[Federal Register Volume 76, Number 77 (Thursday, April 21, 2011)]
[Rules and Regulations]
[Pages 22566-22602]
[FR Doc No: 2011-8168]

Vol. 76

Thursday,

No. 77

April 21, 2011

Part III

Environmental Protection Agency

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40 CFR Part 63

National Emission Standards for Hazardous Air Pollutant Emissions:
Group I Polymers and Resins; Marine Tank Vessel Loading Operations;
Pharmaceuticals Production; and the Printing and Publishing Industry;
Final Rule

Federal Register / Vol. 76 , No. 77 / Thursday, April 21, 2011 /
Rules and Regulations

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 63

[EPA-HQ-OAR-2010-0600; FRL-9291-3]
RIN 2060-AO91

National Emission Standards for Hazardous Air Pollutant
Emissions: Group I Polymers and Resins; Marine Tank Vessel Loading
Operations; Pharmaceuticals Production; and the Printing and Publishing
Industry

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is taking final action for four national emission
standards for hazardous air pollutants (NESHAP) that regulate 12
industrial source categories evaluated in our risk and technology
review. The four NESHAP include: National Emissions Standards for Group
I Polymers and Resins (Butyl Rubber Production, Epichlorohydrin
Elastomers Production, Ethylene Propylene Rubber Production,
Hypalon\TM\ Production, Neoprene Production, Nitrile Butadiene Rubber
Production, Polybutadiene Rubber Production, Polysulfide Rubber
Production, and Styrene Butadiene Rubber and Latex Production); Marine
Tank Vessel Loading Operations; Pharmaceuticals Production; and The
Printing and Publishing Industry.
    For some source categories, EPA is finalizing our decisions
concerning the residual risk and technology reviews. For the Marine
Tank Vessel Loading Operations NESHAP and the Group I Polymers and
Resins NESHAP, EPA is finalizing emission standards to address certain
emission sources not previously regulated under the NESHAP. EPA is also
finalizing changes to the Pharmaceuticals Production NESHAP to correct
an editorial error. For each of the four NESHAP, EPA is finalizing
revisions to the regulatory provisions related to emissions during
periods of startup, shutdown, and malfunction and promulgating
provisions addressing electronic submission of emission test results.

DATES: This final action is effective on April 21, 2011.

ADDRESSES: EPA has established a docket for this action under Docket ID
No. EPA-HQ-OAR-2010-0600. 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<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: For questions about this final action,
contact Ms. Mary Tom Kissell, Office of Air Quality Planning and
Standards, Sector Policies and Programs Division, Refining and
Chemicals Group (E143-01), U.S. Environmental Protection Agency,
Research Triangle Park, NC 27711; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; and e-mail address<EMAIL_ADDRESS>For
additional contact information, see the following SUPPLEMENTARY
INFORMATION section.

SUPPLEMENTARY INFORMATION: For specific information regarding the
modeling methodology, contact Ms. Elaine Manning, Office of Air Quality
Planning and Standards, Health and Environmental Impacts Division, Air
Toxics Assessment Group (C539-02), U.S. Environmental Protection
Agency, Research Triangle Park, NC 27711; telephone number: (919) 541-
5499; fax number:<PHONE_NUMBER>; and e-mail address:
<EMAIL_ADDRESS>For information about the applicability of
these four 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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Group I Polymers and Resins.  Marcia Mia (202) 564- Nick Parsons, (919)
                               7042,                 541-5372,
<EMAIL_ADDRESS><EMAIL_ADDRESS>Marine Tank Vessel Loading    Maria Malave, (202)   Steve Shedd, (919)
 Operations.                   564-7027,             541-5397,
<EMAIL_ADDRESS><EMAIL_ADDRESS>                               v.                    .
Pharmaceuticals Production..  Marcia Mia, (202)     Nick Parsons, (919)
                               564-7042,             541-5372,
<EMAIL_ADDRESS><EMAIL_ADDRESS>The Printing and Publishing   Rafael Sanchez,       David Salman, (919)
 Industry.<PHONE_NUMBER>,       541-5402,
                               sanchez.rafael@epa. <EMAIL_ADDRESS>                               gov.                  .
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\1\ OECA stands for EPA's Office of Enforcement and Compliance
  Assurance.
\2\ OAQPS stands for EPA's Office of Air Quality Planning and Standards.

    Background Information Document. On October 21, 2010 (75 FR 65068),
EPA proposed revisions to six NESHAP that regulate 16 industrial source
categories evaluated in our risk and technology review. The six NESHAP
and industrial source categories are: National Emissions Standards for
Hazardous Air Pollutant Emissions: Hard and Decorative Chromium
Electroplating and Chromium Anodizing Tanks; Group I Polymers and
Resins; Marine Tank Vessel Loading Operations; Pharmaceuticals
Production; The Printing and Publishing Industry; and Steel Pickling--
HCl Process Facilities and Hydrochloric Acid Regeneration. In this
action, we are finalizing decisions for four of these NESHAP--Group I
Polymers and Resins; Marine Tank Vessel Loading Operations;
Pharmaceuticals Production; and The Printing and Publishing Industry.
We will finalize our decisions for the Hard and Decorative Chromium
Electroplating and Chromium Anodizing Tanks NESHAP and the Steel
Pickling--HCl Process Facilities and Hydrochloric Acid Regeneration in
a future rulemaking.\1\ A summary of the public comments on the
proposal, and EPA's responses to the comments, is

available in Docket ID No. EPA-HQ-OAR-2010-0600.
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    \1\ We addressed two additional source categories as part of
this proposed rule, Hard and Decorative Chromium Electroplating and
Chromium Anodizing Tanks and Steel Pickling--HCl Process Facilities
and Hydrochloric Acid Regeneration, and we plan to take final action
on those two source categories in June 2011.
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    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 Rules
    A. What are the final rule amendments for the Group I Polymers
and Resins source categories?
    B. What are the final rule amendments for the Marine Tank Vessel
Loading Operations (MTVLO) source category?
    C. What are the final rule amendments for the Pharmaceuticals
Production source category?
    D. What are the final rule amendments for the Printing and
Publishing Industry source category?
    E. What are the requirements during periods of startup,
shutdown, and malfunction?
    F. What are the requirements for submission of emissions test
results to EPA?
    G. What are the effective and compliance dates of the standards?
IV. Summary of Significant Changes Since Proposal
    A. What changes did we make to the risk assessments for these
source categories since proposal?
    B. What changes did we make to the Group I Polymers and Resins
MACT since proposal?
    C. What changes did we make to the Marine Tank Vessel Loading
Operations MACT since proposal?
V. Summary of Significant Comments and Responses
    A. EPA's Authority Under CAA Section 112
    B. Group I Polymers and Resins
    C. Marine Tank Vessel Loading Operations
    D. Startup, Shutdown, and Malfunction (SSM) Requirements
VI. Impacts of the Final Rules
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

    A red-line version of the regulatory language that incorporates the
changes in this action is available in the docket.

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
------------------------------------------------------------------------
Group I Polymers and Resins:
    Butyl Rubber Production.............          325212            1307
    Epichlorohydrin Elastomers                    325212            1311
     Production.........................
    Ethylene Propylene Rubber Production          325212            1313
    Hypalon\TM\ Production..............          325212            1315
    Neoprene Production.................          325212            1320
    Nitrile Butadiene Rubber Production.          325212            1321
    Polybutadiene Rubber Production.....          325212            1325
    Polysulfide Rubber Production.......          325212            1332
    Styrene Butadiene Rubber and Latex            325212            1339
     Production.........................
Marine Tank Vessel Loading Operations...            4883            0603
Pharmaceuticals Production..............            3254            1201
The Printing and Publishing Industry....           32311            0714
------------------------------------------------------------------------
\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 categories listed. To determine whether your
facility would be affected, you should examine the applicability
criteria in the appropriate NESHAP. If you have any questions regarding
the applicability of any of these 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/atw/rrisk/rtrpg.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 Clean Air Act (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 June 20, 2011. Under section 307(b)(2) of the CAA, the
requirements established by these final rules may not be challenged
separately in any civil or criminal proceedings brought by 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 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 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, EPA may adopt
standards equal to existing MACT standards if EPA determines that the
existing standards are sufficiently protective. NRDC v. EPA, 529 F.3d
1077, 1083 (D.C. Cir. 2008).
    On October 21, 2010, EPA published a proposed rule and supplemental
notice of proposed rulemaking in the Federal Register for these four
NESHAP that took into consideration the RTR analyses. For these
NESHAP--Group I Polymers and Resins, Marine Tank Vessel Loading
Operations, Pharmaceuticals Production, and The Printing and Publishing
Industry--this action provides EPA's final determinations pursuant to
the RTR provisions of CAA section 112. In addition, we are promulgating
amendments as follows:
     For the Marine Tank Vessel Loading Operations NESHAP and
Group I Polymers and Resins NESHAP, pursuant to CAA section 112(d)(2)
and (3), EPA is finalizing revisions to address certain emission
sources not currently regulated under the standards.
     For the Pharmaceuticals Production NESHAP, EPA is
finalizing changes to correct an editorial error.
     For each of the four NESHAP, EPA is finalizing revisions
to requirements in each NESHAP related to emissions during periods of
startup, shutdown, and malfunction (SSM).
     For each of the four NESHAP, EPA is finalizing revisions
to requirements in each NESHAP related to electronic reporting.

III. Summary of the Final Rules

A. What are the final rule amendments for the Group I Polymers and
Resins source categories?

    The National Emission Standards for Hazardous Air Pollutant
Emissions: Group I Polymers and Resins were promulgated on September 5,
1996 (62 FR 46925), and codified at 40 CFR part 63, subpart U. The
Group I Polymers and Resins MACT standards apply to major sources and
regulate HAP emissions from nine source categories: Butyl Rubber
Production, Epichlorohydrin Elastomers Production, Ethylene Propylene
Rubber Production, Hypalon\TM\ Production, Neoprene Production, Nitrile
Butadiene Rubber (NBR) Production, Polybutadiene Rubber Production,
Polysulfide Rubber Production, and Styrene Butadiene Rubber and Latex
Production.
    The Group I Polymers and Resins MACT standards regulate HAP
emissions resulting from the production of elastomers (i.e., synthetic
rubber). An elastomer is a synthetic polymeric material that can
stretch to at least twice its original length and then return rapidly
to approximately its original length when released. Elastomers are
produced via a polymerization/copolymerization process, in which
monomers undergo intermolecular chemical bond formation to form a very
large polymer molecule. Generally, the production of elastomers entails
four processes: (1) Raw material (i.e., solvent) storage and refining;
(2) polymer formation in a reactor (either via the solution process,
where monomers are dissolved in an organic solvent, or the emulsion
process, where monomers are dispersed in water using a soap solution);
(3) stripping and material recovery; and (4) finishing (i.e., blending,
aging, coagulation, washing, and drying).
    Sources of HAP emissions from elastomers production include raw
material storage vessels, front-end

process vents, back-end process operations, wastewater operations, and
equipment leaks. The ``front-end'' processes include pre-
polymerization, reaction, stripping, and material recovery operations;
and the ``back-end'' process includes all operations after stripping
(predominantly drying and finishing). Typical control devices used to
reduce organic HAP emissions from front-end process vents include
flares, incinerators, absorbers, carbon adsorbers, and condensers.
Emissions from storage vessels are controlled by floating roofs or by
routing them to a control device.
    While emissions from back-end process operations can be controlled
with control devices such as incinerators, the most common method of
reducing these emissions is the pollution prevention method of reducing
the amount of residual HAP that is contained in the raw product going
to the back-end operations. Emissions from wastewater are controlled by
a variety of methods, including equipment modifications (e.g., fixed
roofs on storage vessels and oil water separators; covers on surface
impoundments, containers, and drain systems), treatment to remove the
HAP (steam stripping, biological treatment), control devices, and work
practices.
    Emissions from equipment leaks are typically reduced by leak
detection and repair work practice programs, and in some cases, by
equipment modifications.
    For these five Group I Polymers and Resins \2\ source categories--
Epichlorohydrin Elastomers Production; HypalonTM Production;
Polybutadiene Rubber Production; Styrene Butadiene Rubber and Latex
Production; and NBR Production--we have determined that the current
MACT standards reduce risk to an acceptable level, provide an ample
margin of safety to protect public health, and prevent adverse
environmental effects. We are, therefore, re-adopting the existing MACT
standards to satisfy section 112(f) of the CAA. We have also determined
that there have been no significant developments in practices,
processes, or control technologies since promulgation of the MACT
standards, and that, therefore, it is not necessary to revise the MACT
standard pursuant to CAA section 112(d)(6).\3\
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    \2\ We previously re-adopted the existing MACT standards to
satisfy section 112(f) of the CAA for four Group I Polymers and
Resins source categories--Neoprene Rubber Production; Ethylene
Propylene Rubber Production; Butyl Rubber Production; and
Polysulfide Rubber Production. See 73 FR 76220, published December
16, 2008.
    \3\ We note there are no longer any operating facilities in the
United States that produce Hypalon\TM\, and we do not anticipate
that any will begin operation in the future.
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    We are eliminating the subcategories in the Butyl Rubber source
category (Butyl Rubber and Halobutyl Rubber) because the technical
differences that distinguished the subcategories when the original rule
was developed no longer exist. The existing requirements for facilities
producing either butyl rubber or halobutyl rubber as the primary
product are identical, and, therefore, the removal of the subcategory
distinction does not affect these requirements. The source category
remains named Butyl Rubber Production. We are establishing standards at
the MACT floor level of control for previously unregulated hydrochloric
acid (HCl) emissions from front-end process vents in the Butyl Rubber
and Ethylene Propylene Rubber source categories. We are also
establishing standards at the MACT floor level of control for
previously unregulated back-end process operations in the
Epichlorohydrin Elastomers, NBR, Neoprene, and Butyl Rubber source
categories.
    The numerical emission standards that are being finalized in this
action for new and existing major source facilities in the Group 1
Polymers and Resins source categories are shown in Table 3 of this
preamble.

BILLING CODE 6560-50-P

[GRAPHIC] [TIFF OMITTED] TR21AP11.001

BILLING CODE 6560-50-C

    We are finalizing changes to the Group I Polymers and Resins MACT
standards to eliminate the SSM exemption. These changes revise Table 1
in 40 CFR part 63, subpart U 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 Group I Polymers and Resins MACT
standards to operate in a manner that minimizes emissions, removing the
SSM plan requirement, removing the explanation of applicability of
emissions standards during periods of SSM, revising the definition of
initial start-up to remove references to malfunctions, clarifying the
required conditions for performance tests, and revising the SSM-
associated monitoring, 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.
    We are also requiring the electronic submittal of performance test
data to increase the ease and efficiency of data submittal and to
improve data accessibility. Specifically, owners and operators of Group
I Polymers and Resins facilities are required to submit electronic
copies of applicable reports of performance tests to EPA's WebFIRE
database through an electronic emissions test report structure called
the Electronic Reporting Tool (ERT). This requirement to submit
performance test data electronically to EPA does not require any
additional performance testing, and applies only to those performance
tests conducted using test methods that are supported by the ERT.
    We anticipate that the front-end process vent limits will not
require additional control to meet the floor-level standards for HCl
emissions from front-end process operations at the facilities in the
Butyl Rubber and Ethylene Propylene Rubber source categories. We
anticipate that facilities in the Butyl Rubber, Epichlorohydrin
Elastomers, Neoprene Rubber, and NBR source categories will not require
additional control to meet the floor-level standards for the back-end
process operations.
    To demonstrate compliance with the front-end process vent HCl
emissions provisions of the final rule, the facility owner or operator
will be required to submit an initial notification of the calculated
front-end HCl limit for the facility and to perform and record monthly
calculations of the mass of HCl emissions and the mass of elastomer
product produced. These recorded monthly calculations are required to
be submitted in the semi-annual compliance reports already required by
existing provisions of the rule.
    To demonstrate compliance with the back-end process operation
provisions of the final rule, the facility owner or operator will be
required to submit an initial notification of the calculated back-end
limit for the facility, and to perform and record monthly calculations
of the mass of HAP emissions and the mass of elastomer product
produced. These recorded monthly calculations are required to be
submitted in the semi-annual compliance reports already required by
existing provisions of the rule.
    The final changes to the Group I Polymers and Resins MACT standards
are not expected to result in substantial emissions reduction or
economic impacts. We have determined that facilities in the Group 1
Polymers and Resins categories can meet the applicable emissions limits
at all times, including periods of startup and shutdown, with the
exception of the organic HAP emissions limits applicable to front-end
process vents at facilities in the Butyl Rubber and Ethylene Propylene
Rubber source categories. We have determined that facilities in the
Butyl Rubber and Ethylene Propylene Rubber source categories cannot
meet the applicable organic HAP emission limits applicable to
continuous front-end process vents during periods of shutdown.
Therefore, we are establishing alternative emissions limits during
these periods. No substantial changes in costs to industry are
predicted.

B. What are the final rule amendments for the Marine Tank Vessel
Loading Operations (MTVLO) source category?

    MTVLO are loading operations conducted at marine terminals in which
liquid commodities, such as crude oil, gasoline, and other fuels or
chemicals, are pumped from the terminal's large, above-ground storage
tanks through a network of pipes into a storage compartment (tank) on
the vessel. Emissions occur as vapors are displaced from the tank as it
is being filled. Most MTVLO facilities are either independent terminals
or are associated with synthetic organic chemical manufacturers or with
petroleum refineries (although MTVLO at petroleum refineries are part
of the Petroleum Refinery source category).
    For these MTVLO facilities, we have determined that the current
MACT standards reduce risk to an acceptable level, provide an ample
margin of safety to protect public health, and prevent adverse
environmental effects. We are, therefore, re-adopting the existing MACT
standards to satisfy section 112(f) of the CAA. We have also determined
that the costs of the only significant development in practices,
processes, or control technologies since promulgation of the MACT
standards is disproportionate to the emission reduction that would be
achieved, and we are not adopting additional technology standards
pursuant to CAA section 112(d)(6).
    We are finalizing changes to the MTVLO MACT standards to require
standards for two subcategories of MTVLO facilities for which the
current MTVLO MACT standards do not include emission standards. These
subcategories are facilities with MTVLO that emit less than 10/25 TPY
of HAP that are located at a major source of HAP emissions and
facilities located more than 0.5 miles from shore. For these source
categories, we are adding a requirement for the facilities to perform
submerged fill. This requirement is the MACT floor level of control.
    We are finalizing changes to the MTVLO MACT standards to eliminate
the SSM exemption. These changes revise Table 1 in 40 CFR part 63,
subpart Y 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 MTVLO MACT standards to operate in a manner
that minimizes emissions, clarifying the required conditions for
performance tests, and revising the SSM-associated monitoring,
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.
    Additionally, we are requiring the electronic submittal of
performance test data to increase the ease and efficiency of data
submittal and to improve data accessibility. Specifically, owners and
operators of MTVLO are required to submit electronic copies of
applicable reports of performance tests to EPA's WebFIRE database
through an electronic emissions test report structure called the ERT.
This requirement to submit performance test data electronically to EPA
does not require any additional performance testing, and applies only
to those performance tests conducted using test methods that are
supported by the ERT. The final changes to the

MTVLO MACT standards will have little or no impact on HAP emissions or
costs because facilities currently use submerged fill, as required by
Coast Guard regulations.\4\
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    \4\ 46 CFR 153.282.
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C. What are the final rule amendments for the Pharmaceuticals
Production source category?

    The pharmaceutical manufacturing process consists of chemical
production operations that produce drugs and medications. These
operations include chemical synthesis (deriving a drug's active
ingredient) and chemical formulation (producing a drug in its final
form). Emissions occur from breathing and withdrawal losses from
chemical storage tanks, venting of process vessels, leaks from piping
and equipment used to transfer HAP compounds (equipment leaks), and
volatilization of HAP from wastewater streams.
    For the reasons provided in the proposed rule and in the support
documents in the docket, we have determined that the current MACT
standards for Pharmaceutical Production facilities reduce risk to an
acceptable level, provide an ample margin of safety to protect public
health, and prevent adverse environmental effects. We are, therefore,
re-adopting the existing MACT standards to satisfy section 112(f) of
the CAA. We have also determined that there have been no significant
developments in practices, processes, or control technologies since
promulgation of the MACT standards, and that, therefore, it is not
necessary to revise the MACT standards pursuant to CAA section
112(d)(6).
    We are finalizing changes to the Pharmaceutical Production MACT
standards to eliminate the SSM exemption. These changes revise Table 1
in 40 CFR part 63, subpart GGG to indicate that several requirements of
the 40 CFR General Provisions related to periods of SSM do not apply.
We are adding provisions to the Pharmaceuticals Production MACT
standards to operate in a manner that minimizes emissions, removing the
SSM plan requirement, removing the exemption provisions for periods of
SSM in 40 CFR 63.1250(g), requiring that delay of equipment leak repair
plans be contained in a separate document, clarifying the required
conditions for performance tests, and revising the SSM-associated
monitoring, 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.
    We are also requiring the electronic submittal of performance test
data to increase the ease and efficiency of data submittal and to
improve data accessibility. Specifically, owners and operators of
Pharmaceuticals Production facilities are required to submit electronic
copies of applicable reports of performance tests to EPA's WebFIRE
database through an electronic emissions test report structure called
the ERT. This requirement to submit performance test data
electronically to EPA does not require any additional performance
testing, and applies only to those performance tests conducted using
test methods that are supported by the ERT.
    We are also finalizing a correction to an editorial error in 40 CFR
63.1257(e)(2)(iii)(A)(6)(ii). This section incorrectly provides that
only one of the three listed criteria must be met for the inlet to the
equalization tank to be considered the inlet to the biological
treatment process. The final correction specifies that all of the
criteria must be met.
    These revisions to the Pharmaceutical Production MACT standards are
not expected to result in substantial emissions reduction or economic
impacts. We have determined that facilities in this source category can
meet the applicable emissions standards at all times, including periods
of startup and shutdown, are in compliance with the current MACT
standard. No substantial changes in costs to industry are predicted.
The correction to the editorial error may result in minimal costs to
add or move equipment and may also result in some small amount of
emission reductions for any facility that was meeting only one or two
of the three listed criteria. However, as the intent of the current
MACT standards at the time they were promulgated was to require
facilities to meet all three criteria, the costs and emission
reductions associated with this requirement were factored into the
impacts of the MACT standards at the time the standards were
promulgated in 1998. See 63 FR 50287.

D. What are the final rule amendments for the Printing and Publishing
Industry source category?

    Printing and publishing facilities are those facilities that use
rotogravure, flexography, and other methods, such as lithography,
letterpress, and screen printing, to print on a variety of substrates,
including paper, plastic film, metal foil, and vinyl. The Printing and
Publishing Industry MACT standards include two subcategories: (1)
Publication rotogravure printing and (2) product and packaging
rotogravure and wide-web flexographic printing. Emissions occur from
the evaporation of solvents in the inks and from cleaning solvents. The
emission points include printing presses and associated dryers and ink
and solvent storage.
    For the reasons provided in the proposed rule and in the support
documents in the docket, we have determined that the current MACT
standards for Printing and Publishing facilities reduce risk to an
acceptable level, provide an ample margin of safety to protect public
health, and prevent adverse environmental effects. We are, therefore,
re-adopting the existing MACT standards to satisfy section 112(f) of
the CAA. We have also determined that the costs of the only significant
development in practices, processes, or control technologies since
promulgation of the MACT standards is disproportionate to the emission
reduction that would be achieved, and, therefore, we are not adopting
additional technology standards pursuant to CAA section 112(d)(6).
    We are finalizing changes to the Printing and Publishing Industry
MACT standards to eliminate the SSM exemption. These changes revise
Table 1 in 40 CFR part 63, subpart KK 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 Printing
and Publishing Industry 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 monitoring, 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.
    We are also requiring the electronic submittal of performance test
data to increase the ease and efficiency of data submittal and to
improve data accessibility. Specifically, owners and operators of
printing and publishing facilities are required to submit electronic
copies of applicable reports of performance tests to EPA's WebFIRE

database through an electronic emissions test report structure called
the Electronic ERT. This requirement to submit performance test data
electronically to EPA does not require any additional performance
testing, and applies only to those performance tests conducted using
test methods that are supported by the ERT.
    These revisions to the Printing and Publishing Industry MACT
standards are not expected to result in substantial emissions reduction
or economic impacts. We have determined that facilities in this source
category can meet the applicable emissions standards at all times,
including periods of startup and shutdown, are in compliance with the
current MACT standards. No substantial changes in costs to industry are
predicted.

E. 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 EPA's CAA section 112
regulations governing the emissions of HAP during periods of 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 is part of a
regulation, commonly referred to as the ``General Provisions Rule,''
that 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 emission standards during
periods of SSM.
    While the Court's ruling in Sierra Club v. EPA, 551 F.3d 1019 (DC
Cir. 2008), did not directly affect all the NESHAP rules being
addressed, the legality of source category-specific SSM provisions,
such as those in all four NESHAP rules, are called into question based
on the reasoning in that decision.
    We have eliminated the SSM exemptions in these four NESHAP.
Consistent with Sierra Club v. EPA, EPA's standards in these rules will
apply at all times. We have eliminated or revised certain recordkeeping
and reporting requirements that were related to the SSM exemption that
no longer applies. EPA has attempted to ensure that we have not
included in the regulatory language any provisions that are
inappropriate, unnecessary, or redundant in light of the removal of the
SSM exemption.
    EPA has not established different standards for periods of startup
and shutdown for three of the four NESHAP addressed in this rule
because we believe compliance with the standards is achievable during
these periods. In the case of MTVLO, loading of marine tank vessels
occurs in ``batches,'' and general practice is for the loading
operators to test out the vapor control system before it is attached to
the tank vessel. In the case of the Pharmaceuticals Production MACT
standards, we expect the difference in emission levels during periods
of startup and shutdown are insignificant and that facilities in this
source category should be able to comply with the standards during
these times. In the case of the Printing and Publishing MACT standards,
we believe there are sufficiently long averaging times incorporated
into the emissions limits that facilities should be able to comply
during periods of startup and shutdown. In the case of Group I Polymers
and Resins, one commenter stated that organic HAP emissions that are
required to be sent to emissions control equipment (i.e., flares) may
not be able to comply with the MACT standards during periods of
shutdown. The commenter stated that they may not always be able to
route some of their process vents to a flare during periods of shutdown
due to the low pressure or low heating value in the process vent. EPA
agrees with the commenter that it is not possible to comply with the
applicable standard during periods of shutdown, and has provided an
alternative standard applicable during these times.
    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 equipment,
process equipment, or a process to operate in a normal or usual manner
* * *'' (40 CFR 60.2). 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 CAA
section 112, emissions 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
CAA 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 EPA
accounts for variability in setting emissions standards consistent with
the CAA section 112 case law, nothing in that case law requires the
Agency to consider malfunctions as part of that analysis. CAA Section
112 uses the concept of ``best controlled'' and ``best performing''
unit in defining the level of stringency that CAA 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. EPA's
approach to malfunctions is consistent with CAA 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 standards as a result of a

malfunction event, 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. EPA would also consider whether the source's
failure to comply with the CAA section 112 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, 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)). EPA is, therefore, adding to the final
rules an affirmative defense to civil penalties for exceedances of
emission limits that are caused by malfunctions. See 40 CFR 63.482
(Group I Polymers and Resins), 63.561 (MTVLO), 63.822 (The Printing and
Publishing Industry), 63.1251 (Pharmaceuticals Production). The
regulations define ``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. See 40 CFR 63.480 (Group I Polymers
and Resins), 40 CFR 63.560 (MTVLO), 40 CFR 63.820 (The Printing and
Publishing Industry), 40 CFR 63.1250 (Pharmaceuticals Production). The
source must prove by a preponderance of evidence that it has met all of
the elements set forth in affirmative defense. 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 40 CFR 63.6(e)(1)(i), 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 CAA (see also 40 CFR
part 22.77).

F. What are the requirements for submission of emissions test results
to EPA?

    EPA must have performance test data to conduct effective reviews of
CAA sections 112 and 129 standards, as well as for many other purposes,
including compliance determinations, emission factor development, and
annual emission rate determinations. In conducting these required
reviews, EPA has found it ineffective and time consuming, not only for
us, but also for regulatory agencies, and source owners and operators,
to locate, collect, and submit performance test data because of varied
locations for data storage and varied data storage methods. In recent
years, though, performance test data in electronic format have become
readily available, making it possible to move to an electronic data
submittal system that would increase the ease and efficiency of data
submittal and improve data accessibility.
    In this action, as a step to increase the ease and efficiency of
data submittal and improve data accessibility, EPA is requiring the
electronic submittal of select performance test data. Specifically, EPA
is requiring owners and operators of sources subject to these MACT
standards to submit electronic copies of applicable reports of
performance tests to EPA's WebFIRE database. The WebFIRE database was
constructed to store performance test data for use in developing
emission factors. A description of the WebFIRE database is available at
http://cfpub.epa.gov/oarweb/index.cfm?action=fire.main. Data entry will
be through an electronic emissions test report structure called the
ERT.
    The ERT will be able to transmit the electronic report through
EPA's Central Data Exchange (CDX) network for storage in the WebFIRE
database. Although ERT is not the only electronic interface that can be
used to submit performance test data to the CDX for entry into WebFIRE,
it makes submittal of data very straightforward and easy. A description
of the ERT can be found at http://www.epa.gov/ttn/chief/ert/ert_tool.html.
    The requirement to submit performance test data electronically to
EPA would not require any additional performance testing, and would
apply to those performance tests conducted using test methods that are
supported by the ERT. The ERT contains a specific electronic data entry
form for most of the commonly used EPA reference methods. A listing of
the pollutants and test methods supported by the ERT is available at
http://www.epa.gov/ttn/chief/ert/ert_tool.html. When a facility
submits performance test data to CDX, there will be no additional
requirements for performance test data compilation. Moreover, we
believe that industry will benefit from this new electronic data
submittal requirement. Having these data, EPA will be able to develop
improved emission factors, make fewer information requests, and
promulgate better regulations. The information to be reported is
already required for the existing test methods, and is necessary to
evaluate the conformance to the test method.
    One major advantage of submitting performance test data through the
ERT is a standardized method to compile and store much of the
documentation required to be reported by this rule that also clearly
states what testing information would be required. Another important
benefit of submitting these data to EPA at the time the source test is
conducted is that it should substantially reduce the effort involved in
data collection activities in the future. When EPA has performance test
data in hand, there will likely be fewer or less substantial data
collection requests in conjunction with prospective required residual
risk assessments or technology reviews. This results in a reduced
burden on both affected facilities (in terms of reduced manpower to
respond to data collection requests) and EPA (in terms of preparing and
distributing data collection requests and assessing the results).

    State, local, and tribal agencies will benefit from electronic data
submission as their review of the data will be more streamlined and
accurate, because they would not have to re-enter the data to assess
the calculations and verify the data entry. Finally, another benefit of
submitting data to WebFIRE electronically is that these data will
greatly improve the overall quality of the existing and new emission
factors by supplementing the pool of emissions test data upon which the
emission factor is based, and by ensuring that data are more
representative of current industry operational procedures. A common
complaint heard from industry and regulators is that emission factors
are outdated or not representative of a particular source category. By
receiving and incorporating data for most performance tests, EPA will
be able to ensure that emission factors, when updated, represent the
most current range of operational practices. In summary, in addition to
supporting regulation development, control strategy development, and
other air pollution control activities, having an electronic database
populated with performance test data will save industry, State, local,
and tribal agencies, and EPA significant time, money, and effort while
improving the quality of emission inventories, and, as a result, air
quality regulations.

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

    The revisions to the MACT standards being promulgated in this
action are effective on April 21, 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, April 21, 2011.
The electronic reporting requirements for the four MACT standards being
addressed in this action are effective on January 1, 2012. For the
Group 1 Polymers and Resins MACT standards, the compliance date for
existing sources for the new MACT standards applicable to front-end and
back-end process operations is 1 year from the effective date of the
standards, April 23, 2012. For the Marine Tank Vessel Loading
Operations MACT standards, the compliance date for the new requirements
for submerged fill is 1 year from the effective date of the standards,
April 23, 2012. The compliance date for the corrected provision in the
Pharmaceuticals Production MACT standards is the effective date of the
standards, April 21, 2011. Beyond the revised SSM and electronic
reporting requirements, there are no changes to The Printing and
Publishing Industry MACT standards.

IV. Summary of Significant Changes Since Proposal

A. What changes did we make to the risk assessments for these source
categories since proposal?

    CAA section 112(f)(2) requires us to determine whether certain
emissions standards reduce risk to an acceptable level, and once we
have ensured that the risk is acceptable, whether the standards provide
an ample margin of safety to protect public health and prevent an
adverse environmental effect. First we determine whether there is an
acceptable risk. EPA generally presumes that, if the maximum individual
risk (MIR) is no higher than 100-in-1 million, that risk is acceptable.
In addition to MIR, EPA also considers a series of other health
measures and factors to complete an overall judgment on acceptability.
In some cases, these health measures and factors taken together may
provide a more realistic description of the magnitude of risk in the
exposed population than MIR alone. If the risk is unacceptable, EPA
must require additional controls, without consideration of cost, to
ensure an acceptable level of risk. After determining that the level of
risk is acceptable, EPA evaluates whether the standards provide an
ample margin of safety by considering costs and economic impacts of
controls, technological feasibility, and other relevant factors, in
addition to those health measures and factors considered to determined
acceptability. Considering all of these factors, EPA ensures that the
standard is set at a level that provides an ample margin of safety to
protect public health, as required by CAA section 112(f).
    At proposal, we conducted risk assessments that provided estimates
of the MIR posed by the allowable and actual HAP emissions from each
source in a category, the distribution of cancer risks within the
exposed populations, cancer incidence, hazard index (HI) for chronic
exposures to HAP with non-cancer health effects, and hazard quotient
(HQ) for acute exposures to HAP with non-cancer health effects. We
found that the residual risks to public health from all source
categories subject to these four MACT standards are acceptable, and,
further, that the existing standards provide an ample margin of safety
to protect public health and pose no adverse environmental effects.
Thus, we proposed that no additional controls would be required to
address such risks. Specifically, we found that the lifetime cancer
risk to the individual most exposed to emissions from each of these
seven source categories \5\ was less than 100-in-1 million for both the
actual emissions and the emissions that would occur if emissions from
the source categories were at the maximum levels allowed by the
standards. Additional analyses showed that the cancer incidence and
number of people with cancer risk over 1-in-1 million were low. In
addition, a review of the acute non-cancer exposures showed that none
of these seven source categories posed an appreciable risk of acute
non-cancer health effects. We also determined that HAP emissions from
these source categories were not expected to result in adverse
environmental effects.
---------------------------------------------------------------------------

    \5\ The seven source categories for which we conducted RTR are
Epichlorohydrin Elastomers Production; Polybutadiene Rubber
Production; Styrene Butadiene Rubber and Latex Production; and NBR
Production; Marine Tank Vessel Loading Operations, Pharmaceuticals
Production; and Printing and Publishing. We did not conduct RTR for
four of the Group I Polymers and Resins source categories (Butyl
Rubber Production; Ethylene Propylene Rubber Production; Polysulfide
Rubber Production; and Neoprene), because we previously re-adopted
the existing MACT standard to satisfy section 112(f) of the CAA. See
73 FR 76220, published December 16, 2008. In addition, we did not
conduct RTR for Hypalon\TM\ Production, because there are no longer
any facilities operating in the United States.
---------------------------------------------------------------------------

    To support our decisions regarding acceptability and ample margin
of safety in the proposal, we also conducted risk assessments that
accounted for HAP emissions from entire facilities at which a source
covered by one of the standards under review was located. With the
exception of two facilities with MTVLO on-site that had facility-wide
risks greater than 100-in-1 million, based on the data we had at that
time, we concluded, for purposes of the proposal, that the facility-
wide risk for sources in the four source categories was also relatively
low. As a result of data and information received from commenters on
the proposal, we now project the highest facility-wide risk with MTVLO
on-site is approximately 90-in-1 million.
    Uncertainty and the potential for bias are inherent in all risk
assessments, including those performed for the source categories
addressed in these final rules. Although uncertainty exists, we believe
that our approach, which used conservative tools and assumptions,
ensures that our decisions are health-protective. A discussion of the
uncertainties in the emissions datasets, dispersion modeling,
inhalation exposure estimates, and dose-response relationships is
provided in the preamble to the proposed rule. See 75 FR 65081-65083.

B. What changes did we make to the Group I Polymers and Resins MACT
since proposal?

    We are eliminating the subcategories (i.e., Butyl Rubber and
Halobutyl Rubber) in the Butyl Rubber source category because we agree
with commenters who stated that both facilities in the Butyl Rubber
source category now produce halobutyl rubber as the primary product,
and the technical differences that distinguished the subcategories no
longer exist. The current MACT standards for facilities in this source
category are not affected by the removal of the subcategory distinction
because the existing standards are identical for each subcategory. In
October 2010, we proposed the same standards for both subcategories for
the front-end process operations. However, we proposed different
standards for each subcategory for the back-end process operations.
Considering that both facilities would now be identified as being part
of one source category by primary product determination, it would not
be appropriate to finalize the proposed requirements that were based on
analyses of each facility in its own subcategory. To address the two
facilities together in one Butyl Rubber source category, we re-
evaluated the emissions reductions, costs, and other impacts of
controls for both the back-end operations and the front-end process
vents for these two facilities. For the front-end process vents, we had
proposed beyond-the-floor standards for both the Butyl Rubber
subcategory and the Halobutyl Rubber subcategory, along with the
Ethylene Propylene Rubber source category. Based on our revised
analyses, we are setting requirements for the combined Butyl Rubber
source category at the MACT floor level of control. The requirements
for the Ethylene Propylene Rubber source category are also being set at
the MACT floor level of control. For the back-end process operations,
we had proposed beyond-the-floor standards for the Butyl Rubber
subcategory, and the MACT floor level of control for the Halobutyl
Rubber subcategory. Based on our revised analyses, we are setting
requirements for the combined Butyl Rubber source category at the MACT
floor level of control.
    We are finalizing our proposal to set standards at the MACT floor
level of control for back-end process operations in the Epichlorohydrin
Elastomers, NBR, and Neoprene source categories. However, based on
information we received during the comment period, we have revised some
of the MACT floor limits for these source categories. Information
received for the only facility in the Neoprene Rubber Production source
category corrected the emissions rate of one HAP emissions source, and
we have revised the MACT floor limit for that source category to
reflect the corrected emissions rate. We also received information
during the comment period for the one facility in the NBR source
category, which showed that, due to the different grades of product
produced, the rate of emissions per unit of production varies.
Similarly, the one facility in the Epichlorohydrin Elastomers source
category also expected to have variations in the rate of emissions per
unit of production, based on its different grades of product produced.
Considering this variation in emissions, we increased the limit of the
MACT floor for these source categories to allow for the observed
variability in emissions per unit of production. We also added factors
to account for variation in emissions per unit of production for the
Butyl Rubber and Ethylene Propylene Rubber source categories, based on
information received for the facilities in this source category.

C. What changes did we make to the Marine Tank Vessel Loading
Operations MACT since proposal?

    We proposed the MACT floor as submerged fill for the two
subcategories not previously regulated (facilities emitting less than
10/25 TPY of HAP from MTVLO, and those ``offshore'' facilities located
more than 0.5 miles from shore). Additionally, under the CAA section
112(d)(6) technology review of the existing MTVLO MACT, and as setting
the beyond-the-floor MACT standards for the two subcategories not
previously regulated, we proposed that existing facilities loading 1
million barrels per year (bbl/yr) of gasoline install vapor controls,
either meeting 97-percent control, or the equivalent emission limit of
10 milligrams per liter (mg/l).
    We are finalizing the proposed MACT floor work practice to require
submerged fill of liquids into marine tank vessels at those previously
unregulated sources. However, as a result of information received
during the comment period, we are not finalizing the requirements we
proposed under the technology review requirements of CAA section
112(d)(6), the beyond the floor and technology review requirements for
vapor control technology for facilities loading 1 million bbl/yr.

V. Summary of Significant Comments and Responses

    In the proposed action, we requested public comments on our
residual risk reviews, our technology reviews, proposed amendments to
delete the startup and shutdown exemptions and the malfunction
exemption, the control of unregulated HAP, and clarification of rule
provisions. We received written comments from 104 commenters. Our
responses to the public comments that changed the basis for our
decisions or are otherwise significant are provided below.\6\
---------------------------------------------------------------------------

    \6\ See Summary of Public Comments and Responses for Group I
Polymers and Resins, Marine Tank Vessel Loading Operations,
Pharmaceutical Production, and The Printing and Publishing NESHAP
(March 2011), for summaries of other comments and our responses to
them.
---------------------------------------------------------------------------

A. EPA's Authority Under CAA Section 112

    Comment: We received comments both in favor of and objecting to
EPA's consideration of various factors in determining acceptable risk.
Some commenters argue that the two-step process developed to address
residual risk and determine ``ample margin of safety'' in the Benzene
NESHAP should be preserved. Commenters also request that EPA continue
to use its discretion to determine that a maximum cancer risk of 100-
in-1 million is acceptable. Another commenter supports EPA's commitment
to avoid establishing inflexible decision points for acceptable risks
or ample margin of safety. Commenters also debate whether EPA has the
authority to evaluate, or should, as a matter of policy, evaluate
facility-wide risk, demographic assessments, and risks based on actual
or allowable emissions.
    Response: For the four rules we are finalizing, our evaluation of
facility-wide risk, demographics, and allowable emissions did not
change our decisions about acceptability and ample margin of safety.
Therefore, comments on how these factors were used by EPA in
determining acceptable risks are not germane to these final rules. We
note, however, that section 112(f)(2) of the CAA expressly preserves
our use of the two-step process for developing standards to address
residual risk and interpret ``ample margin of safety'' as developed in
the Benzene NESHAP.\7\ In both the Benzene NESHAP and our

Residual Risk Report \8\ to Congress, we explain that we do not define
``rigid line(s) of acceptability'' and that we will consider a series
of other health measures and factors in determining if risk is
acceptable. Our authority to use the two-step process laid out in the
Benzene NESHAP, and to consider a variety of measures of risk to public
health is discussed more thoroughly in the preamble to the proposal.
See 75 FR 65071-65073.
---------------------------------------------------------------------------

    \7\ See National Emission Standards for Hazardous Air
Pollutants: Benzene Emissions from Maleic Anhydride Plants,
Ethylbenzene/Styrene Plants, Benzene Storage Vessels, Benzene
Equipment Leaks, and Coke By-Product Recovery Plants (Benzene
NESHAP) (54 FR 38044, September 14, 1989).
    \8\ See Residual Risk Report to Congress, EPA-453/R-99-001
(March 1999).
---------------------------------------------------------------------------

    Comment: Some commenters state that our review under CAA section
112(d)(6) should be limited to only advances in work practices and
control technologies, and should not include emission points not
regulated by the existing MACT standard. Expanding rule applicability
should not be considered, as it has nothing to do with developments in
practices, processes, or control technologies and is not indicated in
the CAA as a basis for the technology review. The commenter states that
EPA already made applicability determinations in the original MACT
rules by evaluating the floor and beyond-the-floor options, and nothing
in the CAA warrants review of these determinations. The commenters also
state these changes should only be considered in the CAA section 112(f)
risk review to reduce risks.
    Some commenters stated that a review under CAA section 112(d)(6) is
not required if the post-MACT emissions levels result in risks that are
deemed to be protective of public health with an ample margin of
safety. Furthermore, they stated that EPA should exempt source
categories from CAA section 112(d)(6) review once this level has been
achieved. They add that the review under CAA section 112(d)(6) should
be considered an extension of the main purpose of CAA section 112,
which is to reduce the public's exposure to air toxics, and not to
impose new technology just because it is available. One commenter
states that it was the intent of Congress for the MACT standards to
ultimately reduce risk from sources to a level considered acceptable,
and there is no legislative history to suggest that Congress expected
EPA to revise MACT standards after these levels had been achieved.
    Another commenter states an opposing view, saying that, in keeping
with the context of CAA section 112(d), which requires technology-based
standards that reflect the maximum degree of emission reduction
achievable, CAA section 112(d)(6) serves as an on-going ratchet to
continually require EPA to update standards to keep pace with new
technology. The commenter states that the decision of the Court in the
Hazardous Organic NESHAP (HON) \9\ ruling, while not requiring
recalculation of the floor for that standard, did so only for that MACT
because there were no new developments in practices, processes, or
control technologies, and expressly declined to decide whether EPA was
required to recalculate the floors for other instances where there were
such developments.
---------------------------------------------------------------------------

    \9\ NRDC and LEAN v. EPA, 529 F.3d 1077 (D.C. Cir. 2008).
---------------------------------------------------------------------------

    Response: We note that we do not consider unregulated emission
points under CAA section 112(d)(6). To the extent there are unregulated
emission points, we set standards under CAA sections 112(d)(2) and (3).
We are not revising any of the four MACT rules in this notice pursuant
to the CAA section 112(d)(6) review. Instead, for the newly regulated
emissions points in the Group I Polymers and Resins source categories
and in the Marine Tank Vessel Loading Operations source category we are
promulgating MACT standards under CAA sections 112(d)(2)-(3).
    In our CAA section 112(d)(6) review of pre-existing standards, we
consider both improvements in practices, processes, or control
technologies that we may have previously considered, as well as
practices, processes, or control technologies that are new, or were
unknown to us when the original MACT rule was developed. Because
incremental changes in the practices, processes, or control
technologies can have a significant impact on emissions, these changes
are considered in our analysis of whether to revise the MACT standards
under CAA section 112(d)(6). In considering both existing and new
practices, processes, and control technologies, we consider costs and
other factors in determining whether it is ``necessary'' to revise the
existing standard.
    We disagree with the view that a determination under CAA section
112(f) of an ample margin of safety and no adverse environmental
effects alone will, in all cases, cause us to determine that a revision
is not necessary under CAA section 112(d)(6). In some cases, even if
risk factors remain the same from one round of CAA section 112(d)(6)
review to another, changes in costs or availability of control
technology may be sufficient to alter a previous conclusion about
whether to impose further controls. We also disagree with the assertion
that the HON Court's ruling that CAA section 112(d)(6) does not require
re-calculation of MACT floors was limited to instances in which there
have not been developments in practices, processes, or control
technologies. In fact, the Court was quite clear on this point, and
declined to rule only on whether it was appropriate for EPA to consider
costs and risks in conducting CAA section 112(d)(6) reviews, as the
issue was rendered moot by the litigants' failure to preserve it. See
NRDC v. EPA, 529 F.3d at 1084 (``It has been argued that EPA was
obliged to completely recalculate the maximum achievable control
technology--in other words, to start from scratch. We do not think the
words `review, and revise as necessary' can be construed reasonably as
imposing any such obligation. Even if the statute did impose such an
obligation, petitioners have not identified any post-1994 technological
innovations that EPA has overlooked.'').
    Comment: Commenters state that EPA does not have the authority
under CAA section 112(d)(2) or (3) to later review and possibly revise
the MACT determination once a MACT determination has been made for a
source category. Several commenters state that EPA only has the
authority to revisit the rulemaking if a timely legal challenge to the
standard is lodged. The commenters further note they are not aware of
any instance where EPA has revisited a beyond-the-floor analysis in the
absence of a Court decision, rule vacatur, or settlement agreement.
Commenters also state that reassessing MACT standards and imposing more
stringent requirements would also be inconsistent with Congress's
desire for finality evident in the judicial review provisions of CAA
section 307(b), which provides that challenges to MACT standards must
be raised within 60 days of their promulgation, assuring that regulated
entities, EPA, and the public know what emissions limitations will
apply to a source rather than having those limitations be subject to
flux.
    In contrast, one commenter states that it is appropriate and
essential that EPA establish control for all emissions sources,
including sources that previously had ``no control'' floors, under CAA
section 112(d)(6). The commenter states that EPA should continue to do
this for all MACT standards.
    Response: Under CAA section 112(d)(2), the EPA must promulgate
technology-based standards that reflect the maximum degree of emission
reductions of HAP achievable (after considering cost, energy
requirements, and non-air quality health and environmental impacts).
Nothing in the

CAA or its legislative history suggests that EPA is prohibited from
reviewing and revising MACT standards, except as part of the CAA
section 112(d)(6) or CAA section 112(f) reviews. Where we identify
emission points that were erroneously not previously regulated under a
MACT rule, we may identify MACT floor and beyond-the-floor control
options for existing and new sources. An agency generally remains free
to revise improperly promulgated or otherwise unsupportable rules, even
in the absence of a remand from a Court. United Gas Improvement Co. v.
Callery Props., Inc., 382 U.S. 223, 229 (1966) (``An agency, like a
court, can undo what is wrongfully done by virtue of its order.'');
Macktal v. Chao, 286 F.3d 822, 825-26 (5th Cir. 2002) (``[I]t is
generally accepted that in the absence of a specific statutory
limitation, an administrative agency has the inherent authority to
reconsider its decisions.''). Agencies have particularly broad
authority to revise their regulations to correct their errors. Last
Best Beef, LLC v. Dudas, 506 F.3d 333, 340 (4th Cir. 2007); Friends of
the Boundary Water Wilderness v. Bosworth, 437 F.3d 815, 823 (8th Cir.
2006) (``It is widely accepted that an agency may, on its own
initiative, reconsider its interim or even final decisions, regardless
of whether the applicable statute and agency regulations expressly
provide for such review.'') (citations omitted). Moreover, an agency
may reconsider its methodologies and application of its statutory
requirements and may even completely reverse course, regardless of
whether a court has determined that its original regulation is flawed,
so long as the agency explains its bases for doing so. Motor Vehicle
Mfrs. Ass'n v. State Farm Mutual Auto Ins. Co., 463 U.S. 29, 42 (1983);
FCC v. Fox Television Stations, Inc., 129 S. Ct. 1800, 1810 (2009);
Nat'l Cable & Telecomms. Ass'n v. Brand X Internet Servs., 545 U.S.
967, 981-82 (2005) (internal citations omitted): (``'An initial agency
interpretation is not instantly carved in stone. On the contrary, the
agency * * * must consider varying interpretations and the wisdom of
its policy on a continuing basis,' Chevron, supra at 863-864[], for
example, in response to changed factual circumstances, or a change in
administration. That is, no doubt, why in Chevron itself, this Court
deferred to an agency interpretation that was a recent reversal of
agency policy.'')
    Here, both the Polymers and Resins I and the Marine Tank Vessel
Loading Operations NESHAP, as originally promulgated, did not contain
MACT standards for certain significant HAP emissions points, and, we
are, therefore, appropriately promulgating standards for those
emissions points under CAA sections 112(d)(2)-(3) for the first time.
CAA section 112(d)(6) and CAA section 112(f)(2) do not govern the
initial establishment of the MACT standards. This approach is
consistent with other recent actions that establish MACT standards for
the first time for significant emissions points that had not been
previously addressed by CAA section 112 (d) standards. See, e.g.,
National Emission Standards for Hazardous Air Pollutants from Petroleum
Refineries; Final Rule, 74 FR 55670, 556773-74 (October 28, 2009).

B. Group 1 Polymers and Resins

    Comment: One commenter states that, due to changes made at a
facility since MACT promulgation, the facility would no longer fall
into the Butyl Rubber subcategory, based on the primary product made,
and would be in the Halobutyl Rubber subcategory. (The Butyl Rubber and
Halobutyl Rubber subcategories comprise the Butyl Rubber source
category.) However, the unit at this facility that produces halobutyl
rubber as the primary product is a flexible operations unit that
produces three major products, one of which is still butyl rubber, and,
therefore, emits significantly different emissions from the only other
halobutyl rubber facility in the United States, which produces
halobutyl rubber exclusively. Commenters recommend EPA revise the Butyl
Rubber source category descriptions to distinguish between halobutyl
rubber-only and flexible units, and to apply primary product
determinations only at the category level, and not the subcategory
level. The commenters further state that, if these facilities are not
separated into different subcategories and are both included in the
Halobutyl Rubber subcategory, the current proposal and supporting
analyses will not be applicable, and new analyses and proposal will be
needed.
    Response: Currently there are only two facilities in the United
States that produce either butyl or halobutyl rubber. Since one of
these facilities can produce both butyl rubber and halobutyl rubber,
and since halobutyl rubber is the primary product for both of these
facilities, we have concluded that there is no longer a need to
maintain the subcategory distinction in the Butyl Rubber source
category in the current MACT standards. Therefore, we have removed the
subcategories of Halobutyl Rubber and Butyl Rubber in the Butyl Rubber
source category, and both facilities that were in these subcategories
will now be included in the Butyl Rubber source category. The Group I
Polymers and Resins MACT standards create separate source categories or
subcategories by requiring different standards for different types of
primary products. In the final rule, we have removed the language that
distinguishes halobutyl rubber as a separate product type, which has
the effect of removing the subcategories from the Butyl Rubber source
category. While the existing MACT standards have identical requirements
for the Butyl and Halobutyl Rubber subcategories, we proposed different
requirements for these subcategories for back-end process operations,
and common requirements for the front-end process vents at proposal.
    With the removal of the subcategory distinction, we have revised
our analyses of the emissions reductions, costs, and other impacts of
controls for both the front-end and back-end process operations for
these two facilities. Based on these analyses, we determined that the
beyond-the-floor standards for front-end process operations that were
proposed separately for both the Butyl Rubber and Halobutyl Rubber
subcategories, which are a 98-percent reduction in organic HAP, and a
99-percent reduction in hydrogen halides and halogens, are not cost-
effective for the Butyl Rubber source category. We are setting
requirements for the combined front-end process operations for the
Butyl Rubber source category at the MACT floor level of control. For
the back-end process operations, we proposed beyond-the-floor standards
for the Butyl Rubber subcategory, and the MACT floor level of control
for the Halobutyl Rubber subcategory. Based on our revised analyses,
the beyond-the-floor level of control, which is a 98-percent reduction
in organic HAP, is not cost-effective for the Butyl Rubber source
category. We are setting requirements for the combined back-end process
operations for the Butyl Rubber source category at the MACT floor level
of control. The current MACT standards are not affected by the removal
of the subcategory distinction because the existing standards are
identical for each subcategory.
    Comment: One commenter stated that, if a facility was subject to
MACT standards limiting HCl emissions from its front-end process vents
in the Butyl Rubber source category and the Ethylene Propylene Rubber
source category, then it would be unacceptable business practice to
route those emissions to the proposed shared control device. A shared
control device

would limit operating flexibility, cause lost business due to shutdown
of both units for expected maintenance of thermal oxidizers and halogen
scrubbers, and the potential for lost business, excess emissions, and
dual violations from both units from unplanned shutdowns. The commenter
states that EPA, therefore, needs to consider separate controls for
each unit, a spare thermal oxidizer and halogen scrubber, or the
significant lost business and other costs and emission impacts of
having a shared control device in the beyond-the-floor costs analysis
for the proposed control. The commenter estimates that the costs for
the units to be controlled separately are $20,600/ton HCl emissions
reduced for the unit in the Butyl Rubber source category (note that the
commenter refers to this as the halobutyl rubber unit, since that is
the product being produced), and $51,000/ton HCl emissions reduced for
the unit in the Ethylene Propylene Rubber source category. Commenters
also stated that the proposed beyond-the-floor MACT standards to
control front-end process vents in the Butyl Rubber and Ethylene
Propylene Rubber source categories are not cost-effective and should
not be finalized. One commenter provided data showing costs to range
from $16,900/ton of HAP emissions reduced to $80,100/ton of HAP
emissions reduced to meet the proposed front-end process vent MACT
standards.
    Response: We disagree with the claim that the CAA precludes our
taking note of the co-location of these units in estimating the costs
to control the HCl from these units. Nevertheless, based on information
received during the comment period, we recalculated separate source
category cost estimates for control of HCl from ethylene propylene
rubber and butyl rubber units for the one facility where these units
are co-located. The changes from the estimate at proposal primarily
include using a recuperative thermal oxidizer rather than a direct
flame incinerator, and including additional ductwork and pumps needed
to convey emissions to the control devices. We estimate that,
considered separately, the cost to control the ethylene propylene
rubber front-end process vents would be approximately $19,000/ton HCl
emissions reduced, and the cost to control the butyl rubber front-end
process vents would be approximately $12,000/ton HCl emission reduced.
    Comment: Commenters state that the proposed beyond-the-floor MACT
standards to control the back-end process vents in the Butyl Rubber
source category are not cost-effective, and should not be finalized.
One commenter provided data showing costs to range from $72,300/ton of
HAP emissions reduced to $75,600/ton of HAP emissions reduced to meet
the proposed back-end process vent MACT standards.
    Response: With the removal of the subcategory distinction, we
revised our analyses of the emissions reductions, costs, and other
impacts of the beyond-the-floor option identified at proposal. This
beyond-the-floor option would require the ducting of emissions from the
uncontrolled back-end process operations to a control device for the
two facilities now in the Butyl Rubber source category. In this revised
analysis, we considered information provided during the comment period
regarding the types of oxidizers and ducting equipment that would be
needed for the facilities in this source category for the beyond-the-
floor control option, as well as the provided information on process
flow rates. From the revised analysis, we estimate that thermal
oxidizers would achieve an emissions reduction of 98 percent, resulting
in a decrease in hexane emissions of approximately 66 TPY. The capital
costs of this option are estimated to be approximately $3.5 million,
total annual costs are estimated to be approximately $1.5 million, and
the cost-effectiveness values would be approximately $23,000 per ton of
HAP emissions reduced. We believe the costs of this beyond-the-floor
option are not reasonable, given the level of emission reduction.
Therefore, we are finalizing the MACT floor level of emissions. We have
determined that the MACT floor level of control for the source category
is a production-based limit reflecting each source's organic HAP
emissions divided by its total elastomer product leaving the stripper
in 2009, multiplied by a variability factor of 1.35. In establishing
the floor-level limit, the variability factor was included to account
for the historic variability in the amount of emissions per unit of
production at these facilities.
    Comment: Commenters noted that the emissions from back-end process
operations for facilities in the Epichlorohydrin Elastomers, NBR, and
Butyl Rubber source categories, and HCl emissions from front-end
process operations in the Ethylene Propylene Rubber and Butyl Rubber
source categories will vary only by the mass of polymer product
produced, because there is only one facility in each source category.
The commenters note that the proposed MACT standards were based on
emissions data and associated production levels for certain years.
These commenters state that it is not appropriate to set the standards
in this way, as it does not allow for variability in the manufacturing
process, or the potential for the production of different product mixes
and volumes in the future. One commenter suggests using 2008 emissions,
and, perhaps, other recent years of data in setting the limits. Another
commenter suggests that EPA look at the statistical variation over
time, and, if EPA revisits the current subcategorization scheme within
the Butyl Rubber source category, then EPA should also consider
variability in source design and operation. The commenter also notes
that, over the last 10 years, emissions from back-end process vents
varied by up to 43 percent from their levels in 2006 due to factors
such as weather conditions, grade slate changes (such as product grade
or slight variations in product type), and process and control device
reliability/service. Both commenters submitted additional emissions
data for EPA's consideration.
    Response: We have adjusted the emissions limits in the final rule
to better account for process variability and other factors for the
front-end process vent MACT limits in the Butyl Rubber and Ethylene
Propylene Rubber source categories and the back-end MACT limits for the
Butyl Rubber, Epichlorohydrin Elastomers, and NBR source
categories.\10\ For the Butyl Rubber source category, up to 10 years of
annual emissions and annual production data were submitted for the two
facilities in the source category. These data showed that the emissions
per unit production varied up to 74 percent higher for HCl from front-
end process vents than that reported in 2010, and varied up to 35
percent higher for back-end process vents than that reported for 2009.
To account for this variability, we included a variability factor of 74
percent over the HCl emissions per unit production in 2010 in the
front-end process operations limit, and a variability factor of 35
percent over the emissions per unit production in 2009 in the back-end
process operations limit for this source category. For the Ethylene
Propylene Rubber source category, historical annual emissions and
annual production data were submitted for the one affected facility in
the source category. These data showed that the emissions per unit
production varied up to 39 percent higher for HCl from front-end
process vents than reported in 2010. To account for this variability,
we included a variability factor of 39 percent over the HCl emissions
per unit production in 2010 in the front-end

process operations limit. Similarly, for the NBR source category,
historical annual emissions and production data were submitted after
the comment period for the one facility in the source category. While
this facility recently installed emissions control systems beyond those
required to meet the current MACT requirements, after these control
were in place, the data showed that emissions per unit production
varied up to 42 percent higher than that reported for 2009. To account
for this variability, we included a variability factor of 42 percent
over the emissions per unit production in 2009 in the back-end process
operations limit for this source category. For the Epichlorohydrin
Elastomers source category, historical annual emissions indicative of
the expected variation of emissions was unavailable. Due to the
similarities between the NBR and Epichlorohydrin Elastomers facilities
in the equipment used, and how they operate their back-end processes,
however, the same 42-percent variability factor was applied to the
emissions per unit production in 2009 in the back-end process
operations limit.
---------------------------------------------------------------------------

    \10\ See Regulatory Alternative Impacts for Group I Polymers and
Resins (March 2011) in the docket.
---------------------------------------------------------------------------

    Comment: Commenters stated that EPA should provide an allowance for
maintenance of any thermal oxidizer required to be installed. One
commenter notes that a regenerative thermal oxidizer (RTO) requires
maintenance that sometimes necessitates that the RTO be bypassed. The
commenter notes that back-end process vents at existing sources in the
Butyl Rubber source category are currently permitted to allow bypass
emissions during maintenance work on the control device up to the
permitted limit with the use of purchased Emission Reduction Credits in
Texas, and an allowance for bypass emissions is included in the unit
operating permit in Louisiana. The commenter suggests that the MACT
standards for the back-end process vents should recognize that
bypassing currently occurs for RTO-controlled emissions, and allow for
it in the MACT standards.
    Response: We recognize that bypassing currently occurs. However,
the Court has made clear that MACT standards must apply at all times.
See Sierra Club v. EPA, 551 F.3d 1019 (D.C. Cir. 2008), cert. denied,
130 S. Ct. 1735 (U.S. 2010). The emission limits we are finalizing for
the back-end process operations are in the format of a 12-month rolling
average, and, therefore, facilities may bypass only provided that they
are in continuous compliance with the standards.
    Comment: Commenters requested that EPA clarify the definition of
back-end processes specifically to exclude operations that have
essentially no HAP emission potential, such as handling and storage of
finished products. They stated that it would also be helpful for the
Agency to clarify that surge control vessels, equipment leaks, storage
vessels, and wastewater, which are regulated by the Group I Polymers
and Resins MACT, are not included in the definition of back-end
processes.
    Response: We agree with the commenters that the proposed definition
of back-end processes was unclear, and that surge control vessels,
equipment leaks, storage vessels, and wastewater are regulated in the
existing Group I Polymers and Resins MACT standards, and that handling
and storage of finished products is not part of the back-end process
operations. We have revised the language in the final rule accordingly.
    Comment: Commenters request clarification that, in the absence of
allowing 4 years for compliance, the first compliance demonstration
would be 24 months after the publication date for emission limits,
based on a 12-month rolling average. This would allow for data
collection to begin in the first month after the compliance date (13th
month after promulgation) and provide for 1 year of data to be used in
the compliance demonstration. One commenter requested that compliance
not be determined on less than a 12-month basis, because this would
limit the variability allowed for in the rolling 12-month limit.
    Response: We agree with the commenter that compliance should be
determined on a 12-month basis. The first time 12 months of data will
be available will be in the 13th month after the compliance date, which
is the 25th month after the publication date. To demonstrate
compliance, the 12-month rolling average information must be included
in the first periodic report that occurs after 12 months of data have
been collected. We have clarified the timing of the compliance
demonstration in the final rule language.

C. Marine Tank Vessel Loading Operations

    Comment: Commenters stated that there were errors in the 2005
National Emissions Inventory (NEI) data set, and that EPA significantly
overestimated the MIR for the MTVLO source category for each of these
facilities due to data errors.
    Response: At proposal, we found that the current MACT-based
standards both provide an ample margin of safety to protect public
health and prevent adverse environmental effects, and, therefore, did
not make any changes to the existing standards due to the risk
analysis. We found that three facilities had MIR greater than 1-in-1
million (values of 10-, 20-, and 20-in-1 million) for the MTVLO source
category. We identified two facilities with facility-wide MIR greater
than 100-in-1 million (each with values of 200). Using new data
obtained since proposal, we corrected the errors noted by the
commenters for both MTVLO emission sources and other emission sources
at the facilities. We found incorrect latitudes and longitudes for some
emission sources, incorrect emissions reported for some sources, or
incorrectly identified HAP. We updated the 2005 NEI data sets for each
facility with corrected data, and conducted a reanalysis of the risk
using the corrected data set. The revised risk assessment results show
no facilities with MTVLO have a facility-wide risk of greater than 100-
in-1 million.\11\ Based on 2005 emissions data, MTVLO source category
emissions from one facility result in a MIR of 50-in-1 million (20
percent from benzene and 80 percent from butadiene), however, this
facility reports in its public comments an 89- percent reduction in
benzene emissions and a 97-percent reduction in butadiene emissions
between years 2006 and 2009. Based on this information, the revised MIR
associated with actual MTVLO emissions from this facility is less than
1-in-1 million.\12\ No other facility has MTVLO emissions resulting in
a MIR greater than 1-in-1 million. The corrections to the emission data
files and risk results are included in memoranda in the docket.
---------------------------------------------------------------------------

    \11\ Of the two facilities with MTVLO that previously showed
facility-wide risks exceeding 100-in-1 million, the revised risk
assessment results show one facility has facility-wide risks of 70-
in-1 million, and the other has facility-wide risks of 40-in-1
million.
    \12\ For this facility, reported actual and allowable emission
are the same; therefore, the MIR is the same for both.
---------------------------------------------------------------------------

    Comment: One commenter noted that it is not clear whether offshore
loading terminals at refineries would be exempt from proposed changes
to MTVLO MACT. The commenter recommended rule text changes for 40 CFR
63.560(d)(6). The commenter noted that their facility may be one of the
few (or only) offshore loading terminals in the United States, meaning
the cost analysis and controls selected for this subcategory by the
MTVLO MACT proposal are likely to set a precedent in the Refinery RTR
rule process.

    Response: We have considered the comment and agree that the
proposed rule was not clear. Therefore, this final rule clarifies
applicability for petroleum refineries.
    Comment: Three commenters supported submerged fill requirements.
One commenter supported the requirement for submerged fill for
previously-exempt subcategories, and stated that submerged fill is
cost-effective. One commenter agreed with EPA's decision to establish
submerged fill as the MACT floor. The Commenter noted that submerged
fill, as defined by the Coast Guard, has been standard industry
practice for some time, reduces HAP emissions, and eliminates static
electricity from free-falling cargo, thereby enhancing operational
safety. One commenter suggested that if additional control is needed, a
work practice standard (submerged fill) should be adopted for the
offshore loading subcategory instead of 99-percent efficient vapor
control systems.
    Response: The commenters agree with the proposal to require
submerged fill as the floor level of control for the two subcategories
not previously regulated (those facilities emitting less than 10/25 TPY
of HAP from MTVLO, and those facilities located more than 0.5 miles
from shore). We have included the submerged fill requirement in the
final rule.
    Comment: One commenter noted the discussion in the preamble is
confusing concerning whether the proposed 1 million bbl/yr threshold is
a MACT measure, or a reasonably available control technology (RACT)
measure. The preamble states that the existing MACT standards require
vapor recovery control for at least 10 million bbl/yr of gasoline,
however, this provision is in the RACT provisions of the existing rule.
Furthermore, the commenter asserts that the proposal preamble justifies
the proposed new 1 million bbl/yr threshold on a volatile organic
compounds (VOC) RACT basis rather than a HAP (MACT) basis, and
describes the lower threshold as a beyond-the-floor MACT measure for
the two previously-exempt subcategories. In addition, the commenter
noted that the throughput threshold for a major source is 5 million
bbl/yr, and asked how a facility only loading 1 million bbl/yr could be
considered a major source, and subject to MACT. The commenter stated
that the preamble discussion should be consistent with both the basis
presented for justification of this measure, and the language of the
rule.
    Response: The proposed and final rules only pertain to the MACT
requirements in the rule that address major sources of HAP; no changes
were proposed for the RACT requirements.\13\ While the commenter noted
that a particular throughput would be required to define a major source
of HAP, the throughput levels for MTVLO were not defined with the
intent of identifying a major source. Applicability for the current
rule is two-fold: (1) Is the facility, as a whole, a major source of
HAP; and (2) does the facility conduct MTVLO.
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    \13\ RACT and MACT requirements are both included in 40 CFR part
63, subpart Y--National Emission Standards of Marine Tank Vessel
Loading Operations.
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    We agree that the discussion in the proposed preamble regarding the
gasoline throughput thresholds used to analyze the proposed 1 million
bbl/yr gasoline threshold was not clear (75 FR 65115). As discussed
below, we have not included a requirement for MTVLO facilities with a
throughput of 1 million bbl/yr of gasoline to install and operate vapor
recovery controls in the final rule.
    Comment: Two commenters stated that EPA's cost-effectiveness
determination for the beyond-the-floor MACT is flawed/not accurate, and
noted concerns that the cost analysis is based on information from one
vendor, for one control technology, for a single facility, and assumed
installation costs. One commenter stated that EPA's cost information
was limited. One commenter indicated that beyond-the-floor MACT options
must be cost-effective in reducing HAP, and since EPA's estimated cost
was $74,000/ton HAP emissions reduced, it is not cost-effective, and,
thus, illegal to promulgate this requirement as a MACT measure. The
commenter stated that the real cost, based on corrected values of HAP
content, would be $180,000/ton HAP emissions reduced. The commenter
requested that EPA rescind the proposed action.
    Commenters stated that the EPA does not have the authority to
consider non-HAP emission reductions in conducting a review of existing
MACT standards under CAA section 112(d). The commenters noted that, in
setting MACT standards, the CAA expressly forbids EPA from considering
the co-benefits of non-HAP emissions reductions, and the MACT floor
must be based on the HAP emission reductions achieved; any beyond-the-
floor standard may be based only on consideration of the cost of
achieving HAP emission reductions, and any non-air quality health and
environmental impacts and energy requirements.
    Response: As discussed earlier, we established and proposed the
MACT floor as submerged fill for the two subcategories not previously
regulated (facilities emitting less than 10/25 TPY of HAP from MTVLO,
and those ``offshore'' facilities located more than 0.5 miles from
shore). Additionally, under the CAA section 112(d)(6) technology review
of the existing MTVLO MACT, and as setting the beyond-the-floor MACT
standards for the two subcategories not previously regulated, we
proposed that existing facilities loading 1 million bbl/yr of gasoline,
install vapor controls either meeting 97-percent control, or the
equivalent emission limit of 10 mg/l (10 milligrams of total organic
compound emissions per liter of gasoline loaded). At proposal, we
estimated the cost and emissions reductions for installing vapor
controls for facilities loading 1 million bbl/yr of gasoline, and we
estimated a cost of $74,000/ton HAP emissions reduction (190 TPY HAP
emissions reduction) and $5,500/ton VOC emissions reduction (2,600 TPY
VOC emissions reduction).
    As discussed in the cost section of the response to comment and the
cost memoranda in the docket, we received and considered the comments
on the control costs, emission rate differences for ships and barges,
additional costs for offshore facilities, and the HAP content in
gasoline. All those factors change the cost-effectiveness calculations.
Based on information received as part of the comments, we reevaluated
the costs used at proposal. The revised costs and emissions for the
proposed threshold of 1 million bbl/yr gasoline are as high as $500,000
per ton of HAP emissions reduced (1.9 tons of HAP reduced annually per
facility) for loading ships offshore. Looking at a less stringent
threshold for the final rule of 7 million bbl/yr of gasoline loaded
would likely achieve little or no HAP or VOC emission reductions, since
many facilities near that threshold were required to install controls
under the current rule. We agree with commenters that these costs are
unreasonable. Therefore, we are not including the proposed vapor
controls for loading 1 million bbl/yr of gasoline requirement in the
final rule. We disagree with the commenter that we cannot consider VOC
benefits, but, given that we are not requiring these additional vapor
controls for HAP, the issue is now moot.
    Comment: One commenter stated that VOC and HAP emission rates from
ships and barges at their facility are lower than EPA uses in its cost-
effectiveness determinations. EPA used the uncontrolled gasoline
loading emissions factor for barges (3.4 pounds (lb) VOC/1,000 gallons
(gal) loaded), but should

use the emissions factor for ocean-going ships and barges (1.8 lb VOC/
1,000 gal loaded); AP-42 notes in Chapter 5 that vapor saturation is
much lower in ship and barge loading.
    Response: We agree with the commenter that the emission factors for
ships and barges, as applicable to the type of marine vessel being
loaded, should be considered for estimating VOC and HAP emissions. We
have revised the emission estimates using the barge and ship emission
factors from AP-42.
    Comment: One commenter noted that HAP content in the vapor phase is
3.0 percent, and not the 7.3 percent determined by EPA in the proposal.
The commenter provided the analysis showing the calculations, based on
conventional gasoline, where the commenter assumed no methyl tertiary
butyl ether (MTBE) in the gasoline; no change to the total partial
pressure; and benzene concentration of 1.8 percent. Another commenter
stated the HAP emissions factor is approximately 50 percent of the EPA
factor.
    Response: In the proposal, we determined that the HAP content in
the vapor phase of gasoline of 7.3 percent (based on 2006 gasoline
composition) was appropriate, and used 7.3 percent in our emissions
estimates for gasoline loading at MTVLO. We reviewed and considered the
data provided by the commenter, and reviewed HAP content information
from several other sources that have more recent gasoline composition
data. We conducted a reanalysis of the HAP content, looking at both
conventional and reformulated gasoline, considering the phase-out of
MTBE and the requirements for reduced benzene content. Based on the
revised analysis, we concluded that a good typical value for HAP
content in the vapor is 5.0 percent. The revised analysis of HAP
content in gasoline is in a memorandum in the docket.
    Comment: Commenters argued that lean oil absorption technology is
not capable of meeting the rule efficiency, is not in common use for
MTVLO, and must be demonstrated as an effective technology for MTVLO.
One commenter cited an instance where lean oil absorption installed on
MTVLO was unable to meet control requirements in their permit. The
commenter stated that lean oil absorption is typically used in smaller
applications. Commenters stated that EPA must provide actual
performance data for lean oil absorption technology in the MTVLO source
category.
    Response: Lean oil absorption systems are not new control
technologies for MTVLO. Lean oil absorption was discussed as a vapor
recovery device, in addition to refrigeration (condenser) systems and
carbon adsorption systems, for marine vessel loading in the 1987
National Research Council, Committee on Control and Recovery of
Hydrocarbons Vapors from Ships and Barges report, Controlling
Hydrocarbon Emissions from Tank Vessel Loading. Lean oil absorption
also was discussed in the 1992 proposal, Technical Support Document for
MTVLO (EPA-450/3-92-001a), and has been installed as vapor recovery
devices for MTVLO. While we have not selected a beyond-the-floor option
as MACT, we would like to clarify that lean oil absorption systems were
included in the cost analysis for the beyond-the-floor option, because
lean oil absorption systems achieving an emission reduction efficiency
of 97 percent are used by at least one MTVLO facility, and because the
units are a relatively less expensive control technology option that
has the added benefit of recovered product.

D. Startup, Shutdown, and Malfunction (SSM) Requirements

    Comment: Two commenters state that EPA offers little support for
the assertion that it is reasonable to interpret CAA section 112 as not
requiring EPA to account for malfunctions in setting emissions
standards, or that malfunctions are not a distinct operating mode. The
commenters state that it does not make sense for EPA to assert that
malfunctions are part of normal operations, but then exclude emissions
from these parts of normal operations in the determination of the
emissions limits. The commenters state that, due to the unplanned
nature and variety of potential malfunctions, it would be difficult, if
not impossible, for EPA to gather data and set an emissions standard
for periods of malfunction. Due to these difficulties, the commenters
suggest that, under the authority of CAA section 112(h), EPA prescribe
alternative design, equipment, work practice, or operational standards
where it is not feasible to set or enforce a numerical emissions limit.
The commenters add that there are work practices that can be identified
as being the best to minimize emissions during a malfunction, and EPA
must acknowledge the fact that even the best-performing sources
experience malfunction events.
    Response: 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 CAA section 112,
emissions 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 CAA 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 EPA accounts for
variability in setting emissions standards consistent with the CAA
section 112 case law, nothing in that case law requires the Agency to
consider malfunctions as part of that analysis.
    CAA section 112 uses the concept of ``best controlled'' and ``best
performing'' unit in defining the level of stringency that CAA 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. 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 (D.C. 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 (D.C. 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. EPA's approach
to malfunctions is consistent with CAA section 112, and is a reasonable
interpretation of the statute.
    Comment: Several commenters argued that emissions limits should not
apply during SSM events, while other commenters stated that SSM
emissions should be included in calculations of emissions and
standards. Commenters suggested that requiring continuous compliance
during periods of SSM constitutes beyond-the-floor requirements, and
the Agency should have to justify this more stringent level of control,
because facilities would need to install redundant control systems and
bypass systems. They further stated that, in order to assure that SSM
are appropriately accommodated, EPA must either assure that the data on
which the standard is based include representative data from such
periods, or, alternatively, set a separate work practice standard to
properly accommodate SSM, and they cited case law supporting
establishment of special SSM provisions. Further, several commenters
stated that compliance with emissions standards during malfunction
events will be difficult to gauge since emissions testing during such
events is nearly impossible, given the sporadic and unpredictable
nature of malfunctions. The commenters contended that the rules could
have the effect of forcing units to choose between safety and
compliance with emissions requirements. The commenters stated that, for
some affected units, malfunctions, by their very nature, create unsafe
conditions which can lead to excessive combustible mixtures that can
result in explosions, equipment damage, and personnel hazards.
Commenters also noted that some of the MACT standards included in this
action did not rely exclusively upon the General Provisions, and, thus,
were not immediately affected by the Court's vacatur of the SSM
exemptions in the General Provisions. The commenters pointed out that,
given that these categories were not immediately affected, EPA is not
compelled to remove the exemptions that are established within these
individual category-specific MACT standards.
    Other commenters expressed support for requiring continuous
compliance with the MACT standards, including periods of SSM. They
noted that malfunctions are also preventable, and, thus, there should
be no relief from the standards during these events.
    Response: At this time, we are not promulgating separate emission
standards for periods of startup and shutdown for three of the four
categories addressed in this rule, because we believe compliance with
the standards is achievable during these periods. In the case of the
Pharmaceuticals Production MACT standards, we expect the difference in
emission levels during periods of startup and shutdown are
insignificant, and that facilities in this source category should be
able to comply with the standards during these times. In the case of
the Printing and Publishing MACT standards, we believe there are
sufficiently long averaging times incorporated into the emissions
limits that facilities should be able to comply during periods of
startup and shutdown. In the case of MTVLO, loading of marine tank
vessels occurs in ``batches,'' and general practice is for the loading
operators to test out the vapor control system before it is attached to
the tank vessel. In the case of Group I Polymers and Resins, one
commenter stated that organic HAP emissions that are required to be
sent to emissions control equipment (i.e., flares) may not be able to
comply with the MACT standards during periods of shutdown. The
commenter stated that they may not always be able to route some of
their process vents to a flare during periods of shutdown due to low
pressure or low heat content in the process vent. EPA agrees with the
commenter that it is not possible to comply with the applicable
standard during periods of shutdown, and is establishing alternative
emissions standards that apply during these periods.
    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 equipment,
process equipment, or a process to operate in a normal or usual manner
* * *'' (40 CFR 60.2). EPA has determined that malfunctions should not
be viewed as a distinct operating mode, and, therefore, any emissions
that occur at such times do not need to be factored into development of
CAA section 112 standards, which, once promulgated, apply at all times.
Also refer to section III.E of this preamble, and the response to
comments document available in the docket for this action for
additional discussion of this issue.
    Comment: Commenters on the Group I Polymers and Resins MACT
disagreed with EPA's statement that the proposed rules will reduce the
reporting burden associated with having to prepare and submit an SSM
report. The commenters also state that the claims EPA makes that EPA is
not proposing any new paperwork requirements is false if a facility
wants to claim an affirmative defense. The affirmative defense
provision contains much more onerous reporting and implied
recordkeeping requirements than the existing rules. The commenters
state that EPA needs to account for the information collection burden
associated with affirmative defense in the Information Collection
Request (ICR) for the SSM portion of the Group I Polymers and Resins
MACT, and otherwise comply with the Paperwork Reduction Act.
    Response: As discussed in section VII.B of this preamble, EPA is
providing the public with an estimate of the relative magnitude of the
burden associated with an assertion of the affirmative defense position
adopted by a source, and is providing administrative adjustments to the
ICR for the MACT standards subject to these final rules that show what
the notification, recordkeeping, and reporting requirements associated
with the assertion of the affirmative defense might entail.
    Comment: Two commenters note that, in making changes to the rules
to exclude the SSM exemption and add the general duty clause to the
MACT standards, three of the six MACT standards in the proposal include
the statement that ``the general duty to minimize emissions does not
require the owner or operator to make any further efforts to reduce
emissions if levels required by this standard have been achieved,'' but
the other three do not (i.e., Group I Polymers and Resins, MTLVO, and
Printing and Publishing Industry MACT standards). The commenters state
that this clarifying language should be included in all six standards.
    Response: We agree that this language should be included in each of
the six MACT standards, and we have added this clarifying language to
40 CFR 63.823(b) in the Printing and Publishing Industry MACT standards
and 40 CFR 63.562(e) in the MTVLO MACT standards. However, we find that
40 CFR 63.483 in the Group 1 Polymers and Resins MACT standards already
includes this language, and we have not revised the proposed language.

VI. Impacts of the Final Rules

    The final changes to the Group I Polymers and Resins, MTVLO,
Pharmaceuticals Production, and the Printing and Publishing Industry
MACT standards are not estimated to have any significant emission
reductions, costs, or other impacts.

VII. Statutory and Executive Order Reviews

A. Executive Orders 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, 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 information collection requirements in the final rules have
been submitted for approval to OMB under the Paperwork Reduction Act,
44 U.S.C. 3501, et seq. The information collection requirements are not
enforceable until OMB approves them.
    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 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.
    These final rules would require maintenance inspections of the
control devices, but would not require any notifications or reports
beyond those required by the General Provisions. The recordkeeping
requirements require only the specific information needed to determine
compliance.
    When a malfunction occurs, sources must report them according to
the applicable reporting requirements of 40 CFR part 63, subparts U, Y,
KK, and GGG. An affirmative defense to civil penalties for exceedances
of emission limits that are caused by malfunctions is available to a
source if it can demonstrate that certain criteria and requirements are
satisfied. The criteria ensure that the affirmative defense is
available only where the event that causes an exceedance of the
emission limit meets the narrow definition of malfunction in 40 CFR
63.2 (sudden, infrequent, not reasonable preventable, and not caused by