[Federal Register Volume 83, Number 71 (Thursday, April 12, 2018)]
[Rules and Regulations]
[Pages 15748-15753]
[FR Doc No: 2018-07651]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2016-0651; FRL-9975-01]

Clethodim; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
clethodim in or on multiple commodities which are identified and
discussed later in this document. In addition, this regulation removes
several previously established tolerances that are superseded by this
final rule. Interregional Research Project Number 4 (IR-4) requested
these tolerances under the Federal Food, Drug, and Cosmetic Act
(FFDCA).

DATES: This regulation is effective April 12, 2018. Objections and
requests for hearings must be received on or before June 11, 2018, 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-2016-0651, 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: Michael L. Goodis, 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 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 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-2016-0651 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
June 11, 2018. 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-2016-0651, 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 March 23, 2017 (82 FR 14846) (FRL-9957-
99), 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
6E8510) by Interregional Research Project Number 4 (IR-4), 500 College
Road East, Suite 201 W, Princeton NJ 08540. The petition requested that
40 CFR 180.458 be amended by establishing tolerances for residues of
the herbicide, clethodim, 2-[(1E)-1-[[[(2E)-3-chloro-2-
propenyl]oxy]imino]propyl]-5-[2-(ethylthio)propyl]-3-hydroxy-2-
cyclohexen-1-one, and its metabolites containing the 5-(2-
ethylthiopropyl)cyclohexene-3-one and 5-(2-ethylthiopropyl)-5-
hydroxycyclohexene-3-one moieties and their sulphoxides and sulphones,
calculated as the stoichiometric equivalent of clethodim, in or on
almond, hulls at 0.2 parts per million (ppm); Brassica, leafy greens,
subgroup 4-16B at 3.0 ppm; leaf petiole vegetable subgroup 22B at 0.60
ppm; leafy greens subgroup 4-16A at 2.0 ppm; nut, tree, group 14-12 at
0.2 ppm; okra at 1.5 ppm; onion, green, subgroup 3-07B at 2.0 ppm;
stalk and stem vegetable subgroup 22A at 1.7 ppm; vegetable, Brassica,
head and stem, group 5-16 at 3.0 ppm; and vegetable, fruiting, group 8-
10, except okra at 1.0 ppm. Upon establishment of proposed tolerances
above, the Petitioner requests that 40 CFR part 180.458 be amended by
removing existing tolerances for residues of clethodim in or on the raw
agricultural commodities asparagus at 1.7 ppm; Brassica, head and stem,
subgroup 5A at 3.0 ppm; Brassica, leafy greens, subgroup 5B at 3.0 ppm;
leaf petioles subgroup 4B at 0.60 ppm; leafy greens subgroup 4A at 2.0
ppm; onion, green at 2.0 ppm; turnip, greens at 3.0 ppm; and vegetable,
fruiting, group 8-10 at 1.0 ppm that are superseded by this final rule.
That document referenced a summary of the petition prepared by Valent
USA Corporation, the registrant, which is available in the docket,
http://www.regulations.gov. Comments were received on the notice of
filing. EPA's responses to these comments are discussed in Unit IV.C.
    Consistent with the authority in FFDCA 408(d)(4)(A)(i), EPA is
issuing tolerances that vary from what the petitioner sought. The
reason for these changes is explained in Unit IV.D.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of, and to make a
determination on aggregate exposure for clethodim including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with clethodim 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.
    The clethodim toxicity database shows relatively low toxicity with
the liver being the target organ based on repeated dosing by either
oral or dermal routes in rats, mice, and dogs. The observed liver
effects are characterized by increased liver weights, clinical
chemistry changes, and centrilobular hepatic hypertrophy. Most liver
effects that occurred at or below 100 milligrams/kilogram body weight
(mg/kg bw) were considered as adaptive effects and not adverse.
Decreased body weight was also a common finding across studies and
species. In the 1-year dog oral toxicity study, hematological changes
such as increased platelet and leukocyte counts and slight elevation of
glucose levels (in dogs only) were also seen.
    No developmental effects were present in the rabbits. In the rat
developmental toxicity study, reduced fetal body weights and an
increase in the incidence of delayed ossification of the lower
vertebrae were seen at the dose (350 mg/kg/day) where maternal toxicity
(excessive salivation and lacrimation, red nasal discharge) was also
observed. No reproductive or offspring effects were seen in the 2-
generation rat reproduction study. Therefore, the toxicity data showed
no increased susceptibility in the young. The clethodim database also
showed no potential for neurotoxicity or immunotoxicity.
    Results of rat and mouse carcinogenicity studies did not show
treatment-related increases in tumor incidence. Therefore, clethodim is
not shown to be genotoxic and is classified as ``not likely to be
carcinogenic to humans.''
    Specific information on the studies received and the nature of the
adverse effects caused by clethodim 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 entitled, ``SUBJECT: Clethodim. Human
Health Aggregate Risk Assessment for the Proposed New Uses on Tree Nut
Group 14-12; Okra; Crop Group Conversions for Brassica Leafy Greens
Subgroup 4-16B; Leafy Green Subgroup 4-16A; Leaf Petiole Vegetable
Subgroup 22B; Stalk and Stem Vegetable Subgroup 22A; Vegetable,
Brassica Head and Stem, Group 5-16; Expansion of Commodity Residue
Tolerance to Green Onion Subgroup 3-07B and Response to 6(a)(2) Data
Submission'' dated March 19, 2018 at 33-38 in docket ID number EPA-HQ-
OPP-2016-0651.

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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for clethodim used for
human risk assessment is discussed in Unit III of the final rule
published in the Federal Register of May 6, 2016 (81 FR 27339) (FRL-
9945-68).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to clethodim, EPA considered exposure under the petitioned-for
tolerances as well as all existing clethodim tolerances in 40 CFR
180.458. EPA assessed dietary exposures from clethodim 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 clethodim. In estimating acute
dietary exposure, EPA used the Dietary Exposure Evaluation Model
software with the Food Commodity Intake Database (DEEM-FCID), Version
3.16, which incorporates 2003-2008 food consumption data from the U.S.
Department of Agriculture's (USDA's) National Health and Nutrition
Examination Survey, What We Eat in America, (NHANES/WWEIA). As to
residue levels in food, EPA conducted unrefined acute dietary analyses
assuming tolerance levels for all commodities and 100 percent crop-
treated (PCT). DEEM version 7.81 default processing factors were
assumed, except where tolerances were established for processed
commodities.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used DEEM-FCID, Version 3.16, which incorporates 2003-
2008 food consumption data from the USDA's NHANES/WWEIA. As to residue
levels in food, EPA conducted unrefined chronic dietary analyses
assuming tolerance levels for all commodities and 100 PCT. DEEM version
7.81 default processing factors were assumed, except where tolerances
were established for processed commodities.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that clethodim does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
    iv. Anticipated residue and PCT information. EPA did not use
anticipated residue or PCT information in the dietary assessment for
clethodim. Tolerance-level residues and 100 PCT were assumed for all
food commodities.
    2. Dietary exposure from drinking water. The Agency used screening-
level water exposure models in the dietary exposure analysis and risk
assessment for clethodim in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of clethodim. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Surface and ground water contamination may occur from clethodim as
well as its sulfoxide and sulfone degradates. Exposure from water
contamination is primarily associated with clethodim sulfone and
clethodim sulfoxide rather than parent clethodim based on greater
persistence and mobility of these degradates. Thus, the exposure
assessments were based on the total toxic residue rather than parent
only.
    Based on the First Index Reservoir Screening Tool (FIRST) and
Pesticide Root Zone Model Ground Water (PRZM GW), the estimated
drinking water concentrations (EDWCs) of clethodim for acute exposures
are estimated to be 330 parts per billion (ppb) for surface water and
1,430 ppb for ground water. For chronic exposures for non-cancer
assessments EDWCs are estimated to be 137 ppb for surface water and
1,150 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 1,430 ppb was used to
assess the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 1,150 ppb was used to
assess the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
    Clethodim is currently registered for the following uses that could
result in residential exposures: In and around ornamental plant beds,
landscaped area, trees, and ground covers (mulch). EPA assessed
residential exposure using the following assumptions:
    In a reassessment of existing residential uses of clethodim
conducted to reflect updates to EPA's 2012 Residential SOPs along with
policy changes for body weight assumptions, the Agency assessed short-
term residential handler (adult only) inhalation exposure. There is
potential residential dermal post-application exposure from the
existing use of clethodim on ornamentals. However, since there is no
adverse systemic hazard via the dermal route of exposure, and there is
no incidental oral exposure expected from clethodim use on ornamental
plants, a residential post-application assessment has not been
conducted. Further information regarding EPA standard assumptions and
generic inputs for residential exposures may be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
    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 clethodim to share a common mechanism of toxicity
with any other substances, and clethodim does not appear to produce a
toxic metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that clethodim 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 the policy statements
released by EPA's Office of Pesticide Programs concerning common
mechanism determinations and procedures for cumulating effects from
substances found to have a common mechanism on EPA's website at http://www2.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 FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
    2. Prenatal and postnatal sensitivity. There is no evidence of
increased susceptibility of fetuses as compared to maternal animals
following in utero and/or postnatal exposure to clethodim in the
developmental toxicity studies in rats or rabbits, and no increased
sensitivity in pups as compared to adults in the 2-generation rat
reproduction toxicity study. There are no residual uncertainties
concerning prenatal and postnatal 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 clethodim is complete and sufficient
for selecting toxicity endpoints and PODs for assessing risks.
    ii. There is no indication that clethodim is a neurotoxic chemical
and there is no need for a developmental neurotoxicity study or
additional UFs to account for neurotoxicity.
    iii. There is no evidence that clethodim results in increased
susceptibility of fetuses as compared to maternal animals following in
utero and/or postnatal exposure to clethodim in the prenatal
developmental toxicity studies in rats or rabbits, and no increased
sensitivity in pups as compared to adults in the 2-generation rat
reproduction toxicity study. In the rat developmental study, reduced
ossification seen at the same dose that resulted in maternal toxicity
is considered secondary to reduced maternal body weight, and is not
considered qualitative susceptibility.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were determined based
on 100 PCT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to clethodim in drinking water. Post application
exposure of children and incidental oral exposures to toddlers are
expected to be negligible. All exposure estimates are based on
conservative assumptions that will not underestimate the exposure and
risks posed by clethodim.

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. The acute aggregate risk is equivalent to the acute
dietary risk.
    Using the exposure assumptions discussed in this unit for acute
exposure, the acute dietary exposure from food and water to clethodim
will occupy 29% of the aPAD, at the 95th percentile of exposure for all
infants (<1 year old), the population group receiving the greatest
exposure.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
clethodim from food and water will utilize 30% of the cPAD for all
infants (<1 year old) the population group receiving the greatest
exposure. There are no chronic residential exposure scenarios.
Therefore, the chronic aggregate risk would be equivalent to the
chronic dietary exposure (food and drinking water) estimate.
    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). Clethodim 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 clethodim.
    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 a short-term aggregate risk
estimate for adults ages 20 to 49 is a MOE of 2,100. Because EPA's
level of concern for clethodim is a MOE of 100 or below, this MOE is
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).
    Intermediate-term exposure is not expected for the residential
exposure pathway. Therefore, the intermediate-term aggregate exposure
would be equivalent to the chronic dietary exposure estimate.
    5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, clethodim is not expected to pose a cancer risk to humans.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to clethodim residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate analytical methods are available for enforcing clethodim
tolerances in/on the proposed/registered plant commodities. Samples
were analyzed for residues of clethodim and metabolites containing the
2-cyclohexen-1-one moiety using the gas chromatography/mass
spectroscopy (GC/MS) Method YARL-0602D, adapted from Method RM-26B-3
entitled, ``The Determination of Clethodim Residues in Crops, Chicken
and Beef Tissues, Milk and Eggs'' (revision dated January 20, 1994).
The method converts residues of clethodim and metabolites to clethodim
sulfoxide (CSO) and clethodim 5 hydroxy sulfoxide (5-OH
CSO2), which are determined as their dimethyl esters (DME
and DME-OH, respectively).

Method RM-26B-3 is the enforcement method for tolerances for clethodim
including its metabolites and degradates.
    The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number:<PHONE_NUMBER>; email address:
[email protected].

B. International Residue Limits

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

C. Response to Comments

    The Agency received four comments on the notice of filing (NOF) for
this petition. While none of the commenters mentioned any specific
concerns with the clethodim tolerances noticed in the NOF, two comments
generally opposed the use of chemicals or pesticides in or food and two
comments generally urged the Agency to ensure protection of the
environment and human health by reviewing science and determining
whether use of pesticide is safe for human consumption.
    The Agency recognizes that some individuals believe that certain
pesticides are ``toxic chemicals'' that should not be permitted in our
food; however, no new information demonstrating toxicity or exposure of
clethodim that EPA could use to evaluate the safety of the pesticide
was provided by commenters. The existing legal framework provided by
section 408 of the Federal Food, Drug and Cosmetic Act (FFDCA) states
that tolerances may be set when persons seeking such tolerances or
exemptions have demonstrated that the pesticide meets the safety
standard imposed by that statute. When new or amended tolerances are
requested for residues of a pesticide in food or feed, the Agency, as
is required by section 408 of FFDCA, estimates the risk of the
potential exposure to these residues. The Agency has conducted that
risk assessment, which includes the consideration of long-term animal
studies with clethodim, and concluded that there is a reasonable
certainty that no harm will result from aggregate human exposure to
clethodim and that, accordingly, the use of clethodim on petitioned-for
food commodities is ``safe.''

D. Revisions to Petitioned-For Tolerances

    In accordance with its standard practice to provide greater
precision about the levels of residues that are permitted by a
tolerance, EPA is adding an additional significant figure to the
petitioned-for tolerance values for Almond hulls and Nut, tree, group
14-12. This is to avoid the situation where residues may be higher than
the tolerance level, but as a result of rounding would be considered
non-violative (for example, Almond tolerance proposed at 0.2 ppm was
established at 0.20 ppm, to avoid an observed hypothetical tolerance at
0.24 ppm being rounded to 0.2 ppm).

E. International Trade Considerations

    In this final rule, EPA is establishing a crop subgroup tolerance
for subgroup 22A (stalk and stem vegetable) at 1.7 ppm. This subgroup
includes the commodity kohlrabi, for which a tolerance is currently set
at 3.0 ppm, as one of the commodities in the currently established
tolerance for Brassica, head and stem subgroup 5A. Setting a new
tolerance at 1.7 ppm on kohlrabi as part of subgroup 22A has a
potentially trade restrictive effect on the import of kohlrabi. In the
2016 crop grouping rule, kohlrabi was moved to the stalk and stem
vegetable subgroup 22A. See 81 FR 26471 (May 3, 2016).
    In accordance with the World Trade Organization's (WTO) Sanitary
and Phytosanitary Measures (SPS) Agreement, EPA intends to promptly
publish this action with the WTO. In addition, EPA is allowing the
existing kohlrabi tolerance to remain in effect for six months
following publication of this rule in order to provide a six-month
reasonable interval for producers in exporting countries to adapt the
modified tolerances. Before that date, residues of clethodim in or on
kohlrabi will be permitted at the current tolerance levels; after that
date, residues will need to be in compliance with the new tolerance
levels.
    The tolerance level is appropriate based on available data and
residue levels resulting from registered use patterns. The tolerance
levels are not discriminatory; the same food safety standard contained
in the FFDCA applies equally to domestically produced and imported
foods. None of the other tolerance actions taken in this rulemaking
restrict permissible pesticide residues below currently allowed levels
in the United States.
    Any commodities listed in the regulatory text of this document that
are treated with the pesticides subject to this final rule, and that
are in the channels of trade following the expiration of the tolerance,
shall be subject to FFDCA section 408(1)(5). Under this unit, any
residues of these pesticides in or on such food shall not render the
food adulterated so long as it is shown to the satisfaction of the Food
and Drug Administration that:
    1. The residue is present as the result of an application or use of
the pesticide at a time and in a manner that was lawful under FIFRA.
    2. The residue does not exceed the level that was authorized at the
time of the application or use to be present on the food under a
tolerance or exemption from tolerance. Evidence to show that food was
lawfully treated may include records that verify the dates that the
pesticide was applied to such food.

V. Conclusion

    Therefore, tolerances are established for residues of the herbicide
clethodim, 2-[(1E)-1-[[[(2E)-3-chloro-2-propenyl]oxy]imino]propyl]-5-
[2-(ethylthio)propyl]-3-hydroxy-2-cyclohexen-1-one, and its metabolites
containing the 5-(2-ethylthiopropyl)cyclohexene-3-one and 5-(2-
ethylthiopropyl)-5-hydroxycyclohexene-3-one moieties and their
sulphoxides and sulphones, calculated as the stoichiometric equivalent
of clethodim, in or on Almond, hulls at 0.20 ppm; Brassica, Leafy,
greens, subgroup 4-16B at 3.0 ppm; Leaf petiole vegetable subgroup 22B
at 0.60 ppm; Leafy greens subgroup 4-16A at 2.0 ppm; Nut, tree, group
14-12 at 0.20 ppm; Okra 1.5 ppm; Onion, green, subgroup 3-07B at 2.0
ppm; Stalk and stem vegetable subgroup 22A at 1.7 ppm; Vegetable,
Brassica, head and stem, group 5-16 at 3.0 ppm; and Vegetable,
fruiting, group 8-10, except okra at 1.0 ppm. In addition, established
tolerances in or on ``Asparagus''; ``Brassica, head and stem, subgroup
5A''; ``Brassica, leafy greens, subgroup 5B''; ``Leaf petioles subgroup
4B'';

``Leafy greens subgroup 4A''; ``Onion, green''; ``Turnip, greens''; and
``Vegetable, fruiting, group 8-10'' are removed as they are superseded
by this final tolerance rule. To minimize the potential for trade
irritation, the Agency is allowing the existing tolerance for kohlrabi
to remain in place for six months by adding an expiration date of six
months following publication of this rule to each individual tolerance.
Since kohlrabi is currently contained within the existing subgroup 5A
tolerance, which is being removed by this action, the Agency is listing
kohlrabi as a separate tolerance at 3.0 ppm to remain in effect for a
six-month period.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997)); or Executive Order 13771,
entitled ``Reducing Regulations and Controlling Regulatory Costs'' (82
FR 9339, February 3, 2017). 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: March 19, 2018.
Michael L. Goodis,
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.  180.458:
0
a. Remove the entries for ``Asparagus''; ``Brassica, head and stem,
subgroup 5A''; ``Brassica, leafy greens, subgroup 5B''; ``Leaf petioles
subgroup 4B''; ``Leafy greens subgroup 4A''; ``Onion, green'';
``Turnip, greens''; and ``Vegetable, fruiting, group 8-10''; from the
table in paragraph (a).
0
b. Add alphabetically the entries to the table in paragraph (a)
``Almond, hulls''; ``Brassica, Leafy, greens, subgroup 4-16B'';
``Kohlrabi''; ``Leaf petiole vegetable subgroup 22B''; ``Leafy greens
subgroup 4-16A''; ``Nut, tree, group 14-12''; ``Okra''; ``Onion, green,
subgroup 3-07B''; ``Stalk and stem vegetable subgroup 22A'';
``Vegetable, Brassica, head and stem, group 5-16''; and ``Vegetable,
fruiting, group 8-10, except okra''.
0
c. Add footnote 1 to the table in paragraph (a).
    The additions and revisions read as follows:

Sec.  180.458  Clethodim; tolerances for residues.

    (a) * * *

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

                                * * * * *
Almond, hulls...............................................        0.20

                                * * * * *
Brassica, leafy, greens, subgroup 4-16B.....................         3.0

                                * * * * *
Kohlrabi 1..................................................         3.0
Leaf petiole vegetable subgroup 22B.........................        0.60
Leafy greens subgroup 4-16A.................................         2.0

                                * * * * *
Nut, tree, group 14-12......................................        0.20
Okra........................................................         1.5

                                * * * * *
Onion, green, subgroup 3-07B................................         2.0

                                * * * * *
Stalk and stem vegetable subgroup 22A.......................         1.7

                                * * * * *
Vegetable, brassica, head and stem, group 5-16..............         3.0
Vegetable, fruiting, group 8-10, except okra................         1.0

                                * * * * *
------------------------------------------------------------------------
1 This tolerance expires on October 12, 2018.

* * * * *
[FR Doc. 2018-07651 Filed 4-11-18; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 179 (Monday, September 18, 2017)]
[Notices]
[Pages 43607-43609]
[FR Doc No: 2017-19708]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-81583; File No. SR-Phlx-2017-72]

Self-Regulatory Organizations; NASDAQ PHLX LLC; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Add a Missing
Letter to Section IV, Part D of the Pricing Schedule

September 12, 2017.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\, and Rule 19b-4 thereunder,\2\ notice is hereby given
that on September 1, 2017, NASDAQ PHLX LLC (``Phlx'' or ``Exchange'')
filed with the Securities and Exchange Commission (``SEC'' or
``Commission'') the proposed rule change as described in Items I and
II, below, which Items have been prepared by the Exchange. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to add a missing letter to Section IV, Part D
of the Pricing Schedule.
    The text of the proposed rule change is set forth below. Proposed
new language is italicized.
* * * * *

NASDAQ PHLX LLC PRICING SCHEDULE

THE EXCHANGE CALCULATES FEES ON A TRADE DATE BASIS.

POLICY FOR AMENDING BILLING INFORMATION: CORRECTIONS SUBMITTED AFTER
TRADE DATE AND PRIOR TO THE ISSUANCE OF AN INVOICE BY THE EXCHANGE MUST
BE SUBMITTED TO THE EXCHANGE IN WRITING AND MUST BE ACCOMPANIED BY
SUPPORTING DOCUMENTATION. ONLY MEMBERS MAY SUBMIT TRADE CORRECTIONS.

ALL BILLING DISPUTES MUST BE SUBMITTED TO THE EXCHANGE IN WRITING AND
MUST BE ACCOMPANIED BY SUPPORTING DOCUMENTATION. ALL DISPUTES MUST BE
SUBMITTED NO LATER THAN SIXTY (60) DAYS AFTER RECEIPT OF A BILLING
INVOICE, EXCEPT FOR DISPUTES CONCERNING NASDAQ PSX FEES, PROPRIETARY
DATA FEED FEES AND CO-LOCATION SERVICES FEES. THE EXCHANGE CALCULATES
FEES ON A TRADE DATE BASIS. ONLY MEMBERS MAY SUBMIT BILLING DISPUTES.

* * * * *

IV. Other Transaction Fees

* * * * *

D. Options Regulatory Fee

$0.0045 per contract side

    The Options Regulatory Fee (``ORF'') is assessed by Phlx to each
Phlx member for options transactions cleared by The Options Clearing
Corporation (``OCC'') in the Customer range where: (1) the execution
occurs on Phlx or (2) the execution occurs on another exchange and is
cleared by a Phlx member. The ORF is collected by OCC on behalf of Phlx
from (1) Phlx clearing members for all Customer transactions they clear
or (2) non-members for all Customer transactions they clear that were
executed on Phlx. Phlx uses reports from OCC when assessing and
collecting ORF. The Exchange will notify members via an Options Trader
Alert of any change in the amount of the fee at least 30 calendar days
prior to the effective date of the change.
* * * * *

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and the
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange recently filed a proposal to amend the Exchange's
Options Regulatory Fee at Section IV, Part D of the Pricing
Schedule.\3\ In that proposal, the Exchange inadvertently forgot to add
the ``c'' in the word ``clearing'' in the following sentence: ``The ORF
is collected by OCC on behalf of Phlx from (1) Phlx learing members for
all Customer transactions they clear or (2) non-members for all
Customer transactions they clear that were executed on Phlx. Phlx uses
reports from OCC when assessing and collecting ORF.'' The Exchange is
filing this proposed rule change to add the ``c'' in the word
``clearing'' to clarify the sentence.
---------------------------------------------------------------------------

    \3\ See Securities and Exchange Act Release No. 81343 (August 8,
2017), 82 FR 37964 (August 14, 2017) (SR-Phlx-2017-54).
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\4\ in general, and furthers the objectives of Section
6(b)(5) of the Act,\5\ in particular, in that it is designed to promote
just and equitable principles of trade, to remove impediments to and
perfect the mechanism of a free and open market and a national market
system, and, in general to protect investors and the public interest,
by clarifying the rule text to make clear its intended meaning.
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 78f(b).
    \5\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Exchange proposes to correct the typographical error in the
rule text of the Pricing Schedule related to the manner in which the
Exchange collects the Options Regulatory Fee. The Exchange believes
that clarifying the rule text is consistent with the Act in that it
will protect investors and the public interest by correcting the
spelling of a word to make clear the intended meaning.

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. The proposed change is a non-
substantive amendment to correct a typographical error related to the
spelling of a word in the rule text.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were either solicited or received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A)(iii) of the Act \6\ and
subparagraph (f)(6) of Rule 19b-4 thereunder.\7\
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \7\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
---------------------------------------------------------------------------

    A proposed rule change filed pursuant to Rule 19b-4(f)(6) under the
Act \8\ normally does not become operative for 30 days after the date
of its filing. However, Rule 19b-4(f)(6)(iii) \9\ permits the
Commission to designate a shorter time if such action is consistent
with the protection of investors and the public interest. The Exchange
has asked the Commission to waive the 30-day operative delay so that
the proposal may become operative immediately upon filing. The Exchange
states that waiver of the 30-day operative delay would avoid potential
confusion that may be caused from the omission of the letter ``c'' from
the word ``clearing.'' Based on the foregoing, the Commission believes
the waiver of the operative delay is consistent with the protection of
investors and the public interest. Therefore, the Commission hereby
waives the operative delay and designates the proposal operative upon
filing.\10\
---------------------------------------------------------------------------

    \8\ 17 CFR 240.19b-4(f)(6).
    \9\ 17 CFR 240.19b-4(f)(6)(iii).
    \10\ For purposes only of waiving the 30-day operative delay,
the Commission has also considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).

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

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is: (i)
Necessary or appropriate in the public interest; (ii) for the
protection of investors; or (iii) otherwise in furtherance of the
purposes of the Act. If the Commission takes such action, the
Commission shall institute proceedings to determine whether the
proposed rule should be approved or disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-Phlx-2017-72 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.

All submissions should refer to File Number SR-Phlx-2017-72. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-Phlx-2017-72, and should be
submitted on or before October 10, 2017.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
---------------------------------------------------------------------------

    \11\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-19708 Filed 9-15-17; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 246 (Wednesday, December 26, 2018)]
[Rules and Regulations]
[Pages 66133-66136]
[FR Doc No: 2018-27747]

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

40 CFR Part 52

[EPA-R04-OAR-2018-0432; FRL-9988-25-Region 4]

Air Plan Approval; North Carolina: NOX Rule Revisions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is approving
portions of a State Implementation Plan (SIP) revision submitted by the
State of North Carolina, through the North Carolina Division of Air
Quality (NCDAQ) on June 5, 2017, as supplemented on June 28, 2018. This
submittal seeks to revise the State's SIP-approved rules regarding
nitrogen oxides (NOX) emissions from large stationary
combustion sources. This action is being taken pursuant to section 110
of the Clean Air Act (CAA or Act).

DATES: This rule will be effective January 25, 2019.

ADDRESSES: EPA has established a docket for this action under Docket
Identification No. EPA-R04-OAR-2018-0432. All documents in the docket
are listed on the www.regulations.gov website. Although listed in the
index, some information may not be publicly available, i.e.,
Confidential Business Information or other information whose disclosure
is restricted by statute. Certain other material, such as copyrighted
material, is not placed on the internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either electronically through www.regulations.gov or in hard
copy at the Air Regulatory Management Section, Air Planning and
Implementation Branch, Air, Pesticides and Toxics Management Division,
U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW,
Atlanta, Georgia 30303-8960. EPA requests that if at all possible, you
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section to schedule your inspection. The Regional Office's

official hours of business are Monday through Friday 8:30 a.m. to 4:30
p.m., excluding Federal holidays.

FOR FURTHER INFORMATION CONTACT: Jane Spann, Air Regulatory Management
Section, Air Planning and Implementation Branch, Pesticides and Toxics
Management Division, Region 4, U.S. Environmental Protection Agency, 61
Forsyth Street SW, Atlanta, Georgia 30303-8960. Ms. Spann can be
reached by phone at<PHONE_NUMBER> or via electronic mail at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. This Action

    Pursuant to section 110 of the CAA, EPA is approving changes to the
North Carolina SIP. EPA has evaluated the relevant portions of North
Carolina's June 5, 2017, SIP revision, as supplemented on June 28,
2018, and has determined that they meet the applicable requirements of
the CAA and EPA regulations.\1\ In this final rulemaking, EPA is also
responding to comments received on the proposed rulemaking.
---------------------------------------------------------------------------

    \1\ On June 5, 2017, NCDAQ submitted a SIP revision addressing
regulations under 15A North Carolina Administrative Code (NCAC) 02D
Sections .1407--``Boilers and Indirect-Fired Process Heaters'' and
.1408--``Stationary Combustion Turbines'' that is separate from the
SIP revision that EPA is finalizing today. On August 14, 2002, and
again on November 19, 2008, NCDAQ submitted amendments to Sections
.1407 and .1408 along with many other rule amendments. NCDAQ's
intention, as outlined in its June 5, 2017, SIP submittal for
Sections .1407 and .1408, was to withdraw the November 19, 2008,
submittal related to these rules. However, EPA already approved the
portion of the November 19, 2008, submittal related to Sections
.1407 and .1408 on May 9, 2013. See 78 FR 27065. Therefore, no
further action is needed on the June 5, 2017 SIP submittal
containing Sections .1407 and .1408 as the latest version of these
rules have been previously incorporated into the federally-approved
SIP.
---------------------------------------------------------------------------

II. Background

    On September 18, 2001, North Carolina submitted rule sections
regarding the control of NOX emissions from large stationary
combustion sources to EPA for approval into its SIP.\2\ North Carolina
submitted rule changes under 15A North Carolina Administrative Code
(NCAC) 02D .1400--``Nitrogen Oxides'' at the following Sections:
.1401--``Definitions''; .1403--``Compliance Schedules''; .1413--
``Sources Not Otherwise Listed in This Section''; .1414--``Tune-up
Requirements''; and .1423--``Large Internal Combustion Engines'' as
well as other rules not related to today's proposed action.\3\ The
submittal also included Section .1406--``Utility Boilers (Repealed)''
with no regulatory text. EPA approved the September 18, 2001, SIP
revision on December 27, 2002, with the exception of Section .1406 and
the addition of Sections .1413 and .1414, among others. EPA did not act
on Section .1406 because the rule contained no regulatory text and
because Section .1406 was not in the SIP, thus there was nothing to
repeal. See 67 FR 78987 for further information.
---------------------------------------------------------------------------

    \2\ See Section .1402--``Applicability'' and the definition of
``source'' in Section .1401 for the scope of this rule section.
    \3\ In the table of North Carolina regulations federally
approved into the SIP at 40 CFR 52.1770(c), 15A NCAC 02D is referred
to as ``Subchapter 2D Air Pollution Control Requirements.''
---------------------------------------------------------------------------

    On August 14, 2002, North Carolina submitted a SIP revision to EPA
containing changes under Subchapter 2D to its Section .1400
NOX rules. The submission included changes to Sections
.1401--``Definitions''; .1403--``Compliance Schedules''; .1413--
``Sources Not Otherwise Listed in This Section''; .1414--``Tune-up
Requirements''; and .1423--``Large Internal Combustion Engines'' as
well as changes to other rules not related to today's proposed action.
The submittal again included Section .1406--``Utility Boilers
(Repealed)'' with no regulatory text. North Carolina took these rule
changes to hearing on May 21, 2001, and June 5, 2001. EPA did not act
on the August 14, 2002, submittal.
    On June 5, 2017, North Carolina withdrew its August 14, 2002, SIP
submittal and resubmitted the changes to Sections .1401, .1403, .1413,
.1414, and .1423 contained in the 2002 submittal along with the repeal
of Section .1406. The June 5, 2017, submittal relies on the hearing
record associated with the August 14, 2002, submittal because the rule
text is identical. On June 28, 2018, North Carolina supplemented its
June 5, 2017, submittal to acknowledge that Sections .1413 and .1414
are not in the SIP.
    In a notice of proposed rulemaking (NPRM) published on November 5,
2018, EPA proposed approval of the June 5, 2017, SIP submission, as
supplemented June 28, 2018. See 83 FR 55335. Comments on the NPRM were
due on or before November 26, 2018. EPA received supporting comments
and adverse comments on the proposed rule. The Agency has summarized
and responded to the potentially adverse comments below (the commenters
are hereinafter collectively referred to as ``the Commenter'').

III. Response to Comment

    Comment 1: The Commenter states that the world has vastly changed
since the enactment of the Clean Air Act and that the ``science used
through the NC DAQ has changed along with it.'' The Commenter further
states that the ``State Implementation Plan though the Clean Air Act
has been untouched since 2001, and if this is the third of these
attempts it is vital to comply with some of the requests. Climate
change policy as matured in North Carolina, and this is another part of
that development.''
    Response 1: It is unclear how the comment relates to the proposal
or how the Commenter would like EPA to change the proposed rule. EPA
has modified the North Carolina SIP numerous times since 2001 in
response to SIP revisions submitted by the State and is taking action
to further modify the SIP as described in the NPRM. See 40 CFR
52.1770(c) and (e). Furthermore, the SIP revision at issue is focused
on the control of NOX emissions and does not expressly
address climate change.
    Comment 2: The Commenter notes that North Carolina replaced the
phrase ``optimization of'' with ``utilization'' in the definition of
``reasonable effort'' in Section .1401. According to the Commenter,
``it seems as though North Carolina is trying to avoid an efficient use
of the abatement technology,'' ``avoiding the Clean Air Act's goal,''
and ``not putting in maximum effort to abate NOX.''
    Response 2: The criterion for EPA approval in this instance is
whether, under CAA section 110(l), the SIP revision would interfere
with any applicable requirement concerning attainment and reasonable
further progress or any other applicable CAA requirement. As discussed
in the NPRM, EPA does not believe that approval would violate section
110(l) given the limited applicability of the provision, the continued
requirement to follow manufacturers' recommendations or other similar
guidance, the fact that it was state effective in 2002, and the lack of
nonattainment areas in the State for any criteria pollutant.
    Comment 3: Regarding Section .1413--Sources Not Otherwise Listed in
This Section, the Commenter states that it is important to specify RACT
in the SIP ``as it shows the EPA is requiring all sources of
NOX combustion to specify their usage of RACT.'' The
Commenter states that the rule ``could go a step further and the EPA
could mandate Best Available Control Technology [BACT]. This makes it
seem like North Carolina is trying to slide around the rule and not
implement the best-case scenario in terms of abatement.''
    Response 3: EPA agrees that it should incorporate Section .1413
into the SIP as a strengthening measure. As a point of clarification,
the rule does not require

``all sources of NOX combustion to specify their usage of
RACT.'' The rule requires certain sources of NOX--other than
boilers, indirect-fired process heaters, stationary combustion
turbines, and stationary internal combustion engines--at facilities
with a potential to emit of 100 tons per year or more of NOX
or 560 pounds per calendar day or more from May 1 through September 30
to apply RACT.
    Regarding the comments concerning BACT, EPA cannot mandate the use
of this control technology under this circumstance. BACT is a CAA
requirement for major new or modified stationary sources subject to the
Prevention of Significant Deterioration (PSD) program under Title I,
Part C of the Act. North Carolina did not submit Section .1413 to EPA
to satisfy the State's PSD obligations under the CAA, and EPA has
already approved North Carolina's PSD program at 15A NCAC 02D .0530,
including its BACT provisions, as meeting CAA requirements and
incorporated the program into the SIP. See, e.g., 47 FR 7836 (February
23, 1982).
    Comment 4: Regarding Section .1403--Compliance Schedules, the
Commenter notes that EPA is not acting on this rule because it already
approved a previous submission. The Commenter then states that EPA
``should look into this rule further, as the last effective revision
for this rule was in 2002. Schedules change, and this could be another
example of the EPA not being strict enough in implementing the Clean
Air Act's statutes on North Carolina.''
    Response 4: It is unclear how the Commenter would like EPA to
change the proposed rule, and EPA does not agree that the last
effective revision for Section .1403 was in 2002. North Carolina last
modified Section .1403 on July 1, 2007, and EPA approved that version
of the rule into the SIP on May 9, 2013. See 78 FR 27065. Because the
2007 version of the rule (approved by EPA in 2013) superseded the July
15, 2002, version contained in the June 5, 2017, SIP revision, EPA is
not taking action on the portion of the submittal regarding Section
.1403.
    Comment 5: The Commenter states that the SIP revisions ``do a good
job in creating a better understanding of North Carolina's abatement
efforts, however the EPA could revisit rules of the previous
submissions. They have chosen to not take action on several rules, but
these rules .1403, .1406 and .1423 could better strengthen the SIP if
they were updated and better evaluated.''
    Response 5: It is unclear how the Commenter would like EPA to
change the proposed rule or how Sections .1403, .1406, and .1423 could
strengthen the SIP ``if they were updated and better evaluated.'' As
discussed in Response 4, EPA has already incorporated the most recent
state-effective version of Section .1403 into the SIP. EPA is not
acting on Section .1406--Utility Boilers (Repealed) because the rule
contains no regulatory text and because EPA never incorporated Section
.1406 into the SIP. EPA is not acting on Section .1423 at this time.
Any future action on that rule will occur in a separate rulemaking. To
the extent that the Commenter wants EPA to revisit rules of previous
SIP submissions, EPA notes that this action is limited to the June 5,
2017 SIP revision and that previous SIP submissions on these rules are
no longer before the Agency for review.

IV. Incorporation by Reference

    In this document, EPA is finalizing regulatory text that includes
incorporation by reference. In accordance with requirements of 1 CFR
51.5, EPA is finalizing the incorporation by reference North Carolina
regulations under Subchapter 2D Air Pollution Control Requirements,
Section .1401--``Definitions,'' modified to clarify which definitions
outside of the rule apply to Section .1400, including definitions from
the CFR, add a definition for ``combustion turbine,'' modify the
definition of ``reasonable effort,'' ``emergency generator,''
``emergency use internal combustion engines,'' ``fossil fuel fired,''
``ozone season,'' ``seasonal energy input'' and ``seasonal energy
output,'' and renumber the paragraphs within the rule, state effective
on July 15, 2002; Section .1413--``Sources Not Otherwise Listed in This
Section,'' which includes rules for NOX sources not
otherwise listed in section .1400, state effective on July 18, 2002;
and Section .1414--``Tune-Up Requirements,'' which includes tune-up
requirements for certain boilers, indirect-fired process heaters and
stationary internal combustion engines, state effective on July 18,
2002. EPA has made, and will continue to make, these materials
generally available through www.regulations.gov and at the EPA Region 4
Office (please contact the person identified in the FOR FURTHER
INFORMATION CONTACT section of this preamble for more information).
Therefore, these materials have been approved by EPA for inclusion in
the State implementation plan, have been incorporated by reference by
EPA into that plan, are fully federally enforceable under sections 110
and 113 of the CAA as of the effective date of the final rulemaking of
EPA's approval, and will be incorporated by reference in the next
update to the SIP compilation.\4\
---------------------------------------------------------------------------

    \4\ See 62 FR 27968 (May 22, 1997).
---------------------------------------------------------------------------

V. Final Action

    Pursuant to section 110 of the CAA, EPA is approving the
aforementioned changes to the North Carolina SIP.

VI. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. See 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. This action merely
approves state law as meeting Federal requirements and does not impose
additional requirements beyond those imposed by state law. For that
reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because SIP approvals are exempted under
Executive Order 12866;
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as

appropriate, disproportionate human health or environmental effects,
using practicable and legally permissible methods, under Executive
Order 12898 (59 FR 7629, February 16, 1994).
    The SIP is not approved to apply on any Indian reservation land or
in any other area where EPA or an Indian tribe has demonstrated that a
tribe has jurisdiction. In those areas of Indian country, the rule does
not have tribal implications as specified by Executive Order 13175 (65
FR 67249, November 9, 2000), nor will it impose substantial direct
costs on tribal governments or preempt tribal law.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action 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. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by February 25, 2019. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. This action may not be challenged later in proceedings to
enforce its requirements. See section 307(b)(2).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Nitrogen dioxide, Ozone,
Reporting and recordkeeping requirements, Volatile organic compounds.

    Dated: December 6, 2018.
Mary S. Walker,
Acting Regional Administrator, Region 4.

    40 CFR part 52 is amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

    Authority: 42.U.S.C. 7401 et seq.

Subpart II--North Carolina

0
2. In Sec.  52.1770, the table in paragraph (c)(1) is amended by:
0
a. Revising the entry ``Section .1401''.
0
b. Adding the entries ``Section .1413'' and ``Section .1414'' in
numerical order.
    The additions and revision read as follows:

Sec.  52.1770  Identification of plan.

* * * * *
    (c) * * *

                                   (1) EPA-Approved North Carolina Regulations
----------------------------------------------------------------------------------------------------------------
                                                           State
        State citation               Title/subject       effective     EPA approval date         Explanation
                                                            date
----------------------------------------------------------------------------------------------------------------
                                Subchapter 2D Air Pollution Control Requirements
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                                          Section .1400 Nitrogen Oxides
----------------------------------------------------------------------------------------------------------------
Section .1401.................  Definitions...........    7/15/2002  12/26/2018, [insert    ....................
                                                                      Federal Register
                                                                      citation].

                                                  * * * * * * *
Section .1413.................  Sources Not Otherwise     7/18/2002  12/26/2018, [insert    ....................
                                 Listed in This                       Federal Register
                                 Section.                             citation].
Section .1414.................  Tune-Up Requirements..    7/18/2002  12/26/2018, [insert    ....................
                                                                      Federal Register
                                                                      citation].

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

* * * * *
[FR Doc. 2018-27747 Filed 12-21-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 77, Number 101 (Thursday, May 24, 2012)]
[Rules and Regulations]
[Page 30891]
[FR Doc No: 2012-12595]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 100

[Docket No. USCG-2009-0996]

Hydroplane Races Within the Captain of the Port Puget Sound Area
of Responsibility

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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SUMMARY: The Coast Guard will enforce the Special Local Regulation for
Hydroplane Races within the Captain of the Port Puget Sound Area of
Responsibility for the Tastin' n' Racin' hydroplane event in Lake
Sammamish, WA on June 9th and 10th, 2012. This action is necessary to
restrict vessel movement in the vicinity of the race courses thereby
ensuring the safety of participants and spectators during these events.
During the enforcement period non-participant vessels are prohibited
from entering the designated race areas. Spectator craft entering,
exiting or moving within the spectator area must operate at speeds
which will create a minimum wake.

DATES: The regulations in 33 CFR 100.1308 will be enforced from 9 a.m.
through 6 p.m. on June 9, 2012 and from 9 a.m. through 6 p.m. on June
10, 2012.

FOR FURTHER INFORMATION CONTACT: If you have questions on this notice,
call or email Ensign Anthony P. LaBoy, Sector Puget Sound Waterways
Management Division, Coast Guard; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Coast Guard is providing notice of
enforcement of the Special Local Regulation for Hydroplane Races within
the Captain of the Port Puget Sound Area of Responsibility 33 CFR
100.1308. The Lake Sammamish area, 33 CFR 100.1308(a)(3) will be
enforced on June 9, 2012, from 9 a.m. to 6 p.m. and on June 10, 2012
from 9 a.m. to 6 p.m. These regulations can be found in the March 29,
2011 issue of the Federal Register (76 FR 17341).
    Under the provisions of 33 CFR 100.1308, the regulated area shall
be closed for the duration of the event to all vessel traffic not
participating in the event and authorized by the event sponsor or Coast
Guard Patrol Commander.
    When this special local regulation is enforced, non-participant
vessels are prohibited from entering the designated race areas unless
authorized by the designated on-scene Patrol Commander. Spectator craft
may remain in designated spectator areas but must follow the directions
of the designated on-scene Patrol Commander. The event sponsor may also
function as the designated on-scene Patrol Commander. Spectator craft
entering, exiting or moving within the spectator area must operate at
speeds which will create a minimum wake.
    Emergency Signaling: A succession of sharp, short signals by
whistle or horn from vessels patrolling the areas under the discretion
of the designated on-scene Patrol Commander shall serve as a signal to
stop. Vessels signaled shall stop and shall comply with the orders of
the patrol vessel. Failure to do so may result in expulsion from the
area, citation for failure to comply, or both.
    This notice is issued under authority of 33 CFR 100.1308 and 5
U.S.C. 552(a). In addition to this notice in the Federal Register, the
Coast Guard will provide the maritime community with advance
notification of this enforcement period via the Local Notice to
Mariners. If the Captain of the Port determines that the regulated area
need not be enforced for the full duration stated in this notice, he
may use a Broadcast Notice to Mariners to grant general permission to
enter the regulated area.

    Dated: May 13, 2012.
S.J. Ferguson,
Captain, U.S. Coast Guard, Captain of the Port, Puget Sound.
[FR Doc. 2012-12595 Filed 5-23-12; 8:45 a.m.]
BILLING CODE 9110-04-P


[Federal Register Volume 83, Number 169 (Thursday, August 30, 2018)]
[Rules and Regulations]
[Pages 44207-44209]
[FR Doc No: 2018-18735]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2018-0036; Product Identifier 2017-SW-015-AD; Amendment
39-19354; AD 2018-16-14]
RIN 2120-AA64

Airworthiness Directives; Bell Helicopter Textron Inc.,
Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for Bell
Helicopter Textron Inc. (Bell) Model 212, Model 412, and Model 412EP
helicopters. This AD requires replacing the emergency flotation system
(EFS) tube assembly. This AD was prompted by a report of an EFS tube
assembly failure. The actions of this AD are intended to address an
unsafe condition on these products.

DATES: This AD is effective October 4, 2018.

ADDRESSES: For service information identified in this final rule,
contact Bell Helicopter Textron, Inc., P.O. Box 482, Fort Worth, TX
76101; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; or at http://www.bellcustomer.com/files/. You may review a copy of the referenced
service information at the FAA, Office of the Regional Counsel,
Southwest Region, 10101 Hillwood Pkwy., Room 6N-321, Fort Worth, TX
76177.

Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0036; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this AD, the economic evaluation, any comments received, and other
information. The street address for Docket Operations (phone: 800-647-
5527) is U.S.

Department of Transportation, Docket Operations, M-30, West Building
Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC
20590.

FOR FURTHER INFORMATION CONTACT: Rory Rieger, Aviation Safety Engineer,
DSCO Branch, AIR-7J0, FAA, 10101 Hillwood Pkwy., Fort Worth, TX 76177;
telephone<PHONE_NUMBER>; email [email protected].

SUPPLEMENTARY INFORMATION:

Discussion

    On January 26, 2018, at 83 FR 3630, the Federal Register published
our notice of proposed rulemaking (NPRM), which proposed to amend 14
CFR part 39 by adding an AD that would apply to Bell Model 212, Model
412, and Model 412EP helicopters with a certain EFS tube assembly
installed. The NPRM proposed to require, within 300 hours time-in-
service (TIS), replacing any EFS tube assembly part number (P/N) 412-
073-820-101 with an unknown manufacture date or that was manufactured
before July 28, 2016. The NPRM also proposed to prohibit installing on
any helicopter an EFS tube assembly P/N 412-073-820-101 that was
manufactured before July 28, 2016 or that has an unknown manufacture
date.
    The NPRM was prompted by a report from Bell that an EFS tube
assembly separated from the valve during a 2-year inflation test. A
subsequent investigation found that excessive sleeve preset force
during manufacturing caused cracks in the sleeve of the tube assembly,
which may result in the EFS float failing to deploy. Bell determined
that only those EFS tube assemblies with P/N 412-073-820-101 that were
shipped prior to July 28, 2016, were subject to this manufacturing
defect. Bell states that because this manufacturing defect is difficult
to detect, affected EFS tube assemblies in service must be replaced.
The affected parts were associated with a single Bell supplier that is
no longer manufacturing the tube assembly.

Comments

    We gave the public the opportunity to participate in developing
this AD, but we did not receive any comments on the NPRM.

FAA's Determination

    We have reviewed the relevant information and determined that an
unsafe condition exists and is likely to exist or develop on other
products of these same type designs and that air safety and the public
interest require adopting the AD requirements as proposed.

Related Service Information

    We reviewed Bell Alert Service Bulletin (ASB) 212-11-143 for Bell
Model 212 helicopters, and ASB 412-11-147 for Bell Model 412 and 412EP
helicopters, both Revision C and dated December 22, 2016. Each ASB
describes and illustrates procedures to replace the tube assembly
within 600 flight hours or by March 31, 2017.

Differences Between This AD and the Service Information

    The service information requires compliance within 600 flight hours
or by March 31, 2017; this AD requires compliance within 300 hours TIS.

Costs of Compliance

    We estimate that this AD will affect 250 helicopters of U.S.
Registry.
    We estimate that operators will incur the following costs in order
to comply with this AD. At an average labor rate of $85 per hour,
replacing a tube assembly will require about 6 work-hours and required
parts will cost $4,902, for a total cost of $5,412 per helicopter and
$1,353,000 for the U.S. fleet.
    According to Bell's service information, some of the costs of this
AD may be covered under warranty, thereby reducing the cost impact on
affected individuals. We do not control warranty coverage by Bell.
Accordingly, we have included all costs in our cost estimate.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have 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.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866;
    (2) Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979);
    (3) Will not affect intrastate aviation in Alaska to the extent
that it justifies making a regulatory distinction; and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared an economic evaluation of the estimated costs to comply
with this AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13   [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

2018-16-14 Bell Helicopter Textron Inc.: Amendment 39-19354; Docket
No. FAA-2018-0036; Product Identifier 2017-SW-015-AD.

(a) Applicability

    This AD applies to Bell Helicopter Textron Inc. Model 212, Model
412, and Model 412EP helicopters, certificated in any category, with
an emergency flotation system (EFS) tube assembly part number (P/N)
412-073-820-101 with a date of manufacture before July 28, 2016, or
an unknown date of manufacture installed.

(b) Unsafe Condition

    This AD defines the unsafe condition as a crack on an EFS tube
assembly. This condition could result in failure of the

emergency floats to inflate during an emergency water landing.

(c) Effective Date

    This AD becomes effective October 4, 2018.

(d) Compliance

    You are responsible for performing each action required by this
AD within the specified compliance time unless it has already been
accomplished prior to that time.

(e) Required Actions

    (1) Within 300 hours time-in-service:
    (i) Remove the EFS tube assembly from service.
    (ii) Lubricate the shoulder of the sleeves, threads, and seat of
each mating fitting with anti-seize compound.
    (iii) Install an EFS tube assembly not listed in paragraph (a)
of this AD.
    (2) After the effective date of this AD, do not install an EFS
tube assembly listed in paragraph (a) of this AD on any helicopter.

(f) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, DSCO Branch, FAA, may approve AMOCs for this
AD. Send your proposal to: Rory Rieger, Aviation Safety Engineer,
DSCO Branch, AIR-7J0, FAA, 10101 Hillwood Pkwy., Fort Worth, TX
76177; telephone<PHONE_NUMBER>; email [email protected].
    (2) For operations conducted under a 14 CFR part 119 operating
certificate or under 14 CFR part 91, subpart K, we suggest that you
notify your principal inspector, or lacking a principal inspector,
the manager of the local flight standards district office or
certificate holding district office before operating any aircraft
complying with this AD through an AMOC.

(g) Additional Information

    Bell Helicopter Alert Service Bulletins 212-11-143 and 412-11-
147, both Revision C and dated December 22, 2016, which are not
incorporated by reference, contain additional information about the
subject of this AD. For service information identified in this AD,
contact Bell Helicopter Textron, Inc., P.O. Box 482, Fort Worth, TX
76101; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; or at http://www.bellcustomer.com/files/. You may review a copy of information at
the FAA, Office of the Regional Counsel, Southwest Region, 10101
Hillwood Pkwy., Room 6N-321, Fort Worth, TX 76177.

(h) Subject

    Joint Aircraft Service Component (JASC) Code: 3212 Emergency
Flotation Section.

    Issued in Fort Worth, Texas, on August 3, 2018.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2018-18735 Filed 8-29-18; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 77, Number 149 (Thursday, August 2, 2012)]
[Notices]
[Pages 46091-46092]
[FR Doc No: 2012-18870]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9710-5]

Notice of Proposed Administrative Settlement Pursuant to the
Comprehensive Environmental Response, Compensation, and Liability Act,
As Amended; Anaconda Copper Mine Site

AGENCY: Environmental Protection Agency.

ACTION: Notice, request for public comments.

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SUMMARY: In accordance with Section 122(i) of the Comprehensive
Environmental Response, Compensation, and Liability Act (``CERCLA''),
as amended, 42 U.S.C. 9622(i), notice is hereby given of a proposed
Settlement Agreement and Order on Consent for Removal Action by Bona
Fide Administrative Agreement for Recovery of Past Response Costs
(``Agreement,'' Region 9 Docket No. 9-2012-07) pursuant to Section
122(h) of CERCLA concerning the ANACONDA COPPER MINE SITE (the
``Site''), located in Yerington, Lyon County, Nevada. The respondent is
Singatse Peak Services (``Respondent''). Through the proposed
Agreement, the Respondent will fund up to $420,000 toward a response
action by EPA to address releases from the Arimetco heap leach fluid
management system (``FMS''). Respondent will conduct a study to assess
options to ensure approximately five years of fluid capacity in the
FMS, and may pay toward any response to implement a selected option.
The Agreement provides Respondent with a covenant not to sue for past
costs at the Site and response actions funded in the Agreement, as well
as contribution protection. For thirty (30) days following the date of
publication of this Notice, the Agency will receive written comments
relating to the proposed Agreement, and EPA's responses to comments
received will be available for public inspection at EPA's Region IX
offices, located at 75 Hawthorne Street, San Francisco, California
94105.

DATES: Comments must be submitted on or before September 4, 2012.

ADDRESSES: The proposed Agreement may be obtained from Bryan Goodwin,
in the Office of Regional Counsel, telephone<PHONE_NUMBER>. Comments
regarding the proposed Agreement should be addressed to Mr. Goodwin at
the U.S. Environmental Protection Agency (ORC-3), 75 Hawthorne Street,
San Francisco, California 94105, and should reference the Singatse Peak
Services Agreement for the Anaconda Copper Mine Site, and Region IX
Docket No. 9-2012-07.

FOR FURTHER INFORMATION CONTACT: Andrew Helmlinger, Office of Regional
Counsel,<PHONE_NUMBER>, U.S. Environmental Protection Agency, Region
9, 75 Hawthorne Street, San Francisco, CA 94105.

    Dated: July 23, 2012.
Jane Diamond,
Director, Superfund Division.
[FR Doc. 2012-18870 Filed 8-1-12; 8:45 am]
BILLING CODE 6560-50-P