institute for Safer Chemical
Alternatives, located at 121 Elmwood Road, Lunenburg, MA 01462-1464;
     Park Northwest Pollution Prevention Resource Center,
located at 13751 Lake City Way NE, Suite 305, Seattle, WA 98125;
     Research Triangle Institute, located at 3040 E Cornwallis
Road, RTP, NC 27709;
     Ross Strategic, located at 1325 4th Ave., Suite 1600,
Seattle, WA 98101;
     Rumley Solutions, Inc., DBA Hummingbird, located at 976
Brady Ave. NW, Suite 100, Atlanta, GA 30318;
     Syracuse Research Corporation, Inc. (SRC), located at 7502
Round Pond Rd., North Syracuse, NY 13212; and
     At the telework locations of the personnel of the
contractor and subcontractors in accordance with EPA's TSCA CBI
Protection Manual and the Rules of Behavior for Virtual Desktop Access
to OPPT Materials, including TSCA CBI.
    Access to TSCA data, including CBI, will continue until November
30, 2027. If the contract is extended, this access will also continue
for the duration of the extended contract without further notice.
    The personnel of the contractor and subcontractors will be required
to sign nondisclosure agreements and will be briefed on specific
security procedures for TSCA CBI.
    Authority: 15 U.S.C. 2601 et seq.

    Dated: September 18, 2023.
Pamela Myrick,
Director, Project Management and Operations Division, Office of
Pollution Prevention and Toxics.
[FR Doc. 2023-20575 Filed 9-21-23; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 79, Number 242 (Wednesday, December 17, 2014)]
[Rules and Regulations]
[Pages 75050-75054]
[FR Doc No: 2014-29589]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2014-0987]
RIN 1625-AA11

Regulated Navigation Area; Herbert C. Bonner Bridge, Oregon
Inlet, NC

AGENCY: Coast Guard, DHS.

ACTION: Interim final rule; and request for comments.

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SUMMARY: The Coast Guard is establishing a Regulated Navigation Area
(RNA) on the navigable waters of

Oregon Inlet, NC surrounding the Herbert C. Bonner Bridge. This RNA
will allow the Coast Guard to enforce vessel traffic restrictions
within the RNA when necessary to safeguard people and vessels from the
hazards associated with potential catastrophic structural damage that
could occur due to vessel allisions with the bridge.

DATES: This rule is effective without actual notice on December 17,
2014. For the purposes of enforcement, actual notice will be used from
November 25, 2014 until December 17, 2014.
    Comments and related material must be received by the Coast Guard
on or before February 17, 2015.
    Requests for public meetings must be received by the Coast Guard on
or before January 16, 2015.

ADDRESSES: Documents mentioned in this preamble are part of Docket
Number USCG-2014-0987. To view documents mentioned in this preamble as
being available in the docket, go to http://www.regulations.gov, type
the docket number in the ``SEARCH'' box and click ``SEARCH.'' Click on
``Open Docket Folder'' on the line associated with this rulemaking. You
may also visit the Docket Management Facility in Room W12-140 on the
ground floor of the Department of Transportation West Building, 1200
New Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    You may submit comments, identified by docket number, using any one
of the following methods:
    (1) Federal eRulemaking Portal: http://www.regulations.gov.
    (2) Fax:<PHONE_NUMBER>.
    (3) Mail or Delivery: Docket Management Facility (M-30), U.S.
Department of Transportation, West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue SE., Washington, DC 20590-0001. Deliveries
accepted between 9 a.m. and 5 p.m., Monday through Friday, except
federal holidays. The telephone number is<PHONE_NUMBER>.
    See the ``Public Participation and Request for Comments'' portion
of the SUPPLEMENTARY INFORMATION section below for further instructions
on submitting comments. To avoid duplication, please use only one of
these three methods.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email LT Derek Burrill, Waterways Management Division Chief,
U.S. Coast Guard Sector North Carolina, telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>If you have questions on viewing or
submitting material to the docket, call Cheryl Collins, Program
Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Acronyms

COTP Captain of the Port
DHS Department of Homeland Security
FR Federal Register
RNA Regulated Navigation Area

A. Public Participation and Request for Comments

    We encourage you to participate in this rulemaking by submitting
comments and related materials. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided.

1. Submitting Comments

    If you submit a comment, please include the docket number for this
rulemaking, indicate the specific section of this document to which
each comment applies, and provide a reason for each suggestion or
recommendation. You may submit your comments and material online at
http://www.regulations.gov, or by fax, mail, or hand delivery, but
please use only one of these means. If you submit a comment online, it
will be considered received by the Coast Guard when you successfully
transmit the comment. If you fax, hand deliver, or mail your comment,
it will be considered as having been received by the Coast Guard when
it is received at the Docket Management Facility. We recommend that you
include your name and a mailing address, an email address, or a
telephone number in the body of your document so that we can contact
you if we have questions regarding your submission.
    To submit your comment online, go to http://www.regulations.gov,
type the docket number in the ``SEARCH'' box and click ``SEARCH.''
Click on ``Submit a Comment'' on the line associated with this
rulemaking.
    If you submit your comments by mail or hand delivery, submit them
in an unbound format, no larger than 8\1/2\ by 11 inches, suitable for
copying and electronic filing. If you submit comments by mail and would
like to know that they reached the Facility, please enclose a stamped,
self-addressed postcard or envelope. We will consider all comments and
material received during the comment period and may change the rule
based on your comments.

2. Viewing Comments and Documents

    To view comments, as well as documents mentioned in this preamble
as being available in the docket, go to http://www.regulations.gov,
type the docket number in the ``SEARCH'' box and click ``SEARCH.''
Click on Open Docket Folder on the line associated with this
rulemaking. You may also visit the Docket Management Facility in Room
W12-140 on the ground floor of the Department of Transportation West
Building, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

3. Privacy Act

    Anyone can search the electronic form of comments received into any
of our dockets by the name of the individual submitting the comment (or
signing the comment, if submitted on behalf of an association,
business, labor union, etc.). You may review a Privacy Act notice
regarding our public dockets in the January 17, 2008, issue of the
Federal Register (73 FR 3316).

4. Public Meeting

    We do not now plan to hold a public meeting. But you may submit a
request for one on or before January 16, 2015, using one of the methods
specified under ADDRESSES. Please explain why you believe a public
meeting would be beneficial. If we determine that one would aid this
rulemaking, we will hold one at a time and place announced by a later
notice in the Federal Register.

B. Regulatory History and Information

    The Coast Guard is issuing this interim final rule without prior
notice and opportunity to comment pursuant to authority under section
4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.''
    Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause
exists for not publishing a notice of proposed rulemaking (NPRM) with
respect to this rule. Immediate action is necessary to protect the
maritime public who transit Oregon Inlet and motorists that use the
Herbert C. Bonner bridge. Vessel strikes to the Herbert C. Bonner
Bridge could cause catastrophic damage to the bridge makes immediate
action necessary to minimize the risk of potential loss of life, damage
to the bridge, and the impact on access to Hatteras Island.
Accordingly, waiting for a comment

period to run is impractical as it would expose the public to a longer
danger period.
    The particular facts about the Bonner Bridge and the waterway
require special vessel traffic control measures. A bridge strike by a
vessel could cause catastrophic damage to the bridge, impacting
motorists, mariners, local businesses and residents of Hatteras Island,
NC. The North Carolina Department of Transportation (NC DOT) indicates
that the Bonner Bridge has a very low sufficiency rating. Sufficiency
rating is an overall rating of a bridge's fitness for the duty that it
performs. In addition, recent hydrographic survey data reports indicate
shoaling is present in the vicinity of the navigation span. When such
shoaling is present, the Coast Guard has observed vessels attempting to
transit through alternate spans of the Herbert C. Bonner Bridge.
Transiting through alternate spans is hazardous as they are not
intended for navigation. The un-fendered or unprotected structural
components of the bridge among these spans are more vulnerable to
damage caused by a vessel strike, increasing the risk of consequent
catastrophic damage.
    For the same reasons as discussed about, under 5 U.S.C. 553(d)(3),
the Coast Guard finds that good cause exists for making this rule
effective less than 30 days after publication in the Federal Register.

C. Basis and Purpose

    This rulemaking is authorized by 33 U.S.C. 1231; 46 U.S.C. Chapter
701, 3306, 3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6,
160.5; Pub. L. 107-295, 116 Stat. 2064; and DHS Delegation No. 0170.1.
Under these authorities the Coast Guard may establish an RNA in defined
water areas that are determined to have hazardous conditions and in
which vessel traffic can be regulated in the interest of safety. The
purpose of this RNA is to reduce the risk of a bridge strike resulting
from a vessel transiting through alternative spans of the Herbert C.
Bonner Bridge, which are not intended for navigation. A bridge strike
to un-fendered or unprotected structural elements of the Bonner Bridge
would introduce a clear and present danger to stability of the bridge,
motorists, mariners, and indirect impacts on local businesses and
residents of Hatteras Island, NC.
    U.S. Army Corps of Engineers (USACE) hydrographic survey data
provide to the Coast Guard over the past two years indicates shoaling
to depths of less than 3 feet at mean low water within the approaches
to the Bonner Bridge on a frequently occurring basis. When shoaling is
present in the vicinity of the navigation span, vessels attempt to
transit through alternate spans. Transiting through alternate spans is
hazardous. Mariners transiting near and through the unprotected
structural components increase the potential of a bridge strike; these
spans do not have fenders or other mechanisms to protect the bridge
from vessel strikes. Vessels that transit alternate bridge spans risk
safe navigation as there are no advertised vertical and horizontal
clearances in these areas.
    The Coast Guard has also considered the North Carolina Department
of Transportation (NC DOT) recent biennial bridge inspection in
accordance with National Bridge Inspection Standards (NBIS) for the
Herbert C. Bonner Bridge. This report takes into account the
substructure and superstructure inspections along with analysis of the
maritime navigational and motor vehicle concerns. The report noted
weakened pile supports as a result of section loss and substructure
erosion to the point of showing exposed rebar. Information provided to
the Coast Guard by NC DOT indicates that the Herbert C. Bonner Bridge
has a very low sufficiency rating. Due to the dynamic nature of Oregon
Inlet waterway, frequent dredging and realignment of the approach
channel east of the bridge have become routine. Passage of hurricanes
and strong low pressure systems, i.e. Nor'easters exacerbate tidal
current and the seasonal fluctuations of the inlet's water depths.
Maintenance of adequate depth and adequate channel alignment is a
temporary measure that typically provides for safe vessel navigation
for a very limited time period for safe vessel navigation. Maintenance
dredging of the Federal Navigation Project is dependent on available
funding, marine weather dredging windows, and channel condition
surveys. Because many of these factors are uncontrollable, dredging
operations are not regularly scheduled maintenance activities.
    The Herbert C. Bonner Bridge is the only vehicular access to
Hatteras Island for residents, commercial vendors, and business owners
transiting from Nags Head-Bodie Island to Hatteras Island. The Bonner
Bridge is subject to heavy traffic volume, particularly during the
summer tourist season. Risks to the lives of mariners, vehicle motorist
and passengers, have been considered in the development of this
rulemaking.

D. Discussion of the Interim Rule

    To address the aforementioned hazards, this rule will establish
restrictions for the Oregon Inlet waterway by prohibiting vessels with
certain characteristics from transiting under or within 100 yards
either side of the Herbert C. Bonner Bridge. The Coast Guard invites
comments and will consider comments in development of a final
regulation. This RNA will be effective with actual notice for purposes
of enforcement on November 25, 2014. The restrictions for navigation
will be enforceable 24 hours a day as long as this RNA is in effect.
The Coast Guard will enforce the restriction, however, only when
necessary to protect people and vessels from hazards. As indicated
above, the Coast Guard expects to restrict marine traffic if there is
shoaling that impacts safe vessel transit through the navigation span,
or there is damage to the bridge that presents a hazard to people and
vessels.
    There are alternate routes for vessels bound for Oregon Inlet,
North Carolina and inland waterfront communities, including Wanchese,
NC. Those alternate routes include transiting through Beaufort Inlet or
Chesapeake Bay and the Atlantic Intracoastal Waterway and Sounds of
North Carolina. The distance from Oregon Inlet Lighted Whistle Buoy
``OI'' to Wanchese, North Carolina via Beaufort Inlet, the Atlantic
Intracoastal Waterway and Pamlico Sound is approximately 190 nautical
miles. The distance from Oregon Inlet Lighted Whistle Buoy ``OI'' to
Wanchese, North Carolina via Chesapeake Bay, the Atlantic Intracoastal
Waterway and Albemarle Sound is approximately 200 nautical miles.
    Whenever it is determined that a waterway restriction for Oregon
Inlet is necessary, the Coast Guard will provide the public with as
much advanced notice as possible of the closure dates and times. Such
notice will be readily provided via http://homeport.uscg.mil/, Local
Notice to Mariners, Broadcast Notice to Mariners, and other methods
described in 33 CFR 165.7.

E. Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on these statutes and executive orders.

1. Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, as
supplemented by Executive Order 13563, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under

section 6(a)(3) of Executive Order 12866 or under section 1 of
Executive Order 13563. The Office of Management and Budget has not
reviewed it under those Orders.
    This regulation will restrict access within the Regulated
Navigation Area at Oregon Inlet and the Herbert C. Bonner Bridge, the
effect of this rule will not be significant because: (i) The Coast
Guard will make extensive notifications of the regulated area to the
maritime public via maritime advisories so mariners can adjust their
plans accordingly; and (ii) vessels impacted by this regulation may
request permission from Commander Coast Guard Sector North Carolina/
COTP North Carolina to transit the regulated area on a case by case
basis.

2. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as
amended, requires federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The Coast Guard
certifies under 5 U.S.C. 605(b) that this rule will not have a
significant economic impact on a substantial number of small entities.
The regulation may have an economic impact on vessels that normally
transit Oregon Inlet. These small entities are primarily commercial and
recreational fishing vessels. Operation of vessels of certain
characteristics in this RNA will be prohibited from transiting Oregon
Inlet by the Captain of the Port (COTP) or designated representative
when shoaling in the vicinity of the Herbert C. Bonner Bridge creates
unsafe condition for vessels. The potential risk of loss of life,
damage to the bridge, and the impact on access to Hatteras Island
outweighs the benefits of permitting navigation in the vicinity or
under the Bonner Bridge.
    Although the Oregon Inlet area is used by many small entities,
including commercial and recreational fishing businesses, alternate
routes are available to vessels. The Coast Guard will make extensive
notifications of the regulated navigation area to the maritime public
via maritime advisories so mariners can adjust their plans accordingly;
and in extreme circumstances, vessels prohibited from entry may request
permission from Commander Coast Guard Sector North Carolina/COTP North
Carolina to transit the RNA on a case by case basis.

3. Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT,
above.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

4. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

5. Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and determined
that this rule does not have implications for federalism.

6. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

7. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

8. Taking of Private Property

    This rule will not cause a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

9. Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

10. Protection of Children From Environmental Health Risks

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

11. Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.

12. Energy Effects

    This action is not a ``significant energy action'' under Executive
Order 13211, Actions Concerning Regulations That Significantly Affect
Energy Supply, Distribution, or Use.

13. Technical Standards

    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

14. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA)(42 U.S.C. 4321-4370f), and have determined
that this action is one of a category of actions that do not
individually or cumulatively have a significant effect on the human
environment. This rule involves

establishment of a Regulated Navigation Area. This rule is
categorically excluded from further review under paragraph 34(g) of
Figure 2-1 of the Commandant Instruction. Preliminary environmental
analysis checklist supporting this determination and Categorical
Exclusion Determination are available in the docket where indicated
under ADDRESSES. We seek any comments or information that may lead to
the discovery of a significant environmental impact from this rule.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures and Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS.

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 33 U.S.C. 1231; 46 U.S.C. Chapter 701, 3306, 3703; 50
U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, 160.5; Pub. L. 107-
295, 116 Stat. 2064; Department of Homeland Security Delegation No.
0170.1.

0
2. Add Sec.  165.520 to read as follows:

Sec.  165.520  Regulated Navigation Area; Herbert C. Bonner Bridge,
Oregon Inlet, NC.

    (a) Regulated area. The following area is a Regulated Navigation
Area (RNA): All navigable waters of Oregon Inlet, North Carolina within
100 yards under or surrounding any portion of the Herbert C. Bonner
Bridge.
    (b) Definitions. As used in this section:
    (1) Captain of the Port means the Captain of the Port (COTP) North
Carolina.
    (2) Captain of the Port Representative means any Coast Guard
commissioned, warrant, or petty officer who has been authorized by the
Captain of the Port North Carolina to act as a designated
representative of the COTP.
    (3) Official patrol vessel means any Coast Guard, Coast Guard
Auxiliary, state, or local law enforcement vessel(s) assigned and
authorized by COTP North Carolina.
    (c) Regulations. (1) The general regulations governing Regulated
Navigation Areas found in 33 CFR 165.10, 165.11, and 165.13, including
the Regulated Navigation Area described in paragraph (a) of this
section and the following regulations, apply.
    (2) Operation of vessels of certain characteristics in this RNA
will be prohibited by the Captain of the Port (COTP) or designated
representative in order to safeguard people and vessels from the
hazards associated with shoaling and the Herbert C. Bonner Bridge from
the potential catastrophic structural damage that could occur from a
vessel bridge strike. The COTP or designated representative will
evaluate local marine environmental conditions prior to issuing
restrictions regarding vessel navigation. Factors that will be
considered include, but are not limited to: Hydrographic survey data,
vessel characteristics such as displacement, tonnage, length and draft,
current weather conditions including visibility, wind, sea state, and
tidal currents.
    (3) The Coast Guard will notify the public of restrictions via
Local Notice to Mariners, Broadcast Notice to Mariners, and via other
methods described in 33 CFR 165.7. Additionally, Coast Guard personnel
may be on-scene to advise the public of enforcement of any restrictions
on vessel navigation within the RNA.
    (4) In accordance with the general regulations, entry into,
anchoring, or movement within the RNA, during periods of enforcement,
is prohibited unless authorized by the Captain of the Port (COTP) or
the COTP's on-scene designated representative. The ``on-scene
designated representative'' of the COTP is any Coast Guard
commissioned, warrant or petty officer who has been designated by the
COTP to act on the COTP's behalf. The on-scene representative may be on
a Coast Guard vessel; State agency vessel, or other designated craft;
or may be on shore and will communicate with vessels via VHF-FM marine
band radio or loudhailer. Members of the Coast Guard Auxiliary may be
present to assist COTP representatives with notification of vessel
operators regarding the contents of this regulation.
    (5) Any deviation from paragraph (c)(4) of this section due to
extreme circumstances must be authorized by the Coast Guard District
Commander, the Captain of the Port (COTP) or the COTP's designated
representative. Vessels granted permission to transit the RNA must do
so in accordance with the directions provided by the COTP or COTP
representative to that vessel. To request permission to transit the
regulated navigation area, the COTP or COTP representative can be
contacted at Coast Guard Sector North Carolina, telephone number (910)
343-3880, or on VHF-FM marine band radio channel 13 (165.65MHz) or
channel 16 (156.8 MHz). During periods of enforcement, all persons and
vessels given permission to enter or transit within the RNA must comply
with the instructions of the COTP or designated representative. Upon
being hailed by an official patrol vessel by siren, radio, flashing-
light, or other means, the operator of a vessel must proceed as
directed.
    (d) Enforcement. The Coast Guard may be assisted in the patrol and
enforcement of the Regulated Navigation Area by other Federal, State,
and local agencies. The COTP may impose additional requirements within
the RNA due to unforeseen changes to shoaling of Oregon Inlet or
structural integrity of the Herbert C. Bonner Bridge.
    (e) Notification. The Coast Guard will rely on the methods
described in 33 CFR 165.7 to notify the public of the date, time and
duration of any closure of the RNA. Violations of this RNA may be
reported to the COTP at<PHONE_NUMBER> or on VHF-FM channel 16.

    Dated: November 25, 2014.
Stephen P. Metruck,
Rear Admiral, U.S. Coast Guard, Commander, Fifth Coast Guard District.
[FR Doc. 2014-29589 Filed 12-16-14; 8:45 am]
BILLING CODE 9110-04-P