[Federal Register Volume 76, Number 154 (Wednesday, August 10, 2011)]
[Rules and Regulations]
[Pages 49303-49312]
[FR Doc No: 2011-20210]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R05-OAR-2008-0448; FRL-9450-1]

Approval and Promulgation of Air Quality Implementation Plans;
Minnesota; Rules Update

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: EPA is taking several actions on a revision to the Minnesota
State Implementation Plan (SIP) which updates Minnesota's rules in the
SIP. The Minnesota Pollution Control Agency (MPCA) submitted the SIP
revision to EPA on May 5, 2008. The revisions to Minnesota's air
quality rules reflect changes that have occurred to the state rules
since 1998. EPA is approving the majority of MPCA's submittal, which
will result in consistent enforceability of rules at the state and
Federal levels. EPA is deferring action on two sections of Minnesota's
rules related to the state's operating permit program. Finally, EPA is
disapproving the state's request to remove the Minneapolis/St. Paul
vehicle inspection and maintenance program from the Minnesota SIP.
These actions are consistent with the Clean Air Act (CAA) and EPA
regulations.

DATES: This direct final rule will be effective October 11, 2011,
unless EPA receives adverse comments by September 9, 2011. If adverse
comments are received, EPA will publish a timely withdrawal of the
direct final rule in the Federal Register informing the public that the
rule will not take effect.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R05-
OAR-2008-0448, by one of the following methods:
    1. http://www.regulations.gov: Follow the on-line instructions for
submitting comments.
    2. E-mail<EMAIL_ADDRESS>    3. Fax:<PHONE_NUMBER>.
    4. Mail: Doug Aburano, Chief, Control Strategies Section, Air
Programs Branch (AR-18J), U.S. Environmental Protection Agency, 77 West
Jackson Boulevard, Chicago, Illinois 60604.
    5. Hand Delivery: Doug Aburano, Chief, Control Strategies Section,
Air Programs Branch (AR-18J), U.S. Environmental Protection Agency, 77
West Jackson Boulevard, Chicago, Illinois 60604. Such deliveries are
only accepted during the Regional Office normal hours of operation, and
special arrangements should be made for deliveries of boxed
information. The Regional Office official hours of business are Monday
through Friday, 8:30 a.m. to 4:30 p.m., excluding Federal holidays.
    Instructions: Direct your comments to Docket ID No. EPA-R05-OAR-
2008-0448. 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 http://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 http://

www.regulations.gov or in hard copy at the Environmental Protection
Agency, Region 5, Air and Radiation Division, 77 West Jackson
Boulevard, Chicago, Illinois 60604. This facility is open from 8:30
a.m. to 4:30 p.m., Monday through Friday, excluding Federal holidays.
We recommend that you telephone Christos Panos, Environmental Engineer,
at<PHONE_NUMBER>, before visiting the Region 5 office.

FOR FURTHER INFORMATION CONTACT: Christos Panos, Environmental
Engineer, Attainment Planning and Maintenance Section, Air Programs
Branch (AR-18J), U.S. Environmental Protection Agency, Region 5, 77
West Jackson Boulevard, Chicago, Illinois 60604,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA. This supplementary information
section is arranged as follows:

I. Review of State Submittal
II. What action is EPA taking?
III. Statutory and Executive Order Reviews

I. Review of State Submittal

    Since EPA last approved rules into the Minnesota SIP in 1998,
Minnesota has revised or updated many of its air rules. These revisions
have not been incorporated into the Minnesota SIP. This has resulted in
out-of-date rules in the Minnesota SIP, which can result in
inconsistent enforceability of rules at the state and Federal levels.
On May 5, 2008, the Minnesota Pollution Control Agency (MPCA) submitted
a request to update the rules contained in the Minnesota SIP to be
consistent with the rules changes that have occurred at the state
level, as well as to remove a number of regulations that have been
repealed by the state and no longer need to be included in the
Minnesota SIP. The following sections of Minnesota's air rules have
undergone changes: Minnesota Rules chapter 7001 Permits and
Certifications; Minn. R. ch. 7002 Permit Fees; Minn. R. ch. 7005
Definitions and Abbreviations; Minn. R. ch. 7007 Air Emissions Permits;
Minn. R. ch. 7008 Exempt Air Emissions; Minn. R. ch. 7009 Ambient Air
Quality Standards; Minn. R. ch. 7011 Standards for Stationary Sources;
Minn. R. ch. 7017 Monitoring and Testing Requirements; Minn. R. ch.
7019 Emission Inventory Requirements; Minn. R. ch. 7023 Mobile and
Indirect Sources. All rule changes were made under the MPCA's
rulemaking authority and went through appropriate public participation
procedures as required by state law. The rule revisions do not
adversely affect the air quality in the state of Minnesota and are
being approved for their SIP strengthening purposes.

Summary of Changes to Minnesota's Air Rules

    Minnesota performed a series of so-called ``Omnibus'' rulemakings
to implement minor changes, correct mistakes, clarify requirements, and
address comments from industry, MPCA, and EPA to previously adopted
rules. Most of these changes were minor and were not significant enough
to warrant individual rulemakings. The changes correct and improve
rules to make them more understandable, up-to-date, and streamlined.
Summaries of the more significant changes to the rules are described
below.
    The amendments to Minn. R. ch. 7005 add definitions that are used
in Minn. R. ch. 7007, 7008, and 7011. For example, the definition of
``emission factors'' has changed to reflect inclusion of Hazardous Air
Pollutants in EPA databases, to remove the obsolete AIRS database, and
to remove the implied hierarchy of emission factor sources. Other
changes to Minn. R. ch. 7005 include changes to the definitions of
``construction'' and ``begin actual construction'' (and removal of the
term ``commence'' and its definition) for consistency with the EPA
definitions and to clarify what activities may occur prior to obtaining
a permit.
    In Minn. R. ch. 7009, MPCA updated the rule to reflect changes to
the ozone and PM2.5 National Ambient Air Quality Standards (NAAQS). The
state also made changes to the rule to clarify which facilities are
required to prepare emission reduction plans and clarified the
requirements for submitting these plans to the MPCA.
    In Minn. R. ch. 7011, MPCA clarified that the control equipment
rules, Minn. R. 7011.0060 to 7011.0080, apply to facilities that
elected to use default control efficiencies, monitoring and
recordkeeping requirements, and updated the rules so that they reflect
modern day control assumptions and can potentially be utilized by more
permittees to help them determine permit applicability. In addition,
changes were made to the pollution control equipment listed in the
table in Minn. R. 7011.0080 to define certain terms, to add listed
control equipment, and to otherwise clarify requirements for control
efficiency and control equipment operation and monitoring.
    In Minn. R. 7011.0900-0922, MPCA amended the asphalt concrete plant
rules by adding performance standards for hot mix asphalt plants. The
amendments to the asphalt plant performance standards added operation,
record keeping, and monitoring requirements for hot mix asphalt plant
control equipment and dryer burners, outlined performance test
frequency which is dependent on control equipment type, changed the
opacity standard for existing plants to remove allowance of opacity
excursions, listed materials allowed to be processed by hot mix asphalt
plants, and allowed small production throughput increases for all
plants which test at less than 80% of their emission limit and
additional increase for plants with baghouses whose tested emission
rate is less than 50% of their emission limit.
    The changes to Minn. R. ch. 7017 relate to the use of two types of
Continuous Monitoring Systems (CMS)--Continuous Emission Monitoring
Systems (CEMS) and Continuous Opacity Monitoring Systems (COMS). Prior
to the revisions, CMS related requirements were scattered throughout a
number of locations within Minnesota's rules. The current SIP approved
CEMS rule, Minn. R. 7017.1000, was repealed and replaced with more
detailed CMS rules which consolidated all CMS requirements. Minn. R.
7017.1002 to 7017.1220 identify which facilities are required to
install CMS and the various testing, installation, certification,
operational and design requirements for the monitoring systems. The
revised CMS rules also delineate the recordkeeping and submittal
requirements. All facilities which report CMS derived emissions data to
MPCA will be subject to the requirements of the revised CMS rules.
    Amendments that MPCA made to Minn. R. ch. 7019 include changes
related to emission inventory requirements such as: added ammonia as an
inventory pollutant; increased allowable capture efficiency for VOC
controls with hoods from 60 to 80 percent; allow the use of stack test
data up to 10 years old; and, for stack test data over 10 years old, to
allow the use of the higher of either the emission factor derived from
the stack test or the default emission factor.

EPA Deferred Actions

    Minnesota also made several changes to Minn. R. ch. 7007, including
rules to implement Minnesota's operating permit program under Title V
of the CAA. EPA expressed concerns about the approvability of certain
amended provisions related to the state's Title V operating permit
program. Therefore, in a letter dated December 13, 2010, MPCA withdrew
its submittal of Minn. R. ch.

7007 for inclusion into the Minnesota SIP. Although MPCA indicated in
their December 13, 2010, letter that Minn. R. 7007.5000, relating to
Best Available Retrofit Technology, should be approved into the SIP,
MPCA also stated that they made the same request to approve Minn. R.
7007.5000 in their December 30, 2009, submittal of the Minnesota
Regional Haze SIP. EPA will therefore defer rulemaking on Minn. R.
7007.5000 until it takes action on the Minnesota Regional Haze SIP. In
addition, because of the permitting relationship to Minn. R. ch. 7007,
EPA will defer rulemaking on changes to Minn. R. ch. 7002 and Minn. R.
ch. 7008 until MPCA resubmits Minn. R. ch. 7007 for approval into the
SIP. (Minn. R. ch. 7002 addresses permit fees and Minn. R. ch. 7008
addresses permit exemptions and insignificant activities for purposes
of Minn. R. ch. 7007.)

Elimination of Regulations

    In their May 5, 2008, submittal MPCA also requested the removal
from the SIP of several obsolete rules that were repealed by the state
in 2005. This included changes to Minn. R. ch. 7001, which established
permits and certifications issued by the MPCA. Language currently in
the SIP governing mobile sources and indirect source permits for
parking facilities is also obsolete as the rules governing indirect
source permits were repealed by the Minnesota Legislature in 2001. The
portions of Minn. R. ch. 7001 that were retained by MPCA do not relate
to air permits or any air quality related requirements. Therefore, EPA
is granting MPCA's request for removal of Minn. R. ch. 7001 from the
SIP.
    A second set of regulations requested for removal by MPCA are
contained in Minn. R. ch. 7011. This includes a large portion of the
rules in Minn. R. 7011.1200, which relate to Standards of Performance
for waste combustors. The rules as currently approved into the SIP have
been repealed by MPCA, and Minnesota's new rules governing these
sources have been submitted to EPA as a 111(d) plan. EPA agrees with
MPCA that the new rules do not need to be considered for inclusion into
the SIP. MPCA also repealed the state standards of performance for
portland cement plants in Minn. R. 7011.0800, as there are no existing
portland cement plants in the state. All new plants would be subject to
40 CFR part 60, subpart F, ``Standards of Performance for Portland
Cement Plants,'' that was incorporated by reference by the state in
Minn. R. 7011.0830. Finally, the permitting exemption for concrete
manufacturing plants was repealed from Minn. R. 7011.0860 and moved to
Minn. R. ch. 7008. EPA concurs with Minnesota's request and is removing
these regulations from Minn. R. ch. 7011 in the SIP.
    A final set of regulations requested for removal, Minn. R.
7023.1010 through 7023.1105, concern the Minneapolis/St. Paul vehicle
inspection and maintenance program. The Minneapolis/St. Paul carbon
monoxide (CO) nonattainment area was redesignated to attainment on
October 29, 1999, at 64 FR 58344, effective November 29, 1999. MPCA
explained that the Minnesota Legislature determined Minn. R. 7023.1010
through 7023.1105 to be obsolete and deleted or repealed the rules due
to the state's termination of the vehicle inspection and maintenance
program as a result of the area's attainment of the CO NAAQS.
Therefore, in addition to Minn. R. 7023.1010 through 7023.1105, MPCA
also requested that Minnesota Statutes 116.60 through 116.65, which
comprised the vehicle inspection and maintenance program, be removed
from the SIP. In its submittal MPCA states that the rules and the
Statutes are no longer necessary as the area has achieved the NAAQS for
CO. However, in their March 23, 1998, request to redesignate the
Minneapolis/St. Paul CO nonattainment area to attainment, Minnesota
retained the vehicle inspection and maintenance program as a
contingency measure in the maintenance plan for the area. EPA approved
the Minneapolis/St. Paul CO maintenance plan into the SIP as part of
the October 29, 1999, redesignation of the area. Because the CO
maintenance plan is still in effect for the Minneapolis/St. Paul area,
EPA finds that the vehicle inspection and maintenance program (Minn. R.
7023.1010 through 7023.1105 and Minnesota Statutes 116.60 through
116.65) needs to be retained as part of the Minnesota SIP. Therefore
EPA is disapproving the state's request to remove Minn. R. 7023.1010
through 7023.1105 and Minnesota Statutes 116.60 through 116.65 from the
Minnesota SIP.

II. What action is EPA taking?

    EPA is approving the request made by MPCA on May 5, 2008, to revise
and update Minnesota's air rules in the Minnesota SIP. In addition,
this action removes obsolete permit, portland cement plant and waste
combustor rules from the SIP. EPA is not taking action on revisions to
Minn. R. ch. 7007, Rules Governing Air Emission Permits, as the state
withdrew this portion of their submittal from EPA consideration. EPA is
also deferring rulemaking on changes to Minn. R. ch. 7002 and Minn. R.
ch. 7008 until MPCA resubmits Minn. R. ch. 7007 for approval into the
SIP. Finally, EPA is retaining the Minneapolis/St. Paul vehicle
inspection and maintenance program as part of the Minnesota SIP. The
codification of this rulemaking delineates the revised SIP.
    We are publishing this action without prior proposal because we
view this as a noncontroversial 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 state plan amendment if relevant
adverse written comments are filed. This rule will be effective October
11, 2011 without further notice unless we receive relevant adverse
written comments by September 9, 2011. If we receive such comments, we
will withdraw this action before the effective date by publishing a
subsequent document that will withdraw the final action. All public
comments received will then be addressed in a subsequent final rule
based on the proposed action. The EPA will not institute a second
comment period. Any parties interested in commenting on this action
should do so at this time. Please note that if EPA receives adverse
comment on an amendment, paragraph, or section of this rule and if that
provision may be severed from the remainder of the rule, EPA may adopt
as final those provisions of the rule that are not the subject of an
adverse comment. If we do not receive any comments, this action will be
effective October 11, 2011.

III. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA 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 CAA. Accordingly, this
action merely approves state law as meeting Federal requirements and
does not impose additional requirements. 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 CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    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 CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by October 11, 2011. 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. Parties with objections to this direct final rule are
encouraged to file a comment in response to the parallel notice of
proposed rulemaking for this action published in the proposed rules
section of today's Federal Register, rather than file an immediate
petition for judicial review of this direct final rule, so that EPA can
withdraw this direct final rule and address the comment in the proposed
rulemaking. 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, Carbon monoxide,
Hydrocarbons, Incorporation by reference, Intergovernmental relations,
Lead, New source review, Nitrogen dioxide, Ozone, Particulate matter,
Sulfur oxides, Volatile organic compounds.

    Dated: July 29, 2011.
Susan Hedman,
Regional Administrator, Region 5.

    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 Y--Minnesota

0
2. In Sec.  52.1220 the table in paragraph (c) is amended by revising
the entries for ``CHAPTER 7005 DEFINITIONS AND ABBREVIATIONS'',
``CHAPTER 7009 AMBIENT AIR QUALITY STANDARDS'', ``CHAPTER 7011
STANDARDS FOR STATIONARY SOURCES'', ``CHAPTER 7017 MONITORING AND
TESTING REQUIREMENTS'', and ``CHAPTER 7019 EMISSION INVENTORY
REQUIREMENTS'' to read as follows:

Sec.  52.1220  Identification of plan.

* * * * *
    (c) * * *

                                       EPA-Approved Minnesota Regulations
----------------------------------------------------------------------------------------------------------------
                                                        State
    Minnesota  citation           Title/subject       effective      EPA approval date           Comments
                                                         date
----------------------------------------------------------------------------------------------------------------

----------------------------------------------------------------------------------------------------------------
                                                  * * * * * * *
                                   CHAPTER 7005 DEFINITIONS AND ABBREVIATIONS
----------------------------------------------------------------------------------------------------------------
7005.0100..................  Definitions...........     11/19/07  08/10/11, [Insert page  ......................
                                                                   number where the
                                                                   document begins].
7005.0110..................  Abbreviations.........  07/93-06/94  08/10/11, [Insert page  18 SR 1412.
                                                                   number where the
                                                                   document begins].

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                                   CHAPTER 7009 AMBIENT AIR QUALITY STANDARDS
----------------------------------------------------------------------------------------------------------------
7009.0010..................  Definitions...........     10/18/93  05/24/95, 60 FR 27411.
7009.0020..................  Prohibited emissions..     10/18/93  05/24/95, 60 FR 27411.
7009.0050..................  Interpretation and         06/01/99  08/10/11, [Insert page
                              measurement                          number where the
                              methodology, except                  document begins].
                              for hydrogen sulfide.
7009.0060..................  Measurement             07/94-06/95  08/10/11, [Insert page  19 SR 550.
                              methodology for                      number where the
                              hydrogen sulfide.                    document begins].
7009.0070..................  Time of compliance....     10/18/93  05/24/95, 60 FR 27411.  7.

7009.0080..................  State ambient air          06/01/99  08/10/11, [Insert page  ......................
                              quality standards.                   number where the
                                                                   document begins].
----------------------------------------------------------------------------------------------------------------
                                             Air Pollution Episodes
----------------------------------------------------------------------------------------------------------------
7009.1000..................  Air pollution episodes     03/18/96  08/10/11, [Insert page  ......................
                                                                   number where the
                                                                   document begins].
7009.1010..................  Definitions...........     10/18/93  05/24/95, 60 FR 27411.  ......................
7009.1020..................  Episode levels........     10/18/93  05/24/95, 60 FR 27411.  ......................
7009.1030..................  Episode declaration...     10/18/93  05/24/95, 60 FR 27411.  ......................
7009.1040..................  Control actions.......     01/12/98  08/10/11, [Insert page  ......................
                                                                   number where the
                                                                   document begins].
7009.1050..................  Emergency powers......     10/18/93  05/24/95, 60 FR 27411.  ......................
7009.1060..................  Table 1...............     10/18/93  05/24/95, 60 FR 27411   ......................
7009.1070..................  Table 2: emission          10/18/93  05/24/95, 60 FR 27411.  ......................
                              reduction objectives
                              for particulate
                              matter.
7009.1080..................  Table 3: emission          10/18/93  05/24/95, 60 FR 27411.  ......................
                              objectives for sulfur
                              oxides.
7009.1090..................  Table 4: emission          10/18/93  05/24/95, 60 FR 27411.  ......................
                              reduction objectives
                              for nitrogen oxides.
7009.1100..................  Table 5: emission          10/18/93  05/24/95, 60 FR 27411.  ......................
                              reduction objectives
                              for hydrocarbons.
7009.1110..................  Table 6: emission          10/18/93  05/24/95, 60 FR 27411.  ......................
                              reduction objectives
                              for carbon monoxide.
----------------------------------------------------------------------------------------------------------------
                                         Adoption of Federal Regulations
----------------------------------------------------------------------------------------------------------------
7009.9000..................  Determining conformity     11/20/95  04/23/97, 62 FR 19674.  ......................
                              of general Federal
                              actions to state or
                              Federal
                              implementation plans.
----------------------------------------------------------------------------------------------------------------
                                  CHAPTER 7011 STANDARDS FOR STATIONARY SOURCES
----------------------------------------------------------------------------------------------------------------
Generally..................
7011.0010..................  Applicability of           06/01/99  08/10/11, [Insert page  ......................
                              standards of                         number where the
                              performance.                         document begins].
7011.0020..................  Circumvention.........     10/18/93  05/24/95, 60 FR 27411.  ......................
----------------------------------------------------------------------------------------------------------------
                                                Control Equipment
----------------------------------------------------------------------------------------------------------------
7011.0060..................  Definitions...........     11/19/07  08/10/11, [Insert page  ......................
                                                                   number where the
                                                                   document begins].
7011.0061..................  Incorporation by           11/19/07  08/10/11, [Insert page  ......................
                              reference.                           number where the
                                                                   document begins].
7011.0065..................  Applicability.........     11/19/07  08/10/11, [Insert page  ......................
                                                                   number where the
                                                                   document begins].
7011.0070..................  Listed control             11/19/07  08/10/11, [Insert page  ......................
                              equipment and control                number where the
                              equipment                            document begins].
                              efficiencies.
7011.0072..................  Requirements for           11/19/07  08/10/11, [Insert page  ......................
                              certified hoods.                     number where the
                                                                   document begins].
7011.0075..................  Listed control             11/19/07  08/10/11, [Insert page  ......................
                              equipment general                    number where the
                              requirements.                        document begins].
7011.0080..................  Monitoring and record      11/19/07  08/10/11, [Insert page  ......................
                              keeping for listed                   number where the
                              control equipment.                   document begins].
----------------------------------------------------------------------------------------------------------------
                                 Emission Standards for Visible Air Contaminants
----------------------------------------------------------------------------------------------------------------
7011.0100..................  Scope.................     10/18/93  05/24/95, 60 FR 27411.  ......................
7011.0105..................  Visible emission           07/13/98  08/10/11, [Insert page  ......................
                              restrictions for                     number where the
                              existing facilities.                 document begins].
7011.0110..................  Visible emission           01/12/98  08/10/11, [Insert page  ......................
                              restrictions for new                 number where the
                              facilities.                          document begins].
7011.0115..................  Performance tests.....  07/93-06/94  08/10/11, [Insert page  18 SR 1412.
                                                                   number where the
                                                                   document begins].
----------------------------------------------------------------------------------------------------------------
                                      Control of Fugitive Pariculate Matter
----------------------------------------------------------------------------------------------------------------
7011.0150..................  Preventing particulate     03/18/96  08/10/11, [Insert page  ......................
                              matter from becoming                 number where the
                              airborne.                            document begins].
----------------------------------------------------------------------------------------------------------------
                                 Indirect Heating Fossil-Fuel-Burning Equipment
----------------------------------------------------------------------------------------------------------------
7011.0500..................  Definitions...........     10/18/93  05/24/95, 60 FR 27411.  ......................

7011.0505..................  Determination of           10/18/93  05/24/95, 60 FR 27411.  ......................
                              applicable standards
                              of performance.
7011.0510..................  Standards of               07/13/98  08/10/11, [Insert page  ......................
                              performance for                      number where the
                              existing indirect                    document begins].
                              heating equipment.
7011.0515..................  Standards of               07/13/98  08/10/11, [Insert page  ......................
                              performance for new                  number where the
                              indirect heating                     document begins].
                              equipment.
7011.0520..................  Allowance for stack        10/18/93  05/24/95, 60 FR 27411.
                              height for indirect
                              heating equipment.
7011.0525..................  High heating value....     10/18/93  05/24/95, 60 FR 27411.
7011.0530..................  Performance test           10/18/93  05/24/95, 60 FR 27411.
                              methods.
7011.0535..................  Performance test           01/12/98  08/10/11, [Insert page
                              procedures.                          number where the
                                                                   document begins].
7011.0540..................  Derate................     10/18/93  05/24/95, 60 FR 27411.
7011.0545..................  Table I: existing          10/18/93  05/24/95, 60 FR 27411.
                              indirect heating
                              equipment.
7011.0550..................  Table II: new indirect     10/18/93  05/24/95, 60 FR 27411.
                              heating equipment.
7011.0551..................  Record keeping and         05/11/98  08/10/11, [Insert page
                              reporting for                        number where the
                              indirect heating                     document begins].
                              units combusting
                              solid waste.
7011.0553..................  Nitrogen oxides         07/94-06/95  08/10/11, [Insert page  19 SR 1666.
                              emission reduction                   number where the
                              requirements for                     document begins].
                              affected sources.
----------------------------------------------------------------------------------------------------------------
                                  Direct Heating Fossil-Fuel-Burning Equipment
----------------------------------------------------------------------------------------------------------------
7011.0600..................  Definitions...........     10/18/93  05/24/95, 60 FR 27411.  ......................
7011.0605..................  Determination of           10/18/93  05/24/95, 60 FR 27411.  ......................
                              applicable standards
                              of performance.
7011.0610..................  Standards of               07/13/98  08/10/11, [Insert page  ......................
                              performance for                      number where the
                              fossil-fuel-burning                  document begins].
                              direct heating
                              equipment.
7011.0615..................  Performance test           10/18/93  05/24/95, 60 FR 27411.  ......................
                              methods.
7011.0620..................  Performance test           01/12/98  08/10/11, [Insert page  ......................
                              procedures.                          number where the
                                                                   document begins].
7011.0625..................  Record keeping and         05/11/98  08/10/11, [Insert page  ......................
                              reporting for direct                 number where the
                              heating units                        document begins].
                              combusting solid
                              waste.
----------------------------------------------------------------------------------------------------------------
                                          Industrial Process Equipment
----------------------------------------------------------------------------------------------------------------
7011.0700..................  Definitions...........     10/18/93  05/24/95, 60 FR 27411.
7011.0705..................  Scope.................     10/18/93  05/24/95, 60 FR 27411.
7011.0710..................  Standards of               07/13/98  08/10/11, [Insert page  ......................
                              performance for pre-                 number where the
                              1969 industrial                      document begins].
                              process equipment.
7011.0715..................  Standards of               10/18/93  05/24/95, 60 FR 27411.  ......................
                              performance for post-
                              1969 industrial
                              process equipment.
7011.0720..................  Performance test           10/18/93  05/24/95, 60 FR 27411.  ......................
                              methods.
7011.0725..................  Performance test        07/93-06/94  08/10/11, [Insert page  18 SR 1412.
                              procedures.                          number where the
                                                                   document begins].
7011.0730..................  Table 1...............     11/19/07  08/10/11, [Insert page  ......................
                                                                   number where the
                                                                   document begins].
7011.0735..................  Table 2...............     10/18/93  05/24/95, 60 FR 27411.
----------------------------------------------------------------------------------------------------------------
                              Concrete Manufacturing Plant Standards Of Performance
----------------------------------------------------------------------------------------------------------------
7011.0850..................  Definitions...........     04/21/03  08/10/11, [Insert page  ......................
                                                                   number where the
                                                                   document begins].
7011.0852..................  Standards of               11/23/98  08/10/11, [Insert page  ......................
                              performance for                      number where the
                              concrete                             document begins].
                              manufacturing plants.
7011.0854..................  Concrete manufacturing     11/23/98  08/10/11, [Insert page  ......................
                              plant control                        number where the
                              equipment                            document begins].
                              requirements.
7011.0857..................  Preventing particulate     11/23/98  08/10/11, [Insert page  ......................
                              matter from becoming                 number where the
                              airborne.                            document begins].
7011.0858..................  Noise.................     11/23/98  08/10/11, [Insert page  ......................
                                                                   number where the
                                                                   document begins].
7011.0859..................  Shutdown and breakdown     11/23/98  08/10/11, [Insert page  ......................
                              procedures.                          number where the
                                                                   document begins].
7011.0865..................  Incorporations by          04/21/03  08/10/11, [Insert page  ......................
                              reference.                           number where the
                                                                   document begins].
7011.0870..................  Stage-one vapor            04/21/03  08/10/11, [Insert page  ......................
                              recovery.                            number where the
                                                                   document begins].
----------------------------------------------------------------------------------------------------------------
                                             Hot Mix Asphalt Plants
----------------------------------------------------------------------------------------------------------------
7011.0900..................  Definitions...........     06/01/99  08/10/11, [Insert page  ......................
                                                                   number where the
                                                                   document begins].

7011.0903..................  Compliance with            04/15/96  08/10/11, [Insert page  ......................
                              ambient air quality                  number where the
                              standards.                           document begins].
7011.0905..................  Standards of               04/15/96  08/10/11, [Insert page  ......................
                              performance for                      number where the
                              existing asphalt                     document begins].
                              concrete plants.
7011.0911..................  Maintenance of dryer       04/15/96  08/10/11, [Insert page  ......................
                              burner.                              number where the
                                                                   document begins].
7011.0913..................  Hot mix asphalt plant      05/24/04  08/10/11, [Insert page  ......................
                              materials, fuels, and                number where the
                              additives operating                  document begins].
                              requirements.
7011.0917..................  Asphalt plant control      11/29/04  08/10/11, [Insert page  ......................
                              equipment                            number where the
                              requirements.                        document begins].
7011.0920..................  Performance tests.....     04/15/96  08/10/11, [Insert page  ......................
                                                                   number where the
                                                                   document begins].
7011.0922..................  Operational                04/15/96  08/10/11, [Insert page  ......................
                              requirements and                     number where the
                              limitations from                     document begins].
                              performance tests.
----------------------------------------------------------------------------------------------------------------
                                     Bulk Agricultural Commodity Facilities
----------------------------------------------------------------------------------------------------------------
7011.1000..................  Definitions...........     10/18/93  05/24/95, 60 FR 27411.  ......................
7011.1005..................  Standards of               11/19/07  08/10/11, [Insert page  ......................
                              performance for dry                  number where the
                              bulk agricultural                    document begins].
                              commodity facilities.
7011.1010..................  Nuisance..............     10/18/93  05/24/95, 60 FR 27411.  ......................
7011.1015..................  Control requirements       10/18/93  05/24/95, 60 FR 27411.  ......................
                              schedule.
----------------------------------------------------------------------------------------------------------------
                                            Coal Handling Facilities
----------------------------------------------------------------------------------------------------------------
7011.1100..................  Definitions...........     10/18/93  05/24/95, 60 FR 27411.  ......................
7011.1105..................  Standards of               01/12/98  08/10/11, [Insert page  ......................
                              performance for                      number where the
                              certain coal handling                document begins].
                              facilities.
7011.1110..................  Standards of               01/12/98  08/10/11, [Insert page  ......................
                              performance for                      number where the
                              existing outstate                    document begins].
                              coal handling
                              facilities.
7011.1115..................  Standards of               10/18/93  05/24/95, 60 FR 27411.  ......................
                              performance for
                              pneumatic coal-
                              cleaning equipment
                              and thermal dryers at
                              any coal handling
                              facility.
7011.1120..................  Exemption.............     10/18/93  05/24/95, 60 FR 27411.  ......................
7011.1125..................  Cessation of               10/18/93  05/24/95, 60 FR 27411.  ......................
                              operations.
7011.1135..................  Performance test        07/93-06/94  08/10/11, [Insert page  18 SR 1412.
                              procedures.                          number where the
                                                                   document begins].
7011.1140..................  Dust suppressant           10/18/93  05/24/95, 60 FR 27411.  ......................
                              agents.
----------------------------------------------------------------------------------------------------------------
                                                Waste Combustors
----------------------------------------------------------------------------------------------------------------
7011.1201..................  Definitions...........     05/11/98  08/10/11, [Insert page  ......................
                                                                   number where the
                                                                   document begins].
7011.1205..................  Incorporations by          05/11/98  08/10/11, [Insert page  ......................
                              reference.                           number where the
                                                                   document begins].
----------------------------------------------------------------------------------------------------------------
                                                  Incinerators
----------------------------------------------------------------------------------------------------------------
7011.1300..................  Definitions...........     10/18/93  05/24/95, 60 FR 27411.  ......................
7011.1305..................  Standards of               07/13/98  08/10/11, [Insert page  ......................
                              performance for                      number where the
                              existing sewage                      document begins].
                              sludge incinerators.
7011.1310..................  Standards of               01/12/98  08/10/11, [Insert page  ......................
                              performance for new                  number where the
                              sewage sludge                        document begins].
                              incinerators.
7011.1315..................  Monitoring of              10/18/93  05/24/95, 60 FR 27411.  ......................
                              operations.
7011.1320..................  Performance test           10/18/93  05/24/95, 60 FR 27411.  ......................
                              methods.
7011.1325..................  Performance test        07/93-06/94  08/10/11, [Insert page  18 SR 1412.
                              procedures.                          number where the
                                                                   document begins].
----------------------------------------------------------------------------------------------------------------
                                              Petroleum Refineries
----------------------------------------------------------------------------------------------------------------
7011.1400..................  Definitions...........     10/18/93  05/24/95, 60 FR 27411.  ......................
7011.1405..................  Standards of               07/13/98  08/10/11, [Insert page  ......................
                              performance for                      number where the
                              existing affected                    document begins].
                              facilities at
                              petroleum refineries.
7011.1410..................  Standards of               07/13/98  08/10/11, [Insert page  ......................
                              performance for new                  number where the
                              affected facilities                  document begins].
                              at petroleum
                              refineries.
7011.1415..................  Exemptions............     01/12/98  08/10/11, [Insert page  ......................
                                                                   number where the
                                                                   document begins].
7011.1420..................  Emission monitoring...     03/01/99  08/10/11, [Insert page  ......................
                                                                   number where the
                                                                   document begins].
7011.1425..................  Performance test           10/18/93  05/24/95, 60 FR 27411.  ......................
                              methods.

7011.1430..................  Performance test        07/93-06/94  08/10/11, [Insert page  18 SR 1412.
                              procedures.                          number where the
                                                                   document begins].
----------------------------------------------------------------------------------------------------------------
                          Liquid Petroleum And Volatile Organic Liquid Storage Vessels
----------------------------------------------------------------------------------------------------------------
7011.1500..................  Definitions...........     06/01/99
7011.1505..................  Standards of               10/18/93  05/24/95, 60 FR 27411.  ......................
                              performance for
                              storage vessels.
7011.1510..................  Monitoring of              10/18/93  05/24/95, 60 FR 27411.  ......................
                              operations.
7011.1515..................  Exception.............     10/18/93  05/24/95, 60 FR 27411.  ......................
----------------------------------------------------------------------------------------------------------------
                                              Sulfuric Acid Plants
----------------------------------------------------------------------------------------------------------------
7011.1600..................  Definitions...........     01/12/98
7011.1605..................  Standards of               10/18/93  05/24/95, 60 FR 27411.  ......................
                              performance of
                              existing sulfuric
                              acid production units.
7011.1615..................  Continuous emission        03/01/99  08/10/11, [Insert page  ......................
                              monitoring.                          number where the
                                                                   document begins].
7011.1620..................  Performance test           10/18/93  05/24/95, 60 FR 27411.  ......................
                              methods.
7011.1625..................  Performance test                 *1  08/10/11, [Insert page  ......................
                              procedures.                          number where the
                                                                   document begins].
7011.1630..................  Exceptions............  07/93-06/94  08/10/11, [Insert page  18 SR 1412.
                                                                   number where the
                                                                   document begins].
----------------------------------------------------------------------------------------------------------------
                                               Nitric Acid Plants
----------------------------------------------------------------------------------------------------------------
7011.1700..................  Definitions...........     10/18/93  05/24/95, 60 FR 27411.  ......................
7011.1705..................  Standards of               01/12/98  08/10/11, [Insert page  ......................
                              performance for                      number where the
                              existing nitric acid                 document begins].
                              production units.
7011.1715..................  Emission monitoring...     03/01/99  08/10/11, [Insert page  ......................
                                                                   number where the
                                                                   document begins].
7011.1720..................  Performance test           10/18/93  05/24/95, 60 FR 27411.  ......................
                              methods.
7011.1725..................  Performance test        07/93-06/94  08/10/11, [Insert page  18 SR 1412.
                              procedures.                          number where the
                                                                   document begins].
----------------------------------------------------------------------------------------------------------------
                               Emission Standards For Inorganic Fibrous Materials
----------------------------------------------------------------------------------------------------------------
7011.2100..................  Definitions...........     10/18/93  05/24/95, 60 FR 27411.  ......................
7011.2105..................  Spraying of inorganic      10/18/93  05/24/95, 60 FR 27411.  ......................
                              fibrous materials.
----------------------------------------------------------------------------------------------------------------
                                     Stationary Internal Combustion Engines
----------------------------------------------------------------------------------------------------------------
7011.2300..................  Standards of               02/21/95  08/10/11, [Insert page  ......................
                              performance for                      number where the
                              stationary internal                  document begins].
                              combustion engines.
----------------------------------------------------------------------------------------------------------------
                                CHAPTER 7017 MONITORING AND TESTING REQUIREMENTS
----------------------------------------------------------------------------------------------------------------
7017.0100..................  Establishing               02/28/95  10/14/97, 62 FR 53239.  ......................
                              violations.
----------------------------------------------------------------------------------------------------------------
                                         Compliance Assurance Monitoring
----------------------------------------------------------------------------------------------------------------
7017.0200..................  Incorporation by           05/24/04  08/10/11, [Insert page  ......................
                              reference.                           number where the
                                                                   document begins].
----------------------------------------------------------------------------------------------------------------
                                          Continuous Monitoring Systems
----------------------------------------------------------------------------------------------------------------
7017.1002..................  Definitions...........     03/01/99  08/10/11, [Insert page  ......................
                                                                   number where the
                                                                   document begins].
7017.1004..................  Applicability.........     03/01/99  08/10/11, [Insert page  ......................
                                                                   number where the
                                                                   document begins].
7017.1006..................  Requirement to install     03/01/99  08/10/11, [Insert page  ......................
                              monitor.                             number where the
                                                                   document begins].
7017.1010..................  Incorporation of           03/01/99  08/10/11, [Insert page  ......................
                              Federal monitoring                   number where the
                              requirements by                      document begins].
                              reference.
7017.1020..................  Continuous emission     07/94-06/95  08/10/11, [Insert page  19 SR 1666.
                              monitoring by                        number where the
                              affected sources.                    document begins].
7017.1030..................  Agency access to           03/01/99  08/10/11, [Insert page  ......................
                              witness or conduct                   number where the
                              tests.                               document begins].
7017.1035..................  Testing required......     03/01/99  08/10/11, [Insert page  ......................
                                                                   number where the
                                                                   document begins].
7017.1040..................  Installation               03/01/99  08/10/11, [Insert page  ......................
                              requirements.                        number where the
                                                                   document begins].

7017.1050..................  Monitor certification      03/01/99  08/10/11, [Insert page  ......................
                              and recertification                  number where the
                              test.                                document begins].
7017.1060..................  Precertification test      03/01/99  08/10/11, [Insert page  ......................
                              requirements.                        number where the
                                                                   document begins].
7017.1070..................  Certification test         03/01/99  08/10/11, [Insert page  ......................
                              procedures.                          number where the
                                                                   document begins].
7017.1080..................  Certification test         03/01/99  08/10/11, [Insert page  ......................
                              report requirements.                 number where the
                                                                   document begins].
7017.1090..................  Monitor operational        03/01/99  08/10/11, [Insert page  ......................
                              requirements.                        number where the
                                                                   document begins].
7017.1100..................  Evidence of                03/01/99  08/10/11, [Insert page  ......................
                              noncompliance.                       number where the
                                                                   document begins].
7017.1110..................  Excess emissions           03/01/99  08/10/11, [Insert page  ......................
                              reports.                             number where the
                                                                   document begins].
7017.1120..................  Submittals............     03/01/99  08/10/11, [Insert page  ......................
                                                                   number where the
                                                                   document begins].
7017.1130..................  Record keeping........     03/01/99  08/10/11, [Insert page  ......................
                                                                   number where the
                                                                   document begins].
7017.1135..................  Applicability.........     03/01/99  08/10/11, [Insert page  ......................
                                                                   number where the
                                                                   document begins].
7017.1140..................  CEMS design                03/01/99  08/10/11, [Insert page  ......................
                              requirements.                        number where the
                                                                   document begins].
7017.1150..................  CEMS testing company       03/01/99  08/10/11, [Insert page  ......................
                              requirement.                         number where the
                                                                   document begins].
7017.1160..................  CEMS monitoring data..     03/01/99  08/10/11, [Insert page  ......................
                                                                   number where the
                                                                   document begins].
7017.1170..................  Quality assurance and      03/01/99  08/10/11, [Insert page  ......................
                              control requirements                 number where the
                              for CEMS.                            document begins].
7017.1180..................  Quality control            03/01/99  08/10/11, [Insert page  ......................
                              reporting and                        number where the
                              notification                         document begins].
                              requirements for CEMS.
7017.1185..................  Applicability.........     03/01/99  08/10/11, [Insert page  ......................
                                                                   number where the
                                                                   document begins].
7017.1190..................  COMS design                03/01/99  08/10/11, [Insert page  ......................
                              requirements.                        number where the
                                                                   document begins].
7017.1200..................  COMS monitoring data..     03/01/99  08/10/11, [Insert page  ......................
                                                                   number where the
                                                                   document begins].
7017.1210..................  Quality assurance and      03/01/99  08/10/11, [Insert page  ......................
                              control requirements                 number where the
                              for COMS.                            document begins].
7017.1220..................  Quality assurance and      03/01/99  08/10/11, [Insert page  ......................
                              control reporting                    number where the
                              requirements for COMS.               document begins].
----------------------------------------------------------------------------------------------------------------
                                                Performance Tests
----------------------------------------------------------------------------------------------------------------
7017.2001..................  Applicability.........     07/13/98  08/10/11, [Insert page  ......................
                                                                   number where the
                                                                   document begins].
7017.2005..................  Definitions...........     11/19/07  08/10/11, [Insert page  ......................
                                                                   number where the
                                                                   document begins].
7017.2010..................  Incorporation of test      07/13/98  08/10/11, [Insert page  ......................
                              methods by reference.                number where the
                                                                   document begins].
7017.2015..................  Incorporation of           07/13/98  08/10/11, [Insert page  ......................
                              Federal testing                      number where the
                              requirements by                      document begins].
                              reference.
7017.2018..................  Submittals............     05/24/04  08/10/11, [Insert page  ......................
                                                                   number where the
                                                                   document begins].
7017.2020..................  Performance tests          11/19/07  08/10/11, [Insert page  ......................
                              general requirements.                number where the
                                                                   document begins].
7017.2025..................  Operational                03/01/99  08/10/11, [Insert page  ......................
                              requirements and                     number where the
                              limitations.                         document begins].
7017.2030..................  Performance test           03/01/99  08/10/11, [Insert page  ......................
                              pretest requirements.                number where the
                                                                   document begins].
7017.2035..................  Performance test           07/13/98  08/10/11, [Insert page  ......................
                              reporting                            number where the
                              requirements.                        document begins].
7017.2040..................  Certification of           07/13/98  05/13/02, 67 FR 31963.  ......................
                              performance test
                              results.
7017.2045..................  Quality assurance          07/13/98  08/10/11, [Insert page  ......................
                              requirements.                        number where the
                                                                   document begins].
7017.2050..................  Performance test           07/13/98  08/10/11, [Insert page  ......................
                              methods.                             number where the
                                                                   document begins].
7017.2060..................  Performance test           07/13/98  08/10/11, [Insert page  ......................
                              procedures.                          number where the
                                                                   document begins].
----------------------------------------------------------------------------------------------------------------

                                  CHAPTER 7019 EMISSION INVENTORY REQUIREMENTS
----------------------------------------------------------------------------------------------------------------
7019.1000..................  Shutdowns and              06/01/99  08/10/11, [Insert page  ......................
                              breakdowns.                          number where the
                                                                   document begins].
7019.3000..................  Emission inventory....     11/19/07  08/10/11, [Insert page  ......................
                                                                   number where the
                                                                   document begins].
7019.3020..................  Calculation of actual      11/19/07  08/10/11, [Insert page  ......................
                              emissions for                        number where the
                              emission inventory.                  document begins].
7019.3030..................  Method of calculation.     11/19/07  08/10/11, [Insert page  ......................
                                                                   number where the
                                                                   document begins].
7019.3040..................  Continuous emission        03/01/99  08/10/11, [Insert page  ......................
                              monitor (CEM) data.                  number where the
                                                                   document begins].
7019.3050..................  Performance test data.     11/19/07  08/10/11, [Insert page  ......................
                                                                   number where the
                                                                   document begins].
7019.3060..................  Volatile organic               1997  08/10/11, [Insert page  21 SR 165.
                              compound (VOC)                       number where the
                              material balance.                    document begins].
7019.3070..................  So material balance...         1997  08/10/11, [Insert page  21 SR 165.
                                                                   number where the
                                                                   document begins].
7019.3080..................  Emission factors......     11/19/07  08/10/11, [Insert page  ......................
                                                                   number where the
                                                                   document begins].
7019.3090..................  Enforceable                    1997  08/10/11, [Insert page  21 SR 165.
                              limitations.                         number where the
                                                                   document begins].
7019.3100..................  Facility proposal.....         1997  08/10/11, [Insert page  21 SR 165.
                                                                   number where the
                                                                   document begins].

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

* * * * *
[FR Doc. 2011-20210 Filed 8-9-11; 8:45 am]
BILLING CODE 6560-50-P


Hours per
Response
Total Hours
201.26(c)(1)(i) 18 1 18 24 432
610.68(c)(1)(i) 10 1 10 24 240
801.128(c)(1)(i) and
809.11(c)(1)(i) 2 1 2 24 48
Total
720
1
There are no capital costs or operating and maintenance costs associated with this collection of information.
Although FDA cannot predict the
number of future requests, based on
limited information within FDA, we
estimate that approximately 30
respondents will request annually one
exception or alternative to labeling
provisions to avoid misbranding of their
products in the SNS. The estimate of
one request per respondent is based on
the anticipated occasional occurrence of
a product being misbranded while in
the SNS. We are estimating that each
respondent will spend from 8 to 24
hours preparing each request. The hours
per response are based on estimated
time that it takes to prepare a
supplement to an application, which
may be considered similar to a request
for an exception or alternative.
The information collection provisions
in §§314.70, 601.12, 807.81 and 814.39
have been approved under OMB control
numbers 0910–0001 (expires May 31,
2008), 0910–0338 (expires September
30, 2008), 0910–0120 (expires August
31, 2010), and 0910–0231 (expires
September 30, 2007), respectively.
The information collection provisions
for this interim final rule have been
approved under the emergency
processing provisions of the PRA. The
assigned OMB approval number of this
collection of information is 0910–0614.
This approval expires on June 30, 2008.
Interested persons are requested to fax
comments regarding the information
collection by (see DATES) to the Office
of Information and Regulatory Affairs,
OMB (see ADDRESSES).
An agency may not conduct or
sponsor, and a person is not required to
respond to, a collection of information
unless it displays a currently valid OMB
control number.
VIII. Environmental Impact
The agency has determined under 21
CFR 25.30(k) that this action is of a type
that does not individually or
cumulatively have a significant effect on
the human environment. Therefore,
neither an environmental assessment
nor an environmental impact statement
is required.
IX. Federalism
As stated in the preamble, FDA has
analyzed this interim final rule in
accordance with the principles set forth
in Executive Order 13132. Section 4(a)
of this Executive Order requires
agencies to ‘‘construe * * * a Federal
statute to preempt State law only where
the statute contains an express
preemption provision or there is some
other clear evidence that the Congress
intended preemption of State law, or
where the exercise of State authority
conflicts with the exercise of Federal
authority under the Federal statute.’’ In
this rule, FDA is revising certain
requirements concerning the format and
content of labeling for human drugs,
biological products, and medical
devices that are or will be included in
the SNS to provide for exceptions or
alternatives to these requirements under
specified circumstances. To the extent
that a State requires labeling that
directly conflicts with, is different from,
or is in addition, to any exceptions or
alternatives granted under this rule, the
State-required labeling would be subject
to implied conflict preemption.
Moreover, certain State requirements
regarding the format and content of
nonprescription drug labeling and/or
labeling of approved medical devices
may be subject to the express
preemption provisions in section 751 of
the FFD&C Act (21 U.S.C. 360k)
(nonprescription drugs) and section 521
of the FFD&C Act (approved medical
devices).
FDA is aware that State requirements
on medical product labeling, often as a
result of product liability lawsuits, may
conflict with Federal requirements. FDA
restated its longstanding views on
preemption in the preamble to the
recently promulgated final rule entitled
‘‘Requirements on Content and Format
of Labeling for Human Prescription
Drug and Biological Products’’ (see 71
FR 3922 at 3933 through 3936 and 3967
through 3969). That discussion is
applicable to this interim final rule as
well, and reflects the agency’s current
position on this issue.
Section 4(c) of Executive Order 13132
instructs us to restrict any Federal
preemption of State law to the
‘‘minimum level necessary to achieve
the objectives of the statute pursuant to
which the regulations are promulgated.’’
This interim final rule meets the
preceding requirement because, as
discussed previously, it would preempt
only State laws that directly conflict
with, are different from, or are in
addition to any Federal requirements.
Section 4(d) of Executive Order 13132
states that when an agency foresees the
possibility of a conflict between State
law and federally protected interests
within the agency’s area of regulatory
responsibility, the agency ‘‘shall
consult, to the extent practicable, with
appropriate State and local officials in
an effort to avoid such a conflict.’’ In
this case, FDA foresees the possibility of
a conflict between State law and
federally protected interests within the
agency’s area of regulatory
responsibility.
Section 4(e) of Executive Order 13132
adds that ‘‘when an agency proposes to
act through adjudication or rulemaking
to preempt State law, the agency ‘‘shall
provide all affected State and local
officials notice and an opportunity for
appropriate participation in the
proceedings.’’ FDA is seeking input
from all stakeholders on the provisions
of this interim final rule through
publication of the rule in the Federal
Register, and will consult with State
and local officials in an effort to avoid
conflicts between State law and Federal
protected interests in accordance with
Executive Order 13132.
In conclusion, the agency believes
that it has complied with all of the
applicable requirements under
Executive Order 13132 and has
determined that this interim final rule is
consistent with the Executive order.
X. Request for Comments
Interested persons may submit to the
Division of Dockets Management (see
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ADDRESSES
) written or electronic
comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
List of Subjects
21 CFR Part 201
Drugs, Labeling, Reporting and
recordkeeping requirements.
21 CFR Part 312
Drugs, Exports, Imports,
Investigations, Labeling, Medical
research, Reporting and recordkeeping
requirements, Safety.
21 CFR Part 314
Administrative practice and
procedure, Confidential business
information, Drugs, Reporting and
recordkeeping requirements.
21 CFR Part 601
Administrative practice and
procedure, Biologics, Confidential
business information.
21 CFR Part 610
Biologics, Labeling, Reporting and
recordkeeping requirements.
21 CFR Part 801
Labeling, Medical devices, Reporting
and recordkeeping requirements.
21 CFR Part 807
Confidential business information,
Imports, Medical devices, Reporting and
recordkeeping requirements.
21 CFR Part 809
Labeling, Medical devices.
21 CFR Part 812
Health records, Medical devices,
Medical research, Reporting and
recordkeeping requirements.
21 CFR Part 814
Administrative practice and
procedure, Confidential business
information, Medical devices, Medical
research, Reporting and recordkeeping
requirements.
ٱ
Therefore, under the Federal Food,
Drug, and Cosmetic Act and the Public
Health Service Act, and under authority
delegated to the Commissioner of Food
and Drugs, 21 CFR chapter I is amended
as follows:
PART 201—LABELING
ٱ
1. The authority citation for 21 CFR
part 201 continues to read as follows:
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 355, 358, 360, 360b, 360gg–360ss, 371,
374, 379e; 42 U.S.C. 216, 241, 262, 264.
ٱ
2. Add §201.26 to subpart A to read
as follows:
§201.26
Exceptions or alternatives to
labeling requirements for human drug
products held by the Strategic National
Stockpile.
(a) The appropriate FDA Center
Director may grant an exception or
alternative to any provision listed in
paragraph (f) of this section and not
explicitly required by statute, for
specified lots, batches, or other units of
a human drug product, if the Center
Director determines that compliance
with such labeling requirement could
adversely affect the safety, effectiveness,
or availability of such product that is or
will be included in the Strategic
National Stockpile.
(b)(1)(i) A Strategic National Stockpile
official or any entity that manufactures
(including labeling, packing, relabeling,
or repackaging), distributes, or stores a
human drug product that is or will be
included in the Strategic National
Stockpile may submit, with written
concurrence from a Strategic National
Stockpile official, a written request for
an exception or alternative described in
paragraph (a) of this section to the
Center Director.
(ii) The Center Director may grant an
exception or alternative described in
paragraph (a) of this section on his or
her own initiative.
(2) A written request for an exception
or alternative described in paragraph (a)
of this section must:
(i) Identify the specified lots, batches,
or other units of the human drug
product that would be subject to the
exception or alternative;
(ii) Identify the labeling provision(s)
listed in paragraph (f) of this section
that are the subject of the exception or
alternative request;
(iii) Explain why compliance with
such labeling provision(s) could
adversely affect the safety, effectiveness,
or availability of the specified lots,
batches, or other units of a human drug
product that are or will be held in the
Strategic National Stockpile;
(iv) Describe any proposed safeguards
or conditions that will be implemented
so that the labeling of the product
includes appropriate information
necessary for the safe and effective use
of the product, given the anticipated
circumstances of use of the product;
(v) Provide a draft of the proposed
labeling of the specified lots, batches, or
other units of the human drug product
subject to the exception or alternative;
and
(vi) Provide any other information
requested by the Center Director in
support of the request.
(c) The Center Director must respond
in writing to all requests under this
section.
(d) A grant of an exception or
alternative under this section will
include any safeguards or conditions
deemed appropriate by the Center
Director so that the labeling of product
subject to the exception or alternative
includes the information necessary for
the safe and effective use of the product,
given the anticipated circumstances of
use.
(e) If you are a sponsor receiving a
grant of a request for an exception or
alternative to the labeling requirements
under this section:
(1) You need not submit a supplement
under §314.70(a) through (c) or
§601.12(f)(1) through (f)(2) of this
chapter; however,
(2) You must report any grant of a
request for an exception or alternative
under this section as part of your annual
report under §§314.70(d) or 601.12(f)(3)
of this chapter.
(f) The Center Director may grant an
exception or alternative under this
section to the following provisions of
this chapter, to the extent that the
requirements in these provisions are not
explicitly required by statute:
(1) §201.1(h)(1) through (h)(2), (h)(5)
through (h)(6), and (i);
(2) §201.10(a), (d)(2), (f), (g)(1), and
(h)(1);
(3) §201.17;
(4) §201.18;
(5) §201.19;
(6) §201.20;
(7) §201.21;
(8) §201.22;
(9) §201.24; and
(10) §312.6.
PART 312—INVESTIGATIONAL NEW
DRUG APPLICATION
ٱ
3. The authority citation for 21 CFR
part 312 continues to read as follows:
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 355, 356, 371, 381, 382, 383, 393; 42
U.S.C. 262.
ٱ
4. Section 312.6 is amended by adding
paragraph (c) to read as follows:
§312.6
Labeling of an investigational new
drug.
* * * * *
(c) The appropriate FDA Center
Director, according to the procedures set
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forth in §§201.26 or 610.68 of this
chapter, may grant an exception or
alternative to the provision in paragraph
(a) of this section, to the extent that this
provision is not explicitly required by
statute, for specified lots, batches, or
other units of a human drug product
that is or will be included in the
Strategic National Stockpile.
PART 314—APPLICATIONS FOR FDA
APPROVAL TO MARKET A NEW DRUG
ٱ
5. The authority citation for 21 CFR
part 314 continues to read as follows:
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 355, 355a, 356, 356a, 356b, 356c, 371,
374, 379e.
ٱ
6. Section 314.70 is amended by
revising paragraph (a)(1) to read as
follows:
§314.70
Supplements and other changes
to an approved application.
(a) * * *
(1)(i) Except as provided in paragraph
(a)(1)(ii) of this section, the applicant
must notify FDA about each change in
each condition established in an
approved application beyond the
variations already provided for in the
application. The notice is required to
describe the change fully. Depending on
the type of change, the applicant must
notify FDA about the change in a
supplement under paragraph (b) or (c) of
this section or by inclusion of the
information in the annual report to the
application under paragraph (d) of this
section.
(ii) The submission and grant of a
written request for an exception or
alternative under §201.26 of this
chapter satisfies the applicable
requirements in paragraphs (a) through
(c) of this section. However, any grant
of a request for an exception or
alternative under §201.26 of this
chapter must be reported as part of the
annual report to the application under
paragraph (d) of this section.
* * * * *
PART 601—LICENSING
ٱ
7. The authority citation for 21 CFR
part 601 continues to read as follows:
Authority: 15 U.S.C. 1451–1561; 21 U.S.C.
321, 351, 352, 353, 355, 356b, 360, 360c–
360f, 360h–360j, 371, 374, 379e, 381; 42
U.S.C. 216, 241, 262, 263, 264; sec 122, Pub.
L. 105–115, 111 Stat. 2322 (21 U.S.C. 355
note).
ٱ
8. Section 601.12 is amended by
revising paragraph (f)(3)(i)(D) and by
adding paragraph (f)(5) to read as
follows:
§601.12
Changes to an approved
application.
* * * * *
(f) * * *
(3)(i) * * *
(D) A change made pursuant to an
exception or alternative granted under
§201.26 or §610.68 of this chapter.
* * * * *
(5) The submission and grant of a
written request for an exception or
alternative under §201.26 or §610.68 of
this chapter satisfies the requirements in
paragraphs (f)(1) through (f)(2) of this
section.
* * * * *
PART 610—GENERAL BIOLOGICAL
PRODUCTS STANDARDS
ٱ
9. The authority citation for 21 CFR
part 610 continues to read as follows:
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 355, 360, 360c, 360d, 360h, 360i, 371,
372, 374, 381; 42 U.S.C. 216, 262, 263, 263a,
264.
ٱ
10. Add §610.68 to subpart G to read
as follows:
§610.68
Exceptions or alternatives to
labeling requirements for biological
products held by the Strategic National
Stockpile.
(a) The appropriate FDA Center
Director may grant an exception or
alternative to any provision listed in
paragraph (f) of this section and not
explicitly required by statute, for
specified lots, batches, or other units of
a biological product, if the Center
Director determines that compliance
with such labeling requirement could
adversely affect the safety, effectiveness,
or availability of such product that is or
will be included in the Strategic
National Stockpile.
(b)(1)(i) A Strategic National Stockpile
official or any entity that manufactures
(including labeling, packing, relabeling,
or repackaging), distributes, or stores a
biological product that is or will be
included in the Strategic National
Stockpile may submit, with written
concurrence from a Strategic National
Stockpile official, a written request for