[Federal Register Volume 86, Number 240 (Friday, December 17, 2021)]
[Rules and Regulations]
[Pages 71573-71574]
[FR Doc No: 2021-27337]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2021-0902]

Safety Zone; San Francisco New Year's Eve Fireworks Display; San
Francisco Bay, San Francisco, CA

AGENCY: Coast Guard, DHS.

ACTION: Notification of enforcement of regulation.

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SUMMARY: The Coast Guard will enforce the safety zone in the navigable
waters of the San Francisco Bay near the Ferry Plaza in San Francisco,
CA for the San Francisco New Year's Eve Fireworks Display in the
Captain of the Port, San Francisco area of responsibility during the
dates and times noted below. This action is necessary to protect
personnel, vessels, and the marine environment from the dangers
associated with pyrotechnics. During the enforcement period,
unauthorized persons or vessels are prohibited from entering into,
transiting through, or remaining in the safety zone, unless authorized
by the Patrol Commander (PATCOM) or other federal, state, or local law
enforcement agencies on scene to assist the Coast Guard in enforcing
the regulated area.

DATES: The regulation in 33 CFR 165.1191, Table 1, Item number 24, will
be enforced from noon on December 31, 2021, through 12:45 a.m. on
January 1, 2022, or as announced via Broadcast Notice to Mariners.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
notification of enforcement, call or email Lieutenant Anthony Solares,
U.S. Coast Guard Sector San Francisco; telephone<PHONE_NUMBER> or
email at [email protected].

SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the safety zone
established in 33 CFR 165.1191, Table 1, Item number 24, for the San
Francisco New Year's Eve Firework Display from noon on December 31,
2021 through 12:45 a.m. on January 1, 2022. The Coast Guard will
enforce a 100-foot safety zone around the two fireworks barges during
the loading, standby, transit, and arrival of the fireworks barges from
the loading location to the display location and until the start of the
fireworks display. On December 31, 2021, the fireworks barges will be
loaded with pyrotechnics at Pier 50 in San Francisco, CA from
appoximately noon until approximately 6 p.m. The fireworks barges will
remain on standby at the loading location until their transit to the
display location. From 10:45 p.m. to 11:15 p.m. on December 31, 2021
the loaded fireworks barges will transit from Pier 50 to the launch
site near the San Francisco Ferry Plaza in approximate position
37[deg]47'45'' N, 122[deg]23'15'' W (NAD 83), where they will remain
until the conclusion of the fireworks display. At approximately 11:59
p.m. on December 31, 2021, 15-minutes prior to the fireworks display,
the safety zone will expand to encompass all navigable waters, from
surface to bottom, within a circle formed by connecting all points
1,000 feet out from the fireworks barges. The firework barges will be
near the San Francisco Ferry Plaza in San Francisco, CA in approximate
position 37[deg]47'45'' N, 122[deg]23'15'' W (NAD 83) as set forth in
33 CFR 165.1191, Table 1, Item number 24. The safety zone will be
enforced until 12:45 a.m. on January 1, 2022, or as announced via
Broadcast Notice to Mariners.
    In addition to this notification in the Federal Register, the Coast
Guard plans to provide notification of the safety zone and its
enforcement period via the Local Notice to Mariners.
    Under the provisions of 33 CFR 165.1191, unauthorized persons or
vessels are prohibited from entering

into, transiting through, or anchoring in the safety zone during all
applicable effective dates and times, unless authorized to do so by the
PATCOM or other Official Patrol, defined as a federal, state, or local
law enforcement agency on scene to assist the Coast Guard in enforcing
the regulated area. Additionally, each person who receives notice of a
lawful order or direction issued by the PATCOM or Official Patrol shall
obey the order or direction. The PATCOM or Official Patrol may, upon
request, allow the transit of commercial vessels through regulated
areas when it is safe to do so.
    If the Captain of the Port determines that the regulated area need
not be enforced for the full duration stated in this notice, a
Broadcast Notice to Mariners may be used to grant general permission to
enter the regulated area.

    Dated: December 13, 2021.
Taylor Q. Lam,
Captain, U.S. Coast Guard, Captain of the Port, San Francisco.
[FR Doc. 2021-27337 Filed 12-16-21; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 83, Number 55 (Wednesday, March 21, 2018)]
[Rules and Regulations]
[Pages 12269-12274]
[FR Doc No: 2018-05641]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0211; FRL-9973-11]

S-Metolachlor; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of S-
metolachlor in or on sugarcane, cane and sugarcane molasses. Syngenta
Crop Protection requested these tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective March 21, 2018. Objections and
requests for hearings must be received on or before May 21, 2018, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2017-0211, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

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

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

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

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

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2017-0211 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
May 21, 2018. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2017-0211, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of September 15, 2017 (82 FR 43352) (FRL-
9965-43), 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
6F8519) by Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro,
NC 27419. The petition requested that 40 CFR part 180 be amended by
establishing tolerances for residues of the herbicide S-metolachlor in
or on sugarcane at 0.4 parts per million (ppm) and sugarcane molasses
at 1.5 ppm. That document referenced a summary of the petition prepared
by Syngenta Crop Protection, 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.
    Based upon review of the data supporting the petition, EPA is

establishing a tolerance for sugarcane, cane below the level requested.
The reason for this change is explained in Unit IV.D.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for S-metolachlor including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with S-metolachlor
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 existing toxicological database is primarily comprised of
studies conducted with metolachlor. However, bridging studies indicate
that the metolachlor toxicology database can be used to assess toxicity
for S-metolachlor. In subchronic (metolachlor and S-metolachlor) and
chronic (metolachlor) toxicity studies in dogs and rats decreased body
weight and body weight gain were the most commonly observed effects. No
systemic toxicity was observed in rabbits when metolachlor was
administered dermally. There was no evidence of neurotoxic effects in
the available toxicity studies, and there is no evidence of
immunotoxicity in the submitted mouse immunotoxicity study.
    Prenatal developmental studies in the rat and rabbit with both
metolachlor and S-metolachlor revealed no evidence of a qualitative or
quantitative susceptibility in fetal animals. A 2-generation
reproduction study with metolachlor in rats showed no evidence of
parental or reproductive toxicity. There are no residual uncertainties
with regard to pre- and/or postnatal toxicity.
    Metolachlor has been evaluated for carcinogenic effects in the
mouse and the rat. Although treatment with metolachlor did not result
in an increase in treatment-related tumors in male rats or in male or
female mice, metolachlor caused an increase in liver tumors in female
rats. There was no evidence of mutagenic or cytogenetic effects in vivo
or in vitro. Based on the information available in 1994, metolachlor
was classified as a Group C possible human carcinogen, in accordance
with the 1986 Guidelines for Carcinogen Risk Assessment. Based on that
classification and consistent with the data available at that time, EPA
determined that a non-linear approach (i.e., reference dose (RfD))
would be protective for all chronic toxicity, including
carcinogenicity, that could result from exposure to metolachlor.
    In 2017, EPA re-assessed the cancer classification for metolachlor
in order to take into account additional mechanistic studies on s-
metolachlor that were submitted to assess a human relevance framework
analysis for a mitogenic mode of action (MOA) for liver tumors in
female rats. Based on comparable effects of S-metolachlor and
metolachlor shown in several associative events supporting the mode of
action hypothesis, the Agency concluded that the in vitro and in vivo
data reasonably explains the tumorigenic effects of metolachlor and
adequately demonstrates dose and temporal concordance to support key
events for the MOA leading to liver tumors in female rats.
Specifically, the Agency found that the development of liver tumors in
rats orally administered metolachlor is initiated by activation of
constitutive androstane receptor (CAR) in liver hepatocytes followed by
altered gene expression, transient increased cell proliferation,
increased hepatocellular foci, and hepatocyte toxicity (increased liver
weight and liver hypertrophy).
    Consequently, in accordance with the EPA's Final Guidelines for
Carcinogen Risk Assessment (March 2005), EPA has reclassified
metolachlor/S-metolachlor as ``Not Likely to be Carcinogenic to
Humans'' at doses that do not induce cellular proliferation in the
liver. This classification was based on convincing evidence of a CAR-
mediated mitogenic MOA for liver tumors in female rats. Because the
current chronic RfD is protective for any proliferative responses in
the liver and the other key events in the MOA for the formation of
liver tumors, a non-linear approach (i.e., RfD) would adequately
account for all the chronic toxicity, including carcinogenicity, that
could result from exposure to metolachlor/S-metolachlor.
    Specific information on the studies received and the nature of the
adverse effects caused by S-metolachlor 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 ``S-metolachlor--Human
Health Risk Assessment for the Establishment of Permanent Tolerances
for Use of the Herbicide on Sugarcane (PP#6F8519)'' on pages 36-42 in
docket ID number EPA-HQ-OPP-2017-0211.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www2.epa.gov/
pesticide-science-and-

assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for S-metolachlor used for
human risk assessment is shown in Table 1 of this unit.

 Table 1--Summary of Toxicological Doses and Endpoints for S-metolachlor for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                    Point of  departure
        Exposure/scenario            and  uncertainty/    RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (General population  NOAEL = 300 mg/kg/    Acute RfD = 3.0 mg/  Developmental Toxicity Study--Rat.
 including infants and children).   day.                  kg/day.             Metolachlor LOAEL = 1,000 mg/kg/
                                   UFA = 10x...........  aPAD = 3.0 mg/kg/     day based increased incidence of
                                   UFH = 10x...........   day.                 death, clinical signs (clonic and/
                                   FQPA SF = 1x........                        or tonic convulsions, excessive
                                                                               salivation, urine-stained
                                                                               abdominal fur and/or excessive
                                                                               lacrimation) and decreased body
                                                                               weight gain.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)  NOAEL = 9.7 mg/kg/    Chronic RfD = 0.097  One Year Chronic Toxicity--Dog.
                                    day.                  mg/kg/day.          Metolachlor LOAEL = 33 mg/kg/day
                                   UFA = 10x...........  cPAD = 0.097 mg/kg/   based decreased body weight gain
                                   UFH = 10x...........   day.                 in females.
                                   FQPA SF = 1x........
----------------------------------------------------------------------------------------------------------------
Incidental oral short-term (1 to   NOAEL = 50 mg/kg/day  LOC for MOE = 100..  Developmental Toxicity Study--Rat.
 30 days).                         UFA = 10x...........                       S-metolachlor LOAEL = 500 mg/kg/
                                   UFH = 10x...........                        day based on increased incidence
                                   FQPA SF = 1x........                        of clinical signs, decreased body
                                                                               weight/body weight gain, food
                                                                               consumption and food efficiency
                                                                               seen in maternal animals.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)  Classification: Metolachlor/S-metolachlor has been classified as ``Not Likely
                                         to be Carcinogenic to Humans'' at doses that do not induce cellular
                                     proliferation in the liver, with risk quantitated using a non-linear (RfD)
                                                                      approach.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = Lowest-observed-adverse-effect-level. LOC = Level
  of concern. mg/kg/day = Milligram/kilogram/day. MOE = Margin of exposure. NOAEL = No-observed-adverse-effect-
  level. PAD = Population adjusted dose (a = Acute, c = Chronic). RfD = Reference dose. UF = Uncertainty factor.
  UFA = Extrapolation from animal to human (interspecies). UFH = Potential variation in sensitivity among
  members of the human population (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to S-metolachlor, EPA considered exposure under the
petitioned-for tolerances as well as all existing S-metolachlor and
metolachlor tolerances in 40 CFR 180.368. EPA assessed dietary
exposures from S-metolachlor and metolachlor 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 S-metolachlor. In estimating acute
dietary exposure, EPA used food consumption information from the United
States Department of Agriculture's (USDA) National Health and Nutrition
Examination Survey/What We Eat in America, (NHANES/WWEIA). As to
residue levels in food, EPA assumed tolerance-level residues and 100
percent crop treated (PCT).
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA's NHANES/
WWEIA. As to residue levels in food, EPA assumed tolerance-level
residues and 100 PCT.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that a nonlinear RfD approach is appropriate for assessing
cancer risk to S-metolachlor. Therefore, a separate quantitative cancer
exposure assessment is unnecessary since the chronic dietary risk
estimate will be protective of potential cancer risk.
    iv. Anticipated residue and PCT information. EPA did not use
anticipated residue or PCT information in the dietary assessment for S-
metolachlor. Tolerance-level residues and 100 PCT were assumed for all
food commodities.
    2. Dietary exposure from drinking water. The Agency used screening-
level water exposure models in the dietary exposure analysis and risk
assessment for S-metolachlor in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of S-metolachlor. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    The Agency assessed parent metolachlor, and the metabolites CGA-
51202 (metolachlor-OA), CGA-40172, and CGA-50720 together in the
drinking water assessment using a total toxic residues (TTR) approach
where half-lives were recalculated to collectively account for the
parent and the combined residues of concern.
    Based on the Surface Water Concentration Calculator (SWCC), the
Pesticide Root Zone Model Ground Water (PRZM GW), and the Screening
Concentration in Ground Water (SCI-GROW), the estimated drinking water
concentrations (EDWCs) of S-metolachlor and its metabolites for acute
exposures are estimated to be 371 parts per billion (ppb) for surface
water and 1,060 ppb for ground water, and for chronic exposures are
estimated to be 43.70 ppb for surface water and 978 ppb in ground
water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 1,060 ppb was used to
assess the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 978 ppb was used to assess
the contribution to drinking water.

    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
    S-metolachlor is currently registered for the following uses that
could result in residential exposures: On commercial (sod farm) and
residential warm-season turf grasses and other non-crop land including
golf courses, sports fields, and ornamental gardens. EPA assessed
residential exposure using the following assumptions: For residential
handlers, in previous human health risk assessments for S-metolachlor
inhalation exposure/risk to residential handlers was assessed and
resulted in no risks of concern. However, all registered S-metolachlor
labels with residential use sites require that handlers wear specific
clothing (e.g., long-sleeve shirt/long pants) and personal protective
equipment (e.g., gloves). Based on current policy, the Agency assumes
these products are not intended for homeowner use and, therefore, a
quantitative residential handler assessment was not conducted.
    For residential post-application, there is the potential for short-
term incidental oral exposure for individuals exposed as a result of
being in an environment that has been previously treated with S-
metolachlor. The quantitative exposure/risk assessment for residential
post-application exposures is based on the following scenario: Hand-to-
mouth incidental oral exposure of children 1-2 years old playing on
turf treated with S-metolachlor.
    Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    EPA has not found S-metolachlor to share a common mechanism of
toxicity with any other substances, and S-metolachlor does not appear
to produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that S-
metolachlor does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's website at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
    2. Prenatal and postnatal sensitivity. There was no evidence of
increased quantitative or qualitative fetal susceptibility in the
prenatal developmental studies in rats and rabbits or in the
reproductive toxicity study in rats, with either metolachlor or S-
metolachlor. In general, significant developmental toxicity was not
seen in rats or rabbits with either compound. The only effects observed
in fetal animals were in the rat prenatal developmental study and
included slightly decreased number of implantations per dam, decreased
number of live fetuses/dam, increased number of resorptions/dam and
significant decrease in mean fetal body weight. These effects occurred
at maternally toxic doses (1,000 mg/kg/day).
    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 for all scenarios assessed as part of EPA's
determination of safety for S-metolachlor. This decision is based on
the following findings:
    i. The toxicology database for metolachlor and S-metolachlor is
complete, with the exception of a required subchronic inhalation study
for metolachlor. Although the Agency has determined that a 10X database
uncertainty factor should be retained to account for the lack of the
subchronic inhalation study, the Agency does not expect inhalation
exposures to result from the use of S-metolachlor.
    ii. There is no indication that S-metolachlor is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity.
    iii. There is no evidence that S-metolachlor results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to S-metolachlor in drinking water. EPA used
similarly conservative assumptions to assess post-application
incidental oral exposure of children 1 to less-than 2 years old. These
assessments will not underestimate the exposure and risks posed by S-
metolachlor.

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. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to S-metolachlor will occupy 6.1% of the aPAD for all infants less than
1-year old, the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
S-metolachlor from food and water will utilize 58% of the cPAD for all
infants less than 1-year old, the population group receiving the
greatest exposure. Based on the explanation in Unit III.C.3., regarding
residential use patterns, chronic residential exposure to residues of
S-metolachlor 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).
    S-metolachlor is currently registered for uses that could result in
short-term residential exposure, and the Agency has determined that it
is appropriate to aggregate chronic exposure through food and water
with short-term residential exposures to S-metolachlor.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in an aggregate MOE of 700 for
children 1-2 years old, the only population group of concern. Because
EPA's level of concern for S-metolachlor is a MOE of 100 or below, this
MOE is not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level).
    An intermediate-term adverse effect was identified; however, S-
metolachlor is not registered for any use patterns that would result in
intermediate-term residential exposure. Intermediate-term risk is
assessed based on intermediate-term residential exposure plus chronic
dietary exposure. Because there is no 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 intermediate-term risk), no further assessment
of intermediate-term risk is necessary, and EPA relies on the chronic
dietary risk assessment for evaluating intermediate-term risk for S-
metolachlor.
    5. Aggregate cancer risk for U.S. population. As discussed in Unit
III.A, the chronic dietary risk assessment is protective of any
potential cancer effects. Based on the results of that assessment, EPA
concludes that S-metolachlor is not expected to pose a cancer risk to
humans.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to S-metolachlor residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate methodology is available for enforcing the established and
recommended tolerances. PAM Vol. II, Pesticide Regulation Section
180.368, lists a gas chromatography with nitrogen-phosphorus detector
(GC/NPD) method (Method I) for determining residues in/on plant
commodities and a gas chromatography with mass selective detector (GC/
MSD) method (Method II) for determining residues in livestock
commodities. These methods determine residues of metolachlor and its
metabolites as either CGA-37913 or CGA-49751 following acid hydrolysis.

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 Codex has not established any MRLs for either S-metolachlor or
metolachlor.

C. Response to Comments

    One comment was received in response to the notice of filing. The
commenter was against the establishment of any tolerances for S-
metolachlor and stated in part ``allow zero tolerance. Allow zero
residue'' and ``no animals or people should be eating any toxic
chemicals.''
    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 Federal Food, Drug and
Cosmetic Act (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 these S-metolachlor tolerances are safe. The commenter has
provided no information supporting a contrary conclusion.

D. Revisions to Petitioned-For Tolerances

    Although the petitioner requested a tolerance on sugarcane at 0.4
ppm, EPA is establishing the tolerance at 0.20 ppm based on available
field trial data and the use of average values in the Organization for
Economic Cooperation and Development (OECD) tolerance calculation
procedure instead of every individual sample that the petitioner used.
The Agency is also establishing the tolerance for ``sugarcane, cane''
to be consistent with its food and feed commodity vocabulary.

V. Conclusion

    Therefore, tolerances are established for residues of S-metolachlor
in or on sugarcane, cane at 0.20 ppm and sugarcane molasses at 1.5 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), nor is it considered a
regulatory action under Executive Order 13771, entitled ``Reducing
Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3,
2017). This action does not contain any information collections subject
to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501
et seq.), nor does it require any special considerations under
Executive Order 12898, entitled ``Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This action directly regulates growers, food processors, food
handlers, and food

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

VII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: February 28, 2018.
Michael L. Goodis,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. In Sec.  180.368, add alphabetically entries for ``Sugarcane, cane''
and ``Sugarcane, molasses'' to the table in paragraph (a)(2) to read as
follows:

Sec.  180.368  Metolachlor; tolerances for residues.

* * * * *
    (a)(2) * * *

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

                                * * * * *
Sugarcane, cane..............................................       0.20
Sugarcane, molasses..........................................        1.5

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

* * * * *
[FR Doc. 2018-05641 Filed 3-20-18; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: April 24, 2007 (Volume 72, Number 78)]
[Rules and Regulations]
[Page 20409-20414]
[DOCID:fr24ap07-10]

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Part III

Securities and Exchange Commission

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17 CFR Part 230

Covered Securities Pursuant to Section 18 of the Securities Act of
1933; Final Rule

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SECURITIES AND EXCHANGE COMMISSION

17 CFR Part 230

[Release No. 33-8791; File No. S7-18-06]
RIN 3235-AJ73

Covered Securities Pursuant to Section 18 of the Securities Act
of 1933

AGENCY: Securities and Exchange Commission.

ACTION: Final rule.

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SUMMARY: The Securities and Exchange Commission (``SEC'' or
``Commission'') is adopting an amendment to a rule under Section 18 of
the Securities Act of 1933 (``Securities Act'') to designate securities
listed, or authorized for listing, on the Nasdaq Capital Market tier of
The NASDAQ Stock Market LLC (``Nasdaq'') as covered securities for
purposes of Section 18 of the Securities Act. Covered securities under
Section 18 of the Securities Act are exempt from State law registration
requirements. The Commission also is making a correction to the rule
text to conform it to the language of Section 18 of the Securities Act.

DATES: Effective Date: May 24, 2007.

FOR FURTHER INFORMATION CONTACT: Heather Seidel, Assistant Director,
(202) 551-5608, Hong-anh Tran, Special Counsel,<PHONE_NUMBER>, or
Michou Nguyen, Special Counsel,<PHONE_NUMBER>, Division of Market
Regulation (``Division''), Commission, 100 F Street, NE., Washington,
DC 20549-6628.

SUPPLEMENTARY INFORMATION:

I. Introduction

    In 1996, Congress amended Section 18 of the Securities Act to
exempt from state registration requirements securities listed, or
authorized for listing, on the New York Stock Exchange LLC (``NYSE''),
the American Stock Exchange LLC (``Amex''), or the National Market
System of The NASDAQ Stock Market LLC (``Nasdaq/NGM'') \1\
(collectively, the ``Named Markets''), or any national securities
exchange designated by the Commission to have substantially similar
listing standards to those markets.\2\ More specifically, Section 18(a)
of the Securities Act provides that ``no law, rule, regulation, or
order, or other administrative action of any State * * * requiring, or
with respect to, registration or qualification of securities * * *
shall directly or indirectly apply to a security that--(A) is a covered
security.'' \3\ Covered securities are defined in Section 18(b)(1) of
the Securities Act to include those securities listed, or authorized
for listing, on the Named Markets, or securities listed, or authorized
for listing, on a national securities exchange (or tier or segment
thereof) that has listing standards that the Commission determines by
rule are ``substantially similar'' to the Named Markets.\4\
---------------------------------------------------------------------------

    \1\ As of July 1, 2006, the National Market System of The NASDAQ
Stock Market LLC is known as the Nasdaq Global Market. See
Securities Exchange Act Release Nos. 53799 (May 12, 2006), 71 FR
29195 (May 19, 2006) and 54071 (June 29, 2006), 71 FR 38922 (July
10, 2006).
    \2\ See National Securities Markets Improvement Act of 1996,
Pub. L. No. 104-290, 110 Stat. 3416 (October 11, 1996).
    \3\ 15 U.S.C. 77r(a).
    \4\ 15 U.S.C. 77r(b)(1)(A) and (B). In addition, securities of
the same issuer that are equal in seniority or senior to a security
listed on a Named Market or national securities exchange designated
by the Commission as having substantially similar listing standards
to a Named Market are covered securities for purposes of Section 18
of the Securities Act. 15 U.S.C. 77r(b)(1)(C).
---------------------------------------------------------------------------

    Pursuant to Section 18(b)(1)(B) of the Securities Act, the
Commission adopted Rule 146.\5\ Rule 146(b) lists those national
securities exchanges, or segments or tiers thereof, that the Commission
has determined to have listing standards substantially similar to those
of the Named Markets and thus securities listed on such exchanges are
deemed covered securities.\6\
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    \5\ Securities Exchange Act Release No. 39542 (January 13,
1998), 63 FR 3032 (January 21, 1998) (determining that the listing
standards of the Chicago Board Options Exchange, Incorporated
(``CBOE''), Tier 1 of the Pacific Exchange, Inc. (``PCX'') (now
known as NYSE Arca, Inc.), and Tier 1 of the Philadelphia Stock
Exchange, Inc. (``Phlx'') were substantially similar to those of the
Named Markets and that securities listed pursuant to those standards
would be deemed covered securities for purposes of Section 18 of the
Securities Act). In 2004, the Commission amended Rule 146(b) to
designate options listed on the International Securities Exchange,
Inc. (``ISE'') (now known as the International Securities Exchange,
LLC) as covered securities for purposes of Section 18(b) of the
Securities Act.
    \6\ 17 CFR 230.146(b).
---------------------------------------------------------------------------

    Nasdaq has petitioned the Commission to amend Rule 146(b) to
determine that its listing standards for securities listed on the
Nasdaq Capital Market (``NCM'') \7\ are substantially similar to those
of the Named Markets and, accordingly, that securities listed pursuant
to such listing standards are covered securities for purposes of
Section 18(b) of the Securities Act.\8\
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    \7\ The Nasdaq Capital Market was previously named the Nasdaq
SmallCap Market.
    \8\ See letter from Edward S. Knight, Executive Vice President
and General Counsel, Nasdaq, to Nancy M. Morris, Secretary,
Commission, dated March 1, 2006 (File No. 4--513) (``Nasdaq
Petition'').
---------------------------------------------------------------------------

    On November 22, 2006, the Commission issued a release proposing to
amend Rule 146(b) to designate securities listed on the NCM as covered
securities for purposes of Section 18(a) of the Securities Act.\9\ The
Commission received seven comment letters, all expressing overall
support for the Nasdaq Petition.\10\ In connection with its petition,
Nasdaq filed a proposed rule change to amend its quantitative listing
standards for NCM securities to make its NCM listing standards
substantially similar to the Named Markets.\11\ On April 18, 2007, the
Commission approved this proposed rule change.\12\
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    \9\ Securities Act Release No. 8754 (November 16, 2006), 71 FR
67762 (November 22, 2006) (``Proposing Release'').
    \10\ See letter to Nancy M. Morris, Secretary, Commission, from
Alan M. Parness, Vice Chair, State Regulation of Securities
Committee of the American Bar Association Section of Business Law
(``ABA Committee''), dated April 3, 2006 (``ABA Committee April 3rd
Letter''); letter to Nancy M. Morris, Secretary, Commission, from
Patricia D. Struck, The North American Securities Administrators
Association (``NASAA'') President and Wisconsin Securities
Administrator, dated March 29, 2006 (``NASAA March 29th Letter'');
electronic mail to Robert L.D. Colby, Acting Director, Division,
Commission, from Randall Schumann, Legal Counsel, Wisconsin DFI-
Division of Securities, NASAA Corporation Finance Section Member,
dated June 1, 2006; letter to Nancy M. Morris, Secretary,
Commission, from Alan M. Parness, Vice Chair, ABA Committee, dated
December 20, 2006 (``ABA Committee December 20th Letter''); letter
to Nancy M. Morris, Secretary, Commission, from Joseph P. Borg,
NASAA President and Director, Alabama Securities Commission, dated
December 21, 2006 (``NASAA December 21st Letter''); letter to Nancy
M. Morris, Secretary, Commission, from Joseph P. Borg, NASAA
President and Director, Alabama Securities Commission, dated
December 21, 2006 (``NASAA Supplemental Letter''); and letter to
Nancy M. Morris, Secretary, Commission, from Phillip B. Kennedy,
Esq., Gaeta & Eveson, P.A., dated December 19, 2006 (``Kennedy
Letter''). In addition, the Commission's Advisory Committee on
Smaller Public Companies recommended on April 23, 2006 that the
Commission make NCM stocks ``covered securities.'' SEC Advisory
Committee on Smaller Public Companies, Final Report, at 97-100
(2006).
    \11\ See Securities Exchange Act Release Nos. 54378 (August 28,
2006) (``Nasdaq Proposed Rule Change''), 71 FR 52351 (September 5,
2006).
    \12\ Securities Exchange Act Release No. 55642 (April 18, 2007)
(``NCM Listing Standard Amendments'').
---------------------------------------------------------------------------

    Based on the approved changes to the NCM listing standards and
after careful comparison, the Commission concludes that the listing
standards of the NCM are substantially similar to the listing standards
of the Named Markets. Accordingly, the Commission today is amending
Rule 146(b) to designate securities listed, or authorized for listing,
on the NCM as covered securities under Section 18(b)(1) of the
Securities Act.\13\ Amending Rule 146(b) to include securities listed,
or authorized for listing, on the NCM as covered securities will exempt
those securities from state registration

requirements as set forth under Section 18(a) of the Securities
Act.\14\
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 77r(b)(1).
    \14\ 15 U.S.C. 77r(a).
---------------------------------------------------------------------------

II. Amendment to Rule 146(b) to Include Nasdaq NCM Securities

    Under Section 18(b)(1)(B) of the Securities Act,\15\ the Commission
has the authority to compare the listing standards of a petitioner with
those of the NYSE, Amex, or Nasdaq/NGM. The Commission initially
compared Nasdaq's listing standards for all NCM securities with only
one of the Named Markets. If the listing standards in a particular
category did not meet the standards of that market, the Commission
compared the petitioner's standards to the other two Named Markets.\16\
In addition, the Commission interpreted the ``substantially similar''
standard to require listing standards at least as comprehensive as
those of the Named Markets.\17\ If a petitioner's listing standards are
higher than the Named Markets, then the Commission still determined
that the petitioner's listing standards are substantially similar to
the Named Markets. Finally, the Commission notes that differences in
language or approach would not necessarily lead to a determination that
the listing standards of the petitioner are not substantially similar
to those of a Named Market.
---------------------------------------------------------------------------

    \15\ 15 U.S.C. 77r(b)(1)(A).
    \16\ This approach is consistent with the approach that the
Commission has previously taken. See Securities Act Release Nos.
7422 (June 9, 1997), 62 FR 32705 (June 17, 1997) and 7494 (January
13, 1998), 63 FR 3032 (January 21, 1998).
    \17\ Securities Act Release No. 7422, supra note 16.
---------------------------------------------------------------------------

    The Commission has reviewed the NCM's listing standards, as
amended,\18\ and, for the reasons discussed below, believes that the
standards are substantially similar to those of the Named Markets.
Accordingly, the Commission is amending Rule 146(b) to include
securities listed, or authorized for listing, on the NCM. Because the
Commission believes Nasdaq's qualitative listing standards for NCM
securities are identical to the qualitative listing standards for
Nasdaq/NGM securities,\19\ the discussion below focuses on the NCM
quantitative listing standards.
---------------------------------------------------------------------------

    \18\ See NCM Listing Standard Amendments, supra, note 12.
    \19\ Such qualitative listing standards relate to, among other
things, the number of independent directors required, conflicts of
interest, composition of the audit committee, executive
compensation, shareholder meeting requirements, voting rights,
quorum, code of conduct, proxies, shareholder approval of certain
corporate actions, and the annual and interim reports requirements.
See Nasdaq Rule 4350.
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A. Common Stock

    As discussed in the Proposing Release, the Commission preliminarily
believed that some, but not all, of the requirements in Nasdaq's then-
existing quantitative initial listing standards for common stock
listing on the NCM were substantially similar to those of Amex's common
stock listing standards. The NCM Listing Standard Amendments modify
those NCM initial listing standards for common stock to require an
issuer to have:
     Shareholder's equity of $4 million and net income from
continuing operations of $750,000 in the most recently completed fiscal
year or in two of the last three most recently completed fiscal years,
and a market value of publicly held shares of $5 million;
     Shareholder's equity of $4 million, a market value of
listed securities of $50 million, and a market value of publicly held
shares of $15 million; or
     Shareholder's equity of $5 million, a two-year operating
history, and a market value of publicly held shares of $15 million.\20\
---------------------------------------------------------------------------

    \20\ See NCM Listing Standard Amendments, supra, note 12.

In light of these rule changes, the Commission finds the NCM initial
listing standards for common stock to be substantially similar to those
of Amex.
    The Commission finds that the continued listing requirements for
common stock listed on the NCM, while not identical, are substantially
similar to those of Amex. Amex's delisting criteria are triggered by
poor financial condition or operating results of the issuer.\21\
Specifically, Amex will consider delisting an equity issue if: (i)
Stockholders' equity is less than $2 million and such issuer has
sustained losses from continuing operations and/or net losses in two of
its three most recent fiscal years; (ii) stockholders' equity is less
than $4 million and such issuer has sustained losses from continuing
operations and/or net losses in three of its four most recent fiscal
years; (iii) stockholders' equity is less than $6 million if such
issuer has sustained losses from continuing operations and/or net
losses in its five most recent fiscal years; or (iv) the issuer has
sustained losses which are so substantial in relation to its overall
operations or its existing financial resources, or its financial
condition has become so impaired that it appears questionable, in the
opinion of the Exchange, as to whether such company will be able to
continue operations and/or meet its obligations as they mature.\22\
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    \21\ See generally Sections 1001 through 1006 of the Amex
Company Guide.
    \22\ See Section 1003(a) of the Amex Company Guide. Amex also
will consider delisting if: (i) An issuer has sold or otherwise
disposed of its principal operating assets or has ceased to be an
operating company or has discontinued a substantial portion of its
operations or business; (ii) if substantial liquidation of the
issuer has been made; or (iii) if advice has been received, deemed
by the Exchange to be authoritative, that the security is without
value, or in the case of a common stock, such stock has been selling
for a substantial period of time at a low price. See Section 1003(c)
and (f)(v) of the Amex Company Guide.
---------------------------------------------------------------------------

    Although Nasdaq's NCM does not have the same continued listing
requirements, Nasdaq also looks at the financial condition and
operating results of the issuer. Specifically, for continued listing,
Nasdaq requires an issuer to have shareholder's equity of at least $2.5
million, market value of listed securities of at least $35 million, or
net income of $500,000 from continuing operations in the past fiscal
year or two out of its three past fiscal years.\23\ Further, Nasdaq
requires that the listed issue have a minimum bid price for continued
listing of $1 per share.\24\ In addition, for continued listing, Nasdaq
requires an issuer to have a minimum of 500,000 publicly held shares
with a market value of at least $1 million.\25\
    The Commission finds that the maintenance criteria for common stock
listed on Amex and on the NCM are substantially similar.\26\
---------------------------------------------------------------------------

    \23\ Nasdaq Rule 4310(c)(2)(B)(i)-(iii).
    \24\ Nasdaq Rule 4310(c)(4). Amex will consider delisting if the
price per share is ``low.'' See Amex Rule 1003(f)(v).
    \25\ Nasdaq Rule 4310(c)(7)(A). Amex will consider delisting the
common stock of an issuer if the aggregate market value of such
publicly held shares is less than $1 million for more than 90
consecutive days, the number of publicly held shares is less than
200,000 shares, or the number of its public stockholders is less
than 300. See Section 1003(b) of the Amex Company Guide.
    \26\ As noted above, the Commission has interpreted the
substantially similar standard to require listing standards at least
as comprehensive as those of the Named Markets, and differences in
language or approach of the listing standards are not dispositive.
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B. Secondary Classes of Common Stocks

    Only Nasdaq has listing standards for the trading of a secondary
class of common stock. A secondary class of common stock is a class of
common stock of an issuer that has another class of common stock listed
on an exchange. The Commission compared the NCM listing standards for
secondary classes of common stock and preferred stocks with the listing
standards of the Nasdaq/NGM.
    As discussed in the Proposing Release, the Commission preliminarily
believed that with respect to the number

of round lot holders,\27\ bid price,\28\ and number of publicly held
shares \29\ requirements,\30\ Nasdaq's initial and continued listing
requirements for secondary classes of common stock and preferred stocks
listing on the NCM were substantially similar to the listing standards
for the Nasdaq/NGM. The Commission did not, however, believe that the
initial continued listing requirements for market value of publicly
held shares for NCM were substantially similar to Nasdaq/NGM
standards.\31\
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    \27\ Both Nasdaq NCM and NGM require 100 round lot holders. See
NASD Rules 4310(c)(6)(B) and 4420(k)(4). Nasdaq/NGM also requires
100 round lot holders for continued listing. Although the NCM
requirements previously did not explicitly require a continuing
number of round lot holders, the NCM Listing Standard Amendments
clarified that the 100 round lot holders requirement also will apply
as a continued listing requirement for the NCM preferred and
secondary classes of common stock standards. See NCM Listing
Standard Amendments, supra note 12.
    \28\ While the NCM bid price requirement for initial listing is
$4 and the Nasdaq/NGM requirement is $5, the Commission believes
that these standards are substantially similar. Both NGM and NCM
require a $1 bid price for continued listing. See Nasdaq Rules
4310(c)(4), 4420(k)(3), and 4450(h)(3).
    \29\ Both Nasdaq NCM and NGM require 200,000 publicly held
shares for initial listing, and 100,000 publicly held shares for
continued listing. See Nasdaq Rules 4310(c)(7)(B), 4420(k)(1), and
4450(h)(1).
    \30\ The Commission notes that these requirements apply to
instances when the common stock or common stock equivalent security
of the issuer is listed on Nasdaq/NGM, NCM, Global Select Market
(``GSM'') (the GSM is a segment of the NGM, see Securities Exchange
Act Release Nos. 53799 and 54071, supra note 1), or another national
securities exchange. If the common stock or common stock equivalent
is not listed on one of these markets then the security must meet
the common stock listing requirements for the relevant market
(either Nasdaq/NGM or NCM). See generally NASD Rules 4310(c)(6)(B)
and 4420(k).
    \31\ See Proposing Release, supra note 9, at notes 43-44 and
accompanying text.
---------------------------------------------------------------------------

    In the NCM Listing Standard Amendments, Nasdaq increased the NCM
listing standards for both preferred and secondary classes of common
stock for the market value of publicly held shares to $3.5 million for
initial listing and $1 million for continued listing.\32\ Nasdaq also
increased its initial and continued NCM listing rules for secondary
classes of common stock and preferred stock to require that the common
stock or common stock equivalent of the issuer either be listed on
Nasdaq or be a covered security as defined in Rule 146(b).\33\ In light
of these revisions to the NCM's initial and continued listing standards
for secondary classes of common stock and preferred stocks, the
Commission finds that the NCM's rules for initial and continued listing
for secondary classes of common stock and preferred stock are
substantially similar to Nasdaq/NGM's rules.
---------------------------------------------------------------------------

    \32\ See NCM Listing Standard Amendments, supra note 12.
    \33\ Id.
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C. Convertible Debt

    The Commission has compared the NCM listing standards for
convertible debt to Amex's listing standards for debt.\34\ In the NCM
Listing Standards Amendments, Nasdaq added a debt rating requirement
similar to a requirement in Amex's listing standards.\35\ Specifically,
Nasdaq requires that for the initial listing of convertible debt, one
of the following conditions must be met: (i) The issuer of the debt
security must also have an equity security listed on the Amex, NYSE, or
Nasdaq; (ii) an issuer of equity security listed on the Amex, NYSE, or
Nasdaq, directly or indirectly owns a majority interest in, or is under
common control with, the issuer of the debt security; (iii) an issuer
of equity security listed on the Amex, NYSE, or Nasdaq has guaranteed
the debt security; (iv) a nationally recognized securities rating
organization (an ``NRSRO'') has assigned a current rating to the debt
security that is no lower than an S&P Corporation ``B'' rating or
equivalent rating by another NRSRO; or (v) if no NRSRO has assigned a
rating to the issue, an NRSRO has currently assigned an investment
grade rating to an immediately senior issue or a rating that is no
lower than an S&P Corporation ``B'' rating, or an equivalent rating by
another NRSRO, to a pari passu or junior issue.\36\ The Listing
Standards Amendment also requires that current sale information be
available in the United States for the underlying security into which a
convertible debt issue is convertible. Accordingly, the Commission
finds that the NCM's listing standards for convertible debt are
substantially similar to those of Amex.
---------------------------------------------------------------------------

    \34\ See generally Nasdaq Rule 4310(c)(5) and Sections 104 and
1003 of the Amex Company Guide.
    \35\ See NCM Listing Standard Amendments, supra note 12.
    \36\ See Nasdaq Rule 4310(c)(5)(B).
---------------------------------------------------------------------------

    The Commission also finds that the continued listing requirements
for convertible debt securities listed on the NCM are substantially
similar to Amex's requirements. The NCM listing standards require that
the principal amount outstanding be maintained at $5 million.\37\ Amex
generally will delist a bond if the aggregate market value or the
principal amount of the bond publicly held is less than $400,000, or if
the issuer is not able to meet its obligations on the listed debt.\38\
Although not identical, the Commission believes that both standards are
designed to ensure the continued liquidity of the debt security, and
thus are substantially similar.
---------------------------------------------------------------------------

    \37\ Id.
    \38\ See Section 1003(b)(iv) of the Amex Company Guide. Section
1003(e) of the Amex Company Guide states that convertible bonds will
be reviewed when the underlying security is delisted and will be
delisted when the underlying security is no longer the subject of
real-time reporting in the United States. The Commission does not
believe that this is material because although Nasdaq does not have
an identical rule, it does have the discretion to delist beyond its
standards.
---------------------------------------------------------------------------

D. Warrants

    The Commission compared Nasdaq's NCM listing standards for warrants
to the Nasdaq/NGM standards. In the Proposing Release, the Commission
stated that it preliminarily believed that the NCM standards were not
substantially similar to the Nasdaq/NGM standards. The NCM Listing
Standard Amendments, however, increased the required number of warrants
that must be outstanding for initial listing on the NCM from 100,000 to
400,000.\39\ Though not identical, the Commission believes this initial
listing requirement is substantially similar to Nasdaq/NGM requirements
that there be 450,000 warrants outstanding for initial listing. The NCM
Listing Standard Amendments also added a requirement for initial and
continued listing that the security underlying the warrant be listed on
Nasdaq or be a covered security as described in Section 18(b).\40\ The
Commission believes this requirement is substantially similar to the
Nasdaq/NGM standard that requires that, for continued listing, the
common stock of the issuer must continue to be listed on the Nasdaq/
NGM.\41\ In light of the changes made by the NCM Listing Standard
Amendments, the Commission finds the NCM's listing standards for
warrants are substantially similar to those of Nasdaq/NGM.
---------------------------------------------------------------------------

    \39\ See NCM Listing Standard Amendments, supra note 12.
    \40\ Id.
    \41\ See Nasdaq Rule 4450(d).
---------------------------------------------------------------------------

E. Index Warrants

    Index warrants traded on the NCM, must meet the same initial and
continuing listing standards as index warrants traded on the Nasdaq/NGM
market.\42\ Therefore, the Commission finds that the listing standards
for index warrants traded on the NCM are substantially similar to the
standards applicable to index warrants traded on the Nasdaq/NGM market.
---------------------------------------------------------------------------

    \42\ See generally Nasdaq Rule 4310(c)(9)(C).

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

F. Units

    The NCM, Amex, and Nasdaq/NGM all evaluate the initial and
continued listing of a unit by looking to its components.\43\ If all of
the components of a unit individually meet the standards for listing,
then the unit would meet the standards for listing.\44\ In light of the
NCM Listing Standard Amendments, which increase the listing
requirements for the different categories of securities discussed above
that could make up the components of a unit, the Commission finds that
the NCM listing standards for units are substantially similar to both
Amex and Nasdaq/NGM listing standards.\45\
---------------------------------------------------------------------------

    \43\ A unit is a type of security consisting of two or more
different types of securities (e.g., a combination of common stocks
and warrants). See Securities Exchange Act Release No. 48464
(September 9, 2003), 68 FR 54250 (September 16, 2003).
    \44\ See generally Section 101(g) of the Amex Company Guide and
Nasdaq Rules 4310(c)(10) and 4420(h)(1)(a)-(c).
    \45\ See NCM Listing Standard Amendments, supra note 12.
---------------------------------------------------------------------------

III. Other Changes to Rule 146(b)

A. Clarifying Changes in Response to Comments

    In response to comments received from the ABA Committee and NASAA,
the Commission is making a minor amendment to Rule 146(b) to include
securities ``authorized for listing'' on a market named in Rule 146(b).
    NASAA and the ABA Committee expressed concern regarding a
discrepancy between the language of Section 18 under the Securities Act
and Rule 146(b) thereunder. Section 18 defines covered securities as
securities ``listed, or authorized for listing'' on the Named Markets,
or the other exchanges that have listing standards that the Commission
has deemed to be substantially similar to the Named Markets. Rule
146(b), however, deems as ``covered securities'' only securities
listed, not those that are ``authorized for listing,'' pursuant to
exchange rules that the Commission has found to be substantially
similar to the Named Markets. NASAA and the ABA Committee expressed
concern that some issuers that are authorized for listing but not yet
listed on an exchange identified in Rule 146(b) would not clearly be
exempt from state qualification or registration requirements. They
recommend that the Commission clarify the language in Rule 146(b) to
conform it to the language of Section 18(b)(1)(B) of the Securities
Act.\46\ The Commission believes that this clarifying change to Rule
146(b) is consistent with Congressional intent, as well as the
Commission's intent, is appropriate, and addresses the commenters''
concerns.\47\
---------------------------------------------------------------------------

    \46\ See ABA Committee April 3rd Letter; ABA Committee December
20th Letter; and NASAA Supplemental Letter, supra note 10.
    \47\ The Administrative Procedure Act (``APA'') generally
requires an agency to publish notice of a proposed rulemaking in the
Federal Register. The APA's notice and comment requirement does not
apply, however, if the agency ``for good cause finds * * * that
notice and public procedure are impracticable, unnecessary, or
contrary to the public interest.'' Sec. 5. U.S.C. Section
553(b)(3)(B). The Commission finds good cause to include the
language ``authorized for listing'' to the rule because prior notice
is unnecessary. The change does not alter the substance of the rule
and incorporates language from the statute.
---------------------------------------------------------------------------

    Another commenter expressed concern about a perceived ambiguity in
Rule 146(b)(2). Rule 146(b)(2) conditions the designation of securities
on the exchanges specified under Rule 146(b)(1) as ``covered
securities'' as long as their listing standards continue to be
substantially similar to those of the Named Markets. The commenter
believes that it is not clear who makes this determination and
recommends that the phrase ``as determined by the Commission'' should
be added to the language of Rule 146(b)(2).\48\ The Commission believes
that this change is unnecessary because Section 18 clearly states that
``covered securities'' are those the Commission determines are
substantially similar to the Named Markets. Similarly, Rule 146
specifies that it is the Commission that has found that listed
exchanges, or segments thereof, have listing standards substantially
similar to those of the Named Markets. The Commission also notes that
since this rule has been in effect, the problem described by the
commenter has not occurred and does not believe that further amendment
to the language of the rule is required at this time.
---------------------------------------------------------------------------

    \48\ See Kennedy Letter, supra note 10.
---------------------------------------------------------------------------

B. Changes to Exchanges'' Names

    The Commission is amending Rule 146(b), as proposed, to reflect the
following name changes:
     Sections (b)(1) and (b)(2) of Rule 146 use the term
``Nasdaq/NMS'' to refer to the National Market System of The NASDAQ
Stock Market LLC. As noted above, on July 1, 2006, what was the
National Market System of The NASDAQ Stock Market LLC became known as
the Nasdaq Global Market.\49\ The Commission is making a conforming
change to Rule 146(b).
---------------------------------------------------------------------------

    \49\ See Securities Exchange Act Release Nos. 53799 and 54071,
supra note 1.
---------------------------------------------------------------------------

     Rule 146(b)(1)(i) refers to the Pacific Exchange
Incorporated. In April 2006, the Pacific Exchange, Incorporated was
renamed NYSE Arca, Inc.\50\ The Commission is making a conforming
change to Rule 146(b).
---------------------------------------------------------------------------

    \50\ See Securities Exchange Act Release No. 53615 (April 7,
2006), 71 FR 19226 (April 13, 2006).
---------------------------------------------------------------------------

     Rule 146(b)(1)(iv) refers to the International Securities
Exchange, Incorporated. In September 2006, the International Securities
Exchange, Incorporated was renamed the International Securities
Exchange, LLC. The Commission is making a conforming change to Rule
146(b).
     Finally, the Commission is amending paragraph (1)(ii) of
Rule 146(b) to reflect the legal name of the Philadelphia Stock
Exchange, Inc.\51\
---------------------------------------------------------------------------

    \51\ In the Proposing Release, the Nasdaq Global Market and the
Nasdaq Capital Market were inadvertently referred to as the Nasdaq
National Global Market and the Nasdaq National Capital Market. Those
typographical errors are corrected in this adopting release.
---------------------------------------------------------------------------

IV. Paperwork Reduction Act

    The Paperwork Reduction Act of 1995 does not apply because the
proposed amendment to Rule 146(b) does not impose recordkeeping or
information collection requirements or other collection of information,
which require the approval of the Office of Management and Budget under
44 U.S.C. 3501 et seq.

V. Cost-Benefit Analysis

    Congress amended Section 18 of the Securities Act to exempt covered
securities from state registration requirements. These securities are
listed, or authorized for listing, on the Named Markets or any other
national securities exchange determined by the Commission to have
substantially similar listing standards to the Named Markets.\52\
Consistent with statutory authority, the Commission has determined that
the listing standards for securities listed, or authorized for listing,
on the NCM are substantially similar to those of either the Amex or
Nasdaq/NGM. Securities listed, or authorized for listing, on the NCM
therefore would be covered securities subject only to federal
regulation.
---------------------------------------------------------------------------

    \52\ 15 U.S.C. 77r(b)(1)(B).
---------------------------------------------------------------------------

    By exempting securities listed, or authorized for listing, on the
NCM from state law registration requirements, the Commission expects
that the listing process for those securities will become easier as one
layer of regulation is eliminated. Moreover, the Commission also
expects adoption of the rule will reduce the administrative burden the
issuers of covered securities face inasmuch as compliance with state
blue

sky law requirements is preempted.\53\ The Commission solicited
comments concerning the costs and benefits associated with the proposal
and received two comments. The commenters believe that the proposed
amendments to Rule 146(b) to provide ``covered securities'' status for
securities authorized for listing, or approved for listing on the NCM,
should reduce substantial costs for investors, given those securities
would be exempted from state law registration requirements.\54\
---------------------------------------------------------------------------

    \53\ Several commenters also expect this outcome. See ABA
Committee April 3rd Letter; ABA Committee December 20th Letter; and
Kennedy Letter, supra note 10.
    \54\ See ABA Committee December 20th Letter and Kennedy Letter,
supra note 10.
---------------------------------------------------------------------------

    The Commission also believes that the amendment to Rule 146(b) will
permit Nasdaq to compete with other markets whose listed securities are
exempt from state law registration requirements for new securities
products and listings. This result has the potential to enhance
competition and, potentially, liquidity, thus benefiting market
participants and the public. The Commission does not believe that there
are any significant costs to investors associated with the preemption
of state registration requirements for securities listed, or authorized
for listing, on the NCM. The Commission notes that there may be some
cost to investors through the loss of benefits of state registration
and oversight, although the cost is difficult to quantify. Furthermore,
the Commission believes that Congress contemplated these costs to the
economic benefits of exempting covered securities from state
regulation.

VI. Consideration of Promotion of Efficiency, Competition, and Capital
Formation

    As required under the Securities Act,\55\ the Commission considered
the rule's impact on efficiency, competition, and capital formation.
National securities exchanges compete for the listing of securities.
Thus, the Commission believes that amending Rule 146(b) to designate
securities listed, or authorized for listing, on the NCM as covered
securities will offer potential benefits for investors because it would
facilitate the ability of Nasdaq to compete for listings, which will
potentially increase competition and enhance the overall liquidity, and
thus the efficiency of the U.S. securities markets. The Commission also
believes that the rule will serve to reduce the cost of raising capital
because it will streamline the registration process for issuers listing
on the NCM. In addition, the Commission believes that the rule
amendment, consistent with Congressional action, is designed to promote
efficiency by removing a layer of duplicative regulation. The
Commission solicited comments on the amendment's effect on competition,
efficiency, and capital formation. Commenters generally believed that
this proposal would improve efficiency and facilitate capital formation
by eliminating state registration for issuers seeking to list their
securities on the NCM.\56\ The Commission also believes that the
amendment to Rule 146(b) will permit Nasdaq to compete with other
markets whose securities are exempt from state law registration
requirements for new securities products and listings. Finally, the
amendment to Rule 146(b) will not impair efficiency, competition, and
capital formation because it will impose no recordkeeping or compliance
burdens, but will provide a limited purpose exemption under the federal
securities laws. Thus, the Commission concludes that the amendment to
Rule 146(b) would promote efficiency, competition, and capital
formation.
---------------------------------------------------------------------------

    \55\ 15 U.S.C. 77b(b).
    \56\ See ABA Committee April 3rd Letter; ABA Committee December
20th Letter; and Kennedy Letter, supra note 10.
---------------------------------------------------------------------------

VII. Regulatory Flexibility Act Certification

    The Commission has certified, pursuant to Section 605(b) of the
Regulatory Flexibility Act,\57\ that the amendment to Rule 146 will not
have a significant economic impact on a substantial number of small
entities. This certification was incorporated into the Proposing
Release. The Commission solicited comments as to the nature of any
impact on small entities, and generally on whether the amendment to
Rule 146(b) could have an effect that has not been considered. No
comments were received.
---------------------------------------------------------------------------

    \57\ 5 U.S.C. 605(b).
---------------------------------------------------------------------------

VIII. Statutory Authority

    The Commission is amending Rule 146 pursuant to the Securities Act
of 1933,\58\ particularly Sections 18(b)(1)(B) and 19(a).\59\
---------------------------------------------------------------------------

    \58\ 15 U.S.C. 77a et seq.
    \59\ 15 U.S.C. 77r(b)(1)(B) and 77s(a).
---------------------------------------------------------------------------

Text of the Rule

List of Subjects in 17 CFR Part 230

    Securities.

0
For the reasons set forth in the preamble, Title 17, Chapter II of the
Code of Federal Regulations is amended as follows:

PART 230--GENERAL RULES AND REGULATIONS, SECURITIES ACT OF 1933

0
1. The general authority citation for part 230 is revised to read as
follows:

    Authority: 15 U.S.C. 77b, 77c, 77d, 77f, 77g, 77h, 77j, 77r,
77s, 77z-3, 77sss, 78c, 78d, 78j, 78l, 78m, 78n, 78o, 78t, 78w,
78ll(d), 78mm, 80a-8, 80a-24, 80a-28, 80a-29, 80a-30, and 80a-37,
unless otherwise noted.
* * * * *

0
2. Section 230.146 is amended by revising paragraphs (b)(1) and (b)(2)
to read as follows:

Sec.  230.146  Rules under Section 18 of the Act.

* * * * *
    (b) * * *
    (1) For purposes of Section 18(b) of the Act (15 U.S.C. 77r), the
Commission finds that the following national securities exchanges, or
segments or tiers thereof, have listing standards that are
substantially similar to those of the New York Stock Exchange
(``NYSE''), the American Stock Exchange (``Amex''), or the National
Market System of the Nasdaq Stock Market (``Nasdaq/NGM''), and that
securities listed, or authorized for listing, on such exchanges shall
be deemed covered securities:
    (i) Tier I of the NYSE Arca, Inc.;
    (ii) Tier I of the Philadelphia Stock Exchange, Inc.;
    (iii) The Chicago Board Options Exchange, Incorporated;
    (iv) Options listed on the International Securities Exchange, LLC;
and
    (v) The Nasdaq Capital Market.
    (2) The designation of securities in paragraphs (b)(1)(i) through
(v) of this section as covered securities is conditioned on such
exchanges' listing standards (or segments or tiers thereof) continuing
to be substantially similar to those of the NYSE, Amex, or Nasdaq/NGM.

    Dated: April 18, 2007.

    By the Commission.
Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E7-7713 Filed 4-23-07; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 86, Number 203 (Monday, October 25, 2021)]
[Rules and Regulations]
[Pages 58807-58809]
[FR Doc No: 2021-23040]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R10-OAR-2020-0649; FRL-8788-02-R10]

Air Plan Approval; AK; Juneau, Mendenhall Valley Second 10-Year
PM10 Limited Maintenance Plan

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is approving the
Juneau, Mendenhall Valley, Alaska (AK) limited maintenance plan (LMP)
submitted on November 10, 2020, by the Alaska Department of
Environmental Conservation (ADEC or ``the State''). This plan addresses
the second 10-year maintenance period after redesignation for
particulate matter with an aerodynamic diameter less than or equal to a
nominal 10 micrometers (PM10). The plan relies upon control
measures contained in the first 10-year maintenance plan and the
determination that the Mendenhall Valley area currently monitors
PM10 levels well below the PM10 National Ambient
Air Quality Standard (NAAQS or ``the standard''). The EPA is approving
Alaska's LMP as meeting Clean Air Act (CAA) requirements.

DATES: This final rule is effective November 24, 2021.

ADDRESSES: The EPA has established a docket for this action under
Docket ID No. EPA-R10-OAR-2020-0649. All documents in the docket are
listed on the https://www.regulations.gov website. Although listed in
the index, some information is not publicly available, e.g.,
Confidential Business Information or other information the disclosure
of which is restricted by statute. Certain other material, such as
copyrighted material, is not placed on the internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available at https://www.regulations.gov, or please
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section for additional availability information.

FOR FURTHER INFORMATION CONTACT: Christi Duboiski, EPA Region 10, 1200
Sixth Avenue (Suite 155), Seattle, WA 98101, at<PHONE_NUMBER>, or
[email protected].

SUPPLEMENTARY INFORMATION: Throughout this document wherever ``we'' or
``our'' is used, it refers to the EPA.

I. Background

    On November 10, 2020, ADEC submitted to the EPA a second 10-year
PM10 LMP for Juneau, Mendenhall Valley for approval. The SIP
revision, State effective November 7, 2020, fulfills the second 10-year
planning requirement of CAA section 175A(b) to ensure PM10
NAAQS compliance through 2033. The Mendenhall Valley area has been
meeting the PM10 standard for multiple years and was
redesignated to attainment on July 8, 2013, with an approved 10-year
PM10 maintenance plan. The area currently monitors
PM10 levels well below the PM10 NAAQS.
    We proposed to approve the Juneau, Mendenhall Valley second 10-year
LMP on August 11, 2021 (86 FR 43984). The reasons for our approval are
included in that proposal and will not be restated here. The public
comment period for our proposed action closed on September 10, 2021. We
received no public comments. Therefore, we are finalizing our
rulemaking as proposed.

II. Final Action

    In this final action, the EPA is approving the State's second 10-
year LMP for the Juneau, Mendenhall Valley area, submitted on November
10, 2020, as satisfying the requirements of section 175A of the CAA.

III. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, the EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves State law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by State
law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Orders
12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21,
2011);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely

affect small governments, as described in the Unfunded Mandates Reform
Act of 1995 (Pub. L. 104-4);
     Does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide the EPA with the discretionary authority
to address, as appropriate, disproportionate human health or
environmental effects, using practicable and legally permissible
methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
    The SIP is not approved to apply on any Indian reservation land or
in any other area where the EPA or an Indian tribe has demonstrated
that a tribe has jurisdiction. In those areas of Indian country, the
rule does not have tribal implications and it will not impose
substantial direct costs on tribal governments or preempt tribal law as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. The EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by December 27, 2021. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed and shall not postpone the effectiveness of such rule or
action. This action may not be challenged later in proceedings to
enforce its requirements. See section 307(b)(2).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Lead, Nitrogen
dioxide, Ozone, Particulate matter, Reporting and recordkeeping
requirements, Sulfur oxides, Volatile organic compounds.

    Dated: October 18, 2021.
Michelle L. Pirzadeh,
Acting Regional Administrator, Region 10.

    For the reasons set forth in the preamble, 40 CFR part 52 is
amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

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

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

Subpart C--Alaska

0
2. In Sec.  52.70, the table in paragraph (e) is amended by:
0
a. Adding entry ``II.III.D.3.b. Mendenhall Valley Second 10-year
PM10 Limited Maintenance Plan'' after the entry
``II.III.D.3.a Mendenhall Valley PM10 Limited Maintenance
Plan''; and
0
b. Revising the entry ``III.III.D.3. Control Plan for the Mendenhall
Valley of Juneau''.
    The addition and revision read as follows:

Sec.  52.70  Identification of plan.

* * * * *
    (e) * * *

                   EPA-Approved Alaska Nonregulatory Provisions and Quasi-Regulatory Measures
----------------------------------------------------------------------------------------------------------------
                                       Applicable
      Name of SIP provision          geographic or          State       EPA approval date       Explanations
                                  nonattainment  area  submittal date
----------------------------------------------------------------------------------------------------------------
           State of Alaska Air Quality Control Plan: Volume II. Analysis of Problems, Control Actions
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                                 Section III. Areawide Pollutant Control Program
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
II.III.D.3.b. Mendenhall Valley   Mendenhall Valley..      11/10/2020  10//25/2021,        .....................
 Second 10-year PM10 Limited                                            [INSERT Federal
 Maintenance Plan.                                                      Register
                                                                        CITATION].

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                        State of Alaska Air Quality Control Plan: Volume III. Appendices
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                                 Section III. Areawide Pollutant Control Program
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
III.III.D.3. Control Plan for     Mendenhall Valley..      11/10/2020  10//25/2021,        .....................
 the Mendenhall Valley of Juneau.                                       [INSERT Federal
                                                                        Register
                                                                        CITATION].

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

[FR Doc. 2021-23040 Filed 10-22-21; 8:45 am]
BILLING CODE 6560-50-P