TTT. An affirmative defense to civil penalties for exceedances of
emission limits that are caused by malfunctions is available to a
source if it can demonstrate that certain criteria and requirements are
satisfied. The criteria ensure that the affirmative defense is
available only where the event that causes an exceedance of the
emission limit meets the narrow definition of malfunction in 40 CFR
63.2 (sudden, infrequent, not reasonably preventable, and not caused by
poor maintenance and or careless operation) and where the source took
necessary actions to minimize emissions. In addition, the source must
meet certain notification and reporting requirements. For example, the
source must prepare a written root cause analysis and submit a written
report to the Administrator documenting that it has met the conditions
and requirements for assertion of the affirmative defense.
    The EPA is adding affirmative defense to the estimate of burden in
the ICR. To provide the public with an estimate of the relative
magnitude of the burden

associated with an assertion of the affirmative defense position
adopted by a source, the EPA has provided administrative adjustments to
the ICR that show what the notification, recordkeeping, and reporting
requirements associated with the assertion of the affirmative defense
might entail. The EPA's estimate for the required notification,
reports, and records, including the root cause analysis, totals $3,141,
and is based on the time and effort required of a source to review
relevant data, interview plant employees, and document the events
surrounding a malfunction that has caused an exceedance of an emission
limit. The estimate also includes time to produce and retain the record
and reports for submission to the EPA. The EPA provides this
illustrative estimate of this burden, because these costs are only
incurred if there has been a violation, and a source chooses to take
advantage of the affirmative defense.
    Given the variety of circumstances under which malfunctions could
occur, as well as differences among sources' operation and maintenance
practices, we cannot reliably predict the severity and frequency of
malfunction-related excess emissions events for a particular source. It
is important to note that the EPA has no basis currently for estimating
the number of malfunctions that would qualify for an affirmative
defense. Current historical records would be an inappropriate basis, as
source owners or operators previously operated their facilities in
recognition that they were exempt from the requirement to comply with
emissions standards during malfunctions. Of the number of excess
emission events reported by source operators, only a small number would
be expected to result from a malfunction (based on the definition
above), and only a subset of excess emissions caused by malfunctions
would result in the source choosing to assert the affirmative defense.
Thus, we believe the number of instances in which source operators
might be expected to avail themselves of the affirmative defense will
be extremely small. For this reason, we estimate no more than 2 or 3
such occurrences for all sources subject to 40 CFR part 63, subpart TTT
over the 3-year period covered by this ICR. We expect to gather
information on such events in the future, and will revise this estimate
as better information becomes available.
    For the Primary Lead Processing MACT standard, the ICR document
prepared by the EPA, which has been revised to include the amendments
to the standards, has been assigned the EPA ICR number 1856.08. Burden
changes associated with these amendments result from the reporting and
recordkeeping requirements of the affirmative defense provisions added
to the rule. The change in respondents' annual reporting and
recordkeeping burden associated with these amendments for this
collection (averaged over the first 3 years after the effective date of
the standards) is estimated to be 30 labor hours at a cost of $3,141
per year for the affirmative defense reporting. There will be no
capital costs associated with the information collection requirements
of the final rule. There is no estimated change in annual burden to the
Federal government for these amendments. Burden is defined at 5 CFR
1320.3(b).
    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. The OMB control numbers for EPA's
regulations in 40 CFR are listed in 40 CFR part 9. In addition, EPA is
amending the table in 40 CFR part 9 of currently approved OMB control
numbers for various regulations to list the regulatory citations for
the information requirements contained in this final rule.

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 impact of these final rules on small
entities, small entity is defined as: (1) A small business as defined
by the Small Business Administration's regulations at 13 CFR 121.201;
(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 these final rules on
small entities, I certify that this action will not have a significant
economic impact on a substantial number of small entities. This final
action will not impose any requirements on small entities. The costs
associated with the new requirements in these final rules are not
expected to present an undue burden to this industry as discussed
above.

D. Unfunded Mandates Reform Act

    This action contains no Federal mandates under the provisions of
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C.
1531-1538 for State, local, or tribal governments or the private
sector. The action imposes no enforceable duty on any State, local or
tribal governments or the private sector. Therefore, this action is not
subject to the requirements of sections 202 or 205 of the UMRA.
    These rules are also not subject to the regulatory requirements
that might significantly or uniquely affect small governments. They
contain no requirements that apply to such governments or impose
obligations upon them.

E. Executive Order 13132: Federalism

    This action 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. These final rules primarily affect
private industry, and do not impose significant economic costs on State
or local governments. Thus, Executive Order 13132 does not apply to
this action.

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

    This action does not have tribal implications, as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000). It will not have
substantial direct effect on tribal governments, on the relationship
between the Federal government and Indian tribes, or on the
distribution of power and responsibilities between the Federal
government and Indian tribes, as specified in Executive Order 13175.
Thus, Executive Order 13175 does not apply to this action.

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

    This action is not subject to Executive Order 13045 (62 FR 19885,
April 23, 1997), because it is not economically significant as defined
in Executive Order 12866. However, the agency does believe there is a
disproportionate risk to children. Modeled ambient air lead

concentrations from the one facility in this source category are in
excess of the NAAQS for lead, which was set to ``provide increased
protection for children and other at-risk populations against an array
of adverse health effects, most notably including neurological effects
in children, including neurocognitive and neurobehavioral effects.'' 73
FR 67007. However, the control measures promulgated in this notice will
result in lead concentration levels that are in compliance with the
lead NAAQS, thereby mitigating the risk of adverse health effects to
children.

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

    This action is not a ``significant energy action'' as defined in
Executive Order 13211 (66 FR 28355 (May 22, 2001)), because it is not
likely to have a significant adverse energy effect on the supply,
distribution, or use of energy. This action will not create any new
requirements for sources in the energy supply, distribution, or use
sectors. Further, we have concluded that these final rules are not
likely to have any adverse energy effects.

I. National Technology Transfer and Advancement Act

    Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, 12(d) (15 U.S.C. 272 note)
directs the EPA to use voluntary consensus standards (VCS) in its
regulatory activities, unless to do so would be inconsistent with
applicable law or otherwise impractical. VCS are technical standards
(e.g., materials specifications, test methods, sampling procedures, and
business practices) that are developed or adopted by VCS bodies. NTTAA
directs the EPA to provide Congress, through OMB, explanations when the
agency decides not to use available and applicable VCS.
    This action does not involve technical standards. Therefore, the
EPA did not consider the use of any VCS.

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

    Executive Order 12898 (59 FR 7629, February 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.
    The 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 does not
decrease the level of protection provided to human health or the
environment, but in fact decreases emissions of lead. To examine the
potential for any environmental justice issues that might be associated
with this rule, we evaluated the distributions of HAP-related cancer
and non-cancer risks across different social, demographic, and economic
groups within the populations living near the one facility that is
currently operating in this source category. Our analyses also show
that, although there is potential for an adverse environmental and
human health effects from emission of lead, it does not indicate any
significant potential for disparate impacts to the specific demographic
groups analyzed.
    The rule would require additional control measures to address the
identified environmental and health risks and would therefore, decrease
risks to any populations exposed to these sources.

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. The EPA will submit a report containing
this final rule and other required information to the United States
Senate, the United States House of Representatives, and the Comptroller
General of the United States prior to publication of the final 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). The final rules will be
effective on November 15, 2011.

List of Subjects for 40 CFR Part 63

    Environmental protection, Administrative practice and procedures,
Air pollution control, Hazardous substances, Intergovernmental
relations, Reporting and recordkeeping requirements.

    Dated: November 4, 2011.
Lisa P. Jackson,
Administrator.

    For the reasons stated in the preamble, the Environmental
Protection Agency amends title 40, chapter I, of the Code of Federal
Regulations as follows:

PART 63--[AMENDED]

0
1. The authority citation for part 63 continues to read as follows:

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

Subpart TTT--[Amended]

0
2. Section 63.1541 is revised to read as follows:

Sec.  63.1541  Applicability.

    (a) The provisions of this subpart apply to any facility engaged in
producing lead metal from ore concentrates. The category includes, but
is not limited to, the following smelting processes: Sintering,
reduction, preliminary treatment, refining and casting operations,
process fugitive sources, and fugitive dust sources. The sinter process
includes an updraft or downdraft sintering machine. The reduction
process includes the blast furnace, electric smelting furnace with a
converter or reverberatory furnace, and slag fuming furnace process
units. The preliminary treatment process includes the drossing kettles
and dross reverberatory furnace process units. The refining process
includes the refinery process unit. The provisions of this subpart do
not apply to secondary lead smelters, lead refiners, or lead remelters.
    (b) Table 1 of this subpart specifies the provisions of subpart A
of this part that apply and those that do not apply to owners and
operators of primary lead processors.

0
3. Section 63.1542 is amended by adding a definition for ``Affirmative
defense,'' ``Lead refiner,'' ``Lead remelter,'' ``Primary lead
processor,'' and ``Secondary lead smelter;'' removing the definition of
``Primary lead smelter;'' and revising the definitions of ''Fugitive
dust source,'' ``Furnace area,'' ``Malfunction,'' ``Materials storage
and handling area,'' ``Plant roadway,'' ``Process fugitive source,''
``Refining and casting area,'' ``Sinter machine area,'' and ``Tapping
location'' to read as follows:

Sec.  63.1542  Definitions.

* * * * *
    Affirmative defense means, in the context of an enforcement
proceeding, a response or defense put forward by a defendant, regarding
which the defendant has the burden of proof, and

the merits of which are independently and objectively evaluated in a
judicial or administrative proceeding.
* * * * *
    Fugitive dust source means a stationary source of hazardous air
pollutant emissions at a primary lead processor resulting from the
handling, storage, transfer, or other management of lead-bearing
materials where the source is not part of a specific process, process
vent, or stack. Fugitive dust sources include roadways, storage piles,
materials handling transfer points, and materials transport areas.
    Furnace area means any area of a primary lead processor in which a
blast furnace or dross furnace is located.
    Lead refiner means any facility that refines lead metal that is not
located at a primary lead processor.
    Lead remelter means any facility that remelts lead metal that is
not located at a primary lead processor.
    Malfunction means any sudden, infrequent, and not reasonably
preventable failure of air pollution control and monitoring equipment,
process equipment, or a process to operate in a normal or usual manner
which causes, or has the potential to cause, the emission limitations
in an applicable standard to be exceeded. Failures that are caused in
part by poor maintenance or careless operation are not malfunctions.
    Materials storage and handling area means any area of a primary
lead processor in which lead-bearing materials (including ore
concentrate, sinter, granulated lead, dross, slag, and flue dust) are
stored or handled between process steps, including areas in which
materials are stored in piles, bins, or tubs, and areas in which
material is prepared for charging to a sinter machine or smelting
furnace or other lead processing operation.
* * * * *
    Plant roadway means any area of a primary lead processor that is
subject to vehicle traffic, including traffic by forklifts, front-end
loaders, or vehicles carrying ore concentrates or cast lead ingots.
Excluded from this definition are employee and visitor parking areas,
provided they are not subject to traffic by vehicles carrying lead-
bearing materials.
    Primary lead processor means any facility engaged in the production
of lead metal from lead sulfide ore concentrates through the use of
pyrometallurgical or other techniques.
    Process fugitive source means a source of hazardous air pollutant
emissions at a primary lead processor that is associated with lead
smelting, processing or refining but is not the primary exhaust stream
and is not a fugitive dust source. Process fugitive sources include
sinter machine charging locations, sinter machine discharge locations,
sinter crushing and sizing equipment, furnace charging locations,
furnace taps, and drossing kettle and refining kettle charging or
tapping locations.
    Refining and casting area means any area of a primary lead
processor in which drossing or refining operations occur, or casting
operations occur.
    Secondary lead smelter means any facility at which lead-bearing
scrap material, primarily, but not limited to, lead-acid batteries, is
recycled into elemental lead or lead alloys by smelting.
* * * * *
    Sinter machine area means any area of a primary lead processor
where a sinter machine, or sinter crushing and sizing equipment is
located.
* * * * *
    Tapping location means the opening through which lead and slag are
removed from the furnace.

0
4. Section 63.1543 is revised to read as follows:

Sec.  63.1543  Standards for process and process fugitive sources.

    (a) No owner or operator of any existing, new, or reconstructed
primary lead processor shall discharge or cause to be discharged into
the atmosphere lead compounds in excess of 0.97 pounds per ton of lead
metal produced from the aggregation of emissions discharged from air
pollution control devices used to control emissions from the sources
listed in paragraphs (a)(1) through (9) of this section.
    (1) Sinter machine;
    (2) Blast furnace;
    (3) Dross furnace;
    (4) Dross furnace charging location;
    (5) Blast furnace and dross furnace tapping location;
    (6) Sinter machine charging location;
    (7) Sinter machine discharge end;
    (8) Sinter crushing and sizing equipment; and
    (9) Sinter machine area.
    (b) No owner or operator of any existing, new, or reconstructed
primary lead processor shall discharge or cause to be discharged into
the atmosphere lead compounds in excess of 1.2 tons per year from the
aggregation of the air pollution control devices used to control
emissions from furnace area and refining and casting operations.
    (c) The process fugitive sources listed in paragraphs (a)(4)
through (8) of this section must be equipped with a hood and must be
ventilated to a baghouse or equivalent control device. The hood design
and ventilation rate must be consistent with American Conference of
Governmental Industrial Hygienists recommended practices.
    (d) The sinter machine area must be enclosed in a building that is
ventilated to a baghouse or equivalent control device at a rate that
maintains a positive in-draft through any doorway opening.
    (e) Except as provided in paragraph (f) of this section, following
the initial tests to demonstrate compliance with paragraphs (a) and (b)
of this section, the owner or operator of a primary lead processor must
conduct compliance tests for lead compounds on a quarterly basis (no
later than 100 days following any previous compliance test).
    (f) If the 12 most recent compliance tests demonstrate compliance
with the emission limit specified in paragraphs (a) and (b) of this
section, the owner or operator of a primary lead processor shall be
allowed up to 12 calendar months from the last compliance test to
conduct the next compliance test for lead compounds.
    (g) The owner or operator of a primary lead processor must maintain
and operate each baghouse used to control emissions from the sources
listed in paragraphs (a)(1) through (9) and (b) of this section such
that the alarm on a bag leak detection system required under Sec.
63.1547(c)(8) does not sound for more than five percent of the total
operating time in a 6-month reporting period.
    (h) The owner or operator of a primary lead processor must record
the date and time of a bag leak detection system alarm and initiate
procedures to determine the cause of the alarm according to the
corrective action plan required under Sec.  63.1547(f) within 1 hour of
the alarm. The cause of the alarm must be corrected as soon as
practicable.
    (i) At all times, the owner or operator must operate and maintain
any affected source, including associated air pollution control
equipment and monitoring equipment, in a manner consistent with safety
and good air pollution control practices for minimizing emissions.
Determination of whether such operation and maintenance procedures are
being used will be based on information available to the Administrator
which may include, but is not limited to, monitoring results, review of
operation and maintenance procedures, review of operation and
maintenance records, and inspection of the source.

0
5. Section 63.1544 is revised to read as follows:

Sec.  63.1544  Standards for fugitive dust sources.

    (a) Each owner or operator of a primary lead processor must
prepare, and at all times operate according to, a standard operating
procedures manual that describes in detail the measures that will be
put in place to control fugitive dust emissions from the sources listed
in paragraphs (a)(1) through (a)(5) of this section that incorporates
each of the specific work practices listed in paragraphs (a)(1) through
(a)(5) of this section:
    (1) Plant roadways. (i) Paved plant roadways must be cleaned using
a wet sweeper unless the temperature falls below 39 degrees Fahrenheit
or when the application of water results in the formation of ice.
During periods when the temperature is below 39 degrees Fahrenheit,
paved plant roadways must be cleaned using a high efficiency dry
sweeper.
    (ii) Continuously operate a sprinkler system to wet plant roadways
to prevent fugitive dust entrainment. This sprinkler system must be
operated except during periods when the temperature is less than 39
degrees Fahrenheit or when the application of water results in
formation of ice.
    (2) Material storage and handling area(s). (i) Chemically stabilize
inactive concentrate storage piles a minimum of once every month to
reduce particulate from wind born re-suspension.
    (ii) Finished sinter must be sufficiently wetted to ensure fugitive
dust emissions are minimized prior to loading to railcars.
    (3) Sinter machine area(s). (i) Personnel doors must be kept closed
during operations except when entering or exiting the furnace building
by the aid of door weights or similar device for automatic closure.
    (ii) Large equipment doors must remain closed except when entering
or existing the building using an automatic closure system or
equivalent lock-and-key method.
    (iii) It may be necessary to open doors subject to the requirements
in Sec.  63.1544(a)(3)(i) and (ii) to prevent heat stress or exhaustion
of workers inside the sinter plant building. Records of such periods
must be included in the report required under Sec.  63.1549(e)(8).
    (4) Furnace area(s). (i) Personnel doors must be kept closed during
operations except when entering or exiting the furnace building by the
aid of door weights or similar device for automatic closure.
    (ii) Large equipment doors must remain closed except when entering
or existing the building using an automatic closure system or
equivalent lock-and-key method.
    (iii) It may be necessary to open doors subject to the requirements
in Sec.  63.1544(a)(4)(i) and (ii) to prevent heat stress or exhaustion
of workers inside the blast furnace building. Records of such periods
must be included in the report required under Sec.  63.1549(e)(8).
    (5) Refining and casting area(s). (i) Personnel doors must be kept
closed during operations except when entering or exiting the furnace
building by the aid of door weights or similar device for automatic
closure.
    (ii) Large equipment doors must remain closed except when entering
or existing the building using an automatic closure system or
equivalent lock-and-key method.
    (iii) It may be necessary to open doors subject to the requirements
in Sec.  63.1544(a)(5)(i) and (ii) to prevent heat stress or exhaustion
of workers inside the refining and casting building. Records of such
periods must be included in the report required under Sec.
63.1549(e)(8).
    (b) Notwithstanding paragraph (c) of this section, the standard
operating procedures manual shall be submitted to the Administrator or
delegated authority for review and approval.
    (c) Existing manuals that describe the measures in place to control
fugitive dust sources required as part of a State implementation plan
for lead shall satisfy the requirements of paragraph (a) of this
section provided they include all the work practices as described in
paragraphs (a)(1) through (5) of this section and provided they address
all the sources listed in paragraphs (a)(1) through (5) of this
section.
    (d) At all times, the owner or operator must operate and maintain
any affected source, including associated air pollution control
equipment and monitoring equipment, in a manner consistent with safety
and good air pollution control practices for minimizing emissions.
Determination of whether such operation and maintenance procedures are
being used will be based on information available to the Administrator
which may include, but is not limited to, monitoring results, review of
operation and maintenance procedures, review of operation and
maintenance records, and inspection of the source.

0
6. Section 63.1545 is revised to read as follows:

Sec.  63.1545  Compliance dates.

    (a) Each owner or operator of an existing primary lead processor
must achieve compliance with the requirements in Sec.  16.1543(a) no
later than January 17, 2012. Each owner or operator of an existing
primary lead processor must achieve compliance with the requirements of
Sec.  63.1544 no later than February 13, 2012. Each owner or operator
of an existing primary lead processor must achieve compliance with the
requirements in Sec.  63.1543(b) and (e) of this subpart no later than
November 15, 2013.
    (b) Each owner or operator of a new primary lead processor must
achieve compliance with the requirements of this subpart no later than
January 17, 2012 or startup, whichever is later.
    (c) Prior to the dates specified in Sec.  63.1545(a), each owner or
operator of an existing primary lead processor must continue to comply
with the requirements of Sec. Sec.  63.1543 and 63.1544 as promulgated
in the June 4, 1999 NESHAP for Primary Lead Smelting.
    (d) Each owner or operator of an existing primary lead processor
must comply with the requirements of Sec. Sec.  63.1547(g)(1) and (2),
63.1551, and Table 1 of Subpart TTT of Part 63 on November 15, 2011.

0
7. Section 63.1546 is revised to read as follows:

Sec.  63.1546  Performance testing.

    (a) The following procedures must be used to determine quarterly
compliance with the emissions standard for lead compounds under Sec.
63.1543(a) and (b) for existing sources:
    (1) Each owner or operator of existing sources listed in Sec.
63.1543(a)(1) through (9) and (b) must determine the lead compound
emissions rate, in units of pounds of lead per hour according to the
following test methods in appendix A of part 60 of this chapter:
    (i) Method 1 must be used to select the sampling port location and
the number of traverse points.
    (ii) Method 2, 2F, 2G must be used to measure volumetric flow rate.
    (iii) Method 3, 3A, 3B must be used for gas analysis.
    (iv) Method 4 must be used to determine moisture content of the
stack gas.
    (v) Method 12 or Method 29 must be used to determine lead emissions
rate of the stack gas.
    (2) A performance test shall consist of at least three runs. For
each test run with Method 12 or Method 29, the minimum sample time must
be 60 minutes and the minimum volume must be 1 dry standard cubic meter
(35 dry standard cubic feet).
    (3) Performance tests shall be completed quarterly, once every 3
months, to determine compliance.
    (4) The lead emission rate in pounds per quarter is calculated by
multiplying

the quarterly lead emission rate in pounds per hour by the quarterly
plant operating time, in hours as shown in Equation 1:
[GRAPHIC] [TIFF OMITTED] TR15NO11.000

Where:

EPb = quarterly lead emissions, pounds per quarter;
ERPb = quarterly lead emissions rate, pounds per hour;
and
QPOT = quarterly plant operating time, hours per quarter.

    (5) The lead production rate, in units of tons per quarter, must be
determined based on production data for the previous quarter according
to the procedures detailed in paragraphs (a)(5)(i) through (iv) of this
section:
    (i) Total lead products production multiplied by the fractional
lead content must be determined in units of tons.
    (ii) Total copper matte production multiplied by the fractional
lead content must be determined in units of tons.
    (iii) Total copper speiss production multiplied by the fractional
lead content must be determined in units of tons.
    (iv) Total quarterly lead production must be determined by summing
the values obtained in paragraphs (a)(5)(i) through (iii) of this
section.
    (6) To determine compliance with the production-based lead compound
emission rate in Sec.  63.1543(a), the quarterly production-based lead
compound emission rate, in units of pounds of lead emissions per ton of
lead produced, is calculated as shown in Equation 2 by dividing lead
emissions by lead production.
[GRAPHIC] [TIFF OMITTED] TR15NO11.001

Where:

CEPb = quarterly production-based lead compound emission
rate, in units of pounds of lead emissions per ton of lead produced;
EPb = quarterly lead emissions, pounds per quarter; and
PPb = quarterly lead production, tons per quarter.

    (7) To determine quarterly compliance with the emissions standard
for lead compounds under Sec.  63.1543(b), sum the lead compound
emission rates for the current and previous three quarters for the
sources in Sec.  63.1543(b), as determined in accordance with
paragraphs (a)(1) through (4) of this section.
    (b) Owners and operators must perform an initial compliance test to
demonstrate compliance with the sinter building in-draft requirements
of Sec.  63.1543(d) at each doorway opening in accordance with
paragraphs (b)(1) through (4) of this section.
    (1) Use a propeller anemometer or equivalent device.
    (2) Determine doorway in-draft by placing the anemometer in the
plane of the doorway opening near its center.
    (3) Determine doorway in-draft for each doorway that is open during
normal operation with all remaining doorways in their customary
position during normal operation.
    (4) Do not determine doorway in-draft when ambient wind speed
exceeds 2 meters per second.
    (c) Performance tests shall be conducted under such conditions as
the Administrator specifies to the owner or operator based on
representative performance of the affected source for the period being
tested. Upon request, the owner or operator shall make available to the
Administrator such records as may be necessary to determine the
conditions of performance tests.

0
8. Section 63.1547 is revised to read as follows:

Sec.  63.1547  Monitoring requirements.

    (a) Owners and operators of primary lead processors must prepare,
and at all times operate according to, a standard operating procedures
manual that describes in detail the procedures for inspection,
maintenance, and bag leak detection and corrective action for all
baghouses that are used to control process, process fugitive, or
fugitive dust emissions from any source subject to the lead emission
standards in Sec. Sec.  63.1543 and 63.1544, including those used to
control emissions from general ventilation systems.
    (b) The standard operating procedures manual for baghouses required
by paragraph (a) of this section must be submitted to the Administrator
or delegated authority for review and approval.
    (c) The procedures specified in the standard operating procedures
manual for inspections and routine maintenance must, at a minimum,
include the requirements of paragraphs (c)(1) through (8) of this
section.
    (1) Weekly confirmation that dust is being removed from hoppers
through visual inspection or equivalent means of ensuring the proper
functioning of removal mechanisms.
    (2) Daily check of compressed air supply for pulse-jet baghouses.
    (3) An appropriate methodology for monitoring cleaning cycles to
ensure proper operation.
    (4) Monthly check of bag cleaning mechanisms for proper functioning
through visual inspection or equivalent means.
    (5) Quarterly visual check of bag tension on reverse air and
shaker-type baghouses to ensure that bags are not kinked (kneed or
bent) or laying on their sides. Such checks are not required for
shaker-type baghouses using self-tensioning (spring loaded) devices.
    (6) Quarterly confirmation of the physical integrity of the
baghouse through visual inspection of the baghouse interior for air
leaks.
    (7) Quarterly inspection of fans for wear, material buildup, and
corrosion through visual inspection, vibration detectors, or equivalent
means.
    (8) Except as provided in paragraph (h) of this section, continuous
operation of a bag leak detection system.
    (d) The procedures specified in the standard operating procedures
manual for maintenance must, at a minimum, include a preventative
maintenance schedule that is consistent with the baghouse
manufacturer's instructions for routine and long-term maintenance.
    (e) The bag leak detection system required by paragraph (c)(8) of
this section must meet the specifications and requirements of (e)(1)
through (8) of this section.
    (1) The bag leak detection system must be certified by the
manufacturer to be capable of detecting particulate matter emissions at
concentrations of 10 milligram per actual cubic meter (0.0044 grains
per actual cubic foot) or less.
    (2) The bag leak detection system sensor must provide output of
relative particulate matter loadings, and the owner or operator must
continuously record the output from the bag leak detection system.
    (3) The bag leak detection system must be equipped with an alarm
system that will sound when an increase in relative particulate loading
is detected over a preset level, and the alarm must be located such
that it can be heard or otherwise determined by the appropriate plant
personnel.
    (4) Each bag leak detection system that works based on the
triboelectric effect must be installed, calibrated, and maintained in a
manner consistent with guidance provided in the U.S. Environmental
Protection Agency guidance document ``Fabric Filter Bag Leak Detection
Guidance'' (EPA-454/R-98-015). Other bag leak detection systems must be
installed, calibrated, and maintained in a manner consistent with the
manufacturer's written specifications and recommendations.
    (5) The initial adjustment of the system must, at a minimum,
consist of establishing the baseline output by adjusting the
sensitivity (range) and the

averaging period of the device, and establishing the alarm set points
and the alarm delay time.
    (6) Following initial adjustment, the owner or operator must not
adjust the sensitivity or range, averaging period, alarm set points, or
alarm delay time, except as detailed in the approved SOP required under
paragraph (a) of this section. In no event shall the sensitivity be
increased by more than 100 percent or decreased more than 50 percent
over a 365-day period unless a responsible official certifies that the
baghouse has been inspected and found to be in good operating
condition.
    (7) For negative pressure, induced air baghouses, and positive
pressure baghouses that are discharged to the atmosphere through a
stack, the bag leak detector must be installed downstream of the
baghouse and upstream of any wet acid gas scrubber.
    (8) Where multiple detectors are required, the system's
instrumentation and alarm may be shared among detectors.
    (f) The standard operating procedures manual required by paragraph
(a) of this section must include a corrective action plan that
specifies the procedures to be followed in the event of a bag leak
detection system alarm. The corrective action plan must include at a
minimum, procedures to be used to determine the cause of an alarm, as
well as actions to be taken to minimize emissions, which may include,
but are not limited to, the following.
    (1) Inspecting the baghouse for air leaks, torn or broken bags or
filter media, or any other condition that may cause an increase in
emissions.
    (2) Sealing off defective bags or filter media.
    (3) Replacing defective bags or filter media, or otherwise
repairing the control device.
    (4) Sealing off a defective baghouse compartment.
    (5) Cleaning the bag leak detection system probe, or otherwise
repairing or maintaining the bag leak detection system.
    (6) Shutting down the process producing the particulate emissions.
    (g) The percentage of total operating time the alarm on the bag
leak detection system sounds in a 6-month reporting period must be
calculated in order to determine compliance with the five percent
operating limit in Sec.  63.1543(g). The percentage of time the alarm
on the bag leak detection system sounds must be determined according to
paragraphs (g)(1) through (3) of this section.
    (1) For each alarm where the owner or operator initiates procedures
to determine the cause of an alarm within 1 hour of the alarm, 1 hour
of alarm time must be counted.
    (2) For each alarm where the owner or operator does not initiate
procedures to determine the cause of the alarm within 1 hour of the
alarm, alarm time will be counted as the actual amount of time taken by
the owner or operator to initiate procedures to determine the cause of
the alarm.
    (3) The percentage of time the alarm on the bag leak detection
system sounds must be calculated as the ratio of the sum of alarm times
to the total operating time multiplied by 100.
    (h) Baghouses equipped with HEPA filters as a secondary filter used
to control process or process fugitive sources subject to the lead
emission standards in Sec.  63.1543 are exempt from the requirement in
paragraph (c)(8) of this section to be equipped with a bag leak
detector. The owner or operator of an affected source that uses a HEPA
filter must monitor and record the pressure drop across the HEPA filter
system daily. If the pressure drop is outside the limit(s) specified by
the filter manufacturer, the owner or operator must take appropriate
corrective measures, which may include, but not be limited to, the
following:
    (1) Inspecting the filter and filter housing for air leaks and torn
or broken filters.
    (2) Replacing defective filter media, or otherwise repairing the
control device.
    (3) Sealing off a defective control device by routing air to other
comparable control devices.
    (4) Shutting down the process producing the particulate emissions.
    (i) Owners and operators must monitor sinter machine building in-
draft to demonstrate continued compliance with the operating standard
specified in Sec.  63.1543(d) in accordance with either paragraph
(i)(1), (2), or (3) of this section.
    (1) Owners and operators must check and record on a daily basis
doorway in-draft at each doorway in accordance with the methodology
specified in Sec.  63.1546(b).
    (2) Owners and operators must establish and maintain baseline
ventilation parameters which result in a positive in-draft according to
paragraphs (i)(2)(i) through (iv) of this section.
    (i) Owners and operators must install, calibrate, maintain, and
operate a monitoring device that continuously records the volumetric
flow rate through each separately ducted hood; or install, calibrate,
maintain, and operate a monitoring device that continuously records the
volumetric flow rate at the control device inlet of each exhaust system
ventilating the building. The flow rate monitoring device(s) can be
installed in any location in the exhaust duct such that reproducible
flow rate measurements will result. The flow rate monitoring device(s)
must have an accuracy of plus or minus 10 percent over the normal
process operating range and must be calibrated according to
manufacturer's instructions.
    (ii) During the initial demonstration of sinter building in-draft,
and at any time the owner or operator wishes to re-establish the
baseline ventilation parameters, the owner or operator must
continuously record the volumetric flow rate through each separately
ducted hood, or continuously record the volumetric flow rate at the
control device inlet of each exhaust system ventilating the building
and record exhaust system damper positions. The owner or operator must
determine the average volumetric flow rate(s) corresponding to the
period of time the in-draft compliance determinations are being
conducted.
    (iii) The owner or operator must maintain the volumetric flow
rate(s) at or above the value(s) established during the most recent in-
draft determination at all times the sinter machine is in operation.
Volumetric flow rate(s) must be calculated as a 15-minute average.
    (iv) If the volumetric flow rate is monitored at the control device
inlet, the owner or operator must check and record damper positions
daily to ensure they are in the positions they were in during the most
recent in-draft determination.
    (3) An owner or operator may request an alternative monitoring
method by following the procedures and requirements in Sec.  63.8(f) of
the General Provisions.
    (j) Each owner or operator of new or modified sources listed under
Sec.  63.1543 (a)(1) through (9) and (b) must install, calibrate,
maintain, and operate a continuous emission monitoring system (CEMS)
for measuring lead emissions and a continuous emission rate monitoring
system (CERMS) subject to Performance Specification 6 of Appendix B to
part 60.
    (1) Each owner or operator of a source subject to the emissions
limits for lead compounds under Sec.  63.1543(a)and (b) must install a
CEMS for measuring lead emissions within 180 days of promulgation of
performance specifications for lead CEMS.
    (i) Prior to promulgation of performance specifications for CEMS
used to measure lead concentrations, an owner or operator must use the
procedure described in Sec.  63.1546(a)(1)

through (7) of this section to determine compliance.
    (2) If a CEMS used to measure lead emissions is applicable, the
owner or operator must install a CERMS with a sensor in a location that
provides representative measurement of the exhaust gas flow rate at the
sampling location of the CEMS used to measure lead emissions, taking
into account the manufacturer's recommendations. The flow rate sensor
is that portion of the system that senses the volumetric flow rate and
generates an output proportional to that flow rate.
    (i) The CERMS must be designed to measure the exhaust gas flow rate
over a range that extends from a value of at least 20 percent less than
the lowest expected exhaust flow rate to a value of at least 20 percent
greater than the highest expected exhaust gas flow rate.
    (ii) The CERMS must be equipped with a data acquisition and
recording system that is capable of recording values over the entire
range specified in paragraph (j)(2)(i) of this section.
    (iii) Each owner or operator must perform an initial relative
accuracy test of the CERMS in accordance with the applicable
Performance Specification in Appendix B to part 60 of the chapter.
    (iv) Each owner or operator must operate the CERMS and record data
during all periods of operation of the affected facility including
periods of startup, shutdown, and malfunction, except for periods of
monitoring system malfunctions, repairs associated with monitoring
system malfunctions, and required monitoring system quality assurance
or quality control activities (including, as applicable, calibration
checks and required zero and span adjustments.
    (3) Each owner or operator must calculate the lead emissions rate
in tons per year by summing all hours of CEMS data for a year to
determine compliance with Sec.  63.1543(b).
    (i) When the CERMS are unable to provide quality assured data the
following applies:
    (A) When data are not available for periods of up to 48 hours, the
highest recorded hourly emission rate from the previous 24 hours must
be used.
    (B) When data are not available for 48 or more hours, the maximum
daily emission rate based on the previous 30 days must be used.

0
9. Section 63.1548 is revised to read as follows:

Sec.  63.1548  Notification requirements.

    (a) The owner or operator of a primary lead processor must comply
with the notification requirements of Sec.  63.9 of subpart A, General
Provisions as specified in Table 1 of this subpart.
    (b) The owner or operator of a primary lead processor must submit
the standard operating procedures manual for baghouses required under
Sec.  63.1547(a) to the Administrator or delegated authority along with
a notification that the primary lead processor is seeking review and
approval of the manual and procedures. Owners or operators of existing
primary lead processors must submit this notification no later than
November 6, 2000. The owner or operator of a primary lead processor
that commences construction or reconstruction after April 17, 1998,
must submit this notification no later than 180 days before startup of
the constructed or reconstructed primary lead processor, but no sooner
than September 2, 1999.

0
10. Section 63.1549 is revised to read as follows:

Sec.  63.1549  Recordkeeping and reporting requirements.

    (a) The owner or operator of a primary lead processor must comply
with the recordkeeping requirements of Sec.  63.10 of subpart A,
General Provisions as specified in Table 1 of this subpart.
    (b) In addition to the general records required by paragraph (a) of
this section, each owner or operator of a primary lead processor must
maintain for a period of 5 years, records of the information listed in
paragraphs (b)(1) through (10) of this section.
    (1) Production records of the weight and lead content of lead
products, copper matte, and copper speiss.
    (2) Records of the bag leak detection system output.
    (3) An identification of the date and time of all bag leak
detection system alarms, the time that procedures to determine the
cause of the alarm were initiated, the cause of the alarm, an
explanation of the actions taken, and the date and time the cause of
the alarm was corrected.
    (4) Any recordkeeping required as part of the practices described
in the standard operating procedures manual for baghouses required
under Sec.  63.1547(a).
    (5) If an owner or operator chooses to demonstrate continuous
compliance with the sinter building in-draft requirement under Sec.
63.1543(d) by employing the method allowed in Sec.  63.1547(i)(1), the
records of the daily doorway in-draft checks, an identification of the
periods when there was not a positive in-draft, and an explanation of
the corrective actions taken.
    (6) If an owner or operator chooses to demonstrate continuous
compliance with the sinter building in-draft requirement under Sec.
63.1543(d) by employing the method allowed in Sec.  63.1547(i)(2), the
records of the output from the continuous volumetric flow monitor(s),
an identification of the periods when the 15-minute volumetric flow
rate dropped below the minimum established during the most recent in-
draft determination, and an explanation of the corrective actions
taken.
    (7) If an owner or operator chooses to demonstrate continuous
compliance with the sinter building in-draft requirement under Sec.
63.1543(d) by employing the method allowed in Sec.  63.1547(i)(2), and
volumetric flow rate is monitored at the baghouse inlet, records of the
daily checks of damper positions, an identification of the days that
the damper positions were not in the positions established during the
most recent in-draft determination, and an explanation of the
corrective actions taken.
    (8) Records of the occurrence and duration of each malfunction of
operation (i.e., process equipment) or the air pollution control
equipment and monitoring equipment.
    (9) Records of actions taken during periods of malfunction to
minimize emissions in accordance with Sec. Sec.  63.1543(i) and
63.1544(d), including corrective actions to restore malfunctioning
process and air pollution control and monitoring equipment to its
normal or usual manner of operation.
    (c) Records for the most recent 2 years of operation must be
maintained on site. Records for the previous 3 years may be maintained
off site.
    (d) The owner or operator of a primary lead processor must comply
with the reporting requirements of Sec.  63.10 of subpart A, General
Provisions as specified in Table 1 of this subpart.
    (e) In addition to the information required under Sec.  63.10 of
the General Provisions, the owner or operator must provide semi-annual
reports containing the information specified in paragraphs (e)(1)
through (9) of this section to the Administrator or designated
authority.
    (1) The reports must include records of all alarms from the bag
leak detection system specified in Sec.  63.1547(e).
    (2) The reports must include a description of the actions taken
following each bag leak detection system alarm pursuant to Sec.
63.1547(f).
    (3) The reports must include a calculation of the percentage of
time the alarm on the bag leak detection system sounded during the
reporting period pursuant to Sec.  63.1547(g).

    (4) If an owner or operator chooses to demonstrate continuous
compliance with the sinter building in-draft requirement under Sec.
63.1543(d) by employing the method allowed in Sec.  63.1547(i)(1), the
reports must contain an identification of the periods when there was
not a positive in-draft, and an explanation of the corrective actions
taken.
    (5) If an owner or operator chooses to demonstrate continuous
compliance with the sinter building in-draft requirement under Sec.
63.1543(d) by employing the method allowed in Sec.  63.1547(i)(2), the
reports must contain an identification of the periods when the 15-
minute volumetric flow rate(s) dropped below the minimum established
during the most recent in-draft determination, and an explanation of
the corrective actions taken.
    (6) If an owner or operator chooses to demonstrate continuous
compliance with the sinter building in-draft requirement under Sec.
63.1543(d) by employing the method allowed in Sec.  63.1547(i)(2), and
volumetric flow rate is monitored at the baghouse inlet, the reports
must contain an identification of the days that the damper positions
were not in the positions established during the most recent in-draft
determination, and an explanation of the corrective actions taken.
    (7) The reports must contain a summary of the records maintained as
part of the practices described in the standard operating procedures
manual for baghouses required under Sec.  63.1547(a), including an
explanation of the periods when the procedures were not followed and
the corrective actions taken.
    (8) The reports shall contain a summary of the fugitive dust
control measures performed during the required reporting period,
including an explanation of any periods when the procedures outlined in
the standard operating procedures manual required by Sec.  63.1544(a)
were not followed and the corrective actions taken. The reports shall
not contain copies of the daily records required to demonstrate
compliance with the requirements of the standard operating procedures
manuals required under Sec. Sec.  63.1544(a) and 63.1547(a).
    (9) If there was a malfunction during the reporting period, the
report shall also include the number, duration, and a brief description
for each type of malfunction which occurred during the reporting period
and which caused or may have caused any applicable emission limitation
to be exceeded. The report must also include a description of actions
taken by an owner or operator during a malfunction of an affected
source to minimize emissions in accordance with Sec. Sec.  63.1543(i)
and 63.1544(d), including actions taken to correct a malfunction.

0
11. Section 63.1550 is revised to read as follows:

Sec.  63.1550  Delegation of authority.

    (a) In delegating implementation and enforcement authority to a
State under section 112(l) of the act, the authorities contained in
paragraph (b) of this section must be retained by the Administrator and
not transferred to a State.
    (b) Authorities which will not be delegated to States: No
restrictions.

0
12. Section 63.1551 is added to read as follows:

Sec.  63.1551  Affirmative defense for exceedance of emission limit
during malfunction.

    In response to an action to enforce the standards set forth in this
subpart you may assert an affirmative defense to a claim for civil
penalties for exceedances of such standards that are caused by
malfunction, as defined at 40 CFR 63.2. Appropriate penalties may be
assessed, however, if you fail to meet your burden of proving all of
the requirements in the affirmative defense. The affirmative defense
shall not be available for claims for injunctive relief.
    (a) Affirmative defense. To establish the affirmative defense in
any action to enforce such a limit, you must timely meet the
notification requirements in paragraph (b) of this section, and must
prove by a preponderance of evidence that:
    (1) The excess emissions:
    (i) Were caused by a sudden, infrequent, and unavoidable failure of
air pollution control and monitoring equipment, process equipment, or a
process to operate in a normal or usual manner, and
    (ii) Could not have been prevented through careful planning, proper
design or better operation and maintenance practices; and
    (iii) Did not stem from any activity or event that could have been
foreseen and avoided, or planned for; and
    (iv) Were not part of a recurring pattern indicative of inadequate
design, operation, or maintenance; and
    (2) Repairs were made as expeditiously as possible when the
applicable emission limitations were being exceeded. Off-shift and
overtime labor were used, to the extent practicable to make these
repairs; and
    (3) The frequency, amount and duration of the excess emissions
(including any bypass) were minimized to the maximum extent practicable
during periods of such emissions; and
    (4) If the excess emissions resulted from a bypass of control
equipment or a process, then the bypass was unavoidable to prevent loss
of life, personal injury, or severe property damage; and
    (5) All possible steps were taken to minimize the impact of the
excess emissions on ambient air quality, the environment and human
health; and
    (6) All emissions monitoring and control systems were kept in
operation if at all possible, consistent with safety and good air
pollution control practices; and
    (7) All of the actions in response to the excess emissions were
documented by properly signed, contemporaneous operating logs; and
    (8) At all times, the facility was operated in a manner consistent
with good practices for minimizing emissions; and
    (9) A written root cause analysis has been prepared, the purpose of
which is to determine, correct, and eliminate the primary causes of the
malfunction and the excess emissions resulting from the malfunction
event at issue. The analysis shall also specify, using best monitoring
methods and engineering judgment, the amount of excess emissions that
were the result of the malfunction.
    (b) Notification. The owner or operator of the facility
experiencing an exceedance of its emission limit(s) during a
malfunction shall notify the Administrator by telephone or facsimile
(FAX) transmission as soon as possible, but no later than two business
days after the initial occurrence of the malfunction, if it wishes to
avail itself of an affirmative defense to civil penalties for that
malfunction. The owner or operator seeking to assert an affirmative
defense shall also submit a written report to the Administrator within
45 days of the initial occurrence of the exceedance of the standards in
this subpart to demonstrate, with all necessary supporting
documentation, that it has met the requirements set forth in paragraph
(a) of this section. The owner or operator may seek an extension of
this deadline for up to 30 additional days by submitting a written
request to the Administrator before the expiration of the 45 day
period. Until a request for an extension has been approved by the
Administrator, the owner or operator is subject to the requirement to
submit such report within 45 days of the initial occurrence of the
exceedance.

0
13. Table 1 to Subpart TTT of Part 63 is revised to read as follows:

 Table 1 of Subpart TTT--General Provisions Applicability to Subpart TTT
------------------------------------------------------------------------
                                    Applies to
           Reference               subpart  TTT           Comment
------------------------------------------------------------------------

                              * * * * * * *
63.6(a), (b), (c).............  Yes.
63.6(d).......................  No...............  Section reserved.
63.6(e)(1)(i).................  No...............  See 63.1543(i) and
                                                    63.1544(d) for
                                                    general duty
                                                    requirement.
63.6(e)(1)(ii)................  No.
63.6(e)(1)(iii)...............  Yes.
63.6(e)(2)....................  No...............  Section reserved.
63.6(e)(3)....................  No.
63.6(f)(1)....................  No.
63.6(g).......................  Yes.
63.6(h).......................  No...............  No opacity limits in
                                                    rule.
63.6(i).......................  Yes.
63.6(j).......................  Yes.
Sec.   63.7(a)-(d)............  Yes.
Sec.   63.7(e)(1).............  No...............  See 63.1546(c).
Sec.   63.7(e)(2)-(e)(4)......  Yes.
63.7(f), (g), (h).............  Yes.
63.8(a)-(b)...................  Yes.
63.8(c)(1)(i).................  No.
63.8(c)(1)(ii)................  Yes.
63.8(c)(1)(iii)...............  No.
63.8(c)(2)-(d)(2).............  Yes.
63.8(d)(3)....................  Yes, except for
                                 last sentence.
63.8(e)-(g)...................  Yes.
63.9(a), (b), (c), (e), (g),    Yes.
 (h)(1) through (3), (h)(5)
 and (6), (i) and (j).
63.9(f).......................  No.
63.9(h)(4)....................  No...............  Reserved.
63.10(b)(2)(i)................  No.
63.10(b)(2)(ii)...............  No...............  See 63.1549(b)(9) and
                                                    (10) for
                                                    recordkeeping of
                                                    occurrence and
                                                    duration of
                                                    malfunctions and
                                                    recordkeeping of
                                                    actions taken during
                                                    malfunction.
63.10(b)(2)(iii)..............  Yes.
63.10(b)(2)(iv)-(b)(2)(v).....  No.
63.10(b)(2)(vi)-(b)(2)(xiv)...  Yes.
63.(10)(b)(3).................  Yes.
63.10(c)(1)-(9)...............  Yes.
63.10(c)(10)-(11).............  No...............  See 63.1549(b)(9) and
                                                    (10) for
                                                    recordkeeping of
                                                    malfunctions.
63.10(c)(12)-(c)(14)..........  Yes.
63.10(c)(15)..................  No.
63.10(d)(1)-(4)...............  Yes.
63.10(d)(5)...................  No...............  See 63.1549(e)(9) for
                                                    reporting of
                                                    malfunctions.
63.10(e)-(f)..................  Yes.

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

[FR Doc. 2011-29287 Filed 11-14-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 87, Number 17 (Wednesday, January 26, 2022)]
[Notices]
[Pages 4011-4012]
[FR Doc No: 2022-01523]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. IC22-2-000]

Commission Information Collection Activities (Ferc-732) Comment
Request; Extension

AGENCY: Federal Energy Regulatory Commission, Department of Energy.

ACTION: Notice of information collection and request for comments.

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

SUMMARY: In compliance with the requirements of the Paperwork Reduction
Act of 1995, the Federal Energy Regulatory Commission (Commission or
FERC) is soliciting public comment on the currently approved
information collection, FERC-732, (Electric Rate Schedule and Tariffs:
Long-Term Firm Transmission Rights in Organized Electricity Markets),
which will be submitted to the Office of Management and Budget (OMB)
for review. The Commission issued a 60-day notice on November 15, 2021
requesting public comments; no comments were received.

DATES: Comments on the collection of information are due February 25,
2022.

ADDRESSES: Send written comments on FERC-732 to OMB through
www.reginfo.gov/public/do/PRAMain. Attention: Federal Energy Regulatory
Commission Desk Officer. Please identify the OMB Control Number (1902-
0245) in the subject line of your comments. Comments should be sent
within 30 days of publication of this notice to www.reginfo.gov/public/do/PRAMain.
    Please submit copies of your comments to the Commission. You may
submit copies of your comments (identified by Docket No. IC22-2-000) by
one of the following methods:
    Electronic filing through http://www.ferc.gov, is preferred.
     Electronic Filing: Documents must be filed in acceptable
native applications and print-to-PDF, but not in scanned or picture
format.
     For those unable to file electronically, comments may be
filed by USPS mail or by hand (including courier) delivery.
    [cir] Mail via U.S. Postal Service Only: Addressed to: Federal
Energy Regulatory Commission, Secretary of the Commission, 888 First
Street NE, Washington, DC 20426.

    [cir] Hand (including courier) delivery: Deliver to: Federal Energy
Regulatory Commission, 12225 Wilkins Avenue, Rockville, MD 20852.
    Instructions: OMB submissions must be formatted and filed in
accordance with submission guidelines at www.reginfo.gov/public/do/PRAMain. Using the search function under the ``Currently Under Review''
field, select Federal Energy Regulatory Commission; click ``submit,''
and select ``comment'' to the right of the subject collection.
    FERC submissions must be formatted and filed in accordance with
submission guidelines at: http://www.ferc.gov. For user assistance,
contact FERC Online Support by email at [email protected], or
by phone at:<PHONE_NUMBER> (toll-free).
    Docket: Users interested in receiving automatic notification of
activity in this docket or in viewing/downloading comments and
issuances in this docket may do so at https://www.ferc.gov/ferc-online/overview.

FOR FURTHER INFORMATION CONTACT: Ellen Brown may be reached by email at
[email protected], telephone at<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

1. FERC-732

    Title: FERC-732, Electric Rate Schedule and Tariffs: Long-Term Firm
Transmission Rights in Organized Electricity Markets
    OMB Control No.: 1902-0245.
    Type of Request: Three-year extension of the FERC-732 information
collection requirement with no changes to the current reporting
requirements.
    Abstract: 18 CFR part 42 provides the reporting requirements of
FERC-732 as they pertain to long-term transmission rights. To implement
section 1233 \1\ of the Energy Policy Act of 2005 (EPAct 2005),\2\ the
Commission requires each transmission organization that is a public
utility with one or more organized electricity markets to make
available long-term firm transmission rights that satisfy each of the
Commission's guidelines.\3\
---------------------------------------------------------------------------

    \1\ 16 U.S.C. 824.
    \2\ 16 U.S.C. 824q.
    \3\ 18 CFR 42.1(d).
---------------------------------------------------------------------------

    The FERC-732 regulations require that transmission organizations
(that are public utilities with one or more organized electricity
markets) choose one of two ways to file:
     File tariff sheets making long-term firm transmission
rights available that are consistent with each of the guidelines
established by FERC.
     File an explanation describing how their existing tariffs
already provide long-term firm transmission rights that are consistent
with the guidelines.
    Additionally, the Commission requires each transmission
organization to make its transmission planning and expansion procedures
and plans available to the public. FERC-732 enables the Commission to
exercise its wholesale electric rate and electric power transmission
oversight and enforcement responsibilities in accordance with the FPA,
the Department of Energy Organization Act (DOE Act), and EPAct 2005.
    Type of Respondents: Public utility with one or more organized
electricity markets
    Estimate of Annual Burden: \4\ The Commission estimates the total
burden and cost \5\ for this information collection as follows.
---------------------------------------------------------------------------

    \4\ Burden is defined as the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a Federal agency. For
further explanation of what is included in the information
collection burden, refer to 5 CFR 1320.3.
    \5\ FERC staff estimates that industry costs for salary plus
benefits are similar to Commission costs. The FERC 2021 average
salary plus benefits for one FERC full-time equivalent (FTE) is
$180,703/year (or $87.00/hour) posted by the Bureau of Labor
Statistics for the Utilities sector (available at https://www.bls.gov/oes/current/naics3_221000.htm).

                   FERC-732--Electric Rate Schedules and Tariffs: Long-Term Firm Transmission Rights in Organized Electricity Markets
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Total annual
                                                                                Annual  number                     burden hours
                                                                        Number of      of  responses   Total number of     and total         Cost per
                                                                       respondents     per respondent     responses       annual cost    respondent  ($)
                                                                                ($)
                                                                                (1)              (2)   (1) * (2) = (3)     (3) * (4) =        (5) / (1)
                                                                                (5)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Public utility with one or more organized electricity markets......               1                1            \6\ 1      1,180 hrs.;         $102,660
                                                                                $102,660
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Comments: Comments are invited on: (1) Whether the collection of
information is necessary for the proper performance of the functions of
the Commission, including whether the information will have practical
utility; (2) the accuracy of the agency's estimate of the burden and
cost of the collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility and clarity of the information collection; and (4) ways to
minimize the burden of the collection of information on those who are
to respond, including the use of automated collection techniques or
other forms of information technology.
---------------------------------------------------------------------------

    \6\ The ``1'' Tariff filing is a placeholder for future fillers.

    Dated: January 20, 2022.
Kimberly D. Bose,
Secretary.
[FR Doc. 2022-01523 Filed 1-25-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 217 (Monday, November 9, 2020)]
[Notices]
[Pages 71348-71350]
[FR Doc No: 2020-24807]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-2268]

Insanitary Conditions at Compounding Facilities; Guidance for
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled ``Insanitary
Conditions at Compounding Facilities.'' Drug products compounded under
insanitary conditions could become contaminated and cause serious
adverse events, including death, in patients. FDA is issuing this
guidance to help compounding facilities and State regulatory agencies
understand some examples of what FDA considers to be insanitary
conditions that could cause a drug to become contaminated or rendered
injurious to health. These examples are intended to help compounding
facilities take action to prevent the occurrence of these and other
insanitary conditions, as well as to implement appropriate corrective
actions when such conditions already exist.

DATES: The announcement of the guidance is published in the Federal
Register on November 9, 2020.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances on any guidance 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-2016-D-2268 for ``Insanitary Conditions at Compounding
Facilities.'' 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.govinfo.gov/content/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)).
    Submit written requests for single copies of the guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the final guidance document.

FOR FURTHER INFORMATION CONTACT: Jinhee Lee, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 5225, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Insanitary Conditions at Compounding Facilities.'' \1\ Under
section 501(a)(2)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 351(a)(2)(A)), a drug is adulterated if it has been
prepared, packed, or held under insanitary conditions whereby it may
have been contaminated with filth or rendered injurious to health. Drug
products compounded under insanitary conditions could become
contaminated and cause serious adverse events, including death, in
patients. Although sections 503A and 503B of the FD&C Act (21 U.S.C.
353a and 353b) provide exemptions for compounded drugs from specified
provisions of the FD&C Act if certain conditions are met, neither
section provides an exemption from section 501(a)(2)(A) of the FD&C
Act. Any drug that is prepared, packed, or held under insanitary
conditions is deemed to be adulterated under the FD&C Act, including
drugs produced by a compounding facility.
---------------------------------------------------------------------------

    \1\ For the purpose of this guidance, FDA regards compounding
facilities as pharmacies, Federal facilities, and outsourcing
facilities that compound or repackage drugs, or that mix, dilute, or
repackage biological products.
---------------------------------------------------------------------------

    Since the 2012 fungal meningitis outbreak associated with
injectable drug products that a pharmacy compounded and shipped to
patients and healthcare providers across the country, the Agency has
identified insanitary conditions at many of the compounding facilities
that it has inspected, and numerous compounders have voluntarily
recalled drug products intended to be sterile and also temporarily or
permanently ceased sterile operations because of these findings.
Generally, State licensed pharmacies do not register with FDA unless
they are outsourcing facilities. As a result, the Agency is often not
aware of these pharmacies, their conditions and practices, and
potential problems with the quality of their drug products. Although
FDA does conduct some surveillance inspections, FDA does not inspect
the vast majority of State licensed pharmacies in the United States
unless, for example, FDA receives a complaint, such as a report of a
serious adverse event or product quality issue. FDA does, however,
routinely inspect outsourcing facilities registered with FDA.\2\
Regardless of whether a facility is routinely inspected by FDA, it is
critical that both State licensed pharmacies and outsourcing facilities
identify and remediate, as well as work to prevent, the occurrence of
insanitary conditions within their facilities. Because insanitary
conditions can result in drug contamination and patient injury,
corrective action should be implemented expeditiously in order to
prevent the recurrence of such conditions.
---------------------------------------------------------------------------

    \2\ See section 503B(b)(4) of the FD&C Act.
---------------------------------------------------------------------------

    In the Federal Register of September 26, 2018 (83 FR 48631), FDA
announced the availability of a revised draft guidance for industry
entitled ``Insanitary Conditions at Compounding Facilities.'' The
revised draft guidance provided examples of conditions that the Agency
has observed at compounding facilities it has inspected and considers
to be insanitary conditions. The revised draft guidance also described
corrective actions that compounding facilities should take when they
identify such conditions and the regulatory actions FDA may take in
response to identified insanitary conditions.
    FDA received comments on the revised draft guidance from various

stakeholders (e.g., physicians, pharmacies, outsourcing facilities).
Several comments were submitted concerning the implications of the
policies described in the revised draft guidance for physicians who
compound or repackage drug products or mix, dilute, or repackage FDA-
licensed biological products in their offices. In response to these
comments, FDA made changes, where appropriate, in the final guidance.
The changes include adding a footnote to state that ``processing of
beta-lactams'' does not refer to mixing, reconstituting, or other such
acts that are performed in accordance with the directions contained in
FDA-approved labeling; adding a footnote to reflect that the FDA does
not generally object to rapid movement temporary blocking or disruption
of first air in the ISO 5 area when necessary for the safe handling of
radiopharmaceuticals to minimize radiation exposure, and revising the
language in a footnote concerning the scope of physician compounding or
repackaging activities to state that FDA generally does not intend to
take action under section 501(a)(2)(A) of the FD&C Act against a
physician who is compounding a drug product, repackaging an FDA-
approved drug product, or who is mixing, diluting, or repackaging an
FDA-licensed biological product, provided that it occurs in the
physician's office for in-office administration to the physician's
patients; and adding recommendations encouraging compounders to use
risk evaluation strategies and risk management tools to develop
appropriate controls necessary to prevent the occurrence of insanitary
conditions at their facilities. In addition, editorial changes were
made to the guidance for clarity.
    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 ``Insanitary Conditions at Compounding
Facilities.'' The examples described in the final guidance do not
constitute an exhaustive list of conditions FDA considers to be
insanitary conditions. 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.

II. Paperwork Reduction Act of 1995

    This guidance contains no collection of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required.
    However, this guidance refers to a previously approved FDA
collection of information. This collection of information is subject to
review by OMB under the PRA. The collections of information in 21 CFR
part 7 pertaining to FDA's recall regulations have been approved under
OMB control number 0910-0249.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.

    Dated: November 3, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-24807 Filed 11-6-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 126 (Tuesday, July 1, 2014)]
[Rules and Regulations]
[Pages 37224-37226]
[FR Doc No: 2014-15263]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2014-0336 FRL-9912-64-Region-9]

Revisions to the California State Implementation Plan, San
Joaquin Valley Unified Air Pollution Control District

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is taking direct
final action to approve revisions to the San Joaquin Valley Unified Air
Pollution Control District [SJVUAPCD] portion of the California State
Implementation Plan (SIP). These revisions concern basic enforcement
authorities under the Clean Air Act (CAA or the Act).

DATES: This rule is effective on September 2, 2014 without further
notice, unless EPA receives adverse comments by July 31, 2014. If we
receive such comments, we will publish a timely withdrawal in the
Federal Register to notify the public that this direct final rule will
not take effect.

ADDRESSES: Submit comments, identified by docket number EPA-R09-OAR-
2014-0336, by one of the following methods:
    1. Federal eRulemaking Portal: www.regulations.gov. Follow the on-
line instructions.
    2. Email<EMAIL_ADDRESS>    3. Mail or deliver: Andrew Steckel (Air-4), U.S. Environmental
Protection Agency Region IX, 75 Hawthorne Street, San Francisco, CA
94105-3901.
    Instructions: All comments will be included in the public docket
without change and may be made available online at www.regulations.gov,
including any personal information provided, unless the comment
includes Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. Information that you
consider CBI or otherwise protected should be clearly identified as
such and should not be submitted through www.regulations.gov or email.
www.regulations.gov is an ``anonymous access'' system, and EPA will not
know your identity or contact information unless you provide it in the
body of your comment. If you send email directly to EPA, your email
address will be automatically captured and included as part of the
public comment. 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: Generally, documents in the docket for this action are
available electronically at www.regulations.gov and in hard copy at EPA
Region IX, 75 Hawthorne Street, San Francisco, California 94105-3901.
While all documents in the docket are listed at www.regulations.gov,
some information may be publicly available only at the hard copy
location (e.g., copyrighted material, large maps), and some may not be
publicly available in either location (e.g., CBI). To inspect the hard
copy materials, please schedule an appointment during normal business
hours with the contact listed in the FOR FURTHER INFORMATION CONTACT
section.

FOR FURTHER INFORMATION CONTACT: Vanessa Graham, EPA Region IX, (415)
947-4120<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us,''
and ``our'' refer to EPA.

Table of Contents

I. The State's Submittal
    A. What rules did the State submit?
    B. Are there other versions of these rules?
    C. What is the purpose of the submitted rules?
II. EPA's Evaluation and Action
    A. How is EPA evaluating the rules?
    B. Do the rules meet the evaluation criteria?
    C. Public Comment and Final Action
    III. Statutory and Executive Order Reviews

I. The State's Submittal

A. What rules did the State submit?

    Table 1 lists the rules we are approving with the dates that they
were adopted by SJVUAPCD and submitted by the California Air Resource
Board (CARB).

                                            Table 1--Submitted Rules
----------------------------------------------------------------------------------------------------------------
             Local agency                  Rule No.            Rule title             Adopted        Submitted
----------------------------------------------------------------------------------------------------------------
SJVUAPCD..............................            1040  Enforcement.............        12/17/92        09/28/94
SJCUAPCD..............................            1050  Order of Abatement......        12/17/92        09/28/94
SJVUAPCD..............................            1070  Inspections.............        12/17/92        09/28/94
SJVUAPCD..............................            1090  Penalty.................        12/17/92        09/28/94
----------------------------------------------------------------------------------------------------------------

    On March 28, 1995, the submittal for SJVUAPCD Rules 1040, 1050,
1070, and 1090 was deemed by operation of law to meet the completeness
criteria in 40 CFR Part 51 Appendix V, which must be met before formal
EPA review.

B. Are there other versions of these rules?

    There are no previous versions of Rules 1040, 1050, 1070 and 1090
in the SIP.

C. What is the purpose of the submitted rules?

    Rule 1040 defines provisions of the California Health and Safety
Code under which SJVUAPCD rules are enforced.
    Rule 1050 explains the procedures for issuing an order of
abatement, the rules governing hearings in the issuance of orders of
abatement and the penalties for violating orders of abatement.
    Rule 1070 outlines the district's authority in determining
compliance with other District rules and regulations. It also explains
that inspections shall be made by the enforcement agency for the
purpose of obtaining information necessary to determine whether air
pollution sources are in compliance with applicable rules and
regulations.
    Rule 1090 requires that any person or source operation comply with
SJVUAPCD rules and regulations.

II. EPA's Evaluation and Action

A. How is EPA evaluating the rules?

    Generally, SIP rules must be enforceable (see section 110(a) of the
Act), and must not relax existing requirements. (See section
110(a)(1)). These rules support some of the basic infrastructure SIP
requirements described in section 110(a)(2) of the CAA, but do not
impose any specific air pollution control or emission limitations, so
we are not evaluating them with respect to Reasonably Available Control
Technology (RACT) or other CAA requirements regarding SIP stringency.
    Guidance and policy documents that we use to evaluate
enforceability and other CAA requirements consistently include the
following:

``Guidance Document for Infrastructure State Implementation Plan''
Elements under Clean Air Act Sections 110(a)(1) and 110(a)(2), EPA
(September 2013).

B. Do the rules meet the evaluation criteria?

    We believe these rules are consistent with the relevant policy and
guidance regarding enforceability and SIP relaxations. Our Technical
Support Document (TSD) has more information on our evaluation.

C. Public Comment and Final Action

    As authorized in section 110(k)(3) of the Act, EPA is fully
approving the submitted rules because we believe they fulfill all
relevant requirements. We do not think anyone will object to this
approval, so we are finalizing it without proposing it in advance.
However, in the Proposed Rules section of this Federal Register, we are
simultaneously proposing approval of the same submitted rules. If we
receive adverse comments by July 31, 2014, we will publish a timely
withdrawal in the Federal Register to notify the public that the direct
final approval will not take effect and we will address the comments in
a subsequent final action based on the proposal. If we do not receive
timely adverse comments, the direct final approval will be effective
without further notice on September 2, 2014. This will incorporate
these rules into the federally enforceable SIP.
    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.

III. 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 disproportionate human health or environmental effects with
practical, appropriate, 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 2, 2014. 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,
Incorporation by reference, Intergovernmental relations, Lead, Nitrogen
dioxide, Ozone, Particulate matter, Reporting and recordkeeping
requirements, Sulfur Oxides, Volatile organic compounds.

    Dated: May 23, 2014.
Jared Blumenfeld,
Regional Administrator, Region IX.

    Part 52, Chapter I, Title 40 of the Code of Federal Regulations is
amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

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

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

Subpart F--California

0
2. Section 52.220, is amended by adding paragraph (c)(199)(i)(D)(10) to
read as follows:

Sec.  52.220  Identification of plan.

* * * * *
    (c) * * *
    (199) * * *
    (i) * * *
    (D) * * *
    (10) Rules 1040, 1050, 1070 and 1090 adopted on June 18,1992 and
amended on December 17, 1992.
* * * * *
[FR Doc. 2014-15263 Filed 6-30-14; 8:45 am]
BILLING CODE 6560-50-P


Neal Fann/RTP/USEPA/US

03/11/2008 01:34 PM

To

<EMAIL_ADDRESS> cc

Ron Evans/RTP/USEPA/US@EPA, Janet Cakir/RTP/USEPA/US@EPA, Tricia Crabtree/RTP/USEPA/US@EPA, Nathalie Simon/DC/USEPA/US@EPA, Bryan Hubbell/RTP/USEPA/US@EPA

Subject

Sentences on UV-b

Margo,

This is the text to which Bryan referred. Please let us know if you have any comments.

Thanks,

Neal

_________________________________

Neal Fann

USEPA

Office of Air Quality Planning & Standards

Air Benefit and Cost Group

C439-02

RTP, NC 27711

voice:<PHONE_NUMBER>

fax:<PHONE_NUMBER>

----- Forwarded by Neal Fann/RTP/USEPA/US on 03/11/2008 01:32 PM -----

Bryan Hubbell/RTP/USEPA/US

03/11/2008 01:29 PM

To

Ron Evans@EPA, Fann.Neal@epamail.epa.gov@EPA

cc

Subject

Sentences on UV-b

Revised sentences:

"EPA has conducted a screening level analysis of the effects of reduced ozone concentrations on UVB exposures.  This analysis is based on the air quality modeling conducted for the proposed Ozone NAAQS RIA, and is described in Appendix ___ to the this RIA.  The screening analysis has been peer-reviewed and the peer-review comments are provided with the report.  EPA is in the process of evaluating the peer-review comments and potential next steps."

Dr. Bryan J. Hubbell

Senior Advisor for Science and Policy Analysis

Health and Environmental Impacts Division

U.S. EPA/OAQPS (C504-02)

RTP, NC 27711

(919) 541-0621

__________________

New sentence:

"EPA has conducted a screening level analysis of the effects of reduced ozone concentrations on UVB exposures.  This analysis is based on the air quality modeling conducted for the proposed Ozone NAAQS RIA, and is described in Appendix ___ to the this RIA.  The screening analysis has been peer-reviewed and a summary of the peer-review comments and responses are provided with the report."

Replaces the following:

"We will develop approaches for estimating the effects of increased UVB exposures resulting from reductions in tropospheric ozone and will work to present peer-reviewed quantified estimates for the final rule."

Dr. Bryan J. Hubbell

Senior Advisor for Science and Policy Analysis

Health and Environmental Impacts Division

U.S. EPA/OAQPS (C504-02)

RTP, NC 27711

(919) 541-0621