# National Emission Standards for Hazardous Air Pollutants: Miscellaneous Coating Manufacturing Residual Risk and Technology Review > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/fr%3A2019-18344 ## Record - **Collection:** Federal Register - **Document type:** Proposed Rule - **Published:** September 4, 2019 - **Citation:** 84 FR 46610 ## Text ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 63 [EPA-HQ-OAR-2018-0747; FRL-9998-69-OAR] RIN 2060-AU16 National Emission Standards for Hazardous Air Pollutants: Miscellaneous Coating Manufacturing 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 a residual risk and technology review (RTR) of the National Emission Standards for Hazardous Air Pollutants for Miscellaneous Coating Manufacturing (MCM NESHAP) facilities, as required by the Clean Air Act (CAA). The EPA is proposing to find risks due to emissions of air toxics to be acceptable from the MCM source category and to determine that the current NESHAP provides an ample margin of safety to protect public health. The EPA identified no new cost-effective controls under the technology review to achieve further emissions reductions from process units subject to standards under the NESHAP. The EPA is also proposing revisions related to emissions during periods of startup, shutdown, and malfunction (SSM), including clarifying regulatory provisions for certain vent control bypasses; provisions for electronic reporting of performance test results, performance evaluation reports, compliance reports, and Notification of Compliance Status (NOCS) reports; and provisions to conduct periodic performance testing of oxidizers used to reduce emissions of organic hazardous air pollutants (HAP). DATES: Comments. Comments must be received on or before October 21, 2019. Under the Paperwork Reduction Act (PRA), comments on the information collection provisions are best assured of consideration if the Office of Management and Budget (OMB) receives a copy of your comments on or before October 4, 2019. Public hearing. If anyone contacts us requesting a public hearing on or before September 9, 2019, we will hold a hearing. Additional information about the hearing, if requested, will be published in a subsequent Federal Register document and posted at https://www.epa.gov/stationary-sources-air-pollution/miscellaneous-coating-manufacturing-national-emission-standards. 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-2018-0747, 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-2018-0747 in the subject line of the message. • Fax: (202) 566-9744. Attention Docket ID No. EPA-HQ-OAR-2018-0747. • Mail: U.S. Environmental Protection Agency, EPA Docket Center, Docket ID No. EPA-HQ-OAR-2018-0747, Mail Code 28221T, 1200 Pennsylvania Avenue NW, Washington, DC 20460. • Hand/Courier Delivery: EPA Docket Center, WJC West Building, Room 3334, 1301 Constitution Avenue NW, Washington, DC 20004. The Docket Center's hours of operations 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. FOR FURTHER INFORMATION CONTACT: For questions about this proposed action, contact Ms. Angela Carey, Sector Policies and Programs Division (E143-01), Office of Air Quality Planning and Standards, U.S. Environmental Protection Agency, Research Triangle Park, North Carolina 27711; telephone number: (919) 541-2187; fax number: (919) 541-0516; and email address: carey.angela@epa.gov. For specific information regarding the risk modeling methodology, contact Ms. Darcie Smith, 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) 541-2076; fax number: (919) 541-0840; and email address: smith.darcie@epa.gov. For questions about monitoring and testing requirements, contact Mr. Barrett Parker, Sector Policies and Programs Division (D243-05), Office of Air Quality Planning and Standards, U.S. Environmental Protection Agency, Research Triangle Park, North Carolina 27711; telephone number: (919) 541-5635; fax number: (919) 541-4991; and email address: parker.barrett@epa.gov. For information about the applicability of the NESHAP to a particular entity, contact Mr. John Cox, Office of Enforcement and Compliance Assurance, U.S. Environmental Protection Agency, WJC South Building (Mail Code 2227A), 1200 Pennsylvania Avenue NW, Washington DC 20460; telephone number: (202) 564-1395; and email address: cox.john@epa.gov. SUPPLEMENTARY INFORMATION: Public hearing. Please contact Ms. Virginia Hunt at (919) 541-0832 or by email at hunt.virginia@epa.gov to request a public hearing, to register to speak at the public hearing, or to inquire as to whether a public hearing will be held. Docket. The EPA has established a docket for this rulemaking under Docket ID No. EPA-HQ-OAR-2018-0747. All documents in the docket are listed in Regulations.gov . Although listed, some information is not publicly available, e.g., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the internet and will be publicly available only in hard copy. Publicly available docket materials are available either electronically in Regulations.gov or in hard copy at the EPA Docket Center, Room 3334, WJC West Building, 1301 Constitution Avenue NW, Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the EPA Docket Center is (202) 566-1742. Instructions. Direct your comments to Docket ID No. EPA-HQ-OAR-2018-0747. The EPA's policy is that all comments received will be included in the public docket without change and may be made available online at https://www.regulations.gov/, including any personal information provided, unless the comment includes information claimed to be CBI or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through https://www.regulations.gov/ or email. This type of information should be submitted by mail as discussed below. The EPA may publish any comment received to its public docket. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. The EPA will generally not consider comments or comment contents located outside of the primary submission ( i.e., on the Web, cloud, or other file sharing system). For additional submission methods, the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets. The https://www.regulations.gov/ website allows you to submit your comment anonymously, which means the EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an email comment directly to the EPA without going through https://www.regulations.gov/, your email address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the internet. If you submit an electronic comment, the EPA recommends that you include your name and other contact information in the body of your comment and with any digital storage media you submit. If the EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, the EPA may not be able to consider your comment. Electronic files should not include special characters or any form of encryption and be free of any defects or viruses. For additional information about the EPA's public docket, visit the EPA Docket Center homepage at https://www.epa.gov/dockets. Submitting CBI. Do not submit information containing CBI to the EPA through https://www.regulations.gov/ or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information on any digital storage media that you mail to the EPA, mark the outside of the digital storage media as CBI and then identify electronically within the digital storage media the specific information that is claimed as CBI. In addition to one complete version of the comments that includes information claimed as CBI, you must submit a copy of the comments that does not contain the information claimed as CBI directly to the public docket through the procedures outlined in Instructions above. If you submit any digital storage media that does not contain CBI, mark the outside of the digital storage media clearly that it does not contain CBI. Information not marked as CBI will be included in the public docket and the EPA's electronic public docket without prior notice. Information marked as CBI will not be disclosed except in accordance with procedures set forth in 40 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-2018-0747. Preamble acronyms and abbreviations. We use multiple acronyms and terms in this preamble. While this list may not be exhaustive, to ease the reading of this preamble and for reference purposes, the EPA defines the following terms and acronyms here: AEGL acute exposure guideline level AERMOD air dispersion model used by the HEM-3 model CAA Clean Air Act CalEPA California EPA CBI Confidential Business Information CEDRI Compliance and Emissions Data Reporting Interface CFR Code of Federal Regulations EPA Environmental Protection Agency ERPG emergency response planning guideline ERT Electronic Reporting Tool 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 Integrated Risk Information System km kilometer kPa kilopascal MACT maximum achievable control technology MCM miscellaneous coating manufacturing mg/kg-day milligrams per kilogram per day mg/m 3 milligrams per cubic meter MIR maximum lifetime (cancer) 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 NOCS Notification of Compliance Status NRC National Research Council NTTAA National Technology Transfer and Advancement Act OAQPS Office of Air Quality Planning and Standards OECA Office of Enforcement and Compliance Assurance OMB Office of Management and Budget PAH polycyclic aromatic hydrocarbons 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 ppmw parts per million by weight psia pounds per square inch, absolute RBLC Reasonably Available Control Technology, Best Available Control Technology, and Lowest Achievable Emission Rate Clearinghouse REL reference exposure level RFA Regulatory Flexibility Act RfC reference concentration RfD reference dose RTR residual risk and technology review SAB Science Advisory Board SSM startup, shutdown, and malfunction the Court the United States Court of Appeals for the District of Columbia Circuit TOSHI target organ-specific hazard index tpy tons per year TRIM.FaTE Total Risk Integrated Methodology.Fate, Transport, and Ecological Exposure model UF uncertainty factor µg/m 3 microgram per cubic meter UMRA Unfunded Mandates Reform Act URE unit risk estimate VCS voluntary consensus standards VOC volatile organic compounds Organization of this document. The information in this preamble is organized as follows below. In particular, section IV of this preamble describes the majority of the Agency's rationale for the proposed actions in this preamble. Section IV.B of this preamble summarizes the results of the risk assessment. Section IV.C of this preamble summarizes the results of our technology review. Section IV.D of this preamble summarizes other changes we are proposing, including general regulatory language changes related to the removal of SSM exemptions, electronic reporting, and other minor clarifications identified as part our review of the NESHAP and as part of the other proposed revisions in this action. Lastly, section IV.E of this preamble summarizes our rationale for the compliance dates we are proposing. 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 its 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 are the results of the risk assessment and analyses? B. What are our proposed decisions regarding risk acceptability, ample margin of safety, and adverse environmental effect? C. What are the results and proposed decisions based on our technology review? D. What other actions are we proposing? E. What compliance dates are we proposing? V. Summary of Cost, Environmental, and Economic Impacts A. What are the affected sources? B. What are the air quality impacts? C. What are the cost impacts? D. What are the economic impacts? E. What are the benefits? VI. Request for Comments VII. Submitting Data Corrections VIII. Statutory and Executive Order Reviews A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review B. Executive Order 13771: Reducing Regulation and Controlling Regulatory Costs C. Paperwork Reduction Act (PRA) D. Regulatory Flexibility Act (RFA) E. Unfunded Mandates Reform Act (UMRA) F. Executive Order 13132: Federalism G. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments H. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks I. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use J. National Technology Transfer and Advancement Act (NTTAA) and 1 CFR Part 51 K. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations I. General Information A. Does this action apply to me? Table 1 of this preamble lists the NESHAP and associated regulated industrial source categories that are the subject of this proposal. Table 1 is not intended to be exhaustive, but rather provides a guide for readers regarding the entities that this proposed action is likely to affect. The proposed standards, once promulgated, will be directly applicable to the affected sources. Federal, state, local, and tribal government entities would not be affected by this proposed action. As defined in the Initial List of Categories of Sources Under Section 112(c)(1) of the Clean Air Act Amendments of 1990 (see 57 FR 31576, July 16, 1992) and Documentation for Developing the Initial Source Category List, Final Report (see EPA-450/3-91-030, July 1992), the Manufacture of Paints, Coatings, and Adhesives source category “is any facility engaged in their manufacture without regard to the particular end-uses or consumers of such products. The manufacturing of these products may occur in any combination at any facility.” This source category has since been renamed Miscellaneous Coating Manufacturing (MCM). Table 1—NESHAP and Industrial Source Categories Affected By This Proposed Action Source Category and NESHAP NAICS Code 1 Miscellaneous Coating Manufacturing Industry 3255, 3259 1 North American Industry Classification System. B. Where can I get a copy of this document and other related information? In addition to being available in the docket, an electronic copy of this action is available on the internet. 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/miscellaneous-coating-manufacturing-national-emission-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. A redline version of the regulatory language that incorporates the proposed changes in this action is available in the docket for this action (Docket ID No. EPA-HQ-OAR-2018-0747). 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 maximum achievable control technology (MACT) to determine whether additional standards are needed to address any remaining risk associated with HAP emissions. This second stage is commonly referred to as the “residual risk review.” In addition to the residual risk review, the CAA also requires the EPA to review standards set under CAA section 112 every 8 years to determine if there are “developments in practices, processes, or control technologies” that may be appropriate to incorporate into the standards. This review is commonly referred to as the “technology review.” When the two reviews are combined into a single rulemaking, it is commonly referred to as the “risk and technology review.” The discussion that follows identifies the most relevant statutory sections and briefly explains the contours of the methodology used to implement these statutory provisions. 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 provisions for major source standards and area source standards. “Major sources” are those that emit or have the potential to emit 10 tons per year (tpy) or more of a single HAP or 25 tpy or more of any combination of HAP. All other sources are “area sources.” For major sources, CAA section 112(d)(2) provides that the technology-based NESHAP must reflect the maximum degree of emission reductions of HAP achievable (after considering cost, energy provisions, and non-air quality health and environmental impacts). These standards are commonly referred to as MACT standards. CAA section 112(d)(3) also establishes a minimum control level for MACT standards, known as the MACT “floor.” The EPA must also consider control options that are more stringent than the floor. Standards more stringent than the floor are commonly referred to as beyond-the-floor standards. In certain instances, as provided in CAA section 112(h), the EPA may set work practice standards where it is not feasible to prescribe or enforce a numerical emission standard. For area sources, CAA section 112(d)(5) gives the EPA discretion to set standards based on generally available control technologies or management practices (GACT standards) in lieu of MACT standards. The second stage in standard-setting focuses on identifying and addressing any remaining ( i.e., “residual”) risk according to CAA section 112(f). For source categories subject to MACT standards, section 112(f)(2) of the CAA requires the EPA to determine whether promulgation of additional standards is needed to provide an ample margin of safety to protect public health or to prevent an adverse environmental effect. Section 112(d)(5) of the CAA provides that this residual risk review is not required for categories of area sources subject to GACT standards. Section 112(f)(2)(B) of the CAA further expressly preserves the EPA's use of the two-step approach for developing standards to address any residual risk and the Agency's interpretation of “ample margin of safety” developed in the National Emissions Standards for Hazardous Air Pollutants: Benzene Emissions from Maleic Anhydride Plants, Ethylbenzene/Styrene Plants, Benzene Storage Vessels, Benzene Equipment Leaks, and Coke By-Product Recovery Plants (Benzene NESHAP) (54 FR 38044, September 14, 1989). The EPA notified Congress in the Risk Report that the Agency intended to use the Benzene NESHAP approach in making CAA section 112(f) residual risk determinations (EPA-453/R-99-001, p. ES-11). The EPA subsequently adopted this approach in its residual risk determinations and the United States Court of Appeals for the District of Columbia Circuit (the Court) upheld the EPA's interpretation that CAA section 112(f)(2) incorporates the approach established in the Benzene NESHAP. See NRDC v. EPA, 529 F.3d 1077, 1083 (D.C. Cir. 2008). The approach incorporated into the CAA and used by the EPA to evaluate residual risk and to develop standards under CAA section 112(f)(2) is a two-step approach. In the first step, the EPA determines whether risks are acceptable. This determination “considers all health information, including risk estimation uncertainty, and includes a presumptive limit on maximum individual lifetime (cancer) risk (MIR) 1 of approximately 1-in-10 thousand.” 54 FR 38045, September 14, 1989. If risks are unacceptable, the EPA must determine the emissions standards necessary to reduce risk to an acceptable level without considering costs. In the second step of the approach, the EPA considers whether the emissions standards provide an ample margin of safety to protect public health “in consideration of all health information, including the number of persons at risk levels higher than approximately 1 in 1 million, as well as other relevant factors, including costs and economic impacts, technological feasibility, and other factors relevant to each particular decision.” Id. The EPA must promulgate emission standards necessary to provide an ample margin of safety to protect public health or determine that the standards being reviewed provide an ample margin of safety without any revisions. After conducting the ample margin of safety analysis, we consider whether a more stringent standard is necessary to prevent, taking into consideration costs, energy, safety, and other relevant factors, an adverse environmental effect. 1 Although defined as “maximum individual risk,” MIR refers only to cancer risk. MIR, one metric for assessing cancer risk, is the estimated risk if an individual were exposed to the maximum level of a pollutant for a lifetime. CAA section 112(d)(6) separately requires the EPA to review standards promulgated under CAA section 112 and revise them “as necessary (taking into account developments in practices, processes, and control technologies)” no less often than every 8 years. In conducting this review, which we call the “technology review,” the EPA is not required to recalculate the MACT floor. Natural Resources Defense Council (NRDC) v. EPA, 529 F.3d 1077, 1084 (DC Cir. 2008). Association of Battery Recyclers, Inc. v. EPA, 716 F.3d 667 (DC Cir. 2013). The EPA may consider cost in deciding whether to revise the standards pursuant to CAA section 112(d)(6). B. What is this source category and how does the current NESHAP regulate its HAP emissions? As defined in the Initial List of Categories of Sources Under Section 112(c)(1) of the Clean Air Act Amendments of 1990 (see 57 FR 31576, July 16, 1992) and Documentation for Developing the Initial Source Category List, Final Report (see EPA-450/3-91-030, July 1992), the “manufacture of paints, coatings, and adhesives” source category “is any facility engaged in their manufacture without regard to the particular end-uses or consumers of such products. The manufacturing of these products may occur in any combination at any facility.” The MCM source category includes the collection of equipment that is used to manufacture coatings at a facility. MCM operations also include cleaning operations. Coatings are materials such as paints, inks, or adhesive that are intended to be applied to a substrate and consist of a mixture of resins, pigments, solvents, and/or other additives, where the material is produced by a manufacturing operation where materials are blended, mixed, diluted, or otherwise formulated. Coatings do not include materials made in processes where a formulation component is synthesized by chemical reaction or separation activity and then transferred to another vessel where it is formulated to produce a material used as a coating, where the synthesized or separated component is not stored prior to formulation. The equipment controlled by the MCM NESHAP includes process vessels, storage tanks for feedstocks and products, equipment leak components (pumps, compressors, agitators, pressure relief devices (PRDs), sampling connection systems, open-ended valves or lines, valves, connectors, and instrumentation systems), wastewater tanks, heat exchangers, and transfer racks. The current NESHAP regulates process vessels and storage tanks based on the volume of the process vessel or storage tank and the maximum true vapor pressure of the organic HAP processed or stored. Control requirements range from the use of tightly fitted lids on process vessels to also capturing and reducing organic HAP emissions through the use of add-on controls ( i.e., a flare, oxidizer, or condenser). For halogenated vent streams from process vessels and storage tanks, the use of a flare is prohibited, and a halogen reduction device ( i.e., an acid gas scrubber) is required after a combustion control device. For storage tanks, facilities may comply with the provisions in 40 CFR part 63, subpart HHHHH, by complying with the provisions in 40 CFR part 63, subpart WW. The NESHAP regulates emissions from equipment leaks at existing sources by requiring compliance with leak inspection and repair provisions using sight, sound, and smell in 40 CFR part 63, subpart R, or alternatively, the leak detection and repair (LDAR) provisions in 40 CFR part 63, subparts TT or UU. New sources are required to comply with the LDAR provisions in 40 CFR part 63, subparts TT or UU. The NESHAP regulates wastewater streams by requiring the use of fixed roofs on wastewater tanks, treating the wastewater (either on-site or off-site) as a hazardous waste under 40 CFR 264, 265, or 266, or using enhanced biological treatment if the wastewater contains less than 50 parts per million by weight (ppmw) of partially soluble HAP. If the wastewater is treated as a hazardous waste under 40 CFR 264, 265, or 266, it may be treated by steam stripping or incineration. These standards apply only to wastewater streams that contain total partially soluble and soluble HAP at an annual average concentration greater than or equal to 4,000 ppmw and loads greater than or equal to 750 pounds per year (lb/yr) at an existing source or greater than or equal to 1,600 ppmw and any partially soluble and soluble HAP load at a new source. The NESHAP regulates transfer operations if the operation involves the bulk loading of coating products that contain 3.0 million gallons (gal) per year or more of HAP with a weighted average HAP partial pressure greater than or equal to 1.5 pounds per square inch, absolute (psia). Regulated transfer operations are required to reduce emissions by using a closed vent system and a control device (other than a flare) to reduce emissions by at least 75 percent; using a closed vent system and a flare for a non-halogenated vent stream; or using a vapor balancing system. If a non-flare combustion device is used to control a halogenated vent stream, then a halogen reduction device must be used either before or after the combustion device. If used after the combustion device, the halogen reduction device must meet either a minimum 95-percent reduction or a maximum 0.45 kilograms per hour (kg/hr) emission rate of hydrogen halide or halogen. If used before the combustion device, the halogen reduction device must meet a maximum 0.45 kg/hr emission rate of hydrogen halide or halogen. The NESHAP requires heat exchangers to meet the provisions of subpart F, 40 CFR 63.104. Section 63.104 requires the implementation of a LDAR or monitoring program for heat exchange systems, unless the system meets certain design and operation provisions, or it is a once-through system that meets certain National Pollution Discharge Elimination System (NPDES) permit provisions. C. What data collection activities were conducted to support this action? The EPA held discussions with the American Coatings Association and the American Chemistry Council. During these meetings, we obtained supplemental information about the emission inventory, emission processes, control technologies, and speciation profiles. D. What other relevant background information and data are available? The EPA used information from the Reasonably Available Control Technology, Best Available Control Technology, and Lowest Achievable Emission Rate Clearinghouse (RBLC) database, reviewed title V permits for each MCM facility, and reviewed NOCS reports. The EPA reviewed the RBLC to identify potential additional control technologies. No additional control technologies applicable to MCM were found in the RBLC. See sections III.B and IV.D of this preamble and the memorandum, “ Technology Review for the Miscellaneous Coating Manufacturing Source Category,” which is available in the docket for this action. Lastly, the EPA is incorporating into the docket for this rulemaking, all materials associated with the development of the current MCM standards from Docket ID No. A-96-04 and Docket ID No. EPA-HQ-OAR-2003-0178. Publicly available docket materials are available either electronically at https://www.regulations.gov/, or in hard copy at the EPA Docket Center, EPA WJC West Building, Room 3334, 1301 Constitution Ave. NW, Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the EPA Docket Center is (202) 566-1742. 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 action. A. How do we consider risk in our decision-making? As discussed in section II.A of this preamble and in the Benzene NESHAP, in evaluating and developing standards under CAA section 112(f)(2), we apply a two-step approach to determine whether or not risks are acceptable and to determine if the standards provide an ample margin of safety to protect public health. As explained in the Benzene NESHAP, “the first step judgment on acceptability cannot be reduced to any single factor” and, thus, “[t]he Administrator believes that the acceptability of risk under section 112 is best judged on the basis of a broad set of health risk measures and information.” 54 FR 38046, September 14, 1989. Similarly, with regard to the ample margin of safety determination, “the Agency again considers all of the health risk and other health information considered in the first step. Beyond that information, additional factors relating to the appropriate level of control will also be considered, including cost and economic impacts of controls, technological feasibility, uncertainties, and any other relevant factors.” Id. The Benzene NESHAP approach provides flexibility regarding factors the EPA may consider in making determinations and how the EPA may weigh those factors for each source category. The EPA conducts a risk assessment that provides estimates of the MIR posed by the HAP emissions from each source in the source category, the hazard index (HI) for chronic exposures to HAP with the potential to cause noncancer health effects, and the hazard quotient (HQ) for acute exposures to HAP with the potential to cause noncancer health effects. 2 The assessment also provides estimates of the distribution of cancer risk within the exposed populations, cancer incidence, and an evaluation of the potential for an adverse environmental effect. The scope of the EPA's risk analysis is consistent with the EPA's response to comments on our policy under the Benzene NESHAP where the EPA explained that: 2 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. “[t]he policy chosen by the Administrator permits consideration of multiple measures of health risk. Not only can the MIR figure be considered, but also incidence, the presence of non-cancer health effects, and the uncertainties of the risk estimates. In this way, the effect on the most exposed individuals can be reviewed as well as the impact on the general public. These factors can then be weighed in each individual case. This approach complies with the Vinyl Chloride mandate that the Administrator ascertain an acceptable level of risk to the public by employing his expertise to assess available data. It also complies with the Congressional intent behind the CAA, which did not exclude the use of any particular measure of public health risk from the EPA's consideration with respect to CAA section 112 regulations, and thereby implicitly permits consideration of any and all measures of health risk which the Administrator, in his judgment, believes are appropriate to determining what will `protect the public health'.” See 54 FR 38057, September 14, 1989. Thus, the level of the MIR is only one factor to be weighed in determining acceptability of risk. The Benzene NESHAP explained that “an MIR of approximately one in 10 thousand should ordinarily be the upper end of the range of acceptability. As risks increase above this benchmark, they become presumptively less acceptable under CAA section 112, and would be weighed with the other health risk measures and information in making an overall judgment on acceptability. Or, the Agency may find, in a particular case, that a risk that includes an MIR less than the presumptively acceptable level is unacceptable in the light of other health risk factors.” Id. at 38045. In other words, risks that include an MIR above 100-in-1 million may be determined to be acceptable, and risks with an MIR below that level may be determined to be unacceptable, depending on all of the available health information. Similarly, with regard to the ample margin of safety analysis, the EPA stated in the Benzene NESHAP that: “EPA believes the relative weight of the many factors that can be considered in selecting an ample margin of safety can only be determined for each specific source category. This occurs mainly because technological and economic factors (along with the health-related factors) vary from source category to source category.” Id. at 38061. We also consider the uncertainties associated with the various risk analyses, as discussed earlier in this preamble, in our determinations of acceptability and ample margin of safety. The EPA notes that it has not considered certain health information to date in making residual risk determinations. At this time, we do not attempt to quantify the HAP risk that may be associated with emissions from other facilities that do not include the source category under review, mobile source emissions, natural source emissions, persistent environmental pollution, or atmospheric transformation in the vicinity of the sources in the category. The EPA understands the potential importance of considering an individual's total exposure to HAP in addition to considering exposure to HAP emissions from the source category and facility. We recognize that such consideration may be particularly important when assessing noncancer risk, where pollutant-specific exposure health reference levels ( e.g., reference concentrations (RfCs)) are based on the assumption that thresholds exist for adverse health effects. For example, the EPA recognizes that, although exposures attributable to emissions from a source category or facility alone may not indicate the potential for increased risk of adverse noncancer health effects in a population, the exposures resulting from emissions from the facility in combination with emissions from all of the other sources ( e.g., other facilities) to which an individual is exposed may be sufficient to result in an increased risk of adverse noncancer health effects. In May 2010, the Science Advisory Board (SAB) advised the EPA “that RTR assessments will be most useful to decision makers and communities if results are presented in the broader context of aggregate and cumulative risks, including background concentrations and contributions from other sources in the area.” 3 3 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, including those reflected in this action. The Agency (1) conducts facility-wide assessments, which include source category emission points, as well as other emission points within the facilities; (2) combines exposures from multiple sources in the same category that could affect the same individuals; and (3) for some persistent and bioaccumulative pollutants, analyzes the ingestion route of exposure. In addition, the RTR risk assessments consider aggregate cancer risk from all carcinogens and aggregated noncancer HQs for all noncarcinogens affecting the same target organ or target organ system. Although we are interested in placing source category and facility-wide HAP risk in the context of total HAP risk from all sources combined in the vicinity of each source, we are concerned about the uncertainties of doing so. Estimates of total HAP risk from emission sources other than those that we have studied in depth during this RTR review would have significantly greater associated uncertainties than the source category or facility-wide estimates. Such aggregate or cumulative assessments would compound those uncertainties, making the assessments too unreliable. B. How do we perform the technology review? Our technology review focuses on the identification and evaluation of developments in practices, processes, and control technologies that have occurred since the MACT standards were promulgated. Where we identify such developments, we analyze their technical feasibility, estimated costs, energy implications, and non-air environmental impacts. We also consider the emission reductions associated with applying each development. This analysis informs our decision of whether it is “necessary” to revise the emissions standards. In addition, we consider the appropriateness of applying controls to new sources versus retrofitting existing sources. For this exercise, we consider any of the following to be a “development”: • Any add-on control technology or other equipment that was not identified and considered during development of the original MACT standards; • Any improvements in add-on control technology or other equipment (that were identified and considered during development of the original MACT standards) that could result in additional emissions reduction; • Any work practice or operational procedure that was not identified or considered during development of the original MACT standards; • Any process change or pollution prevention alternative that could be broadly applied to the industry and that was not identified or considered during development of the original MACT standards; and • Any significant changes in the cost (including cost effectiveness) of applying controls (including controls the EPA considered during the development of the original MACT standards). In addition to reviewing the practices, processes, and control technologies that were considered at the time we originally developed the NESHAP, we review a variety of data sources in our investigation of potential practices, processes, or controls to consider. See sections II.C and II. D of this preamble for information on the specific data sources that were reviewed as part of the technology review. C. How do we estimate post-MACT risk posed by the source category? In this section, we provide a complete description of the types of analyses that we generally perform during the risk assessment process. In some cases, we do not perform a specific analysis because it is not relevant. For example, in the absence of emissions of HAP known to be persistent and bioaccumulative in the environment (PB-HAP), we would not perform a multipathway exposure assessment. Where we do not perform an analysis, we state that we do not and provide the reason. While we present all of our risk assessment methods, we only present risk assessment results for the analyses actually conducted (see section IV.B of this preamble). The EPA conducts a risk assessment that provides estimates of the MIR for cancer posed by the HAP emissions from each source in the source category, the HI for chronic exposures to HAP with the potential to cause noncancer health effects, and the HQ for acute exposures to HAP with the potential to cause noncancer health effects. The assessment also provides estimates of the distribution of cancer risk within the exposed populations, cancer incidence, and an evaluation of the potential for an adverse environmental effect. The seven sections that follow this paragraph describe how we estimated emissions and conducted the risk assessment. The docket for this rulemaking contains the following document which provides more information on the risk assessment inputs and models: Residual Risk Assessment for the Miscellaneous Coating Manufacturing Source Category in Support of the 2019 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; 4 and described in the SAB review report issued in 2010. They are also consistent with the key recommendations contained in that report. 4 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? For each facility that we determined to be subject to the MACT standards (see section II.B of this preamble), we gathered emissions data from Version 1 of the 2014 National Emissions Inventory (NEI). For each NEI record, we reviewed the source classification code and emission unit and process descriptions, and then assigned the record to an emission source type regulated by the MACT standards ( i.e., each record identified as part of the MCM affected source at each facility was labeled storage tank, waste water, process vessel, equipment leak, or unknown) or an emission source type not regulated by the MACT standards ( i.e., each record that was not identified as part of the MCM affected source at each facility was labeled non-source category type). The non-source category type emissions sources are units or processes that are co-located at one or more of the MCM facilities but are not part of the MCM source category. For example, some of the MCM affected sources are co-located with organic chemical manufacturing operations that are part of a different source category ( i.e., Miscellaneous Organic Chemical Manufacturing) which is regulated by a different NESHAP (40 CFR part 63, subpart FFFF). The EPA reviewed permits, contacted EPA Regional offices, and asked the American Coatings Association to review (and revise, if necessary) the NEI-based data described above, including emission values, emission release point parameters, coordinates, and emission process group assignments. We used all this information to reevaluate our emission process group assignments for each NEI record in the modeling file. We also used this information to update emission release point parameter data. In other words, we used the industry response data wherever possible (in lieu of the data we established using the NEI and gap fill procedures), unless the data failed certain quality assurance checks. For further details on the assumptions and methodologies used to estimate actual emissions and identify the emissions release characteristics, see Appendix 1 of Residual Risk Assessment for the Miscellaneous Coating Manufacturing Source Categories in Support of the 2019 Risk and Technology Review Proposed Rule, in Docket ID No. EPA-HQ-OAR-2018-0747. 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 provisions of the current MACT standards. The emissions allowed under the MACT standards are referred to as the “MACT-allowable” emissions. We discussed the consideration of both MACT-allowable and actual emissions in the final Coke Oven Batteries RTR (70 FR 19998-19999, April 15, 2005) and in the proposed and final Hazardous Organic NESHAP (HON) RTR (71 FR 34428, June 14, 2006, and 71 FR 76609, December 21, 2006, respectively). In those actions, we noted that assessing the risk at the MACT-allowable level is inherently reasonable since that risk reflects the maximum level facilities could emit and still comply with national emission standards. We also explained that it is reasonable to consider actual emissions, where such data are available, in both steps of the risk analysis, in accordance with the Benzene NESHAP approach. (54 FR 38044, September 14, 1989.) For the risk assessment, we have determined that the actual emissions data are reasonable estimates of the MACT-allowable emissions levels for the MCM source category. In preparation of this RTR, we did not conduct an information collection of the equipment in this source category. Instead, we relied primarily upon the 2014 NEI emissions data and readily available title V permit information to characterize the actual emissions from the source category. In addition, the emission standards in 40 CFR part 63, subpart HHHH are generally equipment and work-practice requirements, rather than numerical emission limits. Therefore, we consider the use of 2014 NEI actual emissions as the best available reasonable approximation of allowable emissions for the risk assessment. 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 action were estimated using the Human Exposure Model (HEM-3). 5 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. 5 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. 6 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 7 internal point locations and populations provides the basis of human exposure calculations (U.S. Census, 2010). In addition, for each census block, the census library includes the elevation and controlling hill height, which are also used in dispersion calculations. A third library of pollutant-specific dose-response values is used to estimate health risk. These are discussed below. 6 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). 7 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, September 14, 1989) and the limitations of Gaussian dispersion models, including AERMOD. For each facility, we calculate the maximum individual risk (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, 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 8 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. 8 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. The HQ is the estimated exposure divided by the chronic noncancer dose-response value, which is a value selected from one of several sources. The preferred chronic noncancer dose-response value is the EPA RfC, defined as “an estimate (with uncertainty spanning perhaps an order of magnitude) of a continuous inhalation exposure to the human population (including sensitive subgroups) that is likely to be without an appreciable risk of deleterious effects during a lifetime” ( https://iaspub.epa.gov/sor_internet/registry/termreg/searchandretrieve/glossariesandkeywordlists/search.do?details=&vocabName=IRIS%20Glossary ). In cases where an RfC from the EPA's IRIS is not available or where the EPA determines that using a value other than the RfC is appropriate, the chronic noncancer dose-response value can be a value from the following prioritized sources, which define their dose-response values similarly to the EPA: (1) The Agency for Toxic Substances and Disease Registry (ATSDR) Minimum Risk Level ( https://www.atsdr.cdc.gov/mrls/index.asp ); (2) the CalEPA Chronic Reference Exposure Level (REL) ( https://oehha.ca.gov/air/crnr/notice-adoption-air-toxics-hot-spots-program-guidance-manual-preparation-health-risk-0 ); or (3) as noted above, a scientifically credible dose-response value that has been developed in a manner consistent with the EPA guidelines and has undergone a peer review process similar to that used by the EPA. The pollutant-specific dose-response values used to estimate health risks are available at https://www.epa.gov/fera/dose-response-assessment-assessing-health-risks-associated-exposure-hazardous-air-pollutants. c. Risk From Acute Exposure to HAP That May Cause Health Effects Other Than Cancer For each HAP for which appropriate acute inhalation dose-response values are available, the EPA also assesses the potential health risks due to acute exposure. For these assessments, the EPA makes conservative assumptions about emission rates, meteorology, and exposure location. In this proposed rulemaking, 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, 9 we are revising 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 Miscellaneous Coating Manufacturing Source Category in Support of the 2019 Risk and Technology Review Proposed Rule and in Appendix 5 of the report: Technical Support Document for Acute Risk Screening Assessment. We will be applying this revision in RTR rulemakings proposed on or after June 3, 2019. 9 See, e.g., U.S. EPA. S creening 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, 10 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 ( i.e., 99th percentile) conditions co-occur and that a person is present at the point of maximum exposure. 10 In the absence of hourly emission data, we develop estimates of maximum hourly emission rates by multiplying the average actual annual emission 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 Miscellaneous Coating Manufacturing Source Category in Support of the 2019 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. An acute REL is defined as “the concentration level at or below which no adverse health effects are anticipated for a specified exposure duration.” 11 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. 12 They are guideline levels for “once-in-a-lifetime, short-term exposures to airborne concentrations of acutely toxic, high-priority chemicals.” Id. at 21. The AEGL-1 is specifically defined as “the airborne concentration (expressed as ppm (parts per million) or mg/m 3 (milligrams per cubic meter)) of a substance above which it is predicted that the general population, including susceptible individuals, could experience notable discomfort, irritation, or certain asymptomatic nonsensory effects. However, the effects are not disabling and are transient and reversible upon cessation of exposure.” The document also notes that “Airborne concentrations below AEGL-1 represent exposure levels that can produce mild and progressively increasing but transient and nondisabling odor, taste, and sensory irritation or certain asymptomatic, nonsensory effects.” Id. AEGL-2 are defined as “the airborne concentration (expressed as parts per million or milligrams per cubic meter) of a substance above which it is predicted that the general population, including susceptible individuals, could experience irreversible or other serious, long-lasting adverse health effects or an impaired ability to escape.” Id. 11 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. 12 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.” 13 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 1 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. 13 ERPGS Procedures and Responsibilities. March 2014. American Industrial Hygiene Association. Available at: https://www.aiha.org/get-involved/AIHAGuidelineFoundation/EmergencyResponsePlanningGuidelines/Documents/ERPG%20Committee%20Standard%20Operating%20Procedures%20%20-%20March%202014%20Revision%20%28Updated%2010-2-2014%29.pdf. An acute REL for 1-hour exposure durations is typically lower than its corresponding AEGL-1 and ERPG-1. Even though their definitions are slightly different, AEGL-1s are often the same as the corresponding ERPG-1s, and AEGL-2s are often equal to ERPG-2s. The maximum HQs from our acute inhalation screening risk assessment typically result when we use the acute REL for a HAP. In cases where the maximum acute HQ exceeds 1, we also report the HQ based on the next highest acute dose-response value (usually the AEGL-1 and/or the ERPG-1). For this source category, we used the default acute emissions multiplier of 10 to conservatively estimate maximum hourly rates. 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 determining the off-site acute risks for each facility that had an initial HQ greater than 1. These refinements are discussed more fully in the Residual Risk Assessment for the Miscellaneous Coating Manufacturing Source Category in Support of the 2019 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. For the MCM source category, we identified PB-HAP emissions of cadmium compounds, polycyclic organic matter (POM), arsenic compounds, mercury compounds, and lead compounds, so we proceeded to the next step of the evaluation. Except for lead, the human health risk screening assessment for PB-HAP consists of three progressive tiers. In a Tier 1 screening assessment, we determine whether the magnitude of the facility-specific emissions of the PB-HAP warrants further evaluation to characterize human health risk through ingestion exposure. To facilitate this step, we evaluate emissions against previously developed screening threshold emission rates for several PB-HAP that are based on a hypothetical upper-end screening exposure scenario developed for use in conjunction with the EPA's Total Risk Integrated Methodology.Fate, Transport, and Ecological Exposure (TRIM.FaTE) model. The PB-HAP with screening threshold emission rates are arsenic compounds, cadmium compounds, chlorinated dibenzodioxins and furans, mercury compounds, and POM. Based on the EPA estimates of toxicity and bioaccumulation potential, these pollutants represent a conservative list for inclusion in multipathway risk assessments for RTR rules. (See Volume 1, Appendix D at https://www.epa.gov/sites/production/files/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.” We derive the Tier 1 screening threshold emission rates for these PB-HAP (other than lead compounds) to correspond to a maximum excess lifetime cancer risk of 1-in-1 million ( i.e., for arsenic compounds, polychlorinated dibenzodioxins and furans and POM) or, for HAP that cause noncancer health effects ( i.e., cadmium compounds and mercury compounds), a maximum HQ of 1. If the emission rate of any one PB-HAP or combination of carcinogenic PB-HAP in the Tier 1 screening assessment exceeds the Tier 1 screening threshold emission rate for any facility ( i.e., the screening value is greater than 1), we conduct a second screening assessment, which we call the Tier 2 screening assessment. The Tier 2 screening assessment separates the Tier 1 combine 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 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. 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 14 ) and locally grown or raised foods (90th percentile consumption of locally grown or raised foods for the farmer and gardener scenarios 15 ). If PB-HAP emission rates do not result in a Tier 2 screening value 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. 14 Burger, J. 2002. Daily consumption of wild fish and game: Exposures of high end recreationists. International Journal of Environmental Health Research 12:343-354. 15 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. In evaluating the potential multipathway risk from emissions of lead compounds, rather than developing a screening threshold emission rate, we compare maximum estimated chronic inhalation exposure concentrations to the level of the current National Ambient Air Quality Standard (NAAQS) for lead. 16 Values below the level of the primary (health-based) lead NAAQS are considered to have a low potential for multipathway risk. 16 In doing so, the EPA notes that the legal standard for a primary NAAQS—that a standard is requisite to protect public health and provide an adequate margin of safety (CAA section 109(b))—differs from the CAA section 112(f) standard (requiring, among other things, that the standard provide an “ample margin of safety to protect public health”). However, the primary lead NAAQS is a reasonable measure of determining risk acceptability ( i.e., the first step of the Benzene NESHAP analysis) since it is designed to protect the most susceptible group in the human population—children, including children living near major lead emitting sources. 73 FR 67002/3; 73 FR 67000/3; 73 FR 67005/1. In addition, applying the level of the primary lead NAAQS at the risk acceptability step is conservative, since that primary lead NAAQS reflects an adequate margin of safety. For further information on the multipathway assessment approach, see the Residual Risk Assessment for the Miscellaneous Coating Manufacturing Source Category in Support of the Risk and Technology Review 2019 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 hydrochloric acid (HCl) and hydrogen fluoride (HF). HAP that persist and bioaccumulate are of particular environmental concern because they accumulate in the soil, sediment, and water. The acid gases, HCl and HF, are included due to their well-documented potential to cause direct damage to terrestrial plants. In the environmental risk screening assessment, we evaluate the following four exposure media: Terrestrial soils, surface water bodies (includes water-column and benthic sediments), fish consumed by wildlife, and air. Within these four exposure media, we evaluate nine ecological assessment endpoints, which are defined by the ecological entity and its attributes. For PB-HAP (other than lead), both community-level and population-level endpoints are included. For acid gases, the ecological assessment evaluated is terrestrial plant communities. An ecological benchmark represents a concentration of HAP that has been linked to a particular environmental effect level. For each environmental HAP, we identified the available ecological benchmarks for each assessment endpoint. We identified, where possible, ecological benchmarks at the following effect levels: Probable effect levels, lowest-observed-adverse-effect level, and no-observed-adverse-effect level. In cases where multiple effect levels were available for a particular PB-HAP and assessment endpoint, we use all of the available effect levels to help us to determine whether ecological risks exist and, if so, whether the risks could be considered significant and widespread. For further information on how the environmental risk screening assessment was conducted, including a discussion of the risk metrics used, how the environmental HAP were identified, and how the ecological benchmarks were selected, see Appendix 9 of the Residual Risk Assessment for the Miscellaneous Coating Manufacturing Source Category in Support of the Risk and Technology Review 2019 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 MCM source category emitted any of the environmental HAP. For the MCM source category, we identified emissions of the PB-HAP listed above, plus 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. In Tier 2 of the environmental screening assessment, the screening threshold emission rates are adjusted to account for local meteorology and the actual location of lakes in the vicinity of facilities that did not pass the Tier 1 screening assessment. For soils, we evaluate the average soil concentration for all soil parcels within a 7.5-km radius for each facility and PB-HAP. For the water, sediment, and fish tissue concentrations, the highest value for each facility for each pollutant is used. If emission concentrations from a facility do not exceed the Tier 2 screening threshold emission rate, the facility “passes” the screening assessment and typically is not evaluated further. If emissions from a facility exceed the Tier 2 screening threshold emission rate, we evaluate the facility further in Tier 3. As in the multipathway human health risk assessment, in Tier 3 of the environmental screening assessment, we examine the suitability of the lakes around the facilities to support life and remove those that are not suitable ( e.g., lakes that have been filled in or are industrial ponds), adjust emissions for plume-rise, and conduct hour-by-hour time-series assessments. If these Tier 3 adjustments to the screening threshold emission rates still indicate the potential for an adverse environmental effect ( i.e., facility emission rate exceeds the screening threshold emission rate), we may elect to conduct a more refined assessment using more site-specific information. If, after additional refinement, the facility emission rate still exceeds the screening threshold emission rate, the facility may have the potential to cause an adverse environmental effect. To evaluate the potential for an adverse environmental effect from lead, we compared the average modeled air concentrations (from HEM-3) of lead around each facility in the source category to the level of the secondary NAAQS for lead. The secondary lead NAAQS is a reasonable means of evaluating environmental risk because it is set to provide substantial protection against adverse welfare effects which can include “effects on soils, water, crops, vegetation, man-made materials, animals, wildlife, weather, visibility and climate, damage to and deterioration of property, and hazards to transportation, as well as effects on economic values and on personal comfort and well-being.” d. Acid Gas Environmental Risk Methodology The environmental screening assessment for acid gases evaluates the potential phytotoxicity and reduced productivity of plants due to chronic exposure to HF and HCl. The environmental risk screening methodology for acid gases is a single-tier screening assessment that compares modeled ambient air concentrations (from AERMOD) to the ecological benchmarks for each acid gas. To identify a potential adverse environmental effect (as defined in section 112(a)(7) of the CAA) from emissions of HF and HCl, we evaluate the following metrics: The size of the modeled area around each facility that exceeds the ecological benchmark for each acid gas, in acres and km 2 ; the percentage of the modeled area around each facility that exceeds the ecological benchmark for each acid gas; and the area-weighted average screening value around each facility (calculated by dividing the area-weighted average concentration over the 50-km modeling domain by the ecological benchmark for each acid gas). For further information on the environmental screening assessment approach, see Appendix 9 of the Residual Risk Assessment for the Miscellaneous Coating Manufacturing Source Category in Support of the Risk and Technology Review 2019 Proposed Rule, which is available in the docket for this action. 6. How do we conduct facility-wide assessments? To put the source category risks in context, we typically examine the risks from the entire “facility,” where the facility includes all HAP-emitting operations within a contiguous area and under common control. In other words, we examine the HAP emissions not only from the source category emission points of interest, but also emissions of HAP from all other emission sources at the facility for which we have data. For 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: What data collection activities were conducted to support this action? Once a quality assured source category dataset was available, it was placed back with the remaining records from the NEI for that facility. The facility-wide file was then used to analyze risks due to the inhalation of HAP that are emitted “facility-wide” for the populations residing within 50 km of each facility, consistent with the methods used for the source category analysis described above. For these facility-wide risk analyses, the modeled source category risks were compared to the facility-wide risks to determine the portion of the facility-wide risks that could be attributed to the source category addressed in this action. 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 Miscellaneous Coating Manufacturing Source Category in Support of the Risk and Technology Review 2019 Proposed Rule, available through the docket for this action, provides the methodology and results of the facility-wide analyses, including all facility-wide risks and the percentage of source category contribution to facility-wide risks. 7. How do we consider uncertainties in risk assessment? Uncertainty and the potential for bias are inherent in all risk assessments, including those performed for this proposal. Although uncertainty exists, we believe that our approach, which used conservative tools and assumptions, ensures that our decisions are health and environmentally protective. A brief discussion of the uncertainties in the RTR emissions dataset, dispersion modeling, inhalation exposure estimates, and dose-response relationships follows below. Also included are those uncertainties specific to our acute screening assessments, multipathway screening assessments, and our environmental risk screening assessments. A more thorough discussion of these uncertainties is included in the Residual Risk Assessment for the Miscellaneous Coating Manufacturing Source Category in Support of the Risk and Technology Review 2019 Proposed Rule, which is available in the docket for this action. If a multipathway site-specific assessment was performed for this source category, a full discussion of the uncertainties associated with that assessment can be found in Appendix 11 of that document, Site-Specific Human Health Multipathway Residual Risk Assessment Report. a. Uncertainties in the RTR Emissions Dataset Although the development of the RTR emissions dataset involved quality assurance/quality control processes, the accuracy of emissions values will vary depending on the source of the data, the degree to which data are incomplete or missing, the degree to which assumptions made to complete the datasets are accurate, errors in emission estimates, and other factors. The emission estimates considered in this analysis generally are annual totals for certain years, and they do not reflect short-term fluctuations during the course of a year or variations from year to year. The estimates of peak hourly emission rates for the acute effects screening assessment were based on an emission adjustment factor applied to the average annual hourly emission rates, which are intended to account for emission fluctuations due to normal facility operations. b. Uncertainties in Dispersion Modeling We recognize there is uncertainty in ambient concentration estimates associated with any model, including the EPA's recommended regulatory dispersion model, AERMOD. In using a model to estimate ambient pollutant concentrations, the user chooses certain options to apply. For RTR assessments, we select some model options that have the potential to overestimate ambient air concentrations ( e.g., not including plume depletion or pollutant transformation). We select other model options that have the potential to underestimate ambient impacts ( e.g., not including building downwash). Other options that we select have the potential to either under- or overestimate ambient levels ( e.g., meteorology and receptor locations). On balance, considering the directional nature of the uncertainties commonly present in ambient concentrations estimated by dispersion models, the approach we apply in the RTR assessments should yield unbiased estimates of ambient HAP concentrations. We also note that the selection of meteorology dataset location could have an impact on the risk estimates. As we continue to update and expand our library of meteorological station data used in our risk assessments, we expect to reduce this variability. c. Uncertainties in Inhalation Exposure Assessment Although every effort is made to identify all of the relevant facilities and emission points, as well as to develop accurate estimates of the annual emission rates for all relevant HAP, the uncertainties in our emission inventory likely dominate the uncertainties in the exposure assessment. Some uncertainties in our exposure assessment include human mobility, using the centroid of each census block, assuming lifetime exposure, and assuming only outdoor exposures. For most of these factors, there is neither an under nor overestimate when looking at the maximum individual risk or the incidence, but the shape of the distribution of risks may be affected. With respect to outdoor exposures, actual exposures may not be as high if people spend time indoors, especially for very reactive pollutants or larger particles. For all factors, we reduce uncertainty when possible. For example, with respect to census-block centroids, we analyze large blocks using aerial imagery and adjust locations of the block centroids to better represent the population in the blocks. We also add additional receptor locations where the population of a block is not well represented by a single location. d. Uncertainties in Dose-Response Relationships There are uncertainties inherent in the development of the dose-response values used in our risk assessments for cancer effects from chronic exposures and noncancer effects from both chronic and acute exposures. Some uncertainties are generally expressed quantitatively, and others are generally expressed in qualitative terms. We note, as a preface to this discussion, a point on dose-response uncertainty that is stated in the EPA's 2005 Guidelines for Carcinogen Risk Assessment; namely, that “the primary goal of EPA actions is protection of human health; accordingly, as an Agency policy, risk assessment procedures, including default options that are used in the absence of scientific data to the contrary, should be health protective” (the EPA's 2005 Guidelines for Carcinogen Risk Assessment, page 1-7). This is the approach followed here as summarized in the next paragraphs. Cancer UREs used in our risk assessments are those that have been developed to generally provide an upper bound estimate of risk. 17 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. 18 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, 19 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. 17 IRIS glossary ( https://ofmpub.epa.gov/sor_internet/registry/termreg/searchandretrieve/glossariesandkeywordlists/search.do?details=&glossaryName=IRIS%20Glossary ). 18 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. 19 See A Review of the Reference Dose and Reference Concentration Processes, U.S. EPA, December 2002, and Methods for Derivation of Inhalation Reference Concentrations and Application of Inhalation Dosimetry, U.S. EPA, 1994. Many of the UFs used to account for variability and uncertainty in the development of acute dose-response values are quite similar to those developed for chronic durations. Additional adjustments are often applied to account for uncertainty in extrapolation from observations at one exposure duration ( e.g., 4 hours) to derive an acute dose-response value at another exposure duration ( e.g., 1 hour). Not all acute dose-response values are developed for the same purpose, and care must be taken when interpreting the results of an acute assessment of human health effects relative to the dose-response value or values being exceeded. Where relevant to the estimated exposures, the lack of acute dose-response values at different levels of severity should be factored into the risk characterization as potential uncertainties. Uncertainty also exists in the selection of ecological benchmarks for the environmental risk screening assessment. We established a hierarchy of preferred benchmark sources to allow selection of benchmarks for each environmental HAP at each ecological assessment endpoint. We searched for benchmarks for three effect levels ( i.e., no-effects level, threshold-effect level, and probable effect level), but not all combinations of ecological assessment/environmental HAP had benchmarks for all three effect levels. Where multiple effect levels were available for a particular HAP and assessment endpoint, we used all of the available effect levels to help us determine whether risk exists and whether the risk could be considered significant and widespread. Although we make every effort to identify appropriate human health effect dose-response values for all pollutants emitted by the sources in this risk assessment, some HAP emitted by this source category are lacking dose-response assessments. Accordingly, these pollutants cannot be included in the quantitative risk assessment, which could result in quantitative estimates understating HAP risk. To help to alleviate this potential underestimate, where we conclude similarity with a HAP for which a dose-response value is available, we use that value as a surrogate for the assessment of the HAP for which no value is available. To the extent use of surrogates indicates appreciable risk, we may identify a need to increase priority for an IRIS assessment for that substance. We additionally note that, generally speaking, HAP of greatest concern due to environmental exposures and hazard are those for which dose-response assessments have been performed, reducing the likelihood of understating risk. Further, HAP not included in the quantitative assessment are assessed qualitatively and considered in the risk characterization that informs the risk management decisions, including consideration of HAP reductions achieved by various control options. For a group of compounds that are unspeciated ( e.g., glycol ethers), we conservatively use the most protective dose-response value of an individual compound in that group to estimate risk. Similarly, for an individual compound in a group ( e.g., ethylene glycol diethyl ether) that does not have a specified dose-response value, we also apply the most protective dose-response value from the other compounds in the group to estimate risk. e. Uncertainties in Acute Inhalation Screening Assessments In addition to the uncertainties highlighted above, there are several factors specific to the acute exposure assessment that the EPA conducts as part of the risk review under section 112 of the CAA. The accuracy of an acute inhalation exposure assessment depends on the simultaneous occurrence of independent factors that may vary greatly, such as hourly emission 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 exposure scenario. In most cases, it is unlikely that a person would be located at the point of maximum exposure during the time when peak emissions and reasonable worst-case air dispersion conditions occur simultaneously. f. Uncertainties in the Multipathway and Environmental Risk Screening Assessments For each source category, we generally rely on site-specific levels of PB-HAP or environmental HAP emissions to determine whether a refined assessment of the impacts from multipathway exposures is necessary or whether it is necessary to perform an environmental screening assessment. This determination is based on the results of a three-tiered screening assessment that relies on the outputs from models—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 hydrogen chloride). 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. 20 20 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 RTR. Input uncertainty is concerned with how accurately the models have been configured and parameterized for the assessment at hand. For Tier 1 of the multipathway and environmental screening assessments, we configured the models to avoid underestimating exposure and risk. This was accomplished by selecting upper-end values from nationally representative datasets for the more influential parameters in the environmental model, including selection and spatial configuration of the area of interest, lake location and size, meteorology, surface water, soil characteristics, and structure of the aquatic food web. We also assume an ingestion exposure scenario and values for human exposure factors that represent reasonable maximum exposures. In Tier 2 of the multipathway and environmental screening assessments, we refine the model inputs to account for meteorological patterns in the vicinity of the facility versus using upper-end national values, and we identify the actual location of lakes near the facility rather than the default lake location that we apply in Tier 1. By refining the screening approach in Tier 2 to account for local geographical and meteorological data, we decrease the likelihood that concentrations in environmental media are overestimated, thereby increasing the usefulness of the screening assessment. In Tier 3 of the screening assessments, we refine the model inputs again to account for hour-by-hour plume rise and the height of the mixing layer. We can also use those hour-by-hour meteorological data in a TRIM.FaTE run using the screening configuration corresponding to the lake location. These refinements produce a more accurate estimate of chemical concentrations in the media of interest, thereby reducing the uncertainty with those estimates. The assumptions and the associated uncertainties regarding the selected ingestion exposure scenario are the same for all three tiers. For the environmental screening assessment for acid gases, we employ a single-tiered approach. We use the modeled air concentrations and compare those with ecological benchmarks. For all tiers of the multipathway and environmental screening assessments, our approach to addressing model input uncertainty is generally cautious. We choose model inputs from the upper end of the range of possible values for the influential parameters used in the models, and we assume that the exposed individual exhibits ingestion behavior that would lead to a high total exposure. This approach reduces the likelihood of not identifying high risks for adverse impacts. Despite the uncertainties, when individual pollutants or facilities do not exceed screening threshold emission rates ( i.e., screen out), we are confident that the potential for adverse multipathway impacts on human health is very low. On the other hand, when individual pollutants or facilities do exceed screening threshold emission rates, it does not mean that impacts are significant, only that we cannot rule out that possibility and that a refined assessment for the site might be necessary to obtain a more accurate risk characterization for the source category. The EPA evaluates the following HAP in the multipathway and/or environmental risk screening assessments, where applicable: arsenic, cadmium, dioxins/furans, lead, mercury (both inorganic and methyl mercury), POM, HCl, and HF. These HAP represent pollutants that can cause adverse impacts either through direct exposure to HAP in the air or through exposure to HAP that are deposited from the air onto soils and surface waters and then through the environment into the food web. These HAP represent those HAP for which we can conduct a meaningful multipathway or environmental screening risk assessment. For other HAP not included in our screening assessments, the model has not been parameterized such that it can be used for that purpose. In some cases, depending on the HAP, we may not have appropriate multipathway models that allow us to predict the concentration of that pollutant. The EPA acknowledges that other HAP beyond these that we are evaluating may have the potential to cause adverse effects and, therefore, the EPA may evaluate other relevant HAP in the future, as modeling science and resources allow. IV. Analytical Results and Proposed Decisions A. What are the results of the risk assessment and analyses? As described above, for the MCM source category, we conducted an inhalation risk assessment for all HAP emitted, a multipathway screening assessment on the PB-HAP emitted, and an environmental risk screening assessment on the PB-HAP and acid gases emitted. We present results of the risk assessment briefly below and in more detail in the document titled Residual Risk Assessment for the Miscellaneous Coating Manufacturing Source Category in Support of the 2019 Risk and Technology Review Proposed Rule, which is available in the docket for this rulemaking. 1. Chronic Inhalation Risk Assessment Results Table 2 of this preamble provides a summary of the results of the inhalation risk assessment for the source category. Table 2—MCM Inhalation Risk Assessment Results 5 Number of facilities 1 Maximum individual cancer risk (in 1 million) 2 Population at increased risk of cancer ≥ 1-in-1 million Annual cancer incidence (cases per year) Maximum chronic noncancer TOSHI 3 Maximum screening acute noncancer HQ 4 43 6 3,700 0.002 0.4 2 1 Number of facilities evaluated in the risk analysis. 2 Maximum individual excess lifetime cancer risk due to HAP emissions from the source category. 3 Maximum TOSHI. The target organ system with the highest TOSHI for the source category is respiratory. 4 The maximum estimated acute exposure concentration was divided by available short-term threshold values to develop an array of HQ values. HQ values shown use the lowest available acute threshold value, which in most cases is the REL. When an HQ exceeds 1, we also show the HQ using the next lowest available acute dose-response value. The HQ shown here is for glycol ethers, for which there are no other available acute dose-response values. 5 For this source category, it was determined that baseline allowable emissions are equal to baseline actual emissions and, therefore, the risk summaries are the same. The results of the inhalation risk modeling for both actuals and allowables, as shown in Table 2 of this preamble, indicate the estimated cancer MIR is 6-in-1 million, with chromium (VI) compounds from process vents as the major contributor to the risk. The total estimated cancer incidence from this source category is 0.002 excess cancer cases per year, or one excess case in every 500 years. Approximately 3,700 people are estimated to have cancer risks greater than or equal to 1-in-1 million from HAP emitted from the facilities in this source category. The estimated maximum chronic noncancer TOSHI for the source category is 0.4 (respiratory), driven by emissions of acrylic acid from process vents. No one is exposed to TOSHI levels greater than 1. 2. Screening-Level Acute Risk Assessment Results As shown in Table 2 above, the highest acute HQ based on the reasonable worst-case scenario is 2, based on the REL for glycol ethers. This is the highest HQ that is outside facility boundaries. One facility is estimated to have an HQ greater than 1 based on the REL, which is the only available benchmark for glycol ethers. Acute risk estimates for each facility and pollutant are provided in the risk assessment document, which is available in the docket for this rulemaking. 3. Multipathway Risk Screening Results Potential multipathway health risks under a fisher and farmer/gardener scenario were identified using a three-tier screening assessment of the PB-HAP emitted by facilities in this source category. For carcinogenic PB-HAP, one facility emits arsenic compounds, while two facilities emit POM. None of these emissions exceed a Tier 1 cancer screening value for arsenic or POM. For noncarcinogenic PB-HAP, one facility emits cadmium compounds and one facility emits mercury compounds. None of these emissions exceed a Tier 1 noncancer screening value for cadmium or mercury. Further analyses ( i.e., Tier 2 or 3 screens) were not performed. For lead compounds, we did not estimate any exceedances of the lead NAAQS. 4. Environmental Risk Screening Results A screening-level evaluation of the potential adverse environmental risk associated with emissions of the PB-HAP listed above, plus acid gases (HCl is the only reported acid gas), indicated that no ecological benchmarks were exceeded. For lead compounds, we did not estimate any exceedances of the secondary lead NAAQS. 5. Facility-Wide Risk Results The results of the inhalation risk modeling using facility-wide emissions data indicate that the estimated MIR is 20-in-1 million with emissions of hydrazine from sources subject to other standards driving the risk. These include 40 CFR part 63 subpart FFFF (Miscellaneous Organic Chemicals Manufacturing NESHAP), H (Hazardous Organic NESHAP), and EEEE (Organic Liquids Distribution), which are not part of this source category. The total estimated cancer incidence is 0.006 excess cancer cases per year. Approximately 50,100 people are estimated to have cancer risks greater than or equal to 1-in-1 million. The estimated maximum chronic noncancer TOSHI is 2 (for the neurological target organ), driven by emissions of hydrogen cyanide from non-source category emissions from carbon fiber production. Approximately 80 people are estimated to be exposed to noncancer HI levels greater than 1. 6. What demographic groups might benefit from this regulation? To examine the potential for any environmental justice issues that might be associated with the source category, we performed a demographic analysis, which is an assessment of risk to individual demographic groups of the populations living within 5 km and within 50 km of the facilities. In the analysis, we evaluated the distribution of HAP-related cancer and noncancer risk from the MCM source category across different demographic groups within the populations living near facilities. The results of the demographic analysis are summarized in Table 3 of this preamble. These results, for various demographic groups, are based on the estimated risk from actual emissions levels for the population living within 50 km of the facilities. Table 3—MCM Demographic Risk Analysis Results Nationwide Population with cancer risk at or above 1-in-1 million due to MCM Population with chronic HI above 1 due to MCM Total Population 371,746,049 3,665 0 White and Minority by Percent White 62 64 0 Minority 38 36 0 Minority by Percent African American 12 32 0 Native American 0.8 0.05 0 Hispanic or Latino (includes White and nonwhite) 18 2 0 Other and Multiracial 7 2 0 Income by Percent Below Poverty Level 14 29 0 Above Poverty Level 86 71 0 Education by Percent Over 25 and without High School Diploma 14 19 0 Over 25 and with a High School Diploma 86 81 0 Linguistically Isolated by Percent Linguistically Isolated 6 1 0 The results of the MCM source category demographic analysis indicate that emissions from the source category expose approximately 3,700 people to a cancer risk at or above 1-in-1 million and zero people to a chronic noncancer TOSHI greater than 1. The percentages of the at-risk population in each demographic group (except for African American, Below Poverty Level, Hispanic or Latino, and Above Poverty Level) are similar to (within 5 percent of) their respective nationwide percentages. The African American and Below Poverty Level demographic groups are greater than their respective nationwide percentages, while the Hispanic or Latino (includes White and nonwhite) and Above Poverty Level are lower than their respective nationwide percentages. The methodology and the results of the demographic analysis are presented in a technical report, Risk and Technology Review—Analysis of Demographic Factors for Populations Living Near Miscellaneous Coating Manufacturing Facilities, available in the docket for this action. B. What are our proposed decisions regarding risk acceptability, ample margin of safety, and adverse environmental effect? 1. Risk Acceptability As noted in section II.A of this preamble, the EPA sets standards under CAA section 112(f)(2) using a “two-step standard-setting approach, with an analytical first step to determine an `acceptable risk' that considers all health information, including risk estimation uncertainty, and includes a presumptive limit on MIR of approximately 1-in-10 thousand.” (54 FR 38045, September 14, 1989.) In this proposal, the EPA estimated risks based on actual and allowable emissions from MCM sources, and we considered these in determining acceptability. The estimated inhalation cancer risk to the individual most exposed to actual emissions from the source category is 6-in-1 million. The estimated cancer incidence due to inhalation exposures is 0.002 excess cancer cases per year, or one excess case every 500 years. Approximately 3,700 people face an increased cancer risk greater than 1-in-1 million due to inhalation exposures to HAP emissions from this source category. The estimated maximum chronic noncancer TOSHI from inhalation exposure for this source category is 0.4. Risks for allowable emissions are the same since it was determined that allowable emissions are equal to actual emissions for this source category. The screening assessment of worst-case acute inhalation impacts indicates one facility with an estimated HQ of 2, based on the REL for glycol ethers. Potential multipathway human health risks were estimated using a three-tier screening assessment of the PB-HAP emitted by facilities in this source category, where there were no exceedances of Tier 1 screening values for any PB-HAP emitted and, for lead compounds, no exceedances of the lead NAAQS. In determining whether risks are acceptable for this source category, the EPA considered all available health information and risk estimation uncertainty as described above. The risk results indicate that the inhalation cancer risks to the individual most exposed are far less than 100-in-1 million, which is the presumptive limit of acceptability (see, for example, 54 FR 38045, September 14, 1989). There are no facilities or people exposed at this risk level for either actual or allowable emissions. Also, there are no facilities with an estimated maximum chronic noncancer TOSHI greater than 1. There is one facility with an acute HQ value of 2 based on the REL for glycol ethers; however, given the conservative nature of the acute screening assessment, it is unlikely there are acute impacts from HAP emissions from this category. In addition, there are no exceedances of Tier 1 screening values in the multipathway assessment, nor exceedances of the lead NAAQS. Considering all of the health risk information and factors discussed above, including the uncertainties discussed in section III of this preamble, the EPA proposes that the risks from the MCM source category are acceptable. 2. Ample Margin of Safety Analysis We next considered whether the existing MACT standards provide an ample margin of safety to protect public health. In addition to considering all the health risks and other health information considered in the risk acceptability determination, in the ample margin of safety analysis we evaluated the cost and feasibility of available control technologies and other measures (including the controls, measures, and costs reviewed under the technology review) that could be applied to the source category to further reduce the risks due to emissions of HAP. As noted in our discussion of the technology review in section IV.C of this preamble, we identified two developments in practices, processes, or control technologies for reducing HAP emissions from process vessels in the MCM source category. As part of the risk review, we evaluated these developments to determine whether they could reduce risks and whether it is necessary to require these developments to provide an ample margin of safety to protect public health. Since the baseline risks are being driven by inorganic HAP from process vessels, we evaluated a control option for inorganic HAP emissions from process vessels located at MCM facilities and considered the resulting health information. The control option that we evaluated for inorganic HAP would be similar to those included in 40 CFR part 63, subpart CCCCCCC, the NESHAP for Area Sources for Paints and Allied Products Manufacturing. Additionally, we evaluated increasing the control efficiency requirements for organic HAP emissions from process vessels. The process vessel options did not result in a decrease to the MIR or to the maximum chronic noncancer TOSHI because the MIR facility already had controls in place. However, there was a reduction seen in the population exposed to a cancer risk of 1-in-1 million from 3,700 to 1,900 due to emissions reductions at other facilities. As described in section IV.C of this preamble though, we determined that these options are not cost effective. Overall, the available options could result in small reductions in population risk, but we did not identify any cost-effective options for reducing HAP emissions from the source category. Considering all of the health information presented above, along with the available information regarding the cost of the available options, we propose that the existing standards provide an ample margin of safety to protect public health. We are requesting comment on whether there are other control measures for emission sources in this category that are necessary to provide an ample margin of safety to protect public health. In particular, we are requesting that states identify any controls they have already required for these facilities, controls they are currently considering, or any other controls of which they are aware that are being used to control HAP from these sources. 4. Adverse Environmental Effect Based on the results of the environmental risk screening assessment, we are proposing that HAP emissions from the MCM source category do not present an adverse environmental effect. Thus, we are proposing that it is not necessary to set a more stringent standard to prevent, taking into consideration costs, safety, and other relevant factors, an adverse environmental effect. C. What are the results and proposed decisions based on our technology review? Sources of HAP emissions regulated by the MCM NESHAP are process vessels, storage tanks, transfer racks, equipment leaks, wastewater streams, and heat exchange systems. MCM processes occur as batch operations, which involve intermittent or discontinuous feed of raw materials into equipment, and generally involve emptying of the equipment after the operation ceases and prior to beginning a new operation. To inform our technology reviews for these emission sources, we reviewed the EPA's RBLC and regulatory development efforts for similar sources published after the MCM NESHAP was developed. We then evaluated the impacts of requiring additional controls identified in the technology review for the MCM source category, as described below. 1. Process Vessels Process vessels regulated by the MCM NESHAP are defined as any stationary or portable tank or other vessel with a capacity greater than or equal to 250 gal and in which mixing, blending, diluting, dissolving, temporary holding, and other processing steps occur in the manufacturing of a coating. Process vessels used in MCM generate gaseous streams containing HAP when HAP-containing materials are present in the vessel and more material is added displacing solvent-laden air from inside the vessel, and during product mixing as the HAP-containing contents are agitated. At existing sources, the HAP emissions from portable vessels must be controlled by fitting the vessels with lids that are kept closed at all times when the vessel contains a HAP, except for material additions and sampling. The HAP emissions from stationary vessels must be controlled by fitting the vessels with lids that are kept closed at all times when the vessel contains a HAP, except for material additions and sampling, and by capturing all emissions and routing the captured emissions to a control device. Organic HAP with a vapor pressure equal to or greater than 0.6 kilopascals (kPa) must be reduced by at least 75 percent by weight, and organic HAP with a vapor pressure less than 0.6 kPa must be reduced by at least 60 percent. At new sources, the HAP emissions from portable and stationary process vessels must be controlled by fitting the vessels with lids that are kept closed at all times when the vessel contains a HAP, except for material additions and sampling. The emissions from both portable and stationary process vessels must be captured and the captured emissions reduced by at least 95 percent, as total organic HAP, using a control device other than a flare, reduced by venting non-halogenated vent streams to a flare, or vented to a condenser. If a condenser is used, the condenser must achieve a specified outlet gas temperature depending on the partial pressure of the HAP contained in the vessel. If a combustion device is used to control a halogenated vent stream, then a halogen reduction device ( e.g., a scrubber) must be used to reduce hydrogen halide and halogen HAP by at least 95 percent; or reduce overall emissions of hydrogen halide and halogen HAP to no more than 0.45 kg/hr. We evaluated two options that could be potentially considered technology developments under CAA section 112(d)(6). In the first option, we considered increasing the control efficiency requirement for process vessels at existing sources to match the control requirement for new sources, which would increase the control efficiency for organic HAP with a vapor pressure equal to or greater than 0.6 kPa from 75 percent to 95 percent. We consider this option to be a new development because several facilities have controlled all process vessels with thermal oxidizers to comply with the NESHAP. We estimated the costs of installing a thermal oxidizer on the six plants in the MCM source category that currently do not have a thermal oxidizer instal [Text truncated at 120,000 characters. The full text is on the page linked above.] --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A2019-18344. Public record. Not legal advice.