[Federal Register Volume 88, Number 141 (Tuesday, July 25, 2023)]
[Rules and Regulations]
[Pages 47773-47778]
[FR Doc No: 2023-15679]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2021-0172; FRL-11166-01-OCSPP]

N-(n-Octyl)-2-pyrrolidone in Pesticide Formulations; Tolerance
Exemption

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of N-(n-octyl)-2-pyrrolidone (CAS Reg. No.
2687-94-7) when used as an inert ingredient (solvent) in pesticide
formulations containing prothioconazole as an active ingredient at a
maximum concentration of 15% by weight. International Specialty
Products submitted a petition to EPA under the Federal Food, Drug, and
Cosmetic Act (FFDCA), requesting the exemption. This regulation
eliminates the need to establish a maximum permissible level for
residues of N-(n-octyl)-2-pyrrolidone, when used in accordance with the
terms of the exemption.

DATES: This regulation is effective July 25, 2023. Objections and
requests for hearings must be received on or before September 25, 2023
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-2021-0172, 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 and 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: Charles Smith, Director, Registration
Division (7505T), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number:<PHONE_NUMBER>; email address:
[email protected].

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 40 CFR
part 180 through the Federal Register Office's e-CFR site at https://www.ecfr.gov/current/title-40/chapter-I/subchapter-E/part-180?toc=1.

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

    Under FFDCA section 408(g), 21 U.S.C. 346a(g), 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-2021-0172 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
September 25, 2023. 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-2021-0172, by one of
the following methods:
     Federal eRulemaking Portal: https://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 https://www.epa.gov/dockets/where-send-comments-epa-dockets#express.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Petition for Exemption

    In the Federal Register of March 22, 2021 (86 FR 15162, FRL-10021-
44), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C.
346a, announcing the filing of a pesticide petition (PP IN-11526) by
International Specialty Products, an Ashland Inc. Company, 1005 US 202/
206, Bridgewater, NJ 08807. The petition requested that 40 CFR 180.1130
be amended by establishing an exemption from the requirement of a
tolerance for residues of N-(n-octyl)-2-pyrrolidone (CAS Reg. No. 2687-
94-7) when used as an inert ingredient (solvent) in pesticide
formulations containing prothioconazole at a maximum concentration of
15%. That document referenced a summary of the petition prepared by the
petitioner, which is available in the docket, https://www.regulations.gov. There were no comments received in response to the
notice of filing.

III. Inert Ingredient Definition

    Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125 and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): solvents such as alcohols and
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty
acids; carriers such as clay and diatomaceous earth; thickeners such as
carrageenan and modified cellulose; wetting, spreading, and dispersing
agents; propellants in aerosol dispensers; microencapsulating agents;
and emulsifiers. The term ``inert'' is not intended to imply
nontoxicity; the ingredient may or may not be chemically active.
Generally, EPA has exempted inert ingredients from the requirement of a
tolerance based on the low toxicity of the individual inert
ingredients.

IV. Aggregate Risk Assessment and Determination of Safety

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for 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(c)(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. When making a safety determination for an
exemption for the requirement of a tolerance FFDCA section 408(c)(2)(B)
directs EPA to take into account the considerations in section
408(b)(2)(C) and (D). 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. . . .'' Section 408(b)(2)(D) lists other factors for EPA's
consideration in making safety determinations, e.g., the validity,
completeness, and reliability of available data, nature of toxic
effects, available information concerning the cumulative effects of the
pesticide chemical and other substances with a common mechanism of
toxicity, and available information concerning aggregate exposure
levels to the pesticide chemical and other related substances, among
other factors.
    EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be clearly demonstrated that the risks from
aggregate exposure to pesticide chemical residues under reasonably
foreseeable circumstances will pose no harm to human health. In order
to determine the risks from aggregate exposure to pesticide inert
ingredients, the Agency considers the toxicity of the inert in
conjunction with possible exposure to residues of the inert ingredient
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings. If EPA is able to
determine that a finite tolerance is not necessary to ensure that there
is a reasonable certainty that no harm will result from aggregate
exposure to the inert ingredient, an exemption from the requirement of
a tolerance may be established.
    Consistent with FFDCA section 408(c)(2)(A), and the factors
specified in FFDCA section 408(c)(2)(B), 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 N-(n-octyl)-2-pyrrolidone,
including exposure resulting from the exemption established by this
action. EPA's assessment of exposures and risks associated with N-(n-
octyl)-2-pyrrolidone follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their
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. Specific information on the studies received and the nature
of the adverse effects caused by N-(n-octyl)-2-pyrrolidone as well as
the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-
adverse-effect-level (LOAEL) from the toxicity studies are discussed in
this unit.
    N-(n-octyl)-2-pyrrolidone has low acute toxicity via the oral and
dermal routes. N-(n-octyl)-2-pyrrolidone is considered extremely
irritating to the eyes and skin and is a dermal sensitizer. No acute
inhalation study was available in the database for N-(n-octyl)-2-
pyrrolidone alone; however, a product containing N-(n-octyl)-2-
pyrrolidone and prothioconazole showed low concern for acute inhalation
toxicity.
    Clinical signs of neurotoxicity (e.g., increased salivation,
hunched posture, abnormal gait, and lethargy) are the most sensitive
and common effects observed throughout the database following repeated
dosing. These effects were observed in a 28-day study in rats, 13-week
study in dogs, and a developmental toxicity study in rats.
    No carcinogenicity studies were available in the database for N-(n-
octyl)-2-pyrrolidone. The Agency used a qualitative structure activity
relationship (SAR) database, DEREK11, to determine if there were
structural alerts for potential carcinogenicity for N-(n-octyl)-2-
pyrrolidone. No structural alerts for carcinogenicity were identified
for N-(n-octyl)-2-pyrrolidone. In the

absence of any structural alerts and lack of mutagenicity in available
mutagenicity and genotoxicity studies, N-(n-octyl)-2-pyrrolidone is not
expected to be carcinogenic. The is no evidence of offspring
susceptibility, reproduction toxicity, or teratogenicity in the
available developmental toxicity study in rats and the 1-generation
reproduction toxicity study in rats.
    No immunotoxicity or neurotoxicity studies were available in the
database for N-(n-octyl)-2-pyrrolidone. However, no evidence of
immunotoxicity was observed in the available database, and the selected
endpoints are protective of the neurotoxicity effects observed in the
database.

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 https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/overview-risk-assessment-pesticide-program.
    A summary of the toxicological endpoints for N-(n-octyl)-2-
pyrrolidone used for human risk assessment is shown in Table 1 of this
unit.

    Table 1--Summary of Toxicological Doses and Endpoints for N-(n-Octyl)-2-Pyrrolidone for Use in Human Risk
                                                   Assessment
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                                     Point of departure and
         Exposure/scenario             uncertainty/safety    RfD, PAD, LOC for risk    Study and toxicological
                                             factors               assessment                  effects
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Acute dietary (General population    An acute effect was not found in the database; therefore, an acute dietary
 including infants and children).     assessment is not necessary.
                                    ----------------------------------------------------------------------------
Chronic dietary (All populations)..  NOAEL= 90 mg/kg/day...  Chronic RfD = 90 mg/kg/ [13-week oral Toxicity-dog]
                                     UFA = 10 x............   day.                    LOAEL = 240 mg/kg/day
                                     UFH = 10 x............                           based on neurological
                                                                                effects.
                                     FQPA SF = 1 x.........  cPAD = 0.9 mg/kg/day..
Incidental oral short-term (1 to 30  NOAEL= 90 mg/kg/day...  LOC for MOE <100......  [13-week oral Toxicity-dog]
 days).                              UFA = 10 x............                           LOAEL = 240 mg/kg/day
                                     UFH = 10 x............                           based on neurological
                                     FQPA SF = 1 x.........                           effects.
Dermal short-term (1 to 30 days)     Dermal (or oral) study  LOC for MOE...........  [13-week oral Toxicity-dog]
 and Dermal intermediate-term (1 to   NOAEL = 90 mg/kg/day   <100..................   LOAEL = 240 mg/kg/day
 6 months).                           (dermal absorption                              based on neurological
                                      rate = 100%).                                   effects.
                                     UFA = 10 x............
                                     UFH = 10 x............
                                     FQPA SF = 1 x.........
Inhalation short-term (1 to 30       Inhalation (or oral)    LOC for MOE...........  [13-week oral Toxicity-dog]
 days) and intermediate-term (1 to    study NOAEL = 90 mg/   <100..................   LOAEL = 240 mg/kg/day
 6 months).                           kg/day (inhalation                              based on neurological
                                      absorption rate =                               effects.
                                      100%).
                                     UFA = 10 x............
                                     UFH = 10 x............
                                     FQPA SF = 1 x.........
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Cancer (Oral, dermal, inhalation)..  Based on the lack of mutagenicity in N-(n-octyl)-2-pyrrolidone and the
                                      absence of structural alerts in the DEREK analysis for N-(n-octyl)-2-
                                      pyrrolidone, there is low concern for carcinogenicity.
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FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
  members of the human population (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to N-(n-octyl)-2-pyrrolidone, EPA considered exposure under
the proposed exemption from the requirement of a tolerance and existing
food uses. Dietary exposure may also occur from non-pesticidal uses but
no reliable information is available for non-pesticidal exposures.
Therefore, EPA assessed dietary exposures from pesticidal uses of N-(n-
octyl)-2-pyrrolidone only. EPA assessed dietary exposures from N-(n-
octyl)-2-pyrrolidone 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 not
identified for N-(n-octyl)-2-pyrrolidone.

    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment using DEEM-FCID, Version 4.02, EPA used food consumption
information from USDA's 2005-2010 NHANES/WWEIA. As to residue levels in
food, no residue data were submitted for N-(n-octyl)-2-pyrrolidone. In
the absence of specific residue data, EPA has developed an approach
which uses surrogate information to derive upper bound exposure
estimates for the subject inert ingredient. Upper bound exposure
estimates are based on the highest tolerance for a given commodity from
a list of high use insecticides, herbicides, and fungicides. A complete
description of the general approach taken to assess inert ingredient
risks in the absence of residue data is contained in the memorandum
entitled ``Update to D361707: Dietary Exposure and Risk Assessments for
the Inerts.'' (12/21/2021), which can be found at http://www.regulations.gov in docket ID number EPA-HQ-OPP-2018-0090.
    In the dietary exposure assessment, the Agency assumed that the
residue level of the inert ingredient would be no higher than the
highest tolerance for a given commodity. Implicit in this assumption is
that there would be similar rates of degradation (if any) between the
active and inert ingredient and that the concentration of inert
ingredient in the scenarios leading to these highest levels of
tolerances would be no higher than the concentration of the active
ingredient. While the current request is for use of N-(n-octyl)-2-
pyrrolidone with the active ingredient prothioconazole at a limit of
15% in pesticide formulations, there are already existing food uses
with other active ingredients up to 20% in pesticide formulations. In
order to cover all possible exposure, the dietary exposure assessment
utilized the 20% limitation in pesticide formulations except for all
commodities except cotton, for which the assessment utilized a default
50% concentration.
    The Agency believes the assumptions used to estimate dietary
exposures lead to an extremely conservative assessment of dietary risk
due to a series of compounded conservatisms. First, assuming that the
level of residue for an inert ingredient is equal to the level of
residue for the active ingredient will overstate exposure. The
concentrations of active ingredient in agricultural products are
generally at least 50 percent of the product and often can be much
higher. Further, pesticide products rarely have a single inert
ingredient; rather there is generally a combination of different inert
ingredients used which additionally reduces the concentration of any
single inert ingredient in the pesticide product in relation to that of
the active ingredient.
    Second, the conservatism of this methodology is compounded by EPA's
decision to assume that, for each commodity, the active ingredient
which will serve as a guide to the potential level of inert ingredient
residues is the active ingredient with the highest tolerance level.
This assumption overstates residue values because it would be highly
unlikely, given the high number of inert ingredients, that a single
inert ingredient or class of ingredients would be present at the level
of the active ingredient in the highest tolerance for every commodity.
    Finally, a third compounding conservatism is EPA's assumption that
all foods contain the inert ingredient at the highest tolerance level.
In other words, EPA assumed 100 percent of all foods are treated with
the inert ingredient at the rate and manner necessary to produce the
highest residue legally possible for an active ingredient. In summary,
EPA chose a very conservative method for estimating what level of inert
residue could be on food, then used this methodology to choose the
highest possible residue that could be found on food and assumed that
all food contained this residue. No consideration was given to
potential degradation between harvest and consumption even though
monitoring data shows that tolerance level residues are typically one
to two orders of magnitude higher than actual residues in food when
distributed in commerce.
    Accordingly, although sufficient information to quantify actual
residue levels in food is not available, the compounding of these
conservative assumptions will lead to a significant exaggeration of
actual exposures. EPA does not believe that this approach
underestimates exposure in the absence of residue data.
    2. Dietary exposure from drinking water. For the purpose of the
screening level dietary risk assessment to support this request for an
exemption from the requirement of a tolerance for N-(n-octyl)-2-
pyrrolidone, a conservative drinking water concentration value of 100
parts per billion (ppb) based on screening level modeling was used to
assess the contribution to drinking water for the chronic dietary risk
assessments for N-(n-octyl)-2-pyrrolidone. These values were directly
entered into the dietary exposure model.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., textiles [clothing and diapers], carpets, swimming
pools, and hard surface disinfection on walls, floors, tables).
    N-(n-octyl)-2-pyrrolidone may be used as an inert ingredient in
pesticide products that are registered for specific uses that may
result in residential exposure (e.g., products used in and around the
home). Although there are non-pesticidal uses for N-(n-octyl)-2-
pyrrolidone, no reliable exposure information is available for those
uses. Therefore, a conservative residential exposure and risk
assessment was completed for uses of N-(n-octyl)-2-pyrrolidone as a
pesticide inert ingredient only. The Agency assessed pesticide products
containing N-(n-octyl)-2-pyrrolidone using exposure scenarios that
represent conservative residential handler exposure.
    Short-term and intermediate-term residential exposure for adults
combines high-end dermal and inhalation handler exposure from indoor
hard surface, aerosol sprays and results in a margin of exposure (MOE)
of 210. Short-term and intermediate-term high-end post-application
dermal exposure from contact with mopping/wiping results in an MOE of
520. Short-term residential exposure for children includes total
exposures associated with contact with indoor hard surface, aerosol
sprays result in an MOE of 250. Because EPA's level of concern (LOC)
for N-(n-octyl)-2-pyrrolidone is an MOE below 100, these MOEs are not
of concern.
    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 N-(n-octyl)-2-pyrrolidone to share a common
mechanism of toxicity with any other substances, and N-(n-octyl)-2-
pyrrolidone does not appear to produce a toxic metabolite produced by
other substances. For the purposes of this tolerance exemption,
therefore, EPA has assumed that N-(n-octyl)-2-pyrrolidone 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 website at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

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. 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.
    The Agency has concluded that the FQPA safety factor can be reduced
to 1x for N-(n-octyl)-2-pyrrolidone for all exposure scenarios for the
following reasons:
    i. The toxicity database for N-(n-octyl)-2-pyrrolidone consists of
a developmental toxicity study and 1-generation reproduction study.
There is no evidence of effects on reproductive parameters in the 1-
generation reproduction study, and the offspring effects observed in
the database occurred at the same or higher doses than parental
effects. Therefore, there is no evidence of increased susceptibility in
the database.
    ii. Additionally, the most sensitive endpoint selected, seen in the
13-week oral toxicity study on dogs, is protective of neurotoxic and
all other effects observed in the database.
    iii. There are no residual uncertainties identified in the exposure
databases. As described earlier, EPA used worst case assumptions for
the dietary food exposure assessment. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to N-(n-octyl)-2-pyrrolidone in drinking water. EPA
used similarly conservative assumptions to assess residential post
application exposure of children as well as incidental oral exposure of
children 1-2. These assessments will not underestimate the exposure and
risks posed by N-(n-octyl)-2-pyrrolidone.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified, and no acute dietary endpoint was selected. Therefore,
N-(n-octyl)-2-pyrrolidone is not expected to pose an acute risk.
    2. Chronic risk. A chronic aggregate risk assessment takes into
account chronic exposure estimates from dietary consumption of food and
drinking water. Using the exposure assumptions described in this unit
for chronic exposure, EPA has concluded that chronic exposure to N-(n-
octyl)-2-pyrrolidone from food and water will utilize 45.9% of the cPAD
for children 1-2 years old, the population group receiving the greatest
exposure.
    3. Short-term and intermediate-term risk. Short- and intermediate
term aggregate exposure takes into account short- and intermediate term
residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
    N-(n-octyl)-2-pyrrolidone is currently used as an inert ingredient
in pesticide products that are registered for uses that could result in
short- and intermediate term residential exposure, and the Agency has
determined that it is appropriate to aggregate chronic exposure through
food and water with short- and intermediate term residential exposures
to N-(n-octyl)-2-pyrrolidone.
    Using the exposure assumptions described in this unit for short-
and intermediate term exposures, EPA has concluded that the combined
short- and intermediate term food, water, and residential exposures
result in an aggregate MOE of 126 for adults. Adult residential
pesticide exposure combines high-end dermal and inhalation handler
exposure from indoor hard surface aerosol spray with high end post-
application dermal exposure from indoor mopping/wiping. EPA has
concluded that the combined short- and intermediate term food, water,
and residential exposures result in an aggregate MOE of 121 for
children. Children's residential pesticide exposure includes total
exposures associated with contact with treated indoor surfaces
(mopping/wiping; dermal and hand-to-mouth exposures). Because EPA's
level of concern for N-(n-octyl)-2-pyrrolidone is an MOE of 100 or
below, these MOEs are not of concern.
    4. Aggregate cancer risk for U.S. population. Based on the absence
of structural alerts for potential carcinogenicity in the database and
the lack of mutagenicity concerns, N-(n-octyl)-2-pyrrolidone is not
expected to pose a cancer risk to humans.
    5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children, from aggregate
exposure to N-(n-octyl)-2-pyrrolidone residues. More detailed
information on this action can be found in the document titled ``IN-
11526; N-(n-octyl)-2-pyrrolidone: Human Health Risk and Ecological
Effects Assessment of a Food Use Pesticide Inert Ingredient'' in docket
ID EPA-HQ-OPP-2021-0172.

V. Other Considerations

Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since
the Agency is not establishing a numerical tolerance for residues of N-
(n-octyl)-2-pyrrolidone in or on any food commodities. EPA is
establishing a limitation on the amount of N-(n-octyl)-2-pyrrolidone
that may be used in pesticide formulations. This limitation will be
enforced through the pesticide registration process under the Federal
Insecticide, Fungicide, and Rodenticide Act (``FIFRA''), 7 U.S.C. 136
et seq. EPA will not register any prothioconazole pesticide formulation
for food use that exceeds 15% N-(n-octyl)-2-pyrrolidone in the final
pesticide formulation.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is
established for residues of N-(n-octyl)-2-pyrrolidone (CAS Reg. No.
2687-94-7) when used as an inert ingredient (solvent) in pesticide
formulations containing prothioconazole at a maximum concentration of
15% under 40 CFR 180.1130.

VII. Statutory and Executive Order Reviews

    This action establishes an exemption from the requirement of 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 exemptions 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).

VIII. 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 19, 2023.
Charles Smith,

Director, Registration Division, Office of Pesticide Programs.
    Therefore, for the reasons stated in the preamble, the EPA amends
40 CFR chapter I as follows:

PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES
IN FOOD

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. Amend Sec.  180.1130 by adding paragraph (c) to read as follows:

Sec.  180.1130  N-(n-Octyl)-2-pyrrolidone and N-(n-dodecyl)-2-
pyrrolidone; exemptions from the requirement of a tolerance.

* * * * *
    (c) N-(n-Octyl)-2-pyrrolidone is exempt from the requirement of a
tolerance when used as a solvent in formulations containing
prothioconazole as an active ingredient at a concentration not to
exceed 15% by weight.

[FR Doc. 2023-15679 Filed 7-24-23; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 34 (Friday, February 20, 2015)]
[Notices]
[Page 9267]
[FR Doc No: 2015-03463]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9922-98-Region 6]

Underground Injection Control Program; Hazardous Waste Injection
Restrictions; Petition for Exemption Reissuance--Class I Hazardous
Waste Injection; Lucite International, Inc. Beaumont Site, Nederland,
TX

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of a final decision on a no migration petition
reissuance.

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SUMMARY: Notice is hereby given that a reissuance of an exemption to
the land disposal Restrictions, under the 1984 Hazardous and Solid
Waste Amendments to the Resource Conservation and Recovery Act, has
been granted to Lucite International, Inc. for two Class I hazardous
injection wells located at their Beaumont site located in Nederland,
TX. The company has adequately demonstrated to the satisfaction of the
Environmental Protection Agency by the petition reissuance application
and supporting documentation that, to a reasonable degree of certainty,
there will be no migration of hazardous constituents from the injection
zone for as long as the waste remains hazardous. This final decision
allows the continued underground injection by Lucite, of the specific
restricted hazardous wastes identified in this exemption reissuance,
into Class I hazardous waste injection wells WDW-100 & 101 until
December 31, 2030, unless EPA moves to terminate this exemption.
Additional conditions included in this final decision may be reviewed
by contacting the Region 6 Ground Water/UIC Section. A public notice
was issued December 18, 2014. The public comment period closed on
February 2, 2015. No comments were received. This decision constitutes
final Agency action and there is no Administrative appeal. This
decision may be reviewed/appealed in compliance with the Administrative
Procedure Act.

DATES: This action is effective as of February 5, 2015.

ADDRESSES: Copies of the petition reissuance and all pertinent
information relating thereto are on file at the following location:
Environmental Protection Agency, Region 6, Water Quality Protection
Division, Source Water Protection Branch (6WQ-S), 1445 Ross Avenue,
Dallas, Texas 75202-2733.

FOR FURTHER INFORMATION CONTACT: Philip Dellinger, Chief Ground Water/
UIC Section, EPA--Region 6, telephone<PHONE_NUMBER>.

    Dated: February 5, 2015.
William K. Honker,
Director, Water Quality Protection Division.
[FR Doc. 2015-03463 Filed 2-19-15; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 104 (Monday, June 1, 2015)]
[Notices]
[Pages 31025-31026]
[FR Doc No: 2015-13078]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings--2

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

Filings in Existing Proceedings

    Docket Numbers: RP15-594-000.
    Applicants: KPC Pipeline, LLC.
    Description: Additional information requested in paragraph 11 of
April 21, 2015 Order of KPC Pipeline, LLC.
    Filed Date: 5/1/15.
    Accession Number: 20150501-5479.
    Comments Due: 5 p.m. ET 6/1/15.

    Docket Numbers: RP15-594-000.
    Applicants: KPC Pipeline, LLC.
    Description: Supplement [Excel spreadsheet] to May 1, 2015
Additional information requested in paragraph 11 of April 21, 2015
Order of KPC Pipeline, LLC.
    Filed Date: 5/5/15.
    Accession Number: 20150505-5237.
    Comments Due: 5 p.m. ET 6/1/15.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to protest in any of the above proceedings must
file in accordance with Rule 211 of the Commission's Regulations (18
CFR 385.211) on or before 5:00 p.m. Eastern time on the specified
comment date.
    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 May 20, 2015.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2015-13078 Filed 5-29-15; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 18 (Monday, January 28, 2013)]
[Rules and Regulations]
[Pages 5720-5722]
[FR Doc No: 2013-01634]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2012-1062]
RIN 1625-AA00

Safety Zone, Atlantic Intracoastal Waterway; Oak Island, NC

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is extending the temporary safety zone
established on the waters of the Atlantic Intracoastal Waterway at Oak
Island, North Carolina. The safety zone is necessary to provide for the
safety of mariners on navigable waters during maintenance on the NC 133
Fixed Bridge crossing the Atlantic Intracoastal Waterway, mile 311.8,
at Oak Island, North Carolina. The safety zone extension will
temporarily restrict vessel movement within the designated area
starting on February 14, 2013 through June 15, 2013.

DATES: This rule is effective from February 14, 2013 through June 15,
2013.

ADDRESSES: Documents mentioned in this preamble are part of docket
[USCG-2012-1062]. 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.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email CWO4 Joseph M. Edge, 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
Renee V. Wright, Program Manager, Docket Operations, telephone (202)
366-9826.

SUPPLEMENTARY INFORMATION:

Table of Acronyms

DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking

A. Regulatory History and Information

    The Coast Guard is extending the initial Temporary Final Rule
USCG--2012-0431. On June 15, 2012 a Notice to Proposed Rulemaking was
published in 77 FR 35906 for USCG -2012-0431. A subsequent Notice to
Proposed Rulemaking was published on September 13, 2012 in 77 FR 56587
for USCG-2012-0811. We received no comments on this proposed rule.

B. Basis and Purpose

    North Carolina Department of Transportation has awarded a contract
to Marine Contracting Corporation of Virginia Beach, Virginia to
perform bridge maintenance on the NC 133 Fixed Bridge crossing the
Atlantic Intracoastal Waterway, mile 311.8, at Oak Island, North
Carolina. The contract provides for replacing the fender system which
commenced on September 12, 2012 with an initial completion date of
December 12, 2012. Subsequently, the contractor was granted an
extension by North Carolina Department of Transportation until February
14, 2013. However, due to the presence of rock on the sea bed, which
has impacted the construction progress, NCDOT has granted an additional
extension until June 15, 2013 to complete the bridge maintenance. The
contractor will utilize a 140 foot deck barge with a 40 foot beam as a
work platform and for equipment staging. This safety zone will provide
a safety buffer to transiting vessels as bridge repairs present
potential hazards to mariners and property due to reduction of
horizontal clearance. During this period the Coast Guard will require a
one hour notification to the work supervisor at the NC 133 Fixed Bridge
at the Atlantic Intracoastal Waterway crossing, mile 311.8, Oak Island,
North Carolina. The notification requirement will apply during the
maintenance period for vessels requiring a horizontal clearance of
greater than 50 feet.

C. Discussion of the Final Rule

    The temporary safety zone will encompass the waters directly under
the

NC 133 Fixed Bridge crossing the Atlantic Intracoastal Waterway, mile
311.8, at Oak Island, North Carolina (33[deg]55'18'' N/078[deg]04'22''
W). All vessels transiting this section of the waterway requiring a
horizontal clearance of greater than 50 feet will be required to make a
one hour advanced notification to the work supervisor at the NC 133
Fixed Bridge while the safety zone is in effect. The initial safety
zone was in effect from 8 a.m. September 12, 2012 to 8 p.m. December
12, 2012. An extension changed the end date of the zone to February 14,
2013. Here, the additional extension will again extend the end date
from 8 p.m. February 14, 2013 to 8 p.m. June 15, 2013.

D. 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 rule does not
restrict traffic from transiting through the noted portion of the
Atlantic Intracoastal Waterway; it only imposes a one hour notification
to ensure the waterway is clear of impediment to allow passage to
vessels requiring a horizontal clearance of greater than 50 feet.

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 term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard received no comments from the Small Business
Administration on this rule. 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. This rule affects the following
entities, some of which may be small entities: The owners or operators
of commercial tug and barge companies, recreational and commercial
fishing vessels intending to transit the specified portion of Atlantic
Intracoastal Waterway from 8 p.m. February 14, 2013 through 8 p.m. June
15, 2103.
    This safety zone would not have a significant economic impact on a
substantial number of small entities for the following reasons.
Although the safety zone will apply to the entire width of this section
of the Atlantic Intracoastal Waterway, vessel traffic will be able to
request passage by providing a one hour advanced notification. Before
the effective period, the Coast Guard will issue maritime advisories
widely available to the users of the waterway. If you think that your
business, organization, or governmental jurisdiction qualifies as a
small entity and that this rule would have a significant economic
impact on it, please submit a comment (see ADDRESSES) explaining why
you think it qualifies and how and to what degree this rule would
economically affect it.

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
INTFORMATION 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

    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 the establishment of a temporary safety
zone. This rule is categorically excluded from further review under
paragraph 34(g) of Figure 2-1 of the Commandant Instruction. An
environmental analysis checklist supporting this determination and a
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, 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 temporary Sec.  165.T05-1062 to read as follows:

Sec.  165.T05-1062  Safety Zone; Atlantic Intracoastal Waterway, Oak
Island, NC.

    (a) Regulated area. The following area is a safety zone: This zone
includes the waters directly under and 100 yards either side of the NC
133 Fixed Bridge crossing the Atlantic Intracoastal Waterway, mile
311.8, at Oak Island, North Carolina (33[deg]55'18'' N/078[deg]04'22''
W).
    (b) Regulations. The general safety zone regulations found in 33
CFR 165.23 apply to the safety zone created by this temporary section,
Sec.  165.T05-1062. In addition the following regulations apply:
    (1) All vessels requiring greater than 50 feet horizontal clearance
to safely transit through the NC 133 Fixed Bridge crossing the Atlantic
Intracoastal Waterway, mile 311.8, at Oak Island, North Carolina must
contact the work supervisor on VHF-FM marine band radio channels 13 and
16 one hour in advance of intended transit.
    (2) All Coast Guard assets enforcing this safety zone can be
contacted on VHF-FM marine band radio channels 13 and 16.
    (3) The operator of any vessel within or in the immediate vicinity
of this safety zone shall:
    (i) Stop the vessel immediately upon being directed to do so by any
commissioned, warrant or petty officer on board a vessel displaying a
Coast Guard Ensign, and
    (ii) Proceed as directed by any commissioned, warrant or petty
officer on board a vessel displaying a Coast Guard Ensign.
    (c) Definitions.
    (1) Captain of the Port North Carolina means the Commander, Coast
Guard Sector North Carolina or any Coast Guard commissioned, warrant or
petty officer who has been authorized by the Captain of the Port to act
on his behalf.
    (2) Designated representative means any Coast Guard commissioned,
warrant, or petty officer who has been authorized by the Captain of the
Port North Carolina to assist in enforcing the safety zone described in
paragraph (a) of this section.
    (3) Work Supervisor means the contractors on site representative.
    (d) Enforcement. The U.S. Coast Guard may be assisted by Federal,
State and local agencies in the patrol and enforcement of the zone.
    (e) Enforcement period. This section will be enforced from 8 p.m.
February 14, 2013 through 8 p.m. June 15, 2013, unless cancelled
earlier by the Captain of the Port.

    Dated: January 11, 2013.
A. Popiel,
Captain, U.S. Coast Guard Captain of the Port Sector North Carolina.
[FR Doc. 2013-01634 Filed 1-25-13; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 76, Number 248 (Tuesday, December 27, 2011)]
[Notices]
[Page 80925]
[FR Doc No: 2011-32983]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER12-610-000]

Shiloh III Lessee, LLC; Supplemental Notice That Initial Market-
Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding of
Shiloh III Lessee, LLC's application for market-based rate authority,
with an accompanying rate tariff, noting that such application includes
a request for blanket authorization, under 18 CFR Part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is January 9, 2012.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the web site that enables subscribers to receive email notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please email<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

    Dated: December 19, 2011.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2011-32983 Filed 12-23-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 243 (Monday, December 19, 2016)]
[Notices]
[Pages 91931-91932]
[FR Doc No: 2016-30058]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OGC-2016-0642; FRL 9956-69-OGC]

Proposed Settlement Agreement, Clean Air Act Citizen Suit

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of proposed settlement agreement; request for public
comment.

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SUMMARY: In accordance with section 113(g) of the Clean Air Act, as
amended (``CAA''), notice is hereby given of a proposed settlement
agreement to settle a lawsuit filed by American Chemistry Council
(``Petitioner''), in the United States Court of Appeals for the D.C.
Circuit: American Chemistry Council v. EPA (Case Number 15-1146). On
May 18, 2015, Petitioner and Eastman Chemical Company (``Eastman'')
filed petitions for review of an EPA rule titled ``National Emission
Standards for Hazardous Air Pollutants for Major Sources: Off-Site
Waste Recovery Operations,'' published in the Federal Register on March
18, 2015 (the ``Final Rule''). The proposed settlement agreement would
establish deadlines for EPA to take specified actions.

DATES: Written comments on the proposed settlement agreement must be
received by January 18, 2017.

ADDRESSES: Submit your comments, identified by Docket ID number EPA-HQ-
OGC-2016-0642, online at www.regulations.gov. For comments submitted at
www.regulations.gov, follow the online instructions for submitting
comments. Once submitted, comments cannot be edited or removed from
www.regulations.gov. The EPA may publish any comment received to its
public docket. Do not submit electronically any information you
consider to be Confidential Business Information (``CBI'') or other
information whose disclosure is restricted by statute. Multimedia
submissions (audio, video, etc.) must be accompanied by a written
comment. The written comment is considered the official comment and
should include discussion of all points you wish to make. The EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e. on the web, cloud, or other file sharing
system). For additional submission methods, please contact the person
identified in the FOR FURTHER INFORMATION CONTACT section. For the full
EPA public comment policy, information about CBI or multimedia
submissions, and general guidance on making effective comments, please
visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Emily Seidman, Air and Radiation Law
Office (2344A), Office of General Counsel, U.S. Environmental
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460;
telephone:<PHONE_NUMBER>; fax number<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Additional Information About the Proposed Settlement Agreement

    On May 18, 2015, Petitioner and Eastman filed petitions for review
of an EPA rule titled ``National Emission Standards for Hazardous Air
Pollutants for Major Sources: Off-Site Waste Recovery Operations,''
published at 80 FR 14,248 (March 18, 2015) (the ``Final Rule''). In
addition, Petitioner and Eastman submitted to the EPA a Petition for
Reconsideration of the Final Rule of two issues: (1) equipment leak
detection provisions for connectors; and (2) monitoring requirements
for pressure relief devices (``PRD'') on portable containers. The EPA
granted the request for reconsideration of the Final Rule on the issue
of PRD monitoring requirements for portable containers but denied the
request for reconsideration of the equipment leak detection provisions
for connectors. The EPA provided public notice of this denial through a
Federal Register notice published on May 16, 2016 at 81 FR 30,182. On
September 26, 2016, Eastman filed an unopposed motion for voluntary
dismissal which the court granted.
    The proposed settlement agreement would settle Petitioner's
lawsuit. Under the terms of the proposed settlement agreement, the EPA
will reconsider the Final Rule's provisions relating to PRDs and take
an initial action no later than July 20, 2017 and a final action no
later than January 18, 2018, as long as Petitioner provides the EPA
with the requested data on PRDs identified in Appendix A of the
settlement agreement by no later than October 28, 2016, or a later
date, as provided for in the settlement agreement. Please review the
settlement agreement for additional details, available in the public
docket at EPA-HQ-OGC-2016-0642.
    For a period of 30 days following the date of publication of this
notice, the Agency will receive written comments relating to the
proposed settlement agreement from persons who were not named as
parties or intervenors to the litigation in question. EPA or the
Department of Justice may withdraw or withhold consent to the proposed

settlement agreement if the comments disclose facts or considerations
that indicate that such consent is inappropriate, improper, inadequate,
or inconsistent with the requirements of the Act. Unless EPA or the
Department of Justice determines that consent to the agreement should
be withdrawn or withheld, the terms of the agreement will be affirmed.

II. Additional Information About Commenting on the Proposed Settlement
Agreement

A. How can I get a copy of the proposed settlement agreement?

    The official public docket for this action under Docket ID No. EPA-
HQ-OGC-2016- 0642 contains a copy of the proposed settlement agreement.
The official public docket is available for public viewing at the
Office of Environmental Information (OEI) Docket in the EPA Docket
Center, EPA West, Room 3334, 1301 Constitution Ave. NW., Washington,
DC. The EPA Docket Center 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 OEI Docket is<PHONE_NUMBER>.
    An electronic version of the public docket is available through
www.regulations.gov. You may use the www.regulations.gov to submit or
view public comments, access the index listing of the contents of the
official public docket, and to access those documents in the public
docket that are available electronically. Once in the system, key in
the appropriate docket identification number then select ``search''.
    It is important to note that EPA's policy is that public comments,
whether submitted electronically or in paper, will be made available
for public viewing online at www.regulations.gov without change, unless
the comment contains copyrighted material, CBI, or other information
whose disclosure is restricted by statute. Information claimed as CBI
and other information whose disclosure is restricted by statute is not
included in the official public docket or in the electronic public
docket. EPA's policy is that copyrighted material, including
copyrighted material contained in a public comment, will not be placed
in EPA's electronic public docket but will be available only in
printed, paper form in the official public docket. Although not all
docket materials may be available electronically, you may still access
any of the publicly available docket materials through the EPA Docket
Center.

B. How and to whom do I submit comments?

    You may submit comments as provided in the ADDRESSES section.
Please ensure that your comments are submitted within the specified
comment period. Comments received after the close of the comment period
will be marked ``late.'' EPA is not required to consider these late
comments.
    If you submit an electronic comment, EPA recommends that you
include your name, mailing address, and an email address or other
contact information in the body of your comment and with any disk or CD
ROM you submit. This ensures that you can be identified as the
submitter of the comment and allows EPA to contact you in case EPA
cannot read your comment due to technical difficulties or needs further
information on the substance of your comment. Any identifying or
contact information provided in the body of a comment will be included
as part of the comment that is placed in the official public docket,
and made available in EPA's electronic public docket. If EPA cannot
read your comment due to technical difficulties and cannot contact you
for clarification, EPA may not be able to consider your comment.
    Use of the www.regulations.gov Web site to submit comments to EPA
electronically is EPA's preferred method for receiving comments. The
electronic public docket system is an ``anonymous access'' system,
which means EPA will not know your identity, email address, or other
contact information unless you provide it in the body of your comment.
In contrast to EPA's electronic public docket, EPA's electronic mail
(email) system is not an ``anonymous access'' system. If you send an
email comment directly to the Docket without going through
www.regulations.gov, your email address is automatically captured and
included as part of the comment that is placed in the official public
docket, and made available in EPA's electronic public docket.

    Dated: December 7, 2016.
Lorie J. Schmidt,
Associate General Counsel.
[FR Doc. 2016-30058 Filed 12-16-16; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 78, Number 29 (Tuesday, February 12, 2013)]
[Notices]
[Pages 9906-9907]
[FR Doc No: 2013-03156]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 2

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

    Docket Numbers: ER13-860-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Original Service Agreement No. 3482; Queue No. W3-080
to be effective 1/9/2013.
    Filed Date: 2/1/13.
    Accession Number: 20130201-5043.
    Comments Due: 5 p.m. ET 2/22/13.

    Docket Numbers: ER13-861-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Notice of Cancellation of Original SA No. 3451 in
Docket No. ER13-715-000 to be effective 1/3/2013.
    Filed Date: 2/1/13.
    Accession Number: 20130201-5045.
    Comments Due: 5 p.m. ET 2/22/13.

    Docket Numbers: ER13-862-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Original Service Agreement No. 3481; Queue No. X4-015
to be effective 1/7/2013.
    Filed Date: 2/1/13.
    Accession Number: 20130201-5046.
    Comments Due: 5 p.m. ET 2/22/13.

    Docket Numbers: ER13-863-000.
    Applicants: Arizona Public Service Company.
    Description: APS and SDG&E Kofa Capacitor Bank Project Agreement,
Rate Schedule No. 264 to be effective 4/1/2013.
    Filed Date: 2/1/13.
    Accession Number: 20130201-5067.
    Comments Due: 5 p.m. ET 2/22/13.

    Docket Numbers: ER13-864-000.
    Applicants: American Transmission Systems, Incorporation, PJM
Interconnection, L.L.C.
    Description: ATSI submits First Revised SA No. 2852 among AMP and
FirstEnergy Affiliates to be effective 8/1/2012.
    Filed Date: 2/1/13.
    Accession Number: 20130201-5093.
    Comments Due: 5 p.m. ET 2/22/13.

    Docket Numbers: ER13-865-000.
    Applicants: International Transmission Company.
    Description: International Transmission Company submits Compliance
Refund Report [9/30/2012 Commission Order in PA10-13].
    Filed Date: 2/1/13.
    Accession Number: 20130201-5095.
    Comments Due: 5 p.m. ET 2/22/13.

    Docket Numbers: ER13-866-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Notice of Cancellation of Original SA No. 2842 in Dkt
No. ER11-3348-000 to be effective 1/9/2013.
    Filed Date: 2/1/13.
    Accession Number: 20130201-5107.
    Comments Due: 5 p.m. ET 2/22/13.

    Docket Numbers: ER13-867-000.
    Applicants: Michigan Electric Transmission Company, LLC.
    Description: Michigan Electric Transmission Company, LLC submits
Compliance Refund Report [9/30/2012 Commission Order in PA10-13].
    Filed Date: 2/1/13.
    Accession Number: 20130201-5108.
    Comments Due: 5 p.m. ET 2/22/13.

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

    Dated: February 1, 2013.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2013-03156 Filed 2-11-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: September 17, 2010 (Volume 75, Number 180)]
[Notices]
[Page 57016-57017]
[DOCID:fr17se10-77]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER10-2522-000]

Top of the World Wind Energy, LLC; Supplemental Notice That
Initial Market-Based Rate Filing Includes Request for Blanket Section
204 Authorization

September 10, 2010.
    This is a supplemental notice in the above-referenced proceeding of
Top of the World Wind Energy, LLC's application for market-based rate
authority, with an accompanying rate tariff, noting that such
application includes a request for blanket authorization, under 18 CFR
part 34, of future issuances of securities and assumptions of
liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426, in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214). Anyone filing a motion to intervene or protest must serve a
copy of that document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is September 30, 2010.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://
www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a

document is added to a subscribed docket(s). For assistance with any
FERC Online service, please e-mail<EMAIL_ADDRESS>or call
(866) 208-3676 (toll free). For TTY, call<PHONE_NUMBER>.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-23221 Filed 9-16-10; 8:45 am]
BILLING CODE 6717-01-P