[Federal Register Volume 82, Number 235 (Friday, December 8, 2017)]
[Rules and Regulations]
[Pages 57860-57866]
[FR Doc No: 2017-26517]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0095; FRL-9970-39]

Indoxacarb; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
indoxacarb in or on corn, field, forage; corn, field, stover; corn,
field, grain. E. I. du Pont de Nemours and Company requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective December 8, 2017. Objections and
requests for hearings must be received on or before February 6, 2018,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2017-0095, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

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

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

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

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

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

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2017-0095 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
February 6, 2018. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified

by docket ID number EPA-HQ-OPP-2017-0095, by one of the following
methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of June 8, 2017 (82 FR 26641) (FRL-9961-
14), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
6F8536) by E. I. du Pont de Nemours and Company, 974 Centre Road,
Wilmington, Delaware 19805. The petition requested that 40 CFR part 180
be amended by establishing tolerances for residues of the insecticide
indoxacarb, [(S)-methyl 7-chloro-2,5-dihydro-2-[[(methoxycarbonyl)[4-
(trifluoromethoxy)-phenyl] amino]carbonyl]indeno[1,2e]
[1,3,4]oxadiazine-4a(3H)-carboxylate], and [(R)-methyl 7 chloro-2,5-
dihydro-2[[(methoxycarbonyl)[4-(trifluoromethoxy)phenyl]
amino]carbonyl]indeno[1,2-e][1,3,4] oxadiazine-4a(3H)-carboxylate], in
or on corn, field, forage at 10 parts per million (ppm); corn, field,
stover at 15 ppm; corn, field, aspirated grain fractions at 45 ppm;
corn, field flour at 0.07 ppm; corn, field, meal at 0.03 ppm; corn,
field, oil at 0.05 ppm; corn, field, grain at 0.02 ppm. That document
referenced a summary of the petition prepared by E. I. du Pont de
Nemours and Company, the registrant, which is available in the docket,
http://www.regulations.gov. There were no comments received in response
to the notice of filing.
    Based on available information, EPA is establishing some tolerances
that vary from what the petitioner requested. The reasons for these
changes are discussed 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 indoxacarb including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with indoxacarb follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
    The most common effects resulting from exposure to indoxacarb
(defined by the lowest-observed-adverse-effect-level (LOAEL)) were non-
specific, and included decreases in body weight, food consumption, and
food efficiency. Indoxacarb also affected the hematopoietic system by
decreasing the red blood cell count, hemoglobin, and hematocrit in
rats, dogs, and mice.
    There was no evidence of reproductive effects in rats resulting
from exposure to indoxacarb. There was no evidence of increased
susceptibility in developing fetuses or in offspring following prenatal
and/or postnatal exposure to indoxacarb in rats or rabbits. There was
no evidence of increased susceptibility in the young in the
developmental neurotoxicity study in rats. Neurotoxicity was observed
in rats and mice, but at doses much higher than those selected for
points of departure (PoDs) (which are based on changes in body weight,
food consumption and changes in hematology). There is no evidence
indoxacarb is carcinogenic, teratogenic, mutagenic, or immunotoxic.
    Specific information on the studies received and the nature of the
adverse effects caused by indoxacarb as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the documents, Indoxacarb: Human Health Risk
Assessment for Indoxacarb to Support the Proposed New Uses on Corn
(Field, Pop, and Grown for Seed) in docket ID number EPA-HQ-OPP-2017-
0095 and Indoxacarb: Human Health Draft Risk Assessment for Indoxacarb
to Support Registration Review and the Proposed New Use for Controlling
Ants at Ornamental Nurseries, Sod Farms, and Livestock Corrals of non-
Food Bearing Animals in docket ID number EPA-HQ-OPP-2013-0367.

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 indoxacarb used for
human risk assessment is shown in Table 1 of this unit.

                 Table 1--Summary of Toxicological Doses and Endpoints for Indoxacarb for Use in
                                          Human Health Risk Assessment
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                                     Point of departure  and                                      Study and
        Exposure/scenario              uncertainty/  safety       RfD, PAD, LOC for  risk       toxicological
                                             factors                     assessment                effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (All populations)..  NOAEL = 12 mg/kg/day.......  Acute RfD = 0.12 mg/kg/day.  Acute oral rate
                                   UFA = 10x..................  aPAD = 0.12mg/kg/day.......   neurotoxicity
                                   UFH = 10x..................                                study LOAEL = 50
                                   FQPA SF = 1x...............                                mg/kg/day based on
                                                                                decreased body
                                                                                weight and body-
                                                                                weight gain in
                                                                                females (MP062).
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)  NOAEL= 2.0 mg/kg/day.......  Chronic RfD = 0.02 mg/kg/    Weight of evidence
                                                                 day.                         approach was used
                                                                                from four studies:
                                   UFA = 10x                    cPAD = 0.02 mg/kg/day......  (1) Subchronic
                                   UFH = 10x..................                                toxicity study--
                                   FQPA SF = 1x...............                                rat (MP062). MRID
                                                                                44477129. LOAEL =
                                                                                6.0 (M), 3.8 (F)
                                                                                mg/kg/day based on
                                                                                decreased body
                                                                                weight, body-
                                                                                weight gain, food
                                                                                consumption and
                                                                                food efficiency.
----------------------------------------------------------------------------------------------------------------
                                                                                (2) Subchronic
                                                                                neurotoxicity
                                                                                study--rat
                                                                                (MP062). MRID
                                                                                44477135. LOAEL =
                                                                                5.6 (M), 3.3 (F)
                                                                                mg/kg/day based on
                                                                                decreased body
                                                                                weight and
                                                                                alopecia.
                                                                                (3) Chronic/
                                                                                carcinogenicity
                                                                                study--rat
                                                                                (JW062). MRID
                                                                                44477145. LOAEL =
                                                                                10 (M), 3.6 (F) mg/
                                                                                kg/day based on
                                                                                decreased body
                                                                                weight, body-
                                                                                weight gain, and
                                                                                food consumption
                                                                                and food
                                                                                efficiency;
                                                                                decreased HCT, HGB
                                                                                and RBC at 6
                                                                                months in F only.
                                                                                (4) Two-generation
                                                                                rat reproduction
                                                                                study (JW062).
                                                                                MRID 44477144.
                                                                                LOAEL = 4.4 mg/kg/
                                                                                day based on
                                                                                decreased body
                                                                                weights, body-
                                                                                weight gain, food
                                                                                consumption and
                                                                                food efficiency
                                                                                and increased
                                                                                spleen weights in
                                                                                the F0 and F1
                                                                                females.
----------------------------------------------------------------------------------------------------------------
Incidental oral short-term (1 to   NOAEL= 2.0 mg/kg/day.......  LOC for MOE = 100..........  Weight of evidence
 30 days).                         UFA = 10x..................                                approach was used
                                   UFH = 10x..................                                from four studies:
                                   FQPA SF = 1x...............                               (1) Subchronic
                                                                                toxicity study--
                                                                                rat (MP062). MRID
                                                                                44477129. LOAEL =
                                                                                6.0 (M), 3.8 (F)
                                                                                mg/kg/day based on
                                                                                decreased body
                                                                                weight, body-
                                                                                weight gain, food
                                                                                consumption and
                                                                                food efficiency.
----------------------------------------------------------------------------------------------------------------
                                                                                (2) Subchronic
                                                                                neurotoxicity
                                                                                study--rat
                                                                                (MP062). MRID
                                                                                44477135. LOAEL =
                                                                                5.6 (M), 3.3 (F)
                                                                                mg/kg/day based on
                                                                                decreased body
                                                                                weight and
                                                                                alopecia.
                                                                                (3) Chronic/
                                                                                carcinogenicity
                                                                                study--rat
                                                                                (JW062). MRID
                                                                                44477145. LOAEL =
                                                                                10 (M), 3.6 (F) mg/
                                                                                kg/day based on
                                                                                decreased body
                                                                                weight, body-
                                                                                weight gain, and
                                                                                food consumption
                                                                                and food
                                                                                efficiency;
                                                                                decreased HCT, HGB
                                                                                and RBC at 6
                                                                                months in F only.
                                                                                (4) Two-generation
                                                                                rat reproduction
                                                                                study (JW062).
                                                                                MRID 44477144.
                                                                                LOAEL = 4.4 mg/kg/
                                                                                day based on
                                                                                decreased body
                                                                                weights, body-
                                                                                weight gain, food
                                                                                consumption and
                                                                                food efficiency
                                                                                and increased
                                                                                spleen weights in
                                                                                the F0 and F1
                                                                                females.
----------------------------------------------------------------------------------------------------------------
Short-Term Dermal (1 to 30 days).  A quantitative dermal assessment is not required for indoxacarb, since the
Intermediate-Term Dermal (1-6       calculated human dermal LOAEL exceeds the limit dose of 1,000 mg/kg/day.
 months).
----------------------------------------------------------------------------------------------------------------
Inhalation short-term (1 to 30     Inhalation NOAEL= 23         LOC for MOE = 30...........  28-day rat
 days).                             [micro]g/L/day.                                           inhalation
                                   UFA = 3x...................                                toxicity study
                                   UFH = 10x..................                                (MP062). MRID
                                   FQPA SF = 1x...............                                45870001.
----------------------------------------------------------------------------------------------------------------
Inhalation (1-6 months)..........                                                            The LOAEL of 290
                                                                                [micro]g/L/day is
                                                                                based on increased
                                                                                spleen weights,
                                                                                pigmentation and
                                                                                hematopoiesis in
                                                                                the spleen,
                                                                                hematological
                                                                                changes, mortality
                                                                                (females), and
                                                                                nasal ulceration
                                                                                and inflammation.
----------------------------------------------------------------------------------------------------------------

Cancer (Oral, dermal, inhalation)  ``Not likely'' to be carcinogenic to humans since no evidence of
                                    carcinogenicity in either the rat or mouse studies, and no evidence of
                                    mutagenicity.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. [micro]g/L/day = microgram/liter/day. MOE = margin of
  exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c = chronic).
  RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH =
  potential variation in sensitivity among members of the human population (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to indoxacarb, EPA considered exposure under the petitioned-
for tolerances as well as all existing indoxacarb tolerances in 40 CFR
180.564. EPA assessed dietary exposures from indoxacarb 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 indoxacarb. In conducting the acute dietary exposure assessment EPA
used food consumption information from the 2003-2008 food consumption
data from the U.S. Department of Agriculture's (USDA's) National Health
and Nutrition Examination Survey, What We Eat in America, (NHANES/
WWEIA). In estimating acute dietary exposure, EPA used maximum residue
levels based on the results of field trials reflecting maximum use
patterns in all commodities and used maximum Percent Crop Treated (PCT)
estimates.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment, EPA used food consumption information from the 2003-2008
food consumption data from the U.S. Department of Agriculture's
(USDA's) National Health and Nutrition Examination Survey, What We Eat
in America, (NHANES/WWEIA). In estimating chronic dietary exposure, EPA
used average residue levels based on the results of field trials
reflecting maximum use patterns in all commodities and used average PCT
estimates.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that indoxacarb 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 PCT information. Average or maximum
residues and PCT values were used for food commodities.
    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 maximum and average PCT values for the acute
and chronic dietary assessments, as follows:
     For acute dietary assessment: Apples: 10%; apricots: 15%;
blueberries: 5%; broccoli: 70%, cabbage: 35%; cantaloupe: 10%;
cauliflower: 60%; celery: 5%; cherries: 2.5%; cotton: 2.5%; cucumbers:
10%; grapes: 5%; lettuce: 15%; nectarines: 15%; peaches: 10%; peanuts:
10%; pears: 2.5%; peppers: 30%; plums/prunes: 5%; potatoes: 2.5%;
soybeans: 2.5%; spinach: 5%; squash: 5%; sweet corn: 10%; and tomatoes:
40%.
     For chronic dietary assessment: Apples: 5%; apricots: 5%;
blueberries: 5% broccoli: 45%, cabbage: 20%; cantaloupe: 5%;
cauliflower: 35%; celery: 5%; cherries: 2.5%; cotton: 2.5%; cucumbers:
2.5%; grapes: 2.5%; lettuce: 5%; nectarines: 15%; peaches: 2.5%;
peanuts: 5%; pears: 1%; peppers: 15%; plums/prunes: 5%; potatoes: 2.5%;
soybeans: 1%; spinach: 2.5%; squash: 2.5%; sweet corn: 2.5%; and
tomatoes: 20%.
    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 to 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 2.5%. In those
cases, estimates of average PCT between 1% and 2.5% are rounded to 2.5%
and estimates of average PCT less than 1% are rounded to 1%. 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%, except for those
situations in which the maximum PCT is less than 2.5%. In those cases,
EPA uses a maximum PCT value of 2.5%.
    The Agency believes 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
indoxacarb 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 indoxacarb in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of indoxacarb. 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 Surface Water Concentration Calculator (SWCC) model
and the Pesticide Root Zone Model Ground Water (PRZM GW), the estimated
drinking water concentrations (EDWCs) of indoxacarb for acute exposures
are 39 parts per billion (ppb) for surface water and 131 ppb for ground
water; for chronic exposures the EDWCs are 11 ppb for surface water and
123 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For the acute dietary risk
assessment, a time series distribution of ground water modeled residues
was used to assess the contribution to drinking water. For the chronic
dietary risk assessment, a single point water concentration value of
123 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).
    Indoxacarb is currently registered for the following uses that
could result in residential exposures: Pet spot-on uses, spot, crack
and crevice applications indoors, outdoor broadcast (i.e., turf),
perimeter and foundations, spot (i.e., direct mount applications for
fire ants), and crack and crevice.
    Based on these use scenarios, EPA assessed residential exposure
using the following assumptions:
     Spot and crack and crevice exposures were not assessed due
to formulation types that minimize the potential for handler and post-
application exposures (i.e., gels or bait stations). Risks from spot
and crack and crevice were not assessed because exposures from these
formulation types are expected to be negligible.
     Residential handler exposure: There is a potential for
dermal and inhalation exposure. Residential handler inhalation exposure
is considered negligible for applying ready-to-use pet spot-ons.
Residential handler dermal exposures are expected for ready-to-use pet
spot-ons, however dermal exposures were not assessed due to the lack of
a dermal endpoint. Residential handler inhalation and dermal exposures
are considered negligible for applying ready-to-use arenas (i.e., baits
or stations).
     Residential post-application dermal and incidental oral
exposure: Post-application assessments were not conducted for ant mound
uses, because these are considered perimeter/spot uses; residential
exposure is expected to be negligible. Spot and crack and crevice
exposures were not assessed for gels or bait stations; exposure is
considered negligible. A golfer assessment was not conducted, due to
the lack of a dermal endpoint. Post-application inhalation exposure is
generally not assessed following application to pets and turf. The
combination of low vapor pressure (1.9x10-10 mm Hg at 25 [ordm]C for
indoxacarb) of active ingredients typically used in pet and turf
pesticide products, and the small amounts of pesticide applied to pets
is expected to result in only negligible inhalation exposure. Ingestion
of granules is considered an episodic event and not a routine behavior.
Because the Agency does not expect this to occur on a regular basis,
concern for human health is related to acute poisoning rather than
short-term residue exposure. For these reasons, the episodic ingestion
scenario is not included in the aggregate assessment. The only route of
residential exposure for inclusion in the adult aggregate assessment is
inhalation. However, inhalation exposures cannot be aggregated with
background dietary exposures because the toxicity endpoints for the
inhalation and short-term oral routes are different. Therefore, the
only residential exposures that were combined are for children 1 to <2
years old in the short-term aggregate assessment that reflects hand-to-
mouth exposures from post-application exposure to spot treatment on
carpets, and children 1 to <2 years old in the intermediate- and long-
term aggregate assessment that reflects exposures from treated pets.
    Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    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 indoxacarb to share a common mechanism of
toxicity with any other substances, and indoxacarb does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA assumed that
indoxacarb 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 10 times;, or uses a different additional safety factor when

reliable data available to EPA support the choice of a different
factor.
    2. Prenatal and postnatal sensitivity. There was no evidence of
reproductive effects in rats. There was no evidence of increased
susceptibility in developing fetuses or in the offspring following
prenatal and/or postnatal exposure to indoxacarb in rats or rabbits.
There was no evidence of increased susceptibility in the young in the
developmental neurotoxicity study in rats.
    3. Conclusion. EPA determined reliable data show the safety of
infants and children would be adequately protected if the FQPA SF were
reduced to 1X. That decision is based on the following findings:
    i. The toxicity database for indoxacarb is complete.
    ii. The acute neurotoxicity, subchronic toxicity, and developmental
neurotoxicity studies for indoxacarb are available and all endpoints
used in the risk assessment are protective of neurotoxic effects.
    iii. There is no evidence that indoxacarb results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
    iv. There are no residual uncertainties identified in the exposure
databases. The Agency estimated maximum and average PCT values for the
acute and chronic dietary assessments, respectively, as shown in unit
III.C.i., and unit III.C.ii.
    Food residues were taken from the results of supervised field trial
studies reflecting maximum use patterns. Drinking water residues were
included in the dietary assessments as follows: A point estimate of 123
ppb was used for the chronic assessment and the time series
distribution of ground water modeled residues was used in the acute
assessment as a residue distribution file (RDF) in the Monte Carlo
analysis. For food commodities, RDFs were constructed for the
probabilistic acute dietary assessment as appropriate, and average
residues were computed for blended commodities and for the chronic
dietary assessment.
    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 indoxacarb.

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 indoxacarb will occupy 56% of the aPAD for children ages 1-2, 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
indoxacarb from food and water will utilize 35% of the cPAD for all
infants less than 1-year old, the population group receiving the
greatest exposure. EPA has concluded the combined long-term food,
water, and residential exposures result in aggregate MOEs of 260 (food,
water, and residential) for children aged 1-2. Because EPA's level of
concern for indoxacarb is a MOE of 100 or below, this MOEs is not of
concern. For adults, residential inhalation exposures cannot be
aggregated because they are based on different effects than for oral
exposures. Therefore, long-term aggregate risk for adults is equivalent
to the chronic dietary risk noted in this unit.
    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). Indoxacarb 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 to children aged 1-2 years
through food and water with short-term residential exposures to
indoxacarb. For adults, residential inhalation exposures cannot be
aggregated because they are based on different effects than for oral
exposures. Therefore, short-term aggregate risk for adults is
equivalent to the chronic risk noted in unit III.E.2.
    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 120 (food, water,
and residential) for children aged 1-2. Because EPA's level of concern
for indoxacarb is a MOE of 100 or below, this MOEs is not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). Indoxacarb is currently registered for uses that could result
in intermediate-term residential exposure, and the Agency has
determined that it is appropriate to aggregate chronic exposure to
children aged 1-2 years through food and water with intermediate-term
residential exposures to indoxacarb. For adults, residential inhalation
exposures cannot be aggregated because they are based on different
effects than for oral exposures. Therefore, intermediate-term aggregate
risk for adults is equivalent to the chronic risk noted above in unit
III.E.2.
    Using the exposure assumptions described in this unit for
intermediate-term exposures, EPA has concluded that the combined
intermediate-term food, water, and residential exposures for children
aged 1-2 years result in aggregate MOEs of 260. Because EPA's level of
concern for indoxacarb is a MOE of 100 or below, this MOE is not of
concern.
    5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, indoxacarb 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 indoxacarb residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    For the enforcement of tolerances established on crops, two High
Performance Liquid Chromatograph/Ultraviolet Detection (HPLC/UV)
methods, DuPont protocols AMR 2712-93 and DuPont-11978, are available
for use. The limits of quantitation (LOQs) for these methods range from
0.01 to 0.05 ppm for a variety of plant commodities. A third procedure,
Gas Chromatograph/Mass-Selective Detection (GC/MSD), DuPont method AMR
3493-95 Supplement No. 4, is also available for the confirmation of
residues in plants.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food

safety standards and agricultural practices. EPA considers the
international maximum residue limits (MRLs) established by the Codex
Alimentarius Commission (Codex), as required by FFDCA section
408(b)(4). The Codex Alimentarius is a joint United Nations Food and
Agriculture Organization/World Health Organization food standards
program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    The Codex has not established MRLs in field corn for indoxacarb.

C. Revisions to Petitioned-For Tolerances

    Based on available data and using the Organisation for Economic Co-
operation and Development (OECD) maximum residue limit (MRL)
calculation procedures, EPA determined that the appropriate tolerance
level for corn, field, forage is 6.0 ppm. Based on the corn processing
studies, the Agency determined that there is a low level of residue
concentration from processing; therefore, separate tolerances are not
needed for the processed corn commodities of flour, meal, or oil
because these commodities are covered by the tolerance for corn, field,
grain. The ``grain, aspirated fractions'' tolerance does not need to be
modified for field corn because 40 CFR 180.564(a) currently lists a
tolerance level of 45 ppm for ``grain, aspirated fractions,'' and this
tolerance covers potential indoxacarb residues in aspirated grain
fractions derived from corn.

V. Conclusion

    Therefore, tolerances are established for residues of indoxacarb,
[(S)-methyl 7-chloro-2,5-dihydro-2-[[(methoxycarbonyl)[4-
(trifluoromethoxy)-phenyl] amino]carbonyl]
indeno[1,2e][1,3,4]oxadiazine-4a(3H)-carboxylate], and [(R)-methyl 7
chloro-2,5-dihydro-2[[(methoxycarbonyl)[4-(trifluoromethoxy)phenyl]
amino]carbonyl] indeno [1,2-e][1,3,4] oxadiazine-4a(3H)-carboxylate],
in or on corn, field, forage at 6.0 ppm; corn, field, stover at 15 ppm;
and corn, field, grain at 0.02 ppm.

VI. Statutory and Executive Order Reviews

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

VII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: November 22, 2017.
Michael Goodis,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. In Sec.  180.564, add alphabetically the entries for ``Corn, field,
forage'', ``Corn, field, grain'', and ``Corn, field, stover'' to the
table in paragraph (a)(1) to read as follows:

Sec.  180.564   Indoxacarb; tolerances for residues.

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

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

                                * * * * *
Corn, field, forage.....................................             6.0
Corn, field, grain......................................            0.02
Corn, field, stover.....................................              15

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

* * * * *

[FR Doc. 2017-26517 Filed 12-7-17; 8:45 am]
 BILLING CODE 6560-50-P


Introduction: The U.S. Environmental Protection Agency (EPA) will invite selected State infrastructure financing authorities, herein referred to as "State Revolving Fund Programs," to submit this application for Water Infrastructure Finance and Innovation Act (WIFIA) credit assistance. EPA will use the collected information to further evaluate applicants and develop loan agreement documents. EPA may ask applicants to provide additional supporting materials or to clarify details during the review and negotiation process. The applicant is required to notify of and submit to EPA any updated application materials during the review period. Unsolicited applications will not be considered. ___________________________________________________________________________________ Purpose: Applicants complete this application to provide EPA with information to assess the creditworthiness of the applicant, identify engineering and financial risk, negotiate the terms and conditions of the credit assistance, and calculate the amount of budget authority that will be needed for the loan.  _____________________________________________________________________________________Format: Applications must include all requested information. Applicants must provide electronic files of the entire application and all attachments via email to<EMAIL_ADDRESS>on a USB drive or CD, or uploaded to EPA's SharePoint site. _____________________________________________________________________________________ Fees: Applicants must submit a non-refundable application fee. The application fee is $100,000. An application will not be considered until receipt of the application fee. For further information regarding the application fee, as well as the credit processing fee which will be charged at loan closing, and any other applicable fees, please see the WIFIA fee rule at: https://www.federalregister.gov/documents/2017/06/28/2017-13438/fees-for-water-infrastructure-project-applications-under-wifia.   _____________________________________________________________________________________ Submission: The applicant should submit an application that includes all components on the application checklist. The applicant may indicate if a requirement is not applicable to its loan. If the applicant anticipates a delay in one or more source documents, it may indicate the anticipated date of submitting that document in the application. EPA may request additional items from applicants on a case-by-case basis.  The electronic files (if not provided via email or SharePoint) should be sent to the attention of Director, WIFIA Program; US EPA William Jefferson Clinton West Building‐room 6210 A; 1301 Constitution Ave, NW; Washington, DC 20004. The applicant must use an overnight or courier delivery service (e.g. UPS, FedEx, DHL) to ensure proper delivery of the package. Upon receipt, EPA will provide a confirmation email.  Use of Pay.gov (https://www.pay.gov) to make payments to EPA is the preferred electronic payment method for the Application Fee. The application fee may also be paid via FEDWIRE or by check sent to US EPA; Las Vegas Finance Center; 4220 S. Maryland Pkwy, Bldg C, Ste 503; Las Vegas NV 89119. For questions about payments, contact the US EPA Las Vegas Finance Center at (702)798‐2485 or<EMAIL_ADDRESS>For detailed payment instructions, contact the WIFIA program.

Upon receipt of the application fee and materials, EPA will provide a confirmation email. _____________________________________________________________________________________Selection: EPA's invitation of a prospective borrower to submit an application for the WIFIA program does not imply that EPA has approved all elements proposed in the letter of interest. However, EPA will only select those prospective borrowers that it expects to achieve financial closing.  As such, EPA may require changes in the applicant's financial plan and other factors proposed in the letter of interest. Credit assistance is subject to a determination of creditworthiness, readiness to proceed and negotiation of a credit agreement satisfactory to EPA.  _____________________________________________________________________________________Confidential Business Information:  An applicant may assert a business confidentiality claim covering part or all of the information submitted to EPA as part of its application, in a manner consistent with 40 C.F.R. 2.203, 41 Fed. Reg. 36902 (Sept. 1, 1976), by placing on (or attaching to) the information a cover sheet, stamped or typed legend, or other suitable form of notice employing language such as trade secret, proprietary, or company confidential. The applicant should also state whether it desires confidential treatment until a certain date or until the occurrence of a certain event.  Information covered by a business confidentiality claim will be disclosed by EPA only to the extent and only by means of the procedures set forth under 40 C.F.R. Part 2, Subpart B.  Information that is not accompanied by a business confidentiality claim when it is received by EPA may be made available to the public by EPA without further notice to the applicant.  More information about CBI is available in the WIFIA program handbook and frequently asked questions (FAQ) available at http://www.epa.gov/wifia. _____________________________________________________________________________________Burden: The public reporting and recordkeeping burden for this collection of information is estimated to average 150 hours per response.  Send comments on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques to the Director, Regulatory Support Division, U.S. Environmental Protection Agency (2822T), 1200 Pennsylvania Ave., NW, Washington, D.C. 20460. Include the OMB control number in any correspondence. Do not send the completed form to this address.  _____________________________________________________________________________________Warning: Falsification or misrepresentation of information or failure to file or report information required to be reported may be the basis for denial of financial assistance by the Environmental Protection Agency. Knowing and willful falsification of information required to be submitted and false statements to a Federal Agency may also subject you to criminal prosecution.  See, for example, 18 U.S.C. §1001. _____________________________________________________________________________________ Additional information is available at https://epa.gov/wifia and by contacting<EMAIL_ADDRESS> APPLICATION FORM FOR STATE REVOLVING FUND PROGRAMS Provide the following information in this form or as narrative answers. Narrative answers can reference source documents (include the name of the document and relevant pages or sections). Provide any referenced documents as attachments. Section A: Loan Information

    Legal name of prospective borrower:

   Click or tap here to enter text.

    Other names under which the prospective borrower does business:

   Click or tap here to enter text.             Business street address:

   Click or tap here to enter text.

    Program website:

   Click or tap here to enter text.

    Employer/taxpayer identification number (EIN/TIN):

    Click or tap here to enter text.

    Dun and Bradstreet Data Universal Number System (DUNS) number:

    Click or tap here to enter text.

    Requested amount of the WIFIA loan (in dollars):

   Click or tap here to enter text.

    Estimated total eligible costs (in dollars):

   Click or tap here to enter text.             Indicate the requested loan structure (select only one):  ☐ WIFIA program adopts SRF program's existing indenture ☐ SRF program accepts WIFIA program's standard terms

Section B: Applicant Information

 Describe the applicant's legal structure. Include a copy of the statutory authority under which the entity was created as an attachment, if applicable.    Click or tap here to enter text.  Describe the legal authority of the applicant to carry out proposed activities described in the application packet, including, issuing debt, charging fees, and/or receiving dedicated funding from another entity. Provide documentation as an attachment, if applicable.    Click or tap here to enter text.  Identify what governmental entities (other than the applicant) approved the submission of this application and must approve incurrence of WIFIA debt. Explain the approval process and timeline.    Click or tap here to enter text.  Disclose any current, threatened, or pending litigation involving the applicant.     Click or tap here to enter text.  Describe how the applicant assesses project designs and reviews plans and specifications.     Click or tap here to enter text.  Describe how the applicant assesses proposed project costs for eligibility and reasonableness.    Click or tap here to enter text.  Describe how the applicant assesses the reasonableness and achievability of the proposed development schedules, including the critical path schedule. Include information about how pending actions (e.g., permits, resolutions, documents) that have the potential to delay the implementation of a project on time and within budget are identified.    Click or tap here to enter text.  Describe how the applicant evaluates the expected useful life of a project.         Click or tap here to enter text.      Describe the construction monitoring protocols for projects, including the frequency of construction sites visits.    Click or tap here to enter text.  Describe how the applicant determines Federal cross-cutter (American Iron and Steel, Davis-Bacon, etc) compliance for its financed projects.    Click or tap here to enter text.  Describe how the applicant confirms substantial completion for a project.    Click or tap here to enter text.  Describe how the applicant assesses operations and maintenance plans.        Click or tap here to enter text.      Describe the contingency plans for financing and completion of a project if it is significantly delayed and/or over budget.    Click or tap here to enter text.  Provide the following documents as attachments:  Engineering review and construction monitoring procedures  Programmatic Environmental Assessment Questionnaire for WIFIA Credit Assistance SRF Programs available at https://www.epa.gov/wifia/wifia-programmatic-environmental-assessment-questionnaires

Section C: Financing Plan

 Complete the following sources and uses of funds table, including the proposed WIFIA assistance. Note:  Total sources and uses should be equal to one another and equal the estimated total eligible costs. All estimates should be expressed in year-of-expenditure dollars. Sources and Uses of Funds Table Sources Category Estimated Dollar Value  1. WIFIA Loan Click or tap here to enter text. 2. Revenue Bonds Click or tap here to enter text. 3. Borrower Cash Click or tap here to enter text. 4. Federal Grant Click or tap here to enter text. 5. Interest Click or tap here to enter text. 6. Principal Repayments Click or tap here to enter text. 7. Other (please specify) Click or tap here to enter text. Click or tap here to enter text. 8. Other (please specify) Click or tap here to enter text. Click or tap here to enter text. TOTAL SOURCES Click or tap here to enter text. Project Name Estimated Cost Click or tap here to enter text. Click or tap here to enter text.  Click or tap here to enter text. Click or tap here to enter text. Click or tap here to enter text. Click or tap here to enter text. Click or tap here to enter text. Click or tap here to enter text. Click or tap here to enter text. Click or tap here to enter text. Click or tap here to enter text. Click or tap here to enter text. Click or tap here to enter text. Click or tap here to enter text. Click or tap here to enter text. Click or tap here to enter text. Click or tap here to enter text. Click or tap here to enter text. Click or tap here to enter text. Click or tap here to enter text. TOTAL USES Click or tap here to enter text.

 Select the revenue source(s) that will be used to repay the WIFIA loan:       ☐ Principal and interest loan repayments       ☐ Investment earnings       ☐ SRF program equity       ☐ Other (Please explain): Click or tap here to enter text.                   Is the revenue source(s) identified in question C-2 pledged to anything other than SRF debt service? If yes, explain.        Click or tap here to enter text.      Identify the following proposed terms for the requested WIFIA credit assistance:

 Origination date: Click or tap here to enter text.  Final maturity date: Click or tap here to enter text.  Timing of disbursements: Click or tap here to enter text.  Pledged security: Click or tap here to enter text.  Repayment sources: Click or tap here to enter text.  Amortization schedule: Click or tap here to enter text.  Lien position: Click or tap here to enter text.

 Describe any restrictions that may limit the SRF's program's ability to pursue additional funding or transfer funds from the applicant, such as Additional Bonds Tests or closed indentures.     Click or tap here to enter text.	  Discuss the existing ratings, repayment schedules, and weighted average default ratings of the underlying borrowers?    Click or tap here to enter text.	  Provide the Default Tolerance.    Click or tap here to enter text.	  Describe the portfolio size and concentration.    Click or tap here to enter text.

Section D: Supporting Documents Provide the most recent versions of the following documents as attachments. The document is required unless otherwise noted:  Attachment 1: Intended Use Plan  Attachment 2: Annual Report to EPA Region  Attachments 3-5: Audited program financials for the previous 3 years  Attachment 6: SRF Sample loan agreement  Attachment 7:  Projected Revenue Certificate, which includes pledged loan repayments, annual debt service, and debt service coverage for all outstanding debt until maturity (for SRF programs with existing debt) OR the projected revenue from loan repayments for the life of the SRF loan (for SRF programs with no debt).  Attachment 8: Existing rating agency reports (if available)  Attachment 9: Procedures for reviewing project's Preliminary Engineering Report (PER)  Attachment 10: Procedures for the conducting the state environmental review  Attachment 11: Documentation of SRF program's priority setting system  Attachment 12: Bond Indenture (if applying for OPTION 1)  Attachment 13: Most recent Official Statement (if applying for OPTION 1)  Attachment 14: A preliminary rating letter from a Nationally Recognized Statistical Rating Organization, describing the applicant's ability to obtain an investment grade rating.   Attachment 15:  The underwriting criteria that will be applied to the loans pledged to the WIFIA loan Section C: Project List Complete the following table for the projects that are included in the total eligible project costs. Add or delete rows as needed. Alternatively, this information may be provided in Excel spreadsheet marked as attachment 14. No. Borrower Project Name Brief Description (1-2 sentences) City County Population Loan Amount Status and Finding of State Environmental Review Design Start and End Date Construction Start and End Date Estimated Loan Closing Date 1

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CERTIFICATIONS

 National Environmental Policy Act:  The undersigned acknowledges that EPA will not approve a loan until a final agency determination, such as a Categorical Exclusion (CATEX), Finding of No Significant Impact (FONSI), or a Record of Decision (ROD), has been issued.  American Iron and Steel:  The applicant acknowledges that any project receiving credit assistance under this program for the construction, alteration, maintenance, or repair of a project may only use iron and steel products produced in the United States and must comply with all applicable guidance.  Prevailing Wages:  The applicant acknowledges that all laborers and mechanics employed by contractors or subcontractors on projects receiving credit assistance under this program shall be paid wages at rates not less than those prevailing for the same type of work on similar construction in the immediate locality, as determined by the Secretary of Labor, in accordance with sections 3141-3144, 3146, and 3147 of Title 40 (Davis-Bacon wage rules).  Credit Ratings:  This applicant has received a preliminary rating opinion letter describing its ability to obtain an investment grade rating. This letters or ratings are attached.   Credit Processing Fees:  The undersigned certifies that it will reimburse EPA for its costs incurred in negotiating the credit agreement, irrespective of whether the credit agreement is executed.  Lobbying:  Section 1352 of Title 31, United States Code provides that none of the funds appropriated by any Act of Congress may be expended by a recipient of a contract, grant, loan, or cooperative agreement to pay any person for influencing or attempting to influence an officer or employee of any Federal agency, a Member of Congress, or an employee of a Member of Congress in connection with the award or making of a Federal contract, grant, loan, or cooperative agreement or the modification thereof. EPA interprets this provision to include the use of appropriated funds to influence or attempt to influence the selection for assistance under the WIFIA program. WIFIA applicants must file a declaration: (a) with the submission of an application for WIFIA credit assistance; (b) upon receipt of WIFIA credit assistance (unless the information contained in the declaration accompanying the WIFIA application has not materially changed); and (c) at the end of each calendar quarter in which there occurs any event that materially affects the accuracy of the information contained in any declaration previously filed in connection with the WIFIA credit assistance. The undersigned certifies, to the best of his or her knowledge and belief, that:  No Federal appropriated funds have been paid or will be paid, by or on behalf of the undersigned, to any person for influencing or attempting to influence an officer or employee of an agency, a Member of Congress, an officer or employee of Congress, or an employee of a Member of Congress in connection with the awarding of any Federal contract, the making of any Federal grant, the making of any Federal loan, the entering into of any cooperative agreement, and the extension, continuation, renewal, amendment, or modification of any Federal contract, grant, loan, or cooperative agreement.  If any funds other than Federal appropriated funds have been paid or will be paid to any person for influencing or attempting to influence an officer or employee of any agency, a Member of Congress, an officer or employee of Congress, or an employee of a Member of Congress in connection with this Federal contract, grant, loan, or cooperative agreement, the undersigned shall complete and submit Standard Form-LLL, "Disclosure Form to Report Lobbying," in accordance with its instructions.  The undersigned shall require that the language of this certification be included in the award documents for all subawards at all tiers (including subcontracts, subgrants, and contracts under grants, loans, and cooperative agreements) and that all subrecipients shall certify and disclose accordingly.          This certification is a material representation of fact upon which reliance was placed when this transaction was made or entered into. Submission of this certification is a prerequisite for making or entering into this transaction imposed by section 1352, title 31, U.S. Code. Any person who fails to file the required certification shall be subject to a civil penalty of not less than $10,000 and not more than $100,000 for each such failure.  Debarment: The undersigned further certifies that it is not currently: 1) debarred or suspended  from participating in any Federal programs; 2) formally proposed for debarment, with a final determination still pending; or 3) indicted, convicted, or had a civil judgment rendered against it for any of the offenses listed in the Regulations Governing Debarment and Suspension (Governmentwide Nonprocurement Debarment and Suspension Regulations: 2 C.F.R. Part 180 and Part 1532).  Default/Delinquency:  The undersigned further certifies that neither it nor any of its subsidiaries or affiliates are currently in default or delinquent on any debt or loans provided or guaranteed by the Federal Government.  Other Federal Requirements:  The applicant acknowledges that it must comply with all other federal statutes and regulations, as applicable.  A non-exhaustive list of federal cross-cutting statutes and regulations can be found at: www.epa.gov/wifia.   Name:  Title:   Organization: Street Address:  City/State/Zip:  Phone:  E-mail:

Name:  Title:   Organization: Street Address:  City/State/Zip:  Phone:  E-mail:

Signature:  By submitting this application, the undersigned certifies that the facts stated and the certifications and representations made in this application are true, to the best of the applicant's knowledge and belief after due inquiry, and that the applicant has not omitted any material facts. The undersigned is an authorized representative of the applicant. Signature:  _________________________________________________________________________ Date Signed: ________________________________________________________________________

KEY DEFINITIONS

 Administrator means the Administrator of EPA.      Applicant means the entity submitting the application for WIFIA credit assistance. Only prospective borrowers that are invited to submit a WIFIA application become applicants. The following entities are eligible to receive credit assistance: a corporation, a partnership, a joint venture, a trust, a Federal, State, or local government, a tribal government or consortium of tribal governments, and a State infrastructure financing authority.

 Credit assistance means a secured loan or loan guarantee under WIFIA.

 Credit agreement means a contractual agreement between EPA and the applicant (and the lender, if applicable) that formalizes the terms and conditions established in the term sheet (or conditional term sheet) and authorizes the execution of a secured loan or loan guarantee.

 Investment-grade rating means a rating category of BBB minus, Baa3, bbb minus, BBB (low), or higher assigned by a nationally recognized statistical rating organization (NRSRO) to project obligations offered into the capital markets.      Iron and steel products means the following products made primarily of iron or steel: lined or unlined pipes and fittings, manhole covers and other municipal castings, hydrants, tanks, flanges, pipe clamps and restraints, valves, structural steel, reinforced precast concrete, and construction materials.

 Nationally Recognized Statistical Rating Organization (NRSRO) means a credit rating agency identified and registered by the Office of Credit Ratings in the Securities and Exchange Commission.      Prospective borrower means an entity that is contemplating or is in the process of undertaking the WIFIA application process, or an entity that has undertaken these activities on behalf of another entity. The following entities are eligible to receive credit assistance: a corporation, a partnership, a joint venture, a trust, a Federal, State, or local government, a tribal government or consortium of tribal governments, and a State infrastructure financing authority. Prospective borrowers become applicants when they are invited to apply for WIFIA credit assistance.            State infrastructure financing authority means the State entity established or designated by the Governor of a State to receive a capitalization grant provided by, or otherwise carry out the requirements of, title VI of the Federal Water Pollution Control Act (33 U.S.C. 1381 et. seq.) or section 1452 of the Safe Drinking Water Act (42 U.S.C. 300j - 12).

 WIFIA means the Water Infrastructure Finance and Innovation Act of 2014, Pub. L. 113-121, 128 Stat, 1332, codified at 33 U.S.C. §§ 3901-3914.