[Federal Register Volume 87, Number 215 (Tuesday, November 8, 2022)]
[Rules and Regulations]
[Pages 67371-67375]
[FR Doc No: 2022-23997]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0084; FRL-10295-01-OCSPP]

Acetic Acid, 2-Ethylhexyl Ester; Exemption From the Requirement
of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of acetic acid, 2-ethylhexyl ester (CAS
Reg. No. 103-09-3) when used as an inert ingredient (solvent/cosolvent)
at a concentration not to exceed 50% in pesticide formulations applied
to growing crops. SciReg, Inc., on behalf of Solvay USA Inc., submitted
a petition to EPA under the Federal Food, Drug, and Cosmetic Act
(FFDCA), requesting establishment of an exemption from the requirement
of a tolerance. This regulation eliminates the need to establish a
maximum permissible level for residues of acetic acid, 2-ethylhexyl
ester, when used in accordance with the terms of the exemption.

DATES: This regulation is effective November 8, 2022. Objections and
requests for hearings must be received on or before January 9, 2023,
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-2017-0084, is available at
https://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 and the OPP docket is<PHONE_NUMBER>. For the latest
status information on EPA/DC services, docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Daniel Rosenblatt, Registration
Division (7505T), 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 40 CFR
part 180 through the Office of the Federal Register's e-CFR site at
https://www.ecfr.gov/current/title-40.

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

    Under FFDCA section 408(g), 21 U.S.C. 346a(g), 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-
2017-0084 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 January 9, 2023. 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-2017-0084, by one of
the following methods:
     Federal eRulemaking Portal: https://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 https://www.epa.gov/dockets/where-send-comments-epa-dockets.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Petition for Exemption

    In the Federal Register of June 8, 2017 (82 FR 26641) (FRL-9961-
14), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C.
346a, announcing the filing of a pesticide petition (PP IN-11014) by
SciReg, Inc., 12733 Director's Loop, Woodbridge, VA 22192 on behalf of
Solvay USA Inc., 504 Carnegie Center, Princeton, NJ 08540. The petition
requested that 40 CFR 180.920 be amended by establishing an exemption
from the requirement of a tolerance for residues of acetic acid, 2-
ethylhexyl ester (CAS Reg. No. 103-09-3) when used as an inert
ingredient (solvent/co-solvent) in pesticide formulations at no more
than 50% when applied to growing crops only under 40 CFR 180.920. That
document referenced a summary of the petition prepared by SciReg, Inc.,
on behalf of Solvay USA Inc., the petitioner, which is available in the
docket, https://www.regulations.gov. There were no comments received in
response to the notice of filing.

III. Inert Ingredient Definition

    Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125 and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): solvents such as alcohols and
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty
acids; carriers such as clay and diatomaceous earth; thickeners such as
carrageenan and modified cellulose; wetting, spreading, and dispersing
agents; propellants in aerosol dispensers; microencapsulating agents;
and emulsifiers. The term ``inert'' is not intended to imply
nontoxicity; the ingredient may or may not be chemically active.
Generally, EPA has exempted inert ingredients from the requirement of a
tolerance based on the low toxicity of the individual inert
ingredients.

IV. Aggregate Risk Assessment and Determination of Safety

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for 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(c)(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. When making a safety determination for an
exemption for the requirement of a tolerance FFDCA section 408(c)(2)(B)
directs EPA to consider the considerations in section 408(b)(2)(C) and
(D). 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 . .
. .'' Section 408(b)(2)(D) lists other factors for EPA consideration
making safety determinations, e.g., the validity, completeness, and
reliability of available data, nature of toxic effects, available
information concerning the cumulative effects of the pesticide chemical
and other substances with a common mechanism of toxicity, and available
information concerning aggregate exposure levels to the pesticide
chemical and other related substances, among others.
    EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be clearly demonstrated that the risks from
aggregate exposure to pesticide chemical residues under reasonably
foreseeable circumstances will pose no harm to human health. In order
to determine the risks from aggregate exposure to pesticide inert
ingredients, the Agency considers the toxicity of the inert in
conjunction with possible exposure to residues of the inert ingredient
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings. If EPA is able to
determine that a tolerance is not necessary to ensure that there is a
reasonable certainty that no harm will result from aggregate exposure
to the inert ingredient, an exemption from the requirement of a
tolerance may be established.
    Consistent with FFDCA section 408(c)(2)(A), and the factors
specified in FFDCA section 408(c)(2)(B), 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 acetic acid, 2-ethylhexyl ester
including exposure resulting from the exemption established by this
action. EPA's assessment of exposures and risks associated with acetic
acid, 2-ethylhexyl ester follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Specific information on the studies received and the nature
of the adverse effects caused by acetic acid, 2-ethylhexyl ester as
well as the no-observed-adverse-effect-level (NOAEL) and the lowest-
observed-adverse-effect-level (LOAEL) from the toxicity studies are
discussed in this unit.
    The toxicological database of acetic acid, 2-ethylhexyl ester is
supported by data on the oxy-alkyl acetates and 2-

ethyl-1-hexanol. EPA has determined that it is appropriate to bridge
the data due to similarities in the manufacturing processes, functional
groups/structure, composition, and physical/chemical properties of
these chemicals.
    Based on the results of surrogate data, acetic acid, 2-ethylhexyl
ester is expected to exhibit low levels of acute toxicity via the oral,
dermal, and inhalation routes of exposure. In the rat, the oral
LD50 is 5,000 mg/kg, the dermal LD50 is 3,160 mg/
kg and the inhalation LC is >1,100 ppm. Studies showed slight/moderate
skin and eye irritation and no protein binding alerts for skin
sensitization were found.
    Two oral subchronic studies, a subchronic inhalation study, and a
developmental study conducted using surrogate chemicals were evaluated.
In a 28-day gavage study in rats with oxo-hexyl acetate, no effects
were seen up to the limit dose of 1,000 mg/kg/day. A 90-day study
gavage study in rats with oxo-octyl acetate showed kidney effects (mild
tubular nephropathy) in high-dose males only at the LOAEL of 1,000 mg/
kg/day. The 90-day inhalation study in rats with 2-ethyl-1-hexanol
showed no effects up to the highest dose tested (638.4 mg/m\3\).
    In a developmental toxicity study, oxo-octyl acetate was
administered by gavage to pregnant female rats. Decreased maternal body
weight and food consumption, as well as fetal vertebral malformations,
were noted at 1,000 mg/kg/day only. Two animals in the high dose group
died, no etiology was given. The developmental and maternal systemic
NOAEL was 500 mg/kg/day, and the LOAEL was 1,000 mg/kg/day.
    No evidence of neurotoxicity or immunotoxicity was reported.
Furthermore, concern for carcinogenicity is low based on negative
results in mutagenicity studies, and the lack of structural alerts for
carcinogenicity.

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 https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/overview-risk-assessment-pesticide-program.
    The hazard profile of acetic acid, 2-ethylhexyl ester is adequately
defined. Overall, acetic acid, 2-ethylhexyl ester is of low acute,
subchronic, and developmental toxicity. No systemic toxicity was
observed at doses that are relevant for risk assessment (i.e., doses
below 1,000 mg/kg/day). Since signs of toxicity were not observed below
1,000 mg/kg/day, no toxicological endpoints of concern or PODs were
identified. Therefore, a qualitative risk assessment for acetic acid,
2-ethylhexyl ester can be performed.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to acetic acid, 2-ethylhexyl ester, EPA considered exposure
under the proposed exemption from the requirement of a tolerance. EPA
assessed dietary exposures from acetic acid, 2-ethylhexyl ester in food
as follows:
    Dietary exposure (food and drinking water) to acetic acid, 2-
ethylhexyl ester may occur following ingestion of foods with residues
from their use in accordance with this exemption. However, a
quantitative dietary exposure assessment was not conducted since a
toxicological endpoint for risk assessment was not identified.
    2. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., textiles (clothing and diapers), carpets, swimming
pools, and hard surface disinfection on walls, floors, tables). Acetic
acid, 2-ethylhexyl ester may be present in pesticide and non-pesticide
products that may be used in and around the home. However, a
quantitative residential exposure assessment was not conducted since a
toxicological endpoint for risk assessment was not identified.
    3. 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.''
    Based on the lack of toxicity below the limit dose, EPA has not
found acetic acid, 2-ethylhexyl ester to share a common mechanism of
toxicity with any other substances, and acetic acid, 2-ethylhexyl ester
does not appear to produce a toxic metabolite produced by other
substances. For the purposes of this tolerance exemption, therefore,
EPA has assumed that acetic acid, 2-ethylhexyl ester does not have a
common mechanism of toxicity with other substances. For information
regarding EPA's efforts to determine which chemicals have a common
mechanism of toxicity and to evaluate the cumulative effects of such
chemicals, see EPA's website at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

D. Additional Safety Factor for the Protection of Infants and Children

    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
(FQPA) Safety Factor (SF). In applying this provision, EPA either
retains the default value of 10X, or uses a different additional safety
factor when reliable data available to EPA support the choice of a
different factor.
    Because there were no adverse effects below 1,000 mg/kg/day
associated with acetic acid, 2-ethylhexyl ester, EPA conducted a
qualitative assessment. As part of that assessment, the Agency did not
use safety factors for assessing risk, and no additional safety factor
is needed for assessing risk to infants and children. Based on an
assessment of acetic acid, 2-ethylhexyl ester, EPA has concluded that
there are no toxicological endpoints of concern for

the U.S. population, including infants and children.

E. Aggregate Risks and Determination of Safety

    Because no toxicological endpoints of concern were identified below
the limit dose, 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 acetic acid, 2-ethylhexyl ester
residues.

V. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since
the Agency is not establishing a numerical tolerance for residues of
acetic acid, 2-ethylhexyl ester in or on any food commodities. EPA is
establishing a limitation on the amount of acetic acid, 2-ethylhexyl
ester that may be used in pesticide formulations applied pre-harvest.
This limitation will be enforced through the pesticide registration
process under the Federal Insecticide, Fungicide, and Rodenticide Act
(``FIFRA''), 7 U.S.C. 136 et seq. EPA will not register any pesticide
formulation for food use that exceeds 50% acetic acid, 2-ethylhexyl
ester in the final pesticide formulation.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is
established for residues of acetic acid, 2-ethylhexyl ester (CAS Reg.
No. 103-09-3) when used as an inert ingredient (solvent/co-solvent) at
a maximum of 50% by weight in pesticide formulations applied to growing
crops only under 40 CFR 180.920.

VII. Statutory and Executive Order Reviews

    This action establishes an exemption from the requirement of a
tolerance 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 exemption 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).

VIII. 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 31, 2022.
Jennifer Saunders,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR chapter I as follows:

PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES
IN FOOD

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.  180.920, amend table 1 by adding, in alphabetical order, an
entry for ``Acetic acid, 2-ethylhexyl ester (CAS Reg. No. 103-09-3)''
to read as follows:

Sec.  180.920  Inert ingredients used pre-harvest; exemptions from the
requirement of a tolerance.

* * * * *

                                               Table 1 to 180.920
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            Inert ingredients                          Limits                               Uses
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Acetic acid, 2-ethylhexyl ester (CAS      Not to exceed 50% by weight in    Solvent/Co-solvent.
 Reg. No. 103-09-3).                       pesticide formulation.

                                                  * * * * * * *
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[FR Doc. 2022-23997 Filed 11-7-22; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: October 23, 2008 (Volume 73, Number 206)]
[Rules and Regulations]
[Page 63074-63076]
[DOCID:fr23oc08-8]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 271

[FRL-8733-7]

Minnesota: Final Authorization of State Hazardous Waste
Management Program Revision

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is granting Minnesota Final authorization of the changes
to its hazardous waste program under the Resource Conservation and
Recovery Act (RCRA). The agency published a proposed rule on July 14,
2008 at 73 FR 40263 and provided for public comment. The public comment
period ended on August 13, 2008. We received no comments. No further
opportunity for comment will be provided. EPA has determined that these
changes satisfy all requirements needed to qualify for Final
authorization, and is proposing to authorize the State's changes
through this proposed final action.

DATES: Effective Date: The final authorization will be effective on
October 23, 2008. This approval will expire automatically if the Joint
Powers Agreement (JPA) between the State of Minnesota and Hennepin
County is terminated or expires without renewal.

ADDRESSES: EPA has established a docket for this action under Docket
Identification No. EPA-R05-RCRA-2008-0468. All documents in the docket
are listed in the http://www.regulations.gov index. Although listed in
the index, some of the information is not publicly available, e.g., CBI
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 in http://www.regulations.gov or in
hard copy. You may view and copy Minnesota's application from 9 a.m. to
4 p.m. at the following addresses: U.S. EPA Region 5, LR-8J, 77 West
Jackson Boulevard, Chicago, Illinois, contact: Gary Westefer (312) 886-
7450; or Minnesota Pollution Control Agency, 520 Lafayette Road, North,
St. Paul, Minnesota 55155, contact Tanya Maurice<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Gary Westefer, Minnesota Regulatory
Specialist, U.S. EPA Region 5, LR-8J, 77 West Jackson Boulevard,
Chicago, Illinois 60604,<PHONE_NUMBER>, e-mail<EMAIL_ADDRESS>
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?

    We conclude that Minnesota's application to revise its authorized
program meets all of the statutory and regulatory requirements
established by RCRA. Therefore, we are granting Minnesota final
authorization to operate its hazardous waste program with the changes
described in the authorization application. Minnesota 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 described in its
revised program application, subject to the limitations of 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 Minnesota, including
issuing permits, until the State is granted authorization to do so.

C. What Is the Effect of the Proposed Authorization Decision?

    The effect of this decision is to allow Minnesota to implement the
EPA approved JPA with Hennepin County. Hennepin County will be able to
conduct an agreed number of inspections, within Hennepin County,
annually on behalf of the Minnesota Pollution Control Agency (MPCA).
The JPA does not affect MPCA's enforcement responsibility.
    Minnesota 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,
which include, among others, authority to:
     Do inspections, require monitoring, tests, analyses, or
reports, and
     Enforce RCRA requirements and suspend or revoke permits.
    This action does not impose additional requirements on the
regulated community because there are no new regulations or inspection
requirements created by this action. Metro County authorities,
including Hennepin County, are already performing inspections at RCRA
facilities.

D. Proposed Rule

    On July 14, 2008 (73 FR 40263), EPA published a proposed rule. In
that rule we proposed granting authorization of changes to Minnesota's
hazardous waste program and opened our decision to public comment. The
agency received no comments on this proposal. EPA found Minnnesota's
RCRA program to be satisfactory.

E. What Has Minnesota Previously Been Authorized for?

    Minnesota initially received final authorization on January 28,
1985, effective February 11, 1985 (50 FR 3756) to implement the RCRA
hazardous waste management program. We granted authorization for
changes to their program on July 20, 1987, effective September 18, 1987
(52 FR 27199); on April 24, 1989, effective June 23, 1989 (54 FR 16361)
amended June 28, 1989 (54 FR 27169); on June 15, 1990, effective August
14, 1990 (55 FR 24232); on June 24, 1991, effective August 23, 1991 (56
FR 28709); on March 19, 1992,

effective May 18, 1992 (57 FR 9501); on March 17, 1993, effective May
17, 1993 (58 FR 14321); on January 20, 1994, effective March 21, 1994
(59 FR 2998); and on May 25, 2000, effective August 23, 2000 (65 FR
33774). Minnesota also received authorization for the U.S. Filter
Recovery Services Project XL on May 22, 2001, effective May 22, 2001
(66 FR 28085).

F. What Changes Are We Authorizing With Today's Action?

    On February 25, 2008, Minnesota submitted a final complete program
revision application, seeking authorization of their changes in
accordance with 40 CFR 271.21. We have determined that Minnesota's
hazardous waste program revision satisfies all of the requirements
necessary to qualify for final authorization. Therefore, we are
granting Minnesota final authorization for the following program
change:

------------------------------------------------------------------------
                                   Federal Register
 Description of state initiated      date and page
change  (include checklist #, if     (and/or RCRA       State authority
           relevant)                   statutory
                                      authority)
------------------------------------------------------------------------
Joint Powers Agreement between    42 U.S.C. 6926 and  Minnesota Statutes
 the Minnesota Pollution Control   6929, 40 CFR        sections 13.02,
 Agency and Hennepin County.       271.16 and 271.17.  effective 1974 as
                                                       amended; 13.39,
                                                       effective 1981 as
                                                       amended; 115.071,
                                                       effective 1973 as
                                                       amended; 115.072,
                                                       effective 1973 as
                                                       amended; 116.07,
                                                       effective 1967 as
                                                       amended; 116.075,
                                                       effective 1971 as
                                                       amended; 471.59,
                                                       effective 1943 as
                                                       amended; 473.151,
                                                       effective 1976 as
                                                       amended; 473.811,
                                                       effective 1975 as
                                                       amended.
------------------------------------------------------------------------

    Minnesota entered into the Joint Powers Agreement under its
statutes. Sections 13.02 and 13.39 of the Minnesota Statutes cover data
practices. Section 13.02 includes political subdivisions such as
counties as well as the State agencies. Section 13.39 provides for
public access to all data except that legally classified as nonpublic.
Section 115.071 provides for adequate enforcement tools including civil
and criminal penalties meeting the requirements of 40 CFR 271.16.
Section 115.072 allows the State agency to seek recovery of its
litigation costs. Section 116.07 authorizes MPCA to adopt hazardous
waste rules. Section 116.072 authorizes the issuance of Administrative
Penalty Orders meeting the requirements of 40 CFR 271.16. Section
116.075 governs treatment of trade secret data as does section 473.151,
which also authorizes sharing of this information to comply with
Federal law as required in 40 CFR 271.17(a). Section 471.59 provides
the legal basis for governmental units such as MPCA and Hennepin County
to enter into a cooperative agreement. Section 473.811 provides the
seven Metro Counties (including Hennepin) authority to inspect waste
facilities for enforcement purposes.

G. Where Are the Revised State Rules Different From the Federal Rules?

    In the changes currently being made to Minnesota's program, there
are no revisions of State regulations.

H. Who Handles Permits After the Authorization Takes Effect?

    Minnesota will issue permits for all the provisions for which it is
authorized and will administer the permits it issues. EPA will continue
to implement and issue permits for HSWA requirements for which
Minnesota is not yet authorized. EPA or Minnesota may enforce
compliance with those permits. There are no new permits, or alterations
to existing permits created by the JPA.

I. How Does Today's Action Affect Indian Country (18 U.S.C. 1151) in
Minnesota?

    Minnesota is not authorized to carry out its hazardous waste
program in Indian country, as defined in 18 U.S.C. 1151. This includes:
    1. All lands within the exterior boundaries of Indian Reservations
within or abutting the State of Minnesota, including:
    a. Bois Forte Indian Reservation.
    b. Fond Du Lac Indian Reservation.
    c. Grand Portage Indian Reservation.
    d. Leech Lake Indian Reservation.
    e. Lower Sioux Indian Reservation.
    f. Mille Lacs Indian Reservation.
    g. Prairie Island Indian Reservation.
    h. Red Lake Indian Reservation.
    i. Shakopee Mdewankanton Indian Reservation.
    j. Upper Sioux Indian Reservation.
    k. White Earth Indian Reservation.
    2. Any land held in trust by the U.S. for an Indian tribe, and
    3. Any other land, whether on or off a reservation that qualifies
as Indian country.
    Therefore, this action has no effect on Indian country. EPA will
continue to implement and administer the RCRA program in these lands.

K. Statutory and Executive Order Reviews

    This proposed rule only authorizes hazardous waste requirements
pursuant to RCRA 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 Review

    The Office of Management and Budget has exempted this rule from its
review under Executive Order 12866 (58 FR 51735, October 4, 1993).

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

    After considering the economic impacts of today's rule on small
entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.), I
certify that this rule will not have a significant economic impact on a
substantial number of small entities.

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, 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
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 publication in the Federal
Register. A major rule cannot take effect until 60 days after it is
published in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 271

    Environmental protection, Administrative practice and procedure,
Confidential business information, Hazardous waste, Hazardous waste
transportation, Indian 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: October 10, 2008.
Bharat Mathur,
Acting Regional Administrator, Region 5.
[FR Doc. E8-25315 Filed 10-22-08; 8:45 am]

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