[Federal Register: October 8, 2008 (Volume 73, Number 196)]
[Rules and Regulations]
[Page 58880-58886]
[DOCID:fr08oc08-10]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-1191; FRL-8382-9]

Cymoxanil; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
cymoxanil in or on bulb onion subgroup 3-07A; green onion subgroup 3-
07B; leafy greens subgroup 4A; leaf petioles subgroup 4B; cilantro
leaves; and caneberry subgroup 13-07A. The Interregional Research
Project (IR-4) requested these tolerances under the Federal Food, Drug,
and Cosmetic Act (FFDCA). This regulation also deletes the tolerances
for caneberry and head lettuce.

DATES: This regulation is effective October 8, 2008. Objections and
requests for hearings must be received on or before December 8, 2008,
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: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2007-1191. All documents in the
docket are listed in the docket index available at http://
www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.

FOR FURTHER INFORMATION CONTACT: Barbara Madden, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
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.
Potentially affected entities may include, but are not limited to those
engaged in the following activities:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather to
provide a guide for readers regarding entities likely to be affected by
this action. Other types of entities not listed in this unit could also
be affected. The North American

Industrial Classification System (NAICS) codes have been provided to
assist you and others in determining whether this action might apply to
certain entities. If you have any questions regarding the applicability
of this action to a particular entity, consult the person listed under
FOR FURTHER INFORMATION CONTACT.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing electronically available documents at
http://www.regulations.gov, you may access this Federal Register
document electronically through the EPA Internet under the ``Federal
Register'' listings at http://www.epa.gov/fedrgstr. You may also access
a frequently updated electronic version of EPA's tolerance regulations
at 40 CFR part 180 through the Government Printing Office's pilot e-CFR
site at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 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-2007-1191 in the subject line on the first
page of your submission. All requests must be in writing, and must be
mailed or delivered to the Hearing Clerk as required by 40 CFR part 178
on or before December 8, 2008.
    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 that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit this copy, identified by docket ID number
EPA-HQ-OPP-2007-1191, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW, Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.

II. Petition for Tolerance

    In the Federal Register of March 12, 2008 (73 FR 13225) (FRL-8354-
6), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP
7E7282 and 7E7283) by IR-4, 500 College Rd. East, Suite 201 W,
Princeton, NJ 08540. The petitions requested that 40 CFR 180.503 be
amended by establishing tolerances for residues of the fungicide
cymoxanil, (2-cyano-N-[(ethylamino)carbonyl]-2-(methoxyimino)
acetamide), in or on bulb vegetables group 3-07 at 1.1 parts per
million (ppm); leafy greens subgroup 4A at 19 ppm; cilantro leaves at
19 ppm; caneberry subgroup 13-07A at 4 ppm (PP 7E7283); and leaf
petioles subgroup 4B at 6.0 ppm (PP 7E7282). That notice referenced a
summary of the petition prepared by IR-4 and DuPont, the registrant,
which is available to the public in the docket, http://
www.regulations.gov. Several comments were received from a private
citizen objecting to the sale of the pesticide and animal testing. The
Agency has received these same comments from this commenter on numerous
previous occasions. Refer to Federal Register 70 FR 37686 (June 30,
2005), 70 FR 1354 (January 7, 2005), 69 FR 63096-63098 (October 29,
2004) for the Agency's response to these objections.
    Based upon review of the data supporting the petition, EPA has
determined that the tolerance levels for bulb vegetables should be set
as follows: bulb onion subgroup 3-07A at 0.05 ppm; green onion subgroup
3-07B at 1.1 ppm. The reasons for this change are explained in Unit
IV.D.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue.''
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, 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 the petitioned-for
tolerances for residues of cymoxanil on bulb onion subgroup 3-07A at
0.05 ppm; green onion subgroup 3-07B at 1.1 ppm; leafy greens subgroup
4A at 19 ppm; leaf petioles subgroup 4B at 6.0 ppm; cilantro leaves at
19 ppm; and caneberry subgroup 13-07A at 4.0 ppm. EPA's assessment of
exposures and risks associated with establishing these tolerances
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. Specific information on the studies received and the nature
of the adverse effects caused by cymoxanil as well as the no-observed-
adverse-effect-levels (NOAELs) and the lowest-observed-adverse-effect-
levels (LOAELs) from the toxicity studies can be found at http://
www.regulations.gov in document Cymoxanil; Human Health Risk Assessment
for Proposed Uses on Bulb Vegetables (Crop Group 3-07), Leafy Greens
(Subgroup 4A), and Leaf Petioles (Subgroup 4B), page 16 in docket ID
number EPA-HQ-OPP-2007-1191.
    Cymoxanil has low acute toxicity via oral, dermal, and inhalation
routes of exposure. It is a mild skin irritant, not a skin sensitizer,
and non-irritating to the eye. Systemic toxicity, as evidenced by
decreased body weights, body weight gains, and food consumption, was
observed in subchronic, chronic, developmental, reproductive and
neurotoxicity studies across species. The dog appears to be the most
sensitive species for cymoxanil-induced toxicity

with the thymus gland identified as a target organ in this species
during subchronic and chronic exposures. No evidence of immunotoxicity
was observed following subchronic exposure of rats up to 108
milligrams/kilograms/day (mg/kg/day) in males and 117 mg/kg/day in
females (108/117 (M/F)) or mice up to 218/552 (M/F) mg/kg/day,
respectively. In a 21-day dermal toxicity study in rats, no systemic
toxicity was observed up to the limit dose. In a subchronic
neurotoxicity study in rats, systemic toxicity was observed at 102/137
mg/kg/day (M/F); however, no neurotoxicity and/or neuropathology were
observed up to 224/333 mg/kg/day (M/F; highest dose tested). In
addition, no evidence of neurotoxicity was observed in the
developmental toxicity studies in rats or rabbits, the 2-generation
reproduction study in rats, the subchronic or chronic dog studies, or
the 18-month mouse carcinogenicity study. However, in the combined
chronic toxicity/carcinogenicity study in rats, clinical signs of
hyperactivity and aggressiveness in males (>=30.3 mg/kg/day), as well
as retinal atrophy in both sexes (>=30.3 mg/kg/day) were observed.
    Increased susceptibility of rats and rabbits was observed following
in utero exposure to cymoxanil. In acceptable developmental toxicity
studies in both of these species, developmental effects were seen at
doses below those that caused maternal toxicity. In the rat
developmental toxicity studies, skeletal anomalies, delays in skeletal
ossification, and/or increases in overall malformations were observed
at lower doses than those at which maternal toxicity was observed. In a
rabbit developmental study, increased skeletal malformations were
observed at 8 mg/kg/day (LOAEL), which was also below the maternal
NOAEL of 32 mg/kg/day. Cleft palate was also observed in fetuses at 32
mg/kg/day. In the first 2-generation reproduction toxicity study
(1993), decreased pup viability (PND 0-4) was observed at maternally
toxic doses. In a second 2-generation reproduction toxicity study
(2001), decreased body weight was observed during lactation in both
F1 and F2 offspring at a dose that was lower than
that at which parental toxicity was observed. The increased
susceptibility of offspring observed in this study was concordant with
the results obtained in the developmental toxicity studies. In a
developmental neurotoxicity study, offspring toxicity - adverse effects
included decreased pup survival, decreased pup weight and body weight
gain during early lactation, increases in morphometric measurements
(anterior/posterior cerebrum for males, cerebellar height for females)
at PND 79-83, and decreased retention in the water maze task for adult
females - was observed at the same dose as maternal toxicity (slight
decreases in body weight, body weight gain during gestation, and food
consumption). The LOAEL for both maternal animals and offspring was 100
mg/kg/day. No residual uncertainties exist in the database for pre-/
post-natal toxicity, and the endpoints selected for risk assessment are
considered protective of effects observed in offspring in developmental
and reproduction toxicity studies. The endpoints selected for risk
assessment are further described in section 3.5 of the document:
Cymoxanil; Human Health Risk Assessment for Proposed Uses on Bulb
Vegetables (Crop Group 3-07), Leafy Greens (Subgroup 4A), and Leaf
Petioles (Subgroup 4B), page 13 in docket ID number EPA-HQ-OPP-2007-
1191.
    Cymoxanil was not carcinogenic in rats and mice and is classified
as ``not likely to be carcinogenic to humans.'' The available studies
indicate that cymoxanil is not mutagenic in bacteria or cultured
mammalian cells. There is, however, evidence of clastogenic activity
and induction of unscheduled DNA synthesis in vitro. In contrast,
cymoxanil was neither clastogenic nor aneugenic in vivo in mouse bone
marrow cells and did not induce a genotoxic response in rat somatic or
germinal cells. The negative results from the in vivo mouse bone marrow
micronucleus assay support the lack of a carcinogenic effect in long-
term rat and mouse feeding studies.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no
appreciable risk, a toxicological point of departure (POD) is
identified as the basis for derivation of reference values for risk
assessment. The POD may be defined as the highest dose at which no
adverse effects are observed (the NOAEL) in the toxicology study
identified as appropriate for use in risk assessment. However, if a
NOAEL cannot be determined, the lowest dose at which adverse effects of
concern are identified (the LOAEL) or a Benchmark Dose (BMD) approach
is sometimes used for risk assessment. Uncertainty/safety factors (UFs)
are used in conjunction with the POD to take into account uncertainties
inherent in the extrapolation from laboratory animal data to humans and
in the variations in sensitivity among members of the human population
as well as other unknowns. Safety is assessed for acute and chronic
dietary risks by comparing aggregate food and water exposure to the
pesticide to the acute population adjusted dose (aPAD) and chronic
population adjusted dose (cPAD). The aPAD and cPAD are calculated by
dividing the POD by all applicable UFs. Aggregate short-, intermediate-
, and chronic-term risks are evaluated by comparing food, water, and
residential exposure to the POD to ensure that the margin of exposure
(MOE) called for by the product of all applicable UFs is not exceeded.
This latter value is referred to as the Level of Concern (LOC).
    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
greater than that expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/
pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for cymoxanil used for
human risk assessment can be found at http://www.regulations.gov in
document Cymoxanil; Human Health Risk Assessment for Proposed Uses on
Bulb Vegetables (Crop Group 3-07), Leafy Greens (Subgroup 4A), and Leaf
Petioles (Subgroup 4B), page 16 in docket ID number EPA-HQ-OPP-2007-
1191.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to cymoxanil, EPA considered exposure under the petitioned-for
tolerances as well as all existing cymoxanil tolerances in (40 CFR
180.503). EPA assessed dietary exposures from cymoxanil 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. An acute endpoint of concern
was not identified for the general U.S. population. Therefore, an acute
dietary exposure assessment was performed only for Females 13-49 Years
Old, based upon the NOAEL of 4 mg/kg/day from the rabbit developmental
toxicity study. In estimating acute dietary exposure, EPA used food
consumption information from the United States Department of
Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of
Food Intake by Individuals (CSFII). As to residue levels

in food, EPA assumed that cymoxanil residues were present in all
registered and proposed food commodities at tolerance levels, and 100
percent crop treated (PCT) for all commodities. Dietary Exposure
Evaluation Model (DEEM) version 7.81 default processing factors were
used for all registered and proposed commodities except grapes.
Processing factors for grape juice (1.4x) and raisins (1x) were derived
from grape processing data.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 CSFII. As to residue levels in food, EPA used tolerance level
residues or anticipated residues (field trial residues) and PCT.
Anticipated residues were calculated from average field trial data for
cilantro leaves, chive, grape, green onion, hops, leaf petioles, and
leafy greens. DEEM 7.81 default processing factors were used for all
commodities except grapes. Processing factors for grape juice (1.4x)
and raisins (1x) were derived from grape processing data.
    iii. Cancer. Cymoxanil was not carcinogenic in rats and mice. EPA
classified cymoxanil as ``not likely'' to be a human carcinogen;
therefore a cancer dietary exposure assessment was not performed.
    iv. Anticipated residue and PCT information. Section 408(b)(2)(E)
of FFDCA authorizes EPA to use available data and information on the
anticipated residue levels of pesticide residues in food and the actual
levels of pesticide residues that have been measured in food. If EPA
relies on such information, EPA must require pursuant to FFDCA section
408(f)(1) that data be provided 5 years after the tolerance is
established, modified, or left in effect, demonstrating that the levels
in food are not above the levels anticipated. For the present action,
EPA will issue such data call-ins as are required by FFDCA section
408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be
required to be submitted no later than 5 years from the date of
issuance of these tolerances.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only if:
     Condition a: The data used are reliable and provide a
valid basis to show what percentage of the food derived from such crop
is likely to contain the pesticide residue.
     Condition b: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
     Condition c: Data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area.
In addition, the Agency must provide for periodic evaluation of any
estimates used. To provide for the periodic evaluation of the estimate
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
    The Agency used PCT information as follows: Cucumber, head lettuce,
pepper, potato, and tomato at 10%; pumpkin, squash, and watermelon at
1%.
    In most cases, EPA uses available data from United States
Department of Agriculture/National Agricultural Statistics Service
(USDA/NASS), proprietary market surveys, and the National Pesticide Use
Database for the chemical/crop combination for the most recent 6 years.
EPA uses an average PCT for chronic dietary risk analysis. The average
PCT figure for each existing use is derived by combining available
public and private market survey data for that use, averaging across
all observations, and rounding to the nearest 5%, except for those
situations in which the average PCT is less than one. In those cases,
1% is used as the average PCT and 2.5% is used as the maximum PCT. EPA
uses a maximum PCT for acute dietary risk analysis. The maximum PCT
figure is the highest observed maximum value reported within the recent
6 years of available public and private market survey data for the
existing use and rounded up to the nearest multiple of 5%.
    The Agency believes that the three conditions discussed in Unit
III.C.1.iv. have been met. With respect to Condition a, PCT estimates
are derived from Federal and private market survey data, which are
reliable and have a valid basis. The Agency is reasonably certain that
the percentage of the food treated is not likely to be an
underestimation. As to Conditions b and c, regional consumption
information and consumption information for significant subpopulations
is taken into account through EPA's computer-based model for evaluating
the exposure of significant subpopulations including several regional
groups. Use of this consumption information in EPA's risk assessment
process ensures that EPA's exposure estimate does not understate
exposure for any significant subpopulation group and allows the Agency
to be reasonably certain that no regional population is exposed to
residue levels higher than those estimated by the Agency. Other than
the data available through national food consumption surveys, EPA does
not have available reliable information on the regional consumption of
food to which cymoxanil may be applied in a particular area.
     2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for cymoxanil in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of cymoxanil. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the First Index Reservoir Screening Tool (FIRST), and
Screening Concentration in Ground Water (SCI-GROW) models, the
estimated drinking water concentrations (EDWCs) of cymoxanil for acute
exposures are estimated to be 9.3 parts per billion (ppb) for surface
water and 0.0018 ppb for ground water. EDWCs of cymoxanil for chronic
exposures for non-cancer assessments are estimated to be 0.05 ppb for
surface water and 0.0018 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 9.3 ppb was used to assess
the contribution to drinking water. For chronic dietary risk
assessment, the water concentration value of 0.05 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). Cymoxanil is not
registered for any specific use patterns that would result in
residential exposure.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    EPA has not found cymoxanil to share a common mechanism of toxicity
with any other substances, and cymoxanil does not appear to produce a
toxic metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that cymoxanil 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://www.epa.gov/pesticides/
cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(c) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA safety
factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
    2. Prenatal and postnatal sensitivity. There is an indication of
increased susceptibility of rats and rabbits to in utero exposure to
cymoxanil. In several developmental toxicity studies in the rat and
rabbit, developmental toxicity was observed at doses that were lower
than those that caused maternal toxicity. In the rat developmental
toxicity studies, skeletal anomalies, delays in skeletal ossification,
and/or increases in overall malformations were observed at lower doses
than those at which maternal toxicity was observed. However, in the
developmental neurotoxicity study in rat, offspring toxicity was
observed at the same dose as maternal toxicity. In one rabbit
developmental study, increased skeletal anomalies were observed at 8
mg/kg/day (LOAEL), which was below the maternal NOAEL of 32 mg/kg/day.
In a second rabbit developmental toxicity study, an increased incidence
of visceral and skeletal anomalies was observed at 25 mg/kg bw/day; a
maternal LOAEL was not observed in this study. In the 2-generation
reproduction toxicity study, decreased pup body weight was observed at
a lower dose than that which caused toxicity in adults.
    In the developmental and postnatal studies for which there is
increased susceptibility, the effects are well characterized and
conservative NOAELs were established for developmental and offspring
effects. In addition, the doses selected for risk assessment are based
on the lowest NOAELs from the developmental and reproductive toxicity
studies, where appropriate, and are protective of any potential pre-
and post-natal effects. Therefore, there are low levels of concern and
no residual uncertainties for pre- and post-natal toxicity.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X for acute risk determination. That decision
is based on the following findings:
    i. The toxicity database for cymoxanil is complete for dietary risk
assessment and includes a developmental neurotoxicity study.
    ii. Although there is evidence of increased susceptibility in the
prenatal developmental studies in rats and rabbits, there have not been
any residual uncertainties identified after establishing toxicity
endpoints and traditional uncertainty factors to be used in the risk
assessment of cymoxanil. The degree of concern for pre-and/or postnatal
toxicity is low.
    iii. There are no residual uncertainties identified in the exposure
databases. The acute dietary food exposure assessment was performed
based on 100 PCT and tolerance-level residues, and DEEM default
processing factors for all registered and proposed commodities. The
chronic dietary food assessment was performed incorporating tolerance
levels or anticipated residues (field trial residues) and PCT
(potatoes, head lettuce, peppers, tomatoes, watermelon, cucumber,
pumpkin, and summer and winter squash). EPA believes that the PCT
estimates used are based on reliable data because PCT estimates are
derived from Federal and private market survey data, which are reliable
and have a valid basis. EPA made conservative (protective) assumptions
in the ground and surface water modeling used to assess exposure to
cymoxanil in drinking water. These assessments will not underestimate
the exposure and risks posed by cymoxanil.
    EPA has retained the 10X FQPA safety factor for assessing risk from
chronic dietary exposure to cymoxanil because the LOAEL from the
chronic toxicity study in the dog was used to assess chronic dietary
risk.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic pesticide exposures are
safe by comparing aggregate exposure estimates to the aPAD and cPAD.
The aPAD and cPAD represent the highest safe exposures, taking into
account all appropriate SFs. EPA calculates the aPAD and cPAD by
dividing the POD by all applicable UFs. For linear cancer risks, EPA
calculates the probability of additional cancer cases 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 POD to ensure that the MOE called for
by the product of all applicable UFs is not exceeded.
    1. Acute risk. An acute aggregate risk assessment takes into
account exposure estimates from acute dietary consumption of food and
drinking water. An acute dietary exposure assessment was performed for
females 13-49 years old only, since an acute endpoint of concern was
not identified for the general U.S. population. Using the exposure
assumptions discussed in this unit for acute exposure, the acute
dietary exposure to cymoxanil from food and water will occupy 89% of
the aPAD for females 13-49 years old, the only population subgroup of
concern.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
cymoxanil from food and water will utilize 74% of the cPAD for children
1-2 years old, the population group receiving the greatest exposure.
For the general U.S. population, chronic exposure to cymoxanil from
food and water will utilize 48% of the cPAD. There are no residential
uses for cymoxanil.
    3. Short- and intermediate-term risk. Short- and intermediate-term
aggregate exposure takes into account short- and intermediate-term
residential exposure plus chronic exposure to food and water
(considered to be a background exposure level). Cymoxanil is not
registered for any use patterns that would result in residential
exposure. Therefore, the short- or intermediate-term aggregate risk is
the sum of the risk from exposure to cymoxanil through food and water
and will not be greater than the chronic aggregate risk.
    4. Cancer. Because cymoxanil was not carcinogenic in rats and mice,
EPA concludes that the cancer risk to humans from exposure to cymoxanil
is negligible.
    5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to cymoxanil residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (high performance liquid
chromatography with ultra violet detection (HPLC/UV) and HPLC/MS (mass
spectroscopy)) is available to enforce the tolerance expression. The
method may be requested from: Chief, Analytical Chemistry Branch,
Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350;
telephone number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>
B. International Residue Limits

    There are no CODEX maximum residue levels established for cymoxanil
on any of the commodities for which the tolerances are being
established.

C. Response to Comments

    Comments were submitted by a private citizen who opposed the
establishment of cymoxanil tolerances for the following reasons:
     1. The availability of numerous products previously registered for
the same purpose as the new uses of cymoxanil supported by these
tolerances, and
     2. Cymoxanil is toxic to aquatic plants, bees, and birds, and
therefore has potentially harmful effects on the environment.
These comments are considered irrelevant because the safety standard
for approving tolerances under section 408 of the FFDCA focuses on
potential harm to human health and does not permit consideration of
effects on the environment or the availability of other registered
products. Environmental effects were closely considered in EPA's
decision to register cymoxanil under the Federal Insecticide,
Fungicide, and Rodenticide Act.

D. Revisions to Petitioned-For Tolerances

    Because there is a wide variability in the field trial residues,
EPA has concluded that a group tolerance for bulb vegetables is not
supported by the available data. Therefore, EPA has determined that the
proposed tolerance level for bulb vegetables of 1.1 ppm should be
revised as follows: Bulb onion subgroup 3-07A at 0.05 ppm; green onion
subgroup 3-07B at 1.1 ppm.

V. Conclusion

    Therefore, tolerances are established for residues of cymoxanil,
(2-cyano-N-[(ethylamino)carbonyl]-2-(methoxyimino) acetamide), in or on
bulb onion subgroup 3-07A at 0.05 ppm; green onion subgroup 3-07B at
1.1 ppm; leafy vegetables subgroup 4A at 19 ppm; cilantro leaves at 19
ppm; leaf petioles subgroup 4B at 6.0 ppm; and caneberry subgroup 13-
07A at 4.0 ppm. Additionally, the existing entries for ``Caneberry''
and ``Lettuce, head'' are deleted.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of
FFDCA 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 final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, entitled Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997). This final rule 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 section 408(d) of FFDCA, 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 final rule 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 section 408(n)(4) of FFDCA. 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 final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public Law 104-4).
    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 of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. 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 this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: September 29, 2008.
Donald R. Stubbs,
Acting Director, Registration Division, Office of Pesticide Programs

0
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. Section 180.503 is amended in paragraph (a) by revising the
introductory text, and in the table, by removing the entry for
``Lettuce, head'', revising the entry for ``Caneberry'' and
alphabetically adding the following commodities to read as follows:

Sec. 180.503  Cymoxanil; tolerances for residues

    (a) General. Tolerances are established for residues of the
fungicide, cymoxanil, 2-cyano -N- [(ethylamino)carbonyl]-2-

(methoxyimino) acetamide, in or on the following food commodities:

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Caneberry, subgroup 13A-07...........................                4.0
Cilantro, leaves.....................................                 19
                                * * * * *
Leafy greens, subgroup 4A............................                 19
Leaf petioles, subgroup 4B...........................                6.0
                                * * * * *
Onion, bulb, subgroup 3-07A..........................               0.05
Onion, green, subgroup 3-07B.........................                1.1
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. E8-23864 Filed 10-7-08; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 87, Number 163 (Wednesday, August 24, 2022)]
[Proposed Rules]
[Pages 51933-51941]
[FR Doc No: 2022-18168]

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

40 CFR Part 52

[EPA-R04-OAR-2022-0167; FRL-10150-01-R4]

Air Plan Approval; Kentucky; Boyd and Christian County Limited
Maintenance Plans for the 1997 8-Hour Ozone NAAQS

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve state implementation plan (SIP) revisions submitted by the
Commonwealth of Kentucky, through the Energy and Environment Cabinet
(Cabinet), on March 29, 2021. The SIP revisions include the 1997 8-hour
ozone National Ambient Air Quality Standards (NAAQS or standards)
Limited Maintenance Plans (LMPs) for the Kentucky portion (hereinafter
referred to as the Boyd County Area) of the Huntington-Ashland, WV-KY
1997 8-hour ozone maintenance area (hereinafter referred to as the
Huntington-Ashland, WV-KY Area) and the Kentucky portion (hereinafter
referred to as the Christian County Area) of the Clarksville-
Hopkinsville, TN-KY 1997 8-hour ozone maintenance area (hereinafter
referred to as the Clarksville-Hopkinsville, TN-KY Area). EPA is
proposing to approve Kentucky's LMPs for the Boyd County and Christian
County Areas because they provide for the maintenance of the 1997 8-
hour ozone NAAQS within the Huntington-Ashland, WV-KY Area and the
Clarksville-Hopkinsville, TN-KY Area, respectively. The effect of these
actions would be to make certain commitments related to maintenance of
the 1997 8-hour ozone NAAQS in the Boyd County and Christian County
Areas federally enforceable as part of the Kentucky SIP.

DATES: Comments must be received on or before September 14, 2022.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R04-
OAR-2022-0167 at www.regulations.gov. Follow the online instructions
for submitting comments. Once submitted, comments cannot be edited or
removed from Regulations.gov. EPA may publish any comment received to
its public docket. Do not submit electronically any information you
consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Multimedia
submissions (audio, video, etc.) must be accompanied by a written
comment. The written comment is considered the official comment and
should include discussion of all points you wish to make. EPA will
generally not consider comments or comment contents located outside of
the primary

submission (i.e., on the web, cloud, or other file sharing system). For
additional submission methods, the full EPA public comment policy,
information about CBI or multimedia submissions, and general guidance
on making effective comments, please visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Josue Ortiz Borrero, Air Regulatory
Management Section, Air Planning and Implementation Branch, Air and
Radiation Division, U.S. Environmental Protection Agency, Region 4, 61
Forsyth Street SW, Atlanta, Georgia 30303-8960. The telephone number is
(404) 562-8085. Mr. Ortiz Borrero can also be reached via electronic
mail at [email protected].

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Summary of EPA's Proposed Action
II. Background
III. Kentucky's SIP Submittals
IV. EPA's Evaluation of Kentucky's SIP Submittals
    A. Attainment Emissions Inventory
    B. Maintenance Demonstration
    C. Monitoring Network and Verification of Continued Attainment
    D. Contingency Plan
    E. Conclusion
V. Transportation Conformity
VI. Proposed Actions
VII. Statutory and Executive Order Reviews

I. Summary of EPA's Proposed Action

    In accordance with the Clean Air Act (CAA or Act), EPA is proposing
to approve the Boyd County and Christian County Areas' LMPs for the
1997 8-hour ozone NAAQS, adopted by the Cabinet on March 29, 2021, and
submitted by the Cabinet as revisions to the Kentucky SIP on March 29,
2021. On April 30, 2004, the Huntington-Ashland, WV-KY Area, which
includes the Boyd County Area, was designated as nonattainment for the
1997 8-hour ozone standard. Subsequently, on September 29, 2006, the
Cabinet submitted a redesignation request and the first 10-year
maintenance plan for the Boyd County Area. In 2007, after having clean
data and EPA's approval of a maintenance plan, the Boyd County Area was
redesignated to attainment for the 1997 8-hour ozone NAAQS. See 72 FR
43172 (August 3, 2007).
    Additionally, on April 30, 2004, the Clarksville-Hopkinsville, TN-
KY Area, which includes the Christian County Area, was designated as
nonattainment for the 1997 8-hour ozone standard. Subsequently, on May
20, 2005, the Cabinet submitted a redesignation request and the first
10-year maintenance plan for the Christian County Area. In 2006, after
having clean data and EPA's approval of a maintenance plan, the Area
was redesignated to attainment for the 1997 8-hour ozone NAAQS. See 71
FR 4047 (January 25, 2006).
    The Boyd County and Christian County Areas' LMPs for the 1997 8-
hour ozone NAAQS, submitted by the Cabinet on March 29, 2021, are
designed to maintain the 1997 8-hour ozone NAAQS within the Boyd County
and Christian County Areas through the end of the second 10-year
portion of the maintenance period beyond redesignation. EPA is
proposing to approve the plans because they meet all applicable
requirements under CAA sections 110 and 175A. As a general matter, the
Boyd County and Christian County Areas' LMPs rely on the same control
measures and contingency provisions to maintain the 1997 8-hour ozone
NAAQS during the second 10-year portion of the maintenance periods as
the maintenance plans submitted by the Cabinet for the first 10-year
periods.

II. Background

    Ground-level ozone is formed when oxides of nitrogen
(NOX) and volatile organic compounds (VOC) react in the
presence of sunlight. These two pollutants, referred to as ozone
precursors, are emitted by many types of pollution sources, including
on- and off-road motor vehicles and engines, power plants and
industrial facilities, and smaller area sources such as lawn and garden
equipment and paints. Scientific evidence indicates that adverse public
health effects occur following exposure to ozone, particularly in
children and in adults with lung disease. Breathing air containing
ozone can reduce lung function and inflame airways, which can increase
respiratory symptoms and aggravate asthma and other lung diseases.
    Ozone exposure also has been associated with increased
susceptibility to respiratory infections; increased medication use,
doctor visits, and emergency department visits; and increased hospital
admissions for individuals with lung disease. Children are at increased
risk from exposure to ozone because their lungs are still developing
and they are more likely to be active outdoors, which increases their
exposure.\1\
---------------------------------------------------------------------------

    \1\ See ``Fact Sheet, Proposal to Revise the National Ambient
Air Quality Standards for Ozone,'' January 6, 2010, and 75 FR 2938
(January 19, 2010).
---------------------------------------------------------------------------

    In 1979, under section 109 of the CAA, EPA established primary and
secondary NAAQS for ozone at 0.12 parts per million (ppm), averaged
over a 1-hour period. See 44 FR 8202 (February 8, 1979). On July 18,
1997, EPA revised the primary and secondary NAAQS for ozone to set the
acceptable level of ozone in the ambient air at 0.08 ppm, averaged over
an 8-hour period. See 62 FR 38856 (July 18, 1997).\2\ EPA set the 8-
hour ozone NAAQS based on scientific evidence demonstrating that ozone
causes adverse health effects at lower concentrations and over longer
periods of time than was understood when the pre-existing 1-hour ozone
NAAQS was set. EPA determined that the 8-hour ozone NAAQS would be more
protective of human health, especially for children and adults who are
active outdoors, and for individuals with a pre-existing respiratory
disease, such as asthma.
---------------------------------------------------------------------------

    \2\ In March 2008, EPA completed another review of the primary
and secondary ozone NAAQS and tightened them further by lowering the
level for both to 0.075 ppm. See 73 FR 16436 (March 27, 2008).
Additionally, in October 2015, EPA completed another review of the
primary and secondary ozone NAAQS and tightened them by lowering the
level for both to 0.070 ppm. See 80 FR 65292 (October 26, 2015).
---------------------------------------------------------------------------

    Following promulgation of a new or revised NAAQS, EPA is required
by the CAA to designate areas throughout the nation as attaining or not
attaining the NAAQS. On April 15, 2004, EPA designated the Huntington-
Ashland, WV-KY Area, which consists of Boyd County in Kentucky and
Cabell County and Wayne County in West Virginia, and the Clarksville-
Hopkinsville, TN-KY Area, which consists of Christian County in
Kentucky and Montgomery County in Tennessee, as nonattainment for the
1997 8-hour ozone NAAQS. Those designations became effective on June
15, 2004. See 69 FR 23858 (April 30, 2004).
    Similarly, on May 21, 2012, EPA designated areas as unclassifiable/
attainment or nonattainment for the 2008 8-hour ozone NAAQS. EPA
designated the Boyd County and Christian County Areas as
unclassifiable/attainment for the 2008 8-hour ozone NAAQS. These
designations became effective on July 20, 2012. See 77 FR 30088. On
November 16, 2017, areas were designated for the 2015 8-hour ozone 2015
8-hour ozone NAAQS. The Boyd County and Christian County Areas were
again designated attainment/unclassifiable for the 2015 8-hour ozone
NAAQS, with an effective date of January 16, 2018, for both areas. See
82 FR 54232 (November 16, 2017).
    A state may submit a request that EPA redesignate a nonattainment
area that is attaining a NAAQS to attainment, and, if the area has met
the criteria described in section 107(d)(3)(E) of the CAA, EPA

may approve the redesignation request.\3\ One of the criteria for
redesignation is for the area to have an approved maintenance plan
under CAA section 175A. The maintenance plan must demonstrate that the
area will continue to maintain the NAAQS for the period extending ten
years after redesignation, and it must contain such additional measures
as necessary to ensure maintenance and such contingency provisions as
necessary to assure that violations of the NAAQS will be promptly
corrected. Eight years after the effective date of redesignation, the
state must also submit a second maintenance plan to ensure ongoing
maintenance of the NAAQS for an additional ten years pursuant to CAA
section 175A(b) (i.e., ensuring maintenance for 20 years after
redesignation).
---------------------------------------------------------------------------

    \3\ Section 107(d)(3)(E) of the CAA sets out the requirements
for redesignating a nonattainment area to attainment. They include
attainment of the NAAQS, full approval of the applicable SIP
pursuant to CAA section 110(k), determination that improvement in
air quality is a result of permanent and enforceable reductions in
emissions, demonstration that the state has met all applicable
section 110 and part D requirements, and a fully approved
maintenance plan under CAA section 175A.
---------------------------------------------------------------------------

    EPA has published long-standing guidance for states on developing
maintenance plans. The Calcagni memo \4\ provides that states may
generally demonstrate maintenance by either performing air quality
modeling to show that the future mix of sources and emission rates will
not cause a violation of the NAAQS or by showing that projected future
emissions of a pollutant and its precursors will not exceed the level
of emissions during a year when the area was attaining the NAAQS (i.e.,
attainment year inventory). See Calcagni memo at page 9. EPA clarified
in three subsequent guidance memos that certain areas can meet the CAA
section 175A requirement to provide for maintenance by showing that
they are unlikely to violate the NAAQS in the future, using information
such as the area design values \5\ when the design values are well
below the standard and have been historically stable.\6\ EPA refers to
a maintenance plan containing this streamlined demonstration as an LMP.
---------------------------------------------------------------------------

    \4\ John Calcagni, Director, Air Quality Management Division,
EPA Office of Air Quality Planning and Standards (OAQPS),
``Procedures for Processing Requests to Redesignate Areas to
Attainment,'' September 4, 1992 (Calcagni memo).
    \5\ The ozone design value for a monitoring site is the 3-year
average of the annual fourth-highest daily maximum 8-hour average
ozone concentrations. The design value for an ozone area is the
highest design value of any monitoring site in the area.
    \6\ See ``Limited Maintenance Plan Option for Nonclassifiable
Ozone Nonattainment Areas,'' from Sally L. Shaver, OAQPS, November
16, 1994; ``Limited Maintenance Plan Option for Nonclassifiable CO
Nonattainment Areas,'' from Joseph Paisie, OAQPS, October 6, 1995;
and ``Limited Maintenance Plan Option for Moderate PM10
Nonattainment Areas,'' from Lydia Wegman, OAQPS, August 9, 2001.
Copies of these guidance memoranda can be found in the docket for
this proposed rulemaking.
---------------------------------------------------------------------------

    EPA has interpreted CAA section 175A as permitting the LMP option
because section 175A of the Act does not define how areas may
demonstrate maintenance, and in EPA's experience implementing the
various NAAQS, areas that qualify for an LMP and have approved LMPs
have rarely, if ever, experienced subsequent violations of the NAAQS.
As noted in the LMP guidance memoranda, states seeking an LMP must
still submit the other maintenance plan elements outlined in the
Calcagni memo, including an attainment emissions inventory, provisions
for the continued operation of the ambient air quality monitoring
network, verification of continued attainment, and a contingency plan
in the event of a future violation of the NAAQS. Moreover, a state
seeking an LMP must still submit its section 175A maintenance plan as a
revision to its SIP, with all attendant notice and comment procedures.
While the LMP guidance memoranda were originally written with respect
to certain NAAQS,\7\ EPA has extended the LMP interpretation of section
175A to other NAAQS and pollutants not specifically covered by the
previous guidance memos.\8\
---------------------------------------------------------------------------

    \7\ The prior memos addressed: unclassifiable areas under the 1-
hour ozone NAAQS, nonattainment areas for the PM10
(particulate matter with an aerodynamic diameter less than 10
microns) NAAQS, and nonattainment for the carbon monoxide (CO)
NAAQS.
    \8\ See, e.g., 79 FR 41900 (July 18, 2014) (approval of the
second ten-year LMP for the Grant County 1971 SO2
maintenance area).
---------------------------------------------------------------------------

    In this case, EPA is proposing to approve Kentucky's LMPs because
the Commonwealth has made a showing, consistent with EPA's prior LMP
guidance, that ozone concentrations in the Huntington-Ashland, WV-KY
and Clarksville-Hopkinsville, TN-KY Areas are well below the 1997 8-
hour ozone NAAQS and have been historically stable and that the
Commonwealth has met the other maintenance plan requirements. The
Cabinet submitted the LMPs for the Boyd County and Christian County
Areas to fulfill the CAA's second maintenance plan requirement. EPA's
evaluation of the Boyd County and Christian County Areas' LMPs is
presented in section IV of this document, below.
    On May 20, 2005, and September 29, 2006, the Cabinet submitted
requests to EPA to redesignate the Christian County and Boyd County
Areas, respectively, to attainment for the 1997 8-hour ozone NAAQS.
Those submittals included plans, for inclusion in the Kentucky SIP, to
provide for maintenance of the 1997 8-hour ozone NAAQS in the
Clarksville-Hopkinsville, TN-KY Area through 2016 and in the
Huntington-Ashland, WV-TN Area through 2018. EPA approved the Boyd
County and the Christian County Areas' Maintenance Plans and the
Commonwealth's requests to redesignate these Areas to attainment for
the 1997 8-hour ozone NAAQS, effective September 4, 2007, and February
24, 2006, respectively. See 72 FR 43172 (August 3, 2007) and 71 FR 4047
(January 25, 2006), respectively. Kentucky's March 29, 2021, submittal
contains the second 10-year maintenance plans for the 20-year
maintenance period of the 1997 8-hour ozone NAAQS to ensure continued
maintenance for the Clarksville-Hopkinsville, TN-KY and Huntington-
Ashland, WV-TN Areas.
    Section 175A(b) of the CAA requires states to submit a revision to
the first maintenance plan eight years after redesignation to provide
for maintenance of the NAAQS for ten additional years following the end
of the first 10-year period. However, EPA's final implementation rule
for the 2008 8-hour ozone NAAQS revoked the 1997 8-hour ozone NAAQS and
stated that one consequence of revocation was that areas that had been
redesignated to attainment (i.e., maintenance areas) for the 1997 NAAQS
no longer needed to submit second 10-year maintenance plans under CAA
section 175A(b). See 80 FR 12264, 12315 (March 6, 2015).
    In South Coast Air Quality Management District v. EPA, the United
States Court of Appeals for the District of Columbia Circuit (D.C.
Circuit) vacated EPA's interpretation that, because of the revocation
of the 1997 8-hour ozone NAAQS, second maintenance plans were not
required for ``orphan maintenance areas,'' i.e., areas that had been
redesignated to attainment for the 1997 8-hour ozone NAAQS maintenance
areas and were designated attainment for the 2008 ozone NAAQS. South
Coast, 882 F.3d 1138 (D.C. Cir. 2018). Thus, states with these ``orphan
maintenance areas'' under the 1997 8-hour ozone NAAQS must submit
maintenance plans for the second maintenance period. Accordingly, on
March 29, 2021, Kentucky submitted second maintenance plans for the
Boyd County and Christian County Areas that show that the Areas are
expected to remain in attainment of the 1997 8-hour ozone

NAAQS through 2027 and 2026, respectively.
    In recognition of the continuing record of air quality monitoring
data showing ambient 8-hour ozone concentrations in the Huntington-
Ashland, WV-KY and Clarksville-Hopkinsville, TN-KY Areas well below the
1997 8-hour ozone NAAQS, the Cabinet chose the LMP option for the
development of second 1997 8-hour ozone NAAQS maintenance plans. On
March 29, 2021, the Cabinet adopted the second 10-year 1997 8-hour
ozone maintenance plans and also submitted the Boyd County and the
Christian County Areas' LMPs to EPA as revisions to the Kentucky SIP.

III. Kentucky's SIP Submittals

    As mentioned above, on March 29, 2021, the Cabinet submitted the
Boyd County and Christian County Areas' LMPs to EPA as revisions to the
Kentucky SIP. The submittals include the LMPs, air quality data,
emissions inventory information, and appendices. Appendices to the
plans include comments and responses between EPA and the Cabinet;
documentation of notice, hearing, and public participation prior to
adoption of the plans by the Cabinet on March 29, 2021; and a Cabinet
order, which notes that Kentucky's LMP submittals for the remainder of
the 20-year maintenance period for the Boyd County and the Christian
County Areas are in response to the D.C. Circuit's decision overturning
aspects of EPA's implementation rule for the 2008 8-hour ozone NAAQS
(South Coast, 882 F.3d 1138 (D.C. Cir. 2018)).
    The Boyd County and Christian County Areas' LMPs do not include any
additional emissions reduction measures but rely on the same emission
reduction strategy as the first 10-year maintenance plans that provide
for maintenance of the 1997 ozone NAAQS through 2018 and 2016,
respectively. Prevention of significant deterioration (PSD)
requirements and control measures contained in the SIP will continue to
apply, and Federal measures (e.g., Federal motor vehicle control
programs) will continue to be implemented in the Boyd County and
Christian County Areas.

IV. EPA's Evaluation of Kentucky's SIP Submittals

    EPA has reviewed the Boyd County and Christian County Areas' LMPs,
which are designed to maintain the 1997 8-hour ozone NAAQS within these
Areas through the end of the 20-year period beyond redesignation, as
required under CAA section 175A(b). The following is a summary of EPA's
interpretation of the section 175A requirements \9\ and EPA's
evaluation of how each requirement is met for the Boyd County and
Christian County Areas.
---------------------------------------------------------------------------

    \9\ See Calcagni memo.
---------------------------------------------------------------------------

A. Attainment Emissions Inventory

    For maintenance plans, a state should develop a comprehensive,
accurate inventory of actual emissions for an attainment year to
identify the level of emissions which is sufficient to maintain the
NAAQS. A state should develop this inventory consistent with EPA's most
recent guidance on emissions inventory development. For ozone, the
inventory should be based on typical summer day emissions of VOC and
NOX, as these pollutants are precursors to ozone formation.
1. Attainment Emissions Inventory--Boyd County Area
    The Boyd County Area LMP includes an ozone attainment inventory for
Boyd County that reflects typical summer day emissions in 2014. Table 1
presents a summary of the inventory for 2014 contained in the LMP.\10\
---------------------------------------------------------------------------

    \10\ In response to a comment from EPA regarding discrepancies
between the emissions data in Kentucky's prehearing SIP submittal
and the emissions data in version 2 of the 2014 National Emissions
Inventory (NEI), Kentucky explained in its March 29, 2021, submittal
that it had initially used the NEI 2014 version 1 data but agreed
that updating to 2014 version 2 data would be appropriate. However,
the final submittal still contains a discrepancy in the onroad VOC
emissions data. Therefore, in Table 1 of this document, EPA has
presented the value that was calculated using the 2014 NEI version 2
emissions data.

Table 1--2014 Typical Summer Day \11\ VOC and NOX Emissions for the Boyd
                               County Area
                               [Tons/day]
------------------------------------------------------------------------
                                                          NOX emissions
           Source category              VOC emissions
------------------------------------------------------------------------
Nonpoint............................             13.08              1.29
Nonroad.............................              0.24              0.29
Onroad..............................              1.43              2.81
Point...............................              2.32              7.61
                                     -----------------------------------
    Total...........................             17.07             12.00
------------------------------------------------------------------------

    The LMP guidance indicates that an attainment emissions inventory
should be developed in order to identify emission levels in the area
and provide the area with a basis to maintain the NAAQS. The inventory
should consist of the ozone precursors (NOX and VOC) and
their emissions from a typical summer day measured in tons per day
(tpd). The emissions data are based on the 2014v2 National Emissions
Inventory (NEI) platform for point sources, nonpoint sources, onroad,
and nonroad mobile sources. For Boyd County, point sources make up the
majority of contributions of NOX, at 7.61 tpd. Nonpoint
sources make up the majority of VOC contributions at 13.08 tpd. Based
on our review of the methods, models, and assumptions used by Kentucky
to develop the VOC and NOX estimates, EPA proposes to find
that the Boyd County Area's LMP includes a comprehensive, reasonably
accurate inventory of actual ozone precursor emissions in attainment
year 2014 and proposes to conclude that the plan's inventories are
acceptable for the purposes of a subsequent maintenance plan under CAA
section 175A(b).
---------------------------------------------------------------------------

    \11\ The following formula was used to determine the typical
summer day emissions for each sector: (Annual emissions) x (25
percent annual throughput June-Aug)/92 = typical summer day
emissions. This formula represents the tons per summer day by taking
the annual emissions of NOX and VOC from each source
sector, multiplying it by 0.25 (which represents June, July, and
August, the summer quarter of the calendar year), and then dividing
it by 92 (which accounts for each summer day). Data from the 2014v2
NEI were used for the annual emissions part of the equation.
---------------------------------------------------------------------------

2. Attainment Emissions Inventory--Christian County Area
    The Christian County Area LMP includes an ozone attainment
inventory for Christian County that reflects typical summer day
emissions in 2014. Table 2 presents a summary of the inventory for 2014
contained in the LMP.

   Table 2--2014 Typical Summer Day \12\ VOC and NOX Emissions for the
                          Christian County Area
                               [Tons/day]
------------------------------------------------------------------------
                                                          NOX emissions
           Source category              VOC emissions
------------------------------------------------------------------------
Nonpoint............................             27.04              2.44
Nonroad.............................              0.38              1.08
Onroad..............................              1.99              5.75
Point...............................              1.07              0.32
                                     -----------------------------------
    Total...........................             30.48              9.59
------------------------------------------------------------------------

    As with Boyd County, the emissions data are based on the 2014v2 NEI
platform for point sources, nonpoint sources, onroad, and nonroad
mobile sources. For Christian County, onroad mobile sources make up the
majority of contributions of NOX, at 5.75 tpd. Nonpoint
sources make up the majority of contributions of VOC, at 27.04 tpd.
Based on our review of the methods, models, and assumptions used by
Kentucky to develop the VOC and NOX estimates, EPA proposes
to find that the Christian County Area's LMP includes a comprehensive,
reasonably accurate inventory of actual ozone precursor emissions in
attainment year 2014 and proposes to conclude that the plan's
inventories are acceptable for the purposes of a subsequent maintenance
plan under CAA section 175A(b).
---------------------------------------------------------------------------

    \12\ See footnote 11.
---------------------------------------------------------------------------

B. Maintenance Demonstration

1. Boyd County Area--Maintenance Demonstration for Huntington-Ashland,
WV-KY Area
    The maintenance demonstration requirement is considered to be
satisfied in an LMP if the state can provide sufficient weight of
evidence indicating that air quality in the area is well below the
level of the NAAQS, that past air quality trends have been shown to be
stable, and that the probability of the area experiencing a violation
over the second 10-year maintenance period is low.\13\ These criteria
are evaluated below with regard to the Boyd County Area.
---------------------------------------------------------------------------

    \13\ See footnote 6.
---------------------------------------------------------------------------

a. Evaluation of Ozone Concentrations in Huntington-Ashland, WV-KY Area
    To attain the 1997 8-hour ozone NAAQS, the three-year average of
the fourth-highest daily maximum 8-hour average ozone concentrations
(design value) at each monitor within an area must not exceed 0.08 ppm.
Based on the rounding convention described in 40 CFR part 50, Appendix
I, the 1997 8-hour ozone NAAQS is attained if the design value is 0.084
ppm or below.
    There are currently two ozone monitors in the Huntington-Ashland,
WV-KY Maintenance Area, one in Boyd County, Kentucky, and one in Cabell
County, West Virginia (which was relocated to a new location in 2019).
Based on quality assured and certified monitoring data for 2019-2021,
the current design value for the Huntington-Ashland, WV-KY is 0.059
ppm, or 70 percent of the level of the 1997 8-hour ozone NAAQS.
Consistent with prior guidance, EPA believes that if the most recent
air quality design value for the area is at a level that is well below
the NAAQS (e.g., below 85 percent of the NAAQS, or in this case, below
0.071 ppm), then EPA considers the state to have met the section 175A
requirement for a demonstration that the area will maintain the NAAQS
for the requisite period. Such a demonstration assumes continued
applicability of prevention of significant deterioration requirements
and any control measures already in the SIP and that Federal measures
will remain in place through the end of the second 10-year maintenance
period, absent a showing, consistent with CAA section 110(l), that such
measures are not necessary to assure maintenance.
    Table 3 presents the design values (in ppm) for each monitor in the
Huntington-Ashland, WV-KY Maintenance Area over the 2006-2021 period.
As shown, the AQS monitors in the area--Ashland Primary-(FIVCO) Monitor
(AQS ID 21-019-0017) and Huntington Monitors (AQS ID 54-011-0006 and
AQS 54-011-0007) \14\--have been well below the level of the 1997 8-
hour ozone NAAQS over the entire first 10-year maintenance period since
the Area was redesignated to attainment, and the most recent design
value is below the level of 85 percent of the NAAQS, consistent with
prior LMP guidance.
---------------------------------------------------------------------------

    \14\ The Huntington, WV monitor in Cabell County was relocated,
as explained in the note to Table 3 of this document.
    \15\ See EPA Air Quality Design Values at https://www.epa.gov/air-trends/air-quality-design-values.

                             Table 3--1997 8-Hour Ozone NAAQS Design Values \15\ (ppm) for Monitors in Huntington Ashland, WV-KY Area for the 2006-2021 Time Period
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                2006-   2007-   2008-   2009-   2010-   2011-   2012-   2013-   2014-   2015-   2016-   2017-   2018-   2019-
                             County                                 AQS site ID    2008    2009    2010    2011    2012    2013    2014    2015    2016    2016    2018    2019    2020    2021
                                                                                DV      DV      DV      DV      DV      DV      DV      DV      DV      DV      DV      DV      DV      DV
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Boyd, KY........................................................     21-019-0017   0.074   0.070   0.070   0.069   0.072   0.069   0.068   0.066   0.066   0.065   0.064   0.062   0.061   0.059
Cabell, WV......................................................     54-011-0006   0.080   0.073   0.066   0.067   0.072   0.069   0.065   0.062   0.064   0.064   0.064     (*)     (*)  ......
Cabell, WV......................................................     54-011-0007  ......  ......  ......  ......  ......  ......  ......  ......  ......  ......  ......     (*)     (*)   0.059
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
* The Cabell County, West Virginia, monitor (AQS Site ID 54-011-0006) was relocated to a new site (AQS ID 54-011-0007) before the ozone monitoring season in 2019. As a result, neither site
  collected a complete three-year design value during 2017-2019 and 2018-2020.

    Therefore, the Boyd County Area is eligible for the LMP option, and
EPA proposes to find that the long record of monitored ozone
concentrations that attain the NAAQS, together with the continuation of
existing VOC and NOX emissions control programs, adequately
provide for the maintenance of the 1997 8-hour ozone NAAQS in the Area
through the second 10-year maintenance period and beyond.
    Additional supporting information that the Area is expected to
continue to maintain the NAAQS can be found in

projections of future year design values that EPA recently completed to
assist states with development of interstate transport SIPs for the
2015 ozone NAAQS.\16\ Those projections, made for the year 2023, show
that the highest design value in the Area is projected to be 0.058 ppm.
EPA is not proposing to make any finding in this rulemaking regarding
interstate transport obligations for any state.
---------------------------------------------------------------------------

    \16\ See the spreadsheet titled ``Ozone Monitoring Site Design
Values for 2008 through 2017 and for 2023'' at https://www.epa.gov/airmarkets/memo-and-supplemental-information-regarding-interstate-transport-sips-2015-ozone-naaqs.
---------------------------------------------------------------------------

b. Stability of Ozone Levels in Huntington-Ashland, WV-KY Area
    As discussed above, the Huntington-Ashland, WV-KY Area has
maintained air quality well below the 1997 8-hour ozone NAAQS over the
past fourteen years. Additionally, the design value data shown within
Table 3 of this document, illustrates that ozone levels have been
relatively stable over this timeframe, with an overall downward trend.
For example, the data within Table 3 of this document indicates that
the largest year-over-year change in design value at any one monitor
during fourteen years was seven parts per billion (ppb), which occurred
between the 2006-2008 and between the 2007-2009 and 2008-2010 design
values. Furthermore, the overall ozone concentrations for the Area
decreased by 15 ppb between the 2007-2009 and 2019-2021 design values
at the Ashland Primary-Monitor (AQS ID 21-019-0017). This downward
trend in ozone levels, coupled with the relatively small, year-over-
year variation in ozone design values, makes it reasonable to conclude
that Huntington-Ashland, WV-KY Area will not exceed the 1997 8-hour
ozone NAAQS during the second 10-year maintenance period.
2. Christian County Area--Maintenance Demonstration for Clarksville-
Hopkinsville, TN-KY Area
    As stated above, the maintenance demonstration requirement is
considered to be satisfied in an LMP if the state can provide
sufficient weight of evidence indicating that air quality in the area
is well below the level of the NAAQS, that past air quality trends have
been shown to be stable, and that the probability of the area
experiencing a violation over the second 10-year maintenance period is
low. These criteria are evaluated below with regard to the Christian
County Area.
a. Evaluation of Ozone Air Quality Levels in Clarksville-Hopkinsville,
TN-KY Area
    To attain the 1997 8-hour ozone NAAQS, the three-year average of
the fourth-highest daily maximum 8-hour average ozone concentrations
(design value) at each monitor within an area must not exceed 0.08 ppm.
Based on the rounding convention described in 40 CFR part 50, Appendix
I, the NAAQS is attained if the design value is 0.084 ppm or below.
There is currently one ozone monitor in the Clarksville-Hopkinsville,
TN-KY Maintenance Area, in Christian County, Kentucky.
    Based on quality assured and certified monitoring data for 2019-
2021, the current design value for the Clarksville-Hopkinsville, TN-KY
Area is 0.058 ppm, or 69 percent of the level of the 1997 8-hour ozone
NAAQS. Consistent with prior guidance, EPA believes that if the most
recent air quality design value for the area is at a level that is well
below the NAAQS (e.g., below 85 percent of the NAAQS, or in this case,
below 0.071 ppm), then EPA considers the state to have met the section
175A requirement for a demonstration that the area will maintain the
NAAQS for the requisite period. Such a demonstration assumes continued
applicability of prevention of significant deterioration requirements
and any control measures already in the SIP and that Federal measures
will remain in place through the end of the second 10-year maintenance
period, absent a showing consistent with section 110(l) that such
measures are not necessary to assure maintenance.
    Table 4 presents the design values (in ppm) for the Christian
County, Kentucky, monitor for the three-year periods 2006-2008 through
2019-2021. As shown in Table 4, the Clarksville-Hopkinsville, TN-KY
Area has been well below the level of the 1997 8-hour ozone NAAQS over
the entire first 10-year maintenance period since the Area was
redesignated to attainment, and the most current design value is below
the level of 85 percent of the NAAQS, consistent with prior LMP
guidance.

                      Table 4--1997 8-Hour Ozone NAAQS Design Values (ppm) at the Monitoring Site in the Clarksville-Hopkinsville, TN-KY Area for the 2006-2021 Time Period
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                2006-   2007-   2008-   2009-   2010-   2011-   2012-   2013-   2014-   2015-   2016-   2017-   2018-   2019-
                             County                                 AQS site ID    2008    2009    2010    2011    2012    2013    2014    2015    2016    2016    2018    2019    2020    2021
                                                                                DV      DV      DV      DV      DV      DV      DV      DV      DV      DV      DV      DV      DV      DV
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Christian.......................................................     21-047-0006   0.078   0.074   0.069   0.070   0.073   0.069   0.067   0.063   0.062   0.061   0.060   0.058   0.058   0.058
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

    Therefore, the Christian County Area is eligible for the LMP
option, and EPA proposes to find that the long record of monitored
ozone concentrations that attain the NAAQS, together with the
continuation of existing VOC and NOX emissions control
programs, adequately provide for the maintenance of the 1997 8-hour
ozone NAAQS in the Clarksville-Hopkinsville, TN-KY Area through the
second 10-year maintenance period and beyond.
    Additional supporting information that the Clarksville-
Hopkinsville, TN-KY Area is expected to continue to maintain the NAAQS
can be found in projections of future year design values that EPA
recently completed to assist states with development of interstate
transport SIPs for the 2015 ozone NAAQS.\17\ Those projections, made
for the year 2023, show that the highest design value in the Area is
expected to be 0.056 ppm.
---------------------------------------------------------------------------

    \17\ See the spreadsheet titled ``Ozone Monitoring Site Design
Values for 2008 through 2017 and for 2023'' at https://www.epa.gov/airmarkets/memo-and-supplemental-information-regarding-interstate-transport-sips-2015-ozone-naaqs.
---------------------------------------------------------------------------

b. Stability of Ozone Levels in Clarksville-Hopkinsville Area
    As discussed above, the Clarksville-Hopkinsville, TN-KY Area has
maintained air quality well below the 1997 8-hour ozone NAAQS over the
past fourteen years. Additionally, the design value data shown within
Table 4 of this document, illustrates that ozone levels have been
relatively stable over this timeframe, with an overall downward trend.
For example, the data within Table 4 of this document, indicates that
the largest year-over-year change in design value at any one monitor
during these fourteen years was five ppb which occurred between the
2007-2009 design value and the 2008-2010 design value, and it
represented only a six percent change. Furthermore, the overall ozone
concentrations for the

Clarksville-Hopkinsville, TN-KY Area decreased by 20 ppb between the
2007-2009 and 2019-2021 design values at the Hopkinsville, Kentucky,
monitor (AQS ID 21-047-0006). This downward trend in ozone levels,
coupled with the relatively small, year-over-year variation in ozone
design values, makes it reasonable to conclude that the Clarksville-
Hopkinsville, TN-KY Area will not exceed the 1997 8-hour ozone NAAQS
during the second 10-year maintenance period.

C. Monitoring Network and Verification of Continued Attainment

    EPA annually reviews the ozone monitoring network that the Cabinet
operates and maintains in accordance with 40 CFR part 58. This network
is described in the ambient air monitoring network plan that is
developed by the Cabinet and submitted to EPA annually, following a
public notification and comment process. EPA has reviewed and approved
Kentucky's 2021 Ambient Air Monitoring Network Plan (2021 Annual
Network Plan).\18\
---------------------------------------------------------------------------

    \18\ See Letter from Caroline Y. Freeman, Director, Air and
Radiation Division, US EPA Region 4, to Melissa K. Duff, Director,
Kentucky Division for Air Quality (October 27, 2021) (approving the
2021 Kentucky Ambient Air Monitoring Network Plan) (included in
docket for this proposed rulemaking).
---------------------------------------------------------------------------

    To verify the attainment status of the area over the maintenance
period, the maintenance plan should contain provisions for continued
operation of an appropriate EPA-approved monitoring network in
accordance with 40 CFR part 58. As noted above, the Cabinet's
monitoring networks in the Boyd County and Christian County Areas have
been approved by the EPA in accordance with 40 CFR part 58, and the
Cabinet has committed to continue to maintain a network in accordance
with the EPA requirements. For further details on monitoring, the
reader is referred to the 2021 Kentucky Annual Network Plan \19\ as
well as EPA's approval letter for the 2021 Annual Network Plan, which
can be found in the docket for this proposed action. EPA proposes to
find that the Cabinet's monitoring network is adequate to verify
continued attainment of the 1997 ozone NAAQS in the Huntington-Ashland,
WV-KY and Clarksville-Hopkinsville, TN-KY Areas.
---------------------------------------------------------------------------

    \19\ 2021 Kentucky Annual Ambient Air Monitoring Network Plan.
Commonwealth of Kentucky Energy and Environment Cabinet, Department
for Environmental Protection, Division for Air Quality (June 29,
2021). Available online at: https://eec.ky.gov/Environmental-Protection/Air/Air-Monitoring/Pages/default.aspx.
---------------------------------------------------------------------------

D. Contingency Plan

    Section 175A(d) of the Act requires that a maintenance plan include
contingency provisions. The purpose of such contingency provisions is
to prevent future violations of the NAAQS or to promptly remedy any
NAAQS violations that might occur during the maintenance period. The
state should identify specific triggers which will be used to determine
when the contingency measures need to be implemented.
    For the Boyd County and Christian County Areas, if a monitored
violation of the 8-hour ozone design value occurs in any portion the
Huntington-Ashland, WV-KY Area or Clarksville-Hopkinsville, TN-KY Area,
respectively, or if periodic emission inventory updates reveal
excessive or unanticipated growth in ozone precursor emissions, the
contingency plans in Kentucky's LMPs require the Commonwealth to
evaluate existing control measures to see if any further emission
reduction measures should be implemented. In the event of a monitored
violation of the 1997 ozone NAAQS in the Huntington-Ashland, WV-KY Area
or the Clarksville-Hopkinsville, TN-KY Area, Kentucky commits to adopt,
within a period of nine months, one or more of several potential
contingency measures listed in the plan to re-attain the standard.
After the triggering monitored violation, all of the selected
regulatory programs will be implemented within 18 months.
    The plans also provide that the Cabinet will complete any necessary
analyses to submit to EPA and that contingency measures will be adopted
and implemented as quickly as possible but no later than eighteen
months after the triggering event. Should the affected area return to
attainment prior to the implementation of the contingency measure(s),
those measures may not be implemented. In addition, the plans provide
that Cabinet reserves the right to implement other contingency measures
if new control programs should be developed and deemed more
advantageous for the area. Prior to the implementation of any
contingency measure(s) not listed, the Cabinet will solicit input from
all interested and affected parties in the area. No contingency measure
will be implemented without notification to EPA and approval granted by
EPA.
    EPA proposes to find that the contingency provisions in Kentucky's
second maintenance plans for both the Boyd County and Christian County
Areas for the 1997 8-hour Ozone NAAQS meet the requirements of the CAA
section 175A(d).

E. Conclusion

    EPA proposes to find that the Boyd County and Christian County
Areas' LMPs for the 1997 8-hour ozone NAAQS include an approvable
update of the various elements (including attainment inventory,
assurance of adequate monitoring and verification of continued
attainment, and contingency provisions) of the initial EPA-approved
Maintenance Plan for the 1997 8-hour ozone NAAQS. EPA also proposes to
find that the Boyd County and Christian County Areas qualify for the
LMP option and adequately demonstrate maintenance of the 1997 8-hour
ozone NAAQS through the documentation of monitoring data showing
maximum 1997 8-hour ozone levels well below the NAAQS and historically
stable design values.
    EPA also believes the Boyd County and Christian County Areas' LMPs,
which retain all existing control measures in the SIP, are sufficient
to provide for maintenance of the 1997 8-hour ozone NAAQS in the
Huntington-Ashland, WV-KY and Clarksville-Hopkinsville, TN-KY Areas,
respectively, over the second maintenance period (i.e., through 2027
and 2026, respectively) and thereby satisfy the requirements for such a
plan under CAA section 175A(b). EPA is therefore proposing to approve
Kentucky's March 29, 2021, submission of the Boyd County and Christian
County Areas' LMPs as revisions to the Kentucky SIP.

V. Transportation Conformity

    Transportation conformity is required by section 176(c) of the CAA.
Conformity to a SIP means that transportation activities will not
produce new air quality violations, worsen existing violations, or
delay timely attainment of the NAAQS. See CAA 176(c)(1)(A) and (B).
EPA's transportation conformity rule at 40 CFR part 93, subpart A,
requires that transportation plans, programs, and projects conform to
SIPs and establishes the criteria and procedures for determining
whether they conform. The conformity rule generally requires a
demonstration that emissions from the Regional Transportation Plan
(RTP) and the Transportation Improvement Program (TIP) are consistent
with the motor vehicle emissions budget (MVEB) contained in the control
strategy SIP revision or maintenance plan. See 40 CFR 93.101, 93.118,
and 93.124. A MVEB is defined as ``the portion of the total allowable
emissions defined in the

submitted or approved control strategy implementation plan revision or
maintenance plan for a certain date for the purpose of meeting
reasonable further progress milestones or demonstrating attainment or
maintenance of the NAAQS, for any criteria pollutant or its precursors,
allocated to highway and transit vehicle use and emissions.'' See 40
CFR 93.101.
    Under the conformity rule, LMP areas may demonstrate conformity
without a regional emissions analysis. See 40 CFR 93.109(e). EPA made
findings that the MVEBs in the first 10-years of the 1997 8-hour zone
maintenance plan for the Boyd County and Christian County Areas were
adequate for transportation conformity purposes. In a Federal Register
notice published on August 3, 2007, EPA notified the public of the
adequacy finding for the Boyd County Area through final rulemaking; the
adequacy determination for the Boyd County Area became effective on
September 4, 2007. See 72 FR 43172. In a Federal Register notice
published on January 25, 2006, EPA notified the public of the adequacy
finding for the Christian County Area through a final rule; the
adequacy determination for the Christian County Area became effective
on February 24, 2006. See 71 FR 4047.
    After approval of or an adequacy finding for each of these LMPs,
there is no requirement to meet the budget test pursuant to the
transportation conformity rule for the respective maintenance area. All
actions that would require a transportation conformity determination
for the Boyd County and Christian County Areas under EPA's
transportation conformity rule provisions are considered to have
already satisfied the regional emissions analysis and ``budget test''
requirements in 40 CFR 93.118 as a result of EPA's adequacy finding for
the LMP. See 69 FR 40004 (July 1, 2004).
    However, because LMP areas are still maintenance areas, certain
aspects of transportation conformity determinations still will be
required for transportation plans, programs, and projects.
Specifically, for such determinations, RTPs, TIPs and transportation
projects still will have to demonstrate that they are fiscally
constrained (40 CFR 93.108) and meet the criteria for consultation (40
CFR 93.105) and Transportation Control Measure implementation in the
conformity rule provisions (40 CFR 93.113) as well as meet the hot-spot
requirements for projects (40 CFR 93.116).\20\ Additionally, conformity
determinations for RTPs and TIPs must be determined no less frequently
than every four years, and conformity of plan and TIP amendments and
transportation projects is demonstrated in accordance with the timing
requirements specified in 40 CFR 93.104. In addition, in order for
projects to be approved they must come from a currently conforming RTP
and TIP. See 40 CFR 93.114 and 40 CFR 93.115.
---------------------------------------------------------------------------

    \20\ A conformity determination that meets other applicable
criteria in Table 1 of paragraph (b) of this section (93.109(e)) is
still required, including the hot-spot requirements for projects in
CO, PM10, and fine particulate matter (PM2.5)
areas.
---------------------------------------------------------------------------

VI. Proposed Actions

    Under sections 110(k) and 175A of the CAA and for the reasons set
forth above, EPA is proposing to approve the Boyd County and Christian
County Areas' LMPs for the 1997 8-hour ozone NAAQS, submitted by the
Cabinet on March 29, 2021, as revisions to the Kentucky SIP. EPA is
proposing to approve the Boyd County and Christian County Areas' LMPs
because they include an acceptable update of the various elements of
the 1997 8-hour ozone NAAQS Maintenance Plan approved by EPA for the
first 10-year period (including emissions inventory, assurance of
adequate monitoring and verification of continued attainment, and
contingency provisions), and essentially carry forward all of the
control measures and contingency provisions relied upon in the earlier
plans.
    EPA also finds that the Boyd County and Christian County Areas
qualify for the LMP option and that, therefore, the Boyd County and
Christian County Areas' LMPs adequately demonstrate maintenance of the
1997 8-hour ozone NAAQS through documentation of monitoring data
showing maximum 1997 8-hour ozone levels well below the NAAQS and
continuation of existing control measures. EPA believes that the Boyd
County and Christian County Areas' 1997 8-Hour ozone LMPs are
sufficient to provide for maintenance of the 1997 8-hour ozone NAAQS in
the Huntington-Ashland, WV-KY and Clarksville-Hopkinsville, TN-KY
Areas, respectively, over the second 10-year maintenance period,
through 2027 and 2026, respectively, and thereby satisfy the
requirements for such a plan under CAA section 175A(b).

VII. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. See 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided they meet the criteria of the CAA. These actions merely
propose to approve state law as meeting Federal requirements and do not
impose additional requirements beyond those imposed by state law. For
that reason, these proposed actions:
     Are not significant regulatory actions 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);
     Do not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Are 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.);
     Do 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);
     Do not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Are not economically significant regulatory actions based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Are not significant regulatory actions subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Are 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
     Do not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    The SIP is not approved to apply on any Indian reservation land or
in any other area where EPA or an Indian tribe has demonstrated that a
tribe has jurisdiction. In those areas of Indian country, the proposed
rule does not have tribal implications as specified by Executive Order
13175 (65 FR 67249, November 9, 2000), nor will it impose substantial
direct costs on tribal governments or preempt tribal law.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations,

Nitrogen oxides, Ozone, Reporting and recordkeeping requirements,
Volatile organic compounds.

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

    Dated: August 18, 2022.
Daniel Blackman,
Regional Administrator, Region 4.
[FR Doc. 2022-18168 Filed 8-23-22; 8:45 am]
BILLING CODE 6560-50-P