# Clean Water Act Hazardous Substance Worst Case Discharge Planning Regulations > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/fr%3A2022-05505 ## Record - **Collection:** Federal Register - **Document type:** Proposed Rule - **Published:** March 28, 2022 - **Citation:** 87 FR 17890 ## Text ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 118 and 300 [EPA-HQ-OLEM-2021-0585; FRL-7881-02-OLEM] RIN 2050-AH17 Clean Water Act Hazardous Substance Worst Case Discharge Planning Regulations AGENCY: Environmental Protection Agency (EPA). ACTION: Proposed rule. SUMMARY: The Clean Water Act (CWA) states that regulations shall be issued which require an owner or operator of a facility to prepare and submit a plan for responding, to the maximum extent practicable, to a worst case discharge, and to a substantial threat of such a discharge, of a hazardous substance. The Environmental Protection Agency (EPA or Agency) proposes 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. DATES: Comments must be received on or before May 27, 2022. ADDRESSES: You may send comments, identified by Docket ID No. EPA-HQ-OLEM-2021-0585, by any of the following methods: — Federal eRulemaking Portal: https://www.regulations.gov/ (our preferred method). Follow the online instructions for submitting comments. — Mail: U.S. Environmental Protection Agency, EPA Docket Center, EPA-HQ-OLEM-2021-0585 Docket, Mail Code 28221T, 1200 Pennsylvania Avenue NW, Washington, DC 20460. — Hand delivery or courier (by scheduled appointment only): EPA Docket Center, WJC West Building, Room 3334, 1301 Constitution Avenue NW, Washington, DC 20004. The Docket Center's hours of operations are 8:30 a.m. to 4:30 p.m., Monday through Friday (except Federal holidays). Instructions: All submissions received must include the Docket ID No. for this rulemaking. Comments received may be posted without change to https://www.regulations.gov/, including any personal information provided. For detailed instructions on sending comments and additional information on the rulemaking process, see the “Public Participation” heading of the SUPPLEMENTARY INFORMATION section of this document. Out of an abundance of caution for members of the public and our staff, the EPA Docket Center and Reading Room are open to the public by appointment only to reduce the risk of transmitting COVID-19. Our Docket Center staff also continues to provide remote customer service via email, phone, and webform. Hand deliveries and couriers may be received by scheduled appointment only. For further information on EPA Docket Center services and the current status, please visit us online at https://www.epa.gov/dockets . FOR FURTHER INFORMATION CONTACT: 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. Public Participation A. Written Comments II. 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 costs and benefits of this action? E. List of Abbreviations and Acronyms III. Background A. Statutory Authority and Delegation of Authority 1. Statutory Requirements 2. Delegation of Authority B. CWA Hazardous Substance Designation and Reportable Quantities C. Regulatory Background 1. EPA CWA Hazardous Substance Actions 2. EPA Oil Pollution Prevention Regulation 3. USCG CWA Hazardous Substance Worst Case Discharge Actions D. Litigation E. CWA Hazardous Substance Discharge History and Impacts Analysis 1. Discharge History and Reported Impacts 2. Most Frequently Discharged CWA Hazardous Substances 3. Impacts to Waterways and Sensitive Environments 4. NRC Data Limitations 5. Data Sources Examined F. Analysis of Existing Regulatory Programs IV. Proposed Action A. Applicability Criteria 1. Screening Criteria 2. Substantial Harm Criteria 3. Other Applicability Criteria 4. Worst Case Discharge Calculations 5. Substantial Harm Certification Form B. Response Planning 1. Consistency With NCP and ACPs 2. LEPC or TEPC Coordination 3. QI Designation and Duties 4. CWA Hazardous Substance FRP Components C. Implementation and Enforcement 1. Office Delegation 2. Compliance Dates 3. Confidential Business Information 4. Appeals Process 5. Stakeholder Petitions 6. Consistency With the NCP D. Additional Considerations 1. Communities With Environmental Justice Concerns 2. Climate Change 3. Facility Density V. Statutory and Executive Orders Reviews A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and 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 I. Public Participation A. Written Comments Submit your comments, identified by Docket ID No. EPA-HQ-OLEM-2021-0585 at https://www.regulations.gov (our preferred method), or the other methods identified in the ADDRESSES section, above. Once submitted, comments cannot be edited or removed from the docket. The EPA may publish any comment received to its public docket. Do not submit to EPA's docket at https://www.regulations.gov any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. The EPA will generally not consider comments or comment contents located outside of the primary submission ( i.e., on the web, cloud, or other file sharing system). For additional submission methods, the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets . Due to public health concerns related to COVID-19, the EPA Docket Center and Reading Room are open to the public by appointment only. Our Docket Center staff also continues to provide remote customer service via email, phone, and webform. Hand deliveries or couriers will be received by scheduled appointment only. For further information and updates on EPA Docket Center services, please visit us online at https://www.epa.gov/dockets . The EPA continues to carefully and continuously monitor information from the Centers for Disease Control and Prevention (CDC), local area health departments, and our Federal partners so that the Agency can respond rapidly as conditions change regarding COVID-19. II. General Information A. Does this action apply to me? A list of NAICS codes at the three-digit level 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 Proposed Rule NAICS 3 North American industry classification system (NAICS) description 111 Crop Production 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 311 Food Manufacturing 314 Textile Product Mills 321 Wood Product Manufacturing 322 Paper Manufacturing 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 335 Electrical Equipment, Appliance, and Component Manufacturing 336 Transportation Equipment 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 488 Support Activities for Transportation 493 Warehousing and Storage 511 Publishing Industries (except internet) 522 Credit Intermediation and Related Activities 562 Waste Management and Remediation Services 611 Educational Services 622 Hospitals 811 Repair and Maintenance 812 Personal and Laundry Services 928 National Security and International Affairs This table is not intended to be exhaustive, but rather provides a likely minimal set of affected entities likely to be regulated by this action. This table lists the types of entities that EPA is aware could potentially be subject to this proposed action. Other types of entities not listed in the table may also be subject to this proposed action. To determine whether your facility is subject to this proposed action, you should carefully examine the applicability criteria proposed in § 118.3. If you have questions regarding the applicability of this action to a particular entity or facility, consult the person listed in the FOR FURTHER INFORMATION CONTACT section. B. What action is the Agency taking? The EPA is proposing new requirements for Facility Response Plans (FRPs) for worst case discharges of CWA hazardous substances for onshore facilities 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 proposal 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 costs and benefits of this action? EPA estimated the total costs of the proposed action by combining the per-facility estimates of compliance costs with the estimate of the affected facility universe. EPA estimated the annualized cost of the proposed rule over a 20-year analysis period, using three percent and seven percent discount rates, as presented in Table 2. Table 2—Total Compliance Cost of the Proposed Action, 20-Year Present Value and Annualized ($2020) Present value, 7% Annualized cost, 7% Present value, 3% Annualized cost, 3% Cost $300,375,193 $28,353,293 $410,322,776 $27,580,136 EPA also estimated the annualized cost of the proposed action to EPA to develop and implement the proposed requirements, which can be found in the Regulatory Impact Analysis (RIA) titled, “Regulatory Impact Analysis: Clean Water Act Hazardous Substance Worst Case Discharge Planning Regulations,” available in the docket for this action. The proposed action is expected to have a mitigating effect on CWA hazardous substance worst case discharges because the proposed rule provisions address the kind of damages and adverse impacts expected from this type of discharge. The planning activities associated with developing CWA hazardous substance FRPs are likely to mitigate several damage categories through pre-discharge planning and identification of potential receptors and applicable endpoints; the emergency response information provisions; descriptions of discharge detection systems, hazard evaluation, and training programs; and drills and exercises. Information on previous worst case discharges of a similar nature suggests that the benefits of mitigating these discharges could be large relative to the proposed rule's estimated cost. Sections 6 and 7 of the RIA developed for this proposed action provide additional details on costs and benefits, respectively, and EPA solicits comment on the contents therein and associated data sources. E. List of Abbreviations and Acronyms ACP Area Contingency Plan AEGLs Acute Exposure Guideline Levels for Airborne Chemicals ANPRM Advanced Notice of Proposed Rulemaking APA Administrative Procedures Act AWIA America's Water Infrastructure Act BHP Biodegradation, Hydrolysis, and Photolysis CAA Clean Air Act CASRN Chemical Abstract Service Registry Numbers CBI Confidential Business Information CCC Criterion Continuous Concentration CDC Centers for Disease Control and Prevention CFR Code of Federal Regulations CMC Criterion Maximum Concentration CERCLA Comprehensive Environmental Response, Compensation, and Liability Act of 1980 CFATS Chemical Facility Anti-Terrorism Standards CTAC Chemical Transportation Advisory Committee CWA Clean Water Act DHS United States Department of Homeland Security DOI United States Department of the Interior DOT United States Department of Transportation EJSCREEN Environmental Justice Screening and Mapping Tool E.O. Executive Order EPA United States Environmental Protection Agency EPCRA Emergency Planning and Community Right-to-Know Act ERAP Emergency Response Action Plan ERPGs Emergency Response Planning Guidelines FR Federal Register FRP Facility Response Plan FWSE Fish, Wildlife, and Sensitive Environments HAZWOPER Hazardous Waste Operations and Emergency Response ICR Information Collection Request ICS Incident Command System IDLH Immediately Dangerous to Life or Health IRIS Integrated Risk Information System LC50 Lethal Concentration 50% LD50 Lethal Dose 50% LEPC Local Emergency Planning Committee MCL Maximum Contaminant Level MOU Memorandum of Understanding MRLs Minimum Risk Levels MSHA Mine Safety and Health Administration MTR Marine Transportation Related NAICS North American Industry Classification System NCP National Contingency Plan NIIMS National Interagency Incident Management System NIOSH National Institute for Occupational Safety and Health NOAA National Oceanic and Atmospheric Administration NPDES National Pollutant Discharge Elimination System NPRM Notice of Proposed Rulemaking NRC National Response Center NTSIP National Toxic Substance Incidents Program NTTAA National Technology Transfer and Advancement Act OMB Office of Management and Budget OPA 90 Oil Pollution Act of 1990 OSC On-Scene Coordinator OSHA Occupational Safety and Health Administration OSRO Oil Spill Removal Organization PALs Provisional Advisory Levels for Hazardous Agents PCBs Polychlorinated Biphenyls PHMSA Pipeline and Hazardous Materials Safety Administration PRA Paperwork Reduction Act PREP Preparedness for Response Exercise Program 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 SBA Small Business Administration SDWA Safe Drinking Water Act SERC State Emergency Response Commission SMCRA Surface Mining Control and Reclamation Act SPCC Spill Prevention Control, and Countermeasure SRO Spill Response Organization SWPA Source Water Protection Area TBD Technical Background Document TEPC Tribal Emergency Planning Committee TERC Tribal Emergency Response Commission TRI Toxics Release Inventory TSCA Toxic Substances Control Act of 1976 as amended by the Lautenberg Act TSDF Treatment, Storage, and Disposal Facility UMRA Unfunded Mandates Reform Act USCG United States Coast Guard UST Underground Storage Tank III. 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)). For this action, a facility is determined to be “. . . [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, 1 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 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 Navigable waters are defined in 40 CFR 120.2 as waters of the United States, including the territorial seas. This document will refer to “navigable water” to include “adjoining shorelines and the exclusive economic zone.” (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 vessel or 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 in the CWA (33 U.S.C. 1321(j)(5)(E)) for this action for onshore 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 Area Contingency Plans (ACPs) are required and under relevant FRPs (33 U.S.C. 1321(j)(7)). 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. 2 DOT 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 MOU between EPA, the U.S. Department of the Interior (DOI), and DOT (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. 2 E.O. 12777 Implementation of Section 311 Of The Federal Water Pollution Control Act of October 18, 1972, as Amended, and the Oil Pollution Act of 1990. See https://www.archives.gov/federal-register/executive-orders/1991.html#12777. EPA has delegated authority over offshore facilities landward of the coastline as per 40 CFR part 112 Appendix B. However, this action is limited to non-transportation-related onshore facilities as defined in the consent decree described in Section III.D of this document. EPA solicits data, information, and comment on CWA hazardous substance facilities located offshore landward of the coastline and their regulation under this action. B. CWA Hazardous Substance Designation and Reportable Quantities The term “hazardous substance” is defined in the CWA as those substances designated pursuant to 33 U.S.C 1321(b)(2), wherein EPA is authorized to list hazardous substances which, when discharged in any quantity into jurisdictional waters, present an imminent and substantial danger to public health or welfare, including, but not limited to, fish, shellfish, wildlife, shorelines, and beaches (33 U.S.C. 1321(a)(14)). Once a chemical ( i.e., “element and compound”) is designated as a CWA hazardous substance, the reportable quantity is established by regulation under 33 U.S.C. 1321(b)(4). Section 311 of the CWA prohibits discharges of CWA hazardous substances in quantities that may be harmful into navigable waters and waters of the contiguous zone, except where permitted under the Protocol of 1978 relating to the International Convention for the Prevention of Pollution from Ships, 1973, 3 and where permitted in quantities and at times and locations or under such circumstances or conditions as the President may, by regulation, determine not to be harmful (33 U.S.C 1321(b)(3)). 3 Protocol of 1978 relating to the International Convention for the prevention of pollution from ships, 1973 (with annexes, final act and International Convention of 1973). Concluded at London on 17 February 1978; registered by the International Maritime Organization on 26 November 1983. https://treaties.un.org/doc/Publication/UNTS/Volume%201340/volume-1340-A-22484-English.pdf. C. Regulatory Background 1. EPA CWA Hazardous Substance Actions EPA designated a list of CWA hazardous substances in 40 CFR part 116 4 and subsequently established reportable quantities (RQs) for those substances in 40 CFR part 117, the discharge of which at or above the RQ is a violation of CWA section 311(b)(3) and requires notice, including notice as set forth in 40 CFR 117.21 and the National Contingency Plan in 40 CFR 300.125(a). 5 The RQs constitute the quantities EPA deemed may be harmful and were initially based on a five-level rating system derived from acute aquatic toxicity and set in 40 CFR 117.3. The most acutely toxic CWA hazardous substances were classified as Category X and assigned a one-pound RQ, which was determined based on the smallest container commonly used in commerce. 6 Under EPA's scaled system, EPA assigned the other categories on a proportional basis. If the upper aquatic toxicity limit of a category is 10 times the upper limit of the preceding, more toxic category, then the harmful quantity was set as 10 times larger, excepting category D, at five times larger, and so forth. CWA RQs (in lbs.) for the five categories are X: 1, A: 10, B: 100, C: 1,000, and D: 5,000. 4 43 FR 10474, March 13, 1978. 5 44 FR 50766, August 29, 1979. 6 43 FR 10496, March 13, 1978. 2. EPA Oil Pollution Prevention Regulation Promulgated under the authority of CWA section 311, the Oil Pollution Prevention regulation sets forth requirements for the prevention of, preparedness for, and response to oil discharges at specific non-transportation-related facilities (see 40 CFR part 112). The goal of the regulation is to prevent discharges of oil and oil mixed with hazardous substances from onshore facilities and to contain such discharges. The regulation requires facilities to develop and implement Spill Prevention, Control, and Countermeasure (SPCC) Plans and establishes procedures, methods, and equipment requirements to prevent oil discharges to navigable waters or adjoining shorelines. Additionally, subpart D of the Oil Pollution Prevention regulation requires certain facility owners or operators to prepare and submit a facility response plan (FRP) for responding to a worst case discharge of oil. The Oil Pollution Prevention FRP requirements apply to a subset of SPCC-regulated facilities from which a discharge, or substantial threat of discharge, may cause substantial harm to the environment. 7 7 See 40 CFR part 112 Appendix C. 3. USCG CWA Hazardous Substance Worst Case Discharge Actions In response to OPA 90, the USCG published rulemaking actions regarding response plans for CWA hazardous substances. On May 3, 1996, the USCG published an Advance Notice of Proposed Rulemaking (ANPRM) addressing vessel and facility response plans (61 FR 20084, May 3, 1996). USCG held two public meetings in 1996 and then developed proposed regulations and published two separate NPRMs for tank vessels and MTR facilities in 1999 (64 FR 13734, March 22, 1999) and 2000 (65 FR 17416, March 31, 2000), respectively. On February 17, 2011, USCG reopened the comment period. In 2019, USCG withdrew their proposed rulemakings (84 FR 2799 and 84 FR 2800, February 8, 2019) based on findings of the Chemical Transportation Advisory Committee (CTAC) that the proposed rules are no longer applicable to the current state of chemical industry spill response. Specifically for MTR facilities, “[d]ue to the services and requirements industry frequently engages in to satisfy insurance requirements and company sustainability polices, together with the existence of new terminal inspection protocols like that developed by the Chemical Distribution Institute, CTAC was unable to identify any significant gaps in hazardous substance spill response planning at marine transportation-related facilities that would be reduced by the 2000 proposed rulemaking” (84 FR 2799-2800). Additionally, for vessels, “CTAC also identified many areas in which the NPRM may overlap with existing local, state, and international regulatory schemes as well as current industry practice” (84 FR 2799). To date, a USCG regulation has not been finalized. D. 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 CWA 311(j)(5)(A)(i) and the Administrative Procedures Act (APA). 8 The first claim alleged that EPA's failure 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 . . . constitutes a failure to perform a non-discretionary duty or act in violation of the [CWA].” The second claim alleged that, “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, the plaintiffs and EPA entered discussions regarding a potential resolution of the lawsuit. 8 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 that resolved the litigation. 9 The consent decree requires that within two years (24 months) of entry into the consent decree, or by March 12, 2022, EPA will 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 a half years, or 30 months after publication of the proposal. This proposed action satisfies EPA's first obligation under the consent decree. 9 Envtl. Justice Health All. for Chem. Reform v. EPA, No. 1:19-cv-02516-VM, Document 32 (S.D.N.Y., filed March 12, 2020). E. CWA Hazardous Substance Discharge History and Impacts Analysis To gain a historic perspective of CWA hazardous substance discharges to water over time, EPA researched and analyzed multiple sources of available CWA hazardous substance discharge data. 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. Reporters may not always be familiar with RQ levels for CWA hazardous substances and reported quantities released are usually inaccurate or unknown, the NRC will field and process all reported CWA hazardous substance incidents and forward the initial information to the Federal On-Scene Coordinator (OSC) for further investigation. Reports are also made under the NCP reporting requirement in 40 CFR 300.125. 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. Although the data have limitations of accuracy, completeness, and over- and under-reporting of incidents, the NRC database is the most comprehensive database for CWA hazardous substance discharges. It is important to recognize that these data reflect the impacts reported upon discovery of an incident ( e.g., evacuations, injuries, hospitalizations, fatalities, waterway closures, and water supply contamination), which often result directly from the event that caused the discharge, rather than the totality of impacts that could be attributed to the discharge itself. In many cases, it can take days, weeks, and even months to fully characterize the harm caused by a discharge. NRC data are not updated to reflect that harm. This analysis is also hindered by the lack of a robust national database of the types of CWA hazardous substance discharges that EPA is proposing to regulate in this action. 1. Discharge History and Reported Impacts While there are notable instances of high-volume discharges of non-CWA hazardous substances to water, EPA found limited data on historical worst cases discharges to water of CWA-regulated hazardous substances and the NRC has no information related to the origination of the data cited in this section and Table 3. Between 2010 and 2019, 252,238 total discharges were reported to the NRC. Of those, 98,306 were non-transportation-related, of which CWA hazardous substance discharges comprised 19,657. EPA then identified 2,489 non-transportation-related CWA hazardous substance discharges which either reached water (1,311) or it is unknown whether they reached water (1,178). Of the 2,489 discharges in those categories, 131 had reported impacts. Finally, of those 131, EPA identified 52 discharges of CWA-regulated hazardous substances that could be linked to non-transportation-related facilities ( i.e., within EPA's regulatory jurisdiction). Given the generally cursory nature of data provided to the NRC as part of an emergency notification, the Agency was unable to determine whether any of the 52 discharges could have been considered worst case discharges ( i.e., the largest foreseeable discharge in adverse weather conditions, including a discharge resulting from fire or explosion; see Section IV.A.3.b of this preamble) of CWA hazardous substances based on volume and impacts. 10 10 The NRC database does not identify how many of the 2,489 discharges involving a CWA hazardous substance reached or may have reached navigable waters. For this analysis, EPA took a conservative approach and assumed that all discharges impacted navigable water. Over the 10-year period of 2010 to 2019, the average number of CWA hazardous substance discharges declined from 289 to 219 discharges (a decrease of 24 percent). EPA has no information as to the cause of this decline. 2. Most Frequently Discharged CWA Hazardous Substances A chart of the distribution by CWA hazardous substance of the 2,489 CWA hazardous substance discharges that may have reached water is shown in Table 3. Table 3—Distribution of Discharges by CWA Hazardous Substance 2010 to 2019. CWA Hazardous substance Discharged (percent) PCBs 55 Sulfuric acid 8 Sodium hydroxide 6 Ammonia 5 Benzene 4 Hydrochloric acid 4 Chlorine 4 Sodium hypochlorite 3 Other 12 Source: NRC. The majority of discharges (55 percent, or 1,358) comprised polychlorinated biphenyls (PCBs), typically PCB-containing transformer leaks or discharges, most often due to vehicles colliding with transformers (most likely on telephone poles). Fifteen chemicals accounted for 90 percent of CWA hazardous substance discharge incidents (by frequency, not by volume), 263 of 362 CWA hazardous substances (includes alternate names) had no reported discharges, and 80 CWA hazardous substances had fewer than 10 discharges. EPA banned PCBs in 1979 and while they are no longer commercially produced, they are still present in materials and products produced before the ban. EPA regulates PCBs through the Toxic Substances Control Act of 1976 (TSCA). Implementation of TSCA includes a PCB cleanup policy which addresses mitigating the impacts of PCB discharges. Additionally, most PCBs discharges or threats of discharges are comingled with oil. Oil of any kind and in any form, including oil mixtures, are subject to regulation under EPA's Oil Pollution Prevention regulation. Please see the Technical Background Document (TBD) for additional information. 3. Impacts to Waterways and Sensitive Environments In reviewing the identified 131 non-transportation-related CWA hazardous substance discharges that may have reached water with reported impacts, EPA determined that 46 involved residences, dumping, third-party damage to transformers (typically vehicle crashes), swimming pools, drills or exercises (not actual discharges), vehicles, incidents that occurred outside of the time period (pre-2010) but were reported later, duplicates, incidents outside of the United States, or miscellaneous hydraulic fracturing reports ( e.g., odor coming from tap due to drilling occurring nearby). Of the remaining 86 discharges, 52 could be linked to non-transportation-related facilities that are within EPA's regulatory jurisdiction. Of note: —Water supply contamination: 50 incidents (six discharges reached water, 44 discharges where it is unknown if discharges reached water 11 ) 11 Indicator in NRC database for water contamination provides options of yes, no, and unknown to have reached water. Forty-four of these incidents reported `unknown' if reached water. The data are unclear as to whether any of these incidents reached water and/or whether they contaminated the water. —Waterway traffic corridor closed: Two incidents (one discharge reached water, one discharge where it is unknown if the discharge reached water) Other impacts, 12 to the extent to which known, are described in Table 4. Since the NRC fields and processes initial incident information, impact information cited in Table 4 is most often unknown. 12 No fatalities resulted from a CWA hazardous substance discharge. The only fatality identified was due to a tractor trailer collision on a bridge where the driver perished, and the vehicle landed on the toe of a temporary cap on an EPA Superfund site. Table 4—Other Reported Impacts of CWA Hazardous Substance Discharges From Non-Transportation-Related Facilities That May Have Reached Water 2010 to 2019 Other reported impacts Number of incidents Number of individuals Notes Evacuations 35 1,115 Typically impacts facility workers. Shelter-in-place 1 No data available Barge offloading toluene discharged 50 gallons into the Mississippi River. Injuries (without hospitalizations) 2 4 All reported injuries appear to be workers onsite, but NRC data are not explicit. Hospitalizations 11 18 All reported hospitalizations appear to be workers onsite, but NRC data are not explicit. 4. NRC Data Limitations The NRC data on which EPA relied for this analysis have numerous limitations. As described in the subsequent section, EPA has not been able to identify another dataset which is more complete and/or includes the types of discharges that would be regulated by this proposed rule, so despite their limitations, EPA is using the NRC data for this analysis. There may be impacts ( i.e., additional or other than evacuations, injuries, hospitalizations, fatalities, waterway closures, and water supply contamination) from the universe of CWA hazardous substance discharges to jurisdictional water from non-transportation-related facilities which were not reported to the NRC and, thus, could not be quantified in this analysis. These may include the loss of productivity due to a facility or process unit shutting down because of a discharge, emergency response and restoration costs, transaction costs such as the cost of resulting litigation, damages to water quality, fish kills, or impacts to property values due to changes in perceived risk or reduced ecological services. EPA was not able to identify data sources to quantify these impacts, other than the cited data from the NRC. The NRC data are discussed and analyzed further in the RIA. 5. Data Sources Examined Since the mission of the NRC is to be the initial point of contact for all oil and hazardous substances releases and forward that information to the Federal OSC for response, the initial data collected does, in most cases, have limitations. Due to this lack of information on discharges with impacts in the NRC database, EPA examined additional data sources including: —National Oceanic and Atmospheric Administration (NOAA) Incident News —Risk Management Plan (RMP) 13 rule five-year accident history data 13 Chemical Accident Prevention Provisions, RMP (40 CFR part 68). —Toxics Release Inventory (TRI) discharge to water data —Survey data from previous CWA Hazardous Substance Spill Prevention rulemaking effort 14 14 EPA sent a voluntary survey to states, tribes and U.S. territories in June 2018 as part of the final Clean Water Act Hazardous Substances Spill Prevention rulemaking (84 FR 46100; September 3, 2019) requesting information on the number and type of EPCRA Tier II facilities reporting CWA hazardous substances onsite, as well as information about historical discharges of CWA hazardous substances, ecological and human health impacts of those discharges, and existing state and tribal regulatory programs that serve to prevent discharges of hazardous substances (Docket EPA-HQ-OLEM-2017-0444). —National Toxic Substance Incidents Program (NTSIP) —Chemical Safety and Hazard Investigation Board Reports —State discharge reports EPA did not identify any instances of worst case discharges of CWA hazardous substances ( i.e., the largest foreseeable discharge in adverse weather conditions, including a discharge resulting from fire or explosion, see Section IV.A.3.b of this preamble) previously unknown to the Agency from the above list of data sources. The RIA contains additional information on these data sources and EPA's research to identify discharge information sources. EPA requests data on occurrences of CWA hazardous substance discharges into navigable waters along with documented impacts. F. Analysis of Existing Regulatory Programs To understand the degree to which CWA hazardous substances worst case discharge planning requirements are regulated under existing regulations, the Agency reviewed and analyzed the current Federal and state regulatory framework as well as industry standards for overlap with and coverage of CWA hazardous substance worst case discharge FRP provisions required by CWA section 311(j)(5) as detailed in Section III of this preamble. EPA's analysis did not find any combination of Federal programs that comprehensively cover all the CWA section 311(j)(5)(D) requirements for all CWA hazardous substances. CWA hazardous substance facilities subject to the Oil Pollution Prevention Program requirements or RMP rule will have some overlap for the required program elements. RCRA hazardous waste regulations are comprehensive for CWA hazardous substances present as waste. State programs do not provide uniform coverage and are a patchwork, while industry standards are voluntary. The TBD compares the programs analyzed to the CWA hazardous substance FRP required program elements and provides a matrix of each program examined and elements of those programs that have requirements comparable to those in CWA section 311(j)(5). EPA analyzed the following EPA requirements: —America's Water Infrastructure Act of 2018 Amendments to section 1433 of the Safe Drinking Water Act (42 U.S.C. 300i-2) —Chemical Accident Prevention Provisions, RMP (40 CFR part 68) —Emergency Planning and Community Right-to-Know Act: —Emergency Planning Notification and Emergency Release Notification (40 CFR part 355) —Hazardous Chemical Reporting: Community Right-to-Know (40 CFR part 370) —Toxic Chemical Release Reporting: Community Right-to-Know (40 CFR part 372) —National Pollutant Discharge Elimination System (NPDES) Regulations —NPDES (40 CFR part 122) —General Pretreatment Regulations for Existing and New Sources of Pollution (40—CFR part 403) —Oil Pollution Prevention Regulations —Subpart A, Applicability, Definitions, and General Requirements for All Facilities and All Types of Oils, SPCC (40 CFR part 112) —Subpart D, Response Requirements, FRP (40 CFR 112.20 and 112.21) —Pesticide Regulations —Pesticide Management and Disposal (40 CFR part 165) —Pesticide Agricultural Worker Protection Standard (40 CFR part 170) —Resource Conservation and Recovery Act (RCRA) Regulations —Criteria for Classification of Solid Waste Disposal Facilities and Practices Subpart D, Standards for the Disposal of Coal Combustion Residuals in Landfills and Surface Impoundments (40 CFR part 257) —Standards Applicable to Generators of Hazardous Wastes (40 CFR part 262) —Standards for Owners and Operators of Hazardous Waste Treatment, Storage, and Disposal Facilities (TSDF) (40 CFR parts 264 & 265) —Technical Standards and Corrective Action Requirements for Owners and Operators of Underground Storage Tanks (UST) (40 CFR part 280) —TSCA: PCBs Manufacturing, Processing, Distribution in Commerce, and Use Prohibitions (40 CFR part 761) EPA also analyzed the following non-EPA Federal requirements: —Mine Safety and Health Administration (MSHA) Subchapter H—Education and Training, Subchapter I—Accidents, Injuries, Illnesses, Employment, and Production in Mines (30 CFR parts 46-50) —Occupational Safety and Health Administration Regulations: —Hazard Communication Standard (HazCom) (29 CFR 1910.1200) —Hazardous Waste Operations and Emergency Response (HAZWOPER) (29 CFR 1910.120) —Process Safety Management of Highly Hazardous Chemicals (29 CFR 1910.119) —Emergency Action Plan (29 CFR 1910.38) —Pipeline and Hazardous Materials Safety Administration (PHMSA) Hazardous Materials Regulations (49 CFR parts 171-179) —Surface Mining Control and Reclamation Act (SMCRA) Mineral Resources, Office of Surface Mining Reclamation and Enforcement, Department of the Interior (30 CFR parts 700-999) —United States Department of Homeland Security (DHS) Chemical Facility Anti-Terrorism Standards (CFATS) (6 CFR part 27) EPA also analyzed the existing state regulatory framework for CWA hazardous substance FRPs for all 50 states and found 27 programs with elements potentially comparable to those required by CWA section 311(j)(5), available in the TBD. EPA found state coverage is an inconsistent patchwork and cannot be relied upon for uniform, nationwide CWA hazardous substance FRP requirements. Additionally, EPA analyzed existing industry standards related to CWA hazardous substance FRPs for four standards with elements potentially comparable to those required by CWA section 311(j)(5). However, these standards are voluntary and do not provide comprehensive coverage of proposed CWA hazardous substance FRP program elements. Again, the TBD contains a more detailed discussion of each proposed program element and regulation, program, or standard. EPA solicits comment on this analysis as well as on other programs or standards EPA should examine. IV. Proposed Action EPA is proposing a regulatory program whereby those facilities that could reasonably be expected to cause substantial harm to the environment, based on their location, are required to prepare and submit CWA hazardous substance FRPs for worst case discharges to the EPA. EPA will approve only those CWA hazardous substance FRPs submitted for facilities that could cause significant and substantial harm to the environment. EPA proposes that FRPs must be consistent with the NCP and ACPs; identify the qualified individual 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; 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; describe the training, equipment testing, periodic unannounced drills, and response actions of persons at the facility; and review and update facility response plan periodically and resubmit to the RA for approval of each significant change. Specific CWA hazardous substance FRP components will include: 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, a coordination activities. Please see section IV.B of this preamble for specific discussion of each of these components. To identify potential elements to include in this proposal, EPA reviewed existing regulations that include emergency response planning provisions as well as the USCG regulatory proposals to establish requirements for CWA hazardous substance worst case discharges. Specifically, EPA considered existing requirements for Oil Pollution Prevention FRPs under 40 CFR part 112 (or oil FRPs) given that these requirements have been in place since 1994 and were promulgated under the same statutory authority as this proposal. Of note, CWA hazardous substances vary widely in physical and chemical properties when compared to oils; EPA has closely considered these variations in this proposal. Additionally, EPA examined requirements under the RMP rule under 40 CFR part 68, which implements section 112(r)(7) of the Clean Air Act and requires facilities that use regulated substances to develop an RMP. A. Applicability Criteria The statute governing CWA hazardous substances worst case discharges specifies that those facilities that could reasonably be expected to cause substantial harm to the environment, based on their location, are required to prepare and submit CWA hazardous substance FRPs for worst case discharges to the EPA. EPA will approve or disapprove only those CWA hazardous substance FRPs submitted for “significant and substantial harm facilities.” EPA is proposing in § 118.3 two initial screening criteria to determine whether a facility, because of its location, could cause substantial harm to the environment from a worst case discharge into or onto navigable water. The first step in assessing applicability is to determine whether a facility has the container capacity for a CWA hazardous substance onsite at or above a threshold quantity. If so, the facility owner or operator then determines whether the facility is within one-half mile to navigable water or a conveyance to navigable water. EPA solicits comment on alternative or additional screening criteria with supporting rationale and data. If those two conditions are satisfied, the owner or operator determines whether the facility meets any of the four substantial harm criteria: The ability to adversely impact a public water system; the ability to cause injury to fish, wildlife, and sensitive environments (FWSE); the ability to cause injury to public receptors; and/or having had a reportable discharge of a CWA hazardous substance within the last five years. If any of those substantial harm criteria are met, then the owner or operator must submit a CWA hazardous substance FRP to EPA. Additionally, EPA is proposing in § 118.5(a) that an EPA Regional Administrator has the authority to require CWA hazardous substance FRPs, after consideration of site-specific factors for a facility, regardless of whether a facility meets the criteria in proposed § 118.3. To determine whether a facility could reasonably be expected to cause substantial harm following a CWA hazardous substance worst case discharge, EPA is proposing factors for the RA to evaluate in § 118.5(b). Please see further discussion of Regional Administrator authorities to require CWA hazardous substance FRPs and determination of significant and significant and substantial harm in A.2.f of this section. Proposed applicability criteria include: Threshold Quantity: To account for the 296 different CWA hazardous substances with various properties, EPA is proposing to apply a maximum capacity onsite criterion threshold quantity for each CWA hazardous substance by using a multiplier of the CWA RQ, based on the RQ categories specified in 40 CFR part 117. Facility location: EPA is proposing to use facility location relative to navigable waters as an applicability screening criterion for CWA hazardous substance FRP facilities. Specifically, facilities meeting or exceeding the CWA hazardous substance maximum capacity onsite threshold quantity and located within one-half mile of a navigable water or a conveyance to a navigable water must determine if the facility meets at least one substantial harm criterion. Ability to cause injury to fish, wildlife, and sensitive environments (FWSE): EPA proposes a substantial harm criterion for facilities located at a distance such that a CWA hazardous substance discharge has the potential to cause injury to FWSE. EPA proposes to codify parameters and toxic endpoints to be used by facility owners when determining whether a worst case CWA hazardous substance discharge could cause injury to FWSE. Ability to adversely impact a public water system: EPA is proposing to require facility owners or operators to coordinate with nearby public water systems to determine whether a CWA hazardous substance worst case discharge could adversely impact a public water system. Ability to cause injury to public receptors: EPA is proposing a substantial harm criterion for facilities located at a distance such that a CWA hazardous substance discharge could cause injury to public receptors. EPA proposes a definition for public receptors as those areas where the public could be exposed to a CWA hazardous substance worst case discharge to navigable waters. EPA further proposes that the same parameter and toxic endpoints used for the FWSE substantial harm criterion apply for determining injury to public receptors. Reportable discharge history: EPA is proposing a substantial harm criterion that identifies whether the facility has had a reportable CWA hazardous substance discharge to water within the last five years. A reportable discharge is defined in 40 CFR 117.21 as any discharge in quantities equal to, or exceeding, in any 24-hour period, the reportable quantity in 40 CFR 117.3, the discharge of which violates CWA section 311(b)(3). EP28MR22.242 EPA is proposing a definition of “facility” in § 118.2 that is adopted from the Oil Pollution Prevention regulation at 40 CFR 112.2. 15 This definition is broad and captures the types of facilities intended to be regulated by EPA under CWA hazardous substance worst case discharge regulations. The Agency recognizes that under this definition, the owner or operator has the discretion to determine what constitutes a facility. That is, the proposed rule may become applicable to a facility in cases of aggregation of buildings, structures, or equipment and associated storage or type of activity, or the division of the facility may end applicability due to separation of buildings, structures, or equipment and associated CWA hazardous substance storage or type of activity. However, an owner or operator may not make facility determinations indiscriminately and in such a manner as to simply avoid applicability of the proposed 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 solicits comment on this definition and any appropriate adjustments with supporting rationale and data. 15 See EPA's “SPCC Guidance for Regional Inspectors” https://www.epa.gov/oil-spills-prevention-and-preparedness-regulations/spcc-guidance-regional-inspectors. 1. Screening Criteria a. CWA Hazardous Substance Capacity Threshold Quantity i. 10,000× CWA Hazardous Substance RQ Multiplier In § 118.3, EPA is proposing that if the maximum capacity onsite, as defined in § 118.2 (the total aggregate container capacity for each CWA hazardous substance present at all locations within the entire facility at any one time) at the facility of any CWA hazardous substance, at any one time, meets or exceeds 10,000 times its RQ, the facility has met the threshold quantity. If a facility's container capacity meets or exceeds the threshold quantity for any one CWA hazardous substance and the facility is within one-half mile of navigable waters, then the facility owner or operator must determine if the facility meets at least one substantial harm criterion proposed in this action. If so, the entire facility would be subject to the CWA hazardous substance FRP requirements proposed in this action for all CWA hazardous substances stored or used at the facility. EPA chose to use a multiplier of the CWA hazardous substance RQ as the threshold quantity because RQs represent a quantity that may be harmful when discharged to navigable waters. For a facility to cause substantial harm to the environment, it would need to reasonably be expected to cause a discharge in a quantity larger than the RQ and would therefore need to have the capacity to store significantly larger quantities onsite. RQs exist for all CWA hazardous substances and reflect relative (in relation to other CWA hazardous substances, due to the five categories detailed below, see Table 5) and aquatic toxicity. 16 In accordance with 40 CFR 117.21, CWA hazardous substance discharges to navigable waters or adjoining shorelines require notification to the NRC when the CWA hazardous substance discharge is equal to, or exceeds, in any 24-hour period, the RQ in 40 CFR 117.3. 16 These values were later adopted by Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA). The RQs were originally developed in 1979 and adjusted beginning with an evaluation of the intrinsic physical, chemical, and toxicological properties of each CWA hazardous substance. The intrinsic properties examined, also called the “primary criteria,” were aquatic toxicity, mammalian toxicity (oral, dermal, and inhalation), ignitability, reactivity, chronic toxicity, and potential carcinogenicity. 17 Generally, for each intrinsic property, EPA ranked CWA hazardous substances on a scale, associating a specific range of values on each scale with an RQ value of 1, 10, 100, 1,000, or 5,000 lbs. EPA evaluated the data for each CWA hazardous substance using various primary criteria; each CWA hazardous substance may have received several tentative RQ values based on its particular intrinsic properties. The lowest of the tentative RQs became the “primary criteria RQ” for that substance, which EPA used to assign an initial category of X, A, B, C, or D. After EPA assigned the primary criteria RQ, EPA further evaluated substances for their susceptibility to certain degradative processes, which were used as secondary adjustment criteria. These natural degradative processes were biodegradation, hydrolysis, and photolysis (BHP). If a CWA hazardous substance, when discharged into the environment, degrades relatively rapidly to a less hazardous form by one or more of the BHP processes, its RQ (as determined by the primary RQ adjustment criteria), was generally adjusted down one level ( e.g., from Category A to Category B). Conversely, if a CWA hazardous substance degrades to a more hazardous product after its discharge, the original substance was assigned an RQ equal to the RQ for the more hazardous substance, which may have been one or more levels higher than the RQ for the original substance ( e.g., from Category C to Category A). This approach in developing RQs may not reflect the ignitability or reactivity of single substances or among multiple substances that may comingle, or the potential for the additive or synergistic effects in the toxicity of two or more CWA hazardous substances. 17 In 1979, EPA established RQs at 40 CFR 117 (44 FR 50766, August 29, 1979), which used the acute aquatic toxicity of the CWA hazardous substances to determine RQs. For a detailed discussion of this methodology, see 43 FR 10489-92 (March 13, 1978) and 40 FR 59982-89 (December 30, 1975). In 1985, EPA amended 40 CFR part 117 to make reportable quantities adjusted under CERCLA the applicable reportable quantities for hazardous substances pursuant to CWA section 311 (50 FR 13456, April 4, 1985). In this action, EPA established a methodology for adjusting RQs, which established “primary criteria” as aquatic toxicity, mammalian toxicity (oral, dermal, and inhalation), ignitability, reactivity, and chronic toxicity. EPA subsequently established a methodology for including potential carcinogenicity as a “primary criterion” (see, for example, 54 FR 33418, August 14, 1989 and 54 FR 33426, August 14, 1989). Table 5—CWA Hazardous Substance Categories and Reportable Quantities Category Reportable quantity (lbs) X 1 A 10 B 100 C 1,000 D 5,000 Using the RQ as a basis to characterize a facility that has the ability to cause substantial harm in the event of a worst case discharge has the advantage of building a regulatory structure using existing quantifiable values that have previously been vetted through the rulemaking process. The public, industry, and EPA are familiar with these concepts. Additionally, RQs reflect varying levels of and relative risk, based on the methodology outlined above, so applicability criteria under the proposed rule are scaled to the specific circumstances of each facility, rather than applying a one-size-fits-all approach. However, the properties of listed CWA hazardous substances may not be fully captured in the RQs because the existing RQs may not be based on the most current risk data. This rulemaking is explicitly focused on response planning for worst case CWA hazardous substances discharges to navigable waters. EPA recognizes that multiple factors contribute to the likelihood of a CWA hazardous substance worst case discharge to navigable waters, including but not limited to, physical and chemical properties of the CWA hazardous substance, quantity stored onsite, size of storage containers, cause of the discharge, proximity to navigable waters or conveyances, properties of the terrain, drainage pathways, weather, etc. EPA expects that excessively low threshold quantities would likely be overly cautious and regulate facilities that are not likely to cause substantial harm to the environment. Establishing a lower threshold planning quantity for all CWA hazardous substances could potentially overwhelm local and facility emergency planning efforts and would not be commensurate with the danger posed by individual substances. The 10,000x RQ multiplier assumes that larger capacities of CWA hazardous substances generally correspond to an increased risk of adverse impacts to receptors should a worst case discharge occur. As discussed in Section III of this preamble, the RQs are quantities that “may be harmful,” thus, by definition, they do not represent a worst case discharge quantity. Additionally, as discussed in Section IV(A)(2)(d) of this preamble, the definition of “size classes of releases” in 40 CFR 300.5, which corresponds with hazardous substance releases under the NCP, is not tied to a particular quantity; rather, a major release is a “release of any quantity of hazardous substance(s), pollutant(s), or contaminants(s) that poses a substantial threat to public health or welfare of the United States or the environment or results in significant public concern.” Under the NCP, the On-Scene Coordinator (OSC) makes the final determination of the appropriate classification of a hazardous substance release based on consideration of the particular release ( e.g., size, location, impact, etc.). EPA concludes that to focus on the threat of these major releases, in terms of applicability, adjusting the RQ upward is warranted. EPA recognizes that the multiplier proposed here does not represent a “safe” quantity in the event of a CWA hazardous substance discharge. However, EPA determined the 10,000x RQ multiplier reflects the range of risks posed by the listed CWA hazardous substances, whether they are used at large or small facilities, by preserving the underlying toxicity parameters used to establish the original RQs. EPA notes, however, owners and operators are responsible for remaining cognizant of the maximum capacity(ies) onsite of all CWA hazardous substances at any one time and determining whether the maximum capacity onsite is at or exceeds 10,000x the RQ found at 40 CFR 117.3. The proposed rule requires detailed planning requirements for responding to worst case discharges. These requirements should be triggered only when maximum capacities onsite of CWA hazardous substances are large enough to pose a risk of substantial harm to public health or the environment. While EPA recognizes that site-specific factors, such as site elevations and location and nature of the discharge point, could affect the likelihood or effects of a discharge, EPA does not believe it is feasible to develop a methodology for establishing threshold quantities based on site-specific factors that would be applicable uniformly nationwide for every CWA hazardous substance. This is consistent with EPA's original approach in setting the RQs and reflected in the regulatory history and language. 18 EPA examined other threshold multipliers, available in the RIA, including 10x, 100x, and 1,000x multipliers; however, these multipliers would not focus the proposed emergency planning requirements on those facilities with the greatest potential to cause substantial harm to human health or the environment. EPA solicits comment on using a 10,000x multiplier of the RQs for the screening criteria with supporting rationale and data. EPA also solicits comment on the use of alternative RQ multiplier values, as well as different multipliers for each category of CWA hazardous substance, in addition to any supporting data or studies on this topic. 18 See Footnote 17. I. Alternative Applicability Approaches Establish New Regulatory Thresholds Based on Toxic Endpoints EPA also considered developing applicability thresholds using representative receptors for each of the three categories of receptors considered under this proposed rule (FWSE, public receptors, and public water systems) in order meet the specific objectives of this rule. Under this approach, EPA would set new threshold quantities for each CWA hazardous substance using the most current risk data. Each CWA hazardous substance would be evaluated to determine (1) how a discharge could cause substantial harm to each type of receptor, and (2) the concentration at which substantial harm would be likely to occur for each type of receptor. The lowest concentration that could cause substantial harm to any receptor would serve as the basis for establishing a single applicability threshold for each CWA hazardous substance. A standard conservative dilution factor would be used to relate the substantial harm concentration to a quantity of the CWA hazardous substance onsite at a facility that would then serve as the applicability threshold for that CWA hazardous substance. While this approach could effectively target facilities based on their effects on the receptors of interest, there are significant drawbacks to this strategy. Development of new CWA hazardous substance-specific worst case discharge thresholds would unduly delay implementation of this protective regulation, and there would be data gaps. Additionally, simplifying assumptions would be necessary to develop a dilution factor used to convert a concentration at a downstream receptor to a mass stored at a facility. EPA solicits comment on establishing new regulatory thresholds for CWA hazardous substance FRP applicability using the most current risk data and appropriate endpoints, including the methodology, data, and rationale; appropriate dilution factors; and feasibility of implementation. Establish Thresholds Using Distance-Based Multipliers EPA considered establishing applicability thresholds using distance-based multipliers for CWA hazardous substance RQs. This approach recognizes that the potential for a CWA hazardous substance worst case discharge from a facility to cause substantial harm to a downstream receptor ( i.e., public water system, FWSE, or public receptor) depends on the distance and travel time from the facility to a downstream receptor over land and water, among other factors ( e.g., river width, gage height, flow velocity, land transport considerations, lateral dispersion and/or diffusion). As distance increases, the contaminant concentration at the receptor decreases, while the time available to respond to the discharge increases; thus, the further a facility is from a receptor, the lower the potential for substantial harm, all other factors being equal. By applying a multiplier to the RQ based on the distance from the facility to the nearest downstream receptor, the regulation could better target facilities that are more likely to cause substantial harm in the event of a worst case discharge. Under this approach, an owner or operator would be required to calculate a planning distance to the nearest downstream receptor if the following two conditions are met: The facility has more than 10x the RQ of the CWA hazardous substance onsite and the facility is within one-half mile of navigable water or a conveyance leading to navigable water. The planning distance to the nearest downstream receptor is then used to establish the distance-based applicability threshold using the simple equation: RQ × distance × 100, where distance is the planning distance, in miles, between the facility and the nearest downstream receptor. The planning distance includes travel overland and in water. For a release of the same amount, the concentration at a receptor is inversely proportional to the distance from the point of release to the receptor. Thus, inclusion of a “distance factor” in the equation to establish an applicability threshold will appropriately establish a lower threshold for facilities that are closer to downstream receptors, and thus present a greater risk. Facilities with onsite quantities greater than this distance-based threshold would then be required to conduct an analysis to determine whether the facility has the potential to cause substantial harm in the event of a worst case discharge. Only if the analysis determines that the facility has the potential to cause substantial harm in the event of a worst case discharge would the facility be required to develop a CWA hazardous substance FRP. EPA recognizes that use of planning distance in the applicability determination may better target facilities with the potential to cause substantial harm without unnecessarily increasing the size of the regulated universe, because facilities located further upstream from a receptor would have a proportionately higher applicability threshold. This approach would be more complicated for the regulated community to implement, relative to the use of a single threshold multiplier ( e.g., 10,000), and for EPA to evaluate and enforce. EPA solicits comment on this approach, as well as any supporting data, information pertaining to additional costs, considerations for appropriate multipliers to use, and underlying methodology, data, and rationale. Thresholds From Other Hazardous Substances Regulations (Non-CWA) EPA reviewed other hazardous substance regulations for potential consideration of applicability thresholds, including: —Chemical Accident Prevention Provisions, RMP List of Substances (40 CFR 68.130) —EPCRA Section 302: Threshold Planning Quantities for Emergency Planning (40 CFR part 355, Appendices A and B) —EPCRA Section 304: Reportable Quantities for Emergency Release Notification (40 CFR part 355, Appendices A and B) —EPCRA Sections 311 and 312: Reporting Thresholds for Hazardous Chemical Reporting: Community Right to Know (40 CFR 370.10) —EPCRA Section 313: Toxic Chemical Release Reporting (40 CFR 372.65) These are detailed in the TBD. EPA concluded that the methodologies used to create the reporting thresholds under these regulations are not appropriate for CWA hazardous substance response planning. Additionally, EPA found that only EPCRA Sections 311 and 312 include all substances on the 40 CFR part 116 list of CWA hazardous substances. However, the applicability for EPCRA sections 311 and 312 regulations is if any OSHA hazardous chemical is present at the facility at or above the reporting thresholds at any one time. EPA solicits comment on any other chemical threshold approaches from Federal or state regulations, industry standards, etc. that EPA should consider, including data and rationale. II. Alternative Thresholds by Aggregated Category EPA considered options involving aggregating chemical capacity by RQ category or by removability or recoverability in the event of a discharge. To aggregate by RQ category to determine whether a facility meets the threshold quantity for the maximum capacity onsite proposed in § 118.3(a), a facility could be required to add up the capacities of CWA hazardous substance containers present onsite by category. If, in aggregate, the capacity of those containers in each category reaches the threshold quantity, the owner or operator would be required to determine whether the facility is within one-half mile of navigable water and then whether the facility meets any of the substantial harm criteria. EPA decided this approach is inappropriate due to the wide variability of physicochemical properties for CWA hazardous substances within each category. Additionally, under this approach, facilities with small amounts of multiple chemicals in each category may be required to do facility response planning for improbable events impacting multiple small containers, or other containers where the likelihood of concurrent catastrophic discharge is very low. Finally, this approach would require EPA to select a capacity threshold for each category above which facilities would be regulated. EPA found no basis for selecting a threshold for aggregate capacity for each category. EPA solicits comment on the approach to aggregate CWA hazardous substances within categories to determine whether a facility has reached the threshold quantity for applicability, as well as alternative approaches to aggregating quantities of different CWA hazardous substances with supporting rationale and data. In terms of categorizing CWA hazardous substances by removability and recoverability for response resource planning, EPA previously proposed and revoked rules that could guide that discussion. On March 13, 1978, EPA issued 40 CFR part 117 to determine the removability of each CWA hazardous substance and 40 CFR part 119, which determined units of measurement and penalties (43 FR 10488 and 43 FR 10495). On November 2, 1978, section 311 of the CWA was amended by Public Law 95-576. The amended statute no longer required the Agency to make determinations of removability or units of measurement for computing penalties. Therefore, 40 CFR parts 117 and 119 of the March 13, 1978 regulations were revoked on February 16, 1979 (44 FR 10269). The basis for determining reportable quantities, formerly termed “harmful quantities,” was simplified by the amendment and, thus, part 118 of the March 13, 1978 regulations was also revoked and reportable quantities were reproposed as a new part 117 on February 16, 1979 (44 FR 10271) as “quantities that may be harmful.” In 40 CFR part 117: Determination of Removability of Hazardous Substances (43 FR 10488) (since revoked), EPA discussed designating certain substances as those that can actually be removed under most conditions of discharge. These substances have limited water solubility, a relatively cohesive mass, and are less dense than water. Thus, they resemble petroleum oils in their behavior when discharged to water. The substances can be described as those with specific gravities less than 1.0 and water solubility less than 1,000 mg/l. Accordingly, the revoked final rule made the determination that allyl acetate, ethylbenzene, xylene, allyl chloride, benzene, cyclohexane, isoprene, methyl methacrylate, styrene, and toluene could actually be removed and identified them as oil-like CWA hazardous substances. Additionally, under 40 CFR part 119: Units of Measurement & Rates of Penalty (43 FR 10495) (now revoked), EPA discussed applying an adjustment factor to penalties (0.1 to 1.0) using a profiling operation based on the solubility, density, volatility, and associated propensity for dispersal in water of each CWA hazardous substance. Each CWA hazardous substance was placed in one of eight categories combining these physical, chemical, and dispersal properties in various ways. EPA then ranked the relative harm these categories posed to the environment. Table 6 shows the terms involved; final relative ranking of physical, chemical, and dispersal categories in increasing order of relative damage potential; and physical, chemical, and dispersal factor of each category. Table 6—Material Classification and Relative Harm Material classification Physical/ chemical/ dispersal category Rank Physical/ chemical/ dispersal Insoluble Volatile Floater IVF 1 0.10 Insoluble Nonvolatile Floater INF 2 0.23 Insoluble Sinker IS 3 0.36 Soluble Mixer SM 4 0.49 Precipitator P 5 0.62 Soluble Sinker SS 6 0.75 Soluble Floater SF 7 0.88 Miscible M 8 1.0 The eight categories were defined as: 1. IVF (insoluble volatile floater): Materials lighter than water with a vapor pressure greater than 10 mm Hg and a solubility of less than 1,000 ppm (weight per weight basis) or materials with vapor pressure greater than 100 mm Hg and solubility less than 10,000 ppm. 2. INF (insoluble nonvolatile floater): Materials lighter than water with a vapor pressure greater than 10 mm Hg and a solubility of less than 1,000 ppm (weight per weight basis). 3. IS (insoluble sinker): Materials heavier than water and with a solubility less than 1,000 ppm (weight per weight basis). 4. SM (soluble mixer): Solid substances with a solubility greater than 1,000 grams of solute per 1,000 grams of water. 5. P (precipitator): Salts which dissociate or hydrolyze in water with subsequent precipitation of a toxic ion. 6. SS (soluble sinker): Materials heavier than water and a solubility greater than 1,000 ppm (weight per weight basis). 7. SF (soluble floater): Materials lighter than water and a solubility greater than 1,000 ppm (weight per weight basis). 8. M (miscible): Liquid substances which can freely mix with water in any proportion. EPA considered, but decided against, using these revoked categories for a listed hazardous substance's ability to be removed under most conditions of discharge to aggregate hazardous substances for establishing an applicability threshold quantity. EPA judged that aggregating in this fashion is impractical; may not adequately reflect risks, including inherent, CWA hazardous substance-specific toxic, explosive, ignitable and/or reactive natures, especially during an extreme event; and implementation and compliance would be complicated. Additionally, as these regulations were revoked, industry is unfamiliar with this approach and facility planners do not use these categories in their planning. EPA solicits comment on aggregating CWA hazardous substances, as detailed above, with supporting rationale and data. Additionally, in the USCG proposed rules for tank vessels and MTR facilities (64 FR 13734, March 22, 1999 and 65 FR 17416, March 31, 2000), some CWA hazardous substances were defined as “sinkers” and “floaters”, where “sinkers” are those CWA hazardous substances whose physical and chemical properties, following a discharge into water, result in a substance in the water that does not float, react chemically with water, rapidly vaporize, or rapidly dissolve. Under ambient conditions, these chemicals have a solubility of less than 0.01 percent, specific gravity greater than 1.0, and a vapor pressure less than 1 PSIG. “Floaters” are those CWA hazardous substances whose physical and chemical properties, following a discharge into water, result in a substance on the water surface that does not rapidly sink, react chemically with water, vaporize, or dissolve. Under ambient conditions, these CWA hazardous substances have a solubility of less than 0.01 percent, a specific gravity less than 1.0, and a vapor pressure less than 1 PSIG. Neither a “sinker” or “floater” designation was intended to include CWA hazardous substances that are highly reactive in water or volatile, and therefore could not be reasonably contained or collected under any conditions. Categorizing chemicals in this fashion is more intuitive than the EPA-revoked eight categories in Table 6 above. Additionally, “sinker” and “floater” would specifically link to response requirements, the main focus of this action. However, again due to the wide variability in chemical properties and requirements around responding to a worst case discharge, EPA determined that categorizing and aggregating chemicals generally is not appropriate for this action for the reasons specified above for aggregating by the revoked categories. EPA solicits comment on using “sinkers” and “floaters” as chemical categories to require specific response planning resources be available or contracted, or in aggregating chemicals for threshold determinations with supporting rationale and data. ii. Maximum Capacity Onsite v. Maximum Quantity Onsite EPA is proposing in § 118.2 to define maximum capacity onsite as the total aggregate container capacity of each CWA hazardous substance present at all locations within the entire facility at any given time, similar to the approach taken in the Oil Pollution Prevention regulation (see 40 CFR part 112). EPA is proposing a definition for permanently closed containers in § 118.2 such that facilities would not need to count these containers in their CWA hazardous substance maximum capacity onsite threshold quantity calculations. EPA recognizes that for the chemical industry, chemical inventory quantities routinely fluctuate, and facilities use a wide variety of containers to store CWA hazardous substances; common containers include storage tanks, process vessels, railcars, and other onsite shipping containers not in transportation. Thus, regulating facilities based on the maximum container capacity onsite will allow regulated stakeholders an opportunity to plan for the worst case quantities of CWA hazardous substances at the facility. This approach also allows emergency response planners to reflect the risk posed by CWA hazardous substances onsite in those maximum possible quantities. This is a simpler approach for inspectors to determine facility applicability based on container sizes instead of reviewing and aligning quantities in fluctuating inventories. Furthermore, calculating applicability using container shell capacity could be viewed as a more conservative approach to determine whether a facility has reached the threshold quantity of CWA hazardous substances. There are some limitations to this approach. Chemical mixtures would be complex to regulate, and the approach does not allow for flexibility. Oils are fundamentally different from CWA hazardous substances in that when an oil is mixed with another substance, the entire mixture is subject to regulation under CWA section 311 and the Oil Pollution Prevention regulation. Therefore, when determining applicability for oils, the shell capacity of the container can be taken into account because the entire mixture in the container is considered an oil for regulatory purposes. However, CWA hazardous substances may be combined into mixtures and therefore it is necessary to understand the quantities of each substance in the mixture to determine total quantities onsite when determining applicability. Furthermore, EPA understands that CWA hazardous substance facility quantities and batch process operations often vary and therefore EPA inspectors would still need to consider facility inventories to understand facility storage capacities. Additionally, this approach is not consistent with how industry manages their chemicals under similar chemical preparedness and reporting regulations. The typical amount of CWA hazardous substances at a facility may be less than the total capacity because facilities are overdesigned to meet seasonal demands or changing facility need. Finally, containers may be designed to never actually hold the maximum quantity possible due to the need for freeboard or headspace, thus using the maximum capacity onsite may not be a realistic accounting of CWA hazardous substance quantities for planning purposes. EPA considered proposing that the maximum quantity stored onsite means the total amount of a CWA hazardous substance present at all locations within the entire facility at any given time ( e.g., storage tanks, process vessels, onsite shipping containers) and that this amount be used to determine whether a facility meets or exceeds the threshold quantity proposed in § 118.3(a). This is consistent with other EPA chemical accident preparedness and reporting programs, for example EPCRA Sections 311 and 312. 19 A facility owner or operator would use the maximum total aggregate amount of a CWA hazardous substance in all containers onsite at any one time to calculate this quantity. Once a facility becomes subject to the regulation for one CWA hazardous substance, the facility would include all CWA hazardous substances on site in their planning activities. 19 See 40 CFR part 370. EPA solicits comment on the proposed approach, the definition of permanently closed containers, using maximum quantity onsite rather than maximum capacity onsite for applicability threshold quantity calculations, the number of facilities that may be regulated under the proposed approach versus using maximum quantity onsite, and potential alternative approaches with supporting rationale and data. iii. Accounting for Mixtures When designating CWA hazardous substances, EPA defined mixture in 40 CFR 116.3 to mean any combination of two or more elements and/or compounds in solid, liquid, or gaseous form except where such substances have undergone a chemical reaction so as to become inseparable by physical means. Additionally, 40 CFR 116.4 states that the elements and compounds appearing in Tables 116.4 A and B are designated as hazardous substances in accordance with CWA section 311(b)(2)(A). This designation includes any isomers and hydrates, as well as any solutions and mixtures containing these substances. Under 40 CFR 302.6 Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) Notification Requirements, hazardous substance mixtures are calculated by the following: (i) If the quantity of all of the hazardous constituent(s) of the mixture or solution is known, notification is required where an RQ or more of any hazardous constituent is discharged; (ii) If the quantity of one or more of the hazardous constituent(s) of the mixture or solution is unknown, notification is required where the total amount of the mixture or solution discharged equals or exceeds the RQ for the hazardous constituent with the lowest RQ. As the regulated community is already familiar with determining RQs for mixtures or solutions for release notification under CERCLA section 103(a) (40 CFR 302.6), EPA is proposing the same requirements in § 118.9 for mixtures or solutions in this action. As such, if a facility has a mixture wherein the quantities of all the hazardous constituents of the mixture are known, the threshold quantity would be reached when any individual CWA hazardous substance constituent quantity reaches that level as extrapolated to the maximum container capacity. However, if a facility has a mixture wherein the quantities of the constituents are not known, the facility has met the threshold when the entire quantity of the mixture onsite reaches or exceeds the threshold quantity for the hazardous constituent with the lowest threshold when extrapolated to the maximum container capacity. EPA solicits comment on this approach or suggested alternative approaches with supporting data for determining CWA hazardous substance threshold quantities for mixtures. Because this proposed action would determine threshold quantity applicability based on maximum capacity onsite, a facility would follow the mixture rule proposed in § 118.9 to determine the capacity quantities of CWA hazardous substances onsite. For the worst case discharge planning quantity, please see Section IV.A.4.iv of this preamble. b. Distance to Navigable Water i. One-Half Mile to Navigable Water or Conveyance to Navigable Water EPA is proposing that facilities meeting the threshold quantity of CWA hazardous substances and located within one-half mile of navigable water or a conveyance to navigable water complete the substantial harm determination. This distance is based on research related to the Oil Pollution Prevention FRP regulation. 20 As discussed in the preamble to the Oil Pollution Prevention FRP regulation, 21 all facilities with worst case discharges of oil to navigable water examined in the case studies were located such that their closest opportunity for discharge was within one-half mile of navigable waters. Thus, 40 CFR part 112, Appendix C, Attachment C-III—Calculation of the Planning Distance considers one-half mile proximity to a navigable water or a conveyance to navigable water as part of the planning distance calculation for overland transport. These overland transport planning distance calculations, combined with in-water calculations, determine whether the facility could cause substantial harm to public health and sensitive environments due to a worst case discharge. Additionally, conveyances located close to the facility can provide a direct pathway to navigable waters. If this distance is less than or equal to one-half mile, a discharge from the facility could pose substantial harm given that the time to travel the distance from the storm drain or other conveyance to the navigable water could be considered virtually instantaneous (40 CFR 112, Appendix C). Given that the Oil Pollution Prevention FRP regulation has been in place for over 30 years, industry is familiar with this approach. 20 58 FR 8832, February 17, 1993. 21 ibid. EPA considered using both lower and higher values for the distance to navigable water or conveyances to navigable water and solicits comment on alternative approaches to determining whether a facility, because of its location, could reasonably be expected to cause substantial harm to the environment by discharging CWA hazardous substances into or on the navigable waters, with supporting rationale and data. ii. Alternatives to One-Half Mile to Navigable Water or Conveyance to Navigable Water EPA considered a facility self-determination model, wherein an owner or operator would determine whether the facility has a reasonable expectation to cause substantial harm by discharging to navigable waters based on locational and geographic considerations using EPA-defined criteria. Under this model, the determination would be customized by each facility to their unique circumstances. The main drawback to this approach is that defining universally applicable criteria to determine whether facilities are located at a distance that may cause substantial harm may be complicated and implementation may be difficult and burdensome. EPA also considered establishing proximity distances to navigable waters for CWA hazardous substances using chemical characteristics or historical discharge data. Under this approach, EPA would use available CWA hazardous substance physicochemical data to calculate overland distances to navigable water to indicate that a facility's location potentially poses a substantial threat. However, the Agency concluded that determining the appropriate physicochemical properties influencing fate and transport for the 296 CWA hazardous substances is not feasible when accounting for the large number of mixtures or wastes containing CWA hazardous substances. Additionally, worst case discharge historical data are sparse, and EPA has identified an insufficient number of historical worst case discharges of CWA hazardous substances to accurately set a distance threshold using discharge history data. EPA solicits comment and any information pertinent to these alternative approaches as well as supporting data and rationale. 2. Substantial Harm Criteria After determining whether a facility satisfies the initial screening criteria, EPA is proposing that an owner or operator would then assess whether their facility meets any of the four substantial harm criteria: (1) Ability to cause injury to FWSE, (2) ability to adversely impact a public water system, (3) ability to cause injury to public receptors, and (4) reportable discharge history. If any one of these substantial harm criteria are met, then the facility must prepare and submit a response plan to EPA. EPA considered the substantial harm criteria in the Oil Pollution Prevention regulation in 40 CFR part 112 as a basis for developing CWA hazardous substances substantial harm criteria. These criteria and steps to determine whether they are met are further detailed below. a. Ability to Cause Injury to Fish, Wildlife, and Sensitive Environments (FWSE) i. Proposed Approach EPA is proposing a substantial harm criterion to consider the facility's ability to cause injury to FWSE. This is based on 40 CFR 112.20(f)(1)(ii)(B) for oil FRPs, in which EPA established a criterion for determining injury to FWSE as follows: “The facility is located at a distance . . . such that a discharge from the facility could cause injury to fish and wildlife and sensitive environments . . .” Furthermore, in 40 CFR 112.20(f)(2)(i) EPA identified that an EPA Regional Administrator (RA) shall consider proximity to FWSEs and other areas he or she determines to possess ecological value in his or her assessment of whether a facility could reasonably be expected to cause substantial harm to the environment. EPA judged that a similar approach considering ability to cause injury to FWSE is appropriate to determine the potential for CWA hazardous substance discharges to cause substantial harm to the environment. I. Definition of FWSE 40 CFR part 112 Appendix C references the DOC/NOAA document, “Guidance for Facility and Vessel Response Plans Fish and Wildlife and Sensitive Environments,” which outlines guidance for interpreting fish, wildlife, and sensitive environments (59 FR 14713, March 29, 1994). In six appendices (I-VI), the guidance document outlines the Federal agencies responsible for specific environmental resources (I); critical habitats for endangered/threatened species (II); federally protected areas (III); sensitive biological and human-use resources (IV); ranking of shoreline habitats impacted by oil spills (V); and contact information for regional offices (VI). As part of the statutory requirements under the CWA, any hazardous substances worst case discharge program must “be consistent with the requirements of the National Contingency Plan (NCP) and Area Contingency Plans (ACPs).” 22 EPA is proposing to require owners and operators to evaluate the substantial harm criteria using the fish and wildlife definition under 40 CFR 112.2 (proposed in this rulemaking in § 118.2) as well as use applicable ACP guidance in defining fish, wildlife, and sensitive environments in their respective regions. 22 33 U.S.C. 1321(j)(5)(D)(i). Accessed January 14, 2021. Available at: https://www.govinfo.gov/content/pkg/USCODE-2019-title33/pdf/USCODE-2019-title33-chap26-subchapIII-sec1321.pdf. An ACP is used by all agencies engaged in responding to environmental emergencies within a defined geographical area. When implemented in conjunction with the NCP, the ACP must be adequate to remove a worst-case discharge, and to mitigate or prevent a substantial threat of such discharge from a vessel, offshore facility, or onshore facility operating in or near the defined geographical area. Additionally, the ACP identifies areas within its bounds that may require tailored protection or response strategies due to unique environmental attributes. These may be endangered species habitats or other areas defined by the ACP. The ACP provides guidance on how responders should incorporate the needs of these areas into response strategies. The ACP Fish and Wildlife and Sensitive Environments Plan annex is developed in consultation with the U.S. Fish and Wildlife Service, NOAA, and other interested parties, including state fish and wildlife conservation officials. The annex, consistent with the NCP and Regional Contingency Plans (RCPs), addresses fish and wildlife resources and their habitat, and other areas considered sensitive environments, and provides the necessary information and procedures to immediately and effectively respond to discharges that may adversely affect these resources, including provisions for a response to a worst case discharge (40 CFR 300.210(c)(4)). EPA solicits comment on how FWSEs are defined for this action. II. FWSE Planning Distance Calculation To determine whether a facility could cause substantial harm to a FWSE, EPA is proposing that facilities self-determine formulas and/or methodologies to use for overland transport and transport in water for planning distance, using EPA-provided parameters and the lethal concentration 50 percent (LC50) toxicity intervals provided by EPA (Table 7). The facility owner or operator would be required to evaluate whether the facility is located at a distance such that a worst case discharge from the facility could cause injury to FWSE. EPA is proposing in § 118.10 that a facility owner or operator calculate the worst case discharge scenario of the maximum single CWA hazardous substance container, interconnected containers, pipe, or piping system capacity onsite for a CWA hazardous substance at or above the threshold quantity set in § 118.3(a) that represents the largest capacity. If the worst case discharge scenario indicates that the facility could cause injury to FWSE, then the owner or operator must prepare an FRP that addresses all CWA hazardous substances where the maximum capacity onsite meets or exceeds the threshold quantity. The goal of calculating planning distance is two-fold. First, planning distance determines a facility's potential to cause substantial harm, and second, planning distance may be part of the response plan implementation to identify appropriate response actions. Thus, the worst case discharge scenario is used to both determine applicability and in the hazard evaluation. EPA is proposing to provide the toxicity thresholds and parameters for overland transport and in-water transport, while the facility must determine (1) where the FWSE receptors are located, and (2) if, based on the parameters provided, a worst case discharge of CWA hazardous substances would result in exposure of receptors to a concentration equal to or greater than the toxicity threshold concentration provided by EPA. The following describes the parameters reviewed, the proposed methodology, and toxic endpoints and parameters for planning distance calculations. Toxic Endpoints EPA is proposing in Appendix B of 40 CFR part 118 to use 10 percent of a range of LC50 concentrations. A common risk assessment method, use of an uncertainty factor of 10 to estimate the lower limit by dividing the LC50 threshold by 10 (LC50/10) extrapolates the lethal concentration used in laboratory aquatic toxicity tests to lower concentrations than the lethal dose. This method results in a concentration of concern that is more conservative and likely more relevant to discharges of CWA hazardous substances to the environment. EPA used tests involving adult fathead minnows to create the original RQ classification; they are available for all 296 CWA hazardous substances (43 FR 10474, March 13, 1978). EPA proposes to use 96-hour LC50 intervals for each RQ category as the criterion for FWSE (Table 7). For mixtures of CWA hazardous substances, EPA proposes in § 118.10(a) that an owner or operator shall assume the entire capacity of the container holds the CWA hazardous substance with the lowest RQ. EPA judges that this approach will appropriately capture the risk of CWA hazardous substance worst case discharges causing injury to FWSE. Table 7—Proposed Concentrations for FWSE [Proposed Part 118 Appendix B] Category RQ (lbs.) Aquatic toxicity (mg/L) Lower Upper 10% (mg/L) X 1 0 0.1 0.01 A 10 0.1 1 0.1 B 100 1 10 1 C 1,000 10 100 10 D 5,000 100 500 50 EPA reviewed several options for toxicity endpoints for FWSE. These included both the Criterion Maximum Concentration (CMC) and Criterion Continuous Concentration (CCC), as well as a percentage of the LC50 for acute aquatic toxicity tests. While the CMC and CCC have the advantage of combining the results of multiple toxicity tests, using overarching chemical components, there are 104 freshwater CMCs, 116 freshwater CCCs, 97 saltwater CMCs and 97 saltwater CCCs for CWA hazardous substance chemical compounds. 23 EPA solicits comment on methods of estimating concentrations based on aquatic toxicity testing that are relevant to human and aquatic endpoints for the 296 CWA regulated hazardous substances and how to address mixtures, with supporting rationale and data. 23 Further information is available in the TBD. Planning Distance Parameters EPA is proposing in § 118.10(b) that owners or operators shall use any methodology(ies) or formula(s) that accurately reflect the conditions at the facility location and that consider parameters provided by EPA for overland transport and transport over water. Overland transport parameters shall include ground conditions ( e.g., topography, land use, soil absorption) and properties of the CWA hazardous substance ( e.g., evaporation, reactivity). In-water transport parameters include: The point of entry to the water ( i.e., flow rate, duration, direction of the discharge); conditions of the water ( i.e., velocity, slope, currents, turbulence, water temperature, salinity); and properties of the CWA hazardous substance in water. The proposed approach differs from the Oil Pollution Prevention FRP program which specifies formulas for calculating planning distance and allows the owner or operator to use an alternative formula(s) for calculating planning distance (see 40 CFR part 112 Appendix C, Attachment C-III). In this action, EPA is proposing flexibility for determining planning distance for CWA hazardous substances to account for the variety in chemical and physical properties of the 296 CWA hazardous substances. EPA determined a one-size-fits-all approach for calculating planning distances for CWA hazardous substances is not appropriate for this particular action given the variety of hazardous substances and the range of physicochemical properties resulting in differences in their fate and transport. Facility owners and operators may choose to use existing models and formulas to calculate planning distance such as those in 40 CFR part 112 Appendix C. The owner or operator must provide supporting documentation, rationale, and assumptions for the formula used to calculate planning distance in order for the EPA to evaluate the facility's determination of substantial harm. EPA explored other potential models for planning distance, which are further discussed in the TBD, and considered whether the Agency should specify formulas for calculating planning distance and/or develop a tool to assist facility owners and operators in completing calculations. An example of one such tool is RMP*Comp, a free software program an owner or operator can use to complete the Off-site Consequence Analyses (both worst case scenarios and alternative scenarios) required under the RMP rule. RMP*Comp allows a user to input data elements and then guides the user through the process of conducting the analysis. EPA solicits comment on the various model parameters, in-water and overland transport models, scenarios, and variables which should be included in a potential planning distance calculation as well as whether EPA should develop a comparable tool to the RMP*Comp system for worst case discharges CWA hazardous substances. ii. Alternative Approaches EPA considered using the same parameter and toxic endpoint approach as proposed above, except with endpoints established from the CWA RQ concentrations. In this alternative approach, EPA would use the lower end of each RQ category concentration range for the toxic endpoint value. Although this approach ensures that the program remains consistent by using the RQs, considering both aquatic toxicity and mammalian toxicity (oral), the range of concentrations for each RQ category may be too large to accurately reflect the risk of each substance. EPA solicits comment on this approach and potential alternatives along with supporting data and rationale. EPA also considered specifying formulas by chemical, chemical category, or some other categorization. The Agency evaluated existing modeling programs for water and land but chose not to adopt an approach that specifies formulas for CWA hazardous substance planning distance. 24 The chemical and physical property variation across the 296 CWA hazardous substances make it challenging to adopt a one-size-fits-all approach to accurately calculate planning distances. EPA solicits comment on available technologies, methodologies, modeling programs, or formulas that could be used to establish planning distance. 24 Details on the models evaluated are included in the TBD. b. Ability to Adversely Impact a Public Water System i. Proposed Approach EPA is proposing in § 118.3(c)(2) that facilities located at a distance such that a worst case discharge from the facility has the ability to adversely impact a public water system could reasonably be expected to cause substantial harm to the environment. Facilities would be required to coordinate with the public water system to determine whether concentrations from a worst case CWA hazardous substance discharge would result in scenarios adversely impacting the public water system. Public drinking water was specifically highlighted as an area of risk of substantial harm in the OPA 90 Conference Report under proximity to potable water. 25 EPA proposes in § 118.2 to adopt the definition of public water system as stated in 40 CFR 141.2 and used by the Oil Pollution Prevention FRP program, designating a public water system as a system of public piped water for human consumption with at least fifteen service connections or that regularly services 25 individuals for at least 60 days of the year. 25 Legislative History of the Oil Pollution Act of 1990: Public Law 101-380: 104 Stat. 484: August 18, 1990. in 8 Washington, DC, Covington & Burling; p. 150. In determining whether a CWA hazardous substance discharge would adversely impact a downstream public water system, the facility owner or operator would be required to evaluate whether a worst case discharge concentration would: 1. Violate Federal and state drinking water standards ( e.g., Maximum Contaminant Levels (MCLs)), 2. Compromise the ability of a public water system to produce water that complies with Federal and state drinking water standards, 3. Result in adverse health impacts in individuals exposed to contaminated drinking water, 4. Contaminate public water system infrastructure, and/or 5. Cause a public water system to issue water use restrictions. EPA expects that facilities would need to gather relevant information related to the CWA hazardous substances onsite and information relevant to their fate and transport following a discharge in order to determine whether the facility has the ability to adversely impact public water systems. This may include modeling a worst case discharge scenario and obtaining the arrival time, duration, and concentration of the discharge as it reaches a water intake. With that information, the facility would coordinate with downstream public water systems to determine impacts to the system and would be required to document coordination. State drinking water primacy agencies (“State agency”) may be another resource to aid in determining impacts to public water systems. EPCRA section 304 requires facilities to notify their State Emergency Response Commission (SERC) or Tribal Emergency Response Commission (TERC) and Local Emergency Planning Committee (LEPC) or Tribal Emergency Planning Committee (TEPC) of any releases of extremely hazardous substances (EHSs) defined under EPCRA section 302 or CERCLA hazardous substances at or above their RQ. The America's Water Infrastructure Act (AWIA), which amended EPCRA section 304, requires facilities to notify the applicable State agency, which in turn notifies community water systems of a discharge that has the potential to impact the system's source water. In Appendix A of 40 CFR part 118, EPA is proposing to require facilities to document and retain efforts to coordinate with nearby public water systems regarding this substantial harm criterion. All states, except for Wyoming, have primacy for implementing the Safe Drinking Water Act (SDWA). The EPA Regional Water Program implements the SDWA for Wyoming, Washington DC, several Indian Tribes, and the territories. State drinking water primacy agencies are required to enforce Federal standards. State drinking water programs also have the discretion to (1) place more stringent standards on contaminants regulated under SDWA or (2) regulate a contaminant that is not currently regulated under SDWA. EPA intends the proposed language to encompass Federal drinking water standards as well as more stringent state drinking water regulations. This general approach covers any site-specific considerations and contains clear and unambiguous requirements, as well as negates the need to specify values ( i.e., concentration or total mass) that result in substantial harm; rather, it focuses on adverse outcomes that could result from a worst case discharge. Additionally, this approach avoids the issue of whether drinking water treatment could (or could not) reduce the concentration of the CWA hazardous substance to below harmful levels. EPA recognizes challenges with this approach. First, this approach places a burden on public water systems to voluntarily participate in coordination activities with an unknown number of upstream facilities. A limited number of public water systems could be inundated with coordination requests depending on the number of potentially regulated facilities located upstream. Second, public water systems may not fully understand whether worst-case discharges for particular CWA hazardous substance would result in adverse health impacts in exposed individuals or contaminate their infrastructure given the variability of CWA hazardous substance physiochemical properties and toxicities. This may be especially true for smaller systems that lack the knowledge and resources to assist in this evaluation. EPA recognizes that guidance would need to be developed to support such evaluations. Lastly, given their variability, the treatability of some CWA hazardous substances is not known. Further, if a public water system does not respond to requests to coordinate, facility owners or operators may be in a position to make the determination without the support and expertise of water system staff. In these instances, the regulated facility would measure compliance at the water treatment facility intake. Another challenge with this approach is that it does not consider other water intakes ( e.g., industrial water intakes) that may be downstream of a potentially regulated facility. EPA solicits comment on the merits and limitations of this approach, including situations where a public water system declines to participate or does not respond; suggested alternatives to this approach; and supporting data and rationale for these alternatives. ii. Alternative Approaches EPA considered categorizing all facilities within Source Water Protection Areas (SWPAs) as meeting substantial harm criteria. The 1996 Amendments to SDWA emphasized the importance of pollution prevention to protect the safety of drinking water supplies and required states to create a Source Water Assessment Program for all public water systems. State drinking water programs were required to: 1. Identify the land area(s) which provide water to each public drinking water source in their state; 2. Complete an inventory of existing and potential sources of contamination in those areas; 3. Determine the susceptibility of each drinking water system to contamination; and 4. Distribute the results of the assessment to water users and other interested entities. The 1996 program requirements were intended to provide communities with the information needed to formulate and implement protection measures. By the early 2000s, source water assessments were completed for all public water systems. The 1996 SDWA Amendments do not require states to update source water assessments periodically. However, some states opt to implement state-specific policies requiring periodic evaluations and/or updates of assessments. States may provide access to public water system source water assessment reports on their websites or respond to information requests for these reports. Updating assessment plans by the states is voluntary. As such, states, not EPA, maintain the information and geographic boundaries of SWPAs. For SWPAs that are publicly available, facilities could easily determine whether they are within a boundary and it would obviate the need for distance planning. However, EPA chose not to adopt this approach for several reasons. First, this would increase the number of facilities that must develop facility response plans without clearly focusing on those that could cause the greatest harm. Additionally, many states do not make their SWPAs available to the public, so facility owners or operators would have to request them from the state. Responding to these requests could place a burden on state drinking water programs. Further, EPA does not possess the geographic boundaries of current state SWPAs, which hinders EPA's ability to assess how feasible this option would be to implement. This presents challenges to estimating the facility universe or costs for this approach. Additionally, states regulate and define SWPAs differently, and EPA has no information on how often these areas are updated. SWPAs can be quite large, which would likely expand the facility universe and increase compliance costs imposed on the regulated community without necessarily corresponding to the potential to cause substantial harm. This is especially true in states that identify larger areas, such as entire watersheds, to delineate SWPAs. EPA also considered an approach whereby facility owners or operators would self-determine whether they could adversely impact public water systems using parameters and toxic endpoints. This approach would parallel the methodology recommended to determine impacts to FWSE. Setting concentration thresholds at the drinking water intake would provide certainty to the regulated community. This approach could be less burdensome to regulated facilities if they are not required to coordinate with public water systems. However, the drinking water standards EPA evaluated ( e.g., MCLs) apply only to the finished water rather than source water. Applying those drinking water standards at the water intake, before the water is treated, may not be an accurate reflection of whether a worst case discharge could cause substantial harm. Additionally, it may be impractical, if not impossible, to develop threshold concentrations at the intake that would result in substantial harm that would broadly apply to most public water systems for all the types of substantial harm listed under the preferred option and for all 296 CWA hazardous substances. EPA solicits comment on these approaches and methodologies, with supporting rationale and data. c. Ability To Cause Injury to Public Receptors i. Proposed Approach Given the intrinsic properties ( e.g., physicochemical; toxicity) of some of the CWA hazardous substances, EPA is proposing in § 118.3(c)(3) a separate substantial harm criterion for facilities that could cause injury to public receptors through a worst case discharge to navigable waters. Additionally, EPA is proposing that substantial harm be determined through the same parameter and toxic endpoint approach proposed for FWSE. EPA's proposed definition of public receptor is adapted from an EPA chemical accident prevention and preparedness program, the Clean Air Act (CAA) Risk Management Program, at 40 CFR 68.3, which defines a public receptor as: “offsite residences, institutions ( e.g. schools, hospitals), industrial, commercial, and office buildings, parks, or recreational areas inhabited or occupied by the public at any time without restriction by the facility where members of the public could be exposed to toxic concentrations as a result of a worst case discharge.” However, the definition proposed in § 118.2 is specific to discharges to navigable waters and public receptors subsequently likely to be affected. This approach proposes the same planning distance parameters recommended for FWSE, but sets the toxic endpoints at the upper bound of the 10 percent of the RQ concentration value for mammalian oral toxicity for each of the RQ categories: X, A, B, C, and D. This extrapolates to lower concentrations that are more relevant to discharges of CWA hazardous substances near public receptors (see Table 8, below). While the original CWA hazardous substance RQs were based on aquatic toxicity, subsequent RQ adjustments updated the RQ levels to account for mammalian toxicity (oral, inhalation, and dermal), as well as other physicochemical properties. 26 A substance was rated as toxic based on its LC50 or lethal dose 50 percent (LD50) value, which is the concentration or dose of a substance which causes the death of 50 percent of a defined experimental animal population. Upper-bound toxicity values were identified for each of the three intervals. These values were correlated with a 5,000-lb RQ value. An upper-bound oral (ingestion) toxicity value of 500 mg/kg was adopted based on the assumption of a “standard man” (70 kg body weight, swallow volume of 21 cubic centimeters) being exposed to a situation which would allow him to take one swallow of a CWA hazardous substance. Once the upper-bound toxicity levels were chosen, the toxicity ranges in Table 8 for the 1-, 10-, 100-, 1000-, and 5,000-lb RQ categories were scaled for mammalian toxicity in the same ratios as the ranges for aquatic toxicity. 26 See Footnote 17. The mammalian oral toxicity values, which are of interest for CWA hazardous substance discharges to water and human exposure ( i.e., public receptors), correspond with the aquatic toxicity ranges (presented in mg/kg and mg/L). Because these are both parts per million, EPA proposes using the mg/L concentrations relevant to water in Appendix B of 40 CFR part 118. The lower end of the toxicity levels is effectively 10 percent of the upper bound. For category X, the lower bound is effectively zero, though by taking 10 percent of the upper bound, EPA established a proposed concentration of 0.01 mg/L. Table 8—Proposed Concentrations for Public Receptors Category RQ (lbs) Mammalian toxicity (oral) (mg/kg) Lower Upper 10% (mg/kg) Aquatic toxicity (mg/L) Lower Upper 10% (mg/L) X 1 0 0.1 0.01 0 0.1 0.01 A 10 0.1 1 0.1 0.1 1 0.1 B 100 1 10 1 1 10 1 C 1,000 10 100 10 10 100 10 D 5,000 100 500 50 100 500 50 While this approach does not account for inhalation toxicity, EPA concluded that any air releases (even from a liquid discharge to navigable water) are more appropriately covered under the CAA. This proposal is focused on worst case discharges to navigable water, due to the statutory authority upon which this action is based, however, EPA notes that exposure pathways are complex. In some scenarios, aerial deposition on waterways may be an important exposure pathway for public receptors and FWSE. EPA solicits comment on the appropriateness of requiring facility owners or operators to assess whether worst case discharges could cause injury to public receptors via inhalation exposures to either the parent compounds or degradation byproducts ( e.g., phosgene emanating from chlorinated solvents exposed to high temperatures) and/or following volatilization followed by aerial deposition on waterways of concern. EPA is proposing in § 118.11 that CWA hazardous substance FRPs consider potential inhalation risks in the hazard evaluation, discharge detection systems, and response resources. ii. Alternative Approaches EPA reviewed several information sources for human health toxicity values and associated endpoints for public receptors including: EPA Integrated Risk Information System (IRIS) reference doses or reference concentrations, National I [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%3A2022-05505. Public record. Not legal advice.