National Emission Standards for Hazardous Air Pollutants: Surface Coating of Metal Cans and Surface Coating of Metal Coil Residual Risk and Technology Reviews

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 63

[EPA-HQ-OAR-2017-0684, EPA-HQ-OAR-2017-0685; FRL-9993-45-OAR]

RIN 2060-AT51

National Emission Standards for Hazardous Air Pollutants: Surface Coating of Metal Cans and Surface Coating of Metal Coil Residual Risk and Technology Reviews

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Proposed rule.

SUMMARY:

The Environmental Protection Agency (EPA) is proposing amendments to address the results of the residual risk and technology reviews (RTRs) that the EPA is required to conduct in accordance with the Clean Air Act (CAA) with regard to the National Emissions Standards for Hazardous Air Pollutants (NESHAP) for the Surface Coating of Metal Cans and the NESHAP for the Surface Coating of Metal Coil. The EPA is proposing to find the risks due to emissions of air toxics from these source categories under the current standards to be acceptable and that the standards provide an ample margin of safety to protect public health. We are proposing no revisions to the numerical emission limits based on these analyses. The EPA is proposing to amend provisions addressing emissions during periods of startup, shutdown, and malfunction (SSM); to amend provisions regarding electronic reporting of performance test results; to amend provisions regarding monitoring requirements; and to make miscellaneous clarifying and technical corrections.

DATES:

Comments.

Comments must be received on or before July 19, 2019. 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 July 5, 2019.

Public hearing.

If anyone contacts us requesting a public hearing on or before June 10, 2019, we will hold a hearing. Additional information about the hearing, if requested, will be published in a subsequent

Federal Register

document and posted at

https://www.epa.gov/stationary-sources-air-pollution/surface-coating-metal-cans-national-emission-standards-hazardous

and

https://www.epa.gov/stationary-sources-air-pollution/surface-coating-metal-coil-national-emission-standards-hazardous

. 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-2017-0684 for 40 Code of Federal Regulations (CFR) part 63, subpart KKKK, Surface Coating of Metal Cans, and Docket ID No. EPA-HQ-OAR-2017-0685 for 40 CFR part 63, subpart SSSS, Surface Coating of Metal Coil, as applicable, 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-2017-0684 or EPA-HQ-OAR-2017-0685 (specify the applicable docket number) in the subject line of the message.

•

Fax:

(202) 566-9744. Attention Docket ID No. EPA-HQ-OAR-2017-0684 or EPA-HQ-OAR-2017-0685 (specify the applicable docket number).

•

Mail:

U.S. Environmental Protection Agency, EPA Docket Center, Docket ID No. EPA-HQ-OAR-2017-0684 or EPA-HQ-OAR-2017-0685 (specify the applicable docket number), 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 applicable 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.

FOR FURTHER INFORMATION CONTACT:

For questions about this proposed action, contact Ms. Paula Hirtz, Minerals and Manufacturing Group, 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) 541-2618; fax number: (919) 541-4991; and email address:

hirtz.paula@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.

For questions about monitoring and testing requirements, contact Mr. Ketan Patel, 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) 541-9736; fax number: (919) 541-4991; and email address:

patel.ketan@epa.gov.

For information about the applicability of any of these NESHAP to a particular entity, contact Mr. John Cox, Office of Enforcement and Compliance Assurance, U.S. Environmental Protection Agency, WJC South Building (Mail Code 2227A), 1200 Pennsylvania Avenue NW, Washington, DC 20460; telephone number: (202) 564-1395; and email address:

cox.john@epa.gov.

SUPPLEMENTARY INFORMATION:

Public hearing.

Please contact Ms. Nancy Perry at (919) 541-5628 or by email at

perry.nancy@epa.gov

to request a public hearing, to register to speak at the public hearing, or to inquire as to whether a public hearing will be held.

Docket.

The EPA has established two separate dockets for this rulemaking. Docket ID No. EPA-HQ-OAR-2017-0684 has been established for 40 CFR part 63, subpart KKKK, Surface Coating of Metal Cans, and Docket ID No. EPA-HQ-OAR-2017-0685 has been established for 40 CFR part 63, subpart SSSS, Surface Coating of Metal Coil. All documents in the dockets are listed in

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. Publicly available docket materials are available either electronically in

Regulations.gov

or in hard copy at the EPA Docket Center, Room 3334, WJC West Building, 1301 Constitution Avenue NW, Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the EPA Docket Center is (202) 566-1742.

Instructions.

Direct your comments to Docket ID No. EPA-HQ-OAR-2017-0684 for 40 CFR part 63, subpart KKKK, Surface Coating of Metal Cans (Metal Cans Docket), or Docket ID No. EPA-HQ-OAR-2017-0685 for 40 CFR part 63, subpart SSSS, Surface Coating of Metal Coil (Metal Coil Docket), as applicable to your comments. 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 information that you consider to be CBI or otherwise protected through

https://www.regulations.gov/

or email. 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.

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 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-2017-0684 for 40 CFR part 63, subpart KKKK, Surface Coating of Metal Cans (Metal Cans Docket), or Docket ID No. EPA-HQ-OAR-2017-0685 for 40 CFR part 63, subpart SSSS, Surface Coating of Metal Coil (Metal Coil Docket), as applicable.

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:

ACA American Coatings Association

AEGL acute exposure guideline level

AERMOD air dispersion model used by the HEM-3 model

ASTM American Society for Testing and Materials

BACT best available control technology

BPA bisphenol A

BPA-NI not intentionally containing BPA

CAA Clean Air Act

CalEPA California EPA

CBI Confidential Business Information

CDX Central Data Exchange

CEDRI Compliance and Emissions Data Reporting Interface

CEMS continuous emissions monitoring systems

CFR Code of Federal Regulations

DGME diethylene glycol monobutyl ether

ECHO Enforcement and Compliance History Online

EPA Environmental Protection Agency

ERPG Emergency Response Planning Guideline

ERT Electronic Reporting Tool

FR Federal Register

GACT generally available control technology gal gallon

HAP hazardous air pollutant(s)

HCl hydrochloric acid

HEM-3 Human Exposure Model, Version 1.1.0

HF hydrogen fluoride

HI hazard index

HQ hazard quotient

HQREL hazard quotient recommended exposure limit

IBR incorporation by reference

ICAC Institute of Clean Air Companies

ICR Information Collection Request

IRIS Integrated Risk Information System

kg kilogram

km kilometer

LAER lowest achievable emission rate

lb pound

MACT maximum achievable control technology

mg/m

3

milligrams per cubic meter

MIR maximum individual risk

mm millimeters

NAAQS National Ambient Air Quality Standards

NAICS North American Industry Classification System

NEI National Emission Inventory

NESHAP national emission standards for hazardous air pollutants

NSR New Source Review

NTTAA National Technology Transfer and Advancement Act

OAQPS Office of Air Quality Planning and Standards

OCE overall control efficiency

OMB Office of Management and Budget

OSHA Occupational Safety and Health Administration

PB-HAP hazardous air pollutants known to be persistent and bio-accumulative in the environment

PDF portable document format

POM polycyclic organic matter

ppmv parts per million by volume

PRA Paperwork Reduction Act

PTE permanent total enclosure

RACT reasonably available control technology

RBLC RACT/BACT/LAER Clearinghouse

REL reference exposure level

RFA Regulatory Flexibility Act

RfC reference concentration

RfD reference dose

RTO regenerative thermal oxidizer

RTR residual risk and technology review

SAB Science Advisory Board

SSM startup, shutdown, and malfunction

TOSHI target organ-specific hazard index

tpy tons per year

TRIM.FaTE Total Risk Integrated Methodology.Fate, Transport, and Ecological Exposure model

UF uncertainty factor

µg/m3 micrograms per cubic meter

UMRA Unfunded Mandates Reform Act

URE unit risk estimate

VCS voluntary consensus standards

VOC volatile organic compound

Organization of this document.

The information in this preamble is organized as follows:

I. General Information

A. Does this action apply to me?

B. Where can I get a copy of this document and other related information?

II. Background

A. What is the statutory authority for this action?

B. What are the source categories and how do the current NESHAP regulate their HAP emissions?

C. What data collection activities were conducted to support this action?

D. What other relevant background information and data are available?

III. Analytical Procedures and Decision Making

A. How do we consider risk in our decision-making?

B. How do we perform the technology review?

C. How do we estimate post-MACT risk posed by these source categories?

IV. Analytical Results and Proposed Decisions

A. What are the analytical results and proposed decisions for the Surface Coating of Metal Cans source category?

B. What are the analytical results and proposed decisions for the Surface Coating of Metal Coil source category?

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) and 1 CFR Part 51

K. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations

I. General Information

A. Does this action apply to me?

Table 1 of this preamble lists the NESHAP and associated regulated industrial source categories that are the subject of this proposal. Table 1 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. As defined in the

Initial List of Categories of Sources Under Section 112(c)(1) of the Clean Air Act Amendments of 1990

(see 57 FR 31576, July 16, 1992) and

Documentation for Developing the Initial Source Category List, Final Report

(

see

EPA-450/3-91-030, July 1992), the Surface Coating of Metal Cans source category includes any facility engaged in the coating of metal cans, including: One- and two-piece draw and iron can body coating, sheet coating, three-piece can body assembly coating, or end coating. We estimate that five major source facilities engaged in metal can coating would be subject to this proposal. The Surface Coating of Metal Coil source category includes any facility engaged in the surface coating of metal coil that is a major source of hazardous air pollutant (HAP) emissions. Metal coil is defined as any continuous metal strip (with a thickness of 0.15 millimeters (mm) or more) that is packaged in a roll or coil prior to coating. We estimate that 48 major source facilities engaged in metal coil coating would be subject to this proposal.

Table 1—NESHAP and Industrial Source Categories Affected by This Proposed Action

NESHAP and source category

NAICS code

1

Regulated entities

2

Surface Coating of Metal Cans

332431, 332115, 332116, 332812, 332999

Two-piece Beverage Can Facilities, Three-piece Food Can Facilities, Two-piece Draw and Iron Facilities, One-piece Aerosol Can Facilities.

332431

Can Assembly Facilities.

332812

End Manufacturing Facilities.

Surface Coating of Metal Coil

325992

Photographic Film, Paper, Plate, and Chemical Manufacturing.

326199

All Other Plastics Product Manufacturing.

331110

Iron and Steel Mills and Ferroalloy Manufacturing.

331221

Rolled Steel Shape Manufacturing.

331315

Aluminum Sheet, Plate, and Foil Manufacturing.

331318

Other Aluminum Rolling, Drawing, and Extruding.

331420

Copper Rolling, Drawing, Extruding, and Alloying.

332311

Prefabricated Metal Building and Component Manufacturing.

332312

Fabricated Structural Metal Manufacturing.

332322

Sheet Metal Work Manufacturing.

3

332812

Metal Coating, Engraving (except Jewelry and Silverware), and Allied Services to Manufacturers.

332999

All Other Miscellaneous Fabricated Metal Product Manufacturing.

333249

Other Industrial Machinery Manufacturing.

337920

Blind and Shade Manufacturing.

1

North American Industry Classification System.

2

Regulated entities are major source facilities that apply surface coatings to these parts or products.

3

The majority of coil coating facilities are included in NAICS Code 332812.

B. Where can I get a copy of this document and other related information?

In addition to being available in the dockets for this action, 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/surface-coating-metal-cans-national-emission-standards-hazardous

and

https://www.epa.gov/stationary-sources-air-pollution/surface-coating-metal-coil-national-emission-standards-hazardous.

Following publication in the

Federal Register

, the EPA will post the

Federal Register

version of the proposal and key technical documents at these same websites. Information on the overall RTR program is available at

https://www3.epa.gov/ttn/atw/rrisk/rtrpg.html.

Redline versions of the regulatory language that incorporates the proposed changes in this action are available in the Metal Cans and the Metal Coil Dockets (Docket ID No. EPA-HQ-OAR-2017-0684 and Docket ID No. EPA-HQ-OAR-2017-0685, respectively).

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.

).

1

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 maximum achievable control technology (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 to determine if there are “developments in practices, processes, or control technologies” that may be appropriate to incorporate into the standards. 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 dockets for each subpart in this rulemaking (Docket ID No. EPA-HQ-OAR-2017-0684 for Metal Cans Coating and Docket ID No. EPA-HQ-OAR-2017-0685 for Metal Coil Coating).

1

In addition, section 301 of the CAA provides general authority for the Administrator to “prescribe such regulations as are necessary to carry out his functions” under the CAA.

In the first stage of the CAA section 112 standard setting process, the EPA promulgates technology-based standards under CAA section112(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 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.” 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. In certain instances, as provided in CAA section 112(h), the EPA may set work practice standards where it is not feasible to prescribe or enforce a numerical emission standard. 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 according 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 Risk Report that the Agency intended to use the Benzene NESHAP approach in making CAA section 112(f) residual risk determinations (EPA-453/R-99-001, p. ES-11). The EPA subsequently adopted this approach in its residual risk determinations and the United States Court of Appeals for the District of Columbia Circuit (the Court) upheld the EPA's interpretation that CAA section 112(f)(2) incorporates the approach established in the Benzene NESHAP. See

NRDC

v.

EPA,

529 F.3d 1077, 1083 (D.C. Cir. 2008).

The approach incorporated into the CAA and used by the EPA to evaluate residual risk and to develop standards under CAA section 112(f)(2) is a two-step approach. In the first step, the EPA determines whether risks are acceptable. This determination “considers all health

information, including risk estimation uncertainty, and includes a presumptive limit on maximum individual lifetime [cancer] risk (MIR)

2

of approximately 1-in-10 thousand.” 54 FR 38045, September 14, 1989. 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. 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.

2

Although defined as “maximum individual risk,” MIR refers only to cancer risk. MIR, one metric for assessing cancer risk, is the estimated risk if an individual were exposed to the maximum level of a pollutant for a lifetime.

CAA section 112(d)(6) separately requires the EPA to review standards promulgated under CAA section 112 and revise them “as necessary (taking into account developments in practices, processes, and control technologies)” no less often than every 8 years. In conducting this review, which we call the “technology review,” the EPA is not required to recalculate the MACT floor.

Natural Resources Defense Council (NRDC)

v.

EPA,

529 F.3d 1077, 1084 (D.C. Cir. 2008).

Association of Battery Recyclers, Inc.

v.

EPA,

716 F.3d 667 (D.C. Cir. 2013). The EPA may consider cost in deciding whether to revise the standards pursuant to CAA section 112(d)(6).

B. What are the source categories and how do the current NESHAP regulate their HAP emissions?

1. What is the Surface Coating of Metal Cans source category and how does the current NESHAP regulate its HAP emissions?

a. Source Category Description

The NESHAP for the Surface Coating of Metal Cans source category was promulgated on November 13, 2003 (68 FR 64432), and is codified at 40 CFR part 63, subpart KKKK. Technical corrections and clarifying amendments were promulgated on January 6, 2006 (71 FR 1386). The Surface Coating of Metal Cans NESHAP applies to the surface coating and related operations at each new, reconstructed, and existing affected source of HAP emissions at facilities that are major sources and are engaged in the surface coating of metal cans and ends (including decorative tins) and metal crowns and closures. The Surface Coating of Metal Cans NESHAP (40 CFR 63.3561) defines a “metal can” as “a single-walled container manufactured from metal substrate equal to or thinner than 0.3785 mm (0.0149 inch)” and includes coating operations for the four following subcategories:

• One- and two-piece draw and iron can body coating—includes one-piece aerosol cans, defined as an “aerosol can formed by the draw and iron process to which no ends are attached and a valve is placed directly on top” and two-piece draw and iron cans, defined as a “steel or aluminum can manufactured by the draw and iron process.” These include two-piece beverage cans manufactured to contain drinkable liquids, such as beer, soft drinks, or fruit juices, and two-piece food cans designed to contain edible products other than beverages and to be hermetically sealed.

• Sheetcoating—includes all the flat metal sheetcoating operations associated with the manufacture of three-piece cans, decorative tins, crowns, and closures.

• Three-piece can body assembly coating—includes three-piece aerosol cans, defined as a “steel aerosol can formed by the three-piece can assembly process manufactured to contain food or nonfood products,” and three-piece food cans, defined as a “steel can formed by the three-piece can assembly process manufactured to contain edible products and designed to be hermetically sealed.”

• End coating—includes the application of end seal compounds and repair spray coatings to metal can ends and includes three distinct coating type segments reflecting different end uses: Aseptic end seal compounds, non-aseptic end seal compounds, and repair spray coatings.

The Surface Coating of Metal Cans NESHAP defines a “decorative tin” as “a single-walled container, designed to be covered or uncovered that is manufactured from metal substrate equal to or thinner than 0.3785 mm (0.0149 inch) and is normally coated on the exterior surface with decorative coatings. Decorative tins may contain foods but are not hermetically sealed and are not subject to food processing steps such as retort or pasteurization. Interior coatings are not usually applied to protect the metal and contents from chemical interaction.”

The Surface Coating of Metal Cans NESHAP also defines a “coating” as “a material that is applied to a substrate for decorative, protective, or functional purposes. Such materials include, but are not limited to, paints, sealants, caulks, inks, adhesives, and maskants.” Fusion pastes, ink jet markings, mist solutions, and lubricants, as well as decorative, protective, or functional materials that consist only of protective oils for metals, acids, bases, or any combination of these substances, are not considered coatings under 40 CFR part 63, subpart KKKK.

Based on our search of the National Emission Inventory (NEI) (

www.epa.gov/air-emissions-inventories/national-emissions-inventory-nei

) and the EPA's Enforcement and Compliance History Online (ECHO) database (

echo.epa.gov

) and a review of active air emissions permits, we estimate that five facilities are subject to the Surface Coating of Metal Cans NESHAP. A complete list of facilities subject to the Surface Coating of Metal Cans NESHAP is available in Appendix 1 to the memorandum titled

Technology Review for Surface Coating Operations in the Metal Cans Category,

in the Metal Cans Docket (Docket ID No. EPA-HQ-OAR-2017-0684).

b. HAP Emission Sources

The primary HAP emitted from metal can surface coating operations are organic HAP and include glycol ethers, formaldehyde, xylenes, toluene, methyl isobutyl ketone, 2-(hexyloxy) ethanol, ethyl benzene, and methanol. These HAP account for 99 percent of the HAP emissions from the source category. The HAP emissions from the metal cans category occur from coating application lines, drying and curing ovens, mixing and thinning areas, and cleaning of equipment. The coating application lines and the drying and curing ovens are the largest sources of HAP emissions. The coating application lines apply an exterior base coat to two- and three-piece cans using a lithographic/printing (

i.e.,

roll) application process. The inside, side seam, and repair coatings are spray applied using airless spray equipment and are a minor portion of the can coating operations. As indicated by the name, repair spray coatings are used to cover breaks in the coating that are caused during the formation of the score in easy-open ends or to provide, after the manufacturing process, an additional protective layer for corrosion resistance.

Inorganic HAP emissions were considered in the development of the Surface Coating of Metal Cans NESHAP. Inorganic HAP, including chromium and manganese compounds, are contained in some of the coatings used by this source category. However, the EPA determined that no controls were needed because the coatings used that may contain inorganic HAP were not spray applied. Instead, these coatings were roll applied through direct contact (similar to lithographic printing) with the surface to which they were being applied, and the inorganic HAP became part of the cured coating.

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No inorganic HAP were reported in the NEI data used for this RTR for surface coating operations at major source metal can coating facilities.

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National Emission Standards for Hazardous Air Pollutants: Surface Coating of Metal Cans Background Information for Final Standards.

Summary of Public Comments and Responses. EPA 453/R-03-009. August 2003. Section 2.5.4.

c. NESHAP Requirements for Control of HAP

We estimated that the Surface Coating of Metal Cans NESHAP requirements would reduce the emissions of organic HAP from the source category by 71 percent or 6,800 tpy (68 FR 2110, January 15, 2003). This estimate included two HAP that were since delisted. The delisting of ethylene glycol monobutyl ether occurred in 2004, and the delisting of methyl ethyl ketone occurred in 2005.

The NESHAP specifies numerical emission limits for existing sources and for new and reconstructed sources for organic HAP emissions according to four can coating subcategories. The organic HAP emission limits for existing sources conducting: (1) One- and two-piece draw and iron can body coating (includes two-piece beverage cans, two-piece food cans, and one-piece aerosol cans) ranges from 0.07 to 0.12 kilogram (kg) HAP/liter of coating solids (or 0.59 to 0.99 pound/gallon (lb/gal)); (2) sheet coating is 0.03 kg HAP/liter of coating solids (or 0.26 lb/gal); (3) three piece can assembly (includes inside spray, aseptic, and non-aseptic side seam stripes on food cans, side seam stripes on general line non-food cans, and side seam stripes on aerosol cans) ranges from 0.29 to 1.94 kg HAP/liter of coating solids (or 2.43 to 16.16 lb/gal); and (4) end coating (includes aseptic and non-aseptic end seal compounds and repair spray coatings) ranges from zero to 2.06 kg HAP/liter of coating solids (or zero to 17.17 lb/gal). The organic HAP emission limits for new and reconstructed sources conducting: (1) One and two-piece draw and iron can body coating ranges from 0.04 to 0.08 kg HAP/liter of coating solids (or 0.31 to 0.65 lb/gal); (2) sheet coating is 0.02 kg HAP/liter of coating solids (or 0.17 lb/gal); (3) three piece can assembly ranges from 0.12 to 1.48 kg HAP/liter of coating solids (or 1.03 to 12.37 lb/gal); and (4) end coating ranges from zero to 0.64 kg HAP/liter of coating solids (or zero to 5.34 lb/gal). The specific organic HAP emission limits for each can coating subcategory are listed in Table 3 of the memorandum titled

Technology Review for Surface Coating Operations in the Metal Cans Category,

in the Metal Cans Docket (Docket ID No. EPA-HQ-OAR-2017-0684).

Compliance with the Surface Coating of Metal Cans NESHAP emission limits can be achieved using several different options, including a compliant material option, an emission rate without add-on controls option (averaging option), an emission rate with add-on controls option, or a control efficiency/outlet concentration. For any coating operation(s) on which the facility uses the compliant material option or the emission rate without add-on controls option, the facility is not required to meet any work practice standards.

If the facility uses the emission rate with add-on controls option, the facility must develop and implement a work practice plan to minimize organic HAP emissions from the storage, mixing, and conveying of coatings, thinners, and cleaning materials used in, and waste materials generated by, the coating operation(s) using that option. The plan must specify practices and procedures to ensure that a set of minimum work practices specified in the NESHAP are implemented. The facility must also comply with site-specific operating limits for the emission capture and control system.

2. What is the Surface Coating of Metal Coil source category and how does the current NESHAP regulate its HAP emissions?

a. Source Category Description

The NESHAP for the Surface Coating of Metal Coil source category was promulgated on June 10, 2002 (67 FR 39794), and is codified at 40 CFR part 63, subpart SSSS. A technical correction to the final rule was published on March 17, 2003 (68 FR 12590). The Surface Coating of Metal Coil NESHAP applies to owners or operators of metal coil surface coating operations at facilities that are major sources of HAP.

The Surface Coating of Metal Coil NESHAP (40 CFR 63.5100) applies to the collection of all coil coating lines at a facility and defines a coil coating line as the process for metal coil coating that includes the web unwind or feed station, a series of one or more coating stations, associated curing ovens, wet sections, and quench stations. A coil coating line does not include ancillary operations such as mixing/thinning, cleaning, wastewater treatment, and storage of coating material. The Surface Coating of Metal Coil NESHAP (40 CFR 63.5110) defines a coil coating operation as the collection of equipment used to apply an organic coating to the surface of any continuous metal strip that is 0.006 inch (0.15 millimeter (mm)) thick or more that is packaged in a roll or coil. The Surface Coating of Metal Coil NESHAP also defines a coating material as the coating and other products (

e.g.,

a catalyst and resin in multi-component coatings) combined to make a single material at the coating facility that is applied to metal coil and includes organic solvents used to thin a coating prior to application to the metal coil.

Based on our search of the NEI and EPA's ECHO database and a review of active air emission permits, we estimate that 48 facilities are subject to the Surface Coating of Metal Coil NESHAP. A complete list of facilities we identified as subject to the Surface Coating of Metal Coil NESHAP is available in Appendix 1 to the memorandum titled

Residual Risk Assessment for the Surface Coating of Metal Coil Source Category in Support of the 2019 Risk and Technology Review Proposed Rule

(hereafter referred to as the

Metal Coil Risk Assessment Report

), in the Surface Coating of Metal Coil Docket (Docket ID No. EPA-HQ-OAR-2017-0685).

b. HAP Emission Sources

The primary HAP emitted from metal coil coating operations are organic HAP and include xylenes, glycol ethers, naphthalene, isophorone, toluene, diethylene glycol monobutyl ether (DGME), and ethyl benzene. The majority of organic HAP emissions are from the coating application and the curing ovens.

Inorganic HAP emissions were considered in the development of the Surface Coating of Metal Coil NESHAP. Based on information reported in survey responses during the development of the 2002 proposed NESHAP, inorganic HAP were present in the pigments and film-forming components of some coatings used by this source category. However, we concluded that inorganic HAP are not likely to be emitted from these sources because of the application techniques used (67 FR 46032, July 11, 2002). The data obtained from the NEI and the Toxics Release Inventory for

this RTR included low quantities of inorganic HAP for major source facilities that conduct metal coil operations. Further investigation of these sources concluded that these inorganic emissions were reported in error.

c. NESHAP Requirements for Control of HAP

We estimated that the Surface Coating of Metal Coil NESHAP requirements would reduce the emissions of organic HAP from the source category by approximately 55 percent or 1,318 tpy (65 FR 44616, July 18, 2000). The NESHAP specifies numerical emission limits for organic HAP emissions from the coating application stations and associated curing ovens. The Surface Coating of Metal Coil NESHAP provides options for limiting organic HAP emissions to one of the four specified levels: (1) Use only individually compliant coatings with an organic HAP content that does not exceed 0.046 kg/liter of solids applied, (2) use coatings with an average organic HAP content of 0.046 kg/liter of solids on a rolling 12-month average, (3) use a capture system and add-on control device to either reduce emissions by 98 percent or use a 100-percent efficient capture system (permanent total enclosure (PTE)) and an oxidizer to reduce organic HAP emissions to no more than 20 parts per million by volume (ppmv) as carbon, or (4) use a combination of compliant coatings and control devices to maintain an average equivalent emission rate of organic HAP not exceeding 0.046 kg/liter of solids on a rolling 12-month average basis. These compliance options apply to an individual coil coating line, to multiple lines as a group, or to the entire affected source.

Compliant coatings must contain no organic HAP (each organic HAP that is not an Occupational Safety and Health Administration (OSHA)-defined carcinogen that is measured to be present at less than 1 percent by weight is counted as zero). The NESHAP also sets operating limits for the emission capture and add-on control devices.

C. What data collection activities were conducted to support this action?

For the risk modeling portion of these RTRs, the EPA used data from the 2011 and 2014 NEI. 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 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 points at facilities and the related emissions release parameters. We used NEI emissions and supporting data as the primary data to develop the model input files for the risk assessments for each of these three source categories. Detailed information on the development of the modeling file for the Surface Coating of Metal Cans source category can be found in Appendix 1 to the

Residual Risk Assessment for the Surface Coating of Metal Cans Source Category in Support of the 2019 Risk and Technology Review Proposed Rule

(hereafter referred to as the

Metal Cans Risk Assessment Report

), in the Metal Cans Docket (Docket ID No. EPA-HQ-OAR-2017-0684). Detailed information on the development of the modeling file for the Surface Coating of Metal Coil source category can be found in Appendix 1 to the

Metal Coil Risk Assessment Report,

in the Metal Coil Docket (Docket ID No. EPA-HQ-OAR-2017-0685).

For both the risk modeling and technology review portion of these RTRs, we also gathered data from facility construction and operating permits regarding emission points, air pollution control devices, and process operations. We collected permits and supporting documentation from state permitting authorities through state-maintained online databases. The facility permits were also used to confirm that the facilities were major sources of HAP and were subject to the NESHAP that are the subject of these risk assessments. In certain cases, we contacted industry associations and facility owners or operators to confirm and clarify the sources of emissions that were reported in the NEI. No formal information collection request (ICR) was conducted for this action.

For the technology review portion of these RTRs, we also used information from the EPA's ECHO database as a tool to identify which facilities were potentially subject to the NESHAP. The ECHO database provides integrated compliance and enforcement information for approximately 800,000 regulated facilities nationwide. Using the search feature in ECHO, the EPA identified facilities that could potentially be subject to each of these two NESHAP. We then reviewed operating permits for these facilities, when available, to confirm that they were major sources of HAP with emission sources subject to these NESHAP.

Also for the technology reviews, we collected information from the reasonably available control technology (RACT), best available control technology (BACT), and lowest achievable emission rate (LAER) determinations in the EPA's RACT/BACT/LAER Clearinghouse (RBLC).

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This 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 by a large amount, an NSR permit must be obtained. This central database 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 surface coating operations to reduce air emissions.

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https://www.epa.gov/catc/ractbactlaer-clearinghouse-rblc-basic-information.

Additional information about these data collection activities for the technology reviews is contained in the technology review memoranda titled

Technology Review for Surface Coating Operations in the Metal Cans Category,

May 2017 (hereafter referred to as the

Metal Cans Technology Review Memo

), and the

Technology Review for Surface Coating Operations in the Metal Coil Category,

September 2017 (hereafter referred to as the

Metal Coil Technology Review Memo

), available in the respective Metal Cans and Metal Coil Dockets.

D. What other relevant background information and data are available?

We also reviewed the NESHAP for other surface coating source categories that were promulgated after the Surface Coating of Metal Cans and the Surface Coating of Metal Coil NESHAP as part of the technology review for these source categories. We reviewed the regulatory requirements and/or technical analyses associated with these later regulatory actions to identify any practices, processes, and control technologies considered in those rulemakings that could be applied to emission sources in the Surface Coating of Metal Cans and the Surface Coating of Metal Coil source categories, as well as the costs, non-air impacts, and energy implications associated with the use of those technologies. We also reviewed

information available in the American Coatings Association's (ACA)

Industry Market Analysis,

9th Edition (2014-2019).

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The

ACA Industry Market Analysis

provided information on trends in coatings technology that can affect emissions from the Surface Coating of Metal Cans and the Surface Coating of Metal Coil source categories. Additional details regarding our review of these information sources are contained in the

Metal Cans Technology Review Memo,

and the

Metal Coil Technology Review Memo,

available in the respective Metal Cans and Metal Coil Dockets.

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Prepared for the ACA, Washington, DC, by The ChemQuest Group, Inc., Cincinnati, Ohio. 2015.

III. Analytical Procedures and Decision Making

In this section, we describe the analyses performed to support the proposed decisions for the RTRs and other issues addressed in this proposal.

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 38046, September 14, 1989. 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 the HAP emissions from each source in the source category, the hazard index (HI) for chronic exposures to HAP with the potential to cause noncancer health effects, and the hazard quotient (HQ) for acute exposures to HAP with the potential to cause noncancer health effects.

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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 scope of the EPA's risk analysis is consistent with the EPA's response to comments on our policy under the Benzene NESHAP where the EPA explained that:

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The MIR is defined as the cancer risk associated with a lifetime of exposure at the highest concentration of HAP where people are likely to live. The HQ is the ratio of the potential exposure to the HAP to the level at or below which no adverse chronic non-cancer effects are expected; the HI is the sum of HQs for HAP that affect the same target organ or organ system.

“[t]he policy chosen by the Administrator permits consideration of multiple measures of health risk. Not only can the MIR figure be considered, but also incidence, the presence of noncancer 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'.”

See 54 FR 38057, September 14, 1989. 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. Similarly, with regard to the ample margin of safety analysis, the EPA stated in the Benzene NESHAP that the: “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 categories under review, mobile source emissions, natural source emissions, persistent environmental pollution, or atmospheric transformation in the vicinity of the sources in the categories.

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.”

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Recommendations of the SAB Risk and Technology Review (RTR) Panel are provided in their report, which is available at:

http://yosemite.epa.gov/sab/sabproduct.nsf/4AB3966E263D943A8525771F00668381/$File/EPA-SAB-10-007-unsigned.pdf.

In response to the SAB recommendations, the EPA incorporates cumulative risk analyses into its RTR risk assessments, including those reflected in this proposal. 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 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

• 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 (

i.e.,

the 2003 Surface Coating of Metal Cans NESHAP; and the 2002 Surface Coating of Metal Coil NESHAP) we review a variety of data sources in our investigation of potential practices, processes, or controls that may have not been considered for each of the two source categories during development of the NESHAP. Among the sources we reviewed were the NESHAP for various industries that were promulgated after the MACT standards being reviewed in this action (

e.g.,

NESHAP for Miscellaneous Metal Parts and Products (40 CFR part 63, subpart MMMM)). We also reviewed the results of other technology reviews for other surface coating source categories since the promulgation of the NESHAP (

e.g.,

the technology reviews conducted for the Shipbuilding and Ship Repair (Surface Coating) NESHAP (40 CFR part 63, subpart II) and the Wood Furniture Manufacturing Operations NESHAP (40 CFR part 63, subpart JJ)). We reviewed the regulatory requirements and/or technical analyses associated with these regulatory actions to identify any practices, processes, and control technologies considered in these efforts that could be applied to emission sources in the Surface Coating of Metal Cans and the Surface Coating of Metal Coil source categories, as well as the costs, non-air impacts, and energy implications associated with the use of these technologies. Finally, we reviewed information from other sources, such as state and/or local permitting agency databases and industry-sponsored market analyses and trade journals, to research advancements in add-on controls and lower HAP technology for coatings and solvents. For a more detailed discussion of our methods for performing these technology reviews, refer to the

Metal Cans Technology Review Memo

and the

Metal Coil Technology Review Memo,

which are available in the respective Metal Cans and Metal Coil dockets.

C. How do we estimate post-MACT risk posed by these source categories?

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 assessments in this action. The dockets for this rulemaking contain the following documents which provide more information on the risk assessment inputs and models: Metal Cans Risk Assessment Report and the Metal Coil Risk Assessment Report. 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;

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and described in the SAB review report issued in 2010. They are also consistent with the key recommendations contained in that report.

8

U.S. EPA.

Risk and Technology Review (RTR) Risk Assessment Methodologies: For Review by the EPA's Science Advisory Board with Case Studies—MACT I Petroleum Refining Sources and Portland Cement Manufacturing,

June 2009. EPA-452/R-09-006.

https://www3.epa.gov/airtoxics/rrisk/rtrpg.html.

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 2011 NEI or the 2014 NEI. The 2011 version of the NEI was the most recent version available during the data collection phase of this rulemaking; therefore, most data were obtained from the 2011 NEI. The 2014 NEI was used to supplement the dataset with HAP data for emission units or processes for which the 2011 NEI included only volatile organic compounds (VOC) or particulate matter. In some cases, the industry association or the specific facilities were contacted to confirm emissions that appeared to be outliers, that were otherwise inconsistent with our understanding of the industry, or that were associated with high risk values in our initial risk screening analyses. When appropriate, emission values and release characteristics were revised based on these facility contacts, and these changes were documented. Additional information on the development of the modeling file for each source category, including the development of the actual emissions estimates and emissions release characteristics, can be found in Appendix 1 to the

Metal Cans Risk Assessment Report,

in the Metal Cans Docket and Appendix 1 to the

Metal Coil Risk Assessment Report,

in the Metal Coil Docket.

2. How did we estimate MACT-allowable emissions?

The available emissions data in the RTR emissions dataset include estimates of the mass of HAP emitted during a specified annual time period. These “actual” emission levels are often lower than the emission levels allowed under the requirements of the current MACT standards. The emissions allowed under the MACT standards are referred to as the “MACT-allowable” emissions. We discussed the consideration of both MACT-allowable and actual emissions in the final Coke Oven Batteries RTR (70 FR 19998-19999, April 15, 2005) and in the proposed and final Hazardous Organic NESHAP RTRs (71 FR 34428, June 14, 2006, and 71 FR 76609, December 21, 2006, respectively). In those actions, we noted that assessing the risk at the MACT-allowable level is inherently reasonable since that risk reflects the maximum level facilities could emit and still comply with national emission standards. We also explained that it is reasonable to consider actual emissions, where such data are available, in both steps of the risk analysis, in accordance with the Benzene NESHAP approach. (54 FR 38044, September 14, 1989.)

For both the Surface Coating of Metal Cans and the Surface Coating of Metal Coil source categories, the EPA calculated allowable emissions by developing source category-specific multipliers of 1.1 that was applied to the current emissions for each category to estimate the allowable emissions. The multipliers were based on information obtained from the facility operating permits and the add-on control device control efficiencies for metal can and metal coil coating operations. Both categories have facilities that employ the use of add-on controls with efficiencies that are slightly above the control efficiency level required by the respective NESHAP, which suggests that the actual emissions are slightly lower than the NESHAP allowable levels.

For more details on how the EPA estimated the MACT allowable emissions for the Surface Coating of Metal Cans source category, please see Appendix 1 to the

Metal Cans Risk Assessment Report,

in the Metal Cans Docket (Docket ID No. EPA-HQ-OAR-2017-0684). For more details on how the EPA calculated the MACT allowable emissions for the Surface Coating of Metal Coil source category, please see Appendix 1 to the

Metal Coil Risk Assessment Report,

in the Metal Coil Docket (Docket ID No. EPA-HQ-OAR-2017-0685).

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 source categories addressed in this proposal were estimated using the Human Exposure Model (HEM-3).

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The HEM-3 performs three primary risk assessment activities: (1) Conducting dispersion modeling to estimate the concentrations of HAP in ambient air, (2) estimating long-term and short-term inhalation exposures to individuals residing within 50 kilometers (km) of the modeled sources, and (3) estimating individual and population-level inhalation risk using the exposure estimates and quantitative dose-response information.

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For more information about HEM-3, go to

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

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 facilities.

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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 U.S. and Puerto Rico. A second library of U.S. Census Bureau census block

11

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.

10

U.S. EPA. Revision to the

Guideline on Air Quality Models: Adoption of a Preferred General Purpose (Flat and Complex Terrain) Dispersion Model and Other Revisions

(70 FR 68218, November 9, 2005).

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A census block is the smallest geographic area for which census statistics are tabulated.

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 source categories. 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 (μg/m

3

)) by its unit risk estimate (URE). The URE is an upper-bound estimate of an individual's incremental risk of contracting cancer over a lifetime of exposure to a concentration of 1 microgram of the pollutant per cubic meter of air. For residual risk

assessments, we generally use UREs from the EPA's Integrated Risk Information System (IRIS). For carcinogenic pollutants without IRIS values, we look to other reputable sources of cancer dose-response values, often using California EPA (CalEPA) UREs, where available. In cases where new, scientifically credible dose-response values have been developed in a manner consistent with EPA guidelines and have undergone a peer review process similar to that used by the EPA, we may use such dose-response values in place of, or in addition to, other values, if appropriate. The pollutant-specific dose-response values used to estimate health risk are available at

https://www.epa.gov/fera/dose-response-assessment-assessing-health-risks-associated-exposure-hazardous-air-pollutants.

To estimate individual lifetime cancer risks associated with exposure to HAP emissions from each facility in the source category, we sum the risks for each of the carcinogenic HAP

12

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.

12

The EPA's 2005 Guidelines for Carcinogen Risk Assessment classifies carcinogens as: “carcinogenic to humans,” “likely to be carcinogenic to humans,” and “suggestive evidence of carcinogenic potential.” These classifications also coincide with the terms “known carcinogen, probable carcinogen, and possible carcinogen,” respectively, which are the terms advocated in the EPA's Guidelines for Carcinogen Risk Assessment, published in 1986 (51 FR 33992, September 24, 1986). In August 2000, the document, Supplemental Guidance for Conducting Health Risk Assessment of Chemical Mixtures (EPA/630/R-00/002), was published as a supplement to the 1986 document. Copies of both documents can be obtained from

https://cfpub.epa.gov/ncea/risk/recordisplay.cfm?deid=20533&CFID=70315376&CFTOKEN=71597944.

Summing the risk of these individual compounds to obtain the cumulative cancer risk is an approach that was recommended by the EPA's SAB in their 2002 peer review of the EPA's National Air Toxics Assessment (NATA) titled NATA—

Evaluating the National-scale Air Toxics Assessment 1996 Data—a SAB Advisory,

available at

https://yosemite.epa.gov/sab/sabproduct.nsf/214C6E915BB04E14852570CA007A682C/$File/ecadv02001.pdf.

To assess the risk of noncancer health effects from chronic exposure to HAP, we calculate either an HQ or a target organ-specific hazard index (TOSHI). We calculate an HQ when a single noncancer HAP is emitted. Where more than one noncancer HAP is emitted, we sum the HQ for each of the HAP that affects a common target organ or target organ system to obtain a TOSHI. The HQ is the estimated exposure divided by the chronic noncancer dose-response value, which is a value selected from one of several sources. The preferred chronic noncancer dose-response value is the EPA RfC, defined as “an estimate (with uncertainty spanning perhaps an order of magnitude) of a continuous inhalation exposure to the human population (including sensitive subgroups) that is likely to be without an appreciable risk of deleterious effects during a lifetime” (

https://iaspub.epa.gov/sor_internet/registry/termreg/searchandretrieve/glossariesandkeywordlists/search.do?details=&vocabName=IRIS%20Glossary

). In cases where an RfC from the EPA's IRIS is not available or where the EPA determines that using a value other than the RfC is appropriate, the chronic noncancer dose-response value can be a value from the following prioritized sources, which define their dose-response values similarly to the EPA: (1) The Agency for Toxic Substances and Disease Registry (ATSDR) Minimum Risk Level (

https://www.atsdr.cdc.gov/mrls/index.asp

); (2) the CalEPA Chronic Reference Exposure Level (REL) (

https://oehha.ca.gov/air/crnr/notice-adoption-air-toxics-hot-spots-program-guidance-manual-preparation-health-risk-0

); or (3) as noted above, a scientifically credible dose-response value that has been developed in a manner consistent with the EPA guidelines and has undergone a peer review process similar to that used by the EPA. The pollutant-specific dose-response values used to estimate health risks are available at

https://www.epa.gov/fera/dose-response-assessment-assessing-health-risks-associated-exposure-hazardous-air-pollutants.

c. Risk From Acute Exposure to HAP That May Cause Health Effects Other Than Cancer

For each HAP for which appropriate acute inhalation dose-response values are available, the EPA also assesses the potential health risks due to acute exposure. For these assessments, the EPA makes conservative assumptions about emission rates, meteorology, and exposure location. We use the peak hourly emission rate,

13

worst-case dispersion conditions, and, in accordance with our mandate under section 112 of the CAA, the point of highest off-site exposure to assess the potential risk to the maximally exposed individual.

13

In the absence of hourly emission data, we develop estimates of maximum hourly emission rates by multiplying the average actual annual emissions rates by a factor (either a category-specific factor or a default factor of 10) to account for variability. This is documented in the

Metal Cans Risk Assessment Report and the Metal Coil Risk Assessment Report

and in Appendix 5 of the report: Analysis of Data on Short-term Emission Rates Relative to Long-term Emission Rates. These documents are available in the Metal Cans Docket and the Metal Coil Docket.

To characterize the potential health risks associated with estimated acute inhalation exposures to a HAP, we generally use multiple acute dose-response values, including acute RELs, acute exposure guideline levels (AEGLs), and emergency response planning guidelines (ERPG) for 1-hour exposure durations, if available, to calculate acute HQs. The acute HQ is calculated by dividing the estimated acute exposure 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.”

14

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.

15

They are guideline levels for

“once-in-a-lifetime, short-term exposures to airborne concentrations of acutely toxic, high-priority chemicals.”

Id.

at 21. The AEGL-1 is specifically defined as “the airborne concentration (expressed as ppm (parts per million) or mg/m

3

(milligrams per cubic meter)) of a substance above which it is predicted that the general population, including susceptible individuals, could experience notable discomfort, irritation, or certain asymptomatic nonsensory effects. However, the effects are not disabling and are transient and reversible upon cessation of exposure.” The document also notes that “Airborne concentrations below AEGL-1 represent exposure levels that can produce mild and progressively increasing but transient and nondisabling odor, taste, and sensory irritation or certain asymptomatic, nonsensory effects.”

Id.

AEGL-2 are defined as “the airborne concentration (expressed as parts per million or milligrams per cubic meter) of a substance above which it is predicted that the general population, including susceptible individuals, could experience irreversible or other serious, long-lasting adverse health effects or an impaired ability to escape.”

Id.

14

CalEPA issues acute RELs as part of its Air Toxics Hot Spots Program, and the 1-hour and 8-hour values are documented in

Air Toxics Hot Spots Program Risk Assessment Guidelines, Part I, The Determination of Acute Reference Exposure Levels for Airborne Toxicants, which is available at http://oehha.ca.gov/air/general-info/oehha-acute-8-hour-and-chronic-reference-exposure-level-rel-summary

.

15

National Academy of Sciences, 2001.

Standing Operating Procedures for Developing Acute Exposure Levels for Hazardous Chemicals,

page 2. Available at

https://www.epa.gov/sites/production/files/2015-09/documents/sop_final_standing_operating_procedures_2001.pdf

. Note that the National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances ended in October 2011, but the AEGL program continues to operate at the EPA and works with the National

Academies to publish final AEGLs (

https://www.epa.gov/aegl

).

ERPGs are “developed for emergency planning and are intended as health-based guideline concentrations for single exposures to chemicals.”

16

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.

16

ERPGS Procedures and Responsibilities.

March 2014. American Industrial Hygiene Association. Available at:

https://www.aiha.org/get-involved/AIHAGuidelineFoundation/EmergencyResponsePlanningGuidelines/Documents/ERPG%20Committee%20Standard%20Operating%20Procedures%20%20-%20March%202014%20Revision%20%28Updated%2010-2-2014%29.pdf

.

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 these source categories, we did not have short term emissions data; therefore, we developed source category-specific factors based on information about each industry. We request comment on our assumptions regarding hour-to-hour variation in emissions and our methods of calculating the multiplier for estimating the peak 1-hour emissions for each source category and any additional information that could help refine our approach.

The Surface Coating of Metal Cans source category process is a continuous (non-batch) coating application and curing process that results in consistent emission rates. The sources in this category primarily roll-apply coatings onto the surface of the metal cans. The sources employ the use of various compliance options, which include the use of compliant coatings, coatings when averaged meet the emission limits, and for facilities that cannot use these options, they employ the use of add-on controls. We expect that the hourly variations in emissions from these processes during routine operations to be minimal. Thus, applying the default emission factor of 10 to estimate the worst-case hourly emission rate is not reasonable for this category. We expect that minimal variations in emissions occur due to variations in the organic HAP content of the coatings. We calculated acute emissions by developing a source category-specific multiplier of 1.1 that was applied to the actual annual emissions, which were then divided by the total number of hours in a year (8,760 hours). A further discussion of why this factor was chosen can be found in Appendix 1 to the Metal Cans Risk Assessment Report in the Metal Cans Docket.

Similarly, for the Surface Coating of Metal Coil source category, we expect to see minimal hour-to-hour variation in emissions during routine operations because coil coating operations roll-apply coating onto a moving metal strip (coil) in a continuous coating process. The coil ends are seamed together in a continuous (non-batch) process that achieves a consistent emission rate. Thus, the default emission factor of 10 to estimate the worst-case hourly emission rate is not reasonable for this category. We expect that minimal variation in emissions occur due to variations in the organic HAP content of the coatings from batch to batch. We calculated acute emissions by developing a source category-specific multiplier of 1.1 that was applied to the actual annual emissions, which were then divided by the total number of hours in a year (8,760 hours). A further discussion of why this factor was chosen can be found in Appendix 1 to the Metal Coil Risk Assessment Report in the Metal Coil Docket.

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 (even under the conservative assumptions of the screening assessment), and no further analysis is performed for these HAP. In cases where an acute HQ from the screening step is greater than 1, we consider additional site-specific data to develop a more refined estimate of the potential for acute exposures of concern. For both source categories in this action, the data refinements employed consisted of plotting the HEM-3 polar grid results for each HAP with an acute HQ value greater than 1 on aerial photographs of the facilities. We then assessed whether the highest acute HQs were off-site and at locations that may be accessible to the public (

e.g.,

roadways and public buildings). These refinements are discussed more fully in the

Metal Cans

and

Metal Coil Risk Assessment Reports,

available in the respective Metal Cans and Metal Coil Dockets.

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 categories emit any HAP known to be persistent and bioaccumulative in the environment (PB-HAP), as identified in the EPA's Air Toxics Risk Assessment Library (see Volume 1, Appendix D,

at https://www.epa.gov/fera/risk-assessment-and-modeling-air-toxics-risk-assessment-reference-library

).

For the Surface Coating of Metal Cans 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 the Surface Coating of Metal Coil source category, we identified PB-HAP emissions of lead, so we proceeded to the next step of the evaluation. In this

step, we determine whether the facility-specific emission rates of the emitted PB-HAP are large enough to create the potential for significant human health risk through ingestion exposure under reasonable worst-case conditions. To facilitate this step, we use previously developed screening threshold emission rates for several PB-HAP that are based on a hypothetical upper-end screening exposure scenario developed for use in conjunction with the EPA's Total Risk Integrated Methodology.Fate, Transport, and Ecological Exposure (TRIM.FaTE) model. The PB-HAP with screening threshold emission rates are arsenic compounds, cadmium compounds, chlorinated dibenzodioxins and furans, mercury compounds, and polycyclic organic matter (POM). Based on the EPA estimates of toxicity and bioaccumulation potential, the pollutants above represent a conservative list for inclusion in multipathway risk assessments for RTR rules. (See Volume 1, Appendix D at

https://www.epa.gov/sites/production/files/201308/documents/volume_1_reflibrary.pdf

). In this assessment, we compare the facility-specific emission rates of these PB-HAP to the screening threshold emission rates for each PB-HAP to assess the potential for significant human health risks via the ingestion pathway. We call this application of the TRIM.FaTE model the Tier 1 screening assessment. The ratio of a facility's actual emission rate to the Tier 1 screening threshold emission rate is a “screening value.”

We derive the Tier 1 screening threshold emission rates for these PB-HAP (other than lead compounds) to correspond to a maximum excess lifetime cancer risk of 1-in-1 million (

i.e.,

for arsenic compounds, polychlorinated dibenzodioxins and furans and POM) or, for HAP that cause noncancer health effects (

i.e.,

cadmium compounds and mercury compounds), a maximum HQ of 1. If the emission rate of any one PB-HAP or combination of carcinogenic PB-HAP in the Tier 1 screening assessment exceeds the Tier 1 screening threshold emission rate for any facility (

i.e.,

the screening value is greater than 1), we conduct a second screening assessment, which we call the Tier 2 screening assessment.

In the Tier 2 screening assessment, the location of each facility that exceeds a Tier 1 screening threshold emission rate is used to refine the assumptions associated with the Tier 1 fisher and farmer exposure scenarios at that facility. A key assumption in the Tier 1 screening assessment is that a lake and/or farm is located near the facility. As part of the Tier 2 screening assessment, we use a U.S. Geological Survey (USGS) database to identify actual waterbodies within 50 km of each facility. We also examine the differences between local meteorology near the facility and the meteorology used in the Tier 1 screening assessment. We then adjust the previously-developed Tier 1 screening threshold emission rates for each PB-HAP for each facility based on an understanding of how exposure concentrations estimated for the screening scenario change with the use of local meteorology and USGS waterbody data. If the PB-HAP emission rates for a facility exceed the Tier 2 screening threshold emission rates and data are available, we may conduct a Tier 3 screening assessment. If PB-HAP emission rates do not exceed a Tier 2 screening value of 1, we consider those PB-HAP emissions to pose risks below a level of concern.

There are several analyses that can be included in a Tier 3 screening assessment, depending upon the extent of refinement warranted, including validating that the lakes are fishable, considering plume-rise to estimate emissions lost above the mixing layer, and considering hourly effects of meteorology and plume rise on chemical fate and transport. If the Tier 3 screening assessment indicates that risks above levels of concern cannot be ruled out, the EPA may further refine the screening assessment through a site-specific assessment.

In evaluating the potential multipathway risk from emissions of lead compounds, rather than developing a screening threshold emission rate, we compare maximum estimated chronic inhalation exposure concentrations to the level of the current National Ambient Air Quality Standards (NAAQS) for lead.

17

Values below the level of the primary (health-based) lead NAAQS are considered to have a low potential for multipathway risk.

17

In doing so, the EPA notes that the legal standard for a primary NAAQS—that a standard is requisite to protect public health and provide an adequate margin of safety (CAA section 109(b))—differs from the CAA section 112(f) standard (requiring, among other things, that the standard provide an “ample margin of safety to protect public health”). However, the primary lead NAAQS is a reasonable measure of determining risk acceptability (

i.e.,

the first step of the Benzene NESHAP analysis) since it is designed to protect the most susceptible group in the human population—children, including children living near major lead emitting sources. 73 FR 67002/3; 73 FR 67000/3; 73 FR 67005/1. In addition, applying the level of the primary lead NAAQS at the risk acceptability step is conservative, since that primary lead NAAQS reflects an adequate margin of safety.

For further information on the multipathway assessment approach, see the Metal Coil Risk Assessment Report, which is available in the Metal Coil 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, (POM, mercury (both inorganic mercury and methyl mercury), and lead compounds. The acid gases included in the screening assessment are hydrochloric acid (HCl) and hydrogen fluoride (HF).

HAP that persist and bioaccumulate are of particular environmental concern because they accumulate in the soil, sediment, and water. The acid gases, HCl and HF, are included due to their well-documented potential to cause direct damage to terrestrial plants. In the environmental risk screening assessment, we evaluate the following four exposure media: Terrestrial soils, surface water bodies (includes water-column and benthic sediments), fish consumed by wildlife, and air. Within these four exposure media, we evaluate nine ecological assessment endpoints, which are defined by the ecological entity and its attributes. For PB-HAP (other than lead), both community-level and population-level endpoints are included. For acid gases, the ecological assessment evaluated is terrestrial plant communities.

An ecological benchmark represents a concentration of HAP that has been linked to a particular environmental effect level. For each environmental HAP, we identified the available ecological benchmarks for each assessment endpoint. We identified, where possible, ecological benchmarks at the following effect levels: Probable effect levels, lowest-observed-adverse-

effect level, and no-observed-adverse-effect level. In cases where multiple effect levels were available for a particular PB-HAP and assessment endpoint, we use all of the available effect levels to help us to determine whether ecological risks exist and, if so, whether the risks could be considered significant and widespread.

For further information on how the environmental risk screening assessment was conducted, including a discussion of the risk metrics used, how the environmental HAP were identified, and how the ecological benchmarks were selected, see Appendix 9 of the

Metal Cans Risk Assessment Report

and the

Metal Coil Risk Assessment Report,

in the Metal Cans Docket and the Metal Coil Docket, respectively.

b. Environmental Risk Screening Methodology

For the environmental risk screening assessment, the EPA first determined whether any facilities in the Surface Coating of Metal Cans and Surface Coating of Metal Coil source categories emitted any of the environmental HAP. For the Surface Coating of Metal Cans source category, we identified emissions of HCl and HF. For the Surface Coating of Metal Coil source category, we identified emissions of HF and lead.

Because one or more of the environmental HAP evaluated are emitted by at least one facility in the source categories, we proceeded to the second step of the evaluation for both the Surface Coating of Metal Cans and the Surface Coating of Metal Coil source categories.

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. With the exception of lead, the environmental risk screening assessment for PB-HAP consists of three tiers. The first tier of the environmental risk screening assessment uses the same health-protective conceptual model that is used for the Tier 1 human health screening assessment. TRIM.FaTE model simulations were used to back-calculate Tier 1 screening threshold emission rates. The screening threshold emission rates represent the emission rate in tons per year that results in media concentrations at the facility that equal the relevant ecological benchmark. To assess emissions from each facility in the category, the reported emission rate for each PB-HAP was compared to the Tier 1 screening threshold emission rate for that PB-HAP for each assessment endpoint and effect level. If emissions from a facility do not exceed the Tier 1 screening threshold emission rate, the facility “passes” the screening assessment, and, therefore, is not evaluated further under the screening approach. If emissions from a facility exceed the Tier 1 screening threshold emission rate, we evaluate the facility further in Tier 2.

In Tier 2 of the environmental screening assessment, the screening threshold emission rates are adjusted to account for local meteorology and the actual location of lakes in the vicinity of facilities that did not pass the Tier 1 screening assessment. For soils, we evaluate the average soil concentration for all soil parcels within a 7.5-km radius for each facility and PB-HAP. For the water, sediment, and fish tissue concentrations, the highest value for each facility for each pollutant is used. If emission concentrations from a facility do not exceed the Tier 2 screening threshold emission rate, the facility “passes” the screening assessment and typically is not evaluated further. If emissions from a facility exceed the Tier 2 screening threshold emission rate, we evaluate the facility further in Tier 3.

As in the multipathway human health risk assessment, in Tier 3 of the environmental screening assessment, we examine the suitability of the lakes around the facilities to support life and remove those that are not suitable (

e.g.,

lakes that have been filled in or are industrial ponds), adjust emissions for plume-rise, and conduct hour-by-hour time-series assessments. If these Tier 3 adjustments to the screening threshold emission rates still indicate the potential for an adverse environmental effect (

i.e.,

facility emission rate exceeds the screening threshold emission rate), we may elect to conduct a more refined assessment using more site-specific information. If, after additional refinement, the facility emission rate still exceeds the screening threshold emission rate, the facility may have the potential to cause an adverse environmental effect.

To evaluate the potential for an adverse environmental effect from lead, we compared the average modeled air concentrations (from HEM-3) of lead around each facility in the source category to the level of the secondary NAAQS for lead. The secondary lead NAAQS is a reasonable means of evaluating environmental risk because it is set to provide substantial protection against adverse welfare effects which can include “effects on soils, water, crops, vegetation, man-made materials, animals, wildlife, weather, visibility and climate, damage to and deterioration of property, and hazards to transportation, as well as effects on economic values and on personal comfort and well-being.”

d. Acid Gas Environmental Risk Methodology

The environmental screening assessment for acid gases evaluates the potential phytotoxicity and reduced productivity of plants due to chronic exposure to HF and HCl. The environmental risk screening methodology for acid gases is a single-tier screening assessment that compares modeled ambient air concentrations (from AERMOD) to the ecological benchmarks for each acid gas. To identify a potential adverse environmental effect (as defined in section 112(a)(7) of the CAA) from emissions of HF and HCl, we evaluate the following metrics: The size of the modeled area around each facility that exceeds the ecological benchmark for each acid gas, in acres and km

2

; the percentage of the modeled area around each facility that exceeds the ecological benchmark for each acid gas; and the area-weighted average screening value around each facility (calculated by dividing the area-weighted average concentration over the 50-km modeling domain by the ecological benchmark for each acid gas). For further information on the environmental screening assessment approach, see Appendix 9 of the Metal Cans Risk Assessment Report and Metal Coil Risk Assessment Report, which are available in each respective 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 these source categories, we conducted the facility-wide assessment using a dataset compiled from the 2014 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 categories 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

Metal Cans Risk Assessment Report

and the

Metal Coil Risk Assessment Report,

available respectively in the Metal Cans Docket and the Metal Coil Docket, provide the methodology and results of the facility-wide analyses, including all facility-wide risks and the percentage of source category contribution to facility-wide risks.

7. How do we consider uncertainties in risk assessment?

Uncertainty and the potential for bias are inherent in all risk assessments, including those performed for this proposal. Although uncertainty exists, we believe that our approach, which used conservative tools and assumptions, ensures that our decisions are health and environmentally protective. A brief discussion of the uncertainties in the RTR emissions datasets, 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

Metal Cans Risk Assessment Report

and the

Metal Coil Risk Assessment Report,

available respectively in the Metal Cans Docket and the Metal Coil Docket. 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 Datasets

Although the development of the RTR emissions datasets 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 maximum individual risk 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,

pages 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 bound estimate of risk.

18

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.

19

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,

20

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.

18

IRIS glossary (

https://ofmpub.epa.gov/sor_internet/registry/termreg/searchandretrieve/glossariesandkeywordlists/search.do?details=&glossaryName=IRIS%20Glossary

).

19

An exception to this is the URE for benzene, which is considered to cover a range of values, each end of which is considered to be equally plausible,

and which is based on maximum likelihood estimates.

20

See

A Review of the Reference Dose and Reference Concentration Processes,

U.S. EPA, December 2002, and

Methods for Derivation of Inhalation Reference Concentrations and Application of Inhalation Dosimetry,

U.S. EPA, 1994.

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.

Although we make every effort to identify appropriate human health effect dose-response values for all pollutants emitted by the sources in this risk assessment, some HAP emitted by this source category are lacking dose-response assessments. Accordingly, these pollutants cannot be included in the quantitative risk assessment, which could result in quantitative estimates understating HAP risk. To help to alleviate this potential underestimate, where we conclude similarity with a HAP for which a dose-response value is available, we use that value as a surrogate for the assessment of the HAP for which no value is available. To the extent use of surrogates indicates appreciable risk, we may identify a need to increase priority for an IRIS assessment for that substance. We additionally note that, generally speaking, HAP of greatest concern due to environmental exposures and hazard are those for which dose-response assessments have been performed, reducing the likelihood of understating risk. Further, HAP not included in the quantitative assessment are assessed qualitatively and considered in the risk characterization that informs the risk management decisions, including consideration of HAP reductions achieved by various control options.

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 humans at the location of the maximum concentration. In the acute screening assessment that we conduct under the RTR program, we assume that peak emissions from the source category and worst-case meteorological conditions co-occur, thus, resulting in maximum ambient concentrations. These two events are unlikely to occur at the same time, making these assumptions conservative. We then include the additional assumption that a person is located at this point during this same time period. For these source categories, these assumptions would tend to be worst-case actual exposures as it is unlikely that a person would be located at the point of maximum exposure during the time when peak emissions and worst-case meteorological 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—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 NAAQS standard 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.

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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.

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 the 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 RTR.

Input uncertainty is concerned with how accurately the models have been configured and parameterized for the assessment at hand. For Tier 1 of the multipathway 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 upper-end national values, and we identify the actual location of lakes near the facility rather than the default lake location that we apply in Tier 1. By refining the screening approach in Tier 2 to account for local geographical and meteorological data, we decrease the likelihood that concentrations in environmental media are overestimated, thereby increasing the usefulness of the screening assessment. In Tier 3 of the screening assessments, we refine the model inputs again to account for hour-by-hour plume rise and the height of the mixing layer. We can also use those hour-by-hour meteorological data in a TRIM.FaTE run using the screening configuration corresponding to the lake location. These refinements produce a more accurate estimate of chemical concentrations in the media of interest, thereby reducing the uncertainty with those estimates. The assumptions and the associated uncertainties regarding the selected ingestion exposure scenario are the same for all three tiers.

For the environmental screening assessment for acid gases, we employ a single-tiered approach. We use the modeled air concentrations and compare those with ecological benchmarks.

For all tiers of the multipathway and environmental screening assessments, our approach to addressing model input uncertainty is generally cautious. We choose model inputs from the upper end of the range of possible values for the influential parameters used in the models, and we assume that the exposed individual exhibits ingestion behavior that would lead to a high total exposure. This approach reduces the likelihood of not identifying high risks for adverse impacts.

Despite the uncertainties, when individual pollutants or facilities do not exceed screening threshold emission rates (

i.e.,

screen out), we are confident that the potential for adverse multipathway impacts on human health is very low. On the other hand, when individual pollutants or facilities do exceed screening threshold emission rates, it does not mean that impacts are significant, only that we cannot rule out that possibility and that a refined assessment for the site might be necessary to obtain a more accurate risk characterization for the source category.

The EPA evaluates the following HAP in the multipathway and/or environmental risk screening assessments, where applicable: Arsenic, cadmium, dioxins/furans, lead, mercury (both inorganic and methyl mercury), POM, HCl, and HF. These HAP represent pollutants that can cause adverse impacts either through direct exposure to HAP in the air or through exposure to HAP that are deposited from the air onto soils and surface waters and then through the environment into the food web. These HAP represent those HAP for which we can conduct a meaningful multipathway or environmental screening risk assessment. For other HAP not included in our screening assessments, the model has not been parameterized such that it can be used for that purpose. In some cases, depending on the HAP, we may not have appropriate multipathway models that allow us to predict the concentration of that pollutant. The EPA acknowledges that other HAP beyond these that we are evaluating may have the potential to cause adverse effects and, therefore, the EPA may evaluate other relevant HAP in the future, as modeling science and resources allow.

IV. Analytical Results and Proposed Decisions

A. What are the analytical results and proposed decisions for the Surface Coating of Metal Cans source category?

1. What are the results of the risk assessment and analyses?

As described in section III of this preamble, for the Surface Coating of Metal Cans 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

Metal Cans Risk Assessment Report

in the Metal Cans Docket (Docket ID No. EPA-HQ-OAR-2017-0684).

a. Inhalation Risk Assessment Results

Table 2 of this preamble summarizes the results of the inhalation risk assessment for the source category. As discussed in section III.C.2 of this preamble, we set MACT-allowable HAP emission levels at metal can coating facilities equal to 1.1 times actual emissions. For more detail about the MACT-allowable emission levels, see Appendix 1 to the

Metal Cans Risk Assessment Report

in the Metal Cans Docket.

Table 2—Surface Coating of Metal Cans Source Category Inhalation Risk Assessment Results

Risk assessment

Maximum

individual cancer risk

(in 1 million)

Based on

actual

emissions

Based on

allowable

emissions

Estimated population

at increased risk of

cancer ≥1-in-1 million

Based on

actual

emissions

Based on

allowable

emissions

Estimated annual

cancer incidence

(cases per year)

Based on

actual

emissions

Based on

allowable

emissions

Maximum

chronic noncancer

TOSHI

1

Based on

actual

emissions

Based on

allowable

emissions

Maximum

screening acute

noncancer HQ

2

Based on

actual

emissions

Source Category

3

3

700

800

0.0009

0.001

0.02

0.02

HQREL = 0.4.

Whole Facility

8

1,500

0.002

0.2

1

The TOSHI is the sum of the chronic noncancer HQs for substances that affect the same target organ or organ system.

2

The maximum estimated acute exposure concentration was divided by available short-term threshold values to develop HQ values.

The results of the inhalation risk modeling using actual emissions data, as shown in Table 2 of this preamble, indicate that the maximum individual cancer risk based on actual emissions (lifetime) could be up to 3-in-1 million (driven by formaldehyde from a two-piece can coating line), the maximum chronic noncancer TOSHI value based on actual emissions could be up to 0.02 (driven by formaldehyde from a two-piece can coating line), and the maximum screening acute noncancer HQ value (off-facility site) could be up to 0.4 (driven by formaldehyde). The total estimated annual cancer incidence (national) from these facilities based on actual emission levels is 0.0009 excess

cancer cases per year or 1 case in every 1,100 years.

b. Acute Risk Results

Table 2 of this preamble shows the acute risk results for the Surface Coating of Metal Cans source category. The screening analysis for acute impacts was based on an industry specific multiplier of 1.1, to estimate the peak emission rates from the average rates. For more detailed acute risk results, refer to the

Metal Cans Risk Assessment Report

in the Metal Cans Docket.

c. Multipathway Risk Screening Results

There are no PB-HAP emitted by facilities in the Surface Coating of Metal Cans source category. Therefore, we do not expect any human health multipathway risks as a result of emissions from this source category.

d. Environmental Risk Screening Results

The emissions data for the Surface Coating of Metal Cans source category indicate that two environmental HAP are emitted by sources within this source category: HCl and HF. Therefore, we conducted a screening-level evaluation of the potential for adverse environmental risks associated with emissions of HCl and HF for the Surface Coating of Metal Cans source category. For both HCl and HF, each individual concentration (

i.e.,

each off-site data point in the modeling domain) was below the ecological benchmarks for all facilities. Therefore, we do not expect an adverse environmental effect as a result of HAP emissions from this source category.

e. Facility-Wide Risk Results

Three facilities have a facility-wide cancer MIR greater than or equal to 1-in-1 million. The maximum facility-wide cancer MIR is 8-in-1 million, driven by formaldehyde from miscellaneous industrial processes (other/not classified) and acetaldehyde from beer production (brew kettle). The total estimated cancer incidence from the whole facility is 0.002 excess cancer cases per year, or one excess case in every 500 years. Approximately 1,500 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 three of the five facilities in this source category. The maximum facility-wide TOSHI for the source category is estimated to be less than 1, mainly driven by emissions of acetaldehyde from beer production (brew kettle primarily) and formaldehyde from miscellaneous industrial processes (other/not classified).

f. What demographic groups might benefit from this regulation?

To examine the potential for any environmental justice issues that might be associated with the 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 risk from the Surface Coating of Metal Cans source category across different demographic groups within the populations living near facilities.

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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 above the poverty level, and linguistically isolated people.

The results of the demographic analysis are summarized in Table 3 of this preamble. These results, for various demographic groups, are based on the estimated risk from actual emissions levels for the population living within 50 km of the facilities.

Table 3—Surface Coating of Metal Cans Source Category Demographic Risk Analysis Results

Nationwide

Population with cancer

risk at or above 1-in-1

million due to Surface

Coating of Metal Cans

Population with chronic

hazard index above 1

due to Surface Coating

of Metal Cans

Total Population

317,746,049

700

0

Race by Percent

White

62

92

0

All Other Races

38

8

0

Race by Percent

White

62

92

0

African American

12

0

0

Native American

0.8

0

0

Hispanic or Latino

18

4

0

Other and Multiracial

7

4

0

Income by Percent

Below the Poverty Level

14

4

0

Above the Poverty Level

86

96

0

Education by Percent

Over 25 and Without High a School Diploma

14

4

0

Over 25 and With a High School Diploma

86

96

0

The results of the Surface Coating of Metal Cans source category demographic analysis indicate that emissions from the source category expose approximately 700 people to a cancer risk at or above 1-in-1 million and no one to a chronic noncancer TOSHI greater than 1 (we note that many of those in the first risk group are

the same as those in the second). None of the percentages of the at-risk populations are higher than their respective nationwide percentages.

The methodology and the results of the demographic analysis are presented in a technical report titled

Risk and Technology Review—Analysis of Demographic Factors for Populations Living Near Surface Coating of Metal Cans Source Category Operations,

May 2018 (hereafter referred to as the

Metal Cans Demographic Analysis Report

) in the Metal Cans Docket.

2. What are our proposed decisions regarding risk acceptability, ample margin of safety, and adverse environmental effect?

a. 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 Surface Coating of Metal Cans source category, the risk analysis indicates that the cancer risks to the individual most exposed could be up to 3-in-1 million due to actual emissions or based on allowable emissions. These risks are considerably less than 100-in-1 million, which is the presumptive upper limit of acceptable risk. The risk analysis also shows very low cancer incidence (0.0009 cases per year for actual emissions and 0.001 cases per year for allowable emissions) and we did not identify potential for adverse chronic noncancer health effects. The acute noncancer risks based on actual emissions are low at an HQ of 0.4 for formaldehyde. 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 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 Surface Coating of Metal Cans source category are acceptable.

b. Ample Margin of Safety Analysis

Although we are proposing that the risks from the Surface Coating of Metal Cans source category are acceptable, risk estimates for approximately 700 individuals in the exposed population are above 1-in-1 million at the actual emissions level and 800 individuals at the allowable emissions level. Consequently, we further considered whether the MACT standards for the Surface Coating of Metal Cans source category provide an ample margin of safety to protect public health. In this ample margin of safety analysis, we investigated available emissions control options that might reduce the risk from the source category. We considered this information along with all the health risks and other health information considered in our determination of risk acceptability.

As described in section III.B of this preamble, our technology review focused on identifying developments in practices, processes, and control technologies for the Surface Coating of Metal Cans source category, and the EPA reviewed various information sources regarding emission sources that are currently regulated by the Surface Coating of Metal Cans NESHAP.

The only development identified in the technology review for can coating is the ongoing development and the potential future conversion from conventional interior can coatings that contain bisphenol A (BPA) to interior coatings that do not intentionally contain BPA (BPA-NI). Since BPA and BPA-NI are not HAP, this change would have no effect on the HAP emissions. There were no other technological developments identified that affect HAP emissions for the Surface Coating of Metal Cans source category. Therefore, we are proposing that additional emission controls for this source category are not necessary to provide an ample margin of safety.

c. Environmental Effects

The emissions data for the Surface Coating of Metal Cans source category indicate that two environmental HAP are emitted by sources within this source category: HCl and HF. The screening-level evaluation of the potential for adverse environmental risks associated with emissions of HCl and HF from the Surface Coating of Metal Cans 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.

3. What are the results and proposed decisions based on our technology review?

As described in section III.B of this preamble, our technology review focused on identifying developments in practices, processes, and control technologies for the Surface Coating of Metal Cans source category. The EPA reviewed various information sources regarding emission sources that are currently regulated by the Surface Coating of Metal Cans NESHAP to support the technology review. The information sources included the following: The RBLC; state regulations, facility operating permits, regulatory actions (including technology reviews promulgated for other surface coating NESHAP subsequent to the Surface Coating of Metal Cans NESHAP); a site visit and discussions with individual can coating facilities and the industry trade association. The primary emission sources for the technology review included the following: The coating operations; all storage containers and mixing vessels in which coatings, thinners, and cleaning materials are stored or mixed; all manual and automated equipment and containers used for conveying coatings, thinners, and cleaning materials; and all storage containers and all manual and automated equipment and containers used for conveying waste materials generated by a coating operation.

Based on our review, we did not identify any add-on control technologies, process equipment, work practices, or procedures that had not been previously considered during development of the Surface Coating of Metal Cans NESHAP, and we did not identify any new or improved add-on control technologies that would result in additional emission reductions. A brief summary of the EPA's findings in conducting the technology review of can coating operations follows. For a detailed discussion of the EPA's findings, refer to the Metal Cans Technology Review Memorandum in the Metal Cans Docket.

During the 2003 MACT development for the Surface Coating of Metal Cans NESHAP, numerical emission limits were determined for each coating type segment within the four subcategories for a total of 12 HAP emission limits. The emission limits were based on industry survey responses and the

industry's use of low- or no-HAP coatings and thinners and add-on capture and control technologies. Alternately, the NESHAP provides sources with the option of limiting HAP emissions with capture and add-on control to achieve an overall control efficiency (OCE) of 97 percent for new or reconstructed sources and 95 percent for existing sources. Alternately, sources with add-on controls can choose the option of meeting a HAP concentration limit of 20 ppm by volume dry at the control device outlet. During development of that rulemaking, we identified the beyond-the-floor option to require the use of capture systems and add-on control devices for all metal can surface coating operations. This option was rejected because we determined the additional emission reductions achieved using the beyond-the-floor option did not warrant the costs each affected source would incur (68 FR 2123).

For this technology review, we used the EPA's NEI and the ECHO databases to identify facilities that are currently subject to the Surface Coating of Metal Cans NESHAP. The facility list was also reviewed by the Can Manufacturers Institute (CMI). CMI provided facility operating permits to confirm that only five facilities are currently operating as major sources and are subject to the Surface Coating of Metal Cans NESHAP.

Our search of the RBLC database for improvements in can coating technologies provided results for four metal can coating facilities with permit dates of 2006 or later. All four of the results contained information about the add-on controls used by the facilities. Two facilities reported the use of regenerative thermal oxidizers (RTOs), one reported the use of an induction heater and catalytic oxidation, and one reported the use of thermal oxidation. All of these control technologies were in use by the can coating industry during development of the Surface Coating of Metal Cans NESHAP and were already considered in the development of the Surface Coating of Metal Cans NESHAP. Therefore, we concluded that the results of the search are consistent with current Surface Coating of Metal Cans NESHAP requirements and did not include any improvements in add-on control technology or other equipment that were not identified and considered at that time.

We also conducted a review of the state operating permits for the can coating facilities that are subject to the Surface Coating of Metal Cans NESHAP to determine whether any are using technologies that exceed the MACT level of control or are using technologies that were not considered during the development of the original NESHAP. The permits show that two of the five facilities use no add-on controls (they use the compliant material option or the material averaging option to meet the NESHAP emission limits) and three of the five facilities had only partial control (

i.e.,

not all can coating lines had control). The coating types are not specified in the permits for all facilities, but one permit specified the use of ultraviolet (UV)-cured coatings. The add-on controls in the permits included a thermal oxidizer and two regenerative thermal oxidizers. As a result of the permit review, we concluded that the add-on controls that are now available are essentially the same and have the same emission reduction performance (

i.e.,

95- or 97-percent VOC destruction efficiency) as those that were available when the NESHAP was proposed and promulgated.

We reviewed other surface coating NESHAP promulgated after the Surface Coating of Metal Cans NESHAP to determine whether any requirements exceed the Surface Coating of Metal Cans MACT level of control or included technologies that were not considered during the development of the original Surface Coating of Metal Cans NESHAP. These NESHAP include Surface Coating of Miscellaneous Metal Parts and Products (40 CFR part 63, subpart MMMM), Surface Coating of Plastic Parts and Products (40 CFR part 63, subpart PPPP), and Surface Coating of Automobiles and Light-Duty Trucks (40 CFR part 63, subpart IIII). We also reviewed the results of the technology reviews for the following NESHAP: Printing and Publishing (40 CFR part 63, subpart KK), Shipbuilding and Ship Repair (40 CFR part 63, subpart II), and Wood Furniture Manufacturing (40 CFR part 63, subpart JJ).

Technology reviews for these NESHAP identified PTE and/or RTO as improvements in add-on control technology. Because the Surface Coating of Metal Cans NESHAP already includes a compliance option involving the use of a PTE and an add-on control device, and because these measures were considered in the development of the original Surface Coating of Metal Cans NESHAP, we concluded that these measures do not represent an improvement in control technology under CAA section 112(d)(6).

The technology review conducted for the Wood Furniture Manufacturing NESHAP identified the use of more efficient spray guns as a technology review development and revised the requirements to prohibit the use of conventional spray guns. Air-assisted airless spraying was added as a more efficient coating application technology. This development is not applicable to metal can coating because the primary coating operations are performed using non-spray application methods, such as lithographic printing and other types of direct transfer coating application, or they already use airless spray equipment for the inside spray, side seam spray, and repair coating operations. In conclusion, we found no improvements in add-on control technology or other equipment during review of the RBLC, the state operating permits, and subsequent NESHAP that were not already identified and considered during the Surface Coating of Metal Cans NESHAP development.

Alternatives to conventional solvent-borne coatings were identified and considered during MACT development but were not considered to be suitable for all can coating applications. These alternative coatings include higher solids coatings, waterborne coatings, and low-energy electron beam/ultraviolet cured coatings. Powder coating applications are not common for metal containers. Waterborne and higher solids coatings with lower HAP and VOC content were considered in the development of the proposed and final standards and are reflected in the HAP emission limitations in the final rule. Interior coatings used for cans that contain food or beverages are subject to regulation by the U.S. Food and Drug Administration (FDA), as well as internal approval by the food and beverage manufacturers. The only anticipated technology change in the area of coating reformulation for the Surface Coating of Metal Cans source category is the replacement of coatings that have no intentionally added BPA for both beverage and food cans, referred to as BPA-NI coatings. The major can coating producers are currently devoting much of their research and development efforts to develop BPA-NI systems for new applications and to improve the BPA-NI systems that already exist. However, a complete shift to these coatings is not expected unless driven by FDA regulation or consumer opinion. Therefore, the EPA did not identify any developments in coating technology or other process changes or pollution prevention alternatives that would represent a development relative to the coating technologies on which the final rule is based.

Finally, no improvements in work practices or operational procedures were identified for the Surface Coating of Metal Cans source category that were not previously identified and considered during MACT development.

The current MACT standards require that, if a facility uses add-on controls to comply with the emission limitations, the facility must develop and implement a work practice plan to minimize organic HAP emissions from the storage, mixing, and conveying of coatings, thinners, and cleaning materials used in, and waste materials generated by, those coating operations. If a facility is not using add-on controls and is using either the compliant material option or the emission rate without add on controls option, the facility does not need to comply with work practice standards. Under the emission rate option, HAP emitted from spills or from containers would be counted against the facility in the compliance calculations, so facilities must already minimize these losses to maintain compliance.

Based on these findings, we conclude that there have not been any developments in add-on control technology or other equipment not identified and considered during MACT development, nor any improvements in add-on controls, nor any significant changes in the cost (including cost effectiveness) of the add-on controls. Therefore, we are proposing no revisions to the Surface Coating of Metal Cans NESHAP pursuant to CAA section 112(d)(6). For further discussion of the technology review results, refer to the Metal Cans Technology Review Memorandum in the Metal Cans Docket.

4. What other actions are we proposing for the Surface Coating of Metal Cans source category?

In addition to the proposed actions described above, we are proposing additional revisions to the NESHAP. We are proposing to require electronic submittal of notifications, semiannual reports, and compliance reports (which include performance test reports) for metal cans surface coating facilities. In addition, we are proposing revisions to the SSM provisions of the MACT rule in order to ensure that they are consistent with the Court decision in

Sierra Club

v.

EPA,

551 F. 3d 1019 (D.C. Cir. 2008), which vacated two provisions that exempted sources from the requirement to comply with otherwise applicable CAA section 112(d) emission standards during periods of SSM. We also propose other changes, including updating references to equivalent test methods, making technical and editorial revisions, and incorporation by reference (IBR) of alternative test methods. Our analyses and proposed changes related to these issues are discussed in the sections below.

a. Electronic Reporting Requirements

In this action the EPA proposes to require owners and operators of surface coating of metal can facilities to submit electronic copies of the initial notifications required in 40 CFR 63.9(b) and 63.3510(b), notifications of compliance status required in 40 CFR 63.9(h) and 63.3510(c), performance test reports required in 40 CFR 63.3511(b), and semiannual reports required in 40 CFR 63.3511(a), through the EPA's Central Data Exchange (CDX), using the Compliance and Emissions Data Reporting Interface (CEDRI).

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A description of the electronic 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),

August 8, 2018, in the Metal Cans Docket. This proposed rule requirement would replace the current rule requirement to submit the notifications and reports to the Administrator at the appropriate address listed in 40 CFR 63.13. This proposed rule requirement does not affect submittals required by state air agencies as required by 40 CFR 63.13.

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https://www.epa.gov/electronic-reporting-air-emissions/compliance-and-emissions-data-reporting-interface-cedri.

For the performance test reports required in 40 CFR 63.3511(b), results collected using test methods that are supported by the Electronic Reporting Tool (ERT) as listed on the EPA's ERT website (

https://www3.epa.gov/ttn/chief/ert/ert_info.pdf

) at the time of the performance test are required to be submitted in the format generated through the use of ERT. Performance test results collected using test methods that are not supported by the ERT at the time of the performance test are required to be submitted to the EPA electronically in a portable document format (PDF) using the attachment module of the ERT. Note that all but two of the EPA test methods (EPA Method 25 and optional EPA Method 18) listed under the emissions destruction or removal efficiency section of 40 CFR part 63, subpart KKKK, are currently supported by the ERT. As mentioned above, the rule proposes that, should an owner or operator use EPA Method 25 or EPA Method 18, then its results would be submitted in PDF using the attachment module of the ERT.

For the semiannual reports required in 40 CFR 63.3511(a), the EPA proposes that owners and operators use the final semiannual report template, which will reside in CEDRI, one year after finalizing this proposed action. The

Proposed Electronic Reporting Template for Surface Coating of Metal Cans Subpart KKKK Semiannual Report

is available for review and comment in the Metal Cans Docket as part of this action. We specifically request comment on the format and usability of the template (

e.g.,

filling out and uploading a provided spreadsheet versus entering the required information into an on-line fillable CEDRI web form), as well as the content, layout, and overall design of the template. Prior to availability of the final semiannual compliance report template in CEDRI, owners and operators of affected sources will be required to submit semiannual compliance reports as currently required by the rule. When the EPA finalizes the semiannual compliance report template, metal can sources will be notified about its availability via the CEDRI website. We plan to finalize a required reporting format with the final rule. The owner or operator would begin submitting reports electronically with the next report that is due, once the electronic template has been available for at least 1 year.

For the electronic submittal of initial notifications required in 40 CFR 63.9(b), no specific form is available at this time, so these notifications are required to be submitted electronically in PDF. If electronic forms are developed for these notifications, we will notify sources about their availability via the CEDRI website. For the electronic submittal of notifications of compliance status reports required in 40 CFR 63.9(h), the final semiannual report template discussed above, which will reside in CEDRI, will also contain the information required for the notifications of compliance status report and will satisfy the requirement to provide the notifications of compliance status information electronically, eliminating the need to provide a separate notifications of compliance status report. As stated above, the final semiannual report template will be available after finalizing this proposed action and sources will be required to use the form after one year. Prior to the availability of the final semiannual compliance report template in CEDRI, owners and operators of affected sources will be required to submit semiannual compliance reports as currently required by the rule. As stated above, we will notify sources about the availability of the final semiannual report template via the CEDRI website.

Additionally, the EPA has identified two broad circumstances in which electronic reporting extensions may be provided. 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 EPA is providing these potential extensions to protect owners and operators from noncompliance in cases where they cannot successfully submit a report by the reporting deadline for reasons outside of their control. In 40 CFR 63.3511(f), we propose to address the situation where an extension may be warranted due to outages of the EPA's CDX or CEDRI that precludes an owner or operator from accessing the system and submitting required reports. Also in 40 CFR 63.3511(g), we propose to address the situation where an extension may be warranted due to a force majeure event, which is defined as an event that will be or has been caused by circumstances beyond the control of the affected facility, its contractors, or any entity controlled by the affected facility that prevents an owner or operator from complying with the requirement to submit a report electronically as required by this rule. Examples of such events are acts of nature, acts of war or terrorism, and equipment failures or safety hazards that are beyond the control of the facility.

As discussed in the memorandum Electronic Reporting Requirements

for New Source Performance Standards (NSPS) and National Emission Standards for Hazardous Air Pollutants (NESHAP), August 8, 2018,

electronic submittal of the reports addressed in this proposed action will increase the usefulness of the data contained in those reports, and in keeping with current trends in data availability and transparency, will further assist in the protection of public health and the environment, and will ultimately result in less burden on the regulated facilities. Electronic submittal will also improve compliance by facilitating the ability of regulated facilities to demonstrate compliance and the ability of air agencies and the EPA to assess and determine compliance. Moreover, electronic reporting is consistent with the EPA's plan

24

to implement Executive Order 13563 and the EPA's agency-wide policy

25

developed in response to the White House's Digital Government Strategy.

26

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),

August 8, 2018, available in the Metal Cans docket.

24

Improving Our Regulations: Final Plan for Periodic Retrospective Reviews of Existing Regulations,

August 2011. Available at

https://www.regulations.gov, Document ID No. EPA-HQ-OA-2011-0156-0154.

25

E-Reporting Policy Statement for EPA Regulations,

September 2013,

https://www.epa.gov/sites/production/files/2016-03/documents/epa-ereporting-policy-statement-2013-09-30.pdf.

26

Digital Government: Building a 21st Century Platform to Better Serve the American People,

May 2012. Available at

http://www.whitehouse.gov/sites/default/files/omb/egov/digital-government/digitalgovernment-strategy/pdf.

b. SSM Requirements

1. Proposed Elimination of the SSM Exemption

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 the SSM exemption in this rule. 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 5 to Subpart KKKK of Part 63 (

Applicability of General Provisions to Subpart KKKK,

hereafter referred to as the “General Provisions table to subpart KKKK”), as explained in more detail below in section IV.A.4.b.2 of this preamble. For example, we are proposing to eliminate the incorporation of the General Provisions' requirement that the source develop an SSM plan. Further, we 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 seeking comment on the specific proposed deletions and revisions and also whether additional provisions should be revised to achieve the stated goal.

In proposing these rule amendments, the EPA has taken into account startup and shutdown periods and, for the reasons explained below, has not proposed alternate standards for those periods. Startups and shutdowns are part of normal operations for the Surface Coating of Metal Cans source category. As currently specified in 40 CFR 63.3492(b), any coating operation(s) for which you use the emission rate with add-on controls option must meet operating limits “at all times,” except for solvent recovery systems for which you conduct liquid-liquid material balances according to 40 CFR 63.3541(i). (Solvent recovery systems for which you conduct a liquid-liquid material balance require a monthly calculation of the solvent recovery device's collection and recovery efficiency for volatile organic matter.) Also, as currently specified in 40 CFR 63.3500(a)(2), any coating operation(s) for which you use the emission rate with add-on controls option or the control efficiency/outlet concentration option must be in compliance “at all times” with the emission limits in 40 CFR 63.3490 and work practice standards in 40 CFR 63.3493. During startup and shutdown periods, in order for a facility (using add-on controls to meet the standards) to meet the emission and operating standards, the control device for a coating operation needs to be turned on and operating at specified levels before the facility begins coating operations, and the control equipment needs to continue to be operated until after the facility ceases coating operations. In some cases, the facility needs to run thermal oxidizers on supplemental fuel before VOC levels are sufficient for the combustion to be (nearly) self-sustaining. Note that we are also proposing new related language in 40 CFR 63.3500(b) to require that the owner or operator operate and maintain the coating operation, including pollution control equipment, at all times to minimize emissions. See section IV.A.4.b.2 of this preamble for further discussion of this proposed revision.

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 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 in

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 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. As the Court has recognized, 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 different types of malfunctions that can occur across all sources in the category and given the difficulties associated with

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