# Clean Water Act Hazardous Substance Facility Response Plans > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/fr%3A2024-05870 ## Record - **Collection:** Federal Register - **Document type:** Rule - **Published:** March 28, 2024 - **Citation:** 89 FR 21924 ## Text ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 118 and 300 [EPA-HQ-OLEM-2021-0585; FRL-7881-01-OLEM] RIN 2050-AH17 Clean Water Act Hazardous Substance Facility Response Plans AGENCY: Environmental Protection Agency. ACTION: Final rule. SUMMARY: The U.S. Environmental Protection Agency (EPA or Agency) is finalizing facility response plan requirements for worst case discharges of Clean Water Act (CWA) hazardous substances for onshore non-transportation-related facilities that could reasonably be expected to cause substantial harm to the environment by discharging a CWA hazardous substance into or on the navigable waters, adjoining shorelines, or exclusive economic zone. DATES: This final rule is effective on May 28, 2024. ADDRESSES: The EPA has established a docket for this action under Docket ID No. EPA-HQ-OLEM-2021-0585. All documents in the docket are listed on the http://www.regulations.gov website. Although listed in the index, some information is not publicly available, e.g., 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 form. Publicly available docket materials are available electronically through http://www.regulations.gov. FOR FURTHER INFORMATION CONTACT: Rebecca Broussard, Office of Emergency Management, Mail Code 5104A, Environmental Protection Agency, 1200 Pennsylvania Avenue NW, Washington, DC 20460; telephone number: 202-564-6706; email: broussard.rebecca@epa.gov. SUPPLEMENTARY INFORMATION: Table of Contents I. General Information A. Does this action apply to me? B. What action is the Agency taking? C. What is the Agency's authority for taking this action? D. What are the incremental costs and benefits of this action? E. List of Abbreviations and Acronyms II. Background A. Statutory Authority and Delegation of Authority 1. Statutory Requirements 2. Delegation of Authority B. Litigation C. Proposed Rule III. This Action A. General Comments B. Costs and Benefits of Various Regulatory Provisions C. Background Analyses 1. CWA Hazardous Substance Discharge History and Impacts Analysis 2. Analysis of Existing Programs/Technical Background Document D. Rule Provisions 1. Definitions 2. Applicability 3. General Requirements 4. Regional Administrator Determination of Substantial Harm and Significant and Substantial Harm 5. Appeals 6. Petitions 7. Exceptions and Exemptions 8. Mixtures 9. Worst Case Discharge Calculations 10. Facility Response Plan Requirements 11. Substantial Harm Certification Form 12. Confidential Business Information (CBI) E. Additional Considerations 1. Climate Change 2. Communities With Environmental Justice Concerns 3. Facility Density F. Consistency With the NCP IV. Statutory and Executive Orders Reviews A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review; and Executive Order 14094: Modernizing Regulatory Review B. Paperwork Reduction Act (PRA) C. Regulatory Flexibility Act (RFA) D. Unfunded Mandates Reform Act (UMRA) E. Executive Order 13132: Federalism F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments G. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks H. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution or Use I. National Technology Transfer and Advancement Act (NTTAA) J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations and Executive Order 14096: Revitalizing Our Nation's Commitment to Environmental Justice for All K. Congressional Review Act (CRA) I. General Information A. Does this action apply to me? A list of entities with facilities that could be affected by requirements established under CWA section 311(j)(5) is provided in Table 1: Table 1—Entities Potentially Affected by the Final Rule NAICS 3 NAICS description 111 Crop Production. 112 Animal Production and Aquaculture. 115 Support Activities for Agriculture and Forestry. 211 Oil and Gas Extraction. 212 Mining (except Oil and Gas). 213 Support Activities for Mining. 221 Utilities. 236 Construction of Buildings. 237 Heavy and Civil Engineering Construction. 238 Specialty Trade Contractors. 311 Food Manufacturing. 312 Beverage and Tobacco Product Manufacturing. 313 Textile Mills. 314 Textile Product Mills. 321 Wood Product Manufacturing. 322 Paper Manufacturing. 323 Printing and Related Support Activities. 324 Petroleum and Coal Products Manufacturing. 325 Chemical Manufacturing. 326 Plastics and Rubber Products Manufacturing. 327 Nonmetallic Mineral Product Manufacturing. 331 Primary Metal Manufacturing. 332 Fabricated Metal Product Manufacturing. 333 Machinery Manufacturing. 334 Computer and Electronic Product Manufacturing. 335 Electrical Equipment, Appliance, and Component Manufacturing. 336 Transportation Equipment Manufacturing. 339 Miscellaneous Manufacturing. 423 Merchant Wholesalers, Durable Goods. 424 Merchant Wholesalers, Nondurable Goods. 441 Motor Vehicle and Parts Dealers. 444 Building Material and Garden Equipment and Supplies Dealers. 447 Gasoline Stations. 453 Miscellaneous Store Retailers. 481 Air Transportation. 486 Rail Transportation. 488 Support Activities for Transportation. 493 Warehousing and Storage. 511 Publishing Industries (except Internet). 518 Data Processing, Hosting, and Related Services. 522 Credit Intermediation and Related Activities. 531 Real Estate. 541 Professional, Scientific, and Technical Services. 561 Administrative and Support Services. 562 Waste Management and Remediation Services. 611 Educational Services. 622 Hospitals. 624 Social Assistance. 712 Museums, Historical Sites, and Similar Institutions. 713 Amusement, Gambling, and Recreation Industries. 811 Repair and Maintenance. 812 Personal and Laundry Services. 921 Executive, Legislative, and Other General Government Support. 924 Administration of Environmental Quality Programs. 926 Administration of Economic Programs. 928 National Security and International Affairs. This table is not intended to be exhaustive, but rather provides a guide for readers regarding affected entities likely to be regulated by this action. This table includes the types of entities that EPA is aware could potentially be regulated by this action. Other types of entities not included in the table could also be regulated. To determine whether your entity is regulated by this action, you should carefully examine the applicability criteria found in § 118.3. If you have questions regarding the applicability of this action to a particular entity, consult the person listed in the FOR FURTHER INFORMATION CONTACT section. B. What action is the Agency taking? EPA is finalizing new requirements for Facility Response Plans (FRPs) for worst case discharges of CWA hazardous substances from onshore non-transportation related facilities (hereafter, covered facilities or facility) that, because of their location, could reasonably be expected to cause substantial harm to the environment by discharging into or on the navigable waters, adjoining shorelines, or exclusive economic zone. C. What is the Agency's authority for taking this action? This final rule is authorized by section 311(j)(5) and 501(a) of the CWA, (33 U.S.C. 1321(j)(5), 1361(a)). D. What are the incremental costs and benefits of this action? EPA estimated the total incremental costs of the final action by combining the per-covered facility estimates of compliance costs with the estimate of the affected covered facility universe. EPA estimated the annualized cost of the final rule over a 20-year analysis period, using three percent and seven percent discount rates, as presented in Table 2. Table 2—Total Incremental Compliance Cost of the Final Action, Annualized [2022$] Present value, 7% Annualized cost, 7% Present value, 3% Annualized cost, 3% Facility Cost $1,120,290,646 $105,747,512 $1,641,867,861 $110,359,310 Agency Cost 70,880,205 6,690,590 101,561,496 6,826,528 Total Cost 1,191,170,851 112,438,102 1,743,429,357 117,185,838 The final action is expected to have a mitigating effect on CWA hazardous substance worst case discharges because the rule provisions address the categories of damages and adverse impacts expected from this type of discharge. The planning activities associated with developing FRPs are likely to mitigate several damage categories through pre-discharge planning and identification of potential receptors and applicable endpoints; the emergency response information provision; descriptions of discharge detection systems, hazard evaluation, and training programs; and drills and exercises. Quantifying the costs and benefits of this action is challenging due to a lack of data around the likelihood of a worst case discharge in the baseline, the universe of potentially regulated facilities, costs of program elements, historical discharges, baseline compliance behavior, and the degree to which the final action will mitigate the probability and severity of worst case discharges. Despite the numerous uncertainties associated with estimating the benefits of the final action quantitatively, information on previous worst case discharges of a similar nature suggests that the benefits of mitigating these discharges could be large relative to the final rule's estimated cost. Chapters 5 and 6 of the final rule Regulatory Impact Analysis (RIA) developed for this action provide additional details on costs and benefits, respectively. This analysis, “Regulatory Impact Analysis: Clean Water Act Hazardous Substance Facility Response Plans,” is available in the docket. E. List of Abbreviations and Acronyms ACP Area Contingency Plan ANFO ammonium nitrate-fuel oil APA Administrative Procedures Act BLS United States Bureau of Labor Statistics CAA Clean Air Act CAS Chemical Abstracts Service CBI Confidential Business Information CFR Code of Federal Regulations CERCLA Comprehensive Environmental Response, Compensation, and Liability Act of 1980 CFATS Chemical Facility Anti-Terrorism Standards CRA Congressional Review Act CWA Clean Water Act DHS United States Department of Homeland Security DOI United States Department of the Interior E.O. Executive Order EPA United States Environmental Protection Agency EPCRA Emergency Planning and Community Right-to-Know Act ERAP Emergency Response Action Plan FBI Federal Bureau of Investigation FR Federal Register FRP Facility Response Plan FRS Facility Registry Service FWSE Fish, Wildlife, and Sensitive Environments GIUE Government-Initiated Unannounced Exercises HAZWOPER Hazardous Waste Operations and Emergency Response ICP Integrated Contingency Plan ICR Information Collection Request IPAWS  Integrated Public Alert & Warning System LC50 Lethal Concentration 50% LEPC Local Emergency Planning Committee MCL Maximum Contaminant Level MOU Memorandum of Understanding MTR Marine Transportation-Related NAICS North American Industry Classification System NCEI National Centers for Environmental Information NCP National Contingency Plan NOAA National Oceanic and Atmospheric Administration NPDES National Pollutant Discharge Elimination System NPDWR National Primary Drinking Water Regulations NPRM Notice of Proposed Rulemaking NRC National Response Center NSFCC National Strike Force Coordination Center O&M Operations and Maintenance OMB Office of Management and Budget OPA 90 Oil Pollution Act of 1990 OSC On-Scene Coordinator OSHA Occupational Safety and Health Administration POTW Publicly Owned Treatment Works PRA Paperwork Reduction Act PREP Preparedness for Response Exercise Program PSM Process Safety Management PWS Public Water System QI Qualified Individual RA Regional Administrator RCP Regional Contingency Plan RCRA Resource Conservation and Recovery Act RFA Regulatory Flexibility Act RIA Regulatory Impact Analysis RMP Risk Management Plan RQ Reportable Quantity SDWA Safe Drinking Water Act SDWR State Drinking Water Regulations SERC State Emergency Response Commission SPCC Spill Prevention Control and Countermeasure SRO Spill Response Organization SWPA Source Water Protection Area TBD Technical Background Document TEPC Tribal Emergency Planning Committee TRI Toxics Release Inventory TSDF Treatment, Storage, and Disposal Facility U.S.C. United States Code UMRA Unfunded Mandates Reform Act USCG United States Coast Guard USDOT United States Department of Transportation UST Underground Storage Tank WOTUS Waters of the United States ZOC Zone of Concern II. Background A. Statutory Authority and Delegation of Authority 1. Statutory Requirements The CWA, as amended by the Oil Pollution Act of 1990 (33 U.S.C. 2701 et seq; hereafter, “OPA 90”), states, “The President shall issue regulations which require an owner or operator of a tank vessel or facility . . . to prepare and submit to the President a plan for responding, to the maximum extent practicable, to a worst case discharge, and to a substantial threat of such a discharge, of oil or a hazardous substance” (33 U.S.C. 1321(j)(5)(A)(i)). The statute defines a covered facility as “. . . [an] onshore facility that, because of its location, could reasonably be expected to cause substantial harm to the environment by discharging into or on the navigable waters, adjoining shorelines, or the exclusive economic zone” (33 U.S.C. 1321(j)(5)(C)(iv)). As described below, the Administrator has been delegated this authority under Executive Order (E.O.) 12777 (56 FR 54757, October 18, 1991). The Administrator also has authority under CWA section 501 to prescribe such regulations as are necessary to carry out provisions of the Act. In 33 U.S.C. 1321(j)(5)(D), the CWA states that these response plans must: (1) Be consistent with the National Contingency Plan (NCP) and Area Contingency Plans (ACP); (2) Identify the qualified individual (QI) having full authority to implement removal actions, and require immediate communications between that individual and the appropriate Federal official and the persons providing personnel and equipment; (3) Identify, and ensure by contract or other means approved by the President the availability of private personnel and equipment necessary to remove to the maximum extent practicable a worst case discharge (including a discharge resulting from fire or explosion), and to mitigate or prevent a substantial threat of such a discharge; (4) Describe the training, equipment testing, periodic unannounced drills, and response actions of persons on the vessel or at the facility, to be carried out under the plan to ensure the safety of the facility and to mitigate or prevent the discharge, or the substantial threat of a discharge; (5) Be updated periodically; and (6) Be resubmitted for approval of each significant change. EPA's responsibilities pursuant to the CWA (33 U.S.C. 1321(j)(5)(E)) for this action for facilities that could reasonably be expected to cause significant and substantial harm to the environment by discharging into or on the navigable waters are to: (1) Promptly review plans; (2) Require amendments when plans do not meet the statutory requirements; (3) Approve plans; and (4) Review each plan periodically. Additionally, EPA may require inspection of containment booms, skimmers, vessels, and other major equipment used to remove discharges (33 U.S.C. 1321(j)(6)(A)). EPA also has the authority to conduct unannounced drills of removal capability in areas for which ACPs are required and under relevant FRPs (33 U.S.C. 1321(j)(7)). EPA intends that the provisions of the rule be severable. In the event that any individual provision or part of the rule is invalidated, EPA intends that this would not render the entire rule invalid, and that any individual provisions that can continue to operate will be left in place. The rule contains many discrete provisions that operate independent of each other. For example, the screening criteria are designed to provide an initial, relatively bright line for identifying covered facilities that do not need to engage in any further applicability determination. That is independent of the criteria that actually determine whether a covered facility could cause substantial harm to the environment from a worst case discharge into or on the navigable waters or a conveyance to navigable waters. Thus, the rule would still satisfy the statutory requirements if the one-half mile distance screening criterion were struck down. Similarly, the four substantial harm criteria are independent of one another, and covered facility owners and operators could still conduct a substantial harm analysis to determine whether an FRP is required absent any one substantial harm criterion. Likewise, if the provisions regarding Regional Administrator (RA) determinations were struck down, the rule would still meet statutory requirements and fulfill its purpose. Furthermore, while there are many different components of an FRP, they serve different functions and are independent requirements. 2. Delegation of Authority Under E.O. 12777 (56 FR 54757, October 18, 1991), EPA was delegated the authority to regulate non-transportation-related onshore facilities and non-transportation-related offshore facilities landward of the coastline. The U.S. Department of Transportation (USDOT) was the delegated authority for transportation-related facilities and the U.S. Coast Guard (USCG) was delegated the authority for tank vessels and marine transportation-related (MTR) facilities. Section 2(i) of E.O. 12777 allows for further delegation between the agencies as later occurred in a February 3, 1994 memorandum of understanding (MOU) between EPA, the U.S. Department of the Interior (DOI), and USDOT (59 FR 9494, February 28, 1994). DOI redelegated 33 U.S.C. 1321(j)(5) authority to regulate non-transportation-related offshore facilities landward of the coastline to EPA. This MOU applies to both oil and CWA hazardous substance facilities. EPA has delegated authority over offshore facilities landward of the coastline as per 40 CFR part 112 Appendix B. However, this final action is limited to non-transportation-related onshore facilities as defined in the consent decree described below. B. Litigation On March 21, 2019, the Natural Resources Defense Council, on behalf of Clean Water Action, and the Environmental Justice Health Alliance for Chemical Policy Reform filed suit in the United States District Court for the Southern District of New York alleging violations of the CWA section 311(j)(5)(A)(i) and the Administrative Procedures Act (APA). 1 The first claim alleged that EPA failed to issue “regulations mandated by the [CWA] requiring non-transportation-related substantial-harm facilities to plan, prevent, mitigate and respond to worst case spills of hazardous substances . . . [which] constitutes a failure to perform a non-discretionary duty or act in violation of the [CWA].” The second claim alleged, “EPA's failure to issue these regulations constitute[d] Agency action unlawfully withheld contrary to and in violation of the [APA] and the [CWA].” The plaintiffs requested an order from the Court to compel EPA to promulgate CWA Hazardous Substance Worst Case Discharge Planning Regulations. Following EPA's Answer, filed on June 4, 2019, Plaintiffs and EPA entered discussions regarding a potential resolution of the lawsuit. 1 Complaint for Declaratory and Injunctive Relief, Environmental Justice Health Alliance for Chemical Policy Reform v. EPA, No. 1-19-cv-02516 (S.D.N.Y., filed March 21, 2019). The plaintiffs and EPA entered into a consent decree on March 12, 2020, which resolved the claims of the suit. 2 The consent decree requires that within two years (24 months) of entry into the consent decree, i.e., by March 12, 2022, EPA sign a notice of proposed rulemaking pertaining to the issuance of the CWA Hazardous Substance Worst Case Discharge Planning Regulations for non-transportation-related onshore facilities. The consent decree further requires EPA to sign a notice taking final action within an additional two and half years, or 30 months after publication of the proposal. On March 28, 2022 (87 FR 17890), EPA proposed to require planning for worst case discharges of CWA hazardous substances for onshore non-transportation-related facilities. This final action satisfies EPA's second obligation under the consent decree. 2 Envtl. Justice Health All. for Chem. Reform v. U.S. EPA, Case1:19-cv-02516-VM, Document 32 (S.D.N.Y., filed March 12, 2020). C. Proposed Rule On March 28, 2022, EPA proposed to require planning for worst case discharges of CWA hazardous substances for onshore non-transportation-related facilities that could reasonably be expected to cause substantial harm to the environment by discharging CWA hazardous substances into or on the navigable waters, adjoining shorelines, or exclusive economic zone, with a 60-day comment period, which was later extended to 120 days. EPA proposed that FRPs must (1) be consistent with the NCP and ACPs; (2) identify the QI having full authority to implement response actions and require immediate communications between that individual and the appropriate Federal official and the persons providing personnel and equipment, with a description of duties; (3) identify, and ensure by contract or other approved means, the availability of private personnel and equipment necessary to respond to the maximum extent practicable to a worst case discharge of CWA hazardous substances (including a discharge resulting from fire or explosion), and to mitigate or prevent a substantial threat of such a discharge; (4) describe the training, equipment testing, periodic unannounced drills, and response actions of persons at the covered facility; (5) be reviewed and updated periodically and resubmitted to the RA for approval of each significant change. In developing CWA hazardous substance worst case discharge plan components, EPA considered existing requirements for the Oil Pollution Prevention FRP regulation under 40 CFR 112.20 given that these requirements have been in place since 1994 and were promulgated under the same statutory authority as the proposal. Notwithstanding the differences between CWA hazardous substances and oil, EPA understands that, where possible, there is value to having a high level of consistency between similar regulatory programs. Even if this rule applies to a different set of regulated entities, there will be synergy among local responders, States, and others, such as spill response organizations (SROs) and consultants, that have experience with worst case discharge planning. Invariably, the experience of implementing and complying with the Oil Pollution Prevention FRP regulation will make this rule easier to comply with, understand, and implement. Additionally, EPA examined elements under the Risk Management Plan (RMP) regulation under 40 CFR part 68, which implements section 112(r)(7) of the Clean Air Act (CAA) and requires facilities that use regulated substances to develop an RMP. Specific CWA hazardous substance FRP components in the proposed rule included: facility information, owner or operator information, hazard evaluation, reportable discharge history, response personnel and equipment, evidence of contracts or other approved means to ensure the availability of personnel and equipment, notification lists, discharge information, personnel roles and responsibilities, response equipment information, evacuation plans, discharge detection systems, response actions, disposal plans, containment measures, training and exercise procedures, self-inspection, and coordination activities. Eight commenters requested a 60-day extension to submit comments. In response, EPA extended the original comment period an additional 60 days, to July 26, 2022. EPA received a total of 220 unique comments: 59 organization comments from 53 unique organizations, 158 private citizens, and 3 mass mailer campaigns representing a total of 29,860 signatories. III. This Action After issuing its proposal, EPA received comments on numerous issues relating to: 1. General comments; 2. Costs and benefits of various regulatory provisions; 3. Background analyses; and 4. Proposed provisions. EPA has structured this document to address these issues and discuss each proposal element, related significant comments, and how any changes EPA considered are reflected in the final rule. A. General Comments As discussed above in Section II.A.1 of this preamble, Congress directed EPA to issue regulations to address worst case discharges for both oil and CWA hazardous substances, providing clear and unambiguous authority for this action. While some commenters asserted that the Agency has the authority to decide not to proceed with the rulemaking and questioned the data analysis supporting this action, including the breadth of the potentially regulated community, EPA has judged the underlying data as sufficient to warrant a regulatory program as detailed in the RIA, available in the docket. While worst case discharges historically may be rare, that in and of itself is not a rationale for not planning for a worst case discharge. This is especially true given trends in natural disasters in the US, with more than $1 trillion in damage from 2016-2022, 3 illustrating that planning for severe weather events is critical as they become more common and intense and reflecting the long term challenges posed by climate change. 4 Additionally, the requirements follow the statutory directives set forth in 33 U.S.C. 1321(j)(5)(D). Indeed, OPA 90 is clear in directing the President to promulgate regulations for worst case discharges of CWA hazardous substances, regardless of the number of facilities that may be ultimately regulated. EPA is following the same approach as the Oil Pollution Prevention FRP regulation, which was promulgated under the same statutory authority, and as such disagrees with commenters who argued that the proposal represents administrative overreach. Worst case discharge planning provisions will appropriately place response planning responsibilities on covered facility owners and operators, as is clearly the Congressional intent, as per the OPA 90 Conference Report, while enumerating EPA's role in oversight and enforcement. 3 National Oceanic and Atmospheric Administration (NOAA) National Centers for Environmental Information (NCEI). (2023). U.S. Billion-Dollar Weather and Climate Disasters. https://www.ncei.noaa.gov/access/billions/, DOI: 10.25921/stkw-7w73. 4 U.S. Global Change Research Program (USGCRP). (2017). Climate Science Special Report: Fourth National Climate Assessment, Volume I, Chapter 7: Precipitation Change in the United States. https://science2017.globalchange.gov/chapter/7/. EPA notes that in March 2000, USCG published a notice of proposed rulemaking (NPRM) in the Federal Register entitled “Marine Transportation-Related Facility Response Plans for Hazardous Substances” (65 FR 17416, March 31, 2000) under the same CWA authority as this final rule. USCG then withdrew that rulemaking in February 2019 (84 FR 2799). Given that nearly 20 years elapsed between the proposal and withdrawal, it is unsurprising that USCG found the proposed rule was no longer appropriate to the current state of spill response in the chemical industry. USCG also noted that their NPRM may overlap with existing local and State regulatory schemes as well as current industry practice. EPA has reviewed USCG's actions, reports, and findings. EPA did not find sufficient overlap for onshore non-transportation-related facilities to justify not promulgating this regulation as per Chapter 2 of the Technical Background Document (TBD), available in the docket. Finally, to commenters who pointed to the no action final rule under CWA 311(j)(1)(C) (84 FR 46100, October 3, 2019), that rulemaking is outside the scope of this final rule and the Agency conclusion there has no bearing here. EPA disagrees with commenters who asserted they were not adequately notified as per the APA. The proposal was clear and the comment period was ample. Indeed, the Agency extended the comment period to 120 days from 60 days to accommodate commenters who requested additional time (87 FR 29728, May 16, 2022). Several commenters noted that the rule does not fully define “waters of the United States” (WOTUS) and that this causes the term “navigable waters” to be “very ambiguous.” The commenters highlighted a related and, at the time, pending Supreme Court decision and EPA rulemaking that would ultimately clarify these concerns. These commenters stressed the importance of holding off from any final rulemaking until the court decision is issued or navigable waters is more clearly defined while additional commenters recommended EPA release a supplementary proposed rule once `WOTUS' and `navigable waters' are clearly defined. EPA disagrees with the comment. Following the Supreme Court's May 25, 2023, decision in Sackett v. Environmental Protection Agency, 143 S. Ct. 1322 (2023), the EPA and Department of the Army developed a rule to amend the final “Revised Definition of `Waters of the United States'” rule consistent with Sackett (88 FR 61964, Sept. 8, 2023). EPA has determined that the rule should cite to the definition in 40 CFR 120.2 to determine whether a particular water is a water of the United States, as opposed to establishing a separate definition. The revised definition provides clarity and citing to this definition will ensure consistency with the Supreme Court's decision in Sackett, as well as ensuring greater understanding and consistency nationwide. Because this definition is also used by other regulatory programs, it provides the greatest amount of information and experience regarding its applicability. The Agency disagrees with commenters who asserted that this definition is prohibitively technical or costly; and notes that the September 2023 definition, issued following Sackett, covers fewer waters than the rule that was in place at the time comments were received. In sum, it is the Agency's position that the regulated community has sufficient information to determine whether they are more than one-half mile from navigable waters or a conveyance to navigable waters such that they are not subject to the rule. Doing so, as some commenters suggest, could inadvertently inject unintended ambiguities or questions about applicability, causing more uncertainty, not less. Finally, EPA acknowledges concerns raised about the impact of litigation and court rulings on post-2015 definitions of “waters of the United States,” and a resulting patchwork of definitions across the country. Needless to say, this is a different rule and while EPA recognizes that due to ongoing litigation there is variation among jurisdictions as to which definition of “waters of the United States” governs, e.g., using the pre-2015 definition in the SPCC context, presumably at some point the litigation will be resolved resulting in national consistency and, in any event, introducing another variation would do nothing to advance national consistency. To the contrary, codifying yet another definition would introduce more complexity within every jurisdiction by requiring regulated entities that need to comply with different CWA regulations to navigate two different definitions within that jurisdiction. Thus, even if currently there is variation with respect to which definition (pre- or post-2015) applies in different jurisdictions, there is merit to having the definition be consistent for regulated parties within their jurisdiction for purposes of the CWA (see Operative Definition of Waters of the United States chart at: https://www.epa.gov/wotus/definition-waters-united-states-rule-status-and-litigation-update ). B. Costs and Benefits of Various Regulatory Provisions EPA estimated the total costs of the final action by combining the per-covered facility estimates with the estimate of the affected facility universe. To provide information about the scale of costs that covered facilities will incur, EPA compiled estimates of unit compliance costs for each of the program elements in the final action. EPA developed unit burden estimates for individual elements of the response plan on a first- and subsequent-year basis. EPA also estimated the extent of baseline compliance for facilities subject to the rule due to the overlap in facilities and program elements in the existing Oil Pollution Prevention FRP, RMP, and Resource Conservation and Recovery Act (RCRA) regulatory requirements, as these three regulations have the most significant crossover. EPA estimated an average compliance cost per covered facility after accounting for baseline compliance with existing regulations by multiplying labor rates and unit burdens. EPA has prepared and posted in the docket an RIA of the potential costs and benefits associated with this action. As presented in Chapter 5 of that analysis, EPA estimated the final rule will result in total annualized costs of 112.4 to 117.2 million per year, at 7 percent and 3 percent discount rates, respectively. This cost includes 92.0-93.5 million for existing covered facilities to comply, 13.7-16.9 million for projected new covered facilities to comply in the future, and 6.7-6.8 million for the Agency to administer the regulations. Table 3 and Table 4 present the estimated costs of the final rule by FRP program component for covered facilities and the Agency, respectively. See Chapter 6 of the final rule RIA for additional details regarding benefits of the final action. Table 3—Total Cost of the Final Action, Facilities, Annualized (2022) Response plan requirements Present value, 7% Annualized cost, 7% Present value, 3% Annualized cost, 3% Facilities completing the substantial harm certification only Rule Familiarization $2,840,473 $268,121 $2,950,783 $198,339 Substantial Harm Certification Form 51,660,843 4,876,418 57,916,345 3,892,888 Subtotal, Substantial Harm Certification Form only facilities 54,501,316 5,144,539 60,867,128 4,091,227 Facilities developing FRPs Rule Familiarization 2,120,519 200,162 2,202,869 148,067 Substantial Harm Determination 38,419,664 3,626,544 43,071,820 2,895,103 Facility and Owner Information 1,234,121 116,492 1,383,558 92,997 Emergency Response 501,508,344 47,338,840 730,536,570 49,103,533 Hazard Evaluation 16,929,190 1,597,996 18,979,110 1,275,694 Discharge Detection 1,456,263 137,461 1,632,598 109,736 Response Actions, Disposal, and Containment 7,407,466 699,212 8,304,421 558,188 Drills & Exercises 253,557,291 23,934,015 376,924,100 25,335,220 LEPC/TEPC Coordination 46,538,057 4,392,863 69,523,895 4,673,098 Training 3,597,780 339,605 4,670,568 313,936 FRP Amendments 38,554,948 3,639,314 59,705,771 4,013,166 ERAP 9,234,533 871,675 13,347,586 897,167 Subtotal, FRP facilities 920,558,174 86,894,179 1,330,282,867 89,415,904 Subtotal, Existing Facilities 975,059,491 92,038,718 1,391,149,995 93,507,131 Subtotal, Projected New Facilities 145,231,155 13,708,794 250,717,866 16,852,179 Grand Total, Facilities 1,120,290,646 105,747,512 1,641,867,861 110,359,310 Table 4—Total Cost of the Final Action, the Agency, Annualized (2022) Agency cost Annualized cost, 7% Annualized cost, 3% Review Existing Facility Plans $1,359,732 $1,126,250 Review New Facility Plans 345,366 389,990 Government-Initiated Unannounced Exercises (GIUEs) and Inspections 3,846,625 4,141,097 FRP Amendments 289,529 311,693 IT/Data Management and Integration 849,339 857,498 Total 6,690,590 6,826,528 The benefits of the final action are assessed qualitatively and include a wide diversity of potential benefit mechanisms, such as reductions in impacts to public water systems (PWS) and waterways used for recreational and commercial purposes; impacts to the ecosystem and environment; impacts to human health; and other socioeconomic impacts driven by business disruption, evacuations, and other elements of emergency response. These benefits include prevention of economic loss in value of homes near discharges 5 and the economic losses to communities affected by a discharge. See Chapter 6 of the final rule RIA for additional details regarding benefits of the final action. 5 Burton, K., Maas, A., and Lee, K. (2022). A Case Study in Contamination: Persistent Home Value Losses Associated with the Elk River Spill. https://jareonline.org/articles/a-case-study-in-contamination-persistent-home-value-losses-associated-with-the-elk-river-spill/ ). The Agency disagrees with commenters who assert that EPA has underestimated costs. EPA recognizes commenters' concern that covered facility owners or operators will need to spend some resources to determine whether they meet the initial screening criteria, and for those that do, potentially significantly more resources and time determining whether they meet any of the substantial harm criteria, preparing an FRP including in-depth hazard evaluations, and potentially revising the FRP. The Agency has accounted for these costs, as well as all other aspects of the regulatory program in Chapter 5 of the final RIA. The Agency proposed that if the maximum capacity onsite exceeds 10,000x the reportable quantity (RQ), a covered facility meets the threshold quantity screening criterion. While EPA proposed a 10,000x RQ multiplier, the Agency has determined that a 1,000x RQ multiplier will more appropriately screen for covered facilities that could cause substantial harm to the environment from a worst case discharge of a CWA hazardous substance, to fully address the range of potential releases that merit worst case discharge planning and response. This results in substantially more covered facilities having to determine whether they are subject to the planning requirements of the rule, i.e., meet the initial screening criteria in the first instance, and analyzing the substantial harm criteria. The Agency also revised the economic analysis for the final rule, estimating annualized costs for regulated facilities of approximately 117 million per year, as documented in section 5.5 the final RIA. EPA estimated the total costs of the final action by combining per-facility estimates with the estimate of the affected facility universe. To provide information about the scale of costs that covered facilities would incur, EPA compiled estimates of unit compliance costs for each of the program elements in the final action. EPA developed unit burden estimates for individual elements of the response plan on a first- and subsequent-year basis. EPA calculated the annualized total cost to regulated facilities of the final action over a 20-year analysis period, using the three percent and seven percent discount rates. The Agency also notes that the majority of labor burden for regulated facility staff are estimated using labor rates of $93.50 and $70.84, based on U.S. Bureau of Labor Statistics (BLS) wage data. The Agency also recognizes the role of consultants in facility planning efforts. This cost is accounted for as an annually recurring cost of $18,471 per facility for contractor support. C. Background Analyses 1. CWA Hazardous Substance Discharge History And Impacts Analysis EPA maintains that it has sufficient data to support the need for this final rule. As detailed in the final rule RIA, EPA analyzed National Response Center (NRC) data on CWA hazardous substances discharges to water. 40 CFR 117.21 requires immediate notification to the NRC once the person in charge of a vessel or an offshore or onshore facility has knowledge of a discharge of a CWA hazardous substance from the facility in quantities equal to or exceeding its assigned RQ in any 24-hour period. NRC data are generated by notifications received immediately following a discharge and often lack complete information on chemicals and quantities discharged, incident and response details, impacts, and locations. While EPA's analysis of NRC data shows a decline in the average number of CWA hazardous substance discharges from 2010 to 2019, past discharge history is not a guarantee of future outcomes, nor does the number of discharges definitively indicate the level of impact of those discharges. Thus, it's possible that a smaller number of higher consequence discharges could cause more adverse impacts due to the circumstances of the incident. Moreover, NRC data are a starting point for further analysis to inform CWA hazardous substance worst case discharge occurrences. Based on past experiences of oil and chemical spills, EPA has observed data gaps with NRC reports, but continues to improve oil and CWA hazardous substance spill data as incidents progress through regional and EPA Emergency Operation Center reporting. Furthermore, NRC data is the most complete dataset available, and it does show that CWA hazardous substance discharges to water continue to occur. Accordingly, EPA has determined that worst case discharge planning regulations for CWA hazardous substances are critical to protect the environment, keep our waterways safe and clean, and protect human health. While 10 CWA hazardous substances account for most of the CWA hazardous substance discharges reported to the NRC, as detailed in section 3.1 of the RIA, these data often lack the names and quantities of chemicals discharged, and do not reflect future probabilities of release. Also, the frequency of reported releases does not reflect the impacts that could occur with a worst case discharge. While some commenters suggested narrowing the number of CWA hazardous substances covered by the rule, changing the list of CWA hazardous substances in 40 CFR part 116 is outside the scope of this action. Moreover, EPA has no reliable information to support the commenter claim that the industry is already devoting the necessary resources and capabilities to prevent and respond to discharges that may reach navigable waters or a conveyance to navigable waters. And even if there is any merit to the commenter's assertion, that would generally serve to change the baseline, mitigating the impact of this rule, and not a reason to have no rule or even the playing field between those that are responsibly planning for such events and those that are not. In any case, EPA intends to work collaboratively with industry to ensure robust response plans for CWA hazardous substance worst case discharges into or on navigable waters or a conveyance to navigable waters that could cause substantial harm to the environment. Additionally, while this final regulation does not address the causes of worst case discharges, it does require comprehensive response planning regardless of how a CWA hazardous substance discharge occurs. By focusing on covered facilities within one half mile to navigable waters or a conveyance to navigable waters and above the threshold quantity that also meet one or more proposed substantial harm criteria, the final regulation will appropriately ensure robust planning for covered facilities that pose the highest risk of causing substantial harm to the environment. 2. Analysis of Existing Programs/Technical Background Document In sum, EPA's analysis found few Federal programs that comprehensively cover all the CWA section 311(j)(5)(D) requirements for all CWA hazardous substances. While CWA hazardous substance covered facilities subject to the Oil Pollution Prevention Program FRP requirements or RMP regulations, among others, have some overlap for the required program elements, those programs do not cover all requirements in CWA section 311(j)(5)(D) for CWA hazardous substances. EPA also recognizes commenter feedback that industry guidance and voluntary programs are valuable resources for ensuring safe, protective practices. However, those practices are not enforceable nor required and do not fulfill the statutory requirements of this action. In addition, EPA acknowledges State programs may be comprehensive for CWA hazardous substance worst case discharge planning. The Agency agrees with commenters who stated that duplicative requirements should be avoided and refers the commenters to Chapter 2 of the TBD for more information and analysis. As such, a regulated facility owner or operator may augment an existing plan with the requirements of this rule or use an Integrated Contingency Plan (ICP) approach, such as One Plan, which will reduce the administrative burden. However, an owner or operator may not assume they are compliant with this regulation due to their compliance under other programs ( e.g., the Oil Pollution Prevention FRP regulation, RMP regulation). See the Response to Comments document for specific responses to each program, in the docket for this action. Please see section III.D.7 of this Preamble for a discussion of exemptions. D. Rule Provisions 1. Definitions Some commenters requested that EPA revise its definitions of key terms. EPA has considered these comments carefully as is committed to providing clarity throughout this action. i. Adverse Weather EPA considered comments advocating that the definition of “adverse weather” should be revised. To the extent that commenters are concerned with “ambiguity,” it seems largely because they are interested in narrowing the definition to a limited number of clearly delineated events. However, the definition is intentionally broad and meant to capture the wide range of potential weather changes and conditions due to the nation's varying regional weather patterns. Prescribing specific types of events or adverse weather conditions is unrealistic and does not represent the myriad challenges facing our nation due to climate change. EPA also disagrees with commenters who asserted that the breadth of this definition will cause uneven implementation of the final rule; rather, it will allow covered facility owners or operators and local emergency planners to consider the full range of potential adverse weather events, taking into consideration varying local and regional weather patterns (current and future), that could impact the covered facility and affect worst case discharge response planning as well as changing conditions and emerging threats such as the widening impact of extreme heat. For example, while specific events, such as “20-year storm conditions” may be useful as one type of climatological condition to consider in one region, EPA agrees that it is equally important to consider effects of, for example, increased drought or lack of rain activity in other regions and the effects on a potential worst case discharges of CWA hazardous substances. As such, EPA has added language describing some types of climate change impacts that may need to be considered when accounting for adverse weather conditions during a worst case discharge of CWA hazardous substances into or on the navigable waters or a conveyance to navigable water, such as the increased frequency and intensity of adverse weather, temperature fluctuations, rising seas, storm surges, inland and coastal flooding, drought, wildfires, and permafrost melt in northern areas. EPA chose to define “adverse weather” in this final rule differently from the Oil Pollution Prevention regulation definition of adverse weather found in 40 CFR 112.2 due to the variance in physicochemical properties among oil and the 296 CWA hazardous substances as well as how different types of adverse weather may impact the analysis of appropriate response actions for those myriad CWA hazardous substances. This is another reason why a broad definition of “adverse weather” is appropriate for this rule. EPA recognizes that, given the increased probability of extreme weather events, historic incidents are becoming less of a predictor of future effects. Compliance assistance will be available to aid owners or operators in determining the appropriate types and severity of weather events, sea level rise, drought, flooding, heat, wildfire, and subsidence risk, etc., to consider for their worst case discharge in adverse weather, as well as references and data sources. ii. Container While several commenters noted that the definition of “container” is not consistent with the Oil Pollution Prevention regulation in 40 CFR 112.2 and that there is no corresponding definition in this action for “bulk storage container.” The primary reason for this is because the two regulations do not cover the same substances. Additionally, while the Oil Pollution Prevention regulation has determined that a 55-gallon de minimis container size is appropriate, as noted by commenters, this is not the case for CWA hazardous substances. To the contrary, certain CWA hazardous substances have been determined that they “may be harmful” at quantities as low as one pound. Accordingly, a 55-gallon container size would be an inappropriate de minimis amount for all substances because smaller containers may contain hazardous levels of substances that could cause substantial harm in the event of a worst case discharge, especially when aggregated. Additionally, CWA hazardous substances are stored in a wide variety of containers, and CWA hazardous substances are typically measured and regulated 6 by mass ( e.g., pounds), not volume (gallons), underscoring why a 55-gallon de minimis container standard would be unsuitable. Because of the variation of the chemical properties, including toxicity, of CWA hazardous substances, EPA has no basis for setting a de minimis container size at 55-gallons or any other level, including the RQ level, as suggested by some commenters. Furthermore, the OPA Conference Report states that “. . . the selection criteria should not necessarily omit those smaller facilities that are near major water supplies or that are near environmentally sensitive areas.” (H.R. Rep. No. 101-653, 10lst Cong., 2d Sess., p.151.). Threshold determinations must consider all CWA hazardous substance present at the covered facility in the aggregate, but without consideration to container size or capacity because the maximum quantity onsite may contribute to the potential harm posed by a covered facility. Finally, two commenters asked for additional examples of containers. Accordingly, EPA notes that containers may consist of a rail car or other mobile storage not under active shipping papers, process vessel, canister, drum, bulk storage tank, dumpster, tote, or bulk cargo container positioned on land, among other things. For the reasons enumerated above, EPA is finalizing the definition of container as proposed. 6 EPCRA Reporting Rule (40 CFR part 370), RMP regulation (40 CFR part 68), DHS CFATS (6 CFR part 27), OSHA's PSM (29 CFR 1910.119). iii. Conveyance to Navigable Waters EPA considered whether to include a rule-specific definition for “conveyance to a navigable waterway.” EPA is aware that the CWA definition of “point source” at 33 U.S. Code § 1362(14) uses the term conveyance and includes some examples. However, EPA determined that cross-referencing that description of conveyance, with its specific exclusions, would not be appropriate for this rule. In this rule, conveyances are a critical consideration in a facility's worst case discharge scenarios because a straight-line analysis may overlook an opportunity to travel via pipe or open channel that could more easily enter navigable waters. Indeed, the concern is not particular types of structures or pathways (and categorizing them) but that a conveyance to navigable waters can result in a more immediate discharge to navigable waters. Moreover, while there are some broad categorical generalizations that can be made about what constitutes a conveyance to navigable waters, there are factual elements that necessarily make the determination a case-by-case determination (even if most of the time it will be straightforward, if not obvious), i.e., where identifying particular types of conveyances will not suffice or capture the variations that exist in the real world. In any case, in terms of a definition, conveyance is meant to have its normal English language definition and usage. That said, consistent with having the elements of the initial screen be relatively straightforward, EPA is clarifying that it considers a conveyance to navigable waters in the context of this rule to be a means of transport that provides a direct pathway to navigable waters. In the majority of cases, a means of transport will be discernible, confined, and discrete, and thus will present a straightforward factual scenario. Some examples are a storm drain, pipe, or channel that discharge directly into navigable waters. A few commenters had categorical questions about types of structures or features such as a dry gulch, a wellhead, subsurface water or even groundwater. While EPA could make some generalization that it does or does not expect that any of these examples would serve as a means of transport, the reality is there will inevitably be situations where it will depend on the specific facts to determine whether a given structure or feature (no matter what it is called) serves as a means of transport to navigable waters. Finally, given the purpose of the rule, EPA disagrees that the inclusion of a means of transport that could result in a more immediate discharge to navigable waters in the initial screen (and in some cases may require some analysis), makes the reach or scope of the rule “unbounded.” iv. Distance to Endpoint EPA is adjusting the definition of distance to endpoint for clarity and to reflect that the distance represents the greatest distance a CWA hazardous substance can travel in a worst case discharge to navigable waters or a conveyance into or on the navigable waters while still being able to cause injury to fish, wildlife, or sensitive environments (FWSE) or public receptors, or adversely impact a PWS. v. Endpoint Accordingly with the definition of distance to endpoint above, EPA is adjusting the definition of endpoint to clarify that it represents the concentration at which a worst case discharge of a CWA hazardous substance into or on the navigable waters has the ability to cause injury to FWSE or public receptors, or adversely impact a PWS. vi. Facility Some commenters asserted that the definition of “facility” is unclear while others were concerned about the possibility of gamesmanship in drawing facility boundaries. EPA is adjusting the definition to reflect the Preamble to the proposed rule, that stated that an owner or operator may not make determinations as to what constitutes a covered facility indiscriminately and in such a manner as to simply avoid applicability of the final rule (for example, the division of one facility into separate facilities with one CWA hazardous substance container located at each facility where all containers are located side-by-side or in close proximity to each other and are used for the same purpose). EPA maintains that the flexibility afforded to owners or operators in determining what constitutes a covered facility allows those most knowledgeable about its operations to decide whether it should be aggregated or divided, which may vary widely due to the range of CWA hazardous substance operations and types of facilities. Furthermore, EPA notes that it is adopted from the Oil Pollution Prevention regulation at 40 CFR 112.2, is appropriately broad, and captures the types of facilities intended to be regulated by EPA under CWA hazardous substance worst case discharge regulations. Please see the Response to Comments document in the docket for further discussion. EPA has adjusted the definition to separate out non-transportation-related onshore facilities for clarity and ease of navigation in the document. vii. Injury Because of the need to maintain consistency with the NCP, the Agency has determined it is appropriate to use the definition of “injury” established by the Natural Resource Trustees for this rule. Federal officials authorized by the President and the authorized representatives of Indian Tribes and State and foreign governments act as public trustees to recover damages to natural resources under their trusteeship. Under the NCP, each trustee has responsibilities for protection of resources; mitigation and assessment of damage; and restoration, rehabilitation, replacement, or acquisition of resources equivalent to those affected (40 CFR 300.615). EPA maintains that the definition of “injury” is appropriate to assess substantial harm based on the extensive experience of the Natural Resource Trustees in conducting evaluations of CWA hazardous substance impacts on natural resources. The definition of “injury” in 40 CFR 112.2 of the Oil Pollution Prevention regulation was adapted from the definition of “injury” in the DOI Natural Resources Damage Assessments (NRDA) final rule at 43 CFR part 11 and includes only the part of the definition that addresses oil discharges, which EPA is now adapting for this regulation to provide regulatory consistency. In response to the commenters who stated that the definition of “injury” could apply to “insubstantial effects” rather than “substantial harm,” EPA notes that the definition of “injury” is intended to assist in the identification of covered facilities that could cause substantial harm. The potential for a spill to cause an injury to FWSE or public receptors is coupled with the screening criteria to determine if a covered facility could cause substantial harm to the environment. In that context, causing injury indicates the potential for a worst case discharge to cause substantial harm to the environment. EPA concludes that the injury relies on changes that have been demonstrated to adversely impact the resources in question, or services provided by those resources. While “injury” to a public receptor as a concept may be new to the regulatory community, EPA holds that it is an important consideration due to the variability of CWA hazardous substances, how they act in water, their effects on human health and the environment, and their impact on the potentially exposed public. EPA agrees with the commenter who asserted that just being a measurable effect does not mean that the effect is “substantial;” however, the endpoints in Appendix B are not limited to just measurable effects. Indeed, the endpoints are both measurable and indicate a covered facility could cause substantial harm to the environment due a worst case discharge into or on the navigable waters or a conveyance to navigable waters. viii. Maximum Quantity Onsite EPA has revised the definition of “maximum capacity onsite” to “maximum quantity onsite.” This is based on the decision to use a threshold quantity based on quantity, not capacity, discussed below in section III.D.2.ii. Please note, a covered facility owner or operator must plan proactively for future anticipated product onsite and FRP threshold quantities are based on the maximum quantity onsite at any time for each CWA hazardous substance. For example, a covered facility with both chlorine and benzene onsite must consider when those CWA hazardous substances will be at their maximum quantity onsite both as to whether they meet the threshold quantity and for planning purposes. If the owner or operator is developing a plan in January and does not want to amend their plan in the coming months, the maximum quantity onsite for chlorine may occur in March and the maximum quantity onsite of benzene may occur in September. For the FRP to be valid without amendments, it must plan for the maximum quantities onsite for each CWA hazardous substance at any time, so both maximum quantities onsite, regardless as to whether the times overlap. ix. Permanently Closed EPA is removing the definition of “permanently closed” because a CWA hazardous substance maximum quantity onsite, threshold quantity, and worst case discharge scenario quantities in the final rule are based on using quantity, not capacity, discussed below in section III.D.2.ii. x. Publicly Owned Treatment Works EPA is adding a definition for publicly owned treatment works (POTW), referring to the existing definition in 40 CFR 403.3, but including federally owned treatment works for the purposes of this final rule. xi. Public Receptor Some commenters suggested that the definition of “public receptor” is too broad. However, EPA's definition of “public receptor” is intentionally so in order to cover a wide variety of areas through which the public has access to navigable waters and could be affected by a worst case discharge. EPA did not include first responders in the definition of public receptor, as one commenter suggested, because first responders are covered in a facility and community's health and safety plan and emergency planning. While this definition is not part of the Oil Pollution Prevention regulation in 40 CFR part 112, CWA hazardous substances differ from oil in important and varied ways and require different considerations. For instance, certain CWA hazardous substances may have no realistic means of recovery once the substance enters a waterbody, meaning that receptors must be prepared for and swiftly notified of the diluted substance as it travels downstream. As with other aspects of this rule, EPA intends to provide compliance assistance to covered facility owners or operators on types of areas they should consider when determining their ability to cause injury to public receptors. xii. Public Vessel EPA did not receive any comments on the definition of public vessel and has adjusted the definition to refer to the definition in section 311(a)(4) of the CWA. This will provide regulatory consistency with other CWA programs and reflect the statutory authority of this action rather than creating a new definition just for use in this regulation. xiii. Vessel EPA did not receive any comments on the definition of vessel has adjusted the definition to refer to the sections 311(a)(4) of the CWA and 101(28) of the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA). This will provide regulatory consistency with other CWA and CERCLA programs and reflect the statutory authority of this action, rather than creating a new definition just for use in this regulation. xiv. Water Distribution System EPA has revised the definition for accuracy and to align with its use in other EPA programs in order to more accurately reflect drinking water system characteristics. 7 7 https://www.epa.gov/dwreginfo/drinking-water-distribution-system-tools-and-resources. xv. Wellhead Protection Area EPA is adding a definition for wellhead protection area for consistency with the Oil Pollution Prevention FRP regulation and to aid responders in identifying risks in the event of a worst case discharge to protect drinking water sources. xvi. Worst Case Discharge Some commenters suggested EPA change its definition of worst case discharge; however, EPA concludes that the current definition is designed to capture the worst case discharge and consistent with the statutory authority of this action. It is worth noting, however, that discharges in compliance with NPDES (40 CFR part 122) are not covered by this regulation. To commenters concerned with impacts due to climate change, a largest foreseeable discharge must already be evaluated in adverse weather conditions, including those due to climate change, which may include challenging climatic conditions such the increased frequency and intensity of extreme weather events, temperature fluctuations, rising seas, storm surges, inland and coastal flooding, drought, wildfires, and permafrost melt in northern areas. In addition, EPA refers commenters to 40 CFR 118.10 and section III.D.9 of this preamble for more specific language and discussion on worst case discharge calculations. xvii. Other Definitions EPA did not receive major substantive comments on the remaining definitions in § 118.2 and is finalizing them as proposed, with some separated out for clarity. 2. Applicability In 40 CFR 118.3, EPA set forth a two-step applicability process, whereby a covered facility owner or operator assesses two screening criteria, and, if both criteria are met, the owner or operator then, and only then, assesses the ability to cause substantial harm to the environment through four substantial harm criteria (all described in detail below). To ensure that EPA tied the proposed applicability provisions to the statutory requirements, the Agency proposed four substantial harm criteria to target covered facilities that could cause substantial harm to the environment by discharging into or on navigable waters or a conveyance to navigable waters. Additionally, EPA proposed location-based criteria (using both distance from navigable waters or conveyance and planning distance calculations) to ensure covered facilities are regulated based on their location, as required by statute. In combination with the screening criteria, EPA determined that the substantial harm criteria reflect real world scenarios whereby a worst case discharge could cause substantial harm to the environment. Some commenters raised concerns about the level of responsibility on owners or operators to determine if they are subject to the rule. While EPA staff will be available to work with facilities and provide compliance assistance, consistent with Congressional intent, the responsibility for safeguarding their materials and for planning for a worst case discharge of CWA hazardous substances into or on the navigable waters or a conveyance to navigable waters rests first and foremost with the covered facility owner or operator (H.R. Rep. No. 101-653, 101st Cong., 2d Sess. 1990). Figure 1—Final Applicability Criteria for CWA Hazardous Substance FRP-Subject Facilities ER28MR24.014 i. Example of the Applicability Determination Process Below is a detailed discussion of the applicability determination process in 40 CFR 118.3. The first step is to complete the screening criteria, which are to be assessed concurrently; there is no implied order of which screening criterion to assess initially, and a covered facility owner or operator may choose to examine either their distance to navigable waters or a conveyance to navigable waters or threshold quantity first, whichever is preferable to their circumstances. In this example, the owner or operator chooses to determine if their maximum quantity/quantities onsite of CWA hazardous substance(s) meets or exceeds the threshold quantity first. The aggregate maximum quantity onsite at any time of benzene (a listed hazardous substance as found in 40 CFR 116.4) is 15,000 pounds. Since benzene has an RQ of 10 and the RQ multiplier is 1,000, the threshold quantity for benzene is 10,000 pounds. Because the covered facility's maximum quantity onsite exceeds the threshold quantity for benzene, it meets this screening criterion. If there are mixtures containing CWA hazardous substances onsite, the owner or operator must follow the requirements regarding mixtures, as detailed in section III.D.8 of this preamble. The covered facility owner or operator then determines whether it has a maximum quantity onsite at any time that meets or exceeds the threshold quantity for each other CWA hazardous substance onsite and in mixtures following the same procedure. Alternatively, if a covered facility does not have any CWA hazardous substances that meet the CWA hazardous substance screening threshold (1,000x RQ), it need not proceed further with the applicability determination. Again, if the covered facility meets the CWA hazardous substance threshold quantity screening criterion, the owner or operator next determines its distance to navigable waters or a conveyance to navigable waters. In this instance, the covered facility boundary or nearest opportunity for discharge nearest to a navigable water or a conveyance to navigable water as assessed using an online mapping tool is 0.3 miles. Thus, the covered facility is within one-half mile of navigable waters or a conveyance to navigable waters. Since the covered facility meets both prongs of the screening criteria, the owner or operator then determines whether it meets any of the substantial harm criteria. If a covered facility is not within one-half mile of a navigable waters or a conveyance to navigable waters, the owner or operator need not proceed further. Similar to the screening criteria, there is no implied order of operations in determining whether a covered facility meets any of the substantial harm criteria, and an owner or operator may proceed through the criteria as preferred. However, unlike the screening criteria (where both prongs need to be met), if an owner operator determines that the covered facility meets one of the substantial harm criteria, the owner or operator must submit an FRP to EPA. In addition, the owner or operator must still assess the other substantial harm criteria, as it is important to have a guide to all the potential areas of impact in the case of a worst case discharge as well as past vulnerabilities as shown through previous reportable discharges. Therefore, the assessments for all four criteria must be included in the FRP or Appendix A: Substantial Harm Certification Form. Proceeding through each of the substantial harm criteria, for the substantial harm criteria based on calculating distances to endpoints (FWSEs and public receptors and the ability to adversely impact a PWS), EPA expects that covered facility owners or operators will need to gather information related to the CWA hazardous substances onsite above the threshold quantity and information relevant to their fate and transport following a worst case discharge. This may include modeling a worst case discharge scenario under various flow conditions to obtain the arrival time, duration, and concentration of the discharge as it reaches a FWSE, public receptor, or water intake. Typically, low flow conditions will result in larger peak concentrations of the discharged substance, and thus could be more likely to cause substantial harm. Next, a covered facility owner or operator determines whether a worst case discharge of each CWA hazardous substance with a maximum quantity onsite above the threshold quantity could cause injury to FWSE. To calculate the quantity of a worst case discharge for each CWA hazardous substance onsite above the threshold quantity, the owner or operator identifies the maximum CWA hazardous substance container, interconnected containers, pipe, or piping system quantity onsite. Then, a covered facility owner or operator consults the relevant ACP (available by contacting their EPA regional office) to identify FWSE that could potentially be reached by a worst case discharge. To calculate planning distance, the owner or operator must consider the factors for overland and in water transport detailed in § 118.10(b)(3)(i) and (ii), as well as adverse weather conditions in § 118.10(b)(3)(iii) and properties of the CWA hazardous substance in 40 CFR 118.10(b)(3)(iv) or associated aqueous products. Once an owner or operator completes the planning distance calculations, they compare the concentration-based ( i.e., mg/L) results to the chart in Appendix B to determine whether a worse case discharge could cause injury to FWSE. To determine whether a covered facility could cause injury to a public receptor, the owner or operator follows the same steps as for FWSE, but uses the appropriate concentration-based ( i.e., mg/kg) endpoint values found in Appendix B. To identify public receptors, an owner or operator may consult local maps, local authorities, their Local Emergency Planning Committee (LEPC) or Tribal Emergency Planning Committee (TEPC), or any other available information about parks, recreational areas, docks, or other public spaces inhabited, occupied, or used by the public at any time where members of the public could be injured as a result of a worst case discharge into or on the navigable waters or a conveyance to navigable waters. To evaluate whether a worst case discharge from a covered facility could adversely impact a PWS, the owner or operator determines whether a worst case discharge would result in certain outcomes as detailed below by working with potentially affected PWSs. Using information including properties of CWA hazardous substances onsite and information relevant to their fate and transport arrival time, duration, and concentration of the discharge as it reaches a water intake, the owner or operator coordinates with downstream PWSs to determine impacts to the system and documents that coordination. If the owner or operator has made and documented good faith efforts but is nonetheless unable to work with the PWS, the covered facility will use the estimated concentration of the CWA hazardous substance from a worst case discharge at the water intake to assess the potential to adversely impact a PWS. Specifically, an owner or operator must assess each of the following impacts: —Violation of a National Primary Drinking Water Standard or State Drinking Water Regulation: To assess whether a worst case discharge violates any National Primary Drinking Water Regulations (NPDWR) or State Drinking Water Regulations (SDWR), a covered facility owner or operator determines whether the released CWA hazardous substance, aqueous products, or a chemical product that forms when the CWA hazardous substance reacts with drinking water treatment chemicals, is subject to a NPDWR or SDWR, and is predicted to exceed the maximum contaminant level (MCL) at the point of compliance with the NPDWR or SDWR. For example, benzene is a CWA hazardous substance and is subject to a NPDWR with an MCL of 0.005 mg/L measured at the entry point to the water distribution system. An example of a chemical product that could form through a reaction is the CWA hazardous substance ammonium thiocyanate, which reacts with free chlorine to form cyanogen chloride and/or free cyanide, both of which are acutely toxic above a threshold and are regulated under SDWA. —Interference with the ability of PWSs to comply with any NPDWR or SDWR: To assess whether a worst case discharge compromises the ability of the PWS to produce water that complies with any NPDWR or SDWR, a covered facility owner or operator determines whether the released CWA hazardous substance alters water quality or interferes with treatment processes in a manner that impacts a PWS's ability to produce water that complies with an NPDWR or SDWR. For example, a release of a strong acid, such as sulfuric acid in sufficient quantity may reduce water alkalinity to a degree where the PWS can no longer maintain adequate corrosion control, putting it at risk of a violation under the Lead and Copper Rule (40 CFR part 141 subpart I). —Threat to public health: To assess whether a worst case discharge results in adverse health impacts in people exposed to the maximum concentration that could enter a drinking water distribution system, a covered facility owner or operator determines whether the released CWA hazardous substance, aqueous products, or a chemical product that forms when the CWA hazardous substance reacts with drinking water treatment chemicals, is predicted to exceed scientifically accepted reference concentrations below which adverse human health impacts are not expected. An example of such reference concentrations are EPA's established Drinking Water Health Advisories, which are intended to protect public health during an emergency, such as a chemical release. As an example, benzene has a one-day Drinking Water health advisory of 0.2 mg/L. —Contamination of PWS infrastructure: To assess whether a worst case discharge will contaminate PWS infrastructure, including but not limited to intake structures, treatment facilities, and drinking water distribution systems, or premise plumbing systems 8 to a degree that requires remediation to restore system components to acceptable performance, a covered facility owner or operator determines whether the released CWA hazardous substance, aqueous products, or a chemical product that forms when the CWA hazardous substance reacts with drinking water treatment chemicals, is likely to corrode, foul, adhere to, adsorb into, permeate into, or otherwise damage components and materials used at any point in the PWS, from the intake through premise plumbing systems. For example, CWA hazardous substances that are oil-like can foul water treatment filtration media, making it ineffective. 8 https://www.epa.gov/emergency-response-research/premise-plumbing-decontamination. —Impact to aesthetic characteristics of drinking water: To assess whether a worst case discharge impairs the taste, odor, or other aesthetic characteristic of the water entering a drinking water distribution system to a degree that could make the water unacceptable to consumers and that could prompt the PWS to issue use restrictions, a covered facility owner or operator determines whether the released CWA hazardous substance, aqueous products, or a chemical product that forms when the CWA hazardous substance reacts with drinking water treatment chemicals, is predicted to exceed scientifically accepted reference concentrations, below which aesthetic impacts from the CWA hazardous substance are not expected. For example, a CWA hazardous substance at a concentration above established taste and odor thresholds could prompt a water system to issue use restrictions, such as a “do not drink” order. When available, secondary MCLs established under SDWA should be used as a reference concentration for aesthetic impacts. For example, chloride has a secondary MCL of 250 mg/L—above this concentration, the taste of the water may be unacceptable to customers. Several CWA hazardous substances, such as hydrochloric acid, would increase the chloride concentration in water. When assessing each criterion for substantial harm to PWSs, the covered facility owner or operator should attempt to work collaboratively with the downstream PWS(s) to determine precisely how the worst case discharge would impact the system. Given the complexity of fate and transport of a CWA hazardous substance in aqueous environments as well as the impact of drinking water treatment processes on the CWA hazardous substance, system specific information from the PWS will facilitate the most accurate assessment for the potential of the CWA hazardous substance to cause substantial harm to the PWS. However, if the covered facility owner or operator has made and documented good faith efforts but is nonetheless unable to work with the PWS in this assessment, the owner or operator must use the predicted concentration of the CWA hazardous substance at the drinking water intake resulting from a worst case discharge, along with scientifically accepted information about the impact of common water treatment processes ( e.g., chlorination) on the CWA hazardous substance to make the substantial harm determination. The covered facility owner or operator must consider each of the five potentially adverse outcomes to PWSs described above and determine the concentration at which the adverse outcome could occur. The lowest concentration at which any of the five adverse outcomes could occur must be used in the substantial harm determination, and if the concentration at the reference point ( e.g., at the intake, at the entry point to the distribution system) is equal to or greater than the concentration at which the adverse outcome could occur, then the covered facility meets this substantial harm criterion. Finally, a covered facility owner or operator assesses whether they have had a reportable discharge of a CWA hazardous substance (a discharge over the RQ) to navigable waters in the last five years. This could be accomplished by reviewing discharge records and those submitted to the NRC in the event of a reportable discharge. If the covered facility CWA hazardous substance maximum quantity onsite meets or exceeds the threshold quantity and it is located within one-half mile of navigable waters or a conveyance to navigable waters, but does not meet any of substantial harm criteria, the owner or operator must still submit a Substantial Harm Certification Form (Appendix A) to EPA, including supporting calculations and modeling. If the covered facility meets at least one of the substantial harm criteria, the owner or operator must complete and submit an FRP to EPA that includes information on each CWA hazardous substance onsite above the threshold quantity, along with their Substantial Harm Certification Form. Below is a detailed discussion of the significant comments and EPA's responses, as well as adjustments made to the regulatory text. ii. Threshold Quantity In 40 CFR 118.3, EPA proposed that if the maximum capacity onsite exceeds 10,000x the RQ, a covered facility meets the threshold quantity screening criterion. While EPA proposed using 10,000x RQ multiplier for threshold quantities, the Agency has determined that a 1,000x RQ multiplier will more appropriately screen for covered facilities that could cause substantial harm to the environment from a worst case discharge. For example, some commenters criticized the 10,000x multiplier citing a lack of evidence that those facilities under that threshold quantity would not be reasonably be expected to cause substantial harm to the environment from a worst case discharge. Therefore, the commenters urged EPA to take a more precautionary approach and not exclude these facilities from determining their ability to cause substantial harm to the environment. Since threshold quantity is a screening tool, i.e., a covered facility with less than that amount is not covered by the rule and need not consider whether it may reasonably cause a worst case discharge in the first instance, setting a lower initial screening level at this stage has merit, since even with less than a 10,000x RQ amount, it is reasonably foreseeable that a covered facility could cause substantial harm from a worst case discharge. Said another way, setting the threshold quantity too high may mean that higher risk covered facilities are not required to determine their ability to cause substantial harm at all, which could leave the environment more vulnerable to worst case discharges. Several commenters supported the initial proposed 10,000x RQ multiplier, but EPA agrees with other commenters who suggested lowering the RQ multiplier to 1,000x. See Chapter 2 of the RIA for this final rule for a detailed analysis of covered facilities with CWA hazardous substances onsite at the 1,000x and 10,000x RQ multiplier levels. This analysis shows that at the 1,000x RQ multiplier, a number of additional covered facilities with CWA hazardous substances onsite that present a significant threat to downstream PWSs, FWSEs, and public receptors will need to determine if they meet the substantial harm criteria. For example, for covered facilities with 1,000x RQ onsite of arsenic trioxide (arsenic, a known toxin regulated under the Safe Drinking Water Act (SDWA)), 66% would now meet the quantity threshold, versus 50% at 10,000x RQ. Similarly, for covered facilities with benzene onsite, a known carcinogen also regulated under the SDWA, 75% would now meet the threshold quantity versus 32% at 10,000x RQ. A few other examples include lead sulfate (lead, regulated under SDWA), 66% of covered facilities at 1,000x RQ versus 17% at 10,000x RQ; sodium arsenate (arsenic, a known toxin regulated under SDWA), 100% of covered facilities at 1,000x RQ versus 11% at 10,000x RQ; and hydrogen cyanide (cyanide, regulated under SDWA), 57% at 1,000x RQ versus 29% at 10,000x RQ. These additional covered facilities evaluating their substantial harm criteria will significantly add to protection of the environment. EPA disagrees with commenters who argued that this lower multiplier value will bring in too many covered facilities under the rule without a concomitant increase in environmental protection. First, meeting the threshold quantity does not automatically make a covered facility subject to the rule. Second, a lower threshold quantity is appropriate for an initial screening criterion, ensuring that only covered facilities that are unlikely to meet the substantial harm criteria are excluded from the scope of the rule. Accordingly, EPA has judged that the screening criteria in conjunction with the substantial harm criteria appropriately targets those covered facilities that could cause substantial harm to the environment from a worst case discharge of CWA hazardous substances into or on the navigable waters. To the commenters who asked for more information on the basis of the threshold quantity, the RQ multiplier reflects relative toxicity parameters used to establish the original RQs. See section IV.A.1.a.i of the proposed rule preamble, Docket ID EPA-HQ-OLEM-2021-0585-0001, for a discussion on RQs and how they were derived. The RQs provide a means to use an existing regulatory structure that already considers risk on a scale and that has been successfully used for release notification for decades. EPA also balanced the variability among the 296 CWA hazardous substances and tailoring threshold amount against a uniform, easily applied, mass-based RQ multiplier, as advocated for by many commenters, deciding on balance in favor of using a single RQ multiplier. In addition, while the proposal focused on capturing larger capacity covered facilities that could pose a greater risk, with additional consideration, in EPA's judgment, a 1,000x multiplier for determining the threshold quantity as a screening criterion more effectively represents the potential risks associated with a worst case discharge. In this final rule, EPA has adjusted its approach to use maximum quantity onsite (inventory) rather than maximum container capacity onsite as the basis for assessing risk to the environment. EPA based this decision largely on the fact that risk determinations using maximum quantity onsite will more accurately reflect the hazard posed and has been used successfully in other EPA chemical regulations, such that this is standard business practice. Additionally, since containers are typically measured by volume and CWA hazardous substances may vary dramatically in weight due to their physical properties, there is not a clear association between container size and quantity of CWA hazardous substances onsite, which many commenters raised as an unnecessary complication. Thus, a covered facility owner, operator, or inspector would have to convert the volume of each CWA hazardous substance container onsite to a chemical-specific weight in order to compare reported values and determine if the covered facility meets the threshold quantity, exacerbating conversion difficulties discussed in the proposed rule including at 87 FR 17900 and raised by several commenters. While the Oil Pollution Prevention FRP regulations use container capacity for applicability threshold determination, this is consistent with how oil is measured and regulated, using volume (gallons). On the chemical side, CWA hazardous substances (and all chemicals that EPA and other Federal agencies regulate) are measured and regulated by weight, typically in pounds. CWA RQs are also weight-based (1, 10, 100, 1,000, and 5,000 pounds). The OPA Conference Report (H.R. Rep. No. 101-653, 101st Cong., 2d Sess. 1990) specifically directed EPA to account for oil storage capacity, but it has no corresponding language for CWA hazardous substances. As oil and the 296 CWA hazardous substances differ in important and myriad ways, it is reasonable to pursue a different approach in terms of determining the appropriate amount that should be used for determining threshold quantities and as a planning factor. In so doing, EPA is responding to commenter concerns about covered facilities that may have capacity for but will never actually have CWA hazardous substances onsite in quantities sufficient to meet the threshold quantity but (if capacity were the metric) could be subject to the rule, especially considering some CWA hazardous substances will never be stored at the full capacity of a container due to their physical properties. For example, several commenters noted that for one of the highest volume and occurrence CWA hazardous substances, anhydrous ammonia, containers are prohibited to be filled beyond 85% liquid volume to allow expansion and contraction. For mixtures, using capacity gets even more complicated, an issue raised by many commenters, since a covered facility owner or operator, or EPA inspector would have to convert varying volumes of CWA hazardous substances into weights, then extrapolate based on their proportions to the full capacity of the container. This seems needlessly complex and potentially introduces calculation errors into threshold applicability determinations and worst case discharge scenario quantities. To add to the complexity, CWA hazardous substance and mixtures can be present onsite in myriad types of containers and configurations. EPA understands the concern regarding fluctuating quantities and numbers of containers, particularly at certain batch processors and in some industries and also the use of mobile storage containers and notes that the maximum quantity onsite must reflect the aggregated quantity at the covered facility across all containers, including but not limited to rail cars or other mobile storage not under active shipping papers, process vessels, canisters, drums, bulk storage tanks, dumpsters, totes, or bulk cargo containers positioned on land. However, EPA disagrees with commenters who asserted that the only way to adequately plan for response to worst case discharges is to account for the full storage capacity for CWA hazardous substances. Indeed, EPA and other Federal regulators routinely use actual chemical inventory quantities for a variety of regulatory and planning purposes. EPA intends that an FRP for CWA hazardous substances be forward-looking and account for the maximum quantity onsite at any time. On balance, EPA believes that choosing quantity over capacity is appropriate in terms of implementability and the risks presented. Moreover, covered facilities have many incentives to accurately track their inventories over time. iii. Proximity to Navigable Waters or a Conveyance to Navigable Waters EPA is retaining the proposed location-based screening criterion that covered facilities must determine whether they are located within one-half mile of navigable waters or a conveyance to navigable waters, while clarifying that this should be measured from the facility boundary or nearest opportunity for discharge. This distance is based on research related to the Oil Pollution Prevention FRP regulation. On balance, while the Agency agrees that there are significant differences between oil and CWA hazardous substances, one-half mile is an appropriate distance to infer that a covered facility has a reasonable expectation to discharge to navigable waters or a conveyance to navigable waters in the event of a worst case discharge. Some commenters argued that the distance should be extended farther for more complete protection of the nation's waters and in the context of CWA hazardous substances. However, in EPA's analysis, 80% of covered facilities with CWA hazardous substances onsite were within one-half mile to navigable waters (see Chapter 2 of the RIA in the rulemaking docket). To extend the distance would make the criterion effectively meaningless because nearly every covered facility that meets or exceeds the threshold quantity would meet this screening criterion. While commenters were concerned about differences in topography complicating determinations of whether a covered facility is within one-half mile of navigable waters or a conveyance to navigable waters, this distance should be measured from the nearest opportunity for discharge and industry will be able to comply using widely available electronic mapping tools. EPA has determined that the one-half mile distance is protective and simple to calculate, and covered facility owners or operators will have the opportunity to model a worst case discharge in evaluating the substantial harm criteria that depend on planning distance. Additionally, an owner or operator may appeal to the RA if they believe there is no reasonable expectation to discharge into or on navigable waters or a conveyance to navigable waters from their covered facility. EPA agrees with commenters who stated that one-half mile to navigable waters or conveyance to navigable waters applicability requirement is important to minimize harms to the environment. The Agency again notes that this is an initial screening criterion; it does not mean that a facility is subject by the rule. Rather, it means that if a covered facility does not meet either of these initial screening thresholds, it is not subject to the rule and need not do any further analysis. Only covered facilities within one-half mile to navigable water or a conveyance that also meets or exceeds a threshold quantity must then determine whether they satisfy any of the substantial harm criteria. EPA recognizes commenter concerns regarding CWA hazardous substances that have physical properties ( e.g., viscosity, vapor pressure, etc.) that preclude the substance from reaching navigable waters or a conveyance to navigable waters. However, a covered facility owner or operator will consider these properties, and their implications for the ability of the substance to impact water, when they evaluate the substantial harm criteria, not in the initial screening criteria. A covered facility will need to determine its distance to navigable waters or a conveyance to navigable waters regardless of the route or method of travel of a CWA hazardous substance in a worst case discharge. iv. Substantial Harm Criteria In § 118.3(c), EPA proposed four substantial harm criteria. EPA is retaining these criteria in the final rule, with minor modifications. Below is a summary of changes and responses to major comments. Several commenters asserted that the extensive efforts to assess whether they meet the substantial harm criteria were essentially requiring compliance with the rule. EPA disagrees with this premise; indeed, the reason for the initial screening criteria is to mitigate the impact on covered facilities that would not meet the substantial harm criteria. However, given the variability of the CWA hazardous substances at issue (including variations in transport, fate, and other chemical characteristics), it is inevitable that some covered facilities that meet the screening criteria will nonetheless not meet any of the substantial harm criteria. Because of the myriad of variables involved, the analysis is necessarily case-by-case. And while simplicity can reduce costs, it also often faces the dilemma of being either over or under inclusive. So, while EPA determined that simple to apply, bright line screening criteria were appropriate to satisfy the requirements of the statute in terms of adequately protecting human health and the environment, a more nuanced analysis of the substantial harm criteria to determine which covered facilities must incur the added cost of preparing an FRP is warranted. Nevertheless, in principle, EPA agrees that making it as easy as possible to conduct these assessments is an important goal and will facilitate the successful implementation of this rule. EPA intends to continue to identity and provide tools to the regulated community and the public to support these determinations. To commenters who suggested a standalone substantial harm criterion based on the potential impacts of worst case discharges to navigable waters or a conveyance to navigable waters on communities with environmental justice concerns, EPA recognizes the unique risks faced by these communities. In § 118.5(b), an RA may determine that a covered facility could cause substantial harm to the environment due to its potential impacts on communities with environmental justice concerns. Another issue for communities with environmental justice concerns is the potential cumulative impact of multiple covered facilities in one area where any one covered facility may not have a maximum quantity onsite that meets or exceeds the threshold quantity of CWA hazardous substances, but it seems likely that if one covered facility experienced a worst case discharge due to extreme weather conditions, others could be similarly impacted and the collective effects could cause substantial harm to the environment. Upon consideration and in response to commenter concerns, an RA may now consider concerns regarding co-located covered facilities when determining whether a covered facility has the potential to cause substantial harm to the environment. a. Ability To Cause Injury to FWSE In § 118.3(c)(1), EPA proposed and is retaining in the final rule a substantial harm criterion to consider the covered facility's ability to cause injury to FWSE. Relatedly, the Agency proposed in Appendix B, and is retaining in the final rule, 10 percent of Lethal Concentrations 50% (LC50) as the toxic endpoints a covered facility owner or operator must use to perform planning distance calculations. FWSEs are identified in ACPs. This regulation does not alter how FWSEs are identified or what constitutes FWSE. EPA has added language that facility owners and operators must also consider aqueous products that form when the CWA hazardous substance enters water to ensure the full range of risk is represented in this assessment. EPA disagrees with the commenter who requested that the regulated community should identify endpoints for individual CWA hazardous substances (as opposed to categories of CWA hazardous substances) and incorporate these facility-defined endpoint concentrations given EPA approval. Determining these on a site-by-site and CWA hazardous substance-by-substance basis would be prohibitively difficult to assess. On a case-by-case basis, a covered facility owner or operator may appeal a substantial harm determination to the RA if they disagree with the planning distance calculations. EPA maintains that the LC50-based endpoints appropriately model for effects on wildlife, regardless of the type of hazardous substance discharge or type of waterbody. One commenter requested that EPA acknowledge that “not all navigable waters identify fish, wildlife, and sensitive environments and public receptors in their Area Contingency Plans,” and asked for flexibility in these determinations because of these situations, specifically referencing the Oil Pollution Prevention FRP regulation's vulnerability analysis, § 112.20(h)(4) and section 1.4.1 of Appendix F. EPA is aware that ACPs currently may not reflect impacts of worst discharge of CWA hazardous substances to navigable waters. Working with Federal response partners, the Agency intends to provide compliance assistance to covered facilities to ensure these areas are properly identified and impacts are assessed. In addition, the owner or operator is responsible for identifying public receptors, not just ACPs. b. Ability to Adversely Impact a Public Water System EPA proposed in §  118.3(c)(2) and is retaining in the final rule the substantial harm criterion for covered facilities located at a distance such that a worst case discharge has the ability to adversely impact a PWS. Covered facilities are required to coordinate with the PWS to determine whether predicted concentrations from a worst case CWA hazardous substance discharge would result in substantial harm to the PWS. EPA has added language that facility owners and operators must also consider aqueous products that form when the CWA hazardous substance enters water to ensure the full range of risk is represented in this assessment. However, several commenters expressed concern with EPA's approach. Some commenters requested that EPA provide detailed, transparent, and clear guidance about the applicable drinking water standards to prevent inconsistencies in implementation and confusion for covered facilities. An owner or operator must assess the possibility of a worst case discharge to cause any of the impacts enumerated in § 118.3(c)(2)(ii) through (v). Information that supports this assessment includes NPDWR, SDWR, human health impact thresholds, taste and odor thresholds, and physicochemical properties of the CWA hazardous substance. Furthermore, EPA intends to provide compliance assistance to covered facility owners or operators in making these assessments, including resources that crosswalk CWA hazardous substances against existing NPDWR. Additionally, several commenters suggested that EPA allow covered facility owners or operators to show a good-faith effort of coordination with PWSs through documented attempts, especially in certain circumstances where coordination is difficult or not possible. EPA agrees and is revising the requirement to more clearly state that owner or operators may show a good-faith effort of coordination with PWSs through documented attempts where coordination is difficult or not possible. (i) Alternative Approaches —Source Water Protection Areas (SWPAs): As part of the proposal, EPA considered requiring covered facilities within SWPAs to prepare an FRP. Although several commenters supported this approach, largely for the reasons enumerated in the proposal preamble at IV.A.2.b.ii EPA has decided not to finalize this requirement. On the one hand, SWPAs would be a useful tool that could eliminate the need for distance planning if they were universally available and uniformly applied. However, they are not. Moreover, EPA is concerned with the burden that would be placed on State drinking water programs to respond to requests for SWPAs from covered facilities if this were a requirement of the rule. Commenters provided no data or information to support the assertion that responding to requests for SWPAs from covered facilities would likely not place a significant burden on State drinking water programs. One purpose of this final regulation is to implement congressional intent by shifting the responsibility for planning from public resources to private covered facilities that pose a substantial risk to the environment in the event of a worst case discharge into or on the navigable waters or a conveyance to navigable waters, not create new burdens for State drinking water programs or PWSs. Furthermore, requiring additional updating of SWPAs or uniformity in their application so that they could be used as a substantial harm criterion is outside the scope of this rulemaking. —Groundwater: Including potential discharges to groundwater is outside of the scope of this final rule, which is specific to onshore non-transportation-related facilities that, because of their location, could reasonably be expected to cause substantial harm to the environment by a worst case discharge into or on navigable waters or a conveyance to navigable waters. Nonetheless, several commenters requested that EPA include a provision to protect groundwater under the final rule. One commenter recognized that groundwater is not jurisdictional water of the United States under the CWA but argued that the rule affects the quality of groundwater drawn by groundwater-supplied PWSs regulated under the SDWA as well as nearby groundwater users and other downstream surface water users if the groundwater discharges to surface water. Again, navigable waters does not, by definition, include groundwater. —Zones Of Concern (ZOCs): EPA disagrees with commenters who posited that the source water zones of concern (ZOCs) described in the report “Occurrence of Releases with the Potential to Impact Sources of Drinking Water” (EPA 817-R-21-001) are appropriate for this regulation. The ZOCs used in the study described in the referenced report were intended to provide a uniform definition for identifying whether releases captured by the NRC would be included in the analysis or not. The methodology was not designed to identify worst case discharges. As noted in Section 2.6 of the referenced report: Limitations of the Methodology, “It is possible that releases significantly impacting a source of drinking water occurred outside a zone of concern. Conversely, it is also possible that releases within a zone of concern did not significantly impact the source water.” The criteria in the final rule, which are based on whether a worst case discharge from a covered facility could cause substantial harm to a PWS are outcome based and therefore will more appropriately target covered facilities for regulation compared to the ZOCs in the referenced report. c. Ability To Cause Injury to Public Receptors In §  118.3(c)(3), EPA proposed a substantial harm criterion for covered facilities that could cause injury to public receptors through a worst case discharge into or on navigable waters or a conveyance to navigable waters, using the same parameter and toxic endpoint approach proposed for FWSE. EPA is retaining this provision in this final action. Several commenters expressed concern with EPA's proposal to have a separate substantial harm criterion for covered facilities that could cause injury to public receptors through a worst case discharge into or on the navigable waters or a conveyance to navigable waters and asserted that this is out of scope of the CWA. EPA disagrees that this substantial harm criterion does not fall under the scope of the CWA or the stated purpose of this final rule. The scope of the rule is onshore non-transportation-related facilities that, because of their location, could reasonably be expected to cause substantial harm to the environment by a worst case discharge into or on navigable waters or a conveyance to navigable waters. Public receptors are defined as areas through which the public has access to navigable waters, thus tying this criterion to the statutory authority. Covered facility owner or operators should include impacts to public receptors in their hazard evaluations in § 118.11(b)(3), based on the physicochemical properties of the CWA hazardous substances onsite and their potential effects as well as the potential economic effects to businesses. d. Reportable Discharge History In §  118.3(c)(4), EPA proposed, and is retaining in the final action, that a reportable discharge history is a substantial harm criterion, meaning the covered facility has had a discharge of a CWA hazardous substance at or exceeding the RQ, as listed in 40 CFR 117.3, that violates CWA section 311(b)(3), i.e., that reaches navigable waters or adjoining shorelines. If a covered facility that meets the screening criteria has had a reportable discharge within the last five years that reached navigable waters, it will be considered to have the potential to cause substantial harm in the event of a worst case discharge. Reportable discharge history will be limited to the preceding five years, so if a covered facility has had a reportable discharge outside of that date range, it does not meet that substantial harm criterion. EPA clarifies here that discharges permitted under National Pollutant Discharge Elimination System (NPDES) are not subject to this regulation (40 CFR part 122). EPA notes that the fact that a reportable discharge in this context means that the discharge entered into or on navigable waters in quantities that may be harmful. Furthermore, these discharges are required to be reported to the NRC, so evaluating whether a covered facility has had one in the last five years should add no burden. Additionally, discharge history may indicate deficiencies at a covered facility and so warrant further care and additional planning, as shown in the related study of oil spills discussed in the preamble to the Oil Pollution Prevention FRP regulation (58 FR 8832, February 17, 1993). EPA maintains that five years is a reasonable look back window and ample time for a covered facility to improve spill resilience as demonstrated through the lack of reportable discharges into or on navigable waters. EPA agrees with commenters that limiting the reportable discharge releases into or on navigable waters is reasonable and has added clarifying text to the final rule. The Agency is not expanding the discharge history criterion to cover other reportable discharges ( e.g., to land) given that the authority for this action is specific to impacts into or on navigable waters, adjoining shorelines, or exclusive economic zone. e. Passive Mitigation, Administrative Controls, and Secondary Containment EPA did not propose and is not including provisions regarding passive mitigation, administrative controls, or secondary containment in this rule. This is a planning regulation, as per its statutory authority under the CWA 311(j)(5). As such, the Agency is not incorporating mitigation techniques into the screening criteria, determinations of substantial harm, nor in the FRP hazard evaluation. As per the CWA, as amended by the OPA, a worst case discharge is defined as “the largest foreseeable discharge in adverse weather conditions.” The OPA Conference Report goes on to state that the largest foreseeable spill from a given type of facility is intended to describe a case that is worse than either the largest spill to date or the maximum most probable spill for that type of facility. Further, Congress' intent was that the worst case discharge reflects the partial failure of various preventive systems, and that the private sector be encouraged to increase its spill response capability (H.R. Rep. No. 101-653, 101st Cong., 2d Sess. 1990). Relatedly, in extreme weather events, mitigation systems may fail. In addition, written administrative controls may be overridden or overlooked, making it foreseeable that a worst case discharge could occur notwithstanding such controls. Furthermore, although EPA encourages covered facilities to implement additional release prevention, detection, and mitigation measures such as those cited by commenters, the Agency believes that the effects of these measures on the size and impact of a potential spill are not readily quantifiable, nor easily supported with historical spill evidence. CWA hazardous substances vary widely in physicochemical properties and prevention and response strategies correspondingly differ based on the substance. EPA maintains that incorporating factors into the worst case discharge calculation that consider the risks associated with a variety of site-specific conditions regarding passive mitigation or administrative controls will, in general, be too complex for this rulemaking, and will require a very detailed verification and inspection processes. Requirements to prevent CWA hazardous substance discharges are based on many different regulatory regimes and industry standards and thus may be difficult for an inspector to assess and requiring installation or operation of such systems is outside the scope of this final action. As a result, EPA does not believe that it is feasible or warranted to include a calculation of mitigation measures tied to a reduction in the worst case discharge volume. Nonetheless, if an owner or operator believes that the circumstances of the covered facility are such that it could not cause substantial harm to the environment from a worst case discharge to navigable waters or a conveyance to navigable waters, they may appeal the substantial harm determination to their RA. For these reasons, EPA maintains that it is inappropriate to include secondary containment, administrative controls, and passive mitigation in this final rule. f. Transfers Over Water EPA did not propose an additional or different substantial harm criteria for covered facilities that transfer CWA hazardous substances over water. The Agency received comments both supporting and opposing such a provision. EPA has decided against including one in this final action. First and foremost, the USCG has primary responsibility for MTR facilities and would be the implementing Agency for any CWA hazardous substance FRP regulations for that type of facility. Should the USCG initiate a rulemaking for facilities over which it and the Agency share jurisdiction, the two agencies will collaborate to ensure consistency. Moreover, EPA did not receive data or information to support adding this as a substantial harm criterion. EPA notes that should a covered facility within EPA's jurisdiction have a reportable discharge during transfers over water, this would meet the § 118.3(c)(4) substantial harm criterion ( i.e., reportable discharge of a CWA hazardous substances under § 117.21 within last five years). 3. General Requirements In § 118.4, EPA proposed and is finalizing, with some adjustments, general requirements and compliance dates for CWA hazardous substance FRPs. In § 118.4(a), to aid in informing the regulated community of their responsibilities under this regulation, the Agency has added “implement” to the list of items a covered facility must do regarding their FRP. This will reduce uncertainty and make clear that plans must be in place and followed. In § 118.4(a), EPA has changed the language for plan submission to emphasize that there is an initial 36-month implementation period. This will allow covered facilities ample time to familiarize themselves with the rule requirements, gauge seasonal and commodity flow-related inventory fluctuations to determine the maximum quantity onsite at any time, perform planning distance calculations, and prepare their plans. Plan preparation, submission, and implementation timelines are as follows: —Initially regulated covered facilities (covered facilities in operation on November 30, 2026, and that meet the criteria in § 118.3 or are notified by an RA as in § 118.5): by June 1, 2027. —Newly regulated covered facilities (covered facilities that meet the criteria in § 118.3 or are notified by an RA as in § 118.5 after November 30, 2026: Within 6 months. —Newly constructed covered facilities (covered facilities starting operations after June 1, 2027: Prior to the start of operations and including a 60-day start up period adjustment phase. —Covered facilities regulated as a result of a planned event or change: Prior to the start of operations and including a 60-day start up period adjustment phase, but no sooner than June 1, 2027. An example of a facility characteristic change could be processing expansion whereby nearest opportunity to discharge moves within one-half mile to navigable waters or a conveyance to navigable waters, such as adding a rail spur. —Covered facilities regulated as a result of an unplanned event or change: Prior to the start of operations and including a 60-day start up period adjustment phase, but no sooner than November 30, 2026. Newly constructed covered facility owners or operators should use projected CWA hazardous substance maximum quantities onsite to develop the FRP, which can then be adjusted during the 60-day operational start up period. For covered facilities meeting the criteria in §  118.3(a) and (b), Appendix A: Substantial Harm Certification Forms must be submitted to EPA by June 1, 2027, while covered facilities meeting that criteria at a later date have 60 days to submit their forms to EPA, but no sooner than June 1, 2027. The Agency has adjusted this timeline from one month to recognize that the required calculations may require additional time and resources. EPA recognizes that some commenters believe that the timelines provided are too short or insufficient for FRP development and submission. In response, all covered facilities now have 36 months following the effective date to comply with the requirements in 40 CFR part 118. On the other hand, some commenters would prefer a swifter implementation period. However, due to resource constraints and the complexity of implementing a new regulatory program, EPA had judged a 36-month implementation period to be warranted. Moreover, as this is a new program, albeit modeled on an existing program, EPA is prepared to provide necessary compliance assistance as facilities develop plans for the first time. Although EPA understands that current practices at some covered facilities may present challenges with meeting the 60-day window for changes to FRPs, documenting and adjusting material changes must be done swiftly to ensure that plans adequately prepare for worst case discharges of CWA hazardous substances. Longer timelines could render the FRP unusable as a response plan. Larger and more complex batch processors, laboratories, and facilities require proactive planning for the anticipated maximum quantities onsite. In addition, as detailed in the proposal, these timelines are roughly based on OPA 90 transition provisions, which directed EPA to issue regulations for oil worst case discharge response plans (oil FRPs) under section 311(j)(5) of the CWA within 24 months. Facilities could submit the oil FRPs beginning 30 months from enactment and were required to be submitted by 36 months of enactment. For existing and new facilities, oil FRPs were to be submitted within six months from the time of discovery or notification that a facility could cause “substantial harm.” This timeline is similar to that of the oil FRP program, where an oil FRP must be resubmitted within 60 days of each material change in facility or plan that could affect the adequacy of a facility's response capabilities, such as the ability to respond to a worst case discharge. EPA has added § 118.4(a)(6), whereby a covered facility owner or operator must review and recertify their plan Agency every five years. This will ensure that FRPs stay updated and that owners or operators remain cognizant of their responsibilities under this regulation. A five-year review period is common in EPA programs and the Agency judges this to be a necessary component of an effective program. EPA has added § 118.4(a)(7), whereby a covered facility owner or operator must evaluate their operations if EPA adds or removes a CWA hazardous substance from the list at 40 CFR 116.4 or adjusts relevant RQs as found in 40 CFR 117.3. Such additions, deletions, or adjustments are done through a formal notice and comment rulemaking procedure, so the regulated community will be on notice and have ample opportunity to review such proceedings before they become final. If a covered facility becomes newly subject to this regulation at that time, the owner or operator has six months to submit a new or updated FRP to EPA. 4. Regional Administrator Determination of Substantial Harm and Significant and Substantial Harm In proposed § 118.5, EPA detailed a process by which an RA may require a covered facility to prepare a CWA hazardous substance FRP after consideration of site-specific factors. EPA has added a provision in § 118.5(a) whereby the RA may require amendments to FRPs submitted under their authority in § 118.5. Additionally, the Agency proposed factors for the RA to consider in § 118.5(b), as well as the factors in § 118.3. Some commenters urged EPA to remove the provision regarding the process for RAs to determine that a covered facility could cause subs [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%3A2024-05870. Public record. Not legal advice.