[Federal Register Volume 77, Number 135 (Friday, July 13, 2012)]
[Rules and Regulations]
[Pages 41284-41291]
[FR Doc No: 2012-17021]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2011-0398; FRL-9352-2]

Azoxystrobin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
azoxystrobin in or on multiple commodities which are identified and
discussed later in this document. Interregional Research Project Number
4 (IR-4) and Syngenta Crop Protection requested these tolerances under
the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective July 13, 2012. Objections and
requests for hearings must be received on or before September 11, 2012,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2011-0398; FRL-9352-2, is
available either electronically through http://www.regulations.gov or
in hard copy at the OPP Docket in the Environmental Protection Agency
Docket Center (EPA/DC), located in EPA West, Rm. 3334, 1301
Constitution Ave. NW., Washington, DC 20460-0001. The Public Reading
Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday,
excluding legal holidays. The telephone number for the Public Reading
Room is<PHONE_NUMBER>, and the telephone number for the OPP Docket is
(703) 305-5805. Please review the visitor instructions and additional
information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Andrew Ertman, Registration Division,
(7505P) Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; email 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 get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2011-0398 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
September 11, 2012. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any confidential business information
(CBI) for inclusion in the public docket. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit a copy of your non-CBI objection or
hearing request, identified by docket ID number EPA-HQ-OPP-2011-0398,
by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), Mail Code: 28221T, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.htm.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerances

    In the Federal Register of July 20, 2011 (76 FR 43231) (FRL-8880-
1), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21 U.S.C.
346a(d)(3), announcing the filing of a pesticide petition (PP 1E7851)
by Interregional Research Project Number 4 (IR-4), 500 College Road
East, Suite 201W, Princeton, NJ 08540. The petition requested that 40
CFR 180.507 be amended by:
     Establishing tolerances for residues of the fungicide
azoxystrobin, (methyl (E)-2-[2-[6-(2-cyanophenoxy)pyrimidin-4-
yloxy]phenyl]-3-methoxyacrylate) and the Z isomer of azoxystrobin,
(methyl (Z)-2-[2-[6-(2-cyanophenoxy)pyrimidin-4-yloxy]pheny1]-3-
methoxyacrylate) in or on onion, bulb subgroup 3-07A at 1.0 parts per
million (ppm); onion, green subgroup 3-07B, at 7.5 ppm; caneberry
subgroup 13-07A, at 5.0 ppm; bushberry subgroup 13-07B, at 3.0 ppm;
small fruit vine climbing subgroup, except fuzzy kiwifruit, 13-07F, at
1.0 ppm; low growing berry subgroup 13-07G, except cranberry, at 10.0
ppm; vegetable, fruiting, subgroup 8-10A, at 0.2 ppm; vegetable,
fruiting, subgroups 8-10B, at 2.0 ppm; fruit, citrus, group 10-10, at
10.0 ppm; rapeseed subgroup 20A, at 1.0 ppm; sunflower subgroup 20B, at
0.5 ppm; cottonseed subgroup 20C, at 0.6 ppm; wasabi, at 50.0 ppm; and
dragon fruit, at 2.0 ppm;
     Changing the tolerance for vegetable, tuberous and corm,
subgroup 1C from 0.03 ppm to 6.0 ppm; and
     Upon approval of the tolerances above, by removing the
established tolerances for onion, bulb at 1.0 ppm; onion, green at 7.5
ppm; caneberry subgroup 13-A at 5.0 ppm; bushberry subgroup 13B at 3.0
ppm; Juneberry at 3.0 ppm; lingonberry at 3.0 ppm; salal at 3.0 ppm;
grape at 1.0 ppm; strawberry at 10.0 ppm; tomato at 0.2 ppm; vegetable,
fruiting, group 8 except tomato at 2.0 ppm; fruit, citrus, group 10 at
10.0 ppm; canola, seed at 1.0 ppm; cotton, undelinted seed at 0.6 ppm;
crambe, seed at 0.5 ppm; flax, seed at 0.5 ppm; mustard, field, seed at
0.5 ppm; mustard, Indian, seed at 0.5 ppm; mustard, seed at 0.5 ppm;
rapeseed, Indian at 0.5 ppm; rapeseed, seed at 0.5 ppm; safflower, seed
at 0.5 ppm; sunflower, seed at 0.5 ppm; potato at 0.03 ppm.
    In the Federal Register of November 9, 2011 (76 FR 69690) (FRL-
9325-1), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
1F7891) by Syngenta Crop Protection, LLC., P.O. Box 18300, Greensboro,
NC 27419-8300. The petition requested that 40 CFR 180.507 be amended by
establishing a tolerance for residues of the fungicide azoxystrobin,
(methyl (E)-2-[2-[6-(2-cyanophenoxy)pyrimidin-4-yloxy]phenyl]-3-
methoxyacrylate) and the Z isomer of azoxystrobin, (methyl (Z)-2-[2-[6-
(2-cyanophenoxy)pyrimidin-4-yloxy]phenyl]-3-methoxyacrylate) in or on
sugarcane at 0.2 ppm.
    The notices referenced summaries of the petitions prepared by
Syngenta, the registrant, which are available in the docket, http://www.regulations.gov. There were no comments received in response to
these notices of filing.
    Based upon review of the data supporting the petition, EPA has
modified the levels at which tolerances are being established for
various commodities. The reason for these changes is explained in Unit
IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. * *
*''
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for azoxystrobin including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with azoxystrobin 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.
    Azoxystrobin has low acute toxicity via the oral, dermal and
inhalation routes of exposure. It is not an eye or skin irritant and is
not a skin sensitizer. Dietary administration of azoxystrobin to rats
resulted in decreased body weights, decreased food intake and
utilization, increased diarrhea and other clinical toxicity
observations (increased urinary incontinence, hunched postures and
distended abdomens). In addition, liver effects characterized by
increased liver weights, increases in alkaline phosphatase and gama
glutamyltransferase, decreases in albumin, gross and histological
lesions in the liver and bile ducts, were seen in rats. In dogs,
effects on liver/biliary function were found after oral administration.
    In the acute neurotoxicity study in rats, increased incidence of
diarrhea was observed at all dose levels tested including the lowest-
observed-adverse-effect-level (LOAEL). Decreased body weight/weight
gain and food utilization was noted in the rat subchronic neurotoxicity
study. There were no consistent indications of treatment-related
neurotoxicity in either the acute or subchronic neurotoxicity studies.
    In the rat developmental toxicity study, diarrhea, urinary
incontinence and salivation were observed in maternal animals; in the
rabbit developmental toxicity study, maternal animals exhibited
decreased body weight gain. No adverse treatment-related developmental
effects were seen in either study. In the rat reproduction study,
offspring and parental effects (decreased body weights and increased
adjusted liver weights) were observed at the same dose.
    There was no evidence of carcinogenicity in rats and mice at
acceptable dose levels. As a result, EPA has classified azoxystrobin as
``not likely to be carcinogenic to humans.'' Azoxystrobin induced a
weak mutagenic response in the mouse lymphoma assay, but the activity
expressed in vitro is not expected to be expressed in whole animals.
    Specific information on the studies received and the nature of the
adverse effects caused by azoxystrobin as well as the no-observed-
adverse-effect-level (NOAEL) and the LOAEL from the toxicity studies
can be found at http://www.regulations.gov in docket ID number EPA-HQ-
OPP-2011-0398 on pages 38-40 of the document titled ``Azoxystrobin:
Human Health Risk Assessment for Proposed Uses on Dragon Fruit, Wasabi,
and Tuberous and Corm Vegetables (Subgroup 1C), and from the Revisions
to Various Crop Groups (Onion Subgroups 3-07 A, B; Fruiting Vegetable
Subgroups 8-10 A, B; Small Fruit and Berry Subgroups 13-07 A, B, F, G,
Oilseeds Subgroups A, B, C; and Citrus Fruit Group 10-10).''

B. Toxicological Points of Departure/Levels of Concern

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

  Table--Summary of Toxicological Doses and Endpoints for Azoxystrobin for Use in Human Health Risk Assessment
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                                        Point of departure and
          Exposure/scenario               uncertainty/safety     RfD, PAD, LOC for risk  Study and toxicological
                                               factors                 assessment                effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (All Populations)......  LOAEL = 200 mg/kg/day..  Acute RfD = 0.67 mg/kg/  Acute Neurotoxicity--
                                       UFA = 10x..............   day.                     Rat. LOAEL = 200 mg/kg/
                                       UFH = 10x..............  aPAD = 0.67 mg/kg/day..   day based on diarrhea
                                       FQPA SF = 3x UFL.......                            at 2-hours post dose
                                                                                at all dose levels up
                                                                                to and including to
                                                                                LOAEL.
Chronic dietary (All Populations)....  NOAEL= 18 mg/kg/day....  Chronic RfD = 0.18 mg/   Combined Chronic
                                       UFA = 10x..............   kg/day.                  Toxicity/
                                       UFH = 10x..............  cPAD = 0.18 mg/kg/day..   Carcinogenicity
                                       FQPA SF = 1x...........                            Feeding Study--Rat.
                                                                                LOAEL = 82.4/117 mg/kg/
                                                                                day (M/F) based on
                                                                                reduced body weights
                                                                                in both sexes and bile
                                                                                duct lesions in males.
Incidental oral short-term (1 to 30    NOAEL= 25 mg/kg/day....  LOC for MOE = 100......  Prenatal Developmental
 days).                                UFA = 10x..............                            Oral Toxicity--Rat.
                                       UFH = 10x..............                            LOAEL = 100 mg/kg/day
                                       FQPA SF = 1x...........                            based on increased
                                                                                maternal diarrhea,
                                                                                urinary incontinence,
                                                                                and salivation.

Inhalation short-term (1 to 30 days).  Oral study NOAEL= 25 mg/ LOC for MOE = 100......  Prenatal Developmental
                                        kg/day (inhalation                                Oral Toxicity--Rat.
                                        absorption rate =                                 LOAEL = 100 mg/kg/day
                                        100%).                                            based on increased
                                       UFA = 10x..............                            maternal diarrhea,
                                       UFH = 10x..............                            urinary incontinence,
                                       FQPA SF = 1x...........                            and salivation.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
  members of the human population (intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. mg/kg/day =
  milligrams/kilogram/day.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to azoxystrobin, EPA considered exposure under the petitioned-
for tolerances as well as all existing azoxystrobin tolerances in 40
CFR 180.507. EPA assessed dietary exposures from azoxystrobin in food
as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
    Such effects were identified for azoxystrobin. In estimating acute
dietary exposure, EPA used food consumption information from the U.S.
Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide
Continuing Surveys of Food Intake by Individuals (CSFII). As to residue
levels in food, the acute dietary assessment used tolerance levels for
all commodities, except citrus fruits where the highest residue from
crop field trials was used, and 100 percent crop treated (PCT) for all
commodities. Default processing factors were assumed except for where
tolerances were established for processed commodities.
    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, the chronic dietary
analysis for azoxystrobin was conducted using tolerance levels and
average PCT estimates when available. Default processing factors were
assumed except for where tolerances were established for processed
commodities.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that azoxystrobin does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information.
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and
information on the anticipated residue levels of pesticide residues in
food and the actual levels of pesticide residues that have been
measured in food. If EPA relies on such information, EPA must require
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after
the tolerance is established, modified, or left in effect,
demonstrating that the levels in food are not above the levels
anticipated. For the present action, EPA will issue such data call-ins
as are required by FFDCA section 408(b)(2)(E) and authorized under
FFDCA section 408(f)(1). Data will be required to be submitted no later
than 5 years from the date of issuance of these tolerances.
    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 estimated the PCT for existing uses as follows:
    Almonds, 25%; apricots, 10%; artichokes, 25%; asparagus, 2.5%;
green beans, 10%; blackberries, 5%; blueberries, 10%; broccoli, 5%;
cabbage, 10%; cantaloupes, 10%; carrots, 10%; cauliflower, 2.5%;
celery, 10%; cherries, 5%; corn, 2.5%; cotton, 5%; cucumbers, 20%; dry
beans/peas, 1%; garlic, 60%; grapefruit, 20%; grapes, 5%; hazelnuts
(filberts), 5%; lettuce, 2.5%; onions, 10%; oranges, 5%; peaches, 5%;
peanuts, 15%; green peas, 2.5%; pecans, 2.5%; peppers, 15%; pistachios,
15%; potatoes, 35%; prunes, 2.5%; pumpkins, 20%; raspberries, 5%; rice,
35%; soybeans, 2.5%; spinach, 10%; squash, 15%; strawberries, 30%;
sugar beets, 5%; sweet corn, 10%; tangerines, 15%; tomatoes, 15%;
walnuts, 1%; watermelon, 20%; wheat, 2.5%.
    In most cases, EPA uses available data from USDA/National
Agricultural Statistics Service (NASS), proprietary market surveys, and
the National Pesticide Use Database for the chemical/crop combination
for the most recent 6-7 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 1%. 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
azoxystrobin 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 azoxystrobin in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of azoxystrobin. 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),
Screening Concentration in Ground Water (SCI-GROW), the Pesticide Root
Zone Model (PRZM) and the Exposure Analysis Modeling System (EXAMS)
models, the estimated drinking water concentrations (EDWCs) of
azoxystrobin for acute exposures are estimated to be 173 parts per
billion (ppb) and 33 ppb for chronic exposures. For ground water, the
estimated drinking water concentration is 3.1 ppb.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 173 ppb was used to assess
the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 33 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).
    Azoxystrobin is currently registered for the following uses that
could result in residential exposures: Outdoor residential (lawns,
ornamentals, flower gardens, vegetables, fruit and nut trees, berries
and vines) and recreational (golf courses, parks and athletic fields)
sites. Additionally, it is registered for use on indoor carpets/other
surfaces by non-commercial applicators, and in treated paints
(preservative incorporation). EPA assessed residential exposure using
the new 2012 updated residential standard operating procedures (SOPs)
that are now used in all human health assessments. For residential
handler exposure, the Agency assumed that most residential use will
result in short-term (1 to 30 days) dermal and inhalation exposures.
The worst-case scenario used was painting with an airless sprayer.
Residential handlers are assumed to be wearing short-sleeved shirts,
short pants, shoes and socks during application of azoxystrobin.
Because there was no dermal endpoint chosen for azoxystrobin,
residential handler risk from exposure to azoxystrobin was assessed for
the inhalation route only.
    The Agency assumed that post-application exposure in residential
settings is expected to be short-term in duration only. No dermal
endpoint was chosen for azoxystrobin; therefore, a dermal post-
application risk assessment was not conducted. Residential post-
application inhalation exposure in outdoor settings is considered
negligible; however, residential post-application inhalation exposure
has been assessed. The scenarios evaluated were short-term post-
application inhalation (indoor), short-term incidental oral ingestion
from treated indoor surfaces (hand-to-mouth vinyl/hard surfaces and
carpet/textile surfaces), and short-term incidental oral ingestion from
treated turf (hand-to-mouth, mouthing grass, and soil ingestion).
    Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at http://www.epa.gov/pesticides/science/residential-exposure-sop.html.
    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 azoxystrobin to share a common mechanism of
toxicity with any other substances, and azoxystrobin does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
azoxystrobin 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 Web site 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. The prenatal and postnatal
toxicity database for azoxystrobin is complete and includes prenatal
developmental toxicity studies in rats and rabbits and a 2-generation
reproduction study in rats. In these studies, offspring toxicity was
observed at equivalent or higher doses than those resulting in parental
toxicity; thus, there is no evidence of increased susceptibility and
there are no residual uncertainties with regard to prenatal and/or
postnatal toxicity.
    3. Conclusion. EPA has determined that reliable data show that it
would be safe for infants and children to reduce the FQPA safety factor
to 1X for short-term, intermediate term, and chronic risk assessment.
This determination is based on the following considerations:
    i. The toxicity database for azoxystrobin is complete except for
immunotoxicity testing. Changes to 40 CFR part 158 make immunotoxicity
testing (OPPTS Guideline 870.7800) required for pesticide registration;
however, the existing data are sufficient for endpoint selection for
exposure/risk assessment scenarios, and for evaluation of the
requirements under the FQPA. There are no indications in the available
studies that organs associated with immune function, such as the thymus
and spleen, are affected by azoxystrobin and azoxystrobin does not
belong to a class of chemicals (e.g., the organotins,

heavy metals, or halogenated aromatic hydrocarbons) that would be
expected to be immunotoxic. Based on the above considerations in this
unit, EPA does not believe that conducting the immunotoxicity study
will result in a dose less than the point of departure already used in
this risk assessment, and an additional database uncertainty factor
(UF) for potential immunotoxicity does not need to be applied.
    ii. Clinical signs noted in the acute and subchronic neurotoxicity
studies were not considered treatment related because of a lack of
dose-response, inconsistency of observations at different time points,
variability of pretreatment values and/or small magnitude of response.
There is no need for a developmental neurotoxicity study or additional
UFs to account for neurotoxicity.
    iii. There is no evidence that azoxystrobin results in increased
susceptibility to in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
    iv. The acute dietary exposure assessment was performed based on
tolerance-level residues for all crops except citrus, and the chronic
dietary exposure assessment was performed based on tolerance level
residues for all crops. The acute dietary assessment incorporated 100
PCT information, and the chronic dietary exposure assessment was
somewhat refined using PCT information for selected crops. EPA made
conservative (protective) assumptions in the ground and surface water
modeling used to assess exposure to azoxystrobin in drinking water. EPA
used similarly conservative assumptions to assess post-application
exposure of children as well as incidental oral exposure of toddlers.
These assessments will not underestimate the exposure and risks posed
by azoxystrobin.
    Despite these considerations supporting removal of the FQPA SF, EPA
has retained the FQPA SF, reduced to 3X, in assessing acute dietary
risk. An additional safety factor is needed for acute risk assessment
to account for the use of a LOAEL from the acute neurotoxicity study in
rats in deriving the acute reference dose used for assessing acute
dietary exposure for all populations including infants and children. To
account for the use of a LOAEL from the acute neurotoxicity study in
rats, the Agency believes that a 3X FQPA SF (as opposed to a 10X) will
be adequate to extrapolate a NOAEL in assessing acute risk and that no
additional safety factor is needed for short-term, intermediate-term,
and chronic risk assessment based on the following considerations:
     The effect seen (transient diarrhea seen in the rat) is of
a nature that is relatively insignificant;
     The diarrhea was only seen in studies involving gavage
dosing in the rat but not in repeat dosing through dietary
administration in rats and mice, and not through gavage dosing in
rabbits; and
     The very high dose level needed to reach the acute oral
lethal dose (LD50) (>5,000 milligrams/kilogram (mg/kg)), and
the overall low toxicity of azoxystrobin.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to azoxystrobin will occupy 42% of the aPAD for children 1 to 2 years
old, the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
azoxystrobin from food and water will utilize 16% of the cPAD for
children 1 to 2 years old, the population group receiving the greatest
exposure. Based on the explanation in Unit III.C.3., regarding
residential use patterns, chronic residential exposure to residues of
azoxystrobin is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
    Azoxystrobin is currently registered for uses that could result in
short-term residential exposure, and the Agency has determined that it
is appropriate to aggregate chronic exposure through food and water
with short-term residential exposures to azoxystrobin.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in aggregate MOEs of 460 for adult
males, 470 for females 13 to 49 years old and 200 for children 1 to 2
years old. Because EPA's level of concern for azoxystrobin is a MOE of
100 or below, these MOEs are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level).
    An intermediate-term adverse effect was identified; however,
azoxystrobin is not registered for any use patterns that would result
in intermediate-term residential exposure. Intermediate-term risk is
assessed based on intermediate-term residential exposure plus chronic
dietary exposure. Because there is no intermediate-term residential
exposure and chronic dietary exposure has already been assessed under
the appropriately protective cPAD (which is at least as protective as
the POD used to assess intermediate-term risk), no further assessment
of intermediate-term risk is necessary, and EPA relies on the chronic
dietary risk assessment for evaluating intermediate-term risk for
azoxystrobin.
    5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, azoxystrobin is not expected to pose a cancer risk to humans.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population or to infants and children from aggregate
exposure to azoxystrobin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodologies are available to enforce the
tolerance expression and have been submitted to FDA for inclusion in
the Pesticide Analytical Manual (PAM) Volume II: A gas chromatography
method with nitrogen-phosphorus detection (GC/NPD), RAM 243/04, for the
enforcement of tolerances for residues of azoxystrobin and its Z-isomer
in crop commodities; and a GC/NPD method, RAM 255/01, for the
enforcement of tolerances of azoxystrobin in livestock commodities. The
methods may be requested from: Chief, Analytical Chemistry Branch,
Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350;
telephone

number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    The following tolerances being established by this document are in
harmony with the equivalent Codex MRLs are harmonized (Codex
commodities in brackets): Caneberry subgroup 13-07A (berries and other
small fruits, except cranberry, grapes and strawberry); berry, low
growing, subgroup 13-07G, except cranberry (strawberries); sunflower
subgroup 20B (sunflower seed); bushberry, subgroup 13-07B (berries and
other small fruits, except cranberry, grapes and strawberry);
cottonseed, subgroup 20C (cotton seed); fruit, citrus, group 10-10
(citrus fruits); fruit, small vine climbing, except fuzzy kiwifruit,
13-07F (grape); and pepper/eggplant subgroup 8-10B (fruiting vegetables
other than cucurbits except mushrooms and sweet corn). The following
tolerances could not be harmonized with Codex MRLs: Berry, low growing
subgroup 13-07G, except cranberry (berries and other small fruits,
except cranberry, grapes and strawberry); dragon fruit (mango); onion,
bulb and green subgroups 3-07A & B (bulb vegetables); tomato subgroup
8-10A (fruiting vegetables other than cucurbits except mushrooms and
sweet corn); vegetable, tuberous and corm subgroup 1C (root and tuber
vegetables); and wasabi fresh and dry (herbs, fresh and dry). The
disharmony is caused by various issues, including different Codex
classification for crop grouping, different calculation procedures for
establishing MRLs, different use patterns, and different data sets.
There are no Codex MRLs) for residues of azoxystrobin and its Z-isomer
for sugarcane.

C. Revisions to Petitioned-For Tolerances

    Several of the tolerances have been revised from what was proposed
in the initial petition. EPA is increasing the proposed crop group
tolerances for bushberry, subgroup 13-07B; cottonseed subgroup 20C;
citrus fruit, group 10-10; fruit, small vine climbing, except fuzzy
kiwifruit subgroup 13-07F, and pepper/eggplant subgroup 8-10B to
harmonize the numerical portion of the tolerance with the Codex MRL.
Also, based on the Organization for Economic Cooperation and
Development (OECD) calculation procedures for the current post-harvest
potato use data, EPA increased the requested tolerance for vegetable,
tuberous and corm, subgroup 1C from 6.0 ppm to 8.0 ppm. It should be
noted that there is an existing tolerance on potato at 0.03 ppm that is
based on foliar use. The substantial increase from 0.03 ppm to 8.0 ppm
results from the post-harvest use, as opposed to the previous foliar-
only use.
    EPA is also revising some of the commodity definitions in the
tolerance table to be consistent with EPA's preferred terms for food
and feed.

V. Conclusion

    Therefore, tolerances are established for residues of azoxystrobin,
(methyl (E)-2-[2-[6-(2-cyanophenoxy)pyrimidin-4-yloxy]phenyl]-3-
methoxyacrylate) and the Z isomer of azoxystrobin, (methyl (Z)-2-[2-[6-
(2-cyanophenoxy)pyrimidin-4-yloxy]phenyl]-3-methoxyacrylate) in or on
onion, bulb, subgroup 3-07A at 1.0 ppm; onion, green, subgroup 3-07B at
7.5 ppm; tomato subgroup 8-10A at 0.2 ppm; pepper/eggplant subgroup 8-
10B at 3.0 ppm; fruit, citrus, group 10-10 at 15.0 ppm; caneberry
subgroup 13-07A at 5.0 ppm; bushberry subgroup 13-07B at 5.0 ppm;
fruit, small vine climbing, except fuzzy kiwifruit, subgroup 13-07F at
2.0 ppm; berry, low growing, subgroup 13-07G, except cranberry at 10.0
ppm; rapeseed subgroup 20A at 1.0 ppm; sunflower subgroup 20B at 0.5
ppm; cottonseed subgroup 20C at 0.7 ppm; wasabi, fresh at 50 ppm;
wasabi, dry at 260 ppm; dragon fruit at 2.0 ppm; vegetable, tuberous
and corm, subgroup 1C at 8.0 ppm, and sugarcane, cane at 0.2 ppm.
    And lastly, due to the tolerances established above by this
document, the following existing tolerances are removed as unnecessary:
Onion, bulb; onion, green; caneberry subgroup 13A; bushberry subgroup
13B; Juneberry; lingonberry; salal; grape; strawberry; tomato;
vegetable, fruiting, group 8 except tomato; fruit, citrus, group 10;
canola, seed; cotton, undelinted seed; crambe, seed; flax, seed;
mustard, field, seed; mustard, Indian, seed; mustard, seed; rapeseed,
Indian; rapeseed, seed; safflower, seed; sunflower, seed; potato; okra.

 VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under FFDCA section 408(d)
in response to petitions 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 FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
    This 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 FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination

with Indian Tribal Governments'' (65 FR 67249, November 9, 2000) do not
apply to this 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) (Pub. L.
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 U.S.C.
804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: July 3, 2012.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. In Sec.  180.507 revise the table in paragraph (a)(1) to read as
follows:

Sec.  180.507  Azoxystrobin; tolerances for residues.

    (a) * * *
    (1) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Acerola.....................................................         2.0
Almond, hulls...............................................         4.0
Animal feed, nongrass, group 18, forage.....................          45
Animal feed, nongrass, group 18, hay........................         120
Artichoke, globe............................................         4.0
Asparagus...................................................        0.04
Atemoya.....................................................         2.0
Avocado.....................................................         2.0
Banana......................................................           *
Barley, bran................................................         6.0
Barley, forage..............................................          25
Barley, grain...............................................         3.0
Barley, hay.................................................        15.0
Barley, straw...............................................         7.0
Berry, low growing, subgroup 13-07G, except cranberry.......        10.0
Biriba......................................................         2.0
Brassica, head and stem, subgroup 5A........................         3.0
Brassica, leafy greens, subgroup 5B.........................          25
Bushberry subgroup 13-07B...................................         5.0
Caneberry subgroup 13-07A...................................         5.0
Canistel....................................................         2.0
Cherimoya...................................................         2.0
Cilantro, leaves............................................        30.0
Citrus, dried pulp..........................................        20.0
Citrus, oil.................................................        40.0
Corn, field, forage.........................................        12.0
Corn, field, grain..........................................        0.05
Corn, field, refined oil....................................         0.3
Corn, field, stover.........................................        25.0
Corn, pop, grain............................................        0.05
Corn, pop, stover...........................................        25.0
Corn, sweet, forage.........................................        12.0
Corn, sweet, kernel plus cob with husks removed.............        0.05
Corn, sweet, stover.........................................        25.0
Cotton, gin byproducts......................................          45
Cottonseed subgroup 20C.....................................         0.7
Cranberry...................................................        0.50
Custard apple...............................................         2.0
Dragon fruit................................................         2.0
Feijoa......................................................         2.0
Fruit, citrus, group 10-10..................................        15.0
Fruit, small vine climbing, except fuzzy kiwifruit, subgroup         2.0
 13-07F.....................................................
Fruit, stone, group 12......................................         1.5
Grain, aspirated fractions..................................         420
Grass, forage...............................................          15
Grass, hay..................................................          20
Guava.......................................................         2.0
Herb Subgroup 19A, dried leaves.............................         260
Herb Subgroup 19A, fresh leaves.............................          50
Hop, dried cones............................................        20.0
Ilama.......................................................         2.0
Jaboticaba..................................................         2.0
Jackfruit...................................................         2.0
Longan......................................................         2.0
Loquat......................................................         2.0
Lychee......................................................         2.0
Mango.......................................................         2.0
Nut, tree, group 14.........................................        0.02
Onion, bulb, subgroup 3-07A.................................         1.0
Onion, green, subgroup 3-07B................................         7.5
Papaya......................................................         2.0
Passionfruit................................................         2.0
Pawpaw......................................................         2.0
Pea and bean, dried shelled, except soybean, subgroup 6C....         0.5
Pea and bean, succulent shelled, subgroup 6B................         0.5
Peanut......................................................         0.2
Peanut, hay.................................................        15.0
Peanut, refined oil.........................................         0.6
Pepper/eggplant subgroup 8-10B..............................         3.0
Peppermint, tops............................................          30
Persimmon...................................................         2.0
Pistachio...................................................        0.50
Pulasan.....................................................         2.0
Rambutan....................................................         2.0
Rapeseed subgroup 20A.......................................         1.0
Rice, grain.................................................         5.0
Rice, hulls.................................................          20
Rice, straw.................................................          12
Rice, wild, grain...........................................         5.0
Sapodilla...................................................         2.0
Sapote, black...............................................         2.0
Sapote, mamey...............................................         2.0
Sapote, white...............................................         2.0
Sorghum, grain, forage......................................          25
Sorghum, grain, grain.......................................          11
Sorghum, grain, stover......................................          40
Soursop.....................................................         2.0
Soybean, hay................................................        55.0
Soybean, hulls..............................................         1.0
Soybean, seed...............................................         0.5
Spanish lime................................................         2.0
Spearmint, tops.............................................          30
Spice Subgroup 19B, except black pepper.....................          38
Star apple..................................................         2.0
Starfruit...................................................         2.0
Sugar apple.................................................         2.0
Sugarcane, cane.............................................         0.2
Sunflower subgroup 20B......................................         0.5
Tamarind....................................................         2.0
Tomato, paste...............................................         0.6
Tomato subgroup 8-10A.......................................         0.2
Turnip, greens..............................................          25
Vegetable, cucurbit, group 9................................         0.3
Vegetable, foliage of legume, group 7.......................        30.0
Vegetable, leafy, except brassica, group 4..................        30.0
Vegetable, leaves of root and tuber, group 2................        50.0
Vegetable, legume, edible podded, subgroup 6A, except                3.0
 soybean....................................................
Vegetable, root, subgroup 1A................................         0.5
Vegetable, tuberous and corm, subgroup 1C...................         8.0
Wasabi, dry.................................................         260
Wasabi, fresh...............................................          50
Watercress..................................................         3.0
Wax jambu...................................................         2.0
Wheat, bran.................................................        0.20
Wheat, forage...............................................          25
Wheat, grain................................................        0.10
Wheat, hay..................................................          15
Wheat, straw................................................         4.0
------------------------------------------------------------------------
* 2.0 (of which not more than 0.1 is contained in the pulp)

* * * * *
[FR Doc. 2012-17021 Filed 7-12-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 86, Number 219 (Wednesday, November 17, 2021)]
[Proposed Rules]
[Pages 64108-64110]
[FR Doc No: 2021-24901]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2020-0705; FRL-9235-01-R4]

Air Plan Approval; North Carolina: Mecklenburg General Provisions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve a State Implementation Plan (SIP) revision to the Mecklenburg
County portion of the North Carolina SIP, hereinafter referred to as
the Mecklenburg County Local Implementation Plan (LIP). The revision
was submitted through the North Carolina Division Air Quality (NCDAQ),
on behalf of Mecklenburg County Air Quality (MCAQ), via a letter dated
April 24, 2020, and was received by EPA on June 19, 2020. The revision
updates several Mecklenburg County Air Pollution Control Ordinance
(MCAPCO) rules incorporated into the LIP, including updating and
revising certain definitions. EPA is proposing to approve these changes
pursuant to the Clean Air Act (CAA or Act).

DATES: Comments must be received on or before December 17, 2021.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R04-
OAR-2020-0705, 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 www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Pearlene Williams, 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) 562-9144. Ms. Williams can also be reached via electronic mail at
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    The Mecklenburg County LIP was originally submitted to EPA on June
14, 1990, and EPA approved the plan on May 2, 1991. See 56 FR 20140.
Mecklenburg County prepared three submittals in order to modify the LIP
for, among other things, general consistency with the North Carolina
SIP.\1\ The three submittals were submitted to EPA as follows: NCDAQ
transmitted the October 25, 2017, submittal to EPA but withdrew it from
review through a letter dated February 15, 2019. On April 24, 2020,
NCDAQ resubmitted the October 25, 2017, update to EPA and also
submitted the January 21, 2016, and January 14, 2019, updates. Due to
an inconsistency with public notice at the local level, these
submittals were withdrawn from EPA through a letter dated February 15,
2019. Mecklenburg County corrected this error, and NCDAQ submitted the

updates in a revision dated April 24, 2020.\2\
---------------------------------------------------------------------------

    \1\ The Mecklenburg County, North Carolina revision that is
dated April 24, 2020, and received by EPA on June 19, 2020, is
comprised of three previous submittals--one dated January 21, 2016;
one dated October 25, 2017; and one dated January 14, 2019.
    \2\ The April 24, 2020, submittal was received by EPA on June
19, 2020.
---------------------------------------------------------------------------

II. What action is EPA proposing to take?

    On April 24, 2020, NCDAQ submitted to EPA changes to the MCAPCO to
be incorporated into the LIP.\3\ The January 14, 2019 portion of this
submission includes changes to Rules 1.5102--Definition of Terms and
1.5111--General Recordkeeping, Reporting and Monitoring Requirements of
MCAPCO Article 1.0000--Permitting Provisions for Air Pollution Sources,
Rules and Operating Regulations for Acid Rain Sources, Title V and
Toxic Air Pollutants. The January 21, 2016 portion of this submission
includes changes and updates to Rule 1.5104--General Duties and Powers
of the Director, With the Approval of the Board of MCAPCO Article
1.0000. These revisions are described in more detail below:
---------------------------------------------------------------------------

    \3\ The April 24, 2020, submittal contains changes to other
Mecklenburg LIP-approved rules that are not addressed in this
notice. EPA will be acting on those rules in separate actions.
---------------------------------------------------------------------------

    1. Rule 1.5102--Definition of Terms is revised to add several new
terms and to remove several obsolete terms from Rule
1.5102.4 5 The term ``Construction'' is added and defined as
the change in the method of operation or any change, including on-site
fabrication, erection, installation, replacement, demolition, or
modification of a source, that results in a change in emissions or
affects the compliance status. Some activities excluded from the
definition include clearing and grading, building access roads, and
other activities. ``EPA Approves'' is added and defined as the full,
interim or partial approvals by EPA. ``Facility'' is added and defined
as all pollutant-emitting activities located on one or more contiguous
or adjacent properties under common control. ``Insignificant
Activities'' is added and defined as activities that are insignificant
due to their category, size, or production rate. ``Potential
Emissions'' is added and defined as ``emissions of any air pollutant
that would occur at the facility's maximum capacity to emit any air
pollutant under its physical and operational design.'' This term allows
Federally enforceable limitations, placed on the facility's physical or
operational capacities, to be considered as part of the facility's
design, and includes air pollution control equipment, restriction on
hours of operation or the type or amount of material combusted, stored,
or processed. This term also includes fugitive emissions as defined at
40 CFR 70.2, however it does not include a facility's secondary
emissions nor emissions from insignificant activities. ``Regulated Air
Pollutant'' is defined as nitrogen oxides or any volatile organic
compound as defined under 40 CFR 51.100; any pollutant for which there
is an ambient air quality standard as defined pursuant to 40 CFR part
50; any pollutant that is regulated pursuant to MCAPCO Regulation
2.0524--New Source Performance Standards, MCAPCO Regulation 2.1110--
National Emission Standards for Hazardous Air Pollutants, MCAPCO
Regulation 2.1111--Maximum Achievable Control Technology, or 40 CFR
parts 60, 61, or 63; any pollutant subject to a standard promulgated
pursuant to section 112 of the CAA or other requirements established
pursuant to section 112 of the CAA, including section 112(g) (but only
for the facility subject to section 112 (g)(2) of the CAA), section 112
(G) or (r) of the CAA and any Class I or II substance listed pursuant
to section 602 of the CAA; or any toxic air pollutant listed in MCAPCO
Regulation 2.1104--Toxic Air Pollutant Guidelines. Rule 1.5102 is also
revised to add the following additional terms: ``Administrator,'' ``Air
Pollutant,'' ``Allowable Emissions,'' ``Applicable Requirements,''
``Applicant,'' ``Application Package,'' ``CFR,'' ``EPA,'' ``Equivalent
Unadulterated Fuels,'' ``Federally Enforceable'' or ``Federal
Enforceable,'' ``Fuel Combustion Equipment,'' ``Green Wood,''
``Hazardous Air Pollutant,'' ``Lesser Quantity Cutoff,'' ``Major
Facility,'' ``Modification,'' ``Modified Facility,'' ``New Facility,''
``Owner'' or ``Operator,'' ``Peak Shaving Generator,'' ``Permit,''
``Permittee,'' ``Plans and Specifications,'' ``Responsible Official,''
``Saw Mill,'' ``Title IV Source,'' ``Title V Source,'' ``Toxic Air
Pollutants,'' and ``Unadulterated Fossil Fuel.'' These revisions
generally correspond to the definitions in the state-approved SIP at
15A NCAC 02Q .0103 with minor exceptions.\6\ Lastly, Rule 1.5102 is
revised to remove the definitions of Cleaning Fires, Condensed Fumes,
Dust-separating Equipment, Effective Stack Height, Low Volatile Solid
Fuel, Smoke Density Measuring Device and Undesirable Level. Each of
these terms are not operative in the currently approved version of the
LIP because these terms do not appear elsewhere in the LIP. Therefore,
their removal has no practical effect and will streamline Rule 1.5102.
---------------------------------------------------------------------------

    \4\ Although the definitions in Rule 1.5102 are global
definitions that generally apply throughout the LIP, these
definitions do not apply where they ``conflict[ ] with any
definition(s) included in MCAPCO Article 2.0000--`Air Pollution
Control Regulations and Procedures.' '' For example, the Rule 1.5102
definitions do not apply where they conflict with definitions
applicable to Mecklenburg's prevention of significant deterioration
(PSD) or nonattainment new source review (NNSR) programs. For
Mecklenburg's PSD program, ``the definitions contained in 40 CFR
51.166(b) and 40 CFR 51.301 apply'' pursuant to Rule 2.0530(a)
(unless an exception is explicitly stated in Rule 2.0530). For
Mecklenburg's NNSR program, ``the definitions contained in 40 CFR
51.165(a)(1) and 40 CFR 51.301 apply'' pursuant to Rule 2.0531(a)
(unless an exception is explicitly stated in Rule 2.0531).
Mecklenburg has requested minor changes to Rule 2.0530 (relating to
PSD), which EPA will address in a separate notice.
    \5\ The reader should refer to the underlying submittal from
MCAQ for the precise language of each definition. The descriptions
of the definitions in this section are intended merely as a summary,
and not as a complete restatement of each definition.
    \6\ The SIP-approved statewide rules for North Carolina include
a related ``Definitions'' section at 15A NCAC 02Q .0103. Due to
differences between the LIP and the SIP, MCAPCO Rule 1.5102 and 15A
NCAC 02Q .0103 are not identical, with each containing certain
definitions that do not exist in the other version.
---------------------------------------------------------------------------

    2. Rule 1.5104--General Duties and Powers of the Director, With the
Approval of the Board is revised to make minor changes to wording, such
as removing the word ``to'' from the beginning of certain paragraphs
throughout for uniformity, capitalizing the word ``regulations'' in
paragraph (c), and capitalizing the first letter of each word in the
paragraphs where the word ``to'' was removed.
    Paragraph (l) adds language to clarify that the Director makes
inspections of sources and conducts tests as necessary.
    Finally, the word ``and'' is also removed at the end of paragraph
(k) to allow for the addition of a new paragraph, paragraph (m), which
identifies the Director's duty to require the facility to conduct tests
and gather information to document compliance with emission standards
and to effectuate the purpose of the Ordinance.
    3. Rule 1.5111--General Recordkeeping, Reporting and Monitoring
Requirements is revised to make minor edits to punctuation, changing
commas to semi-colons, and changing the word ``under'' to ``pursuant
to.'' Additionally, the phrase ``and transportation facilities'' is
removed from Rule 1.5111(f) and the reporting threshold in Rule
1.5111(f) is reduced from 25 tons per year to 5 tons per year of actual
emissions of nitrogen oxides or volatile organic compounds for sources
that emit these pollutants.
    EPA is proposing to approve the incorporation of the aforementioned
revisions to the MCAPCO rules into the Mecklenburg LIP because these
rules add clarity to the LIP and are consistent

with the CAA and applicable regulations.

III. Incorporation by Reference

    In this document, EPA is proposing to include in a final EPA rule
regulatory text that includes incorporation by reference. In accordance
with requirements of 1 CFR 51.5, EPA is proposing to incorporate by
reference MCAPCO Rules 1.5102--Definition of Terms and 1.5111--General
Recordkeeping, Reporting and Monitoring Requirements, both which have
an effective date of December 18, 2018; as well as Rule 1.5104--General
Duties and Powers of the Director, With the Approval of the Board, with
an effective date of December 15, 2015, into the Mecklenburg County
portion of the North Carolina SIP. EPA has made, and will continue to
make, these materials generally available through www.regulations.gov
and at the EPA Region 4 office (please contact the person identified in
the FOR FURTHER INFORMATION CONTACT section of this preamble for more
information).

IV. Proposed Action

    EPA is proposing to approve and incorporate into the Mecklenburg
County LIP revisions to MCAPCO Rules 1.5102--Definition of Terms and
1.5111--General Recordkeeping, Reporting and Monitoring Requirements,
effective on December 18, 2018, as well as Rule 1.5104--General Duties
and Powers of the Director, With the Approval of the Board, effective
on December 15, 2015. EPA is proposing to approve these changes because
they are consistent with the CAA.

V. 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. This proposed action merely
proposes to approve state law as meeting Federal requirements and does
not impose additional requirements beyond those imposed by state law.
For that reason, this proposed action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 1356-3 (76 FR 3821, January 21, 2011);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide 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 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, Reporting, and recordkeeping
requirements.

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

    Dated: November 8, 2021.
John Blevins,
Acting Regional Administrator, Region 4.
[FR Doc. 2021-24901 Filed 11-16-21; 8:45 am]
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[Federal Register Volume 84, Number 212 (Friday, November 1, 2019)]
[Notices]
[Pages 58816-58817]
[FR Doc No: 2019-23958]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Docket No. FAA-2019-0896]

Agency Information Collection Activities: Requests for Comments;
Clearance of New Approval of Information Collection: Flight Attendant
Fatigue Risk Management Plan

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request the Office of
Management and Budget (OMB) approval for a new information collection.
The collection involves submission of Fatigue Risk Management Plans
(FRMP) for flight attendants of certificate holders operating under
Title 14 of the Code of Federal Regulations (CFR) part 121. The
certificate holders will submit the information to be collected to the
FAA for review and acceptance as required by Section 335(b) of Public
Law 115-254, the FAA Reauthorization Act of 2018.

DATES: Written comments should be submitted by December 31, 2019.

ADDRESSES: Please send written comments:
    By Electronic Docket: www.regulations.gov (Enter docket number into
search field).
    By mail: Sandra Ray, Federal Aviation Administration, Policy
Integration Branch AFS-270, 1187 Thorn Run Road, Suite 200, Coraopolis,
PA 15108.
    By fax:<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Daniel T. Ronneberg by email at:
<EMAIL_ADDRESS>phone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) Whether the proposed
collection of information is necessary for FAA's performance; (b) the
accuracy of the estimated burden; (c) ways for FAA to enhance the
quality, utility and clarity of the information collection; and (d)
ways that the burden could be minimized without reducing the quality of
the collected information. The agency will summarize and/or include
your comments in the request for OMB's clearance of this information
collection.
    OMB Control Number: 2120-XXXX.
    Title: Flight Attendant Fatigue Risk Management Plan.
    Form Numbers: There are no forms associated with this collection.
    Type of Review: Clearance of a new information collection.
    Background: On October 5, 2018, Congress enacted Public Law 115-
254, the FAA Reauthorization Act of 2018 (``the Act''). Section 335(b)
of the Act required each certificate holder operating under 14 CFR part
121 to submit to the FAA for review and acceptance a Fatigue Risk
Management Plan (FRMP) for each certificate holder's flight attendants.
Section 335(b) contains the required contents of the FRMP, including a
rest scheme consistent with current flight time and duty period
limitations and development and use of methodology to continually
assess the effectiveness of the ability of the plan to improve
alertness and mitigate performance errors. Section 335(b) requires that
each certificate holder operating under 14 CFR part 121 shall update
its FRMP every two years and submit the update to the FAA for review
and acceptance. Further, section 335(b) of the Act requires each
certificate holder operating under 14 CFR part 121 to comply with its
FRMP that is accepted by the FAA.
    Respondents: 70 Part 121 Air Carriers.
    Frequency: Once for initial acceptance of the plan, then every two
years for submission of an updated plan.
    Estimated Average Burden per Response: 20 hours for air carriers
submitting the initial plan for review and acceptance and 5 hours for
air carriers submitting an updated plan.
    Estimated Total Annual Burden: 20 hours per air carrier submitting
the initial plan for review and acceptance, 5 hours every two years for
update and resubmission of the plan.

    Issued in Washington, DC, on October 29, 2019.
Sandra L. Ray,
Aviation Safety Inspector, FAA, Policy Integration Branch, AFS-270.
[FR Doc. 2019-23958 Filed 10-31-19; 8:45 am]
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[Federal Register: December 16, 2008 (Volume 73, Number 242)]
[Notices]
[Page 76370-76371]
[DOCID:fr16de08-69]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

Agency Information Collection Activities: Proposed Collection;
Comment Request

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice; 60-day notice and request for comments; Revision of a
currently approved collection, OMB Number 1660-0083, FEMA Form 116-1,
FEMA Form 085-1, FEMA Form 090-1.

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SUMMARY: The Federal Emergency Management Agency, as part of its
continuing effort to reduce paperwork and respondent burden, invites
the general public and other Federal agencies to take this opportunity
to comment on a continuing information collection. In accordance with
the Paperwork Reduction Act of 1995, this notice seeks comments
concerning the Loan Package for Community Disaster Loans and Special
Community Disaster Loan Programs. This collection allows the government
to make loans to communities that have suffered economic problems due
to disasters.

SUPPLEMENTARY INFORMATION: The Community Disaster Loan Program (CDL) is
authorized by Section 417 of the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, Public Law 93-288, as amended, provides
policies and procedures for local governments and State and Federal
officials concerning the Community Disaster Loan Program; FEMA
regulations 44 CFR, Part 206.364, Subpart K, implements the statutes.
The Assistant Administrator may make a CDL to any local government
which has suffered a substantial loss of tax or other revenues as a
result of a major disaster or emergency and which demonstrates a need
for Federal financial assistance in order to perform its governmental
functions.

Collection of Information

    Title: Application for Community Disaster Loan (CDL) Program and
the Special Community Disaster Loan (SCDL) Program.
    Type of Information Collection: Revision of a currently approved
collection.
    OMB Number: 1660-0083.
    Form Numbers: FEMA Form 116-1 Promissory Note, FEMA Form 085-1
Local Government Resolution Collateral Security, and FEMA Form 090-1
Certification of Eligibility for Community Disaster Loans.
    Abstract: The Loan Package for the Community Disaster Loan and
Special Community Disaster Loan Programs provides States, Local and
Tribal governments that have suffered substantial loss of tax or other
revenues as a result of a major disaster or emergency, the opportunity
to obtain financial assistance in order to perform their governmental
functions. Local governments can submit a loan package for the
traditional and Special Community Disaster Loan Programs. These loans
must be justified on the basis of need and actual expenses.
    Affected Public: State, Local, or Tribal Government.
    Estimated Total Annual Burden Hours: 875 hours.

                                                 Table A.12--Estimated Annualized Burden Hours and Costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                              No. of        Avg. burden    Total annual                    Total annual
        Type of respondent           Form name/form No.       No. of       responses per   per response     burden (in      Avg. hourly     respondent
                                                            respondents     respondent      (in hours)        hours)         wage rate         cost
--------------------------------------------------------------------------------------------------------------------------------------------------------
Local Government..................  Certification of                  50               1             2.5             125          $46.22          $5,778
                                     Eligibility for
                                     Community Disaster
                                     Loans/FEMA Form 090-
                                     1.
Local Government..................  Promissory Note/FEMA              50               1             4.0             200           46.22           9,244
                                     Form 116-1.
Local Government..................  Local Government                  50               1            10.0             500           46.22          23,110
                                     Resolution--Collate
                                     ral Security/FEMA
                                     Form 085-1.
Local Government..................  Letter of                         50               1             1.0              50           46.22           2,311
                                     Application.
                                                         -----------------------------------------------------------------------------------------------
    Total.........................                                    50                                             875                          40,443
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Estimated Cost: The estimated annualized cost to respondents based
on wage rate categories is $40,443.00. The estimated annual cost to the
Federal Government is $1,009,800.00.
    Comments: Written comments are solicited to (a) evaluate whether
the proposed data collection is necessary for the proper performance of
the agency, including whether the information shall have practical
utility; (b) evaluate the accuracy of the agency's estimate of the
burden of the proposed collection of information, including the
validity of the methodology and assumptions used; (c) enhance the
quality, utility, and clarity of the information to be collected; and
(d) minimize the burden of the collection of information on those who
are to respond, including through the use of appropriate automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submission of responses. Comments must be submitted on or February 17,
2009.

ADDRESSES: Interested persons should submit written comments to Office
of Management, Records Management Division, Federal Emergency
Management Agency, 500 C Street, SW., Washington, DC 20472, Mail Drop
Room 301.

FOR FURTHER INFORMATION CONTACT: Contact John Wilmot, Community
Disaster Loan Program Manager, Public Assistance Division, Disaster
Assistance

Directorate,<PHONE_NUMBER> for additional information. You may contact
the Records Management Branch for copies of the proposed collection of
information at facsimile number<PHONE_NUMBER> or e-mail address: FEMA-
<EMAIL_ADDRESS>
Samuel C. Smith,
Acting Director, Records Management Division, Office of Management,
Federal Emergency Management Agency, Department of Homeland Security.
[FR Doc. E8-29767 Filed 12-15-08; 8:45 am]

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