[Federal Register Volume 82, Number 231 (Monday, December 4, 2017)]
[Rules and Regulations]
[Pages 57151-57158]
[FR Doc No: 2017-25828]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2016-0314; FRL-9969-13]

Ethofumesate; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
ethofumesate in or on beet, sugar, molasses and beet, sugar, roots. In
addition, this regulation eliminates tolerances for residues of
ethofumesate that are superseded by the tolerances established by this
final rule. Interregional Research Project Number 4 (IR-4) requested
these tolerances under the Federal Food, Drug, and Cosmetic Act
(FFDCA).

DATES: This regulation is effective December 4, 2017. Objections and
requests for hearings must be received on or before February 2, 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-2016-0314, 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, Director,
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-2016-0314 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 2, 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-2016-0314, 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 July 20, 2016 (81 FR 47150) (FRL-9948-
45), 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
6E8472) by IR-4, IR-4 Project Headquarters, 500 College Road East,
Suite 201W, Princeton, NJ 08540. The petition requested that 40 CFR
180.345 be amended by increasing the existing tolerance for the
combined residues of the herbicide ethofumesate (2-ethoxy-2,3-dihydro-
3,3-dimethyl-5-benzofuranyl methanesulfonate) and its metabolites (2-
hydroxy-2,3-dihydro-3,3-dimethyl-5-benzofuranyl methanesulfonate and
2,3-dihydro-3,3-dimethyl-2-oxo-5-benzofuranyl methanesulfonate) both
calculated as the parent compound, in or on beet, sugar, molasses from
0.5 to 2.5 parts per million (ppm); beet, sugar, refined sugar from 0.2
to 1.0 ppm; beet, sugar, roots from 0.3 to 1.5 ppm; and beet, sugar,
tops from 4.0 to 30.0 ppm. That document referenced a summary of the
petition prepared by Willowood USA, LLC, the registrant, which is
available in the docket, http://www.regulations.gov. One comment was
received on the notice of filing. EPA's response to the comment is
found in Unit IV.C.
    Based upon review of the data supporting the petition, EPA is
establishing tolerances that differ from what the petitioner requested.
The reasons for these changes are explained in Unit IV.D.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
    Consistent with 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 ethofumesate including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with ethofumesate follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity database 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 liver is the main target organ in rats and dogs, and the major
critical effects seen in oral studies are decreased body weight/body
weight gain and hepatic toxicity in the rat, dog and/or rabbit. Mice
are relatively insensitive to ethofumesate up to the limit dose
following subchronic and chronic dietary exposure.
    Ethofumesate did not demonstrate the potential to cause
neurotoxicity in four species (rats, mice, dogs and rabbits).
    Rats did not show evidence of developmental, maternal, or offspring
toxicity or susceptibility in a three-generation reproduction study or
any developmental or maternal toxicity in the developmental toxicity
study. Although increased prenatal quantitative sensitivity (increased
resorptions, increased post-implantation loss and incomplete
ossification of the vertebral arches) was observed in the rabbit
developmental toxicity study, the developmental toxicity no observed
adverse effect levels (NOAELs) and lowest observed adverse effect
levels (LOAELs) are well characterized. In maternal rabbits, effects
included decreased body weight, increased mortality, abortions and
complete litter resorption at levels in excess of the limit dose.
    Ethofumesate is classified as ``Not Likely to be Carcinogenic to
Humans'', based on bioassays in the rat and the mouse, combined with a
lack of in vitro or in vivo mutagenicity supported by a battery of
mutagenicity studies that showed no evidence of a mutagenic effect.
    Specific information on the studies received and the nature of the
adverse effects caused by ethofumesate 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 document, ``Ethofumesate. Human Health Risk
Assessment for an Amended Use on Sugar Beets'' dated October 4, 2017 at
pages 33-36 in docket ID number EPA-HQ-OPP-2016-0314.

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

   Table Summary of Toxicological Doses and Endpoints for ethofumesate for Use in Human Health Risk Assessment
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                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
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Acute dietary (Females 13-49       NOAEL = 30 mg/kg/day  Acute RfD = 0.30 mg/ Developmental toxicity study in
 years of age).                    UFA = 10x...........   kg/day.              rabbit.
                                   UFH =10x............  aPAD = 0.30 mg/kg/   Developmental LOAEL = 300 mg/kg/
                                   FQPA SF = 1x........   day.                 day based on increased
                                   Total UF = 100......                        resorptions, post-implantation
                                                                               loss and incomplete ossification
                                                                               of the vertebral arches.
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Acute Dietary General population   No appropriate acute endpoint identified for the general population including
 including infants and children.                                infants and children.
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Chronic dietary (Females 13-49     NOAEL = 30 mg/kg/day  Chronic RfD = 0.30   Developmental toxicity study in
 years of age).                    UFA = 10x...........   mg/kg/day.           rabbit.
                                   UFH = 10x...........  cPAD = 0.30 mg/kg/   Developmental LOAEL = 300 mg/kg/
                                   FQPA SF = 1x........   day.                 day based on increased
                                   Total UF = 100......                        resorptions, post-implantation
                                                                               loss and incomplete ossification
                                                                               of the vertebral arches.
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Chronic Dietary, General           NOAEL= 127 mg/kg/day  cRfD = 1.3 mg/kg/    Chronic oral toxicity/
 population including infants and  UFA=10..............   day.                 carcinogenicity study (rat).
 children.                         UFH=10..............  cPAD = 1.3 mg/kg/    LOAEL = 469 mg/kg/day based on
                                   FQPA SF = 1X........   day.                 decreased body weight gain in
                                   Total UF = 100......                        females.
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Incidental oral short-term (1 to   NOAEL= 190 mg/kg/day  Residential LOC for  90-day oral toxicity study (rats).
 30 days) & intermediate-term (1   UFA = 10x...........   MOE = 100.          LOAEL = 1900 mg/kg/day based on
 to 6 months) Infants and          UFH = 10x...........                        based on reduced body weight
 children only.                    FQPA SF = 1x........                        gain, microscopic lesions in the
                                   Total UF = 100......                        liver and kidney in male rats and
                                                                               reduced body weight/weight gain
                                                                               in females.
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Dermal short-term (1 to 30 days)   NOAEL = 30 mg/kg/day  LOC for MOE = 100..  Developmental toxicity study
 Females 13-49 years of age.       Dermal absorption                           (rabbits).
                                    rate (DAF) = 27%.                         Developmental LOAEL = 300 mg/kg/
                                   UFA = 10x...........                        day based on increased
                                   UFH = 10x...........                        resorptions, post-implantation
                                   FQPA SF = 1x........                        loss and incomplete ossification
                                   Total UF = 100......                        of the vertebral arches.
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Dermal short-term General          NOAEL= 190 mg/kg/day  LOC for MOE = 100..  90-day oral toxicity study (rats).
 population including infants and  DAF rate = 27%......                       LOAEL = 1900 mg/kg/day based on
 children.                         UFA = 10x...........                        reduced body weight gain,
                                   UFH = 10x...........                        microscopic lesions in the liver
                                   FQPA SF = 1x........                        and kidney in male rats and
                                                                               reduced body weight/weight gain
                                                                               in females.
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Inhalation (short and              NOAEL= 30 mg/kg/day.  LOC for MOE = 100..  Developmental toxicity study
 intermediate) Females 13-49       Inhalation & oral                           (rabbits).
 years of age.                      toxicity considered                       Developmental LOAEL = 300 mg/kg/
                                    equivalent.                                day based on increased
                                   UFA = 10x...........                        resorptions, post-implantation
                                   UFH = 10x...........                        loss and incomplete ossification
                                   FQPA SF = 1x........                        of the vertebral arches.
                                   Total UF = 100......
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Inhalation (short and              NOAEL = 190.........  LOC for MOE = 100..  90-day oral toxicity study (rats).
 intermediate term) General        Inhalation & oral                          LOAEL = 1900 mg/kg/day based on
 population including infants and   toxicity considered                        reduced body weight gain,
 children.                          equivalent.                                microscopic lesions in the liver
                                   UFA = 10x...........                        and kidney in male rats and
                                   UFH = 10x...........                        reduced body weight/weight gain
                                   FQPA SF = 1x........                        in females.
                                   Total UF = 100......
                                  ------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)           Classification: ``Not likely to be carcinogenic to humans''.
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FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
  members of the human population (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to ethofumesate, EPA considered exposure under the petitioned-
for tolerances as well as all existing ethofumesate tolerances in 40
CFR 180.345. EPA assessed dietary exposures from ethofumesate 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. Because no appropriate
endpoint was identified for the general population including infants
and children, a quantitative acute dietary exposure assessment was not
conducted for these populations. Such effects were observed for the
population subgroup females 13-49 years of age.
    In estimating acute dietary exposure for females 13-49 years, EPA
used food consumption information from the United States Department of
Agriculture (USDA's) National Health and Nutrition Examination Survey,
What We Eat in America (NHANES/WWEIA) from 2003 through 2008. As to
residue levels in food, EPA used an unrefined determination based on
tolerance-level residues, 100 percent crop treated (PCT) information
for all commodities, and Dietary Exposure Evaluation Model (DEEM) 7.81
default processing factors, where available.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA's 2003-2008
NHANES/WWEIA. As to residue levels in food, EPA used an unrefined
determination based on 100 PCT, tolerance-level residues for all
commodities, and Dietary Exposure Evaluation Model

(DEEM) 7.81 default processing factors, where available.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that ethofumesate 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.
The Agency did not use anticipated residue data or percent crop treated
estimates.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for ethofumesate in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of ethofumesate. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the Tier I: First Index Reservoir Screening Tool (FIRST)
and Tier II: Pesticide Root Zone Model Ground Water (PRZM GW)/PWC, the
estimated drinking water concentrations (EDWCs) of ethofumesate (parent
compound only) for acute exposures are estimated to be 416 parts per
billion (ppb) for surface water and 750 ppb for ground water. For
chronic exposures for non-cancer assessments are estimated to be 123
ppb for surface water and 695 ppb for ground water.
    Modeled estimates of drinking water concentrations of ethofumesate
for parent compound only, were directly entered into the dietary
exposure model. For acute dietary risk assessment, the water
concentration value of 750 ppb was used to assess the contribution to
drinking water. For chronic dietary risk assessment, the water
concentration value of 695 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).
    Ethofumesate is currently registered for the following uses that
could result in residential exposures: ornamental lawns and turf
(including golf courses, parks, cemeteries, and homeowner/commercial
lawns). EPA assessed residential exposure using the following
assumptions: All ethofumesate products are intended for either
agricultural use or require professional application for ornamental
turf. Although registered products are labeled for use on home lawns,
residential handler exposures are not anticipated because the label
language requiring personal protective equipment (PPE) and prohibiting
the use of handheld equipment indicate that the product is not intended
for homeowner use. Therefore, the Agency has not conducted a
residential handler assessment.
    There is potential for ethofumesate residential post-application
exposure for individuals exposed as a result of being in an environment
that has been previously treated. Residential post-application dermal
(adults and children) and incidental oral (children only) exposures are
anticipated from the registered turf uses. EPA conducted screening
level calculations on the scenarios most likely to result in highest
possible exposure. These scenarios are:
     For children 1 to <2 years old: incidental ingestion
(hand-to-mouth), incidental ingestion (turf-to-mouth), incidental
ingestion (soil-to-mouth), and dermal exposure
     for adults and youths (11 to <16 years old: dermal
exposure (golfing, lawn mowing, etc.).

Post-application exposures were calculated by considering the potential
sources of exposure then calculating dermal and/or incidental oral
exposure and risks. Further information regarding EPA standard
assumptions and generic inputs for residential exposures may be found
at http://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to ethofumesate and any other
substances and ethofumesate does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that ethofumesate 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/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the Food Quality
Protection Act Safety Factor (FQPA SF). In applying this provision, EPA
either retains the default value of 10X, or uses a different additional
safety factor when reliable data available to EPA support the choice of
a different factor.
    2. Prenatal and postnatal sensitivity. There are no concerns or
uncertainties for pre- and/or post-natal toxicity resulting from
exposure to ethofumesate. There is no evidence that ethofumesate
results in increased susceptibility in in utero exposure to
ethofumesate in the prenatal developmental study in rats. Increased
pre-natal quantitative susceptibility was observed in the rabbit
developmental toxicity study. The Agency concluded, however, that there
is no concern that the risk assessment will not adequately safeguard
against potential pre- and post-natal toxicity because the
developmental toxicity NOAELs/LOAELs are well characterized and are
used as endpoints for risk assessment for the appropriate population
subgroups.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
    i. The toxicity database for ethofumesate is sufficiently complete
and adequate for characterizing potential pre- and/or post-natal risks
to infants and children. Available studies supporting this decision
include developmental toxicity studies in rats and rabbits, and a
three-generation reproduction study in rats.
    Based on all available hazard and exposure data for ethofumesate,
the Agency determined that the subchronic inhalation, acute and
subchronic neurotoxicity, and the immunotoxicity

studies for ethofumesate were not necessary and waived those
requirements. The existing ethofumesate database is extensive and
adequately sufficient to permit a full assessment of risks associated
with proposed new uses under consideration.
    ii. There is no indication that ethofumesate is a neurotoxic
chemical. Ethofumesate did not cause clear clinical or
histopathological signs of neurotoxicity in four species tested (rats,
rabbits, mice and dogs) as evaluated by the current studies within the
database. In addition, there was no evidence of neurotoxicity observed
in the toxicity databases of chemicals in the same class as
ethofumesate. Therefore, EPA is not requiring a developmental
neurotoxicity study nor incorporating an additional UFs to account for
neurotoxicity.
    iii. There is no evidence that ethofumesate results in increased
susceptibility in in utero exposure to ethofumesate in the prenatal
developmental study in rats. No rat developmental effects were seen at
the highest dose tested (limit dose of 1000 mg/kg). There is, however,
quantitative evidence for increased susceptibility following in utero
exposure to ethofumesate in an adequate developmental toxicity study in
the rabbit. At 300 mg/kg/day, no maternal toxicity was reported, but
developmental toxicity was observed as increased resorptions, post-
implantation loss and skeletal abnormalities (incomplete ossification
of vertebral arches). However, the developmental toxicity NOAELs and
LOAELs are well characterized and are used as endpoints for risk
assessment for the appropriate population subgroups.
    There was no quantitative or qualitative evidence of increased
susceptibility in the three-generation reproduction study in rats with
ethofumesate since maternal, reproductive and offspring toxicity were
not observed at any dose tested up to 5000 ppm (397 and 463 mg/kg/day,
males and females, respectively). Although a limit dose was not
achieved and no maternal toxicity reported, a new study was not
required because the highest dose tested was similar to the dose level
that caused toxicity to rats in the chronic/carcinogenicity dietary
study.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary exposure analyses are unlikely to underestimate
exposure. The acute and chronic dietary food and drinking water
exposure assessments were performed based on 100 PCT information for
all commodities, tolerance-level residues, and Dietary Exposure
Evaluation Model (DEEM) 7.81 default processing factors where
available. The dietary exposure analyses also assumed that all drinking
water will contain ethofumesate at the highest EDWC levels modeled by
EPA. The Agency used similarly conservative assumptions to assess post-
application exposure of adults and children. The residential exposure
estimates are based on EPA's 2012 Residential Standard Operations
Procedures (SOPs). These assessments will not underestimate the
exposure and risks posed by ethofumesate.

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 population-adjusted dose (aPAD) and chronic population-adjusted
dose (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 ethofumesate will occupy 14% of the aPAD at the 95th percentile for
females 13-49 years old, the only population subgroup for which an
acute dietary endpoint attributable to a single exposure was
identified.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure from food and drinking water only as chronic
exposure from residential uses of ethofumesate is not expected, EPA
identified separate chronic dietary endpoints for the general
population, including infants and children, as well as for the
population subgroup of females 13-49 years of age. Based on the input
parameters and assumptions, the chronic dietary risk estimate for the
U.S. population was determined to be 1.2% of the cPAD with the
population subgroup of females 13-49 years having the highest risk
estimate at 5.2% of the cPAD. EPA concluded that ethofumesate risk
estimates for all population subgroups were below the level of concern
of <100% of the cPAD.
    3. Short- and intermediate-term aggregate risk. Short- and
intermediate-term aggregate exposures take into account short- and
intermediate-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
    Ethofumesate is currently registered for uses that could result in
short-term residential exposure. Residential exposure to ethofumesate
is not anticipated from the amended uses that are the subject of this
regulatory action; however, it is anticipated from currently registered
residential uses of ethofumesate. Residential exposures are only
expected to be short-term in duration; however, since the point of
departure is the same for short and intermediate-term exposures, the
short-term aggregate is protective of any longer-term exposures.
    Aggregate risk estimates (MOEs) were derived using recommended
exposure scenarios including: For adults, dermal post-application
exposure from high contact activities on treated turf; for children,
including ages 11 to <16 years and 6 to <11 years, dermal post-
application exposure from golfing on treated turf; and for children (1
to <2 years), combined dermal plus hand-to-mouth post-application
exposure from high contact activities on treated turf.
    EPA short-term aggregate risk calculations of aggregate MOEs,
combining average food and drinking water, plus residential exposures
(total exposure), ranged from 120 for females 13-49 years; to 430 for
children 1 to <2 years; to 770 for adults, 20-49 years and
significantly higher for population subgroups, children 6 to 11 years
and youth 11 to <16 years. These short-term aggregate risk estimates
are not of concern to EPA (i.e., MOEs are >= 100).
    4. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, ethofumesate is not expected to pose a cancer risk to humans.
    5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to ethofumesate residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (Method I in PAM Vol. II is listed
as an adequate tolerance enforcement method for plants) is available to
enforce the tolerance expression.
    The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number:<PHONE_NUMBER>;

email address: [email protected].

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    There are no Codex MRLs established for the residues of
ethofumesate in/on any sugar beet raw agricultural or processed
commodity.

C. Response to Comments

    One commenter supported the tolerance action but expressed concerns
about the need for additional data to assess the toxicity of
ethofumesate to bioaccumulate and to contribute to obesity and
diabetes. To the extent the commenter is concerned about impacts on
aquatic life, earthworms, and other non-human organisms, this comment
is outside the scope of review appropriate for a tolerance safety
assessment under section 408 of the FFDCA. If the commenter is raising
concerns about potential human harm, the Agency has considered all the
available data and determined that the tolerances are safe; there is
nothing in the toxicity database that would suggest toxicity concerns
related to diabetes or obesity.
    The octanol-water partition coefficient (log Kow) for
ethofumesate is 2.8. Compounds with log Kow values less than
three are unlikely to bioaccumulate substantially. Therefore, further
assessment of the bioaccumulation of ethofumesate is not warranted at
this time.

D. Revisions to Petitioned-For Tolerances

    EPA is not increasing the existing tolerance for ``Beet, sugar,
tops'' because it is unnecessary due to the fact that this commodity is
no longer a significant livestock feed item or a recognized human food.
    Although the petitioner requested an increase in the existing
sugar, beet, refined sugar tolerance, EPA has determined that the
tolerance is not needed because the limit established for the raw
agricultural commodity (RAC) (beet, sugar, roots at 1.5 ppm) is
sufficient to cover residues in this processed commodity (at 1.0 ppm).
    In setting the sugar beet molasses tolerance, EPA used the
empirical processing factor previously derived for determining the
concentration of residues in this processed commodity, which results in
a tolerance of 2.0 ppm rather 2.5 ppm as requested.
    The tolerance expressions at 180.345 paragraphs (a) and (c) for
ethofumesate are being revised to comply with current EPA policies and
to accommodate updated tolerance enforcement methods that convert the
NC 20645 (2-(2-hydroxy-5-methanesulfonyloxyphenyl) methylpropanoic
acid) metabolite to NC9607 (3,3-dimethyl-5-[(methylsulfonyl)oxy]-2(3H)-
benzofuranone) prior to quantitation.

V. Conclusion

    Therefore, tolerances are established for residues of the herbicide
ethofumesate in or on beet, sugar, molasses at 2.0 ppm and beet, sugar,
roots at 1.5 ppm. Also, the tolerance for beet, sugar, refined is
deleted because residues in that processed commodity are covered by the
tolerance for beet, sugar, roots.

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: October 26, 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.  180.345:
0
i. Revise the introductory text of paragraph (a);
0
ii. Remove the entry for ``Beet, sugar, refined sugar'' from the table
in paragraph (a);
0
iii. Revise the entries for ``Beet, sugar, molasses'' and ``Beet,
sugar, roots'' in the table in paragraph (a): and
0
iv. Revise the introductory text of paragraph (c) to read as follows:

Sec.  180.345  Ethofumesate; tolerances for residues.

    (a) General. Tolerance are established for residues of the
herbicide ethofumesate, including its metabolites and degradates, in or
on the commodities in the table below. Compliance with the tolerance
levels specified below is to be determined by measuring only the sum of
ethofumesate, 2-ethoxy-2,3-dihydro-3,3-dimethyl-5-benzofuranyl
methanesulfonate, and its metabolites 2-hydroxy-2,3-dihydro-3,3-
dimethyl-5-benzofuranyl methanesulfonate, and 2,3-dihydro-3,3-dimethyl-
2-oxo-5-benzofuranylmethanesulfonate, calculated as the stoichiometric
equivalent of ethofumesate, in or on the following food commodities.

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

                                * * * * *
Beet, sugar, molasses.......................................         2.0
Beet, sugar, roots..........................................         1.5

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

* * * * *
    (c) Tolerances with regional registrations. Tolerances with a
regional registration, as defined in Sec.  180.1(l) are established for
residues of the herbicide ethofumesate, including its metabolites and
degradates, in or on the commodities in the table below. Compliance
with the tolerance levels specified is to be determined by measuring
only the sum of ethofumesate, 2-ethoxy-2,3-dihydro-3,3-dimethyl-5-
benzofuranyl methanesulfonate, and its metabolites 2-hydroxy-2,3-
dihydro-3,3-dimethyl-5-benzofuranyl methanesulfonate, and 2,3-dihydro-
3,3-dimethyl-2-oxo-5-benzofuranylmethanesulfonate, calculated as the
stoichiometric equivalent of ethofumesate, in or on the raw
agricultural commodities.
* * * * *
[FR Doc. 2017-25828 Filed 12-1-17; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 27 (Thursday, February 8, 2018)]
[Notices]
[Page 5675]
[FR Doc No: 2018-02540]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No. PE-2016-123]

Petition for Exemption; Summary of Petition Received; Minnesota
Department of Natural Resources

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of petition for exemption received.

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SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of 14 CFR. The purpose of this notice is to
improve the public's awareness of, and participation in, this aspect of
FAA's regulatory activities. Neither publication of this notice nor the
inclusion or omission of information in the summary is intended to
affect the legal status of the petition or its final disposition.

DATES: Comments on this petition must identify the petition docket
number and must be received on or before February 28, 2018.

ADDRESSES: You may send comments identified by Docket Number FAA-2016-
9416 using any of the following methods:
     Government-wide rulemaking website: Go to http://www.regulations.gov and follow the instructions for sending your
comments electronically.
     Mail: Send comments to the Docket Management Facility;
U.S. Department of Transportation, 1200 New Jersey Avenue SE, West
Building, Ground Floor, Room W12-140, Washington, DC 20590.
     Fax: Fax comments to the Docket Management Facility at
202-493-2251.
     Hand Delivery: Bring comments to the Docket Management
Facility in Room W12-140 of the West Building, Ground Floor at 1200 New
Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    Privacy: We will post all comments we receive, without change, to
http://www.regulations.gov, including any personal information you
provide. Using the search function of our docket website, anyone can
find and read the comments received into any of our dockets, including
the name of the individual sending the comment (or signing the comment
for an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78).
    Docket: To read background documents or comments received, go to
http://www.regulations.gov at any time or to the Docket Management
Facility in Room W12-140 of the West Building, Ground Floor at 1200 New
Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Nia Daniels,<PHONE_NUMBER>, 800
Independence Avenue SW, Washington, DC 20591.

    This notice is published pursuant to 14 CFR 11.85.

    Issued in Washington, DC.
Lirio Liu,
Director, Office of Rulemaking.

Petition for Exemption

    Docket No.: FAA-2016-9416.
    Petitioner: Minnesota Department of Natural Resources.
    Section of 14 CFR Affected: 135.503, 135.505, and 135.507.
    Description of Relief Sought: The Minnesota Department of Natural
Resources (MNDNR) petitions for its contracted vendors to have and
maintain an FAA-approved Hazmat Will-Carry manual. Its vendors will be
required to follow and carry this and other hazmat documents onboard
the aircraft at all times, as well as, completing a training course.

[FR Doc. 2018-02540 Filed 2-7-18; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 80, Number 76 (Tuesday, April 21, 2015)]
[Notices]
[Pages 22257-22258]
[FR Doc No: 2015-09203]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Opportunity for Public Comment on Surplus Property
Release at Jack Edwards Airport, Gulf Shores, AL

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of intent to rule on land release request.

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

SUMMARY: Under the provisions of title 49, U.S.C. 47153(c), notice is
being given that the FAA is considering a request from the City of Gulf
Shores and the City of Gulf Shores Airport Authority to waive the
requirement that a 11.48-acre parcel of surplus property, located at
the Jack Edwards Airport, be used for aeronautical purposes.

DATES: Comments must be received on or before May 21, 2015.

ADDRESSES: Comments on this notice may be mailed or delivered in
triplicate to the FAA at the following address: Jackson Airports
District Office, 100 West Cross Street, Suite B, Jackson, MS 39208-
2307.
    In addition, one copy of any comments submitted to the FAA must be
mailed or delivered to Mr. Robert Craft, Mayor of Gulf Shores, Alabama
at the following address: P.O. Box 299, Gulf Shores, AL 36547-0299.

FOR FURTHER INFORMATION CONTACT: Kevin L. Morgan, Program Manager,

Jackson Airports District Office, 100 West Cross Street, Suite B,
Jackson, MS 39208-2307,<PHONE_NUMBER>. The land release request may be
reviewed in person at this same location.

SUPPLEMENTARY INFORMATION: The FAA is reviewing a request by the City
of Gulf Shores and City of Gulf Shores Airport Authority to release
11.48 acres of surplus property at the Jack Edwards Airport. The
property will be purchased by the City of Gulf Shores at fair market
value. The released property will be used for civic and safety
facilities or as approved by FAA. The property is located on the
northwest corner of airport and is adjacent to Gulf Shores Parkway. The
net proceeds from the sale of this property will be used for airport
purposes.
    Any person may inspect the request in person at the FAA office
listed above under FOR FURTHER INFORMATION CONTACT.
    In addition, any person may, upon request, inspect the request,
notice and other documents germane to the request in person at the
office of the Gulf Shores Airport Authority.

    Issued in Jackson, Mississippi on April 13, 2015.
RANS D. Black,
Manager, Jackson Airports District Office, Southern Region.
[FR Doc. 2015-09203 Filed 4-20-15; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 80, Number 167 (Friday, August 28, 2015)]
[Rules and Regulations]
[Pages 52194-52198]
[FR Doc No: 2015-21385]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 271

[EPA-R05-RCRA-2014-0689; FRL-9933-29--Region 5]

Michigan: Final Authorization of State Hazardous Waste Management
Program Revision

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: Michigan applied to the Environmental Protection Agency (EPA)
for final authorization of certain changes to its hazardous waste
program under the Resource Conservation and Recovery Act (RCRA). On
March 31, 2015, EPA published a proposed rule to authorize the changes
and opened a public comment period under Docket ID No. EPA-R05-RCRA-
2014-0689. The comment period closed on June 1, 2015. EPA received no
comments on the proposed rule. EPA has decided that the changes to
Michigan's program satisfy all requirements necessary to qualify for
final authorization, and EPA is

authorizing those changes to Michigan's authorized hazardous waste
program in this final rule.

DATES: Final authorization for the changes to the hazardous waste
program in Michigan will be effective at 1 p.m. EST on August 28, 2015.

ADDRESSES: Docket: All documents in the docket are listed in the
regulations.gov index under Docket Identification No. EPA-2014-R05-
RCRA-2014-0689. Although listed in the index, some of the information
is not publicly available, e.g., Confidential Business Information or
other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, will be publicly
available only in hard copy. Publicly available docket materials are
available either electronically at regulations.gov or in hard copy at
the following addresses, Monday through Friday, excluding legal
holidays, between the hours of 9:00 a.m. to 4:00 p.m.: U.S.
Environmental Protection Agency, Region 5, 77 West Jackson Boulevard,
Chicago, Illinois, contact: Judith Greenberg, telephone<PHONE_NUMBER>;
or Michigan Department of Environmental Quality, Constitution Hall, 525
West Allegan Street, Lansing, Michigan, contact: Ronda Blayer,
telephone<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Judith Greenberg, U.S. EPA, Region 5,
Land and Chemicals Division, 77 West Jackson Blvd., Mail Code LR-8J,
Chicago, Illinois 60604, email<EMAIL_ADDRESS>phone number
(312) 886-4179.

SUPPLEMENTARY INFORMATION:

A. Why are revisions to State programs necessary?

    States which have received final authorization from EPA under RCRA
section 3006(b), 42 U.S.C. 6926(b), must maintain a hazardous waste
program that is equivalent to, consistent with, and no less stringent
than the federal program. As the federal program changes, states must
change their programs and ask EPA to authorize the changes. Changes to
state programs may be necessary when federal or state statutory or
regulatory authority is modified or when certain other changes occur.
Most commonly, states must change their programs because of changes to
EPA's regulations in 40 Code of Federal Regulations (CFR) parts 124,
260 through 266, 268, 270, 273 and 279.

B. What decisions have we made in this rule?

    EPA has made a final determination that Michigan's revisions to its
authorized hazardous waste management program meet all of the statutory
and regulatory requirements established by RCRA for authorization.
Therefore, EPA is authorizing the revised State of Michigan hazardous
waste management program, as described in the Attorney General's
Statement in the June 2014 authorization revision application, and as
discussed in section E of this rule. Michigan has responsibility for
permitting treatment, storage and disposal facilities (TSDFs) within
its borders (except in Indian Country) and for carrying out the aspects
of the RCRA program covered by its revised program application, subject
to the limitations of RCRA, including the Hazardous and Solid Waste
Amendments of 1984 (HSWA). New federal requirements and prohibitions
imposed by federal regulations that EPA promulgates under the authority
of HSWA take effect in authorized states before they are authorized for
the requirements. Thus, EPA will implement those requirements and
prohibitions in Michigan, including issuing permits, until the State is
granted authorization to do so.

C. What has Michigan previously been authorized for?

    Michigan's hazardous waste management program received final
authorization effective on October 16, 1986 (51 FR 36804-36805, October
16, 1986). Subsequently, EPA authorized revisions to the State's
program effective January 23, 1990 (54 FR 48608, November 24, 1989);
January 24, 1991 (56 FR 18517, January 24, 1991); November 30, 1993 (58
FR 51244, October 1, 1993); January 13, 1995 (60 FR 3095, January 13,
1995); April 8, 1996 (61 FR 4742, February 8, 1996); November 14, 1997
(62 FR 61775, November 14, 1997); June 1, 1999 (64 FR 10111, March 2,
1999); July 31, 2002 (67 FR 49617, July 31, 2002); March 9, 2006 (71 FR
12141, March 9, 2006); January 7, 2008 (73 FR 1077, January 7, 2008);
and March 2, 2010 (75 FR 9345, March 2, 2010).

D. What is the effect of this authorization decision?

    The effect of this decision is that a facility in Michigan subject
to RCRA has to comply with the authorized state requirements in lieu of
the corresponding federal requirements in order to comply with RCRA,
and those authorized requirements will be federally enforceable.
Additionally, such persons must comply with any applicable federal
requirements, such as, for example, HSWA requirements issued by EPA for
which the state has not received authorization, and RCRA requirements
that are not supplanted by authorized state-issued requirements.
Michigan continues to have enforcement responsibilities under its state
hazardous waste program for violations of such program, but EPA retains
its authority under RCRA sections 3007, 3008, 3013, and 7003, and any
other applicable statutory and regulatory provisions, which include,
among others, authority to:
     Perform inspections; require monitoring, tests, analyses
or reports;
     Enforce RCRA requirements; suspend, terminate, modify or
revoke permits; and
     Take enforcement actions regardless of whether the State
has taken its own actions.
    This final action approving these revisions does not impose
additional requirements on the regulated community because the
regulations for which Michigan is authorized are already effective
under state law and are not changed by EPA's final action.

E. What changes are we authorizing with today's action?

    This final rule addresses a program revision application that
Michigan submitted to EPA in June 2014, in accordance with 40 CFR
271.21, seeking authorization of changes to the state program. On March
31, 2015, EPA published a proposed rule (80 FR 17021) stating the
Agency's intent to grant final authorization for revisions to
Michigan's hazardous waste management program. The public comment
period on this proposed rule ended on June 1, 2015. EPA received no
comments during the public comment period.
    EPA has determined that Michigan's changes to its program satisfy
all of the requirements necessary to qualify for final authorization.
With this final action, EPA authorizes Michigan for the following
federal rules (a table with a list of the State analogs is provided in
the March 31, 2015, proposed rule) and the following state-initiated
changes:
     NESHAP: Final Standards for Hazardous Waste Combustors
(Phase I Final Replacement Standards and Phase II) Amendments, 73 FR
18970, April 8, 2008, Checklist 217.\1\
---------------------------------------------------------------------------

    \1\ Revision Checklists generally reflect changes to federal
regulations pursuant to a particular Federal Register notice; EPA
publishes these checklists as aids to states to use for development
of their authorization revision application. See EPA's RCRA State
Authorization Web site at http://www.epa.gov/epawaste/laws-regs/state/index.htm.

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

     F019 Exemption for Wastewater Treatment Sludges from Auto
Manufacturing Zinc Phosphating Processes, June 4, 2008, 73 FR 31756,
Checklist 218.
     Academic Laboratories Generator Standards, December 1,
2008, 73 FR 72912, Checklist 220.
     OECD Requirements: Export Shipments of Spent Lead-Acid
Batteries, January 8, 2010, 75 FR 1236, Checklist 222.
     Hazardous Waste Technical Corrections and Clarifications
Rule, as amended, March 16, 2010, 75 FR 12989; and June 4, 2010, 75 FR
31716, Checklist 223.
     Removal of Saccharin and Its Salts, December 17, 2010, 75
FR 78918, Checklist 225.
     Corrections to the Academic Generator Standards, December
20, 2010, 75 FR 79304, Checklist 226.
     Revisions of the Treatment Standards for Carbamate Wastes,
June 13, 2011, 75 FR 34147, Checklist 227.
     Hazardous Waste Technical Corrections and Clarifications,
April 13, 2012, 77 FR 22229, Checklist 228.
     Equivalent state-initiated changes:
    Michigan administrative rules R 299.9102 (definition of
``construction permit'' removed), R 299.9106(e) (definition of
``operating license'' modified), R 299.9224, R 299.9225, R
299.9304(2)(b), R 299.9409(4), R 299.9501 (except second sentence only
of paragraph (3)(d)), R 299.9505, R 299.9524, R 299.9603, R
299.9604(2), R 299.9605, R 299.9609, R 299.9610(3), R 299.9612, R
299.9615, R 299.9616, R 299.9623, R 299.9629, R 299.9640, R 299.9707, R
299.9708, R 299.9808, and R 299.9821, effective November 5, 2013.

F. Which revised state rules are different from the federal rules?

    The most significant differences between the state rules we are
authorizing and their analogous federal rules are summarized below. It
should be noted that this summary does not describe every difference or
every detail regarding the differences that are described. Members of
the regulated community are advised to read the complete rules to
ensure that they understand the requirements with which they will need
to comply.
    EPA has found that aspects of the Michigan program are more
stringent than the federal program. All of these more stringent
requirements are part of the federally enforceable RCRA program
authorized by the EPA and must be complied with in addition to the
state requirements which track the minimum federal requirements. These
more stringent requirements are found at:
    Michigan's rules at (references are to the Michigan Administrative
Code):
    R 299.9601(1), (2), (2)(b), (c), (d), (e), (f), (g), (h) and (i); R
299.9608(1), (6) and (8); R 299.9615; and R 299.9702(1) are more
stringent than the federal analogs at 40 CFR Sec. Sec.  265.56(b),
265.71, 265.72, 265.142(a), 265.174, 265.190(a), 265.193, 265.194,
265.197, 265.201, and 265.340(b)(1) since the State rules include
provisions that require compliance with standards equivalent to 40 CFR
part 264 rather than 40 CFR part 265.
    Michigan's rules at R 299.9601(2)(a) and R 299.9602 are more
stringent since the rules impose requirements regarding environmental
and human health standards generally.
    Michigan's rules at R 299.9615(4) are more stringent since the
State rules require tank systems to also comply with Michigan 1941 Act
207 standards (which govern above-ground storage tanks).
    Michigan's rules at R 299.9623(9) are more stringent since the
State rules require incinerators to comply with Michigan Part 55
standards (which address air pollution).
    Michigan does not allow containment buildings, making the state
requirements more stringent than the federal requirements at 40 CFR
262.10(f), (k)(1) and (k); 262.11(d); 262.41(b); 263.12; 40 CFR part
264 subpart DD; 40 CFR 265 subpart DD; and 40 CFR part 264 appendix I,
Tables 1 and 2.
    Michigan's rules at R 299.9629(7)-(7)(c) are more stringent, since
the State rules require (1) timely notification of an exceedance of a
groundwater/surface water interface standard based on acute toxicity
and established pursuant to part 201 and part 31 of Act 451; and (2)
implementation of interim measures to prevent exceedance at the
monitoring wells along with a proposal and schedule for completing
corrective action to prevent a discharge that exceeds the standard.
    Michigan's rules at R 299.11002(1) and (2) are more stringent than
the federal analogs at 40 CFR 260.11(d) and (d)(1) since the State
adopts updated versions of the ``Flammable and Combustible Liquids
Code.''
    EPA has also found that aspects of Michigan's revised program are
broader in scope than the federal program. State provisions that EPA
determines are broader in scope are not part of the federally
authorized program and are not federally enforceable. Michigan's
program revisions include the following rules that are broader in scope
than the federal program (references are to the Michigan Administrative
Code): R 299.9226, R 299.9501(3)(d) (second sentence only) and R
299.9507, as amended effective November 5, 2013.
    The following Michigan administrative rules that were broader in
scope than the federal program were rescinded effective November 5,
2013: R 299.9221 (Table 203b), R 299.9223 (Table 204b), R 299.9904, R
299.9905, R 299.9906, and R 299.11101, R 299.11102, R 299.11103, R
299.11104, R 299.11105, R 299.11106, and R 299.11107.
    EPA does not authorize States to administer federal import and
export functions in any section of the RCRA hazardous waste
regulations. Although states do not receive authorization to administer
the federal government's import and export functions, found in 40 CFR
part 262, subparts E, F and H, state programs are still required to
adopt the federal import and export provisions to maintain their
equivalency with the federal program. The State amended the following
state import and export rules to include the federal rule on
Organization for Economic Cooperation and Development (OECD)
Requirements; Export Shipments of Spent Lead-Acid Batteries (75 FR
1236, January 8, 2010): R 299.9301(7); R 299.9309(1), (3) and (4); R
299.9312(1) and (2); R 299.9401(5); R 299.9601(2)(c), (3) and (9); R
299.9605(1) and (4); R 299.9608(1), (4) and (8); R 299.9804(7) and (8);
and R 299.11003(1)(k), (m), (n) and (p) and (2).

G. Who handles permits after final authorization takes effect?

    Michigan will issue permits for all the provisions for which it is
authorized and will administer the permits it issues. EPA will continue
to administer any RCRA hazardous waste permits or portions of permits
which EPA issued prior to the effective date of the final authorization
until they expire or are terminated. EPA will not issue any more new
permits or new portions of permits for the provisions listed above
after the effective date of the final authorization. EPA will continue
to implement and issue permits for HSWA requirements for which Michigan
is not yet authorized.

H. How does today's action affect Indian Country (18 U.S.C. 1151) in
Michigan?

    Michigan is not authorized to carry out its hazardous waste program
in Indian Country within the State, as

defined in 18 U.S.C. 1151. This includes:
    1. All lands within the exterior boundaries of Indian reservations
within the State of Michigan;
    2. Any land held in trust by the U.S. for an Indian tribe; and
    3. Any other land, whether on or off an Indian reservation that
qualifies as Indian Country.
    Therefore, authorizing Michigan for these revisions does not affect
Indian Country in Michigan. EPA continues to implement and administer
the RCRA program in Indian Country. It is EPA's long-standing position
that the term ``Indian lands'' used in past Michigan hazardous waste
approvals is synonymous with the term ``Indian Country.'' Washington
Dep't of Ecology v. U.S. EPA, 752 F.2d 1465, 1467, n.1 (9th Cir. 1985).
See 40 CFR 144.3 and 258.2.

I. What is codification and is EPA codifying Michigan's hazardous waste
program as authorized in this rule?

    Codification is the process of placing a state's statutes and
regulations that comprise a state's authorized hazardous waste program
into the Code of Federal Regulations. We do this by referencing the
authorized state rules in 40 CFR part 272. Michigan's rules, up to and
including those revised October 19, 1991, have previously been codified
through incorporation-by-reference effective April 24, 1989 (54 FR
7421, February 21, 1989); as amended effective March 31, 1992 (57 FR
3724, January 31, 1992). We reserve the amendment of 40 CFR part 272,
subpart X, for the codification of Michigan's program changes until a
later date.

J. Statutory and Executive Order Reviews

    This proposed rule only authorizes hazardous waste requirements
pursuant to RCRA section 3006 and imposes no requirements other than
those imposed by state law (see Supplementary Information, Section A.
Why Are Revisions to State Programs Necessary?). Therefore, this rule
complies with applicable executive orders and statutory provisions as
follows:

1. Executive Order 18266: Regulatory Planning and Review and Executive
Order 13563: Improving Regulations and Regulatory Review

    The Office of Management and Budget has exempted this rule from its
review under Executive Orders 12866 (58 FR 51735, October 4, 1993) and
Executive Order 13563 (76 FR 3821 January 21, 2011).

2. Paperwork Reduction Act

    This rule does not impose an information collection burden under
the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
et seq.).

3. Regulatory Flexibility Act

    This rule authorizes state requirements for the purpose of RCRA
3006 and imposes no additional requirements beyond those required by
state law. Accordingly, I certify that this rule will not have a
significant economic impact on a substantial number of small entities
under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.).

4. Unfunded Mandates Reform Act

    Because this rule approves pre-existing requirements under state
law and does not impose any additional enforceable duty beyond that
required by state law, it 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).

5. Executive Order 13132: Federalism

    Executive Order 13132 (64 FR 43255, August 10, 1999) does not apply
to this rule because it will not have federalism implications (i.e.,
substantial direct effects on the states, on the relationship between
the national government and the states, or on the distribution of power
and responsibilities among the various levels of government).

6. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    Executive Order 13175 (65 FR 67249, November 9, 2000) does not
apply to this rule because it will not have tribal implications (i.e.,
substantial direct effects on one or more Indian tribes, or on the
relationship between the Federal Government and Indian tribes, or on
the distribution of power and responsibilities between the Federal
Government and Indian tribes).

7. Executive Order 13045: Protection of Children From Environmental
Health and Safety Risks

    This rule is not subject to Executive Order 13045 (62 FR 19885,
April 23, 1997), because it is not economically significant as defined
in Executive Order 12866 and because the EPA does not have reason to
believe the environmental health or safety risks addressed by this
action present a disproportionate risk to children.

8. Executive Order 13211: Actions That Significantly Affect Energy
Supply, Distribution, or Use

    This rule is not subject to Executive Order 13211 (66 FR 28355, May
22, 2001), because it is not a significant regulatory action as defined
in Executive Order 12866.

9. National Technology Transfer Advancement Act

    EPA approves state programs as long as they meet criteria required
by RCRA, so it would be inconsistent with applicable law for EPA, in
its review of a state program, to require the use of any particular
voluntary consensus standard in place of another standard that meets
the requirements of RCRA. Thus, the requirements of section 12(d) of
the National Technology Transfer and Advancement Act of 1995 (15 U.S.C.
272 note) do not apply to this rule.

10. Executive Order 12988

    As required by Section 3 of Executive Order 12988 (61 FR 4729,
February 7, 1996), in issuing this rule, EPA has taken the necessary
steps to eliminate drafting errors and ambiguity, minimize potential
litigation, and provide a clear legal standard for affected conduct.

11. Executive Order 12630: Evaluation of Risk and Avoidance of
Unanticipated Takings

    EPA has complied with Executive Order 12630 (53 FR 8859, March 18,
1988) by examining the takings implications of the rule in accordance
with the Attorney General's Supplemental Guidelines for the Evaluation
of Risk and Avoidance of Unanticipated Takings issued under the
executive order.

12. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low Income Populations

    Because this rule proposes authorization of pre-existing state
rules and imposes no additional requirements beyond those imposed by
state law and there are no anticipated significant adverse human health
or environmental effects, the rule is not subject to Executive Order
12898 (59 FR 7629, February 16, 1994).

13. Congressional Review Act

    EPA will submit a report containing this rule and other information
required by the Congressional Review Act (5 U.S.C. 801 et seq.) to the
U.S. Senate, the U.S. House of Representatives, and the Comptroller
General of the United States prior to the publication 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 271

    Environmental protection; Administrative practice and procedure;
Confidential business information; Hazardous materials transportation;
Hazardous waste; Indians--lands; Intergovernmental relations;
Penalties; Reporting, and Recordkeeping requirements.

    Authority: This action is issued under the authority of Sections
2002(a), 3006 and 7004(b) of the Solid Waste Disposal Act, as
amended, 42 U.S.C. 6912(a), 6926, 6974(b).

    Dated: August 10, 2015.
Susan Hedman,
Regional Administrator, Region 5.
[FR Doc. 2015-21385 Filed 8-27-15; 8:45 am]
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