National Emission Standards for Hazardous Air Pollutants: Flexible Polyurethane Foam Fabrication Operations Residual Risk and Technology Review and Flexible Polyurethane Foam Production and Fabrication Area Source Technology Review, 1868-1890 [2021-00250]
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(c) Electronic data. By order, the judge
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Signed on this 14th day of December, 2020,
in Washington, DC.
Eugene Scalia,
Secretary of Labor.
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ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 63
[EPA–HQ–OAR–2020–0572; FRL–10017–90–
OAR]
RIN 2060–AU57
National Emission Standards for
Hazardous Air Pollutants: Flexible
Polyurethane Foam Fabrication
Operations Residual Risk and
Technology Review and Flexible
Polyurethane Foam Production and
Fabrication Area Source Technology
Review
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
AGENCY:
This action presents the
proposed results of the U.S.
Environmental Protection Agency’s
(EPA’s) residual risk and technology
review (RTR) required under the Clean
Air Act (CAA) for the National Emission
Standards for Hazardous Air Pollutants
(NESHAP) for major source Flexible
Polyurethane Foam Fabrication
Operations, initially promulgated in
2003. Pursuant to the CAA, this action
also presents the proposed results of the
technology review for the NESHAP for
two area source categories, Flexible
Polyurethane Foam Production and
Flexible Polyurethane Foam
Fabrication, which are combined in one
subpart initially promulgated in 2007.
In this action, the EPA is proposing to
establish a numeric emission limit for
one major source subcategory; remove
exemptions for periods of startup,
shutdown, and malfunction (SSM) and
specify that the emissions standards
apply at all times; require periodic
performance tests; and require
electronic reporting of performance test
results and compliance reports.
Implementation of these proposed rules
is not expected to result in significant
changes to the hazardous air pollutant
(HAP) emissions from affected facilities
in these three source categories or to
human health impacts or environmental
impacts associated with those
emissions. However, this action, if
finalized, would result in improved
monitoring, compliance, and
implementation of the existing
standards and codify existing industry
practices to prevent backsliding.
DATES: Comments. Comments must be
received on or before February 25, 2021.
Under the Paperwork Reduction Act
(PRA), comments on the information
collection provisions are best assured of
consideration if the Office of
SUMMARY:
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Management and Budget (OMB)
receives a copy of your comments on or
before February 10, 2021.
Public hearing: If anyone contacts us
requesting a public hearing on or before
January 19, 2021, we will hold a virtual
public hearing. See SUPPLEMENTARY
INFORMATION for information on
requesting and registering for a public
hearing.
You may send comments,
identified by Docket ID No. EPA–HQ–
OAR–2020–0572 by any of the following
methods:
• Federal eRulemaking Portal:
https://www.regulations.gov/ (our
preferred method). Follow the online
instructions for submitting comments.
• Email: a-and-r-docket@epa.gov.
Include Docket ID No. EPA–HQ–OAR–
2020–0572- in the subject line of the
message.
• Fax: (202) 566–9744. Attention
Docket ID No. EPA–HQ–OAR–2020–
0572.
• Mail: U.S. Environmental
Protection Agency, EPA Docket Center,
Docket ID No. EPA–HQ–OAR–2020–
0572 EPA Mail Code 28221T, 1200
Pennsylvania Avenue NW, Washington,
DC 20460.
• Hand/Courier Delivery: EPA Docket
Center, WJC West Building, Room 3334,
1301 Constitution Avenue NW,
Washington, DC 20004. The Docket
Center’s hours of operation are 8:30
a.m.–4:30 p.m., Monday–Friday (except
federal holidays).
Instructions: All submissions received
must include the Docket ID No. for this
rulemaking. Comments received may be
posted without change to https://
www.regulations.gov/, including any
personal information provided. For
detailed instructions on sending
comments and additional information
on the rulemaking process, see the
SUPPLEMENTARY INFORMATION section of
this document. Out of an abundance of
caution for members of the public and
our staff, the EPA Docket Center and
Reading Room are closed to the public,
with limited exceptions, to reduce the
risk of transmitting COVID–19. Our
Docket Center staff will continue to
provide remote customer service via
email, phone, and webform. We
encourage the public to submit
comments via https://
www.regulations.gov/ or email, as there
may be a delay in processing mail and
faxes. Hand deliveries and couriers may
be received by scheduled appointment
only. For further information on EPA
Docket Center services and the current
status, please visit us online at https://
www.epa.gov/dockets.
ADDRESSES:
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For
questions about this proposed action,
contact Dr. Tina Ndoh, Sector Policies
and Programs Division (D243–04),
Office of Air Quality Planning and
Standards, U.S. Environmental
Protection Agency, Research Triangle
Park, North Carolina 27711; telephone
number: (919) 541–1516; fax number:
(919) 541–4991; and email address:
ndoh.tina@epa.gov. For specific
information regarding the risk modeling
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.
SUPPLEMENTARY INFORMATION:
Participation in virtual public
hearing. Please note that the EPA is
deviating from its typical approach for
public hearings because the President
has declared a national emergency. Due
to the current Centers for Disease
Control and Prevention (CDC)
recommendations, as well as state and
local orders for social distancing to limit
the spread of COVID–19, the EPA
cannot hold in-person public meetings
at this time.
To request a virtual public hearing,
contact the public hearing team at (888)
372–8699 or by email at
SPPDpublichearing@epa.gov. If
requested, the virtual hearing will be
held on January 26, 2021. The hearing
will convene at 9:00 a.m. Eastern Time
(ET) and will conclude at 3:00 p.m. ET.
The EPA may close a session 15 minutes
after the last pre-registered speaker has
testified if there are no additional
speakers. The EPA will announce
further details at https://www.epa.gov/
stationary-sources-air-pollution/flexiblepolyurethane-foam-fabricationoperations-national-emission.
Upon publication of this document in
the Federal Register, the EPA will begin
pre-registering speakers for the hearing,
if a hearing is requested. To register to
speak at the virtual hearing, please use
the online registration form available at
https://www.epa.gov/stationary-sourcesair-pollution/flexible-polyurethanefoam-fabrication-operations-nationalemission or contact the public hearing
team at (888) 372–8699 or by email at
SPPDpublichearing@epa.gov. The last
day to pre-register to speak at the
hearing will be January 25, 2021. Prior
to the hearing, the EPA will post a
general agenda that will list preregistered speakers in approximate
order at: https://www.epa.gov/
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The EPA will make every effort to
follow the schedule as closely as
possible on the day of the hearing;
however, please plan for the hearings to
run either ahead of schedule or behind
schedule.
Each commenter will have 5 minutes
to provide oral testimony. The EPA
encourages commenters to provide the
EPA with a copy of their oral testimony
electronically (via email) by emailing it
to ndoh.tina@epa.gov. The EPA also
recommends submitting the text of your
oral testimony as written comments to
the rulemaking docket.
The EPA may ask clarifying questions
during the oral presentations but will
not respond to the presentations at that
time. Written statements and supporting
information submitted during the
comment period will be considered
with the same weight as oral testimony
and supporting information presented at
the public hearing.
Please note that any updates made to
any aspect of the hearing will be posted
online at https://www.epa.gov/
stationary-sources-air-pollution/flexiblepolyurethane-foam-fabricationoperations-national-emission. While the
EPA expects the hearing to go forward
as set forth above, please monitor our
website or contact the public hearing
team at (888) 372–8699 or by email at
SPPDpublichearing@epa.gov to
determine if there are any updates. The
EPA does not intend to publish a
document in the Federal Register
announcing updates.
If you require the services of a
translator or a special accommodation
such as audio description, please preregister for the hearing with the public
hearing team and describe your needs
by January 19, 2021. The EPA may not
be able to arrange accommodations
without advanced notice.
Docket. The EPA has established a
docket for this rulemaking under Docket
ID No. EPA–HQ–OAR–2020–0572. All
documents in the docket are listed in
https://www.regulations.gov/. Although
listed, some information is not publicly
available, e.g., Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
Certain other material, such as
copyrighted material, is not placed on
the internet and will be publicly
available only in hard copy. With the
exception of such material, publicly
available docket materials are available
electronically in Regulations.gov.
Instructions. Direct your comments to
Docket ID No. EPA–HQ–OAR–2020–
0572. The EPA’s policy is that all
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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 CBI or other information
whose disclosure is restricted by statute.
Do not submit electronically any
information that you consider to be CBI
or other information whose disclosure is
restricted by statute. This type of
information should be submitted by
mail as discussed below.
The EPA may publish any comment
received to its public docket.
Multimedia submissions (audio, video,
etc.) must be accompanied by a written
comment. The written comment is
considered the official comment and
should include discussion of all points
you wish to make. The EPA will
generally not consider comments or
comment contents located outside of the
primary submission (i.e., on the Web,
cloud, or other file sharing system). For
additional submission methods, the full
EPA public comment policy,
information about CBI or multimedia
submissions, and general guidance on
making effective comments, please visit
https://www.epa.gov/dockets/
commenting-epa-dockets.
The https://www.regulations.gov/
website allows you to submit your
comment anonymously, 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
digital storage media 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.
The EPA is temporarily suspending
its Docket Center and Reading Room for
public visitors, with limited exceptions,
to reduce the risk of transmitting
COVID–19. Our Docket Center staff will
continue to provide remote customer
service via email, phone, and webform.
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We encourage the public to submit
comments via https://
www.regulations.gov/ as there may be a
delay in processing mail and faxes.
Hand deliveries or couriers will be
received by scheduled appointment
only. For further information and
updates on EPA Docket Center services,
please visit us online at https://
www.epa.gov/dockets.
The EPA continues to carefully and
continuously monitor information from
the CDC, local area health departments,
and our Federal partners so that we can
respond rapidly as conditions change
regarding COVID–19.
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 any digital
storage media that you mail to the EPA,
mark the outside of the digital storage
media as CBI and then identify
electronically within the digital storage
media 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 directly to
the public docket through the
procedures outlined in Instructions
above. If you submit any digital storage
media that does not contain CBI, mark
the outside of the digital storage media
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: OAQPS Document Control
Officer (C404–02), OAQPS, U.S.
Environmental Protection Agency,
Research Triangle Park, North Carolina
27711, Attention Docket ID No. EPA–
HQ–OAR–2020–0572. Note that written
comments containing CBI and
submitted by mail may be delayed and
no hand deliveries will be accepted.
Preamble acronyms and
abbreviations. We use multiple
acronyms and terms in this preamble.
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:
AEGL acute exposure guideline level
AERMOD air dispersion model used by the
HEM–3 model
ATSDR Agency for Toxic Substances and
Disease Registry
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CAA Clean Air Act
CalEPA California EPA
CBI Confidential Business Information
CDC Centers for Disease Control and
Prevention
CDX Central Data Exchange
CEDRI Compliance and Emissions Data
Reporting
CFR Code of Federal Regulations
EPA Environmental Protection Agency
ERPG emergency response planning
guideline
ERT Electronic Reporting Tool
GACT generally available control
technology
HAP hazardous air pollutant(s)
HCl hydrochloric acid
HEM–3 Human Exposure Model, Version
1.5.5
HF hydrogen fluoride
HI hazard index
HQ hazard quotient
IRIS Integrated Risk Information System
km kilometer
MACT maximum achievable control
technology
mg/m3 milligrams per cubic meter
MIR maximum individual risk
NAICS North American Industry
Classification System
NATA National Air Toxics Assessment
NEI National Emissions Inventory
NESHAP national emission standards for
hazardous air pollutants
NSR New Source Review
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
PDF portable document format
POM polycyclic organic matter
ppm parts per million
RBLC Reasonably Available Control
Technology, Best Available Control
Technology, and Lowest Achievable
Emission Rate Clearinghouse
REL reference exposure level
RfC reference concentration
RfD reference dose
RTR residual risk and technology review
SAB Science Advisory Board
SDS safety data sheets
SSM startup, shutdown, and malfunction
TDI toluene diisocyanate
TOSHI target organ-specific hazard index
tpy tons per year
TRI Toxics Release Inventory
TRIM.FaTE Total Risk Integrated
Methodology.Fate, Transport, and
Ecological Exposure model
UF uncertainty factor
URE unit risk estimate
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?
II. Background
A. What is the statutory authority for this
action?
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B. What are the source categories and how
do the current NESHAP regulate their
HAP emissions?
C. What data collection activities were
conducted to support this action?
D. What other relevant background
information and data are available?
III. Analytical Procedures and DecisionMaking
A. How do we consider risk in our
decision-making?
B. How do we perform the technology
review?
C. How do we estimate post-MACT risk
posed by the source category?
IV. Analytical Results and Proposed
Decisions
A. What actions are we taking pursuant to
CAA sections 112(d)(2) and 112(d)(3) for
the Flexible Polyurethane Foam
Fabrication Operations source category?
B. What are the results of the risk
assessment and analyses for the Flexible
Polyurethane Foam Fabrication
Operations source category?
C. What are our proposed decisions
regarding risk acceptability, ample
margin of safety, and adverse
environmental effect?
D. What are the results and proposed
decisions based on our technology
review for the Flexible Polyurethane
Foam Fabrication Operations major
source category and for the Flexible
Polyurethane Foam Production and
Fabrication area source categories?
E. What other actions are we proposing?
F. 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. Executive Order 13771: Reducing
Regulations and Controlling Regulatory
Costs
C. Paperwork Reduction Act (PRA)
D. Regulatory Flexibility Act (RFA)
E. Unfunded Mandates Reform Act
(UMRA)
F. Executive Order 13132: Federalism
G. Executive Order 13175: Consultation
and Coordination With Indian Tribal
Governments
H. Executive Order 13045: Protection of
Children From Environmental Health
Risks and Safety Risks
I. Executive Order 13211: Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use
J. National Technology Transfer and
Advancement Act (NTTAA)
K. Executive Order 12898: Federal Actions
To Address Environmental Justice in
Minority Populations and Low-Income
Populations
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I. General Information
A. Does this action apply to me?
The source categories that are the
subject of this proposal are Flexible
Polyurethane Foam Fabrication
Operations Major Sources regulated
under 40 CFR part 63, subpart
MMMMM, and Flexible Polyurethane
Foam Production and Flexible
Polyurethane Foam Fabrication Area
Sources, regulated under 40 CFR part
63, subpart OOOOOO. The North
American Industry Classification
System (NAICS) code for fabricators of
flexible polyurethane foam industry is
326150. This list of categories and
NAICS codes is not intended to be
exhaustive, but rather provides a guide
for readers regarding the entities that
this proposed action is likely to affect.
The proposed standards, once
promulgated, will be directly applicable
to the affected sources. Federal, state,
local, and tribal government entities
would not be affected by this proposed
action.
The Flexible Polyurethane Foam
Fabrication Operations major source
category was added to the EPA’s HAP
source category list in 1996. (61 FR
28197, June 4, 1996.) The NESHAP for
that major source category, 40 CFR part
63, subpart MMMMM, was promulgated
in 2003. (68 FR 18062, April 14, 2003.)
The Flexible Polyurethane Foam
Fabrication area source category was
added to the EPA’s HAP source category
list in 1999. (64 FR 38706, July 19,
1999.) The Flexible Polyurethane Foam
Production area source category was
added to the EPA’s HAP source category
list in 2002. (67 FR 70427, November
22, 2002.) The Flexible Polyurethane
Foam Production major source category,
Part 63, subpart III, was included on the
EPA’s initial HAP source category list.
(57 FR 31576, July 16, 1992.) The
maximum achievable control
technology (MACT) standards for
subpart III were initially promulgated in
1998. (63 FR 53980, October 7, 1998.)
The EPA established one area source
NESHAP at 40 CFR part 63, subpart
OOOOOO, that applies to the two area
source categories due to similarity of
their operations and because they are
often collocated. (72 FR 38864, July 16,
2007.)
The Flexible Polyurethane Foam
Fabrication Operations major source
category and the Flexible Polyurethane
Foam Fabrication area source category
include facilities engaged in cutting,
gluing, and/or laminating pieces of
flexible polyurethane foam. Those
source categories include fabrication
operations that are collocated with foam
production plants as well as those
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located offsite from foam production
plants. Emissions from foam fabrication
primarily result from the lamination of
polyurethane foam to adhere foam to
other substrates and from the use of
HAP-based adhesives in the gluing
process. The Flexible Polyurethane
Foam Production area source category
includes facilities that manufacture
foam made from a polymer containing a
plurality of carbamate linkages in the
chain backbone (polyurethane).
Polyurethane is commonly made by
reacting a polyisocyanate with an
organic polyhydroxyl material in the
presence of water. Application of
blowing agents, catalysts, surfactants,
and fillers transform the polyurethane
into a foam with specialized properties.
This proposed action addresses the
major source NESHAP that applies to
the Flexible Polyurethane Foam
Fabrication Operations major source
category and also addresses the area
source NESHAP that applies to the
Flexible Polyurethane Foam Production
area source category and the Flexible
Polyurethane Foam Fabrication area
source category.
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. Following
signature by the EPA Administrator, the
EPA will post a copy of this proposed
action at https://www.epa.gov/
stationary-sources-air-pollution/flexiblepolyurethane-foam-fabricationoperations-national-emission.
Following publication in the Federal
Register, the EPA will post the Federal
Register version of the proposal and key
technical documents at this same
website. Information on the overall RTR
program is available at https://
www3.epa.gov/ttn/atw/rrisk/rtrpg.html.
The proposed changes to the CFR that
would be necessary to incorporate the
changes proposed in this action are set
out in an attachment to the
memorandum titled Proposed
Regulation Edits for 40 CFR Part 63,
subparts MMMMM and OOOOOO,
available in the docket for this action
(Docket ID No. EPA–HQ–OAR–2020–
0572). This document includes the
specific proposed amendatory language
for revising the CFR and, for the
convenience of interested parties, a
redline version of the regulations.
Following signature by the EPA
Administrator, the EPA will also post a
copy of this memorandum and the
attachment to https://www.epa.gov/
stationary-sources-air-pollution/flexible-
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II. Background
A. What is the statutory authority for
this action?
The statutory authority for this action
is provided by sections 112 and 301 of
the CAA, as amended (42 U.S.C. 7401 et
seq.). Section 112 of the CAA
establishes a two-stage regulatory
process to develop standards for
emissions of HAP from stationary
sources. Generally, the first stage
involves establishing technology-based
standards and the second stage involves
evaluating those standards that are
based on MACT to determine whether
additional standards are needed to
address any remaining risk associated
with HAP emissions. This second stage
is commonly referred to as the ‘‘residual
risk review.’’ In addition to the residual
risk review, the CAA also requires the
EPA to review standards set under CAA
section 112 every 8 years and revise the
standards as necessary taking into
account any ‘‘developments in
practices, processes, or control
technologies.’’ This review is commonly
referred to as the ‘‘technology review.’’
When the two reviews are combined
into a single rulemaking, it is commonly
referred to as the ‘‘risk and technology
review.’’ The discussion that follows
identifies the most relevant statutory
sections and briefly explains the
contours of the methodology used to
implement these statutory requirements.
A more comprehensive discussion
appears in the document titled CAA
Section 112 Risk and Technology
Reviews: Statutory Authority and
Methodology, in the docket for this
proposed rule (Docket ID No. EPA–HQ–
OAR–2020–0572).
In the first stage of the CAA section
112 standard setting process, the EPA
promulgates technology-based standards
under CAA section 112(d) for categories
of sources identified as emitting one or
more of the HAP listed in CAA section
112(b). Sources of HAP emissions are
either major sources or area sources, and
CAA section 112 establishes different
requirements for major source standards
and area source standards. ‘‘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. All
other sources are ‘‘area sources.’’ For
major sources, CAA section 112(d)(2)
provides that the technology-based
NESHAP must reflect the maximum
degree of emission reductions of HAP
achievable (after considering cost,
energy requirements, and non-air
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quality health and environmental
impacts). These standards are
commonly referred to as MACT
standards. CAA section 112(d)(3) also
establishes a minimum control level for
MACT standards, known as the MACT
‘‘floor.’’ In certain instances, as
provided in CAA section 112(h), the
EPA may set work practice standards in
lieu of numerical emission standards.
The EPA must also consider control
options that are more stringent than the
floor. Standards more stringent than the
floor are commonly referred to as
beyond-the-floor standards. For area
sources, CAA section 112(d)(5) gives the
EPA discretion to set standards based on
generally available control technologies
or management practices (GACT
standards) in lieu of MACT standards.
The second stage in standard-setting
focuses on identifying and addressing
any remaining (i.e., ‘‘residual’’) risk
pursuant to CAA section 112(f). For
source categories subject to MACT
standards, section 112(f)(2) of the CAA
requires the EPA to determine whether
promulgation of additional standards is
needed to provide an ample margin of
safety to protect public health or to
prevent an adverse environmental
effect. Section 112(d)(5) of the CAA
provides that this residual risk review is
not required for categories of area
sources subject to GACT standards.
Section 112(f)(2)(B) of the CAA further
expressly preserves the EPA’s use of the
two-step approach 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 Residual
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 the United States
Court of Appeals for the District of
Columbia Circuit (the court) upheld the
EPA’s interpretation that CAA section
112(f)(2) incorporates the approach
established in the Benzene NESHAP.
See NRDC v. EPA, 529 F.3d 1077, 1083
(D.C. Cir. 2008).
The approach incorporated into the
CAA and used by the EPA to evaluate
residual risk and to develop standards
under CAA section 112(f)(2) is a twostep approach. In the first step, the EPA
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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) 1 of approximately 1
in 10 thousand.’’ (54 FR at 38045). If
risks are unacceptable, the EPA must
determine the emissions standards
necessary to reduce risk to an acceptable
level without considering costs. In the
second step of the approach, the EPA
considers whether the emissions
standards provide an ample margin of
safety to protect public health ‘‘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
emission standards necessary to provide
an ample margin of safety to protect
public health or determine that the
standards being reviewed provide an
ample margin of safety without any
revisions. 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.
CAA section 112(d)(6) separately
requires the EPA to review standards
promulgated under CAA section 112
and revise them ‘‘as necessary (taking
into account developments in practices,
processes, and control technologies)’’ no
less often than every 8 years. In
conducting this review, which we call
the ‘‘technology 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 EPA may consider
cost in deciding whether to revise the
standards pursuant to CAA section
112(d)(6). The EPA is required to
address regulatory gaps, such as missing
standards for listed air toxics known to
be emitted from the source category.
Louisiana Environmental Action
Network (LEAN) v. EPA, 955 F.3d 1088
(D.C. Cir. 2020). Section 112(k)(3)(B) of
the CAA required the EPA to identify at
least 30 HAP that pose the greatest
potential health threat in urban areas,
and CAA section 112(c)(3) requires the
1 Although defined as ‘‘maximum individual
risk,’’ MIR refers only to cancer risk. MIR, one
metric for assessing cancer risk, is the estimated
risk if an individual were exposed to the maximum
level of a pollutant for a lifetime.
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EPA to regulate the area source
categories that represent 90 percent of
the emissions of the 30 ‘‘listed’’ HAP
(‘‘urban HAP’’).
B. What are the source categories and
how do the current NESHAP regulate
their HAP emissions?
For both the Flexible Polyurethane
Foam Fabrication Operations major
source category and the Flexible
Polyurethane Foam Fabrication area
source category, operations involve
cutting, bonding, and/or laminating
pieces of flexible polyurethane foam
together or to other substrates. Typical
bonding techniques include gluing,
taping, and flame lamination. In years
preceding the listing of the flexible
polyurethane foam fabrication major
and area source categories, some foam
fabrication operations may have used
methylene chloride-based adhesives to
adhere pieces of foam together;
however, the industry no longer uses
any methylene chloride-based
adhesives. Most foam fabrication
adhesives are applied by workers using
spray guns. Application of adhesives is
typically performed in large open
rooms, with workstations spaced along
a conveyor that moves the pieces of
foam to be glued together. Loop slitter
adhesive use is a specialized type of
foam fabrication adhesive use. Loop
slitters are equipment used at slabstock
foam production and/or fabrication
facilities to slice large foam ‘‘buns’’ into
thin sheets. Adhesive is used to attach
the ends of the foam buns to one
another before they are mounted on the
loop slitter. The amount of adhesive
used for loop slitters is relatively low
because the adhesive is not applied
continuously, just once or twice per
shift when the foam buns are loaded
onto the loop slitter. Flame lamination
refers to the bonding of foam to any
substrate (e.g., fabric, foam, plastic)
where the bonding agent is scorched or
melted foam. Thin sheets of foam are
passed under a flame which scorches
the foam surface and makes it sticky.
The tacky foam sheet is then applied
and adhered to a substrate.
The Flexible Polyurethane Foam
Production area source category
includes facilities that manufacture
foam made from polyurethanes, which
are in the class of compounds called
‘‘reaction polymers.’’ Application of
blowing agents, catalysts, surfactants,
and fillers transforms the polyurethane
into a foam with specialized properties.
There are three types of polyurethane
foam production facilities: Slabstock
flexible polyurethane foam (slabstock
foam), molded flexible polyurethane
foam (molded foam), and rebond foam.
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Slabstock foam is produced in large
continuous buns that are then cut into
the desired size and shape. Slabstock
foam is used in a wide variety of
applications, including furniture and
mattresses. Molded foam is produced by
‘‘shooting’’ the foam mixture into a
mold of the desired shape and size.
Molded foam is used in office furniture,
automobile seats, novelties, and many
other applications. Rebond foam is
made from scrap foam that is converted
into a material primarily used for carpet
underlay.
The EPA estimates that there are 32
facilities currently subject to the area
source standards, of which
approximately 20 are believed to be
owned by small businesses.
The EPA promulgated MACT
standards for major source Flexible
Polyurethane Foam Fabrication
Operations facilities in 2003 under 40
CFR part 63, subpart MMMMM. The
standards apply to major sources of
HAP at existing and new flexible
polyurethane foam fabrication facilities.
Because of their potential to generate
HAP emissions, the processing units of
interest at foam fabrication facilities are
loop slitters and flame lamination units.
The MACT standards for Flexible
Polyurethane Foam Fabrication
Operations require HAP emissions
reductions and control for new flame
lamination units and prohibit use of
HAP-based adhesives in new and
existing loop slitting operations. For
new flame lamination units, a 90percent reduction in HAP emissions is
required. For existing flame lamination
units, there are currently no MACT
emission limits. For new and existing
loop slitters, the MACT standards
prohibit use of any adhesive containing
5 percent or more (by weight) of total
HAP. The EPA estimates that there are
currently three facilities subject to
subpart MMMMM—two in Indiana, and
one in New Mexico.
Both the Flexible Polyurethane Foam
Production and Flexible Polyurethane
Fabrication Operations area source
categories were listed for regulation due
to emissions of the urban HAP
methylene chloride. At the time of the
initial area source standards
promulgation, methylene chloride was
the only urban HAP used at foam
production and foam fabrication
facilities. Now, however, there are no
known urban HAP used at foam
production and foam fabrication
facilities. In the past, slabstock foam
production facilities sometimes used
methylene chloride as an auxiliary
blowing agent to control the density and
other properties of the foam as it
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expanded during the pouring process.2
Methylene chloride was also sometimes
used as an equipment cleaner, in
particular for mix heads. A small
number of molded and rebond foam
facilities used methylene chloride in
mold release agents, and some molded
foam facilities used it as a mixhead
cleaner. Foam fabricators used
methylene chloride-based adhesives to
adhere pieces of foam to one another.
Flame laminators have never used
methylene chloride and, as such, are not
regulated by the area source standards.
In 2007, the EPA promulgated GACT
standards for the Flexible Polyurethane
Foam Production area source category
and the Flexible Polyurethane Foam
Fabrication area source category
together under 40 CFR part 63, subpart
OOOOOO. The GACT standards
required that methylene chloride be
significantly reduced or eliminated from
slabstock foam production, molded
foam release agents, equipment
cleaning, rebond foam mold release
agents, and from foam fabrication
adhesive use. Although both area source
categories were listed for regulation due
to emissions of the urban HAP
methylene chloride, the EPA finds that
methylene chloride is no longer used
within either source category.
C. What data collection activities were
conducted to support this action?
For the Flexible Foam Fabrication
Operations NESHAP RTR, the EPA used
emissions and supporting data from the
2017 and 2014 National Emissions
Inventory (NEI), 2018 and 2019 Toxics
Release Inventory (TRI) data, and 2014
stack test data from one facility to
develop the model input files for the
residual risk assessments for major
source flexible foam fabrication
facilities.
The NEI is a database that contains
information about sources that emit
criteria air pollutants, their precursors,
and HAP. The database includes
estimates of annual air pollutant
emissions from point, nonpoint, and
mobile sources in the 50 states, the
District of Columbia, Puerto Rico, and
the U.S. Virgin Islands. The EPA
collects this information and releases an
updated version of the NEI database
every 3 years. The NEI includes data
necessary for conducting risk modeling,
including annual HAP emissions
estimates from individual emission
sources at facilities and the related
emissions release parameters. In certain
2 Other regulations address methylene chloride.
For example, the EPA listed methylene chloride as
an unacceptable (prohibited) blowing agent for use
in flexible polyurethane under section 612 of the
CAA (81 FR 86778, December 1, 2016).
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cases, we contacted state inventory
compilers and facility owners or
operators to confirm and clarify the
sources of emissions, emissions
estimates, and release parameters that
were reported in the NEI.
The TRI is a resource for learning
about toxic chemical releases and
pollution prevention activities reported
by industrial and federal facilities. The
TRI tracks the management of certain
toxic chemicals that may pose a threat
to human health and the environment.
U.S. facilities in different industry
sectors must report annually how much
of each chemical is released to the
environment and/or managed through
recycling, energy recovery, and
treatment.3
Additional information on the
development of the modeling file can be
found in Appendix 1 to the Residual
Risk Assessment for the Flexible
Polyurethane Foam Fabrication
Operations Source Category in Support
of the 2020 Risk and Technology Review
Proposed Rule, which is available in the
docket for this proposed rule (Docket ID
No. EPA–HQ–OAR–2020–0572).
For the Flexible Foam Production and
Fabrication area source standards, we
relied on information provided by
industry to determine whether any
urban HAP were emitted from the
regulated facilities. Through industry
meetings and email and telephone
conversations, the EPA found that there
are no additional urban HAP emitted
from flexible foam production and
fabrication facilities subject to area
source standards. Detailed information
of the technology review can be found
in the memorandum titled Technology
Review for the Flexible Polyurethane
Foam Production and Fabrication Area
Source Categories, which is available in
the docket for this proposed rule
(Docket ID No. EPA–HQ–OAR–2020–
0572).
The Flexible Polyurethane Foam
Production and Flexible Polyurethane
Foam Fabrication MACT standards were
promulgated in 1998 and 2003
respectively. Since that time, the EPA
has developed air toxics regulations for
a number of additional source categories
that emit HAP from the same types of
emission sources that are present in the
Flexible Polyurethane Foam Production
and Fabrication source categories. In air
toxic regulatory actions carried out
subsequent to the initial MACT
standard development for these source
categories, the EPA has consistently
evaluated any new practices, processes,
and control technologies. A review of
3 Available at https://www.epa.gov/toxics-releaseinventory-tri-program.
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these initial and subsequent air toxics
regulations, including supporting
documentation used in the rulemakings,
was conducted to determine whether
any practices, processes, or control
technologies could be applied to the
Flexible Foam Fabrication source
category.
One potential development in
practices, processes, and control
technologies was identified through the
review of other air toxics regulations,
which is discussed further in section
IV.D of this document.
D. What other relevant background
information and data are available?
For the risk review portion of the
RTR, we reviewed facility permits for
the three major sources subjected to the
Flexible Polyurethane Foam Fabrication
Operations NESHAP. Facility permits
provide data on maximum allowable
emissions and other relevant production
and emission factors.
For the technology review portion of
the RTR, we collected information from
the Reasonably Available Control
Technology, Best Available Control
Technology, and Lowest Achievable
Emission Rate Clearinghouse (RBLC) to
identify developments in practices,
processes, and control technologies
since the MACT standards were
developed. The RBLC is a database that
contains case-specific information on air
pollution technologies that have been
required to reduce the emissions of air
pollutants from stationary sources.
Under the EPA’s New Source Review
(NSR) program, if a facility is planning
new construction or a modification that
will increase the air emissions above
certain defined thresholds, an NSR
permit must be obtained. The RBLC
promotes the sharing of information
among permitting agencies and aids in
case-by-case determinations for NSR
permits. We examined information
contained in the RBLC to determine
what technologies are currently used for
these source categories to reduce air
emissions. Additional information about
these data collection activities for the
technology reviews is contained in the
technology review memorandum titled
Technology Review for the Flexible
Polyurethane Foam Fabrication
Operations Source Category, which is
available in the docket for this proposed
rule (Docket ID No. EPA–HQ–OAR–
2020–0572).
The RBLC provides several options
for searching the permit database online to locate applicable control
technologies. Our initial search of the
RBLC specified processes in
polyurethane foam products
manufacturing, with permits dating
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back to 2001. This search did not
provide any results for foam fabrication
operations. Further searches of the
database were conducted based on
relevant keywords. The search included
all available data fields, which among
others, included the following:
• RBLC ID;
• Facility Name and State;
• Permit Date;
• Process name;
• Throughput;
• Pollutant;
• Control technology;
• Percent efficiency of control; and
• Pollutants/Compliance Notes.
The results of this search are presented
in Appendix 1 of the Technology
Review for the Flexible Polyurethane
Foam Manufacturing Source Category.
As shown in Appendix 1, no control
technologies more stringent than the
Flexible Polyurethane Foam NESHAP
were identified through this search.
Two of the three facilities subject to
major source standards have loop slitter
operations and use adhesives. Both
facilities provided the EPA with safety
data sheets (SDS) for the adhesives in
use. Those SDS were used to determine
chemical composition and potential
HAP emissions from the adhesives.
Additional background information on
adhesive use and regulation was
collected through review of other
NESHAP in similar industrial sectors.
Specifically, we searched for other
NESHAP regulating HAP emissions
from coatings and adhesives and
compared the stringency of those
standards to the existing requirements
for HAP adhesives for loop slitters. Data
from the SDS provided and the
NESHAP for similar source categories
were also used in the technology
evaluation for the Flexible Polyurethane
Foam Fabrication Operations NESHAP.
The findings for the technology review
are discussed further in section IV.D of
this preamble.
III. Analytical Procedures and
Decision-Making
In this section, we describe the
analyses performed to support the
proposed decisions for the RTR and
other issues addressed in this proposal.
In this proposed action, pursuant to
CAA section 112(f), the EPA is
conducting a risk review for the major
source NESHAP (40 CFR part 63,
subpart MMMMM) MACT standards for
Flexible Polyurethane Foam Fabrication
Operations. Consistent with the
provision regarding alternative
standards for area sources in CAA
section 112(d)(5), the risk review does
not cover the NESHAP for area sources.
Therefore, the discussions of risk
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assessment methods and modeling
analyses described in the following
paragraphs only apply to the major
source category.
However, pursuant to CAA section
112(d)(6), the EPA is proposing the
technology review for both the major
source NESHAP and the area source
NESHAP (40 CFR part 63, subpart
OOOOOO). Therefore, the discussions
in the paragraphs below regarding how
the EPA conducted the technology
reviews apply to both major sources and
area sources.
A. How do we consider risk in our
decision-making?
As discussed in section II.A of this
preamble and in the Benzene NESHAP,
in evaluating and developing standards
under CAA section 112(f)(2), we apply
a two-step approach to determine
whether or not risks are acceptable and
to determine if the standards provide an
ample margin of safety to protect public
health. 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 section 112 is
best judged on the basis of a broad set
of health risk measures and
information.’’ (54 FR at 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 approach
provides flexibility regarding factors the
EPA may consider in making
determinations and how the EPA may
weigh those factors for each source
category. The EPA conducts a risk
assessment that provides estimates of
the MIR posed by emissions of HAP that
are carcinogens 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.4 The assessment also provides
estimates of the distribution of cancer
4 The MIR is defined as the cancer risk associated
with a lifetime of exposure at the highest
concentration of HAP where people are likely to
live. The HQ is the ratio of the potential HAP
exposure concentration to the noncancer doseresponse value; the HI is the sum of HQs for HAP
that affect the same target organ or organ system.
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risk within the exposed populations,
cancer incidence, and an evaluation of
the potential for an adverse
environmental effect. The scope of the
EPA’s risk analysis is consistent with
the explanation in the EPA’s response to
comments on our policy under the
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The 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.
This approach complies with the Vinyl
Chloride mandate that the Administrator
ascertain an acceptable level of risk to the
public by employing his 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 his judgment, believes are
appropriate to determining what will
‘‘protect the public health’’.
(54 FR at 38057). Thus, the level of the
MIR is only one factor to be weighed in
determining acceptability of risk. 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 an MIR less than the
presumptively acceptable level is
unacceptable in the light of other health
risk factors.’’ Id. at 38045. In other
words, risks that include an MIR above
100-in-1 million may be determined to
be acceptable, and risks with an MIR
below that level may be determined to
be unacceptable, depending on all of the
available health information. 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
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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 the HAP risk that
may be associated with emissions from
other facilities that do not include the
source category under review, mobile
source emissions, natural source
emissions, persistent environmental
pollution, or atmospheric
transformation in the vicinity of the
sources in the category.
The EPA 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 noncancer
risk, where pollutant-specific exposure
health reference levels (e.g., reference
concentrations (RfCs)) are based on the
assumption that thresholds exist for
adverse health effects. For example, the
EPA recognizes that, although exposures
attributable to emissions from a source
category or facility alone may not
indicate the potential for increased risk
of adverse noncancer 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 an increased risk
of adverse noncancer health effects. In
May 2010, the Science Advisory Board
(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.’’ 5
In response to the SAB
recommendations, the EPA incorporates
cumulative risk analyses into its RTR
risk assessments. The Agency (1)
conducts facility-wide assessments,
which include source category emission
points, as well as other emission points
within the facilities; (2) combines
exposures from multiple sources in the
same category that could affect the same
individuals; and (3) for some persistent
5 Recommendations of the SAB Risk and
Technology Review Methods Panel are provided in
their report, which is available at: https://
yosemite.epa.gov/sab/sabproduct.nsf/
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and bioaccumulative pollutants,
analyzes the ingestion route of
exposure. In addition, the RTR risk
assessments consider aggregate cancer
risk from all carcinogens and aggregated
noncancer HQs for all noncarcinogens
affecting the same target organ or target
organ system.
Although we are interested in placing
source category and facility-wide HAP
risk in the context of total HAP risk
from all sources combined in the
vicinity of each source, we are
concerned about the uncertainties of
doing so. Estimates of total HAP risk
from emission sources other than those
that we have studied in depth during
this RTR review 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.
B. How do we perform the technology
review?
Our technology review primarily
focuses on the identification and
evaluation of developments in practices,
processes, and control technologies that
have occurred since the MACT
standards were promulgated. Where we
identify such developments, we analyze
their technical feasibility, estimated
costs, energy implications, and non-air
environmental impacts. We also
consider the emission reductions
associated with applying each
development. This analysis informs our
decision of whether it is ‘‘necessary’’ to
revise the emissions standards. In
addition, we consider the
appropriateness of applying controls to
new sources versus retrofitting existing
sources. For this exercise, we consider
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; and
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• 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).
In addition to reviewing the practices,
processes, and control technologies that
were considered at the time we
originally developed the NESHAP, we
review a variety of data sources in our
investigation of potential practices,
processes, or controls to consider. We
also review the NESHAP and the
available data to determine if there are
any unregulated emissions of HAP
within the source category and evaluate
this data for use in developing new
emission standards. See sections II.C
and II.D of this preamble for information
on the specific data sources that were
reviewed as part of the technology
review.
C. How do we estimate post-MACT risk
posed by the source category?
In this section, we provide a complete
description of the types of analyses that
we generally perform during the risk
assessment process. In some cases, we
do not perform a specific analysis
because it is not relevant. For example,
in the absence of emissions of HAP
known to be persistent and
bioaccumulative in the environment
(PB–HAP), we would not perform a
multipathway exposure assessment.
Where we do not perform an analysis,
we state that we do not and provide the
reason. While we present all of our risk
assessment methods, we only present
risk assessment results for the analyses
actually conducted (see section IV.B of
this preamble).
The EPA conducts a risk assessment
that provides estimates of the MIR for
cancer posed by the HAP emissions
from each source in the source category,
the HI for chronic exposures to HAP
with the potential to cause noncancer
health effects, and the HQ for acute
exposures to HAP with the potential to
cause noncancer health effects. The
assessment also provides estimates of
the distribution of cancer risk within the
exposed populations, cancer incidence,
and an evaluation of the potential for an
adverse environmental effect. The seven
sections that follow this paragraph
describe how we estimated emissions
and conducted the risk assessment. The
docket for this proposed rule contains
the following document that provides
more information on the risk assessment
inputs and models: Residual Risk
Assessment for the Flexible
Polyurethane Foam Fabrication
Operations Source Category in Support
of the 2020 Risk and Technology Review
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Proposed Rule. The methods used to
assess risk (as described in the seven
primary steps below) are consistent with
those described by the EPA in the
document reviewed by a panel of the
EPA’s SAB in 2009; 6 and described in
the SAB review report issued in 2010.
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?
The actual emissions and the
emission release characteristics for each
facility were obtained primarily from
either the 2014 NEI or the 2017 NEI;
most data were obtained from the 2017
NEI, unless a facility was not included
in that base year file, in which case the
2014 NEI data were used. In one
instance, a facility was contacted to
confirm emissions that appeared to be
outliers because they were inconsistent
with our understanding of the industry.
That facility provided a test report
containing data that were more
consistent with our understanding of
emissions from the industry and were
ultimately used as actual emissions for
the risk modeling file. Additional
information on the development of the
modeling file for the Flexible
Polyurethane Foam Fabrication
Operations source category, including
the development of the actual emissions
and emissions release characteristics,
can be found in the memorandum,
Emissions Data for the National
Emission Standards for Hazardous Air
Pollutants for Flexible Polyurethane
Foam Fabrication Operations, which is
available in the respective docket for
this action.
2. How did we estimate MACTallowable emissions?
The available emissions data in the
RTR emissions dataset include estimates
of the mass of HAP emitted during a
specified annual time period. These
‘‘actual’’ emission levels are often lower
than the emission levels allowed under
the requirements of the current MACT
standards. The emissions allowed under
the MACT standards are referred to as
the ‘‘MACT-allowable’’ emissions. We
discussed the consideration of both
MACT-allowable and actual emissions
in the final Coke Oven Batteries RTR (70
FR 19992, 19998 and 19999, April 15,
6 U.S. EPA. 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, June 2009. EPA–452/R–09–
006. Available at: https://www3.epa.gov/airtoxics/
rrisk/rtrpg.html.
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2005) and in the proposed and final
Hazardous Organic NESHAP RTR (71
FR 34421, 34428, June 14, 2006, and 71
FR 76603, 76609, December 21, 2006,
respectively). In those actions, we noted
that assessing the risk at the MACTallowable level is inherently reasonable
since that risk reflects 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 approach
(54 FR 38044).
For the Flexible Polyurethane Foam
Fabrication Operations source category,
allowable emissions were assumed to be
equal to actual emissions. For the
subcategory of flame laminators, there
currently are no emissions limits for
existing sources, and there have been no
new sources since the promulgation of
the standards. Therefore, we conclude
that the emissions that are allowed
under the existing standards are equal to
actual emissions. For the loop slitter
subcategory, there were no HAP
emissions from the adhesive, and we are
not aware of any HAP-based substitutes
that could be used in place of current
industry practice; therefore, we again
conclude that allowable emissions
would be equal to actual emissions,
which in this case are zero.
3. How do we conduct dispersion
modeling, determine inhalation
exposures, and estimate individual and
population inhalation risk?
Both long-term and short-term
inhalation exposure concentrations and
health risk from the major source
category addressed in this proposal
were estimated using the Human
Exposure Model (HEM–3).7 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, and (3) estimating
individual and population-level
inhalation risk using the exposure
estimates and quantitative doseresponse information.
a. Dispersion Modeling
The air dispersion model AERMOD,
used by the HEM–3 model, is one of the
EPA’s preferred models for assessing air
pollutant concentrations from industrial
7 For more information about HEM–3, go to
https://www.epa.gov/fera/risk-assessment-andmodeling-human-exposure-model-hem.
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facilities.8 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 (2016) of hourly surface and upper
air observations from 824
meteorological stations selected to
provide coverage of the United States
and Puerto Rico. A second library of
United States Census Bureau census
block 9 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-specific dose-response
values is used to estimate health risk.
These are discussed below.
b. Risk From Chronic Exposure to HAP
In developing the risk assessment for
chronic exposures, we use the estimated
annual average ambient air
concentrations of each HAP emitted by
each source in the major source
category. The HAP air concentrations at
each nearby census block centroid
located within 50 km of the facility are
a surrogate for the chronic inhalation
exposure concentration for all the
people who reside in that census block.
A distance of 50 km is consistent with
both the analysis supporting the 1989
Benzene NESHAP (54 FR 38044,
September 14, 1989) and the limitations
of Gaussian dispersion models,
including AERMOD.
For each facility, we calculate the MIR
as the cancer risk associated with a
continuous lifetime (24 hours per day,
7 days per week, 52 weeks per year, 70
years) exposure to the maximum
concentration at the centroid of each
inhabited census block. We calculate
individual cancer risk by multiplying
the estimated lifetime exposure to the
ambient concentration of each HAP (in
micrograms per cubic meter) by its unit
risk estimate (URE). The URE is an
upper-bound estimate of an individual’s
incremental risk 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 UREs from the EPA’s Integrated Risk
8 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).
9 A census block is the smallest geographic area
for which census statistics are tabulated.
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Information System (IRIS). For
carcinogenic pollutants without IRIS
values, we look to other reputable
sources of cancer dose-response values,
often using California EPA (CalEPA)
UREs, where available. In cases where
new, scientifically credible doseresponse 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 doseresponse values in place of, or in
addition to, other values, if appropriate.
The pollutant-specific dose-response
values used to estimate health risk are
available at https://www.epa.gov/fera/
dose-response-assessment-assessinghealth-risks-associated-exposurehazardous-air-pollutants.
To estimate individual lifetime cancer
risks associated with exposure to HAP
emissions from each facility in the
source category, we sum the risks for
each of the carcinogenic HAP 10 emitted
by the modeled facility. We estimate
cancer risk at every census block within
50 km of every facility in the source
category. The MIR is the highest
individual lifetime cancer risk estimated
for any of those census blocks. In
addition to calculating the MIR, we
estimate the distribution of individual
cancer risks for the source category by
summing the number of individuals
within 50 km of the sources whose
estimated risk falls within a specified
risk range. We also estimate annual
cancer incidence by multiplying the
estimated lifetime cancer risk at each
census block by the number of people
residing in that block, summing results
for all of the census blocks, and then
dividing this result by a 70-year
lifetime.
10 The EPA’s 2005 Guidelines for Carcinogen Risk
Assessment classifies carcinogens as: ‘‘carcinogenic
to humans,’’ ‘‘likely to be carcinogenic to humans,’’
and ‘‘suggestive evidence of carcinogenic
potential.’’ These classifications also coincide with
the terms ‘‘known carcinogen, probable carcinogen,
and possible carcinogen,’’ respectively, which are
the terms advocated in the EPA’s Guidelines for
Carcinogen Risk Assessment, published in 1986 (51
FR 33992, September 24, 1986). In August 2000, the
document, Supplemental Guidance for Conducting
Health Risk Assessment of Chemical Mixtures
(EPA/630/R–00/002), was published as a
supplement to the 1986 document. Copies of both
documents can be obtained from https://
cfpub.epa.gov/ncea/risk/recordisplay.cfm?deid=
20533&CFID=70315376&CFTOKEN=71597944.
Summing the risk of these individual compounds
to obtain the cumulative cancer risk is an approach
that was recommended by the EPA’s SAB in their
2002 peer review of the 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 noncancer health
effects from chronic exposure to HAP,
we calculate either an HQ or a target
organ-specific hazard index (TOSHI).
We calculate an HQ when a single
noncancer HAP is emitted. Where more
than one noncancer HAP is emitted, we
sum the HQ for each of the HAP that
affects a common target organ or target
organ system to obtain a TOSHI. The
HQ is the estimated exposure divided
by the chronic noncancer dose-response
value, which is a value selected from
one of several sources. The preferred
chronic noncancer dose-response value
is the EPA RfC, 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’’ (https://
iaspub.epa.gov/sor_internet/registry/
termreg/searchandretrieve/
glossariesandkeywordlists/
search.do?details=&
vocabName=IRIS%20Glossary). In cases
where an RfC from the EPA’s IRIS is not
available or where the EPA determines
that using a value other than the RfC is
appropriate, the chronic noncancer
dose-response value can be a value from
the following prioritized sources, which
define their dose-response values
similarly to the EPA: (1) The Agency for
Toxic Substances and Disease Registry
(ATSDR) Minimum Risk Level (https://
www.atsdr.cdc.gov/mrls/index.asp); (2)
the CalEPA Chronic Reference Exposure
Level (REL) (https://oehha.ca.gov/air/
crnr/notice-adoption-air-toxics-hotspots-program-guidance-manualpreparation-health-risk-0); 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. The pollutant-specific
dose-response values used to estimate
health risks are available at https://
www.epa.gov/fera/dose-responseassessment-assessing-health-risksassociated-exposure-hazardous-airpollutants.
c. Risk From Acute Exposure to HAP
That May Cause Health Effects Other
Than Cancer
For each HAP for which appropriate
acute inhalation dose-response values
are available, the EPA also assesses the
potential health risks due to acute
exposure. For these assessments, the
EPA makes conservative assumptions
about emission rates, meteorology, and
exposure location. As part of our efforts
to continually improve our
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methodologies to evaluate the risks that
HAP emitted from categories of
industrial sources pose to human health
and the environment,11 we revised our
treatment of meteorological data to use
reasonable worst-case air dispersion
conditions in our acute risk screening
assessments instead of worst-case air
dispersion conditions. This revised
treatment of meteorological data and the
supporting rationale are described in
more detail in Residual Risk Assessment
for Flexible Polyurethane Foam
Fabrication Operations Source Category
in Support of the 2020 Risk and
Technology Review Proposed Rule and
in Appendix 5 of the report: Technical
Support Document for Acute Risk
Screening Assessment. This revised
approach has been used in this
proposed rule and in all other RTR
rulemakings proposed on or after June 3,
2019.
To assess the potential acute risk to
the maximally exposed individual, we
use the peak hourly emission rate for
each emission point,12 reasonable
worst-case air dispersion conditions
(i.e., 99th percentile), and the point of
highest off-site exposure. Specifically,
we assume that peak emissions from the
source category and reasonable worstcase air dispersion conditions co-occur
and that a person is present at the point
of maximum exposure.
To characterize the potential health
risks associated with estimated acute
inhalation exposures to a HAP, we
generally use multiple acute doseresponse values, including acute RELs,
acute exposure guideline levels
(AEGLs), and emergency response
planning guidelines (ERPG) for 1-hour
exposure durations, if available, to
calculate acute HQs. The acute HQ is
calculated by dividing the estimated
acute exposure concentration by the
acute dose-response value. For each
HAP for which acute dose-response
values are available, the EPA calculates
acute HQs.
An acute REL is defined as ‘‘the
concentration level at or below which
no adverse health effects are anticipated
11 See, e.g., U.S. EPA, Screening Methodologies to
Support Risk and Technology Reviews (RTR): A
Case Study Analysis (Draft Report, May 2017).
https://www3.epa.gov/ttn/atw/rrisk/rtrpg.html.
12 In the absence of hourly emission data, we
develop estimates of maximum hourly emission
rates by multiplying the average actual annual
emissions rates by a factor (either a categoryspecific factor or a default factor of 10) to account
for variability. This is documented in Residual Risk
Assessment for Flexible Polyurethane Foam
Fabrication Operations Source Category in Support
of the 2020 Risk and Technology Review Proposed
Rule and in Appendix 5 of the report: Technical
Support Document for Acute Risk Screening
Assessment. Both are available in the docket for this
rulemaking.
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for a specified exposure duration.’’ 13
Acute RELs are based on the most
sensitive, relevant, adverse health effect
reported in the peer-reviewed medical
and toxicological literature. They are
designed to protect the most sensitive
individuals in the population through
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. AEGLs represent
threshold exposure limits for the general
public and are applicable to emergency
exposures ranging from 10 minutes to 8
hours.14 They are guideline levels for
‘‘once-in-a-lifetime, short-term
exposures to airborne concentrations of
acutely toxic, high-priority chemicals.’’
Id. at 21. The AEGL–1 is 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.’’
The document also notes that ‘‘Airborne
concentrations below AEGL–1 represent
exposure levels that can produce mild
and progressively increasing but
transient and nondisabling odor, taste,
and sensory irritation or certain
asymptomatic, nonsensory effects.’’ Id.
AEGL–2 are defined 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.
ERPGs are ‘‘developed for emergency
planning and are intended as healthbased guideline concentrations for
13 CalEPA
issues acute RELs as part of its Air
Toxics Hot Spots Program, and the 1-hour and 8hour values are documented in Air Toxics Hot
Spots Program Risk Assessment Guidelines, Part I,
The Determination of Acute Reference Exposure
Levels for Airborne Toxicants, which is available at
https://oehha.ca.gov/air/general-info/oehha-acute8-hour-and-chronic-reference-exposure-level-relsummary.
14 National Academy of Sciences, 2001. Standing
Operating Procedures for Developing Acute
Exposure Levels for Hazardous Chemicals, page 2.
Available at https://www.epa.gov/sites/production/
files/2015-09/documents/sop_final_standing_
operating_procedures_2001.pdf. Note that the
National Advisory Committee for Acute Exposure
Guideline Levels for Hazardous Substances ended
in October 2011, but the AEGL program continues
to operate at the EPA and works with the National
Academies to publish final AEGLs (https://
www.epa.gov/aegl).
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single exposures to chemicals.’’ 15 Id. at
1. The ERPG–1 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 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.
An acute REL for 1-hour exposure
durations is typically lower than its
corresponding AEGL–1 and ERPG–1.
Even though their definitions are
slightly different, AEGL–1s are often the
same as the corresponding ERPG–1s,
and AEGL–2s are often equal to ERPG–
2s. The maximum HQs from our acute
inhalation screening risk assessment
typically result when we use the acute
REL for a HAP. In cases where the
maximum acute HQ exceeds 1, we also
report the HQ based on the next highest
acute dose-response value (usually the
AEGL–1 and/or the ERPG–1).
For this source category, we used a
default multiplier of 10 to provide a
conservatively high estimate of acute
effects.
In our acute inhalation screening risk
assessment, acute impacts are deemed
negligible for HAP for which acute HQs
are less than or equal to 1, and no
further analysis is performed for these
HAP. In cases where an acute HQ from
the screening step is greater than 1, we
assess the site-specific data to ensure
that the acute HQ is at an off-site
location.
4. How do we conduct the
multipathway exposure and risk
screening assessment?
The EPA conducts a tiered screening
assessment examining the potential for
significant human health risks due to
exposures via routes other than
inhalation (i.e., ingestion). We first
determine whether any sources in the
source category emit any HAP known to
be persistent and bioaccumulative in the
environment, as identified in the EPA’s
15 ERPGS Procedures and Responsibilities. March
2014. American Industrial Hygiene Association.
Available at: https://www.aiha.org/get-involved/
AIHAGuidelineFoundation/
EmergencyResponsePlanningGuidelines/
Documents/ERPG%20Committee%20Standard
%20Operating%20Procedures%20%20%20March%202014%20Revision
%20%28Updated%2010-2-2014%29.pdf.
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Air Toxics Risk Assessment Library (see
Volume 1, Appendix D, at https://
www.epa.gov/fera/risk-assessment-andmodeling-air-toxics-risk-assessmentreference-library). For the Flexible
Polyurethane Foam Fabrication
Operations source category, we did not
identify emissions of any PB–HAP.
Because we did not identify PB–HAP
emissions, no further evaluation of
multipathway risk was conducted for
this source category.
For further information on the
multipathway assessment approach, see
the Residual Risk Assessment for the
Flexible Polyurethane Foam Fabrication
Operations Source Category in Support
of the 2020 Risk and Technology Review
Proposed Rule, which is available in the
docket for this action.
5. How do we conduct the
environmental risk screening
assessment?
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a. Adverse Environmental Effect,
Environmental HAP, and Ecological
Benchmarks
The EPA conducts a screening
assessment to examine the potential for
an adverse environmental effect 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.’’
The EPA focuses on eight HAP, which
are referred to as ‘‘environmental HAP,’’
in its screening assessment: Six PB–
HAP and two acid gases. The PB–HAP
included in the screening assessment
are arsenic compounds, cadmium
compounds, dioxins/furans, polycyclic
organic matter (POM), mercury (both
inorganic mercury and methyl mercury),
and lead compounds. The acid gases
included in the screening assessment
are hydrochloric acid (HCl) and
hydrogen fluoride (HF).
HAP that persist and bioaccumulate
are of particular environmental concern
because they accumulate in the soil,
sediment, and water. The acid gases,
HCl and HF, are included due to their
well-documented potential to cause
direct damage to terrestrial plants. In the
environmental risk screening
assessment, we evaluate the following
four exposure media: Terrestrial soils,
surface water bodies (includes watercolumn and benthic sediments), fish
consumed by wildlife, and air. Within
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these four exposure media, we evaluate
nine ecological assessment endpoints,
which are defined by the ecological
entity and its attributes. For PB–HAP
(other than lead), both community-level
and population-level endpoints are
included. For acid gases, the ecological
assessment evaluated is terrestrial plant
communities.
An ecological benchmark represents a
concentration of HAP that has been
linked to a particular environmental
effect level. For each environmental
HAP, we identified the available
ecological benchmarks for each
assessment endpoint. We identified,
where possible, ecological benchmarks
at the following effect levels: probable
effect levels, lowest-observed-adverseeffect level, and no-observed-adverseeffect level. In cases where multiple
effect levels were available for a
particular PB–HAP and assessment
endpoint, we use all of the available
effect levels to help us to determine
whether ecological risks exist and, if so,
whether the risks could be considered
significant and widespread.
For further information on how the
environmental risk screening
assessment was conducted, including a
discussion of the risk metrics used, how
the environmental HAP were identified,
and how the ecological benchmarks
were selected, see Appendix 9 of the
Residual Risk Assessment for the
Flexible Polyurethane Foam Fabrication
Operations Source Category in Support
of the 2020 Risk and Technology Review
Proposed Rule, which is available in the
docket for this action.
b. Environmental Risk Screening
Methodology
For the environmental risk screening
assessment, the EPA first determined
whether any facilities in the Flexible
Polyurethane Foam Fabrication
Operations source category emitted any
of the environmental HAP. For the
Flexible Polyurethane Foam Fabrication
Operations source category, we
identified emissions of HCl. Because
one or more of the environmental HAP
evaluated emitted HCl by at least one
facility in the source category, we
proceeded to the second step of the
evaluation.
c. PB–HAP Methodology
The environmental screening
assessment includes six PB–HAP,
arsenic compounds, cadmium
compounds, dioxins/furans, POM,
mercury (both inorganic mercury and
methyl mercury), and lead compounds.
For the Flexible Polyurethane Foam
Fabrication Operations source category,
we did not identify emissions of any
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PB–HAP. Because we did not identify
PB–HAP emissions, no further
evaluation of PB–HAP for the
environmental risk assessment was
conducted for this source category.
For further information on the PB–
HAP environmental assessment
approach, see the Residual Risk
Assessment for the Flexible
Polyurethane Foam Fabrication
Operations Source Category in Support
of the 2020 Risk and Technology Review
Proposed Rule, available in the docket
for this proposed rule (Docket ID No.
EPA–HQ–OAR–2020–0572).
d. Acid Gas Environmental Risk
Methodology
The environmental screening
assessment for acid gases evaluates the
potential phytotoxicity and reduced
productivity of plants due to chronic
exposure to HF and HCl. The
environmental risk screening
methodology for acid gases is a singletier screening assessment that compares
modeled ambient air concentrations
(from AERMOD) to the ecological
benchmarks for each acid gas. To
identify a potential adverse
environmental effect (as defined in
section 112(a)(7) of the CAA) from
emissions of HF and HCl, we evaluate
the following metrics: The size of the
modeled area around each facility that
exceeds the ecological benchmark for
each acid gas, in acres and square
kilometers; the percentage of the
modeled area around each facility that
exceeds the ecological benchmark for
each acid gas; and the area-weighted
average screening value around each
facility (calculated by dividing the areaweighted average concentration over the
50-km modeling domain by the
ecological benchmark for each acid gas).
For further information on the
environmental screening assessment
approach, see Appendix 9 of the
Residual Risk Assessment for the
Flexible Polyurethane Foam Fabrication
Operations Source Category in Support
of the 2020 Risk and Technology Review
Proposed Rule, which is available in the
docket for this action.
6. How do 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 emission sources at
the facility for which we have data. For
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this source category, we conducted the
facility-wide assessment using a dataset
compiled from the 2014 and 2017 NEI.
The source category records of that NEI
dataset were removed, evaluated, and
updated as described in section II.C of
this preamble: What data collection
activities were conducted to support this
action? Once a quality assured source
category dataset was available, it was
placed back with the remaining records
from the NEI for that facility. The
facility-wide file was then used to
analyze 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
source category risks were compared to
the facility-wide risks to determine the
portion of the facility-wide risks that
could be attributed to the source
category addressed in this proposal. We
also specifically examined the facility
that was associated with the highest
estimate of risk and determined the
percentage of that risk attributable to the
source category of interest. The Residual
Risk Assessment for the Flexible
Polyurethane Foam Fabrication
Operations Source Category in Support
of the 2020 Risk and Technology Review
Proposed Rule, available through the
docket for this action, provides the
methodology and results of the facilitywide analyses, including all facilitywide risks and the percentage of source
category contribution to facility-wide
risks.
7. How do we consider uncertainties in
risk assessment?
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 approach, which
used conservative tools and
assumptions, ensures that our decisions
are health and environmentally
protective. A brief discussion of the
uncertainties in the RTR emissions
dataset, dispersion modeling, inhalation
exposure estimates, and dose-response
relationships follows below. Also
included are those uncertainties specific
to our acute screening assessments,
multipathway screening assessments,
and our environmental risk screening
assessments. A more thorough
discussion of these uncertainties is
included in the Residual Risk
Assessment for the Flexible
Polyurethane Foam Fabrication
Operations Source Category in Support
of the 2020 Risk and Technology Review
Proposed Rule, which is available in the
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docket for this action. If a multipathway
site-specific assessment was performed
for this source category, a full
discussion of the uncertainties
associated with that assessment can be
found in Appendix 11 of that document,
Site-Specific Human Health
Multipathway Residual Risk Assessment
Report.
a. Uncertainties in the RTR Emissions
Dataset
Although the development of the RTR
emissions 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 emission
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
emission rates for the acute effects
screening assessment were based on an
emission adjustment factor applied to
the average annual hourly emission
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 estimate 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 overestimate 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. We also note that the
selection of meteorology dataset
location could have an impact on the
risk estimates. As we continue to update
and expand our library of
meteorological station data used in our
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risk assessments, we expect to reduce
this variability.
c. Uncertainties in Inhalation Exposure
Assessment
Although every effort is made to
identify all of the relevant facilities and
emission points, as well as to develop
accurate estimates of the annual
emission rates for all relevant HAP, the
uncertainties in our emission inventory
likely dominate the uncertainties in the
exposure assessment. Some
uncertainties in our exposure
assessment include human mobility,
using the centroid of each census block,
assuming lifetime exposure, and
assuming only outdoor exposures. For
most of these factors, there is neither an
under nor overestimate when looking at
the MIR or the incidence, but the shape
of the distribution of risks may be
affected. With respect to outdoor
exposures, actual exposures may not be
as high if people spend time indoors,
especially for very reactive pollutants or
larger particles. For all factors, we
reduce uncertainty when possible. For
example, with respect to census-block
centroids, we analyze large blocks using
aerial imagery and adjust locations of
the block centroids to better represent
the population in the blocks. We also
add additional receptor locations where
the population of a block is not well
represented by a single location.
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 noncancer effects from both chronic
and acute exposures. Some
uncertainties are generally expressed
quantitatively, and others are generally
expressed in qualitative terms. We note,
as a preface to this discussion, a point
on dose-response uncertainty that is
stated in the EPA’s 2005 Guidelines for
Carcinogen Risk Assessment; 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’’
(the EPA’s 2005 Guidelines for
Carcinogen Risk Assessment, page 1–7).
This is the approach followed here as
summarized in the next paragraphs.
Cancer UREs used in our risk
assessments are those that have been
developed to generally provide an upper
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bound estimate of risk.16 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). In some
circumstances, the true risk could be as
low as zero; however, in other
circumstances the risk could be
greater.17 Chronic noncancer RfC and
reference dose (RfD) values represent
chronic exposure levels that are
intended to be health-protective levels.
To derive dose-response values that are
intended to be ‘‘without appreciable
risk,’’ the methodology relies upon an
uncertainty factor (UF) approach,18
which considers uncertainty, variability,
and gaps in the available data. The UFs
are applied to derive dose-response
values that are intended to protect
against appreciable risk of deleterious
effects.
Many of the UFs used to account for
variability and uncertainty in the
development of acute dose-response
values are quite similar to those
developed for chronic durations.
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 dose-response value at
another exposure duration (e.g., 1 hour).
Not all acute dose-response 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
dose-response value or values being
exceeded. Where relevant to the
estimated exposures, the lack of acute
dose-response values at different levels
of severity should be factored into the
risk characterization as potential
uncertainties.
Uncertainty also exists in the
selection of ecological benchmarks for
the environmental risk screening
assessment. We established a hierarchy
of preferred benchmark sources to allow
selection of benchmarks for each
environmental HAP at each ecological
assessment endpoint. We searched for
benchmarks for three effect levels (i.e.,
no-effects level, threshold-effect level,
16 IRIS glossary (https://ofmpub.epa.gov/sor_
internet/registry/termreg/searchandretrieve/
glossariesandkeywordlists/search.do?details=&
glossaryName=IRIS%20Glossary).
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.
18 See A Review of the Reference Dose and
Reference Concentration Processes, U.S. EPA,
December 2002, and Methods for Derivation of
Inhalation Reference Concentrations and
Application of Inhalation Dosimetry, U.S. EPA,
1994.
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and probable effect level), but not all
combinations of ecological assessment/
environmental HAP had benchmarks for
all three effect levels. Where multiple
effect levels were available for a
particular HAP and assessment
endpoint, we used all of the available
effect levels to help us determine
whether risk exists and whether the risk
could be considered significant and
widespread.
For a group of compounds that are
unspeciated (e.g., glycol ethers), we
conservatively use the most protective
dose-response 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 dose-response value, we also
apply the most protective dose-response
value from the other compounds in the
group to estimate risk.
e. Uncertainties in Acute Inhalation
Screening Assessments
In addition to the uncertainties
highlighted above, there are several
factors specific to the acute exposure
assessment that the EPA conducts as
part of the risk review under section 112
of the CAA. 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 the
presence of a person. In the acute
screening assessment that we conduct
under the RTR program, we assume that
peak emissions from the source category
and reasonable worst-case air dispersion
conditions (i.e., 99th percentile) cooccur. We then include the additional
assumption that a person is located at
this point at the same time. Together,
these assumptions represent a
reasonable worst-case actual exposure
scenario. In most cases, it is unlikely
that a person would be located at the
point of maximum exposure during the
time when peak emissions and
reasonable worst-case air dispersion
conditions occur simultaneously.
f. Uncertainties in the Multipathway
and Environmental Risk Screening
Assessments
For each source category, we
generally rely on site-specific levels of
PB–HAP or environmental HAP
emissions to determine whether a
refined assessment of the impacts from
multipathway exposures is necessary or
whether it is necessary to perform an
environmental screening assessment.
This determination is based on the
results of a three-tiered screening
assessment that relies on the outputs
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from models—Total Risk Integrated
Methodology.Fate, Transport, and
Ecological Exposure model (TRIM.FaTE)
and AERMOD—that estimate
environmental pollutant concentrations
and human exposures for five PB–HAP
(dioxins, POM, mercury, cadmium, and
arsenic) and two acid gases (HF and
HCl). For lead, we use AERMOD to
determine ambient air concentrations,
which are then compared to the
secondary National Ambient Air Quality
Standards for lead. 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
Model uncertainty concerns whether
the model adequately represents the
actual processes (e.g., movement and
accumulation) that might occur in the
environment. For example, does the
model adequately describe the
movement of a pollutant through the
soil? This type of uncertainty is difficult
to quantify. However, based on feedback
received from previous EPA SAB
reviews and other reviews, we are
confident that the models used in the
screening assessments are appropriate
and state-of-the-art for the multipathway
and environmental screening risk
assessments conducted in support of
RTRs.
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 and environmental
screening assessments, we configured
the models to avoid underestimating
exposure and risk. This was
accomplished by selecting upper-end
values from nationally representative
datasets 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, 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 and
environmental screening assessments,
we refine the model inputs to account
for meteorological patterns in the
vicinity of the facility versus using
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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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
screening assessment. In Tier 3 of the
screening assessments, we refine the
model inputs again to account for hourby-hour plume-rise and the height of the
mixing layer. We can also use those
hour-by-hour meteorological data in a
TRIM.FaTE run using the screening
configuration corresponding to the lake
location. These refinements produce a
more accurate estimate of chemical
concentrations in the media of interest,
thereby reducing the uncertainty with
those estimates. The assumptions and
the associated uncertainties regarding
the selected ingestion exposure scenario
are the same for all three tiers.
For the environmental screening
assessment for acid gases, we employ a
single-tiered approach. We use the
modeled air concentrations and
compare those with ecological
benchmarks.
For all tiers of the multipathway and
environmental screening assessments,
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 not
exceed screening threshold emission
rates (i.e., 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
exceed screening threshold emission
rates, it does not mean that impacts are
significant, only that we cannot rule out
that possibility and that a refined
assessment for the site might be
necessary to obtain a more accurate risk
characterization for the source category.
The EPA evaluates the following HAP
in the multipathway and/or
environmental risk screening
assessments, where applicable: Arsenic,
cadmium, dioxins/furans, lead, mercury
(both inorganic and methyl mercury),
POM, HCl, and HF. These HAP
represent pollutants that can cause
adverse impacts either through direct
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exposure to HAP in the air or through
exposure to HAP that are deposited
from the air onto soils and surface
waters and then through the
environment into the food web. These
HAP represent those HAP for which we
can conduct a meaningful multipathway
or environmental screening risk
assessment. For other HAP not included
in our screening assessments, the model
has not been parameterized such that it
can be used for that purpose. In some
cases, depending on the HAP, we may
not have appropriate multipathway
models that allow us to predict the
concentration of that pollutant. The EPA
acknowledges that other HAP beyond
these that we are evaluating may have
the potential to cause adverse effects
and, therefore, the EPA may evaluate
other relevant HAP in the future, as
modeling science and resources allow.
IV. Analytical Results and Proposed
Decisions
A. What actions are we taking pursuant
to CAA sections 112(d)(2) and 112(d)(3)
for the Flexible Polyurethane Foam
Fabrication Operations source category?
We are proposing pursuant to CAA
section 112(d)(2) and (3) to establish a
numeric limit for HCl emissions from
existing flame laminators. The results
and proposed decisions based on the
analyses performed pursuant to CAA
section 112(d)(2) and (3) are presented
below.
For the Flexible Polyurethane Foam
Fabrication Operations source category,
there are four unregulated existing
source flame laminators at two facilities.
For major sources, the EPA is required
to set technology-based standards that
reflect the maximum reductions of HAP
achievable (after considering cost,
energy requirements, and non-air health
and environmental impacts) and are
commonly referred to as MACT
standards. Furthermore, CAA section
112(d)(3)(B) provides that MACT shall
not be less stringent than ‘‘the average
emission limitation achieved by the best
performing five sources (for which the
Administrator has or could reasonably
obtain emissions information) in the
category for categories with fewer than
30 sources. In this category, the MACT
floor for existing sources is the average
(or mean) of the four known flame
lamination sources. However, emissions
data for HCl emissions from only one of
these units is available. As this is the
only unit of which we are aware that
has had emissions testing conducted for
HCl, the proposed MACT floor is based
on the HCl data for this unit. In order
to determine the level of the MACT
floor, the Upper Prediction Limit
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method was used in order to account for
variability in flame laminator emissions
performance, and the MACT floor was
calculated at 1.45 pounds per hour of
HCl.20
When establishing an emission
standard pursuant to section 112 of the
CAA, the EPA must also determine
whether to control emissions ‘‘beyond
the floor’’ after considering the costs,
non-air quality health and
environmental impacts, and energy
requirements of such more stringent
control. For the existing source flame
laminators, the EPA evaluated whether
a beyond-the-floor emissions limit
would be appropriate; specifically, we
evaluated whether the incremental
emissions reduction achievable with a
venturi scrubber would be cost effective.
The venturi scrubber was the only
control technology in use at flame
lamination sources that was identified
by the EPA with the initial
promulgation of the NESHAP, and no
other developments in control
technologies were identified in the
review of these standards. The EPA’s
previous cost estimates of this
technology conducted for the proposal
of the NESHAP in 2001 showed that the
average cost per ton of HCl emissions
reduced was approximately $18,000. As
nothing has substantially changed with
this technology or in how it would be
implemented, the EPA assumes that the
cost effectiveness today would be
similar to that previously estimated,
once the costs of inflation are
considered. Inflated to 2020 dollars, the
average incremental cost per ton of HCl
emissions reduced is estimated to be
approximately $26,000. We do not find
this to be cost effective for the control
of HCl and, therefore, propose that floorlevel MACT controls are appropriate for
existing flame laminators.
B. What are the results of the risk
assessment and analyses for the Flexible
Polyurethane Foam Fabrication
Operations source category?
As described in section III.C of this
preamble, for the Flexible Polyurethane
Foam Fabrication Operations major
source category, we conducted a risk
assessment for all HAP emitted. We
present results of the risk assessment
briefly below and in more detail in the
Flexible Polyurethane Foam Fabrication
Risk Assessment Report, in the docket
for this action (Docket ID No. EPA–HQ–
OAR–2020–0572).
20 MACT Floor and Beyond-the-Floor Analysis for
Existing Flame Laminators in the Flexible
Polyurethane Foam Fabrication Source Category
(EPA–HQ–OAR–2020–0572).
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1. Chronic Inhalation Risk Assessment
Results
Table 1 below provides a summary of
the results of the inhalation risk
assessment for the source category. As
discussed in section III.C of this
preamble, we set MACT-allowable HAP
emission levels equal to actual
emissions. For more detail about the
1883
MACT-allowable emission levels, see
Appendix 1 to the Flexible Polyurethane
Foam Fabrication Risk Assessment
Report, in the docket for this action.
TABLE 1—FLEXIBLE POLYURETHANE FOAM FABRICATION SOURCE CATEGORY INHALATION RISK ASSESSMENT RESULTS
Maximum individual cancer
risk
(in 1 million)
Risk assessment
Based on
actual
emissions
Source category ..............
Whole Facility ..................
0
0.1
Based
on
allowable
Emissions
2. Screening Level Acute Risk
Assessment Results
Table 1 of this preamble shows the
acute risk results for the Flexible
Polyurethane Foam Fabrication source
category. The screening analysis for
acute impacts was based on an
emissions multiplier of 10 for all
emissions sources, to estimate the peak
emission rates from the average rates.
The maximum screening acute
noncancer HQ value (off-facility site) is
0.003 driven by HCl. For more detailed
acute risk screening results, refer to the
Flexible Polyurethane Foam Fabrication
Risk Assessment Report, in the docket
for this action.
3. Multipathway Risk Screening Results
No PB–HAP are emitted from the
Flexible Polyurethane Foam Fabrication
source category, therefore, a
multipathway assessment was not
conducted.
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4. Environmental Risk Screening Results
As described in section III.A of this
document, we conducted an
environmental risk screening
assessment for the Flexible
21 The TOSHI is the sum of the chronic noncancer
HQ for substances that affect the same target organ
or organ system.
22 The maximum estimated acute exposure
concentration was divided by available short-term
threshold values to develop HQ values.
21:32 Jan 08, 2021
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Based
on
allowable
emissions
Based on
actual
emissions
0
....................
The results of the inhalation risk
modeling using actual emissions data,
as shown in Table 1 of this preamble,
indicate that no carcinogens are emitted
by this category. Therefore, the cancer
MIR based on actual emissions (lifetime)
is zero and the total estimated annual
cancer incidence (national) from these
facilities based on actual emission levels
is zero excess cancer cases per year. The
maximum chronic noncancer TOSHI
value based on actual emissions is 0.002
driven by HCl.
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Estimated population at increased risk of cancer
≥ 1-in-1 million
0
0
Estimated annual cancer
incidence
(cases per year)
Based on
actual
emissions
0
....................
0
0.00001
Based
on
allowable
emissions
0
....................
Polyurethane Foam Fabrication source
category for HCl.
For HCl, the average modeled
concentration around each facility (i.e.,
the average concentration of all off-site
data points in the modeling domain) did
not exceed any ecological benchmark. In
addition, each individual modeled
concentration of HCl and HF (i.e., each
off-site data point in the modeling
domain) was below the ecological
benchmarks for all facilities. Based on
the results of the environmental risk
screening analysis, we do not expect an
adverse environmental effect as a result
of HAP emissions from this source
category.
5. Facility-Wide Risk Results
As shown in Table 1, the maximum
facility-wide cancer MIR is 0.1-in-1
million, driven by 2,4/2,6-toluene
diisocyanate mixture (TDI) emissions
from a vertical non-category point
source and a non-category fugitive point
source. The total estimated cancer
incidence from the whole facility is
0.00001 excess cancer cases per year, or
one excess case in every 100,000 years.
No people were estimated to have
cancer risks above 1-in-1 million from
exposure to HAP emitted from both
MACT and non-MACT sources at the
three facilities in this source category.
The maximum facility-wide TOSHI for
the source category is estimated to be
0.2, mainly driven by 2,4/2,6-TDI
emissions from a vertical non-category
point source and a non-category fugitive
point source.
6. What demographic groups might
benefit from this regulation?
To examine the potential for any
environmental justice issues that might
be associated with the Flexible
Polyurethane Foam Fabrication
Operations major source category, we
performed a demographic analysis,
which is an assessment of risks to
individual demographic groups of the
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Maximum chronic noncancer TOSHI 21
Based on
actual
emissions
0.002
0.2
Maximum screening acute noncancer HQ22
Based
on
allowable
emissions
Based on actual
emissions
0.002
....................
HQREL = <1
..............................
populations living within 5 km and
within 50 km of the facilities. In the
analysis, we evaluated the distribution
of HAP-related cancer and noncancer
risks from the Flexible Polyurethane
Foam Fabrication Operations major
source category across different
demographic groups within the
populations living near facilities.23
Results of the demographic analysis
for the source category indicate that the
minority population is slightly higher
within 5 km of the three facilities than
the national percentage (40 percent
versus 38 percent). This difference is
accounted for by the larger African
American population around the
facilities (17 percent versus 12 percent
nationally). In addition, the percentage
of the population living within 5 km of
facilities in the source category is
greater than the corresponding national
percentage for the demographic groups,
‘‘Ages 0 to 17’’ and ‘‘Below the Poverty
Level.’’ When examining the risk levels
of those exposed to emissions from
Flexible Polyurethane Foam Fabrication
facilities, we find that no one is exposed
to a cancer risk at or above 1-in-1
million or to a chronic noncancer
TOSHI greater than 1. The methodology
and the results of the demographic
analysis are presented in a technical
report, Risk and Technology Review—
Analysis of Demographic Factors for
Populations Living Near Flexible
Polyurethane Foam Fabrication
Operations Source Category, September
2020 (hereafter referred to as the
Flexible Polyurethane Foam Fabrication
Demographic Analysis Report),
available in the docket for this action.
23 Demographic groups included in the analysis
are: White, African American, Native American,
other races and multiracial, Hispanic or Latino,
children 17 years of age and under, adults 18 to 64
years of age, adults 65 years of age and over, adults
without a high school diploma, people living below
the poverty level, people living two times the
poverty level, and linguistically isolated people.
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C. What are our proposed decisions
regarding risk acceptability, ample
margin of safety, and adverse
environmental effect?
flexible polyurethane foam fabrication
facilities are not necessary to provide an
ample margin of safety to protect public
health.
1. Risk Acceptability
As noted in section III.A 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 noncancer risk ranges,
cancer incidence, the maximum
noncancer TOSHI, the maximum acute
noncancer HQ, the extent of noncancer
risks, the distribution of cancer and
noncancer risks in the exposed
population, and risk estimation
uncertainties (54 FR 38044, September
14, 1989).
For the Flexible Polyurethane Foam
Fabrication Operations major source
category, the risk analysis indicates that
there is no cancer risk due to actual
emissions or allowable emissions. Since
there is no cancer risk, the risks are
considerably less than 100-in-1 million,
which is the presumptive upper limit of
acceptable risk. The risk analysis also
shows we did not identify a potential
for adverse chronic noncancer health
effects. The acute noncancer risks based
on actual emissions are low at an HQ of
less than 1 (based on the REL) for HCl.
Therefore, we find there is little
potential concern of acute noncancer
health impacts from actual emissions. In
addition, the risk assessment indicates
no significant potential for
multipathway health effects.
Considering all of the health risk
information and factors discussed
above, including the uncertainties
discussed in section III.C.7 of this
preamble, we propose to find that the
risks from the Flexible Polyurethane
Foam Fabrication source category are
acceptable.
3. Environmental Effect
The emissions data for the Flexible
Polyurethane Foam Fabrication
Operations major source category
indicate that one environmental HAP is
emitted by sources within this source
category: HCl. The screening-level
evaluation of the potential for adverse
environmental effects associated with
emissions of HCl from the Flexible
Polyurethane Foam Fabrication source
category indicated that each individual
concentration (i.e., each off-site data
point in the modeling domain) was
below the ecological benchmarks for all
facilities. In addition, we are unaware of
any adverse environmental effects
caused by 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.
2. Ample Margin of Safety Analysis
We are proposing that the risks from
the Flexible Polyurethane Foam
Fabrication Operations major source
category are acceptable. No carcinogens
are emitted by the Flexible Polyurethane
Foam Fabrication source category.
Therefore, there are no individuals in
the exposed population with lifetime
cancer risks above 1-in-1 million as a
result of actual or allowable emissions
from this category. In addition, the
maximum chronic noncancer TOSHI
value based on actual and allowable
emissions is well below 1 (0.002 and
0.2, respectively) and the maximum
screening acute noncancer HQ value
(off-facility site) is also well below 1
(0.003). Therefore, we are proposing that
additional emissions controls for
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D. What are the results and proposed
decisions based on our technology
review for the Flexible Polyurethane
Foam Fabrication Operations major
source category and for the Flexible
Polyurethane Foam Production and
Fabrication area source categories?
As described in section III.B of this
preamble, our technology review
focused on the identification and
evaluation of potential developments in
practices, processes, and control
technologies that have occurred since
the major source and area source
NESHAP for Flexible Polyurethane
Foam Fabrication were promulgated in
2003 and 2007, respectively. During the
technology review we identified
existing flame laminators as an
unregulated process in the major source
category. This proposal included the
establishment of MACT standards for
that process is described in section IV.A
of this preamble. In conducting the
technology review, we reviewed various
information sources regarding the
emissions from flexible polyurethane
foam fabrication operations facilities
and flexible polyurethane foam
production facilities. We conducted
separate but similar reviews for the
Flexible Polyurethane Foam major
source category and the two area source
categories. The reviews included a
search of the RBLC database, reviews of
air permits for flexible polyurethane
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foam fabrication operations facilities
and flexible polyurethane foam
production facilities, and a review of
emissions standards for similar source
categories. We reviewed these data
sources for information on practices,
processes, and control technologies that
were not considered during the
development of the Flexible
Polyurethane Foam Fabrication
Operations NESHAP and the Flexible
Polyurethane Foam Production and
Fabrication area source NESHAP. We
also looked for information on
improvements in practices, processes,
and control technologies that have been
employed since development of the
NESHAP. Through searches of the data
sources described in section IV.D of this
preamble, one development in a
practice, process, or control technology
was identified for loop slitter use in the
Flexible Polyurethane Foam Fabrication
Operations major source category.
A loop slitter is a large machine used
to create thin sheets of foam from the
large blocks of foam or ‘‘buns’’ created
at a foam production plant. A slitter
consists of a large, vertical, oval
conveyor belt and a cutting mechanism,
which cuts a thin sheet of foam to the
desired thickness. When the buns are
mounted on the conveyor of the slitter,
they are glued end-to-end, forming a
loop. Loop slitter emissions of HAP can
occur from the application of the
adhesives used to glue the foam buns
together if the adhesive used contains
HAP. The application of the adhesive is
performed at the beginning of the loop
slitting process, which can run for
several hours before the bun is fully cut
and the machine is loaded with new
buns of foam.
At the time of the development of the
NESHAP, the EPA found that the foam
fabrication industry had effectively
discontinued the use of adhesives
containing methylene chloride, which
was the primary HAP in the adhesives
used, and had switched to other
adhesives that did not contain
methylene chloride or other HAP. As a
result, for both existing and new loop
slitters, the MACT standard for loop
slitters proposed in 2001 was the
prohibition of HAP-based adhesives.
The definition in the 2001 proposed
standards for a HAP-based adhesive was
an adhesive containing detectable HAP.
In comments on the proposed standards,
industry representatives indicated that
the adhesives used contained small
amounts of HAP rather than the
estimated zero HAP content. In response
to these comments, the definition of
HAP-based adhesive was revised in the
promulgated rule to be an adhesive
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containing 5 percent (by weight) or
greater of HAP.
For new and existing loop slitters, we
identified a potential development in
existing practices and control
techniques not currently required by the
Flexible Polyurethane Foam Fabrication
Operations MACT standards. Through
the review of other air toxics MACT
standards, we noted that several other
NESHAP, developed both before and
after the Flexible Polyurethane Foam
Fabrication Operations NESHAP,
include a definition of non-HAP
adhesive or coating (where the coating
definition included adhesives) with a
lower percentage of HAP content than
that of the definition included in the
Flexible Polyurethane Foam Fabrication
Operations rule.
Additionally, through review of SDS
provided by industry, we found that the
current adhesives used in loop slitting
operations are less than 1-percent HAP
content by total weight. Based on the
current industry standards of adhesive
usage containing less than 1-percent
HAP and the definition for HAP-based
adhesive from similar source categories
regulating adhesives, we are proposing
to revise the definition of ‘‘HAP-based
adhesive’’ to read: ‘‘an adhesive
containing 1 percent (by weight) or
more of HAP, according to EPA Method
311 (appendix A to 40 CFR part 63) or
another approved alternative.’’ This
lowering of the total HAP weight of an
adhesive from 5 percent to 1 percent is
not expected to yield any reductions in
emissions but will codify current
industry practices and prevent
backsliding.
We propose to amend 40 CFR
63.8802(a)(1)(i) and (a)(3)(i), which
describe how to determine the mass
fraction of HAP in each material used,
to remove references to Occupational
Safety and Health Administration
(OSHA)-defined carcinogens as
specified in 29 CFR 1910.1200(d)(4).
The reference to OSHA-defined
carcinogens as specified in 29 CFR
1910.1200(d)(4) was intended to specify
which compounds must be included in
calculating total HAP content of a
coating material if they are present at
0.1-percent or greater by mass. We are
proposing to remove these references
because 29 CFR 1910.1200(d)(4) has
been amended and no longer readily
defines which compounds are
carcinogens. We are proposing to
replace these references to OSHAdefined carcinogens and 29 CFR
1910.1200(d)(4) with a list (in proposed
new Table 8 to 40 CFR part 63, subpart
MMMMM) of those HAP that must be
included in calculating total HAP
content of a coating material if they are
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present at 0.1 percent or greater by
mass.
We propose to include HAP in
proposed Table 8 to 40 CFR part 63,
subpart MMMMM if they were
categorized in the EPA’s Prioritized
Chronic Dose-Response Values for
Screening Risk Assessments (May 9,
2014), as a ‘‘human carcinogen,’’
‘‘probable human carcinogen,’’ or
‘‘possible human carcinogen’’ according
to The Risk Assessment Guidelines of
1986 (EPA/600/8–87/045, August
1987),24 or as ‘‘carcinogenic to
humans,’’ ‘‘likely to be carcinogenic to
humans,’’ or with ‘‘suggestive evidence
of carcinogenic potential’’ according to
the Guidelines for Carcinogen Risk
Assessment (EPA/630/P–03/001F,
March 2005).25
For the Flexible Polyurethane Foam
Production and Flexible Polyurethane
Foam Fabrication area source categories,
we find that there are no additional
emissions of the listed urban HAP
methylene chloride. As noted in section
II.B of this document, methylene
chloride is no longer used within either
source category. Additionally, we did
not find any advances in technologies
during our review of the source
categories. Detailed information of the
technology review can be found in the
memorandum titled Technology Review
for the Flexible Polyurethane Foam
Production and Fabrication Area Source
Categories, which is available in the
docket for this proposed rule (Docket ID
No. EPA–HQ–OAR–2020–0572).
E. What other actions are we proposing?
In addition to the proposed actions
described above, we are proposing
additional revisions to the NESHAP. We
are proposing revisions to the SSM
provisions of the MACT rule in order to
ensure that they are consistent with the
decision in Sierra Club v. EPA, 551 F.
3d 1019 (D.C. Cir. 2008), in which the
court vacated two provisions that
exempted sources from the requirement
to comply with otherwise applicable
CAA section 112(d) emission standards
during periods of SSM. We also are
proposing various other changes to
reporting and recordkeeping
requirements and to periodic testing
requirements. Our analyses and
proposed changes related to these issues
are discussed below.
In its 2008 decision in Sierra Club v.
EPA, 551 F.3d 1019 (D.C. Cir. 2008), the
court vacated portions of two provisions
in the EPA’s CAA section 112
24 See https://www.epa.gov/fera/dose-responseassessment-assessing-health-risks-associatedexposure-hazardous-air-pollutants.
25 See https://www.epa.gov/risk/guidelinescarcinogen-risk-assessment.
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regulations governing the emissions of
HAP during periods of SSM.
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 CAA section 112
standards apply continuously.
We are proposing the elimination of
SSM exemptions in this rule, including
any reference to requirements included
in 40 CFR part 63, subpart A (General
Provisions). Consistent with Sierra Club
v. EPA, we are proposing standards in
this rule that apply at all times. We are
also proposing several revisions to Table
7 to 40 CFR part 63, subpart MMMMM,
as is explained in more detail below.
For example, we are proposing to
eliminate the incorporation of the
General Provisions’ requirement that
each source develop an SSM plan. 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.
Periods of startup, normal operations,
and shutdown are all predictable and
routine aspects of a source’s operations.
Malfunctions, in contrast, are neither
predictable nor routine. Instead, they
are, by definition, sudden, infrequent,
and not reasonably preventable failures
of an emissions control, process, or
monitoring equipment. (40 CFR 63.2,
Definition of malfunction). The EPA
interprets CAA section 112 as not
requiring emissions that occur during
periods of malfunction to be factored
into development of CAA section 112
standards, and this reading has been
upheld as reasonable by the court. See
U.S. Sugar Corp. v. EPA, 830 F.3d 579,
606–610 (2016). 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
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category. There is nothing in CAA
section 112 that directs the Agency to
consider malfunctions in determining
the level ‘‘achieved’’ by the best
performing sources when setting
emission standards. The court has
recognized that the phrase ‘‘average
emissions limitation achieved by the
best performing 12 percent of’’ sources
‘‘says nothing about how the
performance of the best units is to be
calculated.’’ Nat’l Ass’n of Clean Water
Agencies v. EPA, 734 F.3d 1115, 1141
(D.C. Cir. 2013). While the EPA
accounts for variability in setting
emissions standards, nothing in CAA
section 112 requires the Agency to
consider malfunctions as part of that
analysis. The EPA is not required to
treat a malfunction in the same manner
as the type of variation in performance
that occurs during routine operations of
a source. A malfunction is a failure of
the source to perform in a ‘‘normal or
usual manner’’ and no statutory
language compels the EPA to consider
such events in setting CAA section 112
standards.
As the court recognized in U.S. Sugar
Corp., accounting for malfunctions in
setting standards would be difficult, if
not impossible, given the myriad 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. U.S. Sugar Corp. at
608 (‘‘The EPA would have to conceive
of a standard that could apply equally
to the wide range of possible boiler
malfunctions, ranging from an explosion
to minor mechanical defects. Any
possible standard is likely to be
hopelessly generic to govern such a
wide array of circumstances.’’). As such,
the performance of units that are
malfunctioning is not ‘‘reasonably’’
foreseeable. See, e.g., Weyerhaeuser Co.
v. Costle, 590 F.2d 1011, 1058 (D.C. Cir.
1978) (‘‘In the nature of things, no
general limit, individual permit, or even
any upset provision can anticipate all
upset situations. After a certain point,
the transgression of regulatory limits
caused by ‘uncontrollable acts of third
parties,’ such as strikes, sabotage,
operator intoxication or insanity, and a
variety of other eventualities, must be a
matter for the administrative exercise of
case-by-case enforcement discretion, not
for specification in advance by
regulation.’’).
Moreover, emissions during a
malfunction event can be significantly
higher than emissions at any other time
of source operation. For example, if an
air pollution control device with 99percent removal goes off-line as a result
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of a malfunction (as might happen if, for
example, the bags in a baghouse catch
fire) and the emission unit is a steady
state-type unit that would take days to
shut down, the source would go from
99-percent control to zero control until
the control device was repaired. The
source’s emissions during the
malfunction would be 100 times higher
than during normal operations. As such,
the emissions over a 4-day malfunction
period would exceed the annual
emissions of the source during normal
operations. As this example illustrates,
accounting for malfunctions could lead
to standards that are not reflective of
(and are significantly less stringent
than) levels that are achieved by a wellperforming non-malfunctioning source.
It is reasonable to interpret CAA section
112 to avoid such a result. The EPA’s
approach to malfunctions is consistent
with CAA section 112 and is a
reasonable interpretation of the statute.
Although no statutory language
compels the EPA to set standards for
malfunctions, the EPA has the
discretion to do so where feasible. For
example, in the Petroleum Refinery
Sector RTR, the EPA established a work
practice standard for unique types of
malfunction that result in releases from
pressure relief devices or emergency
flaring events because the EPA had
information to determine that such work
practices reflected the level of control
that applies to the best performers. 80
FR 75178, 75211 through 14 (December
1, 2015). The EPA considers whether
circumstances warrant setting standards
for a particular type of malfunction and,
if so, whether the EPA has sufficient
information to identify the relevant bestperforming sources and establish a
standard for such malfunctions. We also
encourage commenters to provide any
such information.
In the event that a source fails to
comply with the applicable CAA section
112(d) standards as a result of a
malfunction event, the EPA would
determine an appropriate response
based on, among other things, the good
faith efforts of the source to minimize
emissions during malfunction periods,
including preventative and corrective
actions, as well as root cause analyses
to ascertain and rectify excess
emissions. The EPA would also
consider whether the source’s failure to
comply with the CAA section 112(d)
standard was, in fact, sudden,
infrequent, not reasonably preventable,
and was not instead caused, in part, by
poor maintenance or careless operation.
40 CFR 63.2 (Definition of malfunction).
If the EPA determines in a particular
case that an enforcement action against
a source for violation of an emission
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standard is warranted, the source can
raise any and all defenses in that
enforcement action and the federal
district court will determine what, if
any, relief is appropriate. The same is
true for citizen enforcement actions.
Similarly, the presiding officer in an
administrative proceeding can consider
any defense raised and determine
whether administrative penalties are
appropriate.
In summary, the EPA interpretation of
the CAA and, in particular, CAA section
112 is reasonable and encourages
practices that will avoid malfunctions.
Administrative and judicial procedures
for addressing exceedances of the
standards fully recognize that violations
may occur despite good faith efforts to
comply and can accommodate those
situations. See U.S. Sugar Corp., 830
F.3d at 606–610. Therefore, we are
proposing to change the requirements
for SSM by removing the exemption for
new flame laminators from the
requirements to meet the standard
during SSM periods and by removing
the requirement to develop and
implement an SSM plan. The EPA is
proposing revisions to Table 7 of
subpart MMMMM, The Applicability of
General Provisions, to remove SSM
exemptions and plan development for
new flame lamination sources.
Electronic reporting. The EPA is
proposing that owners or operators of
flexible polyurethane foam fabrication
operations facilities submit electronic
copies of required performance test
reports, performance evaluation reports,
and periodic reports through the EPA’s
Central Data Exchange (CDX) using the
Compliance and Emissions Data
Reporting Interface (CEDRI). A
description of the electronic data
submission process is provided in the
memorandum, Electronic Reporting
Requirements for New Source
Performance Standards (NSPS) and
National Emission Standards for
Hazardous Air Pollutants (NESHAP)
Rules, available in the docket for this
action. The proposed rule requires that
performance test results collected using
test methods that are supported by the
EPA’s Electronic Reporting Tool (ERT)
as listed on the ERT website 26 at the
time of the test be submitted in the
format generated through the use of the
ERT or an electronic file consistent with
the xml schema on the ERT website, and
other performance test results be
submitted in portable document format
(PDF) using the attachment module of
the ERT. The proposed rule requires
that Notification of Compliance Status
26 https://www.epa.gov/electronic-reporting-airemissions/electronic-reporting-tool-ert.
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reports be submitted as a PDF upload in
CEDRI.
For performance test reports,
performance evaluation reports, and
periodic reports, the proposed rule
requires that owners or operators use
the appropriate spreadsheet template to
submit information to CEDRI. A draft
version of the proposed template(s) for
these reports is included in the docket
for this action.27 The EPA specifically
requests comment on the content,
layout, and overall design of the
template(s).
Additionally, the EPA has identified
two broad circumstances in which
electronic reporting extensions may be
provided. These circumstances are (1)
outages of the EPA’s CDX or CEDRI
which preclude an owner or operator
from accessing the system and
submitting required reports and (2) force
majeure events, which are defined as
events that will be or have been caused
by circumstances beyond the control of
the affected facility, its contractors, or
any entity controlled by the affected
facility that prevent an owner or
operator from complying with the
requirement to submit a report
electronically. Examples of force
majeure events are acts of nature, acts
of war or terrorism, or equipment failure
or safety hazards beyond the control of
the facility. The EPA is providing these
potential extensions to protect owners
or operators from noncompliance in
cases where they cannot successfully
submit a report by the reporting
deadline for reasons outside of their
control. In both circumstances, the
decision to accept the claim of needing
additional time to report is within the
discretion of the Administrator, and
reporting should occur as soon as
possible.
The electronic submittal of the reports
addressed in this proposed rulemaking
will increase the usefulness of the data
contained in those reports, is in keeping
with current trends in data availability
and transparency, will further assist in
the protection of public health and the
environment, will improve compliance
by facilitating the ability of regulated
facilities to demonstrate compliance
with requirements, and by facilitating
the ability of delegated state, local,
tribal, and territorial air agencies and
the EPA to assess and determine
compliance, and will ultimately reduce
burden on regulated facilities, delegated
air agencies, and the EPA. Electronic
reporting also eliminates paper-based,
manual processes, thereby saving time
27 See Flexible Foam Fabrication ERT templates,
available at Docket ID. No. EPA–HQ–OAR–2020–
0572.
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and resources, simplifying data entry,
eliminating redundancies, minimizing
data reporting errors, and providing data
quickly and accurately to the affected
facilities, air agencies, the EPA, and the
public. Moreover, electronic reporting is
consistent with the EPA’s plan 28 to
implement Executive Order 13563 and
is in keeping with the EPA’s Agencywide policy 29 developed in response to
the White House’s Digital Government
Strategy.30 For more information on the
benefits of electronic reporting, see the
memorandum, Electronic Reporting
Requirements for New Source
Performance Standards (NSPS) and
National Emission Standards for
Hazardous Air Pollutants (NESHAP)
Rules, referenced earlier in this section.
F. What compliance dates are we
proposing?
The EPA is proposing that affected
sources that commenced construction or
reconstruction on or before January 11,
2021, must comply with all of the
amendments, with the exception of the
proposed electronic format for
submitting notifications and compliance
reports, no later than 180 days after the
effective date of the final rule, or upon
startup, whichever is later. Affected
sources that commence construction or
reconstruction after January 11, 2021,
must comply with all requirements of
the subpart, including the amendments
being proposed, with the exception of
the proposed electronic format for
submitting notifications and compliance
reports, no later than the effective date
of the final rule or upon startup,
whichever is later. All affected facilities
would have to continue to meet the
current requirements of 40 CFR part 63,
subpart MMMMM, until the applicable
compliance date of the amended rule.
The final action is not expected to be a
‘‘major rule’’ as defined by 5 U.S.C.
804(2), so the effective date of the final
rule will be the promulgation date as
specified in CAA section 112(d)(10).
For existing sources, we are proposing
four changes that would impact ongoing
compliance requirements for 40 CFR
part 63, subpart MMMMM. As
28 The EPA’s Final Plan for Periodic Retrospective
Reviews, August 2011. Available at: https://
www.regulations.gov/document?D=EPA-HQ-OA2011-0156-0154.
29 E-Reporting Policy Statement for EPA
Regulations, September 2013. Available at https://
www.epa.gov/sites/production/files/2016-03/
documents/epa-ereporting-policy-statement-201309-30.pdf.
30 Digital Government: Building a 21st Century
Platform to Better Serve the American People, May
2012. Available at https://
obamawhitehouse.archives.gov/sites/default/files/
omb/egov/digital-government/digitalgovernment.html.
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discussed elsewhere in this preamble,
we are proposing to add numeric limits
for HCl emissions from existing flame
laminators. We are also proposing a
requirement that notifications,
performance test results, and
compliance reports be submitted
electronically.
Our experience with similar
industries that are required to convert
reporting mechanisms to install
necessary hardware and software,
become familiar with the process of
submitting performance test results
electronically through the EPA’s CEDRI,
test these new electronic submission
capabilities, and reliably employ
electronic reporting shows that a time
period of a minimum of 90 days, and,
more typically, 180 days, is generally
necessary to accomplish these revisions.
For the proposed SSM revisions, we
recognize that there are no facilities that
are currently using the SSM provisions
for new flame laminators, since there
have not been any new sources since the
standard was promulgated. As a result,
we do not believe that any additional
time is needed for compliance with the
revised SSM provisions.
We have consulted with the regulated
industry regarding the proposed limits
for existing flame laminators, and the
requirement to conduct performance
testing to demonstrate initial
compliance within 180 days of the
publication of the final rule and no less
than every 5 years thereafter, to better
understand the likely implications of
the proposed revisions. There are two
impacted facilities, owned by one
parent company, and representatives
from that company have indicated that
performance testing could be done
within the proposed time frame for
compliance. For the proposed limit for
existing sources, we believe that the two
facilities that would be subject to the
standards are able to meet the limit
without add-on controls. However, we
do recognize that facilities will need
time to conduct performance tests and
demonstrate compliance with the
proposed emission limit.
The EPA recognizes the confusion
that multiple and different compliance
dates for individual requirements would
create and the additional burden such
an assortment of dates would impose.
From our assessment of the timeframe
needed for compliance with the entirety
of the revised requirements, the EPA
considers a period of 180 days to be the
most expeditious compliance period
practicable and is, thus, proposing that
all affected sources that commenced
construction or reconstruction on or
before January 11, 2021, be in
compliance with all of this regulation’s
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revised requirements within 180 days of
the regulation’s effective date, with the
exception of the electronic reporting
requirements.
We solicit comment on the proposed
compliance periods, and we specifically
request submission of information from
sources in this source category regarding
specific actions that would need to be
undertaken to comply with the
proposed amended requirements and
the time needed to make the
adjustments for compliance with any of
the revised requirements. We note that
information provided may result in
changes to the proposed compliance
dates.
V. Summary of Cost, Environmental,
and Economic Impacts
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A. What are the affected sources?
Currently, three major sources subject
to the Flexible Polyurethane Foam
Fabrication Operations NESHAP are
operating in the United States. The
affected sources under the NESHAP
include flexible polyurethane foam
fabrication plant sites that operate loop
slitters and/or flame laminators.
Facilities that use loop slitter adhesive
processes would be required to comply
with a ban on the use of adhesives
containing air toxics. However, the EPA
estimates that current air toxic
emissions from loop slitter adhesive
users are essentially zero as the result of
changes in adhesive composition
required by OSHA’s permissible
exposure limit for methylene chloride
prior to the promulgation of the original
MACT standard. Additionally, the EPA
estimates that current air toxic
emissions from flame laminators for the
entire source category are less than 3.5
tpy.
Currently, there are approximately 32
area sources subject to the Flexible
Polyurethane Foam Production and
Fabrication NESHAP. The area source
standard only regulates methylene
chloride emissions and, similar to the
major source standards, emissions of
methylene chloride are essentially zero
as required by OSHA’s permissible
exposure limit for methylene chloride
prior to the promulgation of the original
GACT standards. Based on information
provided by industry, there are no
emissions of methylene chloride from
these sources. For detailed information
please see the memorandum titled
Technology Review for the Flexible
Polyurethane Foam Production and
Fabrication Area Source Categories,
located in the docket for this action.
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21:32 Jan 08, 2021
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B. What are the air quality impacts?
E. What are the benefits?
Current estimated emissions from the
Flexible Polyurethane Foam Fabrication
Operations source category are
approximately 3.5 tpy. We do not
estimate any HAP emission reductions
from the proposed requirement for
MACT limits for existing flame
laminators nor from the proposed
revision to the definition of HAP-based
adhesives for loop slitters. Both
proposed revisions reflect current
practices.
Although the EPA does not anticipate
any significant reductions in HAP
emissions as a result of the proposed
amendments, the action, if finalized as
proposed, would result in
improvements to the rule and prevent
backsliding. Specifically, the proposed
amendments codify existing industry
practices both for existing flame
laminators and for new and existing
sources of adhesives used with loop
slitters. The proposed revisions also
amend the standards such that they
apply at all times. Additionally, the
proposed amendments requiring
electronic submittal of initial
notifications, performance test results,
and semiannual reports will increase
the usefulness of the data, are in
keeping with current trends of data
availability, will further assist in the
protection of public health and the
environment, and will ultimately result
in less burden on the regulated
community. See section IV.E of this
preamble for more information.
C. What are the cost impacts?
The proposed revisions to the Flexible
Polyurethane Foam Fabrication
Operations NESHAP for major sources
are expected to have minimal cost
impacts. The costs are associated with
periodic emissions performance testing,
electronic reporting, and reviewing the
proposed rule. Three major source
facilities are affected by these costs. The
one-time cost associated with reviewing
the proposed rule and becoming
familiar with the electronic reporting
system is estimated to be $2,200 per
facility in 2019 dollars. The EPA
estimates the cost of the HCl emissions
testing requirement to be $12,000 per
test. This test is required every 5 years.
Prior to the initial test, installation and
calibration of equipment is required
which costs an estimated $3,200. The
total cost per facility in Year 1 is
estimated to be $17,300, and subsequent
costs are estimated to be $12,000 every
5 years thereafter.
D. What are the economic impacts?
The proposed revisions to the Flexible
Polyurethane Foam Fabrication
Operations NESHAP for major sources
and the Flexible Polyurethane Foam
Production and Fabrication NESHAP for
area sources are not expected to have
market impacts. Over a 10-year
timeframe from 2021 to 2030, the net
present value of the estimated cost
impacts is $83,000 at a 3-percent
discount rate and $77,600 at a 7-percent
discount rate in 2019 dollars. The
equivalent annualized value of the cost
impacts is $9,700 at a 3-percent
discount rate and $11,000 at a 7-percent
discount rate. Since the costs associated
with the proposed rule are minimal, no
significant economic impacts are
anticipated due to the proposed
revisions. See the memorandum titled
Economics Memo Flex Foam NESHAP
Proposal, in the docket for discussion of
the facility-level cost estimates as well
as the net present value and equivalent
annualized value estimates.
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VI. Request for Comments
We solicit comments on 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 for download on the RTR
website at https://www.epa.gov/
stationary-sources-air-pollution/flexiblepolyurethane-foam-fabricationoperations-national-emission. 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
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downloaded from the RTR website,
complete the following steps:
1. Within this downloaded file, enter
suggested 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 emission revisions (e.g.,
performance test reports, material
balance calculations).
4. Send the entire downloaded file
with suggested revisions in Microsoft®
Access format and all accompanying
documentation to Docket ID No. EPAHQ-OAR-2020-0572 (through the
method described in the ADDRESS
section of this preamble).
5. If you are providing comments on
a single facility or mulitiple facilities,
you need only submit one file for all
facilities. The file should contain all
suggested for all sources at the facility
(or facilities). 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 project website at https://
www.epa.gov/stationary-sources-airpollution/flexible-polyurethane-foamfabrication-operations-nationalemission.
VIII. Statutory and Executive Order
Reviews
Additional information about these
statutes and Executive Orders can be
found at https://www.epa.gov/lawsregulations/laws-and-executive-orders.
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 and was, therefore, not
submitted to OMB for review.
B. Executive Order 13771: Reducing
Regulations and Controlling Regulatory
Costs
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This action is not expected to be an
Executive Order 13771 regulatory action
because this action is not significant
under Executive Order 12866.
C. Paperwork Reduction Act (PRA)
The information collection activities
in this proposed rule have been
submitted for approval to OMB under
the PRA. The Information Collection
Request (ICR) document that the EPA
prepared has been assigned EPA ICR
number 2027.08. You can find a copy of
VerDate Sep<11>2014
21:32 Jan 08, 2021
Jkt 253001
the ICR in the docket for this rule, and
it is briefly summarized here. The ICR
is specific to information collection
associated with the Flexible
Polyurethane Foam Fabrication
Operations source category, through
amendments to 40 CFR part 63, subpart
MMMMM. (The subject rulemaking
imposes no new information collection
associated with either the Flexible
Polyurethane Foam Production area
source category or the Flexible
Polyurethane Foam Fabrication area
source category.) We are proposing
changes to the recordkeeping and
reporting requirements associated with
40 CFR part 63, subpart MMMMM, in
the form of: Requiring periodic (every 5
years) performance tests at major
sources; eliminating the SSM plan and
reporting requirements; including
reporting requirements for deviations in
the semiannual report; and including
the requirement for electronic submittal
of reports. In addition, the number of
facilities subject to the standards
changed. The number of respondents
was reduced from 20 to 3 based on
consultation with industry
representatives and state/local agencies.
Respondents/affected entities: The
respondents to the recordkeeping and
reporting requirements are owners or
operators of flexible polyurethane foam
fabrication operations subject to 40 CFR
part 63, subpart MMMMM.
Respondent’s obligation to respond:
Mandatory (40 CFR part 63, subpart
MMMMM).
Estimated number of respondents: 3
facilities.
Frequency of response: The frequency
of responses varies depending on the
burden item. Responses include onetime review of rule amendments, reports
of periodic performance tests, and
semiannual compliance reports.
Total estimated burden: The annual
recordkeeping and reporting burden for
responding facilities to comply with all
of the requirements in the NESHAP,
averaged over the 3 years of this ICR, is
estimated to be 148 hours (per year).
The average annual burden to the
Agency over the 3 years after the
amendments are final is estimated to be
51 hours (per year) for the Agency.
Burden is defined at 5 CFR 1320.3(b).
Total estimated cost: The annual
recordkeeping and reporting cost for
responding facilities to comply with all
of the requirements in the NESHAP,
averaged over the 3 years of this ICR, is
estimated to be $15,000 (rounded, per
year). There are no estimated capital
and operation and maintenance costs.
The total average annual Agency cost
over the first 3 years after the
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1889
amendments are final is estimated to be
$2,500.
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.
Submit your comments on the
Agency’s need for this information, the
accuracy of the provided burden
estimates, and any suggested methods
for minimizing respondent burden to
the EPA using the docket identified at
the beginning of this rule. You may also
send your ICR-related comments to
OMB’s Office of Information and
Regulatory Affairs via email to OIRA_
submission@omb.eop.gov, Attention:
Desk Officer for the EPA. Since OMB is
required to make a decision concerning
the ICR between 30 and 60 days after
receipt, OMB must receive comments no
later than February 10, 2021. The EPA
will respond to any ICR-related
comments in the final rule.
D. Regulatory Flexibility Act (RFA)
I certify that this action will not have
a significant economic impact on a
substantial number of small entities
under the RFA. In making this
determination, the impact of concern is
any significant adverse economic
impact on small entities. An agency may
certify that a rule will not have a
significant economic impact on a
substantial number of small entities if
the rule relieves regulatory burden, has
no net burden, or otherwise has a
positive economic effect on the small
entities subject to the rule. As proposed,
this action would potentially impose
new requirements only on major
sources, and none of the major sources
in the Flexible Polyurethane Foam
Fabrication Operations source category
are considered a small entity. We have,
therefore, concluded that this action
will have no net regulatory burden for
all directly regulated small entities.
E. Unfunded Mandates Reform Act
(UMRA)
This action does not contain an
unfunded mandate of $100 million or
more as described in UMRA, 2 U.S.C.
1531–1538, and does not significantly or
uniquely affect small governments. The
action imposes no enforceable duty on
any state, local, or tribal governments or
the private sector.
F. Executive Order 13132: Federalism
This action does not have federalism
implications. It will not have substantial
direct effects on the states, on the
relationship between the national
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government and the states, or on the
distribution of power and
responsibilities among the various
levels of government.
G. Executive Order 13175: Consultation
and Coordination With Indian Tribal
Governments
This action does not have tribal
implications as specified in Executive
Order 13175. No tribal facilities are
known to be engaged in the industries
that would be affected by this action nor
are there any adverse health or
environmental effects from this action.
Thus, Executive Order 13175 does not
apply to this action.
H. Executive Order 13045: Protection of
Children From Environmental Health
Risks and Safety Risks
This action is not subject to Executive
Order 13045 because it is not
economically significant as defined in
Executive Order 12866, and because the
EPA does not believe the environmental
health or safety risks addressed by this
action present a disproportionate risk to
children. This action’s health and risk
assessments are contained in sections
III.A, IV.B, and IV.C of this preamble.
I. Executive Order 13211: Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use
This action is not subject to Executive
Order 13211 because it is not a
significant regulatory action under
Executive Order 12866.
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J. National Technology Transfer and
Advancement Act (NTTAA)
This rulemaking does not involve
technical standards.
21:32 Jan 08, 2021
Jkt 253001
List of Subjects in 40 CFR Part 63
Environmental protection, Air
pollution control, Hazardous
substances, Reporting and
recordkeeping requirements.
Andrew Wheeler,
Administrator.
[FR Doc. 2021–00250 Filed 1–8–21; 8:45 am]
BILLING CODE 6560–50–P
K. Executive Order 12898: Federal
Actions To Address Environmental
Justice in Minority Populations and
Low-Income Populations
The EPA believes that this action does
not have disproportionately high and
adverse human health or environmental
effects on minority populations, lowincome populations, and/or indigenous
peoples, as specified in Executive Order
12898 (59 FR 7629, February 16, 1994).
The documentation for this decision
is contained in sections IV.B and IV.C
of this preamble. As discussed in
sections IV.B and IV.C of this preamble,
we performed a demographic analysis
for the Flexible Polyurethane Foam
Fabrication Operations major source
category, which is an assessment of
risks to individual demographic groups,
of the population close to the facilities
(within 50 km and within 5 km). In our
analysis, we evaluated the distribution
VerDate Sep<11>2014
of HAP-related cancer risks and
noncancer hazards from the Flexible
Polyurethane Foam Fabrication
Operations major source category across
different social, demographic, and
economic groups within the populations
living near operations identified as
having the highest risks. Results of the
demographic analysis performed for the
Flexible Polyurethane Foam Fabrication
Operations major source category
indicate that the minority population is
slightly higher within 5 km of the three
facilities than the national percentage
(40 percent versus 38 percent). This
difference is accounted for by the larger
African American population around
the facilities (17 percent versus 12
percent nationally). In addition, the
percentage of the population living
within 5 km of facilities in the source
category is greater than the
corresponding national percentage for
the demographic groups, ‘‘Ages 0 to 17’’
and ‘‘Below the Poverty Level.’’ When
examining the risk levels of those
exposed to emissions from flexible
polyurethane foam fabrication facilities,
we find that no one is exposed to a
cancer risk at or above 1-in-1 million or
to a chronic noncancer TOSHI greater
than 1.
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 700
[EPA–HQ–OPPT–2020–0493; FRL–10018–
40]
RIN 2070–AK64
Fees for the Administration of the
Toxic Substances Control Act (TSCA)
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
AGENCY:
The Environmental Protection
Agency (EPA) is proposing updates and
adjustments to the 2018 fees rule
established under the Toxic Substances
Control Act (TSCA). TSCA requires EPA
to review and, if necessary, adjust the
fees every three years, after consultation
with parties potentially subject to fees.
This document describes the proposed
SUMMARY:
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modifications to the TSCA fees and fee
categories for fiscal years 2022, 2023
and 2024, and explains the methodology
by which these TSCA fees were
determined. EPA is proposing to add
three new fee categories: A Bona Fide
Intent to Manufacture or Import Notice,
a Notice of Commencement of
Manufacture or Import, and an
additional fee associated with test
orders. In addition, EPA is proposing
exemptions for entities subject to certain
fee triggering activities; including: An
exemption for research and
development activities, an exemption
for entities manufacturing less than
2,500 lbs. of a chemical subject to an
EPA-initiated risk evaluation fee; an
exemption for manufacturers of
chemical substances produced as a nonisolated intermediate; and exemptions
for manufacturers of a chemical
substance subject to an EPA-initiated
risk evaluation if the chemical
substance is imported in an article,
produced as a byproduct, or produced
or imported as an impurity. EPA is
updating its cost estimates for
administering TSCA, relevant
information management activities and
individual fee calculation
methodologies. EPA is proposing a
volume-based fee allocation for EPAinitiated risk evaluation fees in any
scenario where a consortium is not
formed and is proposing to require
export-only manufacturers to pay fees
for EPA-initiated risk evaluations. EPA
is also proposing various changes to the
timing of certain activities required
throughout the fee payment process.
DATES: Comments must be received on
or before February 25, 2021.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPPT–2020–0493,
through the Federal eRulemaking Portal
at https://www.regulations.gov. Follow
the online instructions for submitting
comments. Do not submit electronically
any information you consider to be
Confidential Business Information (CBI)
or other information whose disclosure is
restricted by statute.
Please note that due to the public
health emergency the EPA Docket
Center (EPA/DC) and Reading Room
was closed to public visitors on March
31, 2020. Our EPA/DC staff will
continue to provide customer service
via email, phone, and webform. For
further information on EPA/DC services,
docket contact information and the
current status of the EPA/DC and
Reading Room, please visit https://
www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: For
technical information contact: Marc
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]]>Agencies
[Federal Register Volume 86, Number 6 (Monday, January 11, 2021)]
[Proposed Rules]
[Pages 1868-1890]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-00250]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 63
[EPA-HQ-OAR-2020-0572; FRL-10017-90-OAR]
RIN 2060-AU57
National Emission Standards for Hazardous Air Pollutants:
Flexible Polyurethane Foam Fabrication Operations Residual Risk and
Technology Review and Flexible Polyurethane Foam Production and
Fabrication Area Source Technology Review
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: This action presents the proposed results of the U.S.
Environmental Protection Agency's (EPA's) residual risk and technology
review (RTR) required under the Clean Air Act (CAA) for the National
Emission Standards for Hazardous Air Pollutants (NESHAP) for major
source Flexible Polyurethane Foam Fabrication Operations, initially
promulgated in 2003. Pursuant to the CAA, this action also presents the
proposed results of the technology review for the NESHAP for two area
source categories, Flexible Polyurethane Foam Production and Flexible
Polyurethane Foam Fabrication, which are combined in one subpart
initially promulgated in 2007. In this action, the EPA is proposing to
establish a numeric emission limit for one major source subcategory;
remove exemptions for periods of startup, shutdown, and malfunction
(SSM) and specify that the emissions standards apply at all times;
require periodic performance tests; and require electronic reporting of
performance test results and compliance reports. Implementation of
these proposed rules is not expected to result in significant changes
to the hazardous air pollutant (HAP) emissions from affected facilities
in these three source categories or to human health impacts or
environmental impacts associated with those emissions. However, this
action, if finalized, would result in improved monitoring, compliance,
and implementation of the existing standards and codify existing
industry practices to prevent backsliding.
DATES: Comments. Comments must be received on or before February 25,
2021. Under the Paperwork Reduction Act (PRA), comments on the
information collection provisions are best assured of consideration if
the Office of Management and Budget (OMB) receives a copy of your
comments on or before February 10, 2021.
Public hearing: If anyone contacts us requesting a public hearing
on or before January 19, 2021, we will hold a virtual public hearing.
See SUPPLEMENTARY INFORMATION for information on requesting and
registering for a public hearing.
ADDRESSES: You may send comments, identified by Docket ID No. EPA-HQ-
OAR-2020-0572 by any of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov/
(our preferred method). Follow the online instructions for submitting
comments.
Email: [email protected]. Include Docket ID No. EPA-
HQ-OAR-2020-0572- in the subject line of the message.
Fax: (202) 566-9744. Attention Docket ID No. EPA-HQ-OAR-
2020-0572.
Mail: U.S. Environmental Protection Agency, EPA Docket
Center, Docket ID No. EPA-HQ-OAR-2020-0572 EPA Mail Code 28221T, 1200
Pennsylvania Avenue NW, Washington, DC 20460.
Hand/Courier Delivery: EPA Docket Center, WJC West
Building, Room 3334, 1301 Constitution Avenue NW, Washington, DC 20004.
The Docket Center's hours of operation are 8:30 a.m.-4:30 p.m., Monday-
Friday (except federal holidays).
Instructions: All submissions received must include the Docket ID
No. for this rulemaking. Comments received may be posted without change
to https://www.regulations.gov/, including any personal information
provided. For detailed instructions on sending comments and additional
information on the rulemaking process, see the SUPPLEMENTARY
INFORMATION section of this document. Out of an abundance of caution
for members of the public and our staff, the EPA Docket Center and
Reading Room are closed to the public, with limited exceptions, to
reduce the risk of transmitting COVID-19. Our Docket Center staff will
continue to provide remote customer service via email, phone, and
webform. We encourage the public to submit comments via https://www.regulations.gov/ or email, as there may be a delay in processing
mail and faxes. Hand deliveries and couriers may be received by
scheduled appointment only. For further information on EPA Docket
Center services and the current status, please visit us online at
https://www.epa.gov/dockets.
[[Page 1869]]
FOR FURTHER INFORMATION CONTACT: For questions about this proposed
action, contact Dr. Tina Ndoh, Sector Policies and Programs Division
(D243-04), Office of Air Quality Planning and Standards, U.S.
Environmental Protection Agency, Research Triangle Park, North Carolina
27711; telephone number: (919) 541-1516; fax number: (919) 541-4991;
and email address: [email protected]. For specific information
regarding the risk modeling 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:
[email protected].
SUPPLEMENTARY INFORMATION:
Participation in virtual public hearing. Please note that the EPA
is deviating from its typical approach for public hearings because the
President has declared a national emergency. Due to the current Centers
for Disease Control and Prevention (CDC) recommendations, as well as
state and local orders for social distancing to limit the spread of
COVID-19, the EPA cannot hold in-person public meetings at this time.
To request a virtual public hearing, contact the public hearing
team at (888) 372-8699 or by email at [email protected]. If
requested, the virtual hearing will be held on January 26, 2021. The
hearing will convene at 9:00 a.m. Eastern Time (ET) and will conclude
at 3:00 p.m. ET. The EPA may close a session 15 minutes after the last
pre-registered speaker has testified if there are no additional
speakers. The EPA will announce further details at https://www.epa.gov/stationary-sources-air-pollution/flexible-polyurethane-foam-fabrication-operations-national-emission.
Upon publication of this document in the Federal Register, the EPA
will begin pre-registering speakers for the hearing, if a hearing is
requested. To register to speak at the virtual hearing, please use the
online registration form available at https://www.epa.gov/stationary-sources-air-pollution/flexible-polyurethane-foam-fabrication-operations-national-emission or contact the public hearing team at
(888) 372-8699 or by email at [email protected]. The last day
to pre-register to speak at the hearing will be January 25, 2021. Prior
to the hearing, the EPA will post a general agenda that will list pre-
registered speakers in approximate order at: https://www.epa.gov/stationary-sources-air-pollution/flexible-polyurethane-foam-fabrication-operations-national-emission.
The EPA will make every effort to follow the schedule as closely as
possible on the day of the hearing; however, please plan for the
hearings to run either ahead of schedule or behind schedule.
Each commenter will have 5 minutes to provide oral testimony. The
EPA encourages commenters to provide the EPA with a copy of their oral
testimony electronically (via email) by emailing it to
[email protected]. The EPA also recommends submitting the text of your
oral testimony as written comments to the rulemaking docket.
The EPA may ask clarifying questions during the oral presentations
but will not respond to the presentations at that time. Written
statements and supporting information submitted during the comment
period will be considered with the same weight as oral testimony and
supporting information presented at the public hearing.
Please note that any updates made to any aspect of the hearing will
be posted online at https://www.epa.gov/stationary-sources-air-pollution/flexible-polyurethane-foam-fabrication-operations-national-emission. While the EPA expects the hearing to go forward as set forth
above, please monitor our website or contact the public hearing team at
(888) 372-8699 or by email at [email protected] to determine if
there are any updates. The EPA does not intend to publish a document in
the Federal Register announcing updates.
If you require the services of a translator or a special
accommodation such as audio description, please pre-register for the
hearing with the public hearing team and describe your needs by January
19, 2021. The EPA may not be able to arrange accommodations without
advanced notice.
Docket. The EPA has established a docket for this rulemaking under
Docket ID No. EPA-HQ-OAR-2020-0572. All documents in the docket are
listed in https://www.regulations.gov/. Although listed, some
information is not publicly available, e.g., Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. Certain other material, such as copyrighted material, is
not placed on the internet and will be publicly available only in hard
copy. With the exception of such material, publicly available docket
materials are available electronically in Regulations.gov.
Instructions. Direct your comments to Docket ID No. EPA-HQ-OAR-
2020-0572. 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 CBI or other information whose disclosure is restricted by
statute. Do not submit electronically any information that you consider
to be CBI or other information whose disclosure is restricted by
statute. This type of information should be submitted by mail as
discussed below.
The EPA may publish any comment received to its public docket.
Multimedia submissions (audio, video, etc.) must be accompanied by a
written comment. The written comment is considered the official comment
and should include discussion of all points you wish to make. The EPA
will generally not consider comments or comment contents located
outside of the primary submission (i.e., on the Web, cloud, or other
file sharing system). For additional submission methods, the full EPA
public comment policy, information about CBI or multimedia submissions,
and general guidance on making effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets.
The https://www.regulations.gov/ website allows you to submit your
comment anonymously, 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
digital storage media 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.
The EPA is temporarily suspending its Docket Center and Reading
Room for public visitors, with limited exceptions, to reduce the risk
of transmitting COVID-19. Our Docket Center staff will continue to
provide remote customer service via email, phone, and webform.
[[Page 1870]]
We encourage the public to submit comments via https://www.regulations.gov/ as there may be a delay in processing mail and
faxes. Hand deliveries or couriers will be received by scheduled
appointment only. For further information and updates on EPA Docket
Center services, please visit us online at https://www.epa.gov/dockets.
The EPA continues to carefully and continuously monitor information
from the CDC, local area health departments, and our Federal partners
so that we can respond rapidly as conditions change regarding COVID-19.
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
any digital storage media that you mail to the EPA, mark the outside of
the digital storage media as CBI and then identify electronically
within the digital storage media 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 directly
to the public docket through the procedures outlined in Instructions
above. If you submit any digital storage media that does not contain
CBI, mark the outside of the digital storage media 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: OAQPS Document Control Officer (C404-02), OAQPS,
U.S. Environmental Protection Agency, Research Triangle Park, North
Carolina 27711, Attention Docket ID No. EPA-HQ-OAR-2020-0572. Note that
written comments containing CBI and submitted by mail may be delayed
and no hand deliveries will be accepted.
Preamble acronyms and abbreviations. We use multiple acronyms and
terms in this preamble. 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:
AEGL acute exposure guideline level
AERMOD air dispersion model used by the HEM-3 model
ATSDR Agency for Toxic Substances and Disease Registry
CAA Clean Air Act
CalEPA California EPA
CBI Confidential Business Information
CDC Centers for Disease Control and Prevention
CDX Central Data Exchange
CEDRI Compliance and Emissions Data Reporting
CFR Code of Federal Regulations
EPA Environmental Protection Agency
ERPG emergency response planning guideline
ERT Electronic Reporting Tool
GACT generally available control technology
HAP hazardous air pollutant(s)
HCl hydrochloric acid
HEM-3 Human Exposure Model, Version 1.5.5
HF hydrogen fluoride
HI hazard index
HQ hazard quotient
IRIS Integrated Risk Information System
km kilometer
MACT maximum achievable control technology
mg/m\3\ milligrams per cubic meter
MIR maximum individual risk
NAICS North American Industry Classification System
NATA National Air Toxics Assessment
NEI National Emissions Inventory
NESHAP national emission standards for hazardous air pollutants
NSR New Source Review
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
PDF portable document format
POM polycyclic organic matter
ppm parts per million
RBLC Reasonably Available Control Technology, Best Available Control
Technology, and Lowest Achievable Emission Rate Clearinghouse
REL reference exposure level
RfC reference concentration
RfD reference dose
RTR residual risk and technology review
SAB Science Advisory Board
SDS safety data sheets
SSM startup, shutdown, and malfunction
TDI toluene diisocyanate
TOSHI target organ-specific hazard index
tpy tons per year
TRI Toxics Release Inventory
TRIM.FaTE Total Risk Integrated Methodology.Fate, Transport, and
Ecological Exposure model
UF uncertainty factor
URE unit risk estimate
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?
II. Background
A. What is the statutory authority for this action?
B. What are the source categories and how do the current NESHAP
regulate their HAP emissions?
C. What data collection activities were conducted to support
this action?
D. What other relevant background information and data are
available?
III. Analytical Procedures and Decision-Making
A. How do we consider risk in our decision-making?
B. How do we perform the technology review?
C. How do we estimate post-MACT risk posed by the source
category?
IV. Analytical Results and Proposed Decisions
A. What actions are we taking pursuant to CAA sections 112(d)(2)
and 112(d)(3) for the Flexible Polyurethane Foam Fabrication
Operations source category?
B. What are the results of the risk assessment and analyses for
the Flexible Polyurethane Foam Fabrication Operations source
category?
C. What are our proposed decisions regarding risk acceptability,
ample margin of safety, and adverse environmental effect?
D. What are the results and proposed decisions based on our
technology review for the Flexible Polyurethane Foam Fabrication
Operations major source category and for the Flexible Polyurethane
Foam Production and Fabrication area source categories?
E. What other actions are we proposing?
F. 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. Executive Order 13771: Reducing Regulations and Controlling
Regulatory Costs
C. Paperwork Reduction Act (PRA)
D. Regulatory Flexibility Act (RFA)
E. Unfunded Mandates Reform Act (UMRA)
F. Executive Order 13132: Federalism
G. Executive Order 13175: Consultation and Coordination With
Indian Tribal Governments
H. Executive Order 13045: Protection of Children From
Environmental Health Risks and Safety Risks
I. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use
J. National Technology Transfer and Advancement Act (NTTAA)
K. Executive Order 12898: Federal Actions To Address
Environmental Justice in Minority Populations and Low-Income
Populations
[[Page 1871]]
I. General Information
A. Does this action apply to me?
The source categories that are the subject of this proposal are
Flexible Polyurethane Foam Fabrication Operations Major Sources
regulated under 40 CFR part 63, subpart MMMMM, and Flexible
Polyurethane Foam Production and Flexible Polyurethane Foam Fabrication
Area Sources, regulated under 40 CFR part 63, subpart OOOOOO. The North
American Industry Classification System (NAICS) code for fabricators of
flexible polyurethane foam industry is 326150. This list of categories
and NAICS codes is not intended to be exhaustive, but rather provides a
guide for readers regarding the entities that this proposed action is
likely to affect. The proposed standards, once promulgated, will be
directly applicable to the affected sources. Federal, state, local, and
tribal government entities would not be affected by this proposed
action.
The Flexible Polyurethane Foam Fabrication Operations major source
category was added to the EPA's HAP source category list in 1996. (61
FR 28197, June 4, 1996.) The NESHAP for that major source category, 40
CFR part 63, subpart MMMMM, was promulgated in 2003. (68 FR 18062,
April 14, 2003.) The Flexible Polyurethane Foam Fabrication area source
category was added to the EPA's HAP source category list in 1999. (64
FR 38706, July 19, 1999.) The Flexible Polyurethane Foam Production
area source category was added to the EPA's HAP source category list in
2002. (67 FR 70427, November 22, 2002.) The Flexible Polyurethane Foam
Production major source category, Part 63, subpart III, was included on
the EPA's initial HAP source category list. (57 FR 31576, July 16,
1992.) The maximum achievable control technology (MACT) standards for
subpart III were initially promulgated in 1998. (63 FR 53980, October
7, 1998.) The EPA established one area source NESHAP at 40 CFR part 63,
subpart OOOOOO, that applies to the two area source categories due to
similarity of their operations and because they are often collocated.
(72 FR 38864, July 16, 2007.)
The Flexible Polyurethane Foam Fabrication Operations major source
category and the Flexible Polyurethane Foam Fabrication area source
category include facilities engaged in cutting, gluing, and/or
laminating pieces of flexible polyurethane foam. Those source
categories include fabrication operations that are collocated with foam
production plants as well as those located offsite from foam production
plants. Emissions from foam fabrication primarily result from the
lamination of polyurethane foam to adhere foam to other substrates and
from the use of HAP-based adhesives in the gluing process. The Flexible
Polyurethane Foam Production area source category includes facilities
that manufacture foam made from a polymer containing a plurality of
carbamate linkages in the chain backbone (polyurethane). Polyurethane
is commonly made by reacting a polyisocyanate with an organic
polyhydroxyl material in the presence of water. Application of blowing
agents, catalysts, surfactants, and fillers transform the polyurethane
into a foam with specialized properties.
This proposed action addresses the major source NESHAP that applies
to the Flexible Polyurethane Foam Fabrication Operations major source
category and also addresses the area source NESHAP that applies to the
Flexible Polyurethane Foam Production area source category and the
Flexible Polyurethane Foam Fabrication area source category.
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. Following signature by the
EPA Administrator, the EPA will post a copy of this proposed action at
https://www.epa.gov/stationary-sources-air-pollution/flexible-polyurethane-foam-fabrication-operations-national-emission. Following
publication in the Federal Register, the EPA will post the Federal
Register version of the proposal and key technical documents at this
same website. Information on the overall RTR program is available at
https://www3.epa.gov/ttn/atw/rrisk/rtrpg.html.
The proposed changes to the CFR that would be necessary to
incorporate the changes proposed in this action are set out in an
attachment to the memorandum titled Proposed Regulation Edits for 40
CFR Part 63, subparts MMMMM and OOOOOO, available in the docket for
this action (Docket ID No. EPA-HQ-OAR-2020-0572). This document
includes the specific proposed amendatory language for revising the CFR
and, for the convenience of interested parties, a redline version of
the regulations. Following signature by the EPA Administrator, the EPA
will also post a copy of this memorandum and the attachment to https://www.epa.gov/stationary-sources-air-pollution/flexible-polyurethane-foam-fabrication-operations-national-emission.
II. Background
A. What is the statutory authority for this action?
The statutory authority for this action is provided by sections 112
and 301 of the CAA, as amended (42 U.S.C. 7401 et seq.). Section 112 of
the CAA establishes a two-stage regulatory process to develop standards
for emissions of HAP from stationary sources. Generally, the first
stage involves establishing technology-based standards and the second
stage involves evaluating those standards that are based on MACT to
determine whether additional standards are needed to address any
remaining risk associated with HAP emissions. This second stage is
commonly referred to as the ``residual risk review.'' In addition to
the residual risk review, the CAA also requires the EPA to review
standards set under CAA section 112 every 8 years and revise the
standards as necessary taking into account any ``developments in
practices, processes, or control technologies.'' This review is
commonly referred to as the ``technology review.'' When the two reviews
are combined into a single rulemaking, it is commonly referred to as
the ``risk and technology review.'' The discussion that follows
identifies the most relevant statutory sections and briefly explains
the contours of the methodology used to implement these statutory
requirements. A more comprehensive discussion appears in the document
titled CAA Section 112 Risk and Technology Reviews: Statutory Authority
and Methodology, in the docket for this proposed rule (Docket ID No.
EPA-HQ-OAR-2020-0572).
In the first stage of the CAA section 112 standard setting process,
the EPA promulgates technology-based standards under CAA section 112(d)
for categories of sources identified as emitting one or more of the HAP
listed in CAA section 112(b). Sources of HAP emissions are either major
sources or area sources, and CAA section 112 establishes different
requirements for major source standards and area source standards.
``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. All other sources are ``area sources.'' For major
sources, CAA section 112(d)(2) provides that the technology-based
NESHAP must reflect the maximum degree of emission reductions of HAP
achievable (after considering cost, energy requirements, and non-air
[[Page 1872]]
quality health and environmental impacts). These standards are commonly
referred to as MACT standards. CAA section 112(d)(3) also establishes a
minimum control level for MACT standards, known as the MACT ``floor.''
In certain instances, as provided in CAA section 112(h), the EPA may
set work practice standards in lieu of numerical emission standards.
The EPA must also consider control options that are more stringent than
the floor. Standards more stringent than the floor are commonly
referred to as beyond-the-floor standards. For area sources, CAA
section 112(d)(5) gives the EPA discretion to set standards based on
generally available control technologies or management practices (GACT
standards) in lieu of MACT standards.
The second stage in standard-setting focuses on identifying and
addressing any remaining (i.e., ``residual'') risk pursuant to CAA
section 112(f). For source categories subject to MACT standards,
section 112(f)(2) of the CAA requires the EPA to determine whether
promulgation of additional standards is needed to provide an ample
margin of safety to protect public health or to prevent an adverse
environmental effect. Section 112(d)(5) of the CAA provides that this
residual risk review is not required for categories of area sources
subject to GACT standards. Section 112(f)(2)(B) of the CAA further
expressly preserves the EPA's use of the two-step approach 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 Residual 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 the United States Court of Appeals for the District of Columbia
Circuit (the court) upheld the EPA's interpretation that CAA section
112(f)(2) incorporates the approach established in the Benzene NESHAP.
See NRDC v. EPA, 529 F.3d 1077, 1083 (D.C. Cir. 2008).
The approach incorporated into the CAA and used by the EPA to
evaluate residual risk and to develop standards under CAA section
112(f)(2) is a two-step approach. 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)
\1\ of approximately 1 in 10 thousand.'' (54 FR at 38045). If risks are
unacceptable, the EPA must determine the emissions standards necessary
to reduce risk to an acceptable level without considering costs. In the
second step of the approach, the EPA considers whether the emissions
standards provide an ample margin of safety to protect public health
``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 emission standards
necessary to provide an ample margin of safety to protect public health
or determine that the standards being reviewed provide an ample margin
of safety without any revisions. 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.
---------------------------------------------------------------------------
\1\ Although defined as ``maximum individual risk,'' MIR refers
only to cancer risk. MIR, one metric for assessing cancer risk, is
the estimated risk if an individual were exposed to the maximum
level of a pollutant for a lifetime.
---------------------------------------------------------------------------
CAA section 112(d)(6) separately requires the EPA to review
standards promulgated under CAA section 112 and revise them ``as
necessary (taking into account developments in practices, processes,
and control technologies)'' no less often than every 8 years. In
conducting this review, which we call the ``technology 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 EPA may consider cost in deciding whether to revise the
standards pursuant to CAA section 112(d)(6). The EPA is required to
address regulatory gaps, such as missing standards for listed air
toxics known to be emitted from the source category. Louisiana
Environmental Action Network (LEAN) v. EPA, 955 F.3d 1088 (D.C. Cir.
2020). Section 112(k)(3)(B) of the CAA required the EPA to identify at
least 30 HAP that pose the greatest potential health threat in urban
areas, and CAA section 112(c)(3) requires the EPA to regulate the area
source categories that represent 90 percent of the emissions of the 30
``listed'' HAP (``urban HAP'').
B. What are the source categories and how do the current NESHAP
regulate their HAP emissions?
For both the Flexible Polyurethane Foam Fabrication Operations
major source category and the Flexible Polyurethane Foam Fabrication
area source category, operations involve cutting, bonding, and/or
laminating pieces of flexible polyurethane foam together or to other
substrates. Typical bonding techniques include gluing, taping, and
flame lamination. In years preceding the listing of the flexible
polyurethane foam fabrication major and area source categories, some
foam fabrication operations may have used methylene chloride-based
adhesives to adhere pieces of foam together; however, the industry no
longer uses any methylene chloride-based adhesives. Most foam
fabrication adhesives are applied by workers using spray guns.
Application of adhesives is typically performed in large open rooms,
with workstations spaced along a conveyor that moves the pieces of foam
to be glued together. Loop slitter adhesive use is a specialized type
of foam fabrication adhesive use. Loop slitters are equipment used at
slabstock foam production and/or fabrication facilities to slice large
foam ``buns'' into thin sheets. Adhesive is used to attach the ends of
the foam buns to one another before they are mounted on the loop
slitter. The amount of adhesive used for loop slitters is relatively
low because the adhesive is not applied continuously, just once or
twice per shift when the foam buns are loaded onto the loop slitter.
Flame lamination refers to the bonding of foam to any substrate (e.g.,
fabric, foam, plastic) where the bonding agent is scorched or melted
foam. Thin sheets of foam are passed under a flame which scorches the
foam surface and makes it sticky. The tacky foam sheet is then applied
and adhered to a substrate.
The Flexible Polyurethane Foam Production area source category
includes facilities that manufacture foam made from polyurethanes,
which are in the class of compounds called ``reaction polymers.''
Application of blowing agents, catalysts, surfactants, and fillers
transforms the polyurethane into a foam with specialized properties.
There are three types of polyurethane foam production facilities:
Slabstock flexible polyurethane foam (slabstock foam), molded flexible
polyurethane foam (molded foam), and rebond foam.
[[Page 1873]]
Slabstock foam is produced in large continuous buns that are then cut
into the desired size and shape. Slabstock foam is used in a wide
variety of applications, including furniture and mattresses. Molded
foam is produced by ``shooting'' the foam mixture into a mold of the
desired shape and size. Molded foam is used in office furniture,
automobile seats, novelties, and many other applications. Rebond foam
is made from scrap foam that is converted into a material primarily
used for carpet underlay.
The EPA estimates that there are 32 facilities currently subject to
the area source standards, of which approximately 20 are believed to be
owned by small businesses.
The EPA promulgated MACT standards for major source Flexible
Polyurethane Foam Fabrication Operations facilities in 2003 under 40
CFR part 63, subpart MMMMM. The standards apply to major sources of HAP
at existing and new flexible polyurethane foam fabrication facilities.
Because of their potential to generate HAP emissions, the processing
units of interest at foam fabrication facilities are loop slitters and
flame lamination units. The MACT standards for Flexible Polyurethane
Foam Fabrication Operations require HAP emissions reductions and
control for new flame lamination units and prohibit use of HAP-based
adhesives in new and existing loop slitting operations. For new flame
lamination units, a 90-percent reduction in HAP emissions is required.
For existing flame lamination units, there are currently no MACT
emission limits. For new and existing loop slitters, the MACT standards
prohibit use of any adhesive containing 5 percent or more (by weight)
of total HAP. The EPA estimates that there are currently three
facilities subject to subpart MMMMM--two in Indiana, and one in New
Mexico.
Both the Flexible Polyurethane Foam Production and Flexible
Polyurethane Fabrication Operations area source categories were listed
for regulation due to emissions of the urban HAP methylene chloride. At
the time of the initial area source standards promulgation, methylene
chloride was the only urban HAP used at foam production and foam
fabrication facilities. Now, however, there are no known urban HAP used
at foam production and foam fabrication facilities. In the past,
slabstock foam production facilities sometimes used methylene chloride
as an auxiliary blowing agent to control the density and other
properties of the foam as it expanded during the pouring process.\2\
Methylene chloride was also sometimes used as an equipment cleaner, in
particular for mix heads. A small number of molded and rebond foam
facilities used methylene chloride in mold release agents, and some
molded foam facilities used it as a mixhead cleaner. Foam fabricators
used methylene chloride-based adhesives to adhere pieces of foam to one
another. Flame laminators have never used methylene chloride and, as
such, are not regulated by the area source standards.
---------------------------------------------------------------------------
\2\ Other regulations address methylene chloride. For example,
the EPA listed methylene chloride as an unacceptable (prohibited)
blowing agent for use in flexible polyurethane under section 612 of
the CAA (81 FR 86778, December 1, 2016).
---------------------------------------------------------------------------
In 2007, the EPA promulgated GACT standards for the Flexible
Polyurethane Foam Production area source category and the Flexible
Polyurethane Foam Fabrication area source category together under 40
CFR part 63, subpart OOOOOO. The GACT standards required that methylene
chloride be significantly reduced or eliminated from slabstock foam
production, molded foam release agents, equipment cleaning, rebond foam
mold release agents, and from foam fabrication adhesive use. Although
both area source categories were listed for regulation due to emissions
of the urban HAP methylene chloride, the EPA finds that methylene
chloride is no longer used within either source category.
C. What data collection activities were conducted to support this
action?
For the Flexible Foam Fabrication Operations NESHAP RTR, the EPA
used emissions and supporting data from the 2017 and 2014 National
Emissions Inventory (NEI), 2018 and 2019 Toxics Release Inventory (TRI)
data, and 2014 stack test data from one facility to develop the model
input files for the residual risk assessments for major source flexible
foam fabrication facilities.
The NEI is a database that contains information about sources that
emit criteria air pollutants, their precursors, and HAP. The database
includes estimates of annual air pollutant emissions from point,
nonpoint, and mobile sources in the 50 states, the District of
Columbia, Puerto Rico, and the U.S. Virgin Islands. The EPA collects
this information and releases an updated version of the NEI database
every 3 years. The NEI includes data necessary for conducting risk
modeling, including annual HAP emissions estimates from individual
emission sources at facilities and the related emissions release
parameters. In certain cases, we contacted state inventory compilers
and facility owners or operators to confirm and clarify the sources of
emissions, emissions estimates, and release parameters that were
reported in the NEI.
The TRI is a resource for learning about toxic chemical releases
and pollution prevention activities reported by industrial and federal
facilities. The TRI tracks the management of certain toxic chemicals
that may pose a threat to human health and the environment. U.S.
facilities in different industry sectors must report annually how much
of each chemical is released to the environment and/or managed through
recycling, energy recovery, and treatment.\3\
---------------------------------------------------------------------------
\3\ Available at https://www.epa.gov/toxics-release-inventory-tri-program.
---------------------------------------------------------------------------
Additional information on the development of the modeling file can
be found in Appendix 1 to the Residual Risk Assessment for the Flexible
Polyurethane Foam Fabrication Operations Source Category in Support of
the 2020 Risk and Technology Review Proposed Rule, which is available
in the docket for this proposed rule (Docket ID No. EPA-HQ-OAR-2020-
0572).
For the Flexible Foam Production and Fabrication area source
standards, we relied on information provided by industry to determine
whether any urban HAP were emitted from the regulated facilities.
Through industry meetings and email and telephone conversations, the
EPA found that there are no additional urban HAP emitted from flexible
foam production and fabrication facilities subject to area source
standards. Detailed information of the technology review can be found
in the memorandum titled Technology Review for the Flexible
Polyurethane Foam Production and Fabrication Area Source Categories,
which is available in the docket for this proposed rule (Docket ID No.
EPA-HQ-OAR-2020-0572).
The Flexible Polyurethane Foam Production and Flexible Polyurethane
Foam Fabrication MACT standards were promulgated in 1998 and 2003
respectively. Since that time, the EPA has developed air toxics
regulations for a number of additional source categories that emit HAP
from the same types of emission sources that are present in the
Flexible Polyurethane Foam Production and Fabrication source
categories. In air toxic regulatory actions carried out subsequent to
the initial MACT standard development for these source categories, the
EPA has consistently evaluated any new practices, processes, and
control technologies. A review of
[[Page 1874]]
these initial and subsequent air toxics regulations, including
supporting documentation used in the rulemakings, was conducted to
determine whether any practices, processes, or control technologies
could be applied to the Flexible Foam Fabrication source category.
One potential development in practices, processes, and control
technologies was identified through the review of other air toxics
regulations, which is discussed further in section IV.D of this
document.
D. What other relevant background information and data are available?
For the risk review portion of the RTR, we reviewed facility
permits for the three major sources subjected to the Flexible
Polyurethane Foam Fabrication Operations NESHAP. Facility permits
provide data on maximum allowable emissions and other relevant
production and emission factors.
For the technology review portion of the RTR, we collected
information from the Reasonably Available Control Technology, Best
Available Control Technology, and Lowest Achievable Emission Rate
Clearinghouse (RBLC) to identify developments in practices, processes,
and control technologies since the MACT standards were developed. The
RBLC is a database that contains case-specific information on air
pollution technologies that have been required to reduce the emissions
of air pollutants from stationary sources. Under the EPA's New Source
Review (NSR) program, if a facility is planning new construction or a
modification that will increase the air emissions above certain defined
thresholds, an NSR permit must be obtained. The RBLC promotes the
sharing of information among permitting agencies and aids in case-by-
case determinations for NSR permits. We examined information contained
in the RBLC to determine what technologies are currently used for these
source categories to reduce air emissions. Additional information about
these data collection activities for the technology reviews is
contained in the technology review memorandum titled Technology Review
for the Flexible Polyurethane Foam Fabrication Operations Source
Category, which is available in the docket for this proposed rule
(Docket ID No. EPA-HQ-OAR-2020-0572).
The RBLC provides several options for searching the permit database
on-line to locate applicable control technologies. Our initial search
of the RBLC specified processes in polyurethane foam products
manufacturing, with permits dating back to 2001. This search did not
provide any results for foam fabrication operations. Further searches
of the database were conducted based on relevant keywords. The search
included all available data fields, which among others, included the
following:
RBLC ID;
Facility Name and State;
Permit Date;
Process name;
Throughput;
Pollutant;
Control technology;
Percent efficiency of control; and
Pollutants/Compliance Notes.
The results of this search are presented in Appendix 1 of the
Technology Review for the Flexible Polyurethane Foam Manufacturing
Source Category. As shown in Appendix 1, no control technologies more
stringent than the Flexible Polyurethane Foam NESHAP were identified
through this search.
Two of the three facilities subject to major source standards have
loop slitter operations and use adhesives. Both facilities provided the
EPA with safety data sheets (SDS) for the adhesives in use. Those SDS
were used to determine chemical composition and potential HAP emissions
from the adhesives. Additional background information on adhesive use
and regulation was collected through review of other NESHAP in similar
industrial sectors. Specifically, we searched for other NESHAP
regulating HAP emissions from coatings and adhesives and compared the
stringency of those standards to the existing requirements for HAP
adhesives for loop slitters. Data from the SDS provided and the NESHAP
for similar source categories were also used in the technology
evaluation for the Flexible Polyurethane Foam Fabrication Operations
NESHAP. The findings for the technology review are discussed further in
section IV.D of this preamble.
III. Analytical Procedures and Decision-Making
In this section, we describe the analyses performed to support the
proposed decisions for the RTR and other issues addressed in this
proposal.
In this proposed action, pursuant to CAA section 112(f), the EPA is
conducting a risk review for the major source NESHAP (40 CFR part 63,
subpart MMMMM) MACT standards for Flexible Polyurethane Foam
Fabrication Operations. Consistent with the provision regarding
alternative standards for area sources in CAA section 112(d)(5), the
risk review does not cover the NESHAP for area sources. Therefore, the
discussions of risk assessment methods and modeling analyses described
in the following paragraphs only apply to the major source category.
However, pursuant to CAA section 112(d)(6), the EPA is proposing
the technology review for both the major source NESHAP and the area
source NESHAP (40 CFR part 63, subpart OOOOOO). Therefore, the
discussions in the paragraphs below regarding how the EPA conducted the
technology reviews apply to both major sources and area sources.
A. How do we consider risk in our decision-making?
As discussed in section II.A of this preamble and in the Benzene
NESHAP, in evaluating and developing standards under CAA section
112(f)(2), we apply a two-step approach to determine whether or not
risks are acceptable and to determine if the standards provide an ample
margin of safety to protect public health. 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 section 112 is best judged on the basis of
a broad set of health risk measures and information.'' (54 FR at
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 approach provides flexibility regarding factors
the EPA may consider in making determinations and how the EPA may weigh
those factors for each source category. The EPA conducts a risk
assessment that provides estimates of the MIR posed by emissions of HAP
that are carcinogens 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.\4\ The assessment also provides estimates of the distribution
of cancer
[[Page 1875]]
risk within the exposed populations, cancer incidence, and an
evaluation of the potential for an adverse environmental effect. The
scope of the EPA's risk analysis is consistent with the explanation in
the EPA's response to comments on our policy under the Benzene NESHAP:
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\4\ The MIR is defined as the cancer risk associated with a
lifetime of exposure at the highest concentration of HAP where
people are likely to live. The HQ is the ratio of the potential HAP
exposure concentration to the noncancer dose-response value; the HI
is the sum of HQs for HAP that affect the same target organ or organ
system.
The 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. This approach complies with the
Vinyl Chloride mandate that the Administrator ascertain an
acceptable level of risk to the public by employing his 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 his judgment, believes are
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appropriate to determining what will ``protect the public health''.
(54 FR at 38057). Thus, the level of the MIR is only one factor to be
weighed in determining acceptability of risk. 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 an MIR less than the presumptively acceptable level
is unacceptable in the light of other health risk factors.'' Id. at
38045. In other words, risks that include an MIR above 100-in-1 million
may be determined to be acceptable, and risks with an MIR below that
level may be determined to be unacceptable, depending on all of the
available health information. 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 the HAP risk that may be associated with emissions
from other facilities that do not include the source category under
review, mobile source emissions, natural source emissions, persistent
environmental pollution, or atmospheric transformation in the vicinity
of the sources in the category.
The EPA 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
noncancer risk, where pollutant-specific exposure health reference
levels (e.g., reference concentrations (RfCs)) are based on the
assumption that thresholds exist for adverse health effects. For
example, the EPA recognizes that, although exposures attributable to
emissions from a source category or facility alone may not indicate the
potential for increased risk of adverse noncancer 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 an increased risk of adverse noncancer health effects. In May
2010, the Science Advisory Board (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.'' \5\
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\5\ Recommendations of the SAB Risk and Technology Review
Methods Panel are provided in their report, which is available at:
https://yosemite.epa.gov/sab/sabproduct.nsf/
4AB3966E263D943A8525771F00668381/$File/EPA-SAB-10-007-unsigned.pdf.
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In response to the SAB recommendations, the EPA incorporates
cumulative risk analyses into its RTR risk assessments. The Agency (1)
conducts facility-wide assessments, which include source category
emission points, as well as other emission points within the
facilities; (2) combines exposures from multiple sources in the same
category that could affect the same individuals; and (3) for some
persistent and bioaccumulative pollutants, analyzes the ingestion route
of exposure. In addition, the RTR risk assessments consider aggregate
cancer risk from all carcinogens and aggregated noncancer HQs for all
noncarcinogens affecting the same target organ or target organ system.
Although we are interested in placing source category and facility-
wide HAP risk in the context of total HAP risk from all sources
combined in the vicinity of each source, we are concerned about the
uncertainties of doing so. Estimates of total HAP risk from emission
sources other than those that we have studied in depth during this RTR
review 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.
B. How do we perform the technology review?
Our technology review primarily focuses on the identification and
evaluation of developments in practices, processes, and control
technologies that have occurred since the MACT standards were
promulgated. Where we identify such developments, we analyze their
technical feasibility, estimated costs, energy implications, and non-
air environmental impacts. We also consider the emission reductions
associated with applying each development. This analysis informs our
decision of whether it is ``necessary'' to revise the emissions
standards. In addition, we consider the appropriateness of applying
controls to new sources versus retrofitting existing sources. For this
exercise, we consider 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; and
[[Page 1876]]
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).
In addition to reviewing the practices, processes, and control
technologies that were considered at the time we originally developed
the NESHAP, we review a variety of data sources in our investigation of
potential practices, processes, or controls to consider. We also review
the NESHAP and the available data to determine if there are any
unregulated emissions of HAP within the source category and evaluate
this data for use in developing new emission standards. See sections
II.C and II.D of this preamble for information on the specific data
sources that were reviewed as part of the technology review.
C. How do we estimate post-MACT risk posed by the source category?
In this section, we provide a complete description of the types of
analyses that we generally perform during the risk assessment process.
In some cases, we do not perform a specific analysis because it is not
relevant. For example, in the absence of emissions of HAP known to be
persistent and bioaccumulative in the environment (PB-HAP), we would
not perform a multipathway exposure assessment. Where we do not perform
an analysis, we state that we do not and provide the reason. While we
present all of our risk assessment methods, we only present risk
assessment results for the analyses actually conducted (see section
IV.B of this preamble).
The EPA conducts a risk assessment that provides estimates of the
MIR for cancer posed by the HAP emissions from each source in the
source category, the HI for chronic exposures to HAP with the potential
to cause noncancer health effects, and the HQ for acute exposures to
HAP with the potential to cause noncancer health effects. The
assessment also provides estimates of the distribution of cancer risk
within the exposed populations, cancer incidence, and an evaluation of
the potential for an adverse environmental effect. The seven sections
that follow this paragraph describe how we estimated emissions and
conducted the risk assessment. The docket for this proposed rule
contains the following document that provides more information on the
risk assessment inputs and models: Residual Risk Assessment for the
Flexible Polyurethane Foam Fabrication Operations Source Category in
Support of the 2020 Risk and Technology Review Proposed Rule. The
methods used to assess risk (as described in the seven primary steps
below) are consistent with those described by the EPA in the document
reviewed by a panel of the EPA's SAB in 2009; \6\ and described in the
SAB review report issued in 2010. They are also consistent with the key
recommendations contained in that report.
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\6\ U.S. EPA. 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, June 2009. EPA-452/R-09-006. Available at: https://www3.epa.gov/airtoxics/rrisk/rtrpg.html.
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1. How did we estimate actual emissions and identify the emissions
release characteristics?
The actual emissions and the emission release characteristics for
each facility were obtained primarily from either the 2014 NEI or the
2017 NEI; most data were obtained from the 2017 NEI, unless a facility
was not included in that base year file, in which case the 2014 NEI
data were used. In one instance, a facility was contacted to confirm
emissions that appeared to be outliers because they were inconsistent
with our understanding of the industry. That facility provided a test
report containing data that were more consistent with our understanding
of emissions from the industry and were ultimately used as actual
emissions for the risk modeling file. Additional information on the
development of the modeling file for the Flexible Polyurethane Foam
Fabrication Operations source category, including the development of
the actual emissions and emissions release characteristics, can be
found in the memorandum, Emissions Data for the National Emission
Standards for Hazardous Air Pollutants for Flexible Polyurethane Foam
Fabrication Operations, which is available in the respective docket for
this action.
2. How did we estimate MACT-allowable emissions?
The available emissions data in the RTR emissions dataset include
estimates of the mass of HAP emitted during a specified annual time
period. These ``actual'' emission levels are often lower than the
emission levels allowed under the requirements of the current MACT
standards. The emissions allowed under the MACT standards are referred
to as the ``MACT-allowable'' emissions. We discussed the consideration
of both MACT-allowable and actual emissions in the final Coke Oven
Batteries RTR (70 FR 19992, 19998 and 19999, April 15, 2005) and in the
proposed and final Hazardous Organic NESHAP RTR (71 FR 34421, 34428,
June 14, 2006, and 71 FR 76603, 76609, December 21, 2006,
respectively). In those actions, we noted that assessing the risk at
the MACT-allowable level is inherently reasonable since that risk
reflects 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 approach
(54 FR 38044).
For the Flexible Polyurethane Foam Fabrication Operations source
category, allowable emissions were assumed to be equal to actual
emissions. For the subcategory of flame laminators, there currently are
no emissions limits for existing sources, and there have been no new
sources since the promulgation of the standards. Therefore, we conclude
that the emissions that are allowed under the existing standards are
equal to actual emissions. For the loop slitter subcategory, there were
no HAP emissions from the adhesive, and we are not aware of any HAP-
based substitutes that could be used in place of current industry
practice; therefore, we again conclude that allowable emissions would
be equal to actual emissions, which in this case are zero.
3. How do we conduct dispersion modeling, determine inhalation
exposures, and estimate individual and population inhalation risk?
Both long-term and short-term inhalation exposure concentrations
and health risk from the major source category addressed in this
proposal were estimated using the Human Exposure Model (HEM-3).\7\ 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,
and (3) estimating individual and population-level inhalation risk
using the exposure estimates and quantitative dose-response
information.
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\7\ For more information about HEM-3, go to https://www.epa.gov/fera/risk-assessment-and-modeling-human-exposure-model-hem.
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a. Dispersion Modeling
The air dispersion model AERMOD, used by the HEM-3 model, is one of
the EPA's preferred models for assessing air pollutant concentrations
from industrial
[[Page 1877]]
facilities.\8\ 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 (2016) of hourly surface and
upper air observations from 824 meteorological stations selected to
provide coverage of the United States and Puerto Rico. A second library
of United States Census Bureau census block \9\ 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-specific dose-response values is used to estimate health
risk. These are discussed below.
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\8\ 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).
\9\ A census block is the smallest geographic area for which
census statistics are tabulated.
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b. Risk From Chronic Exposure to HAP
In developing the risk assessment for chronic exposures, we use the
estimated annual average ambient air concentrations of each HAP emitted
by each source in the major source category. The HAP air concentrations
at each nearby census block centroid located within 50 km of the
facility are a surrogate for the chronic inhalation exposure
concentration for all the people who reside in that census block. A
distance of 50 km is consistent with both the analysis supporting the
1989 Benzene NESHAP (54 FR 38044, September 14, 1989) and the
limitations of Gaussian dispersion models, including AERMOD.
For each facility, we calculate the MIR as the cancer risk
associated with a continuous lifetime (24 hours per day, 7 days per
week, 52 weeks per year, 70 years) exposure to the maximum
concentration at the centroid of each inhabited census block. We
calculate individual cancer risk by multiplying the estimated lifetime
exposure to the ambient concentration of each HAP (in micrograms per
cubic meter) by its unit risk estimate (URE). The URE is an upper-bound
estimate of an individual's incremental risk 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 UREs from the EPA's Integrated Risk Information System
(IRIS). For carcinogenic pollutants without IRIS values, we look to
other reputable sources of cancer dose-response values, often using
California EPA (CalEPA) UREs, 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-
response values in place of, or in addition to, other values, if
appropriate. The pollutant-specific dose-response values used to
estimate health risk are available at https://www.epa.gov/fera/dose-response-assessment-assessing-health-risks-associated-exposure-hazardous-air-pollutants.
To estimate individual lifetime cancer risks associated with
exposure to HAP emissions from each facility in the source category, we
sum the risks for each of the carcinogenic HAP \10\ emitted by the
modeled facility. We estimate cancer risk at every census block within
50 km of every facility in the source category. The MIR is the highest
individual lifetime cancer risk estimated for any of those census
blocks. In addition to calculating the MIR, we estimate the
distribution of individual cancer risks for the source category by
summing the number of individuals within 50 km of the sources whose
estimated risk falls within a specified risk range. We also estimate
annual cancer incidence by multiplying the estimated lifetime cancer
risk at each census block by the number of people residing in that
block, summing results for all of the census blocks, and then dividing
this result by a 70-year lifetime.
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\10\ The EPA's 2005 Guidelines for Carcinogen Risk Assessment
classifies carcinogens as: ``carcinogenic to humans,'' ``likely to
be carcinogenic to humans,'' and ``suggestive evidence of
carcinogenic potential.'' These classifications also coincide with
the terms ``known carcinogen, probable carcinogen, and possible
carcinogen,'' respectively, which are the terms advocated in the
EPA's Guidelines for Carcinogen Risk Assessment, published in 1986
(51 FR 33992, September 24, 1986). In August 2000, the document,
Supplemental Guidance for Conducting Health Risk Assessment of
Chemical Mixtures (EPA/630/R-00/002), was published as a supplement
to the 1986 document. Copies of both documents can be obtained from
https://cfpub.epa.gov/ncea/risk/recordisplay.cfm?deid=20533&CFID=70315376&CFTOKEN=71597944. Summing
the risk of these individual compounds to obtain the cumulative
cancer risk is an approach that was recommended by the EPA's SAB in
their 2002 peer review of the 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 noncancer health effects from chronic
exposure to HAP, we calculate either an HQ or a target organ-specific
hazard index (TOSHI). We calculate an HQ when a single noncancer HAP is
emitted. Where more than one noncancer HAP is emitted, we sum the HQ
for each of the HAP that affects a common target organ or target organ
system to obtain a TOSHI. The HQ is the estimated exposure divided by
the chronic noncancer dose-response value, which is a value selected
from one of several sources. The preferred chronic noncancer dose-
response value is the EPA RfC, 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'' (https://iaspub.epa.gov/sor_internet/registry/termreg/searchandretrieve/glossariesandkeywordlists/search.do?details=&vocabName=IRIS%20Glossary). In cases where an RfC
from the EPA's IRIS is not available or where the EPA determines that
using a value other than the RfC is appropriate, the chronic noncancer
dose-response value can be a value from the following prioritized
sources, which define their dose-response values similarly to the EPA:
(1) The Agency for Toxic Substances and Disease Registry (ATSDR)
Minimum Risk Level (https://www.atsdr.cdc.gov/mrls/index.asp); (2) the
CalEPA Chronic Reference Exposure Level (REL) (https://oehha.ca.gov/air/crnr/notice-adoption-air-toxics-hot-spots-program-guidance-manual-preparation-health-risk-0); 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. The pollutant-specific dose-
response values used to estimate health risks are available at https://www.epa.gov/fera/dose-response-assessment-assessing-health-risks-associated-exposure-hazardous-air-pollutants.
c. Risk From Acute Exposure to HAP That May Cause Health Effects Other
Than Cancer
For each HAP for which appropriate acute inhalation dose-response
values are available, the EPA also assesses the potential health risks
due to acute exposure. For these assessments, the EPA makes
conservative assumptions about emission rates, meteorology, and
exposure location. As part of our efforts to continually improve our
[[Page 1878]]
methodologies to evaluate the risks that HAP emitted from categories of
industrial sources pose to human health and the environment,\11\ we
revised our treatment of meteorological data to use reasonable worst-
case air dispersion conditions in our acute risk screening assessments
instead of worst-case air dispersion conditions. This revised treatment
of meteorological data and the supporting rationale are described in
more detail in Residual Risk Assessment for Flexible Polyurethane Foam
Fabrication Operations Source Category in Support of the 2020 Risk and
Technology Review Proposed Rule and in Appendix 5 of the report:
Technical Support Document for Acute Risk Screening Assessment. This
revised approach has been used in this proposed rule and in all other
RTR rulemakings proposed on or after June 3, 2019.
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\11\ See, e.g., U.S. EPA, Screening Methodologies to Support
Risk and Technology Reviews (RTR): A Case Study Analysis (Draft
Report, May 2017). https://www3.epa.gov/ttn/atw/rrisk/rtrpg.html.
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To assess the potential acute risk to the maximally exposed
individual, we use the peak hourly emission rate for each emission
point,\12\ reasonable worst-case air dispersion conditions (i.e., 99th
percentile), and the point of highest off-site exposure. Specifically,
we assume that peak emissions from the source category and reasonable
worst-case air dispersion conditions co-occur and that a person is
present at the point of maximum exposure.
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\12\ In the absence of hourly emission data, we develop
estimates of maximum hourly emission rates by multiplying the
average actual annual emissions rates by a factor (either a
category-specific factor or a default factor of 10) to account for
variability. This is documented in Residual Risk Assessment for
Flexible Polyurethane Foam Fabrication Operations Source Category in
Support of the 2020 Risk and Technology Review Proposed Rule and in
Appendix 5 of the report: Technical Support Document for Acute Risk
Screening Assessment. Both are available in the docket for this
rulemaking.
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To characterize the potential health risks associated with
estimated acute inhalation exposures to a HAP, we generally use
multiple acute dose-response values, including acute RELs, acute
exposure guideline levels (AEGLs), and emergency response planning
guidelines (ERPG) for 1-hour exposure durations, if available, to
calculate acute HQs. The acute HQ is calculated by dividing the
estimated acute exposure concentration by the acute dose-response
value. For each HAP for which acute dose-response values are available,
the EPA calculates acute HQs.
An acute REL is defined as ``the concentration level at or below
which no adverse health effects are anticipated for a specified
exposure duration.'' \13\ Acute RELs are based on the most sensitive,
relevant, adverse health effect reported in the peer-reviewed medical
and toxicological literature. They are designed to protect the most
sensitive individuals in the population through 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. AEGLs represent
threshold exposure limits for the general public and are applicable to
emergency exposures ranging from 10 minutes to 8 hours.\14\ They are
guideline levels for ``once-in-a-lifetime, short-term exposures to
airborne concentrations of acutely toxic, high-priority chemicals.''
Id. at 21. The AEGL-1 is 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.'' The document also notes that ``Airborne concentrations
below AEGL-1 represent exposure levels that can produce mild and
progressively increasing but transient and nondisabling odor, taste,
and sensory irritation or certain asymptomatic, nonsensory effects.''
Id. AEGL-2 are defined 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.
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\13\ CalEPA issues acute RELs as part of its Air Toxics Hot
Spots Program, and the 1-hour and 8-hour values are documented in
Air Toxics Hot Spots Program Risk Assessment Guidelines, Part I, The
Determination of Acute Reference Exposure Levels for Airborne
Toxicants, which is available at https://oehha.ca.gov/air/general-info/oehha-acute-8-hour-and-chronic-reference-exposure-level-rel-summary.
\14\ National Academy of Sciences, 2001. Standing Operating
Procedures for Developing Acute Exposure Levels for Hazardous
Chemicals, page 2. Available at https://www.epa.gov/sites/production/files/2015-09/documents/sop_final_standing_operating_procedures_2001.pdf. Note that the
National Advisory Committee for Acute Exposure Guideline Levels for
Hazardous Substances ended in October 2011, but the AEGL program
continues to operate at the EPA and works with the National
Academies to publish final AEGLs (https://www.epa.gov/aegl).
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ERPGs are ``developed for emergency planning and are intended as
health-based guideline concentrations for single exposures to
chemicals.'' \15\ Id. at 1. The ERPG-1 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 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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\15\ ERPGS Procedures and Responsibilities. March 2014. American
Industrial Hygiene Association. Available at: https://www.aiha.org/get-involved/AIHAGuidelineFoundation/EmergencyResponsePlanningGuidelines/Documents/ERPG%20Committee%20Standard%20Operating%20Procedures%20%20-%20March%202014%20Revision%20%28Updated%2010-2-2014%29.pdf.
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An acute REL for 1-hour exposure durations is typically lower than
its corresponding AEGL-1 and ERPG-1. Even though their definitions are
slightly different, AEGL-1s are often the same as the corresponding
ERPG-1s, and AEGL-2s are often equal to ERPG-2s. The maximum HQs from
our acute inhalation screening risk assessment typically result when we
use the acute REL for a HAP. In cases where the maximum acute HQ
exceeds 1, we also report the HQ based on the next highest acute dose-
response value (usually the AEGL-1 and/or the ERPG-1).
For this source category, we used a default multiplier of 10 to
provide a conservatively high estimate of acute effects.
In our acute inhalation screening risk assessment, acute impacts
are deemed negligible for HAP for which acute HQs are less than or
equal to 1, and no further analysis is performed for these HAP. In
cases where an acute HQ from the screening step is greater than 1, we
assess the site-specific data to ensure that the acute HQ is at an off-
site location.
4. How do we conduct the multipathway exposure and risk screening
assessment?
The EPA conducts a tiered screening assessment examining the
potential for significant human health risks due to exposures via
routes other than inhalation (i.e., ingestion). We first determine
whether any sources in the source category emit any HAP known to be
persistent and bioaccumulative in the environment, as identified in the
EPA's
[[Page 1879]]
Air Toxics Risk Assessment Library (see Volume 1, Appendix D, at
https://www.epa.gov/fera/risk-assessment-and-modeling-air-toxics-risk-assessment-reference-library). For the Flexible Polyurethane Foam
Fabrication Operations source category, we did not identify emissions
of any PB-HAP. Because we did not identify PB-HAP emissions, no further
evaluation of multipathway risk was conducted for this source category.
For further information on the multipathway assessment approach,
see the Residual Risk Assessment for the Flexible Polyurethane Foam
Fabrication Operations Source Category in Support of the 2020 Risk and
Technology Review Proposed Rule, which is available in the docket for
this action.
5. How do we conduct the environmental risk screening assessment?
a. Adverse Environmental Effect, Environmental HAP, and Ecological
Benchmarks
The EPA conducts a screening assessment to examine the potential
for an adverse environmental effect 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.''
The EPA focuses on eight HAP, which are referred to as
``environmental HAP,'' in its screening assessment: Six PB-HAP and two
acid gases. The PB-HAP included in the screening assessment are arsenic
compounds, cadmium compounds, dioxins/furans, polycyclic organic matter
(POM), mercury (both inorganic mercury and methyl mercury), and lead
compounds. The acid gases included in the screening assessment are
hydrochloric acid (HCl) and hydrogen fluoride (HF).
HAP that persist and bioaccumulate are of particular environmental
concern because they accumulate in the soil, sediment, and water. The
acid gases, HCl and HF, are included due to their well-documented
potential to cause direct damage to terrestrial plants. In the
environmental risk screening assessment, we evaluate the following four
exposure media: Terrestrial soils, surface water bodies (includes
water-column and benthic sediments), fish consumed by wildlife, and
air. Within these four exposure media, we evaluate nine ecological
assessment endpoints, which are defined by the ecological entity and
its attributes. For PB-HAP (other than lead), both community-level and
population-level endpoints are included. For acid gases, the ecological
assessment evaluated is terrestrial plant communities.
An ecological benchmark represents a concentration of HAP that has
been linked to a particular environmental effect level. For each
environmental HAP, we identified the available ecological benchmarks
for each assessment endpoint. We identified, where possible, ecological
benchmarks at the following effect levels: probable effect levels,
lowest-observed-adverse-effect level, and no-observed-adverse-effect
level. In cases where multiple effect levels were available for a
particular PB-HAP and assessment endpoint, we use all of the available
effect levels to help us to determine whether ecological risks exist
and, if so, whether the risks could be considered significant and
widespread.
For further information on how the environmental risk screening
assessment was conducted, including a discussion of the risk metrics
used, how the environmental HAP were identified, and how the ecological
benchmarks were selected, see Appendix 9 of the Residual Risk
Assessment for the Flexible Polyurethane Foam Fabrication Operations
Source Category in Support of the 2020 Risk and Technology Review
Proposed Rule, which is available in the docket for this action.
b. Environmental Risk Screening Methodology
For the environmental risk screening assessment, the EPA first
determined whether any facilities in the Flexible Polyurethane Foam
Fabrication Operations source category emitted any of the environmental
HAP. For the Flexible Polyurethane Foam Fabrication Operations source
category, we identified emissions of HCl. Because one or more of the
environmental HAP evaluated emitted HCl by at least one facility in the
source category, we proceeded to the second step of the evaluation.
c. PB-HAP Methodology
The environmental screening assessment includes six PB-HAP, arsenic
compounds, cadmium compounds, dioxins/furans, POM, mercury (both
inorganic mercury and methyl mercury), and lead compounds. For the
Flexible Polyurethane Foam Fabrication Operations source category, we
did not identify emissions of any PB-HAP. Because we did not identify
PB-HAP emissions, no further evaluation of PB-HAP for the environmental
risk assessment was conducted for this source category.
For further information on the PB-HAP environmental assessment
approach, see the Residual Risk Assessment for the Flexible
Polyurethane Foam Fabrication Operations Source Category in Support of
the 2020 Risk and Technology Review Proposed Rule, available in the
docket for this proposed rule (Docket ID No. EPA-HQ-OAR-2020-0572).
d. Acid Gas Environmental Risk Methodology
The environmental screening assessment for acid gases evaluates the
potential phytotoxicity and reduced productivity of plants due to
chronic exposure to HF and HCl. The environmental risk screening
methodology for acid gases is a single-tier screening assessment that
compares modeled ambient air concentrations (from AERMOD) to the
ecological benchmarks for each acid gas. To identify a potential
adverse environmental effect (as defined in section 112(a)(7) of the
CAA) from emissions of HF and HCl, we evaluate the following metrics:
The size of the modeled area around each facility that exceeds the
ecological benchmark for each acid gas, in acres and square kilometers;
the percentage of the modeled area around each facility that exceeds
the ecological benchmark for each acid gas; and the area-weighted
average screening value around each facility (calculated by dividing
the area-weighted average concentration over the 50-km modeling domain
by the ecological benchmark for each acid gas). For further information
on the environmental screening assessment approach, see Appendix 9 of
the Residual Risk Assessment for the Flexible Polyurethane Foam
Fabrication Operations Source Category in Support of the 2020 Risk and
Technology Review Proposed Rule, which is available in the docket for
this action.
6. How do 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 emission sources at the facility for which we have data.
For
[[Page 1880]]
this source category, we conducted the facility-wide assessment using a
dataset compiled from the 2014 and 2017 NEI. The source category
records of that NEI dataset were removed, evaluated, and updated as
described in section II.C of this preamble: What data collection
activities were conducted to support this action? Once a quality
assured source category dataset was available, it was placed back with
the remaining records from the NEI for that facility. The facility-wide
file was then used to analyze 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 source category risks were compared to the
facility-wide risks to determine the portion of the facility-wide risks
that could be attributed to the source category addressed in this
proposal. We also specifically examined the facility that was
associated with the highest estimate of risk and determined the
percentage of that risk attributable to the source category of
interest. The Residual Risk Assessment for the Flexible Polyurethane
Foam Fabrication Operations Source Category in Support of the 2020 Risk
and Technology Review Proposed Rule, available through the docket for
this action, provides the methodology and results of the facility-wide
analyses, including all facility-wide risks and the percentage of
source category contribution to facility-wide risks.
7. How do we consider uncertainties in risk assessment?
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 approach, which used
conservative tools and assumptions, ensures that our decisions are
health and environmentally protective. A brief discussion of the
uncertainties in the RTR emissions dataset, dispersion modeling,
inhalation exposure estimates, and dose-response relationships follows
below. Also included are those uncertainties specific to our acute
screening assessments, multipathway screening assessments, and our
environmental risk screening assessments. A more thorough discussion of
these uncertainties is included in the Residual Risk Assessment for the
Flexible Polyurethane Foam Fabrication Operations Source Category in
Support of the 2020 Risk and Technology Review Proposed Rule, which is
available in the docket for this action. If a multipathway site-
specific assessment was performed for this source category, a full
discussion of the uncertainties associated with that assessment can be
found in Appendix 11 of that document, Site-Specific Human Health
Multipathway Residual Risk Assessment Report.
a. Uncertainties in the RTR Emissions Dataset
Although the development of the RTR emissions 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 emission
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 emission
rates for the acute effects screening assessment were based on an
emission adjustment factor applied to the average annual hourly
emission 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 estimate
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 overestimate 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. We also note that the selection of meteorology dataset
location could have an impact on the risk estimates. As we continue to
update and expand our library of meteorological station data used in
our risk assessments, we expect to reduce this variability.
c. Uncertainties in Inhalation Exposure Assessment
Although every effort is made to identify all of the relevant
facilities and emission points, as well as to develop accurate
estimates of the annual emission rates for all relevant HAP, the
uncertainties in our emission inventory likely dominate the
uncertainties in the exposure assessment. Some uncertainties in our
exposure assessment include human mobility, using the centroid of each
census block, assuming lifetime exposure, and assuming only outdoor
exposures. For most of these factors, there is neither an under nor
overestimate when looking at the MIR or the incidence, but the shape of
the distribution of risks may be affected. With respect to outdoor
exposures, actual exposures may not be as high if people spend time
indoors, especially for very reactive pollutants or larger particles.
For all factors, we reduce uncertainty when possible. For example, with
respect to census-block centroids, we analyze large blocks using aerial
imagery and adjust locations of the block centroids to better represent
the population in the blocks. We also add additional receptor locations
where the population of a block is not well represented by a single
location.
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 noncancer effects from both chronic and acute
exposures. Some uncertainties are generally expressed quantitatively,
and others are generally expressed in qualitative terms. We note, as a
preface to this discussion, a point on dose-response uncertainty that
is stated in the EPA's 2005 Guidelines for Carcinogen Risk Assessment;
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'' (the EPA's 2005
Guidelines for Carcinogen Risk Assessment, page 1-7). This is the
approach followed here as summarized in the next paragraphs.
Cancer UREs used in our risk assessments are those that have been
developed to generally provide an upper
[[Page 1881]]
bound estimate of risk.\16\ 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). In some circumstances, the true
risk could be as low as zero; however, in other circumstances the risk
could be greater.\17\ Chronic noncancer RfC and reference dose (RfD)
values represent chronic exposure levels that are intended to be
health-protective levels. To derive dose-response values that are
intended to be ``without appreciable risk,'' the methodology relies
upon an uncertainty factor (UF) approach,\18\ which considers
uncertainty, variability, and gaps in the available data. The UFs are
applied to derive dose-response values that are intended to protect
against appreciable risk of deleterious effects.
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\16\ IRIS glossary (https://ofmpub.epa.gov/sor_internet/registry/termreg/searchandretrieve/glossariesandkeywordlists/search.do?details=&glossaryName=IRIS%20Glossary).
\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.
\18\ See A Review of the Reference Dose and Reference
Concentration Processes, U.S. EPA, December 2002, and Methods for
Derivation of Inhalation Reference Concentrations and Application of
Inhalation Dosimetry, U.S. EPA, 1994.
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Many of the UFs used to account for variability and uncertainty in
the development of acute dose-response values are quite similar to
those developed for chronic durations. 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 dose-
response value at another exposure duration (e.g., 1 hour). Not all
acute dose-response 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 dose-response value or values
being exceeded. Where relevant to the estimated exposures, the lack of
acute dose-response values at different levels of severity should be
factored into the risk characterization as potential uncertainties.
Uncertainty also exists in the selection of ecological benchmarks
for the environmental risk screening assessment. We established a
hierarchy of preferred benchmark sources to allow selection of
benchmarks for each environmental HAP at each ecological assessment
endpoint. We searched for benchmarks for three effect levels (i.e., no-
effects level, threshold-effect level, and probable effect level), but
not all combinations of ecological assessment/environmental HAP had
benchmarks for all three effect levels. Where multiple effect levels
were available for a particular HAP and assessment endpoint, we used
all of the available effect levels to help us determine whether risk
exists and whether the risk could be considered significant and
widespread.
For a group of compounds that are unspeciated (e.g., glycol
ethers), we conservatively use the most protective dose-response 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 dose-response value, we also
apply the most protective dose-response value from the other compounds
in the group to estimate risk.
e. Uncertainties in Acute Inhalation Screening Assessments
In addition to the uncertainties highlighted above, there are
several factors specific to the acute exposure assessment that the EPA
conducts as part of the risk review under section 112 of the CAA. 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 the presence of a
person. In the acute screening assessment that we conduct under the RTR
program, we assume that peak emissions from the source category and
reasonable worst-case air dispersion conditions (i.e., 99th percentile)
co-occur. We then include the additional assumption that a person is
located at this point at the same time. Together, these assumptions
represent a reasonable worst-case actual exposure scenario. In most
cases, it is unlikely that a person would be located at the point of
maximum exposure during the time when peak emissions and reasonable
worst-case air dispersion conditions occur simultaneously.
f. Uncertainties in the Multipathway and Environmental Risk Screening
Assessments
For each source category, we generally rely on site-specific levels
of PB-HAP or environmental HAP emissions to determine whether a refined
assessment of the impacts from multipathway exposures is necessary or
whether it is necessary to perform an environmental screening
assessment. This determination is based on the results of a three-
tiered screening assessment that relies on the outputs from models--
Total Risk Integrated Methodology.Fate, Transport, and Ecological
Exposure model (TRIM.FaTE) and AERMOD--that estimate environmental
pollutant concentrations and human exposures for five PB-HAP (dioxins,
POM, mercury, cadmium, and arsenic) and two acid gases (HF and HCl).
For lead, we use AERMOD to determine ambient air concentrations, which
are then compared to the secondary National Ambient Air Quality
Standards for lead. 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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Model uncertainty concerns whether the model adequately represents
the actual processes (e.g., movement and accumulation) that might occur
in the environment. For example, does the model adequately describe the
movement of a pollutant through the soil? This type of uncertainty is
difficult to quantify. However, based on feedback received from
previous EPA SAB reviews and other reviews, we are confident that the
models used in the screening assessments are appropriate and state-of-
the-art for the multipathway and environmental screening risk
assessments conducted in support of RTRs.
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 and environmental screening assessments, we
configured the models to avoid underestimating exposure and risk. This
was accomplished by selecting upper-end values from nationally
representative datasets 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, 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 and environmental screening
assessments, we refine the model inputs to account for meteorological
patterns in the vicinity of the facility versus using
[[Page 1882]]
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 screening assessment. In Tier 3 of the
screening assessments, we refine the model inputs again to account for
hour-by-hour plume-rise and the height of the mixing layer. We can also
use those hour-by-hour meteorological data in a TRIM.FaTE run using the
screening configuration corresponding to the lake location. These
refinements produce a more accurate estimate of chemical concentrations
in the media of interest, thereby reducing the uncertainty with those
estimates. The assumptions and the associated uncertainties regarding
the selected ingestion exposure scenario are the same for all three
tiers.
For the environmental screening assessment for acid gases, we
employ a single-tiered approach. We use the modeled air concentrations
and compare those with ecological benchmarks.
For all tiers of the multipathway and environmental screening
assessments, 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 not exceed screening threshold emission rates (i.e., 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 exceed screening threshold emission rates, it does not
mean that impacts are significant, only that we cannot rule out that
possibility and that a refined assessment for the site might be
necessary to obtain a more accurate risk characterization for the
source category.
The EPA evaluates the following HAP in the multipathway and/or
environmental risk screening assessments, where applicable: Arsenic,
cadmium, dioxins/furans, lead, mercury (both inorganic and methyl
mercury), POM, HCl, and HF. These HAP represent pollutants that can
cause adverse impacts either through direct exposure to HAP in the air
or through exposure to HAP that are deposited from the air onto soils
and surface waters and then through the environment into the food web.
These HAP represent those HAP for which we can conduct a meaningful
multipathway or environmental screening risk assessment. For other HAP
not included in our screening assessments, the model has not been
parameterized such that it can be used for that purpose. In some cases,
depending on the HAP, we may not have appropriate multipathway models
that allow us to predict the concentration of that pollutant. The EPA
acknowledges that other HAP beyond these that we are evaluating may
have the potential to cause adverse effects and, therefore, the EPA may
evaluate other relevant HAP in the future, as modeling science and
resources allow.
IV. Analytical Results and Proposed Decisions
A. What actions are we taking pursuant to CAA sections 112(d)(2) and
112(d)(3) for the Flexible Polyurethane Foam Fabrication Operations
source category?
We are proposing pursuant to CAA section 112(d)(2) and (3) to
establish a numeric limit for HCl emissions from existing flame
laminators. The results and proposed decisions based on the analyses
performed pursuant to CAA section 112(d)(2) and (3) are presented
below.
For the Flexible Polyurethane Foam Fabrication Operations source
category, there are four unregulated existing source flame laminators
at two facilities. For major sources, the EPA is required to set
technology-based standards that reflect the maximum reductions of HAP
achievable (after considering cost, energy requirements, and non-air
health and environmental impacts) and are commonly referred to as MACT
standards. Furthermore, CAA section 112(d)(3)(B) provides that MACT
shall not be less stringent than ``the average emission limitation
achieved by the best performing five sources (for which the
Administrator has or could reasonably obtain emissions information) in
the category for categories with fewer than 30 sources. In this
category, the MACT floor for existing sources is the average (or mean)
of the four known flame lamination sources. However, emissions data for
HCl emissions from only one of these units is available. As this is the
only unit of which we are aware that has had emissions testing
conducted for HCl, the proposed MACT floor is based on the HCl data for
this unit. In order to determine the level of the MACT floor, the Upper
Prediction Limit method was used in order to account for variability in
flame laminator emissions performance, and the MACT floor was
calculated at 1.45 pounds per hour of HCl.\20\
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\20\ MACT Floor and Beyond-the-Floor Analysis for Existing Flame
Laminators in the Flexible Polyurethane Foam Fabrication Source
Category (EPA-HQ-OAR-2020-0572).
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When establishing an emission standard pursuant to section 112 of
the CAA, the EPA must also determine whether to control emissions
``beyond the floor'' after considering the costs, non-air quality
health and environmental impacts, and energy requirements of such more
stringent control. For the existing source flame laminators, the EPA
evaluated whether a beyond-the-floor emissions limit would be
appropriate; specifically, we evaluated whether the incremental
emissions reduction achievable with a venturi scrubber would be cost
effective. The venturi scrubber was the only control technology in use
at flame lamination sources that was identified by the EPA with the
initial promulgation of the NESHAP, and no other developments in
control technologies were identified in the review of these standards.
The EPA's previous cost estimates of this technology conducted for the
proposal of the NESHAP in 2001 showed that the average cost per ton of
HCl emissions reduced was approximately $18,000. As nothing has
substantially changed with this technology or in how it would be
implemented, the EPA assumes that the cost effectiveness today would be
similar to that previously estimated, once the costs of inflation are
considered. Inflated to 2020 dollars, the average incremental cost per
ton of HCl emissions reduced is estimated to be approximately $26,000.
We do not find this to be cost effective for the control of HCl and,
therefore, propose that floor-level MACT controls are appropriate for
existing flame laminators.
B. What are the results of the risk assessment and analyses for the
Flexible Polyurethane Foam Fabrication Operations source category?
As described in section III.C of this preamble, for the Flexible
Polyurethane Foam Fabrication Operations major source category, we
conducted a risk assessment for all HAP emitted. We present results of
the risk assessment briefly below and in more detail in the Flexible
Polyurethane Foam Fabrication Risk Assessment Report, in the docket for
this action (Docket ID No. EPA-HQ-OAR-2020-0572).
[[Page 1883]]
1. Chronic Inhalation Risk Assessment Results
Table 1 below provides a summary of the results of the inhalation
risk assessment for the source category. As discussed in section III.C
of this preamble, we set MACT-allowable HAP emission levels equal to
actual emissions. For more detail about the MACT-allowable emission
levels, see Appendix 1 to the Flexible Polyurethane Foam Fabrication
Risk Assessment Report, in the docket for this action.
Table 1--Flexible Polyurethane Foam Fabrication Source Category Inhalation Risk Assessment Results
--------------------------------------------------------------------------------------------------------------------------------------------------------
Maximum individual Estimated population at Estimated annual cancer Maximum chronic Maximum screening
cancer risk (in 1 increased risk of cancer incidence (cases per noncancer TOSHI \21\ acute noncancer
million) >= 1-in-1 million year) -------------------------- HQ\22\
Risk assessment ------------------------------------------------------------------------------ ------------------
Based on Based on Based on Based on Based on Based on Based on Based on
actual allowable actual allowable actual allowable actual allowable Based on actual
emissions Emissions emissions emissions emissions emissions emissions emissions emissions
--------------------------------------------------------------------------------------------------------------------------------------------------------
Source category.............. 0 0 0 0 0 0 0.002 0.002 HQREL = <1
Whole Facility............... 0.1 ........... 0 ........... 0.00001 ........... 0.2 ........... .................
--------------------------------------------------------------------------------------------------------------------------------------------------------
The results of the inhalation risk modeling using actual emissions
data, as shown in Table 1 of this preamble, indicate that no
carcinogens are emitted by this category. Therefore, the cancer MIR
based on actual emissions (lifetime) is zero and the total estimated
annual cancer incidence (national) from these facilities based on
actual emission levels is zero excess cancer cases per year. The
maximum chronic noncancer TOSHI value based on actual emissions is
0.002 driven by HCl.
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\21\ The TOSHI is the sum of the chronic noncancer HQ for
substances that affect the same target organ or organ system.
\22\ The maximum estimated acute exposure concentration was
divided by available short-term threshold values to develop HQ
values.
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2. Screening Level Acute Risk Assessment Results
Table 1 of this preamble shows the acute risk results for the
Flexible Polyurethane Foam Fabrication source category. The screening
analysis for acute impacts was based on an emissions multiplier of 10
for all emissions sources, to estimate the peak emission rates from the
average rates. The maximum screening acute noncancer HQ value (off-
facility site) is 0.003 driven by HCl. For more detailed acute risk
screening results, refer to the Flexible Polyurethane Foam Fabrication
Risk Assessment Report, in the docket for this action.
3. Multipathway Risk Screening Results
No PB-HAP are emitted from the Flexible Polyurethane Foam
Fabrication source category, therefore, a multipathway assessment was
not conducted.
4. Environmental Risk Screening Results
As described in section III.A of this document, we conducted an
environmental risk screening assessment for the Flexible Polyurethane
Foam Fabrication source category for HCl.
For HCl, the average modeled concentration around each facility
(i.e., the average concentration of all off-site data points in the
modeling domain) did not exceed any ecological benchmark. In addition,
each individual modeled concentration of HCl and HF (i.e., each off-
site data point in the modeling domain) was below the ecological
benchmarks for all facilities. Based on the results of the
environmental risk screening analysis, we do not expect an adverse
environmental effect as a result of HAP emissions from this source
category.
5. Facility-Wide Risk Results
As shown in Table 1, the maximum facility-wide cancer MIR is 0.1-
in-1 million, driven by 2,4/2,6-toluene diisocyanate mixture (TDI)
emissions from a vertical non-category point source and a non-category
fugitive point source. The total estimated cancer incidence from the
whole facility is 0.00001 excess cancer cases per year, or one excess
case in every 100,000 years. No people were estimated to have cancer
risks above 1-in-1 million from exposure to HAP emitted from both MACT
and non-MACT sources at the three facilities in this source category.
The maximum facility-wide TOSHI for the source category is estimated to
be 0.2, mainly driven by 2,4/2,6-TDI emissions from a vertical non-
category point source and a non-category fugitive point source.
6. What demographic groups might benefit from this regulation?
To examine the potential for any environmental justice issues that
might be associated with the Flexible Polyurethane Foam Fabrication
Operations major source category, we performed a demographic analysis,
which is an assessment of risks to individual demographic groups of the
populations living within 5 km and within 50 km of the facilities. In
the analysis, we evaluated the distribution of HAP-related cancer and
noncancer risks from the Flexible Polyurethane Foam Fabrication
Operations major source category across different demographic groups
within the populations living near facilities.\23\
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\23\ Demographic groups included in the analysis are: White,
African American, Native American, other races and multiracial,
Hispanic or Latino, children 17 years of age and under, adults 18 to
64 years of age, adults 65 years of age and over, adults without a
high school diploma, people living below the poverty level, people
living two times the poverty level, and linguistically isolated
people.
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Results of the demographic analysis for the source category
indicate that the minority population is slightly higher within 5 km of
the three facilities than the national percentage (40 percent versus 38
percent). This difference is accounted for by the larger African
American population around the facilities (17 percent versus 12 percent
nationally). In addition, the percentage of the population living
within 5 km of facilities in the source category is greater than the
corresponding national percentage for the demographic groups, ``Ages 0
to 17'' and ``Below the Poverty Level.'' When examining the risk levels
of those exposed to emissions from Flexible Polyurethane Foam
Fabrication facilities, we find that no one is exposed to a cancer risk
at or above 1-in-1 million or to a chronic noncancer TOSHI greater than
1. The methodology and the results of the demographic analysis are
presented in a technical report, Risk and Technology Review--Analysis
of Demographic Factors for Populations Living Near Flexible
Polyurethane Foam Fabrication Operations Source Category, September
2020 (hereafter referred to as the Flexible Polyurethane Foam
Fabrication Demographic Analysis Report), available in the docket for
this action.
[[Page 1884]]
C. What are our proposed decisions regarding risk acceptability, ample
margin of safety, and adverse environmental effect?
1. Risk Acceptability
As noted in section III.A 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 noncancer risk
ranges, cancer incidence, the maximum noncancer TOSHI, the maximum
acute noncancer HQ, the extent of noncancer risks, the distribution of
cancer and noncancer risks in the exposed population, and risk
estimation uncertainties (54 FR 38044, September 14, 1989).
For the Flexible Polyurethane Foam Fabrication Operations major
source category, the risk analysis indicates that there is no cancer
risk due to actual emissions or allowable emissions. Since there is no
cancer risk, the risks are considerably less than 100-in-1 million,
which is the presumptive upper limit of acceptable risk. The risk
analysis also shows we did not identify a potential for adverse chronic
noncancer health effects. The acute noncancer risks based on actual
emissions are low at an HQ of less than 1 (based on the REL) for HCl.
Therefore, we find there is little potential concern of acute noncancer
health impacts from actual emissions. In addition, the risk assessment
indicates no significant potential for multipathway health effects.
Considering all of the health risk information and factors
discussed above, including the uncertainties discussed in section
III.C.7 of this preamble, we propose to find that the risks from the
Flexible Polyurethane Foam Fabrication source category are acceptable.
2. Ample Margin of Safety Analysis
We are proposing that the risks from the Flexible Polyurethane Foam
Fabrication Operations major source category are acceptable. No
carcinogens are emitted by the Flexible Polyurethane Foam Fabrication
source category. Therefore, there are no individuals in the exposed
population with lifetime cancer risks above 1-in-1 million as a result
of actual or allowable emissions from this category. In addition, the
maximum chronic noncancer TOSHI value based on actual and allowable
emissions is well below 1 (0.002 and 0.2, respectively) and the maximum
screening acute noncancer HQ value (off-facility site) is also well
below 1 (0.003). Therefore, we are proposing that additional emissions
controls for flexible polyurethane foam fabrication facilities are not
necessary to provide an ample margin of safety to protect public
health.
3. Environmental Effect
The emissions data for the Flexible Polyurethane Foam Fabrication
Operations major source category indicate that one environmental HAP is
emitted by sources within this source category: HCl. The screening-
level evaluation of the potential for adverse environmental effects
associated with emissions of HCl from the Flexible Polyurethane Foam
Fabrication source category indicated that each individual
concentration (i.e., each off-site data point in the modeling domain)
was below the ecological benchmarks for all facilities. In addition, we
are unaware of any adverse environmental effects caused by 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.
D. What are the results and proposed decisions based on our technology
review for the Flexible Polyurethane Foam Fabrication Operations major
source category and for the Flexible Polyurethane Foam Production and
Fabrication area source categories?
As described in section III.B of this preamble, our technology
review focused on the identification and evaluation of potential
developments in practices, processes, and control technologies that
have occurred since the major source and area source NESHAP for
Flexible Polyurethane Foam Fabrication were promulgated in 2003 and
2007, respectively. During the technology review we identified existing
flame laminators as an unregulated process in the major source
category. This proposal included the establishment of MACT standards
for that process is described in section IV.A of this preamble. In
conducting the technology review, we reviewed various information
sources regarding the emissions from flexible polyurethane foam
fabrication operations facilities and flexible polyurethane foam
production facilities. We conducted separate but similar reviews for
the Flexible Polyurethane Foam major source category and the two area
source categories. The reviews included a search of the RBLC database,
reviews of air permits for flexible polyurethane foam fabrication
operations facilities and flexible polyurethane foam production
facilities, and a review of emissions standards for similar source
categories. We reviewed these data sources for information on
practices, processes, and control technologies that were not considered
during the development of the Flexible Polyurethane Foam Fabrication
Operations NESHAP and the Flexible Polyurethane Foam Production and
Fabrication area source NESHAP. We also looked for information on
improvements in practices, processes, and control technologies that
have been employed since development of the NESHAP. Through searches of
the data sources described in section IV.D of this preamble, one
development in a practice, process, or control technology was
identified for loop slitter use in the Flexible Polyurethane Foam
Fabrication Operations major source category.
A loop slitter is a large machine used to create thin sheets of
foam from the large blocks of foam or ``buns'' created at a foam
production plant. A slitter consists of a large, vertical, oval
conveyor belt and a cutting mechanism, which cuts a thin sheet of foam
to the desired thickness. When the buns are mounted on the conveyor of
the slitter, they are glued end-to-end, forming a loop. Loop slitter
emissions of HAP can occur from the application of the adhesives used
to glue the foam buns together if the adhesive used contains HAP. The
application of the adhesive is performed at the beginning of the loop
slitting process, which can run for several hours before the bun is
fully cut and the machine is loaded with new buns of foam.
At the time of the development of the NESHAP, the EPA found that
the foam fabrication industry had effectively discontinued the use of
adhesives containing methylene chloride, which was the primary HAP in
the adhesives used, and had switched to other adhesives that did not
contain methylene chloride or other HAP. As a result, for both existing
and new loop slitters, the MACT standard for loop slitters proposed in
2001 was the prohibition of HAP-based adhesives. The definition in the
2001 proposed standards for a HAP-based adhesive was an adhesive
containing detectable HAP. In comments on the proposed standards,
industry representatives indicated that the adhesives used contained
small amounts of HAP rather than the estimated zero HAP content. In
response to these comments, the definition of HAP-based adhesive was
revised in the promulgated rule to be an adhesive
[[Page 1885]]
containing 5 percent (by weight) or greater of HAP.
For new and existing loop slitters, we identified a potential
development in existing practices and control techniques not currently
required by the Flexible Polyurethane Foam Fabrication Operations MACT
standards. Through the review of other air toxics MACT standards, we
noted that several other NESHAP, developed both before and after the
Flexible Polyurethane Foam Fabrication Operations NESHAP, include a
definition of non-HAP adhesive or coating (where the coating definition
included adhesives) with a lower percentage of HAP content than that of
the definition included in the Flexible Polyurethane Foam Fabrication
Operations rule.
Additionally, through review of SDS provided by industry, we found
that the current adhesives used in loop slitting operations are less
than 1-percent HAP content by total weight. Based on the current
industry standards of adhesive usage containing less than 1-percent HAP
and the definition for HAP-based adhesive from similar source
categories regulating adhesives, we are proposing to revise the
definition of ``HAP-based adhesive'' to read: ``an adhesive containing
1 percent (by weight) or more of HAP, according to EPA Method 311
(appendix A to 40 CFR part 63) or another approved alternative.'' This
lowering of the total HAP weight of an adhesive from 5 percent to 1
percent is not expected to yield any reductions in emissions but will
codify current industry practices and prevent backsliding.
We propose to amend 40 CFR 63.8802(a)(1)(i) and (a)(3)(i), which
describe how to determine the mass fraction of HAP in each material
used, to remove references to Occupational Safety and Health
Administration (OSHA)-defined carcinogens as specified in 29 CFR
1910.1200(d)(4). The reference to OSHA-defined carcinogens as specified
in 29 CFR 1910.1200(d)(4) was intended to specify which compounds must
be included in calculating total HAP content of a coating material if
they are present at 0.1-percent or greater by mass. We are proposing to
remove these references because 29 CFR 1910.1200(d)(4) has been amended
and no longer readily defines which compounds are carcinogens. We are
proposing to replace these references to OSHA-defined carcinogens and
29 CFR 1910.1200(d)(4) with a list (in proposed new Table 8 to 40 CFR
part 63, subpart MMMMM) of those HAP that must be included in
calculating total HAP content of a coating material if they are present
at 0.1 percent or greater by mass.
We propose to include HAP in proposed Table 8 to 40 CFR part 63,
subpart MMMMM if they were categorized in the EPA's Prioritized Chronic
Dose-Response Values for Screening Risk Assessments (May 9, 2014), as a
``human carcinogen,'' ``probable human carcinogen,'' or ``possible
human carcinogen'' according to The Risk Assessment Guidelines of 1986
(EPA/600/8-87/045, August 1987),\24\ or as ``carcinogenic to humans,''
``likely to be carcinogenic to humans,'' or with ``suggestive evidence
of carcinogenic potential'' according to the Guidelines for Carcinogen
Risk Assessment (EPA/630/P-03/001F, March 2005).\25\
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\24\ See https://www.epa.gov/fera/dose-response-assessment-assessing-health-risks-associated-exposure-hazardous-air-pollutants.
\25\ See https://www.epa.gov/risk/guidelines-carcinogen-risk-assessment.
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For the Flexible Polyurethane Foam Production and Flexible
Polyurethane Foam Fabrication area source categories, we find that
there are no additional emissions of the listed urban HAP methylene
chloride. As noted in section II.B of this document, methylene chloride
is no longer used within either source category. Additionally, we did
not find any advances in technologies during our review of the source
categories. Detailed information of the technology review can be found
in the memorandum titled Technology Review for the Flexible
Polyurethane Foam Production and Fabrication Area Source Categories,
which is available in the docket for this proposed rule (Docket ID No.
EPA-HQ-OAR-2020-0572).
E. What other actions are we proposing?
In addition to the proposed actions described above, we are
proposing additional revisions to the NESHAP. We are proposing
revisions to the SSM provisions of the MACT rule in order to ensure
that they are consistent with the decision in Sierra Club v. EPA, 551
F. 3d 1019 (D.C. Cir. 2008), in which the court vacated two provisions
that exempted sources from the requirement to comply with otherwise
applicable CAA section 112(d) emission standards during periods of SSM.
We also are proposing various other changes to reporting and
recordkeeping requirements and to periodic testing requirements. Our
analyses and proposed changes related to these issues are discussed
below.
In its 2008 decision in Sierra Club v. EPA, 551 F.3d 1019 (D.C.
Cir. 2008), the court vacated portions of two provisions in the EPA's
CAA section 112 regulations governing the emissions of HAP during
periods of SSM. 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 CAA section 112 standards apply
continuously.
We are proposing the elimination of SSM exemptions in this rule,
including any reference to requirements included in 40 CFR part 63,
subpart A (General Provisions). Consistent with Sierra Club v. EPA, we
are proposing standards in this rule that apply at all times. We are
also proposing several revisions to Table 7 to 40 CFR part 63, subpart
MMMMM, as is explained in more detail below. For example, we are
proposing to eliminate the incorporation of the General Provisions'
requirement that each source develop an SSM plan. 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.
Periods of startup, normal operations, and shutdown are all
predictable and routine aspects of a source's operations. Malfunctions,
in contrast, are neither predictable nor routine. Instead, they are, by
definition, sudden, infrequent, and not reasonably preventable failures
of an emissions control, process, or monitoring equipment. (40 CFR
63.2, Definition of malfunction). The EPA interprets CAA section 112 as
not requiring emissions that occur during periods of malfunction to be
factored into development of CAA section 112 standards, and this
reading has been upheld as reasonable by the court. See U.S. Sugar
Corp. v. EPA, 830 F.3d 579, 606-610 (2016). 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
[[Page 1886]]
category. There is nothing in CAA section 112 that directs the Agency
to consider malfunctions in determining the level ``achieved'' by the
best performing sources when setting emission standards. The court has
recognized that the phrase ``average emissions limitation achieved by
the best performing 12 percent of'' sources ``says nothing about how
the performance of the best units is to be calculated.'' Nat'l Ass'n of
Clean Water Agencies v. EPA, 734 F.3d 1115, 1141 (D.C. Cir. 2013).
While the EPA accounts for variability in setting emissions standards,
nothing in CAA section 112 requires the Agency to consider malfunctions
as part of that analysis. The EPA is not required to treat a
malfunction in the same manner as the type of variation in performance
that occurs during routine operations of a source. A malfunction is a
failure of the source to perform in a ``normal or usual manner'' and no
statutory language compels the EPA to consider such events in setting
CAA section 112 standards.
As the court recognized in U.S. Sugar Corp., accounting for
malfunctions in setting standards would be difficult, if not
impossible, given the myriad 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. U.S. Sugar Corp. at
608 (``The EPA would have to conceive of a standard that could apply
equally to the wide range of possible boiler malfunctions, ranging from
an explosion to minor mechanical defects. Any possible standard is
likely to be hopelessly generic to govern such a wide array of
circumstances.''). As such, the performance of units that are
malfunctioning is not ``reasonably'' foreseeable. See, e.g.,
Weyerhaeuser Co. v. Costle, 590 F.2d 1011, 1058 (D.C. Cir. 1978) (``In
the nature of things, no general limit, individual permit, or even any
upset provision can anticipate all upset situations. After a certain
point, the transgression of regulatory limits caused by `uncontrollable
acts of third parties,' such as strikes, sabotage, operator
intoxication or insanity, and a variety of other eventualities, must be
a matter for the administrative exercise of case-by-case enforcement
discretion, not for specification in advance by regulation.'').
Moreover, emissions during a malfunction event can be significantly
higher than emissions at any other time of source operation. For
example, if an air pollution control device with 99-percent removal
goes off-line as a result of a malfunction (as might happen if, for
example, the bags in a baghouse catch fire) and the emission unit is a
steady state-type unit that would take days to shut down, the source
would go from 99-percent control to zero control until the control
device was repaired. The source's emissions during the malfunction
would be 100 times higher than during normal operations. As such, the
emissions over a 4-day malfunction period would exceed the annual
emissions of the source during normal operations. As this example
illustrates, accounting for malfunctions could lead to standards that
are not reflective of (and are significantly less stringent than)
levels that are achieved by a well-performing non-malfunctioning
source. It is reasonable to interpret CAA section 112 to avoid such a
result. The EPA's approach to malfunctions is consistent with CAA
section 112 and is a reasonable interpretation of the statute.
Although no statutory language compels the EPA to set standards for
malfunctions, the EPA has the discretion to do so where feasible. For
example, in the Petroleum Refinery Sector RTR, the EPA established a
work practice standard for unique types of malfunction that result in
releases from pressure relief devices or emergency flaring events
because the EPA had information to determine that such work practices
reflected the level of control that applies to the best performers. 80
FR 75178, 75211 through 14 (December 1, 2015). The EPA considers
whether circumstances warrant setting standards for a particular type
of malfunction and, if so, whether the EPA has sufficient information
to identify the relevant best-performing sources and establish a
standard for such malfunctions. We also encourage commenters to provide
any such information.
In the event that a source fails to comply with the applicable CAA
section 112(d) standards as a result of a malfunction event, the EPA
would determine an appropriate response based on, among other things,
the good faith efforts of the source to minimize emissions during
malfunction periods, including preventative and corrective actions, as
well as root cause analyses to ascertain and rectify excess emissions.
The EPA would also consider whether the source's failure to comply with
the CAA section 112(d) standard was, in fact, sudden, infrequent, not
reasonably preventable, and was not instead caused, in part, by poor
maintenance or careless operation. 40 CFR 63.2 (Definition of
malfunction).
If the EPA determines in a particular case that an enforcement
action against a source for violation of an emission standard is
warranted, the source can raise any and all defenses in that
enforcement action and the federal district court will determine what,
if any, relief is appropriate. The same is true for citizen enforcement
actions. Similarly, the presiding officer in an administrative
proceeding can consider any defense raised and determine whether
administrative penalties are appropriate.
In summary, the EPA interpretation of the CAA and, in particular,
CAA section 112 is reasonable and encourages practices that will avoid
malfunctions. Administrative and judicial procedures for addressing
exceedances of the standards fully recognize that violations may occur
despite good faith efforts to comply and can accommodate those
situations. See U.S. Sugar Corp., 830 F.3d at 606-610. Therefore, we
are proposing to change the requirements for SSM by removing the
exemption for new flame laminators from the requirements to meet the
standard during SSM periods and by removing the requirement to develop
and implement an SSM plan. The EPA is proposing revisions to Table 7 of
subpart MMMMM, The Applicability of General Provisions, to remove SSM
exemptions and plan development for new flame lamination sources.
Electronic reporting. The EPA is proposing that owners or operators
of flexible polyurethane foam fabrication operations facilities submit
electronic copies of required performance test reports, performance
evaluation reports, and periodic reports through the EPA's Central Data
Exchange (CDX) using the Compliance and Emissions Data Reporting
Interface (CEDRI). A description of the electronic data submission
process is provided in the memorandum, Electronic Reporting
Requirements for New Source Performance Standards (NSPS) and National
Emission Standards for Hazardous Air Pollutants (NESHAP) Rules,
available in the docket for this action. The proposed rule requires
that performance test results collected using test methods that are
supported by the EPA's Electronic Reporting Tool (ERT) as listed on the
ERT website \26\ at the time of the test be submitted in the format
generated through the use of the ERT or an electronic file consistent
with the xml schema on the ERT website, and other performance test
results be submitted in portable document format (PDF) using the
attachment module of the ERT. The proposed rule requires that
Notification of Compliance Status
[[Page 1887]]
reports be submitted as a PDF upload in CEDRI.
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\26\ https://www.epa.gov/electronic-reporting-air-emissions/electronic-reporting-tool-ert.
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For performance test reports, performance evaluation reports, and
periodic reports, the proposed rule requires that owners or operators
use the appropriate spreadsheet template to submit information to
CEDRI. A draft version of the proposed template(s) for these reports is
included in the docket for this action.\27\ The EPA specifically
requests comment on the content, layout, and overall design of the
template(s).
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\27\ See Flexible Foam Fabrication ERT templates, available at
Docket ID. No. EPA-HQ-OAR-2020-0572.
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Additionally, the EPA has identified two broad circumstances in
which electronic reporting extensions may be provided. These
circumstances are (1) outages of the EPA's CDX or CEDRI which preclude
an owner or operator from accessing the system and submitting required
reports and (2) force majeure events, which are defined as events that
will be or have been caused by circumstances beyond the control of the
affected facility, its contractors, or any entity controlled by the
affected facility that prevent an owner or operator from complying with
the requirement to submit a report electronically. Examples of force
majeure events are acts of nature, acts of war or terrorism, or
equipment failure or safety hazards beyond the control of the facility.
The EPA is providing these potential extensions to protect owners or
operators from noncompliance in cases where they cannot successfully
submit a report by the reporting deadline for reasons outside of their
control. In both circumstances, the decision to accept the claim of
needing additional time to report is within the discretion of the
Administrator, and reporting should occur as soon as possible.
The electronic submittal of the reports addressed in this proposed
rulemaking will increase the usefulness of the data contained in those
reports, is in keeping with current trends in data availability and
transparency, will further assist in the protection of public health
and the environment, will improve compliance by facilitating the
ability of regulated facilities to demonstrate compliance with
requirements, and by facilitating the ability of delegated state,
local, tribal, and territorial air agencies and the EPA to assess and
determine compliance, and will ultimately reduce burden on regulated
facilities, delegated air agencies, and the EPA. Electronic reporting
also eliminates paper-based, manual processes, thereby saving time and
resources, simplifying data entry, eliminating redundancies, minimizing
data reporting errors, and providing data quickly and accurately to the
affected facilities, air agencies, the EPA, and the public. Moreover,
electronic reporting is consistent with the EPA's plan \28\ to
implement Executive Order 13563 and is in keeping with the EPA's
Agency-wide policy \29\ developed in response to the White House's
Digital Government Strategy.\30\ For more information on the benefits
of electronic reporting, see the memorandum, Electronic Reporting
Requirements for New Source Performance Standards (NSPS) and National
Emission Standards for Hazardous Air Pollutants (NESHAP) Rules,
referenced earlier in this section.
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\28\ The EPA's Final Plan for Periodic Retrospective Reviews,
August 2011. Available at: https://www.regulations.gov/document?D=EPA-HQ-OA-2011-0156-0154.
\29\ E-Reporting Policy Statement for EPA Regulations, September
2013. Available at https://www.epa.gov/sites/production/files/2016-03/documents/epa-ereporting-policy-statement-2013-09-30.pdf.
\30\ Digital Government: Building a 21st Century Platform to
Better Serve the American People, May 2012. Available at https://obamawhitehouse.archives.gov/sites/default/files/omb/egov/digital-government/digital-government.html.
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F. What compliance dates are we proposing?
The EPA is proposing that affected sources that commenced
construction or reconstruction on or before January 11, 2021, must
comply with all of the amendments, with the exception of the proposed
electronic format for submitting notifications and compliance reports,
no later than 180 days after the effective date of the final rule, or
upon startup, whichever is later. Affected sources that commence
construction or reconstruction after January 11, 2021, must comply with
all requirements of the subpart, including the amendments being
proposed, with the exception of the proposed electronic format for
submitting notifications and compliance reports, no later than the
effective date of the final rule or upon startup, whichever is later.
All affected facilities would have to continue to meet the current
requirements of 40 CFR part 63, subpart MMMMM, until the applicable
compliance date of the amended rule. The final action is not expected
to be a ``major rule'' as defined by 5 U.S.C. 804(2), so the effective
date of the final rule will be the promulgation date as specified in
CAA section 112(d)(10).
For existing sources, we are proposing four changes that would
impact ongoing compliance requirements for 40 CFR part 63, subpart
MMMMM. As discussed elsewhere in this preamble, we are proposing to add
numeric limits for HCl emissions from existing flame laminators. We are
also proposing a requirement that notifications, performance test
results, and compliance reports be submitted electronically.
Our experience with similar industries that are required to convert
reporting mechanisms to install necessary hardware and software, become
familiar with the process of submitting performance test results
electronically through the EPA's CEDRI, test these new electronic
submission capabilities, and reliably employ electronic reporting shows
that a time period of a minimum of 90 days, and, more typically, 180
days, is generally necessary to accomplish these revisions. For the
proposed SSM revisions, we recognize that there are no facilities that
are currently using the SSM provisions for new flame laminators, since
there have not been any new sources since the standard was promulgated.
As a result, we do not believe that any additional time is needed for
compliance with the revised SSM provisions.
We have consulted with the regulated industry regarding the
proposed limits for existing flame laminators, and the requirement to
conduct performance testing to demonstrate initial compliance within
180 days of the publication of the final rule and no less than every 5
years thereafter, to better understand the likely implications of the
proposed revisions. There are two impacted facilities, owned by one
parent company, and representatives from that company have indicated
that performance testing could be done within the proposed time frame
for compliance. For the proposed limit for existing sources, we believe
that the two facilities that would be subject to the standards are able
to meet the limit without add-on controls. However, we do recognize
that facilities will need time to conduct performance tests and
demonstrate compliance with the proposed emission limit.
The EPA recognizes the confusion that multiple and different
compliance dates for individual requirements would create and the
additional burden such an assortment of dates would impose. From our
assessment of the timeframe needed for compliance with the entirety of
the revised requirements, the EPA considers a period of 180 days to be
the most expeditious compliance period practicable and is, thus,
proposing that all affected sources that commenced construction or
reconstruction on or before January 11, 2021, be in compliance with all
of this regulation's
[[Page 1888]]
revised requirements within 180 days of the regulation's effective
date, with the exception of the electronic reporting requirements.
We solicit comment on the proposed compliance periods, and we
specifically request submission of information from sources in this
source category regarding specific actions that would need to be
undertaken to comply with the proposed amended requirements and the
time needed to make the adjustments for compliance with any of the
revised requirements. We note that information provided may result in
changes to the proposed compliance dates.
V. Summary of Cost, Environmental, and Economic Impacts
A. What are the affected sources?
Currently, three major sources subject to the Flexible Polyurethane
Foam Fabrication Operations NESHAP are operating in the United States.
The affected sources under the NESHAP include flexible polyurethane
foam fabrication plant sites that operate loop slitters and/or flame
laminators. Facilities that use loop slitter adhesive processes would
be required to comply with a ban on the use of adhesives containing air
toxics. However, the EPA estimates that current air toxic emissions
from loop slitter adhesive users are essentially zero as the result of
changes in adhesive composition required by OSHA's permissible exposure
limit for methylene chloride prior to the promulgation of the original
MACT standard. Additionally, the EPA estimates that current air toxic
emissions from flame laminators for the entire source category are less
than 3.5 tpy.
Currently, there are approximately 32 area sources subject to the
Flexible Polyurethane Foam Production and Fabrication NESHAP. The area
source standard only regulates methylene chloride emissions and,
similar to the major source standards, emissions of methylene chloride
are essentially zero as required by OSHA's permissible exposure limit
for methylene chloride prior to the promulgation of the original GACT
standards. Based on information provided by industry, there are no
emissions of methylene chloride from these sources. For detailed
information please see the memorandum titled Technology Review for the
Flexible Polyurethane Foam Production and Fabrication Area Source
Categories, located in the docket for this action.
B. What are the air quality impacts?
Current estimated emissions from the Flexible Polyurethane Foam
Fabrication Operations source category are approximately 3.5 tpy. We do
not estimate any HAP emission reductions from the proposed requirement
for MACT limits for existing flame laminators nor from the proposed
revision to the definition of HAP-based adhesives for loop slitters.
Both proposed revisions reflect current practices.
C. What are the cost impacts?
The proposed revisions to the Flexible Polyurethane Foam
Fabrication Operations NESHAP for major sources are expected to have
minimal cost impacts. The costs are associated with periodic emissions
performance testing, electronic reporting, and reviewing the proposed
rule. Three major source facilities are affected by these costs. The
one-time cost associated with reviewing the proposed rule and becoming
familiar with the electronic reporting system is estimated to be $2,200
per facility in 2019 dollars. The EPA estimates the cost of the HCl
emissions testing requirement to be $12,000 per test. This test is
required every 5 years. Prior to the initial test, installation and
calibration of equipment is required which costs an estimated $3,200.
The total cost per facility in Year 1 is estimated to be $17,300, and
subsequent costs are estimated to be $12,000 every 5 years thereafter.
D. What are the economic impacts?
The proposed revisions to the Flexible Polyurethane Foam
Fabrication Operations NESHAP for major sources and the Flexible
Polyurethane Foam Production and Fabrication NESHAP for area sources
are not expected to have market impacts. Over a 10-year timeframe from
2021 to 2030, the net present value of the estimated cost impacts is
$83,000 at a 3-percent discount rate and $77,600 at a 7-percent
discount rate in 2019 dollars. The equivalent annualized value of the
cost impacts is $9,700 at a 3-percent discount rate and $11,000 at a 7-
percent discount rate. Since the costs associated with the proposed
rule are minimal, no significant economic impacts are anticipated due
to the proposed revisions. See the memorandum titled Economics Memo
Flex Foam NESHAP Proposal, in the docket for discussion of the
facility-level cost estimates as well as the net present value and
equivalent annualized value estimates.
E. What are the benefits?
Although the EPA does not anticipate any significant reductions in
HAP emissions as a result of the proposed amendments, the action, if
finalized as proposed, would result in improvements to the rule and
prevent backsliding. Specifically, the proposed amendments codify
existing industry practices both for existing flame laminators and for
new and existing sources of adhesives used with loop slitters. The
proposed revisions also amend the standards such that they apply at all
times. Additionally, the proposed amendments requiring electronic
submittal of initial notifications, performance test results, and
semiannual reports will increase the usefulness of the data, are in
keeping with current trends of data availability, will further assist
in the protection of public health and the environment, and will
ultimately result in less burden on the regulated community. See
section IV.E of this preamble for more information.
VI. Request for Comments
We solicit comments on 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 for
download on the RTR website at https://www.epa.gov/stationary-sources-air-pollution/flexible-polyurethane-foam-fabrication-operations-national-emission. 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
[[Page 1889]]
downloaded from the RTR website, complete the following steps:
1. Within this downloaded file, enter suggested 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 emission revisions (e.g.,
performance test reports, material balance calculations).
4. Send the entire downloaded file with suggested revisions in
Microsoft[reg] Access format and all accompanying documentation to
Docket ID No. EPA-HQ-OAR-2020-0572 (through the method described in the
ADDRESS section of this preamble).
5. If you are providing comments on a single facility or mulitiple
facilities, you need only submit one file for all facilities. The file
should contain all suggested for all sources at the facility (or
facilities). We request that all data revision comments be submitted in
the form of updated Microsoft[reg] Excel files that are generated by
the Microsoft[reg] Access file. These files are provided on the project
website at https://www.epa.gov/stationary-sources-air-pollution/flexible-polyurethane-foam-fabrication-operations-national-emission.
VIII. Statutory and Executive Order Reviews
Additional information about these statutes and Executive Orders
can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders.
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 and was,
therefore, not submitted to OMB for review.
B. Executive Order 13771: Reducing Regulations and Controlling
Regulatory Costs
This action is not expected to be an Executive Order 13771
regulatory action because this action is not significant under
Executive Order 12866.
C. Paperwork Reduction Act (PRA)
The information collection activities in this proposed rule have
been submitted for approval to OMB under the PRA. The Information
Collection Request (ICR) document that the EPA prepared has been
assigned EPA ICR number 2027.08. You can find a copy of the ICR in the
docket for this rule, and it is briefly summarized here. The ICR is
specific to information collection associated with the Flexible
Polyurethane Foam Fabrication Operations source category, through
amendments to 40 CFR part 63, subpart MMMMM. (The subject rulemaking
imposes no new information collection associated with either the
Flexible Polyurethane Foam Production area source category or the
Flexible Polyurethane Foam Fabrication area source category.) We are
proposing changes to the recordkeeping and reporting requirements
associated with 40 CFR part 63, subpart MMMMM, in the form of:
Requiring periodic (every 5 years) performance tests at major sources;
eliminating the SSM plan and reporting requirements; including
reporting requirements for deviations in the semiannual report; and
including the requirement for electronic submittal of reports. In
addition, the number of facilities subject to the standards changed.
The number of respondents was reduced from 20 to 3 based on
consultation with industry representatives and state/local agencies.
Respondents/affected entities: The respondents to the recordkeeping
and reporting requirements are owners or operators of flexible
polyurethane foam fabrication operations subject to 40 CFR part 63,
subpart MMMMM.
Respondent's obligation to respond: Mandatory (40 CFR part 63,
subpart MMMMM).
Estimated number of respondents: 3 facilities.
Frequency of response: The frequency of responses varies depending
on the burden item. Responses include one-time review of rule
amendments, reports of periodic performance tests, and semiannual
compliance reports.
Total estimated burden: The annual recordkeeping and reporting
burden for responding facilities to comply with all of the requirements
in the NESHAP, averaged over the 3 years of this ICR, is estimated to
be 148 hours (per year). The average annual burden to the Agency over
the 3 years after the amendments are final is estimated to be 51 hours
(per year) for the Agency. Burden is defined at 5 CFR 1320.3(b).
Total estimated cost: The annual recordkeeping and reporting cost
for responding facilities to comply with all of the requirements in the
NESHAP, averaged over the 3 years of this ICR, is estimated to be
$15,000 (rounded, per year). There are no estimated capital and
operation and maintenance costs. The total average annual Agency cost
over the first 3 years after the amendments are final is estimated to
be $2,500.
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.
Submit your comments on the Agency's need for this information, the
accuracy of the provided burden estimates, and any suggested methods
for minimizing respondent burden to the EPA using the docket identified
at the beginning of this rule. You may also send your ICR-related
comments to OMB's Office of Information and Regulatory Affairs via
email to [email protected], Attention: Desk Officer for the
EPA. Since OMB is required to make a decision concerning the ICR
between 30 and 60 days after receipt, OMB must receive comments no
later than February 10, 2021. The EPA will respond to any ICR-related
comments in the final rule.
D. Regulatory Flexibility Act (RFA)
I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA. In
making this determination, the impact of concern is any significant
adverse economic impact on small entities. An agency may certify that a
rule will not have a significant economic impact on a substantial
number of small entities if the rule relieves regulatory burden, has no
net burden, or otherwise has a positive economic effect on the small
entities subject to the rule. As proposed, this action would
potentially impose new requirements only on major sources, and none of
the major sources in the Flexible Polyurethane Foam Fabrication
Operations source category are considered a small entity. We have,
therefore, concluded that this action will have no net regulatory
burden for all directly regulated small entities.
E. Unfunded Mandates Reform Act (UMRA)
This action does not contain an unfunded mandate of $100 million or
more as described in UMRA, 2 U.S.C. 1531-1538, and does not
significantly or uniquely affect small governments. The action imposes
no enforceable duty on any state, local, or tribal governments or the
private sector.
F. Executive Order 13132: Federalism
This action does not have federalism implications. It will not have
substantial direct effects on the states, on the relationship between
the national
[[Page 1890]]
government and the states, or on the distribution of power and
responsibilities among the various levels of government.
G. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
This action does not have tribal implications as specified in
Executive Order 13175. No tribal facilities are known to be engaged in
the industries that would be affected by this action nor are there any
adverse health or environmental effects from this action. Thus,
Executive Order 13175 does not apply to this action.
H. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks
This action is not subject to Executive Order 13045 because it is
not economically significant as defined in Executive Order 12866, and
because the EPA does not believe the environmental health or safety
risks addressed by this action present a disproportionate risk to
children. This action's health and risk assessments are contained in
sections III.A, IV.B, and IV.C of this preamble.
I. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use
This action is not subject to Executive Order 13211 because it is
not a significant regulatory action under Executive Order 12866.
J. National Technology Transfer and Advancement Act (NTTAA)
This rulemaking does not involve technical standards.
K. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations
The EPA believes that this action does not have disproportionately
high and adverse human health or environmental effects on minority
populations, low-income populations, and/or indigenous peoples, as
specified in Executive Order 12898 (59 FR 7629, February 16, 1994).
The documentation for this decision is contained in sections IV.B
and IV.C of this preamble. As discussed in sections IV.B and IV.C of
this preamble, we performed a demographic analysis for the Flexible
Polyurethane Foam Fabrication Operations major source category, which
is an assessment of risks to individual demographic groups, of the
population close to the facilities (within 50 km and within 5 km). In
our analysis, we evaluated the distribution of HAP-related cancer risks
and noncancer hazards from the Flexible Polyurethane Foam Fabrication
Operations major source category across different social, demographic,
and economic groups within the populations living near operations
identified as having the highest risks. Results of the demographic
analysis performed for the Flexible Polyurethane Foam Fabrication
Operations major source category indicate that the minority population
is slightly higher within 5 km of the three facilities than the
national percentage (40 percent versus 38 percent). This difference is
accounted for by the larger African American population around the
facilities (17 percent versus 12 percent nationally). In addition, the
percentage of the population living within 5 km of facilities in the
source category is greater than the corresponding national percentage
for the demographic groups, ``Ages 0 to 17'' and ``Below the Poverty
Level.'' When examining the risk levels of those exposed to emissions
from flexible polyurethane foam fabrication facilities, we find that no
one is exposed to a cancer risk at or above 1-in-1 million or to a
chronic noncancer TOSHI greater than 1.
List of Subjects in 40 CFR Part 63
Environmental protection, Air pollution control, Hazardous
substances, Reporting and recordkeeping requirements.
Andrew Wheeler,
Administrator.
[FR Doc. 2021-00250 Filed 1-8-21; 8:45 am]
BILLING CODE 6560-50-P
