[Federal Register Volume 84, Number 188 (Friday, September 27, 2019)]
[Notices]
[Pages 51165-51167]
[FR Doc No: 2019-21001]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-6294]

Changes to Existing Medical Software Policies Resulting From
Section 3060 of the 21st Century Cures Act; Guidance for Industry and
Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance entitled ``Changes to Existing
Medical Software Policies Resulting From Section 3060 of the 21st
Century Cures Act.'' This guidance provides clarity on FDA's current
thinking regarding changes made by the 21st Century Cures Act (Cures
Act) to the definition of a medical device and the resulting effect on
guidances related to medical device software.

DATES: The announcement of the guidance is published in the Federal
Register on September 27, 2019.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2017-D-6294 for ``Changes to Existing Medical Software Policies
Resulting from Section 3060 of the 21st Century Cures Act; Guidance for
Industry and Food and Drug Administration Staff.'' Received comments
will be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled
``Changes to Existing Medical Software Policies Resulting from Section
3060 of the 21st Century Cures Act'' to the Office of the Center
Director, Guidance and Policy Development, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002; or the Office
of Communication, Outreach, and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your request.

FOR FURTHER INFORMATION CONTACT: Bakul Patel, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5458, Silver Spring, MD 20993-0002,<PHONE_NUMBER>;
or Stephen Ripley, Center for Biologics Evaluation and Research, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA has long regulated software that meets the definition of a
device. Section 3060(a) of the Cures Act, enacted on December 13, 2016
(Pub. L. 114-255), amended the Federal Food, Drug, and Cosmetic Act
(FD&C Act) to exclude certain software functions from the definition of
device under section 201(h) of the FD&C Act (21 U.S.C. 321(h)). The
software functions that are removed from the definition of device are
described in section 520(o)(1) of the FD&C Act (21 U.S.C. 360j(o)(1)),
and the intended uses of such software functions can be summarized as
follows: (1) For administrative support of a healthcare facility, (2)
for maintaining or encouraging a healthy lifestyle, (3) to serve as
electronic patient records, (4) for transferring, storing, converting
formats, or displaying data, or (5) providing certain types of clinical
decision support to a healthcare provider unless interpreting or
analyzing a clinical test or other device data.
    This guidance provides FDA's current thinking regarding the amended
device definition and the resulting effect the amended definition has
on published FDA guidance, including the policies expressed in guidance
about mobile medical applications; medical device data systems used for
the electronic transfer, storage, display, or conversion of medical
device data; medical image storage devices, used to store or retrieve
medical images electronically; and general wellness products. This
guidance focuses on the first four categories of software functions
that are excluded from the device definition. FDA will address the
fifth category in a separate guidance. Elsewhere in this

issue of the Federal Register, FDA is announcing the availability of
the draft guidance entitled ``Clinical Decision Support Software'' to
provide clarification of its interpretation of section 520(o)(1)(E) of
the FD&C Act, which describes certain software functions intended to
provide decision support for the diagnosis, treatment, prevention,
cure, or mitigation of disease or other conditions. Section 520(o)(2)
of the FD&C Act describes the regulation of a product with multiple
functions, including at least one device function and at least one
software function that is not a device. FDA intends to provide
recommendations on the regulation of such products with
multifunctionality in a separate guidance document.
    FDA considered comments received on the draft guidance that
appeared in the Federal Register of December 8, 2017 (82 FR 57991). FDA
revised the guidance as appropriate in response to the comments. FDA
has provided additional clarity that hardware intended to transfer,
store, convert formats, and display medical device data and results
remain devices, while software functions intended to transfer, store,
convert formats, or display data are no longer devices if they meet the
definition in 520(o)(1)(D) of the FD&C Act. The examples included in
the draft of this guidance that described alarms, alerts, or flags have
been removed from this guidance, because they are not excluded from the
definition of device under section 520(o)(1)(D) of the FD&C Act in that
these functions involve analysis or interpretation of laboratory test
or other device data and results. These functions are addressed in
section 520(o)(1)(E) of the FD&C Act, the regulation of which will be
described in the separate ``Clinical Decision Support Software''
guidance document.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Changes to Existing Medical Software
Policies Resulting from Section 3060 of the 21st Century Cures Act.''
It does not establish any rights for any person and is not binding on
FDA or the public. You can use an alternative approach if it satisfies
the requirements of the applicable statutes and regulations. This
guidance is not subject to Executive Order 12866.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
downloading an electronic copy from the internet. A search capability
for all Center for Devices and Radiological Health guidance documents
is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also
available at https://www.regulations.gov or https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics. Persons unable to download an electronic copy of ``Changes
to Existing Medical Software Policies Resulting from Section 3060 of
the 21st Century Cures Act'' may send an email request to<EMAIL_ADDRESS>to receive an electronic copy of the document.
Please use the document number 17030 to identify the guidance you are
requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information. These collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3520). The collections of information in
the following FDA regulations have been approved by OMB as listed in
the following table:

------------------------------------------------------------------------
          21 CFR part                   Topic           OMB Control No.
------------------------------------------------------------------------
807, subparts A through D.....  Establishment                  0910-0625
                                 Registration And
                                 Device Listing.
807, subpart E................  Premarket                      0910-0120
                                 Notification.
800, 801, and 809.............  Medical Device                 0910-0485
                                 Labeling Regulations.
803...........................  Medical Devices;               0910-0437
                                 Medical Device
                                 Reporting;
                                 Manufacturer
                                 Reporting, Importer
                                 Reporting, User
                                 Facility Reporting,
                                 Distributor
                                 Reporting.
820...........................  Current Good                   0910-0073
                                 Manufacturing
                                 Practice (CGMP);
                                 Quality System (QS)
                                 Regulation.
------------------------------------------------------------------------

    Dated: September 23, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-21001 Filed 9-26-19; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 75, Number 141 (Friday, July 23, 2010)]
[Rules and Regulations]
[Pages 43062-43066]
[FR Doc No: 2010-17975]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R06-OAR-2007-0210; FRL-9177-4]

Approval and Promulgation of Air Quality Implementation Plans;
Texas; Revisions to Emissions Inventory Reporting Requirements and
Conformity of General Federal Actions, Including Revisions Allowing
Electronic Reporting Consistent With the Cross Media Electronic
Reporting Rule

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: EPA is approving Texas State Implementation Plan (SIP)
revisions that were submitted by the Governor of Texas and by the Texas
Commission on Environmental Quality (TCEQ) respectively on December 17,
1999 and February 26, 2007. The revisions pertain to regulations on
reporting air pollution emissions (emission inventories), and
conformity of general federal actions to SIPs. The revisions on
emissions inventories allow the state to collect additional data
related to emissions from stationary sources and contain requirements
for sources in regions that are in violation of a national ambient air
quality standard (NAAQS) to report typical daily emissions of carbon
monoxide and ozone precursor gases during the winter and summer months,
respectively. The revisions also allow for electronic reporting of
documents required under federally authorized programs and designated
state programs, including emissions inventories from stationary
sources. The revisions to regulations on conformity of general federal
actions to SIPs are non-substantive. EPA is approving the revisions
pursuant to Section 110, part D of the Federal Clean Air Act (CAA).

DATES: This rule is effective on September 21, 2010 without further
notice, unless EPA receives relevant adverse comment by August 23,
2010. If EPA receives such comment, EPA will publish a timely
withdrawal in the Federal Register informing the public that this rule
will not take effect.

ADDRESSES: Submit your comments, identified by Docket No. EPA-R06-OAR-
2007-0210, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     EPA Region 6 ``Contact Us'' Web site: http://epa.gov/region6/r6coment.htm. Please click on ``6PD'' (Multimedia) and select
``Air'' before submitting comments.
     E-mail: Mr. Guy Donaldson at<EMAIL_ADDRESS>Please
also send a copy by e-mail to the person listed in the FOR FURTHER
INFORMATION CONTACT section below.
      Fax: Mr. Guy Donaldson, Chief, Air Planning Section (6PD-
L), at fax number<PHONE_NUMBER>.
     Mail: Mr. Guy Donaldson, Chief, Air Planning Section (6PD-
L), Environmental Protection Agency, 1445 Ross Avenue, Suite 1200,
Dallas, Texas 75202-2733.
     Hand or Courier Delivery: Mr. Guy Donaldson, Chief, Air
Planning Section (6PD-L), Environmental Protection Agency, 1445 Ross
Avenue, Suite 1200, Dallas, Texas 75202-2733. Such deliveries are
accepted only between the hours of 8 a.m. and 4 p.m. weekdays except
for legal holidays. Special arrangements should be made for deliveries
of boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-R06-OAR-
2007-0210. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through http://www.regulations.gov or e-mail. The http://www.regulations.gov Web site
is an ``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through http://www.regulations.gov your e-mail address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses.
    Docket: All documents in the docket are listed in the
www.regulations.gov index. Although listed in the index, some
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 www.regulations.gov or in hard copy at the Air Planning Section
(6PD-L), Environmental Protection Agency, 1445 Ross Avenue, Suite 700,
Dallas, Texas 75202-2733. The file will be made available by
appointment for public inspection in the Region 6 FOIA Review Room
between the hours of 8:30 a.m. and 4:30 p.m. weekdays except for legal
holidays. Contact the person listed in the FOR FURTHER INFORMATION
CONTACT paragraph below or Mr. Bill Deese at<PHONE_NUMBER> to make an
appointment. If possible, please make the appointment at least two
working days in advance of your visit. There will be a 15 cent per page
fee for making photocopies of documents. On the day of the visit,
please check in at the EPA Region 6 reception area at 1445 Ross Avenue,
Suite 700, Dallas, Texas.
    The State submittal is also available for public inspection at the
State Air Agency listed below during official business hours by
appointment: Texas Commission on Environmental Quality, Office of Air
Quality, 12124 Park 35 Circle, Austin, Texas 78753.

FOR FURTHER INFORMATION CONTACT: Emad Shahin, Air Planning Section
(6PD-L), Environmental Protection Agency, Region 6, 1445 Ross Avenue,
Suite 700, Dallas, Texas 75202-2733, telephone<PHONE_NUMBER>; fax number
214-665-7263; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, whenever ``we'',
``us'', or ``our'' is used, we mean the EPA.

Outline

I. What action is EPA taking?
II. What is a SIP?
III. What is the background for this action?
IV. What is EPA's evaluation of the revision?
V. Statutory and Executive Order Reviews

I. What action is EPA taking?

    EPA is approving revisions to the Texas SIP that pertain to
regulations on reporting of emissions (emissions inventories) submitted
by stationary sources of air pollutants and conformity of general
Federal actions to SIPs. Revisions were adopted by the State of Texas
on December 1, 1999, and submitted to EPA Region 6 on December 17,
1999. Additional revisions to the emissions inventory regulations were
adopted on February 7, 2007, and submitted to EPA on February 26, 2007.
Specifically we are approving:
     Revisions to 30 TAC 101.10 Emissions Inventory
Requirements, submitted December 1999;
     Revisions to 30 TAC 101.30, Conformity of General Federal
Actions to State Implementation Plans submitted December 1999; and
     The creation of Chapter 19, Electronic Reporting (30 TAC
19) submitted February 2007.
    This approval does not address the revision of 30 TAC 101.1
(Definitions) and adding of 30 TAC 101.28 (Stringency Determination for
Federal Operating Permits) which were submitted on December 17, 1999.
The revisions to section 101.1 were later

superceded by revisions adopted by Texas on September 26, 2001, and
approved by EPA on November 14, 2001 (66 FR 57252). Because the
December 17, 1999, revisions 101.1 were superceded by the 2001
submission which has already been approved, no action or review is
needed here. EPA intends to take action on 30 TAC 101.28 at a later
time. A more complete description of the revisions is available in the
Technical Support Document (TSD) posted on www.regulations.gov.
    We are approving the revisions pursuant to Section 110, part D of
the CAA. The reporting of additional emissions and emissions-related
data will help to achieve and continue to maintain the NAAQS in Texas.
Regulated entities that submit emissions inventories will be allowed to
do so electronically. Approving these revisions and the administrative
changes to the general conformity rule will make the federal SIP
consistent with the state's rules.
    We are also making a ministerial correction to the table in 40 CFR
52.2270(c) to reflect the correct title of the EPA approved regulation
in the Texas SIP. The ministerial correction applies to the table entry
for Section 101.30, which should be titled ``Conformity of General
Federal Actions to State Implementation Plans''.
    EPA is publishing this rule without prior proposal because we view
this as a non-controversial amendment and anticipate no adverse
comments. However, in the proposed rules section of this Federal
Register publication, we are publishing a separate document that will
serve as the proposal to approve the SIP revision if relevant adverse
comments are received. This rule will be effective on September 21,
2010 without further notice unless we receive relevant adverse comment
by August 23, 2010. If we receive relevant adverse comments, we will
publish a timely withdrawal in the Federal Register informing the
public that the rule will not take effect. We will address all public
comments in a subsequent final rule based on the proposed rule. We will
not institute a second comment period on this action. Any parties
interested in commenting must do so now. Please note that if we receive
adverse comment on an amendment, paragraph, or section of this rule and
if that provision may be severed from the remainder of the rule, we may
adopt as final those provisions of the rule that are not the subject of
an adverse comment.

II. What is a SIP?

    Section 110 of the CAA requires states to develop air pollution
regulations and control strategies to ensure that air quality meets the
national ambient air quality standards (NAAQS) established by EPA.
NAAQS are established under section 109 of the CAA and currently
address six criteria pollutants: Carbon monoxide (CO), nitrogen
dioxide, ozone, lead (Pb), particulate matter (PM), and sulfur dioxide
(SO2).
    A SIP is a set of air pollution regulations, control strategies,
other means or techniques, and technical analyses developed by the
state, to ensure that the state meets the NAAQS. It is required by
section 110 and other provisions of the CAA. A SIP protects air quality
primarily by addressing air pollution at its point of origin. A SIP can
be extensive, containing state regulations or other enforceable
documents, and supporting information such as emissions inventories,
monitoring networks, and modeling demonstrations. Each state must
submit regulations and control strategies to EPA for approval and
incorporation into the federally-enforceable SIP.

III. What is the background for this action?

    On December 17, 1999, the Governor of Texas submitted rules for
inclusion into the SIP which amended regulations on emissions
inventories submitted by stationary sources of air pollutants and
conformity of general Federal actions to SIPs. The revisions to 30 TAC
101.10, emissions inventory requirements: (1) Allow the state to
collect additional data related to emissions from stationary sources,
(2) contain requirements for sources in regions that are in violation
of a NAAQS to report typical daily emissions of carbon monoxide and
ozone precursor gases during the winter and summer months,
respectively, (3) delete a requirement to report allowable emissions in
the emissions inventory report, (4) add a requirement for facilities to
report actual emissions for the statewide annual inventory update if a
change in operating conditions results in a change from the most
recently submitted emissions data of at least 5 tons per year in total
annual emissions of volatile organic compounds, NOX, CO,
SO2, Pb, or PM, (5) require submission of calculations
representative of emission producing processes where continuous
emission monitoring system data is not available, and (6) remove
obsolete language that referred to inventory requirements due in 1992
and 1993.
    The revisions to the regulation on conformity of general federal
actions to SIPs, (30 TAC 101.30), are non-substantive changes.
Definitions in the regulation were moved to another part of the Texas
Administrative Code (30 TAC 101.1, Definitions) or were deleted if they
were already part of the Code.
    On October 13, 2005 EPA published the final Cross Media Electronic
Reporting Rule (CROMERR) in the Federal Register, (70 FR 59848).
CROMERR establishes electronic reporting as an acceptable regulatory
alternative to paper reporting and establishes requirements to assure
that electronic documents are as legally dependable as their paper
counterparts. Subpart D of the CROMERR requires states, tribal or local
government agencies that receive or wish to receive electronic reports
under their EPA-authorized programs to apply to EPA for a revision to
those programs and get EPA's approval. On February 26, 2007 Texas
submitted to EPA revisions to the emissions inventory reporting
regulations. The revisions allow for electronic reporting of emissions
consistent with CROMERR.
    On October 14, 2008, the Texas Commission on Environmental Quality
(TCEQ) submitted two applications to EPA for approval under CROMERR;
one for their Net Discharge Monitoring Report (NetDMR) and the second,
for the State of Texas Environmental Electronic Reporting System
(STEERS) electronic document receiving systems for revision or
modification of multiple authorized programs under 40 CFR parts 51, 60,
63, 70, 123, 142, 233-404, 271, 281, and 403. EPA approved the
applications and published a Federal Register notice on April 27, 2009
(74 FR 19082) to allow electronic reporting for specific authorized
programs under Title 40.

IV. What is EPA's evaluation of the revision?

    EPA has evaluated the state's submittals that pertain to (1)
Reporting of emissions and emission-related data by stationary sources
of air pollutants, (2) conformity of general Federal actions to SIPs,
and (3) allowing electronic reporting into Texas' SIP, and have
determined that they meet the applicable requirements of the CAA and
EPA air quality regulations because they are consistent with EPA's
requirements for emissions reporting, conformity, and electronic
reporting. (For further information on our evaluation see the TSD for
this action). This approval will make these revised regulations
federally enforceable. Enforcement of the regulations in a state SIP
before and after it is incorporated into the federally approved SIP is
primarily a state responsibility. However, after the regulations are
federally approved, we are authorized to take enforcement

action against violators. Citizens are also offered legal recourse to
address violations as described in Section 304 of the CAA. Approval
will also help make the federally approved SIP consistent with state
regulations.
    For additional information on our evaluation please refer to the
Technical Support Document found in the electronic docket.

V. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this action merely approves state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the state, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action 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. 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).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by September 21, 2010. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purposes of
judicial review nor does it extend the time within which a petition for
judicial review may be filed, and shall not postpone the effectiveness
of such rule or action. This action may not be challenged later in
proceedings to enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Ozone, Reporting and
recordkeeping requirements, Volatile organic compounds.

    Dated: July 12, 2010.
Al Armendariz,
Regional Administrator, Region 6.

0
40 CFR part 52 is amended as follows:

PART 52--[AMENDED]

0
1. The authority citation for part 52 continues to read as follows:

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

Subpart SS--Texas

0
2. The first table in Sec.  52.2270(c) titled ``EPA Approved Texas
Regulations'' is amended by:
0
a. Immediately before the heading ``Chapter 101--General Air Quality
Rules'' adding a new centered heading in numerical order for ``Chapter
19--Electronic Reporting''; followed by a centered heading for
``Subchapter A--General Provisions''; followed by entries for Sections
19.1 and 19.3; followed by a centered heading for ``Subchapter B--
Electronic Reporting Requirements''; followed by entries for sections
19.10, 19.12, and 19.14.
0
b. Revising the entries for Sections 101.10 and 101.30 under ``Chapter
101--General Air Quality Rules''.
    The additions and revisions read as follows:

Sec.  52.2270  Identification of plan.

* * * * *
    (c) * * *

                                    EPA Approved Regulations in the Texas SIP
----------------------------------------------------------------------------------------------------------------
                                                 State approval/
       State citation           Title/subject    submittal date  EPA approval date           Explanation
----------------------------------------------------------------------------------------------------------------
                                        Chapter 19--Electronic Reporting
                                        Subchapter A--General Provisions
----------------------------------------------------------------------------------------------------------------
Section 19.1................  Definitions......        2/7/2007  July 23, 2010
                                                                  [Insert FR page
                                                                  number where
                                                                  document begins.
Section 19.3................  Applicability....        2/7/2007  July 23, 2010
                                                                  [Insert FR page
                                                                  number where
                                                                  document begins.
----------------------------------------------------------------------------------------------------------------

                                 Subchapter B--Electronic Reporting Requirements
----------------------------------------------------------------------------------------------------------------
Section 19.10...............  Use of Electronic        2/7/2007  July 23, 2010
                               Document                           [Insert FR page
                               Receiving System.                  number where
                                                                  document begins.
Section 19.12...............  Authorized               2/7/2007  July 23, 2010
                               Electronic                         [Insert FR page
                               Signature.                         number where
                                                                  document begins.
Section 19.14...............  Enforcement......        2/7/2007  July 23, 2010
                                                                  [Insert FR page
                                                                  number where
                                                                  document begins.
----------------------------------------------------------------------------------------------------------------
                                     Chapter 101--General Air Quality Rules
                                           Subchapter A--General Rules
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Section 101.10..............  Emissions               12/1/1999  July 23, 2010
                               Inventory                          [Insert FR page
                               Requirements.                      number where
                                                                  document begins.

                                                  * * * * * * *
Section 101.30..............  Conformity of           12/1/1999  July 23, 2010
                               General Federal                    [Insert FR page
                               Actions to State                   number where
                               Implementation                     document begins.
                               Plans.

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

[FR Doc. 2010-17975 Filed 7-22-10; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: October 27, 2008 (Volume 73, Number 208)]
[Rules and Regulations]
[Page 63639-63647]
[DOCID:fr27oc08-14]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 147

[EPA-R08-OW-2007-0153; FRL-8733-4]

Fort Peck Assiniboine and Sioux Tribes in Montana; Underground
Injection Control (UIC) Program; Primacy Approval and Minor Revisions

AGENCY: Environmental Protection Agency.

ACTION: Final rule.

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

SUMMARY: EPA is approving an application from the Fort Peck Assiniboine
and Sioux Tribes in Montana under section 1425 of the Safe Drinking
Water Act (SDWA) to implement an underground injection control (UIC)
program for Class II (oil and gas-related) injection wells. EPA is also
revising regulations that are not specific to the Fort Peck Tribes'
application.

DATES: Effective Dates: This approval is effective November 26, 2008.
The incorporation by reference of certain publications listed in the
regulations is approved by the Director of the Federal Register as of
November 26, 2008.

ADDRESSES: EPA has established a docket for this action under Docket ID
No. EPA-R08-OW-2007-0153. All documents in the docket are listed on the
http://www.regulations.gov Web site. Although listed in the index, some
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 in the Ground Water
Program, EPA Region 8, 1595 Wynkoop Street, Denver, CO 80202-1129. This
Docket Facility is open Monday through Friday, between 8 a.m. and 4
p.m., excluding legal holidays. The Docket telephone number is 303-312-
6079.

FOR FURTHER INFORMATION CONTACT: Douglas Minter, U.S. Environmental
Protection Agency, 8P-W-GW, 1595 Wynkoop Street, Denver, CO 80202-1129.
Phone number:<PHONE_NUMBER>. E-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Regulated Entities

------------------------------------------------------------------------
                                                         North American
                                     Examples of            Industry
           Category             potentially regulated    Classification
                                       entities              System
------------------------------------------------------------------------
State, Local, and Tribal        State, local, and                 924110
 Governments.                    Tribal governments
                                 that own and operate
                                 Class II injection
                                 wells within the
                                 boundaries of the
                                 Fort Peck Indian
                                 Reservation.
Industry......................  Private owners and                221310
                                 operators of Class
                                 II injection wells
                                 within the
                                 boundaries of the
                                 Fort Peck Indian
                                 Reservation.
Municipalities................  Municipal owners and              924110
                                 operators of Class
                                 II injection wells
                                 within the
                                 boundaries of the
                                 Fort Peck Indian
                                 Reservation.
------------------------------------------------------------------------

This table is not intended to be exhaustive, but rather provides a
guide for readers regarding entities likely to be regulated by this
action. This table lists the types of entities that EPA is now aware
could potentially be regulated by this action. Other types of entities
not listed in the table could also be regulated. If you have questions
regarding the applicability of this action to a particular entity,
consult the person listed in the preceding FOR FURTHER INFORMATION
CONTACT section.

II. Introduction

    The Fort Peck Assiniboine and Sioux Tribes of Montana (the ``Fort
Peck Tribes'') applied to EPA under sections 1422 and 1425 of the Safe
Drinking Water Act (``SDWA''), 42 U.S.C. 300h-1 and 300h-4, for
approval of the Fort Peck Tribes' program regulating Class II (oil and
gas-related) underground injection wells on the Fort Peck Indian
Reservation in Montana. Because the Fort Peck Tribes sought primacy
only for the Class II UIC program, EPA is approving their program under
SDWA section 1425. EPA's decision is based on a careful and extensive
legal and technical review of the Tribes' application. As a result of
this review, EPA has determined that the Fort Peck Tribes meet all
requirements of section 1451 of the SDWA, including that the Tribes
have demonstrated adequate jurisdictional authority over all Class II
injection activities on the Reservation, including those conducted by
nonmembers. EPA has also determined that the Tribes' program meets all
applicable requirements for approval under SDWA section 1425, and that
they are capable of administering an effective UIC Class II program in
a manner consistent with the terms and purposes of the SDWA and all
applicable regulations.

III. Legal Authorities

    These regulations are being promulgated under authority of sections
1422, 1425, 1450 and 1451 of the Safe Drinking Water Act, 42 U.S.C.
300h-1, 300h-4, 300j-9 and 300j-11.

A. Requirements for State UIC Programs

    Section 1421 of the SDWA requires the Administrator of EPA to
promulgate minimum requirements for effective State UIC programs to
prevent underground injection activities that endanger underground
sources of drinking water (``USDWs''). Sections 1422 and 1425 of the
SDWA establish requirements for States seeking EPA approval of State
UIC programs.
    States that seek approval for UIC programs under section 1422 of
the SDWA must demonstrate their UIC program is at least as stringent as
the federal minimum requirements. EPA has promulgated a regulation
setting forth the applicable procedures and substantive requirements.
This regulation has been codified in the Code of Federal Regulations
(40 CFR part 145). It includes requirements for State permitting
programs (by reference to certain provisions of 40 CFR parts 124 and
144), compliance evaluation programs, enforcement authority, and
information sharing.
    For States that seek approval under Section 1425 of the SDWA, which
provides an alternative set of requirements for Class II programs, EPA
has published interim guidance in the Federal Register (46 FR 27333-
27339, May 19, 1981), describing how States may apply for program
approval under section 1425 and setting forth the criteria EPA will use
in approving or disapproving applications under this provision. By
demonstrating that its program represents an effective program to
prevent endangerment of USDWs and meets the more general statutory
requirements of section 1421(b)(1)(A) through (D), a State may obtain
primacy for a Class II UIC program.

B. Tribal UIC Programs

    Section 1451 of the SDWA and 40 CFR 145.52 authorize the
Administrator of EPA to treat an Indian Tribe in the same manner as a
State for purposes of the UIC program if the Tribe demonstrates that:
(1) It is recognized by the Secretary of the Interior; (2) it has a
governing body carrying out substantial governmental duties and powers
over a defined area; (3) the functions to be exercised by the Tribe are
within an area of the Tribal government's jurisdiction; and (4) the
Tribe is reasonably expected to be capable, in the EPA Administrator's
judgment, of implementing a program consistent with the terms and
purposes of the SDWA and applicable regulations.
    Under section 1451 of the SDWA and 40 CFR part 145, Subpart E, EPA
is authorized to treat Indian Tribes similarly to States and may
approve Tribal UIC programs. Tribes may apply for primacy under either
or both sections 1422 and 1425 of the SDWA, and the references in 40
CFR part 145 and EPA's May 19, 1981 interim guidance to ``State''
programs are also construed to include eligible ``Tribal'' programs.
(See 40 CFR 145.1(h), which provides that all requirements of parts
124, 144, 145, and 146 that apply to States with UIC primacy also apply
to

Indian Tribes except where specifically noted.)

IV. Fort Peck Tribes' Application

    On December 18, 1995, the Fort Peck Tribes submitted an initial
application for primacy for all Class II wells on all lands within the
exterior boundaries of the Fort Peck Indian Reservation (the
``Reservation''). This application included comments received during
the public comment period and hearing the Tribes held on September 20,
1995. On April 22, 1996, EPA determined that the Fort Peck Tribes'
application was complete. On September 12, 1997, EPA published a notice
in the Federal Register (62 FR 48086-48087) requesting initial comments
and scheduling a public hearing on the application. A similar public
notice was also published in newspapers in Great Falls, Billings, and
Poplar, Montana. A public hearing was held on October 16, 1997, in
Poplar, Montana. Public comments received by EPA and the Tribes, and
EPA's and the Tribes' responses to these comments, are summarized in
the Federal Register notice of EPA's proposed approval of the Tribes'
application noted under VI. Response to Public Comments. On February
12, 1998, EPA provided a set of formal comments to the Fort Peck Tribes
for incorporation into their application. In response, the Fort Peck
Tribes submitted a revised application on July 27, 1999, stating that
the Fort Peck Tribal Executive Board had formally adopted underground
injection control provisions in the Tribal Code and requesting primacy
under both Sections 1422 and 1425 of the SDWA. Since this submission,
EPA and the Tribes have: (1) Conducted additional analyses which have
been incorporated into EPA's Decision Document (see Section V) and the
Tribes' application; and (2) updated their Memorandum of Agreement
(MOA).

V. Explanation of This Action

    After reviewing the very few public comments received on its
January 30, 2008, proposal, EPA is approving the Fort Peck Tribes'
Class II UIC program under SDWA Section 1425 with minor revisions to
the Tribes' Program Description (PD) in their application. As a result,
the Fort Peck Tribes will assume primary enforcement authority (except
for the authority that EPA will retain to take criminal actions: (1)
Against non-Indians; and (2) against Indians where the potential fine
required is greater than $5,000 or where the penalty will require
imprisonment for more than one year, in accordance with 25 U.S.C. 1302)
for regulating all Class II injection activities on all lands within
the exterior boundaries of the Reservation.
    EPA's Decision Document in support of EPA's approval is part of the
public record and is available for public review. The Decision Document
includes findings that the Fort Peck Tribes meet all requirements of
section 1451 of the SDWA, including that the Tribes have demonstrated
adequate jurisdictional authority over all Class II injection
activities on the Reservation, including those conducted by nonmembers,
and that the Fort Peck Tribes' program meets all applicable
requirements for approval under section 1425 of the SDWA.
    The Fort Peck Tribes will administer and enforce their Class II
program with respect to all Class II injection wells on the
Reservation. EPA is amending 40 CFR part 147 to revise the reference to
the EPA-administered program for Class II injection wells on the
Reservation to refer to the Fort Peck Tribes' Class II program. EPA
will continue to administer its UIC program for Class I, III, IV, and V
wells on the Reservation. (Although the Tribal Code prohibits injection
in Class I, III, and IV wells, these prohibitions are separate from the
Class II program that EPA is approving in this action.) As noted above,
EPA will also retain Class II-related criminal enforcement authority
against non-Indians on the Reservation, and against Indians on the
Reservation where the potential fine required is greater than $5,000 or
where the penalty will require imprisonment for more than one year.
    EPA will oversee the Fort Peck Tribes' administration of the Class
II program on the Reservation. Part of EPA's oversight responsibility
will include requiring quarterly reports of non-compliance and annual
UIC program performance reports pursuant to 40 CFR 144.8. The
Memorandum of Agreement between EPA and the Fort Peck Tribes requires,
among other things, that EPA review all permits associated with aquifer
exemptions not previously approved by EPA.
    The provisions of the Tribal Code that contain standards,
requirements, and procedures applicable to owners or operators of Class
II wells on the Reservation are being incorporated by reference into 40
CFR part 147. Any provisions incorporated by reference, as well as all
Tribal permit conditions or permit denials issued pursuant to such
provisions, are enforceable by EPA pursuant to section 1423 of the SDWA
and 40 CFR 147.1(e).

Cross Media Electronic Reporting Rule

    EPA was recently made aware that its analysis of the Fort Peck
Tribes' program with respect to 40 CFR 145.11 in its proposed Decision
Document for this action did not include a discussion of the Tribal
program's consistency with 40 CFR 145.11(a)(33). 40 CFR 145.11(a)(33)
requires that State programs under that part that ``wish to receive
electronic documents'' have legal authority to implement 40 CFR Part 3,
the Cross Media Electronic Reporting Rule (CROMERR) (see 70 FR 59879,
October 13, 2005). CROMERR includes requirements applicable to States,
Tribes, and local governments administering or seeking to administer
authorized programs under Title 40 of the CFR where such programs
receive electronic documents in lieu of paper to satisfy requirements
under such programs. EPA has consulted with the Fort Peck Tribes and
determined that the Tribes' UIC Program does not accept electronic
copies of official documents or records, and therefore has concluded
that the Tribes' program is consistent with 40 CFR 145.11(a)(33).

VI. Response to Public Comments

    EPA published its proposal to approve the Fort Peck Tribes'
application in the Federal Register on January 30, 2008. As part of its
proposal, EPA requested public comment and announced that a public
hearing would be held on February 25, 2008. The public comments
received, and EPA's responses to them, are summarized below.
    Comment: One Class II injection well owner/operator objected to
Tribal regulation of non-tribally owned and operated wells located on
fee land within the Reservation.
    Response: EPA carefully considered the Tribes' application under
the statutory and regulatory framework set out in the SDWA and at 40
CFR 145.52 and concluded that the Tribes have demonstrated adequate
jurisdictional authority over all Class II injection well activities
within the exterior boundaries of the Reservation, including those
conducted by non-Tribal members on fee lands. Detailed findings that
form the basis of this conclusion are included under Section VIII.
Generalized Findings and in EPA's Decision Document supporting EPA's
approval of the Tribes' application, which is available for public
review.
    Comment: This commenter also expressed concern that Tribal
regulation of its Class II injection well would enable the Tribes to
require that: (1) Only Tribal members be hired to operate

and maintain this well; and (2) tribal employment-related monetary
payments be made to the Tribes. This commenter stated that if the
Tribes did regulate their Class II injection well, EPA should
explicitly state in its authorization that Tribal employment or related
monetary payments will not become a condition in the UIC permit.
    Response: This comment raises issues that are outside the scope of
EPA's action approving the Tribes' program. Employment rights and
authority to require monetary payments related to employment are
outside the scope of EPA's Federal UIC program.
    Comment: The Tribes described how their Office of Environmental
Protection (OEP) has further enhanced its technical and administrative
expertise and gained additional experience in assuming responsibility
for Class II injection well program implementation since the original
application was submitted. The Tribes also requested that the following
sections of the Program Description (PD) in their application be
updated: (1) OEP's two year projected budget for implementing its Class
II injection well program; and (2) OEP's organizational chart.
    Response: These two sections of the Tribes' PD have been updated.
In addition, EPA noted in its January 30, 2008, proposal that the
Tribes' original request for an aquifer exemption for the Dakota Sand
formation did not reflect the Tribes' current intent, since the Tribes
have subsequently decided not to pursue this exemption at this time.
Consequently, reference to the Tribes' original request has been
deleted from the PD.
    Comment: The Bureau of Land Management (BLM) expressed its desire
to develop a Memorandum of Understanding (MOU) with the Tribes for
purposes of Class II injection well program implementation.
Specifically, the BLM stated that it would like to encourage the Tribes
to enter into a MOU with the BLM to delineate its trust
responsibilities for Class II injection wells and ensure protection of
tribal or allotted mineral resources on the Reservation. The BLM cited
similar MOUs currently in place with EPA's and Montana's Class II
injection well programs.
    Response: EPA fully supports the development of a new MOU between
the Tribes and the BLM, and has communicated to both parties that it is
willing to assist in the development of this document.

VII. Other Changes to UIC Regulations

    This rule includes the following revisions to 40 CFR 147.1 that are
not specific to the Fort Peck Tribes: (1) Revising 40 CFR 147.1 to
include specific references to Tribal programs in light of the fact
that EPA is approving its first Tribal UIC program; and (2) reserving
40 CFR 147.1(f), because it duplicates 40 CFR 9.1. EPA's regulations
are codifying these minor revisions to account for the fact that such
programs may be run by Tribes.

VIII. Generalized Findings

    As described earlier, EPA's decision to approve the Fort Peck
Tribes to implement a Class II UIC program includes findings that the
Tribes meet all requirements of section 1451 of the SDWA, including
that the Tribes have demonstrated adequate jurisdictional authority
over all Class II injection activities on the Reservation, including
those conducted by nonmembers. With regard to authority over nonmember
activities on nonmember-owned fee lands, EPA finds that the Tribes have
demonstrated such authority under the test established by the United
States Supreme Court in Montana v. United States, 450 U.S. 544 (1981)
(Montana test). Under the Montana test, the Supreme Court held that
absent a Federal grant of authority, Tribes generally lack inherent
jurisdiction over the activities of nonmembers on nonmember-owned fee
lands. However, the Court also found that Indian Tribes retain inherent
sovereign power to exercise civil jurisdiction over nonmember
activities on nonmember-owned fee lands within the reservation where:
(1) Nonmembers enter into ``consensual relationships with the Tribe or
its members, through commercial dealing, contracts, leases, or other
arrangements'' or (2) ``* * * [nonmember] conduct threatens or has some
direct effect on the political integrity, the economic security or the
health or welfare of the Tribe.'' Id. at 565-66. In analyzing Tribal
assertions of inherent authority over nonmember activities on Indian
reservations, the Supreme Court has reiterated that the Montana test
remains the relevant standard. See e.g., Strate v. A-1 Contractors, 520
U.S. 438, 445 (1997) (describing Montana as ``the pathmarking case
concerning Tribal civil authority over nonmembers''); Nevada v. Hicks,
533 U.S. 353, 358 (2001) (``Indian Tribes' regulatory authority over
nonmembers is governed by the principles set forth in [Montana]'');
Plains Commerce Bank v. Long Family Land & Cattle Co., Inc., 128 S.Ct.
2709 (2008).
    As part of the public record available for review, EPA's Decision
Document, and Appendix A thereto, sets forth the Agency's specific
factual findings relating to the Tribes' demonstration of inherent
authority over the UIC Class II activities of nonmembers under the
Montana test and, in particular, the potential for direct effects of
nonmember UIC activities on the Tribes' health, welfare, political
integrity, and economic security that are serious and substantial. In
addition, EPA is publishing the general findings set forth below
regarding the effects of underground injection activities. These
general findings provide a backdrop for EPA's analysis of the Tribes'
assertion of authority under the Montana test and, in effect,
supplement the Agency's factual findings specific to the Fort Peck
Tribes and to the Fort Peck Reservation.

A. General Finding on Human Health and Welfare, and Economic and
Political Impacts

    In enacting part C of the SDWA, Congress generally recognized that
if left unregulated or improperly managed, underground injection can
endanger drinking water sources and thus has the potential to cause
serious and substantial, harmful impacts on human health and welfare,
and economic and political interests. As stated in the legislative
history of the SDWA:

    [U]nderground injection of contaminants is clearly an increasing
problem. Municipalities are increasingly engaging in underground
injection of sewage, sludge, and other wastes. Industries are
injecting chemicals, byproducts, and wastes. Energy production
companies are using injection techniques to increase production and
to dispose of unwanted brines brought to the surface during
production. Even government agencies, including the military, are
getting rid of difficult to manage waste problems by underground
disposal methods. Part C is intended to deal with all of the
foregoing situations insofar as they may endanger USDWs.\1\
---------------------------------------------------------------------------

    \1\ See H.R. Report No. 93-1185, 93rd Congress, 2nd Session
(1974), reprinted in ``A Legislative History of the Safe Drinking
Water Act,'' February, 1982, by the Government Printing Office,
Serial No. 97-9, page 561.

    In response to the problem of the substantial risks inherent in
underground injection activities, Congress enacted section 1421 of the
SDWA ``to assure that drinking water sources, actual and potential, are
not rendered unfit for such use by underground injection of
contaminants.'' \2\
---------------------------------------------------------------------------

    \2\ Id., page 560.
---------------------------------------------------------------------------

    In enacting the SDWA, Congress also generally found that waste
disposal practices, including mismanaged underground injection
activities, could have serious and substantial, harmful impacts on
human health and welfare,

---------------------------------------------------------------------------
and economic and political interests. For example, Congress found that:

    Federal air and water pollution control legislation have
increased the pressure to dispose of waste materials on or below
land, frequently in ways, such as subsurface injection, which
endanger drinking water quality. Moreover, the national economy may
be expected to be harmed by unhealthy drinking water and the
illnesses which may result therefrom.\3\
---------------------------------------------------------------------------

    \3\ Id., page 540.

    Congress specifically noted several economic and political
consequences that can result from the degradation of good quality
drinking water supplies, including: (1) Inhibition of interstate
tourism and travel; (2) loss of economic productivity because of
absence from employment due to illness; (3) limited ability of a town
or region to attract workers; and (4) impaired economic growth of a
town or region, and, ultimately, the nation.\4\
---------------------------------------------------------------------------

    \4\ Id., page 540.
---------------------------------------------------------------------------

    As the Agency charged by Congress with implementing part C of the
SDWA and assuring implementation of effective UIC programs throughout
the United States, EPA agrees with these Congressional findings. EPA
finds that underground injection activities, if not effectively
regulated, can have serious and substantial, harmful impacts on human
health and welfare, and economic and political interests. In making
this finding, EPA recognizes that: (1) The underground injection
activities, currently regulated as five distinct classes of injection
wells as defined in the UIC regulations, typically emplace a variety of
potentially harmful organic and inorganic contaminants (e.g., brines
and hazardous wastes) into the ground; (2) these injected contaminants
have the potential to enter USDWs through a variety of migratory
pathways if injection wells are not properly managed; and (3) once
present in USDWs, these injected contaminants can have harmful impacts
on human health and welfare, and economic and political interests, that
are both serious and substantial.
    In 1980, EPA issued a document entitled, ``Underground Injection
Control Regulations: Statement of Basis and Purpose,'' which provides
the rationale for the Agency in proposing specific regulatory controls
for a variety of underground injection activities. These controls, or
technical requirements (e.g., testing to ensure the mechanical
integrity of an injection well), were promulgated to prevent release of
pollutants through the six primary ``pathways of contamination,'' or
well-established and recognized ``ways in which fluids can escape the
well or injection horizon and enter USDWs.'' \5\ EPA has found that
USDW contamination from one or more of these pathways can occur from
underground injection activity of all classes (I-V) of injection wells.
---------------------------------------------------------------------------

    \5\ ``Underground Injection Control Regulations: Statement of
Basis and Purpose,'' EPA, (May, 1980), page 7.
---------------------------------------------------------------------------

    The six pathways are:
    1. Migration of fluids through a leak in the casing of an injection
well and directly into a USDW;
    2. Vertical migration of fluids through improperly abandoned and
improperly completed wells in the vicinity of injection well
operations;
    3. Direct injection of fluids into or above a USDW;
    4. Upward migration of fluids through the annulus, which is the
space located between the injection well's casing and the well bore.
This can occur if there is sufficient injection pressure to push such
fluid into an overlying USDW;
    5. Migration of fluids from an injection zone through the confining
strata over or underlying a USDW. This can occur if there is sufficient
injection pressure to push fluid through a stratum, which is either
fractured or permeable, and into the adjacent USDW; and
    6. Lateral migration of fluids from within an injection zone into a
portion of that stratum considered to be a USDW. In this scenario,
there may be no impermeable layer or other barrier to prevent migration
of such fluids.\6\
---------------------------------------------------------------------------

    \6\ ``Underground Injection Control Regulations: Statement of
Basis and Purpose,'' EPA, (May, 1980), pp. 7-17.
---------------------------------------------------------------------------

    Moreover, consistent with EPA's findings, the U.S. Department of
the Interior has recognized the ability of injection wells to
contaminate surface waters that are hydrogeologically connected to
contaminated ground water.\7\ Such contamination of surface waters
could further cause negative impacts on human health and welfare, and
economic and political interests.
---------------------------------------------------------------------------

    \7\ See Federal Water Quality Administration's Order COM 5040.10
(1970), as referred to in H.R. Report No. 93-1185, 561.
---------------------------------------------------------------------------

    In sum, EPA finds that, given the common presence of contaminants
in injected fluids, serious and substantial contamination of ground
water and surface water resources can result from improperly regulated
underground injection activities. Moreover, such contamination has the
potential to cause correspondingly serious and substantial harm to
human health and welfare, and economic and political interests. EPA
also has determined that Congress reached a similar finding when it
enacted part C of the SDWA, directing EPA to establish UIC programs to
mitigate and prevent such harm through the proper regulation of
underground injection activities.

B. General Finding on the Protection of Safe Drinking Water Sources as
Necessary To Protect Self-Government

    Consistent with the finding that improperly managed underground
injection activities can have direct harmful effects on human health
and welfare, and economic and political interests that are serious and
substantial, EPA has determined that proper management of such
activities serves the purpose of protecting these human health and
welfare, and economic and political interests. Protection of these
interests is a core governmental function, the exercise of which is
integral to, and is a necessary aspect of, self-government. See 56 FR
64876, 64879 (December 12, 1991); Montana v. EPA, 137 F.3d 1135, 1140-
41 (9th Cir. 1998). EPA has determined that Congress reached this
conclusion in enacting the SDWA, and that Congress considered the water
quality protection functions authorized by the SDWA to be a necessary
act of self government, serving to protect essential and vital public
interests by ensuring that the public's essential drinking water
sources are safe from contamination, including contamination caused by
underground injection activities.
    The above findings regarding the effects on human health and
welfare, and economic and political interests are generally true for
human beings and their communities, wherever they may be located. EPA
has determined that the above findings are generally true for any
Federal, State and/or Tribal government having responsibility for
protecting human health and welfare. With specific relevance to Tribes,
EPA has long noted the relationship between proper environmental
management within Indian country and Tribal self-government and self-
sufficiency. Moreover, in the 1984 EPA Policy for the Administration of
Environmental Programs on Indian Reservations, EPA determined that as
part of the ``principle of Indian self-government,'' Tribal governments
are the ``appropriate non-Federal parties for making decisions and
carrying out program responsibilities affecting Indian reservations,
their environments, and the health and welfare of the reservation
populace,'' consistent with Agency standards and regulations. (EPA
Policy for the Administration of Environmental Programs on Indian
Reservations, Paragraph 2, November 8, 1984). EPA

interprets section 1451 of the SDWA, in providing for the approval of
Tribal programs under the Act, as authorizing eligible Tribes to assume
a primary role in protecting drinking water sources. These general
findings provide a backdrop for EPA's legal analysis of the Fort Peck
Tribes' Application and, in effect, supplement EPA's factual findings
specific to the Fort Peck Tribes and to the Fort Peck Reservation,
contained in the Decision Document and Appendix A thereto, and the Fort
Peck Tribes' similar conclusions, contained in their Application,
pertaining specifically to the Fort Peck Tribes and the Fort Peck
Reservation.

IX. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review

    This action is not a ``significant regulatory action'' under the
terms of Executive Order 12866 (58 FR 51735, October 4, 1993) and is
therefore not subject to review under the EO.

B. Paperwork Reduction Act

    This action does not impose any new information collection burden.
Reporting or recordkeeping requirements will be based on the Tribal
Code, and the Fort Peck Tribes are not subject to the Paperwork
Reduction Act. However, the Office of Management and Budget (OMB) has
previously approved the information collection requirements contained
in the existing regulations (40 CFR sections 144-148) under the
provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. and
has assigned OMB control number 2040-0042. The OMB control numbers for
EPA's regulations in 40 CFR are listed in part 9.

C. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) generally requires an agency
to prepare a regulatory flexibility analysis of any rule subject to
notice and comment rulemaking requirements under the Administrative
Procedure Act or any other statute unless the agency certifies that the
rule will not have a significant economic impact on a substantial
number of small entities. Small entities include small businesses,
small organizations, and small governmental jurisdictions.
    For purposes of assessing the impacts of this rule on small
entities, small entity is defined as: (1) A small business that is
primarily engaged in crude petroleum and natural gas extraction as
defined by NAICS Code 211111 according to Small Business Administration
size standards for entities employing fewer than 500 employees; (2) a
small governmental jurisdiction that is a government of a city, county,
town, school district or special district with a population of less
than 50,000; and (3) a small organization that is any not-for-profit
enterprise which is independently owned and operated and is not
dominant in its field.
    After considering the economic impacts of today's final rule on
small entities, I certify that this action will not have a significant
economic impact on a substantial number of small entities. The small
entities directly regulated by this final rule are owners or operators
of Class II wells, employing fewer than 500 employees. We have
determined that less than 7 small entities will experience an impact of
greater than 1 percent of annual revenues. These entities will be
subject to requirements substantially similar to the existing
requirements of EPA's program under 40 CFR 147.1351(a) and will not
incur significant new costs as a result of this rule. For example, the
Tribes will charge an annual $200 permitting fee for each Class II well
on the Reservation. While this will impose a new cost on a small
entity, this cost will not have a significant economic impact on a
substantial number of small entities due to the few small entities
owning/operating the 23 Class II wells on the Reservation. Moreover, in
approving State UIC programs imposing similar fees on a greater number
of small entities, EPA determined that these new costs did not have a
significant economic impact on a substantial number of small entities.
    Although this rule will not have a significant economic impact on a
substantial number of small entities, EPA nonetheless has tried to
reduce the impact of this rule on small entities. The Fort Peck Tribes'
program is more stringent than the existing Federal program in certain
respects. For example, unlike the existing Federal program, the Fort
Peck Tribes' program requires permits for all Class II wells, with no
provision for authorization by rule. (See section 202(c) of the Tribal
Code.) However, because all Class II wells now in operation on the
Reservation currently hold EPA permits, this more stringent requirement
will not impose a significant economic impact on the owners or
operators of these wells. Other requirements in the Fort Peck Tribes'
program that are more stringent than the existing Federal program are
identified in the Decision Document available for public review and are
mostly minor observation, recording, and reporting requirements. These
requirements also will not impose a significant economic effect on the
owners or operators of these wells.

D. Unfunded Mandates Reform Act

    Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), 2
U.S.C. 1531-1538, requires Federal agencies, unless otherwise
prohibited by law, to assess the effects of their regulatory actions on
State, local, and tribal governments and the private sector. Federal
agencies must also develop a plan to provide notice to small
governments that might be significantly or uniquely affected by any
regulatory requirements. The plan must enable officials of affected
small governments to have meaningful and timely input in the
development of EPA regulatory proposals with significant Federal
intergovernmental mandates and must inform, educate, and advise small
governments on compliance with the regulatory requirements. The rule
imposes no enforceable duty on any State, local or tribal governments
or the private sector. EPA's approval of the Fort Peck Tribes' program
will not constitute a ``Federal mandate'' because there is no
requirement that Tribes establish UIC regulatory programs and because
the program is a Tribal, rather than a Federal program. Thus, this rule
is not subject to the requirements of sections 202 and 205 of the UMRA.
In developing this rule, EPA consulted with small governments under a
plan developed pursuant to section 203 of UMRA concerning the
regulatory requirements in the rule that might significantly or
uniquely affect small governments. The only small government directly
affected by this rule is the Fort Peck Tribal government. Accordingly,
EPA has made the Tribes fully aware of the Federal requirements for
approval to administer their own Class II UIC program; enabled the
Tribes to have meaningful and timely input in the development of this
rule; and informed, educated, and advised the Tribes on compliance with
these requirements. However, the Tribal government is only implementing
and complying with these regulatory requirements because it has: (1)
Voluntarily requested EPA approval to administer their own Class II UIC
program; and (2) voluntarily assumed the Tribal share of the costs for
doing so.

E. Executive Order 13132--Federalism

    Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August
10, 1999), requires EPA to develop an accountable process to ensure
``meaningful and timely input by State

and local officials in the development of regulatory policies that have
federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive Order to include regulations
that have ``substantial direct effects on States, on the relationship
between the national government and States, or on the distribution of
power and responsibilities among the various levels of government.''
    This final rule does not have federalism implications. It will not
have 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,
as specified in Executive Order 13132. This rule will merely put in
place a Tribal regulatory program that is identical in many respects to
the existing Federal program and more stringent in certain respects, as
explained in more detail in the Decision Document. EPA will continue to
administer its Class I, III, IV, and V UIC programs on the Reservation.
Authorizing the Fort Peck Tribes to administer the Class II program
will not substantially alter the distribution of power and
responsibilities among levels of government or significantly change
EPA's relationship with Montana. The substitution of a Tribal Class II
program in place of an EPA-administered Class II program on the Fort
Peck Reservation will impose no additional costs on the State of
Montana. Thus, Executive Order 13132 does not apply to this rule.

F. Executive Order 13175--Consultation and Coordination With Indian
Tribal Governments

    Subject to the Executive Order 13175 (65 FR 67249, November 6,
2000) EPA may not issue a regulation that has tribal implications, that
imposes substantial direct compliance costs, and that is not required
by statute, unless the Federal government provides the funds necessary
to pay the direct compliance costs incurred by tribal governments, or
EPA consults with tribal officials early in the process of developing
the proposed regulation and develops a tribal summary impact statement.
    EPA has concluded that this action will have tribal implications.
However, it will neither impose substantial direct compliance costs on
tribal governments, nor preempt Tribal law. The Fort Peck Tribes have
voluntarily requested EPA approval to administer their own Class II UIC
program and have voluntarily assumed the Tribal share of the costs for
doing so.
    EPA consulted with tribal officials early in the process of
developing this regulation to permit them to have meaningful and timely
input into its development. EPA has made the Tribes fully aware of the
Federal requirements for approval to administer their own Class II UIC
program; enabled the Tribes to have meaningful and timely input in the
development of this rule; and informed, educated, and advised the
Tribes on compliance with these requirements. (See sections IV, V, and
VI for more information.)

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

    EPA interprets EO 13045 (62 FR 19885, April 23, 1997) as applying
only to those regulatory actions that concern health or safety risks,
such that the analysis required under section 5-501 of the EO has the
potential to influence the regulation. This action is not subject to EO
13045 because it approves a tribal primary enforcement (primacy)
program. The Fort Peck Tribes' Class II UIC program is more stringent
than the existing Federal program; the Tribal program requirements have
been established to prevent underground injection activities that
endanger USDWs. The Fort Peck Tribal Executive Board has formally
adopted underground injection control provisions in the Tribal Code in
their program to safeguard these resources for all potential users,
including but not limited to children.

H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use

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

I. National Technology Transfer and Advancement Act

    Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (``NTTAA''), Public Law No. 104-113, 12(d) (15 U.S.C. 272
note) directs EPA to use voluntary consensus standards in its
regulatory activities unless to do so would be inconsistent with
applicable law or otherwise impractical. Voluntary consensus standards
are technical standards (e.g., materials specifications, test methods,
sampling procedures, and business practices) that are developed or
adopted by voluntary consensus standards bodies. NTTAA directs EPA to
provide Congress, through OMB, explanations when the Agency decides not
to use available and applicable voluntary consensus standards.
    This action does not involved technical standards. Therefore, EPA
did not consider the use of any voluntary consensus standards.

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

    Executive Order (EO) 12898 (59 FR 7629 (Feb. 16, 1994)) establishes
federal executive policy on environmental justice. Its main provision
directs federal agencies, to the greatest extent practicable and
permitted by law, to make environmental justice part of their mission
by identifying and addressing, as appropriate, disproportionately high
and adverse human health or environmental effects of their programs,
policies, and activities on minority populations and low-income
populations in the United States.
    EPA has determined that this final rule will not have
disproportionately high and adverse human health or environmental
effects on minority or low-income populations because it increases the
level of environmental protection for all affected populations without
having any disproportionately high and adverse human health or
environmental effects on any population, including any minority or low-
income population. This final rule will put in place a Tribal
regulatory program that is more stringent than the Federal program and,
therefore, will increase the level of protection. For example, unlike
the existing Federal program, the Fort Peck Tribes' program requires
permits for all Class II wells, with no provision for authorization by
rule. Moreover, in approving the Tribes' own Class II program, EPA is
enhancing the Tribes' ability to determine its own UIC affairs on its
Reservation.

K. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule 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). This
rule will be effective November 26, 2008.

List of Subjects in 40 CFR Part 147

    Environmental protection, Indian-lands, Intergovernmental
relations, Reporting and recordkeeping requirements, Water supply,
Incorporation by reference.

    Dated: October 17, 2008.
Stephen L. Johnson,
Administrator.

0
For the reasons set out in the preamble, Title 40 chapter I of the Code
of Federal Regulations is amended as follows:

PART 147--STATE, TRIBAL, AND EPA-ADMINISTERED UNDERGROUND INJECTION
CONTROL PROGRAMS

0
1. The authority citation for part 147 is revised to read as follows:

    Authority: 42 U.S.C. 300h et seq.; and 42 U.S.C. 6901 et seq.

0
2. Part 147 heading is revised as set forth above.

Subpart A--[AMENDED]

0
3. Section 147.1 is revised to read as follows:

Sec.  147.1  Purpose and scope.

    (a) This part sets forth the applicable Underground Injection
Control (UIC) programs for each of the States, territories, and
possessions identified pursuant to the Safe Drinking Water Act (SDWA)
as needing a UIC program, including any Indian country geographically
located within those States, territories, and possessions.
    (b) The applicable UIC programs set forth in this part may be
State-administered programs approved by EPA, Tribally-administered
programs approved by EPA, or Federally-administered programs
promulgated by EPA. In some cases, the applicable UIC program for a
particular area may consist of a State-administered or Tribally-
administered program applicable to some classes of wells and a
Federally-administered program applicable to other classes of wells.
Approval of a State or Tribal program is based upon a determination by
the Administrator that the program meets the requirements of section
1422 or section 1425 of the SDWA, any other applicable provisions of
this subpart, and the applicable provisions of 40 CFR parts 124, 144,
145 and 146. A Federally-administered program is promulgated in those
instances where the State or Tribe has not submitted any program for
approval or where the submitted program does not meet the minimum
Federal statutory and regulatory requirements.
    (c) In the case of each State or Tribal program approved by EPA
pursuant to section 1422 of the SDWA, the relevant subpart describes
the major elements of that program, including the relevant State or
Tribal statutes and regulations, the Statement(s) of Legal Authority,
the Memorandum of Agreement, and the Program Description. State or
Tribal statutes and regulations that contain standards, requirements,
and procedures applicable to owners or operators have been incorporated
by reference pursuant to regulations of the Office of the Federal
Register. Material incorporated by reference is available for
inspection in the appropriate EPA Regional office, in EPA Headquarters,
and at the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, call (202)
741-6030, or go to: http://www.archives.gov/federal_register/code_
of_federal_regulations/ibr_locations.html. Other State or Tribal
statutes and regulations containing standards and procedures that
constitute elements of a State or Tribal program but do not apply
directly to owners or operators have been listed but have not been
incorporated by reference.
    (d) In the case of any program promulgated under section 1422 for a
State or Tribe that is to be administered by EPA, the relevant State or
Tribal subpart makes applicable the provisions of 40 CFR parts 124,
144, 146, and 148, and any other additional requirements pertinent to
the specific State or Tribal program.
    (e) Regulatory provisions incorporated by reference (in the case of
approved State or Tribal programs) or promulgated by EPA (in the case
of EPA-administered programs), and all permit conditions or permit
denials issued pursuant to such regulations, are enforceable by the
Administrator pursuant to section 1423 of the SDWA.
    (f) [Reserved].

Subpart BB--[Amended]

0
4. Section 147.1351 is amended by revising the first sentence of
paragraph (a) and by revising paragraph (b) to read as follows:

Sec.  147.1351  EPA-administered program.

    (a) Contents. The UIC program in the State of Montana for Class I,
III, IV, and V wells, and for all Classes of wells in Indian country in
Montana, except for Class II wells on all lands within the exterior
boundaries of the Fort Peck Indian Reservation, is administered by EPA.
* * *
    (b) Effective dates. The effective date for the UIC program for
Class I, III, IV, and V wells for all lands in Montana, including all
Indian country in Montana, and for Class II wells for all Indian
country in Montana other than the Fort Peck Indian Reservation, is June
25, 1984. The effective date for the EPA-approved State-administered
UIC Class II program for all lands in Montana, except for those in
Indian country, is provided in Sec.  147.1350.

0
5. Subpart JJJ is added to read as follows:

Subpart JJJ--Assiniboine and Sioux Tribes

Sec.  147.3200  Fort Peck Indian Reservation: Assiniboine & Sioux
Tribes--Class II wells.

    The UIC program for Class II injection wells on all lands within
the exterior boundaries of the Fort Peck Indian Reservation is the
program administered by the Assiniboine and Sioux (Fort Peck) Tribes
approved by EPA pursuant to section 1425 of the SDWA. Notice of this
approval was published in the Federal Register on October 27, 2008; the
effective date of this program is November 26, 2008. This program
consists of the following elements as submitted to EPA in the Fort Peck
Tribes' program application:
    (a) Incorporation by Reference. The requirements set forth in the
Fort Peck Tribes' Statutes, Regulations, and Resolutions notebook,
dated June 2008, are hereby incorporated by reference and made part of
the applicable UIC program under the SDWA for the Fort Peck Indian
Reservation. This incorporation by reference was approved by the
Director of the Federal Register in accordance with 5 U.S.C. 552(a) and
1 CFR part 51. Copies may be obtained or inspected at the Fort Peck
Tribal Offices, 605 Indian Avenue, Poplar, Montana 59255, (406) 768-
5155, at the Environmental Protection Agency, Region 8, 1595 Wynkoop
Street, Denver, Colorado 80202-1129,<PHONE_NUMBER>, or at the National
Archives and Records Administration (NARA). For information on the
availability of this material at NARA, call<PHONE_NUMBER>, or go to:
http://www.archives.gov/federal_register/code_of_federal_
regulations/ibr_locations.html.
    (b) Memorandum of Agreement (MOA). The MOA between EPA and the Fort
Peck Tribes signed by EPA on July 31, 2007.
    (c) Statements of legal authority. Letters to EPA from Sonosky,
Chambers, Sachse, Endreson & Perry, dated

September 4, 2003 (attaching a June 17, 2002 letter), March 27, 2001,
July 19, 1999, March 13, 1995, March 16, 1994, November 4, 1992, July
14, 1989, and April 13, 1989, and letters submitted as part of the Fort
Peck Tribes' application.
    (d) Program Description. The Program Description submitted as part
of the Fort Peck Tribes' application, and any other materials submitted
as part of the application or as a supplement to it.

[FR Doc. E8-25317 Filed 10-24-08; 8:45 am]

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