[Federal Register Volume 88, Number 225 (Friday, November 24, 2023)]
[Notices]
[Page 82344]
[FR Doc No: 2023-25961]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 4202-000]

KEI (Maine) Power Management (II) LLC; Notice of Authorization
for Continued Project Operation

    The license for the Lowell Tannery Hydroelectric Project No. 4202
was issued for a period ending September 30, 2023.
    Section 15(a)(1) of the FPA, 16 U.S.C. 808(a)(1), requires the
Commission, at the expiration of a license term, to issue from year-to-
year an annual license to the then licensee(s) under the terms and
conditions of the prior license until a new license is issued, or the
project is otherwise disposed of as provided in section 15 or any other
applicable section of the FPA. If the project's prior license waived
the applicability of section 15 of the FPA, then, based on section 9(b)
of the Administrative Procedure Act, 5 U.S.C. 558(c), and as set forth
at 18 CFR 16.21(a), if the licensee of such project has filed an
application for a subsequent license, the licensee may continue to
operate the project in accordance with the terms and conditions of the
license after the minor or minor part license expires, until the
Commission acts on its application. If the licensee of such a project
has not filed an application for a subsequent license, then it may be
required, pursuant to 18 CFR 16.21(b), to continue project operations
until the Commission issues someone else a license for the project or
otherwise orders disposition of the project.
    If the project is subject to section 15 of the FPA, notice is
hereby given that an annual license for Project No. 4202 is issued to
KEI (Maine) Power Management (II) LLC for a period effective October 1,
2023, through September 30, 2024, or until the issuance of a new
license for the project or other disposition under the FPA, whichever
comes first. If issuance of a new license (or other disposition) does
not take place on or before September 30, 2024, notice is hereby given
that, pursuant to 18 CFR 16.18(c), an annual license under section
15(a)(1) of the FPA is renewed automatically without further order or
notice by the Commission, unless the Commission orders otherwise.
    If the project is not subject to section 15 of the FPA, notice is
hereby given that KEI (Maine) Power Management (II) LLC is authorized
to continue operation of the Lowell Tannery Hydroelectric Project under
the terms and conditions of the prior license until the issuance of a
subsequent license for the project or other disposition under the FPA,
whichever comes first.

    Dated: November 17, 2023.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2023-25961 Filed 11-22-23; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 199 (Monday, October 15, 2018)]
[Rules and Regulations]
[Pages 51863-51867]
[FR Doc No: 2018-22279]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0273; FRL-9983-96]

Etoxazole; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
etoxazole in or on multiple commodities which are identified and
discussed later in this document. In addition, it removes certain
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 October 15, 2018. Objections and
requests for hearings must be received on or before December 14, 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-2017-0273, 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-2017-0273 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
December 14, 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-2017-0273, 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 October 23, 2017 (82 FR 49020) (FRL-
9967-37), 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
7E8559) by IR-4 Project Headquarters, 500 College Road East, Suite 201
W, Princeton, New Jersey 08540. The petition requested that 40 CFR
180.593 be amended by establishing tolerances for residues of the
miticide/insecticide etoxazole, (2-(2,6-difluorophenyl)-4-[4-(1,1-
dimethylethyl)-2-ethoxyphenyl]-4,5-dihydrooxazole), in or on Corn,
sweet, kernel plus cob with husks removed at 0.01 parts per million
(ppm); Corn, sweet, forage at 1.5 ppm; Corn, sweet, stover at 5.0 ppm;
Fruit, pome, group 11-10 at 0.20 ppm; Nut, tree, group 14-12 at 0.01
ppm; Fruit, stone, group 12-12 at 1.0 ppm; and Cottonseed subgroup 20C
at 0.05 ppm. In addition, upon establishment of new tolerances
referenced above, the petitioner requested the removal of existing
tolerances in 40 CFR 180.593 for residues of etoxazole in or on Fruit,
pome, group 11 at 0.20 ppm; Fruit, stone, group 12, except plum at 1.0
ppm; Nut, tree, group 14 at 0.01 ppm; Cotton, undelinted seed at 0.05
ppm; Pistachio at 0.01 ppm; Plum at 0.15 ppm; and Plum, prune, dried at
0.30 ppm. That document referenced a summary of the petition prepared
by Valent U.S.A. Corporation, the registrant, which is available in the
docket, http://www.regulations.gov. There were no comments received in
response to the notice of filing.
    Consistent with the authority in FFDCA 408(d)(4)(A)(i), EPA is
issuing tolerances that vary from what the

petitioner sought. The reasons for these changes are explained in Unit
IV.C.

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 etoxazole including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with etoxazole follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
    The effects in the etoxazole database show liver toxicity in all
species tested (enzyme release, hepatocellular swelling and
histopathological indicators), and the severity does not appear to
increase with time. In rats only, there were effects on incisors
(elongation, whitening, and partial loss of upper and/or lower
incisors). There is no evidence of neurotoxicity or immunotoxicity. No
toxicity was seen at the limit dose in a 28-day dermal toxicity study
in rats. Etoxazole was not mutagenic.
    No increased quantitative or qualitative susceptibilities were
observed following in utero exposure to rats or rabbits in the
developmental studies; however, offspring toxicity was more severe
(increased pup mortality) than maternal toxicity (increased liver and
adrenal weights) at the same dose (158.7 milligram/kilogram/day (mg/kg/
day)) in the rat reproduction study indicating increased qualitative
susceptibility. Etoxazole is not likely to be carcinogenic. This
decision was based on weight-of-evidence approach including the lack of
carcinogenicity in two studies in mice, lack of carcinogenicity in one
study in rats, and the lack of hormonal and reproductive effects in
special studies. Etoxazole was categorized as having low acute toxicity
via the oral, dermal, and inhalation routes. It is not an eye or dermal
irritant or a dermal sensitizer.
    Specific information on the studies received and the nature of the
adverse effects caused by etoxazole 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 titled ``Etoxazole: Human Health Risk
Assessment in Support of Proposed Use a Sweet Corn, and Proposed Crop
Group Updates for Pome Fruit 11-10, Tree Nut Group 14-12, Stone Fruit
Group 12-12, and Cotton Subgroup 20C at pages 22-27 in docket ID number
EPA-HQ-OPP-2017-0273.

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 etoxazole used for
human risk assessment is shown in Table 1 of this unit.

   Table 1--Summary of Toxicological Doses and Endpoints for Etoxazole for Use in Human Health Risk Assessment
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                                   POD and uncertainty/   RfD, PAD, LOC for
        Exposure/Scenario           FQPA Safety factors    risk assessment      Study and toxicological effects
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Chronic dietary (All populations)  NOAEL = 4.62 mg/kg/   cPAD = cRfD = 0.046  Chronic Oral Toxicity Study--Dog.
                                    day.                  mg/kg/day.          LOAEL = 23.5 mg/kg/day based upon
                                   UFA = 10x...........                        increased alkaline phosphatase
                                   UFH = 10x...........                        activity, increased liver
                                   FQPA SF = 1x........                        weights, liver enlargement
                                                                               (females), and incidences of
                                                                               centrilobular hepatocellular
                                                                               swelling in the liver.
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Cancer (Oral, dermal, inhalation)   EPA has classified etoxazole as ``not likely to be carcinogenic to humans''
                                     according to EPA Proposed Guidelines for Carcinogen Risk Assessment (April
                                                                     10, 1996).
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FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. mg/kg/day =
  milligram/kilogram/day. NOAEL = no-observed-adverse-effect-level. PAD = population-adjusted dose (a = acute, c
  = chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human
  (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to etoxazole, EPA considered exposure under the petitioned-for
tolerances as well as all existing etoxazole tolerances in 40 CFR
180.593. EPA assessed dietary exposures from etoxazole 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.
    No such effects were identified in the toxicological studies for
etoxazole; therefore, a quantitative acute dietary exposure assessment
is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA National
Health and Nutrition Examination Survey, What We Eat in America
(NHANES/WWEIA; 2003-2008). As to residue levels in food, EPA assumed
tolerance-level residues or tolerance-level residues adjusted to
account for the residues of concern, 100% crop treated (PCT), and in
the absence of empirical data, default processing factors.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
classified etoxazole as ``not likely'' to be carcinogenic to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue and/or PCT information in the
dietary assessment for etoxazole. 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 etoxazole in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of etoxazole. 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.
    Based on the First Index Reservoir Screening Tool (FIRST), and
Pesticide Root Zone Model Ground Water (PRZM GW) models, the estimated
drinking water concentrations (EDWCs) of etoxazole for chronic
exposures are estimated to be 4.761 parts per billion (ppb) for surface
water and <0.01 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For the chronic dietary risk
assessment, the water concentration of value 4.761 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). Etoxazole is not
registered for any specific use patterns that would result in
residential exposure.
    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 etoxazole to share a common mechanism of toxicity
with any other substances, and etoxazole does not appear to produce a
toxic metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that etoxazole does not
have a common mechanism of toxicity with other substances. For
information regarding EPA's efforts to determine which chemicals have a
common mechanism of toxicity and to evaluate the cumulative effects of
such chemicals, see EPA's website at 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 Food Quality
Protection Act Safety Factor (FQPA SF). In applying this provision, EPA
either retains the default value of 10X, or uses a different additional
safety factor when reliable data are available to EPA support the
choice of a different factor.
    2. Prenatal and postnatal sensitivity. No increased quantitative or
qualitative susceptibilities were observed following in utero exposure
to rats or rabbits in the developmental studies. There is evidence of
increased qualitative offspring susceptibility in the rat reproduction
study, but the concern is low since: (1) The effects in pups are well-
characterized with a clear NOAEL; (2) the selected endpoints are
protective of the doses where the offspring toxicity is observed; and
(3) offspring effects occur at the same doses as parental toxicity so
protecting for parental effects is protective of offspring effects.
There are no residual uncertainties for pre- and post-natal 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 etoxazole is complete.

    ii. There is no indication that etoxazole is a neurotoxic chemical
and there is no need for a developmental neurotoxicity study or
additional UFs to account for neurotoxicity.
    iii. The observed qualitative postnatal susceptibility is protected
for by the selected endpoints.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to etoxazole in drinking water. These assessments
will not underestimate the exposure and risks posed by etoxazole.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
etoxazole is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
etoxazole from food and water will utilize 15% of the cPAD for children
1-2 years old, the population group receiving the greatest exposure.
There are no residential uses for etoxazole.
    3. Short- and Intermediate-term risks. Short- and intermediate-term
aggregate exposures take into account short- and intermediate-term
residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
    A short- and intermediate-term adverse effect was identified;
however, etoxazole is not registered for any use patterns that would
result in either short- or intermediate-term residential exposure.
Short- and intermediate-term risks are assessed based on short- or
intermediate-term residential exposure plus chronic dietary exposure.
Because there is no short- or intermediate-term residential exposure
and chronic dietary exposure has already been assessed under the
appropriately protective cPAD (which is at least as protective as the
POD used to assess short- or intermediate-term risks), no further
assessment of short- or intermediate-term risk is necessary, and EPA
relies on the chronic dietary risk assessment for evaluating short- and
intermediate-term risks for etoxazole.
    4. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, etoxazole is not expected to pose a cancer risk to humans.
    5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to etoxazole residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate methodologies (Valent Method RM-37, gas chromatography/
mass-selective detector (GC/MSD) or GC/nitrogen-phosphorus detector
(NPD)) are available to enforce the tolerance expression.
    The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number:<PHONE_NUMBER>; email address:
[email 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.
    Codex has established maximum residue limits (MRLs) for residues of
etoxazole in or on pome fruit (0.07 ppm) and tree nut (0.01 ppm). The
relevant U.S. tolerances are harmonized with the tree nut MRL but
cannot be harmonized with the pome fruit MRL because doing so could
result in exceedances for application consistent with the domestic
registration.

C. Revisions to Petitioned-for Tolerances

    Instead of the petitioned-for tolerance on Fruit, stone, group 12-
12 at 1.0 ppm, EPA is establishing separate subgroup tolerances for
this crop group including Cherry subgroup 12-12A at 1.0 ppm, Peach
subgroup 12-12B at 1.0 ppm, and Plum subgroup 12-12C at 0.15 ppm; and
is retaining the existing separate, lower tolerance on Plum, prune,
dried at 0.30 ppm as that remains necessary to cover the processed
commodity. Separate subgroup tolerances are being established because
there is more than a factor of five between the residue levels for the
cherry and peach subgroups and the residues levels for commodities in
the plum subgroup.

V. Conclusion

    Therefore, tolerances are established for residues of etoxazole,
(2-(2,6-difluorophenyl)-4-[4-(1,1-dimethylethyl)-2-ethoxyphenyl]-4,5-
dihydrooxazole, in or on Cherry subgroup 12-12A at 1.0 ppm; Corn,
sweet, forage at 1.5 ppm; Corn, sweet, kernel plus cob with husks
removed at 0.01 ppm; Corn, sweet, stover at 5.0 ppm; Cottonseed
subgroup 20C at 0.05 ppm; Fruit, pome, group 11-10 at 0.20 ppm; Nut,
tree group 14-12 at 0.01 ppm, Peach subgroup 12-12B at 1.0 ppm and Plum
subgroup 12-12C at 0.15 ppm. In addition, this regulation removes
existing tolerances in 40 CFR 180.593 for residues of etoxazole in or
on Fruit, pome, group 11 at 0.20 ppm; Fruit, stone, group 12, except
plum at 1.0 ppm; Nut, tree, group 14 at 0.01 ppm; Cotton, undelinted
seed at 0.05 ppm; Pistachio at 0.01 ppm; and Plum at 0.15 ppm that are
superseded by this action.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect

Energy Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001) or
Executive Order 13045, entitled ``Protection of Children from
Environmental Health Risks and Safety Risks'' (62 FR 19885, April 23,
1997); 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: October 2, 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. Amend the table in Sec.  180.593(a) as follows:
0
a. Add alphabetically the entries for ``Cherry subgroup 12-12A'';
``Corn, sweet, forage''; ``Corn, sweet, kernel plus cob with husks
removed''; ``Corn, sweet, stover''; ``Cottonseed subgroup 20C'';
``Fruit, pome, group 11-10''; ``Nut, tree group 14-12''; Peach subgroup
12-12B''; and ``Plum subgroup 12-12C''.
0
b. Remove the entries for ``Cotton, undelinted seed''; ``Fruit, pome,
group 11''; ``Fruit, stone, group 12, except plum''; ``Nut, tree, group
14''; ``Pistachio''; and ``Plum.''

Sec.  180.593   Etoxazole; tolerances for residues.

    (a) * * *

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

                                * * * * *
Cherry subgroup 12-12A......................................         1.0

                                * * * * *
Corn, sweet, forage.........................................         1.5
Corn, sweet, kernel plus cob with husks removed.............        0.01
Corn, sweet, stover.........................................         5.0

                                * * * * *
Cottonseed subgroup 20C.....................................        0.05
Fruit, pome, group 11-10....................................        0.20

                                * * * * *
Nut, tree group 14-12.......................................        0.01

                                * * * * *
Peach subgroup 12-12B.......................................         1.0

                                * * * * *
Plum subgroup 12-12C........................................        0.15

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

* * * * *
[FR Doc. 2018-22279 Filed 10-12-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 87, Number 144 (Thursday, July 28, 2022)]
[Proposed Rules]
[Pages 45284-45288]
[FR Doc No: 2022-16098]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2022-0979; Project Identifier MCAI-2022-00171-T]
RIN 2120-AA64

Airworthiness Directives; Embraer S.A. (Type Certificate
Previously Held by Yabor[atilde] Ind[uacute]stria Aeron[aacute]utica
S.A.; Embraer S.A.) Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: The FAA proposes to supersede Airworthiness Directive (AD)
2019-25-16, which applies to certain Embraer S.A. Model ERJ 170-100 LR,
-100 STD, -100 SE, and -100 SU airplanes; and Model ERJ 170-200 LR, -
200 SU, -200 STD, and -200LL airplanes. AD 2019-25-16 requires revising
the existing maintenance or inspection program, as applicable, to
incorporate new or more restrictive airworthiness limitations. Since
the FAA issued AD 2019-25-16, the FAA has determined that new or more
restrictive airworthiness limitations are necessary. This proposed AD
would continue to require the actions in AD 2019-25-16 and require
revising the existing maintenance or inspection program, as applicable,
to incorporate additional new or more restrictive airworthiness
limitations and incorporate certain structural modifications, as
specified in an Ag[ecirc]ncia Nacional de Avia[ccedil][atilde]o Civil
(ANAC) AD, which is proposed for incorporation by reference. The FAA is
proposing this AD to address the unsafe condition on these products.

DATES: The FAA must receive comments on this proposed AD by September
12, 2022.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to www.regulations.gov.
Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    For ANAC material that will be incorporated by reference (IBR) in
this AD, contact National Civil Aviation Agency (ANAC), Aeronautical
Products Certification Branch (GGCP), Rua Dr. Orlando Feirabend Filho,
230--Centro Empresarial Aquarius--Torre B--Andares 14 a 18, Parque
Residencial Aquarius, CEP 12.246-190--S[atilde]o Jos[eacute] dos
Campos--SP, Brazil; telephone 55 (12) 3203-6600; email [email protected];
internet www.anac.gov.br/en/. You may find this material on the ANAC
website at https://sistemas.anac.gov.br/certificacao/DA/DAE.asp. For
Embraer service information identified in this proposed AD, contact
Embraer S.A., Technical Publications Section (PC 060), Av. Brigadeiro
Faria Lima, 2170--Putim--12227-901 S[atilde]o Jose dos Campos--SP--
Brasil; telephone +55 12 3927-5852 or +55 12 3309-0732; fax +55 12
3927-7546; email [email protected]; internet www.flyembraer.com.
You may view this material at the FAA, Airworthiness Products Section,
Operational Safety Branch, 2200 South 216th St., Des Moines, WA. For
information on the availability of this material at the FAA, call 206-
231-3195. The ANAC AD is also available in the AD docket at
www.regulations.gov by searching for and locating Docket No. FAA-2022-
0979.

Examining the AD Docket

    You may examine the AD docket at www.regulations.gov by searching
for and locating Docket No. FAA-2022-0979; 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 NPRM, the mandatory
continuing airworthiness information (MCAI), any comments received, and
other information. The street address for Docket Operations is listed
above.

FOR FURTHER INFORMATION CONTACT: Krista Greer, Aerospace Engineer,
Large Aircraft Section, FAA, International Validation Branch, 2200
South 216th St., Des Moines, WA 98198; telephone<PHONE_NUMBER>; email
[email protected].

SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under ADDRESSES. Include ``Docket No. FAA-2022-0979; Project Identifier
MCAI-2022-00171-T'' at the beginning of your comments. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. The FAA
will consider all comments received by the closing date and may amend
this proposal because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
www.regulations.gov, including any personal information you provide.
The agency will also post a report summarizing each substantive verbal
contact received about this NPRM.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this NPRM contain commercial
or financial information that is customarily treated as private, that
you actually treat as private, and that is relevant or responsive to
this NPRM, it is important that you clearly designate the submitted
comments as CBI. Please mark each page of your submission containing
CBI as ``PROPIN.'' The FAA will treat such marked submissions as
confidential under the FOIA, and they will not be placed in the public
docket of this NPRM. Submissions containing CBI should be sent to
Krista Greer, Aerospace Engineer, Large Aircraft Section, FAA,
International Validation Branch, 2200 South 216th St., Des Moines, WA
98198; telephone<PHONE_NUMBER>; email [email protected]. Any
commentary that the FAA receives which is not specifically designated
as CBI will be placed in the public docket for this rulemaking.

Background

    The FAA issued AD 2019-25-16, Amendment 39-21015 (85 FR 453,
January 6, 2020) (AD 2019-25-16), which applies to certain Embraer S.A.
Model ERJ 170-100 LR, -100 STD, -100 SE, and -100 SU airplanes; and
Model ERJ 170-200 LR, -200 SU, -200 STD, and 200 LL airplanes. AD 2019-
25-16 requires revising the existing maintenance or inspection program,
as applicable, to incorporate new or more restrictive airworthiness
limitations; and adds airplanes to the applicability. The FAA issued AD
2019-25-16 to address fatigue cracking of various principal structural
elements (PSEs); such cracking could result in reduced structural
integrity of the airplane and to prevent safety significant latent
failures; such failures, in combination with one or more other
specified failures or events, could result in a hazardous or
catastrophic failure condition of avionics, hydraulic systems, fire
detection systems, fuel systems, or other critical systems.
Furthermore, the FAA issued AD 2019-25-16 to address potential ignition
sources inside fuel tanks caused by latent failures, alterations,
repairs, or maintenance actions; such failures, in combination with
flammable fuel vapors, could result in fuel tank explosions and
consequent loss of the airplane.

Actions Since AD 2019-25-16 Was Issued

    Since the FAA issued AD 2019-25-16, the FAA has determined that new
or more restrictive airworthiness limitations are necessary.
    ANAC, which is the aviation authority for Brazil, has issued ANAC
AD 2022-02-01, effective February 9, 2022 (ANAC AD 2022-02-01) (also
referred to as the MCAI), to correct an unsafe condition for all
Embraer S.A. Model ERJ 170-100 STD, ERJ 170-100 LR, ERJ 170-100 SU, ERJ
170-100 SE, ERJ 170-200 STD, ERJ 170-200 LR, ERJ 170-200 SU, and ERJ
170-200 LL airplanes. ANAC AD 2022-02-01 supersedes ANAC AD 2019-05-1,
effective May 2, 2019; corrected July 1, 2019 (ANAC AD 2019-05-01),
which corresponds to FAA AD 2019-25-16.
    This proposed AD was prompted by a determination that new or more
restrictive airworthiness limitations are necessary. The FAA is
proposing this AD to address fatigue cracking of various PSEs; such
cracking could result in reduced structural integrity of the airplane
and to address safety significant latent failures; such failures, in
combination with one or more other specified failures or events, could
result in a hazardous or catastrophic failure condition of avionics,
hydraulic systems, fire detection systems, fuel systems, or other
critical systems. Furthermore, the FAA is also proposing this AD to
address potential ignition sources inside fuel tanks caused by latent
failures, alterations, repairs, or maintenance actions; such failures,
in combination with flammable fuel vapors, could result in fuel tank
explosions and consequent loss of the airplane. See the MCAI for
additional background information.

Other Relevant Rulemaking

    ANAC has also issued ANAC AD 2022-05-02, effective May 13, 2022
(ANAC AD 2022-05-02), which corresponds to FAA AD 2022-11-51, Amendment
39-22074 (87 FR 33623, June 3, 2022) (AD 2022-11-51). AD 2022-11-51
applies to certain Embraer S.A. Model ERJ 170-200 STD, ERJ 170-200 LR,
ERJ 170-200 SU, and ERJ 170-200 LL airplanes. AD 2022-11-51 requires a
detailed inspection for cracks of affected wing tip connections,
corrective actions if necessary, and revision of the existing
maintenance or inspection program. Incorporating maintenance review
board report (MRBR) task number 57-30-002-0002, ``Enhanced Wingtip to
Wing Spar Attachments--Internal'' is part of the requirements of
paragraph (g) of AD 2022-11-51 and paragraph (h)(6) of AD 2022-11-51
includes exceptions for that task. The FAA issued AD 2022-11-51 to
address cracks that could develop on the wing tip connection area that
can affect its structural integrity to the point of an in-flight
detachment, which, even if sufficient controllability of the airplane
is maintained for the safe continuation of the flight, could result in
the detached part damaging other airplane parts and affecting
controllability, as well as damaging property and injuring persons on
the ground.
    Since all airplanes affected by AD 2022-11-51 already incorporated
MRBR task number 57-30-002-0002, this proposed AD does not require
incorporating MRBR task number 57-30-002-0002 as part of the revision
of the existing maintenance or inspection program required by paragraph
(i) of this proposed AD.

Related Service Information Under 1 CFR Part 51

    ANAC AD 2022-02-01 describes new or more restrictive airworthiness
limitations for airplane structures and the incorporation of certain
structural modifications (i.e., reinforcement of left-hand (LH) and
right-hand (LH) wing spar II lower; and reinforcement of the wing lower
skin chordwise splices of LH and RH wing) before the defined structural
modifications points (SMP).
    This AD also requires Appendix A--Airworthiness Limitations of
EMBRAER 170/175 Maintenance Review Board Report (MRBR), MRB-1621,
Revision 14, dated September 27, 2018; and Embraer Temporary Revision
(TR) 14-1, dated November 13, 2018, to Part 4-Life-Limited Items, of
Appendix A of EMBRAER 170/175 Maintenance Review Board Report (MRBR),
MRB-1621, Revision 14, dated September 27, 2018; which the Director of
the Federal Register approved for incorporation by reference as of
February 10, 2020 (85 FR 453).
    This material is reasonably available because the interested
parties have access to it through their normal course of business or by
the means identified in the ADDRESSES section.

Differences Between This Proposed AD and the MCAI

    ANAC AD 2022-02-01 supersedes ANAC AD 2019-05-01; however ANAC AD
2022-02-01 does not retain any requirements from ANAC AD 2019-05-01.
ANAC AD 2022-02-01 only requires airworthiness limitations that are in
Part 2 of the referenced MRBR. This proposed AD would retain the
airworthiness limitations for Parts 1, 3, and 4 of the MRBR.

FAA's Determination

    These products have been approved by the aviation authority of
another country and are approved for operation in the United States.
Pursuant to the FAA's bilateral agreement with the State of Design
Authority, it has notified the FAA of the unsafe condition described in
the MCAI referenced above. The FAA is issuing this NPRM after
determining that the unsafe condition described previously is likely to
exist or develop in other products of these same type designs.

Proposed AD Requirements in This NPRM

    This proposed AD would retain the requirements of AD 2019-25-16.
This proposed AD would also require revising the existing maintenance
or inspection program, as applicable, to incorporate new or more
restrictive airworthiness limitations, which are specified in ANAC AD
2022-02-01 described previously, as proposed for incorporation by
reference. Any differences with ANAC AD 2022-02-01 are identified as
exceptions in the regulatory text of this AD except as

discussed under ``Differences Between this Proposed AD and the MCAI.''
    This proposed AD would require revisions to certain operator
maintenance documents to include new actions (e.g., inspections).
Compliance with these actions is required by 14 CFR 91.403(c). For
airplanes that have been previously modified, altered, or repaired in
the areas addressed by this proposed AD, the operator may not be able
to accomplish the actions described in the revisions. In this
situation, to comply with 14 CFR 91.403(c), the operator must request
approval for an alternative method of compliance (AMOC) according to
paragraph (l)(1) of this proposed AD.

Explanation of Required Compliance Information

    In the FAA's ongoing efforts to improve the efficiency of the AD
process, the FAA developed a process to use some civil aviation
authority (CAA) ADs as the primary source of information for compliance
with requirements for corresponding FAA ADs. The FAA has been
coordinating this process with manufacturers and CAAs. As a result, the
FAA proposes to incorporate ANAC AD 2022-02-01 by reference in the FAA
final rule. This proposed AD would, therefore, require compliance with
ANAC AD 2022-02-01 in its entirety through that incorporation, except
for any differences identified as exceptions in the regulatory text of
this proposed AD. Service information required by ANAC AD 2022-02-01
for compliance will be available at www.regulations.gov by searching
for and locating Docket No. FAA-2022-0979 after the FAA final rule is
published.

Airworthiness Limitation ADs Using the New Process

    The FAA's process of incorporating by reference MCAI ADs as the
primary source of information for compliance with corresponding FAA ADs
has been limited to certain MCAI ADs (primarily those with service
bulletins as the primary source of information for accomplishing the
actions required by the FAA AD). However, the FAA is now expanding the
process to include MCAI ADs that require a change to airworthiness
limitation documents, such as airworthiness limitation sections.
    For these ADs that incorporate by reference an MCAI AD that changes
airworthiness limitations, the FAA requirements are unchanged.
Operators must revise the existing maintenance or inspection program,
as applicable, to incorporate the information specified in the new
airworthiness limitation document. The airworthiness limitations must
be followed according to 14 CFR 91.403(c) and 91.409(e).
    The previous format of the airworthiness limitation ADs included a
paragraph that specified that no alternative actions (e.g.,
inspections), or intervals may be used unless the actions and intervals
are approved as an AMOC in accordance with the procedures specified in
the AMOCs paragraph under ``Additional FAA Provisions.'' This new
format includes a ``New Provisions for Alternative Actions and
Intervals'' paragraph that does not specifically refer to AMOCs, but
operators may still request an AMOC to use an alternative action or
interval.

Costs of Compliance

    The FAA estimates that this proposed AD affects 662 airplanes of
U.S. registry. The FAA estimates the following costs to comply with
this proposed AD:
    The FAA estimates the total cost per operator for the retained
actions from AD 2019-25-16 to be $7,650 (90 work-hours x $85 per work-
hour).
    The FAA has determined that revising the existing maintenance or
inspection program takes an average of 90 work-hours per operator,
although the agency recognizes that this number may vary from operator
to operator. Since operators incorporate maintenance or inspection
program changes for their affected fleet(s), the FAA has determined
that a per-operator estimate is more accurate than a per-airplane
estimate.
    The FAA estimates the total cost per operator for the new proposed
revision to the existing maintenance or inspection program to be $7,650
(90 work-hours x $85 per work-hour).

                                     Estimated Costs for Required Actions *
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
              Action                        Labor cost            Parts cost        product         operators
----------------------------------------------------------------------------------------------------------------
New proposed actions..............  196 work-hours x $85 per          $98,860         $115,520      $76,474,240
                                     hour = $16,660.
----------------------------------------------------------------------------------------------------------------
* Table does not include estimated costs for revising the existing maintenance or inspection program.

    According to the manufacturer, some or all of the costs of this
proposed AD may be covered under warranty, thereby reducing the cost
impact on affected individuals. The FAA does not control warranty
coverage for affected individuals. As a result, the FAA has included
all known costs in the 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.
    The FAA is 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

    The FAA determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would 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 this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Would not affect intrastate aviation in Alaska, and
    (3) Would not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 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:
0
a. Removing Airworthiness Directive (AD) 2019-25-16, Amendment 39-21015
(85 FR 453, January 6, 2020); and
0
b. Adding the following new AD:

Embraer S.A. (Type Certificate Previously Held by Yabor[atilde]
Ind[uacute]stria Aeron[aacute]utica S.A.; Embraer S.A.): Docket No.
FAA-2022-0979; Project Identifier MCAI-2022-00171-T.

(a) Comments Due Date

    The FAA must receive comments on this airworthiness directive
(AD) by September 12, 2022.

(b) Affected ADs

    This AD replaces AD 2019-25-16, Amendment 39-21015 (85 FR 453,
January 6, 2020) (AD 2019-25-16).

(c) Applicability

    This AD applies to all Embraer S.A. Model ERJ 170-100 LR, -100
STD, -100 SE, and -100 SU airplanes; and Model ERJ 170-200 LR, -200
SU, -200 STD, and -200 LL airplanes, certificated in any category.

(d) Subject

    Air Transport Association (ATA) of America Code 05, Time Limits/
Maintenance Checks; 27, Flight controls; 28, Fuel; 52, Doors; 53,
Fuselage; 54, Nacelles/pylons; 55, Stabilizers; 57, Wings; 71,
Powerplant; and 78, Exhaust.

(e) Unsafe Condition

    This AD was prompted by a determination that new or more
restrictive airworthiness limitations are necessary. The FAA is
issuing this AD to address fatigue cracking of various principal
structural elements (PSEs); such cracking could result in reduced
structural integrity of the airplane. The FAA is also issuing this
AD to address safety significant latent failures; such failures, in
combination with one or more other specified failures or events,
could result in a hazardous or catastrophic failure condition of
avionics, hydraulic systems, fire detection systems, fuel systems,
or other critical systems. Furthermore, the FAA is issuing this AD
to address potential ignition sources inside fuel tanks caused by
latent failures, alterations, repairs, or maintenance actions; such
failures, in combination with flammable fuel vapors, could result in
fuel tank explosions and consequent loss of the airplane.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Retained Revision of the Existing Maintenance or Inspection
Program, With No Changes

    This paragraph restates the requirements of paragraph (i) of AD
2019-25-16, with no changes. For Model ERJ 170-100 LR, -100 STD, -
100 SE, and -100 SU airplanes; and Model ERJ 170-200 LR, -200 SU, -
200 STD, and -200LL airplanes; manufacturer serial numbers 17000002,
17000004 through 17000013 inclusive, and 17000015 through 17000761
inclusive: Within 90 days after February 10, 2022 (the effective
date of AD 2019-25-16), revise the existing maintenance or
inspection program, as applicable, to incorporate the information
specified in Part 1-Certification Maintenance Requirements, Part 2-
Airworthiness Limitation Inspections (ALI)-Structures, Part 3-Fuel
System Limitation Items, and Part 4-Life Limited Items; and EMBRAER
Temporary Revision (TR) 14-1, dated November 13, 2018, to part 4-
Life Limited Items; of Appendix A of the EMBRAER 170/175 MRBR, MRB-
1621, Revision 14, dated September 27, 2018 (EMBRAER 170/175 MRB-
1621, Revision 14). The initial compliance time for doing the tasks
is at the later of the times specified in paragraphs (g)(1) and (2)
of this AD.
    (1) Within the applicable times specified in EMBRAER 170/175
MRB-1621, Revision 14. For the purposes of this AD, the initial
compliance times (identified as ``Threshold'' or ``T'' in EMBRAER
170/175 MRB-1621, Revision 14) are expressed in ``total flight
cycles'' or ``total flight hours,'' as applicable.
    (2) Within 90 days or 600 flight cycles after February 10, 2022
(the effective date of AD 2019-25-16), whichever occurs later.

(h) Retained Restrictions on Alternative Actions, Intervals, and
CDCCLs, With No Changes

    This paragraph restates the requirements of paragraph (j) of AD
2019-25-16, with no changes. Except as required by paragraph (i) of
this AD: After the existing maintenance or inspection program has
been revised as required by paragraph (g) of this AD, no alternative
actions (e.g., inspections), intervals, or CDCCLs may be used unless
the actions, intervals, and CDCCLs are approved as an AMOC in
accordance with the procedures specified in paragraph (l)(1) of this
AD.

(i) New Revision of the Existing Maintenance or Inspection Program

    Except as specified in paragraph (j) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, ANAC AD 2022-02-01, effective February 9, 2022
(ANAC AD 2022-02-01). Accomplishing the revision of the existing
maintenance or inspection program required by this paragraph
terminates the requirements for Part 2--Airworthiness Limitation
Inspections (ALI)-Structures specified in paragraph (g) of this AD
only.

(j) Exceptions to ANAC AD 2022-02-01

    (1) Where ANAC AD 2022-02-01 refers to its effective date, this
AD requires using the effective date of this AD.
    (2) The ``Alternative method of compliance (AMOC)'' section of
ANAC AD 2022-02-01 does not apply to this AD.
    (3) Where paragraph (b)(1) of ANAC AD 2022-02-01 specifies
incorporating all airworthiness limitations in Part 2 of the service
information specified in paragraph (b)(1) of ANAC AD 2022-02-01, for
this AD, do not incorporate the threshold and interval for
maintenance review board report (MRBR) task number 57-30-002-0002,
``Enhanced Wingtip to Wing Spar Attachments--Internal.''
    Note 1 to paragraph (j)(3): AD 2022-11-51 requires, among other
actions, incorporating alternate thresholds and intervals for MRBR
task number 57-30-002-0002. The airplanes affected by MRBR task
number 57-30-002-0002 are identified in paragraph (c) of AD 2022-11-
51.

(k) New Provisions for Alternative Actions and Intervals

    After the existing maintenance or inspection program has been
revised as required by paragraph (i) of this AD, no alternative
actions (e.g., inspections), intervals, and CDCCLs are allowed
unless they are approved as specified in paragraph (f) of ANAC AD
2022-02-01.

(l) Additional FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Large Aircraft Section, International Validation Branch, FAA, has
the authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or responsible Flight
Standards Office, as appropriate. If sending information directly to
the Large Aircraft Section, International Validation Branch, send it
to the attention of the person identified in paragraph (m)(2) of
this AD. Information may be emailed to: [email protected].
    (i) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the responsible Flight Standards Office.
    (ii) AMOCs approved previously for AD 2019-25-16 are approved as
AMOCs for the corresponding provisions of paragraph (g) of this AD.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, Large Aircraft
Section, International Validation Branch, FAA; or ANAC; or ANAC's
authorized Designee. If approved by the ANAC Designee, the approval
must include the Designee's authorized signature.
    (3) Required for Compliance (RC): Except as required by
paragraph (l)(2) of this AD, if any service information referenced
in AD

2022-02-01 contains steps in the Accomplishment Instructions or
figures that are labeled as RC, the instructions in RC steps,
including subparagraphs under an RC step and any figures identified
in an RC step, must be done to comply with this AD; any steps
including substeps under those steps, that are not identified as RC
are recommended. The instructions in steps, including substeps under
those steps, not identified as RC may be deviated from using
accepted methods in accordance with the operator's maintenance or
inspection program without obtaining approval of an AMOC, provided
the instructions identified as RC can be done and the airplane can
be put back in an airworthy condition. Any substitutions or changes
to instructions identified as RC require approval of an AMOC. If a
step or substep is labeled ``RC Exempt,'' then the RC requirement is
removed from that step or substep.

(m) Related Information

    (1) For ANAC AD 2022-02-01, contact National Civil Aviation
Agency (ANAC), Aeronautical Products Certification Branch (GGCP),
Rua Dr. Orlando Feirabend Filho, 230--Centro Empresarial Aquarius--
Torre B--Andares 14 a 18, Parque Residencial Aquarius, CEP 12.246-
190--S[atilde]o Jos[eacute] dos Campos--SP, Brazil; telephone 55
(12) 3203-6600; email [email protected]; internet www.anac.gov.br/en/.
You may find this ANAC AD on the ANAC website at https://sistemas.anac.gov.br/certificacao/DA/DAE.asp. You may view this
material at the FAA, Airworthiness Products Section, Operational
Safety Branch, 2200 South 216th St., Des Moines, WA. For information
on the availability of this material at the FAA, call<PHONE_NUMBER>.
This material may be found in the AD docket at www.regulations.gov
by searching for and locating Docket No. FAA-2022-0979.
    (2) For more information about this AD, contact Krista Greer,
Aerospace Engineer, Large Aircraft Section, FAA, International
Validation Branch, 2200 South 216th St., Des Moines, WA 98198;
telephone<PHONE_NUMBER>; email [email protected].
    (3) For Embraer service information identified in this AD,
contact Embraer S.A., Technical Publications Section (PC 060), Av.
Brigadeiro Faria Lima, 2170--Putim--12227-901 S[atilde]o Jose dos
Campos--SP--Brasil; telephone +55 12 3927-5852 or +55 12 3309-0732;
fax +55 12 3927-7546; email [email protected]; internet
www.flyembraer.com. You may view this service information at the
FAA, Airworthiness Products Section, Operational Safety Branch, 2200
South 216th St., Des Moines, WA. For information on the availability
of this material at the FAA, call<PHONE_NUMBER>.

    Issued on July 21, 2022.
Christina Underwood,
Acting Director, Compliance & Airworthiness Division, Aircraft
Certification Service.
[FR Doc. 2022-16098 Filed 7-27-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 85, Number 117 (Wednesday, June 17, 2020)]
[Notices]
[Page 36578]
[FR Doc No: 2020-13016]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

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

    Docket Numbers: RP20-947-000.
    Applicants: Rockies Express Pipeline, LLC.
    Description: Section 4(d) Rate Filing: REX 2020-06-05 Negotiated
Rate Agreement to be effective 6/5/2020.
    Filed Date: 6/5/20.
    Accession Number: 20200605-5199.
    Comments Due: 5 p.m. ET 6/17/20.

    Docket Numbers: RP20-948-000.
    Applicants: Transcontinental Gas Pipe Line Company, LLC.
    Description: Section 4(d) Rate Filing: Limited Section 4 Station
240 LNG to be effective 5/1/2020.
    Filed Date: 6/8/20.
    Accession Number: 20200608-5164.
    Comments Due: 5 p.m. ET 6/22/20.

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

    Dated: June 9, 2020.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2020-13016 Filed 6-16-20; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 226 (Friday, November 22, 2019)]
[Notices]
[Pages 64531-64533]
[FR Doc No: 2019-25326]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0369]

Product-Specific Guidances; Draft and Revised Draft Guidances for
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of additional draft and revised draft product-specific
guidances. The guidances provide product-specific recommendations on,
among other things, the design of bioequivalence (BE) studies to
support abbreviated new drug applications (ANDAs). In the Federal
Register of June 11, 2010, FDA announced the availability of a guidance
for industry entitled ``Bioequivalence Recommendations for Specific
Products'' that explained the process that would be used to make
product-specific guidances available to the public on FDA's website.
The guidances identified in this notice were developed using the
process described in that guidance.

DATES: Submit either electronic or written comments on the draft
guidance by January 21, 2020 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2007-D-0369 for ``Product-Specific Guidances; Draft and Revised
Draft Guidances for Industry.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)). Submit written requests for single copies of the draft
guidances to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD
20993-0002. Send one self-addressed adhesive label to assist that
office in processing your requests. See the SUPPLEMENTARY INFORMATION
section for electronic access to the draft guidance documents.

FOR FURTHER INFORMATION CONTACT: Wendy Good, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 75, Rm. 4714, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of June 11, 2010 (75 FR 33311), FDA
announced the availability of a guidance for industry entitled
``Bioequivalence Recommendations for Specific Products'' that explained
the process that would be used to make product-specific guidances
available to the public on FDA's website at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.
    As described in that guidance, FDA adopted this process as a means
to develop and disseminate product-specific guidances and provide a
meaningful opportunity for the public to consider and comment on those
guidances. Under that process, draft guidances are posted on FDA's
website and announced periodically in the Federal Register. The public
is encouraged to submit comments on those recommendations within 60
days of their announcement in the Federal Register. FDA considers any
comments received and either publishes final guidances or publishes
revised draft guidances for comment. Guidances were last announced in
the Federal Register on September 17, 2019. This notice announces draft
product-specific guidances, either new or revised, that are posted on
FDA's website.

II. Drug Products for Which New Draft Product-Specific Guidances are
Available

    FDA is announcing the availability of new draft product-specific
guidances for industry for drug products containing the following
active ingredients:

     Table 1--New Draft Product-Specific Guidances for Drug Products
------------------------------------------------------------------------
                          Active ingredient(s)
-------------------------------------------------------------------------
Acetaminophen; Benzhydrocodone hydrochloride.
Betamethasone dipropionate; Calcipotriene.
Cefaclor.
Chlorzoxazone (multiple reference listed drugs).
Copper.
Dolutegravir sodium; Rilpivirine hydrochloride.
Doxycycline hyclate.
Encorafenib.
Fluorometholone acetate.
Indocyanine green.
Isoniazid; Pyrazinamide; Rifampin.
Isosorbide dinitrate.
Ketoprofen.
Latanoprost; Netarsudil dimesylate.
Lidocaine.
Lorlatinib.
Lovastatin.
Lutetium dotatate Lu-177.
Medroxyprogesterone acetate.
Meloxicam.
Mifepristone.
Migalastat hydrochloride.
Omadacycline tosylate (multiple reference listed drugs).
Oxymetazoline hydrochloride.
Pimavanserin tartrate.
Sumatriptan succinate.
Tetracaine hydrochloride.
Timolol maleate.
------------------------------------------------------------------------

III. Drug Products for Which Revised Draft Product-Specific Guidances
are Available

    FDA is announcing the availability of revised draft product-
specific guidances for industry for drug products containing the
following active ingredients:

   Table 2--Revised Draft Product-Specific Guidances for Drug Products
------------------------------------------------------------------------
                          Active ingredient(s)
-------------------------------------------------------------------------
Adapalene (multiple reference listed drugs).
Adapalene; Benzoyl peroxide (multiple reference listed drugs).
Azacitidine.
Baclofen.
Benzoyl peroxide; Clindamycin phosphate (multiple reference listed
 drugs).
Benzoyl peroxide; Erythromycin (multiple reference listed drugs).
Capsaicin.
Cariprazine hydrochloride.
Clindamycin phosphate (multiple reference listed drugs).
Clindamycin phosphate; Tretinoin.
Clonidine.
Clonidine hydrochloride.
Dapsone (multiple reference listed drugs).
Diclofenac epolamine.
Didanosine.
Disopyramide phosphate.
Doxepin hydrochloride.
Estradiol (multiple reference listed drugs).
Estradiol; Levonorgestrel.
Estradiol; Norethindrone acetate.
Ethinyl estradiol; Norelgestromin.
Fentanyl.
Flavoxate hydrochloride.
Granisetron.
Indapamide.
Lidocaine.
Lithium carbonate.
Menthol; Methyl salicylate.
Metformin hydrochloride; Repaglinide.
Methylphenidate.
Mifepristone.
Molindone hydrochloride.
Mycophenolate mofetil.
Nicotine.
Nitrofurantoin, Macrocrystalline.
Nitrofurantoin; Nitrofurantoin, Macrocrystalline.
Nitroglycerin (multiple reference listed drugs).
Oxybutynin (multiple reference listed drugs).
Pimecrolimus.
Prednisolone sodium phosphate.
Rivastigmine.
Roflumilast.
Rotigotine.
Scopolamine.
Selegiline.
Sulfacetamide sodium.
Sulfadiazine.
Tazarotene (multiple reference listed drugs).
Terazosin hydrochloride.
Testosterone.
Tinidazole.
Tipiracil hydrochloride; Trifluridine.
Tretinoin (multiple reference listed drugs).
------------------------------------------------------------------------

    For a complete history of previously published Federal Register
notices related to product-specific guidances, go to https://www.regulations.gov and enter Docket No. FDA-2007-D-0369.
    These draft guidances are being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). These draft guidances,
when finalized, will represent the current thinking of FDA on, among
other things, the product-specific design of BE studies to support
ANDAs. They do not establish any rights for any person and are not
binding on FDA or the public. You can use an alternative approach if it
satisfies the requirements of the applicable statutes and regulations.

IV. Electronic Access

    Persons with access to the internet may obtain the draft guidances
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.

    Dated: November 18, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-25326 Filed 11-21-19; 8:45 am]
 BILLING CODE 4164-01-P