[Federal Register Volume 76, Number 220 (Tuesday, November 15, 2011)]
[Rules and Regulations]
[Pages 70834-70859]
[FR Doc No: 2011-29287]

Vol. 76

Tuesday,

No. 220

November 15, 2011

Part II

Environmental Protection Agency

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40 CFR Part 63

National Emission Standards for Hazardous Air Pollutant Emissions for
Primary Lead Processing; Final Rule

Federal Register / Vol. 76 , No. 220 / Tuesday, November 15, 2011 /
Rules and Regulations

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 63

[EPA-HQ-OAR-2004-0305; FRL-9491-2]
RIN 2060-AQ43

National Emission Standards for Hazardous Air Pollutant Emissions
for Primary Lead Processing

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This action finalizes the residual risk and technology review
conducted for the Primary Lead Processing source category regulated
under national emission standards for hazardous air pollutants
(NESHAP). This action finalizes amendments to the NESHAP that include
revision of the rule's title and applicability provision, revisions to
the stack emission limits for lead, work practice standards to minimize
fugitive dust emissions, and the modification and addition of testing
and monitoring and related notification, recordkeeping, and reporting
requirements. It also finalizes revisions to the regulatory provisions
related to emissions during periods of startup, shutdown, and
malfunction and makes minor non-substantive changes to the rule.

DATES: This final action is effective on November 15, 2011.

ADDRESSES: The EPA has established a docket for this action under
Docket ID No. EPA-HQ-OAR-2004-0305. All documents in the docket are
listed on the http://www.regulations.gov Web site. Although listed in
the index, some information is not publicly available, e.g.,
confidential business information (CBI) or other information whose
disclosure is restricted by statute. Certain other material, such as
copyrighted material, is not placed on the Internet, and will be
publicly available only in hard copy form. Publicly available docket
materials are available either electronically through http://www.regulations.gov, or in hard copy at the EPA Docket Center, EPA West
Building, Room Number 3334, 1301 Constitution Ave. NW., Washington, DC.
The Public Reading Room hours of operation are 8:30 a.m. to 4:30 p.m.
Eastern Standard Time (EST), Monday through Friday. The telephone
number for the Public Reading Room is<PHONE_NUMBER>, and the telephone
number for the Air and Radiation Docket and Information Center is (202)
566-1742.

FOR FURTHER INFORMATION CONTACT: For questions about this final action,
contact Mr. Nathan Topham, Office of Air Quality Planning and
Standards, Sector Policies and Programs Division, U.S. Environmental
Protection Agency, Research Triangle Park, NC 27711; telephone number:
(919) 541-0483; fax number:<PHONE_NUMBER>; and email address:
<EMAIL_ADDRESS>For additional contact information, see the
following SUPPLEMENTARY INFORMATION section.

SUPPLEMENTARY INFORMATION:  For specific information regarding the
modeling methodology, contact Dr. Michael Stewart, Office of Air
Quality Planning and Standards, Health and Environmental Impacts
Division, Air Toxics Assessment Group (C504-06), U.S. Environmental
Protection Agency, Research Triangle Park, NC 27711; telephone number:
(919) 541-7524; fax number:<PHONE_NUMBER>; and email address:
<EMAIL_ADDRESS>For information about the applicability of
this NESHAP to a particular entity, contact the appropriate person
listed in Table 1 to this preamble.

  Table 1--List of EPA Contacts for the NESHAP Addressed in This Action
------------------------------------------------------------------------
         NESHAP for:            OECA Contact \1\      OAQPS Contact \2\
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Primary Lead Processing.....  Maria Malave, (202)   Nathan Topham, (919)
                               564-7027,             541-0483,
<EMAIL_ADDRESS><EMAIL_ADDRESS>                               v.                    ov.
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\1\ EPA's Office of Enforcement and Compliance Assurance.
\2\ EPA's Office of Air Quality Planning and Standards.

    Background Information Document. On February 17, 2011 (76 FR 9410),
the EPA proposed revisions to the Primary Lead Smelting NESHAP based on
evaluations performed by the EPA in order to conduct our risk and
technology review. In this action, we are finalizing decisions and
revisions for the rule. Some of the significant comments and our
responses are summarized in this preamble; a summary of the other
public comments on the proposal, and the EPA's responses to those
comments, is available in Docket ID No. EPA-HQ-OAR-2004-0305. A red-
line version of the regulatory language that incorporates the changes
in this action is available in the docket.
    Organization of This Document. The following outline is provided to
aid in locating information in the preamble.

I. General Information
    A. Does this action apply to me?
    B. Where can I get a copy of this document?
    C. Judicial Review
II. Background
III. Summary of the Final Rule
    A. What are the final rule amendments for the Primary Lead
Processing source category?
    B. What are the requirements during periods of startup,
shutdown, and malfunction?
    C. What are the effective and compliance dates of the standards?
IV. Summary of Significant Changes Since Proposal
    A. Changes to the Risk Assessment Performed Under Section 112(f)
of the Clean Air Act
    B. Changes to the Technology Review Performed Under Section
112(d)(6) of the Clean Air Act
    C. Other Changes Since Proposal
V. Summary of Significant Comments and Responses
    A. Timeline for Compliance
    B. The EPA's Authority Under Section 112 of the Clean Air Act
    C. Primary Lead Processing Risk Assessment
VI. Impacts of the Final Rule
VII. Statutory and Executive Order Reviews
    A. Executive Orders 12866: Regulatory Planning and Review, and
Executive Order 13563: Improving Regulation and Regulatory Review
    B. Paperwork Reduction Act
    C. Regulatory Flexibility Act
    D. Unfunded Mandates Reform Act
    E. Executive Order 13132: Federalism
    F. Executive Order 13175: Consultation and Coordination With
Indian Tribal Governments
    G. Executive Order 13045: Protection of Children From
Environmental Health Risks and Safety Risks
    H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use
    I. National Technology Transfer and Advancement Act
    J. Executive Order 12898: Federal Actions To Address
Environmental Justice in Minority Populations and Low-Income
Populations

    K. Congressional Review Act

I. General Information

A. Does this action apply to me?

    Regulated Entities. Categories and entities potentially regulated
by this action include:

 Table 2--NESHAP and Industrial Source Categories Affected by This Final
                                 Action
------------------------------------------------------------------------
    NESHAP and source category        NAICS \1\ code     MACT \2\ code
------------------------------------------------------------------------
Primary Lead Processing...........             331419               0204
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\1\ North American Industry Classification System.
\2\ Maximum Achievable Control Technology.

    Table 2 is not intended to be exhaustive, but rather provides a
guide for readers regarding entities likely to be affected by the final
action for the source category listed. To determine whether your
facility would be affected, you should examine the applicability
criteria in the appropriate national emission standards for hazardous
air pollutants (NESHAP). As defined in the source category listing
report published by the EPA in 1992, the Primary Lead Smelting source
category is defined as any facility engaged in producing lead metal
from ore concentrates; including, but not limited to, the following
smelting processes: Sintering, reduction, preliminary treatment, and
refining operations.\1\ To be consistent with the 1992 listing, the EPA
is revising the applicability of the Primary Lead Smelting NESHAP to
apply to any facility that produces lead metal from lead ore
concentrates and is changing the title of the rule to reference Primary
Lead Processing. For clarification purposes, all reference to lead
emissions in this preamble means ``lead compounds'' (which is a
hazardous air pollutant) and all reference to lead production means
elemental lead (which is not a hazardous air pollutant) as provided
under Clean Air Act (CAA) section 112(b)(7)).
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    \1\ USEPA. Documentation for Developing the Initial Source
Category List--Final Report, USEPA/OAQPS, EPA-450/3-91-030, July,
1992.
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    If you have any questions regarding the applicability of any aspect
of the Primary Lead Processing NESHAP, please contact the appropriate
person listed in Table 1 of this preamble in the preceding FOR FURTHER
INFORMATION CONTACT section.

B. Where can I get a copy of this document?

    In addition to being available in the docket, an electronic copy of
this final action will also be available on the World Wide Web (www)
through the Technology Transfer Network (TTN). Following signature, a
copy of the final action will be posted on the TTN's policy and
guidance page for newly proposed and promulgated rules at the following
address: http://www.epa.gov/ttn/caaa/new.html. The TTN provides
information and technology exchange in various areas of air pollution
control.
    Additional information is available on the residual risk and
technology review (RTR) web page at http://www.epa.gov/ttn/atw/rrisk/rtrpg.html. This information includes source category descriptions and
detailed emissions and other data that were used as inputs to the risk
assessments.

C. Judicial Review

    Under section 307(b)(1) of the CAA, judicial review of this final
action is available only by filing a petition for review in the United
States Court of Appeals for the District of Columbia Circuit by January
17, 2012. Under section 307(b)(2) of the CAA, the requirements
established by this final rule may not be challenged separately in any
civil or criminal proceedings brought by the EPA to enforce the
requirements.
    Section 307(d)(7)(B) of the CAA further provides that ``[o]nly an
objection to a rule or procedure which was raised with reasonable
specificity during the period for public comment (including any public
hearing) may be raised during judicial review.'' This section also
provides a mechanism for us to convene a proceeding for
reconsideration, ``[i]f the person raising an objection can demonstrate
to the EPA that it was impracticable to raise such objection within
[the period for public comment] or if the grounds for such objection
arose after the period for public comment (but within the time
specified for judicial review) and if such objection is of central
relevance to the outcome of the rule.'' Any person seeking to make such
a demonstration to us should submit a Petition for Reconsideration to
the Office of the Administrator, U.S. EPA, Room 3000, Ariel Rios
Building, 1200 Pennsylvania Ave. NW., Washington, DC 20460, with a copy
to both the person(s) listed in the preceding FOR FURTHER INFORMATION
CONTACT section, and the Associate General Counsel for the Air and
Radiation Law Office, Office of General Counsel (Mail Code 2344A), U.S.
EPA, 1200 Pennsylvania Ave. NW., Washington, DC 20460.

II. Background

    Section 112 of the CAA establishes a two-stage regulatory process
to address emissions of hazardous air pollutants (HAP) from stationary
sources. In the first stage, after the EPA has identified categories of
sources emitting one or more of the HAP listed in section 112(b) of the
CAA, section 112(d) calls for us to promulgate NESHAP for those
sources. ``Major sources'' are those that emit, or have the potential
to emit, any single HAP at a rate of 10 tons per year (TPY) or more, or
25 TPY or more of any combination of HAP. For major sources, these
technology-based standards must reflect the maximum degree of emission
reductions of HAP achievable (after considering cost, energy
requirements, and non-air quality health and environmental impacts) and
are commonly referred to as maximum achievable control technology
(MACT) standards.
    For MACT standards, the statute specifies certain minimum
stringency requirements, which are referred to as floor requirements
and may not be based on cost considerations. See CAA section 112(d)(3).
For new sources, the MACT floor cannot be less stringent than the
emission control that is achieved in practice by the best controlled
similar source. The MACT standards for existing sources can be less
stringent than floors for new sources, but they cannot be less
stringent than the average emission limitation achieved by the best-
performing 12 percent of existing sources in the category or
subcategory (or the best-performing five sources for categories or
subcategories with fewer

than 30 sources). In developing MACT, we must also consider control
options that are more stringent than the floor, under CAA section
112(d)(2). We may establish standards more stringent than the floor,
based on the consideration of the cost of achieving the emissions
reductions, any non-air quality health and environmental impacts, and
energy requirements. In promulgating MACT standards, CAA section
112(d)(2) directs us to consider the application of measures,
processes, methods, systems, or techniques that reduce the volume of or
eliminate HAP emissions through process changes, substitution of
materials, or other modifications; enclose systems or processes to
eliminate emissions; collect, capture, or treat HAP when released from
a process, stack, storage, or fugitive emissions point; and/or are
design, equipment, work practice, or operational standards.
    In the second stage of the regulatory process, we undertake two
different analyses, as required by the CAA: section 112(d)(6) of the
CAA calls for us to review these technology-based standards and to
revise them ``as necessary (taking into account developments in
practices, processes, and control technologies)'' no less frequently
than every 8 years; and within 8 years after promulgation of the
technology standards, CAA section 112(f) calls for us to evaluate the
risk to public health remaining after application of the technology-
based standards and to revise the standards, if necessary, to provide
an ample margin of safety to protect public health or to prevent,
taking into consideration costs, energy, safety, and other relevant
factors, an adverse environmental effect. In doing so, the EPA may
adopt standards equal to existing MACT standards if the EPA determines
that the existing standards are sufficiently protective. NRDC v. EPA,
529 F.3d 1077, 1083 (DC Cir. 2008).
    On February 17, 2011, the EPA published a proposed rule in the
Federal Register for the Primary Lead Smelting NESHAP, 40 CFR part 63
subpart TTT, that took into consideration the residual risk and
technology review (RTR) analyses for that source category. This action
provides the EPA's final determinations pursuant to the RTR provisions
of CAA section 112 for the Primary Lead Processing source category.
Specifically, as a result of our analyses, we are revising the
requirements of the NESHAP to ensure public health and the environment
are protected consistent with section 112(f) and that emission
reductions are consistent with what is economically and technically
feasible under section 112(d)(6). In addition, we are taking the
following actions:
     Revising the requirements in the NESHAP related to
emissions during periods of startup, shutdown, and malfunction (SSM).
     Revising the title of the rule and amending the
applicability section consistent with the definition of the source
category adopted in 1992, to provide that the NESHAP applies to any
facility processing lead ore concentrate to produce lead metal.
     Replacing the definition of ``primary lead smelter'' with
a definition of ``primary lead processor'' and adding definitions of
``secondary lead smelters,'' ``lead refiners,'' and ``lead remelters.''
     Incorporating the use of plain language into the rule.
     Addressing technical and editorial corrections in the
rule.
     Responding to the January 2009 petition for rulemaking
from the Natural Resources Defense Council (NRDC) that the original
primary lead NESHAP should have included an emission standard for
organic HAP and announcing our intention to collect additional data
needed to develop a standard for organic HAP.
    We note that the Doe Run Herculaneum Smelter, the only facility in
the source category, is subject to a Consent Decree requiring
submission of a facility-wide cleanup plan by January 1, 2013, shutdown
of their sintering operations by the end of 2013, and shutdown of the
blast furnace by April 30, 2014. The Consent Decree will achieve
drastic reductions in emissions of lead and other pollutants and will
provide substantial environmental and public health benefits. The
Herculaneum area has also been designated as a nonattainment area for
the 2008 National Ambient Air Quality Standards (NAAQS) for lead.
Attainment of the 2008 Lead NAAQS (which is demonstrated based on three
years of data at or below the level of the NAAQS) is required by
December 2015. The State of Missouri is required to submit its
attainment demonstration State Implementation Plan (SIP) by June 30,
2012.

III. Summary of the Final Rule

A. What are the final rule amendments for the Primary Lead Processing
source category?

    The National Emission Standards for Hazardous Air Pollutant
Emissions: Primary Lead Smelting was promulgated on June 6, 1999 (64 FR
30204), and codified at 40 CFR part 63, subpart TTT. The primary lead
processing industry consists of facilities that produce lead metal from
ore concentrates. The source category covered by this MACT standard
currently includes only one operating facility, The Doe Run Company in
Herculaneum, Missouri.
    For the reasons provided in the proposed rule and in the support
documents in the docket, we have determined that the risks associated
with this source category are unacceptable and are therefore
promulgating requirements to reduce the risk to an acceptable level.
Once risk is reduced to an acceptable level, we analyze whether there
are additional controls that will provide an ample margin of safety,
considering cost, energy, safety, and other relevant factors. We have
concluded that there are no additional cost-effective controls
available beyond those that we are requiring to reduce risk to an
acceptable level and thus the same controls to ensure an acceptable
level of risk will also provide an ample margin of safety. To satisfy
section 112(f) of the CAA, we are, therefore, revising the existing
MACT standard to include:
     An emission cap of 1.2 TPY for the furnace area stack and
the refining operation stacks, combined.\2\
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    \2\ EPA notes that it is setting a combined emission limit for
these sources because, as noted in the proposal (76 FR 9432), and
the risk assessment documents to support the proposed and final
rulemakings, these sources have overlapping points of maximum lead
impact.
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     Work practice standards to minimize fugitive dust
emissions.
    To satisfy section 112(d)(6) of the CAA, we are revising the
existing MACT standard to include a reduction of the lead emission
limit for the main stack. The MACT standard is being lowered from the
current 1.0 pound per ton of lead produced to 0.97 pound of lead per
ton of lead produced based on a determination that developments in
practices, processes, or control technologies since promulgation of the
MACT standards demonstrate that the facility can meet a reduced
emission limit from the main stack pursuant to CAA section 112(d)(6).
    In addition to our reviews under sections 112(f) and 112(d)(6) of
the CAA, we are promulgating the following:
     The revision of the applicability section of the rule
consistent with the definition of the source category adopted in 1992,
subpart TTT which applies to any facility that produces lead metal from
lead concentrate ore.
     Changes to the Primary Lead Processing MACT standards to

eliminate the SSM exemption. These changes revise Table 1 in 40 CFR
part 63, subpart TTT to indicate that several requirements of the 40
CFR part 63 General Provisions related to periods of SSM do not apply.
We are adding provisions to the Primary Lead Processing MACT standards
requiring sources to operate in a manner that minimizes emissions,
removing the SSM plan requirement, clarifying the required conditions
for performance tests, and revising the SSM-associated recordkeeping
and reporting requirements to require reporting and recordkeeping for
periods of malfunction. We are also adding provisions to provide an
affirmative defense against civil penalties for exceedances of emission
standards caused by malfunctions, as well as criteria for establishing
the affirmative defense.
     Replacement of the word ``shall'' with the word ``must''
in the regulatory text. We are also replacing ``thru'' with
``through.'' We are replacing the definition of ``primary lead
smelter'' with a definition of ``primary lead processor'' and adding
definitions of ``secondary lead smelters,'' ``lead refiners,'' and
``lead remelters.''
    These revisions to the Primary Lead Processing MACT standard are
expected to result in emissions reductions in lead and other hazardous
air pollutants and increased compliance costs to the industry. No
economic impacts on small businesses are expected as a result of the
revisions to the rule. We have determined that the one facility in this
source category can meet the applicable emissions standards at all
times, including periods of startup and shutdown, in compliance with
the current MACT standards.

B. What are the requirements during periods of startup, shutdown, and
malfunction?

    The United States Court of Appeals for the District of Columbia
Circuit vacated portions of two provisions in the EPA's CAA Section 112
regulations governing the emissions of HAP during periods of startup,
shutdown, and malfunction (SSM). Sierra Club v. EPA, 551 F.3d 1019 (DC
Cir. 2008), cert. denied, 130 S. Ct. 1735 (U.S. 2010). Specifically,
the Court vacated the SSM exemption contained in 40 CFR 63.6(f)(1) and
40 CFR 63.6(h)(1), that are part of a regulation, commonly referred to
as the ``General Provisions Rule,'' that the EPA promulgated under
section 112 of the CAA. When incorporated into CAA Section 112(d)
regulations for specific source categories, these two provisions exempt
sources from the requirement to comply with the otherwise applicable
CAA section 112(d) emission standard during periods of SSM.
    We have eliminated the SSM exemption in this rule. Consistent with
Sierra Club v. EPA, the EPA has established standards in this rule that
apply at all times. We have also revised Table 1 (the General
Provisions table) in several respects. For example, we have eliminated
that incorporation of the General Provisions' requirement that the
source develop an SSM plan. We have also eliminated or revised certain
recordkeeping and reporting that related to the SSM exemption. The EPA
has attempted to ensure that we have not included in the regulatory
language any provisions that are inappropriate, unnecessary, or
redundant in the absence of the SSM exemption.
    In establishing the standards in this rule, the EPA has taken into
account startup and shutdown periods and, for the reasons explained
below, has not established different standards for those periods.
Information on periods of startup and shutdown in the industry indicate
that emissions during these periods do not increase. Furthermore, all
processes are controlled by either control devices or work practices,
and these controls would not typically be affected by startup or
shutdown. Also, compliance with the standards requires averaging of
emissions over three-month periods, which accounts for the variability
of emissions that may result during periods of startup and shutdown.
Therefore, separate standards for periods of startup and shutdown are
not being promulgated.
    Periods of startup, normal operations, and shutdown are all
predictable and routine aspects of a source's operations. However, by
contrast, malfunction is defined as a ``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 * * *'' (40 CFR 63.2). The EPA has determined that CAA
section 112 does not require that emissions that occur during periods
of malfunction be factored into development of CAA section 112
standards. Under section 112, emission standards for new sources must
be no less stringent than the level ``achieved'' by the best controlled
similar source and for existing sources generally must be no less
stringent than the average emission limitation ``achieved'' by the best
performing 12 percent of sources in the category. There is nothing in
section 112 that directs the Agency to consider malfunctions in
determining the level ``achieved'' by the best performing or best
controlled sources when setting emission standards. Moreover, while the
EPA accounts for variability in setting emissions standards consistent
with the section 112 caselaw, nothing in that caselaw requires the
Agency to consider malfunctions as part of that analysis. Section 112
uses the concept of ``best controlled'' and ``best performing'' unit in
defining the level of stringency that section 112 performance standards
must meet. Applying the concept of ``best controlled'' or ``best
performing'' to a unit that is malfunctioning presents significant
difficulties, as malfunctions are sudden and unexpected events.
    Further, accounting for malfunctions would be difficult, if not
impossible, given the myriad different types of malfunctions that can
occur across all sources in the category and given the difficulties
associated with predicting or accounting for the frequency, degree, and
duration of various malfunctions that might occur. As such, the
performance of units that are malfunctioning is not ``reasonably''
foreseeable. See, e.g., Sierra Club v. EPA, 167 F.3d 658, 662 (DC Cir.
1999) (EPA typically has wide latitude in determining the extent of
data-gathering necessary to solve a problem. We generally defer to an
agency's decision to proceed on the basis of imperfect scientific
information, rather than to ``invest the resources to conduct the
perfect study.''). See also, Weyerhaeuser v. Costle, 590 F.2d 1011,
1058 (DC Cir. 1978) (``In the nature of things, no general limit,
individual permit, or even any upset provision can anticipate all upset
situations. After a certain point, the transgression of regulatory
limits caused by `uncontrollable acts of third parties,' such as
strikes, sabotage, operator intoxication or insanity, and a variety of
other eventualities, must be a matter for the administrative exercise
of case-by-case enforcement discretion, not for specification in
advance by regulation.''). In addition, the goal of a best controlled
or best performing source is to operate in such a way as to avoid
malfunctions of the source and accounting for malfunctions could lead
to standards that are significantly less stringent than levels that are
achieved by a well-performing non-malfunctioning source. The EPA's
approach to malfunctions is consistent with section 112 and is a
reasonable interpretation of the statute.
    In the event that a source fails to comply with the applicable CAA
section 112(d) standards as a result of a malfunction event, the EPA
would determine an appropriate response based on, among other things,
the good

faith efforts of the source to minimize emissions during malfunction
periods, including preventative and corrective actions, as well as root
cause analyses to ascertain and rectify excess emissions. The EPA would
also consider whether the source's failure to comply with the CAA
section 112(d) standard was, in fact, ``sudden, infrequent, not
reasonably preventable'' and was not instead ``caused in part by poor
maintenance or careless operation.'' 40 CFR 63.2 (definition of
malfunction).
    Finally, the EPA recognizes that even equipment that is properly
designed and maintained can sometimes fail and that such failure can
sometimes cause an exceedance of the relevant emission standard. (See,
e.g., State Implementation Plans: Policy Regarding Excessive Emissions
During Malfunctions, Startup, and Shutdown (Sept. 20, 1999); Policy on
Excess Emissions During Startup, Shutdown, Maintenance, and
Malfunctions (Feb. 15, 1983)). The EPA is therefore adding to the final
rule an affirmative defense to civil penalties for exceedances of
emission limits that are caused by malfunctions. See 40 CFR 63.1542
Primary Lead Processing (defining ``affirmative defense'' to mean, 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.). We also have
added other regulatory provisions to specify the elements that are
necessary to establish this affirmative defense; the source must prove
by a preponderance of the evidence that it has met all of the elements
set forth in 63.1551 Primary Lead Processing. (See 40 CFR 22.24). 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 reasonable preventable and not caused by poor maintenance and or
careless operation). For example, to successfully assert the
affirmative defense, the source must prove by a preponderance of the
evidence that excess emissions ``[w]ere 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 * * *.'' The criteria also are designed to ensure that
steps are taken to correct the malfunction, to minimize emissions in
accordance with section 63.1543(i) and 63.1544(d), and to prevent
future malfunctions. For example, the source must prove by a
preponderance of the evidence that ``[r]epairs were made as
expeditiously as possible when the applicable emission limitations were
being exceeded * * *'' and that ``[a]ll possible steps were taken to
minimize the impact of the excess emissions on ambient air quality, the
environment and human health * * *.'' In any judicial or administrative
proceeding, the Administrator may challenge the assertion of the
affirmative defense and, if the respondent has not met its burden of
proving all of the requirements in the affirmative defense, appropriate
penalties may be assessed in accordance with Section 113 of the Clean
Air Act (see also 40 CFR 22.27).
    The EPA included an affirmative defense in the final rule in an
attempt to balance a tension, inherent in many types of air regulation,
to ensure adequate compliance while simultaneously recognizing that
despite the most diligent of efforts, emission limits may be exceeded
under circumstances beyond the control of the source. The EPA must
establish emission standards that ``limit the quantity, rate, or
concentration of emissions of air pollutants on a continuous basis.''
42 U.S.C. 7602(k) (defining ``emission limitation and emission
standard''). See generally Sierra Club v. EPA, 551 F.3d 1019, 1021 (DC
Cir. 2008) Thus, the EPA is required to ensure that section 112
emissions limitations are continuous. The affirmative defense for
malfunction events meets this requirement by ensuring that even where
there is a malfunction, the emission limitation is still enforceable
through injunctive relief. While ``continuous'' limitations, on the one
hand, are required, there is also caselaw indicating that in many
situations it is appropriate for the EPA to account for the practical
realities of technology. For example, in Essex Chemical v. Ruckelshaus,
486 F.2d 427, 433 (DC Cir. 1973), the DC Circuit acknowledged that in
setting standards under CAA section 111 ``variant provisions'' such as
provisions allowing for upsets during startup, shutdown and equipment
malfunction ``appear necessary to preserve the reasonableness of the
standards as a whole and that the record does not support the `never to
be exceeded' standard currently in force.'' See also, Portland Cement
Association v. Ruckelshaus, 486 F.2d 375 (DC Cir. 1973). Though
intervening caselaw such as Sierra Club v. EPA and the CAA 1977
amendments undermine the relevance of these cases today, they support
EPA's view that a system that incorporates some level of flexibility is
reasonable. The affirmative defense simply provides for a defense to
civil penalties for excess emissions that are proven to be beyond the
control of the source. By incorporating an affirmative defense, the EPA
has formalized its approach to upset events. In a Clean Water Act
setting, the Ninth Circuit required this type of formalized approach
when regulating ``upsets beyond the control of the permit holder.''
Marathon Oil Co. v. EPA, 564 F.2d 1253, 1272-73 (9th Cir. 1977). But
see, Weyerhaeuser Co. v. Costle, 590 F.2d 1011, 1057-58 (DC Cir. 1978)
(holding that an informal approach is adequate). The affirmative
defense provisions give the EPA the flexibility to both ensure that its
emission limitations are ``continuous'' as required by 42 U.S.C.
section 7602(k), and account for unplanned upsets and thus support the
reasonableness of the standard as a whole.

C. What are the effective and compliance dates of the standards?

    The revisions to the MACT standards being promulgated in this
action are effective on November 15, 2011. For the MACT standards being
addressed in this action, the compliance date for the revised SSM
requirements is the effective date of the standards, November 15, 2011.
The compliance date for the revised emission standard in section
16.1543(a) is January 17, 2012. The compliance date for the revised
requirements in section 16.1544 is February 13, 2012. The compliance
date for the new refining and furnace area stack emission limit is 2
years from the effective date of the standard, November 15, 2013.

IV. Summary of Significant Changes Since Proposal

A. Changes to the Risk Assessment Performed Under Section 112(f) of the
Clean Air Act

    As noted above, in February of 2011 EPA published the notice of
proposed rulemaking: National Emission Standards for Hazardous Air
Pollutants: Primary Lead Smelting. In the proposed rulemaking, EPA
presented a number of options for additional controls on the primary
lead smelting source category, which currently includes only one
facility operating in the United States. In the proposed rule, EPA
solicited comment on these options as well as on all the analyses and
data the options were based upon, including the risk methods and
results presented in the draft document: Draft Residual Risk

Assessment for the Primary Lead Smelting Source Category.
    During the public comment period for the proposed rule, the one
facility in the source category, The Doe Run Company, submitted
substantially updated emissions, meteorological, facility boundary, as
well as other relevant information bearing on the risk assessment (see
docket number: EPA-HQ-OAR-2004-0305 for Doe Run's public comments). As
a result, to support this final rulemaking EPA revised its analyses to
reflect the information received during the public comment period for
the proposed rule. Revised methods, model inputs, and risk results are
presented in the report: ``Residual Risk Assessment for the Primary
Lead Smelting Source Category'' which is available in the docket for
this rulemaking. In addition, a discussion of the updated emissions
information used in the final risk assessment can be found in the
Technical Support Document for the final rule, which can also be found
in the docket for this rulemaking.
    Table 3 presents the results of the final baseline risk assessment,
with respect to the risks due to lead emissions, broken down by
emission point. In the baseline scenario, we estimate that
approximately 1,550 people may be exposed to lead concentrations above
the NAAQS. Results indicate that emissions from the refining stacks and
furnace area stacks can likely result in exceedences of the NAAQS for
lead beyond the fenceline of the facility.\3\ These results also
indicate that fugitive dust emissions could result in exposures
approximately equal to the level of the NAAQS at the location of
maximum impact. The results also indicate that emissions from the main
stack do not likely result in exceedences of the NAAQS for lead beyond
the fenceline of the facility because emissions are highly dispersed
due to the height of the main stack.
---------------------------------------------------------------------------

    \3\ For the reasons noted in the proposed rulemaking, 76 FR at
9421, we used the level of the lead NAAQS as the level above which
we think an unacceptable risk is presented to the public.

     Table 3--Summary of Lead Concentrations Relative to the NAAQS Based on Estimated Actual 2009 Emissions
----------------------------------------------------------------------------------------------------------------
                                                   2009 Emissions
                 Emission point                         (tpy)                    Offsite impact \3\
----------------------------------------------------------------------------------------------------------------
Main stack \1\..................................              68.3  0.9 times the NAAQS.
Refining stacks \2\.............................               9.1  8 times the NAAQS.
Furnace area stack: (Controlled blast and                      2.5  2 times the NAAQS.
 drossing fugitives).
Fugitive dust...................................               1.0  1 times the NAAQS.
----------------------------------------------------------------------------------------------------------------
\1\ Results presented for the main stack in this table consider the good engineering practice (GEP) stack height
  of 330 feet (as was done in the SIP and in modeling submitted by the Doe Run Company in its public comments on
  the proposed rulemaking). The actual height of the main stack is approximately 550 feet, and thus the impact
  would likely be lower had actual stack height been modeled.
\2\ Emission sources controlled by baghouses 8 and 9 at the Doe Run facility.
\3\ For a given emission point, the model receptor location with the highest modeled 3-month ambient lead
  concentration was determined. This highest 3-month ambient lead concentration was then divided by the NAAQS
  (0.15 [mu]g/m\3\) for lead to determine the maximum offsite impact for a given emission point.

    Consistent with the risk assessment to support the proposed
rulemaking, the risk assessment to support the final rulemaking also
indicates that risks are unacceptable. This decision considers all the
risk estimates presented in the risk assessment document, but is
primarily based on lead emissions from the furnace area stack and the
refining operations stacks. We note that while the risk assessment
supporting the proposed rulemaking estimated that a combined emission
limit for the furnace area and refining operations should be set at
0.91 tons of lead per year to ensure that risks are acceptable, the
updated risk assessment estimates that a combined emission limit of 1.2
tons of lead per year will ensure that ambient lead concentrations from
those emission points do not result in lead levels in the ambient air
above the level of the NAAQS for lead, thereby resulting in acceptable
lead risk. In our ample margin of safety analysis, we identified no
cost-effective controls that are capable of achieving emission levels
below 1.2 tons per year, as described in the technical support
document. Thus, the EPA is promulgating a combined lead emission limit
for the furnace area and refining operations stacks at 1.2 tons per
year.\4\ In addition, the risk assessment projected ambient lead
concentrations from fugitive dust emissions to be very close to the
NAAQS for lead at the location of maximum impact; thus with respect to
fugitive dust emissions, since only minimal (if any) reductions beyond
those already in place are needed to ensure lead levels in the air do
not exceed the NAAQS, the EPA believes that the work practice standards
being promulgated in this rule, which are more stringent than currently
required by the 1999 NESHAP, will ensure an acceptable level of risk.
---------------------------------------------------------------------------

    \4\ EPA notes that it is setting a combined emission limit for
these sources because, as noted in the proposal (76 FR 9432), and
the risk assessment documents to support the proposed and final
rulemakings, these sources have overlapping points of maximum lead
impact.
---------------------------------------------------------------------------

    Moreover, since this NESHAP includes work practice standards to
minimize fugitive dust emissions, and since ambient monitoring for lead
is already conducted very close to this facility and in the local
community to demonstrate whether the area is attaining the lead NAAQS,
we have decided that fenceline monitoring to specifically demonstrate
that the source has adopted sufficient work practice standards to
ensure fugitive emissions do not cause exceedances of the NAAQS is not
necessary.
    In addition to the updated lead risk assessment results presented
above, we also note that there were changes to our cancer, acute, and
PB-HAP multipathway screening analyses for non-lead HAP as a result of
the new risk analysis performed for the final rule. With respect to our
updated cancer risk assessment, we estimate that the maximum individual
risk (MIR) of cancer is 20 in a million (as compared to 30 in a million
based on the risk assessment to support the proposed rule), and that
the cancer incidence is 0.008, or 1 excess cancer case every 125 years
(as compared to 0.0008 based on the risk assessment to support the
proposed rule). In addition, the refined worst-case acute hazard
quotient (HQ) value is 2.0 (based on the REL for arsenic), driven by
arsenic emissions from the main stack (as compared to 0.6 based on the
REL for arsenic and driven by arsenic fugitive dust emissions as
indicated by the risk assessment to

support the proposed rule). Finally, while the worst-case multipathway
screen to support the proposed rule indicated that no non-lead PB-HAP
exceeded screening levels for potential multipathway effects, in the
risk assessment to support the final rulemaking, the worst-case
multipathway screening level was exceeded with respect to cadmium
emissions. This is the result of the revised emissions information
provided by the company during the comment period, which indicated
higher cadmium emissions from the main stack than were assumed for
purposes of the risk assessment performed for the proposed rule.
    In considering the updated non-lead risk results presented above,
we note that while cancer incidence increased in our updated risk
assessment, cancer incidence remains very low with 1 excess cancer case
being estimated every 125 years.
    With respect to the worst-case acute HQ value of 2 based on the REL
for arsenic due to emissions from the main stack, we note that this is
a conservative, worst-case analysis of the potential for acute health
effects. We also note that in contrast to the risk analysis to support
the proposed rulemaking, the final risk analysis modeled the main stack
at the good engineering practice (GEP) stack height of 330 feet rather
than the actual stack height of 550 feet. Thus it is very likely that
the maximum potential worst-case HQ value is significantly lower than
2.
    Finally, with respect to the exceedence of the worst-case
multipathway screening level for cadmium, we note that this only
indicates the potential for cadmium exposures above the chronic
noncancer reference dose (RfD) for cadmium. That is, while in general,
emission rates below the worst-case multipathway screening level
indicate no significant potential for multipathway related health
effects, emission levels above this worst-case screening level only
indicate the potential for multipathway-related health risks of concern
based on a worst-case scenario. We were not able to refine our multi-
pathway analysis beyond the worst-case screening assessment. As a
result, based on worst case screening, we cannot state whether or not
there are going to be multipathway risks at true exposure levels, we
can only say that worst case modeling suggests there could be potential
risks. However, due to the highly conservative nature of this screening
assessment and the uncertainties related to the results, we have
concluded that, after implementation of the controls required by this
rule, risks will be acceptable, considering the combination of
potential multipathway risks, cancer risks, chronic non-cancer risks,
and acute non-cancer risks. We also reviewed whether there were cost-
effective controls that could further reduce risks as part of our ample
margin of safety analysis. The controls we are requiring to address
lead emissions also reduce emissions of non-lead HAP. We were unable to
identify any technically feasible cost effective additional controls
that would further reduce emissions of lead and non-lead HAP. We are
therefore determining that the standards we are promulgating today
provide an ample margin of safety to protect public health.
    In summary, the final rule includes an emission standard of 1.2
tons per year of lead emissions from refining and furnace area stacks,
combined. The standard also includes a requirement for the facility to
employ work practice standards to minimize fugitive dust emissions,
including cleaning plant roadways, stabilization of material during
storage and handling, and ensuring that doorways to process areas
remain closed. In summary, we conclude that these standards being
promulgated today will ensure risks are acceptable and public health is
protected with an ample margin of safety and that there will not be an
adverse environmental effect from HAP emissions from the one lead
processing facility in this source category.

B. Changes to the Technology Review Performed Under Section 112(d)(6)
of the Clean Air Act

    In the proposed rule, the main stack was subject to an emission
limit of 0.22 pounds of lead per ton of lead produced based on our
section 112(d)(6) technology review. That proposed limit was based on
information that indicated the source had significantly lower emissions
than the emission limit of 1 pound of lead per ton of lead produced
(lb/ton) required in the 1999 MACT standard. However, in comments
received on the proposed rule, The Doe Run Company indicated that the
proposed emission limit of 0.22 lb/ton under Section 112(d)(6) could
not be met and that the data on which that emission limit was based
were not accurate. The facility provided a 2009 stack emissions test
for the main stack that indicated that emissions at the facility are
significantly higher than we assumed as the basis for the proposed
limit. For purposes of our analysis for the final rule, the EPA
recalculated the emissions performance achieved for the main stack as
demonstrated by the 2009 and 2008 stack tests and considered an
estimate of emission variability in order to determine whether it was
appropriate to revise the emission limit based on what the source was
able to achieve in practice. Based on the revised analysis, we are
promulgating an emission limit for the main stack of 0.97 pounds of
lead per ton of lead produced.
    We have also changed the compliance date for the main stack to
reflect compliance ``as expeditiously as possible'' under section
112(i)(3) of the CAA. The compliance date for the 0.97 lb/ton limit is
60 days from the date of publication of the final rule.

C. Other Changes Since Proposal

    The EPA has decided not to include the refining and furnace area
emissions as part of a facility wide emission limit as was proposed. We
received comments from Doe Run on the proposed rule that inclusion of
these sources in the production based emission limit in section
63.1543(a) was not necessary and that these sources would
simultaneously be required to comply with the standard for refining and
furnace area emissions proposed under section 112(f) and the production
based limit proposed under section 112(d)(6). We agree with the
commenters and we are establishing a separate emission limit of 1.2
tons per year of lead emissions that applies to the combined emissions
of the refining and furnace area stacks. The emission standard limits
the combined emissions from these two stacks because the revised risk
assessment indicated that the location of maximum impact for these two
stacks overlapped at the same receptor. A production based emission
limit will continue to apply to sources in section 63.1543(a)(1)-(9).
    As mentioned earlier, we are not finalizing a requirement for
fenceline monitoring to ensure that fugitive dust emissions do not
cause an exceedance of the NAAQS offsite. The revised modeling showed
substantially lower ambient concentrations due to fugitive dust
emissions relative to the modeling performed for the proposed rule. We
estimate current fugitive dust emissions result in maximum lead levels
offsite that are approximately equal to the NAAQS. We are promulgating
work practice standards beyond what is required by the 1999 rule that
must be implemented by the source in order to ensure that fugitive
emissions will not result in an exceedance of the NAAQS and thus result
in an unacceptable risk. We expect that after implementation of this
revised NESHAP, fugitive dust emissions from primary lead processing

facilities will not result in exposures levels above the NAAQS. Since
the risk levels are much lower than we had estimated at proposal, and
since we are promulgating specific work practice requirements to
minimize fugitive dust emissions, we have determined that the proposed
fenceline monitoring requirement is not necessary to show compliance
with this NESHAP. Furthermore, there are already several monitors
nearby that measure ambient lead levels and that should provide
sufficient indication of whether fugitive lead emissions have been
sufficiently reduced.
    In recent rules promulgated under section 112 and 129, the EPA has
revised certain terms and conditions of the affirmative defense in
response to concerns raised by various commenters. The EPA is adopting
those same revisions in this rule. Specifically, the EPA is revising
the affirmative defense language to delete ``short'' from
63.1551(a)(1)(i), because other criteria in the affirmative defense
require that the source assure that the duration of the excess
emissions ``were minimized to the maximum extent practicable.'' The EPA
is also deleting the term ``severe'' in the phrase ``severe personal
injury'' in 63.1551(a)(4) because we do not think it is appropriate to
make the affirmative defense available only when bypass was unavoidable
to prevent severe personal injury. In addition, the EPA is revising
63.1551(a)(6) to add ``consistent with good air pollution control
practice for minimizing emissions.'' The EPA is also revising the
language of 63.1551(a)(9) to clarify that the purpose of the root cause
analysis is to determine, correct, and eliminate the primary cause of
the malfunction. The root cause analysis itself does not necessarily
require that the cause be determined, corrected or eliminated. However,
in most cases, the EPA believes that a properly conducted root cause
analysis will have such results. In addition, the EPA is revising
63.1551(b) to state that a written report must be submitted within 45
days of the initial occurrence of the malfunction and that the source
may seek an extension of up to an additional 30 days.

V. Summary of Significant Comments and Responses

    In the proposed action, we requested public comments on all aspects
of the proposal, including our residual risk reviews and resulting
proposed standards, our technology reviews and resulting proposed
standard, and our proposed amendments to delete the startup and
shutdown exemptions and the malfunction exemption and to establish an
affirmative defense for malfunctions.
    We received written comments from 16 commenters. Our responses to
some of the significant public comments are provided below. Responses
to the comments that are not in the preamble have been placed in the
docket. See Summary of Public Comments and Responses for Primary Lead
Processing NESHAP (October 2011), for summaries of other comments and
our responses to them.

A. Timeline for Compliance

    Comment: Two commenters opposed the compliance timing and supported
extending the compliance date beyond two years for several reasons. One
commenter stated that according to the time line in the proposed rule,
the facility will operate in its current form for only a few months
after the compliance date of the rule. This creates a dilemma for the
State and facility in terms of implementation, planning, resources and
compliance. The commenter suggested that the implementation and
attainment schedules for this MACT rule should correspond to those of
the 2008 NAAQS.
    One commenter identified three provisions they suggest could be
used to allow more than 2 years for compliance: (1) 112(i)(3)(A)
establishes 3 years for compliance for section 112 standards, (2)
112(i)(5) allows exemption for up to 6 years for facilities
demonstrating 90 percent reduction in HAP prior to first proposal of a
section 112(d) standard, and (3) 112(h)(3) allows an alternative means
of compliance in some circumstances. The commenter stated that the
import of the underlying statutory authority relates to the compliance
period for existing sources. Under the EPA practice, a three-year
compliance period applies to section 112(d) MACT standards, while a
two-year period applies to section 112(f) standards. Although the EPA
seems to have reflexively applied the section 112(f) period, this
approach is not foreordained in the present circumstances.
Specifically, section 112(i)(3)(A), which allows a three-year
compliance period for any section 112 standard, merits consideration in
light of the various proposed MACT standards, including a plant-wide
section 112(d)(6) standard. With regard to the authority under section
112(i)(5), the commenter states that emissions have been reduced from
140 tons in the year 2000 to less than 14 tons in 2009, representing a
decrease of over 90%. With regard to section 112(h)(3), the commenter
believes that the two year compliance period has serious adverse
economic effects on the company and the new hydrometallurgical process
can be considered an alternative means of emission limitation.
    The commenter also stated that the circumstances of this case
present a unique challenge in determining an appropriate compliance
deadline for a new primary lead smelting MACT standard. The commenter
stated that there were several differences from the typical MACT
rulemaking: Instead of multiple sources within a category, there is
only one facility in the category; by virtue of a federally enforceable
consent decree, the facility must terminate its present operations by
April 30, 2014; and assuming a final rule issues on October 31, 2011,
and a two-year compliance deadline, the compliance period would be at
most six months prior to stoppage of many of the current operations. If
forced to achieve compliance that would last only for such a short
period, the facility would face severe economic hardship that could
jeopardize its ability to finance and to build a new hydrometallurgical
lead production process that would largely eliminate lead emissions.
These circumstances raise questions as to the legal necessity as well
as the feasibility and practicality of implementing a two-year
compliance deadline.
    Further, it was incorrectly assumed that a two-year compliance
period is consistent with the schedule of required actions contained in
the Consent Decree, when the opposite is true. Requiring MACT standard
compliance six months before the required termination of Doe Run's
existing lead smelting seriously erodes several Consent Decree goals:
Introducing a new hydrometallurgical lead production process that
minimizes lead emissions, assuring continued primary lead production in
the United States, and promoting the development of the most
technologically advanced lead production process in the world.
    Finally, the commenter stated that the primary lead RTR proposal
effectively accelerates the compliance date for the lead NAAQS for the
Doe Run facility. According to the commenter a two-year compliance
timeframe relies, in part, on the various steps that must be undertaken
to implement a plan to monitor lead concentration in air. But this
reliance is also misplaced because it requires Doe Run to comply with
the new Lead NAAQS in 2013, or more than two years before the Lead
NAAQS itself requires compliance. No statutory authority supports such
accelerated compliance for the lead NAAQS or preemption of the SIP
process. In short,

the two-year timeframe rests on faulty grounds: Factually, it is
inconsistent with the Consent Decree requirements, and legally, it
unlawfully attempts to speed up the previously-established compliance
timeframe for the lead NAAQS.
    Response: Section 112(i)(3) establishes the compliance timeframe
for any standard issued under section 112 for existing sources and
provides that the compliance date shall be as expeditiously as
practicable but no later than 3 years following the effective date of
the standard. Section 112(f)(4), however, expressly provides more
specific requirements for standards issued under section 112(f) and
thus for section 112(f) standards those more prescriptive requirements
govern in place of the compliance requirements in section 112(i)(3).
Specifically, section 112(f)(4) provides that a source cannot emit an
air pollutant in violation of a standard issued under subsection (f)
except that the standard will not apply until 90 days after its
effective date. It also provides that the Administrator may grant a
waiver for a period of up to 2 years from the effective date if
necessary for the installation of controls and if measures will be
taken in the interim to ensure public health is protected from imminent
endangerment. Thus, for standards applicable to the furnace and
refinery area emissions and the work practice standards to address
fugitive emissions, which were issued under section 112(f), the
compliance period may not exceed two years from the effective date of
the standard. We are providing 90 days for compliance with the work
practice standards and two years for compliance with the standards
applicable to the furnace and refinery area stacks.
    The main stack emission limit, proposed under 112(d)(6), is subject
to the section 112(i)(3) compliance provisions. We are establishing an
emission standard of 0.97 lb Pb/ton of lead produced that would replace
the existing standard of 1 lb Pb/ton of lead produced. This standard is
based on the level of emissions that the source is already achieving in
practice and thus no additional controls would be needed to meet that
emission limit for the main stack. For that reason, we are requiring
compliance with the new limit for the main stack within 60 days of the
effective date of this final rule as this timeframe constitutes
compliance ``as expeditiously as practicable.''
    Concerning section 112(i)(5), the provision only applies to
standards promulgated pursuant to section 112(d) (and not 112(f)) and
also only where a source achieves a 90% reduction (95% in the case of
HAPs that are particulate matter) prior to the proposal of the section
112(d) standard. Thus, this provision does not apply to the standards
established under 112(f) in this final rule. With regard to the
emission standard proposed for the main stack, stack test data indicate
that the main stack emissions are substantially higher than the 14 tons
per year value cited by the commenter. Based on performance test data,
the facility has not achieved the reductions in emissions required to
apply the alternative compliance dates in section 112(i)(5).
    Section 112(h)(3) allows the Administrator through notice and
comment rulemaking to accept an alternative means of emission limit in
place of a work practice standard established under 112(h)(1) if the
owner or operator of a source establishes that such alternative means
will achieve reductions at least equivalent to those that would be
achieved by the work practice standard. It is unclear precisely what
the commenter is suggesting with regard to this provision. However, it
seems they may be suggesting that the new hydrometallurgical process
that they plan to install after they close the pyrometallurgical
processes should be considered an alternative means of compliance with
the work practice standard. It is unclear how this process would
address the emissions covered by the work practice standards we are
establishing which are intended to address current fugitive dust
emissions from the facility. Those emissions are almost exclusively
from lead entrenched in open areas and the installation of a new
process for lead processing would not appear to affect those emissions.
Moreover, we understand that the new hydrometallurgical process won't
be operational until sometime after the compliance date for the work
practice standards we are requiring. Thus, even if that process would
address in whole or in part the fugitive dust emissions addressed
through the work practice standards, it would not be an appropriate
substitute in the absence of being able to achieve the necessary
reductions within the compliance period. We note that our determination
here does not preclude Doe Run from submitting additional information
that may further support a demonstration under section 112(h)(3) and
for which we could take further action in a separate rulemaking.
    As to the concerns the commenter raises about this situation being
unique, we do not disagree. However, the statute is clear that the
maximum compliance period for standards issued pursuant to section
112(f) is two years. The commenter submits no facts or information that
supports a legal basis for providing a longer period for compliance for
the refining and furnace area stack limits and for the work practice
standards to minimize fugitive dust emissions.
    Finally, we note that the Lead NAAQS does not apply to a specific
facility but rather is a level that must be met within the designated
nonattainment area. However, we recognize that Doe Run is the only
stationary industrial source creating the Jefferson County lead
nonattainment area and the reductions required under the rule will help
bring the area into attainment with the lead NAAQS. However, this
regulation does not preempt the SIP process; the State of Missouri is
still required to submit a state implementation plan demonstrating how
the area will attain and maintain the lead NAAQS. In doing so, the
State may rely on any reductions required under this regulation.
Finally, we note that this regulation does not ``speed up'' the
compliance timeframe for meeting the Lead NAAQS. The CAA requires areas
to attain the various NAAQS as expeditiously as practicable, but no
later than specified dates. For the 2008 lead NAAQS, areas are required
to attain the standard as expeditiously as practicable, but no later
than December 31, 2015. The Act not only contemplates but requires, if
practicable, for areas to attain the 2008 lead NAAQS earlier than
December 31, 2015.
    Additionally, we are not requiring fenceline monitoring as part of
the final NESHAP amendments. Therefore, the commenter's concerns
related to potential conflict between monitoring for the NAAQS and this
NESHAP are no longer relevant.
    Comment: One commenter stated that the proposed emission standards
and ambient standard had negative implications for determining
compliance under the proposed two-year compliance period and the
``plantwide reductions'' that are ``required under section 112(f)(2).''
76 FR at 9437/1. According to the commenter, the only plant-wide
reduction proposed in the rule is the plant wide limit of 0.22 pounds
per ton produced while the other two new numerical standards are the
0.91 tpy limit for furnace area and refining and casting operations and
the 0.15 [mu]g/m\3\ limit for ambient lead concentrations.
    The commenter stated that the three proposed numerical standards
present a confusing regulatory regime as to which standard ultimately
controls for determining compliance. If, for

example, Doe Run achieves an aggregate emission of 0.22 lb/ton on a
facility wide basis but exceeds 0.91 tpy for its furnace and refining
and casting operations, would it be in compliance?
    Of the three numerical standards, the commenter stated that only
the 0.91 tpy limit can arguably be linked to Section 112(f), and even
that is unclear. The 0.91 tpy standard is derived from the Lead NAAQS
risk analysis. Despite this starting point, this standard is subsumed
in the proposed 0.22 lb/ton plant-wide limit which arose under the
section 112(d)(6) technology review, adjusted for ``variability in the
operations and emissions.'' While an effort is made to differentiate
the components of the 0.22 lb/ton standard as to which portion fits
under what statutory authority, this single plant-wide emission
standard rests on the section 112(d)(6) review. Although not explicitly
stated, this plant-wide standard offers more than an ample margin of
safety.
    Response: We have decided not to include a facility-wide limit that
would include the refining and furnace area stacks as well as to the
main stack. Instead, the 1.2 tpy emissions standard we are promulgating
under section 112(f) will apply to combined emissions from the refining
and furnace area stacks. The 0.97 lb/ton emission standard that we are
promulgating pursuant to section 112(d)(6) will replace the 1.0 lb/ton
limit in the original MACT rule and will apply to the same sources
subject to the limit in the original MACT rule. Additionally, we have
eliminated the fenceline monitoring requirement from the final rule.
These changes should alleviate the regulatory confusion that could
arise over the limits in the proposal. Furthermore, we believe a plant-
wide limit is not necessary to address the residual risk and technology
review requirements of the Act. As provided in the preamble to the
proposed and final rules, we evaluated each of the emission stacks
separately to determine whether additional controls are necessary under
section 112(f) or 112(d)(6) and a plant-wide limit is not needed under
either of those statutory requirements.

B. The EPA's Authority Under Section 112 of the Clean Air Act

    Comment: One commenter stated that the modification to the
applicability provision does not comport with how smelting is defined
and used and that the source category listing was intended to cover
smelting only, not other processes. The commenter lists several issues
supporting this position:
     The opening phrase of the first sentence ``The Primary
Lead Smelting source category,'' describes and limits ``any facility''
to mean those involving smelting; and the ``includes, but is not
limited to'' language does not apply to any lead producing process, but
only to ``the following smelting processes.''
     The list of processes identified all involve
pyrometallurgical activities: Sintering process, blast furnace,
electric smelting furnace, reverberatory furnace, slag fuming furnace,
drossing kettles, and dross reverberatory furnace.
     The plain meaning of that language evidences intent to
cover any and all types of pyrometallurgical processes for producing
lead but shows no attempt to encompass other, as yet unknown, lead
production processes.
     Isolating the phrase ``including, not limited to'' from
the company it keeps to justify an expansive reading goes well beyond
the meaning of the listing as a whole and thus cannot stand.
    The commenter also stated that the proposed change in applicability
is inconsistent with the statutory structure for formulating source
categories: ``To the extent practicable, the categories and
subcategories listed under this subsection shall be consistent with the
list of source categories established pursuant to section 7411 of this
title and part C of this subchapter.'' The commenter cited several
instances in the statute where Primary Lead Smelting is referred to as
a pyrometallurgical process. In summation, the commenter states that
the statutory directive of CAA section 112(c)(1) to assure consistency
between a source category definition and how the same terms are used in
other parts of the Act demonstrates that the statutory and regulatory
use of ``primary lead smelting'' and ``primary lead smelter'' was
consistently designed to cover only pyrometallurgical processes. The
EPA's assertion that the originally formulated primary lead smelting
source category has a ``broader definition'' is inconsistent with the
original source category language and the pyro-oriented definitions
applied to primary lead smelting/smelter found throughout the statute
and regulations.
    The commenter also stated that the EPA's effort to recast the
primary lead smelting category is barred by the failure to show a major
source would be present. The new hydrometallurgical process bears no
resemblance to the current pyrometallurgical process, other than
feedstock and end product. The new process will have drastically
reduced lead emissions and is presented as a minor source in the Doe
Run Air Construction Permit Application for the New Lead Technology
submitted to the Missouri Department of Natural Resources.
    Response: Section 112(c)(1) describes the process for creating the
source category list. To the extent that the commenter is concerned
that the source category listing for primary lead was not issued
consistent with the requirements of section 112(c)(1), such claim is
untimely. We disagree with the commenter that the source category
description must be read to be limited to pyrometallurgical processes.
The source category description was intended to include all processes
used to produce lead metal from ore concentrates, as evidenced by the
first sentence of the category description. While it is true that at
the time of the source category listing, the hydrometallurgical process
described by the commenter did not exist, the language left open the
possibility that other lead metal production processes might be
developed in the future and would be covered under the source category
listing.
    Although, the source category name in the 1999 NESHAP was ``primary
lead smelting'' rather than ``primary lead processing,'' it was given
that title because, at that time smelting was the only technology used
to process lead ore into lead metal. However, the three-word title
should not be read as limiting the broader language in the description
of the source category, which provides the full evidence of EPA's
intent of what should be included in the source category.
    Recently, during the development of this RTR rulemaking, we became
aware of a new primary lead processing and production technology (i.e.,
hydrometallurgical process). It is our understanding that even after
this new technology is in place, the facility plans to continue
operating some of the same thermal processes in use now and subject to
the NESHAP (such as refining and casting) which continue to have the
potential to emit significant amounts of lead. We also note that this
facility will continue to have the potential for fugitive emissions.
For these reasons, we conclude that it is appropriate and necessary to
update the title for the MACT standard and the applicability section of
the standard, consistent with the description of the listed source
category, to ensure these emissions points continue to be subject to
emissions standards. However, it is also important to note that the
rule being promulgated today has no requirements that apply to the
hydrometallurgical processes themselves, since this process currently
does not exist at this facility.

As noted in the response to comments, if a new process such as the
hydrometallurgical process is developed and put into use in the future,
then EPA would consider what standards to propose for such process
after such process is operational.
    We believe section 112(d)(1) provides the authority for this
revision to the standard. That provision requires EPA to ``promulgate
regulations establishing emission standards for each category or
subcategory of major sources and area sources'' of the hazardous air
pollutants listed in section 112(b)(1). Because EPA's initial
promulgation of the MACT standard did not fully describe the source
category, and thus did not regulate all potential sources within the
source category, we believe it is now appropriate to revise the
applicability provision to fully cover the sources as provided under
the source category listing.
    Comment: A commenter stated that the proposed rule does not suggest
that the new lead production processes should be listed as area
sources. If the EPA could make the necessary ``adverse effects
finding'' for including a hydrometallurgical lead production process as
an area source, a separate NESHAP would be required for a new area
source. The EPA lacks authority to subsume a new area source into the
Primary Lead Smelting major source category, as it would require in the
proposed rule. Therefore, the EPA must show that either Doe Run's new
lead production process or the entire Doe Run facility after the new
process is operational would or could emit more than 10 tpy of lead if
the facility is to remain a major source category and the proposed rule
offers no documented evidence that Doe Run's hydrometallurgical lead
production process or the Herculaneum facility after the new process
becomes operational would constitute a major source. The commenter
contended that neither the new process nor the entire Herculaneum
facility would be a major source. Plant-wide emissions at Doe Run's
facility after the new process becomes operational are estimated to
approximate 0.65 tpy. Absent the presence of a major source at Doe
Run's facility, the new lead production process cannot be treated as a
major source category.
    Response: As explained in detail elsewhere, the EPA has the
authority to impose additional requirements on emission points already
subject to an emission standard and to impose requirements on
previously unregulated emission points in performing a risk and
technology review. The EPA has exercised that authority here by
establishing emission limitations for activities previously only
subject to work practice requirements. The commenter's arguments to the
contrary notwithstanding, the revised applicability definition will
result in a source category containing a major source, the Doe Run
facility. Doe Run is currently a major source of lead emissions and
will be a major source of such emissions on the date by which it must
initially comply with the newly established emission limits for
refining activities. Thus, regardless of the level of its emissions
following conversion to the hydrometallurgical process, Doe Run must
meet the newly established emission limits by the specified date(s). As
noted elsewhere, a new hydrometallurgical process is not subject to an
emission limit under the existing MACT standard as it now exists or
following the changes resulting from this rulemaking; we would consider
an appropriate emission limit for the hydrometallurgical process once
that process is a demonstrated technology.
    Comment: Another commenter stated that the EPA appropriately
proposes to update the applicability of the MACT to cover Doe Run's new
type of facility.
    Response: We agree with this comment.
    Comment: Two commenters stated that the EPA cannot use section
112(f) authority to establish an ambient air standard because this type
of standard is not an ``emission standard.''
    The commenters stated that the NAAQS does not fit within the
meaning of ``emission standard'' as used in CAA sections 112(d)(6) or
(f)(2), the EPA's stated authority for the proposed rule. Section
112(f)(2) is entitled ``Emission standards'' and the second sentence,
where the ``ample margin of safety'' factor is found, has ``emission
standard'' as its subject; these specific references clarify the use of
``standards'' elsewhere in the subsection means ``emission standard.''
Likewise, section 112(d)(6) gives the Administrator authority to revise
``emission standards.'' Both subsections limit the EPA's rule-
promulgating authority to setting ``emission standards.''
    According to commenters, Congress defined ``emission standard'' in
CAA section 302(k) to ``mean a requirement established by the * * *
Administrator which limits the quantity, rate or concentration of
emissions of air pollutants on a continuous basis, including any
requirement relating to the operation or maintenance of a source * * *
and any design, equipment, work practice or operational standard
promulgated under this chapter.'' The language can only be reasonably
read to allow a standard applicable to emissions from specific
source(s). The lead (or any other) NAAQS, by definition, is not
targeted to specific source(s), but applies generally to the national
ambient air. See, e.g., CAA section 109(a)(1)(A) (``regulations
prescribing a national primary ambient air quality standard * * * for
each air pollutant'').
    The commenters stated that the contrasting language highlights that
the lead NAAQS does not qualify as an emission standard within the
meaning of section 112. The NAAQS addresses ambient air rather than
emissions from a source, and as a result the NAAQS does not put any
limits on the quantity, rate, or concentration of emissions from a
particular source or on its operation, maintenance, design, or work
practices, all of which are central to the section 112(f)(2) mandate or
on the practices, processes, and control technologies related to
sources central to section 112(d)(6). Further, a NAAQS limits ambient
air lead without regard to source category or types of sources, while
the MACT standards are particularized to control emissions at specific
sources. Thus, the primary lead smelting emission standards differ from
the secondary lead smelting emission standards, but the same lead
ambient air standards apply throughout the country without regard to
such distinctions. In short, the lead NAAQS does not fit the meaning of
``emission standard'' as used in section 112 and therefore cannot be
properly used as the MACT standard here.
    One commenter stated further that this error is not cured by the
wording of proposed section 63.1544(a), which states: ``No owner * * *
shall discharge or cause to be discharged into the atmosphere lead
compounds that cause the concentration of lead in air to exceed 0.15
[mu]g/m\3\ on a 3-month rolling average measured at locations approved
by the Administrator.'' As such, proposed section 63.1544(a) measures
ambient air levels for compliance (``concentration of lead in air * * *
at locations'') in what appears to match the source monitoring of
ambient air required for the Lead NAAQS. See 73 FR at 67052, section
50.16(a) and at 67059, section 58.10; see also 76 FR at 9436/1
(proposing that compliance ``be demonstrated using a compliance
monitoring system''). As such, proposed section 63.1544(a) does not
limit the quantity, rate, or concentration of emissions from a
specified source or take into account developments in practices,
processes, and control technologies. Compare 40 CFR

63.1544(a)(2010) (requiring ``manual that describes in detail the
measures that will be put in place to control fugitive dust emissions
from the sources''). Measuring ambient air at locations presumably near
the source does not fall within the standards allowed by CAA section
112, and, in any event, is redundant to the same monitoring and
limitations already established under the Lead NAAQS. Consequently, the
proposed rule exceeds the statutory authority granted by section 112,
and therefore cannot be adopted.
    One commenter stated that the proposal requests comments on a work
practices standard operating procedure (SOP) alternative to ambient air
monitoring. As opposed to using the Lead NAAQS, which is not an
emission standard under Section 112, the alternative SOP proposal is
consistent with the MACT directive that emission reductions be tied to
specific sources.
    One commenter stated that the proposed ambient lead standard is
procedurally flawed because the EPA fails to explain the legal basis
for imposing such a standard under section 112(f). The agency's legal
authority is of central relevance to this aspect of the proposal and
the failure to clearly describe the legal basis for the standard
violates the EPA's obligation under section 307(d)(3)(C) to set forth
the ``major legal interpretations'' that underlie the proposal.
    Response: The commenters mistake the purpose of the fenceline
monitoring requirement in the proposed rule. The proposed rule
established emissions standards from the main, furnace area, and
refinery operations stacks and further provided that fugitive dust
emissions would need to be addressed by work practice standards (as is
allowed under section 112(h)(1)). Finally, we proposed a fenceline
monitoring requirement to ensure that the work practice standards
adequately address fugitive dust emissions consistent with the
requirements of section 112(f). However, we have eliminated the
fenceline monitoring requirement in the final rule. Instead, we are
specifying work practice standards to minimize fugitive dust emissions.
Because we are not requiring fenceline monitoring in this final rule,
the commenter's concerns related to redundant monitoring requirements
need not be addressed.
    We disagree with the suggestion that we do not provide the legal
basis for our proposed rule. The preamble clearly explains that we are
addressing residual risk for this source category under section 112(f)
and clearly explains the rationale for the proposed rule and the basis
for the proposed requirements. (See 76 FR 9412-9414 for a discussion of
the statutory authority underlying the proposed revisions to the
standard.) With regard to fugitive dust emissions, we are establishing
a requirement for work practice standards consistent with section
112(h)(1) in lieu of an emission standard because these fugitive dust
emissions, which are predominantly from materials handling and roadways
cannot be captured and vented to a stack for which we could establish
an emission limit.
    Comment: One commenter stated that the CAA limits the EPA's ability
to regulate pollutants subject to NAAQS (``criteria pollutants'') to
that regime and does not allow supplemental (or supplanting) regulation
of them under NESHAP. The commenter cited CAA section 112(b)(2) that
states in relevant part: ``No air pollutant which is listed under
section 7408(a) of this title may be added to the list under this
section'' with certain exceptions not relevant here. Section 7408(a)
provides the statutory authority for setting NAAQS. Also, CAA section
112(b)(7) removes elemental lead from consideration as a HAP. According
to the commenter, the prohibition is not only clear, but also
expansive: The statute ``unqualifiedly prohibits listing a criteria
pollutant as a HAP, that is, regardless of the reason.'' Nat'l Lime
Ass'n v. EPA, 233 F.3d 625, 638 (DC Cir. 2000).
    Response: As we recognized in the preamble to the proposed rule,
under section 112(b)(7) elemental lead may not be listed as a HAP under
section 112 and the references to ``lead'' in the proposed rule
referred to ``lead compounds'' which are expressly listed as a HAP in
CAA section 112(b)(1). 76 FR 9412. Because lead compounds are a listed
HAP, we are required to regulate them under section 112, as we did when
we established the original MACT standard for primary lead in 1999. 64
FR 30194. The lead emitted from primary lead processing is lead
compounds with elemental lead present only in trace amounts.\5\ The
commenter did not provide any data to refute this. Thus, we disagree
with the commenter that we are attempting to regulate in contravention
of section 112(b)(7) in this action.
---------------------------------------------------------------------------

    \5\ Harrison, R.M. and Williams, C.R. (1981). Environmental
Science and Technology, Vol. 15:10, p. 1197-1204.; Ohmsen, G.S.
(2001). Journal of the Air and Waste Management Association, Vol.
51, p. 1443-1451.; Uzu, G., Sobanska, S., Sarret, G., Sauvain, J.J.,
Prad[egrave]re, P., and Dumat, C. (2011). Journal of Hazardous
Materials, Vol. 186, p. 1018-1027.; Spear, T.M., Svee, W., Vincent,
J.H., and Stanisich, N. (1998). Environmental Health Perspectives,
Vol. 106:9, p. 565-571.; Czaplicka, M., and Buzek, [Lstrok]. (2011).
Water, Air, & Soil Pollution, Vol. 218, p. 157-163.; Sobanska, S.,
Ricq, N., Laboudigue, A., Guillermo, R., Br[eacute]mard, C.,
Laureyns, J., Merlin, J.C., Wignacourt, J.P. (1999). Environmental
Science and Technology, Vol. 33, p. 1334-1339.; Harrison, R.M. and
Williams, C.R. (1983). The Science of the Total Environment, Vol.
31, p. 129-140.; Batonneau, Y., Bremard, C., Gengembre, L.,
Laureyns, J., Maguer, A.L., Maguer, D.L., Perdrix, E., and Sobanska,
S. (2004). Environmental Science and Technology, Vol. 38, p. 5281-
5289.; Foster, R.L. and Lott, P.F. (1980). Environmental Science and
Technology, Vol. 14:10, p. 1240-1244.
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    The National Lime opinion cited by the commenters addressed a
different issue than the one being at issue here. In that case, the
issue was whether the EPA could use a NAAQS pollutant (particulate
matter) as a surrogate for HAP metal emissions. While certain HAP
listed in 112(b)(1) are considered particulate matter, ``particulate
matter'' is not listed on the 112(b)(1) list. In that case, the court
rejected the argument by the National Lime Association that the EPA was
regulating particulate matter ``through the back door.'' In the present
situation, the EPA is not regulating lead ``through the back door'' in
this rulemaking.
    Comment: One commenter stated that the EPA unlawfully refused to
set a standard for organic HAP. According to the commenter, the EPA
must set an emission standard for the organic HAP listed on the section
112(b)(1) list that this source category emits. Specifically, the
commenter argues that:

``[w]hen EPA performs a section 112(d)(6) review, it must consider
the ongoing legality and effectiveness of the existing standard.
Explicitly, in the current rulemaking EPA must ``review, and revise
as necessary'' the existing MACT standard. 42 U.S.C. section
7412(d)(6). It is clearly ``necessary'' for EPA to close inherently
unlawful gaps in the original MACT, by setting a standard for an
uncontrolled HAP. Indeed, EPA has recognized the need and done this
during its section 112(d)(6) review in its recent rulemaking for
Marine Tank Vessel Loading Operations and Group I Polymers and
Resins where it proposed a standard for previously uncontrolled
subcategories of these sources. See Proposed Rule, 75 Fed. Reg.
65068, 65115, 65106 (Oct. 21, 2010). EPA has no legal basis for
failing to set a MACT standard now for the uncontrolled HAPs for the
primary lead source category.''

    Response: We disagree with the commenter that section 112(d)(6)
mandates that the EPA must correct any deficiency in an underlying MACT
standard when it conducts the ``technology review'' under that section.
We believe that section 112 does not expressly address this issue, and
the EPA has discretion in determining how to address a purported flaw
in a promulgated standard. The ``as necessary'' language cited by the

commenter must be read in the context of the provision, which focuses
on the review of developments that have occurred since the time of the
original promulgation of the MACT standard and thus should not be read
as a mandate to correct flaws that existed at the time of the original
promulgation. In several recent rulemakings, we have chosen to fix
underlying defects in existing MACT standards under sections 112(d)(2)
and (3), the provisions that directly govern the initial promulgation
of MACT standards (see National Emission Standards for Hazardous Air
Pollutants From Petroleum Refineries, October 28, 2009, 74 FR 55670;
and National Emission Standards for Hazardous Air Pollutants: Group I
Polymers and Resins; Marine Tank Vessel Loading Operations;
Pharmaceuticals Production; and the Printing and Publishing Industry,
April 21, 2011, 76 FR 22566). (We note that the commenter incorrectly
states that we revised those standards under 112(d)(6)). We believe
that our approach is reasonable because using those provisions ensures
that the process and considerations are those associated with initially
establishing a MACT standard, and it is reasonable to make corrections
following the process that would have been followed if we had not made
an error at the time of the original promulgation.
    Nevertheless, based on our review of the commenter's 2009 petition
and their additional comments on this proposed rulemaking, we agree
that the Primary Lead Smelting NESHAP should have included an emission
standard for organic HAP. We have evaluated available data and believe
that we need additional data in order to set an emission standard for
organic HAP that is representative of current operations and emissions.
We intend to collect the needed data and propose a MACT emission
standard under section 112(d)(2) and (3) of the CAA. Accordingly, we
are not taking final action on the 2009 petition with respect to the
issue of setting a standard or standards for organic HAP and will
address that petition once we have gathered the necessary data.

C. Primary Lead Processing Risk Assessment

    Comment: One commenter stated that the EPA failed to consider or
account for cumulative risk and that there is no rational or scientific
basis to dismiss consideration of the cumulative risk of exposures to
HAPs due to uncertainties. The commenter urged that these uncertainties
require protective action rather than inaction. The commenter stated
that the EPA's Science Advisory Board (SAB) in May 2010 urged the EPA
to use the RTR rulemaking process to do this as well as perform a
sensitivity analysis to identify the major uncertainties in both the
human health and ecological risk assessments. According to the
commenter, the SAB and numerous other scientific experts have
developed, and are in the process of developing, cutting edge methods
to perform these assessments and that the EPA, as the lead
environmental agency of the United States, has a responsibility to show
leadership in this process. It should rely on the significant
information already available and also use the current and future RTR
rulemakings to further advance this process.
    The commenter stated that it could be done on a site-specific basis
or for the industry as a whole. Uncertainty in estimates of HAP in
ambient air has been characterized, so the data available from the
National-Scale Air Toxics Assessments (NATA) would allow a defensible
estimate of what might be expected from other sources.
    Response: We disagree with the commenter that our risk assessments
do not consider cumulative risk. We note that our assessment of cancer
risks is, in fact, cumulative, summing the risks associated with all
carcinogens emitted by the facility. Similarly, the use of the target
organ specific hazard index (TOSHI) for chronic non-cancer effects
evaluates the cumulative effects of HAP on a given target organ.
Further, our assessment for Primary Lead Processing is cumulative in
that it considers all emission points within the fenceline (since they
are all covered by the MACT). Moreover, the level of the lead NAAQS,
which we used as the metric for defining unacceptable risk, was set
based on all air-related exposures in its derivation and thus is also a
cumulative standard. We note that for the present rulemaking, our
consideration of cumulative risks for the Doe Run facility is the same
as that for the industry as a whole since Doe Run is the only facility
within the source category.
    We further disagree with the commenter's assertion that a
comprehensive quantitative assessment of risks from all sources outside
the source category is required under the statute. If such were in fact
the case, the task of completing such a requirement would take an
interminable length of time. Instead, to provide the quantitative risk
information necessary to inform RTR regulatory decisions, the EPA
conducts a comprehensive assessment of the risks associated with
exposure to the HAPs emitted by the source category (i.e., those
emissions that can actually be affected by the specific rulemaking) and
supplements that with additional information about other possible
concurrent and relevant risks that is readily available. In some cases,
we have additional information about HAP emissions that are outside the
scope of the particular rulemaking but within the boundaries of the
subject facilities. In other cases, we may have ambient HAP monitoring
data that can be considered as part of the regulatory decision-making.
In still other cases, we may have very little additional risk
information that can be considered. In all cases, however, when we
consider additional information about risks, we also consider its
attendant uncertainties, and information which carries significant
uncertainties generally carries much less weight in the overall
regulatory decision.
    All of the quantitative risk assessment information about HAP
emissions from the source category under consideration is also
considered in the manner prescribed by the decision framework set forth
by the CAA for residual risk decision-making (i.e., the Benzene
decision framework), and this means that the general guidelines of risk
acceptability have been developed in a way that they already take into
account the impossibility of accurately quantifying the health risks
posed by outside forces on every individual in the population. They do
this by noting that the guidelines apply in ``the world in which we
live,'' a world which is acknowledged to be ``not risk-free,'' but
rather a world which is full of risks, many of which can simply not be
quantified. This acknowledgment allows the EPA to make risk-based
decisions by focusing on the risks associated with the emissions that
are themselves the subject of regulation being considered, and not get
distracted by the daunting task of assessing all the other concurrent
potential risks that may or may not be relevant and can't be impacted
by the regulation in question anyway.
    Comment: Two commenters took issue with the modeling methodology
used for the RTR proposal and disagreed with the risk results based on
a number of concerns.
    One commenter stated that the RTR modeling characterized the
maximum air lead concentrations near the facility to be fifty times the
2008 NAAQS which is inconsistent with both recent air quality
monitoring data and Missouri's 2007 attainment demonstration modeling
and stated that the proposed RTR modeling overestimated the maximum air
lead concentration by at

least a factor of five. The commenter stated that the inaccuracies of
the EPA's proposed modeling analysis will be in conflict with future
baseline and attainment demonstration modeling based on more accurate
data, especially since the RTR proposes to correlate the MACT standard
with the 2008 NAAQS. The commenter recommended that the EPA remodel
this facility using higher quality input data that are more
representative of current operations at the Herculaneum facility, to
obtain results that better reflect the actual monitored 3-month lead
concentrations. Alternately, the commenter stated that the EPA should
either defer to appropriate air quality monitoring information or to
the modeling run used for the 2007 SIP revision attainment
demonstration as the basis for this RTR. Some commenters also suggested
using AERMOD modeling followed by LEADPOST, rather than using HEM-3 to
ultimately calculate 3-month rolling average lead concentrations.
    Two commenters identified specific issues with regard to the
modeling approach and input data including:
     The ratio of modeled results to monitored data should not
exceed a factor of two. The commenter provided specific corrections and
analysis of data.
     The NAAQS attainment demonstration model developed by the
State of Missouri and the RTR modeling, although conducted for
different purposes, are both based on compliance with the same standard
for the same geographic location. Therefore, the output of both
dispersion models, whether for residual risk assessment or SIP
development, should reflect the maximum ambient air lead concentration.
The commenter stated that any data limitations should be addressed with
input from the commenter.
     Improvements from the 2007 SIP for the fugitive emissions
from the sinter plant and blast furnace building do not appear to be
reflected in the run script of the model, resulting in concentrations
up to fifty times the NAAQS. The commenter stated that actual
monitoring data from 2010 show a maximum three-month average ambient
air concentration of 1.12 [mu]g/m\3\ at the Main Street site. This
actual monitored value is in line with the MDNR modeled estimate from
the 2007 SIP revision and is recommended to be the basis for the risk
assessment.
     The EPA did not provide a modeling protocol for their
dispersion modeling, or all of the modeling inputs, post processing and
other data in the docket for public review. Therefore, a complete,
replicable public review of the model and assessment of the proposed
RTR could not be made. The commenter identified several specific
modeling parameters and data elements that were not correctly applied
during the proposal modeling run which could have significantly
affected the results including model control options, run script
parameters, volume sources modeled as point sources, inaccurate
fenceline/boundary locations, incorrect elevations for sources and
receptors, and old census data information for receptor centroids.
    Response: Because of the availability of newer emissions data, more
detailed site-specific meteorological data, as well as updated facility
boundary and other information provided by Doe Run in comments on the
proposed rule, we have remodeled the facility with these newer data. We
remodeled using AERMOD in the default mode to estimate monthly lead
concentrations, and we used the building and particle data submitted by
one commenter to model building downwash and plume depletion. We used
the LEADPOST processor to calculate 3-month rolling averages. In
addition, using the updated facility boundary information, the EPA also
removed census blocks that would now be considered onsite. The methods
and results of this modeling effort can be found in the document:
Residual Risk Assessment for the Primary Lead Smelting Source Category,
which is available in the docket for this rulemaking. The EPA notes
that the results of this modeling effort are similar to results
submitted by the Doe Run Company to the State as part of a SIP (this
Doe Run modeling effort was also submitted to the EPA as part of its
public comments). Moreover, the EPA notes that a comparison of modeled
lead concentrations at the sites of six lead monitors are within 50
percent of measured concentrations at those monitors. These results are
similar to a model-to-monitor comparison submitted by Doe Run in its
public comments.
    We note that the docket included all of the input files and
documentation needed to reproduce the modeling that was performed for
the proposal risk assessment.
    Comment: With respect to using the NAAQS to evaluate potential
multipathway risks from lead, one commenter stated that the risk
assessment used to set the NAAQS was based on quantitative studies of
young children and that while ``the Lead NAAQS obviously applies to all
ages, that was a qualitative risk management decision made as a matter
of policy'' and that ``the task at hand is to provide a quantitative
risk assessment of the maximum non-adverse facility-level emissions
rate for all ages, which cannot be done on the basis of a risk
assessment that studied children only.
    Response: The lead NAAQS was a public health policy judgment
considering the available health evidence and risk analyses as well as
the uncertainties associated with the health evidence and risk
analyses. We disagree with the commenter that the lead NAAQS cannot be
used in a quantitative manner. The review of the lead NAAQS clearly
resulted in a quantitative standard: 3-month maximum lead concentration
not to exceed a level of 0.15 [mu]g/m\3\. This standard was set to
protect public health, including the health of sensitive populations,
with an adequate margin of safety. As the commenter notes, the lead
NAAQS applies in all areas of the United States and is meant to protect
the public health with an adequate margin of safety regardless of the
age of the individuals living in a particular area.
    Comment: One commenter stated that rather than finalizing this
proposal as it stands, the best available science directs the EPA to
set a residual risk standard that incorporates protective health
benchmarks and assures that children living near the facility will not
face an unacceptable neurological effect, such as the loss of IQ
points. This includes protecting children against a blood lead level
change of 1.0 [mu]g/dL or more, a benchmark used by California for the
blood lead level change that is associated with a child's loss of one
IQ point. Because there is no safe level of lead exposure and because
lead persists in the environment, resulting in reservoirs in soils and
dusts, the EPA has an obligation to control emissions from this source
category promptly and in a precautionary manner. The commenter stated
that the EPA should consider requiring zero lead emissions. At a
minimum, the EPA should set a standard that would ensure that the
ambient air concentration for lead in the local community does not
exceed the level of 0.02 [mu]g/m\3\ as a one-month average, in order to
protect children. As this is the level the Children's Health Protection
Advisory Committee had recommended for the lead NAAQS, the EPA must
also set additional protections beyond this ambient air limit in order
to provide an ``ample margin of safety.''
    Response: In order to assess multipathway risks associated with
emissions of lead, the EPA compared modeled rolling three month average
lead concentrations estimated from emissions from the one source in
this category to the NAAQS for lead. As

noted above, we believe that this is a reasonable approach given that
the NAAQS is a health based standard set to protect the public health,
including the health of sensitive sub-populations (such as children)
with an adequate margin of safety. Moreover, the risk assessment
supporting the NAAQS considered direct inhalation exposures and
indirect air-related multi-pathway exposures from industrial sources
like primary and secondary lead smelting operations. We conclude that
the level of the NAAQS presents an acceptable level of risk from lead
in ambient air. Moreover, we are promulgating emissions limits (for the
furnace area and refining operation stacks) to reduce emissions and
promulgating specific work practice standards to minimize fugitive
emissions to ensure that emissions do not result in exceedances of the
NAAQS. As part of our ``ample margin of safety'' analysis, we examined
whether there were additional cost effective controls available to
further reduce emissions and risks. As explained elsewhere in this
notice and in other supporting documents available in the docket, we
have not identified any additional cost effective controls to reduce
emissions further and provide further risk reductions.
    With respect to the California benchmark for protecting children,
the EPA has a hierarchy of appropriate health benchmark values. In
general, this hierarchy places greater weight on EPA derived health
benchmarks than those from other agencies (http://www.epa.gov/ttn/atw/nata1999/99pdfs/healtheffectsinfo.pdf). For the reasons provided above,
we believe that the lead NAAQS level establishes an appropriate
benchmark for addressing the acceptable level of risk and we disagree
with the commenter that we should instead use an ambient concentration
of 0.02 [mu]g/m\3\ based on a one month average.\6\
---------------------------------------------------------------------------

    \6\ This level is well below the background ambient lead levels
measured in the area during the SIP process. See docket ID EPA-HQ-
OAR-2006-0735-5204.
---------------------------------------------------------------------------

    Comment: With regard to the source category's emissions of two
dozen other hazardous air pollutants, including cadmium and arsenic,
one commenter stated that the EPA should determine that this health
risk is also unacceptable. With thousands of people exposed to a
lifetime risk of cancer above 1 in a million, and with at least 200
exposed to a lifetime risk of up to 30 in a million, the EPA must
recognize that this risk is too high for this local community. The EPA
should set a standard that would reduce cancer risks to an acceptable
level and ensure an ample margin of safety from non-lead emissions.
    Response: With respect to cancer risk, section 112 provides for EPA
to follow the benzene decision framework for determining acceptability.
Under that framework, cancer risk less than 100 in a million is
generally considered acceptable, although this is not a bright line and
EPA examines a variety of health factors to make its determination.
Once we concluded that the risk from non-lead HAP was acceptable, we
then considered whether there were additional cost-effective controls
that would further reduce risk from the other HAP emitted in order to
provide an ample margin of safety. Because the controls for other HAP
were the same as the controls for lead, we determined (for the same
reason we did for lead) that there were no additional cost effective
controls and that the acceptable level of HAP emissions also provided
an ample margin of safety.
    Comment: One commenter stated that they oppose the use of the lead
NAAQS assessment instead of a multi-pathway risk assessment because the
lead NAAQS provides an inappropriate level of protection, i.e., the
lead NAAQS requires an adequate margin of safety while a residual risk
standard requires an ample margin of safety. The commenter stated that
a residual risk standard should provide a level of protection that is
higher than the NAAQS. Moreover, the commenter noted that the NAAQS is
set to protect sensitive populations while residual risk rules are set
to protect the greatest number of individuals possible from
unacceptable risk. The proposed rule based on the lead NAAQS will not
provide as high a level of protection as required by CAA section
112(f)(2).
    Response: We disagree with the commenter that the lead NAAQS
assessment should not be considered as part of our residual risk
analysis because it provides an inappropriate level of protection. The
lead NAAQS is set at a level to protect public health, including the
health of sensitive populations, most critical for lead, the health of
children. That does not suggest that non-sensitive populations are not
protected, but rather that the NAAQS is set at a level that will not
only protect the general population but also those who are more
sensitive to lead exposures. In the proposed rule, the level of the
NAAQS, which protects public health with an adequate margin of safety,
was used to determine whether or not there was unacceptable risk. Once
we determined a level of emissions that results in risks being
acceptable, under the two-step residual risk decision process, the EPA
then considered whether there were additional controls that might
further reduce risk to achieve an ample margin of safety considering
cost and feasibility. We did not identify any additional cost-effective
controls beyond those that would need to be implemented to ensure an
acceptable level of risk. Thus, with regard to the two stack emissions
points (the furnace area stack and the refinery stacks) for which we
are requiring action to ensure an acceptable level of risk, and for
fugitive dust emissions, for which we are specifying work practice
standards, we have concluded that there are no additional cost-
effective controls and that an ample margin of safety will be provided
by the same controls that ensure an acceptable level of risk. Moreover,
there are no additional cost effective controls to further reduce
emissions from the main stack beyond those controls that are already
applied. Therefore, an ample margin of safety will be provided by the
current level of control for the main stack. A more detailed
presentation of the economic analysis of additional controls for the
refining, furnace area, and main stacks can be found in the technical
support document, which is available in the docket.
    Comment: One commenter stated that the EPA has not appropriately
accounted for or prevented environmental risks from lead or non-lead
emissions as required by section 112(f)(2)(A). According to the
commenter, using the NAAQS to assess ecological risk is problematic and
EPA's approach of assuming that ``when exposure levels are not
anticipated to adversely affect human health, they also are not
anticipated to adversely affect the environment,'' 76 FR at 9425, is
illogical and unlawful. Further, based on the information the EPA has
gathered about the local environment around the Doe Run facility, the
EPA cannot assume that there would be no effects either to wildlife or
to natural resources in the environment either from inhalation or air
deposition of HAP emissions, exacerbated by persistence and
bioaccumulation. As the EPA's own Scientific Advisory Board has stated:
``The assumption that ecological receptors will be protected if human
health is protected is incorrect.'' SAB May 2010 at 48.
    Response: The EPA is unaware of any data indicating a direct
atmospheric impact of non-lead HAP emitted from this source category on
receptors such as plants, birds, and wildlife. Given that there is no
information supporting that

there is an effect, we find it appropriate to assume that exposure
levels not expected to harm humans are also not expected to harm
ecological receptors.
    Although the ecological effects of lead are well documented, there
was a lack of evidence at the time of the last lead NAAQS review
linking various ecological effects to specific levels of lead in the
air. It was determined that the evidence did not provide a sufficient
basis for establishing a separate secondary standard, but that revising
the secondary standard to be equal to the revised primary standard
would provide substantial additional protection to ecological receptors
from the effects of lead. Thus, we find it appropriate to consider the
secondary lead NAAQS when evaluating the potential for adverse
environmental effects.
    Comment: One commenter generally stated that the EPA must not use
the secondary NAAQS as a benchmark to determine whether there will be
environmental effects and that the use of the lead NAAQS to evaluate
ecologic risks is inappropriate. The commenter states that the EPA
should recognize that the establishment of the Secondary lead NAAQS at
the same level of the Primary Lead NAAQS was a risk management
decision, rather than a decision quantitatively founded in risk
assessment. The commenter cited that in establishing the lead NAAQS,
the EPA introduced its approach by describing the ``substantial
limitations in the evidence, especially the lack of evidence linking
various effects to specific levels of ambient Pb'' (U.S. EPA, 2008. P.
67007), and ultimately concluded that the secondary lead NAAQS should
be set equal to the primary lead NAAQS.
    In contrast, in this proposed rule, the EPA concludes that
``ambient lead concentrations above the lead NAAQS indicates potential
for adverse environmental effects'' (76 FR 9421).
    Response: The secondary lead NAAQS was set to protect against
adverse welfare effects (including adverse environmental effects) and
has the same averaging time, form, and level as the primary standard.
Thus, we find it appropriate to consider the secondary lead NAAQS when
considering the potential for adverse environmental effects. The
commenter is correct that we stated in the proposed rule that ``ambient
lead concentrations above the lead NAAQS indicates potential for
adverse environmental effects.'' This statement is entirely consistent
with the idea that the secondary lead NAAQS was set at a level above
which there may be adverse environmental effects but does not support a
conclusion that there are adverse environmental effects below that
level that must be addressed as part of this residual risk
determination. As we have noted previously, there are not sufficient
data supporting that a lower level is necessary to protect against an
environmental risk.
    Comment: One commenter stated that in evaluating potential
multipathway risks from PB-HAP other than lead, the EPA used de minimis
emission rates to screen for potentially significant multi-pathway
impacts, but for lead, this method was abandoned. The commenter
disagrees with this approach, stating, ``This comparison mirrors NAAQS
source monitoring for attainment purposes in its use of the national
ambient air lead level as the benchmark. As such, it is not a proper
surrogate for ``facility-level de minimis emission rates'' used as the
chronic reference benchmarks for CAA section 112 risk assessments.''
    Response: The EPA disagrees that comparing modeled 3-month rolling
average lead concentrations to the NAAQS for lead mirrors source
monitoring for NAAQS attainment purposes and that this approach is not
a proper surrogate for facility-level de minimis emission rates used as
the chronic reference benchmarks for CAA section 112 risk assessments.
In general, determining attainment for the lead NAAQS is based on
aggregate ambient monitoring of all potential sources of lead in a
given area. In contrast, the Primary Lead Smelting Risk Assessment and
Preamble clearly state that 3-month rolling average lead concentrations
are based on modeled lead concentrations from lead emissions from the
one facility in the source category. 76 FR 9421. Thus, for example,
while for NAAQS attainment purposes ambient lead concentrations
resulting from lead haul roads outside the facility boundary would
contribute to the overall 3-month rolling average ambient lead
concentration measured at a nearby ambient lead monitor, for purposes
of the risk assessment to support this rulemaking, these types of
offsite emission sources were not included when modeling 3-month
rolling lead concentrations (i.e., only emission sources from within
the facility boundary were used as inputs into the dispersion model to
estimate resulting modeled 3-month average lead concentrations).
    The NAAQS for lead was set to protect, with an adequate margin of
safety, human health, including the health of children and other at-
risk populations, against an array of adverse health effects, most
notably including neurological effects, particularly neurobehavioral
and neurocognitive effects, in children (73 FR 67007). In developing
the NAAQS for lead, because of the multi-pathway, multi-media impacts
of lead, the risk assessment supporting the NAAQS considered direct
inhalation exposures and indirect air-related multi-pathway exposures
from industrial sources like primary and secondary lead smelting
operations. It also considered background lead exposures from other
sources (like contaminated drinking water and exposure to lead-based
paints). The EPA believes that the lead NAAQS is a reasonable benchmark
to evaluate the potential for multipathway health effects from lead.
    Finally, as noted in the risk assessment document, there is no RfD
or other comparable chronic health benchmark value for lead compounds.
That is, in 1988, the EPA's IRIS program reviewed the health effects
data regarding lead and its inorganic compounds and determined that it
would be inappropriate to develop an RfD for these compounds, saying,
``A great deal of information on the health effects of lead has been
obtained through decades of medical observation and scientific
research. This information has been assessed in the development of air
and water quality criteria by the Agency's Office of Health and
Environmental Assessment (OHEA) in support of regulatory decision-
making by the Office of Air Quality Planning and Standards (OAQPS) and
by the Office of Drinking Water (ODW). By comparison to most other
environmental toxicants, the degree of uncertainty about the health
effects of lead is quite low. It appears that some of these effects,
particularly changes in the levels of certain blood enzymes and in
aspects of children's neurobehavioral development, may occur at blood
lead levels so low as to be essentially without a threshold. The
agency's RfD Work Group discussed inorganic lead (and lead compounds)
at two meetings (07/08/1985 and 07/22/1985) and considered it
inappropriate to develop an RfD for inorganic lead.'' The EPA's IRIS
assessment for Lead and compounds (inorganic) (CASRN 7439-92-1), http://www.epa.gov/iris/subst/0277.htm.
    Comment: One commenter stated that the EPA must include a plain
language statement of health risks and benefits of the proposed rule.
As part of its rulemaking proposal, the EPA should include a plain
statement of the health impacts and risks at issue. For example, the
commenter stated that the MIR and chronic and risk numbers are not
easily

understandable by the general public; the IQ point losses at stake or
how it is setting a standard to address these are not discussed, and
the types of cancer or the nature of the health disorders or other
adverse effects that most of these types of HAP emissions present to
the public are not discussed. The commenter stated that this type of
``[e]xpanded discussion is important to understanding the `real-world'
risk, including dealing with health disparities.'' SAB May 2010 at 50.
    A full elaboration of the types of health impacts at issue here,
ranging from significant IQ loss (due to lead emissions), to a high
lifetime cancer risk (from non-lead emissions), for this particular
community, is needed to inform the EPA's and the public's consideration
of what level of risk is acceptable or unacceptable, and what standard
is required to provide an ample margin of safety.
    Response: The EPA strives to communicate its health and risk
information to the public in a manner that is concise, informative, and
readily understandable. In the risk assessment document, we discuss the
various metrics used to characterize risk associated with the source
category (e.g., see section 2.3 of the risk assessment document for a
discussion of the MIR). Moreover, while the commenter is correct that
we do not discuss in detail the neurological effects associated with
exposure to lead (e.g., loss of IQ points in children), we do reference
the final lead NAAQS decision, which does discuss in detail the health
effects associated with lead exposure. With regard to how the proposed
controls limit the health risks associated with lead exposure, we noted
in the preamble of the proposed rule that the proposed controls would
ensure that the facility's contribution to ambient concentrations of
lead were at or below the NAAQS for lead and that this represents an
acceptable level of risk since the lead NAAQS was set to protect public
health, including the health of sensitive populations (e.g., children),
from the adverse health effects associated with lead exposure.
Moreover, although the requirements that we are promulgating in today's
action are somewhat different than the proposed requirements, we
believe that the requirements that we are promulgating will also ensure
that the facility's contribution to ambient concentrations of lead will
not present an unacceptable level of risk. In addition, as discussed
previously, we have not identified any additional cost-effective
controls and we therefore conclude that the same level of controls to
achieve acceptable risks will also provide an ample margin of safety.
    With regard to discussing specific types of cancers potentially
associated with exposure to a given HAP, we note that the cancer unit
risk estimates used in the risk assessment are not associated with
specific types of cancers, but rather with the risk of cancer in
general. Moreover, since many of the cancer studies the unit risk
estimates take into account are animal studies, there is appreciable
uncertainty as to whether the same types of cancers would be seen in
humans. Thus, we find it appropriate to express the results of our
cancer assessment in terms of general cancer risk.

VI. Impacts of the Final Rule

    The revisions to the Primary Lead Processing MACT standard will
ensure that emissions from the one source in this source category do
not present an unacceptable level of risk and will also provide an
ample margin of safety. The estimated reductions include as much as 10
tons per year of lead from the furnace area and refining operations
stacks. We also expect reductions will be achieved with the additional
work practices, but we have not been able to quantify those reductions.
These controls and work practices will also reduce emissions of other
HAP emitted from the facility. The costs of these controls and work
practices were not directly considered in the decision because these
controls and practices are necessary to ensure that risks are
acceptable. The EPA evaluated control practices and technology and
associated costs in determining that the same requirements needed to
achieve acceptable risks would also provide an ample margin of safety.
In addition, we considered other available practices, processes and
control technologies. For the same reason we concluded that no
additional controls were necessary to provide an ample margin of
safety, we concluded that there were no additional cost effective
developments in practices, processes or control technologies for any
sources other than the main stack.

VII. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review, and Executive
Order 13563: Improving Regulation and Regulatory Review

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
action is a ``significant regulatory action.'' This action is a
significant regulatory action because it raises novel legal and policy
issues. Accordingly, the EPA submitted this action to the Office of
Management and Budget (OMB) for review under Executive Order 12866 and
Executive Order 13563 (76 FR 3821, January 21, 2011), and any changes
made in response to OMB recommendations have been documented in the
docket for this action.

B. Paperwork Reduction Act

    The Office of Management and Budget (OMB) has approved the
information collection requirements contained in this rule under the
provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. and
has assigned OMB control number 2060-0414.
    The information requirements are based on notification,
recordkeeping, and reporting requirements in the NESHAP General
Provisions (40 CFR part 63, subpart A), which are mandatory for all
operators subject to national emission standards. These recordkeeping
and reporting requirements are specifically authorized by section 114
of the CAA (42 U.S.C. 7414). All information submitted to the EPA
pursuant to the recordkeeping and reporting requirements for which a
claim of confidentiality is made is safeguarded according to agency
policies set forth in 40 CFR part 2, subpart B.
    This final rule includes new paperwork requirements for increased
frequency for stack testing as described in 40 CFR 63.1546.
    When a malfunction occurs, sources must report the event according
to the applicable reporting requirements of 40 CFR part 63, subpart