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, 22566-22602 [2011-8168]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 76, Number 77 (Thursday, April 21, 2011)]
[Rules and Regulations]
[Pages 22566-22602]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-8168]



[[Page 22565]]

Vol. 76

Thursday,

No. 77

April 21, 2011

Part III





Environmental Protection Agency





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



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

[[Page 22566]]


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

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.

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

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 
https://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 https://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 (202) 566-1744, and the telephone number for the Air and Radiation 
Docket and Information Center is (202) 566-1742.

FOR FURTHER INFORMATION CONTACT: For questions about this final action, 
contact 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: (919) 541-4516; fax 
number: (919) 685-3219; and e-mail address: kissell.mary@epa.gov. 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: (919) 541-0840; and e-mail address: 
manning.elaine@epa.gov. 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\
------------------------------------------------------------------------
Group I Polymers and Resins.  Marcia Mia (202) 564- Nick Parsons, (919)
                               7042,                 541-5372,
                               mia.marcia@epa.gov.   parsons.nick@epa.gov.
Marine Tank Vessel Loading    Maria Malave, (202)   Steve Shedd, (919)
 Operations.                   564-7027,             541-5397,
                               malave.maria@epa.go   shedd.steve@epa.gov
                               v.                    .
Pharmaceuticals Production..  Marcia Mia, (202)     Nick Parsons, (919)
                               564-7042,             541-5372,
                               mia.marcia@epa.gov.   parsons.nick@epa.gov.
The Printing and Publishing   Rafael Sanchez,       David Salman, (919)
 Industry.                     (202) 564-7028,       541-5402,
                               sanchez.rafael@epa.   salman.dave@epa.gov
                               gov.                  .
------------------------------------------------------------------------
\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

[[Page 22567]]

available in Docket ID No. EPA-HQ-OAR-2010-0600.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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: https://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 https://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

[[Page 22568]]

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

[[Page 22569]]

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\
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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

[[Page 22570]]

[GRAPHIC] [TIFF OMITTED] TR21AP11.001

BILLING CODE 6560-50-C

[[Page 22571]]

    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

[[Page 22572]]

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\
---------------------------------------------------------------------------

    \4\ 46 CFR 153.282.
---------------------------------------------------------------------------

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

[[Page 22573]]

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

[[Page 22574]]

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 
https://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 https://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 
https://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).

[[Page 22575]]

    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.

[[Page 22576]]

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 
long