# 86 FR 1362: National Emission Standards for Hazardous Air Pollutants: Mercury Cell Chlor-Alkali Plants Residual Risk and Technology Review

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/FR_PRORULE_2021-00174

## Section

- **Citation:** 86 FR 1362
- **Heading:** National Emission Standards for Hazardous Air Pollutants: Mercury Cell Chlor-Alkali Plants Residual Risk and Technology Review
- **Jurisdiction:** Federal
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** August 14, 2026
- **Source:** Compiled text
- **Location:** Federal Register / Vol. 86 / 86 FR 1362

## Text

ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 63 [EPA-HQ-OAR-2020-0560; FRL-10018-95-OAR] RIN 2060-AU59 National Emission Standards for Hazardous Air Pollutants: Mercury Cell Chlor-Alkali Plants Residual Risk and Technology Review AGENCY:
Environmental Protection Agency (EPA).

ACTION:
Proposed rule.

SUMMARY:
The U.S. Environmental Protection Agency (EPA) is proposing the results of the residual risk and technology review (RTR) of the National Emission Standards for Hazardous Air Pollutants (NESHAP) for mercury emissions from Mercury Cell Chlor-Alkali Plants, as required by the Clean Air Act (CAA). The EPA is proposing to find risks due to emissions of hazardous air pollutants (HAP) to be acceptable from the Mercury Cell Chlor-Alkali Plants source category, and to determine that the current NESHAP provides an ample margin of safety to protect public health and that no more stringent standards are necessary to prevent, taking into consideration costs, energy, safety, and other relevant factors, an adverse environmental effect. The EPA is proposing to amend the requirements for cell room fugitive mercury emissions to require work practice standards for the cell rooms and to require instrumental monitoring of cell room fugitive mercury emissions under the technology review. Furthermore, under our technology review and maximum achievable control technology (MACT) analysis, we are proposing to not require conversion to non-mercury production technology and invite comments and data and information regarding this proposed determination. In addition, the EPA is proposing standards for fugitive chlorine emissions from mercury cell chlor-alkali plants, which are not currently regulated under the NESHAP. The EPA is proposing to address applicability for thermal mercury recovery units when chlorine and caustic are no longer produced in mercury cells
gy and invite comments and data and information regarding this proposed determination. In addition, the EPA is proposing standards for fugitive chlorine emissions from mercury cell chlor-alkali plants, which are not currently regulated under the NESHAP. The EPA is proposing to address applicability for thermal mercury recovery units when chlorine and caustic are no longer produced in mercury cells. The EPA is also proposing revisions related to emissions during periods of startup, shutdown, and malfunction (SSM); provisions for electronic submission of performance test results, performance evaluation reports, and Notification of Compliance Status (NOCS) reports; and correction of various compliance errors in the current rule.

DATES:

Comments. Comments must be received on or before February 22, 2021. Under the Paperwork Reduction Act (PRA), comments on the information collection provisions are best assured of consideration if the Office of Management and Budget (OMB) receives a copy of your comments on or before February 8, 2021.
Public hearing: If anyone contacts us requesting a public hearing on or before January 13, 2021, we will hold a virtual public hearing. See SUPPLEMENTARY INFORMATION for information on requesting and registering for a public hearing.

ADDRESSES:
You may send comments, identified by Docket ID No. EPA-HQ-OAR-2020-0560, by any of the following methods:
• Federal eRulemaking Portal: https://www.regulations.gov/ (our preferred method). Follow the online instructions for submitting comments.
• Email: a-and-r-docket@epa.gov. Include Docket ID No. EPA-HQ-OAR-2020-0560 in the subject line of the message.
• Fax: (202) 566-9744. Attention Docket ID No. EPA-HQ-OAR-2020-0560.
• Mail: U.S. Environmental Protection Agency, EPA Docket Center, Docket ID No. EPA-HQ-OAR-2020-0560, Mail Code 28221T, 1200 Pennsylvania Avenue NW, Washington, DC 20460
online instructions for submitting comments.
• Email: a-and-r-docket@epa.gov. Include Docket ID No. EPA-HQ-OAR-2020-0560 in the subject line of the message.
• Fax: (202) 566-9744. Attention Docket ID No. EPA-HQ-OAR-2020-0560.
• Mail: U.S. Environmental Protection Agency, EPA Docket Center, Docket ID No. EPA-HQ-OAR-2020-0560, Mail Code 28221T, 1200 Pennsylvania Avenue NW, Washington, DC 20460.
• Hand Delivery or Courier (by scheduled appointment only): EPA Docket Center, WJC West Building, Room 3334, 1301 Constitution Avenue NW, Washington, DC 20004. The Docket Center's hours of operation are 8:30 a.m.-4:30 p.m., Monday-Friday (except Federal holidays).
Instructions: All submissions received must include the Docket ID No. for this rulemaking. Comments received may be posted without change to https://www.regulations.gov/, including any personal information provided. For detailed instructions on sending comments and additional information on the rulemaking process, see the SUPPLEMENTARY INFORMATION section of this document. Out of an abundance of https://www.regulations.gov/ or email, as there may be a delay in processing mail and faxes. Hand deliveries and couriers may be received by scheduled appointment only. For further information on EPA Docket Center services and the current status, please visit us online at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
For questions about this proposed action, contact Phil Mulrine, Sector Policies and Programs Division (D243-02), Office of Air Quality Planning and Standards, U.S. Environmental Protection Agency, Research Triangle Park, North Carolina 27711; telephone number: (919) 541-5289; fax number: (919) 541-4991; and email address: mulrine.phil@epa.gov. For specific information regarding the risk modeling methodology, contact James Hirtz, Health and Environmental Impacts Division (C539-02), Office of Air Quality Planning and Standards, U.S
Planning and Standards, U.S. Environmental Protection Agency, Research Triangle Park, North Carolina 27711; telephone number: (919) 541-5289; fax number: (919) 541-4991; and email address: mulrine.phil@epa.gov. For specific information regarding the risk modeling methodology, contact James Hirtz, 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) 541-0881; fax number: (919) 541-0840; and email address: hirtz.james@epa.gov.

SUPPLEMENTARY INFORMATION:

Participation in virtual public hearing. Please note that the EPA is deviating from its typical approach because the President has declared a national emergency. Due to the current Centers for Disease Control and Prevention (CDC) recommendations, as well as state and local orders for social distancing to limit the spread of COVID-19, the EPA cannot hold in-person public meetings at this time.
To request a virtual public hearing, contact (888) 372-8699 or by email at SPPDpublichearing@epa.gov. If requested, the virtual hearing will be held on January 25, 2021. The hearing will convene at 9:00 a.m. Eastern Time (ET) and will conclude at 3:00 p.m. ET. The EPA may close a session 15 minutes after the last pre-registered speaker has testified if there are no additional speakers. The EPA will announce further details on the virtual public hearing at https://www.epa.gov//stationary-sources-air-pollution/mercury-cell-chloralkali-plants-national-emissions-standards.
The EPA will begin pre-registering speakers for the hearing upon publication of this document in the Federal Register , if a hearing is requested
stered speaker has testified if there are no additional speakers. The EPA will announce further details on the virtual public hearing at https://www.epa.gov//stationary-sources-air-pollution/mercury-cell-chloralkali-plants-national-emissions-standards.
The EPA will begin pre-registering speakers for the hearing upon publication of this document in the Federal Register , if a hearing is requested. To register to speak at the virtual hearing, please use the online registration form available at https://www.epa.gov/stationary-sources-air-pollution/mercury-cell-chloralkali-plants-national-emissions-standards or contact the public hearing team at (888) 372-8699 or by email at SPPDpublichearing@epa.gov. The last day to pre-register to speak at the hearing will be January 21, 2021. Prior to the hearing, the EPA will post a general agenda that will list pre-registered speakers in approximate order at: https://www.epa.gov/stationary-sources-air-pollution/mercury-cell-chloralkali-plants-national-emissions-standards.
The EPA will make every effort to follow the schedule as closely as possible on the day of the hearing; however, please plan for the hearings to run either ahead of schedule or behind schedule.
Each commenter will have 5 minutes to provide oral testimony. The EPA encourages commenters to provide the EPA with a copy of their oral testimony electronically (via email) by emailing it to Phil Mulrine at mulrine.phil@epa.gov. The EPA also recommends submitting the text of your oral testimony as written comments to the rulemaking docket.
The EPA may ask clarifying questions during the oral presentations but will not respond to the presentations at that time. Written statements and supporting information submitted during the comment period will be considered with the same weight as oral testimony and supporting information presented at the public hearing
he text of your oral testimony as written comments to the rulemaking docket.
The EPA may ask clarifying questions during the oral presentations but will not respond to the presentations at that time. Written statements and supporting information submitted during the comment period will be considered with the same weight as oral testimony and supporting information presented at the public hearing.
Please note that any updates made to any aspect of the hearing is posted online at https://www.epa.gov/stationary-sources-air-pollution/mercury-cell-chloralkali-plants-national-emissions-standards. While the EPA expects the hearing to go forward as set forth above, please monitor our website or contact the public hearing team at (888) 372-8699 or by email at SPPDpublichearing@epa.gov to determine if there are any updates. The EPA does not intend to publish a document in the Federal Register announcing updates.
If you require the services of a translator or a special accommodation such as audio description, please pre-register for the hearing with the public hearing team and describe your needs by January 15, 2021. The EPA may not be able to arrange accommodations without advanced notice.
Docket. The EPA has established a docket for this rulemaking under Docket ID No. EPA-HQ-OAR-2020-0560. In addition to this docket established for this rulemaking, relevant information can be found in dockets for previous rulemakings; EPA-HQ-OAR-2002-0016 and EPA HQ-OAR-2002-0017. All documents in the docket are listed in https://www.regulations.gov/. Although listed, some information is not publicly available, e.g., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the internet and will be publicly available only in hard copy. With the exception of such material, publicly available docket materials are available electronically in Regulations.gov .
Instructions. Direct your comments to Docket ID No
Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the internet and will be publicly available only in hard copy. With the exception of such material, publicly available docket materials are available electronically in Regulations.gov .
Instructions. Direct your comments to Docket ID No. EPA-HQ-OAR-2020-0560. The EPA's policy is that all comments received will be included in the public docket without change and may be made available online at https://www.regulations.gov/, including any personal information provided, unless the comment includes information claimed to be CBI or other information whose disclosure is restricted by statute. Do not submit electronically any information that you consider to be CBI or other information whose disclosure is restricted by statue. 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 https://www.epa.gov/dockets
-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 https://www.epa.gov/dockets.
The EPA is temporarily suspending its Docket Center and Reading Room for public visitors, with limited exceptions, to reduce the risk of transmitting COVID-19. Our Docket Center staff will continue to provide remote customer service via email, phone, and webform. We encourage the public to submit comments via https://www.regulations.gov/ as there may be a delay in processing mail and faxes. Hand deliveries or couriers will be received by scheduled appointment only. For further information and updates on EPA Docket Center services, please visit us online at https://www.epa.gov/dockets.
The EPA continues to carefully and continuously monitor information from the CDC, local area health departments, and our Federal partners so that we can respond rapidly as conditions change regarding COVID-19.
Submitting CBI. Do not submit information containing CBI to the EPA through https://www.regulations.gov/ or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information on any digital storage media that you mail to the EPA, mark the outside of the digital storage media as CBI and then identify electronically within the digital storage media the specific information that is claimed as CBI. In addition to one complete version of the comments that includes information claimed as CBI, you must submit a copy of the comments that does not contain the information claimed as CBI directly to the public docket through the procedures outlined in Instructions above
ge media as CBI and then identify electronically within the digital storage media the specific information that is claimed as CBI. In addition to one complete version of the comments that includes information claimed as CBI, you must submit a copy of the comments that does not contain the information claimed as CBI directly to the public docket through the procedures outlined in Instructions above. If you submit any digital storage media that does not contain CBI, mark the outside of the digital storage media clearly that it does not contain CBI. Information not marked as CBI will be included in the public docket and the EPA's electronic public docket without prior notice. Information marked as CBI will not be disclosed except in accordance with procedures set forth in 40 Code of Federal Regulations (CFR) part 2. Send or deliver information identified as CBI only to the following address: OAQPS Document Control Officer (C404-02), OAQPS, U.S. Environmental Protection Agency, Research Triangle Park, North Carolina 27711, Attention Docket ID No. EPA-HQ-OAR-2020-0560. Note that written comments containing CBI and submitted by mail may be delayed and no hand deliveries will be accepted.
Preamble acronyms and abbreviations. We use multiple acronyms and terms in this preamble. While this list may not be exhaustive, to ease the reading of this preamble and for reference purposes, the EPA defines the following terms and acronyms here:
AEGL acute exposure guideline level two AERMOD air dispersion model used by the HEM-3 model CAA Clean Air Act CalEPA California EPA CBI Confidential Business Information CDX Central Data Exchange CEDRI Compliance and Emissions Data Reporting Interface CFR Code of Federal Regulations ECHO EPA's Enforcement and Compliance History Online database EPA Environmental Protection Agency ERPG emergency response planning guidelines ERT Electronic Reporting Tool GACT generally available control technology HAP hazardous air pollutant(s) HCl hydrochloric acid HEM-3 Human Exposure Model, Version 1.5.5
e CEDRI Compliance and Emissions Data Reporting Interface CFR Code of Federal Regulations ECHO EPA's Enforcement and Compliance History Online database EPA Environmental Protection Agency ERPG emergency response planning guidelines ERT Electronic Reporting Tool GACT generally available control technology HAP hazardous air pollutant(s) HCl hydrochloric acid HEM-3 Human Exposure Model, Version 1.5.5 HF hydrogen fluoride HI hazard index HQ hazard quotient ICR Information Collection Request IRIS EPA's Integrated Risk Information System km kilometer MACT maximum achievable control technology MIR maximum individual risk NAAQS National Ambient Air Quality Standards NAICS North American Industry Classification System NEI National Emissions Inventory NESHAP national emission standards for hazardous air pollutants NOAEL No Observed Adverse Effect Level NOCS Notification of Compliance Status report NRDC Natural Resources Defense Council NSPS new source performance standards 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 PM particulate matter POM polycyclic organic matter ppm parts per million PRA Paperwork Reduction Act REL reference exposure level RfC reference concentration RTR residual risk and technology review SAB Science Advisory Board SSM startup, shutdown, and malfunction SV screening value 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 URE unit risk estimate USGS U.S. Geological Survey 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
nsport, and Ecological Exposure model UF uncertainty factor URE unit risk estimate USGS U.S. Geological Survey 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 is this source category and how does the current NESHAP regulate HAP emissions? C. What data collection activities were conducted to support this action? D. What other relevant background information and data are available? III. Analytical Procedures and Decision-Making A. How do we consider risk in our decision-making? B. How do we perform the technology review? C. How do we estimate post-MACT risk posed by the source category? IV. Analytical Results and Proposed Decisions A. What actions are we taking pursuant to CAA sections 112(d)(2) and 112(d)(3)? B. What are the results of the risk assessment and analyses? C. What are our proposed decisions regarding risk acceptability, ample margin of safety, and adverse environmental effect? D. What are the results and proposed decisions based on our technology review? E. What other actions are we proposing? F. What compliance dates are we proposing? V. Summary of Cost, Environmental, and Economic Impacts A. What are the affected sources? B. What are the air quality impacts? C. What are the cost impacts? D. What are the economic impacts? E. What are the benefits? VI. Request for Comments VII. Submitting Data Corrections VIII. Statutory and Executive Order Reviews A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review B. Executive Order 13771: Reducing Regulations and Controlling Regulatory Costs C. Paperwork Reduction Act (PRA) D. Regulatory Flexibility Act (RFA) E. Unfunded Mandates Reform Act (UMRA) F. Executive Order 13132: Federalism G
ns VIII. Statutory and Executive Order Reviews A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review B. Executive Order 13771: Reducing Regulations and Controlling Regulatory Costs C. Paperwork Reduction Act (PRA) D. Regulatory Flexibility Act (RFA) E. Unfunded Mandates Reform Act (UMRA) F. Executive Order 13132: Federalism G. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments H. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks I. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use J. National Technology Transfer and Advancement Act (NTTAA) K. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations I. General Information
A. Does this action apply to me?
The source category that is the subject of this proposal is Mercury Cell Chlor-Alkali Plants regulated under 40 CFR part 63, subpart IIIII. The North American Industry Classification System (NAICS) code for the chlor-alkali industry is 325180. 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.
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 EPA listed the Chlorine Production source category. Subsequently, on December 19, 2003, the EPA divided the Chlorine Production source category into two subcategories because of the differences in the production methods and the HAP emitted
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 EPA listed the Chlorine Production source category. Subsequently, on December 19, 2003, the EPA divided the Chlorine Production source category into two subcategories because of the differences in the production methods and the HAP emitted. These subcategories are: (1) Mercury cell chlor-alkali plants; and (2) chlorine production plants that do not rely upon mercury cells for chlorine production ( e.g., diaphragm cell chlor-alkali plants, membrane cell chlor-alkali plants, etc.). The EPA issued separate final actions in December 2003 to address emissions of mercury from the mercury cell chlor-alkali plant subcategory sources (68 FR 70904) and deleted the non-mercury cell subcategory (68 FR 70948). This action addresses the Mercury Cell Chlor-Alkali Plant source category, where a mercury cell chlor-alkali plant is any facility where mercury cells are used to manufacture product chlorine, product caustic, and by-product hydrogen and where mercury may be recovered from wastes.
B. Where can I get a copy of this document and other related information?
In addition to being available in the docket, an electronic copy of this action is available on the internet. Following signature by the EPA Administrator, the EPA will post a copy of this proposed action at https://www.epa.gov/stationary-sources-air-pollution/mercury-cell-chloralkali-plants-national-emissions-standards . Following publication in the Federal Register , the EPA will post the Federal Register version of the proposal and key technical documents at this same website. Information on the overall RTR program is available at https://www3.epa.gov/ttn/atw/rrisk/rtrpg.html
his proposed action at https://www.epa.gov/stationary-sources-air-pollution/mercury-cell-chloralkali-plants-national-emissions-standards . Following publication in the Federal Register , the EPA will post the Federal Register version of the proposal and key technical documents at this same website. Information on the overall RTR program is available at https://www3.epa.gov/ttn/atw/rrisk/rtrpg.html.
The proposed changes to the CFR that would be necessary to incorporate the changes proposed in this action are set out in an attachment to the memorandum titled Proposed Regulation Edits for 40 CFR part 63, subpart IIIII, available in the docket for this action (Docket ID No. EPA-HQ-OAR-2020-0560). The document includes the specific proposed amendatory language for revising the CFR and, for the convenience of interested parties, a redline version of the regulation. Following signature by the EPA Administrator, the EPA will also post a copy of this memorandum and the attachments to https://www.epa.gov/stationary-sources-air-pollution/mercury-cell-chloralkali-plants-national-emissions-standards.
II. Background
A. What is the statutory authority for this action?
The statutory authority for this action is provided by sections 112 and 301 of the CAA, as amended (42 U.S.C. 7401 et seq. ). Section 112 of the CAA establishes a two-stage regulatory process to develop standards for emissions of HAP from stationary sources. Generally, the first stage involves establishing technology-based standards and the second stage involves evaluating those standards that are based on MACT to determine whether additional standards are needed to address any remaining risk associated with HAP emissions
ection 112 of the CAA establishes a two-stage regulatory process to develop standards for emissions of HAP from stationary sources. Generally, the first stage involves establishing technology-based standards and the second stage involves evaluating those standards that are based on MACT to determine whether additional standards are needed to address any remaining risk associated with HAP emissions. This second stage is commonly referred to as the “residual risk review.” In addition to the residual risk review, the CAA also requires the EPA to review standards set under CAA section 112 every 8 years and revise the standards as necessary taking into account any “developments in practices, processes, or control technologies.” This review is commonly referred to as the “technology review.” When the two reviews are combined into a single rulemaking, it is commonly referred to as the “risk and technology review.” The discussion that follows identifies the most relevant statutory sections and briefly explains the contours of the methodology used to implement these statutory reqruirements. A more comprehensive discussion appears in the document titled CAA Section 112 Risk and Technology Reviews: Statutory Authority and Methodology, in the docket for this rulemaking.
In the first stage of the CAA section 112 standard setting process, the EPA promulgates technology-based standards under CAA section 112(d) for categories of sources identified as emitting one or more of the HAP listed in CAA section 112(b). Sources of HAP emissions are either major sources or area sources, and CAA section 112 establishes different requirements for major source standards and area source standards. “Major sources” are defined in CAA section 112(a)(1) as 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 (not including motor vehicles or nonroad vehicles) are “area sources,” as defined in CAA section 112(a)(2)
shes different requirements for major source standards and area source standards. “Major sources” are defined in CAA section 112(a)(1) as 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 (not including motor vehicles or nonroad vehicles) are “area sources,” as defined in CAA section 112(a)(2). 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.” In certain instances, as provided in CAA section 112(h), the EPA may set work practice standards in lieu of numerical emission standards. The EPA must also consider control options that are more stringent than the floor. Standards more stringent than the floor are commonly referred to as beyond-the-floor standards. For area sources, CAA section 112(d)(5) gives the EPA discretion to set standards based on generally available control technologies or management practices (GACT standards) in lieu of MACT standards.
The second stage in standard-setting focuses on identifying and addressing any remaining ( i.e., “residual”) risk pursuant to CAA section 112(f). For source categories subject to MACT standards, section 112(f)(2) of the CAA requires the EPA to determine whether 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
). For source categories subject to MACT standards, section 112(f)(2) of the CAA requires the EPA to determine whether NRDC v. EPA, 529 F.3d 1077, 1083 (D.C. Cir. 2008).
The approach incorporated into the CAA and used by the EPA to evaluate residual risk and to develop standards under CAA section 112(f)(2) is a two-step approach. In the first step, the EPA determines whether risks are acceptable. This determination “considers all health information, including risk estimation uncertainty, and includes a presumptive limit on maximum individual lifetime [cancer] risk (MIR) 1 of approximately 1- in-10 thousand.” (54 FR 38045). If risks are unacceptable, the EPA must determine the emissions standards necessary to reduce risk to an acceptable level without considering costs. In the second step of the approach, the EPA considers whether the emissions standards provide an ample margin of safety to protect public health “in consideration of all health information, including the number of persons at risk levels higher than approximately 1 in 1 million, as well as other relevant factors, including costs and economic impacts, technological feasibility, and other factors relevant to each particular decision.” Id. The EPA must promulgate emission standards necessary to provide an ample margin of safety to protect public health or determine that the standards being reviewed provide an ample margin of safety without any revisions. After conducting the ample margin of safety analysis, we consider whether a more stringent standard is necessary to prevent, taking into consideration costs, energy, safety, and other relevant factors, an “adverse environmental effect” as defined in CAA section 112(a)(7).
1 Although defined as “maximum individual risk,” MIR refers only to cancer risk. MIR, one metric for assessing cancer risk, is the estimated risk if an individual were exposed to the maximum level of a pollutant for a lifetime
s necessary to prevent, taking into consideration costs, energy, safety, and other relevant factors, an “adverse environmental effect” as defined in CAA section 112(a)(7).
1 Although defined as “maximum individual risk,” MIR refers only to cancer risk. MIR, one metric for assessing cancer risk, is the estimated risk if an individual were exposed to the maximum level of a pollutant for a lifetime.
CAA section 112(d)(6) separately requires the EPA to review standards promulgated under CAA section 112 and revise them “as necessary (taking into account developments in practices, processes, and control technologies)” no less often than every 8 years. In conducting this review, which we call the “technology review,” the EPA is not required to recalculate the MACT floor. Natural Resources Defense Council (NRDC) v. EPA, 529 F.3d 1077, 1084 (D.C. Cir. 2008). Association of Battery Recyclers, Inc. v. EPA, 716 F.3d 667 (D.C. Cir. 2013). The EPA may consider cost in deciding whether to revise the standards pursuant to CAA section 112(d)(6). The EPA is required to address regulatory gaps, such as missing standards for listed HAP known to be emitted from the source category. Louisiana Environmental Action Network (LEAN) v. EPA, 955 F.3d 1088 (D.C. Cir. 2020).
B. What is this source category and how does the current NESHAP regulate HAP emissions?
The Chlorine Production source category was initially listed as a category of major sources of HAP pursuant to section 112(c)(1) of the CAA on July 16, 1992 (57 FR 31576). At the time of the initial listing, the EPA defined the Chlorine Production source category as follows:
The Chlorine Production Source Category includes any facility engaged in the production of chlorine
ulate HAP emissions?
The Chlorine Production source category was initially listed as a category of major sources of HAP pursuant to section 112(c)(1) of the CAA on July 16, 1992 (57 FR 31576). At the time of the initial listing, the EPA defined the Chlorine Production source category as follows:
The Chlorine Production Source Category includes any facility engaged in the production of chlorine. The category includes, but is not limited to, facilities producing chlorine by the following production methods: Diaphragm cell, mercury cell, membrane cell, hybrid fuel cell, Downs cell, potash manufacture, hydrochloric acid decomposition, nitrosyl chloride process, nitric acid/salt process, Kel-Chlor process, and sodium chloride/sulfuric acid process. 2
2 Documentation for Developing the Initial Source Category List. U.S. Environmental Protection Agency. EPA-450/3-91-030. July 1992. p. A-67. Available at: https://www3.epa.gov/ttn/atw/socatlst/socatpg.html.
Based on the differences in the production methods and the HAP emitted, the EPA decided to divide the Chlorine Production source category into two subcategories: (1) Mercury cell chlor-alkali plants; and (2) chlorine production plants that do not rely upon mercury cells for chlorine production (diaphragm cell chlor-alkali plants, membrane cell chlor-alkali plants, etc.). On July 3, 2002, the EPA issued separate proposals to address emissions of mercury from the mercury cell chlor-alkali plant subcategory sources (67 FR 44672) and emissions of chlorine and hydrochloric acid (HCl) from both subcategories (67 FR 44713). Separate final actions were taken on both proposals on December 19, 2003. As part of these separate final actions, the EPA deleted the non-mercury cell subcategory under the authority of CAA section 112(c)(9)(B)(ii) of the CAA (68 FR 70948)
mercury cell chlor-alkali plant subcategory sources (67 FR 44672) and emissions of chlorine and hydrochloric acid (HCl) from both subcategories (67 FR 44713). Separate final actions were taken on both proposals on December 19, 2003. As part of these separate final actions, the EPA deleted the non-mercury cell subcategory under the authority of CAA section 112(c)(9)(B)(ii) of the CAA (68 FR 70948).
The final rule for the Mercury Cell Chlor-Alkali Plants subcategory (68 FR 70904, December 19, 2003, codified at 40 CFR part 63 subpart IIIII), which covers both major and area sources, included standards for mercury emissions from two types of affected sources at plant sites where chlorine and caustic are produced in mercury cells: Mercury cell chlor-alkali production facilty affected sources and mercury recovery facility affected sources. The rule prohibits mercury emissions from new and reconstructed mercury cell chlor-alkali production facilities. 40 CFR 63.8190(a)(1). For existing mercury cell chlor-alkali production facilities, the standards include emission limitations for mercury emissions from process vents (including emissions from end-box ventilation systems and hydrogen systems) and work practices for fugitive mercury emissions from the cell room. 40 CFR 8190(a)(2), 8192(a) through (f). For new, reconstructed, and existing mercury recovery facilities, the NESHAP includes emission limitations for mercury emissions from oven type thermal recovery unit vents and non-oven type thermal recovery unit vents. 40 CFR 63.8190(a)(3). The rule did not include standards for chlorine or HCl, citing the authority of section 112(d)(4) of the CAA (68 FR 70906). In its 2003 action (68 FR 70904), the EPA promulgated the initial Mercury Cell Chlor-Alkali Plants NESHAP pursuant to CAA section 112(d)(2) and added the source category to the EPA's Source Category List under CAA sections 112(c)(1), as well as under (c)(3) and (k)(3)(B) and (c)(6), in each case because of the mercury emissions
l, citing the authority of section 112(d)(4) of the CAA (68 FR 70906). In its 2003 action (68 FR 70904), the EPA promulgated the initial Mercury Cell Chlor-Alkali Plants NESHAP pursuant to CAA section 112(d)(2) and added the source category to the EPA's Source Category List under CAA sections 112(c)(1), as well as under (c)(3) and (k)(3)(B) and (c)(6), in each case because of the mercury emissions.
Following promulgation of the 2003 Mercury Cell Chlor-Alkali Plants NESHAP, the EPA received a petition to reconsider several aspects of the rule from the Natural Resources Defense Council (NRDC). NRDC also filed a petition for judicial review of the rule in the U.S. Court of Appeals for the District of Columbia Circuit. In a letter dated April 8, 2004, the EPA granted NRDC's petition for reconsideration and on July 20, 2004, the court placed the petition for judicial review in abeyance pending the EPA's action on reconsideration. The EPA issued proposals on June 11, 2008 (73 FR 33258), and on March 14, 2011 (76 FR 13852), to respond to the reconsideration petition. We discuss the reconsideration and the 2008 and 2011 proposals further in section IV.A.2 of this preamble.
The use of mercury cell technology has been declining for decades due to conversions to non-mercury processes and closures. For example, in 1993, there were about 13 facilities in the U.S., and when we initiated the development of this RTR proposed rule in early 2020, there were two facilities operating. Since that time, one facility (Ashta Chemicals in Ohio) ceased operating the mercury cell process. 3 So, now only one mercury cell chlor-alkali plant remains in operation. The one remaining mercury cell chlor-alkali facility is owned by Westlake Chemical (operated by Eagle Natrium, LLC) and is located in Marshall County, West Virginia. This is a large integrated chemical production facility whose products include chlorine and caustic from their chlor-alkali processes
g the mercury cell process. 3 So, now only one mercury cell chlor-alkali plant remains in operation. The one remaining mercury cell chlor-alkali facility is owned by Westlake Chemical (operated by Eagle Natrium, LLC) and is located in Marshall County, West Virginia. This is a large integrated chemical production facility whose products include chlorine and caustic from their chlor-alkali processes. In addition to the mercury cell process, chlorine and caustic are also produced in diagraghm cells at the site.
3 Ashta Chemicals in Ashtabula, Ohio, has stopped operating the mercury cell process, and is on schedule to complete the conversion to membrane cells by end of 2020. Source: Personal communication, phone conversation: Between Brittany Johnson, Environmental Manager, Ashta Chemicals and Phil Norwood, SC&A, Contractor for U.S. EPA, December 4, 2020.
C. What data collection activities were conducted to support this action?
Data sources used for this effort include the 2017 National Emissions Inventory (NEI), title V permit information, conversations with the West Virginia Department of Environmental Protection, and conversations with facility representatives. The NEI data were examined, and the processes and related emission sources associated with the mercury cell chlor-alkali plant were identified. In addition, information from data collection efforts from previous regulatory efforts for the source category were consulted, including studies that were conducted for the 2002 proposals, the 2003 final actions, and the 2008 and 2011 proposals cited above.
D. What other relevant background information and data are available?
There are other sources that are often used by the EPA in obtaining information for RTRs. Examples include the EPA's Enforcement and Compliance History Online (ECHO) database, the Reasonably Available Control Technology/Best Available Control Technology/Lowest Achievable Emission Rate Clearinghouse, and NESHAP for similar industries
t other relevant background information and data are available?
There are other sources that are often used by the EPA in obtaining information for RTRs. Examples include the EPA's Enforcement and Compliance History Online (ECHO) database, the Reasonably Available Control Technology/Best Available Control Technology/Lowest Achievable Emission Rate Clearinghouse, and NESHAP for similar industries. However, these sources were not utilized for the review for the Mercury Cell Chlor-Alkali Plants NESHAP because (1) the mercury cell processes are primarily sources of fugitive emissions and are unique such that control measures and work practices from other industries would not be applicable, and (2) since there is only one operating facility, it was more practical to focus on the specifics of that single facility.
III. Analytical Procedures and Decision-Making
In this section, we describe the analyses performed to support the proposed decisions for the RTR and other issues addressed in this proposal.
A. How do we consider risk in our decision-making?
As discussed in section II.A of this preamble and in the Benzene NESHAP, in evaluating and developing standards under CAA section 112(f)(2), we apply a two-step approach to determine whether or not risks are acceptable and to determine if the standards provide an ample margin of safety to protect public health. As explained in the Benzene NESHAP, “the first step judgment on acceptability cannot be reduced to any single factor” and, thus, “[t]he Administrator believes that the acceptability of risk under section 112 is best judged on the basis of a broad set of health risk measures and information.” (54 FR at 38046). Similarly, with regard to the ample margin of safety determination, “the Agency again considers all of the health risk and other health information considered in the first step
reduced to any single factor” and, thus, “[t]he Administrator believes that the acceptability of risk under section 112 is best judged on the basis of a broad set of health risk measures and information.” (54 FR at 38046). Similarly, with regard to the ample margin of safety determination, “the Agency again considers all of the health risk and other health information considered in the first step. Beyond that information, additional factors relating to the appropriate level of control will also be considered, including cost and economic impacts of controls, technological feasibility, uncertainties, and any other relevant factors.” Id.
The Benzene NESHAP approach provides flexibility regarding factors the EPA may consider in making determinations and how the EPA may weigh those factors for each source category. The EPA conducts a risk assessment that provides estimates of the MIR posed by emissions of HAP that are carcinogens from each source in the source category, the hazard index (HI) for chronic exposures to HAP with the potential to cause noncancer health effects, and the hazard quotient (HQ) for acute exposures to HAP with the potential to cause noncancer health effects. 4 The assessment also provides estimates of the distribution of cancer risk within the exposed populations, cancer incidence, and an evaluation of the potential for an adverse environmental effect. The scope of the EPA's risk analysis is consistent with the explanation in the EPA's response to comments on our policy under the Benzene NESHAP:
4 The MIR is defined as the cancer risk associated with a lifetime of exposure at the highest concentration of HAP where people are likely to live. The HQ is the ratio of the potential HAP exposure concentration to the noncancer dose-response value; the HI is the sum of HQs for HAP that affect the same target organ or organ system.
The policy chosen by the Administrator permits consideration of multiple measures of health risk
er risk associated with a lifetime of exposure at the highest concentration of HAP where people are likely to live. The HQ is the ratio of the potential HAP exposure concentration to the noncancer dose-response value; the HI is the sum of HQs for HAP that affect the same target organ or organ system.
The policy chosen by the Administrator permits consideration of multiple measures of health risk. Not only can the MIR figure be considered, but also incidence, the presence of non-cancer health effects, and the uncertainties of the risk estimates. In this way, the effect on the most exposed individuals can be reviewed as well as the impact on the general public. These factors can then be weighed in each individual case. This approach complies with the Vinyl Chloride mandate that the Administrator ascertain an acceptable level of risk to the public by employing his expertise to assess available data. It also complies with the Congressional intent behind the CAA, which did not exclude the use of any particular measure of public health risk from the EPA's consideration with respect to CAA section 112 regulations, and thereby implicitly permits consideration of any and all measures of health risk which the Administrator, in his judgment, believes are appropriate to determining what will “protect the public health”.
(54 FR at 38057). Thus, the level of the MIR is only one factor to be weighed in determining acceptability of risk. The Benzene NESHAP explained that “an MIR of approximately one in 10 thousand should ordinarily be the upper end of the range of acceptability. As risks increase above this benchmark, they become presumptively less acceptable under CAA section 112, and would be weighed with the other health risk measures and information in making an overall judgment on acceptability. Or, the Agency may find, Id. at 38045
zene 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, Id. at 38045. In other words, risks that include an MIR above 100-in-1 million may be determined to be acceptable, and risks with an MIR below that level may be determined to be unacceptable, depending on all of the available health information. Similarly, with regard to the ample margin of safety analysis, the EPA stated in the Benzene NESHAP that: “EPA believes the relative weight of the many factors that can be considered in selecting an ample margin of safety can only be determined for each specific source category. This occurs mainly because technological and economic factors (along with the health-related factors) vary from source category to source category.” Id. at 38061. We also consider the uncertainties associated with the various risk analyses, as discussed earlier in this preamble, in our determinations of acceptability and ample margin of safety. The EPA notes that it has not considered certain health information to date in making residual risk determinations. At this time, we do not attempt to quantify the HAP risk that may be associated with emissions from other facilities that do not include the source category under review, mobile source emissions, natural source emissions, persistent environmental pollution, or atmospheric transformation in the vicinity of the sources in the category.
The EPA understands the potential importance of considering an individual's total exposure to HAP in addition to considering exposure to HAP emissions from the source category and facility
ot include the source category under review, mobile source emissions, natural source emissions, persistent environmental pollution, or atmospheric transformation in the vicinity of the sources in the category.
The EPA understands the potential importance of considering an individual's total exposure to HAP in addition to considering exposure to HAP emissions from the source category and facility. We recognize that such consideration may be particularly important when assessing noncancer risk, where pollutant-specific exposure health reference levels ( e.g., reference concentrations (RfCs)) are based on the assumption that thresholds exist for adverse health effects. For example, the EPA recognizes that, although exposures attributable to emissions from a source category or facility alone may not indicate the potential for increased risk of adverse noncancer health effects in a population, the exposures resulting from emissions from the facility in combination with emissions from all of the other sources ( e.g., other facilities) to which an individual is exposed may be sufficient to result in an increased risk of adverse noncancer health effects. In May 2010, the Science Advisory Board (SAB) advised the EPA “that RTR assessments will be most useful to decision makers and communities if results are presented in the broader context of aggregate and cumulative risks, including background concentrations and contributions from other sources in the area.” 5
5 Recommendations of the SAB Risk and Technology Review Methods Panel are provided in their report, which is available at: https://yosemite.epa.gov/sab/sabproduct.nsf/4AB3966E263D943A8525771F00668381/$File/EPA-SAB-10-007-unsigned.pdf.
In response to the SAB recommendations, the EPA incorporates cumulative risk analyses into its RTR risk assessments
tributions from other sources in the area.” 5
5 Recommendations of the SAB Risk and Technology Review Methods Panel are provided in their report, which is available at: https://yosemite.epa.gov/sab/sabproduct.nsf/4AB3966E263D943A8525771F00668381/$File/EPA-SAB-10-007-unsigned.pdf.
In response to the SAB recommendations, the EPA incorporates cumulative risk analyses into its RTR risk assessments. The Agency (1) conducts facility-wide assessments, which include source category emission points, as well as other emission points within the facilities; (2) combines exposures from multiple sources in the same category that could affect the same individuals; and (3) for some persistent and bioaccumulative pollutants, analyzes the ingestion route of exposure. In addition, the RTR risk assessments consider aggregate cancer risk from all carcinogens and aggregated noncancer HQs for all noncarcinogens affecting the same target organ or target organ system.
Although we are interested in placing source category and facility-wide HAP risk in the context of total HAP risk from all sources combined in the vicinity of each source, we are concerned about the uncertainties of doing so. Estimates of total HAP risk from emission sources other than those that we have studied in depth during this RTR review would have significantly greater associated uncertainties than the source category or facility-wide estimates. Such aggregate or cumulative assessments would compound those uncertainties, making the assessments too unreliable.
B. How do we perform the technology review?
Our technology review primarily focuses on the identification and evaluation of developments in practices, processes, and control technologies that have occurred since the MACT standards were promulgated. Where we identify such developments, we analyze their technical feasibility, estimated costs, energy implications, and non-air environmental impacts. We also consider the emission reductions associated with applying each development
es 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, we review a variety of data sources in our investigation of potential practices, processes, or controls to consider. We also review the NESHAP and the available data to determine if there are any unregulated emissions of HAP within the source category and evaluate this data for use in developing new emission standards
echnologies that were considered at the time we originally developed the NESHAP, we review a variety of data sources in our investigation of potential practices, processes, or controls to consider. We also review the NESHAP and the available data to determine if there are any unregulated emissions of HAP within the source category and evaluate this data for use in developing new emission standards. See sections II.C and II.D of this preamble for information on the specific data sources that were reviewed as part of the technology review.
C. How do we estimate post-MACT risk posed by the source category?
In this section, we provide a complete description of the types of analyses that we generally perform during the risk assessment process. In some cases, we do not perform a specific analysis because it is not relevant. For example, in the absence of emissions of HAP known to be persistent and bioaccumulative in the environment (PB-HAP), we would not perform a multipathway exposure assessment. Where we do not perform an analysis, we state that we do not and provide the reason. While we present all of our risk assessment methods, we only present risk assessment results for the analyses actually conducted (see section IV.B of this preamble).
The EPA conducts a risk assessment that provides estimates of the MIR for cancer posed by the HAP emissions Residual Risk Assessment for the Mercury Cell Chlor-Alkali Plant Source Category in Support of the 2020 Risk and Technology Review Proposed Rule. The methods used to assess risk (as described in the seven primary steps below) are consistent with those described by the EPA in the document reviewed by a panel of the EPA's SAB in 2009; 6 and described in the SAB review report issued in 2010. They are also consistent with the key recommendations contained in that report.
6 U.S. EPA
Support of the 2020 Risk and Technology Review Proposed Rule. The methods used to assess risk (as described in the seven primary steps below) are consistent with those described by the EPA in the document reviewed by a panel of the EPA's SAB in 2009; 6 and described in the SAB review report issued in 2010. They are also consistent with the key recommendations contained in that report.
6 U.S. EPA. Risk and Technology Review (RTR) Risk Assessment Methodologies: For Review by the EPA's Science Advisory Board with Case Studies—MACT I Petroleum Refining Sources and Portland Cement Manufacturing, June 2009. EPA-452/R-09-006. https://www3.epa.gov/airtoxics/rrisk/rtrpg.html.
1. How did we estimate actual emissions and identify the emissions release characteristics?
The HAP emissions from the single mercury cell chlor-alkali plant includes mercury and chlorine. Hydrochloric acid historically had been associated with these facilities, but based on recent reviews of available information and discussions with Westlake Chemical, we conclude that any HCl emissions from the remaining operating facility in West Virginia are due to non-source category emissions sources such as HCl production operations ( i.e., they are not emitted by an affected source subject to the standards applicable to mercury cell chlor-alkali plants). The mercury emissions are emitted from several emission sources within the mercury cell chlor-alkali facility affected source at the one operating mercury cell chlor-alkali plant, which, for the purposes of the source category risk assessment, have been categorized into two general emission process groups: (1) Process vents and (2) fugitives from the mercury cell room building. Based on available data, we conclude the chlorine emissions are mostly or entirely emitted as fugitive emissions associated with the cell room or from pipes or other equipment used to pump the product chlorine to the chlorine storage units or other associated equipment in the mercury cell chlor-alkali facility affected source
(1) Process vents and (2) fugitives from the mercury cell room building. Based on available data, we conclude the chlorine emissions are mostly or entirely emitted as fugitive emissions associated with the cell room or from pipes or other equipment used to pump the product chlorine to the chlorine storage units or other associated equipment in the mercury cell chlor-alkali facility affected source. The main source of emissions data used in our analyses was the NEI data submitted for calendar year 2017. Data on the numbers, types, dimensions, and locations of the emission points and non-point sources for each facility were obtained from the NEI and Google Earth TM . A description of the data, approach, and rationale used to develop actual HAP emissions estimates is discussed in more detail in the document, Development of the Residual Risk Review Emissions Dataset for the Mercury Cell Chlor-Alkali Plants Source Category, which is available in the docket (Docket ID No. EPA-HQ-OAR-2020-0560).
2. How did we estimate MACT-allowable emissions?
The available emissions data in the RTR emissions dataset include estimates of the mass of HAP emitted during a specified annual time period. These “actual” emission levels are often lower than the emission levels allowed under the requirements of the current MACT standards. The emissions allowed under the MACT standards are referred to as the “MACT-allowable” emissions. We discussed the consideration of both MACT-allowable and actual emissions in the final Coke Oven Batteries RTR (70 FR 19992, 19998 through 19999, April 15, 2005) and in the proposed and final Hazardous Organic NESHAP RTR (71 FR 34421, 34428, June 14, 2006, and 71 FR 76603, 76609, December 21, 2006, respectively). In those actions, we noted that assessing the risk at the MACT-allowable level is inherently reasonable since that risk reflects the maximum level facilities could emit and still comply with national emission standards
rough 19999, April 15, 2005) and in the proposed and final Hazardous Organic NESHAP RTR (71 FR 34421, 34428, June 14, 2006, and 71 FR 76603, 76609, December 21, 2006, respectively). In those actions, we noted that assessing the risk at the MACT-allowable level is inherently reasonable since that risk reflects the maximum level facilities could emit and still comply with national emission standards. We also explained that it is reasonable to consider actual emissions, where such data are available, in both steps of the risk analysis, in accordance with the Benzene NESHAP approach. (54 FR 38044)
For the Mercury Cell Chlor-Alkali Plants source category, the EPA assumed actual emissions are equal to allowable emissions. Allowable emissions are the estimated emissions that would occur under normal full-capacity operating conditions and as allowed under the applicable MACT standards. There is no available data that suggests the facility is operating at less than full capacity. There is also no evidence that the facility is controlling point source emissions to a degree greater than the emission limitations or that they are performing practices in excess of the required work practices for the control of fugitive emissions. This means that they are not reducing emissions beyond the levels required by the MACT standards which would result in actual emissions being less than allowable emissions. In addition, a review of ECHO indicates no enforcement actions for violations of the title V operating limits over the last 5 years, which would result in actual emissions being greater than allowable. Therefore, we are comfortable with the assumption that actual emissions are equal to the allowable emissions.
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 category addressed in this proposal were estimated using the Human Exposure Model (HEM-3)
with the assumption that actual emissions are equal to the allowable emissions.
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 category addressed in this proposal were estimated using the Human Exposure Model (HEM-3). 7 The HEM-3 performs three primary risk assessment activities: (1) Conducting dispersion modeling to estimate the concentrations of HAP in ambient air, (2) estimating long-term and short-term inhalation exposures to individuals residing within 50 kilometers (km) of the modeled sources, and (3) estimating individual and population-level inhalation risk using the exposure estimates and quantitative dose-response information.
7 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. 8 To perform the dispersion modeling and to develop the preliminary risk estimates, HEM-3 draws on three data libraries. The first is a library of meteorological data, which is used for dispersion calculations. This library includes 1 year (2016) of hourly surface and upper air observations from 824 meteorological stations selected to provide coverage of the United States and Puerto Rico. A second library of United States Census Bureau census block 9 internal point locations and
8 U.S. EPA. Revision to the Guideline on Air Quality Models: Adoption of a Preferred General Purpose (Flat and Complex Terrain) Dispersion Model and Other Revisions (70 FR 68218, November 9, 2005).
9 A census block is the smallest geographic area for which census statistics are tabulated.
b
erto Rico. A second library of United States Census Bureau census block 9 internal point locations and
8 U.S. EPA. Revision to the Guideline on Air Quality Models: Adoption of a Preferred General Purpose (Flat and Complex Terrain) Dispersion Model and Other Revisions (70 FR 68218, November 9, 2005).
9 A census block is the smallest geographic area for which census statistics are tabulated.
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 category. The HAP air concentrations at each nearby census block centroid located within 50 km of the facility are a surrogate for the chronic inhalation exposure concentration for all the people who reside in that census block. A distance of 50 km is consistent with both the analysis supporting the 1989 Benzene NESHAP (54 FR 38044) 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
cting 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 10 emitted by the modeled facility. We estimate cancer risk at every census block within 50 km of every facility in the source category. The MIR is the highest individual lifetime cancer risk estimated for any of those census blocks. In addition to calculating the MIR, we estimate the distribution of individual cancer risks for the source category by summing the number of individuals within 50 km of the sources whose estimated risk falls within a specified risk range. We also estimate annual cancer incidence by multiplying the estimated lifetime cancer risk at each census block by the number of people residing in that block, summing results for all of the census blocks, and then dividing this result by a 70-year lifetime
the source category by summing the number of individuals within 50 km of the sources whose estimated risk falls within a specified risk range. We also estimate annual cancer incidence by multiplying the estimated lifetime cancer risk at each census block by the number of people residing in that block, summing results for all of the census blocks, and then dividing this result by a 70-year lifetime.
10 The EPA's 2005 Guidelines for Carcinogen Risk Assessment classifies carcinogens as: “carcinogenic to humans,” “likely to be carcinogenic to humans,” and “suggestive evidence of carcinogenic potential.” These classifications also coincide with the terms “known carcinogen, probable carcinogen, and possible carcinogen,” respectively, which are the terms advocated in the EPA's Guidelines for Carcinogen Risk Assessment, published in 1986 (51 FR 33992, September 24, 1986). In August 2000, the document, Supplemental Guidance for Conducting Health Risk Assessment of Chemical Mixtures (EPA/630/R-00/002), was published as a supplement to the 1986 document. Copies of both documents can be obtained from https://cfpub.epa.gov/ncea/risk/recordisplay.cfm?deid=20533&CFID=70315376&CFTOKEN=71597944. Summing the risk of these individual compounds to obtain the cumulative cancer risk is an approach that was recommended by the EPA's SAB in their 2002 peer review of the EPA's National Air Toxics Assessment (NATA) titled NATA—Evaluating the National-scale Air Toxics Assessment 1996 Data—an SAB Advisory, available at https://yosemite.epa.gov/sab/sabproduct.nsf/214C6E915BB04E14852570CA007A682C/$File/ecadv02001.pdf.
To assess the risk of noncancer health effects from chronic exposure to HAP, we calculate either an HQ or a target organ-specific hazard index (TOSHI). We calculate an HQ when a single noncancer HAP is emitted. Where more than one noncancer HAP is emitted, we sum the HQ for each of the HAP that affects a common target organ or target organ system to obtain a TOSHI
A007A682C/$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
index.asp ); (2) the CalEPA Chronic Reference Exposure Level (REL) ( https://oehha.ca.gov/air/crnr/notice-adoption-air-toxics-hot-spots-program-guidance-manual-preparation-health-risk-0 ); or (3) as noted above, a scientifically credible dose-response value that has been developed in a manner consistent with the EPA guidelines and has undergone a peer review process similar to that used by the EPA. The pollutant-specific dose-response values used to estimate health risks are available at https://www.epa.gov/fera/dose-response-assessment-assessing-health-risks-associated-exposure-hazardous-air-pollutants.
c. Risk From Acute Exposure to HAP That May Cause Health Effects Other Than Cancer
For each HAP for which appropriate acute inhalation dose-response values are available, the EPA also assesses the potential health risks due to acute exposure. For these assessments, the EPA makes conservative assumptions about emission rates, meteorology, and exposure location. As part of our efforts to continually improve our methodologies to evaluate the risks that HAP emitted from categories of industrial sources pose to human health and the environment, 11 we revised our treatment of meteorological data to use reasonable worst-case air dispersion conditions in our acute risk screening assessments instead of worst-case air dispersion conditions. This revised treatment of meteorological data and the supporting rationale are described in more detail in Residual Risk Assessment for the Mercury Cell Chlor-Alkali Plant Source Category in Support of the 2020 Risk and Technology Review Proposed Rule, and in Appendix 5 of the report: Technical Support Document for Acute Risk Screening Assessment. This revised approach has been used in this proposed rule and in all other RTR rulemakings proposed on or after June 3, 2019.
11 See, e.g., U.S. EPA. Screening Methodologies to Support Risk and Technology Reviews (RTR): A Case Study Analysis (Draft Report, May 2017. https://www3.epa.gov/ttn/atw/rrisk/rtrpg.html )
ix 5 of the report: Technical Support Document for Acute Risk Screening Assessment. This revised approach has been used in this proposed rule and in all other RTR rulemakings proposed on or after June 3, 2019.
11 See, e.g., U.S. EPA. Screening Methodologies to Support Risk and Technology Reviews (RTR): A Case Study Analysis (Draft Report, May 2017. https://www3.epa.gov/ttn/atw/rrisk/rtrpg.html ).
To assess the potential acute risk to the maximally exposed individual, we use the peak hourly emission rate for each emission point, 12 reasonable worst-case air dispersion conditions ( i.e., 99th percentile), and the point of highest off-site exposure. Specifically, we assume that peak emissions from the source category and reasonable worst-case air dispersion conditions co-occur and that a person is present at the point of maximum exposure.
12 In the absence of hourly emission data, we develop estimates of maximum hourly emission rates by multiplying the average actual annual emissions rates by a factor (either a category-specific factor or a default factor of 10) to account for variability. This is documented in Residual Risk Assessment for Mercury Cell Chlor-alkali Plants Source Category in Support of the 2020 Risk and Technology Review Proposed Rule, and in Appendix 5 of the report: Technical Support Document for Acute Risk Screening Assessment. Both are available in the docket for this rulemaking.
To characterize the potential health risks associated with estimated acute inhalation exposures to a HAP, we generally use multiple acute dose-response values, including acute RELs, acute exposure guideline levels (AEGLs), and emergency response planning guidelines (ERPG) for 1-hour exposure durations, if available, to calculate acute HQs. The acute HQ is calculated by dividing the estimated acute exposure concentration by the acute dose-response value. For each HAP for which acute dose-response values are available, the EPA calculates acute HQs
values, including acute RELs, acute exposure guideline levels (AEGLs), and emergency response planning guidelines (ERPG) for 1-hour exposure durations, if available, to calculate acute HQs. The acute HQ is calculated by dividing the estimated acute exposure concentration by the acute dose-response value. For each HAP for which acute dose-response values are available, the EPA calculates acute HQs.
An acute REL is defined as “the concentration level at or below which no adverse health effects are anticipated for a specified exposure duration.” 13 Acute RELs are based on the most sensitive, relevant, adverse health effect reported in the peer-reviewed medical and toxicological literature. They are designed to protect the most sensitive individuals in the population through the inclusion of margins of safety. Because margins of safety are incorporated to address data gaps and uncertainties, exceeding the REL does not automatically indicate an adverse health impact. AEGLs represent threshold exposure limits for the general public and are applicable to emergency exposures ranging from 10 minutes to 8 hours. 14 They are guideline levels for “once-in-a-lifetime, short-term exposures to airborne concentrations of acutely toxic, high-priority chemicals.” Id. at 21. The AEGL-1 is specifically defined as “the airborne concentration (expressed as ppm (parts per million) or mg/m 3 (milligrams per cubic meter)) of a substance above which it is predicted that the general population, including susceptible individuals, could experience notable discomfort, irritation, or certain asymptomatic nonsensory effects. However, the effects are not disabling and are transient and reversible upon cessation of exposure.” The document also notes that “Airborne concentrations below AEGL-1 represent exposure levels that can produce mild and progressively increasing but transient and nondisabling odor, taste, and sensory irritation or certain asymptomatic, nonsensory effects.” Id
ertain 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.
13 CalEPA issues acute RELs as part of its Air Toxics Hot Spots Program, and the 1-hour and 8-hour values are documented in Air Toxics Hot Spots Program Risk Assessment Guidelines, Part I, The Determination of Acute Reference Exposure Levels for Airborne Toxicants, which is available at https://oehha.ca.gov/air/general-info/oehha-acute-8-hour-and-chronic-reference-exposure-level-rel-summary.
14 National Academy of Sciences, 2001. Standing Operating Procedures for Developing Acute Exposure Levels for Hazardous Chemicals, page 2. Available at https://www.epa.gov/sites/production/files/2015-09/documents/sop_final_standing_operating_procedures_2001.pdf. Note that the National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances ended in October 2011, but the AEGL program continues to operate at the EPA and works with the National Academies to publish final AEGLs ( https://www.epa.gov/aegl ).
ERPGs are “developed for emergency planning and are intended as health-based guideline concentrations for single exposures to chemicals.” 15 Id. at 1
l 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.” 15 Id. at 1. The ERPG-1 is defined as “the maximum airborne concentration below which it is believed that nearly all individuals could be exposed for up to 1 hour without experiencing other than mild transient adverse health effects or without perceiving a clearly defined, objectionable odor.” Id. at 2. Similarly, the ERPG-2 is defined as “the maximum airborne concentration below which it is believed that nearly all individuals could be exposed for up to one hour without experiencing or developing irreversible or other serious health effects or symptoms which could impair an individual's ability to take protective action.” Id. at 1.
15 ERPGS Procedures and Responsibilities. March 2014. American Industrial Hygiene Association. Available at: https://www.aiha.org/get-involved/AIHAGuidelineFoundation/EmergencyResponsePlanningGuidelines/Documents/ERPG%20Committee%20Standard%20Operating%20Procedures%20%20-%20March%202014%20Revision%20%28Updated%2010-2-2014%29.pdf.
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)
e slightly different, AEGL-1s are often the same as the corresponding ERPG-1s, and AEGL-2s are often equal to ERPG-2s. The maximum HQs from our acute inhalation screening risk assessment typically result when we use the acute REL for a HAP. In cases where the maximum acute HQ exceeds 1, we also report the HQ based on the next highest acute dose-response value (usually the AEGL-1 and/or the ERPG-1).
For this source category, we used a default acute emissions multiplier of 10 as we have no information to suggest another factor to account for variability in hourly emissions data is more appropriate.
In our acute inhalation screening risk assessment, acute impacts are deemed negligible for HAP for which acute HQs are less than or equal to 1, and no further analysis is performed for these HAP. In cases where an acute HQ from the screening step is greater than 1, we assess the site-specific data to ensure that the acute HQ is at an off-site location. For this source category, the data refinements employed consisted of estimating the highest HQ that might occur outside facility boundaries with the use of satellite imagery of the facility with receptor locations. These refinements are discussed more fully in the Residual Risk Assessment for the Mercury Cell Chlor-Alkali Plant Source Category in Support of the 2020 Risk and Technology Review Proposed Rule, which is available in the docket for this source category.
4. How do we conduct the multipathway exposure and risk screening assessment?
The EPA conducts a tiered screening assessment examining the potential for significant human health risks due to exposures via routes other than inhalation ( i.e., ingestion). We first determine whether any sources in the source category emit any HAP known to be persistent and bioaccumulative in the environment, as identified in the EPA's 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 )
due to exposures via routes other than inhalation ( i.e., ingestion). We first determine whether any sources in the source category emit any HAP known to be persistent and bioaccumulative in the environment, as identified in the EPA's 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 Mercury Cell Chlor-Alkali Plant source category, mercury emissions were the only PB-HAP emitted by the source category, so we https://www.epa.gov/sites/production/files/2013-08/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 (SV).”
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 SV is greater than 1), we conduct a second screening assessment, which we call the Tier 2 screening assessment. The Tier 2 screening assessment separates the Tier 1 combined fisher and farmer exposure scenario into fisher, farmer, and gardener scenarios that retain upper-bound ingestion rates
r 1 screening assessment exceeds the Tier 1 screening threshold emission rate for any facility ( i.e., the SV is greater than 1), we conduct a second screening assessment, which we call the Tier 2 screening assessment. The Tier 2 screening assessment separates the Tier 1 combined fisher and farmer exposure scenario into fisher, farmer, and gardener scenarios that retain upper-bound ingestion rates.
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 and assume the fisher only consumes fish from lakes within that 50 km zone. 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 the USGS lakes database.
In the Tier 2 farmer scenario, we maintain an assumption that the farm is located within 0.5 km of the facility and that the farmer consumes meat, eggs, dairy, vegetables, and fruit produced near the facility. We may further refine the Tier 2 screening analysis by assessing a gardener scenario to characterize a range of exposures, with the gardener scenario being more plausible in RTR evaluations. Under the gardener scenario, we assume the gardener consumes home-produced eggs, vegetables, and fruit products at the same ingestion rate as the farmer
dairy, vegetables, and fruit produced near the facility. We may further refine the Tier 2 screening analysis by assessing a gardener scenario to characterize a range of exposures, with the gardener scenario being more plausible in RTR evaluations. Under the gardener scenario, we assume the gardener consumes home-produced eggs, vegetables, and fruit products at the same ingestion rate as the farmer. The Tier 2 screen continues to rely on the high-end food intake assumptions that were applied in Tier 1 for local fish (adult female angler at 99th percentile fish consumption 16 ) and locally grown or raised foods (90th percentile consumption of locally grown or raised foods for the farmer and gardener scenarios 17 ). If PB-HAP emission rates do not result in a Tier 2 SV greater than 1, we consider those PB-HAP emissions to pose risks below a level of concern. If the PB-HAP emission rates for a facility exceed the Tier 2 screening threshold emission rates, we may conduct a Tier 3 screening assessment.
16 Burger, J. 2002. Daily consumption of wild fish and game: Exposures of high end recreationists. International Journal of Environmental Health Research, 12:343-354.
17 U.S. EPA. Exposure Factors Handbook 2011 Edition (Final). U.S. Environmental Protection
Agency, Washington, DC, EPA/600/R-09/052F, 2011.
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, locating residential/garden locations for urban and/or rural settings, 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 (a time-series analysis). If necessary, the EPA may further refine the screening assessment through a site-specific assessment
idating that the lakes are fishable, locating residential/garden locations for urban and/or rural settings, 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 (a time-series analysis). If necessary, the EPA may further refine the screening assessment through a site-specific assessment.
For further information on the multipathway assessment approach, see the Residual Risk Assessment for the Mercury Cell Chlor-Alkali Plant Source Category in Support of the Risk and Technology Review 2020 Proposed Rule, which is available in the docket for this action.
5. How do we conduct the environmental risk screening assessment?
a. Adverse Environmental Effect, Environmental HAP, and Ecological Benchmarks
The EPA conducts a screening assessment to examine the potential for an adverse environmental effect as required under section 112(f)(2)(A) of the CAA. Section 112(a)(7) of the CAA defines “adverse environmental effect” as “any significant and widespread adverse effect, which may reasonably be anticipated, to wildlife, aquatic life, or other natural resources, including adverse impacts on populations of endangered or threatened species or significant degradation of environmental quality over broad areas.”
The EPA focuses on eight HAP, which are referred to as “environmental HAP,” in its screening assessment: Six PB-HAP and two acid gases. The PB-HAP included in the screening assessment are arsenic compounds, cadmium compounds, dioxins/furans, POM, mercury (both inorganic mercury and methyl mercury), and lead compounds. The acid gases included in the screening assessment are 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
nic mercury and methyl mercury), and lead compounds. The acid gases included in the screening assessment are 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-
An ecological benchmark represents a concentration of HAP that has been linked to a particular environmental effect level. For each environmental HAP, we identified the available ecological benchmarks for each assessment endpoint. We identified, where possible, ecological benchmarks at the following effect levels: Probable effect levels, lowest-observed-adverse-effect level, and no-observed-adverse-effect level. In cases where multiple effect levels were available for a particular PB-HAP and assessment endpoint, we use all of the available effect levels to help us to determine whether ecological risks exist and, if so, whether the risks could be considered significant and widespread.
For further information on how the environmental risk screening assessment was conducted, including a discussion of the risk metrics used, how the environmental HAP were identified, and how the ecological benchmarks were selected, see Appendix 9 of the Residual Risk Assessment for the Mercury Cell Chlor-Alkali Plant Source Category in Support of the Risk and Technology Review 2020 Proposed Rule, which is available in the docket for this action.
b. Environmental Risk Screening Methodology
For the environmental risk screening assessment, the EPA first determined whether any facilities in the Mercury Cell Chlor-Alkali Plant source category emitted any of the environmental HAP. For the Mercury Cell Chlor-Alkali Plant source category, we identified emissions of mercury and HCl
oposed Rule, which is available in the docket for this action.
b. Environmental Risk Screening Methodology
For the environmental risk screening assessment, the EPA first determined whether any facilities in the Mercury Cell Chlor-Alkali Plant source category emitted any of the environmental HAP. For the Mercury Cell Chlor-Alkali Plant source category, we identified emissions of mercury and HCl. Because one or more of the environmental HAP evaluated are emitted by at least one facility in the source category, we proceeded to the second step of the evaluation.
c. PB-HAP Methodology
The environmental screening assessment includes six PB-HAP, arsenic compounds, cadmium compounds, dioxins/furans, POM, mercury (both inorganic mercury and methyl mercury), and lead compounds. 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 of pollutant 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
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
dustrial 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 National Ambient Air Quality Standards (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
nmental Risk Methodology
The environmental screening assessment for acid gases evaluates the potential phytotoxicity and reduced productivity of plants due to chronic exposure to HF and HCl. The environmental risk screening methodology for acid gases is a single-tier screening assessment that compares modeled ambient air concentrations (from AERMOD) to the ecological benchmarks for each acid gas. To identify a potential adverse environmental effect (as defined in section 112(a)(7) of the CAA) from emissions of HF and HCl, we evaluate the following metrics: The size of the modeled area around each facility that exceeds the ecological benchmark for each acid gas, in acres and square kilometers; the percentage of the modeled area around each facility that exceeds the ecological benchmark for each acid gas; and the area-weighted average SV around each facility (calculated by dividing the area-weighted average concentration over the 50-km modeling domain by the ecological benchmark for each acid gas). For further information on the environmental screening assessment approach, see Appendix 9 of the Residual Risk Assessment for the Mercury Cell Chlor-Alkali Plant Source Category in Support of the Risk and Technology Review 2020 Proposed Rule, which is available in the docket for this action.
6. How do we conduct facility-wide assessments?
To put the source category risks in context, we typically examine the risks
For this source category, 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. Once a quality assured source category dataset was available, it was placed back with the remaining records from the NEI for that facility
amine the risks
For this source category, 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. Once a quality assured source category dataset was available, it was placed back with the remaining records from the NEI for that facility. The facility-wide file was then used to analyze risks due to the inhalation of HAP that are emitted “facility-wide” for the populations residing within 50 km of each facility, consistent with the methods used for the source category analysis described above. For these facility-wide risk analyses, the modeled source category risks were compared to the facility-wide risks to determine the portion of the facility-wide risks that could be attributed to the source category addressed in this proposal. We also specifically examined the facility that was associated with the highest estimate of risk and determined the percentage of that risk attributable to the source category of interest. The Residual Risk Assessment for the Mercury Cell Chlor-Alkali Plant Source Category in Support of the Risk and Technology Review 2020 Proposed Rule, available through the docket for this action, provides the methodology and results of the facility-wide analyses, including all facility-wide risks and the percentage of source category contribution to facility-wide risks.
For this source category, we conducted the facility-wide assessment using a dataset that the EPA compiled from the 2017 NEI. We used the NEI data for the facility and did not adjust any category or “non-category” data. Therefore, there could be differences in the dataset from that used for the source category assessments described in this preamble. We analyzed risks due to the inhalation of HAP that are emitted “facility-wide” for the populations residing within 50 km of each facility, consistent with the methods used for the source category analysis described above
ot adjust any category or “non-category” data. Therefore, there could be differences in the dataset from that used for the source category assessments described in this preamble. We analyzed risks due to the inhalation of HAP that are emitted “facility-wide” for the populations residing within 50 km of each facility, consistent with the methods used for the source category analysis described above. For these facility-wide risk analyses, we made a reasonable attempt to identify the source category risks, and these risks were compared to the facility-wide risks to determine the portion of facility-wide risks that could be attributed to the source category addressed in this proposal. We also specifically examined the facility that was associated with the highest estimate of risk and determined the percentage of that risk attributable to the source category of interest. The Residual Risk Assessment for the Mercury Cell Chlor-Alkali Plant Source Category in Support of the Risk and Technology Review 2020 Proposed Rule, available through the docket for this action, provides the methodology and results of the facility-wide analyses, including all facility-wide risks and the percentage of source category contribution to facility-wide risks.
7. How do we consider uncertainties in risk assessment?
Uncertainty and the potential for bias are inherent in all risk assessments, including those performed for this proposal. Although uncertainty exists, we believe that our approach, which used conservative tools and assumptions, ensures that our decisions are health and environmentally protective. A brief discussion of the uncertainties in the RTR emissions dataset, dispersion modeling, inhalation exposure estimates, and dose-response relationships follows below. Also included are those uncertainties specific to our acute screening assessments, multipathway screening assessments, and our environmental risk screening assessments
s that our decisions are health and environmentally protective. A brief discussion of the uncertainties in the RTR emissions dataset, dispersion modeling, inhalation exposure estimates, and dose-response relationships follows below. Also included are those uncertainties specific to our acute screening assessments, multipathway screening assessments, and our environmental risk screening assessments. A more thorough discussion of these uncertainties is included in the Residual Risk Assessment for the Mercury Cell Chlor-Alkali Plant Source Category in Support of the Risk and Technology Review 2020 Proposed Rule, which is available in the docket for this action. If a multipathway site-specific assessment was performed for this source category, a full discussion of the uncertainties associated with that assessment can be found in Appendix 11 of that document, Site-Specific Human Health Multipathway Residual Risk Assessment Report.
a. Uncertainties in the RTR Emissions Dataset
Although the development of the RTR emissions dataset involved quality assurance/quality control processes, the accuracy of emissions values will vary depending on the source of the data, the degree to which data are incomplete or missing, the degree to which assumptions made to complete the datasets are accurate, errors in emission estimates, and other factors. The emission estimates considered in this analysis generally are annual totals for certain years, and they do not reflect short-term fluctuations during the course of a year or variations from year to year. The estimates of peak hourly emission rates for the acute effects screening assessment were based on an emission adjustment factor applied to the average annual hourly emission rates, which are intended to account for emission fluctuations due to normal facility operations.
b. Uncertainties in Dispersion Modeling
We recognize there is uncertainty in ambient concentration estimates associated with any model, including the EPA's recommended regulatory dispersion model, AERMOD
ment 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
lities 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
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 through 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)
inogen Risk Assessment, pages 1 through 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)
any of the UFs used to account for variability and uncertainty in the development of acute dose-response values are quite similar to those developed for chronic durations. Additional adjustments are often applied to account for uncertainty in extrapolation from observations at one exposure duration ( e.g., 4 hours) to derive an acute dose-response value at another exposure duration ( e.g., 1 hour). Not all acute dose-response values are developed for the same purpose, and care must be taken when interpreting the results of an acute assessment of human health effects relative to the dose-response value or values being exceeded. Where relevant to the estimated exposures, the lack of acute dose-response values at different levels of severity should be factored into the risk characterization as potential uncertainties.
Uncertainty also exists in the selection of ecological benchmarks for the environmental risk screening assessment. We established a hierarchy of preferred benchmark sources to allow selection of benchmarks for each environmental HAP at each ecological assessment endpoint. We searched for benchmarks for three effect levels ( i.e., no-effects level, threshold-effect level, and probable effect level), but not all combinations of ecological assessment/environmental HAP had benchmarks for all three effect levels. Where multiple effect levels were available for a particular HAP and assessment endpoint, we used all of the available effect levels to help us determine whether risk exists and whether the risk could be considered significant and widespread.
For a group of compounds that are unspeciated ( e.g., glycol ethers), we conservatively use the most protective dose-response value of an individual compound in that group to estimate risk. Similarly, for an individual compound in a group ( e.g., ethylene glycol diethyl ether) that does not have a specified dose-response value, we also apply the most protective dose-response value from the other compounds in the group to estimate risk.
e
ed ( e.g., glycol ethers), we conservatively use the most protective dose-response value of an individual compound in that group to estimate risk. Similarly, for an individual compound in a group ( e.g., ethylene glycol diethyl ether) that does not have a specified dose-response value, we also apply the most protective dose-response value from the other compounds in the group to estimate risk.
e. Uncertainties in Acute Inhalation Screening Assessments
In addition to the uncertainties highlighted above, there are several factors specific to the acute exposure assessment that the EPA conducts as part of the risk review under section 112 of the CAA. The accuracy of an acute inhalation exposure assessment depends on the simultaneous occurrence of independent factors that may vary greatly, such as hourly emissions rates, meteorology, and the presence of a person. In the acute screening assessment that we conduct under the RTR program, we assume that peak emissions from the source category and reasonable worst-case air dispersion conditions ( i.e., 99th percentile) co-occur. We then include the additional assumption that a person is located at this point at the same time. Together, these assumptions represent a reasonable worst-case actual exposure scenario. In most cases, it is unlikely that a person would be located at the point of maximum exposure during the time when peak emissions and reasonable worst-case air dispersion conditions occur simultaneously.
f. Uncertainties in the Multipathway and Environmental Risk Screening Assessments
For each source category, we generally rely on site-specific levels of PB-HAP or environmental HAP emissions to determine whether a refined assessment of the impacts from multipathway exposures is necessary or whether it is necessary to perform an environmental screening assessment
onditions 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. 21
21 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 EPA SAB reviews and other reviews, we are confident that the models used in the screening assessments are appropriate and state-of-the-art for the multipathway and environmental screening risk assessments conducted in support of RTRs
adequately describe the movement of a pollutant through the soil? This type of uncertainty is difficult to quantify. However, based on feedback received from previous EPA SAB reviews and other reviews, we are confident that the models used in the screening assessments are appropriate and state-of-the-art for the multipathway and environmental screening risk assessments conducted in support of RTRs.
Input uncertainty is concerned with how accurately the models have been configured and parameterized for the assessment at hand. For Tier 1 of the multipathway and e

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/FR_PRORULE_2021-00174. Check the current official text before relying on it. Not legal advice.