[Federal Register Volume 86, Number 189 (Monday, October 4, 2021)]
[Notices]
[Page 54686]
[FR Doc No: 2021-21520]

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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:

Filings Instituting Proceedings

    Docket Numbers: RP21-1147-000.
    Applicants: Tuscarora Gas Transmission Company.
    Description: Sec.  4(d) Rate Filing: TXP--SWG Agreement Filing to
be effective 11/1/2021.
    Filed Date: 9/27/21.
    Accession Number: 20210927-5033.
    Comment Date: 5 p.m. ET 10/12/21.

    Docket Numbers: RP21-1148-000.
    Applicants: Transcontinental Gas Pipe Line Company, LLC.
    Description: Sec.  4(d) Rate Filing: Non-Conforming--Atlantic
Sunrise--Leidy Southeast--Six One Commodities to be effective 10/1/
2021.
    Filed Date: 9/27/21.
    Accession Number: 20210927-5143.
    Comment Date: 5 p.m. ET 10/12/21.

    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.

Filings in Existing Proceedings

    Docket Numbers: RP21-1149-000.
    Applicants: Midcontinent Express Pipeline LLC.
    Description: Sec.  4(d) Rate Filing: Removal of Expiring Tenaska
Gas, Castleton, and Tenaska Marketing Agreements to be effective 11/1/
2021.
    Filed Date: 9/28/21.
    Accession Number: 20210928-5034.
    Comment Date: 5 p.m. ET 10/12/21.

    Any person desiring to protest in any the above proceedings must
file in accordance with Rule 211 of the Commission's Regulations (18
CFR 385.211) on or before 5:00 p.m. Eastern time on the specified
comment date.
    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by querying
the docket number.
    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: September 28, 2021.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2021-21520 Filed 10-1-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 175 (Tuesday, September 12, 2023)]
[Rules and Regulations]
[Pages 62464-62471]
[FR Doc No: 2023-19607]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2020-0065; FRL-8786-01-OCSPP]

Fluazaindolizine; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
fluazaindolizine in or on multiple commodities that are identified and
discussed later in this document. E.I. du Pont de Nemours & Company
(``DuPont'', now Corteva) requested these tolerances under the Federal
Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective September 12, 2023. Objections and
requests for hearings must be received on or before November 13, 2023,
and must be filed in accordance with the instructions provided in 40
CFR part

178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2020-0065, is available online at
http://www.regulations.gov or in-person at the Office of Pesticide
Programs Regulatory Public Docket (OPP Docket) in the Environmental
Protection Agency Docket Center (EPA/DC), West William Jefferson
Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, Washington, DC
20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding legal holidays. The telephone
number for the Public Reading Room and the OPP Docket is (202) 566-
1744. For the latest status information on EPA/DC services and docket
access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Charles Smith, Director, Registration
Division (7505T), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number:<PHONE_NUMBER>; email address:
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

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

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Office of the
Federal Register's e-CFR site at https://www.ecfr.gov/current/title40.

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-2020-0065 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
November 13, 2023. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2020-0065, 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.
    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 April 15, 2020 (85 FR 20910) (FRL-10006-
54), 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
9F8795) by E.I. du Pont de Nemours & Company (``DuPont''), Chestnut Run
Plaza, 974 Centre Road, Wilmington, DE 19805. The petition requested to
establish tolerances in the 40 CFR part 180 for residues of the
nematicide, fluazaindolizine, by measuring the sum of post-hydrolysis
residues IN-A5760, IN-F4106, IN-QEK31, IN-QZY47, IN-TMQ01, IN-UJV12,
and IN-UNS90 (expressed in parent equivalents) in or on Carrots at 15
parts per million (ppm); Cucurbit Vegetables (Crop Group 9) at 3 ppm;
Fruiting Vegetables (Crop Group 8-10) at 3 ppm; Sun dried tomatoes at
30 ppm; Tomato paste at 15 ppm; Tomato puree at 6 ppm; Tomato wet
pomace at 6 ppm; Tuberous and Corm Vegetables (Crop Subgroup 1C) at 9
ppm; Dried potato at 30 ppm; Potato process waste at 40 ppm; and
establishing tolerances for residues of fluazaindolizine plus its
metabolites IN-QEK and IN-F4106 (expressed in parent equivalents), in
the animal commodities: Cattle, whole milk at 0.5 ppm; Cattle, fat at
0.09 ppm; Cattle, muscle at 0.02 ppm; Cattle, liver at 0.2 ppm; Cattle,
kidney at 0.5 ppm; Goat, whole milk at 0.5 ppm; Goat, fat at 0.09 ppm;
Goat, muscle at 0.02 ppm; Goat, liver at 0.2 ppm; Goat, kidney at 0.5
ppm; Hog, whole milk at 0.5 ppm; Hog, fat at 0.09 ppm; Hog, muscle at
0.02 ppm; Hog, liver at 0.2 ppm; Hog, kidney at 0.5 ppm; Horse, whole
milk at 0.5 ppm; Horse, fat at 0.09 ppm; Horse, muscle at 0.02 ppm;
Horse, liver at 0.2 ppm; Horse, kidney at 0.5 ppm; Sheep, whole milk at
0.5 ppm; Sheep, fat at 0.09 ppm; Sheep, muscle at 0.02 ppm; Sheep,
liver at 0.2 ppm; Sheep, kidney at 0.5 ppm. In addition, DuPont
proposed pursuant to section 408(d) of the Federal Food, Drug and
Cosmetic Act, 21 U.S.C. 346a(d), to amend 40 CFR part 180 to establish
indirect or inadvertent tolerances for residues of fluazaindolizine, by
measuring the sum of post-hydrolysis residues IN-A5760, IN-F4106, IN-
QEK31, IN-QZY47, IN-TMQ01, IN-UJV12, and IN-UNS90 (expressed in parent
equivalents) in or on the following commodities: Brassica Head and Stem
Vegetables (Crop Group 5-16) at 0.5 ppm; Bulb Vegetables (Crop Group 3-
07) at 3 ppm; Cereal Grains (Crop Group 15) at 3 ppm; Corn milled by-
products at 6 ppm; Foliage of Legume Vegetables (Crop Group 7), Vines
at 8 ppm; Foliage of Legume Vegetables (Crop Group 7), Forage and Straw
at 5 ppm; Foliage of Legume Vegetables (Crop Group 7), Hay at 40 ppm;
Forage, Fodder and Straw of Cereal Grains (Crop Group 16), Fodder at 4
ppm; Forage, Fodder and Straw of Cereal Grains (Crop Group 16), Forage
at 8 ppm; Forage, Fodder and Straw of Cereal Grains (Crop Group 16),
Hay at 15 ppm; Forage, Fodder and Straw of Cereal Grains (Crop Group
16), Straw at 10 ppm; Fruiting Vegetables (Crop Group 8-10) at 1 ppm;
Grain, Aspirated Fractions at 0.5 ppm; Grass, Forage, Fodder and Hay
(Crop Group 17), Forage at 8 ppm; Grass, Forage, Fodder and Hay (Crop
Group 17), Hay at 15

ppm; Leafy Vegetables (Crop Group 4-16) at 9 ppm; Leaves of Root and
Tuber (Crop Group 2) at 15 ppm; Legume Vegetables (Crop Group 6),
Mature Seed at 9 ppm; Legume Vegetables (Crop Group 6), Immature Seed
and Pod at 3 ppm; Low Growing Berry (Crop Subgroup 13-07G) at 0.6 ppm;
Nongrass Animal Feeds (Forage, Fodder, Straw and Hay) (Crop Group 18),
Fodder at 5 ppm; Nongrass Animal Feeds (Forage, Fodder, Straw and Hay)
(Crop Group 18), Forage at 8 ppm; Nongrass Animal Feeds (Forage,
Fodder, Straw and Hay) (Crop Group 18), Hay at 15 ppm; Nongrass Animal
Feeds (Forage, Fodder, Straw and Hay) (Crop Group 18), Straw at 10 ppm;
Oilseed (Crop Group 20) at 9 ppm; Oilseed Crop Group 20), Forage and
Straw at 5 ppm; Root Vegetables (Crop Subgroup 1A) at 7 ppm; Root
Vegetables Except Sugar Beet (Crop Subgroup 1B) at 7 ppm; Soybean Hulls
at 20 ppm; Soybean Meal at 20 ppm; Stalk, Stem and Leaf Petiole
Vegetables (Crop Group 22) at 3 ppm; Strawberry, Dehydrated at 3 ppm;
and Wheat Milled By-Products at 6 ppm. That document referenced a
summary of the petition prepared by DuPont (now Corteva), the
registrant, which is available in the docket, http://www.regulations.gov. A comment was received on the notice of filing.
EPA's response to this comment is discussed in Unit IV.C.
    In the Federal Register of June 28, 2021 (86 FR 33922) (FRL-10025-
08), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), amending the previous NOF dated April 15, 2020 by
announcing commodities that were not included in the previous NOF. E.I.
du Pont de Nemours & Company (``DuPont''), Chestnut Run Plaza, 974
Centre Road, Wilmington, DE 19805, requests to establish a tolerance in
40 CFR part 180 for residues of the nematicide, fluazaindolizine in or
on Poultry, fat at 0.01 ppm; Poultry, meat at 0.01 ppm; Poultry, meat
byproducts at 0.01 ppm; and Eggs at 0.01 ppm. In addition, DuPont is
proposing pursuant to section 408(d) of the Federal Food, Drug and
Cosmetic Act, 21 U.S.C. 346a(d), to amend 40 CFR part 180 to establish
indirect or inadvertent tolerances for residues of fluazaindolizine,
including its metabolites and their conjugates, expressed as the
stoichiometric equivalent of fluazaindolizine, in or on the following
commodity: Grass, forage, fodder and hay, group 17, straw at 0.15 ppm.
    Based upon review of the data supporting the petition, EPA is
establishing tolerances at different levels than petitioned-for and has
determined that tolerances for certain petitioned-for commodities are
not necessary. The Agency has also modified all of the commodity
definitions used and updated certain crop groups. The reasons for these
changes are 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 fluazaindolizine including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with
fluazaindolizine 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 main target organs of fluazaindolizine are the urinary tract
(rat and mouse), liver and/or gallbladder (mouse and dog), and
hematopoietic system (dog). In the mouse carcinogenicity study, the
incidence and severity of amyloidosis in specific tissues was increased
in both sexes. There was no evidence of increased in utero
susceptibility in the rat or rabbit developmental studies; however,
increased quantitative susceptibility was observed in the rat
reproductive toxicity study, based on urinary tract histopathological
lesions in F2 generation weanlings at a lower dose than
doses resulting in toxicity in parental animals. Fluazaindolizine is
classified as ``Not likely to be carcinogenic to humans'' based on lack
of evidence of treatment-related increases in tumors in adequately
conducted carcinogenicity studies in rats and mice.
    Specific information on the studies received and the nature of the
adverse effects caused by fluazaindolizine as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document titled ``Fluazaindolizine: Human
Health Risk Assessment for the New Active Ingredient'' (hereinafter
``Fluazaindolizine Human Health Risk Assessment'') on pages 54-82 in
docket ID number EPA-HQ-OPP-2020-0065.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/pesticide-science-and-assessing-pesticide-risks.
    A summary of the toxicological endpoints for fluazaindolizine used
for

human risk assessment can be found in the Fluazaindolizine Human Health
Risk Assessment.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to fluazaindolizine, EPA considered exposure under the
petitioned-for tolerances. EPA assessed dietary exposures from
fluazaindolizine 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
fluazaindolizine; therefore, a quantitative acute dietary exposure
assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment, EPA used the 2003-2008 food consumption data from the U.S.
Department of Agriculture's National Health and Nutrition Examination
Survey, What We Eat in America (NHANES/WWEIA). As to residue levels in
food, EPA used field-trial based anticipated residue calculations for
all crops and assumed 100 percent crop treated (PCT) for all crops.
    iii. Cancer. Based on the data summarized in the Fluazaindolizine
Human Health Risk Assessment, EPA has concluded that fluazaindolizine
does not pose a cancer risk to humans. Therefore, a dietary exposure
assessment for the purpose of assessing cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information.
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and
information on the anticipated residue levels of pesticide residues in
food and the actual levels of pesticide residues that have been
measured in food. If EPA relies on such information, EPA must require
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after
the tolerance is established, modified, or left in effect,
demonstrating that the levels in food are not above the levels
anticipated. For the present action, EPA will issue such data call-ins
as are required by FFDCA section 408(b)(2)(E) and authorized under
FFDCA section 408(f)(1). Data will be required to be submitted no later
than 5 years from the date of issuance of these tolerances.
    2. Dietary exposure from drinking water. The Agency used screening-
level water exposure models in the dietary exposure analysis and risk
assessment for fluazaindolizine in drinking water. Further information
regarding EPA drinking water models used in pesticide exposure
assessment can be found at http://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/models-pesticide-risk-assessment.
    Separate estimated drinking water concentrations (EDWCs) were
calculated for the metabolite IN-VM862 and a combination of
fluazaindolizine and the other metabolites IN-QEK31, IN-REG72, IN-
F4106, and IN-A5760, due to greater toxicological potency of IN-VM862.
This combination is referred to as the Fluazaindolizine Drinking Water
Total Residue Fraction (FDWTRF). Based on the Pesticide Water
Calculator (PWC), EPA used an EDWC of 990 ppb for FDWTRF and 1,300 ppb
for IN-VM862 in the chronic dietary risk assessment.
    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). Fluazaindolizine 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.''
    Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to fluazaindolizine and any
other substances and fluazaindolizine does not appear to produce a
toxic metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has not assumed that fluazaindolizine
has a common mechanism of toxicity with other substances.
    For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's website at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the 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. Increased quantitative
susceptibility was observed for fluazaindolizine in the rat 2-
generation reproductive study. An increased incidence and severity of
urinary tract histopathology was observed in male and female
F2 weanlings at a lower dose than in P and F1
adult animals. No susceptibility was observed in the rat or rabbit
developmental toxicity studies. The metabolite IN-F4106 showed
increased prenatal susceptibility (decreased fetal body weight) in the
rat developmental toxicity study. However, concern for prenatal
susceptibility is low for both parent and metabolite because clear
NOAELs and LOAELs were identified for fetal toxicity and endpoints
selected for risk assessment are protective of these findings.
    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 fluazaindolizine is complete.
    ii. There is no indication that fluazaindolizine is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional uncertainty factors to account for neurotoxicity.
    iii. Increased quantitative susceptibility was observed for
fluazaindolizine in the rat two-generation reproductive study. However,
as noted above, concern for prenatal susceptibility is low for both
parent and metabolite because clear NOAELs and LOAELs were identified
for fetal toxicity and endpoints selected for risk assessment are
protective of these findings.
    iv. There are no residual uncertainties with regard to the exposure
assessment

for fluazaindolizine. An acute dietary endpoint was not identified for
any population and therefore an assessment of acute dietary risk was
not performed. For chronic dietary exposure, risk estimates were
partially refined by using average field trial residues and empirical
processing factors. Conservative, upper bound estimates were used to
assess exposure to fluazaindolizine and its residues of concern through
drinking water. Based on these considerations, exposure from food and
drinking water will not be underestimated. No residential use patterns
are proposed at this time.

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,
fluazaindolizine 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
fluazaindolizine from food and water will utilize 82% of the cPAD for
all infants less than one year old, the population group receiving the
greatest exposure. There are no residential uses for fluazaindolizine.
    3. Short- and intermediate-term risk. Short- and intermediate-term
aggregate risk takes into account short- and intermediate-term
residential exposure plus chronic exposure to food and water
(considered to be a background exposure level). Short- and
intermediate-term adverse effects were identified; however,
fluazaindolizine is not registered for any use patterns that would
result in either short- or intermediate-term residential 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 risk), 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 risk for fluazaindolizine.
    4. Aggregate cancer risk for U.S. population. Fluazaindolizine 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 fluazaindolizine residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Crops: The petitioner submitted method validation, supplemental
method validation, and radiovalidation data for Method No. DuPont-33861
(Rev. 3). This method successfully quantitates two ion transitions for
fluazaindolizine via liquid chromatography with tandem mass
spectrometry (LC-MS/MS). Method No. DuPont-33861 (Rev. 3) meets HED's
criteria for enforcement analytical methods.
    Livestock: The petitioner submitted method validation and an
independent laboratory validation (ILV) for Method No. DuPont-39226
(Rev. 1). This method successfully quantitates two ion transitions for
fluazaindolizine via LC-MS/MS. Method No. DuPont-39226 (Rev. 1) meets
HED's criteria for enforcement analytical methods.
    The methods 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 has not established any MRLs for fluazaindolizine.

C. Response to Comments

    One comment was received on the April 15, 2020, notice of filing
that stated in part ``this application should be denied. stop using
this chemical.'' Although the Agency recognizes that some individuals
believe that pesticides should be banned on agricultural crops, the
existing legal framework provided by section 408 of the FFDCA
authorizes EPA to establish tolerances when it determines that the
tolerance is safe. Upon consideration of the validity, completeness,
and reliability of the available data as well as other factors the
FFDCA requires EPA to consider, EPA has determined that the
fluazaindolizine tolerances are safe. The commenter has provided no
information indicating that a safety determination cannot be supported.

D. Revisions to Petitioned-For Tolerances

    All tolerance values being established in this rulemaking vary
slightly from what the petitioner requested. This is primarily because
the petitioner proposed various metabolites as residues of concern for
crop and livestock commodities, whereas EPA has concluded that the only
residue needed to measure compliance with the tolerance is
fluazaindolizine. All raw agricultural commodity (RAC) crop tolerances
were calculated according to the Organization for Economic Cooperation
and Development (OECD) tolerance calculation procedure. Tolerances in/
on processed commodities were calculated by multiplying average
processing factors by the mean or highest average field trial (HAFT)
value for blended and non-blended commodities, respectively. Commodity
definitions are used in accordance with EPA's correct commodity
definition guideline.
    EPA is not establishing the requested primary crop tolerances for
dried potato, potato process waste, tomato paste, and tomato puree, or
the requested rotational crop tolerances for aspirated grain fractions
(AGF), corn milled byproducts, soybean hulls, soybean meal, dehydrated
strawberries, and wheat milled byproducts. Residues of parent
fluazaindolizine in these processed commodities are not expected to
concentrate to levels above the associated tolerances for the raw
agricultural commodities, so processed commodity tolerances are not
necessary. The Agency is not establishing the requested primary crop
tolerance on tomato wet pomace, as this processed fraction is not
considered a significant feed item and a tolerance is not necessary.
    The Agency is not establishing the requested rotational crop
tolerance for fruiting vegetable crop group 8-10, as residues of parent
fluazaindolizine are

expected to be below the limit of quantitation (LOQ) in fruiting
vegetables planted as rotational crops and therefore the primary crop
tolerance is adequate.
    The Agency is not establishing the requested rotational crop
tolerances for the straw of commodities in crop groups 7 and 20, as
these are not identified as significant feed items and tolerances are
not needed. Similarly, EPA is not establishing the requested rotational
crop tolerance for the fodder of crop group 18, as this is not a
recognized commodity for the crop group.
    Finally, EPA is establishing rotational crop tolerances for crop
groups 6-22, 7-22, 15-22 and 16-22 rather than the requested rotational
crop tolerances on crop groups 6, 7, 15 and 16. EPA proposed changes to
these four crop groups on January 10, 2022 (87 FR 1091) (FRL-5031-12-
OCSPP) and finalized the revised crop groups as 6-22, 7-22, 15-22 and
16-22 on September 21, 2022 (87 FR 57627) (FRL-5031-13-OCSPP). EPA
regulations state ``Once a revised crop group is established, EPA will
no longer establish tolerances under the pre-existing crop group.'' 40
CFR 180.40(j)(4). EPA has determined that the residue data support
rotational crop tolerances for crop groups 6-22, 7-22, 15-22 and 16-22
based on EPA's practice for evaluating residue data for rotational crop
tolerances and because there were no changes to major crops in groups
6-22, 7-22, 15-22 and 16-22. No food commodities are included in the
revised crop groups that were not already accounted for in the initial
dietary exposure assessment. Therefore, an updated dietary assessment
is not needed, and the exposure and risk assessments do not change as a
result of the crop group updates.

V. Conclusion

    Therefore, tolerances are established for residues of
fluazaindolizine, including its metabolites and degradates in or on
carrot at 0.05 ppm; cattle, fat at 0.01 ppm; cattle, meat at 0.01 ppm;
cattle, meat byproducts at 0.01 ppm; egg at 0.01 ppm; goat, fat at 0.01
ppm; goat, meat at 0.01 ppm; goat, meat byproducts at 0.01 ppm; hog,
fat at 0.01 ppm; hog, meat at 0.01 ppm; hog, meat byproducts at 0.01
ppm; horse, fat at 0.01 ppm; horse, meat at 0.01 ppm; horse, meat
byproducts at 0.01 ppm; milk at 0.01 ppm; poultry, fat at 0.01 ppm;
poultry meat at 0.01 ppm; poultry, meat byproducts at 0.01 ppm; sheep,
fat at 0.01 ppm; sheep, meat at 0.01 ppm; sheep, meat byproducts at
0.01 ppm; tomato, dried at 0.4 ppm; vegetable, cucurbit, group 9 at
0.15 ppm; vegetable, fruiting, group 8-10 at 0.07 ppm; and vegetable,
tuberous and corm, subgroup 1C at 0.2 ppm.
    Additionally, tolerances are established for inadvertent residues
of fluazaindolizine, including its metabolites and degradates in or on
animal feed, nongrass, group 18, forage at 0.01 ppm; animal feed,
nongrass, group 18, hay at 0.015 ppm; animal feed, nongrass, group 18,
straw at 0.15 ppm; berry, low growing, subgroup 13-07G at 0.01 ppm;
grain, cereal, forage, hay, stover, and straw group 16-22, forage at
0.01 ppm; grain, cereal, forage, hay, stover, and straw group 16-22,
hay at 0.015 ppm; grain, cereal, forage, hay, stover, and straw group
16-22, stover at 0.15 ppm; grain, cereal, forage, hay, stover, and
straw group 16-22, straw at 0.15 ppm; grain, cereal, group 15-22 at
0.01 ppm; grass, forage, fodder and hay, group 17, forage at 0.01 ppm;
grass, forage, fodder, and hay, group 17, hay at 0.015 ppm; grass,
forage, fodder and hay, group 17, straw at 0.15 ppm; oilseed group 20
at 0.8 ppm; rapeseed, forage at 0.09 ppm; stalk, stem, and leaf petiole
vegetable group 22 at 0.03 ppm; vegetable, Brassica, head and stem,
group 5-16 at 0.015 ppm; vegetable, bulb, group 3-07 at 0.03 ppm;
vegetable, legume, forage and hay, group 7-22, forage at 0.09 ppm;
vegetable, legume, forage and hay, group 7-22, hay at 0.4 ppm;
vegetable, leafy, group 4-16 at 0.015 ppm; vegetable, leaves of root
and tuber, group 2 at 0.015 ppm; vegetable, legume, group 6-22 at 0.8
ppm; and vegetable, root, subgroup 1B at 0.02 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerances in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or Tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
Tribal Governments, on the relationship between the National Government
and the States or Tribal Governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian Tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping requirements.

    Dated: September 5, 2023.
Edward Messina,
Director, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR chapter I as follows:

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

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

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

0
2. Add Sec.  180.720 to subpart C to read as follows:

Sec.  180.720  Fluazaindolizine; tolerances for residues.

    (a) General. Tolerances are established for residues of the
nematicide fluazaindolizine, including its metabolites and degradates,
in or on the commodities to Table 1 of this section. Compliance with
the tolerance levels specified in Table 1 is to be determined by
measuring only fluazaindolizine, 8-chloro-N-[(2-chloro-5-
methoxyphenyl)sulfonyl]-6-(trifluoromethyl)imidazo[1,2-a]pyridine-2-
carboxamide, in or on the commodity.

                        Table 1 to Paragraph (a)
------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Carrot..................................................            0.05
Cattle, fat.............................................            0.01
Cattle, meat............................................            0.01
Cattle, meat byproducts.................................            0.01
Egg.....................................................            0.01
Goat, fat...............................................            0.01
Goat, meat..............................................            0.01
Goat, meat byproducts...................................            0.01
Hog, fat................................................            0.01
Hog, meat...............................................            0.01
Hog, meat byproducts....................................            0.01
Horse, fat..............................................            0.01
Horse, meat.............................................            0.01
Horse, meat byproducts..................................            0.01
Milk....................................................            0.01
Poultry, fat............................................            0.01
Poultry, meat...........................................            0.01
Poultry, meat byproducts................................            0.01
Sheep, fat..............................................            0.01
Sheep, meat.............................................            0.01
Sheep, meat byproducts..................................            0.01
Tomato, dried...........................................             0.4
Vegetable, cucurbit, group 9............................            0.15
Vegetable, fruiting, group 8-10.........................            0.07
Vegetable, tuberous and corm, subgroup 1C...............             0.2
------------------------------------------------------------------------

    (b)-(c) [Reserved]
    (d) Indirect or inadvertent residues. Tolerances are established
for residues of the nematicide fluazaindolizine, including its
metabolites and degradates, in or on the commodities to Table 2 of this
section. Compliance with the tolerance levels specified in Table 2 is
to be determined by measuring only fluazaindolizine, 8-chloro-N-[(2-
chloro-5-methoxyphenyl)sulfonyl]-6-(trifluoromethyl)imidazo[1,2-
a]pyridine-2-carboxamide, in or on the commodity.

                        Table 2 to Paragraph (d)
------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Animal feed, nongrass, group 18, forage.................            0.01
Animal feed, nongrass, group 18, hay....................           0.015
Animal feed, nongrass, group 18, straw..................            0.15
Berry, low growing, subgroup 13-07G.....................            0.01
Grain, cereal, forage, hay, stover, and straw group 16-             0.01
 22, forage.............................................
Grain, cereal, forage, hay, stover, and straw group 16-            0.015
 22, hay................................................
Grain, cereal, forage, hay, stover, and straw group 16-             0.15
 22, stover.............................................
Grain, cereal, forage, hay, stover, and straw group 16-             0.15
 22, straw..............................................
Grain, cereal, group 15-22..............................            0.01
Grass, forage, fodder and hay, group 17, forage.........            0.01
Grass, forage, fodder and hay, group 17, hay............           0.015
Grass, forage, fodder and hay, group 17, straw..........            0.15
Oilseed group 20........................................             0.8
Rapeseed, forage........................................            0.09
Stalk, stem and leaf petiole vegetable group 22.........            0.03

Vegetable, Brassica, head and stem, group 5-16..........           0.015
Vegetable, bulb, group 3-07.............................            0.03
Vegetable, legume, forage and hay, group 7-22, forage...            0.09
Vegetable, legume, forage and hay, group 7-22, hay......             0.4
Vegetable, leafy, group 4-16............................           0.015
Vegetable, leaves of root and tuber, group 2............           0.015
Vegetable, legume, group 6-22...........................             0.8
Vegetable, root, subgroup 1B............................            0.02
------------------------------------------------------------------------

[FR Doc. 2023-19607 Filed 9-11-23; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 86, Number 223 (Tuesday, November 23, 2021)]
[Rules and Regulations]
[Pages 66456-66458]
[FR Doc No: 2021-25585]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 878

[Docket No. FDA-2018-N-1913]

Medical Devices; General and Plastic Surgery Devices;
Classification of the General Laparoscopic Power Morcellation
Containment System

AGENCY: Food and Drug Administration, HHS.

ACTION: Final amendment; final order.

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

SUMMARY: The Food and Drug Administration (FDA or we) is classifying
the general laparoscopic power morcellation containment system into
class II (special controls). The special controls that apply to the
device type are identified in this order and will be part of the
codified language for the general laparoscopic power morcellation
containment system's classification. We are taking this action because
we have determined that classifying the device into class II (special
controls) will provide a reasonable assurance of safety and
effectiveness of the device. We believe this action will also enhance
patients' access to beneficial innovative devices.

DATES: This order is effective November 23, 2021. The classification
was applicable on December 19, 2017.

FOR FURTHER INFORMATION CONTACT: Cal Rabang, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4633, Silver Spring, MD, 20993-0002,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the general laparoscopic power
morcellation containment system as class II (special controls), which
we have determined will provide a reasonable assurance of safety and
effectiveness. In addition, we believe this action will enhance
patients' access to beneficial innovation, in part by placing the
device into a lower device class than the automatic class III
assignment.
    The automatic assignment of class III occurs by operation of law
and without any action by FDA, regardless of the level of risk posed by
the new device. Any device that was not in commercial distribution
before May 28, 1976, is automatically classified as, and remains
within, class III and requires premarket approval unless and until FDA
takes an action to classify or reclassify the device (see 21 U.S.C.
360c(f)(1)). We refer to these devices as ``postamendments devices''
because they were not in commercial distribution prior to the date of
enactment of the Medical Device Amendments of 1976, which amended the
Federal Food, Drug, and Cosmetic Act (FD&C Act).
    FDA may take a variety of actions in appropriate circumstances to
classify or reclassify a device into class I or II. We may issue an
order finding a new device to be substantially equivalent under section
513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that
does not require premarket approval. We determine whether a new device
is substantially equivalent to a predicate device by means of the
procedures for premarket notification under section 510(k) of the FD&C
Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).
    FDA may also classify a device through ``De Novo'' classification,
a common name for the process authorized under section 513(f)(2) of the
FD&C Act. Section 207 of the Food and Drug Administration Modernization
Act of 1997 established the first procedure for De Novo classification
(Pub. L. 105-115). Section 607 of the Food and Drug Administration
Safety and Innovation Act modified the De Novo application process by
adding a second procedure (Pub. L. 112-144). A device sponsor may
utilize either procedure for De Novo classification.
    Under the first procedure, the person submits a 510(k) for a device
that has not previously been classified. After receiving an order from
FDA classifying the device into class III under section 513(f)(1) of
the FD&C Act, the person

then requests a classification under section 513(f)(2).
    Under the second procedure, rather than first submitting a 510(k)
and then a request for classification, if the person determines that
there is no legally marketed device upon which to base a determination
of substantial equivalence, that person requests a classification under
section 513(f)(2) of the FD&C Act.
    Under either procedure for De Novo classification, FDA is required
to classify the device by written order within 120 days. The
classification will be according to the criteria under section
513(a)(1) of the FD&C Act. Although the device was automatically placed
within class III, the De Novo classification is considered to be the
initial classification of the device.
    When FDA classifies a device into class I or II via the De Novo
process, the device can serve as a predicate for future devices of that
type, including for 510(k)s (see section 513(f)(2)(B)(i)of the FD&C
Act). As a result, other device sponsors do not have to submit a De
Novo request or premarket approval application to market a
substantially equivalent device (see section 513(i) of the FD&C Act,
defining ``substantial equivalence''). Instead, sponsors can use the
less-burdensome 510(k) process, when necessary, to market their device.

II. De Novo Classification

    On September 29, 2017, FDA received Advanced Surgical Concepts
Ltd.'s request for De Novo classification of the ContainOR. FDA
reviewed the request in order to classify the device under the criteria
for classification set forth in section 513(a)(1) of the FD&C Act.
    We classify devices into class II if general controls by themselves
are insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls that, in combination with the general controls, provide
reasonable assurance of the safety and effectiveness of the device for
its intended use (see section 513(a)(1)(B) of the FD&C Act). After
review of the information submitted in the request, we determined that
the device can be classified into class II with the establishment of
special controls. FDA has determined that these special controls, in
addition to the general controls, will provide reasonable assurance of
the safety and effectiveness of the device.
    Therefore, on December 19, 2017, FDA issued an order to the
requester classifying the device into class II. In this final order,
FDA is codifying the classification of the device by adding 21 CFR
878.4825.\1\ We have named the generic type of device general
laparoscopic power morcellation containment system, and it is
identified as a prescription device consisting of an instrument port
and tissue containment method that creates a working space allowing for
direct visualization during a power morcellation procedure following a
laparoscopic procedure for the excision of benign tissue that is not
suspected to contain malignancy.
---------------------------------------------------------------------------

    \1\ FDA notes that the ``ACTION'' caption for this final order
is styled as ``Final amendment; final order,'' rather than ``Final
order.'' Beginning in December 2019, this editorial change was made
to indicate that the document ``amends'' the Code of Federal
Regulations. The change was made in accordance with the Office of
Federal Register's (OFR) interpretations of the Federal Register Act
(44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 and
parts 21 and 22), and the Document Drafting Handbook.
---------------------------------------------------------------------------

    FDA has identified the following risks to health associated
specifically with this type of device and the measures required to
mitigate these risks in table 1.

   Table 1--General Laparoscopic Power Morcellation Containment System
                      Risks and Mitigation Measures
------------------------------------------------------------------------
            Identified risks                   Mitigation measures
------------------------------------------------------------------------
Adverse tissue reaction................  Biocompatibility evaluation.
Infection..............................  Sterilization validation, Shelf
                                          life testing, and Labeling.
Intraperitoneal tissue dissemination...  Non-clinical performance
                                          testing, Animal performance
                                          testing, Shelf life
     Material permeability.       testing, Labeling, and
                                          Training.
     Improper function of
     containment device.
     Inadequate material
     strength.
     Physical trauma to liner
     caused by contact with morcellator
     or grasper/tenaculum.
     Damage to liner
     (intentional or accidental) from
     instrument inserted through
     secondary port.
     Tearing during removal
     with loss of contents into
     abdominal cavity.
     Tearing of the bag due to
     stones contained in tissue.
     Use error.
Traumatic injury to non-target tissue/   Non-clinical performance
 organ.                                   testing, Animal performance
                                          testing, Labeling,
     Active end of morcellator    and Training.
     or grasper/tenaculum breaches
     liner.
     Loss of insufflation.
     Inadequate space to
     perform morcellation.
     Inadequate visualization
     of the laparoscopic instruments
     and tissue specimen relative to
     the external viscera.
     Use error.
Hernia through abdominal wall incision.  Labeling and Training.
Prolongation of procedure and exposure   Labeling and Training.
 to anesthesia.
------------------------------------------------------------------------

    FDA has determined that special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of safety and effectiveness. For a device to fall within this
classification, and thus avoid automatic classification in class III,
it would have to comply with the special controls named in this final
order. The necessary special controls appear in the regulation codified
by this order. We encourage sponsors to consult with us if they wish to
use a non-animal testing method they believe is suitable, adequate,
validated, and feasible. We will consider if such an alternative method
could be assessed for equivalency to an animal test method. This device
is subject to premarket notification requirements under section 510(k)
of the FD&C Act.

    At the time of classification, general laparoscopic power
morcellation containment systems are for prescription use only.
Prescription devices are exempt from the requirement for adequate
directions for use for the layperson under section 502(f)(1) of the
FD&C Act (21 U.S.C. 352(f)(1)) and 21 CFR 801.5, as long as the
conditions of 21 CFR 801.109 are met.

III. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

IV. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to
previously approved collections of information found in other FDA
regulations and guidance. These collections of information are subject
to review by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections
of information in the guidance document ``De Novo Classification
Process (Evaluation of Automatic Class III Designation)'' have been
approved under OMB control number 0910-0844; the collections of
information in 21 CFR part 814, subparts A through E, regarding
premarket approval, have been approved under OMB control number 0910-
0231; the collections of information in part 807, subpart E, regarding
premarket notification submissions, have been approved under OMB
control number 0910-0120; the collections of information in 21 CFR part
820, regarding quality system regulations, have been approved under OMB
control number 0910-0073; and the collections of information in 21 CFR
part 801, regarding labeling, have been approved under OMB control
number 0910-0485.

List of Subjects in 21 CFR Part 878

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act, and
under authority delegated to the Commissioner of Food and Drugs, 21 CFR
part 878 is amended as follows:

PART 878--GENERAL AND PLASTIC SURGERY DEVICES

0
1. The authority citation for part 878 continues to read as follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2. Add Sec.  878.4825 to subpart E to read as follows:

Sec.  878.4825  General laparoscopic power morcellation containment
system.

    (a) Identification. A general laparoscopic power morcellation
containment system is a prescription device consisting of an instrument
port and tissue containment method that creates a working space
allowing for direct visualization during a power morcellation procedure
following a laparoscopic procedure for the excision of benign tissue
that is not suspected to contain malignancy.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) The patient-contacting components of the device must be
demonstrated to be biocompatible.
    (2) Performance testing must demonstrate the sterility of patient-
contacting components of the device.
    (3) Performance data must support the shelf life of the device by
demonstrating continued sterility, package integrity, and device
functionality over the intended shelf life.
    (4) Non-clinical performance data must demonstrate that the device
performs as intended under anticipated conditions of use. The following
performance characteristics must be tested:
    (i) Demonstration of the device impermeability to tissue, cells,
and fluids;
    (ii) Demonstration that the device allows for the insertion/
withdrawal of laparoscopic instruments while maintaining
pneumoperitoneum;
    (iii) Demonstration that the containment system provides adequate
space to perform morcellation and adequate visualization of the
laparoscopic instruments and tissue specimen relative to the external
viscera;
    (iv) Demonstration that compatible laparoscopic instruments and
morcellators do not compromise the integrity of the containment system;
and
    (v) Demonstration that users can adequately deploy the device,
morcellate a specimen without compromising the integrity of the device,
and remove the device without spillage of contents.
    (5) Training must be developed and validated to ensure users can
follow the instructions for use.
    (6) Labeling must include:
    (i) A contraindication for use in gynecological procedures;
    (ii) A contraindication against use of tissue that is known or
suspected to contain malignancy;
    (iii) The following boxed warning: ``Warning: Information regarding
the potential risks of a procedure with this device should be shared
with patients. The use of laparoscopic power morcellators may spread
cancer. The use of this containment system has not been clinically
demonstrated to reduce this risk;''
    (iv) A statement limiting use of device to physicians who have
completed the training program; and
    (v) A shelf life.

    Dated: November 17, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-25585 Filed 11-22-21; 8:45 am]
BILLING CODE 4164-01-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON D.C., 20460

OFFICE  OF

PREVENTION, PESTICIDES AND

TOXIC SUBSTANCES

MEMORANDUM					DATE:  October 31, 2007

				DP Barcode:  D346213

				PC Code:  079401

SUBJECT:	Addendum to the Ecological Risk Assessment of Endosulfan

FROM:	Keith Sappington, Ph.D., Senior Biologist

		Faruque Khan, Senior Agronomist

		Endosulfan Chemical Team

		Thomas Steeger, Ph.D., Senior Biologist

		Reviewer

		Environmental Fate and Effects Division (7507P)

THROUGH:	Mah Shamim, Ph.D., Branch Chief

		Environmental Fate and Effects Division (7507P)

TO:		Tracy Perry, Risk Manager Reviewer

		Robert McNally, Risk Manager

		Special Review and Reregistration Division (7508P)

In 2000, the Environmental Fate and Effects Division (EFED) completed
its draft environmental fate and ecological risk assessment chapter
(ERA) in support of the reregistration eligibility decision (RED) for
endosulfan. The ERA was later revised to reflect public comments and the
final version of the science chapter was completed in February 2002
(USEPA, 2002; DP Barcode D238673).    SEQ CHAPTER \h \r 1 At that time,
the chapter incorporated nonconservative assumptions in its
deterministic aquatic risk assessment and included a probabilistic
exposure assessment for aquatic impacts as well.  In addition, because
the risk assessment did not take into account the toxicity of the
primary transformation product, i.e., endosulfan sulfate, the overall
terrestrial and aquatic risk of endosulfan may have been underestimated.

Subsequent to the publication of the final 2002 ecological risk
assessment, new information related to endosulfan toxicity,
bioaccumulation, monitoring and transport, and ecological incidence have
been obtained by OPP.  The purpose of this addendum is to conduct a
preliminary assessment of this new information in order to: (1) address
the extent to which the previous ecological risk assessment for
endosulfan might change in relation to this new information, and (2)
indicate future avenues where additional data analysis and risk
characterization endosulfan are needed.  Areas of focus include new
information on endosulfan bioaccumulation, ecological effects, exposure
modeling, and monitoring and long-range transport.  The findings from
each of these focus areas are summarized below.  More detailed
information in support of these findings is contained in Appendix 1 and
its attachments (under separate cover).

EXPOSURE CHARACTERIZATION

  	Persistence

Endosulfan is expected to be more persistent than how it was
characterized in the 2002 ERA.  This conclusion is based on the newly
submitted toxicity data on endosulfan sulfate, the major degradate of
endosulfan, which shows that endosulfan sulfate is similar in toxicity
to the parent compound.  Therefore, EFED has used the total residue
method to estimate exposure concentrations for endosulfan and endosulfan
sulfate.  This means that the Agency has based its exposure estimates on
the half life of total endosulfan residue, a comparatively longer half
life than the parent compound.  The total residue aerobic soil half-life
is 1336 days compared to the parent only half-life of 57 and 208 days
for α  and β endosulfan, respectively.

	Exposure Modeling

Revised exposure modeling was conducted based on total endosulfan
residues (α+β+sulfate) for two crop scenarios with the highest
predicted estimated exposure concentrations (EEC): Florida tomatoes and
California strawberries.  Predicted surface water EECs increased by
20-40% compared to EECs used in the 2002 ERA, which reflects the
addition of endosulfan sulfate in the exposure modeling. Predicted peak,
21-d mean, and 60-d mean surface water EECs are: 23, 9.3, and 6.8 ppb
(Florida tomato scenario).  Sediment pore water EECs of about 4 ppb were
predicted using this same crop scenario and did not vary across these
averaging periods.  The EECs predicted from the California strawberry
scenario are about half those of Florida tomato.  However, both
California strawberry and Florida tomato EECs may be underestimated
because the use of plastic mulch practices, which are expected to
increase endosulfan runoff, could not be modeled accurately.

	Monitoring and Long-Range Transport

Numerous literature sources have documented the regional or long-range
transport of endosulfan through various environmental media such as air,
precipitation, water, and sediment. Monitoring studies have detected
endosulfan or endosulfan sulfate in environmental media with regular
frequency in both agriculturally influenced and remote regions.  Recent
studies suggest that desorbed residues of endosulfan volatilize and
continue to recycle in the global system through a process of migration
and redeposition (via wet and dry depositions) as well as air-water
exchange in the northern Hemisphere.  Findings from selected monitoring
studies of endosulfan are summarized below within various environmental
media or regions.

Surface Water

The presence of endosulfan in many ecosystems throughout the U.S. has
led to concern regarding continuing point and non-point sources of
endosulfan in vulnerable areas that may result in acute and chronic
effects on aquatic communities.  These data suggest that in the vicinity
of row crops where endosulfan is reportedly applied, endosulfan residues
have been routinely detected in both the water column and benthic
sediments.  Additionally, the data indicate that residues exceed OPP
acute and chronic risk levels of concern (e.g., south Florida and
California) and that total endosulfan residues have moved to areas
distant from where it was initially applied. Furthermore, in 1998,
Calleguas Creek in California and the Yakima River in Washington State
were classified as impaired water bodies under the Section 303d of the
Clean Water Act due to presence of endosulfan as well as other chemicals

Sediments

etween 1980 and 1999, 199 detections were reported for α-endosulfan
(ranging from 0 to 11000 μg·Kg-1).  For β-endosulfan, there were 667
detections reported (ranging from 0 to 67500 μg·Kg-1).  For endosulfan
sulfate, there were195 detections reported (ranging from 0.2 to 900
μg·Kg-1).

Air

Abundant regional concentration data are available for the Great Lakes
Region from the Integrated Atmospheric Deposition Network (IADN), a
joint US EPA / Environment Canada-monitoring project (Sun et al., 2003,
3006).  These data provide compelling evidence for medium-range airborne
transport of endosulfan and endosulfan sulfate, as endosulfan
concentrations in vapor phase show a clear increasing trend from the
west to east across the region.

Remote Regions

in south-central Canada show the presence of α-and β-endosulfan (Muir
et al., 2004). Mean concentration levels of α-endosulfan ranged from
28.5 – 1.3 pg L-1, and those of β-endosulfan ranged from 10.3 – 0.0
pg L-1 in lakes Opeongo, Nipigon, Britt Brook, and Virgin Pond. No
agricultural area was within 31 miles (50 Km) of any of these lakes,
suggesting that the presence of endosulfan resulted from atmospheric
transportation and deposition. Monitoring and modeling results suggest
that under the conditions prevailing in south-central Canada, endosulfan
can potentially undergo regional-scale atmospheric transport and reach
lakes outside endosulfan use areas.

Precipitation and Snowpack

ion of the Great Lakes region, α- and β-endosulfan concentrations were
regularly determined by IADN at various stations during the period of
1987–1997. Concentration levels of α-endosulfan ranged from 0.13 –
1.95 ng·L-1 and those of β-endosulfan ranged from 0.19 – 6.09
ng·L-1 in Lake Superior and Lake Erie. Higher values were reported from
Lake Michigan ranging from 0.54 – 8.22 ng·L-1 for α- and from 1.06
– 12.13 ng·L-1 for β-endosulfan. Endosulfan and endosulfan sulfate
were detected in seasonal snow pack samples at six national parks in the
Western United States (Hagman et al., 2006). Concentrations of total
endosulfan ranged from 1.5 ng·L-1 to 0.0040 ng·L-1 in Sequoia, Mount
Rainier, Denali, Noatak-Gates, Glacier and Rocky Mountain National
Parks.

Mountainous Areas

The effect of "global distillation" which is believed to account for
transport of persistent organic pollutants (POPs) whereby a compound
could volatilize from warmer regions, undergo long-range atmospheric
transport and subsequently recondense to an accumulation of these
substances in the temperate, higher mountainous and Arctic regions.

 Levels of α-endosulfan found in rain were in a range of < 0.0035 ng/L
to 6.5 ng L-1 while β-endosulfan was determined at concentrations of <
0.012 ng L-1 up to 1.4 ng L-1 McConnell et al. (1998).

Arctic Region

Endosulfan has routinely been detected in arctic regions.  As excerpted
from GFEA (2007):

“ Endosulfan was reported as a widely distributed pesticide in the
atmosphere of Northern polar regions [37]. Unlike for most other
organochlorine pesticides average concentrations of endosulfan in the
Arctic have not changed significantly during the last five years [38].
Concentrations of endosulfan (isomers unspecified) from Arctic air
monitoring stations increased from early to mid-1993and remained at that
level through the end of 1997 at 0.0042-0.0047 ng/m3.”

Bioaccumulation

Three lines of evidence were used to evaluate and characterize the
bioaccumulation potential of endosulfan and its metabolites: (1)
empirical bioconcentration and bioaccumulation experiments, (2)
bioaccumulation modeling in aquatic food webs, and (3) bioaccumulation
modeling in terrestrial food webs. Based on these lines of evidence, the
following conclusions are drawn from this review.

Empirical data on endosulfan bioconcentration and bioaccumulation are
compromised substantially by data quality concerns (i.e., none of the
studies appear to meet OPP data quality guidelines) and therefore, BCF
and BAF values from these studies should be interpreted with caution.

Given these caveats, measured BCF values in fish based on the highest
quality studies range from about 1000 to 3000 (L/kg wet wt.).  This
range in BCF values is also supported by aquatic bioaccumulation
modeling which predict mean and 90th percentile BCFs in the range of
1000 to 2000 L/kg wet wt.  Considering all studies, BCF values exceeded
5000 for one of seven fish species (yellow tetra), which approximated
5700 (based on the BCF ratio method) and 11,600 (based on the kinetic
BCF method).  Substantial uncertainties in the BCF values from the
yellow tetra study are noted, however, as discussed herein.

sulfan (α and β isomers) and its primary degradate (endosulfan
sulfate) appears rapid in fish (half life 2-6 days) based on limited
data.  However, the ability of fish and other aquatic organisms to
depurate endosulfan in the environment may be ameliorated in areas of
broad-scale endosulfan contamination (e.g., certain
agriculturally-influenced ecosystems and even selected remote ecosystems
receiving endosulfan loadings through long-range transport).

Based on one study with daphnids and preliminary aquatic bioaccumulation
modeling results, biomagnification of endosulfan appears unlikely in
typical aquatic food webs.  This finding is consistent with other
bioaccumulation modeling studies published in the literature for
endosulfan and related compounds.

Based largely on indirect evidence from terrestrial bioaccumulation
modeling, the biomagnification of endosulfan by terrestrial organisms
appears to be a concern with predicted biomagnification factors ranging
from 2.5 to 28 for herbivorous and carnivorous wildlife at the top of
arctic food webs.  Additional information on endosulfan in terrestrial
food webs should be evaluated to more fully characterize the
biomagnification of endosulfan by terrestrial organisms.

EFFECTS CHARACTERIZATION

α and β) and the endosulfan sulfate degradate.  The new endosulfan
sulfate toxicity data consisted of:

acute toxicity with two species of estuarine/marine fish

acute and chronic toxicity to one estuarine/marine invertebrate

sediment toxicity with one freshwater and one estuarine/marine
invertebrate

acute oral and dietary toxicity with two avian species.

Based on comparisons made within the same species, the toxicity of
endosulfan sulfate and the parent isomers (α, β) generally appears
similar based on acute studies with bluebill sunfish and mallard duck,
but somewhat less toxic with bobwhite quail.  This information was used
to support the assumption that endosulfan sulfate is similar in toxicity
to the parent compounds.  New information on the toxicity of endosulfan
sulfate did not alter the toxicity values used in determining risk
quotients for aquatic organisms via water column exposure.

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with an estuarine/marine amphipod.

RISK CONCLUSIONS

it is of similar toxicity to the parent isomers (α and β).   Based on
the tomato crop scenario that yielded the largest EECs, acute and
chronic RQ values range from about 30 to 60 for freshwater fish,
respectively (compared to 23 and 44 from the 2002 ERA) to about 230 and
680 for estuarine/marine fish, respectively (compared to 190 and 490
from the  2002 ERA). Acute and chronic RQ values for invertebrates range
from approximately 4 to 130 for freshwater (compared to 3.3 and 93 from
the 2002 ERA) and from 50 to 190 for estuarine/marine (compared to 42 to
130 from the 2002 ERA), respectively.  Findings from ecological
incidents support the findings of endosulfan risk to fish and
invertebrates.

Risks to freshwater and estuarine/marine invertebrates resulting from
sediment exposure to endosulfan are evident from the integration of
exposure and effect characterization.  The RQ values for
sediment-dwelling invertebrates range form 0.9 to 2.8 depending on
species. These RQ values are based on predicted total endosulfan
residues compared to endosulfan sulfate toxicity values, which assumes
similar toxicity of endosulfan sulfate and total endosulfan residues.

Based on preliminary results from an aquatic food web bioaccumulation
model, risks to piscivorous wildlife appear relatively modest with mean
predicted acute RQ values exceeding the Agency acute LOC of 0.1 for one
of eight species modeled (0.15 for river otter) and 90th percentile
estimates exceeding the LOC for three of eight species modeled (0.18,
0.39, 0.20 for mink, river otter and belted kingfisher, respectively).
Predicted chronic RQ values did not exceed the Agency LOC for any of the
eight species modeled.

Risks to nontarget terrestrial wildlife did not change from the 2002 ERA
as a result of this addendum, because currently available terrestrial
exposure models could not address total residue exposure.  Based on the
2002 ERA, RQs for birds and mammals exceed the Agency’s acute and
chronic risk LOCs and range up to a maximum of 2.7 for birds and 40 for
mammals.

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̤̀萑ː␱态킄愂̤摧┞	̤̀␱愁̤摧┞ᤀ Monitoring data
and incident reports confirm that endosulfan is moving through aquatic
and terrestrial food chains and that its use has resulted in adverse
effects on the environment adjacent to and distant from it registered
use sites.

 Meakin, S. What´s New with POPs Research in the Arctic. Northern
Perspectives 26 (1), 6-7 (2000)

Page   PAGE  1  of   NUMPAGES  7


[Federal Register Volume 87, Number 131 (Monday, July 11, 2022)]
[Notices]
[Pages 41160-41162]
[FR Doc No: 2022-14694]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Acceptance of a Noise Exposure Map and Review of a
Noise Compatibility Program

AGENCY: Federal Aviation Administration, DOT.

SUMMARY: The Federal Aviation Administration (FAA) announces its
determination that the noise exposure map submitted by the Port
Authority of New York and New Jersey for LaGuardia Airport is in
compliance with applicable statutory and regulatory requirements, see
SUPPLEMENTARY INFORMATION for details. Further, in conjunction with the
noise exposure map, FAA is reviewing the proposed noise compatibility
program for LaGuardia Airport, which the FAA will approve or disapprove
on or before January 2, 2023. This notice also announces the
availability of this noise compatibility program for public review and
comment.

DATES: The effective date of the FAA's determination on the noise
exposure map is June 16, 2022 and of the start of its review of the
associated noise compatibility program is July 6, 2022. The public
comment period ends September 4, 2022.

FOR FURTHER INFORMATION CONTACT: Andrew Brooks, Regional Environmental
Program Manager, Airports Division, Federal Aviation Administration, 1
Aviation Plaza, Room 516, Jamaica, NY 11434. Phone Number: 718-553-
2511. Comments on the proposed noise compatibility program should also
be submitted to the above office.

SUPPLEMENTARY INFORMATION: This notice announces that the FAA finds
that the revised 2021 noise exposure map (NEM) submitted for LaGuardia
Airport is in compliance with applicable requirements of Title 14, Code
of Federal Regulations (CFR) part 150, (14 CFR part 150) effective June
16, 2022. Further, FAA is reviewing a proposed noise compatibility
program

(NCP) for LaGuardia Airport which will be approved or disapproved on or
before January 2, 2023. This notice also announces the availability of
this program for public review and comment. Per the Aviation Safety and
Noise Abatement Act of 1979, hereinafter referred to as ``the Act''
(also see 49 U.S.C. 47503), an airport operator may submit to the FAA
NEMs which meet applicable regulations and which depict non-compatible
land uses as of the date of submission of such maps, a description of
projected aircraft operations, and the ways in which such operations
will affect such maps. The Act requires such maps to be developed in
consultation with interested and affected parties in the local
community, government agencies, and persons using the airport.
    An airport operator who has submitted NEMs that are found by FAA to
be in compliance with the requirements of 14 CFR part 150, may submit a
NCP for FAA approval which sets forth the measures the operator has
taken or proposes to take to reduce existing non-compatible uses and
prevent the introduction of additional non-compatible uses.
    The Port Authority of New York and New Jersey submitted to the FAA
on June 15, 2022 a revised ``With Program'' 2021 NEM, descriptions and
other documentation that were produced during the development of the
``LaGuardia Airport Title 14 Code of Federal Regulations (CFR) Part 150
Noise Compatibility Program'' (NCP Report), dated June 2022. The
revised ``With Program'' 2021 NEM was submitted to show changes made to
the LaGuardia Airport 2021 NEM previously accepted by the Federal
Aviation Administration on May 15, 2017 (Noise Exposure Map Notice for
LaGuardia Airport, New York City, New York, volume 82, Federal
Register, pages 22714-5, May 15, 2017). The revisions to the previously
approved 2021 NEM depict changes to noise contours from implementation
of noise abatement measures contained within the associated NCP. It was
requested that the FAA review this material as the NEM, as described in
49 U.S.C. 47503 of the Act, and that the noise mitigation measures, to
be implemented jointly by the airport and surrounding communities, be
approved as a NCP under 49 U.S.C. 47504.
    The FAA has completed its review of the revised ``With Program''
2021 NEM and related descriptions submitted by The Port Authority of
New York and New Jersey. The documentation that constitutes the NEM as
defined in 14 CFR 150.7 is the revised ``With Program'' 2021 Future
Year NEM, Map 1 of 6, located in Appendix I-2 of the NCP Report. The
NEMs contain current and forecast information including the depiction
of the airport and its boundaries, the runway configurations, land uses
such as single and two-family residential; multi-family residential;
mixed residential and commercial; commercial and office; industrial and
manufacturing; transportation, parking and utilities; unclassified;
vacant land; open space, cemeteries, and outdoor recreation; places of
worship; schools; historic structures; and day care/assisted living
facilities and those areas within the Day Night Average Sound Level
(DNL) 65, 70 and 75 decibel noise contours. The revised ``With
Program'' 2021 NEM reflects the previous implementation of noise
abatement measure 1 from the noise compatibility program. Accordingly,
all estimates for the non-compatible land area and residential
populations within these contours for the revised ``With Program'' 2021
noise exposure map are shown in Table 3-2 in Chapter 3 of the NCP
Report. The estimates of land use within these contours for the revised
``With Program'' 2021 noise exposure map are shown in Table 2-4 of
Chapter 2 of the NCP Report. Flight tracks are found in Maps 2 of 6
through 6 of 6 in Appendix I-2. The type and frequency of aircraft
operations (including nighttime operations) are found in Chapter 2,
Tables 2-1, 2-2, and 2-3.
    The FAA has determined that these maps for LaGuardia Airport are in
compliance with applicable requirements. This determination is
effective on June 16, 2022. FAA's determination on an airport
operator's NEMs is limited to a finding that the maps were developed in
accordance with the procedures contained in appendix A of 14 CFR part
150. Such determination does not constitute approval of the applicant's
data, information or plans, or constitute a commitment to approve a NCP
or to fund the implementation of that program.
    If questions arise concerning the precise relationship of specific
properties to noise exposure contours depicted on a NEM submitted under
49 U.S.C. 47503, it should be noted that the FAA is not involved in any
way in determining the relative locations of specific properties with
regard to the depicted noise contours, or in interpreting the NEMs to
resolve questions concerning, for example, which properties should be
covered by the provisions of 49 U.S.C. 47506. These functions are
inseparable from the ultimate land use control and planning
responsibilities of local government. These local responsibilities are
not changed in any way under 14 CFR part 150 or through FAA's review of
NEMs. Therefore, the responsibility for the detailed overlaying of
noise exposure contours onto the map depicting properties on the
surface rests exclusively with the airport operator that submitted
those maps, or with those public agencies and planning agencies with
which consultation is required under 49 U.S.C. 47503. The FAA has
relied on the certification by the airport operator, under 14 CFR
150.21, that the statutorily required consultation has been
accomplished.
    The FAA has formally received the NCP for LaGuardia Airport, also
submitted on June 15, 2022. Preliminary review of the submitted
material indicates that it conforms to the requirements for the
submittal of NCPs, but that further review will be necessary prior to
approval or disapproval of the program for LaGuardia Airport. The
formal review period, limited by law to a maximum of 180 days, was
initiated on July 6, 2022 and will be completed on or before January 2,
2023.
    The FAA's detailed evaluation will be conducted under the
provisions of 14 CFR 150.33. The primary considerations in the
evaluation process are whether the proposed measures may reduce the
level of aviation safety, create an undue burden on interstate or
foreign commerce, or be reasonably consistent with obtaining the goal
of reducing existing non-compatible land uses and preventing the
introduction of additional non-compatible land uses.
    Interested persons are invited to comment on the proposed program
with specific reference to these factors. All comments, other than
those properly addressed to local land use authorities, will be
considered by the FAA to the extent practicable. Copies of the NEMs for
LaGuardia Airport, the FAA's evaluation of the maps, and the proposed
NCP for LaGuardia Airport are available for examination online at
http://panynjpart150.com/LGA_FNCP.asp.
    The Port Authority of New York and New Jersey has also made a hard
copy of the document available for review at the LaGuardia Airport
Community Information Center, 98-12 Astoria Boulevard, East Elmhurst,
NY 11369. The document will be available for review from Monday to
Thursday between the hours of 10 a.m. and 4 p.m. Interested parties
should contact Raquel Moss at<PHONE_NUMBER> to arrange for a review.
    Questions regarding this notice may be directed to the individual
named

above under the heading, FOR FURTHER INFORMATION CONTACT.

    Issued in Jamaica, NY, on July 6, 2022.
David A. Fish,
Director, Airports Division, Eastern Region.
[FR Doc. 2022-14694 Filed 7-8-22; 8:45 am]
BILLING CODE 4910-13-P