National Emissions Standards for Hazardous Air Pollutants Residual Risk and Technology Review for Flexible Polyurethane Foam Production, 66107-66138 [2013-24276]
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Vol. 78
Monday,
No. 213
November 4, 2013
Part II
Environmental Protection Agency
EMCDONALD on DSK67QTVN1PROD with PROPOSALS2
40 CFR Part 63
National Emissions Standards for Hazardous Air Pollutants Residual Risk
and Technology Review for Flexible Polyurethane Foam Production;
Proposed Rule
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ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 63
[EPA–HQ–OAR–2012–0510; FRL–9900–94–
OAR]
RIN 2060–AR58
National Emissions Standards for
Hazardous Air Pollutants Residual
Risk and Technology Review for
Flexible Polyurethane Foam
Production
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
AGENCY:
The EPA is proposing
amendments to the National Emissions
Standards for Hazardous Air Pollutants
for Flexible Polyurethane Foam
Production to address the results of the
residual risk and technology review. In
light of our review, we are proposing
amendments that would prohibit the
use of hazardous air pollutant-based
auxiliary blowing agents for slabstock
foam production facilities. In addition,
the EPA is proposing amendments to
correct and clarify regulatory provisions
related to emissions during periods of
startup, shutdown and malfunction; to
add provisions for affirmative defense;
to add requirements for reporting of
performance testing through the
Electronic Reporting Tool; to revise
compliance dates for applicable
proposed actions; to clarify the leak
detection methods allowed for
diisocyanate storage vessels at slabstock
foam production facilities; and to revise
the rule to add a schedule for delay of
leak repairs for valves and connectors.
DATES:
Comments. Comments must be
received on or before December 4, 2013.
A copy of comments on the information
collection provisions should be
submitted to the Office of Management
and Budget (OMB) on or before
December 4, 2013.
Public Hearing. If anyone contacts the
EPA requesting a public hearing by
November 14, 2013, the public hearing
will be held on November 20, 2013,
from 10:00 a.m. to 4:00 p.m. on the EPA
campus at 109 T.W. Alexander Drive in
Research Triangle Park, North Carolina.
If EPA holds a public hearing, the EPA
will keep the record of the hearing open
for 30 days after completion of the
hearing to provide an opportunity for
submission of rebuttal and
supplementary information.
ADDRESSES: Submit your comments,
identified by Docket ID Number EPA–
EMCDONALD on DSK67QTVN1PROD with PROPOSALS2
SUMMARY:
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HQ–OAR–2012–0510, by one of the
following methods:
• https://www.regulations.gov: Follow
the on-line instructions for submitting
comments.
• Email: a-and-r-Docket@epa.gov,
Attention Docket ID Number EPA–EPA–
HQ–OAR–2012–0510.
• Fax: (202) 566–9744, Attention
Docket ID Number EPA–HQ–OAR–
2012–0510.
• Mail: U.S. Postal Service, send
comments to: EPA Docket Center, EPA
West (Air Docket), Attention Docket ID
Number EPA–HQ–OAR–2012–0510,
U.S. Environmental Protection Agency,
Mailcode: 2822T, 1200 Pennsylvania
Ave. NW., Washington, DC 20460.
Please include a total of two copies. In
addition, please mail a copy of your
comments on the information collection
provisions to the Office of Information
and Regulatory Affairs, Office of
Management and Budget, Attn: Desk
Officer for EPA, 725 17th Street NW.,
Washington, DC 20503.
• Hand Delivery: U.S. Environmental
Protection Agency, EPA West (Air
Docket), Room 3334, 1301 Constitution
Ave. NW., Washington, DC 20004,
Attention Docket ID Number EPA–HQ–
OAR–2012–0510. Such deliveries are
only accepted during the Docket’s
normal hours of operation, and special
arrangements should be made for
deliveries of boxed information.
Instructions. Direct your comments to
Docket ID Number EPA–HQ–OAR–
2012–0510. The EPA’s policy is that all
comments received will be included in
the public docket without change and
may be made available online at https://
www.regulations.gov, including any
personal information provided, unless
the comment includes information
claimed to be confidential business
information (CBI) or other information
whose disclosure is restricted by statute.
Do not submit information that you
consider to be CBI or otherwise
protected through https://
www.regulations.gov or email. The
https://www.regulations.gov Web site is
an ‘‘anonymous access’’ system, which
means the EPA will not know your
identity or contact information unless
you provide it in the body of your
comment. If you send an email
comment directly to the EPA without
going through https://
www.regulations.gov, your email
address will be automatically captured
and included as part of the comment
that is placed in the public docket and
made available on the Internet. If you
submit an electronic comment, the EPA
recommends that you include your
name and other contact information in
the body of your comment and with any
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disk or CD–ROM you submit. If the EPA
cannot read your comment due to
technical difficulties and cannot contact
you for clarification, the EPA may not
be able to consider your comment.
Electronic files should not include
special characters or any form of
encryption and be free of any defects or
viruses. For additional information
about the EPA’s public docket, visit the
EPA Docket Center homepage at: https://
www.epa.gov/dockets.
Docket. The EPA has established a
docket for this rulemaking under Docket
ID Number EPA–HQ–OAR–2012–0510.
All documents in the docket are listed
in the regulations.gov index. Although
listed in the index, some information is
not publicly available, e.g., CBI or other
information whose disclosure is
restricted by statute. Certain other
material, such as copyrighted material,
is not placed on the Internet and will be
publicly available only in hard copy.
Publicly available docket materials are
available either electronically in
regulations.gov or in hard copy at the
EPA Docket Center, EPA West, Room
3334, 1301 Constitution Ave. NW.,
Washington, DC. The Public Reading
Room is open from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding
legal holidays. The telephone number
for the Public Reading Room is (202)
566–1744, and the telephone number for
the EPA Docket Center is (202) 566–
1742.
Public Hearing. If anyone contacts the
EPA requesting a public hearing by
November 14, 2013, the public hearing
will be held on November 20, 2013,
from 10:00 a.m. to 4:00 p.m. on the EPA
campus at 109 T.W. Alexander Drive in
Research Triangle Park, North Carolina.
Persons interested in presenting oral
testimony or inquiring as to whether a
public hearing will be held should
contact Ms. Pamela Garrett, Sector
Policies and Programs Division (D243–
01), Office of Air Quality Planning and
Standards, U.S. Environmental
Protection Agency, Research Triangle
Park, North Carolina 27711; telephone
number: (919) 541–7966; fax number:
(919) 541–5450; and email address:
garrett.pamela@epa.gov.
FOR FURTHER INFORMATION CONTACT: For
questions about this proposed action,
contact Ms. Kaye Whitfield, Sector
Policies and Programs Division (D243–
02), Office of Air Quality Planning and
Standards, U.S. Environmental
Protection Agency, Research Triangle
Park, North Carolina 27711; telephone
number: (919) 541–2509; fax number:
(919) 541–5450; and email address:
whitfield.kaye@epa.gov. For specific
information regarding the risk modeling
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methodology, contact Mr. Chris
Sarsony, Health and Environmental
Impacts Division (C539–02), Office of
Air Quality Planning and Standards,
U.S. Environmental Protection Agency,
Research Triangle Park, North Carolina
27711; telephone number: (919) 541–
4843; fax number: (919) 541–0840; and
email address: sarsony.chris@epa.gov.
For information about the applicability
of the National Emission Standards for
Hazardous Air Pollutants (NESHAP) to
a particular entity, contact Mr. Scott
Throwe, Office of Enforcement and
Compliance Assurance; telephone
number: (202) 564–7013; fax number:
(202) 564–0050; and email address:
throwe.scott@epa.gov.
SUPPLEMENTARY INFORMATION:
EMCDONALD on DSK67QTVN1PROD with PROPOSALS2
Preamble Acronyms and Abbreviations
This preamble includes several
acronyms and terms used to describe
industrial processes, data inventories
and risk modeling. While this list may
not be exhaustive, to ease the reading of
this preamble and for reference
purposes, the EPA defines the following
terms and acronyms here:
ABA auxiliary blowing agent
AEGL acute exposure guideline levels
AERMOD air dispersion model used by the
HEM–3 model
BAAQMD Bay Area Air Quality
Management District
CAA Clean Air Act
CalEPA California EPA
CBI Confidential Business Information
CDX Central Data Exchange
CEDRI Compliance and Emissions Data
Reporting Interface
CFR Code of Federal Regulations
EIS Emission Inventory System
EPA Environmental Protection Agency
ERPG Emergency Response Planning
Guidelines
ERT Electronic Reporting Tool
FPUF Flexible Polyurethane Foam
FR Federal Register
HAP hazardous air pollutants
HCl hydrogen chloride
HEM–3 Human Exposure Model, Version
1.1.0
HI hazard index
HF hydrogen fluoride
HQ hazard quotient
ICR information collection request
IRIS Integrated Risk Information System
kg kilogram
km kilometer
lb pound
LDAR leak detection and repair
MACT maximum achievable control
technology
MACT Code Code within the National
Emissions Inventory used to identify
processes included in a source category
mg/kg-day milligrams per kilogram per day
mg/m3 milligrams per cubic meter
MIR maximum individual risk
NAICS North American Industry
Classification System
NEI National Emissions Inventory
NESHAP National Emissions Standards for
Hazardous Air Pollutants
NRC National Research Council
NRDC Natural Resources Defense Council
NTTAA National Technology Transfer and
Advancement Act
OAQPS Office of Air Quality Planning and
Standards
OMB Office of Management and Budget
PB–HAP hazardous air pollutants known to
be persistent and bio-accumulative in the
environment
POM polycyclic organic matter
PFA Polyurethane Foam Association
ppm parts per million
QA quality assurance
REL reference exposure level
RCO recuperative thermal oxidizer
RfC reference concentration
RfD reference dose or daily oral exposure
RTO regenerative thermal oxidizer
RTR residual risk and technology review
SAB Science Advisory Board
SBA Small Business Administration
S/L/Ts State, local, and tribal air pollution
control agencies
SOP standing operating procedures
SSM startup, shutdown and malfunction
TOSHI target organ-specific hazard index
tpy tons per year
TRI Toxics Release Inventory
TRIM Total Risk Integrated Methodology
TTN Technology Transfer Network
UF uncertainty factors
mg/m3 microgram per cubic meter
UMRA Unfunded Mandates Reform Act
URE unit risk estimate
VCS voluntary consensus standards
WWW world wide web
Organization of this Document. The
information in this preamble is
organized as follows:
I. General Information
A. Does this action apply to me?
B. Where can I get a copy of this document
and other related information?
C. What should I consider as I prepare my
comments for the EPA?
II. Background
A. What is the statutory authority for this
action?
B. What is this source category and how do
the MACT standards regulate its HAP
emissions?
C. What data collection activities were
conducted to support this action?
III. Analytical Procedures
A. How did we estimate post-MACT risks
posed by the source category?
B. How did we consider the risk results in
making decisions for this proposal?
C. How did we perform the technology
review?
D. What other analyses and reviews were
conducted in support of this proposal
and how did we conduct those analyses
and reviews?
IV. Analytical Results and Proposed
Decisions
A. What are the results of the risk
assessment and analyses?
B. What are our proposed decisions
regarding risk acceptability, ample
margin of safety and adverse
environmental effects?
C. What are the results and proposed
decisions based on our technology
review?
D. What other actions are we proposing?
E. What compliance dates are we
proposing?
V. Summary of Cost, Environmental and
Economic Impacts
A. What are the affected sources?
B. What are the air quality impacts?
C. What are the cost impacts?
D. What are the economic impacts?
E. What are the benefits?
VI. Request for Comments
VII. Submitting Data Corrections
VIII. Statutory and Executive Order Reviews
A. Executive Order 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
I. General Information
A. Does this action apply to me?
Table 1 of this preamble lists the
industrial source category that is the
subject of this proposal. Table 1 is not
intended to be exhaustive but rather to
provide a guide for readers regarding the
entities that this proposed action is
likely to affect. The proposed standards,
once finalized, will be directly
applicable to the affected sources. One
federal entity is affected by this
proposed action, and no state, local or
tribal government entities are affected
by this proposed action. As defined in
the ‘‘Initial List of Categories of Sources
Under Section 112(c)(1) of the Clean Air
Act Amendments of 1990’’ (see 57 FR
31576, July 16, 1992), the ‘‘Flexible
Polyurethane Foam Production’’ source
category is any facility engaged in the
1 U.S. EPA, 1992. Documentation for Developing
the Initial Source Category List—Final Report. EPA–
450/3–91–030.
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manufacture of foam made from a
polymer containing a plurality of
carbamate linkages in the chain
backbone (polyurethane).1
TABLE 1—NESHAP AND INDUSTRIAL SOURCE CATEGORY AFFECTED BY THIS PROPOSED ACTION
Source category
NESHAP
NAICS
code a
Flexible Polyurethane Foam Production .......................................
Flexible Polyurethane Foam Production .....................................
326150
a North
American Industry Classification System
B. Where can I get a copy of this
document and other related
information?
In addition to being available in the
docket, an electronic copy of this action
is available on the Internet through the
EPA’s Technology Transfer Network
(TTN) Web site, a forum for information
and technology exchange in various
areas of air pollution control. Following
signature by the EPA Administrator, the
EPA will post a copy of this proposed
action on the TTN’s policy and
guidance page for newly proposed or
promulgated rules at: https://
www.epa.gov/ttn/oarpg/t3pfpr.html.
Following publication in the Federal
Register, the EPA will post the Federal
Register version of the proposal and key
technical documents on the project Web
site: https://www.epa.gov/ttn/atw/foam/
foampg.html. Information on the overall
residual risk and technology review
(RTR) program is available at the
following Web site: https://www.epa.gov/
ttn/atw/rrisk/rtrpg.html.
EMCDONALD on DSK67QTVN1PROD with PROPOSALS2
C. What should I consider as I prepare
my comments for the EPA?
Submitting CBI. Do not submit
information containing CBI to the EPA
through https://www.regulations.gov or
email. Clearly mark the part or all of the
information that you claim to be CBI.
For CBI information on a disk or CD–
ROM that you mail to the EPA, mark the
outside of the disk or CD–ROM as CBI
and then identify electronically within
the disk or CD–ROM the specific
information that is claimed as CBI. In
addition to one complete version of the
comments that includes information
claimed as CBI, you must submit a copy
of the comments that does not contain
the information claimed as CBI for
inclusion in the public docket. If you
submit a CD–ROM or disk that does not
contain CBI, mark the outside of the
disk or CD–ROM clearly that it does not
contain CBI. Information not marked as
CBI will be included in the public
docket and the EPA’s electronic public
docket without prior notice. Information
marked as CBI will not be disclosed
except in accordance with procedures
set forth in 40 Code of Federal
Regulations (CFR) part 2. Send or
deliver information identified as CBI
only to the following address: Roberto
Morales, OAQPS Document Control
Officer (C404–02), OAQPS, U.S.
Environmental Protection Agency,
Research Triangle Park, North Carolina
27711, Attention Docket ID Number
EPA–HQ–OAR–2012–0510.
II. Background
A. What is the statutory authority for
this action?
Section 112 of the Clean Air Act
(CAA) establishes a two-stage regulatory
process to address emissions of
hazardous air pollutants (HAP) from
stationary sources. In the first stage,
after the EPA has identified categories of
sources emitting one or more of the HAP
listed in CAA section 112(b), CAA
section 112(d) requires us to promulgate
technology-based NESHAP for those
sources. ‘‘Major sources’’ are those that
emit or have the potential to emit 10
tons per year (tpy) or more of a single
HAP or 25 tpy or more of any
combination of HAP. For major sources,
the technology-based NESHAP must
reflect the maximum degree of
emissions 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.
MACT standards must reflect the
maximum degree of emissions reduction
achievable through the application of
measures, processes, methods, systems
or techniques, including, but not limited
to, measures that (1) reduce the volume
of or eliminate pollutants through
process changes, substitution of
materials or other modifications; (2)
enclose systems or processes to
eliminate emissions; (3) capture or treat
pollutants when released from a
process, stack, storage or fugitive
emissions point; (4) are design,
equipment, work practice or operational
standards (including requirements for
operator training or certification); or (5)
are a combination of the above. CAA
section 112(d)(2)(A)-(E). The MACT
standards may take the form of design,
equipment, work practice or operational
standards where the EPA first
determines either that (1) a pollutant
cannot be emitted through a conveyance
designed and constructed to emit or
capture the pollutant, or that any
requirement for, or use of, such a
conveyance would be inconsistent with
law; or (2) the application of
measurement methodology to a
particular class of sources is not
practicable due to technological and
economic limitations. CAA section
112(h)(1)–(2).
The MACT ‘‘floor’’ is the minimum
control level allowed for MACT
standards promulgated under CAA
section 112(d)(3) and may not be based
on cost considerations. For new sources,
the MACT floor cannot be less stringent
than the emissions control that is
achieved in practice by the bestcontrolled similar source. The MACT
floor for existing sources can be less
stringent than floors for new sources but
not less stringent than the average
emissions 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
standards, the EPA must also consider
control options that are more stringent
than the floor. We may establish
standards more stringent than the floor
based on considerations of the cost of
achieving the emissions reductions, any
non-air quality health and
environmental impacts and energy
requirements.
The EPA is then required to review
these technology-based standards and
revise them ‘‘as necessary (taking into
account developments in practices,
processes and control technologies)’’ no
1 U.S. EPA, 1992. Documentation for Developing
the Initial Source Category List—Final Report. EPA–
450/3–91–030.
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less frequently than every eight years.
CAA section 112(d)(6). In conducting
this review, the EPA is not required to
recalculate the MACT floor. Natural
Resources Defense Council (NRDC) v.
EPA, 529 F.3d 1077, 1084 (D.C. Cir.,
2008). Association of Battery Recyclers,
Inc. v. EPA, 716 F.3d 667 (D.C. Cir.
2013).
The second stage in standard-setting
focuses on reducing any remaining (i.e.,
‘‘residual’’) risk according to CAA
section 112(f). This provision requires,
first, that the EPA prepare a report to
Congress discussing (among other
things) methods of calculating the risks
posed (or potentially posed) by sources
after implementation of the MACT
standards, the public health significance
of those risks and the EPA’s
recommendations as to legislation
regarding such remaining risk. The EPA
prepared and submitted the Residual
Risk Report to Congress, EPA–453/R–
99–001 (Risk Report) in March 1999.
Congress did not act in response,
thereby triggering the EPA’s obligation
under CAA section 112(f)(2) to analyze
and address residual risk.
Section 112(f)(2) of the CAA requires
the EPA to determine for source
categories subject to MACT standards
whether the emission standards provide
an ample margin of safety to protect
public health. Section 112(f)(2)(B) of the
CAA expressly preserves the EPA’s use
of the two-step process for developing
standards to address any residual risk
and the agency’s interpretation of
‘‘ample margin of safety’’ developed in
the National Emissions 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). The
EPA notified Congress in the Risk
Report that the agency intended to use
the Benzene NESHAP approach in
making CAA section 112(f) residual risk
determinations (EPA–453/R–99–001, p.
ES–11). The EPA subsequently adopted
this approach in its residual risk
determinations, and in a challenge to
the risk review for the Synthetic Organic
Chemical Manufacturing source
category, the United States Court of
Appeals for the District of Columbia
Circuit upheld as reasonable the EPA’s
interpretation that subsection 112(f)(2)
incorporates the standards established
in the Benzene NESHAP. See NRDC v.
EPA, 529 F.3d 1077, 1083 (D.C. Cir.
2008) (‘‘[S]ubsection 112(f)(2)(B)
expressly incorporates the EPA’s
interpretation of the Clean Air Act from
the Benzene standard, complete with a
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citation to the Federal Register.’’); see
also A Legislative History of the Clean
Air Act Amendments of 1990, vol. 1, p.
877 (Senate debate on Conference
Report).
The first step in this process is the
determination of acceptable risk. If risks
are unacceptable, the EPA cannot
consider cost in identifying the
emissions standards necessary to bring
risks to an acceptable level. The second
step is the determination of whether
standards must be further revised in
order to provide an ample margin of
safety to protect public health, which is
the level at which the standards must be
set, unless an even more stringent
standard is necessary to prevent, taking
into consideration costs, energy, safety
and other relevant factors, an adverse
environmental effect.
1. Determining Acceptability
The agency in the Benzene NESHAP
concluded that ‘‘that the acceptability of
risk under section 112 is best judged on
the basis of a broad set of health risk
measures and information’’ and that the
‘‘judgment on acceptability cannot be
reduced to any single factor.’’ Id. at
38046. The determination of what
represents an ‘‘acceptable’’ risk is based
on a judgment of ‘‘what risks are
acceptable in the world in which we
live’’ (Risk Report at 178, quoting NRDC
v. EPA, 824 F.2d 1146, 1165 (D.C. Cir.
1987) (en banc) (‘‘Vinyl Chloride’’),
recognizing that our world is not riskfree.
In the Benzene NESHAP, we stated
that ‘‘EPA will generally presume that if
the risk to [the maximum exposed]
individual is no higher than
approximately one in 10 thousand, that
risk level is considered acceptable.’’ 54
FR 38045. We discussed the maximum
individual lifetime cancer risk (or
maximum individual risk (MIR)) as
being ‘‘the estimated risk that a person
living near a plant would have if he or
she were exposed to the maximum
pollutant concentrations for 70 years.’’
Id. We explained that this measure of
risk ‘‘is an estimate of the upper bound
of risk based on conservative
assumptions, such as continuous
exposure for 24 hours per day for 70
years.’’ Id. We acknowledged that
maximum individual lifetime cancer
risk ‘‘does not necessarily reflect the
true risk, but displays a conservative
risk level which is an upper-bound that
is unlikely to be exceeded.’’ Id.
Understanding that there are both
benefits and limitations to using the
MIR as a metric for determining
acceptability, we acknowledged in the
Benzene NESHAP that ‘‘consideration of
maximum individual risk * * * must
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take into account the strengths and
weaknesses of this measure of risk.’’ Id.
Consequently, the presumptive risk
level of 100-in-1 million (1-in-10
thousand) provides a benchmark for
judging the acceptability of maximum
individual lifetime cancer risk, but does
not constitute a rigid line for making
that determination. Further, in the
Benzene NESHAP, we noted that:
[p]articular attention will also be accorded to
the weight of evidence presented in the risk
assessment of potential carcinogenicity or
other health effects of a pollutant. While the
same numerical risk may be estimated for an
exposure to a pollutant judged to be a known
human carcinogen, and to a pollutant
considered a possible human carcinogen
based on limited animal test data, the same
weight cannot be accorded to both estimates.
In considering the potential public health
effects of the two pollutants, the Agency’s
judgment on acceptability, including the
MIR, will be influenced by the greater weight
of evidence for the known human
carcinogen.
Id. at 38046. The agency also explained
in the Benzene NESHAP that:
[i]n establishing a presumption for MIR,
rather than a rigid line for acceptability, the
Agency intends to weigh it with a series of
other health measures and factors. These
include the overall incidence of cancer or
other serious health effects within the
exposed population, the numbers of persons
exposed within each individual lifetime risk
range and associated incidence within,
typically, a 50 km exposure radius around
facilities, the science policy assumptions and
estimation uncertainties associated with the
risk measures, weight of the scientific
evidence for human health effects, other
quantified or unquantified health effects,
effects due to co-location of facilities, and coemission of pollutants.
Id. At 38045. 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 that provided by
maximum individual lifetime cancer
risk alone.
As noted earlier, in NRDC v. EPA, the
court held that section 112(f)(2)
‘‘incorporates the EPA’s interpretation
of the Clean Air Act from the Benzene
Standard.’’ The court further held that
Congress’ incorporation of the Benzene
standard applies equally to carcinogens
and non-carcinogens. 529 F.3d at 1081–
82. Accordingly, we also consider noncancer risk metrics in our determination
of risk acceptability and ample margin
of safety.
2. Determination of Ample Margin of
Safety
CAA section 112(f)(2) requires the
EPA to determine, for source categories
subject to MACT standards, whether
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those standards provide an ample
margin of safety to protect public health.
As explained in the Benzene NESHAP,
‘‘the second step of the inquiry,
determining an ‘ample margin of safety,’
again includes consideration of all of
the health factors, and whether to
reduce the risks even further. . . .
Beyond that information, additional
factors relating to the appropriate level
of control will also be considered,
including costs and economic impacts
of controls, technological feasibility,
uncertainties and any other relevant
factors. Considering all of these factors,
the agency will establish the standard at
a level that provides an ample margin of
safety to protect the public health, as
required by section 112.’’ 54 FR 38046.
According to CAA section
112(f)(2)(A), if the MACT standards for
HAP ‘‘classified as a known, probable,
or possible human carcinogen do not
reduce lifetime excess cancer risks to
the individual most exposed to
emissions from a source in the category
or subcategory to less than one in one
million,’’ the EPA must promulgate
residual risk standards for the source
category (or subcategory), as necessary
to provide an ample margin of safety to
protect public health. In doing so, the
EPA may adopt standards equal to
existing MACT standards if the EPA
determines that the existing standards
(i.e. the MACT standards) are
sufficiently protective. NRDC v. EPA,
529 F.3d 1077, 1083 (D.C. Cir. 2008) (‘‘If
EPA determines that the existing
technology-based standards provide an
‘ample margin of safety,’ then the
Agency is free to readopt those
standards during the residual risk
rulemaking.’’) The EPA must also adopt
more stringent standards, if necessary,
to prevent an adverse environmental
effect,2 but must consider cost, energy,
safety and other relevant factors in
doing so.
The CAA does not specifically define
the terms ‘‘individual most exposed,’’
‘‘acceptable level’’ and ‘‘ample margin
of safety.’’ In the Benzene NESHAP, 54
FR 38044–38045, we stated as an overall
objective:
In protecting public health with an ample
margin of safety under section 112, EPA
strives to provide maximum feasible
protection against risks to health from
hazardous air pollutants by (1) protecting the
greatest number of persons possible to an
individual lifetime risk level no higher than
2 ‘‘Adverse environmental effect’’ is defined as
any significant and widespread adverse effect,
which may be reasonably anticipated to wildlife,
aquatic life or natural resources, including adverse
impacts on populations of endangered or threatened
species or significant degradation of environmental
qualities over broad areas. CAA section 112(a)(7).
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approximately 1-in-1 million and (2) limiting
to no higher than approximately 1-in-10
thousand [i.e., 100-in-1 million] the
estimated risk that a person living near a
plant would have if he or she were exposed
to the maximum pollutant concentrations for
70 years.
The agency further stated that ‘‘[t]he
EPA also considers incidence (the
number of persons estimated to suffer
cancer or other serious health effects as
a result of exposure to a pollutant) to be
an important measure of the health risk
to the exposed population. Incidence
measures the extent of health risks to
the exposed population as a whole, by
providing an estimate of the occurrence
of cancer or other serious health effects
in the exposed population.’’ Id. at
38045.
In the ample margin of safety decision
process, the agency again considers all
of the health risks and other health
information considered in the first step,
including the incremental risk reduction
associated with standards more
stringent than the MACT standard or a
more stringent standard that EPA has
determined is necessary to ensure risk is
acceptable. In the ample margin of
safety analysis, the agency considers
additional factors, including costs and
economic impacts of controls,
technological feasibility, uncertainties
and any other relevant factors.
Considering all of these factors, the
agency will establish the standard at a
level that provides an ample margin of
safety to protect the public health, as
required by CAA section 112(f). 54 FR
38046.
B. What is this source category and how
do the MACT standards regulate its
HAP emissions?
The MACT standards for Flexible
Polyurethane Foam (FPUF) Production
were promulgated on October 7, 1998,
(63 FR 53980) and codified at 40 CFR
part 63, subpart III. The FPUF
Production MACT standards apply to
each new and existing flexible
polyurethane foam or rebond foam
process that produces flexible
polyurethane foam or rebond foam,
emits HAP, and is located at a
contiguous, major source plant site. The
requirements of the standards are the
same for both new and existing sources.
There are three types of FPUF
producers in the source category:
Slabstock, molded and rebond.
Slabstock foam is produced in large
continuous buns that are then cut into
the desired size and shape. Slabstock
foam products are primarily used in
furniture seat cushions and bedding
materials. Molded foam is produced by
‘‘shooting’’ the foam mixture into a
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mold of the desired shape and size.
Molded foam is typically used in
automotive seats, packaging and a range
of specialty products. Rebond foam is
made from scrap foam that is converted
into a material primarily used for carpet
underlay. Rebond foam production is
often co-located with slabstock foam
production facilities.
Slabstock and molded polyurethane
foams are produced by mixing three
major ingredients: A polyol polymer, an
isocyanate and water. The polyol is
either a polyether or polyester polymer
with hydroxyl end groups. Other
ingredients are often added to modify
the polymer, and catalysts are used to
balance the principal foam production
reactions. Auxiliary blowing agents
(ABAs) may be used to produce specific
densities and grades of foam where the
gases produced by the isocyanate-water
reaction are insufficient to achieve the
desired density. ABAs are more widely
used in the production of slabstock
foams than in the production of molded
foams. Rebond foam is produced from
scrap slabstock or molded polyurethane
foam.
The HAP emission points at FPUF
production facilities depend on the type
of foam being produced. Prior to
compliance with the original FPUF
Production MACT standards, the
primary HAP emission point for
slabstock foam facilities was the foam
production line, due to emissions of
HAP ABAs. Other HAP emission points
at slabstock production facilities
include storage vessels and equipment
leaks. At molded and rebond foam
facilities, the primary HAP emission
points are storage vessels and
equipment leaks.
Many facilities discontinued use of
HAP ABAs before the rule’s October
2001 compliance date, allowing these
facilities to be designated as area
sources. Based on the best information
available, slabstock production facilities
using HAP ABAs on, or after, the rule’s
October 2001 compliance date also have
discontinued use of HAP-based ABAs.
We solicit comment on the use of HAPbased ABAs and whether any facilities
in the FPUF production source category
currently use these products.
In the past decade, the FPUF
production source category has
experienced plant closures and
consolidations. Today, there are 13
FPUF production facilities subject to the
MACT standards: 7 slabstock, 6 molded
and 2 rebond. One rebond facility is colocated with a slabstock facility, and the
other rebond facility is co-located with
a molded foam facility. A list of these
facilities is included in the
memorandum, Development of the RTR
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Emissions Dataset for the Flexible
Polyurethane Foam Production Source
Category, which is available in the
docket for this proposed rulemaking.
The FPUF Production MACT
standards contain requirements specific
for each of the three types of foam
production processes. For slabstock
foam production, the FPUF Production
MACT standards include diisocyanate
and HAP ABA emissions reduction
requirements. For molded and rebond
foam production, the FPUF Production
MACT standards prohibit the use of
HAP in mold release agents and
equipment cleaners, except in very
limited circumstances.
For slabstock foam production, the
FPUF Production MACT standards
regulate emissions of diisocyanates from
storage vessels, transfer pumps and
equipment leaks. The storage vessel
requirements include the installation of
either a vapor recovery system or a
carbon adsorption system. Transfer
pumps are required to be either sealless
pumps or pumps submerged in a neutral
oil, and submerged pumps must be
visually inspected periodically for leaks.
All components in diisocyanate service
must be repaired when a leak is
detected.
Standards for HAP ABA emissions at
slabstock facilities include emission
point requirements for the foam
production line, storage vessels,
equipment leaks and equipment
cleaning. For the slabstock production
line, the FPUF Production MACT
standards contain restrictions on the
amount of HAP ABAs that can be used,
based on the grades of foam produced.
The FPUF Production MACT standards
also regulate HAP ABAs by requiring
installation of either a vapor recovery
system or a carbon adsorption system on
storage vessels. For equipment leaks, the
FPUF Production MACT standards
require a leak detection and repair
program (LDAR) for HAP ABAs. The use
of HAP or HAP-based products for
equipment cleaning is prohibited at
slabstock flexible polyurethane foam
production facilities. This proposed rule
also includes an alternative source-wide
HAP ABA emission limit. The sourcewide emission limit allows slabstock
facilities to comply by limiting the total
amount of a single HAP ABA used,
rather than by complying with the
individual HAP ABA emission point
requirements (e.g., production line,
LDAR, equipment cleaning).
For molded foam and rebond foam
production, the FPUF Production
MACT standards prohibit the use of
HAP-based products as mold release
agents and as equipment cleaners,
except that diisocyanates may be used
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to flush the mixhead and associated
piping during startup and maintenance
if the diisocyanates are contained in a
closed-loop system and re-used in
production.
C. What data collection activities were
conducted to support this action?
In 2011, we surveyed nine companies
that own and operate foam production
facilities, as provided for under section
114 of the CAA. We also conducted
plant visits to four facilities in 2012 and
2013, retrieved permit data from
approximately 32 state agencies, and
obtained emissions inventory data from
state agencies. Finally, we reviewed
data in four EPA emission inventory
databases: National Emissions Inventory
(NEI), Emissions Inventory System
(EIS), Toxics Release Inventory (TRI)
and Envirofacts to identify facilities that
may be part of the source category,
emission sources and quantities of
emissions. The CAA section 114
questionnaire included requests for
available information regarding process
equipment, control devices and work
practices for emission reductions, point
and fugitive emissions and other aspects
of facility operations.
The emissions data and risk
assessment inputs for the FPUF
production source category are
described further in the memorandum
Development of the RTR Emissions
Dataset for the Flexible Polyurethane
Foam Production Source Category,
which is available in the docket for this
proposed rulemaking.
III. Analytical Procedures
In this section, we describe the
analyses performed to support the
proposed decisions for the RTR and
other issues addressed in this proposal.
A. How did we estimate post-MACT
risks posed by the source category?
The EPA conducted a risk assessment
that provided estimates of the MIR
posed by the HAP emissions from each
source in the source category, the
hazard index (HI) for chronic exposures
to HAP with the potential to cause noncancer health effects and the hazard
quotient (HQ) for acute exposures to
HAP with the potential to cause noncancer health effects. The assessment
also provided estimates of the
distribution of cancer risks within the
exposed populations, cancer incidence
and an evaluation of the potential for
adverse environmental effects for the
source category. The risk assessment
consisted of eight primary steps, as
discussed below. The docket for this
rulemaking contains the following
document, which provides more
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information on the risk assessment
inputs and models: Draft Residual Risk
Assessment for the Flexible
Polyurethane Foam Production Source
Category. The methods used to assess
risks (as described in the eight primary
steps below) are consistent with those
peer-reviewed by a panel of the EPA’s
Science Advisory Board (SAB) in 2009
and described in their peer review
report issued in 2010; 3 they are also
consistent with the key
recommendations contained in that
report.
1. How did we estimate actual
emissions and identify the emissions
release characteristics?
Data from the 13 existing FPUF
production facilities were used to create
a dataset that is the basis for the risk
assessment. We estimated the amount of
actual and allowable emissions using
data collected through the CAA section
114 request, emission inventories (EIS,
NEI and TRI) and site visits. We
performed quality assurance (QA)
procedures for the emissions data and
release characteristics to identify any
outliers, and then confirmed or
corrected the data. For facilities where
speciated HAP data were unavailable or
unreliable, more recent inventory data
were obtained from state or local
permitting agencies. In addition to the
QA of the source data for the facilities
contained in the dataset, we also
checked the coordinates of every
emission source in the dataset through
visual observations using tools such as
Google Earth and ArcView, and made
corrections, as necessary. Further
information about the development of
the dataset is provided in the technical
document: Draft Development of the
RTR Emissions Dataset for the Flexible
Polyurethane Foam Production Source
Category, which is available in the
docket for this action.
2. How did we estimate MACTAllowable emissions?
The available emissions data in the
MACT dataset include estimates of the
mass of HAP emitted during the
specified annual time period. In some
cases, these ‘‘actual’’ emission levels are
lower than the emission levels a facility
is allowed to emit and still comply with
the MACT standards. The emissions
level allowed to be emitted by the
MACT standards is referred to as the
‘‘MACT-allowable’’ emissions level.
This represents the highest emissions
3 U.S. EPA SAB. Risk and Technology Review
(RTR) Risk Assessment Methodologies: For Review
by the EPA’s Science Advisory Board with Case
Studies—MACT I Petroleum Refining Sources and
Portland Cement Manufacturing, May 2010.
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level that could be emitted by facilities
without violating the MACT standards.
We discussed the use of both MACTallowable and actual emissions in the
final Coke Oven Batteries residual risk
rule (70 FR 19998–19999, April 15,
2005) and in the proposed and final
Hazardous Organic NESHAP residual
risk rules (71 FR 34428, June 14, 2006,
and 71 FR 76609, December 21, 2006,
respectively). In those previous actions,
we noted that assessing the risks at the
MACT-allowable level is inherently
reasonable since these risks reflect the
maximum level facilities could emit and
still comply with national emission
standards. We also explained that it is
reasonable to consider actual emissions,
where such data are available, in both
steps of the risk analysis, in accordance
with the Benzene NESHAP. (54 FR
38044, September 14, 1989.)
For the FPUF production source
category, we determined that actual
emissions are a reasonable estimate of
the MACT-allowable emissions for
molded and rebond foam facilities. The
MACT requirements for these facilities
are HAP use prohibitions, and both the
actual and the MACT-allowable
emissions, while in compliance with
these requirements, are therefore zero.
For slabstock foam production
facilities, we estimate that the level of
diisocyanate actual emissions is a
reasonable estimate of the MACTallowable diisocyanate emissions. The
diisocyanate storage vessels and other
equipment are subject to equipment
standards and work practices. For
equipment standards, sources subject to
the standards are required to install
specific equipment. In order to comply
with this proposed rule, the equipment
must be maintained properly and in
good working condition. Therefore, we
do not expect any difference between
the actual emissions level and the level
allowed by the MACT standards
because the level of control typically
does not vary for equipment standards.
Similarly, we do not expect any
difference between actual and MACTallowable emissions for emission
sources subject to work practice
requirements, provided that facilities
are not conducting additional work
practices proven to reduce emissions
beyond those required in this proposed
rule. We are not aware of any such
situations at facilities in this source
category. Therefore, for facilities
complying with the equipment and
work practice standards, we believe that
the actual diisocyanate emission levels
are a reasonable estimation of the levels
allowed by the standards.
For HAP ABA emissions from
slabstock facilities, we estimate that
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MACT-allowable emissions are higher
than actual emissions. While we believe
that all slabstock production facilities
have discontinued use of HAP-based
ABAs, and they are reporting zero
emissions of HAP ABA, the MACT rule
does not prohibit the use of HAP ABAs.
Therefore, MACT-allowable HAP ABA
emissions were attributed to each
slabstock facility based on emissions
information gathered during
development of the MACT standards.
We assigned appropriate emissions
release parameters for each facility, and
modeled using the same procedures and
tools used for modeling actual
emissions, to obtain facility-specific
maximum risk values based on MACTallowable emissions. The docket for this
rulemaking contains the following
document which provides more
information on the development of
estimated MACT-allowable emissions:
MACT-Allowable Emissions for the
Flexible Polyurethane Foam Production
Source Category.
3. How did we conduct dispersion
modeling, determine inhalation
exposure and estimate individual and
population inhalation risks?
Both long-term and short-term
inhalation exposure concentrations and
health risks from the source category
addressed in this proposal were
estimated using the Human Exposure
Model (Community and Sector HEM–3
version 1.1.0). The HEM–3 performs
three primary risk assessment activities:
(1) Conducting dispersion modeling to
estimate the concentrations of HAP in
ambient air, (2) estimating long-term
and short-term inhalation exposures to
individuals residing within 50
kilometers (km) of the modeled
sources,4 and (3) estimating individual
and population-level inhalation risks
using the exposure estimates and
quantitative dose-response information.
The air dispersion model used by the
HEM–3 model (AERMOD) is one of the
EPA’s preferred models for assessing
pollutant concentrations from industrial
facilities.5 To perform the dispersion
modeling and to develop the
preliminary risk estimates, HEM–3
draws on three data libraries. The first
is a library of meteorological data,
which is used for dispersion
calculations. This library includes 1
year (2011) of hourly surface and upper
air observations for more than 824
4 This metric comes from the Benzene NESHAP.
See 54 FR 38046.
5 U.S. EPA. Revision to the Guideline on Air
Quality Models: Adoption of a Preferred General
Purpose (Flat and Complex Terrain) Dispersion
Model and Other Revisions (70 FR 68218,
November 9, 2005).
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meteorological stations, selected to
provide coverage of the United States
and Puerto Rico. A second library of
United States Census Bureau census
block 6 internal point locations and
populations provides the basis of
human exposure calculations (U.S.
Census, 2010). In addition, for each
census block, the census library
includes the elevation and controlling
hill height, which are also used in
dispersion calculations. A third library
of pollutant unit risk factors and other
health benchmarks is used to estimate
health risks. These risk factors and
health benchmarks are the latest values
recommended by the EPA for HAP and
other toxic air pollutants. These values
are available at: https://www.epa.gov/ttn/
atw/toxsource/summary.html and are
discussed in more detail later in this
section.
In developing the risk assessment for
chronic exposures, we used the
estimated annual average ambient air
concentrations of each HAP emitted by
each source for which we have
emissions data in the source category.
The air concentrations at each nearby
census block centroid were used as a
surrogate for the chronic inhalation
exposure concentration for all the
people who reside in that census block.
We calculated the MIR for each facility
as the cancer risk associated with a
continuous lifetime (24 hours per day,
7 days per week and 52 weeks per year
for a 70-year period) exposure to the
maximum concentration at the centroid
of inhabited census blocks. Individual
cancer risks were calculated by
multiplying the estimated lifetime
exposure to the ambient concentration
of each of the HAP (in micrograms per
cubic meter (mg/m3)) by its unit risk
estimate (URE), which is an upper
bound estimate of an individual’s
probability of contracting cancer over a
lifetime of exposure to a concentration
of 1 microgram of the pollutant per
cubic meter of air. For residual risk
assessments, we generally use URE
values from the EPA’s Integrated Risk
Information System (IRIS). For
carcinogenic pollutants without EPA
IRIS values, we look to other reputable
sources of cancer dose-response values,
often using California EPA (CalEPA)
URE values, where available. In cases
where new, scientifically credible dose
response values have been developed in
a manner consistent with the EPA
guidelines and have undergone a peer
review process similar to that used by
the EPA, we may use such dose6 A census block is the smallest geographic area
for which census statistics are tabulated.
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response values in place of, or, in
addition to, other values, if appropriate.
The EPA estimated incremental
individual lifetime cancer risks
associated with emissions from the
facilities in the source category as the
sum of the risks for each of the
carcinogenic HAP (including those
classified as carcinogenic to humans,
likely to be carcinogenic to humans and
suggestive evidence of carcinogenic
potential 7) emitted by the modeled
sources. Cancer incidence and the
distribution of individual cancer risks
for the population within 50 km of the
sources were also estimated for the
source category as part of this
assessment by summing individual
risks. A distance of 50 km is consistent
with both the analysis supporting the
1989 Benzene NESHAP (54 FR 38044)
and the limitations of Gaussian
dispersion models, including AERMOD.
To assess the risk of non-cancer
health effects from chronic exposures,
we summed the HQ for each of the HAP
that affects a common target organ
system to obtain the HI for that target
organ system (or target organ-specific
HI, TOSHI). The HQ is the estimated
exposure divided by the chronic
reference value, which is either the EPA
reference concentration (RfC) (https://
www.epa.gov/riskassessment/
glossary.htm), defined as ‘‘an estimate
(with uncertainty spanning perhaps an
order of magnitude) of a continuous
inhalation exposure to the human
population (including sensitive
subgroups) that is likely to be without
an appreciable risk of deleterious effects
during a lifetime,’’ or, in cases where an
RfC from the EPA’s IRIS database is not
available, a value from the following
prioritized sources: (1) The Agency for
Toxic Substances and Disease Registry
Minimum Risk Level (https://
www.atsdr.cdc.gov/mrls/index.asp),
which is defined as ‘‘an estimate of
daily human exposure to a hazardous
substance that is likely to be without an
appreciable risk of adverse non-cancer
health effects (other than cancer) over a
specified duration of exposure’’; (2) the
CalEPA Chronic Reference Exposure
7 These classifications also coincide with the
terms ‘‘known carcinogen, probable carcinogen, and
possible carcinogen,’’ respectively, which are the
terms advocated in the EPA’s previous Guidelines
for Carcinogen Risk Assessment, published in 1986
(51 FR 33992, September 24, 1986). Summing the
risks of these individual compounds to obtain the
cumulative cancer risks is an approach that was
recommended by the EPA’s Science Advisory Board
(SAB) in their 2002 peer review of EPA’s National
Air Toxics Assessment (NATA) titled, NATA—
Evaluating the National-scale Air Toxics
Assessment 1996 Data—an SAB Advisory, available
at: https://yosemite.epa.gov/sab/sabproduct.nsf/
214C6E915BB04E14852570CA007A682C/$File/
ecadv02001.pdf.
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Level (REL) (https://www.oehha.ca.gov/
air/hot_spots/pdf/HRAguidefinal.pdf),
which is defined as ‘‘the concentration
level (that is expressed in units of
micrograms per cubic meter (mg/m3) for
inhalation exposure and in a dose
expressed in units of milligram per
kilogram-day (mg/kg-day) for oral
exposures), at or below which no
adverse health effects are anticipated for
a specified exposure duration’’; or (3), as
noted above, a scientifically credible
dose-response value that has been
developed in a manner consistent with
the EPA guidelines and has undergone
a peer review process similar to that
used by the EPA, in place of or in
concert with other values.
The EPA also evaluated screening
estimates of acute exposures and risks
for each of the HAP at the point of
highest off-site exposure for each facility
(i.e., not just the census block
centroids), assuming that a person is
located at this spot at a time when both
the peak (hourly) emissions rate and
worst-case dispersion conditions occur.
The acute HQ is the estimated acute
exposure divided by the acute doseresponse value. In each case, the EPA
calculated acute HQ values using best
available, short-term dose-response
values. These acute dose-response
values, which are described below,
include the acute REL, acute exposure
guideline levels (AEGL) and emergency
response planning guidelines (ERPG) for
1-hour exposure durations. As
discussed below, we used conservative
assumptions for emissions rates,
meteorology and exposure location for
our acute analysis.
As described in the CalEPA’s Air
Toxics Hot Spots Program Risk
Assessment Guidelines, Part I, The
Determination of Acute Reference
Exposure Levels for Airborne Toxicants,
an acute REL value (https://
www.oehha.ca.gov/air/pdf/acuterel.pdf)
is defined as ‘‘the concentration level at
or below which no adverse health
effects are anticipated for a specified
exposure duration.’’ Id. at page 2. Acute
REL values are based on the most
sensitive, relevant, adverse health effect
reported in the peer-reviewed medical
and toxicological literature. Acute REL
values are designed to protect the most
sensitive individuals in the population
by the inclusion of margins of safety.
Because margins of safety are
incorporated to address data gaps and
uncertainties, exceeding the REL does
not automatically indicate an adverse
health impact.
AEGL values were derived in
response to recommendations from the
National Research Council (NRC). As
described in Standing Operating
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Procedures (SOP) of the National
Advisory Committee on Acute Exposure
Guideline Levels for Hazardous
Substances (https://www.epa.gov/oppt/
aegl/pubs/sop.pdf),8 ‘‘the NRC’s
previous name for acute exposure
levels—community emergency exposure
levels—was replaced by the term AEGL
to reflect the broad application of these
values to planning, response, and
prevention in the community, the
workplace, transportation, the military,
and the remediation of Superfund
sites.’’ Id. at 2. This document also
states that AEGL values ‘‘represent
threshold exposure limits for the general
public and are applicable to emergency
exposures ranging from 10 minutes to
eight hours.’’ Id. at 2. The document
lays out the purpose and objectives of
AEGL by stating that ‘‘the primary
purpose of the AEGL program and the
National Advisory Committee for Acute
Exposure Guideline Levels for
Hazardous Substances is to develop
guideline levels for once-in-a-lifetime,
short-term exposures to airborne
concentrations of acutely toxic, highpriority chemicals.’’ Id. at 21. In
detailing the intended application of
AEGL values, the document states that
‘‘[i]t is anticipated that the AEGL values
will be used for regulatory and
nonregulatory purposes by U.S. federal
and state agencies and possibly the
international community in conjunction
with chemical emergency response,
planning and prevention programs.
More specifically, the AEGL values will
be used for conducting various risk
assessments to aid in the development
of emergency preparedness and
prevention plans, as well as real-time
emergency response actions, for
accidental chemical releases at fixed
facilities and from transport carriers.’’
Id. at 31.
The AEGL–1 value is then specifically
defined as ‘‘the airborne concentration
(expressed as ppm (parts per million) or
mg/m3 (milligrams per cubic meter)) of
a substance above which it is predicted
that the general population, including
susceptible individuals, could
experience notable discomfort,
irritation, or certain asymptomatic
nonsensory effects. However, the effects
are not disabling and are transient and
reversible upon cessation of exposure.’’
Id. at 3. The document also notes that,
‘‘Airborne concentrations below AEGL–
1 represent exposure levels that can
produce mild and progressively
increasing but transient and
8 National Academy of Sciences (NAS), 2001.
Standing Operating Procedures for Developing
Acute Exposure Levels for Hazardous Chemicals,
page 2.
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nondisabling odor, taste, and sensory
irritation or certain asymptomatic,
nonsensory effects.’’ Id. Similarly, the
document defines AEGL–2 values as
‘‘the airborne concentration (expressed
as parts per million or milligrams per
cubic meter) of a substance above which
it is predicted that the general
population, including susceptible
individuals, could experience
irreversible or other serious, long-lasting
adverse health effects or an impaired
ability to escape.’’ Id.
ERPG values are derived for use in
emergency response, as described in the
American Industrial Hygiene
Association’s ERP Committee document
titled, ERPGS Procedures and
Responsibilities (https://sp4m.aiha.org/
insideaiha/GuidelineDevelopment/
ERPG/Documents/ERP-SOPs2006.pdf),
which states that, ‘‘Emergency Response
Planning Guidelines were developed for
emergency planning and are intended as
health based guideline concentrations
for single exposures to chemicals.’’ 9 Id.
at 1. The ERPG–1 value is defined as
‘‘the maximum airborne concentration
below which it is believed that nearly
all individuals could be exposed for up
to 1 hour without experiencing other
than mild transient adverse health
effects or without perceiving a clearly
defined, objectionable odor.’’ Id. at 2.
Similarly, the ERPG–2 value is defined
as ‘‘the maximum airborne
concentration below which it is
believed that nearly all individuals
could be exposed for up to one hour
without experiencing or developing
irreversible or other serious health
effects or symptoms which could impair
an individual’s ability to take protective
action.’’ Id. at 1.
As can be seen from the definitions
above, the AEGL and ERPG values
include the similarly-defined severity
levels 1 and 2. For many chemicals, a
severity level 1 value AEGL or ERPG has
not been developed because the types of
effects for these chemicals are not
consistent with the AEGL–1/ERPG–1
definitions; in these instances, we
compare higher severity level AEGL–2
or ERPG–2 values to our modeled
exposure levels to screen for potential
acute concerns. When AEGL–1/ERPG–1
values are available, they are used in
our acute risk assessments.
Acute REL values for 1-hour exposure
durations are typically lower than their
corresponding AEGL–1 and ERPG–1
values. Even though their definitions are
slightly different, AEGL–1 values are
often the same as the corresponding
ERPG–1 values, and AEGL–2 values are
often equal to ERPG–2 values.
Maximum HQ values from our acute
screening risk assessments typically
result when basing them on the acute
REL value for a particular pollutant. In
cases where our maximum acute HQ
value exceeds 1, we also report the HQ
value based on the next highest acute
dose-response value (usually the AEGL–
1 and/or the ERPG–1 value).
To develop screening estimates of
acute exposures in the absence of hourly
emissions data, generally we first
develop estimates of maximum hourly
emissions rates by multiplying the
average actual annual hourly emissions
rates by a default factor to cover
routinely variable emissions. We choose
the factor to use partially based on
process knowledge and engineering
judgment, but also reflecting a Texas
study of short-term emissions
variability, which showed that most
peak emission events in a heavilyindustrialized four-county area (Harris,
Galveston, Chambers and Brazoria
Counties, Texas) were less than twice
the annual average hourly emissions
rate. The highest peak emissions event
was 74 times the annual average hourly
emissions rate, and the 99th percentile
ratio of peak hourly emissions rate to
the annual average hourly emissions
rate was 9.10 Considering this analysis,
to account for more than 99 percent of
the peak hourly emissions, we apply a
conservative screening multiplication
factor of 10 to the average annual hourly
emissions rate in our acute exposure
screening assessments as our default
approach. However, we use a factor
other than 10 if we have information
that indicates that a different factor is
appropriate for a particular source
category. For this source category,
however, there was no such information
available and the default factor of 10
was used in the acute screening process.
As part of our acute risk assessment
process, for cases where acute HQ
values from the screening step were less
than or equal to 1 (even under the
conservative assumptions of the
screening analysis), acute impacts were
deemed negligible and no further
analysis was performed. In cases where
an acute HQ from the screening step
was greater than 1, additional sitespecific data were considered to
develop a more refined estimate of the
potential for acute impacts of concern.
Ideally, we would prefer to have
continuous measurements over time to
see how the emissions vary by each
9 ERP Committee Procedures and Responsibilities.
November 1, 2006. American Industrial Hygiene
Association.
10 See https://www.tceq.state.tx.us/compliance/
field_ops/eer/ or docket to access the
source of these data.
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hour over an entire year. Having a
frequency distribution of hourly
emissions rates over a year would allow
us to perform a probabilistic analysis to
estimate potential threshold
exceedances and their frequency of
occurrence. Such an evaluation could
include a more complete statistical
treatment of the key parameters and
elements adopted in this screening
analysis. However, we recognize that
having this level of data is rare; hence,
our use of the multiplier approach.
To better characterize the potential
health risks associated with estimated
acute exposures to HAP, and in
response to a key recommendation from
the SAB’s peer review of the EPA’s RTR
risk assessment methodologies,11 we
generally examine a wider range of
available acute health metrics (e.g.,
RELs, AEGLs) than we do for our
chronic risk assessments. This is in
response to the SAB’s acknowledgement
that there are generally more data gaps
and inconsistencies in acute reference
values than there are in chronic
reference values. In some cases, when
Reference Value Arrays 12 for HAP have
been developed, we consider additional
acute values (i.e., occupational and
international values) to provide a more
complete risk characterization.
4. How did we conduct the
multipathway exposure and risk
screening?
The EPA conducted a screening
analysis examining the potential for
significant human health risks due to
exposures via routes other than
inhalation (i.e., ingestion). We first
determined whether any sources in the
source category emitted any hazardous
air pollutants known to be persistent
and bioaccumulative in the
environment (PB–HAP). The PB–HAP
compounds or compound classes are
identified for the screening from the
EPA’s Air Toxics Risk Assessment
Library (available at https://
www.epa.gov/ttn/fera/risk_atra_
vol1.html).
For the FPUF production source
category, we did not identify emissions
of any PB–HAP. Because we did not
identify PB–HAP emissions, no further
11 The SAB peer review of RTR Risk Assessment
Methodologies is available at: https://
yosemite.epa.gov/sab/sabproduct.nsf/
4AB3966E263D943A8525771F00668381/$File/EPASAB-10-007-unsigned.pdf.
12 U.S. EPA. (2009) Chapter 2.9 Chemical Specific
Reference Values for Formaldehyde in Graphical
Arrays of Chemical-Specific Health Effect Reference
Values for Inhalation Exposures (Final Report). U.S.
Environmental Protection Agency, Washington, DC,
EPA/600/R–09/061, and available on-line at https://
cfpub.epa.gov/ncea/cfm/
recordisplay.cfm?deid=211003.
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evaluation of multipathway risk was
conducted for this source category.
5. How did we assess risks considering
emissions control options?
In addition to assessing baseline
inhalation risks and screening for
potential multipathway risks, we also
estimated risks considering the potential
emissions reductions that would be
achieved by the control options under
consideration. In these cases, the
expected emissions reductions were
applied to the specific HAP and
emissions points in the source category
dataset to develop corresponding
estimates of risk and incremental risk
reductions.
6. How did we conduct the
environmental risk screening
assessment?
a. Adverse Environmental Effect
The EPA developed a screening
approach to examine the potential for
adverse environmental effects as
required under section 112(f)(2)(A) of
the CAA. Section 112(a)(7) of the CAA
defines ‘‘adverse environmental effect’’
as ‘‘any significant and widespread
adverse effect, which may reasonably be
anticipated, to wildlife, aquatic life, or
other natural resources, including
adverse impacts on populations of
endangered or threatened species or
significant degradation of
environmental quality over broad
areas.’’
EMCDONALD on DSK67QTVN1PROD with PROPOSALS2
b. Environmental HAP
The EPA focuses on seven HAP,
which we refer to as ‘‘environmental
HAP,’’ in its screening analysis: Five
persistent bioaccumulative HAP (PB–
HAP) and two acid gases. The five PB–
HAP are cadmium, dioxins/furans,
polycyclic organic matter (POM),
mercury (both inorganic mercury and
methyl mercury) and lead. The two acid
gases are hydrogen chloride (HCl) and
hydrogen fluoride (HF). The rationale
for including these seven HAP in the
environmental risk screening analysis is
presented below.
HAP that persist and bioaccumulate
are of particular environmental concern
because they accumulate in the soil,
sediment and water. The PB–HAP are
taken up, through sediment, soil, water,
and/or ingestion of other organisms, by
plants or animals (e.g., small fish) at the
bottom of the food chain. As larger and
larger predators consume these
organisms, concentrations of the PB–
HAP in the animal tissues increases as
does the potential for adverse effects.
The five PB–HAP we evaluate as part of
our screening analysis account for 99.8
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percent of all PB–HAP emissions (based
on data from the 2005 NEI).
In addition to accounting for almost
all of the mass of PB–HAP emitted, we
note that the TRIM.Fate model that we
use to evaluate multipathway risk
allows us to estimate concentrations of
cadmium compounds, dioxins/furans,
POM and mercury in soil, sediment and
water. For lead, we currently do not
have the ability to calculate these
concentrations using the TRIM.Fate
model. Therefore, to evaluate the
potential for environmental effects from
lead, we compare the estimated chronic
inhalation exposures from the source
category emissions of lead with the level
of the secondary National Ambient Air
Quality Standard (NAAQS) for lead.13
We consider values below the level of
the secondary lead NAAQS as unlikely
to cause adverse environmental effects.
Due to their well-documented
potential to cause direct damage to
terrestrial plants, we include two acid
gases, HCl and HF, in the environmental
screening analysis. According to the
2005 NEI, HCl and HF account for about
99 percent of the total acid gas HAP
emitted by stationary sources. In
addition to the potential to cause direct
damage to plants, high concentrations of
HF in the air have been linked to
fluorosis in livestock. Air
concentrations of these HAP are already
calculated as part of the human
multipathway exposure and risk
screening analysis using the HEM3–
AERMOD air dispersion model, and we
are able to use the air dispersion
modeling to estimate the potential for an
adverse environmental effect.
For the FPUF production source
category, the data do not show
emissions of any of the seven HAP
(cadmium, dioxins/furans, POM,
mercury, HCL or HF) in the
environmental risk screen. Because we
did not identify emissions of these
seven HAP from the source category, we
did not conduct any further quantitative
evaluation of environmental risk.
The EPA acknowledges that other
HAP beyond the seven HAP discussed
above may have the potential to cause
adverse environmental effects.
Therefore, the EPA may include other
relevant HAP in its environmental risk
screening in the future, as modeling
science and resources allow. The EPA
13 The secondary lead NAAQS is a reasonable
measure of determining whether there is an adverse
environmental effect since it was established
considering ‘‘effects on soils, water, crops,
vegetation, man-made materials, animals, wildlife,
weather, visibility and climate, damage to and
deterioration of property, and hazards to
transportation, as well as effects on economic
values and on personal comfort and well-being.’’
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invites comment on the extent to which
other HAP emitted by the source
category may cause adverse
environmental effects. Such information
should include references to peerreviewed ecological effects benchmarks
that are of sufficient quality for making
regulatory decisions, as well as
information on the presence of
organisms located near facilities within
the source category that such
benchmarks indicate could be adversely
affected.
7. How did we conduct facility-wide
assessments?
To put the source category risks in
context, we typically examine the risks
from the entire ‘‘facility,’’ where the
facility includes all HAP-emitting
operations within a contiguous area and
under common control. In other words,
we examine the HAP emissions not only
from the source category emission
points of interest, but also emissions of
HAP from all other emissions sources at
the facility for which we have data. The
emissions data for estimating these
‘‘facility-wide’’ risks were obtained from
the 2005 NEI (available at https://
www.epa.gov/ttn/atw/nata2005). We
analyzed risks due to the inhalation of
HAP that are emitted ‘‘facility-wide’’ for
the populations residing within 50 km
of each facility, consistent with the
methods used for the source category
analysis described above. For these
facility-wide risk analyses, the modeled
FPUF production source category risks
were compared to the facility-wide risks
to determine the portion of facility-wide
risks that could be attributed to the
FPUF production source category. We
specifically examined the facilities
associated with the highest estimates of
risk and determined the percentage of
that risk attributable to the FPUF
production source category. The Draft
Residual Risk Assessment for the
Flexible Polyurethane Foam Production
Source Category, available through the
docket for this action, provides all the
methodology and results of the facilitywide analyses, including all facilitywide risks and the percentage of FPUF
production source category contribution
to facility-wide risks.
8. How did we consider uncertainties in
risk assessment?
In the Benzene NESHAP, we
concluded that risk estimation
uncertainty should be considered in our
decision-making under the ample
margin of safety framework. Uncertainty
and the potential for bias are inherent in
all risk assessments, including those
performed for this proposal. Although
uncertainty exists, we believe that our
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approach, which used conservative
tools and assumptions, ensures that our
decisions are health-protective. A brief
discussion of the uncertainties in the
emissions dataset, dispersion modeling,
inhalation exposure estimates and doseresponse relationships follows below. A
more thorough discussion of these
uncertainties is included in the Draft
Residual Risk Assessment for the
Flexible Polyurethane Foam Production
Source Category, which is available in
the docket for this action.
a. Uncertainties in the Emissions
Dataset
Although the development of the RTR
dataset involved quality assurance/
quality control processes, the accuracy
of emissions values will vary depending
on the source of the data, the degree to
which data are incomplete or missing,
the degree to which assumptions made
to complete the datasets are accurate,
errors in emissions estimates and other
factors. The emission estimates
considered in this analysis generally are
annual totals for certain years, and they
do not reflect short-term fluctuations
during the course of a year or variations
from year to year. The estimates of peak
hourly emissions rates for the acute
effects screening assessment were based
on an emission adjustment factor
applied to the average annual hourly
emissions rates, which are intended to
account for emission fluctuations due to
normal facility operations.
EMCDONALD on DSK67QTVN1PROD with PROPOSALS2
b. Uncertainties in Dispersion Modeling
We recognize there is uncertainty in
ambient concentration estimates
associated with any model, including
the EPA’s recommended regulatory
dispersion model, AERMOD. In using a
model to estimated ambient pollutant
concentrations, the user chooses certain
options to apply. For RTR assessments,
we select some model options that have
the potential to overestimate ambient air
concentrations (e.g., not including
plume depletion or pollutant
transformation). We select other model
options that have the potential to
underestimate ambient impacts (e.g., not
including building downwash). Other
options that we select have the potential
to either under- or over-estimate
ambient levels (e.g., meteorology and
receptor locations). On balance,
considering the directional nature of the
uncertainties commonly present in
ambient concentrations estimated by
dispersion models, the approach we
apply in the RTR assessments should
yield unbiased estimates of ambient
HAP concentrations.
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c. Uncertainties in Inhalation Exposure
The EPA did not include the effects
of human mobility on exposures in the
assessment. Specifically, short-term
mobility and long-term mobility
between census blocks in the modeling
domain were not considered.14 The
approach of not considering short- or
long-term population mobility does not
bias the estimate of the theoretical MIR
(by definition), nor does it affect the
estimate of cancer incidence because the
total population number remains the
same. It does, however, affect the shape
of the distribution of individual risks
across the affected population, shifting
it toward higher estimated individual
risks at the upper end and reducing the
number of people estimated to be at
lower risks, thereby increasing the
estimated number of people at specific
high risk levels (e.g., 1-in-10 thousand
or 1-in-1 million).
In addition, the assessment predicted
the chronic exposures at the centroid of
each populated census block as
surrogates for the exposure
concentrations for all people living in
that block. Using the census block
centroid to predict chronic exposures
tends to over-predict exposures for
people in the census block who live
farther from the facility and underpredict exposures for people in the
census block who live closer to the
facility. Thus, using the census block
centroid to predict chronic exposures
may lead to a potential understatement
or overstatement of the true maximum
impact, but is an unbiased estimate of
average risk and incidence. We reduce
this uncertainty by analyzing large
census blocks near facilities using aerial
imagery and adjusting the location of
the block centroid to better represent the
population in the block, as well as
adding additional receptors where the
block population is not well represented
by a single location.
The assessment evaluates the cancer
inhalation risks associated with
pollutant exposures over a 70-year
period, which is the assumed lifetime of
an individual. In reality, both the length
of time that modeled emissions sources
at facilities actually operate (i.e., more
or less than 70 years) and the domestic
growth or decline of the modeled
industry (i.e., the increase or decrease in
the number or size of domestic
facilities) will influence the future risks
posed by a given source or source
category. Depending on the
14 Short-term mobility is movement from one
micro-environment to another over the course of
hours or days. Long-term mobility is movement
from one residence to another over the course of a
lifetime.
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characteristics of the industry, these
factors will, in most cases, result in an
overestimate both in individual risk
levels and in the total estimated number
of cancer cases. However, in the
unlikely scenario where a facility
maintains, or even increases, its
emissions levels over a period of more
than 70 years, residents live beyond 70
years at the same location, and the
residents spend most of their days at
that location, then the cancer inhalation
risks could potentially be
underestimated. However, annual
cancer incidence estimates from
exposures to emissions from these
sources would not be affected by the
length of time an emissions source
operates.
The exposure estimates used in these
analyses assume chronic exposures to
ambient (outdoor) levels of pollutants.
Because most people spend the majority
of their time indoors, actual exposures
may not be as high, depending on the
characteristics of the pollutants
modeled. For many of the HAP, indoor
levels are roughly equivalent to ambient
levels, but for very reactive pollutants or
larger particles, indoor levels are
typically lower. This factor has the
potential to result in an overstatement of
25 to 30 percent of exposures.15
In addition to the uncertainties
highlighted above, there are several
factors specific to the acute exposure
assessment that should be highlighted.
The accuracy of an acute inhalation
exposure assessment depends on the
simultaneous occurrence of
independent factors that may vary
greatly, such as hourly emissions rates,
meteorology and human activity
patterns. In this assessment, we assume
that individuals remain for 1 hour at the
point of maximum ambient
concentration as determined by the cooccurrence of peak emissions and worstcase meteorological conditions. These
assumptions would tend to be worstcase actual exposures as it is unlikely
that a person would be located at the
point of maximum exposure during the
time of worst-case impact.
d. Uncertainties in Dose-Response
Relationships
There are uncertainties inherent in
the development of the dose-response
values used in our risk assessments for
cancer effects from chronic exposures
and non-cancer effects from both
chronic and acute exposures. Some
uncertainties may be considered
quantitatively, and others generally are
15 U.S. EPA. National-Scale Air Toxics
Assessment for 1996. (EPA 453/R–01–003; January
2001; page 85.)
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expressed in qualitative terms. We note
as a preface to this discussion a point on
dose-response uncertainty that is
brought out in the EPA’s 2005 Cancer
Guidelines; namely, that ‘‘the primary
goal of EPA actions is protection of
human health; accordingly, as an
Agency policy, risk assessment
procedures, including default options
that are used in the absence of scientific
data to the contrary, should be health
protective’’ (EPA 2005 Cancer
Guidelines, pages 1–7). This is the
approach followed here as summarized
in the next several paragraphs. A
complete detailed discussion of
uncertainties and variability in doseresponse relationships is given in the
Draft Residual Risk Assessment for the
Flexible Polyurethane Foam Production
Source Category, which is available in
the docket for this action.
Cancer URE values used in our risk
assessments are those that have been
developed to generally provide an upper
bound estimate of risk. That is, they
represent a ‘‘plausible upper limit to the
true value of a quantity’’ (although this
is usually not a true statistical
confidence limit).16 In some
circumstances, the true risk could be as
low as zero; however, in other
circumstances the risk could be
greater.17 When developing an upper
bound estimate of risk and to provide
risk values that do not underestimate
risk, health-protective default
approaches are generally used. To err on
the side of ensuring adequate health
protection, the EPA typically uses the
upper bound estimates rather than
lower bound or central tendency
estimates in our risk assessments, an
approach that may have limitations for
other uses (e.g., priority-setting or
expected benefits analysis).
RfCs and reference doses (RfDs)
represent chronic exposure levels that
provide an estimate (with uncertainty
spanning perhaps an order of
magnitude) of a continuous inhalation
exposure or a daily oral exposure,
respectively, to the human population
(including sensitive subgroups) that is
likely to be without an appreciable risk
of deleterious effects during a lifetime.
To derive values that are intended to be
‘‘without appreciable risk,’’ the
methodology relies upon an uncertainty
factor (UF) approach (U.S. EPA, 1993,
1994) which considers uncertainty,
variability and gaps in the available
16 IRIS glossary (https://www.epa.gov/NCEA/iris/
help_gloss.htm).
17 An exception to this is the URE for benzene,
which is considered to cover a range of values, each
end of which is considered to be equally plausible,
and which is based on maximum likelihood
estimates.
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data. The UFs are applied to derive
reference values that are intended to
protect against appreciable risk of
deleterious effects. The UFs are
commonly default values,18 e.g., factors
of 10 or 3, used in the absence of
compound-specific data; where data are
available, UFs may also be developed
using compound-specific information.
When data are limited, more
assumptions are needed and more UFs
are used.
While collectively termed ‘‘UF,’’ these
factors account for a number of different
quantitative considerations when using
observed animal (usually rodent) or
human toxicity data in the development
of the RfC. The UF are intended to
account for: (1) Variation in
susceptibility among the members of the
human population (i.e., inter-individual
variability); (2) uncertainty in
extrapolating from experimental animal
data to humans (i.e., interspecies
differences); (3) uncertainty in
extrapolating from data obtained in a
study with less-than-lifetime exposure
(i.e., extrapolating from sub-chronic to
chronic exposure); (4) uncertainty in
extrapolating the observed data to
obtain an estimate of the exposure
associated with no adverse effects; and
(5) uncertainty when the database is
incomplete or there are problems with
the applicability of available studies.
Many of the UF used to account for
variability and uncertainty in the
development of acute reference values
are quite similar to those developed for
chronic durations, but they more often
use individual UF values that may be
less than 10. The UF are applied based
on chemical-specific or health effectspecific information (e.g., simple
irritation effects do not vary appreciably
between human individuals; hence a
value of 3 is typically used), or based on
the purpose for the reference value (see
18 According to the NRC report, Science and
Judgment in Risk Assessment (NRC, 1994)
‘‘[Default] options are generic approaches, based on
general scientific knowledge and policy judgment,
that are applied to various elements of the risk
assessment process when the correct scientific
model is unknown or uncertain.’’ The 1983 NRC
report, Risk Assessment in the Federal Government:
Managing the Process, defined default option as
‘‘the option chosen on the basis of risk assessment
policy that appears to be the best choice in the
absence of data to the contrary’’ (NRC, 1983a, p. 63).
Therefore, default options are not rules that bind
the agency; rather, the agency may depart from
them in evaluating the risks posed by a specific
substance when it believes this to be appropriate.
In keeping with EPA’s goal of protecting public
health and the environment, default assumptions
are used to ensure that risk to chemicals is not
underestimated (although defaults are not intended
to overtly overestimate risk). See EPA, 2004, An
Examination of EPA Risk Assessment Principles
and Practices, EPA/100/B–04/001 available at:
https://www.epa.gov/osa/pdfs/ratf-final.pdf.
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the following paragraph). The UF
applied in acute reference value
derivation include: (1) Heterogeneity
among humans; (2) uncertainty in
extrapolating from animals to humans;
(3) uncertainty in lowest observed
adverse effect (exposure) level to no
observed adverse effect (exposure) level
adjustments; and (4) uncertainty in
accounting for an incomplete database
on toxic effects of potential concern.
Additional adjustments are often
applied to account for uncertainty in
extrapolation from observations at one
exposure duration (e.g., 4 hours) to
derive an acute reference value at
another exposure duration (e.g., 1 hour).
Not all acute reference values are
developed for the same purpose and
care must be taken when interpreting
the results of an acute assessment of
human health effects relative to the
reference value or values being
exceeded. Where relevant to the
estimated exposures, the lack of shortterm dose-response values at different
levels of severity should be factored into
the risk characterization as potential
uncertainties.
For a group of compounds that are
unspeciated (e.g., glycol ethers), we
conservatively use the most protective
reference value of an individual
compound in that group to estimate
risk. Similarly, for an individual
compound in a group (e.g., ethylene
glycol diethyl ether) that does not have
a specified reference value, we also
apply the most protective reference
value from the other compounds in the
group to estimate risk.
e. Uncertainties in the Multipathway
Assessment
For each source category, we
generally rely on site-specific levels of
PB–HAP emissions to determine
whether a refined assessment of the
impacts from multipathway exposures
is necessary. This determination is
based on the results of a two-tiered
screening analysis that relies on the
outputs from models that estimate
environmental pollutant concentrations
and human exposures for four PB–HAP.
Two important types of uncertainty
associated with the use of these models
in RTR risk assessments and inherent to
any assessment that relies on
environmental modeling are model
uncertainty and input uncertainty.19
19 In the context of this discussion, the term
‘‘uncertainty’’ as it pertains to exposure and risk
encompasses both variability in the range of
expected inputs and screening results due to
existing spatial, temporal, and other factors, as well
as uncertainty in being able to accurately estimate
the true result.
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Model uncertainty concerns whether
the selected models are appropriate for
the assessment being conducted and
whether they adequately represent the
actual processes that might occur for
that situation. An example of model
uncertainty is the question of whether
the model adequately describes the
movement of a pollutant through the
soil. This type of uncertainty is difficult
to quantify. However, based on feedback
received from previous EPA Science
Advisory Board reviews and other
reviews, we are confident that the
models used in the screen are
appropriate and state-of-the-art for the
multipathway risk assessments
conducted in support of RTR.
Input uncertainty is concerned with
how accurately the models have been
configured and parameterized for the
assessment at hand. For Tier 1 of the
multipathway screen, we configured the
models to avoid underestimating
exposure and risk to reduce the
likelihood that the results indicate the
risks are lower than they actually are.
This was accomplished by selecting
upper-end values from nationallyrepresentative data sets for the more
influential parameters in the
environmental model, including
selection and spatial configuration of
the area of interest, lake location and
size, meteorology, surface water and soil
characteristics and structure of the
aquatic food web. We also assume an
ingestion exposure scenario and values
for human exposure factors that
represent reasonable maximum
exposures.
In Tier 2 of the multipathway
assessment, we refine the model inputs
to account for meteorological patterns in
the vicinity of the facility versus using
upper-end national values and we
identify the actual location of lakes near
the facility rather than the default lake
location that we apply in Tier 1. By
refining the screening approach in Tier
2 to account for local geographical and
meteorological data, we decrease the
likelihood that concentrations in
environmental media are overestimated,
thereby increasing the usefulness of the
screen. The assumptions and the
associated uncertainties regarding the
selected ingestion exposure scenario are
the same for Tier 1 and Tier 2.
For both Tiers 1 and 2 of the
multipathway assessment, our approach
to addressing model input uncertainty is
generally cautious. We choose model
inputs from the upper end of the range
of possible values for the influential
parameters used in the models, and we
assume that the exposed individual
exhibits ingestion behavior that would
lead to a high total exposure. This
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approach reduces the likelihood of not
identifying high risks for adverse
impacts.
Despite the uncertainties, when
individual pollutants or facilities do
screen out, we are confident that the
potential for adverse multipathway
impacts on human health is very low.
On the other hand, when individual
pollutants or facilities do not screen out,
it does not mean that multipathway
impacts are significant, only that we
cannot rule out that possibility and that
a refined multipathway analysis for the
site might be necessary to obtain a more
accurate risk characterization for the
source category.
For further information on
uncertainties and the Tier 1 and 2
screening methods, refer to the risk
document Appendix 5, ‘‘Technical
Support Document for TRIM-Based
Multipathway Tiered Screening
Methodology for RTR.’’
B. How did we consider the risk results
in making decisions for this proposal?
As discussed in section II.A of this
preamble, in evaluating and developing
standards under section 112(f)(2), we
apply a two-step process to address
residual risk. In the first step, the EPA
determines whether risks are acceptable.
This determination ‘‘considers all health
information, including risk estimation
uncertainty, and includes a presumptive
limit on maximum individual lifetime
[cancer] risk (MIR) 20 of approximately
[1-in-10 thousand] [i.e., 100-in-1
million].’’ 54 FR 38045. If risks are
unacceptable, the EPA must determine
the emissions standards necessary to
bring risks to an acceptable level
without considering costs. In the second
step of the process, the EPA considers
whether the emissions standards
provide an ample margin of safety ‘‘in
consideration of all health information,
including the number of persons at risk
levels higher than approximately 1-in-1
million, as well as other relevant factors,
including costs and economic impacts,
technological feasibility, and other
factors relevant to each particular
decision.’’ Id. The EPA must promulgate
tighter emission standards if necessary
to provide an ample margin of safety.
After conducting the ample margin of
safety analysis, we consider whether a
more stringent standard is necessary to
prevent, taking into consideration costs,
energy, safety, and other relevant
factors, an adverse environmental effect.
After conducting the ample margin of
20 Although defined as ‘‘maximum individual
risk,’’ MIR refers only to cancer risk. MIR, one
metric for assessing cancer risk, is the estimated
risk were an individual exposed to the maximum
level of a pollutant for a lifetime.
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safety analysis, we consider whether a
more stringent standard is necessary to
prevent, taking into consideration costs,
energy, safety, and other relevant
factors, an adverse environmental effect.
In past residual risk actions, the EPA
considered a number of human health
risk metrics associated with emissions
from the categories under review,
including the MIR, the number of
persons in various risk ranges, cancer
incidence, the maximum non-cancer HI
and the maximum acute non-cancer
hazard. See, e.g., 72 FR 25138, May 3,
2007; 71 FR 42724, July 27, 2006. The
EPA considered this health information
for both actual and allowable emissions.
See, e.g., 75 FR 65068, October 21, 2010;
75 FR 80220, December 21, 2010; 76 FR
29032, May 19, 2011. The EPA also
discussed risk estimation uncertainties
and considered the uncertainties in the
determination of acceptable risk and
ample margin of safety in these past
actions. The EPA considered this same
type of information in support of this
Federal Register notice.
The agency is considering these
various measures of health information
to inform our determinations of risk
acceptability and ample margin of safety
under CAA section 112(f). As explained
in the Benzene NESHAP, ‘‘the first step
judgment on acceptability cannot be
reduced to any single factor’’ and thus
‘‘[t]he Administrator believes that the
acceptability of risk under [previous]
section 112 is best judged on the basis
of a broad set of health risk measures
and information.’’ 54 FR 38046.
Similarly, with regard to the ample
margin of safety determination, ‘‘the
Agency again considers all of the health
risk and other health information
considered in the first step. Beyond that
information, additional factors relating
to the appropriate level of control will
also be considered, including cost and
economic impacts of controls,
technological feasibility, uncertainties,
and any other relevant factors.’’ Id.
The Benzene NESHAP provides
flexibility regarding factors the EPA may
consider in making determinations and
how the EPA may weigh those factors
for each source category. In responding
to comment on our policy under the
Benzene NESHAP, the EPA explained
that:
[t]he policy chosen by the Administrator
permits consideration of multiple measures
of health risk. Not only can the MIR figure
be considered, but also incidence, the
presence of non-cancer health effects, and the
uncertainties of the risk estimates. In this
way, the effect on the most exposed
individuals can be reviewed as well as the
impact on the general public. These factors
can then be weighed in each individual case.
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This approach complies with the Vinyl
Chloride mandate that the Administrator
ascertain an acceptable level of risk to the
public by employing [her] expertise to assess
available data. It also complies with the
Congressional intent behind the CAA, which
did not exclude the use of any particular
measure of public health risk from the EPA’s
consideration with respect to CAA section
112 regulations, and thereby implicitly
permits consideration of any and all
measures of health risk which the
Administrator, in [her] judgment, believes are
appropriate to determining what will ‘protect
the public health.’
54 FR 38057. Thus, the level of the MIR
is only one factor to be weighed in
determining acceptability of risks. The
Benzene NESHAP explained that ‘‘an
MIR of approximately one in 10
thousand should ordinarily be the upper
end of the range of acceptability. As
risks increase above this benchmark,
they become presumptively less
acceptable under CAA section 112, and
would be weighed with the other health
risk measures and information in
making an overall judgment on
acceptability. Or, the Agency may find,
in a particular case, that a risk that
includes MIR less than the
presumptively acceptable level is
unacceptable in the light of other health
risk factors.’’ Id. at 38045. Similarly,
with regard to the ample margin of
safety analysis, the EPA stated in the
Benzene NESHAP that: ‘‘EPA believes
the relative weight of the many factors
that can be considered in selecting an
ample margin of safety can only be
determined for each specific source
category. This occurs mainly because
technological and economic factors
(along with the health-related factors)
vary from source category to source
category.’’ Id. at 38061. We also
consider the uncertainties associated
with the various risk analyses, as
discussed earlier in this preamble, in
our determinations of acceptability and
ample margin of safety.
The EPA notes that it has not
considered certain health information to
date in making residual risk
determinations. At this time, we do not
attempt to quantify those HAP risks that
may be associated with emissions from
other facilities that do not include the
source categories in question, mobile
source emissions, natural source
emissions, persistent environmental
pollution or atmospheric transformation
in the vicinity of the sources in these
categories.
The agency understands the potential
importance of considering an
individual’s total exposure to HAP in
addition to considering exposure to
HAP emissions from the source category
and facility. We recognize that such
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consideration may be particularly
important when assessing non-cancer
risks, where pollutant-specific exposure
health reference levels (e.g., RfCs) are
based on the assumption that thresholds
exist for adverse health effects. For
example, the agency recognizes that,
although exposures attributable to
emissions from a source category or
facility alone may not indicate the
potential for increased risk of adverse
non-cancer health effects in a
population, the exposures resulting
from emissions from the facility in
combination with emissions from all of
the other sources (e.g., other facilities) to
which an individual is exposed may be
sufficient to result in increased risk of
adverse non-cancer health effects. In
May 2010, the SAB advised the EPA
‘‘that RTR assessments will be most
useful to decision makers and
communities if results are presented in
the broader context of aggregate and
cumulative risks, including background
concentrations and contributions from
other sources in the area.’’ 21
In response to the SAB
recommendations, the EPA is
incorporating cumulative risk analyses
into its RTR risk assessments. The
agency is: (1) Conducting facility-wide
assessments, which include source
category emission points as well as
other emission points within the
facilities; (2) considering overlapping
sources in the same category; and (3) for
some persistent and bioaccumulative
pollutants, analyzing the ingestion route
of exposure. In addition, the RTR risk
assessments have always considered
aggregate cancer risk from all
carcinogens and aggregate non-cancer
hazard indices from all non-carcinogens
affecting the same target organ system.
Although we are interested in placing
source category and facility-wide HAP
risks in the context of total HAP risks
from all sources combined in the
vicinity of each source, we are
concerned about the uncertainties of
doing so. Because of the contribution to
total HAP risk from emissions sources
other than those that we have studied in
depth during this RTR review, such
estimates of total HAP risks would have
significantly greater associated
uncertainties than the source category or
facility-wide estimates. Such aggregate
or cumulative assessments would
21 EPA’s responses to this and all other key
recommendations of the SAB’s advisory on RTR
risk assessment methodologies (which is available
at: https://yosemite.epa.gov/sab/sabproduct.nsf/
4AB3966E263D943A8525771F00668381/$File/EPASAB-10-007-unsigned.pdf) are outlined in a memo
to this rulemaking docket from David Guinnup
titled, EPA’s Actions in Response to the Key
Recommendations of the SAB Review of RTR Risk
Assessment Methodologies.
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compound those uncertainties, making
the assessments too unreliable.
C. How did we perform the technology
review?
Our technology review focused on the
identification and evaluation of
developments in practices, processes
and control technologies that have
occurred since the FPUF Production
MACT standards were promulgated.
Where we identified such
developments, in order to inform our
decision of whether it is ‘‘necessary’’ to
revise the emissions standards, we
analyzed the technical feasibility of
applying these developments, and the
estimated costs, energy implications,
non-air environmental impacts, as well
as considering the emissions reductions.
We also considered the appropriateness
of applying controls to new sources
versus retrofitting existing sources.
Based on our analyses of the available
data and information, we identified
potential developments in practices,
processes and control technologies. For
this exercise, we considered any of the
following to be a ‘‘development’’:
• Any add-on control technology or
other equipment that was not identified
and considered during development of
the original MACT standards.
• Any improvements in add-on
control technology or other equipment
(that were identified and considered
during development of the original
MACT standards) that could result in
additional emissions reduction.
• Any work practice or operational
procedure that was not identified or
considered during development of the
original MACT standards.
• Any process change or pollution
prevention alternative that could be
broadly applied to the industry and that
was not identified or considered during
development of the original MACT
standards.
• Any significant changes in the cost
(including cost effectiveness) of
applying controls (including controls
the EPA considered during the
development of the original MACT
standards).
We reviewed a variety of data sources
in our investigation of potential
practices, processes or controls to
consider. Among the sources we
reviewed were the NESHAP for various
industries that were promulgated since
the FPUF Production MACT standards
being reviewed in this action. We
reviewed the regulatory requirements
and/or technical analyses associated
with these regulatory actions to identify
any practices, processes and control
technologies considered in these efforts
that could be applied to emissions
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sources in the FPUF production source
category, as well as the costs, non-air
impacts and energy implications
associated with the use of these
technologies. Additionally, we
requested information from facilities
regarding developments in practices,
processes or control technology. Finally,
we reviewed information from other
sources, such as state and/or local
permitting agency databases and
industry-supported databases.
D. What other analyses and reviews
were conducted in support of this
proposal and how did we conduct those
analyses and reviews?
revisions to the startup, shutdown and
malfunction (SSM) provisions of the
MACT rule in order to ensure that they
are consistent with the court decision in
Sierra Club v. EPA, 551 F.3d 1019 (D.C.
Cir. 2008), which vacated two
provisions that exempted sources from
the requirement to comply with
otherwise applicable section 112(d)
emission standards during periods of
SSM. Our analyses and proposed
changes related to these issues are
presented in section IV.D of this
preamble.
IV. Analytical Results and Proposed
Decisions
This section of the preamble provides
the results of our RTR reviews of the
FPUF Production MACT standards and
our proposed revisions to the FPUF
Production MACT standards regarding
the startup, shutdown and malfunction
provisions.
In addition to the analyses described
above, we reviewed the FPUF
Production MACT standards to
determine whether we should make
additional amendments. From this
review we have identified one
additional revision. We are proposing
A. What are the results of the risk
assessment and analyses?
As described above, for the FPUF
production source category, we
conducted an inhalation risk assessment
for all HAP emitted, a multipathway
screening analysis for PB–HAP emitted
and an environmental HAP screening
analysis. We also performed a facilitywide risk assessment for the facilities in
the source category. Results of the risk
assessment are presented briefly below
and in more detail in the residual risk
document: Draft Residual Risk
Assessment for the Flexible
Polyurethane Foam Production Source
Category, which is available in the
docket for this rulemaking.
1. FPUF Production Source Category
Inhalation Risk Assessment Results
Table 2 of this preamble provides a
summary of the results of the inhalation
risk assessment for the source category.
TABLE 2—FLEXIBLE POLYURETHANE FOAM PRODUCTION INHALATION RISK ASSESSMENT RESULTS
Maximum individual
cancer risk
(in 1 million) 2
Number of facilities 1
13 ...............................
Estimated population at
increased risk of cancer
≥ 1-in-1 million
Estimated annual cancer
incidence
(cases per year)
Maximum chronic noncancer TOSHI 3
Based on
actual
emissions
level 2
Based on
allowable
emissions
level
Based on
actual
emissions
level 2
Based on
allowable
emissions
level
Based on
actual
emissions
level 2
Based on
allowable
emissions
level
Based on
actual
emissions
level
Based on
allowable
emissions
level
0.7
5
0
700
0.00004
0.0004
0.9
0.9
Maximum screening acute
non-cancer HQ 4
Based on actual emissions
level
Based on allowable emissions level
HQERPG–1
0.9
HQREL = 4
HQERPG–1=0.9
=
1 Number
of facilities evaluated in the risk analysis.
individual excess lifetime cancer risk due to HAP emissions from the source category.
TOSHI. The target organ with the highest TOSHI for the FPUF production source category is the respiratory system.
4 The maximum estimated acute exposure concentration was divided by available short-term threshold values to develop an array of HQ values. HQ values shown
use the lowest available acute threshold value, which in most cases is the REL. When HQ values exceed 1, we also show HQ values using the next lowest available
acute dose-response value. See section III.A.3 of this preamble for explanation of acute dose-response values.
2 Maximum
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3 Maximum
The results of the inhalation risk
modeling using actual emissions level
data, as shown in Table 2, indicate that
the maximum lifetime individual cancer
risk could be up to 0.7-in-1 million, the
maximum chronic non-cancer TOSHI
value could be up to 0.9, and the
maximum off-site acute HQ value could
be up to 0.9. The total estimated
national cancer incidence from these
facilities based on actual emission levels
is 0.00004 excess cancer cases per year
or one case in every 25,000 years.
As discussed in section III.A.2, we
also determined that MACT-allowable
HAP ABA emissions levels at slabstock
production facilities are greater than
actual HAP ABA emissions, while
allowable emissions from all other
processes are equal to actual emissions.
The inhalation risk modeling using
MACT-allowable HAP ABA emissions
and the actual emissions for the other
processes at slabstock production
facilities, indicate that the maximum
lifetime individual cancer risk could be
up to 5-in-1 million, the maximum
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chronic non-cancer TOSHI value could
be up to 0.9, and the maximum off-site
acute HQ value could be up to 4, based
on the REL value for methylene
chloride. The total estimated national
cancer incidence from these facilities
based on the MACT-allowable emission
levels is 0.0004 excess cancer cases per
year or one case in every 2,500 years.
For more detail about the MACTallowable emissions levels, see the
memorandum, MACT-Allowable
Emissions for the Flexible Polyurethane
Foam Production Source Category, in
the docket for this rulemaking.
2. Acute Risk Results
Table 2 shows the acute risk results
for the FPUF production source
category. The screening analysis for
worst-case acute impacts was based on
a conservative default emissions
multiplier of 10 to estimate the peak
hourly emission rates from the average
rates. Refer to Appendix 6 of the draft
residual risk document in the docket for
the detailed acute risk results.
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3. Multipathway Risk Screening Results
There are no PB-HAP emitted by
facilities in this category. Therefore, we
do not expect there is a potential for
human health multipathway risks as a
result of emissions of these HAP.
4. Ecological Risk Screening Results
The emissions data for the FPUF
source category indicate that sources
within this source category do not emit
any of the seven pollutants that we
identified as ‘‘environmental HAP,’’ as
discussed earlier in this preamble.
Based on the processes and materials
used in the source category, we do not
expect any of the seven environmental
HAP to be emitted. Also, we are
unaware of any adverse environmental
effect caused by emissions of HAP that
are emitted by this source category.
Therefore, we do not expect an adverse
environmental effect as a result of HAP
emissions from this source category.
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5. Facility-Wide Inhalation Risk
Assessment Results
assessment is based on actual emission
levels. For detailed facility-specific
results, see Appendix 6 of the Draft
Residual Risk Assessment for the
Table 3 displays the results of the
facility-wide risk assessment. This
66123
Flexible Polyurethane Foam Production
Source Category in the docket for this
rulemaking.
TABLE 3—FPUF PRODUCTION FACILITY-WIDE RISK ASSESSMENT RESULTS
Number of facilities analyzed ..........................................................................................................................................................................
Cancer Risk:
Estimated maximum facility-wide individual cancer risk (in 1 million) .....................................................................................................
Number of facilities with estimated facility-wide individual cancer risk of 100-in-1 million or more ........................................................
Number of facilities at which the FPUF production source category contributes 50 percent or more to the facility-wide individual
cancer risks of 100-in-1 million or more ...............................................................................................................................................
Number of facilities with estimated facility-wide individual cancer risk of 1-in-1 million or more ............................................................
Number of facilities at which the FPUF production source category contributes 50 percent or more to the facility-wide individual
cancer risk of 1-in-1 million or more .....................................................................................................................................................
Chronic Non-cancer Risk:
Maximum facility-wide chronic non-cancer TOSHI ..................................................................................................................................
Number of facilities with facility-wide maximum non-cancer TOSHI greater than 1 ...............................................................................
Number of facilities at which the FPUF production source category contributes 50 percent or more to the facility-wide maximum
non-cancer TOSHI of 1 or more ...........................................................................................................................................................
The facility-wide MIR and TOSHI are
based on actual emissions from all
emissions sources at the identified
facilities. The results indicate that 3
facilities have a facility-wide cancer
MIR greater than or equal to 1-in-1
million. The maximum facility-wide
MIR is 20-in-1 million, with emission
points from the FPUF production source
category contributing less than 10
percent of the maximum facility-wide
risk. The maximum facility-wide TOSHI
is 0.9, with the FPUF production source
category contributing 100 percent to the
facility-wide TOSHI.
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6. What demographic groups might
benefit from this regulation?
To determine whether or not to
conduct a demographics analysis, we
look at a combination of factors
including the MIR, non-cancer TOSHI,
population around the facilities in the
source category and other relevant
factors. For the FPUF production source
category, our analyses show that actual
emissions result in no individuals being
exposed to cancer risk greater than 1-in1 million or a non-cancer TOSHI greater
than 1. Therefore, we did not conduct
an assessment of risks to individual
demographic groups for this
rulemaking. However, we did conduct a
proximity analysis, which identifies any
overrepresentation of minority, low
income or indigenous populations near
facilities in the source category. The
results of this analysis are presented in
the section of this preamble titled,
‘‘Executive Order 12898: Federal
Actions to Address Environmental
Justice in Minority Populations and
Low-Income Populations.’’
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B. What are our proposed decisions
regarding risk acceptability, ample
margin of safety and adverse
environmental effects?
1. Risk Acceptability
As noted in section III.C of this
preamble, we weigh all health risk
factors in our risk acceptability
determination, including the cancer
MIR; the number of persons in various
cancer and non-cancer risk ranges;
cancer incidence; the maximum noncancer TOSHI; the maximum acute noncancer HQ; the extent of non-cancer
risks; the potential for adverse
environmental effects; the distribution
of cancer and non-cancer risks in the
exposed population; and risk estimation
uncertainties (54 FR 38044, September
14, 1989).
For the FPUF production source
category, the risk analysis indicates that
the cancer risks to the individual most
exposed could be up to 0.7-in-1 million
due to actual emissions and 5-in-1
million based on MACT-allowable
emissions. These risks are considerably
less than 100-in-1 million, which is the
presumptive upper limit of acceptable
risk. The risk analysis also shows very
low cancer incidence (0.00004 cases per
year), as well as no potential for adverse
chronic or multi-pathway health effects.
In addition, the risk assessment
indicates no significant potential for
multi-pathway health effects or adverse
environmental effects. The acute noncancer risks based on actual emissions
are all below an HQ of 1. Therefore, we
find there is little potential concern of
acute non-cancer health impacts from
actual emissions. For acute non-cancer
risks based on allowable emissions,
there was an HQ of 4 based on the REL
for methylene chloride. Since the acute
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13
20
0
0
3
0
0.9
0
0
modeling scenario is worst-case because
of its confluence of peak emission rates
and worst-case dispersion conditions,
and since the HQ estimates for
methylene chloride based on the AEGL–
1 and ERPG–1 values for this facility are
below 1, we are proposing to find that
acute non-cancer health impacts of
concern are unlikely.
Considering all of the health risk
information and factors discussed
above, including the uncertainties
discussed in section III.A.8 of this
preamble, we propose that the risks
from the FPUF production source
category are acceptable.
2. Ample Margin of Safety Analysis and
Proposed Controls
Although we are proposing that the
risks from the FPUF production source
category are acceptable, risk estimates
for 700 individuals in the exposed
population are above 1-in-1 million at
the MACT-allowable emissions levels.
Consequently, we further considered
whether the FPUF Production MACT
standards provide an ample margin of
safety to protect public health at the
MACT-allowable emissions levels. In
this ample margin of safety analysis, we
investigated available emissions control
options that might reduce the risk
associated with MACT-allowable
emissions from the source category. We
considered this information along with
all of the health risks and other health
information considered in our
determination of risk acceptability.
For HAP used as an ABA at slabstock
foam production facilities, we
considered prohibiting facilities from
using any HAP or HAP-based product as
an ABA, as an option to reduce risks
from this source category. Emissions of
HAP ABA were shown to contribute
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nearly 100 percent to the maximum
individual cancer risks at the MACTallowable emissions level for this source
category. This control option would
require facilities to use ABAs that do
not contain HAP. We estimate the HAP
emissions reduction resulting from this
control option would be approximately
735 tpy from the baseline MACTallowable emissions level. We estimate
there would be no costs associated with
implementation of this option, as all
facilities in the source category are
reporting that they do not have HAP
ABA emissions from the foam
production line, and industry
representatives have confirmed that all
sources have already discontinued use
of a HAP or HAP-based product as an
ABA. Furthermore, there are no
additional costs associated with the
recordkeeping and reporting
requirements for compliance. With this
control option, we estimate the
maximum cancer risks based on
allowable emissions would be reduced
from 5-in-1 million to less than 1-in-1
million, the annual cancer incidence
would be reduced from 0.0004 to
0.00004, the acute HQ would be
reduced from 4 to less than 1 and the
non-cancer TOSHI would remain
unchanged. We believe this HAP ABA
prohibition is technically feasible for all
slabstock FPUF production operations
and is a cost-effective measure to
achieve emissions and health risk
reductions associated with the MACTallowable level of emissions. Therefore,
based on this analysis, we are proposing
under section 112(f)(2) of the CAA to
prohibit the use of HAP or HAP-based
products as ABAs.
We are proposing that the existing
MACT standards, as modified to include
the HAP-based ABA prohibition
described above, will provide an ample
margin of safety to protect public health
and prevent an adverse environmental
effect.
For diisocyanate storage vessels, as
discussed in section IV.C.2. of this
preamble, we identified one control
option to further reduce HAP emissions
from these storage vessels, which were
shown to contribute approximately 1
percent to the maximum individual
cancer risks at the MACT-allowable
emissions level for the source category.
This control option would require
sources to increase storage vessel HAP
emissions control efficiencies to 98
percent, using technologies such as
regenerative thermal oxidizers (RTO) or
recuperative thermal oxidizers (RCO).
We estimate the resulting HAP
reduction would be approximately
0.0026 tpy from the baseline MACTallowable emissions level. The
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estimated cost effectiveness per ton of
HAP emissions reduction would be
$124 million and $269 million, based on
using a RTO and RCO, respectively. The
additional control requirement would
not achieve a reduction in the maximum
individual cancer risks or any of the
other risk metrics due to emissions at
the MACT-allowable level. Due to the
minimal reductions in HAP emissions
and risk, along with the substantial
costs associated with this option, we are
proposing that additional HAP
emissions controls for FPUF production
diisocyanate storage vessels are not
necessary to provide an ample margin of
safety.
For equipment leaks at slabstock foam
production facilities, as discussed in
section IV.C.3. of this preamble, we
identified several control options to
further address risks from leaking
components. We estimate that up to 3
percent of the emissions and associated
risk at the MACT-allowable levels could
be attributed to equipment leaks.22 The
control options identified include the
use of ‘‘leakless’’ valves in diisocyanate
service at slabstock facilities and
implementation of an enhanced LDAR
program for diisocyanate equipment
leaks at slabstock facilities. These
control options would require sources to
use ‘‘leakless’’ valve technology or
implement a LDAR program that would
incorporate monitoring with EPA
Method 21, specific leak definitions,
and possibly a limit on the total number
of non-repairable equipment allowed.
We estimate the HAP reduction
resulting from the ‘‘leakless’’ valve
technology would be 1 tpy from the
baseline MACT-allowable emissions
level, with a cost effectiveness of
$305,000/ton HAP reduction. The HAP
emissions reduction resulting from an
enhanced LDAR program would be 0.38
tpy from the baseline MACT-allowable
emissions level, with a cost
effectiveness of approximately $74,000/
ton HAP reduction. The HAP emissions
reduction resulting from the portion of
an enhanced LDAR program that
incorporates limits on the total number
of non-repairable equipment allowed
would be 0.08 tpy from the baseline
MACT-allowable emissions level, with a
cost effectiveness of approximately
$234,000/ton HAP emissions reduction.
None of these additional control
requirements for diisocyanate
equipment leaks would achieve a
reduction in the maximum individual
22 Hazardous Air Pollutant Emissions from the
Production of Flexible Polyurethane Foam. Basis
and Purpose Document for Proposed Standards.’’
Page 6–9. U.S. EPA Office of Air Quality Planning
and Standards. September 1996.
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cancer risks or any of the other health
risk metrics. Due to the minimal
reductions in HAP emissions and risk,
along with the substantial costs
associated with these options, we are
proposing that additional HAP
emissions controls for FPUF production
diisocyanate equipment leaks are not
necessary to provide an ample margin of
safety.
3. Adverse Environmental Effects
We did not identify emissions of the
seven environmental HAP included in
our environmental risk screening, and
are unaware of any adverse
environmental effects caused by other
HAP emitted by this source category.
Therefore, we do not expect there to be
an adverse environmental effect as a
result of HAP emissions from this
source category, and we are proposing
that it is not necessary to set a more
stringent standard to prevent, taking
into consideration costs, energy, safety,
and other relevant factors, an adverse
environmental effect.
C. What are the results and proposed
decisions based on our technology
review?
As described in section III.C of this
preamble, our technology review
focused on identifying developments in
practices, processes and control
technologies for the emission sources in
the FPUF production source category.
The following sections summarize our
technology review results. More
information concerning our technology
review can be found in the
memorandum titled, Technology Review
and Cost Impacts for the Proposed
Amendments to the Flexible
Polyurethane Foam Production Source
Category, which is available in the
docket.
1. Slabstock Foam Production Line
The current MACT standards allow
limited use of HAP-based ABAs at
slabstock foam production facilities,
while prohibiting the use of HAP-based
products, with limited exceptions, for
specific purposes at other types of FPUF
production facilities (including
equipment cleaning, mixhead flushing
and facilitating mold release at molded
and rebond foam facilities). The FPUF
Production MACT standards also
prohibit HAP and HAP-based products
in equipment cleaners at slabstock foam
facilities (except at facilities operating
under the provisions for a source-wide
emission limit for a single HAP ABA).
Prohibiting the use of HAP-based ABAs
and HAP-based equipment cleaners at
slabstock foam production facilities has
been identified as a development in
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practices and/or processes that could
reduce HAP emissions from the
slabstock foam production line.
At the time of promulgation of the
FPUF MACT standards, the EPA
believed that HAP ABAs were necessary
for production of some grades of foam.
Therefore, the FPUF Production MACT
standards significantly limited the use
of HAP ABAs by slabstock foam
producers, but allowed their use in
production of certain grades of foam.
Available data from EPA databases,
industry survey responses and contacts
with state and local permitting agencies
show that none of the 13 facilities
currently identified as being subject to
the FPUF Production MACT standards
are using any HAP ABAs, or ABAs
containing HAP (i.e., HAP-based ABAs).
Further confirmation was received
through discussions with the
Polyurethane Foam Association (PFA), a
trade association representing the
slabstock polyurethane foam production
industry. Details of the discussion with
PFA are contained in Documentation of
Communications with Industry and
Regulatory Agency Contacts for the
Flexible Polyurethane Foam Industry,
which is available in the docket for this
rulemaking. The discontinuation of
HAP ABAs (or HAP-based ABAs) use by
FPUF producers demonstrates that foam
producers have improved their ability to
produce their products using
alternatives to HAP or HAP-based ABAs
since the promulgation of the original
FPUF Production NESHAP.
No facilities subject to subpart III are
currently using any HAP or HAP-based
ABAs. Therefore, there will be no cost
associated with codifying current
industry practice prohibiting the use of
HAP or HAP-based ABAs. There may be
small cost savings at some facilities due
to reduced monitoring and
recordkeeping costs. Because there are
no estimated costs, the industry is
already complying with this HAP and
HAP-based ABA prohibition in practice,
and reductions in allowable emissions
would be achieved, we are proposing
that it is necessary, pursuant to CAA
section 112(d)(6), to revise the MACT to
prohibit the use of HAP and HAP-based
ABAs at slabstock foam production
facilities. As noted in section IV.B.2., we
are concurrently proposing this HAP
and HAP-based ABA prohibition under
section 112(f)(2) of the CAA to provide
an ample margin of safety to protect
public health. Also, as noted in section
II.B, we solicit comments regarding
whether any facilities subject to subpart
III currently use HAP or HAP-based
ABAs.
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2. Diisocyanate Storage Vessels
The FPUF Production MACT
standards provide two compliance
options for diisocyanate storage vessels:
Equip the storage vessels (tanks) with a
vapor return line from the storage vessel
to the truck or rail car during unloading;
or equip the storage vessel with a carbon
adsorption system which routes
displaced vapors through activated
carbon. These control systems are
estimated to have control efficiencies of
95 percent. For the technology review,
we identified two potential control
options to capture and control
emissions from storage tanks:
Regenerative and recuperative thermal
oxidizers. Both reportedly have control
efficiencies of 98 percent, and known
application to low concentration organic
vapor gas streams. We estimate an
additional emission reduction of 0.0026
tpy would be associated with an
increase from 95 percent estimated HAP
control in the original FPUF MACT
standards to 98 percent HAP control
today. The estimated cost per ton of
emissions reduction would be $124
million and $270 million per ton of
HAP for regenerative and recuperative
thermal oxidizers, respectively.
Based on the high costs and the
minimal emissions reductions that
would be achieved by these
diisocyanate tank controls, we are
proposing that it is not necessary to
revise the MACT standards pursuant to
CAA section 112(d)(6) to provide for a
stricter level of control.
66125
associated with requiring this ‘‘leakless’’
valve technology for valves in
diisocyanate service in the FPUF
production source category using cost
estimates developed for the synthetic
organic chemical manufacturing
industry. Nationwide annual costs were
estimated to be $310,000/yr, with total
capital investments of $2,260,000.
Emission reductions were estimated to
be 1 tpy, resulting in a cost effectiveness
of $305,000/ton HAP reduction.
Based on the high costs and the
minimal emissions reductions that
would be achieved using this
technology, we are proposing that it is
not necessary to revise the MACT
standards pursuant to CAA section
112(d)(6) to require the installation of
‘‘leakless’’ valves.
a. ‘‘Leakless’’ Valves
b. Implementation of Enhanced LDAR
Programs
The current MACT standards require
an LDAR program that employs visual,
audible or other methods for detecting
leaks. This standard requires repair of
leaks within 15 calendar days when
leaks are detected by visual, audible or
any other detection method for
equipment, other than transfer pumps,
in diisocyanate service. Leakless
technology is required for transfer
pumps.
During the development of the MACT
standards, another LDAR program,
using Method 21, was identified as a
beyond-the-floor method for controlling
emissions from equipment leaks at
slabstock foam facilities for equipment
in diisocyanate service, but was not
chosen as the level of the standard. At
that time, the leak definition was set at
a HAP concentration of 10,000 ppm or
greater. Since the development of the
MACT standards, analyses have been
performed by the EPA regarding costs
and emission reductions in the chemical
and petroleum industries associated
with lowering the level at which a HAP
concentration is considered to be a leak
for LDAR programs.23 We used these
analyses in the CAA section 112(d)(6)
technology review for the FPUF
production source category to assess the
effects of adding an enhanced LDAR
program for metering pumps, valves,
connectors and open-ended lines in
diisocyanate service at slabstock foam
production facilities. The LDAR
program would incorporate monitoring,
employing Method 21 of 40 CFR part 60,
Appendix A, and lower leak definitions.
The lower leak definitions considered
‘‘Leakless’’ valves that significantly
reduce emissions are in place in some
facilities outside the FPUF production
source category, particularly oil
refineries. We analyzed the costs
23 Memorandum from Cindy Hancy, RTI to Jodi
Howard, EPA, Analysis of Emission Reduction
Techniques for Equipment Leaks, December 21,
2011. (EPA–HQ–OAR–2002–0037–0180.) See
Attachment 1.
3. Equipment Leaks
For equipment leaks, we identified
two developments in practices, process
or control technologies: Use of
‘‘leakless’’ valves in diisocyanate service
at slabstock facilities and
implementation of an enhanced
equipment LDAR for diisocyanate
equipment leaks at slabstock facilities.
While there are requirements for LDAR
in the original MACT standards, we
further investigated LDAR for
developments that have occurred since
the rule was promulgated. The two
developments in LDAR programs are a
limit on the total number of nonrepairable equipment allowed and the
inclusion of lower leak detection limits
for valves and connectors than those
considered previously for the MACT
standards.
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include two options identified in the
EPA analysis of emissions reduction
techniques for equipment leaks:
1. Leak definition for metering pumps
of 2,000 ppm; leak definition for valves,
connectors and open-ended lines of 500
ppm;
2. Leak definition for valves of 100
ppm; leak definition for metering
pumps, connectors and open-ended
lines of 500 ppm.
We analyzed the costs associated with
an LDAR programs with these two
options for leak definitions for
equipment in diisocyanate service. For
both options, nationwide total annual
costs were estimated to be around
$28,200/yr, with total capital
investments of approximately $32,400.
Reduction of HAP emissions were
estimated to be about 0.38 tpy, resulting
in a cost effectiveness of approximately
$74,000/ton HAP reduction.
The current MACT standards allow
leak repairs to be delayed under certain
circumstances. Limits on the number of
leaking components awaiting repair was
also identified as a potential
development in practice that could
reduce diisocyanate emissions from
equipment leaks. Both the California
Bay Area Air Quality Management
District (BAAQMD) and the South Coast
Air Quality Management District have
LDAR programs that limit the number of
leaking equipment components awaiting
repair. The BAAQMD rule also requires
mass emission testing for leaking valves
and requires valves with a high leak rate
to be repaired within 7 days. We
estimated the costs of requirements
addressing equipment awaiting leak
repair like those of the BAAQMD rule,
irrespective of the other costs for an
LDAR program. Nationwide annual
costs were estimated to be $18,212/yr,
with no capital investments required.
Emission reductions were estimated to
be 0.002 tpy, resulting in a cost
effectiveness of $233,770 per ton of HAP
reduction for equipment in diisocyanate
service at slabstock facilities.
Based on the high costs and the
minimal emissions reduction that
would be achieved with LDAR programs
using Method 21 and either of the leak
definition options, or with the
restrictions on equipment awaiting
repair, we are proposing that it is not
necessary to revise the MACT standards
pursuant to CAA section 112(d)(6) to
require an enhanced LDAR program.
However, we are adding a provision to
the rule to clarify that delay of leak
repairs for valves and connectors must
be completed within 6 months of
detection, as described in section
IV.D.4.
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D. What other actions are we proposing?
1. Startup, Shutdown and Malfunctions
a. Background
The United States Court of Appeals
for the District of Columbia Circuit
vacated portions of two provisions in
the EPA’s CAA section 112 regulations
governing the emissions of HAP during
periods of SSM. Sierra Club v. EPA, 551
F.3d 1019 (D.C. 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) holding that under
section 302(k) of the CAA, emissions
standards or limitations must be
continuous in nature and that the SSM
exemption violates the CAA’s
requirement that some section 112
standards apply continuously.
We are proposing the elimination of
the SSM exemption in this proposed
rule. Therefore, this proposed rule has
changed the indication of ‘‘Yes’’ to ‘‘No’’
in the General Provisions table (Table 2)
of this rule for § 63.6(f), in which
§ 63.6(f)(1) states, ‘‘The non-opacity
emission standards set forth in this part
shall apply at all times except during
periods of startup, shutdown, and
malfunction. . . .’’ Consistent with
Sierra Club v. EPA, the EPA is
proposing standards in this rule that
apply at all times. We are also proposing
several revisions to Table 2
(Applicability of General Provisions), as
is explained in more detail below. We
also are proposing to eliminate and
revise certain recordkeeping and
reporting requirements related to the
SSM exemption as further described
below.
The EPA has attempted to ensure that
the provisions we are proposing to
eliminate are inappropriate,
unnecessary, or redundant in the
absence of the SSM exemption. We are
specifically seeking comment on
whether we have successfully done so.
In proposing the standards in this
rule, the EPA has taken into account
startup and shutdown periods and, for
the reasons explained below, has not
proposed alternate standards for those
periods. Information on periods of
startup and shutdown received from the
facilities in the FPUF production
industry indicate that emissions during
these periods are the same as during
normal operations. The primary means
of compliance with the standards are
through work practices and product
substitutions, which eliminate the use
of HAP, and are in place at all times.
Therefore, separate standards for
periods of startup and shutdown are not
necessary and are not being proposed.
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Periods of startup, normal operations
and shutdown are all predictable and
routine aspects of a source’s operations.
However, by contrast, malfunction is
defined as a ‘‘sudden, infrequent, and
not reasonably preventable failure of air
pollution control and monitoring
equipment, process equipment or a
process to operate in a normal or usual
manner * * *’’ (40 CFR 63.2). The EPA
has determined that CAA section 112
does not require that emissions that
occur during periods of malfunction be
factored into development of CAA
section 112 standards. Under 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 the 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.
Section 112 of the CAA 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 (D.C. Cir. 1999)
(the 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
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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 nonmalfunctioning source. The EPA’s
approach to malfunctions is consistent
with CAA section 112 and is a
reasonable interpretation of the statute.
In the unlikely event that a source
fails to comply with the applicable CAA
section 112(d) standards as a result of a
malfunction event, the EPA would
determine an appropriate response
based on, among other things, the good
faith efforts of the source to minimize
emissions during malfunction periods,
including preventative and corrective
actions, as well as root cause analyses
to ascertain and rectify excess
emissions. The EPA would also
consider whether the source’s failure to
comply with the CAA section 112(d)
standard was, in fact, ‘‘sudden,
infrequent, not reasonably preventable’’
and was not instead ‘‘caused in part by
poor maintenance or careless
operation.’’ 40 CFR 63.2 (definition of
malfunction).
Finally, the EPA recognizes that even
equipment that is properly designed and
maintained can sometimes fail and that
such failure can sometimes cause a
violation of the relevant emission
standard. See, e.g., State
Implementation Plans: Response to
Petition for Rulemaking; Findings of
Excess Emissions During Periods of
Startup, Shutdown, and Malfunction;
Proposed rule, 78 FR 12460 (Feb. 22,
2013); State Implementation Plans:
Policy Regarding Excessive Emissions
During Malfunctions, Startup, and
Shutdown (Sept. 20, 1999); Policy on
Excess Emissions During Startup,
Shutdown, Maintenance, and
Malfunctions (Feb. 15, 1983). The EPA
is, therefore, proposing to add an
affirmative defense to civil penalties for
violations of emission standards that are
caused by malfunctions. (See 40 CFR
63.1292 defining ‘‘affirmative defense’’
to mean, in the context of an
enforcement proceeding, a response or
defense put forward by a defendant,
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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 are proposing
other regulatory provisions to specify
the elements that are necessary to
establish this affirmative defense; the
source must prove by a preponderance
of the evidence that it has met all of the
elements set forth in § 63.1290(e) (See
40 CFR 22.24). The criteria are designed
in part to ensure that the affirmative
defense is available only where the
event that causes a violation of the
emission standard meets the narrow
definition of malfunction in § 63.2
(sudden, infrequent, not reasonably
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 the violation ‘‘[w]as
caused by a sudden, infrequent, and
unavoidable failure of air pollution
control, process equipment, or a process
to operate in a normal or usual manner.
. . .’’ The criteria also are designed to
ensure that steps are taken to correct the
malfunction, to minimize emissions in
accordance with section 63.1290(d) and
to prevent future malfunctions. For
example, the source must prove by a
preponderance of the evidence that
‘‘[r]epairs were made as expeditiously as
possible when a violation occurred. . .’’
and that ‘‘[a]ll possible steps were taken
to minimize the impact of the violation
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 CAA section 113 (see also 40 CFR
22.27).
The EPA included an affirmative
defense in the proposed rule in an
attempt to balance a tension, inherent in
many types of air regulation, to ensure
adequate compliance while
simultaneously recognizing that despite
the most diligent of efforts, emission
standards may be violated under
circumstances beyond the control of the
source. The EPA must establish
emission standards that ‘‘limit the
quantity, rate, or concentration of
emissions of air pollutants on a
continuous basis.’’ 42 U.S.C. 7602(k)
(defining ‘‘emission limitation’’ and
‘‘emission standard’’). See generally
Sierra Club v. EPA, 551 F.3d 1019, 1021
(D.C. Cir. 2008) Thus, the EPA is
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66127
required to ensure that emissions
standards are continuous. The
affirmative defense for malfunction
events meets this requirement by
ensuring that even where there is a
malfunction, the emission standard is
still enforceable through injunctive
relief. The United States Court of
Appeals for the Fifth Circuit recently
upheld the EPA’s view that an
affirmative defense provision is
consistent with CAA section 113(e).
Luminant Generation Co. LLC v. United
States EPA, 714 F.3d 841 (5th Cir. Mar.
25, 2013) (upholding the EPA’s approval
of affirmative defense provisions in a
CAA State Implementation Plan). While
‘‘continuous’’ standards, on the one
hand, are required, there is also case law
indicating that in many situations it is
appropriate for the EPA to account for
the practical realities of technology. For
example, in Essex Chemical v.
Ruckelshaus, 486 F.2d 427, 433 (D.C.
Cir. 1973), the DC Circuit acknowledged
that in setting standards under CAA
section 111 ‘‘variant provisions’’ such as
provisions allowing for upsets during
startup, shutdown and equipment
malfunction ‘‘appear necessary to
preserve the reasonableness of the
standards as a whole and that the record
does not support the ‘never to be
exceeded’ standard currently in force.’’
See also, Portland Cement Association
v. Ruckelshaus, 486 F.2d 375 (D.C. Cir.
1973). Though intervening case law,
such as Sierra Club v. EPA and the CAA
1977 amendments, call into question the
relevance of these cases today, they
support the EPA’s view that a system
that incorporates some level of
flexibility is reasonable. The affirmative
defense simply provides for a defense to
civil penalties for violations that are
proven to be beyond the control of the
source. By incorporating an affirmative
defense, the EPA has formalized its
approach to malfunctions. In a Clean
Water Act setting, the Ninth Circuit
required this type of formalized
approach when regulating ‘‘upsets
beyond the control of the permit
holder.’’ Marathon Oil Co. v. EPA, 564
F.2d 1253, 1272–73 (9th Cir. 1977). See
also, Mont. Sulphur & Chem. Co. v.
EPA, 666 F.3d. 1174 (9th Cir. 2012)
(rejecting industry argument that
reliance on the affirmative defense was
not adequate). But see, Weyerhaeuser
Co. v. Costle, 590 F.2d 1011, 1057–58
(D.C. Cir. 1978) (holding that an
informal approach is adequate). The
affirmative defense provisions give the
EPA the flexibility to both ensure that
its emission standards are ‘‘continuous’’
as required by 42 U.S.C. 7602(k), and
account for unplanned upsets and thus
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support the reasonableness of the
standard as a whole. The EPA is
proposing the affirmative defense
applicable to malfunctions under the
delegation of general regulatory
authority set out in CAA section
301(a)(1), 42 U.S.C. 7601(a)(1), in order
to balance this tension between
provisions of the CAA and the practical
reality, as case law recognizes, that
technology sometimes fails. See
generally Citizens to Save Spencer
County v. U.S. Environmental
Protection Agency, 600 F.2d 844, 873
(D.C. Cir. 1979) (using CAA section
301(a) authority to harmonize
inconsistent guidelines related to the
implementation of federal
preconstruction review requirements).
EMCDONALD on DSK67QTVN1PROD with PROPOSALS2
b. Specific SSM-Related Proposed
Changes
To address the United States Court of
Appeals for the District of Columbia
Circuit vacatur of portions of the EPA’s
CAA section 112 regulations governing
the emissions of HAP during periods of
SSM, we are revising and adding certain
provisions to the FPUF Production rule.
As described in detail below, we are
revising the General Provisions (Table 2)
to change several of the references
related to requirements that apply
during periods of SSM. We are also
adding the following provisions to the
FPUF Production rule: (1) The general
duty to minimize emissions at all times,
(2) the requirement for sources to
comply with the emission limits in the
rule at all times, and (3) malfunction
recordkeeping and reporting
requirements.
i. § 63.1290(d)(4) General Duty
We are proposing to revise the
General Provisions table (Table 2) entry
for § 63.6(e)(1)-(2) by adding rows
specifically for § 63.6(e)(1)(i),
63.6(e)(1)(ii) and 63.6(e)(1)(iii) and to
include a ‘‘no’’ in the second column for
the § 63.6(e)(1)(i) entry. Section
63.6(e)(1)(i) describes the general duty
to minimize emissions. Some of the
language in that section is no longer
necessary or appropriate in light of the
elimination of the SSM exemption. We
are proposing instead to add general
duty regulatory text at § 63.1290(d)(4)
that reflects the general duty to
minimize emissions while eliminating
the reference to periods covered by an
SSM exemption. The current language
in 40 CFR 63.6(e)(1)(i) characterizes
what the general duty entails during
periods of SSM. With the elimination of
the SSM exemption, there is no need to
differentiate between normal operations,
startup and shutdown, and malfunction
events in describing the general duty.
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Therefore the language the EPA is
proposing does not include that
language from § 63.6(e)(1).
We are also proposing to include a
‘‘no’’ in the second column for the
newly added § 63.6(e)(1)(ii) entry.
Section 63.6(e)(1)(ii) imposes
requirements that are not necessary with
the elimination of the SSM exemption
or are redundant of the general duty
requirement being added at
§ 63.1290(d)(4).
ii. Compliance With Standards
We are proposing to revise the
General Provisions table (Table 2) entry
for § 63.6(f) by adding a specific entry
for § 63.6(f)(1) and including a ‘‘no’’ in
the second column for this § 63.6(f)(1)
entry. The current language of section
63.6, paragraph (f)(1) exempts sources
from non-opacity standards during
periods of SSM. As discussed above, the
court in Sierra Club vacated the
exemptions contained in this provision
and held that the CAA requires that
some CAA section 112 standard apply
continuously. Consistent with Sierra
Club, the EPA is proposing to revise
standards in this rule to apply at all
times.
iii. § 63.1307(h) Recordkeeping
We are proposing to revise the
General Provisions table (Table 2) entry
for § 63.10(a)–(b) by adding rows
specifically for § 63.10(a), 63.10(b)(1),
63.10 (b)(2)(i), 63.10 (b)(2)(ii), 63.10
(b)(2)(iii), 63.10 (b)(2)(iv)–(xi), 63.10
(b)(2)(xii), 63.10 (b)(xiii), and 63.10
(b)(2)(xiv) in order to specify changes
we are making to the applicability of
several of the § 63.10(b)(2) paragraphs.
In the entry for § 63.10(b)(2)(i), we are
including a ‘‘no’’ in the second column.
Section 63.10(b)(2)(i) describes the
recordkeeping requirements during
startup and shutdown. These recording
provisions are no longer necessary
because the EPA is proposing that
recordkeeping and reporting applicable
to normal operations will apply to
startup and shutdown. In the absence of
special provisions applicable to startup
and shutdown, such as a startup and
shutdown plan, there is no reason to
retain additional recordkeeping for
startup and shutdown periods.
In the entry for § 63.10(b)(2)(ii), we
are including a ‘‘no’’ in the second
column. Section 63.10(b)(2)(ii) describes
the recordkeeping requirements during
a malfunction. The EPA is proposing to
add such requirements to 40 CFR
63.1307(h). The regulatory text we are
proposing to add differs from the
General Provisions it is replacing in that
the General Provisions requires the
creation and retention of a record of the
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occurrence and duration of each
malfunction of process, air pollution
control, and monitoring equipment. The
EPA is proposing that this requirement
apply to any failure to meet an
applicable standard and is requiring that
the source record the date, time, and
duration of the failure rather than the
‘‘occurrence.’’ The EPA is also
proposing to add to § 63.1307(h) a
requirement that sources keep records
that include a list of the affected sources
or equipment and actions taken to
minimize emissions, an estimate of the
volume of each regulated pollutant
emitted over the standard for which the
source failed to meet a standard, and a
description of the method used to
estimate the emissions. Examples of
such methods would include productloss calculations, mass balance
calculations, measurements when
available, or engineering judgment
based on known process parameters.
The EPA is proposing to require that
sources keep records of this information
to ensure that there is adequate
information to allow the EPA to
determine the severity of any failure to
meet a standard, and to provide data
that may document how the source met
the general duty to minimize emissions
when the source has failed to meet an
applicable standard.
We are including a ‘‘no’’ in the second
column in the entry for § 63.10(b)(2)(iv)
and 63.10(b)(2)(v). When applicable, the
provisions require sources to record
actions taken during SSM events when
actions were inconsistent with their
SSM plan. These requirements are not
appropriate because SSM plans are not
(and were not) required by this rule, and
the General Provisions applicability
table referenced these sections in error.
iv. § 63.1306(f) Reporting
We are proposing to revise the
General Provisions table (Table 2) entry
for § 63.10(d)(4)–(5) by adding a specific
entry for § 63.10(d)(5) and including a
‘‘no’’ in the second column for this
§ 63.10(d)(5) entry. Section 63.10(d)(5)
describes the reporting requirements for
startups, shutdowns, and malfunctions.
To replace the General Provisions
reporting requirement, the EPA is
proposing to add reporting requirements
to 40 CFR 63.1306(f). The replacement
language differs from the General
Provisions requirement in that it
eliminates periodic SSM reports as a
stand-alone report. We are proposing
language that requires sources that fail
to meet an applicable standard at any
time to report the information
concerning such events in the semiannual report for slabstock affected
sources and in the annual compliance
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certification for molded and rebond
affected sources, which are already
required under this rule. We are
proposing that the malfunction report
must contain the number, date, time,
duration, and the cause of such events
(including unknown cause, if
applicable), a list of the affected sources
or equipment, an estimate of the volume
of each regulated pollutant emitted over
any emission limit, and a description of
the method used to estimate the
emissions.
Examples of such methods would
include product-loss calculations, mass
balance calculations, measurements
when available, or engineering
judgment based on known process
parameters. The EPA is proposing this
requirement to ensure that there is
adequate information to determine
compliance, to allow the EPA to
determine the severity of the failure to
meet an applicable standard, and to
provide data that may document how
the source met the general duty to
minimize emissions during a failure to
meet an applicable standard.
The proposed rule eliminates the
cross reference to section 63.10(d)(5)(i)
that contains the description of the
previously required SSM report format
and submittal schedule from this
section. These specifications are no
longer necessary because the events will
be reported in otherwise required
reports with similar format and
submittal requirements.
We note that reporting a failure to
meet an applicable standard could
include malfunction events for which a
source may choose to submit
documentation to support an assertion
of affirmative defense. If a source
provides all the material required in
section 63.1290(e) to support an
affirmative defense, the source need not
submit the same information two times
in the same report. While assertion of an
affirmative defense is not mandatory
and occurs only if a source chooses to
take advantage of the affirmative
defense, the affirmative defense also
requires additional reporting that goes
beyond these routine requirements
related to a failure to meet an applicable
standard for a reason other than a
malfunction.
The proposed rule also eliminates the
cross-reference to section 63.10(d)(5)(ii).
Section 63.10(d)(5)(ii) describes an
immediate report for startups,
shutdown, and malfunctions when a
source failed to meet an applicable
standard but did not follow the SSM
plan. These requirements are not
appropriate because SSM plans are not
required by this rule, and the General
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Provisions applicability table referenced
this section in error.
2. Electronic Reporting of Performance
Test Data
In this proposal, the EPA is describing
a process to increase the ease and
efficiency of performance test data
submittal while improving data
accessibility. Specifically, the EPA is
proposing that owners and operators of
FPUF production facilities submit
electronic copies of required
performance test reports by direct
computer-to-computer electronic
transfer using EPA-provided software.
The direct computer-to-computer
electronic transfer is accomplished
through the EPA’s Central Data
Exchange (CDX) using the Compliance
and Emissions Data Reporting Interface
(CEDRI). The CDX is EPA’s portal for
submittal of electronic data. The EPAprovided software is called the
Electronic Reporting Tool (ERT) which
is used to generate electronic reports of
performance tests and evaluations. The
ERT generates an electronic report
package which will be submitted using
the CEDRI. The submitted report
package will be stored in the CDX
archive (the official copy of record) and
EPA’s public database called WebFIRE.
All stakeholders will have access to all
reports and data in WebFIRE and
accessing these reports and data will be
very straightforward and easy (see the
WebFIRE Report Search and Retrieval
link at https://cfpub.epa.gov/webfire/
index.cfm?action
=fire.searchERTSubmission). A
description and instructions for use of
the ERT can be found at https://
www.epa.gov/ttn/chief/ert/
and CEDRI can be accessed through the
CDX Web site (www.epa.gov/cdx). A
description of the WebFIRE database is
available at: https://cfpub.epa.gov/
oarweb/index.cfm?action=fire.main.
The proposal to submit performance
test data electronically to the EPA
applies only to those performance tests
conducted using test methods that are
supported by the ERT. The ERT
supports 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/.
We believe that industry would
benefit from this proposed approach to
electronic data submittal. Specifically,
by using this approach, industry will
save time in the performance test
submittal process. Additionally, the
standardized format that the ERT uses
allows sources to create a more
complete test report resulting in less
time spent on data backfilling if a source
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failed to include all data elements
required to be submitted. Also through
this proposal industry may only need to
submit a report once to meet the
requirements of the applicable subpart
because stakeholders can readily access
these reports from the WebFIRE
database. This also benefits industry by
cutting back on recordkeeping costs as
the performance test reports that are
submitted to the EPA using CEDRI are
no longer required to be retained in hard
copy, thereby, reducing staff time
needed to coordinate these records.
Since the EPA will already have
performance test data in hand, another
benefit to industry is that fewer or less
substantial data collection requests in
conjunction with prospective required
residual risk assessments or technology
reviews will be needed. This would
result in a decrease in staff time needed
to respond to data collection requests.
State, local and tribal air pollution
control agencies (S/L/Ts) may also
benefit from having electronic versions
of the reports they are now receiving.
For example, S/L/Ts may be able to
conduct a more streamlined and
accurate review of electronic data
submitted to them. For example, the
ERT would allow for an electronic
review process, rather than a manual
data assessment, therefore, making
review and evaluation of the source
provided data and calculations easier
and more efficient. In addition, the
public stands to benefit from electronic
reporting of emissions data because the
electronic data will be easier for the
public to access. How the air emissions
data are collected, accessed and
reviewed will be more transparent for
all stakeholders.
One major advantage of the proposed
submittal of performance test data
through the ERT is a standardized
method to compile and store much of
the documentation required to be
reported by this proposed rule. The ERT
clearly states what testing information
would be required by the test method
and has the ability to house additional
data elements that might be required by
a delegated authority.
In addition the EPA must have
performance test data to conduct
effective reviews of CAA sections 111,
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, the
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. In recent
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EMCDONALD on DSK67QTVN1PROD with PROPOSALS2
years, though, stack testing firms have
typically collected performance test data
in electronic format, 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.
A common complaint heard from
industry and regulators is that emission
factors are outdated or not
representative of a particular source
category. With timely receipt and
incorporation of data from most
performance tests, the EPA would be
able to ensure that emission factors,
when updated, represent the most
current range of operational practices.
Another benefit of the proposed data
submittal to WebFIRE electronically is
that these data would greatly improve
the overall quality of existing and new
emissions factors by supplementing the
pool of emissions test data for
establishing emissions factors.
Finally, the general public would also
benefit from electronic reporting of
emissions data because the data would
be available for viewing sooner and
would be easier for the public to access.
The EPA Web site that stores the
submitted electronic data will be easily
accessible to the public and will provide
a user-friendly interface that any
stakeholder could access.
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 would save industry, state,
local, tribal agencies and the EPA
significant time, money and effort,
while also improving the quality of
emission inventories and air quality
regulations. Electronic databases will
also benefit the general public by
improving accessibility to emissions
data in an efficient and timely manner.
3. Clarification to Diisocyanate Storage
Vessels Leak Detection Methods
The EPA is proposing to clarify the
leak detection methods that may be
used for diisocyanate storage vessels at
slabstock foam production facilities
during unloading events. The current
requirements allow the vapor return line
to be inspected for leaks during
unloading events using visual, audible
or any other detection method. Today,
the EPA is proposing to clarify, that
‘‘any other detection method’’ must be
an instrumental detection method.
4. Clarification to Diisocyanate
Equipment Leak Delay of Repair
Requirements for Valves and Connectors
The FPUF Production MACT
standards generally require equipment
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leaks to be repaired within 15 days.
However, there are also provisions that
allow for a delay of repair. A delay of
repair for pumps is allowed if repair
requires replacing the existing seal
design with a sealless pump, and the
repair is completed as soon as
practicable, but not later than 6 months
after the leak is detected. For valves and
connectors, a delay of repair is allowed
if the owner or operator determines that
diisocyanate emissions of purged
material resulting from immediate
repair are greater than the fugitive
emissions likely to result from a delay
of repair. However, for valves and
connectors, the current provisions do
not state how long such a delay may
last. To be consistent with the
requirements for pumps, we are
proposing to clarify that, for valves and
connectors, the repair must be
completed as soon as practicable, but
not later than 6 months after the leak
was detected.
E. What compliance dates are we
proposing?
We are proposing that FPUF
production facilities comply with the
new proposed requirements prohibiting
the use of HAP ABAs in this action no
later than 90 days after the effective date
of the final rule. This time period will
be sufficient because all FPUF
production facilities have already
discontinued use of HAP ABAs.
We are proposing that facilities must
comply with the SSM reporting and
recordkeeping requirements and
affirmative defense provisions, and
requirements for electronic reporting on
the effective date of the rule. We are
proposing these compliance dates
because the revised SSM requirements
should be immediately implementable
by the facilities upon the next
occurrence of a malfunction, and the
electronic reporting requirements
should be immediately implementable
by the facilities upon their next
performance test.
V. Summary of Cost, Environmental
and Economic Impacts
A. What are the affected sources?
We anticipate that 13 FPUF
production facilities currently operating
in the United States will be affected by
these proposed amendments. We also
expect no new facilities to be
constructed in the foreseeable future.
For more information about expected
new facilities, see the document titled,
Documentation of Communications
with Industry and Regulatory Agency
Contacts for the Flexible Polyurethane
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Foam Industry, located in the docket for
this action.
B. What are the air quality impacts?
The EPA estimates that the proposed
amendments to the FPUF Production
MACT standards will not result in any
directly quantifiable reduction of HAP
emissions. Emissions of HAP from
FPUF production sources have
significantly declined since
promulgation of the FPUF Production
MACT standards because HAP ABAs
are no longer used by FPUF production
facilities. However, as discussed in
section III.A.2, the MACT standards
currently allow sources to use HAP
ABAs. We estimate that the MACTallowable emissions for the FPUF
production source category are 735 tons
of HAP ABAs. If the proposed revision
prohibiting the use of HAP ABAs is
finalized, the MACT-allowable
emissions from ABA use would be zero.
A detailed documentation of the
analysis can be found in: MACTAllowable Emissions for the Flexible
Polyurethane Foam Production Source
Category, which is available in the
docket for this rulemaking.
C. What are the cost impacts?
Under the proposed amendments,
FPUF production facilities are not
expected to incur any costs. However,
there may be small cost savings at some
facilities due to reduced monitoring and
recordkeeping costs. The memorandum,
Technology Review and Cost Impacts
for the Proposed Amendments to the
Flexible Polyurethane Foam Production
Source Category, includes a complete
description of the cost estimate methods
used for the analyses related to the
proposed HAP and HAP-based ABA
prohibition and is available in the
docket.
D. What are the economic impacts?
Because no costs or a small cost
savings are expected as a result of the
proposed amendments, there will not be
any significant impacts on affected firms
and their consumers as a result of this
proposal.
Because no small firms face
significant control costs, there is no
significant impact on small entities.
Thus, this regulation is not expected to
have a significant impact on a
substantial number of small entities.
E. What are the benefits?
We do not anticipate any significant
actual emission reductions of HAP as a
result of these proposed amendments.
However, if finalized, the proposed
prohibition on HAP ABA use would
eliminate the possibility that facilities
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might begin to use HAP ABAs again.
Under the existing rule, those possible
emissions are estimated at 735 tons of
HAP ABAs. If the prohibition is
adopted, no emissions of HAP ABA
would be allowed by the standard.
VI. Request for Comments
We solicit comments on all aspects of
this proposed action. In addition to
general comments on this proposed
action, we are also interested in
additional data that may improve the
risk assessments and other analyses. We
are specifically interested in receiving
any improvements to the data used in
the site-specific emissions profiles used
for risk modeling. Such data should
include supporting documentation in
sufficient detail to allow
characterization of the quality and
representativeness of the data or
information. Section VII of this
preamble provides more information on
submitting data.
EMCDONALD on DSK67QTVN1PROD with PROPOSALS2
VII. Submitting Data Corrections
The site-specific emissions profiles
used in the source category risk and
demographic analyses and instructions
are available on the RTR Web page at:
https://www.epa.gov/ttn/atw/rrisk/
rtrpg.html. The data files include
detailed information for each HAP
emissions release point for the facilities
in the source category.
If you believe that the data are not
representative or are inaccurate, please
identify the data in question, provide
your reason for concern and provide any
‘‘improved’’ data that you have, if
available. When you submit data, we
request that you provide documentation
of the basis for the revised values to
support your suggested changes. To
submit comments on the data
downloaded from the RTR page,
complete the following steps:
1. Within this downloaded file, enter
suggested revisions to the data fields
appropriate for that information.
2. Fill in the commenter information
fields for each suggested revision (i.e.,
commenter name, commenter
organization, commenter email address,
commenter phone number and revision
comments).
3. Gather documentation for any
suggested emissions revisions (e.g.,
performance test reports, material
balance calculations, etc.).
4. Send the entire downloaded file
with suggested revisions in Microsoft®
Access format and all accompanying
documentation to Docket ID Number
EPA–HQ–OAR–2012–0510 (through one
of the methods described in the
ADDRESSES section of this preamble).
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5. If you are providing comments on
a single facility or multiple facilities,
you need only submit one file for all
facilities. The file should contain all
suggested changes for all sources at that
facility. We request that all data revision
comments be submitted in the form of
updated Microsoft® Excel files that are
generated by the Microsoft® Access file.
These files are provided on the RTR
Web page at: https://www.epa.gov/ttn/
atw/rrisk/rtrpg.html.
VIII. Statutory and Executive Order
Reviews
A. Executive Order 12866: Regulatory
Planning and Review and Executive
Order 13563: Improving Regulation and
Regulatory Review
This action is not a ‘‘significant
regulatory action’’ under the terms of
Executive Order 12866 (58 FR 51735,
October 4, 1993) and is therefore not
subject to review under Executive
Orders 12866 and 13563 (76 FR 3821,
January 21, 2011).
B. Paperwork Reduction Act
The information collection
requirements in this proposed rule have
been submitted for approval to OMB
under the Paperwork Reduction Act, 44
U.S.C. 3501, et seq. The Information
Collection Request (ICR) document
prepared by the EPA has been assigned
EPA ICR number 1783.07.
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 emissions standards. These
recordkeeping and reporting
requirements are specifically authorized
by CAA section 114 (42 U.S.C. 7414).
All information submitted to the EPA
pursuant to the recordkeeping and
reporting requirements for which a
claim of confidentiality is made is
safeguarded according to agency
policies set forth in 40 CFR part 2,
subpart B.
For this proposed rule, the EPA is
adding affirmative defense to the
estimate of burden in the ICR. To
provide the public with an estimate of
the relative magnitude of the burden
associated with an assertion of the
affirmative defense position adopted by
a source, the EPA has provided
administrative adjustments to this ICR
to show what the notification,
recordkeeping and reporting
requirements associated with the
assertion of the affirmative defense
might entail. The EPA’s estimate for the
required notification, reports and
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records for any individual incident,
including the root cause analysis, totals
$2,188 for the FPUF production source
category, and is based on the time and
effort required of a source to review
relevant data, interview plant
employees, and document the events
surrounding a malfunction that has
caused an exceedance of an emissions
limit. The estimate also includes time to
produce and retain the record and
reports for submission to the EPA. The
EPA provides this illustrative estimate
of this burden because these costs are
only incurred if there has been a
violation and a source chooses to take
advantage of the affirmative defense.
Given the variety of circumstances
under which malfunctions could occur,
as well as differences among sources’
operation and maintenance practices,
we cannot reliably predict the severity
and frequency of malfunction-related
excess emissions events for a particular
source. It is important to note that the
EPA has no basis currently for
estimating the number of malfunctions
that would qualify for an affirmative
defense. Current historical records
would be an inappropriate basis, as
source owners or operators previously
operated their facilities in recognition
that they were exempt from the
requirement to comply with emissions
standards during malfunctions. Of the
number of excess emissions events
reported by source operators, only a
small number would be expected to
result from a malfunction (based on the
definition above), and only a subset of
excess emissions caused by
malfunctions would result in the source
choosing to assert the affirmative
defense. Thus, we believe the number of
instances in which source operators
might be expected to avail themselves of
the affirmative defense will be
extremely small. With respect to the
FPUF production source category, we
estimate the annual recordkeeping and
reporting burden after the effective date
of the proposed rule for affirmative
defense to be 30 hours at a cost of
$2,188. We expect to gather information
on such events in the future and will
revise this estimate as better information
becomes available.
We estimate approximately 13
regulated entities are currently subject
to 40 CFR part 63, subpart III, and will
be subject to all proposed standards, a
decrease of 119 regulated entities from
our estimate for the previous ICR (EPA
ICR Number 1783.05, OMB Control
Number 2060–0357) for the FPUF
production source category. The annual
monitoring, reporting, and
recordkeeping burden for this collection
(averaged over the first 3 years after the
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effective date of the standards) for
subpart III (FPUF production), including
today’s proposed amendments, is
estimated to be $90,104 per year. This
includes 1,030 labor hours per year at a
total labor cost of $90,104 per year, and
total non-labor capital and operation
and maintenance costs of $0 per year.
This represents a decrease of $760,000
and 8,000 labor hours from the previous
ICR, due primarily to the reduction in
the estimated number of regulated
entities. Our estimate of the burden for
each regulated entity has increased by
$485 and 11 labor hours from the
previous ICR estimate. This increase in
burden for each regulated entity is not
due to the proposed amendments, but is
due to a correction of an error in the
total number of reports required per
year for slabstock foam producers. This
was previously estimated to be two
semi-annual reports per year, but this
estimate did not account for the annual
compliance report.
The total burden for the federal
government (averaged over the first 3
years after the effective date of the
standard) is estimated to be 67 hours per
year at a total labor cost of $3,607 per
year. Burden is defined at 5 CFR
1320.3(b). An agency may not conduct
or sponsor, and a person is not required
to respond to, a collection of
information unless it displays a
currently valid OMB control number.
The OMB control numbers for the EPA’s
regulations in 40 CFR are listed in 40
CFR part 9.
To comment on the agency’s need for
this information, the accuracy of the
provided burden estimates and any
suggested methods for minimizing
respondent burden, the EPA has
established a public docket for this rule,
which includes this ICR, under Docket
ID number EPA–HQ–OAR–2012–0510.
Submit any comments related to the ICR
to the EPA and OMB. See the ADDRESSES
section at the beginning of this notice
for where to submit comments to the
EPA. Send comments to OMB at the
Office of Information and Regulatory
Affairs, Office of Management and
Budget, 725 17th Street NW.,
Washington, DC 20503, Attention: Desk
Office for EPA. Because OMB is
required to make a decision concerning
the ICR between 30 and 60 days after
November 4, 2013, a comment to OMB
is best assured of having its full effect
if OMB receives it by December 4, 2013.
The final rule will respond to any OMB
or public comments on the information
collection requirements contained in
this proposal.
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C. Regulatory Flexibility Act
The Regulatory Flexibility Act
generally requires an agency to prepare
a regulatory flexibility analysis of any
rule subject to notice and comment
rulemaking requirements under the
Administrative Procedure Act or any
other statute unless the agency certifies
that the rule will not have a significant
economic impact on a substantial
number of small entities. Small entities
include small businesses, small
organizations, and small governmental
jurisdictions.
For purposes of assessing the impacts
of this proposed rule on small entities,
small entity is defined as: (1) A small
business as defined by the Small
Business Administration’s (SBA)
regulations at 13 CFR 121.201; (2) a
small governmental jurisdiction that is a
government of a city, county, town,
school district or special district with a
population of less than 50,000; and (3)
a small organization that is any not-forprofit enterprise that is independently
owned and operated and is not
dominant in its field.
After considering the economic
impacts of today’s proposed rule on
small entities, I certify that this action
will not have a significant economic
impact on a substantial number of small
entities. The small entities directly
regulated by this proposed rule are
small businesses. We have determined
that three facilities, or 23 percent of the
13 affected facilities, are small entities.
Total annualized costs for the proposed
rule are estimated to be $0, and no small
entities are projected to incur costs.
Because HAP ABAs are no longer used
by FPUF production facilities, there are
no impacts on any entities subject to
this rulemaking.
We continue to be interested in the
potential impacts of the proposed rule
on small entities and welcome
comments on issues related to such
impacts.
D. Unfunded Mandates Reform Act
This action contains no federal
mandate under the provisions of Title II
of the Unfunded Mandates Reform Act
of 1995 (UMRA), 2 U.S.C. 1531–1538 for
state, local, or tribal governments or the
private sector. This action imposes no
enforceable duties on any state, local or
tribal governments or the private sector.
Therefore, this action is not subject to
the requirements of sections 202 or 205
of the UMRA.
This action is also not subject to the
requirements of section 203 of UMRA
because it contains no regulatory
requirements that might significantly or
uniquely affect small governments
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because it contains no requirements that
apply to such governments nor does it
impose obligations upon them.
E. Executive Order 13132: Federalism
This proposed action does not have
federalism implications. It will not have
substantial direct effects on the states,
on the relationship between the national
government and the states, or on the
distribution of power and
responsibilities among the various
levels of government, as specified in
Executive Order 13132. This action will
not impose substantial direct
compliance costs on state or local
governments, nor will it preempt state
law, and none of the facilities subject to
this action are owned or operated by
state governments. Thus, Executive
Order 13132 does not apply to this
action.
In the spirit of Executive Order 13132,
and consistent with the EPA policy to
promote communications between the
EPA and state and local governments,
the EPA specifically solicits comment
on this action from state and local
officials.
F. Executive Order 13175: Consultation
and Coordination With Indian Tribal
Governments
This action does not have tribal
implications, as specified in Executive
Order 13175 (65 FR 67249, November 9,
2000). There are no FPUF production
facilities that are within 3 miles of tribal
lands. Thus, Executive Order 13175
does not apply to this action.
The EPA specifically solicits
additional comment on this proposed
action from tribal officials.
G. Executive Order 13045: Protection of
Children From Environmental Health
Risks and Safety Risks
This action is not subject to Executive
Order 13045 (62 FR 19885, April 23,
1997) because it is not economically
significant as defined in Executive
Order 12866, and because the agency
does not believe the environmental
health risks or safety risks addressed by
this action present a disproportionate
risk to children. This proposed action’s
health and risk assessments are
contained in section IV of this preamble.
The public is invited to submit
comments or identify peer-reviewed
studies and data that assess effects of
early life exposure to HAP emitted by
FPUF production facilities.
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H. Executive Order 13211: Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use
This action is not a ‘‘significant
energy action’’ as defined in Executive
Order 13211 (66 FR 28355 (May 22,
2001)), because it is not likely to have
a significant adverse effect on the
supply, distribution, or use of energy.
We have concluded that this rule is not
likely to have any adverse energy effects
because the proposed requirements of
this rule will not cause the additional
use of energy by any facilities in the
source category nor is there any
expected impact on sources in the
energy supply, distribution, or use
sectors related to the proposed
provisions of this rule.
I. National Technology Transfer and
Advancement Act
Section 12(d) of the National
Technology Transfer and Advancement
Act of 1995 (‘‘NTTAA’’), Public Law
104–113 (15 U.S.C. 272 note), directs
the EPA to use voluntary consensus
standards (VCS) in its regulatory
activities unless to do so would be
inconsistent with applicable law or
otherwise impractical. VCS are
technical standards (e.g., materials
specifications, test methods, sampling
procedures, and business practices) that
are developed or adopted by voluntary
consensus standards bodies. NTTAA
directs the EPA to provide Congress,
through OMB, explanations when the
agency decides not to use available and
applicable VCS.
The proposed rulemaking involves
technical standards. Therefore, the
agency conducted a search to identify
potentially applicable voluntary
consensus standards. However, we
identified no such standards, and none
were brought to our attention in
comments. Therefore, the EPA has
decided to use EPA Method 25A,
‘‘Determination of Total Gaseous
Organic Concentration Using a Flame
Ionization Analyzer,’’ 40 CFR part 60,
Appendix A, to measure organic
compound concentrations.
EPA welcomes comments on this
aspect of the proposed rulemaking and,
specifically, invites the public to
identify potentially-applicable
voluntary consensus standards and to
explain why such standards should be
used in this regulation.
J. Executive Order 12898: Federal
Actions To Address Environmental
Justice in Minority Populations and
Low-Income Populations
Executive Order 12898 (59 FR 7629,
February 16, 1994) establishes federal
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executive policy on environmental
justice. Its main provision directs
federal agencies, to the greatest extent
practicable and permitted by law, to
make environmental justice part of their
mission by identifying and addressing,
as appropriate, disproportionately high
and adverse human health or
environmental effects of their programs,
policies and activities on minority
populations and low-income
populations in the United States.
The EPA has determined that this
proposed rule will not have
disproportionately high and adverse
human health or environmental effects
on minority or low-income populations,
because it increases the level of
environmental protection for all affected
populations without having any
disproportionately high and adverse
human health or environmental effects
on any population, including any
minority or low-income population.
To gain a better understanding of the
source category and near source
populations, the EPA conducted a
proximity analysis on FPUF production
facilities to identify any
overrepresentation of minority, low
income or indigenous populations. This
analysis only gives some indication of
the prevalence of sub-populations that
may be exposed to air pollution from
the sources; it does not identify the
demographic characteristics of the most
highly affected individuals or
communities, nor does it quantify the
level of risk faced by those individuals
or communities. More information on
the source category’s risk can be found
in section IV of this preamble.
The proximity analysis reveals that
most demographic categories are below
or within 20 percent of their
corresponding national averages. The
one exception is the African American
population. The ratio of African
Americans living within 3 miles of any
source affected by this rule is 48 percent
higher than the national average (19
percent versus 13 percent); however, as
noted previously, risks from this source
category were found to be acceptable for
all populations. Additionally, the
proposed changes to the standard
increase the level of environmental
protection for all affected populations
by ensuring no future emissions
increases from the source category. The
proximity analysis results and the
details concerning their development
are presented in the August 2012
memorandum titled, Environmental
Justice Review: Flexible Polyurethane
Foam Production, a copy of which is
available in the docket for this action
(EPA–HQ–OAR–2012–0510).
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66133
List of Subjects in 40 CFR Part 63
Environmental protection, Air
pollution control, Hazardous
substances, Reporting and
recordkeeping requirements.
Dated: September 26, 2013.
Gina McCarthy,
Administrator.
For the reasons stated in the
preamble, the Environmental Protection
agency (EPA) proposes to amend title
40, chapter I, of the Code of Federal
Regulations (CFR) as follows:
PART 63—[AMENDED]
1. The authority citation for part 63
continues to read as follows:
■
Authority: 42 U.S.C. 7401 et seq.
Subpart III—National Emission
Standards for Hazardous Air Pollutants
for Flexible Polyurethane Foam
Production
2. Section 63.1290 is amended by:
a. Revising paragraph (c); and
b. Adding paragraphs (d) and (e).
The additions and revisions read as
follows:
■
■
■
§ 63.1290
Applicability.
*
*
*
*
*
(c) A process meeting one of the
following criteria listed in paragraphs
(c)(1) and (2) of this section shall not be
subject to the provisions of this subpart:
(1) A process exclusively dedicated to
the fabrication of flexible polyurethane
foam; or
(2) A research and development
process.
(d) Applicability of this subpart. (1)
The emission limitations set forth in
this subpart and the emission
limitations referred to in this subpart
shall apply at all times except during
periods of non-operation of the affected
source (or specific portion thereof)
resulting in cessation of the emissions to
which this subpart applies.
(2) Equipment leak requirements of
§ 63.1294 shall apply at all times except
during periods of non-operation of the
affected source (or specific portion
thereof) in which the lines are drained
and depressurized resulting in cessation
of the emissions to which the
equipment leak requirements apply.
(3) The owner or operator shall not
shut down items of equipment that are
required or utilized for compliance with
this subpart during times when
emissions are being routed to such items
of equipment if the shutdown would
contravene requirements of this subpart
applicable to such items of equipment.
(4) General duty. At all times, the
owner or operator must operate and
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maintain any affected source, including
associated air pollution control
equipment and monitoring equipment,
in a manner consistent with safety and
good air pollution control practices for
minimizing emissions. 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 the applicable
standard have been achieved.
Determination of whether a source is
operating in compliance with operation
and maintenance requirements will be
based on information available to the
Administrator, which may include, but
is not limited to, monitoring results,
review of operation and maintenance
procedures, review of operation and
maintenance records, and inspection of
the source.
(e) Affirmative defense for violation of
emission standards during malfunction.
In response to an action to enforce the
standards set forth in paragraphs
§§ 63.1293, 63.1294, 63.1297, 63.1298,
63.1300, and 63.1301, the owner or
operator may assert an affirmative
defense to a claim for civil penalties for
violations of such standards that are
caused by malfunction, as defined at 40
CFR 63.2. Appropriate penalties may be
assessed if the owner or operator fails to
meet their burden of proving all of the
requirements in the affirmative defense.
The affirmative defense shall not be
available for claims for injunctive relief.
(1) Assertion of affirmative defense.
To establish the affirmative defense in
any action to enforce such a standard,
the owner or operator must timely meet
the reporting requirements in paragraph
(e)(2) of this section, and must prove by
a preponderance of evidence that:
(i) The violation:
(A) Was caused by a sudden,
infrequent, and unavoidable failure of
air pollution control equipment, process
equipment, or a process to operate in a
normal or usual manner; and
(B) Could not have been prevented
through careful planning, proper design
or better operation and maintenance
practices; and
(C) Did not stem from any activity or
event that could have been foreseen and
avoided, or planned for; and
(D) Was not part of a recurring pattern
indicative of inadequate design,
operation, or maintenance; and
(ii) Repairs were made as
expeditiously as possible when a
violation occurred; and
(iii) The frequency, amount, and
duration of the violation (including any
bypass) were minimized to the
maximum extent practicable; and
(iv) If the violation resulted from a
bypass of control equipment or a
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process, then the bypass was
unavoidable to prevent loss of life,
personal injury, or severe property
damage; and
(v) All possible steps were taken to
minimize the impact of the violation on
ambient air quality, the environment,
and human health; and
(vi) All emissions monitoring and
control systems were kept in operation
if at all possible, consistent with safety
and good air pollution control practices;
and
(vii) All of the actions in response to
the violation were documented by
properly signed, contemporaneous
operating logs; and
(viii) At all times, the affected source
was operated in a manner consistent
with good practices for minimizing
emissions; and
(ix) A written root cause analysis has
been prepared, the purpose of which is
to determine, correct, and eliminate the
primary causes of the malfunction and
the violation resulting from the
malfunction event at issue. The analysis
shall also specify, using best monitoring
methods and engineering judgment, the
amount of any emissions that were the
result of the malfunction.
(2) Report. The owner or operator
seeking to assert an affirmative defense
shall submit a written report to the
Administrator with all necessary
supporting documentation, that
explains how it has met the
requirements set forth in paragraph
(e)(1) of this section. This affirmative
defense report shall be included in the
first periodic compliance, deviation
report or excess emission report
otherwise required after the initial
occurrence of the violation of the
relevant standard (which may be the
end of any applicable averaging period).
If such compliance, deviation report or
excess emission report is due less than
45 days after the initial occurrence of
the violation, the affirmative defense
report may be included in the second
compliance, deviation report or excess
emission report due after the initial
occurrence of the violation of the
relevant standard.
■ 3. Section 63.1291 is amended by
revising paragraph (a) to read as follows:
§ 63.1291
Compliance schedule.
(a) Existing affected sources shall be
in compliance with all provisions of this
subpart no later than October 8, 2001,
with the exception of § 63.1297.
Affected sources subject to the
requirements of § 63.1297 shall be in
compliance with the requirements of
this section on or before [DATE 90
DAYS AFTER DATE OF PUBLICATION
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OF FINAL RULE IN THE FEDERAL
REGISTER].
*
*
*
*
*
■ 4. Section 63.1292 is amended by:
■ a. Adding a definition for ‘‘affirmative
defense’’ in alphabetical order;
■ b. Revising the definitions for ‘‘HAPbased,’’ ‘‘Reconstructed source,’’
‘‘Storage vessel’’ and ‘‘Transfer pump’’;
and
■ c. Removing the definitions for ‘‘Highpressure mixhead,’’ ‘‘Indentation Force
Deflection (IFD),’’ ‘‘In HAP ABA
service,’’ ‘‘Recovery device,’’ ‘‘Run of
foam,’’ and ‘‘Transfer vehicle’’.
The additions and revisions read as
follows:
§ 63.1292
Definitions.
*
*
*
*
*
Affirmative defense means, in the
context of an enforcement proceeding, a
response or defense put forward by a
defendant, regarding which the
defendant has the burden of proof, and
the merits of which are independently
and objectively evaluated in a judicial
or administrative proceeding.
*
*
*
*
*
HAP-based means to contain 5
percent (by weight) or more of HAP.
This applies to equipment cleaners,
mixhead flushes, mold release agents
and ABA.
*
*
*
*
*
Reconstructed source means an
affected source undergoing
reconstruction, as defined in subpart A
of this part. For the purposes of this
subpart, process modifications made to
stop using HAP ABA or HAP-based
ABA to meet the requirements of this
subpart shall not be counted in
determining whether or not a change or
replacement meets the definition of
reconstruction.
*
*
*
*
*
Storage vessel means a tank or other
vessel that is used to store diisocyanates
for use in the production of flexible
polyurethane foam. Storage vessels do
not include vessels with capacities
smaller than 38 cubic meters (or 10,000
gallons).
Transfer pump means all pumps used
to transport diisocyanates that are not
metering pumps.
■ 5. Section 63.1293 is revised to read
as follows:
§ 63.1293 Standards for slabstock flexible
polyurethane foam production.
Each owner or operator of a new or
existing slabstock affected source shall
comply with §§ 63.1294, 63.1297 and
63.1298.
■ 6. Section 63.1294 is amended by
revising paragraphs (a)(1)(i), (c) and
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(d)(2)(ii), and by adding paragraph
(d)(2)(iii) to read as follows:
§ 63.1294 Standards for slabstock flexible
polyurethane foam production—
diisocyanate emissions.
(a) * * *
(1) * * *
(i) During each unloading event, the
vapor return line shall be inspected for
leaks by visual, audible, or an
instrumental detection method.
*
*
*
*
*
(c) Other components in diisocyanate
service. If evidence of a leak is found by
visual, audible, or an instrumental
detection method, it shall be repaired as
soon as practicable, but not later than 15
calendar days after it is detected, except
as provided in paragraph (d) of this
section. The first attempt at repair shall
be made no later than 5 calendar days
after each leak is detected.
(d) * * *
(2) * * *
(ii) The purged material is collected
and destroyed or recovered in a control
device when repair procedures are
effected, and
(iii) Repair is completed as soon as
practicable, but not later than 6 months
after the leak was detected.
*
*
*
*
*
§ 63.1295
■
■
■
[Removed and Reserved]
7. Remove and reserve § 63.1295.
§ 63.1296
§ 63.1297 Standards for slabstock flexible
polyurethane foam production—HAP ABA.
Each owner or operator of a new or
existing slabstock affected source shall
not use HAP or a HAP-based material as
an ABA.
■ 10. Revise § 63.1298 to read as
follows:
§ 63.1298 Standards for slabstock flexible
polyurethane foam production—HAP
emissions from equipment cleaning.
Each owner or operator of a new or
existing slabstock affected source shall
not use HAP or a HAP-based material as
an equipment cleaner.
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11. Remove and reserve § 63.1299.
12. Revise § 63.1302 to read as
follows:
■
■
§ 63.1302 Applicability of subpart A
requirements.
The owner or operator of an affected
source shall comply with the applicable
requirements of subpart A of this part,
as specified in Table 1 of this subpart.
■ 13. Section 63.1303 is amended by:
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Jkt 232001
Monitoring requirements.
*
*
*
*
*
(a) Monitoring requirements for
storage vessel carbon adsorption
systems. Each owner or operator using
a carbon adsorption system to meet the
requirements of § 63.1294(a) shall
monitor the concentration level of the
HAP or the organic compounds in the
exhaust vent stream (or outlet stream
exhaust) from the carbon adsorption
system at the frequency specified in
paragraphs (a)(1) or (2) of this section.
*
*
*
*
*
(b) Each owner or operator using a
carbon adsorption system to meet the
requirements of § 63.1294(a) shall
monitor the concentration level of total
organic compounds in the exhaust vent
stream (or outlet stream exhaust) from
the carbon adsorption system using 40
CFR part 60, Appendix A, Method 25A,
reported as propane. The measurement
shall be conducted over at least one 5minute interval during which the
storage vessel is being filled.
[Removed and Reserved]
14. Remove and reserve § 63.1304.
15. Section 63.1306 is amended by:
a. Removing paragraph (c);
b. Redesigating paragraphs (d) and (e)
as paragraphs (c) and (d);
■ c. Revising newly redesignated
paragraphs (c) introductory text and
(c)(3);
■ d. Revising newly redesignated
paragraph (d);
■ e. Revising paragraph (f);
■ f. Redesignating paragraph (g) as
paragraph (e);
■ g. Revising newly redesignated
paragraphs (e)(1) and (2); and
■ h. Adding a new paragraph (g).
The addition and revisions read as
follows:
■
■
■
■
§ 63.1306
Reporting requirements.
*
[Removed and Reserved]
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§ 63.1303
§ 63.1304
[Removed and Reserved]
8. Remove and reserve § 63.1296.
9. Revise § 63.1297 to read as follows:
§ 63.1299
a. Revising paragraph (a) introductory
text;
■ b. Removing paragraphs (a)(3) and
(a)(4);
■ c. Revising paragraph (b); and
■ d. Removing paragraphs (c), (d) and
(e).
The revisions read as follows:
■
*
*
*
*
(c) Notification of compliance status.
Each affected source shall submit a
notification of compliance status report
no later than 180 days after the
compliance date. For slabstock affected
sources, this report shall contain the
information listed in paragraphs (c)(1)
through (3) of this section, as applicable.
This report shall contain the
information listed in paragraph (c)(4) of
this section for molded foam processes
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66135
and in paragraph (c)(5) of this section
for rebond foam processes.
*
*
*
*
*
(3) A statement that the slabstock
foam affected source is in compliance
with §§ 63.1297 and 63.1298, or a
statement that slabstock foam processes
at an affected source are in compliance
with §§ 63.1297 and 63.1298.
*
*
*
*
*
(d) Semiannual reports. Each
slabstock affected source shall submit a
report containing the information
specified in paragraphs (d)(1) through
(3) of this section semiannually no later
than 60 days after the end of each 180
day period. The first report shall be
submitted no later than 240 days after
the date that the Notification of
Compliance Status is due and shall
cover the 6-month period beginning on
the date that the Notification of
Compliance Status Report is due.
(1) For sources complying with the
storage vessel provisions of § 63.1294(a)
using a carbon adsorption system,
unloading events that occurred after
breakthrough was detected and before
the carbon was replaced.
(2) Any equipment leaks that were not
repaired in accordance with
§§ 63.1294(b)(2)(iii) and 63.1294(c).
(3) Any leaks in vapor return lines
that were not repaired in accordance
with § 63.1294(a)(1)(ii).
(e) * * *
(1) The compliance certification shall
be based on information consistent with
that contained in § 63.1308, as
applicable.
(2) A compliance certification
required pursuant to a state or local
operating permit program may be used
to satisfy the requirements of this
section, provided that the compliance
certification is based on information
consistent with that contained in
§ 63.1308, and provided that the
Administrator has approved the state or
local operating permit program under
part 70 of this chapter.
*
*
*
*
*
(f) Malfunction reports. If a source
fails to meet an applicable standard,
slabstock affected sources must report
such events in the next semiannual
report and molded and rebond affected
sources must report such events in the
next annual compliance certification.
Report the number of failures to meet an
applicable standard. For each instance,
report the date, time and duration of
each failure. For each failure, the report
must include a list of the affected
sources or equipment, an estimate of the
volume of each regulated pollutant
emitted over any emission limit, and a
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description of the method used to
estimate the emissions.
(g) Within 60 days after the date of
completing each performance test (as
defined in § 63.2), you must submit the
results of the performance tests required
by this subpart according to the
methods specified in paragraphs (g)(1)
or (g)(2) of this section.
(1) For data collected using test
methods supported by the EPAprovided software, the owner or
operator shall submit the results of the
performance test to the EPA by direct
computer-to-computer electronic
transfer via EPA-provided software,
unless otherwise approved by the
Administrator. Owners or operators,
who claim that some of the information
being submitted for performance tests is
confidential business information (CBI),
must submit a complete file using EPAprovided software that includes
information claimed to be CBI on a
compact disk, flash drive, or other
commonly used electronic storage
media to the EPA. The electronic media
must be clearly marked as CBI and
mailed to U.S. EPA/OAQPS/CORE CBI
Office, Attention: WebFIRE
Administrator, MD C404–02, 4930 Old
Page Rd., Durham, NC 27703. The same
file with the CBI omitted must be
submitted to the EPA by direct
computer-to-computer electronic
transfer via EPA-provided software.
(2) For any performance test
conducted using test methods that are
not compatible with the EPA-provided
software, the owner or operator shall
submit the results of the performance
test to the Administrator at the
appropriate address listed in § 63.13.
■ 16. Section 63.1307 is amended by:
■ a. Removing paragraph (a)(2) and
redesignating paragraphs (a)(3) and
(a)(4) as paragraphs (a)(2) and (a)(3);
■ b. Revising the newly redesignated
paragraphs (a)(2) introductory text,
(a)(2)(ii), and (a)(3) introductory text;
■ c. Revising paragraph (b)(1);
■ d. Revising paragraphs (b)(3)
introductory text, (b)(3)(i) introductory
text and (b)(3)(i)(B);
■ e. Removing paragraph (b)(3)(i)(C);
■ f. Revising paragraphs (b)(3)(ii)
introductory text and (b)(3)(ii)(A);
■ g. Removing paragraph (b)(3)(ii)(D);
■ h. Redesignating paragraphs
(b)(3)(ii)(E) through (b)(3)(ii)(H) as
(b)(3)(ii)(D) through (b)(3)(ii)(G);
■ i. Revising paragraph (c);
■ j. Removing paragraph (d);
■ k. Redesignating paragraphs (e)
through (h) as (d) through (g);
■ l. Revising newly redesignated
paragraph (e); and
■ m. Adding paragraph (h).
The additions and revisions read as
follows:
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§ 63.1307
Recordkeeping requirements.
*
*
*
*
*
(a) * * *
(2) For storage vessels complying
through the use of a carbon adsorption
system, paragraphs (a)(2)(i) or (ii), and
paragraph (a)(2)(iii) of this section.
*
*
*
*
*
(ii) For affected sources monitoring at
an interval no greater than 20 percent of
the carbon replacement interval, in
accordance with § 63.1303(a)(2), the
records listed in paragraphs (a)(2)(ii)(A)
and (B) of this section.
*
*
*
*
*
(3) For storage vessels complying
through the use of a vapor return line,
paragraphs (a)(3)(i) through (iii) of this
section.
*
*
*
*
*
(b) * * * (1) A list of components in
diisocyanate service.
*
*
*
*
*
(3) When a leak is detected as
specified in §§ 63.1294(b)(2)(ii) and
63.1294(c), the requirements listed in
paragraphs (b)(3)(i) and (ii) of this
section apply:
(i) Leaking equipment shall be
identified in accordance with the
requirements in paragraphs (b)(3)(i)(A)
and (B) of this section.
*
*
*
*
*
(B) The identification on equipment
may be removed after it has been
repaired.
(ii) The information in paragraphs
(b)(2)(ii)(A) through (G) shall be
recorded for leaking components.
(A) The operator identification
number and the equipment
identification number.
*
*
*
*
*
(c) The owner or operator of an
affected source subject to § 63.1297 shall
maintain a product data sheet for each
ABA used which includes the HAP
content, in kg of HAP/kg solids (lb HAP/
lb solids).
*
*
*
*
*
(e) The owner or operator of an
affected source following the
compliance methods in § 63.1308(b)(1)
shall maintain records of each use of a
vapor return line during unloading, of
any leaks detected during unloading,
and of repairs of leaks detected during
unloading.
*
*
*
*
*
(h) Malfunction records. Records shall
be kept as specified in paragraphs (h)(1)
through (3) of this section for affected
sources. Records are not required for
emission points that do not require
control under this subpart.
(1) In the event that an affected unit
fails to meet an applicable standard,
PO 00000
Frm 00030
Fmt 4701
Sfmt 4702
record the number of failures. For each
failure, record the date, time and
duration of the failure.
(2) For each failure to meet an
applicable standard, record and retain a
list of the affected sources or equipment,
an estimate of the volume of each
regulated pollutant emitted over any
emission limit and a description of the
method used to estimate the emissions.
(3) Record actions taken to minimize
emissions in accordance with
§ 63.1290(d) and any corrective actions
taken to return the affected unit to its
normal or usual manner of operation.
■ 17. Section 63.1308 is amended by:
■ a. Revising paragraph (a) introductory
text;
■ b. Revising paragraphs (b)(3), (b)(6),
and (c);
■ c. Removing paragraph (d); and
■ d. Redesignating paragraph (e) as (d).
The revisions read as follows:
§ 63.1308
Compliance demonstrations.
(a) For each affected source,
compliance with the requirements
described in Tables 2 and 3 of this
subpart shall mean compliance with the
requirements contained in §§ 63.1293
through 63.1301, absent any credible
evidence to the contrary.
*
*
*
*
*
(b) * * *
(3) For each affected source
complying with § 63.1294(a) in
accordance with § 63.1294(a)(2) through
the alternative monitoring procedures in
§ 63.1303(a)(2), each unloading event
that the diisocyanate storage vessel is
not equipped with a carbon adsorption
system, each time that the carbon
adsorption system is not monitored for
breakthrough in accordance with
§ 63.1303(b)(1) or (2) at the interval
established in the design analysis, and
each unloading event that occurs when
the carbon is not replaced after an
indication of breakthrough;
*
*
*
*
*
(6) For each affected source
complying with § 63.1294(c), each
calendar day after 5 calendar days after
detection of a leak that a first attempt at
repair has not been made, and the
earlier of each calendar day after 15
calendar days after detection of a leak
that a leak is not repaired, or if a leak
is not repaired as soon as practicable,
each subsequent calendar day (with the
exception of situations meeting the
criteria of § 63.1294(d)).
(c) Slabstock affected sources. For
slabstock foam affected sources, failure
to meet the requirements contained in
§§ 63.1297 and 63.1298, respectively,
shall be considered a violation of this
subpart. Violation of each item listed in
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the following paragraphs shall be
considered a separate violation.
(1) For each slabstock foam affected
source subject to the provisions in
§ 63.1297, each calendar day that a HAP
ABA or HAP-based material is used as
an ABA;
(2) For each slabstock foam affected
source subject to the provisions of
§ 63.1298, each calendar day that a
HAP-based material is used as an
equipment cleaner.
*
*
*
*
*
■ 18. Section 63.1309 is amended by
removing paragraph (b)(4) and
redesignating paragraph (b)(5) as (b)(4).
19. Remove Table 1 to Subpart III of
part 63.
■ 20. Redesignate Table 2 to Subpart III
of Part 63 as Table 1 to Subpart III of
Part 63 and amend newly redesignated
Table 1 by:
■ a. Revising the heading of newly
redesignated Table 1;
■ b. Removing entry § 63.6(e)(1)–(2);
■ c. Adding entries § 63.6(e)(1)(i),
§ 63.6(e)(1)(ii) and § 63.6(e)(1)(iii);
■ d. Removing entry § 63.6(e)(3);
■ e. Adding entry § 63.6(e)(2)–(3):
■ f. Removing entry § 63.6(f)–(g);
■ g. Adding entries § 63.6(f)(1),
§ 63.6(f)(2)–(3), and § 63.6(g);
■
h. Removing entry § 63.10(a)–(b);
■ i. Adding entries § 63.10(a),
§ 63.10(b)(1), § 63.10(b)(2)(i),
§ 63.10(b)(2)(ii); § 63.10(b)(2)(iii);
§ 63.10(b)(2)(iv)–(xi); § 63.10(b)(2)(xii);
§ 63.10(b)(2)(xiii), § 63.10(b)(2)(xiv); and
§ 63.10(b)(3);
■ j. Removing entry § 63.10(d)(4)–(5);
and
■ k. Adding entries § 63.10(d)(4) and
§ 63.10(d)(5).
The additions and revisions read as
follows:
■
TABLE 1 TO SUBPART III OF PART 63—APPLICABILITY OF GENERAL PROVISIONS (40 CFR PART 63, SUBPART A) TO
SUBPART III
Subpart A reference
Applies to
subpart III
*
*
§ 63.6(e)(1)(i) ............................................
§ 63.6(e)(1)(ii) ...........................................
§ 63.6(e)(1)(iii) ..........................................
§ 63.6(e)(2)–(3) ........................................
§ 63.6(f)(1) ................................................
§ 63.6(f)(2)–(3) .........................................
§ 63.6(g) ...................................................
*
NO ....................
NO.
YES.
NO.
NO.
YES.
YES.
*
*
§ 63.10(a) .................................................
§ 63.10(b)(1) .............................................
§ 63.10(b)(2)(i) ..........................................
§ 63.10(b)(2)(ii) .........................................
*
YES.
YES.
NO.
NO ....................
§ 63.10(b)(2)(iii) ........................................
§ 63.10(b)(2)(iv)–(xi) .................................
§ 63.10(b)(2)(xii) .......................................
§ 63.10(b)(2)(xiii) ......................................
§ 63.10(b)(2)(xiv) ......................................
§ 63.10(b)(3) .............................................
YES.
NO.
YES.
NO.
YES.
YES.
*
*
§ 63.10(d)(4) .............................................
§ 63.10(d)(5) .............................................
*
YES.
NO ....................
*
*
*
21. Redesignate Table 3 to Subpart III
of Part 63 as Table 2 to Subpart III of
Part 63 and amend newly redesignated
Table 2 by:
■ a. Revising the heading for newly
redesignated Table 2;
EMCDONALD on DSK67QTVN1PROD with PROPOSALS2
■
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Comment
*
*
*
See § 63.1290(d)(4) for general duty requirement.
*
*
*
*
*
*
See § 63.1306(f) for malfunction reporting requirements.
*
*
b. Removing entries for HAP ABA
storage vessels § 63.1295, HAP ABA
pumps § 63.1296(a), HAP ABA valves
§ 63.1296(b), HAP ABA connectors
§ 63.1296(c), Pressure relief devices
§ 63.1296(d), Open-ended valves or
Frm 00031
*
See § 63.1307(h) for recordkeeping of (1) date, time and duration; (2) listing of affected source or equipment and an estimate of the volume of each regulated
pollutant emitted over the standard; and (3) actions to minimize emissions and
any actions taken at the discretion of the owner or operator to prevent recurrence of the failure to meet an applicable requirement.
■
PO 00000
*
*
Fmt 4701
Sfmt 4702
*
*
lines § 63.1296(e), and Production line
§ 63.1297; and
■ c. Adding an entry for ABAs
§ 63.1297.
The revisions and addition read as
follows:
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TABLE 2 TO SUBPART III OF PART 63—COMPLIANCE REQUIREMENTS FOR SLABSTOCK FOAM PRODUCTION AFFECTED
SOURCES
Emission point
compliance
option
Emission point
*
*
*
ABAs § 63.1297 ....................................................................
22. Remove Table 4 to Subpart III of
Part 63.
■ 23. Redesignate Table 5 to Subpart III
of Part 63 as Table 3 to Subpart III of
Part 63 and amend newly redesignated
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■
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Emission,
work practice,
and equipment
standards
*
N/A
Recordkeeping
*
§ 63.1297 ........................
Table 3 by revising the heading to read
as follows:
Table 3 to Subpart III of Part 63—
Compliance Requirements for Molded
PO 00000
Monitoring
*
§ 63.1307(e)
Fmt 4701
Sfmt 9990
*
........................
and Rebond Foam Production Affected
Sources
*
*
*
*
*
[FR Doc. 2013–24276 Filed 11–1–13; 8:45 am]
BILLING CODE 6560–50–P
Frm 00032
Reporting
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Agencies
[Federal Register Volume 78, Number 213 (Monday, November 4, 2013)]
[Proposed Rules]
[Pages 66107-66138]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-24276]
[[Page 66107]]
Vol. 78
Monday,
No. 213
November 4, 2013
Part II
Environmental Protection Agency
-----------------------------------------------------------------------
40 CFR Part 63
National Emissions Standards for Hazardous Air Pollutants Residual Risk
and Technology Review for Flexible Polyurethane Foam Production;
Proposed Rule
Federal Register / Vol. 78 , No. 213 / Monday, November 4, 2013 /
Proposed Rules
[[Page 66108]]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 63
[EPA-HQ-OAR-2012-0510; FRL-9900-94-OAR]
RIN 2060-AR58
National Emissions Standards for Hazardous Air Pollutants
Residual Risk and Technology Review for Flexible Polyurethane Foam
Production
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: The EPA is proposing amendments to the National Emissions
Standards for Hazardous Air Pollutants for Flexible Polyurethane Foam
Production to address the results of the residual risk and technology
review. In light of our review, we are proposing amendments that would
prohibit the use of hazardous air pollutant-based auxiliary blowing
agents for slabstock foam production facilities. In addition, the EPA
is proposing amendments to correct and clarify regulatory provisions
related to emissions during periods of startup, shutdown and
malfunction; to add provisions for affirmative defense; to add
requirements for reporting of performance testing through the
Electronic Reporting Tool; to revise compliance dates for applicable
proposed actions; to clarify the leak detection methods allowed for
diisocyanate storage vessels at slabstock foam production facilities;
and to revise the rule to add a schedule for delay of leak repairs for
valves and connectors.
DATES:
Comments. Comments must be received on or before December 4, 2013.
A copy of comments on the information collection provisions should be
submitted to the Office of Management and Budget (OMB) on or before
December 4, 2013.
Public Hearing. If anyone contacts the EPA requesting a public
hearing by November 14, 2013, the public hearing will be held on
November 20, 2013, from 10:00 a.m. to 4:00 p.m. on the EPA campus at
109 T.W. Alexander Drive in Research Triangle Park, North Carolina. If
EPA holds a public hearing, the EPA will keep the record of the hearing
open for 30 days after completion of the hearing to provide an
opportunity for submission of rebuttal and supplementary information.
ADDRESSES: Submit your comments, identified by Docket ID Number EPA-HQ-
OAR-2012-0510, by one of the following methods:
https://www.regulations.gov: Follow the on-line
instructions for submitting comments.
Email: a-and-r-Docket@epa.gov, Attention Docket ID Number
EPA-EPA-HQ-OAR-2012-0510.
Fax: (202) 566-9744, Attention Docket ID Number EPA-HQ-
OAR-2012-0510.
Mail: U.S. Postal Service, send comments to: EPA Docket
Center, EPA West (Air Docket), Attention Docket ID Number EPA-HQ-OAR-
2012-0510, U.S. Environmental Protection Agency, Mailcode: 2822T, 1200
Pennsylvania Ave. NW., Washington, DC 20460. Please include a total of
two copies. In addition, please mail a copy of your comments on the
information collection provisions to the Office of Information and
Regulatory Affairs, Office of Management and Budget, Attn: Desk Officer
for EPA, 725 17th Street NW., Washington, DC 20503.
Hand Delivery: U.S. Environmental Protection Agency, EPA
West (Air Docket), Room 3334, 1301 Constitution Ave. NW., Washington,
DC 20004, Attention Docket ID Number EPA-HQ-OAR-2012-0510. Such
deliveries are only accepted during the Docket's normal hours of
operation, and special arrangements should be made for deliveries of
boxed information.
Instructions. Direct your comments to Docket ID Number EPA-HQ-OAR-
2012-0510. The EPA's policy is that all comments received will be
included in the public docket without change and may be made available
online at https://www.regulations.gov, including any personal
information provided, unless the comment includes information claimed
to be confidential business information (CBI) or other information
whose disclosure is restricted by statute. Do not submit information
that you consider to be CBI or otherwise protected through https://www.regulations.gov or email. The https://www.regulations.gov Web site
is an ``anonymous access'' system, which means the EPA will not know
your identity or contact information unless you provide it in the body
of your comment. If you send an email comment directly to the EPA
without going through https://www.regulations.gov, your email address
will be automatically captured and included as part of the comment that
is placed in the public docket and made available on the Internet. If
you submit an electronic comment, the EPA recommends that you include
your name and other contact information in the body of your comment and
with any disk or CD-ROM you submit. If the EPA cannot read your comment
due to technical difficulties and cannot contact you for clarification,
the EPA may not be able to consider your comment. Electronic files
should not include special characters or any form of encryption and be
free of any defects or viruses. For additional information about the
EPA's public docket, visit the EPA Docket Center homepage at: https://www.epa.gov/dockets.
Docket. The EPA has established a docket for this rulemaking under
Docket ID Number EPA-HQ-OAR-2012-0510. All documents in the docket are
listed in the regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy. Publicly available docket
materials are available either electronically in regulations.gov or in
hard copy at the EPA Docket Center, EPA West, Room 3334, 1301
Constitution Ave. NW., Washington, DC. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the EPA Docket Center is (202)
566-1742.
Public Hearing. If anyone contacts the EPA requesting a public
hearing by November 14, 2013, the public hearing will be held on
November 20, 2013, from 10:00 a.m. to 4:00 p.m. on the EPA campus at
109 T.W. Alexander Drive in Research Triangle Park, North Carolina.
Persons interested in presenting oral testimony or inquiring as to
whether a public hearing will be held should contact Ms. Pamela
Garrett, Sector Policies and Programs Division (D243-01), Office of Air
Quality Planning and Standards, U.S. Environmental Protection Agency,
Research Triangle Park, North Carolina 27711; telephone number: (919)
541-7966; fax number: (919) 541-5450; and email address:
garrett.pamela@epa.gov.
FOR FURTHER INFORMATION CONTACT: For questions about this proposed
action, contact Ms. Kaye Whitfield, Sector Policies and Programs
Division (D243-02), Office of Air Quality Planning and Standards, U.S.
Environmental Protection Agency, Research Triangle Park, North Carolina
27711; telephone number: (919) 541-2509; fax number: (919) 541-5450;
and email address: whitfield.kaye@epa.gov. For specific information
regarding the risk modeling
[[Page 66109]]
methodology, contact Mr. Chris Sarsony, Health and Environmental
Impacts Division (C539-02), Office of Air Quality Planning and
Standards, U.S. Environmental Protection Agency, Research Triangle
Park, North Carolina 27711; telephone number: (919) 541-4843; fax
number: (919) 541-0840; and email address: sarsony.chris@epa.gov. For
information about the applicability of the National Emission Standards
for Hazardous Air Pollutants (NESHAP) to a particular entity, contact
Mr. Scott Throwe, Office of Enforcement and Compliance Assurance;
telephone number: (202) 564-7013; fax number: (202) 564-0050; and email
address: throwe.scott@epa.gov.
SUPPLEMENTARY INFORMATION:
Preamble Acronyms and Abbreviations
This preamble includes several acronyms and terms used to describe
industrial processes, data inventories and risk modeling. While this
list may not be exhaustive, to ease the reading of this preamble and
for reference purposes, the EPA defines the following terms and
acronyms here:
ABA auxiliary blowing agent
AEGL acute exposure guideline levels
AERMOD air dispersion model used by the HEM-3 model
BAAQMD Bay Area Air Quality Management District
CAA Clean Air Act
CalEPA California EPA
CBI Confidential Business Information
CDX Central Data Exchange
CEDRI Compliance and Emissions Data Reporting Interface
CFR Code of Federal Regulations
EIS Emission Inventory System
EPA Environmental Protection Agency
ERPG Emergency Response Planning Guidelines
ERT Electronic Reporting Tool
FPUF Flexible Polyurethane Foam
FR Federal Register
HAP hazardous air pollutants
HCl hydrogen chloride
HEM-3 Human Exposure Model, Version 1.1.0
HI hazard index
HF hydrogen fluoride
HQ hazard quotient
ICR information collection request
IRIS Integrated Risk Information System
kg kilogram
km kilometer
lb pound
LDAR leak detection and repair
MACT maximum achievable control technology
MACT Code Code within the National Emissions Inventory used to
identify processes included in a source category
mg/kg-day milligrams per kilogram per day
mg/m\3\ milligrams per cubic meter
MIR maximum individual risk
NAICS North American Industry Classification System
NEI National Emissions Inventory
NESHAP National Emissions Standards for Hazardous Air Pollutants
NRC National Research Council
NRDC Natural Resources Defense Council
NTTAA National Technology Transfer and Advancement Act
OAQPS Office of Air Quality Planning and Standards
OMB Office of Management and Budget
PB-HAP hazardous air pollutants known to be persistent and bio-
accumulative in the environment
POM polycyclic organic matter
PFA Polyurethane Foam Association
ppm parts per million
QA quality assurance
REL reference exposure level
RCO recuperative thermal oxidizer
RfC reference concentration
RfD reference dose or daily oral exposure
RTO regenerative thermal oxidizer
RTR residual risk and technology review
SAB Science Advisory Board
SBA Small Business Administration
S/L/Ts State, local, and tribal air pollution control agencies
SOP standing operating procedures
SSM startup, shutdown and malfunction
TOSHI target organ-specific hazard index
tpy tons per year
TRI Toxics Release Inventory
TRIM Total Risk Integrated Methodology
TTN Technology Transfer Network
UF uncertainty factors
[micro]g/m\3\ microgram per cubic meter
UMRA Unfunded Mandates Reform Act
URE unit risk estimate
VCS voluntary consensus standards
WWW world wide web
Organization of this Document. The information in this preamble is
organized as follows:
I. General Information
A. Does this action apply to me?
B. Where can I get a copy of this document and other related
information?
C. What should I consider as I prepare my comments for the EPA?
II. Background
A. What is the statutory authority for this action?
B. What is this source category and how do the MACT standards
regulate its HAP emissions?
C. What data collection activities were conducted to support
this action?
III. Analytical Procedures
A. How did we estimate post-MACT risks posed by the source
category?
B. How did we consider the risk results in making decisions for
this proposal?
C. How did we perform the technology review?
D. What other analyses and reviews were conducted in support of
this proposal and how did we conduct those analyses and reviews?
IV. Analytical Results and Proposed Decisions
A. What are the results of the risk assessment and analyses?
B. What are our proposed decisions regarding risk acceptability,
ample margin of safety and adverse environmental effects?
C. What are the results and proposed decisions based on our
technology review?
D. What other actions are we proposing?
E. What compliance dates are we proposing?
V. Summary of Cost, Environmental and Economic Impacts
A. What are the affected sources?
B. What are the air quality impacts?
C. What are the cost impacts?
D. What are the economic impacts?
E. What are the benefits?
VI. Request for Comments
VII. Submitting Data Corrections
VIII. Statutory and Executive Order Reviews
A. Executive Order 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
I. General Information
A. Does this action apply to me?
Table 1 of this preamble lists the industrial source category that
is the subject of this proposal. Table 1 is not intended to be
exhaustive but rather to provide a guide for readers regarding the
entities that this proposed action is likely to affect. The proposed
standards, once finalized, will be directly applicable to the affected
sources. One federal entity is affected by this proposed action, and no
state, local or tribal government entities are affected by this
proposed action. As defined in the ``Initial List of Categories of
Sources Under Section 112(c)(1) of the Clean Air Act Amendments of
1990'' (see 57 FR 31576, July 16, 1992), the ``Flexible Polyurethane
Foam Production'' source category is any facility engaged in the
[[Page 66110]]
manufacture of foam made from a polymer containing a plurality of
carbamate linkages in the chain backbone (polyurethane).\1\
---------------------------------------------------------------------------
\1\ U.S. EPA, 1992. Documentation for Developing the Initial
Source Category List--Final Report. EPA-450/3-91-030.
Table 1--NESHAP and Industrial Source Category Affected by This Proposed
Action
------------------------------------------------------------------------
NAICS code
Source category NESHAP \a\
------------------------------------------------------------------------
Flexible Polyurethane Foam Flexible Polyurethane 326150
Production. Foam Production.
------------------------------------------------------------------------
\a\ North American Industry Classification System
B. Where can I get a copy of this document and other related
information?
In addition to being available in the docket, an electronic copy of
this action is available on the Internet through the EPA's Technology
Transfer Network (TTN) Web site, a forum for information and technology
exchange in various areas of air pollution control. Following signature
by the EPA Administrator, the EPA will post a copy of this proposed
action on the TTN's policy and guidance page for newly proposed or
promulgated rules at: https://www.epa.gov/ttn/oarpg/t3pfpr.html.
Following publication in the Federal Register, the EPA will post the
Federal Register version of the proposal and key technical documents on
the project Web site: https://www.epa.gov/ttn/atw/foam/foampg.html.
Information on the overall residual risk and technology review (RTR)
program is available at the following Web site: https://www.epa.gov/ttn/atw/rrisk/rtrpg.html.
C. What should I consider as I prepare my comments for the EPA?
Submitting CBI. Do not submit information containing CBI to the EPA
through https://www.regulations.gov or email. Clearly mark the part or
all of the information that you claim to be CBI. For CBI information on
a disk or CD-ROM that you mail to the EPA, mark the outside of the disk
or CD-ROM as CBI and then identify electronically within the disk or
CD-ROM the specific information that is claimed as CBI. In addition to
one complete version of the comments that includes information claimed
as CBI, you must submit a copy of the comments that does not contain
the information claimed as CBI for inclusion in the public docket. If
you submit a CD-ROM or disk that does not contain CBI, mark the outside
of the disk or CD-ROM clearly that it does not contain CBI. Information
not marked as CBI will be included in the public docket and the EPA's
electronic public docket without prior notice. Information marked as
CBI will not be disclosed except in accordance with procedures set
forth in 40 Code of Federal Regulations (CFR) part 2. Send or deliver
information identified as CBI only to the following address: Roberto
Morales, OAQPS Document Control Officer (C404-02), OAQPS, U.S.
Environmental Protection Agency, Research Triangle Park, North Carolina
27711, Attention Docket ID Number EPA-HQ-OAR-2012-0510.
II. Background
A. What is the statutory authority for this action?
Section 112 of the Clean Air Act (CAA) establishes a two-stage
regulatory process to address emissions of hazardous air pollutants
(HAP) from stationary sources. In the first stage, after the EPA has
identified categories of sources emitting one or more of the HAP listed
in CAA section 112(b), CAA section 112(d) requires us to promulgate
technology-based NESHAP for those sources. ``Major sources'' are those
that emit or have the potential to emit 10 tons per year (tpy) or more
of a single HAP or 25 tpy or more of any combination of HAP. For major
sources, the technology-based NESHAP must reflect the maximum degree of
emissions 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.
MACT standards must reflect the maximum degree of emissions
reduction achievable through the application of measures, processes,
methods, systems or techniques, including, but not limited to, measures
that (1) reduce the volume of or eliminate pollutants through process
changes, substitution of materials or other modifications; (2) enclose
systems or processes to eliminate emissions; (3) capture or treat
pollutants when released from a process, stack, storage or fugitive
emissions point; (4) are design, equipment, work practice or
operational standards (including requirements for operator training or
certification); or (5) are a combination of the above. CAA section
112(d)(2)(A)-(E). The MACT standards may take the form of design,
equipment, work practice or operational standards where the EPA first
determines either that (1) a pollutant cannot be emitted through a
conveyance designed and constructed to emit or capture the pollutant,
or that any requirement for, or use of, such a conveyance would be
inconsistent with law; or (2) the application of measurement
methodology to a particular class of sources is not practicable due to
technological and economic limitations. CAA section 112(h)(1)-(2).
The MACT ``floor'' is the minimum control level allowed for MACT
standards promulgated under CAA section 112(d)(3) and may not be based
on cost considerations. For new sources, the MACT floor cannot be less
stringent than the emissions control that is achieved in practice by
the best-controlled similar source. The MACT floor for existing sources
can be less stringent than floors for new sources but not less
stringent than the average emissions 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
standards, the EPA must also consider control options that are more
stringent than the floor. We may establish standards more stringent
than the floor based on considerations of the cost of achieving the
emissions reductions, any non-air quality health and environmental
impacts and energy requirements.
The EPA is then required to review these technology-based standards
and revise them ``as necessary (taking into account developments in
practices, processes and control technologies)'' no
[[Page 66111]]
less frequently than every eight years. CAA section 112(d)(6). In
conducting this review, the EPA is not required to recalculate the MACT
floor. Natural Resources Defense Council (NRDC) v. EPA, 529 F.3d 1077,
1084 (D.C. Cir., 2008). Association of Battery Recyclers, Inc. v. EPA,
716 F.3d 667 (D.C. Cir. 2013).
The second stage in standard-setting focuses on reducing any
remaining (i.e., ``residual'') risk according to CAA section 112(f).
This provision requires, first, that the EPA prepare a report to
Congress discussing (among other things) methods of calculating the
risks posed (or potentially posed) by sources after implementation of
the MACT standards, the public health significance of those risks and
the EPA's recommendations as to legislation regarding such remaining
risk. The EPA prepared and submitted the Residual Risk Report to
Congress, EPA-453/R-99-001 (Risk Report) in March 1999. Congress did
not act in response, thereby triggering the EPA's obligation under CAA
section 112(f)(2) to analyze and address residual risk.
Section 112(f)(2) of the CAA requires the EPA to determine for
source categories subject to MACT standards whether the emission
standards provide an ample margin of safety to protect public health.
Section 112(f)(2)(B) of the CAA expressly preserves the EPA's use of
the two-step process for developing standards to address any residual
risk and the agency's interpretation of ``ample margin of safety''
developed in the National Emissions 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). The EPA notified Congress in the Risk
Report that the agency intended to use the Benzene NESHAP approach in
making CAA section 112(f) residual risk determinations (EPA-453/R-99-
001, p. ES-11). The EPA subsequently adopted this approach in its
residual risk determinations, and in a challenge to the risk review for
the Synthetic Organic Chemical Manufacturing source category, the
United States Court of Appeals for the District of Columbia Circuit
upheld as reasonable the EPA's interpretation that subsection 112(f)(2)
incorporates the standards established in the Benzene NESHAP. See NRDC
v. EPA, 529 F.3d 1077, 1083 (D.C. Cir. 2008) (``[S]ubsection
112(f)(2)(B) expressly incorporates the EPA's interpretation of the
Clean Air Act from the Benzene standard, complete with a citation to
the Federal Register.''); see also A Legislative History of the Clean
Air Act Amendments of 1990, vol. 1, p. 877 (Senate debate on Conference
Report).
The first step in this process is the determination of acceptable
risk. If risks are unacceptable, the EPA cannot consider cost in
identifying the emissions standards necessary to bring risks to an
acceptable level. The second step is the determination of whether
standards must be further revised in order to provide an ample margin
of safety to protect public health, which is the level at which the
standards must be set, unless an even more stringent standard is
necessary to prevent, taking into consideration costs, energy, safety
and other relevant factors, an adverse environmental effect.
1. Determining Acceptability
The agency in the Benzene NESHAP concluded that ``that the
acceptability of risk under section 112 is best judged on the basis of
a broad set of health risk measures and information'' and that the
``judgment on acceptability cannot be reduced to any single factor.''
Id. at 38046. The determination of what represents an ``acceptable''
risk is based on a judgment of ``what risks are acceptable in the world
in which we live'' (Risk Report at 178, quoting NRDC v. EPA, 824 F.2d
1146, 1165 (D.C. Cir. 1987) (en banc) (``Vinyl Chloride''), recognizing
that our world is not risk-free.
In the Benzene NESHAP, we stated that ``EPA will generally presume
that if the risk to [the maximum exposed] individual is no higher than
approximately one in 10 thousand, that risk level is considered
acceptable.'' 54 FR 38045. We discussed the maximum individual lifetime
cancer risk (or maximum individual risk (MIR)) as being ``the estimated
risk that a person living near a plant would have if he or she were
exposed to the maximum pollutant concentrations for 70 years.'' Id. We
explained that this measure of risk ``is an estimate of the upper bound
of risk based on conservative assumptions, such as continuous exposure
for 24 hours per day for 70 years.'' Id. We acknowledged that maximum
individual lifetime cancer risk ``does not necessarily reflect the true
risk, but displays a conservative risk level which is an upper-bound
that is unlikely to be exceeded.'' Id.
Understanding that there are both benefits and limitations to using
the MIR as a metric for determining acceptability, we acknowledged in
the Benzene NESHAP that ``consideration of maximum individual risk * *
* must take into account the strengths and weaknesses of this measure
of risk.'' Id. Consequently, the presumptive risk level of 100-in-1
million (1-in-10 thousand) provides a benchmark for judging the
acceptability of maximum individual lifetime cancer risk, but does not
constitute a rigid line for making that determination. Further, in the
Benzene NESHAP, we noted that:
[p]articular attention will also be accorded to the weight of
evidence presented in the risk assessment of potential
carcinogenicity or other health effects of a pollutant. While the
same numerical risk may be estimated for an exposure to a pollutant
judged to be a known human carcinogen, and to a pollutant considered
a possible human carcinogen based on limited animal test data, the
same weight cannot be accorded to both estimates. In considering the
potential public health effects of the two pollutants, the Agency's
judgment on acceptability, including the MIR, will be influenced by
the greater weight of evidence for the known human carcinogen.
Id. at 38046. The agency also explained in the Benzene NESHAP that:
[i]n establishing a presumption for MIR, rather than a rigid line
for acceptability, the Agency intends to weigh it with a series of
other health measures and factors. These include the overall
incidence of cancer or other serious health effects within the
exposed population, the numbers of persons exposed within each
individual lifetime risk range and associated incidence within,
typically, a 50 km exposure radius around facilities, the science
policy assumptions and estimation uncertainties associated with the
risk measures, weight of the scientific evidence for human health
effects, other quantified or unquantified health effects, effects
due to co-location of facilities, and co-emission of pollutants.
Id. At 38045. 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 that provided by maximum individual
lifetime cancer risk alone.
As noted earlier, in NRDC v. EPA, the court held that section
112(f)(2) ``incorporates the EPA's interpretation of the Clean Air Act
from the Benzene Standard.'' The court further held that Congress'
incorporation of the Benzene standard applies equally to carcinogens
and non-carcinogens. 529 F.3d at 1081-82. Accordingly, we also consider
non-cancer risk metrics in our determination of risk acceptability and
ample margin of safety.
2. Determination of Ample Margin of Safety
CAA section 112(f)(2) requires the EPA to determine, for source
categories subject to MACT standards, whether
[[Page 66112]]
those standards provide an ample margin of safety to protect public
health. As explained in the Benzene NESHAP, ``the second step of the
inquiry, determining an `ample margin of safety,' again includes
consideration of all of the health factors, and whether to reduce the
risks even further. . . . Beyond that information, additional factors
relating to the appropriate level of control will also be considered,
including costs and economic impacts of controls, technological
feasibility, uncertainties and any other relevant factors. Considering
all of these factors, the agency will establish the standard at a level
that provides an ample margin of safety to protect the public health,
as required by section 112.'' 54 FR 38046.
According to CAA section 112(f)(2)(A), if the MACT standards for
HAP ``classified as a known, probable, or possible human carcinogen do
not reduce lifetime excess cancer risks to the individual most exposed
to emissions from a source in the category or subcategory to less than
one in one million,'' the EPA must promulgate residual risk standards
for the source category (or subcategory), as necessary to provide an
ample margin of safety to protect public health. In doing so, the EPA
may adopt standards equal to existing MACT standards if the EPA
determines that the existing standards (i.e. the MACT standards) are
sufficiently protective. NRDC v. EPA, 529 F.3d 1077, 1083 (D.C. Cir.
2008) (``If EPA determines that the existing technology-based standards
provide an `ample margin of safety,' then the Agency is free to readopt
those standards during the residual risk rulemaking.'') The EPA must
also adopt more stringent standards, if necessary, to prevent an
adverse environmental effect,\2\ but must consider cost, energy, safety
and other relevant factors in doing so.
---------------------------------------------------------------------------
\2\ ``Adverse environmental effect'' is defined as any
significant and widespread adverse effect, which may be reasonably
anticipated to wildlife, aquatic life or natural resources,
including adverse impacts on populations of endangered or threatened
species or significant degradation of environmental qualities over
broad areas. CAA section 112(a)(7).
---------------------------------------------------------------------------
The CAA does not specifically define the terms ``individual most
exposed,'' ``acceptable level'' and ``ample margin of safety.'' In the
Benzene NESHAP, 54 FR 38044-38045, we stated as an overall objective:
In protecting public health with an ample margin of safety under
section 112, EPA strives to provide maximum feasible protection
against risks to health from hazardous air pollutants by (1)
protecting the greatest number of persons possible to an individual
lifetime risk level no higher than approximately 1-in-1 million and
(2) limiting to no higher than approximately 1-in-10 thousand [i.e.,
100-in-1 million] the estimated risk that a person living near a
plant would have if he or she were exposed to the maximum pollutant
concentrations for 70 years.
The agency further stated that ``[t]he EPA also considers incidence
(the number of persons estimated to suffer cancer or other serious
health effects as a result of exposure to a pollutant) to be an
important measure of the health risk to the exposed population.
Incidence measures the extent of health risks to the exposed population
as a whole, by providing an estimate of the occurrence of cancer or
other serious health effects in the exposed population.'' Id. at 38045.
In the ample margin of safety decision process, the agency again
considers all of the health risks and other health information
considered in the first step, including the incremental risk reduction
associated with standards more stringent than the MACT standard or a
more stringent standard that EPA has determined is necessary to ensure
risk is acceptable. In the ample margin of safety analysis, the agency
considers additional factors, including costs and economic impacts of
controls, technological feasibility, uncertainties and any other
relevant factors. Considering all of these factors, the agency will
establish the standard at a level that provides an ample margin of
safety to protect the public health, as required by CAA section 112(f).
54 FR 38046.
B. What is this source category and how do the MACT standards regulate
its HAP emissions?
The MACT standards for Flexible Polyurethane Foam (FPUF) Production
were promulgated on October 7, 1998, (63 FR 53980) and codified at 40
CFR part 63, subpart III. The FPUF Production MACT standards apply to
each new and existing flexible polyurethane foam or rebond foam process
that produces flexible polyurethane foam or rebond foam, emits HAP, and
is located at a contiguous, major source plant site. The requirements
of the standards are the same for both new and existing sources.
There are three types of FPUF producers in the source category:
Slabstock, molded and rebond. Slabstock foam is produced in large
continuous buns that are then cut into the desired size and shape.
Slabstock foam products are primarily used in furniture seat cushions
and bedding materials. Molded foam is produced by ``shooting'' the foam
mixture into a mold of the desired shape and size. Molded foam is
typically used in automotive seats, packaging and a range of specialty
products. Rebond foam is made from scrap foam that is converted into a
material primarily used for carpet underlay. Rebond foam production is
often co-located with slabstock foam production facilities.
Slabstock and molded polyurethane foams are produced by mixing
three major ingredients: A polyol polymer, an isocyanate and water. The
polyol is either a polyether or polyester polymer with hydroxyl end
groups. Other ingredients are often added to modify the polymer, and
catalysts are used to balance the principal foam production reactions.
Auxiliary blowing agents (ABAs) may be used to produce specific
densities and grades of foam where the gases produced by the
isocyanate-water reaction are insufficient to achieve the desired
density. ABAs are more widely used in the production of slabstock foams
than in the production of molded foams. Rebond foam is produced from
scrap slabstock or molded polyurethane foam.
The HAP emission points at FPUF production facilities depend on the
type of foam being produced. Prior to compliance with the original FPUF
Production MACT standards, the primary HAP emission point for slabstock
foam facilities was the foam production line, due to emissions of HAP
ABAs. Other HAP emission points at slabstock production facilities
include storage vessels and equipment leaks. At molded and rebond foam
facilities, the primary HAP emission points are storage vessels and
equipment leaks.
Many facilities discontinued use of HAP ABAs before the rule's
October 2001 compliance date, allowing these facilities to be
designated as area sources. Based on the best information available,
slabstock production facilities using HAP ABAs on, or after, the rule's
October 2001 compliance date also have discontinued use of HAP-based
ABAs. We solicit comment on the use of HAP-based ABAs and whether any
facilities in the FPUF production source category currently use these
products.
In the past decade, the FPUF production source category has
experienced plant closures and consolidations. Today, there are 13 FPUF
production facilities subject to the MACT standards: 7 slabstock, 6
molded and 2 rebond. One rebond facility is co-located with a slabstock
facility, and the other rebond facility is co-located with a molded
foam facility. A list of these facilities is included in the
memorandum, Development of the RTR
[[Page 66113]]
Emissions Dataset for the Flexible Polyurethane Foam Production Source
Category, which is available in the docket for this proposed
rulemaking.
The FPUF Production MACT standards contain requirements specific
for each of the three types of foam production processes. For slabstock
foam production, the FPUF Production MACT standards include
diisocyanate and HAP ABA emissions reduction requirements. For molded
and rebond foam production, the FPUF Production MACT standards prohibit
the use of HAP in mold release agents and equipment cleaners, except in
very limited circumstances.
For slabstock foam production, the FPUF Production MACT standards
regulate emissions of diisocyanates from storage vessels, transfer
pumps and equipment leaks. The storage vessel requirements include the
installation of either a vapor recovery system or a carbon adsorption
system. Transfer pumps are required to be either sealless pumps or
pumps submerged in a neutral oil, and submerged pumps must be visually
inspected periodically for leaks. All components in diisocyanate
service must be repaired when a leak is detected.
Standards for HAP ABA emissions at slabstock facilities include
emission point requirements for the foam production line, storage
vessels, equipment leaks and equipment cleaning. For the slabstock
production line, the FPUF Production MACT standards contain
restrictions on the amount of HAP ABAs that can be used, based on the
grades of foam produced. The FPUF Production MACT standards also
regulate HAP ABAs by requiring installation of either a vapor recovery
system or a carbon adsorption system on storage vessels. For equipment
leaks, the FPUF Production MACT standards require a leak detection and
repair program (LDAR) for HAP ABAs. The use of HAP or HAP-based
products for equipment cleaning is prohibited at slabstock flexible
polyurethane foam production facilities. This proposed rule also
includes an alternative source-wide HAP ABA emission limit. The source-
wide emission limit allows slabstock facilities to comply by limiting
the total amount of a single HAP ABA used, rather than by complying
with the individual HAP ABA emission point requirements (e.g.,
production line, LDAR, equipment cleaning).
For molded foam and rebond foam production, the FPUF Production
MACT standards prohibit the use of HAP-based products as mold release
agents and as equipment cleaners, except that diisocyanates may be used
to flush the mixhead and associated piping during startup and
maintenance if the diisocyanates are contained in a closed-loop system
and re-used in production.
C. What data collection activities were conducted to support this
action?
In 2011, we surveyed nine companies that own and operate foam
production facilities, as provided for under section 114 of the CAA. We
also conducted plant visits to four facilities in 2012 and 2013,
retrieved permit data from approximately 32 state agencies, and
obtained emissions inventory data from state agencies. Finally, we
reviewed data in four EPA emission inventory databases: National
Emissions Inventory (NEI), Emissions Inventory System (EIS), Toxics
Release Inventory (TRI) and Envirofacts to identify facilities that may
be part of the source category, emission sources and quantities of
emissions. The CAA section 114 questionnaire included requests for
available information regarding process equipment, control devices and
work practices for emission reductions, point and fugitive emissions
and other aspects of facility operations.
The emissions data and risk assessment inputs for the FPUF
production source category are described further in the memorandum
Development of the RTR Emissions Dataset for the Flexible Polyurethane
Foam Production Source Category, which is available in the docket for
this proposed rulemaking.
III. Analytical Procedures
In this section, we describe the analyses performed to support the
proposed decisions for the RTR and other issues addressed in this
proposal.
A. How did we estimate post-MACT risks posed by the source category?
The EPA conducted a risk assessment that provided estimates of the
MIR posed by the HAP emissions from each source in the source category,
the hazard index (HI) for chronic exposures to HAP with the potential
to cause non-cancer health effects and the hazard quotient (HQ) for
acute exposures to HAP with the potential to cause non-cancer health
effects. The assessment also provided estimates of the distribution of
cancer risks within the exposed populations, cancer incidence and an
evaluation of the potential for adverse environmental effects for the
source category. The risk assessment consisted of eight primary steps,
as discussed below. The docket for this rulemaking contains the
following document, which provides more information on the risk
assessment inputs and models: Draft Residual Risk Assessment for the
Flexible Polyurethane Foam Production Source Category. The methods used
to assess risks (as described in the eight primary steps below) are
consistent with those peer-reviewed by a panel of the EPA's Science
Advisory Board (SAB) in 2009 and described in their peer review report
issued in 2010; \3\ they are also consistent with the key
recommendations contained in that report.
---------------------------------------------------------------------------
\3\ U.S. EPA SAB. Risk and Technology Review (RTR) Risk
Assessment Methodologies: For Review by the EPA's Science Advisory
Board with Case Studies--MACT I Petroleum Refining Sources and
Portland Cement Manufacturing, May 2010.
---------------------------------------------------------------------------
1. How did we estimate actual emissions and identify the emissions
release characteristics?
Data from the 13 existing FPUF production facilities were used to
create a dataset that is the basis for the risk assessment. We
estimated the amount of actual and allowable emissions using data
collected through the CAA section 114 request, emission inventories
(EIS, NEI and TRI) and site visits. We performed quality assurance (QA)
procedures for the emissions data and release characteristics to
identify any outliers, and then confirmed or corrected the data. For
facilities where speciated HAP data were unavailable or unreliable,
more recent inventory data were obtained from state or local permitting
agencies. In addition to the QA of the source data for the facilities
contained in the dataset, we also checked the coordinates of every
emission source in the dataset through visual observations using tools
such as Google Earth and ArcView, and made corrections, as necessary.
Further information about the development of the dataset is provided in
the technical document: Draft Development of the RTR Emissions Dataset
for the Flexible Polyurethane Foam Production Source Category, which is
available in the docket for this action.
2. How did we estimate MACT-Allowable emissions?
The available emissions data in the MACT dataset include estimates
of the mass of HAP emitted during the specified annual time period. In
some cases, these ``actual'' emission levels are lower than the
emission levels a facility is allowed to emit and still comply with the
MACT standards. The emissions level allowed to be emitted by the MACT
standards is referred to as the ``MACT-allowable'' emissions level.
This represents the highest emissions
[[Page 66114]]
level that could be emitted by facilities without violating the MACT
standards. We discussed the use of both MACT-allowable and actual
emissions in the final Coke Oven Batteries residual risk rule (70 FR
19998-19999, April 15, 2005) and in the proposed and final Hazardous
Organic NESHAP residual risk rules (71 FR 34428, June 14, 2006, and 71
FR 76609, December 21, 2006, respectively). In those previous actions,
we noted that assessing the risks at the MACT-allowable level is
inherently reasonable since these risks reflect the maximum level
facilities could emit and still comply with national emission
standards. We also explained that it is reasonable to consider actual
emissions, where such data are available, in both steps of the risk
analysis, in accordance with the Benzene NESHAP. (54 FR 38044,
September 14, 1989.)
For the FPUF production source category, we determined that actual
emissions are a reasonable estimate of the MACT-allowable emissions for
molded and rebond foam facilities. The MACT requirements for these
facilities are HAP use prohibitions, and both the actual and the MACT-
allowable emissions, while in compliance with these requirements, are
therefore zero.
For slabstock foam production facilities, we estimate that the
level of diisocyanate actual emissions is a reasonable estimate of the
MACT-allowable diisocyanate emissions. The diisocyanate storage vessels
and other equipment are subject to equipment standards and work
practices. For equipment standards, sources subject to the standards
are required to install specific equipment. In order to comply with
this proposed rule, the equipment must be maintained properly and in
good working condition. Therefore, we do not expect any difference
between the actual emissions level and the level allowed by the MACT
standards because the level of control typically does not vary for
equipment standards. Similarly, we do not expect any difference between
actual and MACT-allowable emissions for emission sources subject to
work practice requirements, provided that facilities are not conducting
additional work practices proven to reduce emissions beyond those
required in this proposed rule. We are not aware of any such situations
at facilities in this source category. Therefore, for facilities
complying with the equipment and work practice standards, we believe
that the actual diisocyanate emission levels are a reasonable
estimation of the levels allowed by the standards.
For HAP ABA emissions from slabstock facilities, we estimate that
MACT-allowable emissions are higher than actual emissions. While we
believe that all slabstock production facilities have discontinued use
of HAP-based ABAs, and they are reporting zero emissions of HAP ABA,
the MACT rule does not prohibit the use of HAP ABAs. Therefore, MACT-
allowable HAP ABA emissions were attributed to each slabstock facility
based on emissions information gathered during development of the MACT
standards. We assigned appropriate emissions release parameters for
each facility, and modeled using the same procedures and tools used for
modeling actual emissions, to obtain facility-specific maximum risk
values based on MACT-allowable emissions. The docket for this
rulemaking contains the following document which provides more
information on the development of estimated MACT-allowable emissions:
MACT-Allowable Emissions for the Flexible Polyurethane Foam Production
Source Category.
3. How did we conduct dispersion modeling, determine inhalation
exposure and estimate individual and population inhalation risks?
Both long-term and short-term inhalation exposure concentrations
and health risks from the source category addressed in this proposal
were estimated using the Human Exposure Model (Community and Sector
HEM-3 version 1.1.0). The HEM-3 performs three primary risk assessment
activities: (1) Conducting dispersion modeling to estimate the
concentrations of HAP in ambient air, (2) estimating long-term and
short-term inhalation exposures to individuals residing within 50
kilometers (km) of the modeled sources,\4\ and (3) estimating
individual and population-level inhalation risks using the exposure
estimates and quantitative dose-response information.
---------------------------------------------------------------------------
\4\ This metric comes from the Benzene NESHAP. See 54 FR 38046.
---------------------------------------------------------------------------
The air dispersion model used by the HEM-3 model (AERMOD) is one of
the EPA's preferred models for assessing pollutant concentrations from
industrial facilities.\5\ To perform the dispersion modeling and to
develop the preliminary risk estimates, HEM-3 draws on three data
libraries. The first is a library of meteorological data, which is used
for dispersion calculations. This library includes 1 year (2011) of
hourly surface and upper air observations for more than 824
meteorological stations, selected to provide coverage of the United
States and Puerto Rico. A second library of United States Census Bureau
census block \6\ internal point locations and populations provides the
basis of human exposure calculations (U.S. Census, 2010). In addition,
for each census block, the census library includes the elevation and
controlling hill height, which are also used in dispersion
calculations. A third library of pollutant unit risk factors and other
health benchmarks is used to estimate health risks. These risk factors
and health benchmarks are the latest values recommended by the EPA for
HAP and other toxic air pollutants. These values are available at:
https://www.epa.gov/ttn/atw/toxsource/summary.html and are discussed in
more detail later in this section.
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\5\ U.S. EPA. Revision to the Guideline on Air Quality Models:
Adoption of a Preferred General Purpose (Flat and Complex Terrain)
Dispersion Model and Other Revisions (70 FR 68218, November 9,
2005).
\6\ A census block is the smallest geographic area for which
census statistics are tabulated.
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In developing the risk assessment for chronic exposures, we used
the estimated annual average ambient air concentrations of each HAP
emitted by each source for which we have emissions data in the source
category. The air concentrations at each nearby census block centroid
were used as a surrogate for the chronic inhalation exposure
concentration for all the people who reside in that census block. We
calculated the MIR for each facility as the cancer risk associated with
a continuous lifetime (24 hours per day, 7 days per week and 52 weeks
per year for a 70-year period) exposure to the maximum concentration at
the centroid of inhabited census blocks. Individual cancer risks were
calculated by multiplying the estimated lifetime exposure to the
ambient concentration of each of the HAP (in micrograms per cubic meter
([mu]g/m\3\)) by its unit risk estimate (URE), which is an upper bound
estimate of an individual's probability of contracting cancer over a
lifetime of exposure to a concentration of 1 microgram of the pollutant
per cubic meter of air. For residual risk assessments, we generally use
URE values from the EPA's Integrated Risk Information System (IRIS).
For carcinogenic pollutants without EPA IRIS values, we look to other
reputable sources of cancer dose-response values, often using
California EPA (CalEPA) URE values, where available. In cases where
new, scientifically credible dose response values have been developed
in a manner consistent with the EPA guidelines and have undergone a
peer review process similar to that used by the EPA, we may use such
dose-
[[Page 66115]]
response values in place of, or, in addition to, other values, if
appropriate.
The EPA estimated incremental individual lifetime cancer risks
associated with emissions from the facilities in the source category as
the sum of the risks for each of the carcinogenic HAP (including those
classified as carcinogenic to humans, likely to be carcinogenic to
humans and suggestive evidence of carcinogenic potential \7\) emitted
by the modeled sources. Cancer incidence and the distribution of
individual cancer risks for the population within 50 km of the sources
were also estimated for the source category as part of this assessment
by summing individual risks. A distance of 50 km is consistent with
both the analysis supporting the 1989 Benzene NESHAP (54 FR 38044) and
the limitations of Gaussian dispersion models, including AERMOD.
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\7\ These classifications also coincide with the terms ``known
carcinogen, probable carcinogen, and possible carcinogen,''
respectively, which are the terms advocated in the EPA's previous
Guidelines for Carcinogen Risk Assessment, published in 1986 (51 FR
33992, September 24, 1986). Summing the risks of these individual
compounds to obtain the cumulative cancer risks is an approach that
was recommended by the EPA's Science Advisory Board (SAB) in their
2002 peer review of EPA's National Air Toxics Assessment (NATA)
titled, NATA--Evaluating the National-scale Air Toxics Assessment
1996 Data--an SAB Advisory, available at: https://yosemite.epa.gov/
sab/sabproduct.nsf/214C6E915BB04E14852570CA007A682C/$File/
ecadv02001.pdf.
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To assess the risk of non-cancer health effects from chronic
exposures, we summed the HQ for each of the HAP that affects a common
target organ system to obtain the HI for that target organ system (or
target organ-specific HI, TOSHI). The HQ is the estimated exposure
divided by the chronic reference value, which is either the EPA
reference concentration (RfC) (https://www.epa.gov/riskassessment/glossary.htm), defined as ``an estimate (with uncertainty spanning
perhaps an order of magnitude) of a continuous inhalation exposure to
the human population (including sensitive subgroups) that is likely to
be without an appreciable risk of deleterious effects during a
lifetime,'' or, in cases where an RfC from the EPA's IRIS database is
not available, a value from the following prioritized sources: (1) The
Agency for Toxic Substances and Disease Registry Minimum Risk Level
(https://www.atsdr.cdc.gov/mrls/index.asp), which is defined as ``an
estimate of daily human exposure to a hazardous substance that is
likely to be without an appreciable risk of adverse non-cancer health
effects (other than cancer) over a specified duration of exposure'';
(2) the CalEPA Chronic Reference Exposure Level (REL) (https://www.oehha.ca.gov/air/hot_spots/pdf/HRAguidefinal.pdf), which is
defined as ``the concentration level (that is expressed in units of
micrograms per cubic meter ([mu]g/m\3\) for inhalation exposure and in
a dose expressed in units of milligram per kilogram-day (mg/kg-day) for
oral exposures), at or below which no adverse health effects are
anticipated for a specified exposure duration''; or (3), as noted
above, a scientifically credible dose-response value that has been
developed in a manner consistent with the EPA guidelines and has
undergone a peer review process similar to that used by the EPA, in
place of or in concert with other values.
The EPA also evaluated screening estimates of acute exposures and
risks for each of the HAP at the point of highest off-site exposure for
each facility (i.e., not just the census block centroids), assuming
that a person is located at this spot at a time when both the peak
(hourly) emissions rate and worst-case dispersion conditions occur. The
acute HQ is the estimated acute exposure divided by the acute dose-
response value. In each case, the EPA calculated acute HQ values using
best available, short-term dose-response values. These acute dose-
response values, which are described below, include the acute REL,
acute exposure guideline levels (AEGL) and emergency response planning
guidelines (ERPG) for 1-hour exposure durations. As discussed below, we
used conservative assumptions for emissions rates, meteorology and
exposure location for our acute analysis.
As described in the CalEPA's Air Toxics Hot Spots Program Risk
Assessment Guidelines, Part I, The Determination of Acute Reference
Exposure Levels for Airborne Toxicants, an acute REL value (https://www.oehha.ca.gov/air/pdf/acuterel.pdf) is defined as ``the
concentration level at or below which no adverse health effects are
anticipated for a specified exposure duration.'' Id. at page 2. Acute
REL values are based on the most sensitive, relevant, adverse health
effect reported in the peer-reviewed medical and toxicological
literature. Acute REL values are designed to protect the most sensitive
individuals in the population by the inclusion of margins of safety.
Because margins of safety are incorporated to address data gaps and
uncertainties, exceeding the REL does not automatically indicate an
adverse health impact.
AEGL values were derived in response to recommendations from the
National Research Council (NRC). As described in Standing Operating
Procedures (SOP) of the National Advisory Committee on Acute Exposure
Guideline Levels for Hazardous Substances (https://www.epa.gov/oppt/aegl/pubs/sop.pdf),\8\ ``the NRC's previous name for acute exposure
levels--community emergency exposure levels--was replaced by the term
AEGL to reflect the broad application of these values to planning,
response, and prevention in the community, the workplace,
transportation, the military, and the remediation of Superfund sites.''
Id. at 2. This document also states that AEGL values ``represent
threshold exposure limits for the general public and are applicable to
emergency exposures ranging from 10 minutes to eight hours.'' Id. at 2.
The document lays out the purpose and objectives of AEGL by stating
that ``the primary purpose of the AEGL program and the National
Advisory Committee for Acute Exposure Guideline Levels for Hazardous
Substances is to develop guideline levels for once-in-a-lifetime,
short-term exposures to airborne concentrations of acutely toxic, high-
priority chemicals.'' Id. at 21. In detailing the intended application
of AEGL values, the document states that ``[i]t is anticipated that the
AEGL values will be used for regulatory and nonregulatory purposes by
U.S. federal and state agencies and possibly the international
community in conjunction with chemical emergency response, planning and
prevention programs. More specifically, the AEGL values will be used
for conducting various risk assessments to aid in the development of
emergency preparedness and prevention plans, as well as real-time
emergency response actions, for accidental chemical releases at fixed
facilities and from transport carriers.'' Id. at 31.
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\8\ National Academy of Sciences (NAS), 2001. Standing Operating
Procedures for Developing Acute Exposure Levels for Hazardous
Chemicals, page 2.
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The AEGL-1 value is then specifically defined as ``the airborne
concentration (expressed as ppm (parts per million) or mg/m\3\
(milligrams per cubic meter)) of a substance above which it is
predicted that the general population, including susceptible
individuals, could experience notable discomfort, irritation, or
certain asymptomatic nonsensory effects. However, the effects are not
disabling and are transient and reversible upon cessation of
exposure.'' Id. at 3. The document also notes that, ``Airborne
concentrations below AEGL-1 represent exposure levels that can produce
mild and progressively increasing but transient and
[[Page 66116]]
nondisabling odor, taste, and sensory irritation or certain
asymptomatic, nonsensory effects.'' Id. Similarly, the document defines
AEGL-2 values as ``the airborne concentration (expressed as parts per
million or milligrams per cubic meter) of a substance above which it is
predicted that the general population, including susceptible
individuals, could experience irreversible or other serious, long-
lasting adverse health effects or an impaired ability to escape.'' Id.
ERPG values are derived for use in emergency response, as described
in the American Industrial Hygiene Association's ERP Committee document
titled, ERPGS Procedures and Responsibilities (https://sp4m.aiha.org/insideaiha/GuidelineDevelopment/ERPG/Documents/ERP-SOPs2006.pdf), which
states that, ``Emergency Response Planning Guidelines were developed
for emergency planning and are intended as health based guideline
concentrations for single exposures to chemicals.'' \9\ Id. at 1. The
ERPG-1 value is defined as ``the maximum airborne concentration below
which it is believed that nearly all individuals could be exposed for
up to 1 hour without experiencing other than mild transient adverse
health effects or without perceiving a clearly defined, objectionable
odor.'' Id. at 2. Similarly, the ERPG-2 value is defined as ``the
maximum airborne concentration below which it is believed that nearly
all individuals could be exposed for up to one hour without
experiencing or developing irreversible or other serious health effects
or symptoms which could impair an individual's ability to take
protective action.'' Id. at 1.
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\9\ ERP Committee Procedures and Responsibilities. November 1,
2006. American Industrial Hygiene Association.
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As can be seen from the definitions above, the AEGL and ERPG values
include the similarly-defined severity levels 1 and 2. For many
chemicals, a severity level 1 value AEGL or ERPG has not been developed
because the types of effects for these chemicals are not consistent
with the AEGL-1/ERPG-1 definitions; in these instances, we compare
higher severity level AEGL-2 or ERPG-2 values to our modeled exposure
levels to screen for potential acute concerns. When AEGL-1/ERPG-1
values are available, they are used in our acute risk assessments.
Acute REL values for 1-hour exposure durations are typically lower
than their corresponding AEGL-1 and ERPG-1 values. Even though their
definitions are slightly different, AEGL-1 values are often the same as
the corresponding ERPG-1 values, and AEGL-2 values are often equal to
ERPG-2 values. Maximum HQ values from our acute screening risk
assessments typically result when basing them on the acute REL value
for a particular pollutant. In cases where our maximum acute HQ value
exceeds 1, we also report the HQ value based on the next highest acute
dose-response value (usually the AEGL-1 and/or the ERPG-1 value).
To develop screening estimates of acute exposures in the absence of
hourly emissions data, generally we first develop estimates of maximum
hourly emissions rates by multiplying the average actual annual hourly
emissions rates by a default factor to cover routinely variable
emissions. We choose the factor to use partially based on process
knowledge and engineering judgment, but also reflecting a Texas study
of short-term emissions variability, which showed that most peak
emission events in a heavily-industrialized four-county area (Harris,
Galveston, Chambers and Brazoria Counties, Texas) were less than twice
the annual average hourly emissions rate. The highest peak emissions
event was 74 times the annual average hourly emissions rate, and the
99th percentile ratio of peak hourly emissions rate to the annual
average hourly emissions rate was 9.\10\ Considering this analysis, to
account for more than 99 percent of the peak hourly emissions, we apply
a conservative screening multiplication factor of 10 to the average
annual hourly emissions rate in our acute exposure screening
assessments as our default approach. However, we use a factor other
than 10 if we have information that indicates that a different factor
is appropriate for a particular source category. For this source
category, however, there was no such information available and the
default factor of 10 was used in the acute screening process.
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\10\ See https://www.tceq.state.tx.us/compliance/field_ops/eer/ or docket to access the source of these data.
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As part of our acute risk assessment process, for cases where acute
HQ values from the screening step were less than or equal to 1 (even
under the conservative assumptions of the screening analysis), acute
impacts were deemed negligible and no further analysis was performed.
In cases where an acute HQ from the screening step was greater than 1,
additional site-specific data were considered to develop a more refined
estimate of the potential for acute impacts of concern. Ideally, we
would prefer to have continuous measurements over time to see how the
emissions vary by each hour over an entire year. Having a frequency
distribution of hourly emissions rates over a year would allow us to
perform a probabilistic analysis to estimate potential threshold
exceedances and their frequency of occurrence. Such an evaluation could
include a more complete statistical treatment of the key parameters and
elements adopted in this screening analysis. However, we recognize that
having this level of data is rare; hence, our use of the multiplier
approach.
To better characterize the potential health risks associated with
estimated acute exposures to HAP, and in response to a key
recommendation from the SAB's peer review of the EPA's RTR risk
assessment methodologies,\11\ we generally examine a wider range of
available acute health metrics (e.g., RELs, AEGLs) than we do for our
chronic risk assessments. This is in response to the SAB's
acknowledgement that there are generally more data gaps and
inconsistencies in acute reference values than there are in chronic
reference values. In some cases, when Reference Value Arrays \12\ for
HAP have been developed, we consider additional acute values (i.e.,
occupational and international values) to provide a more complete risk
characterization.
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\11\ The SAB peer review of RTR Risk Assessment Methodologies is
available at: https://yosemite.epa.gov/sab/sabproduct.nsf/
4AB3966E263D943A8525771F00668381/$File/EPA-SAB-10-007-unsigned.pdf.
\12\ U.S. EPA. (2009) Chapter 2.9 Chemical Specific Reference
Values for Formaldehyde in Graphical Arrays of Chemical-Specific
Health Effect Reference Values for Inhalation Exposures (Final
Report). U.S. Environmental Protection Agency, Washington, DC, EPA/
600/R-09/061, and available on-line at https://cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid=211003.
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4. How did we conduct the multipathway exposure and risk screening?
The EPA conducted a screening analysis examining the potential for
significant human health risks due to exposures via routes other than
inhalation (i.e., ingestion). We first determined whether any sources
in the source category emitted any hazardous air pollutants known to be
persistent and bioaccumulative in the environment (PB-HAP). The PB-HAP
compounds or compound classes are identified for the screening from the
EPA's Air Toxics Risk Assessment Library (available at https://www.epa.gov/ttn/fera/risk_atra_vol1.html).
For the FPUF production source category, we did not identify
emissions of any PB-HAP. Because we did not identify PB-HAP emissions,
no further
[[Page 66117]]
evaluation of multipathway risk was conducted for this source category.
5. How did we assess risks considering emissions control options?
In addition to assessing baseline inhalation risks and screening
for potential multipathway risks, we also estimated risks considering
the potential emissions reductions that would be achieved by the
control options under consideration. In these cases, the expected
emissions reductions were applied to the specific HAP and emissions
points in the source category dataset to develop corresponding
estimates of risk and incremental risk reductions.
6. How did we conduct the environmental risk screening assessment?
a. Adverse Environmental Effect
The EPA developed a screening approach to examine the potential for
adverse environmental effects as required under section 112(f)(2)(A) of
the CAA. Section 112(a)(7) of the CAA defines ``adverse environmental
effect'' as ``any significant and widespread adverse effect, which may
reasonably be anticipated, to wildlife, aquatic life, or other natural
resources, including adverse impacts on populations of endangered or
threatened species or significant degradation of environmental quality
over broad areas.''
b. Environmental HAP
The EPA focuses on seven HAP, which we refer to as ``environmental
HAP,'' in its screening analysis: Five persistent bioaccumulative HAP
(PB-HAP) and two acid gases. The five PB-HAP are cadmium, dioxins/
furans, polycyclic organic matter (POM), mercury (both inorganic
mercury and methyl mercury) and lead. The two acid gases are hydrogen
chloride (HCl) and hydrogen fluoride (HF). The rationale for including
these seven HAP in the environmental risk screening analysis is
presented below.
HAP that persist and bioaccumulate are of particular environmental
concern because they accumulate in the soil, sediment and water. The
PB-HAP are taken up, through sediment, soil, water, and/or ingestion of
other organisms, by plants or animals (e.g., small fish) at the bottom
of the food chain. As larger and larger predators consume these
organisms, concentrations of the PB-HAP in the animal tissues increases
as does the potential for adverse effects. The five PB-HAP we evaluate
as part of our screening analysis account for 99.8 percent of all PB-
HAP emissions (based on data from the 2005 NEI).
In addition to accounting for almost all of the mass of PB-HAP
emitted, we note that the TRIM.Fate model that we use to evaluate
multipathway risk allows us to estimate concentrations of cadmium
compounds, dioxins/furans, POM and mercury in soil, sediment and water.
For lead, we currently do not have the ability to calculate these
concentrations using the TRIM.Fate model. Therefore, to evaluate the
potential for environmental effects from lead, we compare the estimated
chronic inhalation exposures from the source category emissions of lead
with the level of the secondary National Ambient Air Quality Standard
(NAAQS) for lead.\13\ We consider values below the level of the
secondary lead NAAQS as unlikely to cause adverse environmental
effects.
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\13\ The secondary lead NAAQS is a reasonable measure of
determining whether there is an adverse environmental effect since
it was established considering ``effects on soils, water, crops,
vegetation, man-made materials, animals, wildlife, weather,
visibility and climate, damage to and deterioration of property, and
hazards to transportation, as well as effects on economic values and
on personal comfort and well-being.''
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Due to their well-documented potential to cause direct damage to
terrestrial plants, we include two acid gases, HCl and HF, in the
environmental screening analysis. According to the 2005 NEI, HCl and HF
account for about 99 percent of the total acid gas HAP emitted by
stationary sources. In addition to the potential to cause direct damage
to plants, high concentrations of HF in the air have been linked to
fluorosis in livestock. Air concentrations of these HAP are already
calculated as part of the human multipathway exposure and risk
screening analysis using the HEM3-AERMOD air dispersion model, and we
are able to use the air dispersion modeling to estimate the potential
for an adverse environmental effect.
For the FPUF production source category, the data do not show
emissions of any of the seven HAP (cadmium, dioxins/furans, POM,
mercury, HCL or HF) in the environmental risk screen. Because we did
not identify emissions of these seven HAP from the source category, we
did not conduct any further quantitative evaluation of environmental
risk.
The EPA acknowledges that other HAP beyond the seven HAP discussed
above may have the potential to cause adverse environmental effects.
Therefore, the EPA may include other relevant HAP in its environmental
risk screening in the future, as modeling science and resources allow.
The EPA invites comment on the extent to which other HAP emitted by the
source category may cause adverse environmental effects. Such
information should include references to peer-reviewed ecological
effects benchmarks that are of sufficient quality for making regulatory
decisions, as well as information on the presence of organisms located
near facilities within the source category that such benchmarks
indicate could be adversely affected.
7. How did we conduct facility-wide assessments?
To put the source category risks in context, we typically examine
the risks from the entire ``facility,'' where the facility includes all
HAP-emitting operations within a contiguous area and under common
control. In other words, we examine the HAP emissions not only from the
source category emission points of interest, but also emissions of HAP
from all other emissions sources at the facility for which we have
data. The emissions data for estimating these ``facility-wide'' risks
were obtained from the 2005 NEI (available at https://www.epa.gov/ttn/atw/nata2005). We analyzed risks due to the inhalation of HAP that are
emitted ``facility-wide'' for the populations residing within 50 km of
each facility, consistent with the methods used for the source category
analysis described above. For these facility-wide risk analyses, the
modeled FPUF production source category risks were compared to the
facility-wide risks to determine the portion of facility-wide risks
that could be attributed to the FPUF production source category. We
specifically examined the facilities associated with the highest
estimates of risk and determined the percentage of that risk
attributable to the FPUF production source category. The Draft Residual
Risk Assessment for the Flexible Polyurethane Foam Production Source
Category, available through the docket for this action, provides all
the methodology and results of the facility-wide analyses, including
all facility-wide risks and the percentage of FPUF production source
category contribution to facility-wide risks.
8. How did we consider uncertainties in risk assessment?
In the Benzene NESHAP, we concluded that risk estimation
uncertainty should be considered in our decision-making under the ample
margin of safety framework. Uncertainty and the potential for bias are
inherent in all risk assessments, including those performed for this
proposal. Although uncertainty exists, we believe that our
[[Page 66118]]
approach, which used conservative tools and assumptions, ensures that
our decisions are health-protective. A brief discussion of the
uncertainties in the emissions dataset, dispersion modeling, inhalation
exposure estimates and dose-response relationships follows below. A
more thorough discussion of these uncertainties is included in the
Draft Residual Risk Assessment for the Flexible Polyurethane Foam
Production Source Category, which is available in the docket for this
action.
a. Uncertainties in the Emissions Dataset
Although the development of the RTR dataset involved quality
assurance/quality control processes, the accuracy of emissions values
will vary depending on the source of the data, the degree to which data
are incomplete or missing, the degree to which assumptions made to
complete the datasets are accurate, errors in emissions estimates and
other factors. The emission estimates considered in this analysis
generally are annual totals for certain years, and they do not reflect
short-term fluctuations during the course of a year or variations from
year to year. The estimates of peak hourly emissions rates for the
acute effects screening assessment were based on an emission adjustment
factor applied to the average annual hourly emissions rates, which are
intended to account for emission fluctuations due to normal facility
operations.
b. Uncertainties in Dispersion Modeling
We recognize there is uncertainty in ambient concentration
estimates associated with any model, including the EPA's recommended
regulatory dispersion model, AERMOD. In using a model to estimated
ambient pollutant concentrations, the user chooses certain options to
apply. For RTR assessments, we select some model options that have the
potential to overestimate ambient air concentrations (e.g., not
including plume depletion or pollutant transformation). We select other
model options that have the potential to underestimate ambient impacts
(e.g., not including building downwash). Other options that we select
have the potential to either under- or over-estimate ambient levels
(e.g., meteorology and receptor locations). On balance, considering the
directional nature of the uncertainties commonly present in ambient
concentrations estimated by dispersion models, the approach we apply in
the RTR assessments should yield unbiased estimates of ambient HAP
concentrations.
c. Uncertainties in Inhalation Exposure
The EPA did not include the effects of human mobility on exposures
in the assessment. Specifically, short-term mobility and long-term
mobility between census blocks in the modeling domain were not
considered.\14\ The approach of not considering short- or long-term
population mobility does not bias the estimate of the theoretical MIR
(by definition), nor does it affect the estimate of cancer incidence
because the total population number remains the same. It does, however,
affect the shape of the distribution of individual risks across the
affected population, shifting it toward higher estimated individual
risks at the upper end and reducing the number of people estimated to
be at lower risks, thereby increasing the estimated number of people at
specific high risk levels (e.g., 1-in-10 thousand or 1-in-1 million).
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\14\ Short-term mobility is movement from one micro-environment
to another over the course of hours or days. Long-term mobility is
movement from one residence to another over the course of a
lifetime.
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In addition, the assessment predicted the chronic exposures at the
centroid of each populated census block as surrogates for the exposure
concentrations for all people living in that block. Using the census
block centroid to predict chronic exposures tends to over-predict
exposures for people in the census block who live farther from the
facility and under-predict exposures for people in the census block who
live closer to the facility. Thus, using the census block centroid to
predict chronic exposures may lead to a potential understatement or
overstatement of the true maximum impact, but is an unbiased estimate
of average risk and incidence. We reduce this uncertainty by analyzing
large census blocks near facilities using aerial imagery and adjusting
the location of the block centroid to better represent the population
in the block, as well as adding additional receptors where the block
population is not well represented by a single location.
The assessment evaluates the cancer inhalation risks associated
with pollutant exposures over a 70-year period, which is the assumed
lifetime of an individual. In reality, both the length of time that
modeled emissions sources at facilities actually operate (i.e., more or
less than 70 years) and the domestic growth or decline of the modeled
industry (i.e., the increase or decrease in the number or size of
domestic facilities) will influence the future risks posed by a given
source or source category. Depending on the characteristics of the
industry, these factors will, in most cases, result in an overestimate
both in individual risk levels and in the total estimated number of
cancer cases. However, in the unlikely scenario where a facility
maintains, or even increases, its emissions levels over a period of
more than 70 years, residents live beyond 70 years at the same
location, and the residents spend most of their days at that location,
then the cancer inhalation risks could potentially be underestimated.
However, annual cancer incidence estimates from exposures to emissions
from these sources would not be affected by the length of time an
emissions source operates.
The exposure estimates used in these analyses assume chronic
exposures to ambient (outdoor) levels of pollutants. Because most
people spend the majority of their time indoors, actual exposures may
not be as high, depending on the characteristics of the pollutants
modeled. For many of the HAP, indoor levels are roughly equivalent to
ambient levels, but for very reactive pollutants or larger particles,
indoor levels are typically lower. This factor has the potential to
result in an overstatement of 25 to 30 percent of exposures.\15\
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\15\ U.S. EPA. National-Scale Air Toxics Assessment for 1996.
(EPA 453/R-01-003; January 2001; page 85.)
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In addition to the uncertainties highlighted above, there are
several factors specific to the acute exposure assessment that should
be highlighted. The accuracy of an acute inhalation exposure assessment
depends on the simultaneous occurrence of independent factors that may
vary greatly, such as hourly emissions rates, meteorology and human
activity patterns. In this assessment, we assume that individuals
remain for 1 hour at the point of maximum ambient concentration as
determined by the co-occurrence of peak emissions and worst-case
meteorological conditions. These assumptions would tend to be worst-
case actual exposures as it is unlikely that a person would be located
at the point of maximum exposure during the time of worst-case impact.
d. Uncertainties in Dose-Response Relationships
There are uncertainties inherent in the development of the dose-
response values used in our risk assessments for cancer effects from
chronic exposures and non-cancer effects from both chronic and acute
exposures. Some uncertainties may be considered quantitatively, and
others generally are
[[Page 66119]]
expressed in qualitative terms. We note as a preface to this discussion
a point on dose-response uncertainty that is brought out in the EPA's
2005 Cancer Guidelines; namely, that ``the primary goal of EPA actions
is protection of human health; accordingly, as an Agency policy, risk
assessment procedures, including default options that are used in the
absence of scientific data to the contrary, should be health
protective'' (EPA 2005 Cancer Guidelines, pages 1-7). This is the
approach followed here as summarized in the next several paragraphs. A
complete detailed discussion of uncertainties and variability in dose-
response relationships is given in the Draft Residual Risk Assessment
for the Flexible Polyurethane Foam Production Source Category, which is
available in the docket for this action.
Cancer URE values used in our risk assessments are those that have
been developed to generally provide an upper bound estimate of risk.
That is, they represent a ``plausible upper limit to the true value of
a quantity'' (although this is usually not a true statistical
confidence limit).\16\ In some circumstances, the true risk could be as
low as zero; however, in other circumstances the risk could be
greater.\17\ When developing an upper bound estimate of risk and to
provide risk values that do not underestimate risk, health-protective
default approaches are generally used. To err on the side of ensuring
adequate health protection, the EPA typically uses the upper bound
estimates rather than lower bound or central tendency estimates in our
risk assessments, an approach that may have limitations for other uses
(e.g., priority-setting or expected benefits analysis).
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\16\ IRIS glossary (https://www.epa.gov/NCEA/iris/help_gloss.htm).
\17\ An exception to this is the URE for benzene, which is
considered to cover a range of values, each end of which is
considered to be equally plausible, and which is based on maximum
likelihood estimates.
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RfCs and reference doses (RfDs) represent chronic exposure levels
that provide an estimate (with uncertainty spanning perhaps an order of
magnitude) of a continuous inhalation exposure or a daily oral
exposure, respectively, to the human population (including sensitive
subgroups) that is likely to be without an appreciable risk of
deleterious effects during a lifetime. To derive values that are
intended to be ``without appreciable risk,'' the methodology relies
upon an uncertainty factor (UF) approach (U.S. EPA, 1993, 1994) which
considers uncertainty, variability and gaps in the available data. The
UFs are applied to derive reference values that are intended to protect
against appreciable risk of deleterious effects. The UFs are commonly
default values,\18\ e.g., factors of 10 or 3, used in the absence of
compound-specific data; where data are available, UFs may also be
developed using compound-specific information. When data are limited,
more assumptions are needed and more UFs are used.
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\18\ According to the NRC report, Science and Judgment in Risk
Assessment (NRC, 1994) ``[Default] options are generic approaches,
based on general scientific knowledge and policy judgment, that are
applied to various elements of the risk assessment process when the
correct scientific model is unknown or uncertain.'' The 1983 NRC
report, Risk Assessment in the Federal Government: Managing the
Process, defined default option as ``the option chosen on the basis
of risk assessment policy that appears to be the best choice in the
absence of data to the contrary'' (NRC, 1983a, p. 63). Therefore,
default options are not rules that bind the agency; rather, the
agency may depart from them in evaluating the risks posed by a
specific substance when it believes this to be appropriate. In
keeping with EPA's goal of protecting public health and the
environment, default assumptions are used to ensure that risk to
chemicals is not underestimated (although defaults are not intended
to overtly overestimate risk). See EPA, 2004, An Examination of EPA
Risk Assessment Principles and Practices, EPA/100/B-04/001 available
at: https://www.epa.gov/osa/pdfs/ratf-final.pdf.
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While collectively termed ``UF,'' these factors account for a
number of different quantitative considerations when using observed
animal (usually rodent) or human toxicity data in the development of
the RfC. The UF are intended to account for: (1) Variation in
susceptibility among the members of the human population (i.e., inter-
individual variability); (2) uncertainty in extrapolating from
experimental animal data to humans (i.e., interspecies differences);
(3) uncertainty in extrapolating from data obtained in a study with
less-than-lifetime exposure (i.e., extrapolating from sub-chronic to
chronic exposure); (4) uncertainty in extrapolating the observed data
to obtain an estimate of the exposure associated with no adverse
effects; and (5) uncertainty when the database is incomplete or there
are problems with the applicability of available studies.
Many of the UF used to account for variability and uncertainty in
the development of acute reference values are quite similar to those
developed for chronic durations, but they more often use individual UF
values that may be less than 10. The UF are applied based on chemical-
specific or health effect-specific information (e.g., simple irritation
effects do not vary appreciably between human individuals; hence a
value of 3 is typically used), or based on the purpose for the
reference value (see the following paragraph). The UF applied in acute
reference value derivation include: (1) Heterogeneity among humans; (2)
uncertainty in extrapolating from animals to humans; (3) uncertainty in
lowest observed adverse effect (exposure) level to no observed adverse
effect (exposure) level adjustments; and (4) uncertainty in accounting
for an incomplete database on toxic effects of potential concern.
Additional adjustments are often applied to account for uncertainty in
extrapolation from observations at one exposure duration (e.g., 4
hours) to derive an acute reference value at another exposure duration
(e.g., 1 hour).
Not all acute reference values are developed for the same purpose
and care must be taken when interpreting the results of an acute
assessment of human health effects relative to the reference value or
values being exceeded. Where relevant to the estimated exposures, the
lack of short-term dose-response values at different levels of severity
should be factored into the risk characterization as potential
uncertainties.
For a group of compounds that are unspeciated (e.g., glycol
ethers), we conservatively use the most protective reference value of
an individual compound in that group to estimate risk. Similarly, for
an individual compound in a group (e.g., ethylene glycol diethyl ether)
that does not have a specified reference value, we also apply the most
protective reference value from the other compounds in the group to
estimate risk.
e. Uncertainties in the Multipathway Assessment
For each source category, we generally rely on site-specific levels
of PB-HAP emissions to determine whether a refined assessment of the
impacts from multipathway exposures is necessary. This determination is
based on the results of a two-tiered screening analysis that relies on
the outputs from models that estimate environmental pollutant
concentrations and human exposures for four PB-HAP. Two important types
of uncertainty associated with the use of these models in RTR risk
assessments and inherent to any assessment that relies on environmental
modeling are model uncertainty and input uncertainty.\19\
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\19\ In the context of this discussion, the term ``uncertainty''
as it pertains to exposure and risk encompasses both variability in
the range of expected inputs and screening results due to existing
spatial, temporal, and other factors, as well as uncertainty in
being able to accurately estimate the true result.
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[[Page 66120]]
Model uncertainty concerns whether the selected models are
appropriate for the assessment being conducted and whether they
adequately represent the actual processes that might occur for that
situation. An example of model uncertainty is the question of whether
the model adequately describes the movement of a pollutant through the
soil. This type of uncertainty is difficult to quantify. However, based
on feedback received from previous EPA Science Advisory Board reviews
and other reviews, we are confident that the models used in the screen
are appropriate and state-of-the-art for the multipathway risk
assessments conducted in support of RTR.
Input uncertainty is concerned with how accurately the models have
been configured and parameterized for the assessment at hand. For Tier
1 of the multipathway screen, we configured the models to avoid
underestimating exposure and risk to reduce the likelihood that the
results indicate the risks are lower than they actually are. This was
accomplished by selecting upper-end values from nationally-
representative data sets for the more influential parameters in the
environmental model, including selection and spatial configuration of
the area of interest, lake location and size, meteorology, surface
water and soil characteristics and structure of the aquatic food web.
We also assume an ingestion exposure scenario and values for human
exposure factors that represent reasonable maximum exposures.
In Tier 2 of the multipathway assessment, we refine the model
inputs to account for meteorological patterns in the vicinity of the
facility versus using upper-end national values and we identify the
actual location of lakes near the facility rather than the default lake
location that we apply in Tier 1. By refining the screening approach in
Tier 2 to account for local geographical and meteorological data, we
decrease the likelihood that concentrations in environmental media are
overestimated, thereby increasing the usefulness of the screen. The
assumptions and the associated uncertainties regarding the selected
ingestion exposure scenario are the same for Tier 1 and Tier 2.
For both Tiers 1 and 2 of the multipathway assessment, our approach
to addressing model input uncertainty is generally cautious. We choose
model inputs from the upper end of the range of possible values for the
influential parameters used in the models, and we assume that the
exposed individual exhibits ingestion behavior that would lead to a
high total exposure. This approach reduces the likelihood of not
identifying high risks for adverse impacts.
Despite the uncertainties, when individual pollutants or facilities
do screen out, we are confident that the potential for adverse
multipathway impacts on human health is very low. On the other hand,
when individual pollutants or facilities do not screen out, it does not
mean that multipathway impacts are significant, only that we cannot
rule out that possibility and that a refined multipathway analysis for
the site might be necessary to obtain a more accurate risk
characterization for the source category.
For further information on uncertainties and the Tier 1 and 2
screening methods, refer to the risk document Appendix 5, ``Technical
Support Document for TRIM-Based Multipathway Tiered Screening
Methodology for RTR.''
B. How did we consider the risk results in making decisions for this
proposal?
As discussed in section II.A of this preamble, in evaluating and
developing standards under section 112(f)(2), we apply a two-step
process to address residual risk. In the first step, the EPA determines
whether risks are acceptable. This determination ``considers all health
information, including risk estimation uncertainty, and includes a
presumptive limit on maximum individual lifetime [cancer] risk (MIR)
\20\ of approximately [1-in-10 thousand] [i.e., 100-in-1 million].'' 54
FR 38045. If risks are unacceptable, the EPA must determine the
emissions standards necessary to bring risks to an acceptable level
without considering costs. In the second step of the process, the EPA
considers whether the emissions standards provide an ample margin of
safety ``in consideration of all health information, including the
number of persons at risk levels higher than approximately 1-in-1
million, as well as other relevant factors, including costs and
economic impacts, technological feasibility, and other factors relevant
to each particular decision.'' Id. The EPA must promulgate tighter
emission standards if necessary to provide an ample margin of safety.
After conducting the ample margin of safety analysis, we consider
whether a more stringent standard is necessary to prevent, taking into
consideration costs, energy, safety, and other relevant factors, an
adverse environmental effect. After conducting the ample margin of
safety analysis, we consider whether a more stringent standard is
necessary to prevent, taking into consideration costs, energy, safety,
and other relevant factors, an adverse environmental effect.
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\20\ Although defined as ``maximum individual risk,'' MIR refers
only to cancer risk. MIR, one metric for assessing cancer risk, is
the estimated risk were an individual exposed to the maximum level
of a pollutant for a lifetime.
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In past residual risk actions, the EPA considered a number of human
health risk metrics associated with emissions from the categories under
review, including the MIR, the number of persons in various risk
ranges, cancer incidence, the maximum non-cancer HI and the maximum
acute non-cancer hazard. See, e.g., 72 FR 25138, May 3, 2007; 71 FR
42724, July 27, 2006. The EPA considered this health information for
both actual and allowable emissions. See, e.g., 75 FR 65068, October
21, 2010; 75 FR 80220, December 21, 2010; 76 FR 29032, May 19, 2011.
The EPA also discussed risk estimation uncertainties and considered the
uncertainties in the determination of acceptable risk and ample margin
of safety in these past actions. The EPA considered this same type of
information in support of this Federal Register notice.
The agency is considering these various measures of health
information to inform our determinations of risk acceptability and
ample margin of safety under CAA section 112(f). As explained in the
Benzene NESHAP, ``the first step judgment on acceptability cannot be
reduced to any single factor'' and thus ``[t]he Administrator believes
that the acceptability of risk under [previous] section 112 is best
judged on the basis of a broad set of health risk measures and
information.'' 54 FR 38046. Similarly, with regard to the ample margin
of safety determination, ``the Agency again considers all of the health
risk and other health information considered in the first step. Beyond
that information, additional factors relating to the appropriate level
of control will also be considered, including cost and economic impacts
of controls, technological feasibility, uncertainties, and any other
relevant factors.'' Id.
The Benzene NESHAP provides flexibility regarding factors the EPA
may consider in making determinations and how the EPA may weigh those
factors for each source category. In responding to comment on our
policy under the Benzene NESHAP, the EPA explained that:
[t]he policy chosen by the Administrator permits consideration of
multiple measures of health risk. Not only can the MIR figure be
considered, but also incidence, the presence of non-cancer health
effects, and the uncertainties of the risk estimates. In this way,
the effect on the most exposed individuals can be reviewed as well
as the impact on the general public. These factors can then be
weighed in each individual case.
[[Page 66121]]
This approach complies with the Vinyl Chloride mandate that the
Administrator ascertain an acceptable level of risk to the public by
employing [her] expertise to assess available data. It also complies
with the Congressional intent behind the CAA, which did not exclude
the use of any particular measure of public health risk from the
EPA's consideration with respect to CAA section 112 regulations, and
thereby implicitly permits consideration of any and all measures of
health risk which the Administrator, in [her] judgment, believes are
appropriate to determining what will `protect the public health.'
54 FR 38057. Thus, the level of the MIR is only one factor to be
weighed in determining acceptability of risks. The Benzene NESHAP
explained that ``an MIR of approximately one in 10 thousand should
ordinarily be the upper end of the range of acceptability. As risks
increase above this benchmark, they become presumptively less
acceptable under CAA section 112, and would be weighed with the other
health risk measures and information in making an overall judgment on
acceptability. Or, the Agency may find, in a particular case, that a
risk that includes MIR less than the presumptively acceptable level is
unacceptable in the light of other health risk factors.'' Id. at 38045.
Similarly, with regard to the ample margin of safety analysis, the EPA
stated in the Benzene NESHAP that: ``EPA believes the relative weight
of the many factors that can be considered in selecting an ample margin
of safety can only be determined for each specific source category.
This occurs mainly because technological and economic factors (along
with the health-related factors) vary from source category to source
category.'' Id. at 38061. We also consider the uncertainties associated
with the various risk analyses, as discussed earlier in this preamble,
in our determinations of acceptability and ample margin of safety.
The EPA notes that it has not considered certain health information
to date in making residual risk determinations. At this time, we do not
attempt to quantify those HAP risks that may be associated with
emissions from other facilities that do not include the source
categories in question, mobile source emissions, natural source
emissions, persistent environmental pollution or atmospheric
transformation in the vicinity of the sources in these categories.
The agency understands the potential importance of considering an
individual's total exposure to HAP in addition to considering exposure
to HAP emissions from the source category and facility. We recognize
that such consideration may be particularly important when assessing
non-cancer risks, where pollutant-specific exposure health reference
levels (e.g., RfCs) are based on the assumption that thresholds exist
for adverse health effects. For example, the agency recognizes that,
although exposures attributable to emissions from a source category or
facility alone may not indicate the potential for increased risk of
adverse non-cancer health effects in a population, the exposures
resulting from emissions from the facility in combination with
emissions from all of the other sources (e.g., other facilities) to
which an individual is exposed may be sufficient to result in increased
risk of adverse non-cancer health effects. In May 2010, the SAB advised
the EPA ``that RTR assessments will be most useful to decision makers
and communities if results are presented in the broader context of
aggregate and cumulative risks, including background concentrations and
contributions from other sources in the area.'' \21\
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\21\ EPA's responses to this and all other key recommendations
of the SAB's advisory on RTR risk assessment methodologies (which is
available at: https://yosemite.epa.gov/sab/sabproduct.nsf/
4AB3966E263D943A8525771F00668381/$File/EPA-SAB-10-007-unsigned.pdf)
are outlined in a memo to this rulemaking docket from David Guinnup
titled, EPA's Actions in Response to the Key Recommendations of the
SAB Review of RTR Risk Assessment Methodologies.
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In response to the SAB recommendations, the EPA is incorporating
cumulative risk analyses into its RTR risk assessments. The agency is:
(1) Conducting facility-wide assessments, which include source category
emission points as well as other emission points within the facilities;
(2) considering overlapping sources in the same category; and (3) for
some persistent and bioaccumulative pollutants, analyzing the ingestion
route of exposure. In addition, the RTR risk assessments have always
considered aggregate cancer risk from all carcinogens and aggregate
non-cancer hazard indices from all non-carcinogens affecting the same
target organ system.
Although we are interested in placing source category and facility-
wide HAP risks in the context of total HAP risks from all sources
combined in the vicinity of each source, we are concerned about the
uncertainties of doing so. Because of the contribution to total HAP
risk from emissions sources other than those that we have studied in
depth during this RTR review, such estimates of total HAP risks would
have significantly greater associated uncertainties than the source
category or facility-wide estimates. Such aggregate or cumulative
assessments would compound those uncertainties, making the assessments
too unreliable.
C. How did we perform the technology review?
Our technology review focused on the identification and evaluation
of developments in practices, processes and control technologies that
have occurred since the FPUF Production MACT standards were
promulgated. Where we identified such developments, in order to inform
our decision of whether it is ``necessary'' to revise the emissions
standards, we analyzed the technical feasibility of applying these
developments, and the estimated costs, energy implications, non-air
environmental impacts, as well as considering the emissions reductions.
We also considered the appropriateness of applying controls to new
sources versus retrofitting existing sources.
Based on our analyses of the available data and information, we
identified potential developments in practices, processes and control
technologies. For this exercise, we considered any of the following to
be a ``development'':
Any add-on control technology or other equipment that was
not identified and considered during development of the original MACT
standards.
Any improvements in add-on control technology or other
equipment (that were identified and considered during development of
the original MACT standards) that could result in additional emissions
reduction.
Any work practice or operational procedure that was not
identified or considered during development of the original MACT
standards.
Any process change or pollution prevention alternative
that could be broadly applied to the industry and that was not
identified or considered during development of the original MACT
standards.
Any significant changes in the cost (including cost
effectiveness) of applying controls (including controls the EPA
considered during the development of the original MACT standards).
We reviewed a variety of data sources in our investigation of
potential practices, processes or controls to consider. Among the
sources we reviewed were the NESHAP for various industries that were
promulgated since the FPUF Production MACT standards being reviewed in
this action. We reviewed the regulatory requirements and/or technical
analyses associated with these regulatory actions to identify any
practices, processes and control technologies considered in these
efforts that could be applied to emissions
[[Page 66122]]
sources in the FPUF production source category, as well as the costs,
non-air impacts and energy implications associated with the use of
these technologies. Additionally, we requested information from
facilities regarding developments in practices, processes or control
technology. Finally, we reviewed information from other sources, such
as state and/or local permitting agency databases and industry-
supported databases.
D. What other analyses and reviews were conducted in support of this
proposal and how did we conduct those analyses and reviews?
In addition to the analyses described above, we reviewed the FPUF
Production MACT standards to determine whether we should make
additional amendments. From this review we have identified one
additional revision. We are proposing revisions to the startup,
shutdown and malfunction (SSM) provisions of the MACT rule in order to
ensure that they are consistent with the court decision in Sierra Club
v. EPA, 551 F.3d 1019 (D.C. Cir. 2008), which vacated two provisions
that exempted sources from the requirement to comply with otherwise
applicable section 112(d) emission standards during periods of SSM. Our
analyses and proposed changes related to these issues are presented in
section IV.D of this preamble.
IV. Analytical Results and Proposed Decisions
This section of the preamble provides the results of our RTR
reviews of the FPUF Production MACT standards and our proposed
revisions to the FPUF Production MACT standards regarding the startup,
shutdown and malfunction provisions.
A. What are the results of the risk assessment and analyses?
As described above, for the FPUF production source category, we
conducted an inhalation risk assessment for all HAP emitted, a
multipathway screening analysis for PB-HAP emitted and an environmental
HAP screening analysis. We also performed a facility-wide risk
assessment for the facilities in the source category. Results of the
risk assessment are presented briefly below and in more detail in the
residual risk document: Draft Residual Risk Assessment for the Flexible
Polyurethane Foam Production Source Category, which is available in the
docket for this rulemaking.
1. FPUF Production Source Category Inhalation Risk Assessment Results
Table 2 of this preamble provides a summary of the results of the
inhalation risk assessment for the source category.
Table 2--Flexible Polyurethane Foam Production Inhalation Risk Assessment Results
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Maximum individual Estimated population Estimated annual Maximum chronic non- Maximum screening acute non-cancer HQ \4\
cancer risk (in 1 at increased risk of cancer incidence cancer TOSHI \3\ -------------------------------------------------------
million) \2\ cancer >= 1-in-1 (cases per year) ------------------------
------------------------ million ------------------------
Number of facilities \1\ ------------------------ Based on Based on
Based on Based on Based on Based on Based on Based on actual allowable Based on actual emissions Based on allowable
actual allowable actual allowable actual allowable emissions emissions level emissions level
emissions emissions emissions emissions emissions emissions level level
level \2\ level level \2\ level level \2\ level
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
13...................................... 0.7 5 0 700 0.00004 0.0004 0.9 0.9 HQERPG 1 = 0.9 HQREL = 4
HQERPG 1=0.9
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Number of facilities evaluated in the risk analysis.
\2\ Maximum individual excess lifetime cancer risk due to HAP emissions from the source category.
\3\ Maximum TOSHI. The target organ with the highest TOSHI for the FPUF production source category is the respiratory system.
\4\ The maximum estimated acute exposure concentration was divided by available short-term threshold values to develop an array of HQ values. HQ values shown use the lowest available acute
threshold value, which in most cases is the REL. When HQ values exceed 1, we also show HQ values using the next lowest available acute dose-response value. See section III.A.3 of this
preamble for explanation of acute dose-response values.
The results of the inhalation risk modeling using actual emissions
level data, as shown in Table 2, indicate that the maximum lifetime
individual cancer risk could be up to 0.7-in-1 million, the maximum
chronic non-cancer TOSHI value could be up to 0.9, and the maximum off-
site acute HQ value could be up to 0.9. The total estimated national
cancer incidence from these facilities based on actual emission levels
is 0.00004 excess cancer cases per year or one case in every 25,000
years.
As discussed in section III.A.2, we also determined that MACT-
allowable HAP ABA emissions levels at slabstock production facilities
are greater than actual HAP ABA emissions, while allowable emissions
from all other processes are equal to actual emissions. The inhalation
risk modeling using MACT-allowable HAP ABA emissions and the actual
emissions for the other processes at slabstock production facilities,
indicate that the maximum lifetime individual cancer risk could be up
to 5-in-1 million, the maximum chronic non-cancer TOSHI value could be
up to 0.9, and the maximum off-site acute HQ value could be up to 4,
based on the REL value for methylene chloride. The total estimated
national cancer incidence from these facilities based on the MACT-
allowable emission levels is 0.0004 excess cancer cases per year or one
case in every 2,500 years. For more detail about the MACT-allowable
emissions levels, see the memorandum, MACT-Allowable Emissions for the
Flexible Polyurethane Foam Production Source Category, in the docket
for this rulemaking.
2. Acute Risk Results
Table 2 shows the acute risk results for the FPUF production source
category. The screening analysis for worst-case acute impacts was based
on a conservative default emissions multiplier of 10 to estimate the
peak hourly emission rates from the average rates. Refer to Appendix 6
of the draft residual risk document in the docket for the detailed
acute risk results.
3. Multipathway Risk Screening Results
There are no PB-HAP emitted by facilities in this category.
Therefore, we do not expect there is a potential for human health
multipathway risks as a result of emissions of these HAP.
4. Ecological Risk Screening Results
The emissions data for the FPUF source category indicate that
sources within this source category do not emit any of the seven
pollutants that we identified as ``environmental HAP,'' as discussed
earlier in this preamble. Based on the processes and materials used in
the source category, we do not expect any of the seven environmental
HAP to be emitted. Also, we are unaware of any adverse environmental
effect caused by emissions of HAP that are emitted by this source
category. Therefore, we do not expect an adverse environmental effect
as a result of HAP emissions from this source category.
[[Page 66123]]
5. Facility-Wide Inhalation Risk Assessment Results
Table 3 displays the results of the facility-wide risk assessment.
This assessment is based on actual emission levels. For detailed
facility-specific results, see Appendix 6 of the Draft Residual Risk
Assessment for the Flexible Polyurethane Foam Production Source
Category in the docket for this rulemaking.
Table 3--FPUF Production Facility-Wide Risk Assessment Results
------------------------------------------------------------------------
------------------------------------------------------------------------
Number of facilities analyzed.................................. 13
Cancer Risk:
Estimated maximum facility-wide individual cancer risk (in 20
1 million)................................................
Number of facilities with estimated facility-wide 0
individual cancer risk of 100-in-1 million or more........
Number of facilities at which the FPUF production source 0
category contributes 50 percent or more to the facility-
wide individual cancer risks of 100-in-1 million or more..
Number of facilities with estimated facility-wide 3
individual cancer risk of 1-in-1 million or more..........
Number of facilities at which the FPUF production source 0
category contributes 50 percent or more to the facility-
wide individual cancer risk of 1-in-1 million or more.....
Chronic Non-cancer Risk:
Maximum facility-wide chronic non-cancer TOSHI............. 0.9
Number of facilities with facility-wide maximum non-cancer 0
TOSHI greater than 1......................................
Number of facilities at which the FPUF production source 0
category contributes 50 percent or more to the facility-
wide maximum non-cancer TOSHI of 1 or more................
------------------------------------------------------------------------
The facility-wide MIR and TOSHI are based on actual emissions from
all emissions sources at the identified facilities. The results
indicate that 3 facilities have a facility-wide cancer MIR greater than
or equal to 1-in-1 million. The maximum facility-wide MIR is 20-in-1
million, with emission points from the FPUF production source category
contributing less than 10 percent of the maximum facility-wide risk.
The maximum facility-wide TOSHI is 0.9, with the FPUF production source
category contributing 100 percent to the facility-wide TOSHI.
6. What demographic groups might benefit from this regulation?
To determine whether or not to conduct a demographics analysis, we
look at a combination of factors including the MIR, non-cancer TOSHI,
population around the facilities in the source category and other
relevant factors. For the FPUF production source category, our analyses
show that actual emissions result in no individuals being exposed to
cancer risk greater than 1-in-1 million or a non-cancer TOSHI greater
than 1. Therefore, we did not conduct an assessment of risks to
individual demographic groups for this rulemaking. However, we did
conduct a proximity analysis, which identifies any overrepresentation
of minority, low income or indigenous populations near facilities in
the source category. The results of this analysis are presented in the
section of this preamble titled, ``Executive Order 12898: Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations.''
B. What are our proposed decisions regarding risk acceptability, ample
margin of safety and adverse environmental effects?
1. Risk Acceptability
As noted in section III.C of this preamble, we weigh all health
risk factors in our risk acceptability determination, including the
cancer MIR; the number of persons in various cancer and non-cancer risk
ranges; cancer incidence; the maximum non-cancer TOSHI; the maximum
acute non-cancer HQ; the extent of non-cancer risks; the potential for
adverse environmental effects; the distribution of cancer and non-
cancer risks in the exposed population; and risk estimation
uncertainties (54 FR 38044, September 14, 1989).
For the FPUF production source category, the risk analysis
indicates that the cancer risks to the individual most exposed could be
up to 0.7-in-1 million due to actual emissions and 5-in-1 million based
on MACT-allowable emissions. These risks are considerably less than
100-in-1 million, which is the presumptive upper limit of acceptable
risk. The risk analysis also shows very low cancer incidence (0.00004
cases per year), as well as no potential for adverse chronic or multi-
pathway health effects. In addition, the risk assessment indicates no
significant potential for multi-pathway health effects or adverse
environmental effects. The acute non-cancer risks based on actual
emissions are all below an HQ of 1. Therefore, we find there is little
potential concern of acute non-cancer health impacts from actual
emissions. For acute non-cancer risks based on allowable emissions,
there was an HQ of 4 based on the REL for methylene chloride. Since the
acute modeling scenario is worst-case because of its confluence of peak
emission rates and worst-case dispersion conditions, and since the HQ
estimates for methylene chloride based on the AEGL-1 and ERPG-1 values
for this facility are below 1, we are proposing to find that acute non-
cancer health impacts of concern are unlikely.
Considering all of the health risk information and factors
discussed above, including the uncertainties discussed in section
III.A.8 of this preamble, we propose that the risks from the FPUF
production source category are acceptable.
2. Ample Margin of Safety Analysis and Proposed Controls
Although we are proposing that the risks from the FPUF production
source category are acceptable, risk estimates for 700 individuals in
the exposed population are above 1-in-1 million at the MACT-allowable
emissions levels. Consequently, we further considered whether the FPUF
Production MACT standards provide an ample margin of safety to protect
public health at the MACT-allowable emissions levels. In this ample
margin of safety analysis, we investigated available emissions control
options that might reduce the risk associated with MACT-allowable
emissions from the source category. We considered this information
along with all of the health risks and other health information
considered in our determination of risk acceptability.
For HAP used as an ABA at slabstock foam production facilities, we
considered prohibiting facilities from using any HAP or HAP-based
product as an ABA, as an option to reduce risks from this source
category. Emissions of HAP ABA were shown to contribute
[[Page 66124]]
nearly 100 percent to the maximum individual cancer risks at the MACT-
allowable emissions level for this source category. This control option
would require facilities to use ABAs that do not contain HAP. We
estimate the HAP emissions reduction resulting from this control option
would be approximately 735 tpy from the baseline MACT-allowable
emissions level. We estimate there would be no costs associated with
implementation of this option, as all facilities in the source category
are reporting that they do not have HAP ABA emissions from the foam
production line, and industry representatives have confirmed that all
sources have already discontinued use of a HAP or HAP-based product as
an ABA. Furthermore, there are no additional costs associated with the
recordkeeping and reporting requirements for compliance. With this
control option, we estimate the maximum cancer risks based on allowable
emissions would be reduced from 5-in-1 million to less than 1-in-1
million, the annual cancer incidence would be reduced from 0.0004 to
0.00004, the acute HQ would be reduced from 4 to less than 1 and the
non-cancer TOSHI would remain unchanged. We believe this HAP ABA
prohibition is technically feasible for all slabstock FPUF production
operations and is a cost-effective measure to achieve emissions and
health risk reductions associated with the MACT-allowable level of
emissions. Therefore, based on this analysis, we are proposing under
section 112(f)(2) of the CAA to prohibit the use of HAP or HAP-based
products as ABAs.
We are proposing that the existing MACT standards, as modified to
include the HAP-based ABA prohibition described above, will provide an
ample margin of safety to protect public health and prevent an adverse
environmental effect.
For diisocyanate storage vessels, as discussed in section IV.C.2.
of this preamble, we identified one control option to further reduce
HAP emissions from these storage vessels, which were shown to
contribute approximately 1 percent to the maximum individual cancer
risks at the MACT-allowable emissions level for the source category.
This control option would require sources to increase storage vessel
HAP emissions control efficiencies to 98 percent, using technologies
such as regenerative thermal oxidizers (RTO) or recuperative thermal
oxidizers (RCO). We estimate the resulting HAP reduction would be
approximately 0.0026 tpy from the baseline MACT-allowable emissions
level. The estimated cost effectiveness per ton of HAP emissions
reduction would be $124 million and $269 million, based on using a RTO
and RCO, respectively. The additional control requirement would not
achieve a reduction in the maximum individual cancer risks or any of
the other risk metrics due to emissions at the MACT-allowable level.
Due to the minimal reductions in HAP emissions and risk, along with the
substantial costs associated with this option, we are proposing that
additional HAP emissions controls for FPUF production diisocyanate
storage vessels are not necessary to provide an ample margin of safety.
For equipment leaks at slabstock foam production facilities, as
discussed in section IV.C.3. of this preamble, we identified several
control options to further address risks from leaking components. We
estimate that up to 3 percent of the emissions and associated risk at
the MACT-allowable levels could be attributed to equipment leaks.\22\
The control options identified include the use of ``leakless'' valves
in diisocyanate service at slabstock facilities and implementation of
an enhanced LDAR program for diisocyanate equipment leaks at slabstock
facilities. These control options would require sources to use
``leakless'' valve technology or implement a LDAR program that would
incorporate monitoring with EPA Method 21, specific leak definitions,
and possibly a limit on the total number of non-repairable equipment
allowed. We estimate the HAP reduction resulting from the ``leakless''
valve technology would be 1 tpy from the baseline MACT-allowable
emissions level, with a cost effectiveness of $305,000/ton HAP
reduction. The HAP emissions reduction resulting from an enhanced LDAR
program would be 0.38 tpy from the baseline MACT-allowable emissions
level, with a cost effectiveness of approximately $74,000/ton HAP
reduction. The HAP emissions reduction resulting from the portion of an
enhanced LDAR program that incorporates limits on the total number of
non-repairable equipment allowed would be 0.08 tpy from the baseline
MACT-allowable emissions level, with a cost effectiveness of
approximately $234,000/ton HAP emissions reduction. None of these
additional control requirements for diisocyanate equipment leaks would
achieve a reduction in the maximum individual cancer risks or any of
the other health risk metrics. Due to the minimal reductions in HAP
emissions and risk, along with the substantial costs associated with
these options, we are proposing that additional HAP emissions controls
for FPUF production diisocyanate equipment leaks are not necessary to
provide an ample margin of safety.
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\22\ Hazardous Air Pollutant Emissions from the Production of
Flexible Polyurethane Foam. Basis and Purpose Document for Proposed
Standards.'' Page 6-9. U.S. EPA Office of Air Quality Planning and
Standards. September 1996.
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3. Adverse Environmental Effects
We did not identify emissions of the seven environmental HAP
included in our environmental risk screening, and are unaware of any
adverse environmental effects caused by other HAP emitted by this
source category. Therefore, we do not expect there to be an adverse
environmental effect as a result of HAP emissions from this source
category, and we are proposing that it is not necessary to set a more
stringent standard to prevent, taking into consideration costs, energy,
safety, and other relevant factors, an adverse environmental effect.
C. What are the results and proposed decisions based on our technology
review?
As described in section III.C of this preamble, our technology
review focused on identifying developments in practices, processes and
control technologies for the emission sources in the FPUF production
source category. The following sections summarize our technology review
results. More information concerning our technology review can be found
in the memorandum titled, Technology Review and Cost Impacts for the
Proposed Amendments to the Flexible Polyurethane Foam Production Source
Category, which is available in the docket.
1. Slabstock Foam Production Line
The current MACT standards allow limited use of HAP-based ABAs at
slabstock foam production facilities, while prohibiting the use of HAP-
based products, with limited exceptions, for specific purposes at other
types of FPUF production facilities (including equipment cleaning,
mixhead flushing and facilitating mold release at molded and rebond
foam facilities). The FPUF Production MACT standards also prohibit HAP
and HAP-based products in equipment cleaners at slabstock foam
facilities (except at facilities operating under the provisions for a
source-wide emission limit for a single HAP ABA). Prohibiting the use
of HAP-based ABAs and HAP-based equipment cleaners at slabstock foam
production facilities has been identified as a development in
[[Page 66125]]
practices and/or processes that could reduce HAP emissions from the
slabstock foam production line.
At the time of promulgation of the FPUF MACT standards, the EPA
believed that HAP ABAs were necessary for production of some grades of
foam. Therefore, the FPUF Production MACT standards significantly
limited the use of HAP ABAs by slabstock foam producers, but allowed
their use in production of certain grades of foam.
Available data from EPA databases, industry survey responses and
contacts with state and local permitting agencies show that none of the
13 facilities currently identified as being subject to the FPUF
Production MACT standards are using any HAP ABAs, or ABAs containing
HAP (i.e., HAP-based ABAs). Further confirmation was received through
discussions with the Polyurethane Foam Association (PFA), a trade
association representing the slabstock polyurethane foam production
industry. Details of the discussion with PFA are contained in
Documentation of Communications with Industry and Regulatory Agency
Contacts for the Flexible Polyurethane Foam Industry, which is
available in the docket for this rulemaking. The discontinuation of HAP
ABAs (or HAP-based ABAs) use by FPUF producers demonstrates that foam
producers have improved their ability to produce their products using
alternatives to HAP or HAP-based ABAs since the promulgation of the
original FPUF Production NESHAP.
No facilities subject to subpart III are currently using any HAP or
HAP-based ABAs. Therefore, there will be no cost associated with
codifying current industry practice prohibiting the use of HAP or HAP-
based ABAs. There may be small cost savings at some facilities due to
reduced monitoring and recordkeeping costs. Because there are no
estimated costs, the industry is already complying with this HAP and
HAP-based ABA prohibition in practice, and reductions in allowable
emissions would be achieved, we are proposing that it is necessary,
pursuant to CAA section 112(d)(6), to revise the MACT to prohibit the
use of HAP and HAP-based ABAs at slabstock foam production facilities.
As noted in section IV.B.2., we are concurrently proposing this HAP and
HAP-based ABA prohibition under section 112(f)(2) of the CAA to provide
an ample margin of safety to protect public health. Also, as noted in
section II.B, we solicit comments regarding whether any facilities
subject to subpart III currently use HAP or HAP-based ABAs.
2. Diisocyanate Storage Vessels
The FPUF Production MACT standards provide two compliance options
for diisocyanate storage vessels: Equip the storage vessels (tanks)
with a vapor return line from the storage vessel to the truck or rail
car during unloading; or equip the storage vessel with a carbon
adsorption system which routes displaced vapors through activated
carbon. These control systems are estimated to have control
efficiencies of 95 percent. For the technology review, we identified
two potential control options to capture and control emissions from
storage tanks: Regenerative and recuperative thermal oxidizers. Both
reportedly have control efficiencies of 98 percent, and known
application to low concentration organic vapor gas streams. We estimate
an additional emission reduction of 0.0026 tpy would be associated with
an increase from 95 percent estimated HAP control in the original FPUF
MACT standards to 98 percent HAP control today. The estimated cost per
ton of emissions reduction would be $124 million and $270 million per
ton of HAP for regenerative and recuperative thermal oxidizers,
respectively.
Based on the high costs and the minimal emissions reductions that
would be achieved by these diisocyanate tank controls, we are proposing
that it is not necessary to revise the MACT standards pursuant to CAA
section 112(d)(6) to provide for a stricter level of control.
3. Equipment Leaks
For equipment leaks, we identified two developments in practices,
process or control technologies: Use of ``leakless'' valves in
diisocyanate service at slabstock facilities and implementation of an
enhanced equipment LDAR for diisocyanate equipment leaks at slabstock
facilities. While there are requirements for LDAR in the original MACT
standards, we further investigated LDAR for developments that have
occurred since the rule was promulgated. The two developments in LDAR
programs are a limit on the total number of non-repairable equipment
allowed and the inclusion of lower leak detection limits for valves and
connectors than those considered previously for the MACT standards.
a. ``Leakless'' Valves
``Leakless'' valves that significantly reduce emissions are in
place in some facilities outside the FPUF production source category,
particularly oil refineries. We analyzed the costs associated with
requiring this ``leakless'' valve technology for valves in diisocyanate
service in the FPUF production source category using cost estimates
developed for the synthetic organic chemical manufacturing industry.
Nationwide annual costs were estimated to be $310,000/yr, with total
capital investments of $2,260,000. Emission reductions were estimated
to be 1 tpy, resulting in a cost effectiveness of $305,000/ton HAP
reduction.
Based on the high costs and the minimal emissions reductions that
would be achieved using this technology, we are proposing that it is
not necessary to revise the MACT standards pursuant to CAA section
112(d)(6) to require the installation of ``leakless'' valves.
b. Implementation of Enhanced LDAR Programs
The current MACT standards require an LDAR program that employs
visual, audible or other methods for detecting leaks. This standard
requires repair of leaks within 15 calendar days when leaks are
detected by visual, audible or any other detection method for
equipment, other than transfer pumps, in diisocyanate service. Leakless
technology is required for transfer pumps.
During the development of the MACT standards, another LDAR program,
using Method 21, was identified as a beyond-the-floor method for
controlling emissions from equipment leaks at slabstock foam facilities
for equipment in diisocyanate service, but was not chosen as the level
of the standard. At that time, the leak definition was set at a HAP
concentration of 10,000 ppm or greater. Since the development of the
MACT standards, analyses have been performed by the EPA regarding costs
and emission reductions in the chemical and petroleum industries
associated with lowering the level at which a HAP concentration is
considered to be a leak for LDAR programs.\23\ We used these analyses
in the CAA section 112(d)(6) technology review for the FPUF production
source category to assess the effects of adding an enhanced LDAR
program for metering pumps, valves, connectors and open-ended lines in
diisocyanate service at slabstock foam production facilities. The LDAR
program would incorporate monitoring, employing Method 21 of 40 CFR
part 60, Appendix A, and lower leak definitions. The lower leak
definitions considered
[[Page 66126]]
include two options identified in the EPA analysis of emissions
reduction techniques for equipment leaks:
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\23\ Memorandum from Cindy Hancy, RTI to Jodi Howard, EPA,
Analysis of Emission Reduction Techniques for Equipment Leaks,
December 21, 2011. (EPA-HQ-OAR-2002-0037-0180.) See Attachment 1.
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1. Leak definition for metering pumps of 2,000 ppm; leak definition
for valves, connectors and open-ended lines of 500 ppm;
2. Leak definition for valves of 100 ppm; leak definition for
metering pumps, connectors and open-ended lines of 500 ppm.
We analyzed the costs associated with an LDAR programs with these
two options for leak definitions for equipment in diisocyanate service.
For both options, nationwide total annual costs were estimated to be
around $28,200/yr, with total capital investments of approximately
$32,400. Reduction of HAP emissions were estimated to be about 0.38
tpy, resulting in a cost effectiveness of approximately $74,000/ton HAP
reduction.
The current MACT standards allow leak repairs to be delayed under
certain circumstances. Limits on the number of leaking components
awaiting repair was also identified as a potential development in
practice that could reduce diisocyanate emissions from equipment leaks.
Both the California Bay Area Air Quality Management District (BAAQMD)
and the South Coast Air Quality Management District have LDAR programs
that limit the number of leaking equipment components awaiting repair.
The BAAQMD rule also requires mass emission testing for leaking valves
and requires valves with a high leak rate to be repaired within 7 days.
We estimated the costs of requirements addressing equipment awaiting
leak repair like those of the BAAQMD rule, irrespective of the other
costs for an LDAR program. Nationwide annual costs were estimated to be
$18,212/yr, with no capital investments required. Emission reductions
were estimated to be 0.002 tpy, resulting in a cost effectiveness of
$233,770 per ton of HAP reduction for equipment in diisocyanate service
at slabstock facilities.
Based on the high costs and the minimal emissions reduction that
would be achieved with LDAR programs using Method 21 and either of the
leak definition options, or with the restrictions on equipment awaiting
repair, we are proposing that it is not necessary to revise the MACT
standards pursuant to CAA section 112(d)(6) to require an enhanced LDAR
program. However, we are adding a provision to the rule to clarify that
delay of leak repairs for valves and connectors must be completed
within 6 months of detection, as described in section IV.D.4.
D. What other actions are we proposing?
1. Startup, Shutdown and Malfunctions
a. Background
The United States Court of Appeals for the District of Columbia
Circuit vacated portions of two provisions in the EPA's CAA section 112
regulations governing the emissions of HAP during periods of SSM.
Sierra Club v. EPA, 551 F.3d 1019 (D.C. 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) holding
that under section 302(k) of the CAA, emissions standards or
limitations must be continuous in nature and that the SSM exemption
violates the CAA's requirement that some section 112 standards apply
continuously.
We are proposing the elimination of the SSM exemption in this
proposed rule. Therefore, this proposed rule has changed the indication
of ``Yes'' to ``No'' in the General Provisions table (Table 2) of this
rule for Sec. 63.6(f), in which Sec. 63.6(f)(1) states, ``The non-
opacity emission standards set forth in this part shall apply at all
times except during periods of startup, shutdown, and malfunction. . .
.'' Consistent with Sierra Club v. EPA, the EPA is proposing standards
in this rule that apply at all times. We are also proposing several
revisions to Table 2 (Applicability of General Provisions), as is
explained in more detail below. We also are proposing to eliminate and
revise certain recordkeeping and reporting requirements related to the
SSM exemption as further described below.
The EPA has attempted to ensure that the provisions we are
proposing to eliminate are inappropriate, unnecessary, or redundant in
the absence of the SSM exemption. We are specifically seeking comment
on whether we have successfully done so.
In proposing the standards in this rule, the EPA has taken into
account startup and shutdown periods and, for the reasons explained
below, has not proposed alternate standards for those periods.
Information on periods of startup and shutdown received from the
facilities in the FPUF production industry indicate that emissions
during these periods are the same as during normal operations. The
primary means of compliance with the standards are through work
practices and product substitutions, which eliminate the use of HAP,
and are in place at all times. Therefore, separate standards for
periods of startup and shutdown are not necessary and are not being
proposed.
Periods of startup, normal operations and shutdown are all
predictable and routine aspects of a source's operations. However, by
contrast, malfunction is defined as a ``sudden, infrequent, and not
reasonably preventable failure of air pollution control and monitoring
equipment, process equipment or a process to operate in a normal or
usual manner * * *'' (40 CFR 63.2). The EPA has determined that CAA
section 112 does not require that emissions that occur during periods
of malfunction be factored into development of CAA section 112
standards. Under 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 the
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. Section
112 of the CAA 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 (D.C.
Cir. 1999) (the 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
[[Page 66127]]
general limit, individual permit, or even any upset provision can
anticipate all upset situations. After a certain point, the
transgression of regulatory limits caused by `uncontrollable acts of
third parties,' such as strikes, sabotage, operator intoxication or
insanity, and a variety of other eventualities, must be a matter for
the administrative exercise of case-by-case enforcement discretion, not
for specification in advance by regulation.''). In addition, the goal
of a best controlled or best performing source is to operate in such a
way as to avoid malfunctions of the source and accounting for
malfunctions could lead to standards that are significantly less
stringent than levels that are achieved by a well-performing non-
malfunctioning source. The EPA's approach to malfunctions is consistent
with CAA section 112 and is a reasonable interpretation of the statute.
In the unlikely event that a source fails to comply with the
applicable CAA section 112(d) standards as a result of a malfunction
event, the EPA would determine an appropriate response based on, among
other things, the good faith efforts of the source to minimize
emissions during malfunction periods, including preventative and
corrective actions, as well as root cause analyses to ascertain and
rectify excess emissions. The EPA would also consider whether the
source's failure to comply with the CAA section 112(d) standard was, in
fact, ``sudden, infrequent, not reasonably preventable'' and was not
instead ``caused in part by poor maintenance or careless operation.''
40 CFR 63.2 (definition of malfunction).
Finally, the EPA recognizes that even equipment that is properly
designed and maintained can sometimes fail and that such failure can
sometimes cause a violation of the relevant emission standard. See,
e.g., State Implementation Plans: Response to Petition for Rulemaking;
Findings of Excess Emissions During Periods of Startup, Shutdown, and
Malfunction; Proposed rule, 78 FR 12460 (Feb. 22, 2013); State
Implementation Plans: Policy Regarding Excessive Emissions During
Malfunctions, Startup, and Shutdown (Sept. 20, 1999); Policy on Excess
Emissions During Startup, Shutdown, Maintenance, and Malfunctions (Feb.
15, 1983). The EPA is, therefore, proposing to add an affirmative
defense to civil penalties for violations of emission standards that
are caused by malfunctions. (See 40 CFR 63.1292 defining ``affirmative
defense'' to mean, in the context of an enforcement proceeding, a
response or defense put forward by a defendant, regarding which the
defendant has the burden of proof, and the merits of which are
independently and objectively evaluated in a judicial or administrative
proceeding). We also are proposing other regulatory provisions to
specify the elements that are necessary to establish this affirmative
defense; the source must prove by a preponderance of the evidence that
it has met all of the elements set forth in Sec. 63.1290(e) (See 40
CFR 22.24). The criteria are designed in part to ensure that the
affirmative defense is available only where the event that causes a
violation of the emission standard meets the narrow definition of
malfunction in Sec. 63.2 (sudden, infrequent, not reasonably
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
the violation ``[w]as caused by a sudden, infrequent, and unavoidable
failure of air pollution control, process equipment, or a process to
operate in a normal or usual manner. . . .'' The criteria also are
designed to ensure that steps are taken to correct the malfunction, to
minimize emissions in accordance with section 63.1290(d) and to prevent
future malfunctions. For example, the source must prove by a
preponderance of the evidence that ``[r]epairs were made as
expeditiously as possible when a violation occurred. . .'' and that
``[a]ll possible steps were taken to minimize the impact of the
violation 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 CAA section 113 (see also 40 CFR 22.27).
The EPA included an affirmative defense in the proposed rule in an
attempt to balance a tension, inherent in many types of air regulation,
to ensure adequate compliance while simultaneously recognizing that
despite the most diligent of efforts, emission standards may be
violated under circumstances beyond the control of the source. The EPA
must establish emission standards that ``limit the quantity, rate, or
concentration of emissions of air pollutants on a continuous basis.''
42 U.S.C. 7602(k) (defining ``emission limitation'' and ``emission
standard''). See generally Sierra Club v. EPA, 551 F.3d 1019, 1021
(D.C. Cir. 2008) Thus, the EPA is required to ensure that emissions
standards are continuous. The affirmative defense for malfunction
events meets this requirement by ensuring that even where there is a
malfunction, the emission standard is still enforceable through
injunctive relief. The United States Court of Appeals for the Fifth
Circuit recently upheld the EPA's view that an affirmative defense
provision is consistent with CAA section 113(e). Luminant Generation
Co. LLC v. United States EPA, 714 F.3d 841 (5th Cir. Mar. 25, 2013)
(upholding the EPA's approval of affirmative defense provisions in a
CAA State Implementation Plan). While ``continuous'' standards, on the
one hand, are required, there is also case law indicating that in many
situations it is appropriate for the EPA to account for the practical
realities of technology. For example, in Essex Chemical v. Ruckelshaus,
486 F.2d 427, 433 (D.C. Cir. 1973), the DC Circuit acknowledged that in
setting standards under CAA section 111 ``variant provisions'' such as
provisions allowing for upsets during startup, shutdown and equipment
malfunction ``appear necessary to preserve the reasonableness of the
standards as a whole and that the record does not support the `never to
be exceeded' standard currently in force.'' See also, Portland Cement
Association v. Ruckelshaus, 486 F.2d 375 (D.C. Cir. 1973). Though
intervening case law, such as Sierra Club v. EPA and the CAA 1977
amendments, call into question the relevance of these cases today, they
support the EPA's view that a system that incorporates some level of
flexibility is reasonable. The affirmative defense simply provides for
a defense to civil penalties for violations that are proven to be
beyond the control of the source. By incorporating an affirmative
defense, the EPA has formalized its approach to malfunctions. In a
Clean Water Act setting, the Ninth Circuit required this type of
formalized approach when regulating ``upsets beyond the control of the
permit holder.'' Marathon Oil Co. v. EPA, 564 F.2d 1253, 1272-73 (9th
Cir. 1977). See also, Mont. Sulphur & Chem. Co. v. EPA, 666 F.3d. 1174
(9th Cir. 2012) (rejecting industry argument that reliance on the
affirmative defense was not adequate). But see, Weyerhaeuser Co. v.
Costle, 590 F.2d 1011, 1057-58 (D.C. Cir. 1978) (holding that an
informal approach is adequate). The affirmative defense provisions give
the EPA the flexibility to both ensure that its emission standards are
``continuous'' as required by 42 U.S.C. 7602(k), and account for
unplanned upsets and thus
[[Page 66128]]
support the reasonableness of the standard as a whole. The EPA is
proposing the affirmative defense applicable to malfunctions under the
delegation of general regulatory authority set out in CAA section
301(a)(1), 42 U.S.C. 7601(a)(1), in order to balance this tension
between provisions of the CAA and the practical reality, as case law
recognizes, that technology sometimes fails. See generally Citizens to
Save Spencer County v. U.S. Environmental Protection Agency, 600 F.2d
844, 873 (D.C. Cir. 1979) (using CAA section 301(a) authority to
harmonize inconsistent guidelines related to the implementation of
federal preconstruction review requirements).
b. Specific SSM-Related Proposed Changes
To address the United States Court of Appeals for the District of
Columbia Circuit vacatur of portions of the EPA's CAA section 112
regulations governing the emissions of HAP during periods of SSM, we
are revising and adding certain provisions to the FPUF Production rule.
As described in detail below, we are revising the General Provisions
(Table 2) to change several of the references related to requirements
that apply during periods of SSM. We are also adding the following
provisions to the FPUF Production rule: (1) The general duty to
minimize emissions at all times, (2) the requirement for sources to
comply with the emission limits in the rule at all times, and (3)
malfunction recordkeeping and reporting requirements.
i. Sec. 63.1290(d)(4) General Duty
We are proposing to revise the General Provisions table (Table 2)
entry for Sec. 63.6(e)(1)-(2) by adding rows specifically for Sec.
63.6(e)(1)(i), 63.6(e)(1)(ii) and 63.6(e)(1)(iii) and to include a
``no'' in the second column for the Sec. 63.6(e)(1)(i) entry. Section
63.6(e)(1)(i) describes the general duty to minimize emissions. Some of
the language in that section is no longer necessary or appropriate in
light of the elimination of the SSM exemption. We are proposing instead
to add general duty regulatory text at Sec. 63.1290(d)(4) that
reflects the general duty to minimize emissions while eliminating the
reference to periods covered by an SSM exemption. The current language
in 40 CFR 63.6(e)(1)(i) characterizes what the general duty entails
during periods of SSM. With the elimination of the SSM exemption, there
is no need to differentiate between normal operations, startup and
shutdown, and malfunction events in describing the general duty.
Therefore the language the EPA is proposing does not include that
language from Sec. 63.6(e)(1).
We are also proposing to include a ``no'' in the second column for
the newly added Sec. 63.6(e)(1)(ii) entry. Section 63.6(e)(1)(ii)
imposes requirements that are not necessary with the elimination of the
SSM exemption or are redundant of the general duty requirement being
added at Sec. 63.1290(d)(4).
ii. Compliance With Standards
We are proposing to revise the General Provisions table (Table 2)
entry for Sec. 63.6(f) by adding a specific entry for Sec. 63.6(f)(1)
and including a ``no'' in the second column for this Sec. 63.6(f)(1)
entry. The current language of section 63.6, paragraph (f)(1) exempts
sources from non-opacity standards during periods of SSM. As discussed
above, the court in Sierra Club vacated the exemptions contained in
this provision and held that the CAA requires that some CAA section 112
standard apply continuously. Consistent with Sierra Club, the EPA is
proposing to revise standards in this rule to apply at all times.
iii. Sec. 63.1307(h) Recordkeeping
We are proposing to revise the General Provisions table (Table 2)
entry for Sec. 63.10(a)-(b) by adding rows specifically for Sec.
63.10(a), 63.10(b)(1), 63.10 (b)(2)(i), 63.10 (b)(2)(ii), 63.10
(b)(2)(iii), 63.10 (b)(2)(iv)-(xi), 63.10 (b)(2)(xii), 63.10 (b)(xiii),
and 63.10 (b)(2)(xiv) in order to specify changes we are making to the
applicability of several of the Sec. 63.10(b)(2) paragraphs. In the
entry for Sec. 63.10(b)(2)(i), we are including a ``no'' in the second
column. Section 63.10(b)(2)(i) describes the recordkeeping requirements
during startup and shutdown. These recording provisions are no longer
necessary because the EPA is proposing that recordkeeping and reporting
applicable to normal operations will apply to startup and shutdown. In
the absence of special provisions applicable to startup and shutdown,
such as a startup and shutdown plan, there is no reason to retain
additional recordkeeping for startup and shutdown periods.
In the entry for Sec. 63.10(b)(2)(ii), we are including a ``no''
in the second column. Section 63.10(b)(2)(ii) describes the
recordkeeping requirements during a malfunction. The EPA is proposing
to add such requirements to 40 CFR 63.1307(h). The regulatory text we
are proposing to add differs from the General Provisions it is
replacing in that the General Provisions requires the creation and
retention of a record of the occurrence and duration of each
malfunction of process, air pollution control, and monitoring
equipment. The EPA is proposing that this requirement apply to any
failure to meet an applicable standard and is requiring that the source
record the date, time, and duration of the failure rather than the
``occurrence.'' The EPA is also proposing to add to Sec. 63.1307(h) a
requirement that sources keep records that include a list of the
affected sources or equipment and actions taken to minimize emissions,
an estimate of the volume of each regulated pollutant emitted over the
standard for which the source failed to meet a standard, and a
description of the method used to estimate the emissions. Examples of
such methods would include product-loss calculations, mass balance
calculations, measurements when available, or engineering judgment
based on known process parameters. The EPA is proposing to require that
sources keep records of this information to ensure that there is
adequate information to allow the EPA to determine the severity of any
failure to meet a standard, and to provide data that may document how
the source met the general duty to minimize emissions when the source
has failed to meet an applicable standard.
We are including a ``no'' in the second column in the entry for
Sec. 63.10(b)(2)(iv) and 63.10(b)(2)(v). When applicable, the
provisions require sources to record actions taken during SSM events
when actions were inconsistent with their SSM plan. These requirements
are not appropriate because SSM plans are not (and were not) required
by this rule, and the General Provisions applicability table referenced
these sections in error.
iv. Sec. 63.1306(f) Reporting
We are proposing to revise the General Provisions table (Table 2)
entry for Sec. 63.10(d)(4)-(5) by adding a specific entry for Sec.
63.10(d)(5) and including a ``no'' in the second column for this Sec.
63.10(d)(5) entry. Section 63.10(d)(5) describes the reporting
requirements for startups, shutdowns, and malfunctions. To replace the
General Provisions reporting requirement, the EPA is proposing to add
reporting requirements to 40 CFR 63.1306(f). The replacement language
differs from the General Provisions requirement in that it eliminates
periodic SSM reports as a stand-alone report. We are proposing language
that requires sources that fail to meet an applicable standard at any
time to report the information concerning such events in the semi-
annual report for slabstock affected sources and in the annual
compliance
[[Page 66129]]
certification for molded and rebond affected sources, which are already
required under this rule. We are proposing that the malfunction report
must contain the number, date, time, duration, and the cause of such
events (including unknown cause, if applicable), a list of the affected
sources or equipment, an estimate of the volume of each regulated
pollutant emitted over any emission limit, and a description of the
method used to estimate the emissions.
Examples of such methods would include product-loss calculations,
mass balance calculations, measurements when available, or engineering
judgment based on known process parameters. The EPA is proposing this
requirement to ensure that there is adequate information to determine
compliance, to allow the EPA to determine the severity of the failure
to meet an applicable standard, and to provide data that may document
how the source met the general duty to minimize emissions during a
failure to meet an applicable standard.
The proposed rule eliminates the cross reference to section
63.10(d)(5)(i) that contains the description of the previously required
SSM report format and submittal schedule from this section. These
specifications are no longer necessary because the events will be
reported in otherwise required reports with similar format and
submittal requirements.
We note that reporting a failure to meet an applicable standard
could include malfunction events for which a source may choose to
submit documentation to support an assertion of affirmative defense. If
a source provides all the material required in section 63.1290(e) to
support an affirmative defense, the source need not submit the same
information two times in the same report. While assertion of an
affirmative defense is not mandatory and occurs only if a source
chooses to take advantage of the affirmative defense, the affirmative
defense also requires additional reporting that goes beyond these
routine requirements related to a failure to meet an applicable
standard for a reason other than a malfunction.
The proposed rule also eliminates the cross-reference to section
63.10(d)(5)(ii). Section 63.10(d)(5)(ii) describes an immediate report
for startups, shutdown, and malfunctions when a source failed to meet
an applicable standard but did not follow the SSM plan. These
requirements are not appropriate because SSM plans are not required by
this rule, and the General Provisions applicability table referenced
this section in error.
2. Electronic Reporting of Performance Test Data
In this proposal, the EPA is describing a process to increase the
ease and efficiency of performance test data submittal while improving
data accessibility. Specifically, the EPA is proposing that owners and
operators of FPUF production facilities submit electronic copies of
required performance test reports by direct computer-to-computer
electronic transfer using EPA-provided software. The direct computer-
to-computer electronic transfer is accomplished through the EPA's
Central Data Exchange (CDX) using the Compliance and Emissions Data
Reporting Interface (CEDRI). The CDX is EPA's portal for submittal of
electronic data. The EPA-provided software is called the Electronic
Reporting Tool (ERT) which is used to generate electronic reports of
performance tests and evaluations. The ERT generates an electronic
report package which will be submitted using the CEDRI. The submitted
report package will be stored in the CDX archive (the official copy of
record) and EPA's public database called WebFIRE. All stakeholders will
have access to all reports and data in WebFIRE and accessing these
reports and data will be very straightforward and easy (see the WebFIRE
Report Search and Retrieval link at https://cfpub.epa.gov/webfire/index.cfm?action=fire.searchERTSubmission). A description and
instructions for use of the ERT can be found at https://www.epa.gov/ttn/chief/ert/ and CEDRI can be accessed through the CDX Web site
(www.epa.gov/cdx). A description of the WebFIRE database is available
at: https://cfpub.epa.gov/oarweb/index.cfm?action=fire.main.
The proposal to submit performance test data electronically to the
EPA applies only to those performance tests conducted using test
methods that are supported by the ERT. The ERT supports 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/.
We believe that industry would benefit from this proposed approach
to electronic data submittal. Specifically, by using this approach,
industry will save time in the performance test submittal process.
Additionally, the standardized format that the ERT uses allows sources
to create a more complete test report resulting in less time spent on
data backfilling if a source failed to include all data elements
required to be submitted. Also through this proposal industry may only
need to submit a report once to meet the requirements of the applicable
subpart because stakeholders can readily access these reports from the
WebFIRE database. This also benefits industry by cutting back on
recordkeeping costs as the performance test reports that are submitted
to the EPA using CEDRI are no longer required to be retained in hard
copy, thereby, reducing staff time needed to coordinate these records.
Since the EPA will already have performance test data in hand,
another benefit to industry is that fewer or less substantial data
collection requests in conjunction with prospective required residual
risk assessments or technology reviews will be needed. This would
result in a decrease in staff time needed to respond to data collection
requests.
State, local and tribal air pollution control agencies (S/L/Ts) may
also benefit from having electronic versions of the reports they are
now receiving. For example, S/L/Ts may be able to conduct a more
streamlined and accurate review of electronic data submitted to them.
For example, the ERT would allow for an electronic review process,
rather than a manual data assessment, therefore, making review and
evaluation of the source provided data and calculations easier and more
efficient. In addition, the public stands to benefit from electronic
reporting of emissions data because the electronic data will be easier
for the public to access. How the air emissions data are collected,
accessed and reviewed will be more transparent for all stakeholders.
One major advantage of the proposed submittal of performance test
data through the ERT is a standardized method to compile and store much
of the documentation required to be reported by this proposed rule. The
ERT clearly states what testing information would be required by the
test method and has the ability to house additional data elements that
might be required by a delegated authority.
In addition the EPA must have performance test data to conduct
effective reviews of CAA sections 111, 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, the 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. In recent
[[Page 66130]]
years, though, stack testing firms have typically collected performance
test data in electronic format, 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.
A common complaint heard from industry and regulators is that
emission factors are outdated or not representative of a particular
source category. With timely receipt and incorporation of data from
most performance tests, the EPA would be able to ensure that emission
factors, when updated, represent the most current range of operational
practices. Another benefit of the proposed data submittal to WebFIRE
electronically is that these data would greatly improve the overall
quality of existing and new emissions factors by supplementing the pool
of emissions test data for establishing emissions factors.
Finally, the general public would also benefit from electronic
reporting of emissions data because the data would be available for
viewing sooner and would be easier for the public to access. The EPA
Web site that stores the submitted electronic data will be easily
accessible to the public and will provide a user-friendly interface
that any stakeholder could access.
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 would save industry, state, local, tribal agencies and the
EPA significant time, money and effort, while also improving the
quality of emission inventories and air quality regulations. Electronic
databases will also benefit the general public by improving
accessibility to emissions data in an efficient and timely manner.
3. Clarification to Diisocyanate Storage Vessels Leak Detection Methods
The EPA is proposing to clarify the leak detection methods that may
be used for diisocyanate storage vessels at slabstock foam production
facilities during unloading events. The current requirements allow the
vapor return line to be inspected for leaks during unloading events
using visual, audible or any other detection method. Today, the EPA is
proposing to clarify, that ``any other detection method'' must be an
instrumental detection method.
4. Clarification to Diisocyanate Equipment Leak Delay of Repair
Requirements for Valves and Connectors
The FPUF Production MACT standards generally require equipment
leaks to be repaired within 15 days. However, there are also provisions
that allow for a delay of repair. A delay of repair for pumps is
allowed if repair requires replacing the existing seal design with a
sealless pump, and the repair is completed as soon as practicable, but
not later than 6 months after the leak is detected. For valves and
connectors, a delay of repair is allowed if the owner or operator
determines that diisocyanate emissions of purged material resulting
from immediate repair are greater than the fugitive emissions likely to
result from a delay of repair. However, for valves and connectors, the
current provisions do not state how long such a delay may last. To be
consistent with the requirements for pumps, we are proposing to clarify
that, for valves and connectors, the repair must be completed as soon
as practicable, but not later than 6 months after the leak was
detected.
E. What compliance dates are we proposing?
We are proposing that FPUF production facilities comply with the
new proposed requirements prohibiting the use of HAP ABAs in this
action no later than 90 days after the effective date of the final
rule. This time period will be sufficient because all FPUF production
facilities have already discontinued use of HAP ABAs.
We are proposing that facilities must comply with the SSM reporting
and recordkeeping requirements and affirmative defense provisions, and
requirements for electronic reporting on the effective date of the
rule. We are proposing these compliance dates because the revised SSM
requirements should be immediately implementable by the facilities upon
the next occurrence of a malfunction, and the electronic reporting
requirements should be immediately implementable by the facilities upon
their next performance test.
V. Summary of Cost, Environmental and Economic Impacts
A. What are the affected sources?
We anticipate that 13 FPUF production facilities currently
operating in the United States will be affected by these proposed
amendments. We also expect no new facilities to be constructed in the
foreseeable future. For more information about expected new facilities,
see the document titled, Documentation of Communications with Industry
and Regulatory Agency Contacts for the Flexible Polyurethane Foam
Industry, located in the docket for this action.
B. What are the air quality impacts?
The EPA estimates that the proposed amendments to the FPUF
Production MACT standards will not result in any directly quantifiable
reduction of HAP emissions. Emissions of HAP from FPUF production
sources have significantly declined since promulgation of the FPUF
Production MACT standards because HAP ABAs are no longer used by FPUF
production facilities. However, as discussed in section III.A.2, the
MACT standards currently allow sources to use HAP ABAs. We estimate
that the MACT-allowable emissions for the FPUF production source
category are 735 tons of HAP ABAs. If the proposed revision prohibiting
the use of HAP ABAs is finalized, the MACT-allowable emissions from ABA
use would be zero. A detailed documentation of the analysis can be
found in: MACT-Allowable Emissions for the Flexible Polyurethane Foam
Production Source Category, which is available in the docket for this
rulemaking.
C. What are the cost impacts?
Under the proposed amendments, FPUF production facilities are not
expected to incur any costs. However, there may be small cost savings
at some facilities due to reduced monitoring and recordkeeping costs.
The memorandum, Technology Review and Cost Impacts for the Proposed
Amendments to the Flexible Polyurethane Foam Production Source
Category, includes a complete description of the cost estimate methods
used for the analyses related to the proposed HAP and HAP-based ABA
prohibition and is available in the docket.
D. What are the economic impacts?
Because no costs or a small cost savings are expected as a result
of the proposed amendments, there will not be any significant impacts
on affected firms and their consumers as a result of this proposal.
Because no small firms face significant control costs, there is no
significant impact on small entities. Thus, this regulation is not
expected to have a significant impact on a substantial number of small
entities.
E. What are the benefits?
We do not anticipate any significant actual emission reductions of
HAP as a result of these proposed amendments. However, if finalized,
the proposed prohibition on HAP ABA use would eliminate the possibility
that facilities
[[Page 66131]]
might begin to use HAP ABAs again. Under the existing rule, those
possible emissions are estimated at 735 tons of HAP ABAs. If the
prohibition is adopted, no emissions of HAP ABA would be allowed by the
standard.
VI. Request for Comments
We solicit comments on all aspects of this proposed action. In
addition to general comments on this proposed action, we are also
interested in additional data that may improve the risk assessments and
other analyses. We are specifically interested in receiving any
improvements to the data used in the site-specific emissions profiles
used for risk modeling. Such data should include supporting
documentation in sufficient detail to allow characterization of the
quality and representativeness of the data or information. Section VII
of this preamble provides more information on submitting data.
VII. Submitting Data Corrections
The site-specific emissions profiles used in the source category
risk and demographic analyses and instructions are available on the RTR
Web page at: https://www.epa.gov/ttn/atw/rrisk/rtrpg.html. The data
files include detailed information for each HAP emissions release point
for the facilities in the source category.
If you believe that the data are not representative or are
inaccurate, please identify the data in question, provide your reason
for concern and provide any ``improved'' data that you have, if
available. When you submit data, we request that you provide
documentation of the basis for the revised values to support your
suggested changes. To submit comments on the data downloaded from the
RTR page, complete the following steps:
1. Within this downloaded file, enter suggested revisions to the
data fields appropriate for that information.
2. Fill in the commenter information fields for each suggested
revision (i.e., commenter name, commenter organization, commenter email
address, commenter phone number and revision comments).
3. Gather documentation for any suggested emissions revisions
(e.g., performance test reports, material balance calculations, etc.).
4. Send the entire downloaded file with suggested revisions in
Microsoft[supreg] Access format and all accompanying documentation to
Docket ID Number EPA-HQ-OAR-2012-0510 (through one of the methods
described in the ADDRESSES section of this preamble).
5. If you are providing comments on a single facility or multiple
facilities, you need only submit one file for all facilities. The file
should contain all suggested changes for all sources at that facility.
We request that all data revision comments be submitted in the form of
updated Microsoft[supreg] Excel files that are generated by the
Microsoft[supreg] Access file. These files are provided on the RTR Web
page at: https://www.epa.gov/ttn/atw/rrisk/rtrpg.html.
VIII. Statutory and Executive Order Reviews
A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review
This action is not a ``significant regulatory action'' under the
terms of Executive Order 12866 (58 FR 51735, October 4, 1993) and is
therefore not subject to review under Executive Orders 12866 and 13563
(76 FR 3821, January 21, 2011).
B. Paperwork Reduction Act
The information collection requirements in this proposed rule have
been submitted for approval to OMB under the Paperwork Reduction Act,
44 U.S.C. 3501, et seq. The Information Collection Request (ICR)
document prepared by the EPA has been assigned EPA ICR number 1783.07.
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 emissions standards. These recordkeeping
and reporting requirements are specifically authorized by CAA section
114 (42 U.S.C. 7414). All information submitted to the EPA pursuant to
the recordkeeping and reporting requirements for which a claim of
confidentiality is made is safeguarded according to agency policies set
forth in 40 CFR part 2, subpart B.
For this proposed rule, the EPA is adding affirmative defense to
the estimate of burden in the ICR. To provide the public with an
estimate of the relative magnitude of the burden associated with an
assertion of the affirmative defense position adopted by a source, the
EPA has provided administrative adjustments to this ICR to show what
the notification, recordkeeping and reporting requirements associated
with the assertion of the affirmative defense might entail. The EPA's
estimate for the required notification, reports and records for any
individual incident, including the root cause analysis, totals $2,188
for the FPUF production source category, and is based on the time and
effort required of a source to review relevant data, interview plant
employees, and document the events surrounding a malfunction that has
caused an exceedance of an emissions limit. The estimate also includes
time to produce and retain the record and reports for submission to the
EPA. The EPA provides this illustrative estimate of this burden because
these costs are only incurred if there has been a violation and a
source chooses to take advantage of the affirmative defense.
Given the variety of circumstances under which malfunctions could
occur, as well as differences among sources' operation and maintenance
practices, we cannot reliably predict the severity and frequency of
malfunction-related excess emissions events for a particular source. It
is important to note that the EPA has no basis currently for estimating
the number of malfunctions that would qualify for an affirmative
defense. Current historical records would be an inappropriate basis, as
source owners or operators previously operated their facilities in
recognition that they were exempt from the requirement to comply with
emissions standards during malfunctions. Of the number of excess
emissions events reported by source operators, only a small number
would be expected to result from a malfunction (based on the definition
above), and only a subset of excess emissions caused by malfunctions
would result in the source choosing to assert the affirmative defense.
Thus, we believe the number of instances in which source operators
might be expected to avail themselves of the affirmative defense will
be extremely small. With respect to the FPUF production source
category, we estimate the annual recordkeeping and reporting burden
after the effective date of the proposed rule for affirmative defense
to be 30 hours at a cost of $2,188. We expect to gather information on
such events in the future and will revise this estimate as better
information becomes available.
We estimate approximately 13 regulated entities are currently
subject to 40 CFR part 63, subpart III, and will be subject to all
proposed standards, a decrease of 119 regulated entities from our
estimate for the previous ICR (EPA ICR Number 1783.05, OMB Control
Number 2060-0357) for the FPUF production source category. The annual
monitoring, reporting, and recordkeeping burden for this collection
(averaged over the first 3 years after the
[[Page 66132]]
effective date of the standards) for subpart III (FPUF production),
including today's proposed amendments, is estimated to be $90,104 per
year. This includes 1,030 labor hours per year at a total labor cost of
$90,104 per year, and total non-labor capital and operation and
maintenance costs of $0 per year. This represents a decrease of
$760,000 and 8,000 labor hours from the previous ICR, due primarily to
the reduction in the estimated number of regulated entities. Our
estimate of the burden for each regulated entity has increased by $485
and 11 labor hours from the previous ICR estimate. This increase in
burden for each regulated entity is not due to the proposed amendments,
but is due to a correction of an error in the total number of reports
required per year for slabstock foam producers. This was previously
estimated to be two semi-annual reports per year, but this estimate did
not account for the annual compliance report.
The total burden for the federal government (averaged over the
first 3 years after the effective date of the standard) is estimated to
be 67 hours per year at a total labor cost of $3,607 per year. Burden
is defined at 5 CFR 1320.3(b). An agency may not conduct or sponsor,
and a person is not required to respond to, a collection of information
unless it displays a currently valid OMB control number. The OMB
control numbers for the EPA's regulations in 40 CFR are listed in 40
CFR part 9.
To comment on the agency's need for this information, the accuracy
of the provided burden estimates and any suggested methods for
minimizing respondent burden, the EPA has established a public docket
for this rule, which includes this ICR, under Docket ID number EPA-HQ-
OAR-2012-0510. Submit any comments related to the ICR to the EPA and
OMB. See the ADDRESSES section at the beginning of this notice for
where to submit comments to the EPA. Send comments to OMB at the Office
of Information and Regulatory Affairs, Office of Management and Budget,
725 17th Street NW., Washington, DC 20503, Attention: Desk Office for
EPA. Because OMB is required to make a decision concerning the ICR
between 30 and 60 days after November 4, 2013, a comment to OMB is best
assured of having its full effect if OMB receives it by December 4,
2013. The final rule will respond to any OMB or public comments on the
information collection requirements contained in this proposal.
C. Regulatory Flexibility Act
The Regulatory Flexibility Act generally requires an agency to
prepare a regulatory flexibility analysis of any rule subject to notice
and comment rulemaking requirements under the Administrative Procedure
Act or any other statute unless the agency certifies that the rule will
not have a significant economic impact on a substantial number of small
entities. Small entities include small businesses, small organizations,
and small governmental jurisdictions.
For purposes of assessing the impacts of this proposed rule on
small entities, small entity is defined as: (1) A small business as
defined by the Small Business Administration's (SBA) regulations at 13
CFR 121.201; (2) a small governmental jurisdiction that is a government
of a city, county, town, school district or special district with a
population of less than 50,000; and (3) a small organization that is
any not-for-profit enterprise that is independently owned and operated
and is not dominant in its field.
After considering the economic impacts of today's proposed rule on
small entities, I certify that this action will not have a significant
economic impact on a substantial number of small entities. The small
entities directly regulated by this proposed rule are small businesses.
We have determined that three facilities, or 23 percent of the 13
affected facilities, are small entities. Total annualized costs for the
proposed rule are estimated to be $0, and no small entities are
projected to incur costs. Because HAP ABAs are no longer used by FPUF
production facilities, there are no impacts on any entities subject to
this rulemaking.
We continue to be interested in the potential impacts of the
proposed rule on small entities and welcome comments on issues related
to such impacts.
D. Unfunded Mandates Reform Act
This action contains no federal mandate under the provisions of
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C.
1531-1538 for state, local, or tribal governments or the private
sector. This action imposes no enforceable duties on any state, local
or tribal governments or the private sector. Therefore, this action is
not subject to the requirements of sections 202 or 205 of the UMRA.
This action is also not subject to the requirements of section 203
of UMRA because it contains no regulatory requirements that might
significantly or uniquely affect small governments because it contains
no requirements that apply to such governments nor does it impose
obligations upon them.
E. Executive Order 13132: Federalism
This proposed action does not have federalism implications. It will
not have substantial direct effects on the states, on the relationship
between the national government and the states, or on the distribution
of power and responsibilities among the various levels of government,
as specified in Executive Order 13132. This action will not impose
substantial direct compliance costs on state or local governments, nor
will it preempt state law, and none of the facilities subject to this
action are owned or operated by state governments. Thus, Executive
Order 13132 does not apply to this action.
In the spirit of Executive Order 13132, and consistent with the EPA
policy to promote communications between the EPA and state and local
governments, the EPA specifically solicits comment on this action from
state and local officials.
F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
This action does not have tribal implications, as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000). There are no
FPUF production facilities that are within 3 miles of tribal lands.
Thus, Executive Order 13175 does not apply to this action.
The EPA specifically solicits additional comment on this proposed
action from tribal officials.
G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks
This action is not subject to Executive Order 13045 (62 FR 19885,
April 23, 1997) because it is not economically significant as defined
in Executive Order 12866, and because the agency does not believe the
environmental health risks or safety risks addressed by this action
present a disproportionate risk to children. This proposed action's
health and risk assessments are contained in section IV of this
preamble.
The public is invited to submit comments or identify peer-reviewed
studies and data that assess effects of early life exposure to HAP
emitted by FPUF production facilities.
[[Page 66133]]
H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use
This action is not a ``significant energy action'' as defined in
Executive Order 13211 (66 FR 28355 (May 22, 2001)), because it is not
likely to have a significant adverse effect on the supply,
distribution, or use of energy. We have concluded that this rule is not
likely to have any adverse energy effects because the proposed
requirements of this rule will not cause the additional use of energy
by any facilities in the source category nor is there any expected
impact on sources in the energy supply, distribution, or use sectors
related to the proposed provisions of this rule.
I. National Technology Transfer and Advancement Act
Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (``NTTAA''), Public Law 104-113 (15 U.S.C. 272 note),
directs the EPA to use voluntary consensus standards (VCS) in its
regulatory activities unless to do so would be inconsistent with
applicable law or otherwise impractical. VCS are technical standards
(e.g., materials specifications, test methods, sampling procedures, and
business practices) that are developed or adopted by voluntary
consensus standards bodies. NTTAA directs the EPA to provide Congress,
through OMB, explanations when the agency decides not to use available
and applicable VCS.
The proposed rulemaking involves technical standards. Therefore,
the agency conducted a search to identify potentially applicable
voluntary consensus standards. However, we identified no such
standards, and none were brought to our attention in comments.
Therefore, the EPA has decided to use EPA Method 25A, ``Determination
of Total Gaseous Organic Concentration Using a Flame Ionization
Analyzer,'' 40 CFR part 60, Appendix A, to measure organic compound
concentrations.
EPA welcomes comments on this aspect of the proposed rulemaking
and, specifically, invites the public to identify potentially-
applicable voluntary consensus standards and to explain why such
standards should be used in this regulation.
J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations
Executive Order 12898 (59 FR 7629, February 16, 1994) establishes
federal executive policy on environmental justice. Its main provision
directs federal agencies, to the greatest extent practicable and
permitted by law, to make environmental justice part of their mission
by identifying and addressing, as appropriate, disproportionately high
and adverse human health or environmental effects of their programs,
policies and activities on minority populations and low-income
populations in the United States.
The EPA has determined that this proposed rule will not have
disproportionately high and adverse human health or environmental
effects on minority or low-income populations, because it increases the
level of environmental protection for all affected populations without
having any disproportionately high and adverse human health or
environmental effects on any population, including any minority or low-
income population.
To gain a better understanding of the source category and near
source populations, the EPA conducted a proximity analysis on FPUF
production facilities to identify any overrepresentation of minority,
low income or indigenous populations. This analysis only gives some
indication of the prevalence of sub-populations that may be exposed to
air pollution from the sources; it does not identify the demographic
characteristics of the most highly affected individuals or communities,
nor does it quantify the level of risk faced by those individuals or
communities. More information on the source category's risk can be
found in section IV of this preamble.
The proximity analysis reveals that most demographic categories are
below or within 20 percent of their corresponding national averages.
The one exception is the African American population. The ratio of
African Americans living within 3 miles of any source affected by this
rule is 48 percent higher than the national average (19 percent versus
13 percent); however, as noted previously, risks from this source
category were found to be acceptable for all populations. Additionally,
the proposed changes to the standard increase the level of
environmental protection for all affected populations by ensuring no
future emissions increases from the source category. The proximity
analysis results and the details concerning their development are
presented in the August 2012 memorandum titled, Environmental Justice
Review: Flexible Polyurethane Foam Production, a copy of which is
available in the docket for this action (EPA-HQ-OAR-2012-0510).
List of Subjects in 40 CFR Part 63
Environmental protection, Air pollution control, Hazardous
substances, Reporting and recordkeeping requirements.
Dated: September 26, 2013.
Gina McCarthy,
Administrator.
For the reasons stated in the preamble, the Environmental
Protection agency (EPA) proposes to amend title 40, chapter I, of the
Code of Federal Regulations (CFR) as follows:
PART 63--[AMENDED]
0
1. The authority citation for part 63 continues to read as follows:
Authority: 42 U.S.C. 7401 et seq.
Subpart III--National Emission Standards for Hazardous Air
Pollutants for Flexible Polyurethane Foam Production
0
2. Section 63.1290 is amended by:
0
a. Revising paragraph (c); and
0
b. Adding paragraphs (d) and (e).
The additions and revisions read as follows:
Sec. 63.1290 Applicability.
* * * * *
(c) A process meeting one of the following criteria listed in
paragraphs (c)(1) and (2) of this section shall not be subject to the
provisions of this subpart:
(1) A process exclusively dedicated to the fabrication of flexible
polyurethane foam; or
(2) A research and development process.
(d) Applicability of this subpart. (1) The emission limitations set
forth in this subpart and the emission limitations referred to in this
subpart shall apply at all times except during periods of non-operation
of the affected source (or specific portion thereof) resulting in
cessation of the emissions to which this subpart applies.
(2) Equipment leak requirements of Sec. 63.1294 shall apply at all
times except during periods of non-operation of the affected source (or
specific portion thereof) in which the lines are drained and
depressurized resulting in cessation of the emissions to which the
equipment leak requirements apply.
(3) The owner or operator shall not shut down items of equipment
that are required or utilized for compliance with this subpart during
times when emissions are being routed to such items of equipment if the
shutdown would contravene requirements of this subpart applicable to
such items of equipment.
(4) General duty. At all times, the owner or operator must operate
and
[[Page 66134]]
maintain any affected source, including associated air pollution
control equipment and monitoring equipment, in a manner consistent with
safety and good air pollution control practices for minimizing
emissions. 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 the applicable standard have been achieved.
Determination of whether a source is operating in compliance with
operation and maintenance requirements will be based on information
available to the Administrator, which may include, but is not limited
to, monitoring results, review of operation and maintenance procedures,
review of operation and maintenance records, and inspection of the
source.
(e) Affirmative defense for violation of emission standards during
malfunction. In response to an action to enforce the standards set
forth in paragraphs Sec. Sec. 63.1293, 63.1294, 63.1297, 63.1298,
63.1300, and 63.1301, the owner or operator may assert an affirmative
defense to a claim for civil penalties for violations of such standards
that are caused by malfunction, as defined at 40 CFR 63.2. Appropriate
penalties may be assessed if the owner or operator fails to meet their
burden of proving all of the requirements in the affirmative defense.
The affirmative defense shall not be available for claims for
injunctive relief.
(1) Assertion of affirmative defense. To establish the affirmative
defense in any action to enforce such a standard, the owner or operator
must timely meet the reporting requirements in paragraph (e)(2) of this
section, and must prove by a preponderance of evidence that:
(i) The violation:
(A) Was caused by a sudden, infrequent, and unavoidable failure of
air pollution control equipment, process equipment, or a process to
operate in a normal or usual manner; and
(B) Could not have been prevented through careful planning, proper
design or better operation and maintenance practices; and
(C) Did not stem from any activity or event that could have been
foreseen and avoided, or planned for; and
(D) Was not part of a recurring pattern indicative of inadequate
design, operation, or maintenance; and
(ii) Repairs were made as expeditiously as possible when a
violation occurred; and
(iii) The frequency, amount, and duration of the violation
(including any bypass) were minimized to the maximum extent
practicable; and
(iv) If the violation resulted from a bypass of control equipment
or a process, then the bypass was unavoidable to prevent loss of life,
personal injury, or severe property damage; and
(v) All possible steps were taken to minimize the impact of the
violation on ambient air quality, the environment, and human health;
and
(vi) All emissions monitoring and control systems were kept in
operation if at all possible, consistent with safety and good air
pollution control practices; and
(vii) All of the actions in response to the violation were
documented by properly signed, contemporaneous operating logs; and
(viii) At all times, the affected source was operated in a manner
consistent with good practices for minimizing emissions; and
(ix) A written root cause analysis has been prepared, the purpose
of which is to determine, correct, and eliminate the primary causes of
the malfunction and the violation resulting from the malfunction event
at issue. The analysis shall also specify, using best monitoring
methods and engineering judgment, the amount of any emissions that were
the result of the malfunction.
(2) Report. The owner or operator seeking to assert an affirmative
defense shall submit a written report to the Administrator with all
necessary supporting documentation, that explains how it has met the
requirements set forth in paragraph (e)(1) of this section. This
affirmative defense report shall be included in the first periodic
compliance, deviation report or excess emission report otherwise
required after the initial occurrence of the violation of the relevant
standard (which may be the end of any applicable averaging period). If
such compliance, deviation report or excess emission report is due less
than 45 days after the initial occurrence of the violation, the
affirmative defense report may be included in the second compliance,
deviation report or excess emission report due after the initial
occurrence of the violation of the relevant standard.
0
3. Section 63.1291 is amended by revising paragraph (a) to read as
follows:
Sec. 63.1291 Compliance schedule.
(a) Existing affected sources shall be in compliance with all
provisions of this subpart no later than October 8, 2001, with the
exception of Sec. 63.1297. Affected sources subject to the
requirements of Sec. 63.1297 shall be in compliance with the
requirements of this section on or before [DATE 90 DAYS AFTER DATE OF
PUBLICATION OF FINAL RULE IN THE FEDERAL REGISTER].
* * * * *
0
4. Section 63.1292 is amended by:
0
a. Adding a definition for ``affirmative defense'' in alphabetical
order;
0
b. Revising the definitions for ``HAP-based,'' ``Reconstructed
source,'' ``Storage vessel'' and ``Transfer pump''; and
0
c. Removing the definitions for ``High-pressure mixhead,''
``Indentation Force Deflection (IFD),'' ``In HAP ABA service,''
``Recovery device,'' ``Run of foam,'' and ``Transfer vehicle''.
The additions and revisions read as follows:
Sec. 63.1292 Definitions.
* * * * *
Affirmative defense means, in the context of an enforcement
proceeding, a response or defense put forward by a defendant, regarding
which the defendant has the burden of proof, and the merits of which
are independently and objectively evaluated in a judicial or
administrative proceeding.
* * * * *
HAP-based means to contain 5 percent (by weight) or more of HAP.
This applies to equipment cleaners, mixhead flushes, mold release
agents and ABA.
* * * * *
Reconstructed source means an affected source undergoing
reconstruction, as defined in subpart A of this part. For the purposes
of this subpart, process modifications made to stop using HAP ABA or
HAP-based ABA to meet the requirements of this subpart shall not be
counted in determining whether or not a change or replacement meets the
definition of reconstruction.
* * * * *
Storage vessel means a tank or other vessel that is used to store
diisocyanates for use in the production of flexible polyurethane foam.
Storage vessels do not include vessels with capacities smaller than 38
cubic meters (or 10,000 gallons).
Transfer pump means all pumps used to transport diisocyanates that
are not metering pumps.
0
5. Section 63.1293 is revised to read as follows:
Sec. 63.1293 Standards for slabstock flexible polyurethane foam
production.
Each owner or operator of a new or existing slabstock affected
source shall comply with Sec. Sec. 63.1294, 63.1297 and 63.1298.
0
6. Section 63.1294 is amended by revising paragraphs (a)(1)(i), (c) and
[[Page 66135]]
(d)(2)(ii), and by adding paragraph (d)(2)(iii) to read as follows:
Sec. 63.1294 Standards for slabstock flexible polyurethane foam
production--diisocyanate emissions.
(a) * * *
(1) * * *
(i) During each unloading event, the vapor return line shall be
inspected for leaks by visual, audible, or an instrumental detection
method.
* * * * *
(c) Other components in diisocyanate service. If evidence of a leak
is found by visual, audible, or an instrumental detection method, it
shall be repaired as soon as practicable, but not later than 15
calendar days after it is detected, except as provided in paragraph (d)
of this section. The first attempt at repair shall be made no later
than 5 calendar days after each leak is detected.
(d) * * *
(2) * * *
(ii) The purged material is collected and destroyed or recovered in
a control device when repair procedures are effected, and
(iii) Repair is completed as soon as practicable, but not later
than 6 months after the leak was detected.
* * * * *
Sec. 63.1295 [Removed and Reserved]
0
7. Remove and reserve Sec. 63.1295.
Sec. 63.1296 [Removed and Reserved]
0
8. Remove and reserve Sec. 63.1296.
0
9. Revise Sec. 63.1297 to read as follows:
Sec. 63.1297 Standards for slabstock flexible polyurethane foam
production--HAP ABA.
Each owner or operator of a new or existing slabstock affected
source shall not use HAP or a HAP-based material as an ABA.
0
10. Revise Sec. 63.1298 to read as follows:
Sec. 63.1298 Standards for slabstock flexible polyurethane foam
production--HAP emissions from equipment cleaning.
Each owner or operator of a new or existing slabstock affected
source shall not use HAP or a HAP-based material as an equipment
cleaner.
Sec. 63.1299 [Removed and Reserved]
0
11. Remove and reserve Sec. 63.1299.
0
12. Revise Sec. 63.1302 to read as follows:
Sec. 63.1302 Applicability of subpart A requirements.
The owner or operator of an affected source shall comply with the
applicable requirements of subpart A of this part, as specified in
Table 1 of this subpart.
0
13. Section 63.1303 is amended by:
0
a. Revising paragraph (a) introductory text;
0
b. Removing paragraphs (a)(3) and (a)(4);
0
c. Revising paragraph (b); and
0
d. Removing paragraphs (c), (d) and (e).
The revisions read as follows:
Sec. 63.1303 Monitoring requirements.
* * * * *
(a) Monitoring requirements for storage vessel carbon adsorption
systems. Each owner or operator using a carbon adsorption system to
meet the requirements of Sec. 63.1294(a) shall monitor the
concentration level of the HAP or the organic compounds in the exhaust
vent stream (or outlet stream exhaust) from the carbon adsorption
system at the frequency specified in paragraphs (a)(1) or (2) of this
section.
* * * * *
(b) Each owner or operator using a carbon adsorption system to meet
the requirements of Sec. 63.1294(a) shall monitor the concentration
level of total organic compounds in the exhaust vent stream (or outlet
stream exhaust) from the carbon adsorption system using 40 CFR part 60,
Appendix A, Method 25A, reported as propane. The measurement shall be
conducted over at least one 5-minute interval during which the storage
vessel is being filled.
Sec. 63.1304 [Removed and Reserved]
0
14. Remove and reserve Sec. 63.1304.
0
15. Section 63.1306 is amended by:
0
a. Removing paragraph (c);
0
b. Redesigating paragraphs (d) and (e) as paragraphs (c) and (d);
0
c. Revising newly redesignated paragraphs (c) introductory text and
(c)(3);
0
d. Revising newly redesignated paragraph (d);
0
e. Revising paragraph (f);
0
f. Redesignating paragraph (g) as paragraph (e);
0
g. Revising newly redesignated paragraphs (e)(1) and (2); and
0
h. Adding a new paragraph (g).
The addition and revisions read as follows:
Sec. 63.1306 Reporting requirements.
* * * * *
(c) Notification of compliance status. Each affected source shall
submit a notification of compliance status report no later than 180
days after the compliance date. For slabstock affected sources, this
report shall contain the information listed in paragraphs (c)(1)
through (3) of this section, as applicable. This report shall contain
the information listed in paragraph (c)(4) of this section for molded
foam processes and in paragraph (c)(5) of this section for rebond foam
processes.
* * * * *
(3) A statement that the slabstock foam affected source is in
compliance with Sec. Sec. 63.1297 and 63.1298, or a statement that
slabstock foam processes at an affected source are in compliance with
Sec. Sec. 63.1297 and 63.1298.
* * * * *
(d) Semiannual reports. Each slabstock affected source shall submit
a report containing the information specified in paragraphs (d)(1)
through (3) of this section semiannually no later than 60 days after
the end of each 180 day period. The first report shall be submitted no
later than 240 days after the date that the Notification of Compliance
Status is due and shall cover the 6-month period beginning on the date
that the Notification of Compliance Status Report is due.
(1) For sources complying with the storage vessel provisions of
Sec. 63.1294(a) using a carbon adsorption system, unloading events
that occurred after breakthrough was detected and before the carbon was
replaced.
(2) Any equipment leaks that were not repaired in accordance with
Sec. Sec. 63.1294(b)(2)(iii) and 63.1294(c).
(3) Any leaks in vapor return lines that were not repaired in
accordance with Sec. 63.1294(a)(1)(ii).
(e) * * *
(1) The compliance certification shall be based on information
consistent with that contained in Sec. 63.1308, as applicable.
(2) A compliance certification required pursuant to a state or
local operating permit program may be used to satisfy the requirements
of this section, provided that the compliance certification is based on
information consistent with that contained in Sec. 63.1308, and
provided that the Administrator has approved the state or local
operating permit program under part 70 of this chapter.
* * * * *
(f) Malfunction reports. If a source fails to meet an applicable
standard, slabstock affected sources must report such events in the
next semiannual report and molded and rebond affected sources must
report such events in the next annual compliance certification. Report
the number of failures to meet an applicable standard. For each
instance, report the date, time and duration of each failure. For each
failure, the report must include a list of the affected sources or
equipment, an estimate of the volume of each regulated pollutant
emitted over any emission limit, and a
[[Page 66136]]
description of the method used to estimate the emissions.
(g) Within 60 days after the date of completing each performance
test (as defined in Sec. 63.2), you must submit the results of the
performance tests required by this subpart according to the methods
specified in paragraphs (g)(1) or (g)(2) of this section.
(1) For data collected using test methods supported by the EPA-
provided software, the owner or operator shall submit the results of
the performance test to the EPA by direct computer-to-computer
electronic transfer via EPA-provided software, unless otherwise
approved by the Administrator. Owners or operators, who claim that some
of the information being submitted for performance tests is
confidential business information (CBI), must submit a complete file
using EPA-provided software that includes information claimed to be CBI
on a compact disk, flash drive, or other commonly used electronic
storage media to the EPA. The electronic media must be clearly marked
as CBI and mailed to U.S. EPA/OAQPS/CORE CBI Office, Attention: WebFIRE
Administrator, MD C404-02, 4930 Old Page Rd., Durham, NC 27703. The
same file with the CBI omitted must be submitted to the EPA by direct
computer-to-computer electronic transfer via EPA-provided software.
(2) For any performance test conducted using test methods that are
not compatible with the EPA-provided software, the owner or operator
shall submit the results of the performance test to the Administrator
at the appropriate address listed in Sec. 63.13.
0
16. Section 63.1307 is amended by:
0
a. Removing paragraph (a)(2) and redesignating paragraphs (a)(3) and
(a)(4) as paragraphs (a)(2) and (a)(3);
0
b. Revising the newly redesignated paragraphs (a)(2) introductory text,
(a)(2)(ii), and (a)(3) introductory text;
0
c. Revising paragraph (b)(1);
0
d. Revising paragraphs (b)(3) introductory text, (b)(3)(i) introductory
text and (b)(3)(i)(B);
0
e. Removing paragraph (b)(3)(i)(C);
0
f. Revising paragraphs (b)(3)(ii) introductory text and (b)(3)(ii)(A);
0
g. Removing paragraph (b)(3)(ii)(D);
0
h. Redesignating paragraphs (b)(3)(ii)(E) through (b)(3)(ii)(H) as
(b)(3)(ii)(D) through (b)(3)(ii)(G);
0
i. Revising paragraph (c);
0
j. Removing paragraph (d);
0
k. Redesignating paragraphs (e) through (h) as (d) through (g);
0
l. Revising newly redesignated paragraph (e); and
0
m. Adding paragraph (h).
The additions and revisions read as follows:
Sec. 63.1307 Recordkeeping requirements.
* * * * *
(a) * * *
(2) For storage vessels complying through the use of a carbon
adsorption system, paragraphs (a)(2)(i) or (ii), and paragraph
(a)(2)(iii) of this section.
* * * * *
(ii) For affected sources monitoring at an interval no greater than
20 percent of the carbon replacement interval, in accordance with Sec.
63.1303(a)(2), the records listed in paragraphs (a)(2)(ii)(A) and (B)
of this section.
* * * * *
(3) For storage vessels complying through the use of a vapor return
line, paragraphs (a)(3)(i) through (iii) of this section.
* * * * *
(b) * * * (1) A list of components in diisocyanate service.
* * * * *
(3) When a leak is detected as specified in Sec. Sec.
63.1294(b)(2)(ii) and 63.1294(c), the requirements listed in paragraphs
(b)(3)(i) and (ii) of this section apply:
(i) Leaking equipment shall be identified in accordance with the
requirements in paragraphs (b)(3)(i)(A) and (B) of this section.
* * * * *
(B) The identification on equipment may be removed after it has
been repaired.
(ii) The information in paragraphs (b)(2)(ii)(A) through (G) shall
be recorded for leaking components.
(A) The operator identification number and the equipment
identification number.
* * * * *
(c) The owner or operator of an affected source subject to Sec.
63.1297 shall maintain a product data sheet for each ABA used which
includes the HAP content, in kg of HAP/kg solids (lb HAP/lb solids).
* * * * *
(e) The owner or operator of an affected source following the
compliance methods in Sec. 63.1308(b)(1) shall maintain records of
each use of a vapor return line during unloading, of any leaks detected
during unloading, and of repairs of leaks detected during unloading.
* * * * *
(h) Malfunction records. Records shall be kept as specified in
paragraphs (h)(1) through (3) of this section for affected sources.
Records are not required for emission points that do not require
control under this subpart.
(1) In the event that an affected unit fails to meet an applicable
standard, record the number of failures. For each failure, record the
date, time and duration of the failure.
(2) For each failure to meet an applicable standard, record and
retain a list of the affected sources or equipment, an estimate of the
volume of each regulated pollutant emitted over any emission limit and
a description of the method used to estimate the emissions.
(3) Record actions taken to minimize emissions in accordance with
Sec. 63.1290(d) and any corrective actions taken to return the
affected unit to its normal or usual manner of operation.
0
17. Section 63.1308 is amended by:
0
a. Revising paragraph (a) introductory text;
0
b. Revising paragraphs (b)(3), (b)(6), and (c);
0
c. Removing paragraph (d); and
0
d. Redesignating paragraph (e) as (d).
The revisions read as follows:
Sec. 63.1308 Compliance demonstrations.
(a) For each affected source, compliance with the requirements
described in Tables 2 and 3 of this subpart shall mean compliance with
the requirements contained in Sec. Sec. 63.1293 through 63.1301,
absent any credible evidence to the contrary.
* * * * *
(b) * * *
(3) For each affected source complying with Sec. 63.1294(a) in
accordance with Sec. 63.1294(a)(2) through the alternative monitoring
procedures in Sec. 63.1303(a)(2), each unloading event that the
diisocyanate storage vessel is not equipped with a carbon adsorption
system, each time that the carbon adsorption system is not monitored
for breakthrough in accordance with Sec. 63.1303(b)(1) or (2) at the
interval established in the design analysis, and each unloading event
that occurs when the carbon is not replaced after an indication of
breakthrough;
* * * * *
(6) For each affected source complying with Sec. 63.1294(c), each
calendar day after 5 calendar days after detection of a leak that a
first attempt at repair has not been made, and the earlier of each
calendar day after 15 calendar days after detection of a leak that a
leak is not repaired, or if a leak is not repaired as soon as
practicable, each subsequent calendar day (with the exception of
situations meeting the criteria of Sec. 63.1294(d)).
(c) Slabstock affected sources. For slabstock foam affected
sources, failure to meet the requirements contained in Sec. Sec.
63.1297 and 63.1298, respectively, shall be considered a violation of
this subpart. Violation of each item listed in
[[Page 66137]]
the following paragraphs shall be considered a separate violation.
(1) For each slabstock foam affected source subject to the
provisions in Sec. 63.1297, each calendar day that a HAP ABA or HAP-
based material is used as an ABA;
(2) For each slabstock foam affected source subject to the
provisions of Sec. 63.1298, each calendar day that a HAP-based
material is used as an equipment cleaner.
* * * * *
0
18. Section 63.1309 is amended by removing paragraph (b)(4) and
redesignating paragraph (b)(5) as (b)(4).
0
19. Remove Table 1 to Subpart III of part 63.
0
20. Redesignate Table 2 to Subpart III of Part 63 as Table 1 to Subpart
III of Part 63 and amend newly redesignated Table 1 by:
0
a. Revising the heading of newly redesignated Table 1;
0
b. Removing entry Sec. 63.6(e)(1)-(2);
0
c. Adding entries Sec. 63.6(e)(1)(i), Sec. 63.6(e)(1)(ii) and Sec.
63.6(e)(1)(iii);
0
d. Removing entry Sec. 63.6(e)(3);
0
e. Adding entry Sec. 63.6(e)(2)-(3):
0
f. Removing entry Sec. 63.6(f)-(g);
0
g. Adding entries Sec. 63.6(f)(1), Sec. 63.6(f)(2)-(3), and Sec.
63.6(g);
0
h. Removing entry Sec. 63.10(a)-(b);
0
i. Adding entries Sec. 63.10(a), Sec. 63.10(b)(1), Sec.
63.10(b)(2)(i), Sec. 63.10(b)(2)(ii); Sec. 63.10(b)(2)(iii); Sec.
63.10(b)(2)(iv)-(xi); Sec. 63.10(b)(2)(xii); Sec. 63.10(b)(2)(xiii),
Sec. 63.10(b)(2)(xiv); and Sec. 63.10(b)(3);
0
j. Removing entry Sec. 63.10(d)(4)-(5); and
0
k. Adding entries Sec. 63.10(d)(4) and Sec. 63.10(d)(5).
The additions and revisions read as follows:
Table 1 to Subpart III of Part 63--Applicability of General Provisions
(40 CFR Part 63, Subpart A) to Subpart III
------------------------------------------------------------------------
Applies to subpart
Subpart A reference III Comment
------------------------------------------------------------------------
* * * * * * *
Sec. 63.6(e)(1)(i)........ NO.................. See Sec.
63.1290(d)(4) for
general duty
requirement.
Sec. 63.6(e)(1)(ii)....... NO.
Sec. 63.6(e)(1)(iii)...... YES.
Sec. 63.6(e)(2)-(3)....... NO.
Sec. 63.6(f)(1)........... NO.
Sec. 63.6(f)(2)-(3)....... YES.
Sec. 63.6(g).............. YES.
* * * * * * *
Sec. 63.10(a)............. YES.
Sec. 63.10(b)(1).......... YES.
Sec. 63.10(b)(2)(i)....... NO.
Sec. 63.10(b)(2)(ii)...... NO.................. See Sec.
63.1307(h) for
recordkeeping of
(1) date, time and
duration; (2)
listing of affected
source or equipment
and an estimate of
the volume of each
regulated pollutant
emitted over the
standard; and (3)
actions to minimize
emissions and any
actions taken at
the discretion of
the owner or
operator to prevent
recurrence of the
failure to meet an
applicable
requirement.
Sec. 63.10(b)(2)(iii)..... YES.
Sec. 63.10(b)(2)(iv)-(xi). NO.
Sec. 63.10(b)(2)(xii)..... YES.
Sec. 63.10(b)(2)(xiii).... NO.
Sec. 63.10(b)(2)(xiv)..... YES.
Sec. 63.10(b)(3).......... YES.
* * * * * * *
Sec. 63.10(d)(4).......... YES.
Sec. 63.10(d)(5).......... NO.................. See Sec.
63.1306(f) for
malfunction
reporting
requirements.
* * * * * * *
------------------------------------------------------------------------
0
21. Redesignate Table 3 to Subpart III of Part 63 as Table 2 to Subpart
III of Part 63 and amend newly redesignated Table 2 by:
0
a. Revising the heading for newly redesignated Table 2;
0
b. Removing entries for HAP ABA storage vessels Sec. 63.1295, HAP ABA
pumps Sec. 63.1296(a), HAP ABA valves Sec. 63.1296(b), HAP ABA
connectors Sec. 63.1296(c), Pressure relief devices Sec. 63.1296(d),
Open-ended valves or lines Sec. 63.1296(e), and Production line Sec.
63.1297; and
0
c. Adding an entry for ABAs Sec. 63.1297.
The revisions and addition read as follows:
[[Page 66138]]
Table 2 to Subpart III of Part 63--Compliance Requirements for Slabstock Foam Production Affected Sources
----------------------------------------------------------------------------------------------------------------
Emission, work
Emission point practice, and
Emission point compliance equipment Monitoring Recordkeeping Reporting
option standards
----------------------------------------------------------------------------------------------------------------
* * * * * * *
ABAs Sec. 63.1297............. N/A Sec. 63.1297 .............. Sec. ..............
63.1307(e)
----------------------------------------------------------------------------------------------------------------
0
22. Remove Table 4 to Subpart III of Part 63.
0
23. Redesignate Table 5 to Subpart III of Part 63 as Table 3 to Subpart
III of Part 63 and amend newly redesignated Table 3 by revising the
heading to read as follows:
Table 3 to Subpart III of Part 63--Compliance Requirements for
Molded and Rebond Foam Production Affected Sources
* * * * *
[FR Doc. 2013-24276 Filed 11-1-13; 8:45 am]
BILLING CODE 6560-50-P