[Federal Register Volume 87, Number 138 (Wednesday, July 20, 2022)]
[Rules and Regulations]
[Pages 43214-43219]
[FR Doc No: 2022-15410]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2021-0356; FRL-9839-01-OCSPP]

Spiropidion; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of the
insecticide spiropidion and its metabolites and degradates in or on
multiple commodities which are identified and discussed later in this
document. Syngenta Crop Protection, LLC requested these tolerances
under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective July 20, 2022. Objections and
requests for hearings must be received on or before September 19, 2022
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2021-0356, is available at
https://www.regulations.gov or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket) in the Environmental Protection
Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg.,
Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. The
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room and the OPP Docket is<PHONE_NUMBER>. Please review the
visitor instructions and additional information about the EPA Docket
Center and Reading Room that are available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, Acting Director,
Registration Division (7505T), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Avenue NW,
Washington, DC 20460; 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/title-40.

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-2021-0356 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing and must be received by the Hearing Clerk on or before
September 19, 2022. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-

2021-0356, by one of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets/contacts.html. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at https://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of June 28, 2021 (86 FR 33924) (FRL-10025-
08), 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
0E8880) by Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro,
NC 27419-8300. The petition requested that 40 CFR part 180 be amended
by establishing tolerances for residues of the insecticide spiropidion,
[3-(4-chloro-2,6-dimethyl-phenyl)-8-methoxy-1-methyl-2-oxo-1,8-
diazaspiro[4.5]dec-3-en-4-yl ethyl carbonate] and its metabolite
SYN547305 [3-(4-chloro-2,6-dimethyl-phenyl)-8-methoxy-1-methyl-1,8-
diazaspiro[4.5]decane-2,4-dione; and 2-(4-chloro-2,6-dimethyl-phenyl)-
1-hydroxy-8-methoxy-4-methyl-4,8-diazaspiro[4.5]dec-1-en-3-one], in or
on the following raw agricultural/processed and livestock commodities:
cucurbit vegetables (crop group 9) at 0.8 parts per million (ppm);
fruiting vegetables (crop group 8) at 1.5 ppm; soybeans at 3 ppm;
potato (crop subgroup 1C) at 1.5 ppm; poultry meat at 0.01 ppm; meat
byproducts of poultry at 0.01 ppm; fat of poultry at 0.01 ppm; eggs at
0.01 ppm; milk and milk byproducts at 0.01 ppm; meat byproducts of
cattle, goat, hogs, horses and sheep at 0.3 ppm; fat of cattle, goat,
hogs, horses and sheep at 0.04 ppm; wet tomato peel at 3 ppm; dried
tomato pomace at 40 ppm; tomato paste at 3 ppm; tomato puree at 2 ppm;
dried tomatoes at 15 ppm; soy meal at 5 ppm; soy flour at 5 ppm;
pollard at 4 ppm; soy aspirated grain fractions at 6 ppm; raw peeled
potatoes at 3 ppm; baked potatoes with skin at 3 ppm; potato chips/
fries at 2 ppm; potato granules/flakes at 5 ppm; potato process waste
at 3 ppm; dried potato pulp at 3 ppm; and potato protein at 5 ppm. That
document referenced a summary of the petition prepared by Syngenta Crop
Protection, LLC, the registrant, which is available in the docket,
https://www.regulations.gov. There were no comments received in
response to the notice of filing.
    Based on review of the data supporting the petition and EPA policy,
EPA has revised some of the commodity definitions and tolerance levels
from the petition. The reason 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 spiropidion including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with spiropidion 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 toxicological database for spiropidion is complete and
indicates that decreased body weight and mortality were the most common
adverse effects observed. The dog was the most sensitive species with
effects including severe clinical signs (salivation, unsteadiness on
feet, ataxia, being subdued, twitching, abnormal breathing,
hypersensitivity, and tremors) leading to humane euthanasia after
acute, subchronic and chronic exposure at doses >=30 mg/kg/day. No
additional treatment related effects in dogs were observed at doses
that did not cause severe clinical signs. These effects occurred at
doses ~4x lower and ~7x lower than the doses at which effects were
observed in rats and mice, respectively. In rats, decreased body weight
was observed at the highest dose tested following a 28-day exposure.
Additionally, in rats, minimal to mild thyroid follicular cell
hypertrophy was consistently observed across subchronic durations. In
mice, premature death was observed in both sexes at the highest dose
tested (448.6/465.4 mg/kg/day male/female) following subchronic
exposure. At lower dose levels in mice, increased urea and blood urea
nitrogen concentrations, increased alkaline phosphatase levels
(females), decreased albumin levels and albumin/globulin ratio
(females), and increased liver weights (males) were observed. However,
these findings were not considered adverse, as there were no
corroborating macroscopic or microscopic pathology findings noted in
mice. Following chronic exposure in the rat and mouse, no adverse
effects were observed up to the highest dose tested. Decreased body
weight in males and severe convulsions in females were observed at a
relatively high dose (500 mg/kg) in the acute neurotoxicity study in
rats. No adverse effects were observed in rats following exposures via
the dermal route up to the limit dose.
    There was no evidence of increased pre- or post-natal sensitivity
or susceptibility observed in the database. No adverse parental,
offspring, or reproductive effects were observed in the two-generation
reproductive toxicity study up to the highest dose tested. No adverse
parental or developmental effects were observed in the rat and rabbit
developmental toxicity studies up to the highest dose tested.
    Spiropidion is classified as ``Not Likely to Be Carcinogenic to
Humans'' based on a lack of treatment related neoplastic lesions in two
species and no mutagenic concerns.
    Specific information on the studies received and the nature of the
adverse effects caused by spiropidion 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 https://www.regulations.gov in the
document entitled ``Spiropidion: First Food Use; Human Health Risk
Assessment for the Establishment of Permanent Tolerances without U.S.
Registration for Residues in or on Soybean, Tomato, Bell and Nonbell
Peppers, Muskmelon, Watermelon, Cucumber, Pumpkin, and Potato'' in
docket ID number EPA-HQ-OPP-2021-0356.

B. Toxicological Points of Departure/Levels of Concern

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

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to spiropidion, EPA considered exposure under the petitioned-
for tolerances. EPA assessed dietary exposures from spiropidion in food
as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure. Such effects were identified
for spiropidion. Acute dietary (food only) exposure and risk
assessments were conducted using the Dietary Exposure Evaluation Model
software with the Food Commodity Intake Database (DEEM-FCID) Version
4.02. This software uses 2005-2010 food consumption data from the U.S.
Department of Agriculture's (USDA's) National Health and Nutrition
Examination Survey, What We Eat in America (NHANES/WWEIA). The current
assessment includes bell and nonbell pepper, cucumber, muskmelon,
potato, pumpkin, soybean, tomato, watermelon, and fat and meat
byproducts of cattle, goats, horses, and sheep.
    EPA conducted an unrefined acute dietary (food only) exposure
assessment for the proposed uses of spiropidion. EPA's default
processing factors for potato dry commodities, dried tomato, tomato
paste, tomato puree, and soybean flour were set to 1 as processing data
for these commodities are available and no appreciable concentration of
residues that would require an additional tolerance was identified. In
addition, EPA's default processing factors were also used for dried
bell and dried nonbell pepper. It was assumed that 100% of the crops
were treated. As the request is for tolerances without U.S.
registration, residues in drinking water are not expected.
    Results of the acute dietary assessment indicate that the general
U.S. population and all other population subgroups have exposure and
risk estimates below EPA's level of concern (LOC). The acute dietary
exposure estimate is 3.2% of the aPAD for the general U.S. population,
and 7.3% of the aPAD for the highest exposed population subgroup,
children 1-2 years old.
    ii. Chronic exposure. In conducting the chronic dietary (food only)
exposure assessment, EPA used DEEM-FCID Version 4.02 with 2005-2010
food consumption data from the USDA's NHANES/WWEIA. EPA's default
processing factors for potato dry commodities, dried tomato, tomato
paste, tomato puree, and soybean flour were set to 1 as processing data
for these commodities are available and no concentration of residues
that would require an additional tolerance was required. In addition,
EPA's default processing factors were also used for dried bell and
dried nonbell pepper. It was assumed that 100% of the crops were
treated. As the request is for tolerances without U.S. registration,
residues in drinking water are not expected.
    EPA conducted an unrefined chronic dietary (food only) exposure
assessment for the proposed uses of spiropidion. Results of the chronic
dietary assessment indicate that the general U.S. population and all
other population subgroups have exposure and risk estimates below EPA's
LOC. The chronic dietary exposure estimate is 2.3% of the cPAD for the
general U.S. population, and 6.7% of the cPAD for the highest exposed
population subgroup, children 1-2 years old.
    iii. Cancer. EPA determines whether quantitative cancer exposure
and risk assessments are appropriate for a food-use pesticide based on
the weight of the evidence from cancer studies and other relevant data.
Cancer risk is quantified using a linear or nonlinear approach. If
sufficient information on the carcinogenic mode of action is available,
a threshold or nonlinear approach is used and a cancer RfD is
calculated based on an earlier noncancer key event. If carcinogenic
mode of action data are not available, or if the mode of action data
determines a mutagenic mode of action, a default linear cancer slope
factor approach is utilized. Based on the data summarized in Unit
III.A., EPA has concluded that spiropidion does not pose a cancer risk
to humans. Therefore, a dietary exposure assessment for the purpose of
assessing cancer risk was 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 spiropidion. Tolerance level residues and/or 100
PCT were assumed for all food commodities.
    2. Dietary exposure from drinking water. Spiropidion is not
registered for use in the United States; therefore, EPA assumes that
there is no exposure through groundwater or surface water sources of
drinking water. Because residues are not expected in drinking water,
dietary risk estimates include exposures from food only.
    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 fleas and tick control on pets). Spiropidion 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 spiropidion to share a common mechanism of
toxicity with any other substances, and spiropidion does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, EPA has assumed that spiropidion
does not have a common mechanism of toxicity with other substances. For
information regarding EPA's efforts to determine which chemicals have a
common mechanism of toxicity and to evaluate the cumulative effects of
such chemicals, see EPA's website at https://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional ten-fold (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 (FQPA) Safety Factor (SF). In accordance with Section
408(b)(2)(C) of the Federal Food, Drug, and Cosmetic Act (FFDCA), EPA
either retains the default value of 10x margin of safety 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. The toxicology database is
complete and is adequate for the purpose of assessing prenatal and
postnatal susceptibility based on the following considerations: (1) the
toxicity database is complete and includes adequate studies to assess
potential susceptibility in the young; (2) no effects were identified
in the prenatal developmental studies or in the two-generation
reproduction toxicity study up to the highest dose tested; and (3) the
endpoints chosen for risk assessment are protective of any potential
susceptibility that may occur at higher doses.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF of 10x were reduced to 1x. That decision is based on the
following findings:
    i. The toxicology database is considered complete and is adequate
for the purpose of assessing prenatal and postnatal susceptibility.
Acceptable guideline studies for developmental, reproductive toxicity,
and neurotoxicity are available for FQPA SF assessment.
    ii. There is evidence of potential neurotoxicity in the acute
neurotoxicity study (ACN) (severe convulsions in females) and in the
subchronic and chronic dog studies (clinical signs indicative of
potential neurotoxicity); however, concern is low because (1) the
effects observed in the ACN were observed at a relatively high dose
(500 mg/kg); (2) clear NOAELs were identified for the neurotoxic
effects; and (3) the points of departure chosen for risk assessment are
protective of any potential neurotoxicity observed in the database.
    iii. There was no evidence of increased quantitative or qualitative
pre-natal susceptibility in the rabbit or rat developmental toxicity
studies or postnatal susceptibility in the two-generation reproduction
toxicity study up to the highest doses tested. Even though these
studies did not test up to the limit dose, there is little concern
about the potential for toxicity and/or susceptibility at higher doses
than those tested since (1) the current POD (15 mg/kg/day) is
protective of any potential developmental and/or reproductive effects
that may occur above the highest tested doses used in these studies
(>30.6/24.1 mg/kg/day [M/F]) and (2) the dog is the more sensitive
species and additional developmental and reproductive studies in the
rat and rabbit are not expected to have a lower POD than currently
used.
    iv. There are no residual uncertainties identified in the exposure
databases. An unrefined dietary exposure assessment was completed, and
tolerance level residues and 100 PCT were assumed; therefore, dietary
exposures will not underestimate the exposure and risks posed by
spiropidion.

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
aPAD and 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. Imported commodities will be the only source of
exposure for spiropidion in the U.S.; therefore, the aggregate
assessment was limited to food exposure (acute and chronic). As a
result, the aggregate assessments are equivalent to the dietary
assessments and are not of concern. Based on the explanation in Unit
III.C.3., acute residential exposure to residues of spiropidion is not
expected.
    2. Chronic risk. Imported commodities will be the only source of
exposure for spiropidion in the U.S.; therefore, the aggregate
assessment was limited to food exposure (acute and chronic). As a
result, the aggregate assessments are equivalent to the dietary
assessments and are not of concern. Based on the explanation in Unit
III.C.3., chronic residential exposure to residues of spiropidion is
not expected.
    3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). Because no
short-term exposure scenario has been identified for spiropidion, no
short-term aggregate exposure is expected.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). Because no intermediate-term exposure scenario has been
identified for spiropidion, no intermediate-term aggregate exposure is
expected.
    5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, spiropidion is not expected to pose a cancer risk to humans.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general U.S. population, or to infants and children from
aggregate exposure to spiropidion residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Syngenta has submitted an acceptable method description and method
validation data and an independent laboratory validation (ILV) for a
``Quick, Easy, Cheap, Effective, Rugged, and Safe'' method (QuEChERS)
liquid chromatography done with tandem mass spectroscopy (LC/MS/MS),
Method No. BPL19-0035, for the determination of residues of spiropidion

and metabolite SYN547305 in crop commodities for purposes of regulatory
enforcement. In addition, Syngenta has submitted an acceptable method
description and method validation data and an ILV for LC/MS/MS Method
No. PG26LL for the determination of residues of metabolites SYN547305
(free and conjugated) in livestock commodities for purposes of
regulatory enforcement.
    These methods may be requested from: Analytical Chemistry Branch,
Environmental Science Center, 701 Mapes Road, Suite 5350, 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.
    The Joint Meeting on Pesticide Residues (JMPR) proposed Codex MRLs
for residues of spiropidion in or on soybean; melon, watermelon,
cucumber, tomato, potato, pumpkin, bell and nonbell pepper; meat
byproduct of cattle, goat, hogs, horses, and sheep; fat of cattle,
goat, hogs, horses, and sheep. The JMPR recommendations will be
considered by the Codex Committee on Pesticide Residues (CCPR) and
potentially adopted by the Codex Alimentarius Commission this year. The
tolerance level for residues in pumpkin and tomato have been harmonized
to the proposed Codex MRLs. The tolerance level for residues in bell
and nonbell pepper have not been harmonized with the proposed Codex
MRLs because the MRL is lower than the tolerance for pepper and
harmonizing could result in a situation where compliance with label
directions results in residues in excess of the tolerance.

C. Revisions to Petitioned-For Tolerances

    EPA is establishing tolerances for most of the commodities
requested by the petitioner; however, a number of the tolerances being
established as part of this action differ from what was initially
requested in the tolerance petition. All of the revisions and/or
changes to the petitioned-for tolerances and the reasoning behind those
changes were presented to the petitioner and subsequently accepted. The
reasoning for those revisions are explained in full detail below.
    EPA revised the commodity definitions for the requested tolerances
for soybeans; cucurbit vegetables (crop group 9); fruiting vegetables
(crop group 8); potato (crop subgroup 1C); fat of cattle, goat, horse
and sheep; and meat byproduct of cattle, goat, horse and sheep to be
consistent with EPA's commodity vocabulary. Several of the requested
tolerances are being established at levels that differ from what was
requested based on available residue data and the use of the
Organization for Economic Co-operation and Development (OECD) MRL
calculator and/or for harmonization purposes. EPA has also determined
that tolerances for residues in the processed commodities of potato and
tomato are not required because the tolerances for the raw commodities
are sufficient to cover the processed commodities. In addition, based
upon estimated dietary burden and the results of the metabolism study,
hog and poultry tolerances are not needed. Further, a tolerance for
milk is not being established based upon results in the ruminant
feeding study in that milk does not contain residues of spiropidion.
    EPA has determined that tolerances for residues in the processed
commodities of soybean and pollard are not required. Soybean and
pollard are considered to be minor livestock feed items, and EPA does
not set tolerances for, nor does it require residue data on minor
livestock feed items. The tolerance for soybean, seed is sufficient to
cover these processed commodities; therefore, a tolerance for soybean
and pollard are not needed. Based upon a soybean processing study, EPA
has also determined that a tolerance for soybean aspirated grain
fractions is not required because it is covered by the tolerance set on
soybean, seed.
    Although the petitioner originally requested tolerances for crop
group 8, crop group 9 and crop subgroup 1C, EPA is establishing
tolerances only for the representative commodities for which residue
data were submitted.

V. Conclusion

    Therefore, tolerances are established for residues of the
insecticide spiropidion and its metabolites and degradates in or on
cucumber at 0.8 ppm; muskmelon at 0.9 ppm; pepper, bell at 1.5 ppm;
pepper, nonbell at 1.5 ppm; potato at 1.5 ppm; pumpkin at 0.9 ppm;
soybean, seed at 3 ppm; tomato at 0.8 ppm; watermelon at 0.9 ppm;
cattle, fat at 0.03 ppm; cattle, meat byproducts at 0.3 ppm; goat, fat
at 0.03 ppm; goat, meat byproducts at 0.3 ppm; horse, fat at 0.03ppm;
horse, meat byproducts at 0.3 ppm; sheep, fat at 0.03 ppm; sheep, meat
byproducts at 0.3 ppm. Compliance with tolerances for the plant
commodities will be determined by measuring only the sum of spiropidion
[3-(4-chloro-2,6-dimethyl-phenyl)-8-methoxy-1-methyl-2-oxo-1,8-
diazaspiro[4.5]dec-3-en-4-yl ethyl carbonate] and its metabolite
SYN547305 [3-(4-chloro-2,6-dimethyl-phenyl)-8-methoxy-1-methyl-1,8-
diazaspiro[4.5]decane-2,4-dione; and 2-(4-chloro-2,6-dimethyl-phenyl)-
1-hydroxy-8-methoxy-4-methyl-4,8-diazaspiro[4.5]dec-1-en-3-one],
calculated as the stoichiometric equivalent of spiropidion, in or on
the plant commodities. Compliance with the tolerances for the livestock
commodities will be determined by measuring only SYN547305 [3-(4-
chloro-2,6-dimethyl-phenyl)-8-methoxy-1-methyl-1,8-
diazaspiro[4.5]decane-2,4-dione; and 2-(4-chloro-2,6-dimethyl-phenyl)-
1-hydroxy-8-methoxy-4-methyl-4,8-diazaspiro[4.5]dec-1-en-3-one],
calculated as the stoichiometric equivalent of spiropidion, in or on
the livestock commodities.

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 tolerance
in this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or Tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
Tribal Governments, on the relationship between the National Government
and the States or Tribal Governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian Tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999), and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000), do not apply to this action. In addition,
this action does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act (UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: July 13, 2022.
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.  180.723 to subpart C to read as follows:

Sec.  180.723  Spiropidion; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the
insecticide spiropidion, including its metabolites and degradates, in
or on the commodities in Table 1 to this paragraph (a)(1). Compliance
with the tolerance levels specified in Table 1 to this paragraph (a)(1)
is to be determined by measuring only the sum of spiropidion [3-(4-
chloro-2,6-dimethyl-phenyl)-8-methoxy-1-methyl-2-oxo-1,8-
diazaspiro[4.5]dec-3-en-4-yl ethyl carbonate] and its metabolite
SYN547305 [3-(4-chloro-2,6-dimethyl-phenyl)-8-methoxy-1-methyl-1,8-
diazaspiro[4.5]decane-2,4-dione; and 2-(4-chloro-2,6-dimethyl-phenyl)-
1-hydroxy-8-methoxy-4-methyl-4,8-diazaspiro[4.5]dec-1-en-3-one],
calculated as the stoichiometric equivalent of spiropidion, in or on
the following plant commodities:

                       Table 1 to Paragraph (a)(1)
------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cucumber \1\................................................         0.8
Muskmelon \1\...............................................         0.9
Pepper, bell \1\............................................         1.5
Pepper, nonbell \1\.........................................         1.5
Potato \1\..................................................         1.5
Pumpkin \1\.................................................         0.9
Soybean, seed \1\...........................................           3
Tomato \1\..................................................         0.8
Watermelon \1\..............................................         0.9
------------------------------------------------------------------------
\1\ There are no U.S. registrations for this commodity as of July 20,
  2022.

    (2) Tolerances are established for residues of the insecticide
spiropidion, including its metabolites and degradates, in or on the
commodities in Table 2 to this paragraph (a)(2). Compliance with the
tolerance levels specified in Table 2 to this paragraph (a)(2) is to be
determined by measuring only SYN547305 [3-(4-chloro-2,6-dimethyl-
phenyl)-8-methoxy-1-methyl-1,8-diazaspiro[4.5]decane-2,4-dione; and 2-
(4-chloro-2,6-dimethyl-phenyl)-1-hydroxy-8-methoxy-4-methyl-4,8-
diazaspiro[4.5]dec-1-en-3-one], calculated as the stoichiometric
equivalent of spiropidion, in or on the following livestock
commodities:

                       Table 2 to Paragraph (a)(2)
------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, fat \1\.............................................        0.03
Cattle, meat byproducts \1\.................................         0.3
Goat, fat \1\...............................................        0.03
Goat, meat byproducts \1\...................................         0.3
Horse, fat \1\..............................................        0.03
Horse, meat byproducts \1\..................................         0.3
Sheep, fat \1\..............................................        0.03
Sheep, meat byproducts \1\..................................         0.3
------------------------------------------------------------------------
\1\ There are no U.S. registrations for this commodity as of July 20,
  2022.

    (b)-(d) [Reserved]

[FR Doc. 2022-15410 Filed 7-19-22; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 86, Number 152 (Wednesday, August 11, 2021)]
[Notices]
[Pages 44134-44135]
[FR Doc No: 2021-17104]

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

DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-1998-4334; FMCSA-2000-7918; FMCSA-2003-14504; FMCSA-
2003-15268; FMCSA-2004-17984; FMCSA-2004-18885; FMCSA-2005-20027;
FMCSA-2005-21254; FMCSA-2006-26066; FMCSA-2006-26653; FMCSA-2008-0106;
FMCSA-2008-0340; FMCSA-2009-0086; FMCSA-2010-0385; FMCSA-2011-0010;
FMCSA-2011-0102; FMCSA-2012-0279; FMCSA-2012-0337; FMCSA-2013-0022;
FMCSA-2013-0027; FMCSA-2013-0028; FMCSA-2013-0029; FMCSA-2013-0169;
FMCSA-2014-0004; FMCSA-2014-0006; FMCSA-2014-0008; FMCSA-2014-0298;
FMCSA-2014-0300; FMCSA-2014-0301; FMCSA-2014-0304; FMCSA-2014-0305;
FMCSA-2015-0055; FMCSA-2015-0350; FMCSA-2016-0024; FMCSA-2016-0213;
FMCSA-2016-0377; FMCSA-2017-0014; FMCSA-2017-0019; FMCSA-2018-0018;
FMCSA-2018-0208; FMCSA-2018-0209; FMCSA-2019-0004; FMCSA-2019-0005;
FMCSA-2019-0011]

Qualification of Drivers; Exemption Applications; Vision

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), Department
of Transportation (DOT).

ACTION: Notice of final disposition.

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

SUMMARY: FMCSA announces its decision to renew exemptions for 59
individuals from the vision requirement in the Federal Motor Carrier
Safety Regulations (FMCSRs) for interstate commercial motor vehicle
(CMV) drivers. The exemptions enable these individuals to continue to
operate CMVs in interstate commerce without meeting the vision
requirement in one eye.

DATES: Each group of renewed exemptions were applicable on the dates
stated in the discussions below and will expire on the dates provided
below.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA,
DOT, 1200 New Jersey Avenue SE, Room W64-224, Washington, DC 20590-
0001. Office hours are from 8:30 a.m. to 5 p.m., ET, Monday through
Friday, except Federal holidays. If you have questions regarding
viewing or submitting material to the docket, contact Dockets
Operations,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Public Participation

A. Viewing Comments

    To view comments go to www.regulations.gov. Insert the docket
number, FMCSA-1998-4334, FMCSA-2000-7918, FMCSA-2003-14504, FMCSA-2003-
15268, FMCSA-2004-17984, FMCSA-2004-18885, FMCSA-2005-20027, FMCSA-
2005-21254, FMCSA-2006-26066, FMCSA-2006-26653, FMCSA-2008-0106, FMCSA-
2008-0340, FMCSA-2009-0086, FMCSA-2010-0385, FMCSA-2011-0010, FMCSA-
2011-0102, FMCSA-2012-0279, FMCSA-2012-0337, FMCSA-2013-0022, FMCSA-
2013-0027, FMCSA-2013-0028, FMCSA-2013-0029, FMCSA-2013-0169, FMCSA-
2014-0004, FMCSA-2014-0006, FMCSA-2014-0008, FMCSA-2014-0298, FMCSA-
2014-0300, FMCSA-2014-0301, FMCSA-2014-0304, FMCSA-2014-0305, FMCSA-
2015-0055, FMCSA-2015-0350, FMCSA-2016-0024, FMCSA-2016-0213, FMCSA-
2016-0377, FMCSA-2017-0014, FMCSA-2017-0019, FMCSA-2018-0018, FMCSA-
2018-0208, FMCSA-2018-0209, FMCSA-2019-0004, FMCSA-2019-0005, or FMCSA-
2019-0011 in the keyword box, and click ``Search.'' Next, sort the
results by ``Posted (Newer-Older),'' choose the first notice listed,
and click ``Browse Comments.'' If you do not have access to the
internet, you may view the docket online by visiting Dockets Operations
in Room W12-140 on the ground floor of the DOT West Building, 1200 New
Jersey Avenue SE, Washington, DC 20590-0001, between 9 a.m. and 5 p.m.,
ET, Monday through Friday, except Federal holidays. To be sure someone
is there to help you, please call<PHONE_NUMBER> or<PHONE_NUMBER>
before visiting Dockets Operations.

B. Privacy Act

    In accordance with 5 U.S.C. 553(c), DOT solicits comments from the
public to better inform its rulemaking process. DOT posts these
comments, without edit, including any personal information the
commenter provides, to www.regulations.gov, as described in the system
of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.transportation.gov/privacy.

II. Background

    On June 28, 2021, FMCSA published a notice announcing its decision
to renew exemptions for 59 individuals from the vision requirement in
49 CFR 391.41(b)(10) to operate a CMV in interstate commerce and
requested comments from the public (86 FR 34111). The public comment
period ended on July 28, 2021, and no comments were received.
    FMCSA has evaluated the eligibility of these applicants and
determined that renewing these exemptions would achieve a level of
safety equivalent to, or greater than, the level that would be achieved
by complying with the current regulation Sec.  391.41(b)(10).
    The physical qualification standard for drivers regarding vision
found in Sec.  391.41(b)(10) states that a person is physically
qualified to drive a CMV if that person has distant visual acuity of at
least 20/40 (Snellen) in each eye without corrective lenses or visual
acuity separately corrected to 20/40 (Snellen) or better with
corrective lenses, distant binocular acuity of a least 20/40 (Snellen)
in both eyes with or without corrective lenses, field of vision of at
least 70[deg] in the horizontal meridian in each eye, and the ability
to recognize the colors of traffic signals and devices showing red,
green, and amber.

III. Discussion of Comments

    FMCSA received no comments in this proceeding.

IV. Conclusion

    Based on its evaluation of the 59 renewal exemption applications
and comments received, FMCSA confirms its decision to exempt the
following drivers from the vision requirement in Sec.  391.41(b)(10).
    In accordance with 49 U.S.C. 31136(e) and 31315(b), the following
groups of drivers received renewed exemptions in the month of August
and are discussed below. As of August 8, 2021, and in accordance with
49 U.S.C. 31136(e) and 31315(b), the following 51 individuals have
satisfied the renewal conditions for obtaining an exemption from the
vision requirement in the FMCSRs for interstate CMV drivers (63 FR
66226, 64 FR 16517, 65 FR 66286, 66 FR 13825, 66 FR 17994, 68 FR 13360,
68 FR 15037, 68 FR 19598, 68 FR 33570, 69 FR 33997, 69 FR 53493, 69 FR
61292, 69 FR 62742, 70 FR 2701, 70 FR 12265, 70 FR 14747, 70 FR 16887,
70 FR 25878, 71 FR 62148, 71 FR 63379, 72 FR 184, 72 FR 1051, 72 FR
8417, 72 FR 11425, 72 FR 11426, 72 FR 12665, 72 FR 28093, 72 FR 36099,
73 FR 35197, 73 FR 48275, 73 FR 61925, 73 FR 75803, 73 FR 78423, 74 FR
6209, 74 FR 8302, 74 FR 9329, 74 FR 11991, 74 FR 15586, 74 FR 19267, 74
FR 20253, 74 FR 26466, 74 FR 28094, 75 FR 44051, 75 FR 77492, 75 FR
77942, 75 FR 77949, 75 FR 79083, 76 FR 4413, 76 FR 5425, 76 FR 9856, 76
FR 11215, 76 FR 15360, 76 FR 17483, 76 FR 20076, 76 FR 21796, 76 FR
29022, 76 FR 29026, 76 FR 32016, 76 FR 37173, 76 FR 44082, 77 FR 46153,
77 FR 60008, 77 FR 68202, 77 FR 70534, 77 FR 71671, 77 FR 74734, 78 FR
797, 78 FR 800, 78 FR 9772, 78 FR 12815, 78 FR 12822, 78 FR 16035, 78
FR 16762, 78 FR 18667, 78 FR 22596, 78 FR 22602, 78 FR 24798, 78 FR
27281, 78 FR 30954,

78 FR 32703, 78 FR 41188, 78 FR 46407, 78 FR 51268, 78 FR 57679, 78 FR
64274, 78 FR 77778, 79 FR 18392, 79 FR 29498, 79 FR 35212, 79 FR 41737,
79 FR 46153, 79 FR 47175, 79 FR 56102, 79 FR 65759, 79 FR 65760, 79 FR
69985, 79 FR 73686, 80 FR 603, 80 FR 2473, 80 FR 3305, 80 FR 3308, 80
FR 6162, 80 FR 8927, 80 FR 13070, 80 FR 14220, 80 FR 14223, 80 FR
15859, 80 FR 15863, 80 FR 16500, 80 FR 16502, 80 FR 18693, 80 FR 20562,
80 FR 22773, 80 FR 25766, 80 FR 25768, 80 FR 31957, 80 FR 33007, 80 FR
33011, 80 FR 36395, 80 FR 36398, 80 FR 45573, 80 FR 67481, 81 FR 14190,
81 FR 21655, 81 FR 39100, 81 FR 66718, 81 FR 80161, 81 FR 81230, 81 FR
90050, 81 FR 96165, 81 FR 96180, 82 FR 13043, 82 FR 13045, 82 FR 13048,
82 FR 13187, 82 FR 15277, 82 FR 17736, 82 FR 18949, 82 FR 18956, 82 FR
22379, 82 FR 23712, 82 FR 26224, 82 FR 32919, 82 FR 33542, 82 FR 37499,
83 FR 2306, 83 FR 15195, 83 FR 28325, 83 FR 34661, 83 FR 40638, 83 FR
53727, 83 FR 60954, 84 FR 2305, 84 FR 2311, 84 FR 2314, 84 FR 2323, 84
FR 2326, 84 FR 2328, 84 FR 5550, 84 FR 10389, 84 FR 12665, 84 FR 16320,
84 FR 16327, 84 FR 16336, 84 FR 21393, 84 FR 21397, 84 FR 21401, 84 FR
47057, 84 FR 52166):

Marvin D. Bass (KY)
Raymond L. Bradshaw (TX)
Joel A. Cabrera (FL)
Richard D. Carlson (MN)
David F. Cialdea (MA)
Peter R. Clarke (WA)
Marcus L. Conner (TX)
Jon R. Davidson (CO)
Donald W. Donaldson (GA)
David L. Dykman (ID)
Terry J. Edwards (MO)
Barry J. Ferdinando (NH)
Riche Ford (CO)
Dale R. Goodell (SD)
Thomas A. Grigsby (AR)
Matthew J. Hahn (PA)
Jay A. Harding (OR)
Johnny K. Hiatt (NC)
William G. Holland (AR)
Abdalla M. Jalili (IL)
Francisco J. Jimenez (TX)
Curtis L. Lamb (KS)
David C. Leoffler (CO)
Richard D. Livingston (WI)
Robert R. Martin (VA)
Carl M. McIntire (OH)
Edgar H. Meraz Gardea (NM)
Leonard Morris (NJ)
Timothy L. Morton (NC)
George M. Nelson (OH)
William L. Paschall (MD)
John P. Perez (FL)
Zeljko Popovac (VT)
Roberto A. Ramos (TX)
Donald W. Randall (OR)
Larry F. Reber (OH)
Larry D. Robinson (MO)
Cory W. Schell (WA)
Lynn R. Schraeder (IA)
Leverne F. Schulte, Jr. (OH)
Richie J. Schwendy (IL)
Martin Serrano (IL)
Kyle C. Shover (NJ)
Sammie Q. Soles, Jr. (MI)
Charles T. Spears (VA)
George R. Tieskoetter (IA)
Jaime Valdez (TX)
James K. Waites (AR)
Robert A. Wegner (MN)
Bryon L. Wright (DE)
Dana J. York (PA)

    The drivers were included in docket number FMCSA-1998-4334, FMCSA-
2000-7918, FMCSA-2003-14504, FMCSA-2004-17984, FMCSA-2004-18885, FMCSA-
2005-20027, FMCSA-2006-26066, FMCSA-2006-26653, FMCSA-2008-0106, FMCSA-
2008-0340, FMCSA-2009-0086, FMCSA-2010-0385, FMCSA-2011-0010, FMCSA-
2011-0102, FMCSA-2012-0279, FMCSA-2012-0337, FMCSA-2013-0022, FMCSA-
2013-0027, FMCSA-2013-0028, FMCSA-2013-0169, FMCSA-2014-0004, FMCSA-
2014-0006, FMCSA-2014-0008, FMCSA-2014-0298, FMCSA-2014-0300, FMCSA-
2014-0301, FMCSA-2014-0304, FMCSA-2014-0305, FMCSA-2015-0350, FMCSA-
2016-0024, FMCSA-2016-0213, FMCSA-2016-0377, FMCSA-2017-0014, FMCSA-
2018-0018, FMCSA-2018-0208, FMCSA-2018-0209, FMCSA-2019-0004, and
FMCSA-2019-0005. Their exemptions are applicable as of August 8, 2021
and will expire on August 8, 2023.
    As of August 10, 2021, and in accordance with 49 U.S.C. 31136(e)
and 31315(b), Carl V. Murphy, Jr. (TX) has satisfied the renewal
conditions for obtaining an exemption from the vision requirement in
the FMCSRs for interstate CMV drivers (70 FR 30999, 70 FR 46567, 72 FR
40359, 74 FR 34074, 76 FR 44653, 79 FR 4531, 80 FR 41547, 82 FR 32919,
84 FR 52166).
    This driver was included in docket number FMCSA-2005-21254. The
exemption is applicable as of August 10, 2021 and will expire on August
10, 2023.
    As of August 15, 2021, and in accordance with 49 U.S.C. 31136(e)
and 31315(b), the following three individuals have satisfied the
renewal conditions for obtaining an exemption from the vision
requirement in the FMCSRs for interstate CMV drivers (68 FR 37197, 68
FR 48989, 70 FR 42615, 72 FR 40360, 74 FR 34632, 76 FR 49531, 79 FR
4531, 80 FR 44185, 82 FR 32919, 84 FR 33801, 84 FR 47045, 84 FR 52166):

Christopher G. Jarvela (MI); Guillermo Rocha (CA); and Paul S. Yocum
(IN)

    The drivers were included in docket numbers FMCSA-2003-15268 and
FMCSA-2019-0011. Their exemptions are applicable as of August 15, 2021
and will expire on August 15, 2023.
    As of August 23, 2021, and in accordance with 49 U.S.C. 31136(e)
and 31315(b), Twila G. Cole (OR) has satisfied the renewal conditions
for obtaining an exemption from the vision requirement in the FMCSRs
for interstate CMV drivers (78 FR 34143, 78 FR 52602, 82 FR 32919, 84
FR 52166).

    This driver was included in docket number FMCSA-2013-0029. The
exemption is applicable as of August 23, 2021 and will expire on August
23, 2023.
    As of August 25, 2021, and in accordance with 49 U.S.C. 31136(e)
and 31315(b), the following two individuals have satisfied the renewal
conditions for obtaining an exemption from the vision requirement in
the FMCSRs for interstate CMV drivers (80 FR 44188, 80 FR 62161, 82 FR
32919, 84 FR 52166):

    Robert J. Falanga (FL) and Duane S. Lozinski (IA)

    The drivers were included in docket number FMCSA-2015-0055. Their
exemptions are applicable as of August 25, 2021 and will expire on
August 25, 2023.
    As of August 29, 2021, and in accordance with 49 U.S.C. 31136(e)
and 31315(b), Patrick J. Conner (OK) has satisfied the renewal
conditions for obtaining an exemption from the vision requirement in
the FMCSRs for interstate CMV drivers (82 FR 35043, 82 FR 47295, 84 FR
52166).
    This driver was included in docket number FMCSA-2017-0019. The
exemption is applicable as of August 29, 2021 and will expire on August
29, 2023.
    In accordance with 49 U.S.C. 31315(b), each exemption will be valid
for 2 years from the effective date unless revoked earlier by FMCSA.
The exemption will be revoked if the following occurs: (1) The person
fails to comply with the terms and conditions of the exemption; (2) the
exemption has resulted in a lower level of safety than was maintained
prior to being granted; or (3) continuation of the exemption would not
be consistent with the goals and objectives of 49 U.S.C. 31136(e) and
31315(b).

Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2021-17104 Filed 8-10-21; 8:45 am]
BILLING CODE 4910-EX-P


			  UNITED STATES OF AMERICA

		        DEPARTMENT OF TRANSPORTATION

			  OFFICE OF THE SECRETARY

			          WASHINGTON, D.C.

Issued by the Department of Transportation on January 23, 2004

NOTICE OF ACTION TAKEN -- DOCKETS OST-2000-7490 & 2000-7495

________________________________________________________________________
__________________________________________

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
will be issued in this matter).

Applicant:  Emirates

Background:  On July 1, 2003, we granted Emirates exemption authority to
engage in scheduled foreign air transportation of persons, property and
mail from points behind the United Arab Emirates (U.A.E.), via the
U.A.E. and intermediate points, to a point or points in the United
States and beyond; and authority to conduct charters in accordance with
Part 212 of the Department’s rules.  On the same date, we granted a
joint request of Emirates and Continental Airlines, Inc. for blanket
statements of authorization to conduct reciprocal code share services
between the United Arab Emirates and the United States.  We granted the
authorities subject to an interim condition requested by Emirates in the
referenced Dockets, that Emirates only exercise the authorities as part
of a Department-authorized code-share or wet lease arrangement with a
duly authorized and properly supervised carrier or carriers.  In its
submission in these Dockets, Emirates stated that it would advise the
Department when it was prepared to conduct these operations using its
own aircraft and crews.

By letter dated January 23, 2004, Emirates advised us that it was ready
to conduct the authorized operations with its own aircraft, and asked
that the code-share/wet lease condition be removed.

Applicant representative:  Shelia C. Cheston & David Heffernan (202)
663-6000

DOT Analyst:  Gordon H. Bingham<PHONE_NUMBER>

Disposition:  We have decided to remove the code-share or wet lease
condition from the authorities we granted Emirates on July 1, 2003, in
the above referenced dockets.  In the circumstances presented, including
the notification received from Emirates on January 23, and the fact that
we have been advised that the FAA and the TSA are prepared to allow
Emirates to serve the United States with its own aircraft, we find that
it is in the public interest to remove the code-share or wet lease
condition imposed on Emirates’ in Dockets OST-2000-7490 & 2000-7495.
This means that Emirates may conduct is authorized services to and from
the United States with its own aircraft and crews.

Action taken by:   Paul L. Gretch, Director

		      Office of International Aviation

________________________________________________________________________
_________

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that (1) the applicant was qualified to perform the
proposed operations; (2) our action was consistent with Department
policy; (3) grant of the authority was consistent with the public
interest; and (4) grant of the authority would not constitute a major
regulatory action under the Energy Policy and Conservation Act of 1975.
To the

extent not granted/deferred/dismissed, we denied all requests in the
referenced Docket.  We may amend, modify, or revoke the authority
granted in this Notice at any time without hearing at our discretion.

Persons entitled to petition the Department for review of the action set
forth in this Notice under the Department’s regulations, 14 CFR §
385.30, may file their petitions within seven (7) days after the date of
issuance of this Notice.  This action was effective when taken, and the
filing of a petition for review will not alter such effectiveness.

An electronic version of this document is available on the World Wide
Web at:

http://dms.dot.gov//reports/reports_aviation.asp

				Attachment

Foreign Carrier Conditions

In the conduct of the operations authorized, the foreign carrier
applicant(s) shall:

(1)  Not conduct any operations unless it holds a currently effective
authorization from its homeland for such operations, and it has filed a
copy of such authorization with the Department;

(2)  Comply with all applicable requirements of the Federal Aviation
Administration, including, but not limited to, 14 CFR Parts 129, 91, and
36, and with all applicable U.S. Government requirements concerning
security.  To assure compliance with all applicable U.S. Government
requirements concerning security, the holder shall, before commencing
any new service (including charter flights) from a foreign airport that
would be the holder’s last point of departure for the United States,
contact its Principal Security Inspector (PSI) to advise the PSI of its
plans and to find out whether the Transportation Security Administration
has determined that security is adequate to allow such airport(s) to be
served;

(3)  Comply with the requirements for minimum insurance coverage
contained in 14 CFR Part 205, and, prior to the commencement of any
operations under this authority, file evidence of such coverage, in the
form of a completed OST Form 6411, with the Federal Aviation
Administration’s Program Management Branch (AFS-260), Flight Standards
Service (any changes to, or termination of, insurance also shall be
filed with that office);

(4)  Not operate aircraft under this authority unless it complies with
operational safety requirements at least equivalent to Annex 6 of the
Chicago Convention;

(5)  Conform to the airworthiness and airman competency requirements of
its Government for international air services;

(6)  Except as specifically exempted or otherwise provided for in a
Department Order, comply with the requirements of 14 CFR Part 203,
concerning waiver of Warsaw Convention liability limits and defenses;

(7)  Agree that operations under this authority constitute a waiver of
sovereign immunity, for the purposes of 28 U.S.C. 1605(a), but only with
respect to those actions or proceedings instituted against it in any
court or other tribunal in the United States that are: (a)  based on its
operations in international air transportation that, according to the
contract of carriage, include a point in the United States as a point of
origin, point of destination, or agreed stopping place, or for which the
contract of carriage was purchased in the United States; or (b)  based
on a claim under any international agreement or treaty cognizable in any
court or other tribunal of the United States.  In this condition, the
term "international air transportation" means "international
transportation" as defined by the Warsaw Convention, except that all
States shall be considered to be High Contracting Parties for the
purpose of this definition;

(8)  Except as specifically authorized by the Department, originate or
terminate all flights to/from the United States in its homeland;

(9)  Comply with the requirements of 14 CFR Part 217, concerning the
reporting of scheduled, nonscheduled, and charter data;

(10) If charter operations are authorized, except as otherwise provided
in the applicable aviation agreement, comply with the Department's rules
governing charters (including 14 CFR Parts 212 and 380); and

(11) Comply with such other reasonable terms, conditions, and
limitations required by the public interest as may be prescribed by the
Department, with all applicable orders or regulations of other U.S.
agencies and courts, and with all applicable laws of the United States.

This authority shall not be effective during any period when the holder
is not in compliance with the conditions imposed above.  Moreover, this
authority cannot be sold or otherwise transferred without explicit
Department approval under Title 49 of the U.S. Code.

  We have also amended Emirates’ exemption to substitute our current
standard exemption conditions (attached) for those which had been in
effect at the time of our July 1, 2003 authorization.

08/2003


[Federal Register Volume 81, Number 190 (Friday, September 30, 2016)]
[Rules and Regulations]
[Pages 67112-67113]
[FR Doc No: 2016-23411]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 97

[Docket No. 31096; Amdt. No. 3713]

Standard Instrument Approach Procedures, and Takeoff Minimums and
Obstacle Departure Procedures; Miscellaneous Amendments

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This rule establishes, amends, suspends, or removes Standard
Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums
and Obstacle Departure Procedures (ODPs) for operations at certain
airports. These regulatory actions are needed because of the adoption
of new or revised criteria, or because of changes occurring in the
National Airspace System, such as the commissioning of new navigational
facilities, adding new obstacles, or changing air traffic requirements.
These changes are designed to provide safe and efficient use of the
navigable airspace and to promote safe flight operations under
instrument flight rules at the affected airports.

DATES: This rule is effective September 30, 2016. The compliance date
for each SIAP, associated Takeoff Minimums, and ODP is specified in the
amendatory provisions.
    The incorporation by reference of certain publications listed in
the regulations is approved by the Director of the Federal Register as
of September 30, 2016.

ADDRESSES: Availability of matters incorporated by reference in the
amendment is as follows:

For Examination

    1. U.S. Department of Transportation, Docket Ops-M30, 1200 New
Jersey Avenue SE., West Bldg., Ground Floor, Washington, DC 20590-0001.
    2. The FAA Air Traffic Organization Service Area in which the
affected airport is located;
    3. The office of Aeronautical Navigation Products, 6500 South
MacArthur Blvd., Oklahoma City, OK 73169 or,
    4. The National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, call 202-741-
6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

Availability

    All SIAPs and Takeoff Minimums and ODPs are available online free
of charge. Visit the National Flight Data Center at nfdc.faa.gov to
register. Additionally, individual SIAP and Takeoff Minimums and ODP
copies may be obtained from the FAA Air Traffic Organization Service
Area in which the affected airport is located.

FOR FURTHER INFORMATION CONTACT: Thomas J. Nichols, Flight Procedure
Standards Branch (AFS-420), Flight Technologies and Programs Divisions,
Flight Standards Service, Federal Aviation Administration, Mike
Monroney Aeronautical Center, 6500 South MacArthur Blvd., Oklahoma
City, OK 73169 (Mail Address: P.O. Box 25082, Oklahoma City, OK 73125)
Telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: This rule amends Title 14 of the Code of
Federal Regulations, Part 97 (14 CFR part 97), by establishing,
amending, suspending, or removes SIAPS, Takeoff Minimums and/or ODPS.
The complete regulatory description of each SIAP and its associated
Takeoff Minimums or ODP for an identified airport is listed on FAA form
documents which are incorporated by reference in this amendment under 5
U.S.C. 552(a), 1 CFR part 51, and 14 CFR part 97.20. The applicable FAA
forms are FAA Forms 8260-3, 8260-4, 8260-5, 8260-15A, and 8260-15B when
required by an entry on 8260-15A.
    The large number of SIAPs, Takeoff Minimums and ODPs, their complex
nature, and the need for a special format make publication in the
Federal Register expensive and impractical. Further, airmen do not use
the regulatory text of the SIAPs, Takeoff Minimums or ODPs, but instead
refer to their graphic depiction on charts printed by publishers of
aeronautical materials. Thus, the advantages of incorporation by
reference are realized and publication of the complete description of
each SIAP, Takeoff Minimums and ODP listed on FAA form documents is
unnecessary. This amendment provides the affected CFR sections and
specifies the types of SIAPs, Takeoff Minimums and ODPs with their
applicable effective dates. This amendment also identifies the airport
and its location, the procedure, and the amendment number.

Availability and Summary of Material Incorporated by Reference

    The material incorporated by reference is publicly available as
listed in the ADDRESSES section.
    The material incorporated by reference describes SIAPS, Takeoff
Minimums and/or ODPS as identified in the amendatory language for part
97 of this final rule.

The Rule

    This amendment to 14 CFR part 97 is effective upon publication of
each separate SIAP, Takeoff Minimums and ODP as Amended in the
transmittal. Some SIAP and Takeoff Minimums and textual ODP amendments
may have been issued previously by the FAA in a Flight Data Center
(FDC) Notice to Airmen (NOTAM) as an emergency action of immediate
flight safety relating directly to published aeronautical charts.
    The circumstances that created the need for some SIAP and Takeoff
Minimums and ODP amendments may require making them effective in less
than 30 days. For the remaining SIAPs and Takeoff Minimums and ODPs, an
effective date at least 30 days after publication is provided.
    Further, the SIAPs and Takeoff Minimums and ODPs contained in this
amendment are based on the criteria contained in the U.S. Standard for
Terminal Instrument Procedures (TERPS). In developing these SIAPs and
Takeoff Minimums and ODPs, the TERPS criteria were applied to the

conditions existing or anticipated at the affected airports. Because of
the close and immediate relationship between these SIAPs, Takeoff
Minimums and ODPs, and safety in air commerce, I find that notice and
public procedure under 5 U.S.C. 553(b) are impracticable and contrary
to the public interest and, where applicable, under 5 U.S.C. 553(d),
good cause exists for making some SIAPs effective in less than 30 days.
    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore--(1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26,1979); and
(3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. For the same reason, the FAA
certifies that this amendment will not have a significant economic
impact on a substantial number of small entities under the criteria of
the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 97

    Air traffic control, Airports, Incorporation by reference,
Navigation (air).

    Issued in Washington, DC, on September 9, 2016.
John S. Duncan,
Director, Flight Standards Service.

Adoption of the Amendment

    Accordingly, pursuant to the authority delegated to me, Title 14,
Code of Federal Regulations, Part 97 (14 CFR part 97) is amended by
establishing, amending, suspending, or removing Standard Instrument
Approach Procedures and/or Takeoff Minimums and Obstacle Departure
Procedures effective at 0901 UTC on the dates specified, as follows:

PART 97--STANDARD INSTRUMENT APPROACH PROCEDURES

0
1. The authority citation for part 97 continues to read as follows:

    Authority: 49 U.S.C. 106(f), 106(g), 40103, 40106, 40113, 40114,
40120, 44502, 44514, 44701, 44719, 44721-44722.

0
2. Part 97 is amended to read as follows:

Effective 10 November 2016

Gulkana, AK, Gulkana, Takeoff Minimums and Obstacle DP, Amdt 7A
Napakiak, AK, Napakiak, RNAV (GPS) RWY 16, Orig-A
Napakiak, AK, Napakiak, RNAV (GPS) RWY 34, Orig-A
Scammon Bay, AK, Scammon Bay, RNAV (GPS)-B, Orig-A
Camden, AR, Harrell Field, VOR/DME RWY 1, Amdt 10B
Groveland, CA, Pine Mountain Lake, Takeoff Minimums and Obstacle DP,
Amdt 1
Lodi, CA, Lodi, Takeoff Minimums and Obstacle DP, Amdt 2A
Lodi, CA, Lodi, VOR-A, Amdt 3A
Oakdale, CA, Oakdale, Takeoff Minimums and Obstacle DP, Amdt 1
Stockton, CA, Stockton Metropolitan, ILS OR LOC RWY 29R, Amdt 20B
Stockton, CA, Stockton Metropolitan, VOR RWY 29R, Amdt 18E, CANCELED
Tampa, FL, Tampa Executive, RNAV (GPS) RWY 5, Orig-C
Macon, GA, Middle Georgia Rgnl, ILS OR LOC RWY 5, Amdt 2
Macon, GA, Middle Georgia Rgnl, RNAV (GPS) RWY 5, Amdt 2
Macon, GA, Middle Georgia Rgnl, RNAV (GPS) RWY 14, Amdt 2D
Macon, GA, Middle Georgia Rgnl, RNAV (GPS) RWY 23, Amdt 2D
Macon, GA, Middle Georgia Rgnl, RNAV (GPS) RWY 32, Amdt 1D
Macon, GA, Middle Georgia Rgnl, VOR RWY 14, Amdt 10C
Macon, GA, Middle Georgia Rgnl, VOR RWY 23, Amdt 4D
Macon, GA, Middle Georgia Rgnl, Takeoff Minimums and Obstacle DP,
Amdt 3B
Beverly, MA, Beverly Rgnl, RNAV (GPS) RWY 9, Orig
Beverly, MA, Beverly Rgnl, RNAV (GPS) RWY 27, Amdt 1
Beverly, MA, Beverly Rgnl, RNAV (GPS) RWY 34, Orig-D
Brunswick, ME, Brunswick Executive, ILS OR LOC RWY 1R, Amdt 1
Brunswick, ME, Brunswick Executive, RNAV (GPS) RWY 1R, Amdt 2
Shamokin, PA, Northumberland County, Takeoff Minimums and Obstacle
DP, Amdt 2
State College, PA, University Park, ILS OR LOC RWY 24, Amdt 9B
State College, PA, University Park, RNAV (GPS) RWY 6, Amdt 2
State College, PA, University Park, RNAV (GPS) RWY 24, Amdt 1
Zelienople, PA, Zelienople Muni, RNAV (GPS) RWY 17, Amdt 1
Zelienople, PA, Zelienople Muni, RNAV (GPS) RWY 35, Amdt 1
Pulaski, WI, Carter, Takeoff Minimums and Obstacle DP, Orig,
CANCELED

[FR Doc. 2016-23411 Filed 9-29-16; 8:45 am]
 BILLING CODE 4910-13-P