1868 Federal Register / Vol. 86, No. 6 / Monday, January 11, 2021 / Proposed Rules 

(c) Electronic data. By order, the judge 

may prescribe the format for the 

submission of data that is in electronic 

form. 

(d) Exchange of exhibits. When 

written exhibits are offered in evidence, 

one copy must be furnished to the judge 

and to each of the parties. If the exhibit 

being offered was previously filed with 

the judge, either electronically pursuant 

to paragraph (a) of this section or 

otherwise, and furnished to the other 

parties prior to hearing, the exhibit need 

not be produced at the hearing unless 

the judge directs otherwise. If the 

exhibit being offered at the hearing was 

not furnished to each party or filed with 

the judge prior to the hearing, a paper 

copy of that exhibit for the judge and 

each party must be produced at the 

hearing unless the judge directs 

otherwise. If the judge does not fix a 

date for the exchange of exhibits, the 

parties must exchange copies of exhibits 

at the earliest practicable time before the 

hearing begins. 

(e) Authenticity. The authenticity of a 

document identified in a pre-hearing 

exhibit list is admitted unless a party 

files a written objection to authenticity 

at least seven days before the hearing. 

The judge may permit a party to 

challenge a document’s authenticity if 

the party establishes good cause for its 

failure to file a timely written objection. 

(f) Substitution of copies for original 

exhibits. The judge may permit a party 

to withdraw original documents offered 

in evidence and substitute accurate 

copies of the originals. 

(g) Designation of parts of documents. 

When only a portion of a document 

contains relevant matter, the offering 

party must exclude the irrelevant parts 

to the greatest extent practicable. 

(h) Records in other proceedings. 

Portions of the record of other 

administrative proceedings, civil 

actions, or criminal prosecutions may be 

received in evidence, when the offering 

party shows the copies are accurate. 

Signed on this 14th day of December, 2020, 

in Washington, DC. 

Eugene Scalia, 

Secretary of Labor. 

[FR Doc. 2020–28050 Filed 1–8–21; 8:45 am] 

BILLING CODE 4510–20–P 

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: 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. 


jbell on DSKJLSW7X2PROD with PROPOSALS
Federal Register / Vol. 86, No. 6 / Monday, January 11, 2021 / Proposed Rules 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: 

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/ 

stationary-sources-air-pollution/flexiblepolyurethane-foam-fabricationoperations-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 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 

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. 


jbell on DSKJLSW7X2PROD with PROPOSALS
1870 Federal Register / Vol. 86, No. 6 / Monday, January 11, 2021 / Proposed Rules 

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/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? 

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 


jbell on DSKJLSW7X2PROD with PROPOSALS
Federal Register / Vol. 86, No. 6 / Monday, January 11, 2021 / Proposed Rules 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/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/flexiblepolyurethane-foam-fabricationoperations-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 


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1Although 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. 

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 

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 

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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2Other 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). 

3Available at https://www.epa.gov/toxics-releaseinventory-tri-program. 

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. 

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

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 


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4The 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. 

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 

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 


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5Recommendations 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/EPASAB-10-007-unsigned.pdf. 

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: 

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 

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 

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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6U.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. 

7For more information about HEM–3, go to 

https://www.epa.gov/fera/risk-assessment-andmodeling-human-exposure-model-hem. 

• 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. 

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, 

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 


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8U.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). 

9A census block is the smallest geographic area 

for which census statistics are tabulated. 

10The 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. 

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 

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. 

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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11See, 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. 

13CalEPA 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-acute8-hour-and-chronic-reference-exposure-level-relsummary. 

14National 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). 

15ERPGS 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. 

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 

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 

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 


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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? 

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 

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 

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 

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 


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16 IRIS glossary (https://ofmpub.epa.gov/sor_

internet/registry/termreg/searchandretrieve/

glossariesandkeywordlists/search.do?details=&

glossaryName=IRIS%20Glossary). 

17An 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. 

18See 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. 

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. 

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, 

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 

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 


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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). 

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 

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

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). 


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21The TOSHI is the sum of the chronic noncancer 

HQ for substances that affect the same target organ 

or organ system. 

22The maximum estimated acute exposure 

concentration was divided by available short-term 

threshold values to develop HQ values. 

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. 

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

Risk assessment 

Maximum individual cancer 

risk 

(in 1 million) 

Estimated population at increased risk of cancer ≥ 1-in-1 million Estimated annual cancer 

incidence 

(cases per year) 

Maximum chronic noncancer TOSHI 21

Maximum screening acute noncancer HQ22

Based on 

actual 

emissions 

Based 

on allowable 

Emissions 

Based on 

actual 

emissions 

Based 

on allowable 

emissions 

Based on 

actual 

emissions 

Based 

on allowable 

emissions 

Based on 

actual 

emissions 

Based 

on allowable 

emissions 

Based on actual 

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. 

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

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. 


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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 


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24See https://www.epa.gov/fera/dose-responseassessment-assessing-health-risks-associatedexposure-hazardous-air-pollutants. 

25See https://www.epa.gov/risk/guidelinescarcinogen-risk-assessment. 

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 

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 

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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26https://www.epa.gov/electronic-reporting-airemissions/electronic-reporting-tool-ert. 

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 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 

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 


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27See Flexible Foam Fabrication ERT templates, 

available at Docket ID. No. EPA–HQ–OAR–2020– 

0572. 

28The EPA’s Final Plan for Periodic Retrospective 

Reviews, August 2011. Available at: https://

www.regulations.gov/document?D=EPA-HQ-OA2011-0156-0154. 

29E-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/digitalgovernment.html. 

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 

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 

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 

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/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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Federal Register / Vol. 86, No. 6 / Monday, January 11, 2021 / Proposed Rules 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® 

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 

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 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 

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. 

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, 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 

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 

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) 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: 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 

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 http://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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