Summary of Public Comments

Several commenters supported the U.S. Environmental Protection Agency’s (EPA) proposed rule to require planning for worst case discharges of Clean Water Act (CWA) hazardous substances for onshore non-transportation-related facilities that could reasonably be expected to cause substantial harm to the environment by discharging CWA hazardous substances into or on the navigable waters, adjoining shorelines, or exclusive economic zone (0146, 0148, 0150, 0151, 0154, 0159, 0166, 0169, 0170, 0172, 0174, 0180, 0203, 0213, 0217, 0219, 0220, 0227, 0229, 0230, 0234, 0249, 0250, 0256, 0266, 0275, 0281, 0294, 0301, 0308, 0329, 0333, 0347, 0367). Many of these commenters also provided additional comments, which are categorized under the appropriate topics within this document.

EPA Response:

EPA agrees with commenters who support this action under the CWA statutory authority. Congress directed EPA to issue regulations to address worst case discharges for both oil and CWA hazardous substances, providing clear and unambiguous authority for this action. The CWA, as amended by the Oil Pollution Act of 1990 (OPA; 33 USC 2701 et seq.) 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 USC 1321(j)(5)(A)(i)). The statute defines a covered facility as “. . . [an] onshore facility that, because of its location, could reasonably be expected to cause substantial harm to the environment by discharging into or on the navigable waters, adjoining shorelines, or the exclusive economic zone” (33 USC 1321(j)(5)(C)(iv)). The Administrator has been delegated this authority under Executive Order (EO) 12777 (56 FR 54757, October 18, 1991). The Administrator also has authority under CWA § 501 to prescribe such regulations as are necessary to carry out provisions of the Act.

Oppose Proposed Approach

Public Comment Summary:

Oppose

Several commenters opposed EPA’s proposed rule 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 (0153, 0171, 0173, 0175, 0176, 0179, 0181, 0183, 0185, 0187, 0188, 0189, 0191, 0192, 0193, 0194, 0195, 0197, 0199, 0204, 0205, 0206, 0210, 0211, 0215, 0218, 0219, 0308). Many of these commenters also provided additional comments which are categorized under the appropriate topics within this document.

EPA Response:

EPA disagrees with commenters who do not support this action citing the CWA statutory authority. First, Congress directed EPA to issue regulations to address worst case discharges for both oil and CWA hazardous substances, providing clear and unambiguous authority for this action. Second, this final rule reflects Congress’s intent with the passage of the OPA Amendments to the CWA. Third, EPA has judged the underlying data as sufficient to warrant a regulatory program as detailed in the Regulatory Impact Analysis (RIA), available in the docket.

Regulatory Process

Public Comment Summary:

Support

One commenter expressed appreciation at the opportunity to provide detailed, practicable, and constructive comments on this issue. The commenter noted that lessons learned from the oil Spill Prevention, Control, and Countermeasure (SPCC) rulemaking in 2002 showed that working on these issues as part of the rule development will reduce potential implementation issues for both the regulated community and EPA (0179).

EPA Response:

EPA agrees with commenters who support the opportunity to provide comments and collaborate on this action.

Public Comment Summary:

Oppose

Several commenters requested that EPA provide a 60-day extension to submit comments on the proposed rule, “Clean Water Act Hazardous Substance Worst Case Discharge Planning Regulations” (87 FR 17890, March 28, 2022) (0155, 0157, 0158, 0160, 0161, 0163, 0164, 0165, 0201). Some commenters noted that a 60-day extension of the current comment period would not keep EPA from issuing a final rule by the Consent Decree deadline of September 2024 (0158, 0160, 0161, 0165).

One commenter suggested that extra time should be taken to promulgate this rule to ensure EPA is not imposing duplicative regulations on owner/operators of facilities already regulated under other rules, and to help develop creative solutions for program implementation (0201).

EPA Response:

EPA agrees with commenters who requested a 60-day extension to submit comments. In response to these requests, EPA extended the comment period 60 days, to July 26, 2022. EPA is confident the current timeline of effort is sufficient and that implementation will be effective. Other EPA and federal programs are not specific to worst case discharges of CWA hazardous substances into or on the navigable waters, do not cover all the required program elements under CWA § 311(j)(5), and are not an appropriate substitute. That said, where appropriate, EPA has created exemptions and taken measures to limit duplicative regulatory overlap. The Technical Background Document (TBD) available in the docket details potential regulatory overlap in related programs, and EPA has adjusted some exemptions in § 118.8 to account for existing programs.

Statutory Authority

Public Comment Summary:

Support

Three commenters stated that EPA has authority to promulgate the proposed rule requiring facility response plans (FRPs) (0220, 0347, 0215). One commenter one noted it is EPA’s duty to do so (0347). One commenter argued that the final rule should be more robust to ensure improvement beyond the status quo because the CWA grants EPA both specific authority (33 USC §§ 1321(j)(5)(A)(I), (D)(iii)) and general authority (33 USC § 1321(j)(5)) to create regulations that are more than a mere “paper exercise” (0215).

Two commenters stated that the proposed rule is necessary as it will enhance facility responsibility to prevent risk of CWA hazardous substance contamination of community water systems and because business violations continue to occur (0169, 0220).

EPA Response:

EPA agrees with commenters who state that EPA has authority to promulgate the proposed rule under CWA and that the Agency is obligated to do so. The CWA, as amended by the OPA (33 USC 2701 et seq.) 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 USC 1321(j)(5)(A)(i)). The statute defines a covered facility as “. . . [an] onshore facility that, because of its location, could reasonably be expected to cause substantial harm to the environment by discharging into or on the navigable waters, adjoining shorelines, or the exclusive economic zone” (33 USC 1321(j)(5)(C)(iv)). The Administrator has been delegated this authority under EO 12777 (56 FR 54757, October 18, 1991). The Administrator also has authority under CWA § 501 to prescribe such regulations as are necessary to carry out provisions of the Act. EPA has carefully crafted the final rule provisions to ensure robust facility planning for worst case discharges of CWA hazardous substances into or on the navigable waters or a conveyance to navigable ater.

Public Comment Summary:

Oppose

Four commenters urged EPA to decide not to proceed with the rulemaking (0192, 0204, 0205, 0191). One commenter stated that EPA identified no problem that the proposed rule will solve and no data to support it (0192). Two commenters stated that there should be no duplication of existing requirements (citing House Conf. Rep. 101-653 at 151) (0192, 0205). Two commenters stated that: (1) inaction is considered a final Agency action and, thus, would comply with the court order that resulted from the litigation prompting this rulemaking; (2) statutory and regulatory programs adopted since Congress enacted CWA § 311(j)(1)(C) 45 years ago already achieve the same ends as the proposed action; and (3) EPA should streamline regulations and consider alternatives to imposing new regulations pursuant to EOs 12866, 13563, 13610, and 13777 (0204, 0191). Two commenters brought up a recent example where EPA determined that new requirements would have minimal incremental value and decided not to finalize any new requirements (citing 84 FR 46100, Sept. 3, 2019) (0192, 0205).

One commenter generally believed that the record provided indicated that the proposed rule is redundant with existing regulatory programs (0178). Two commenters noted that a similar response-focused rule proposed by the U.S. Coast Guard (USCG) (65 FR 17416, March 31, 2000) was withdrawn based on findings that the proposed rule was not appropriate for spill response for the industry and due to overlapping with state, local, and international regulations (0179, 0181). One commenter recommended that EPA review the final findings of USCG (0179). Several commenters also noted EPA’s 2019 CWA hazardous substances rulemaking where EPA concluded it was not establishing prevention and containment requirements under CWA § 311 (84 FR 46100-46103, September 3, 2019) (0179, 0181, 0197, 0199). One commenter referred to EPA’s action here as arbitrary (0199). One commenter asked EPA to justify its decision to create this rule given its 2016 conclusion and 2019 RIA, Clean Water Act Hazardous Substances Spill Prevention final action statement regarding how even a robust regulatory program could not reasonably be expected to eliminate all risk and that further regulation would provide only minimal incremental value (0179). One commenter additionally referred to EPA’s 2018 review of CWA § 311(j) program elements that found existing cumulative coverage under federal agency and department programs relevant to CWA hazardous substances (83 FR 29510, June 25, 2018) and indicated its qualitative conclusion that there is significant existing regulatory coverage at the federal and state level to prevent CWA hazardous substance discharges (0181).

One commenter noted that if EPA wishes to change its mind, it must meet the elements identified in National Cable & Telecommunications Ass’n v. Brand X Internet Services, 545 U.S. 967, 981 (2005) to: (1) recognize the discrepancy in its current position and (2) fully explain the basis for taking a different position now (0205).

Several commenters stated that the proposed rule requirements, particularly for development of FRPs, are not consistent with legislative intent (0193, 0219, 0205).

Three commenters stated that the proposed rule represents administrative overreach and is overbroad. The commenters opined that the requirements exceed the scope of what is necessary to protect against substantial harm in the event of a worst case discharge because some discharges have a lesser impact on the environment or are theoretically possible but unlikely to occur or result in significant harm due to mitigating factors (0219, 0205, 0199). One commenter stated that a broader worst case planning requirement hinders EPA’s ability to provide its oversight and enforcement roles under CWA § 311(j)(5)(E) and dilutes local government and company resources. The commenter stated that a new worst case response planning program for onshore facilities is not needed because over 30 years of experience demonstrates that substantial harm from CWA hazardous substance discharges from onshore facilities is a relatively rare occurrence (0205).

Two commenters claimed that the proposed rule is unnecessary, duplicative, and conflicting with other federal and state programs and imposes a regulatory burden with no measurable increase in environmental benefit and therefore encouraged EPA not to finalize the rule (0181, 0206).

One commenter argued that EPA’s criteria for an onshore facility to have to prepare and submit a worst case response plan are arbitrary and capricious because EPA failed to tie the proposed applicability provisions to reasonable potential for substantial harm; EPA did not adequately assess the costs of the proposal and weigh them against the benefits; and it imposes legal burdens for which there will be little or no regulatory benefit. The commenter stated that the proposed criteria for the proposed rule do not reflect a reasonable interpretation of statutory terms or application of facts to implementation, specifically: (1) defining “injury” as any measurable adverse effect fails to give meaning to the statutory requirement that there be potential for “substantial harm” since an effect that is measurable could be unsubstantial and (2) EPA has not explained clearly how a measurable adverse effect on a “public receptor” – defined as a public space that may be occupied or used by people – necessarily constitutes “harm to the environment,” which is the statutory trigger. The commenter noted that EPA has not explained the inconsistency with prior EPA and USCG determinations under CWA § 311. The commenter also stated that EPA deprived the commenter of its right under the Administrative Procedure Act (APA) to have a clear statement of the proposed Agency action and comment effectively (citing Weyerhaeuser Co. v. Costle, 590 F.2d 1011, 1027-28 (D.C. Cir. 1978)) (0205).

EPA Response:

Pursuant to section 311(j)(5) of the CWA, EPA “shall issue regulations which require an owner or operator of a tank vessel or facility […] to prepare and submit to […] 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.” Indeed, EPA was sued for failure to perform this non-discretionary statutory duty with respect to CWA hazardous substances. Because this is an unfulfilled nondiscretionary duty, EPA entered into a consent decree to issue a proposed and final action with respect to CWA hazardous substances at onshore non-transportation related facilities. While some commenters urged EPA to decide to take no action (citing past examples where EPA has decided to take no action), for the reasons enumerated in the preamble to the final rule, EPA has determined that issuing a regulation is warranted. EPA also refers commenters to the RIA available in the docket for its responsibilities under Executive Orders 12866 and 13563.

In response to commenters concerned about EPA not addressing EO 13777, EPA notes that EO 13777 was revoked in 2021. In addition, EO 13610 directs EPA to enhance retrospective regulatory review and does not impose any requirements for rule development.

EPA notes that in March 2000, USCG published a Notice of Proposed Rulemaking (NPRM) in the Federal Register entitled “Marine Transportation-Related Facility Response Plans for Hazardous Substances” (65 FR 17416, March 31, 2000) under the same CWA authority as this final rule. USCG then withdrew that rulemaking in 2019 (84 FR 2799, February 8, 2019). Given that nearly 20 years elapsed between the proposal and withdrawal, it is unsurprising that USCG found the proposed rule was no longer appropriate to the current state of spill response in the chemical industry. USCG also noted that its NPRM may overlap with existing local and state regulatory schemes as well as current industry practice. EPA has reviewed USCG’s actions, reports, and findings. Other EPA programs are not specific to worst case discharges of CWA hazardous substances into or on the navigable waters, do not cover all the required program elements under CWA § 311(j)(5), and are not an appropriate substitute. That said, where appropriate, EPA has created exemptions and taken measures to limit duplicative regulatory overlap. Chapter 2 of the TBD available in the docket details potential regulatory overlap in related programs, and EPA has adjusted some exemptions in § 118.8 to account for existing programs.

To the commenter who stated that if EPA wishes to change its mind, it must meet the elements identified in National Cable & Telecommunications Ass’n v. Brand X Internet Services, 545 U.S. 967, 981 (2005) to (1) recognize the discrepancy in its current position and (2) fully explain the basis for taking a different position now, the commenter misconstrues the situation. EPA has not changed its mind in this action. The commenter is referring to a different rulemaking (CWA Hazardous Substance Discharge Prevention (docket ID EPA-HQ-OLEM-2018-0024)) under a different statutory authority (CWA § 311(j)(1)(C)), which is not the subject of this action. Several other commenters also referenced this previous action, which is not the subject of this final action and covers different required program elements as well as expected outcomes (prevention versus facility response planning).

EPA disagrees that the proposed requirements are not consistent with legislative intent, as the OPA is clear in directing the President to promulgate regulations for worst case discharges of CWA hazardous substances, regardless of the number of facilities that may be ultimately regulated. For the same reasons, EPA disagrees that the proposal represents administrative overreach. Worst case planning provisions will shift response planning responsibilities to facility owner and operators, as Congress clearly intended, and thus will not dilute any EPA oversight or enforcement roles. Additionally, few existing programs cover all required program elements as per the CWA, and EPA has adjusted the exemptions in 40 CFR § 118.8 to reflect commenter concerns regarding overlap and redundance with existing regulatory programs. Additionally, a facility owner or operator may reference existing elements from other response plans, such as an integrated contingency plan (ICP), in their CWA Hazardous Substance FRPs, as is common practice in emergency response planning. While worst case discharges may historically be rare, that does not preclude planning for the future, as severe weather events become more common and intense with the long-term challenges posed by climate change.

EPA disagrees that it failed to tie the proposed applicability provisions to reasonable potential for substantial harm, as the Agency proposed four substantial-harm criteria to address just that issue and ensure that the planning requirements focus on facilities that could cause substantial harm to the environment by discharging into or on the navigable waters. Additionally, EPA proposed location-based criteria (using both distance from navigable water or conveyance and planning distance calculations, based on the Oil Pollution Prevention FRP regulation at 40 CFR § 112.20) to ensure facilities are regulated based on their location, as per the statutory directive. EPA refers the commenter to the RIA available in the docket for the cost-benefit analysis.

Because of the need to maintain consistency with the National Contingency Plan (NCP), the Agency has determined it is appropriate to use the definition of "injury" established by the Natural Resource Trustees for this rule. Federal officials authorized by the President and the authorized representatives of Indian tribes and state and foreign governments act as public trustees to recover damages to natural resources under their trusteeship. Under the NCP, each trustee has responsibilities for protection of resources; mitigation and assessment of damage; and restoration, rehabilitation, replacement, or acquisition of resources equivalent to those affected (40 CFR § 300.615). EPA maintains that the definition of “injury” is appropriate to assess substantial harm based on the extensive experience of the Natural Resource Trustees in conducting evaluations of CWA hazardous substance impacts on natural resources. The definition of “injury” in 40 CFR § 112.2 of the Oil Pollution Prevention regulation was adapted from the definition of “injury” in the Department of the Interior (DOI) Natural Resources Damage Assessments (NRDA) final rule at 43 CFR Part 11 and includes only the part of the definition that addresses oil discharges, which EPA is now adapting for this regulation to provide regulatory consistency.

In response to the commenter who stated that the definition of “injury” could apply to “insubstantial effects” rather than “substantial harm,” EPA notes that the definition of “injury” is intended to assist in the identification of onshore non-transportation-related facilities that could cause substantial harm. The potential for a spill to cause an injury to fish, wildlife, or sensitive environments (FWSE) or public receptors is coupled with the screening criteria to determine if an onshore non-transportation-related facility could cause substantial harm to the environment. In that context, causing injury indicates the potential for a worst case discharge to cause substantial harm to the environment. EPA concludes that the injury relies on changes that have been demonstrated to adversely impact the resources in question, or services provided by those resources.

While “injury” to a public receptor as a concept may be new to the regulatory community, EPA holds that it is an important consideration due to the variability of CWA hazardous substances, how they act in water, their effects environment, and their impact on the potentially exposed public. EPA agrees that a measurable effect is not necessarily substantial, but notes that the proposed endpoints both are measurable and indicate a facility could cause substantial harm from a worst case discharge into or on the navigable waters or a conveyance to navigable water. EPA maintains that harm to the environment may comprise adverse effects on a public receptor. Water quality is one aspect of the proposed substantial harm criteria, and EPA has carefully calibrated the various pieces to ensure protection of PWSs, FWSE, and public receptors.

EPA disagrees that it has not provided a clear statement of the proposed Agency action – while the proposal provided many areas for public participation, this was deliberate and to ensure a full and robust engagement with interested parties.

Background Analyses
1. CWA Hazardous Substance Discharge History and Impacts Analysis

No comments

Discharge History and Reported Impacts

Public Comment Summary:

Oppose

Several commenters do not believe EPA has provided the required data to show the need for this proposed rule (0154, 0171, 0175, 0176, 0179, 0187, 0188, 0191, 0192, 0194, 0197, 0204, 0218, 0229, 0234, 0266). Commenters stated that the 24 percent decline in average discharges per year over the 2010 to 2019 timeframe that EPA noted in the proposed rule shows that there is strong evidence that the industry is already devoting the necessary resources and capabilities to prevent and respond to discharges that may reach navigable waters (0175, 0187, 0188, 0191, 0192, 0194, 0204). To support their comment, a couple of commenters noted that EPA stated in the proposed rule that “[w]hile 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” (0176, 0192).

One commenter suggested that EPA look at how it can work with industry to assist in facilitating the continued decline in discharges. The commenter added that this rule does not offer any measures to support facilities in preventing discharges before they happen and shifting to a proactive focus would yield more significant results and be more acceptable to industry (0194).

Another commenter expressed concerns that EPA is relying solely on the National Response Center (NRC) data, which may misrepresent the nature of the discharges. The commenter noted that NRC reports are required immediately following an incident before a facility has accurate and complete information about the discharge and there is no requirement to update the information or impacts of the incident in NRC reports once additional and more precise information is available. The commenter suggested that EPA perform further analysis to ensure reportable quantities (RQs) were exceeded and releases were to jurisdictional waters, and to clarify any over- or under-reporting during the initial report (0197).

One commenter noted that EPA’s analysis of CWA hazardous substance discharges using NRC data from 2007 to 2016 showed that an overwhelming number of discharges with impacts were attributable to causes that the commenter claimed would not be prevented by additional regulation (e.g., illegal dumping, equipment failure, operator error) (0181).

EPA Response:

EPA has judged the underlying data as sufficient to warrant a regulatory program as detailed in Chapter 3 of the RIA, available in the docket. As detailed therein, EPA analyzed NRC data on CWA hazardous substance discharges to water. Title 40 CFR § 117.21 requires immediate notification to the NRC once the person in charge of a vessel or an offshore or onshore facility has knowledge of a discharge of a CWA hazardous substance from the facility in quantities equal to or exceeding its assigned RQ in any 24-hour period. NRC data are generated by notifications received immediately following a discharge and often lack complete information on chemicals and quantities discharged, incident and response details, impacts, and locations. Nonetheless, NRC data are the most complete dataset available and are a starting point for further analysis to inform CWA hazardous substance worst case discharge occurrences.

Additionally, EPA researched complementary databases to augment the impact information for NRC-reported discharges, as detailed in Chapter 3 of the RIA available in the docket. While EPA’s analysis of NRC data shows a decline in the average number of CWA hazardous substance discharges from 2010 to 2019, past discharge history is not a guarantee of future outcomes, nor does the number of discharges definitively indicate the level of impact of those discharges. Thus, it is possible that a smaller number of higher consequence discharges could cause more adverse impacts due to the circumstances of the incident. Based on past experiences of oil and chemical spills, EPA has observed data gaps with NRC reports, but continues to improve oil and CWA hazardous substance discharge data as incidents progress through regional and EPA Emergency Operations Center reporting. Furthermore, the NRC dataset is the most complete available, and it does show that CWA hazardous substance discharges to water continue to occur. Accordingly, EPA has determined that worst case discharge planning regulations for CWA hazardous substances are critical to protect the environment, keep our waterways safe and clean, and protect human health.

While this final regulation does not address the causes of worst case discharges, it does require comprehensive response planning regardless of how a CWA hazardous substance discharge occurs. By focusing on facilities within one-half mile to navigable waters or a conveyance to navigable waters that also have more than the threshold quantity and meet one or more proposed substantial harm criteria, the final regulation will appropriately ensure robust planning for covered facilities that pose the highest risk of causing substantial harm to the environment.

Most Frequently Discharged CWA Hazardous Substance

Public Comment Summary:

Support

Several commenters agreed stricter regulations on CWA hazardous substances are needed to keep them out of waterways (0148, 0154, 0166, 0203, 0228, 0256). Some commenters specifically stressed the human health risks associated with exposure to polychlorinated biphenyls (PCBs) and polyfluoroalkyl substances (PFAS), citing specific examples of contamination to waterways (0166, 0203, 0227, 0228, 0256). One commenter cited a study by David Carpenter in 2006 showing “PCB exposure, especially during fetal and early life, reduces IQ and alters behavior. The PCBs alter thyroid and reproductive function in both males and females and increase the risk of developing cardiovascular and liver disease and diabetes” (0256). Another commenter cited a cancer study conducted in 1987 and peer-reviewed by 15 PCB experts showing definitive evidence that exposure to PCBs poses considerable cancer risks to humans and animals (0166, 0192, 0201).

Oppose

Several commenters stated that it seems impractical to require worst case discharge planning for all CWA hazardous substances since 15 chemicals accounted for 90 percent of the CWA hazardous substance discharge incidents. The commenters suggested that EPA narrow the number of CWA hazardous substances affected by the proposed rule with a focus on PCBs (0188, 0192, 0197, 0201).

One commenter noted that because PCBs are no longer commercially produced and stored in containers such as tanks, PCBs make up a very small portion of hazardous discharges. The commenter added that stricter regulations on PCBs will, therefore, result in very small improvements in discharges to water bodies while resulting in burdensome costs (0197).

EPA Response:

EPA agrees that worst case discharge regulations for CWA hazardous substances are critical to protect the environment, keeping our waterways safe and clean, and protecting human health but notes that PFAS are not currently listed under 40 CFR Part 116 and thus are not regulated under this action.

While 15 chemicals account for most of the CWA hazardous substance reported discharges to the NRC, these data often lack the names and quantities of chemicals discharged, and do not reflect future probabilities of release. Also, the frequency of reported releases does not reflect the impacts that could occur with a worst case discharge. Despite some commenters suggesting EPA narrow the number of CWA hazardous substances covered by the final rule, changing the list of CWA hazardous substances in 40 CFR Part 116 is outside the scope of this action. With respect to PCBs, their manufacture was banned in 1979 and so they are no longer commercially produced. Currently, as per the EPA’s analysis of NRC data in the TBD, PCB releases most commonly occur due to damage to electrical transformers, where the PCBs are mixed with oil and regulated under the Oil Pollution Prevention Regulation at 40 CFR 112. As other commenters noted, their detrimental health effects when released can be severe, so increased response planning is warranted for those facilities that meet the applicability criteria in 40 CFR Part 118.3.

Impacts to Waterways and Sensitive Environments

Public Comment Summary:

Support

One commenter emphasized support of the proposed rule as it pertains to the impact to waterways and sensitive environments. The commenter noted that waterways need to be protected since they hold diverse marine life as well as give humans food and means of transportation. The commenter added that despite efforts to ban companies from dumping hazardous materials into the ocean, companies continue to dump. Additionally, the commenter stated that even if not directly dumped, hazardous materials can still leak into many different types of waterways. The commenter stated that the proposed rule would help protect waterways and improve marine life and oceans more generally (0305).

EPA Response:

EPA agrees that worst case discharge regulations for CWA hazardous substances are critical to protect the environment, keep our waterways safe and clean, and protect human health.

National Response Center Data Limitations

No comments

Data Sources Examined

Public Comment Summary:

Oppose

One commenter noted that with regards to the examination of data sources, the proposed rule does not reference a recent analysis prepared by EPA’s Water Security Division in support of America’s Water Infrastructure Act of 2018. The commenter stated that this study found that “there is a significant risk of releases into sources of drinking water at a national scale” and “demonstrates that releases to sources of drinking water occurred at an average rate of 393 releases per year over the 10-year study period.” The commenter stated that the report also demonstrates this risk is not equally distributed across the water sector – some community water systems are at substantially greater risk of releases to their source water (0207).

The commenter mentioned that the analysis used to assess the scope of hazardous discharges instances was limited in two respects: (1) most of the data sources are not geared toward capturing worst case discharges of CWA hazardous substances and (2) those discharges observed were constrained to the current list of CWA hazardous substances. The commenter stated that this approach underestimates the potential universe of facilities with CWA hazardous substances onsite because industries are not evenly distributed among the states and certain types of industries may not even be represented in each state. The commenter suggested that EPA should work with states to properly tabulate the actual total universe of facilities with CWA hazardous substances onsite based on Emergency Planning and Community Right-to-Know Act (EPCRA) Tier II reporting data (0207).

EPA Response:

EPA’s Water Security Division report “Occurrence of Releases with the Potential to Impact Sources of Drinking Water” (EPA 817-R-21-001) is a useful reference as to general releases that could reach sources of drinking water. However, the report shows that the majority of historical releases captured in the data are clearly not CWA hazardous substances. In addition, it is unclear as to whether several categories of substances contain CWA hazardous substances (e.g., 56.8 percent (2,401) Refined Oil, 9.4 percent (398) of Crude Petroleum), while transformer oil may contain PCBs, though they were banned in 1979. Additionally, the report covers releases resulting from transportation accidents and illegal dumping, which are outside the scope of this rule. Illegal dumping occurs offsite from a facility and as such would not be regulated under this action, which covers worst case discharges from facilities. The report also shows that 54 percent of releases involved less than 1,000 gallons, and thus would likely not be considered worst case discharges. EPA does not dispute that there is significant risk to sources of drinking water but was unable to reference this report due to its focus on non-CWA hazardous substances and releases with other characteristics outside of the scope of this rule.

EPA has not been able to identify a data source that collects reports of worst case discharges of CWA hazardous substances. In the absence of such a data source, EPA conducted its facility universe estimations using a voluntarily submitted set of EPCRA Tier II data from a 2018 Information Collection Request and extrapolated the data method using North American Industry Classification (NAICS) codes adjusted for industry distribution across different states. EPCRA Tier II reporting data are submitted to the states. EPA has no authority to collect these data and believes it has calculated a reasonable approximation of the facility universe. Furthermore, modifying the list of CWA hazardous substances in 40 CFR Part 116 is outside the scope of this rulemaking.

Analysis of Existing Programs/Technical Background Document/Other Programs or Standards with Potential Overlap

Public Comment Summary:

Support

One commenter pointed to EPA’s analysis finding inconsistent state coverage for CWA hazardous substance discharge protection and stated that it was unsafe for prevention and response to be left to states alone (0347).

Oppose

Several commenters requested that EPA exempt facilities and/or chemicals covered under other regulatory programs. As one such example, several commenters claimed that the Risk Management Program (RMP) at least partially addresses each major aspect of the proposed rule (e.g., hazard assessment, prevention program, emergency response program), would require costly duplicative work, and would not decrease the risks of discharge due to response plans for worst case discharge already being in place under RMP. These commenters asked for exemptions for RMP-covered facilities, chemicals, or both (0175, 0176, 0179, 0180, 0181, 0183, 0184, 0185, 0191, 0194, 0195, 0196, 0199, 0204, 0206, 0211, 0212, 0218, 0219). Several commenters added that the following regulations and programs already prevent and control CWA hazardous substance discharges and may cover all or many CWA hazardous substances: Oil Pollution Prevention regulation FRP; Resource Conservation and Recovery Act (RCRA) (contingency plans in particular); the Occupational Safety and Health Administration’s (OSHA’s) Process Safety Management (PSM); National Pollutant Discharge Elimination System (NPDES); Toxic Substances Control Act (TSCA); Underground Storage Tank (UST); Oil Pollution Prevention SPCC; Bureau of Alcohol, Tobacco, Firearms and Explosives ammonium nitrate-fuel oil (ANFO) requirements; U.S. Department of Transportation (USDOT) for product and waste shipping; U.S. Department of Homeland Security (DHS) Chemical Facility Anti-Terrorism Standards (CFATS); CWA Multi-Sector General Permit and Stormwater Discharges Associated with Industrial Activity; and several state programs (e.g., aboveground storage tanks (ASTs) requiring secondary containment, emergency plans required by Wyoming and California, plans by Louisiana, North Carolina, West Virginia) (0179, 0181, 0183, 0184, 0185, 0186, 0188, 0190, 0192, 0193, 0195, 0199, 0206, 0211, 0212, 0219).

One commenter demonstrated several similar regulatory elements in RCRA regulations for contingency plans, including integration with the NRC and Area Contingency Plans (ACPs) (87 FR 17892, March 28, 2022), and pointed to Congress’s direction to agencies to avoid redundancy under the NCP. The commenter stated that all facilities storing or using CWA hazardous substances above reporting thresholds would trigger the EPCRA Reporting Rule (0181). A few commenters requested that EPA analyze areas of overlap between the proposed rule and existing regulations and then streamline the final rule to avoid duplication (0206, 0211, 0212). One commenter asked that the Office of Emergency Management (OEM) communicate with the RMP office and include in the final preamble how this rule does not duplicate provisions in RMP (0180). Another commenter encouraged OEM to confer with the Office of Resource Conservation and Recovery (ORCR) on the RCRA requirements for facilities (0186).

A few commenters asked EPA to exempt all 40 CFR § 116.4 substances already regulated as oils under 40 CFR Part 112 to avoid duplicative efforts (0179, 0183, 0219). One commenter stressed the importance of avoiding duplicative regulatory burdens and increasing operating costs specifically at agricultural facilities, citing facilities that are covered under RMP for anhydrous ammonia storage (0176). Two commenters also noted the potential dual coverage for ammonia and naphthalene at specific facilities, which could be burdensome and confusing for emergency responders, and requested that EPA exempt it along with other RMP chemicals (0183, 0184). Two commenters stated that EPA should include exemptions following EPCRA 312 Tier II reporting, specifically those listed under 40 CFR § 370.13 for threshold determinations (0199, 0211).

One commenter requested that EPA revise the proposed rule to cover different facilities with different requirements based on their specific processes and requested exemptions for facilities that store and handle pesticide products, noting similar overlap (0176). One commenter noted requirements under the CWA Multi-Sector General Permit for scenario-based emergency procedures for major storms that identify emergency contacts and staff and require training, among other related provisions. The commenter also noted the spill prevention and response measures under NPDES permits for non-stormwater discharge at mine sites. The commenter additionally identified two specific regulatory programs relevant to mining facilities: the Federal Mine Safety and Health Act of 1977, which requires evaluation, storage, and inspection of CWA hazardous substances, and the Surface Mining Control and Reclamation Act (for coal mining facilities), which requires water control structures and monitoring and may require additional preventative measures (0192). One commenter noted OSHA’s PSM program’s goals to prevent or minimize release impacts, along with chemical management plans, and asked for an exemption for facilities and/or substances covered under the program (0219).

One commenter provided chlorine at public water system (PWS) facilities as an example where a gaseous substance is covered under RMP and would not flow directly into a water of the United States (WOTUS) and requested that EPA clarify this type of situation (0180). Another commenter pointed to significant industry guidance for managing chlor-alkali substances as another example where existing commitments support exempting facilities from the proposed rule who are already subject to RMP (0196). One commenter noted two voluntary programs that apply specifically to the fertilizer industry, ResponsibleAg and Recommended Mechanical Integrity Practices for Above Ground Storage Tanks from The Fertilizer Institute. The commenter pointed to ResponsibleAg’s promotion of inspection best practices for hazardous substance tanks, engineering for spill containment, and training, while noting the Recommended Mechanical Integrity Practices for Aboveground Storage Tanks provision of design, build, and inspection guidelines for such tanks to prevent hazardous substance releases (0197). One commenter believed that perceived gaps in existing programs are better implemented by states, refinements to existing programs, or narrowly tailored gap-filling instead of blanket programs (0183).

One commenter relatedly described secondary containment requirements for tanks in Minnesota and threshold requirements for CWA hazardous substances in Colorado requiring secondary containment or double-walled tanks, and the prevalence of facility-maintained emergency response plans that already include specific actions and procedures in the event of a discharge (0185). Another commenter noted that West Virginia’s comprehensive regulations in hazardous waste storage address worst case discharge situations in a different manner, elevating the risk of overlapping or conflicting requirements. The commenter requested exemptions for facilities already regulated at the state level (0190). One commenter noted the provisions in RCRA to use secondary containment systems to mitigate discharges with capacity to contain the largest container or 10 percent of the total container and including leak detection systems, which the commenter stated prevent and control worst case discharges. The commenter cited EPA’s exemption of USTs from CWA § 311(j)(5) requirements, on the basis that 40 CFR Part 280 requirements are comprehensive and require secondary containment, which further support exempting CWA hazardous substances regulated under RCRA due to similar secondary containment standards (0186). One commenter requested that EPA clarify how the proposed rule would affect PWSs that store CWA hazardous substances and asked that no additional or unnecessary burdens be imposed on PWSs through this proposed rule (0180).

EPA Response:

Many commenters point out that other EPA programs cover, in some fashion or another, some CWA hazardous substances and therefore assert this rule is duplicative and should not extend to those chemicals. However, other EPA programs are not specific to worst case discharges of CWA hazardous substances into or on the navigable waters, do not cover all the required program elements under CWA § 311(j)(5), and are not an appropriate substitute. That said, where appropriate, EPA has created exemptions and taken measures to limit duplicative regulatory overlap. Chapter 2 of the TBD available in the docket details potential regulatory overlap in related programs, and EPA has adjusted some exemptions in § 118.8 to account for existing programs.

In addition, a regulated facility owner or operator is able to augment an existing plan with the requirements in the final rule; however, a facility owner or operator may not assume they satisfy the requirements of this rule simply because they are compliant with regulations under other programs. For example, of the 296 CWA hazardous substances listed in 40 CFR § 116.4, 30 are listed at 40 CFR § 68.130 and covered by RMP. For facilities that meet the applicability criteria in 40 CFR § 118.3 for those CWA hazardous substances that are also regulated under RMP, their RMP may be augmented to meet the requirements of 40 CFR Part 118, by adding program elements to their plan. These include a hazard evaluation including worst case discharge scenario analysis; qualified individual (QI)identification and duties; identifying and ensuring removal and mitigation personnel and equipment; and describing training, equipment testing, periodic unannounced drills, and response actions for worst case discharges of CWA hazardous substances into or on the navigable waters or a conveyance to navigable waters. Thus, facilities cannot assume that they meet the requirements of this rule just because they are also regulated under RMP.

After examining the RCRA regulations and commenter concerns, EPA is adding an exemption at § 118.8(b)(2)(viii) for the storage and accumulation of hazardous waste subject to the “Standards for Owners and Operators of Hazardous Waste Treatment, Storage, and Disposal Facilities (TSDF),” 40 CFR Part 264 and Part 265, and “Standards Applicable to Generators of Hazardous Waste,” 40 CFR Part 262, subpart M. For covered facilities subject to the TSDF requirements under 40 CFR Part 264 and Part 265, these regulations comprehensively address the program elements required under CWA § 311(j)(5)(D) and thus are not regulated by this action. For hazardous waste generators covered under 40 CFR Part 262, EPA is exempting those generators subject to subpart M (i.e., large quantity generators) for the same reason; the contingency plan and emergency procedures requirements therein comprehensively address the program elements required under CWA § 311(j)(5)(D). While small quantity generators have preparedness and prevention requirements, these do not cover all the required program elements under CWA § 311(j)(5)(D), and very small quantity generators are not subject to prevention and preparedness requirements nor required to develop a contingency plan and emergency procedures. Since hazardous wastes at these generators may contain CWA hazardous substances and are not subject to all RCRA hazardous waste requirements, EPA has decided that hazardous waste generators not subject to RCRA part 262, subpart M requirements must follow the applicability criteria at § 118.3 to determine if they could cause substantial harm to the environment through a worst case discharge into or on navigable waters. Non-hazardous solid waste is also subject to this final rule.

For specific programs:

The RMP program under the authority in the Clean Air Act (CAA) is for accidental air releases; for that reason alone, it is insufficient to rely upon to determine if a facility could cause substantial harm to the environment by discharging into or on the navigable waters (40 CFR Part 68).
The Oil Pollution Prevention FRP regulation is comprehensive for worst case oil discharge planning but does not address worst case discharges of CWA hazardous substances that are not mixed with oil. Similarly, the Oil Pollution Prevention SPCC program regulates oils, specifically the prevention of oil discharges (40 CFR Part 112) but does not address discharge prevention of CWA hazardous substances unless they are mixed with oil.
OSHA’s PSM program sets requirements for preventing or minimizing the consequences of catastrophic releases of toxic, reactive, flammable, or explosive chemicals in order to protect workers. The provisions of the PSM standard were written to assure safe and healthful working conditions for employees, not to protect the environment from discharges of CWA hazardous substances. (29 CFR § 1910.119).
The CWA NPDES Permit Program, authorized by the CWA, controls water pollution by regulating point sources that discharge pollutants into waters of the United States (WOTUS). An NPDES permit establishes limits on what can be discharged, monitoring and reporting requirements, and other provisions to protect water quality. In essence, the permit translates general requirements of the CWA into specific provisions tailored to the operations of the facility discharging pollutants. A NPDES general permit may be written to establish requirements that apply to eligible facilities with similar operations and types of discharges that obtain authorization to discharge under the general permit. It does not require response planning (40 CFR Part 122).
Bureau of Alcohol, Tobacco, Firearms and Explosives ANFO requirements apply to ANFO, which is not a CWA hazardous substance (27 CFR Part 555).
USDOT regulations for product and waste shipping apply to items in transportation, while this proposal applies explicitly to onshore facilities not in transportation (49 CFR Parts 171-185).
DHS regulations do not require planning for worst case discharges of CWA hazardous substance into navigable water; rather, they identify and regulate high-risk facilities to ensure security measures are in place to reduce the risk that certain dangerous chemicals are weaponized by terrorists (6 CFR Part 27).
The EPCRA Reporting Rule is a reporting rule and does not require worst case discharge planning for CWA hazardous substances into or on the navigable waters (40 CFR Part 370).
PCBs are regulated under TSCA; however, TSCA PCBs Manufacturing, Processing, Distribution in Commerce, and Use Prohibitions (40 CFR Part 761) generally do not have provisions relevant to the requirements in CWA § 311(j)(5), except for the requirement that response plans shall be consistent with the requirements of the NCP and Area Contingency Plans (ACPs). There is no response plan requirement, but reporting requirements reference the NCP. PCBs are usually found in mineral oil, and therefore would be covered under the Oil Pollution Prevention SPCC regulations. However, they are typically not stored in large enough amounts for facilities with PCBs onsite to become subject to the Oil Pollution Prevention FRP rule requirements.

Additionally, EPA excepts tanks already regulated under the UST program at 40 CFR Part 280 at § 118.8(a)(4).

EPA disagrees that the proposal should cover different facilities with different requirements; instead, a facility owner or operator may augment an existing plan with the required program elements or reference existing program elements in their plan. As various EPA pesticide programs do not cover all the required program elements, EPA disagrees that facilities storing those CWA hazardous substances should not be regulated by the proposal. Similarly, any CWA Multi-Sector General Permit, spill prevention and response measures under NPDES permits for non-stormwater discharge at mine sites, Federal Mine Safety and Health Act of 1977 requirements, or Surface Mining Control and Reclamation Act (for coal mining facilities) items that adequately provide coverage for the required program elements may be included in CWA hazardous substance FRPs. However, these are not comprehensive for worst case discharge planning for CWA hazardous substances as per the TBD.

EPA agrees that state coverage for CWA hazardous substance worst case discharge planning is inconsistent and does not fulfill the nationally applicable statutory requirement. EPA also recognizes that industry guidance and voluntary programs are valuable resources for ensuring safe, protective practices. However, those practices are not enforceable nor required, and do not fulfill the statutory requirements of this action. To the extent that state programs are comprehensive for CWA hazardous substance worst case discharge planning, a facility owner or operators may reference their state-required plan in their CWA hazardous substance FRP.

PWSs that have CWA hazardous substances onsite are regulated under this proposal since they could cause substantial harm to the environment from a worst case discharge of CWA hazardous substances into or on the navigable waters or a conveyance to navigable waters.

Finally, EPA is not covering substances present as oil and that may be part of an oil mixture, such as gasoline, at regulated facilities under this action since those are regulated under 40 CFR 112.20.

Proposed Actions
1. Definitions
  1. Facilities Located Offshore Landward of the Coastline

Public Comment Summary:

Oppose

One commenter suggested that both onshore and offshore facilities should be held accountable for creating a cohesive response plan to the unintended hazardous wastes they may produce (0256).

Another commenter suggested that after the proposed rule is implemented, additional research should be done in an effort to examine if the final rule has decreased the amount of CWA hazardous substances released during a worst case discharge scenario. The commenter added that if the final rule leads to a decrease, then it should be further proposed on more facilities that are not onshore, but still remain as an environmental threat (0148).

EPA Response:

The jurisdictional responsibilities for offshore non-transportation-related facilities landward of the coastline, pursuant to § 311 (j)(1)I, (j)(5), and (j)(6)(A) of the CWA, as amended by the OPA (Public Law 101–380) has been delegated to EPA. See 40 CFR Part 112, Appendix B. However, this action is limited to non-transportation-related onshore facilities, in large part, because EPA did not have sufficient data – and no data were submitted – to support additional regulation for facilities offshore landward of the coastline. Therefore, EPA is not expanding the scope of this final action but reserves the right under its authority to add requirements should the need arise and data support it.

Request for Clarification

A couple of commenters requested that EPA provide additional clarity for its definitions of key terms and other guidance for facilities to determine a worst case discharge scenario. These comments claimed that the proposed rule leaves key concepts undefined and asserted that the rule would benefit from additional clarity (0192, 0204).

EPA Response:

EPA is committed to providing clarity throughout this action and has provided it in response to commenter concerns in cases where it was warranted. Please see specific responses to comments for further detail.

Adverse Weather

Public Comment Summary:

Oppose

Several commenters asserted that the definition of “adverse weather” is ambiguous, subjective, and unclear and urged EPA to redefine it in a clear and objective manner. These commenters suggested the ambiguity of this definition will cause uneven implementation and will lead to different interpretations of the proposed rule, which adds a burden on facilities (0175, 0187, 0188, 0191, 0192, 0194, 0196, 0204, 0205, 0218). Another commenter asserted that “adverse weather” is too broadly defined and recommended that EPA instead express an adverse weather condition as a specific design storm event and equip facilities with data to make better informed decisions in preparation for extreme weather (0205). One commenter recommended EPA define “adverse weather” as “20-year storm conditions” to enhance clarity and consistency of this term (0191).

Another commenter urged EPA to provide examples of what is covered by and what exactly “severe extreme weather events” means (e.g., 100-year flood, typical large hurricane event for an area, typical heavy snow event for an area, normal drought conditions for an area). This commenter requested additional clarification on whether most significant impacts of adverse weather events occur during wet or dry weather. This commenter also suggested that severe extreme weather events within this definition should be limited to likely events, not potential events, and boundaries should be set for highly unlikely worst case types of weather events (0179).

Several commenters requested clarification and guidance as to how facilities should evaluate and consider impacts of climate change in evaluating adverse weather conditions, such as sea level rise and increased severe weather events that are harder to predict (0188, 0192, 0197, 0199, 0211, 0213). One commenter requested clarification if the definition of “adverse weather” will include recognition of CWA hazardous substances released in areas of drought with minimal water availability and asked how emergency use of accessible groundwater would be applied in these drought circumstances (0167). A couple of commenters suggested wildfires and flooding should be explicitly added to the definition of “adverse weather” as these events become “more intense and more frequent” due to climate change (0215, 0217). One commenter noted that wildfires and flooding cause damage to infrastructure, equipment, power and communication lines, water supply, and roads; can cause a river to exceed its capacity; and make it difficult to respond to a CWA hazardous substance discharge (0217). One commenter highlighted that the CWA specifically recognizes fires and explosions as potential causes of worst case discharges due to adverse weather, and this rule should follow suit (0215).

A couple of commenters discussed the idea of dilution and how it should be considered in the rule. The commenters noted that when a maximum flood condition is met or heavy rains occur, increased dilution and reduced distances to endpoints may occur (0179, 0205). Additionally, one commenter asserted that drought conditions may be more damaging than a hurricane due to dilution, which the proposed rule did not take into consideration, and that EPA should not include this as a factor for determining overall planning distance (0179). One commenter recommended that EPA understand whether or not response to a worst case discharge during a hurricane or flooding is even feasible given the risk of loss of human life (0205).

EPA Response:

EPA carefully considered all the comments advocating that the definition of “adverse weather” should be revised. To the extent that commenters are concerned with “ambiguity,” it seems largely because they are interested in narrowing the definition to a limited number of clearly delineated events. However, the definition is intentionally broad and meant to capture the wide range of potential weather changes and conditions due to the nation’s varying regional weather patterns. Prescribing specific types of events or adverse weather conditions is unrealistic and does not represent the myriad of challenges facing our nation due to climate change.

EPA also disagrees with commenters who asserted that the breadth of this definition will cause uneven implementation of the final rule; rather, it will allow facility owners or operators and local emergency planners to consider the full range of potential adverse weather events that could impact the facility and affect worst case discharge response planning as well as changing conditions and emerging threats such as the widening impact of extreme heat. For example, while specific events, such as “20-year storm conditions” may be useful as one type of climatological condition to consider in one region, EPA agrees that it is equally important to consider effects of, for example, increased drought or lack of rain activity in other regions and the effects on a potential worst case discharges of CWA hazardous substances. As such, EPA has added language describing some types of climate change impacts that may need to be considered when accounting for adverse weather conditions during a worst case discharge of CWA hazardous substances into or on the navigable waters or a conveyance to navigable water, such as the increased frequency and intensity of extreme weather events, temperature fluctuations, rising seas, storm surges, inland and coastal flooding, drought, wildfires, and permafrost melt in northern areas.

EPA recognizes that, given the increased probability of extreme weather events, historic incidents are becoming less of a predictor of future effects. Compliance assistance will be available to aid owners or operators in determining the appropriate types and severity of weather events, sea level rise, drought, flooding, heat, wildfire, subsidence risk, etc., to consider for their worst case discharge in adverse weather, as well as references and data sources. Additionally, in the final rule, EPA recognizes that risks to discharges due to fire and explosions are explicitly covered by this regulation and notes that emergency response should always prioritize risk to human life. A facility owner or operator would need to plan for potential emergency use of accessible groundwater in coordination with local authorities.

Public Comment Summary:

Collaboration

A couple of commenters highlighted the need to consider collaboration with local and state agencies to avoid duplicative efforts and to use adverse weather planning systems and ACPs already in place (0179, 0205). Adding to this, one of these commenters noted that weather events impact more than one facility and areas beyond the control of individual facilities. The commenter added that collaborating at the ACP level will help address local risks and provide historical insight necessary to determine the level of risk (0179).

EPA Response:

EPA agrees that coordinating plans with state and local agencies, as well as ACPs, is critical for effective response efforts. As per § 118.11(a)(1), all plans must be consistent with the requirements of the NCP (40 CFR Part 300) and applicable ACPs prepared pursuant to § 311(j)(4) of the CWA. In addition, under § 118.12, plans must be coordinated with the local emergency response plan developed by the Local Emergency Planning Committee (LEPC) or Tribal Emergency Planning Committee (TEPC) under § 303 of Title III of the Superfund Amendments and Reauthorization Act of 1986 (SARA; 42 USC 11001 et seq.).

Public Comment Summary:

Oil Pollution Prevention Regulation

A couple of commenters referenced the Oil Pollution Prevention regulation’s definition of adverse weather, which includes factors such as wave height, ice conditions, temperatures, weather-related visibility, and currents. These commenters suggested that this proposed rule should apply clarity and specificity on the definition of “adverse weather” that is similar to the Oil Pollution Prevention regulation (0199, 0211).

EPA Response:

EPA chose to define “adverse weather” in this final rule differently from the Oil Pollution Prevention regulation definition of adverse weather found in 40 CFR § 112.2, which is “weather conditions that make it difficult for response equipment and personnel to cleanup discharged oil or hazardous substances” to highlight the impact of climate change on the analysis of appropriate response actions for myriad CWA hazardous substances. These definitions are complementary, and the definition in 40 CFR § 118.2 does not list specific considerations due to the variance in physiochemical properties of the 296 listed CWA hazardous substances. The list of weather conditions are considerations that the plan holder may take into account when determining their worst case discharge scenario based on local or regional weather patterns.

Container

Public Comment Summary:

Several commenters noted that the definition of “container” is not consistent with the SPCC regulations in 40 CFR Part 112 and does not follow the same exemption for containers below 55 gallons (0179, 0197, 0199, 0204, 0211). One commenter added that it is necessary to set a de minimis capacity of the containers (i.e., 55 gallons as in the SPCC regulation) and referenced 67 FR 47066 (July 17, 2002), which sets a minimum container size of 55 gallons (0179). One commenter stated that by adopting this exemption, it would reduce a site’s burden in accounting for CWA hazardous substances in liter jars or 5-gallon containers for RQ threshold determination (0211).

A few commenters suggested EPA take into consideration the size of the containers when determining the multiplier. The commenters noted that if a facility has many containers that are small in size, the number of containers could trigger the threshold value but would have minimal impact on the worst case discharge quantity (0179, 0201, 0204).

A few commenters recommended the final rule consider including an exclusion for small containers, similarly to the SPCC. The commenters noted that this exclusion would reduce the burden on facilities when determining aggregated onsite capacity and that small containers can easily be cleaned up by site personnel, so they do not have the same impact as a release from a larger container (0184, 0204, 0211).

One commenter stated that containers that are small, such as those in labs, do not pose any “substantial risk” to the environment that would technically fall under this definition (0199). One commenter stated that the definition will allow facilities to concentrate on their response to discharges from sources most likely to present a significant risk to human health and the environment. The commenter also stated that if EPA chooses to include container sizes based on the RQ, they should use a size that is “equal or less than” the RQ. The commenter stated that this will exclude containers that are less than 55 gallons and would help provide clarification for capacity requirements (0179). One commenter recommended EPA narrow its definition to “have a threshold for container size” (0197).

One commenter recommended EPA break containers into bulk storage (fixed, portable, and mobile), manufacturing (process) equipment, and operational equipment to be consistent with 40 CFR Part 112 (0179).

One commenter requested clarification for the term “device” within the definition of “container” (0211). Two commenters noted that while the examples acknowledged in the preamble are helpful, EPA should expand these examples by including language identifying additional examples such as “vessel, canister, drum, tank, dumpster, bulk cargo container” and by noting that containers are “typically sealed or closed with a closure device such as a cover, cap, hatch, lid, plug, seal, valve, or other type of fitting” and “are constructed primarily of non-earthen materials (e.g., wood, concrete, steel, plastic), which provide structural support” (0192, 0211). One commenter emphasized that the “aggregation of capacity” should not necessarily include every container onsite because of the varying impacts from a release by a small container versus a large container. The commenter requested EPA limit the “types and sizes of containers” that are included in the rule (0211). One commenter requested EPA make it clear that its maximum onsite capacity criterion applicable to “containers,” only applies to bulk portable devices and tanks, consistent with its SPCC regulations for oil. The SPCC regulations apply only to bulk aboveground containers, completely buried tanks, any container that is used for standby storage, for seasonal storage, or for temporary storage, or not otherwise permanently closed, and any bunkered tank, partially buried tank, or any container in a vault. The commenter added that that the broad definition of “container” could be interpreted to include a surface impoundment, which is not regulated under SPCC regulations (0197).

One commenter noted the definition implies that containers have piping to and from them that is interconnected, which is too open-ended and should be consistent with the wording found in 40 CFR Part 112 (0179).

One commenter stated that if EPA uses shell capacity, as discussed in the preamble, it is necessary to define the storage of a container using the plain language of shell capacity as found in the definition (0179).

EPA Response:

The primary reason for the definition of “container” and the lack of definition for “bulk storage container” in this action when compared with the Oil Pollution Prevention Regulation in 40 CFR § 112.2 is because the two regulations do not cover the same substances. Additionally, while the Oil Pollution Prevention regulation has determined that a 55-gallon de minimis container size is appropriate, as noted by commenters, this is not the case for CWA hazardous substances. To the contrary, certain CWA hazardous substances have been determined that they “may be harmful” at quantities as low as one pound. Accordingly, a 55-gallon container size would be an inappropriate de minimis amount for all substances because smaller containers may contain hazardous levels of substances that could cause substantial harm in the event of a worst case discharge, especially when aggregated. Additionally, CWA hazardous substances are stored in a wide variety of containers and in different forms (e.g., powder, granular, slurry), and CWA hazardous substances are typically measured and regulated¹ by mass (e.g., pounds), not volume (gallons), underscoring why a 55-gallon de minimis container standard would be unsuitable. Because of the variation of the chemical properties, including toxicity, of CWA hazardous substances, EPA has no basis for setting a de minimis container size or container quantity at 55-gallons or any other level, including the RQ level, as suggested by some commenters. Furthermore, the OPA Conference Report states that “. . . the selection criteria should not necessarily omit those smaller facilities that are near major water supplies or that are near environmentally sensitive areas.” (H.R. Rep. No. 101-653, 101^st Cong., 2d Sess., p. 151). Threshold determinations must consider all CWA hazardous substances present at the facility in the aggregate, but without consideration of container size or capacity because the maximum quantity onsite may contribute to the potential harm posed by a facility. For the commenters who asked for additional examples of containers, EPA notes that containers may consist of a rail car or other mobile storage not under active shipping papers, process vessel, canister, drum, bulk storage tank, dumpster, tote, or bulk cargo container positioned on land, among other things.

“Device” in this regulation is using the commonly understood dictionary definition of “a piece of equipment or a mechanism designed to serve a special purpose or perform a special function”². EPA will provide compliance assistance for implementation with additional examples of containers as needed.

EPA disagrees that the definition implies that containers have piping to and from them that is interconnected and notes that the definition is broad by design and inclusive of process vessels since they may store large quantities of CWA hazardous substances. EPA has no data to suggest excluding process tanks that are specifically used for research and are currently “idle,” as those tanks may still pose a risk of discharge.

Tanks, basins, or lagoons used for wastewater treatment are not excluded from the proposed rule should they contain above the threshold quantity of CWA hazardous substances regardless of how those operations are regulated under 40 CFR § 112.1(6), which applies to oil. EPA has no data to support that tanks, basins, or lagoon used for wastewater treatment are at a very low risk of catastrophic spilling or rupture such that it would be appropriate to categorically exclude them. However, a facility may use the appeals provision in § 118.6 to request reconsideration of their facility status as able to cause substantial harm or significant and substantial harm to the environment in a worst case discharge into or on the navigable waters or a conveyance to navigable water.

The exemption under § 118.8(b)(2)(iv) for use of process water or cooling water is specific to amounts of a CWA hazardous substance present in water drawn into a facility from the environment or municipal sources. For example, chlorine present in water taken from municipal sources does not have to be considered for threshold determination. This is consistent with the approach taken by other chemical regulations, including the Toxics Release Inventory (TRI) and RMP, and DHS’s Chemical Facility Anti-Terrorism Standards (CFATS) program and reflects the low level of risk of such waters. This final action does not define wastewater as part of process water, nor does it include water storage.

EPA recognizes that the proposed maximum capacity calculations for CWA hazardous substances may be complex and include different types of containers and mixtures throughout the operations of a facility. Thus, the Agency has determined that the calculation should be adjusted to reflect maximum quantity onsite, in an effort to better focus on facilities that could cause substantial harm to the environment due to a worst case discharge into or on the navigable waters, as discussed further later in this document and in the preamble to the final action. EPA agrees that plain language using “shell” capacity is useful and will adjust its approach when discussing capacity.

Conveyance

Public Comment Summary:

Several commenters noted that the proposal did not define “conveyance to a navigable waterway.” Without a definition, the commenters are concerned that the rule may be “applied unevenly” depending on each facility’s interpretation of this term as it remains unclear as to which facilities are included in the 0.5-mile screening criterion (0175, 0187, 0191, 0194, 0204, 0218). One commenter suggested EPA clearly define “distance” in the screening context and to “set the facility boundary as the starting point such that, for example, a facility would meet the half-mile threshold criterion if any part of the facility fell within one-half mile of a “navigable water” or conveyance thereto (0215). The commenters stated that by clearly defining this term, facilities will be able to make better informed decisions on whether they meet the screening criteria (0175, 0187, 0191, 0194, 0204, 0218).

Several other commenters expressed concern over the term “conveyance to a navigable waterway” (0179, 0188, 0192, 0196, 0199, 0205, 0211, 0215, 0219). One of these commenters noted that the definition of “conveyance to a navigable waterway” is a key element in determining whether the facility must conduct worst case response planning. The commenter added that the proposal offers uncertainty in that it includes things that are not a waterway (e.g., adjoining shorelines) and references a definition in another regulation that explicitly excludes things that might fall within some interpretations of the term “conveyance” (referencing 40 CFR § 120.2) (0205). One commenter requested EPA provide a definition of what is covered and what extent of conveyance is intended in this definition to help clarify the time duration that should be used to determine whether something will reach navigable water (0179). To provide clarity on this term, one commenter recommended EPA explicitly define “conveyance to navigable waters” to include any human-made or natural feature that would permit a worst case discharge to reach “navigable waters,” regardless of that feature’s status as a “point source” under the CWA (0215). One commenter questioned whether the definition would include artificial or manmade conveyances, or both, and surface or subsurface conveyances, or both. The commenter also questioned how EPA will define and interpret “direct pathway” and “virtually instantaneous” (0188).

One commenter noted that it may be uncertain if there is a “conveyance” onsite and recommended EPA “abandon this effort” due to “the lack of clarity and uncertainty concerning the WOTUS screening criteria alone” (0192).

One commenter requested EPA remove the reference to “conveyances” to navigable waters in the proximity criterion or define and geographically limit this term to ensure that the rule focuses on facilities with the greatest potential to cause substantial harm in the event of a release. The commenter referenced the CWA, which states “conveyance” may include “ditches, fissures, or other features that eventually connect to a navigable water” and has “no limitation on distance or directness.” The commenter asserted that this definition is inconsistent with the overall goal to focus emergency planning requirements on those facilities with the greatest potential to cause substantial harm to human health or the environment (0211). Several commenters suggested that ephemeral features, such as dry washes found in the arid and semi-arid Southwestern United States, should be excluded from any definition of conveyance because of the low probability of a CWA hazardous substance discharge into this feature and because flows are infrequent unless there is substantial rainfall (0199, 0211, 0219). One commenter questioned if a conveyance would pull non-jurisdictional dry washes into the assessment, which would otherwise be out of CWA regulation (0192)

One commenter suggested EPA use the following language to clarify the definition of “conveyance”: “conveyance means a surface hydrological connection to a downstream navigable water…[that] may be based on quantitative data, field observations, professional judgment, among other methods” (0219).

EPA Response:

EPA considered whether to include a definition of a “conveyance” to navigable waters. EPA is aware that the CWA definition of “point source” at 33 U.S. Code § 1362(14) uses the term conveyance and includes some examples. However, EPA determined that cross-referencing that description of conveyance, with its specific exclusions, would not be appropriate for this rule. In this rule, conveyances are a critical consideration in a facility’s worst case discharge scenarios because a straight-line analysis may overlook an opportunity to travel via pipe or open channel that could more easily enter navigable waters. Indeed, the concern is not particular types of structures or pathways (and categorizing them) but that a conveyance to navigable waters can result in a more immediate discharge to navigable waters. Moreover, while there are some broad categorical generalizations that can be made about what constitutes a conveyance to navigable waters, there are factual elements that necessarily make the determination a case-by-case determination (even if most of the time it will be straightforward, if not obvious), i.e., where identifying particular types of conveyances will not suffice or capture the variations that exist in the real world.

In any case, in terms of a definition, conveyance is meant to have its normal English language definition and usage. That said, consistent with having the elements of the initial screen be relatively straightforward, EPA is clarifying that it considers a conveyance to navigable waters in the context of this rule to be a means of transport that provides a direct pathway to navigable waters. In the majority of cases, a means of transport will be discernible, confined, and discrete, and thus will present a straightforward factual scenario. Some examples are a storm drain, pipe, or channel that discharges directly into navigable waters.

EPA notes that conveyances are a critical consideration in a facility’s worst case discharge scenarios because a straight-line analysis may overlook an opportunity to travel via storm drain, pipe, or open channel that could more easily enter navigable waters. This one-half mile assessment is simply an initial screen, designed to clearly define what facilities are not covered, rather than facilities that are covered. The substantial harm analysis will prevent facilities that are geographically attenuated from being covered if the conveyance is such that any discharge would not reach a navigable water in any significant concentration. On the other hand, if the conveyance is a drainage pipe with direct access to a navigable water, such that a substantial harm analysis shows that a worst case discharge would have significant impacts, it would be subject to the requirements of this rule.

This distance is based on research related to the Oil Pollution Prevention FRP regulation. As discussed in the preamble to the Oil Pollution Prevention FRP regulation (58 FR 8832, February 17, 1993), 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.

A few commenters had categorical questions about types of structures or features such as a dry gulch, a wellhead, subsurface water or even groundwater. While EPA could make some generalization that it does or does not expect that any of these examples would serve as a direct means of transport, the reality is there will inevitably be situations where it will depend on the specific facts to determine whether a given structure or feature (no matter what it is called) serves as a direct means of transport to navigable waters. Finally, given the purpose of the rule, EPA disagrees that the inclusion of a means of transport that could result in a more immediate discharge to navigable waters in the initial screen (and in some cases may require some analysis), makes the reach or scope of the rule “unbounded.”

To the commenters who asked for clarification on the distance from which a facility should measure its proximity to navigable waters, a facility owner or operator should use the facility boundary or nearest opportunity to discharge into or on the navigable waters or a conveyance to navigable waters.

Endpoint and Distance to Endpoint

Public Comment Summary:

Request for Clarification

One commenter requested clarity for the definition of “endpoint” to ensure this definition is implemented fairly and equitably. The commenter highlighted that the definition conflates two ideas—the point of compliance, or geographic endpoint, and the target environmental effect, or the toxic endpoint (0179).

One commenter questioned whether “distance to the endpoint” will include releases of wastewaters or substances that could infiltrate the subsurface and reach groundwater that could be carried to a discharge point to jurisdictional surface water, as addressed by the U.S. Supreme Court in County of Maui v. Hawaii Wildlife Fund, 140 S.Ct. 1462 (2020) (0167).

EPA Response:

EPA agrees with the commenter that the proposed definitions of “endpoint” and “distance to endpoint” were confusing. EPA adjusted the definition of distance to endpoint to reflect that the distance represents the greatest distance a CWA hazardous substance can travel in a worst case discharge to navigable waters or a conveyance into or on the navigable waters while still being able to cause injury to FWSE or public receptors, or adversely impact a PWS. Accordingly with the definition of distance to endpoint, EPA adjusted the definition of endpoint to clarify that it represents the concentration at which a worst case discharge of a CWA hazardous substance into or on the navigable waters has the ability to cause injury to FWSE or public receptors as determined by comparing estimated concentration(s) against appropriate category-specific concentration-based values in Appendix B, or adversely impact a PWS.

A worst case discharge of wastewater comprised of CWA hazardous substances may be regulated under this action if that facility meets the applicability criteria in § 118.3. The County of Maui v. Hawaii Wildlife Fund, 140 S.Ct. 1462 (2020), decision was specific to NPDES permits. EPA is clarifying that it considers a conveyance to navigable waters in the context of this rule to be a means of transport that provides a direct pathway to navigable waters. In the majority of cases, a means of transport will be discernible, confined, and discrete, and thus will present a straightforward factual scenario. Some examples are a storm drain, pipe, or channel that discharge directly into navigable waters. While EPA could make some generalization that it does or does not expect that groundwater would serve as a direct means of transport, the reality is there will inevitably be situations where it will depend on the specific facts to determine whether a given situation serves as a direct means of transport to navigable waters.

Facility

Public Comment Summary:

Support

One commenter expressed support of EPA’s definition of facility (0201).

Oppose

Several commenters stressed that the definition of “facility” is unclear. These commenters expressed concern about the uncertainty of the term because currently the term allows owners and operators a “wide range of discretion” when deciding whether two buildings are to be considered separate. These commenters requested EPA develop a concise definition that mitigates any subjectiveness for owners and operators when applying the proposed rule (0175, 0187, 0191, 0194, 0218).

One commenter suggested the definition of “facility” is too “broad” as currently written. The commenter is concerned about the lack of clarity this definition has on “how broad the boundaries of a facility extend” and requested the definition be narrowed to better understand the boundaries of a facility (0192). One commenter stated the proposal creates “uncertainty” as to the rule’s applicability to facilities despite Congress’s effort to clearly state the scope of facilities that would be subject to the CWA § 311(j)(5) plan requirement (0181). One commenter noted the definition of “facility” is too ambiguous and requested that EPA finalize a “firmer and more inclusive” definition (0215).

One commenter requested clarification about whether ‘piping’ also includes water well casing that could intentionally or unintentionally be used to conduct a CWA hazardous substance release toward a jurisdictional surface water in the definition of “facility” (0167).

Several commenters referenced the definition of “facility” found in other federal regulations (0205, 0215, 0216). One of these commenters recommended EPA reference the definition of “facility” found in 40 CFR § 112.2 of the Oil Pollution Prevention regulation (0205). A couple of these commenters recommended EPA consider the definition of “facility” found in EPCRA (0215, 0216). One of these commenters added that the EPCRA definition can ensure facilities do not find a way to break operations into “numerous ‘mini-facilities’” to avoid reaching screening thresholds (0216). Another commenter suggested that a “loophole” in the current definition allows facilities to discern what buildings or structures are separate to avoid reaching the threshold quantity (0180). One commenter suggested if buildings, structures, or equipment are separate they should not be considered one aggregated “facility.” This commenter also recommended that tankage should not be considered part of the facility (0206).

One commenter referenced 42 USC 11049(4) and 40 CFR § 372.3; accord id. § 355.61 (EPCRA), because each include similar central principles when defining “facility” or “stationary source,” respectively. The commenter noted that the definitions include “all buildings, equipment, structures, and other stationary items located on a single or contiguous sites and that are under common ownership, operation, or control.” Additionally, the commenter states that 33 USC § 1321(j)(5)(A)(i) in the CWA incorporates “common ownership and operation” by imposing ownership planning obligations at the owner or operator level. This commenter recommended the rule incorporate these principles in its definition of facility to ensure facilities are adequately prepared to respond to worst case discharges, and to allow data to be easily accessible by EPA, emergency response officials, and the public. The commenter added that if these principles are not included in the definition, facilities may underreport substantial-harm analyses and FRPs, and thus “undercut the community right-to-know value of the rulemaking” and would enhance safety concerns as “fewer facilities would be preparing FRPs” (0215).

Proposed New Regulatory Text

One commenter suggested adding “which are located on a single site or on contiguous or adjacent sites and which are owned or operated by the same person (or by any person which controls, is controlled by, or under common control with, such person)” to the definition of “facility” while removing “[t]he boundaries of a facility depend on several site-specific factors, including but not limited to, the ownership or operation of buildings, structures, and equipment on the same site and types of activity at the site. Contiguous or noncontiguous buildings, properties, parcels, leases, structures, installations, pipes, or pipelines under the ownership or operation of the same person may be considered separate facilities” (0215).

EPA Response:

EPA considered comments regarding the definition of “facility” but maintains that the current definition affords facility owners and operators flexibility to delineate their facility based, among other things, on how it is operated, with one minor adjustment to clarify that owners and operators may subdivide their facility only for legitimate operational and response planning reasons. EPA maintains that this flexibility afforded to owners or operators in determining what constitutes a facility allows those most knowledgeable about its operations to decide whether it should be aggregated or divided, which may vary widely due to the range of CWA hazardous substance operations and types of facilities. Furthermore, EPA notes that the definition of “facility” in this rule is adopted from the Oil Pollution Prevention regulation at 40 CFR § 112.2, is appropriately broad, and captures the types of facilities intended to be regulated by EPA under CWA hazardous substance worst case discharge regulations. EPA agrees that the Oil Pollution Prevention regulation is an appropriate starting point for the definition and has built the proposed definition on that found in 40 CFR § 112.2 while tailoring it to CWA hazardous substances. EPA disagrees that the definition of “facility” found in EPCRA (40 CFR § 355.61) is more appropriate, as EPCRA has different authorizing legislation and different requirements than worst case discharge planning for CWA hazardous substances.

EPA disagrees that definitions found at 42 USC 11049(4) and 40 CFR 372.3 are preferable. CWA hazardous substance operations may cover very large areas and storage practices; it is not reasonable to assume aggregation of CWA hazardous substances for regulatory purposes in every case. EPA lacks data to support the contention that not including principles of common ownership will result in facilities underreporting substantial-harm analyses and FRPs. In fact, this definition may result in more facilities reporting due to subdivided operations submitting more than one CWA FRP, thus enhancing facility and community emergency response planning.

EPA notes that it made explicit in the preamble to the proposed rule and restates here that an owner or operator may not make determinations as to what constitutes a facility indiscriminately and in such a manner as to simply avoid applicability of the final rule (for example, the division of one facility into separate facilities with one CWA hazardous substance container located at each facility where all containers are located side-by-side or in close proximity to each other and are used for the same purpose).

To the commenter concerned with a water well casing that could intentionally or unintentionally be used to conduct a CWA hazardous substance release toward a jurisdictional surface water, this could be considered a “conveyance” to navigable waters and should be considered as such. EPA is clarifying that it considers a conveyance to navigable waters in the context of this rule to be a means of transport that provides a direct pathway to navigable waters. In the majority of cases, a means of transport will be discernible, confined, and discrete, and thus will present a straightforward factual scenario. Some examples are a storm drain, pipe, or channel that discharge directly into navigable waters. While EPA could make some generalization that it does or does not expect that a water well casing would serve as a direct means of transport, the reality is there will inevitably be situations where it will depend on the specific facts to determine whether a given situation serves as a direct means of transport to navigable waters.

Fish, Wildlife, and Sensitive Environments

Public Comment Summary:

Request for Clarification

One commenter requested clarification on whether FWSE include “groundwater-dependent habitats” (0167).

EPA Response:

FWSE are areas identified by their legal designation or by evaluations of Area Committees (for planning) or members of the Federal On-Scene Coordinator’s spill response structure (during responses). A facility owner or operator will have to consult their ACP for these types of designations.

Injury

Public Comment Summary:

Oppose

A couple of commenters disagreed with the definition of “injury” (0179, 0205). One commenter expressed concern that the definition of “injury” is extended to public receptors and is expanded to areas where the public could potentially be present. The commenter noted that “injury” is too broad and can have many meanings in the context of public receptors (0179). One commenter suggested that the proposal failed to give meaning to the statutory requirement that there be potential for “substantial harm,” since an effect that is measurable could be entirely unsubstantial. The commenter noted that it is unclear how a measurable adverse effect on a “public receptor” constitutes “harm to the environment” (0205).

One commenter noted that because “endpoint” is a mathematical estimation of some fraction of a reportable quantity, there is no proof of “injury” to a “public receptor” at that geographic endpoint. The commenter recommended EPA either remove public receptors from the definition of injury, or at least refine the definition to focus more carefully on actual harm to water quality (0179).

EPA Response:

EPA maintains that the definition of “injury” is appropriate to assess substantial harm based on the extensive experience of the Natural Resource Trustees in conducting evaluations of CWA hazardous substance impacts on natural resources. Federal officials authorized by the President and the authorized representatives of Indian tribes and state and foreign governments act as public trustees to recover damages to natural resources under their trusteeship. Under the NCP, each trustee has the responsibilities for protection of resources; mitigation and assessment of damage; and restoration, rehabilitation, replacement, or acquisition of resources equivalent to those affected. Because of the need to maintain consistency with the NCP, the Agency confirms it is appropriate to use the definition of "injury" established by the Natural Resource Trustees for this rule. The definition of “injury” in 40 CFR § 112.2 of the Oil Pollution Program was adapted from the definition of "injury" in the DOI Natural Resources Damage Assessments (NRDA) final rule at 43 CFR Part 11 and includes only that part of the definition that addresses oil discharges, which EPA is now adapting for this regulation.

In response to the commenters who stated that the definition of “injury” should only apply to substantial harm events, EPA notes that the definition of “injury” is intended to assist in the identification of onshore non-transportation-related facilities that could cause substantial harm to the environment. The potential for a discharge to cause injury to FWSE or public receptors is coupled with the screening criteria to determine if an onshore non-transportation-related facility could cause substantial harm to the environment. In that context, causing injury indicates the potential for a worst case discharge to cause substantial harm to the environment. EPA concludes that the injury relies on changes that have been demonstrated to adversely impact the resources in question, or services provided by those resources.

While “injury” to a public receptor as a concept may be new to the regulatory community, EPA holds that it is an important consideration due to the variability of CWA hazardous substances, how they act in water, their effects on the environment, and their impact on the potentially exposed public. EPA agrees that a measurable effect is not necessarily substantial, but notes that the proposed endpoints both are measurable and indicate a facility could cause substantial harm with a worst case discharge. EPA maintains that harm to the environment may comprise adverse effects on a public receptor. Water quality is one aspect of the proposed substantial harm criteria, and EPA has carefully calibrated the various pieces to ensure protection of PWSs, FWSE, and public receptors.

Navigable Waters

Public Comment Summary:

Oppose

Several commenters noted that the proposed rule does not fully define “WOTUS” and asserted that this causes the term “navigable waters” to be “very ambiguous.” The commenters highlighted the fact that there is a current Supreme Court case (Sackett V. EPA) that has yet to be decided and a separate EPA rulemaking in progress defining WOTUS. Due to this, the commenters noted that this proposed rule is “especially difficult” to comply with as the first screening criterion is based on a facility's proximity to navigable waters (0171, 0175, 0176, 0179, 0187, 0188, 0191, 0192, 0194, 0197, 0204, 0205, 0218). Several of these commenters noted that once a decision is issued, this case should provide a definition of WOTUS and more clarity to properly define jurisdiction lines. These commenters also stressed the importance of holding off from any final rulemaking until the court decision is issued or navigable waters is more clearly defined (0171, 0176, 0179, 0188, 0205). Some commenters recommended EPA release a supplementary proposed rule once “WOTUS” and “navigable waters” are clearly defined (0175, 0187, 0191, 0194, 0204, 0218).

One commenter noted that until a decision is issued, it will be impossible for EPA to assess the potential scope of onshore facilities that would be subject to the proposed rule. The commenter added that given the uncertainty of the definition, the number of regulated facilities located within one-half mile of a navigable water will differ, and the relationship of that proximity test to the potential for a facility’s CWA hazardous substance discharge to cause substantial harm to the environment will vary depending on how the water from which proximity is measured will be defined (0205). One commenter noted that EPA must give “fair notice” of the conduct it expects an entity to adhere to and emphasized that EPA has not yet factored in the complexities associated with this part of the evaluation, and the likely need to consult with technical experts and counsel to make this determination, in its cost analysis of the proposed rule (0197).

A couple of commenters asserted that as currently written, the CWA jurisdiction is “very unclear” and would be difficult for a facility to ascertain if they are required to comply with the proposed rule (0176, 0196). One commenter noted that EPA should provide maps of the United States showing which areas are governed by the proposed rule to ensure facilities are aware of their potential regulatory compliance obligations (0176). Due to the ongoing court case, one commenter recommended EPA exempt wetlands from the definition of WOTUS for purposes of this rulemaking because wetlands are not the same as water features that have aquatic resources and drinking water uses (0192).

Several commenters referenced the ongoing review of the definition of “navigable waters” and “WOTUS” by EPA and the U.S. Army Corps of Engineers (proposed rule, 86 FR 69372, December 7, 2021) (0171, 0179, 0188). One of these commenters noted that this definition is crucial to the cost/benefit analysis in this proposal. The commenter added that EPA should not finalize the proposed rule until after the definition of “navigable water” is determined and incorporated into this rule (0179). One commenter emphasized that facilities would need to spend significant financial resources determining whether their facility is within the proximity of a WOTUS and already spend thousands of dollars a year on lawyers and technical consultants to obtain jurisdictional determinations from the U.S. Army Corps of Engineers to determine whether a parcel of land or water feature is a WOTUS for CWA § 404 permits (0188). One commenter added that EPA “will no doubt face litigation over the rule from a variety of parties” even after WOTUS has been defined (0171).

One commenter referenced the 2002 final rule that EPA established, which amended the SPCC regulations to broaden the definition of “navigable waters” to reflect the broad definition of “waters of the United States” found in 40 CFR 122.2 (67 FR 47042, 47142, July 17, 2002). The commenter noted that after this decision, challenges were upheld against certain aspects of the SPCC regulations and by 2008, the U.S. District Court for the District of Columbia ruled that EPA’s promulgation of the revised definition of “navigable waters” in the July 2002 SPCC rule violated the APA (citing American Petroleum Institute v. Johnson, 571 F.Supp.2d 165. D.D.C. 2008). The commenter noted that as a response to this court decision, EPA issued a final rule to amend the SPCC regulations on November 26, 2008, which stayed in effect through 2015. The commenter highlighted that prior to 2015, the SPCC regulations defined “navigable waters of the United States” to mean “navigable waters” as defined in § 502(7) of the Federal Water Pollution Control Act. The commenter concluded that neither the 2015 nor the 2020 rulemakings provided a “reasoned explanation” required in order to apply a broader definition of “navigable waters” to the SPCC program and other CWA § 311 programs; that the revised definitions of “navigable waters” or “WOTUS” are not legally applicable at this time; and that EPA has clarified that determinations of jurisdictional scope are currently based on the pre-2015 regulatory regime. The commenter added that the 2021 proposed revised definition of “navigable waters” also fails to address why it is appropriate to impose a broader definition of “navigable waters” to CWA § 311 programs and recommended EPA should track the 1973 SPCC regulatory definition that was in the pre-2015 SPCC regulations (0211). One commenter requested that EPA use the SPCC 1973 definition of “navigable waters” (0199).

One commenter highlighted that the definition of “navigable water” is different than the definition listed in 40 CFR Part 112 (0179).

One commenter requested clarification whether the definition includes “proximity to navigable water” as addressed by the U.S. Supreme Court in County of Maui v. Hawaii Wildlife Fund, 140 S.Ct. 1462 (2020) (0167).

EPA Response:

EPA disagrees that the final rule does not fully define navigable waters, or waters of the United States. In addition, following the U.S. Supreme Court’s May 25, 2023, decision in the case of Sackett v. EPA, EPA and the Department of the Army developed a rule to amend the final “Revised Definition of ‘Waters of the United States’” rule consistent with the U.S. Supreme Court's May 25, 2023 decision in the case of Sackett v. Environmental Protection Agency (88 FR 61964, Sept. 8, 2023).

EPA has determined that the final rule should cite to the definition in 40 CFR § 120.2 to determine whether a particular water is a WOTUS, as opposed to establishing a separate definition. The revised definition provides clarity and citing to this definition will ensure consistency with the Supreme Court’s decision in Sackett, as well as ensuring greater understanding and consistency nationwide. Because this definition is also used by other regulatory programs, it provides the greatest amount of information and experience regarding its applicability. The Agency disagrees with commenters who asserted that this definition is prohibitively technical or costly (see Chapter 5 of the RIA in the docket for more detailed information about cost estimates); and notes that the September 2023 definition, issued following Sackett, covers fewer waters than the rule that was in place at the time comments were received. In addition, EPA and the U.S. Army Corps of Engineers have tools available to the public to determine the applicability of the recent rulemaking. In sum, it is the Agency’s position that the regulated community has sufficient information to determine whether they are more than one-half mile from navigable waters or a conveyance to navigable waters such that they are not subject to the rule. Doing otherwise, as some commenters suggest, could inadvertently inject unintended ambiguities or questions about applicability, causing more uncertainty, not less.

EPA considered the comments that argued that EPA should use the 1973 SPCC regulatory definition of “navigable waters.” EPA disagrees with commenters who stated that the definition of “navigable waters” for purposes of this rule should be different that the definition of “navigable waters” in CWA § 502(7). Commenters’ reliance on American Petroleum Institute v. Johnson, 571 F.Supp.2d 165 (D.D.C. 2008), is misplaced. First, EPA has previously explained the comprehensive nature of the CWA, and that the centerpiece of that comprehensive framework is the term “navigable waters,” which the CWA broadly defines as “the waters of the United States, including the territorial seas” 33 U.S.C. 1362(7); see, e.g., Final Rule: Revised Definition of “Waters of the United States,” (88 FR 3004, January 18, 2023). Waters satisfying that definition are often called “covered” or “jurisdictional” waters because the term “navigable waters” appears in most of the CWA’s key programs, including those for water quality standards; oil spill prevention, preparedness, and response; and permits regulating the discharge of pollutants. Accordingly, there are important national consistency considerations in terms of regulatory definitions and practices. And perhaps most relevant is that in the Oil Pollution Prevention FRP Rule, 40 CFR Subpart D, “navigable waters” is defined as “waters of the United States, including the territorial seas, as defined in § 120.2 of this chapter” (40 CFR § 112.2).

With respect to American Petroleum Institute, in 2002, EPA revised its regulations defining “waters of the United States” in 40 CFR part 112 to ensure that the rule’s language was consistent with the regulatory language used in other CWA programs (see Oil Pollution Prevention & Response; Non-Transportation-Related Onshore & Offshore Facilities, 67 FR 47042, July 17, 2002). A district court vacated the rule for failure to comply with the Administrative Procedure Act because in that rulemaking the district court was unable to determine whether EPA's change in the definition of “navigable waters” was the result of reasoned decisionmaking and reinstated the prior regulatory language (American Petroleum Ins. v. Johnson, 541 F. Supp.2d 165, 181-185 (D.D.C. 2008)). Thus, that case does not stand for the proposition that it is unreasonable to apply the same regulatory definition for “waters of the United States” to Section 311 of the CWA, where the statute uses “navigable waters.” Said another way, the district court holding did not bar EPA from interpreting “navigable waters” as having the same scope as “waters of the United States” for purposes of section 311 of the CWA. Indeed, EPA has interpreted “navigable waters of the United States” in CWA § 311, in both the pre-2002 regulations and the 2002 rule, to have the same meaning as “navigable waters” in CWA § 502(7). Furthermore, in 2015, EPA issued a final rule defining “waters of the United States” and EPA explained that the definition would apply to the CWA, including section 311 programs. In so doing, the final rule amended each of the relevant regulations with the revised definition (Clean Water Rule: Definition of “Waters of the United States,” 80 FR 37054, June 29, 2015). In 2020, in the Navigable Waters Protection Rule (NWPR), EPA again interpreted “navigable waters,” statutorily defined as “waters of the United States,” in the context of the CWA, including section 311 (85 FR 22250, April 21, 2020). That final rule revised the regulatory definition of “waters of the United States” (which, in turn, defines “navigable waters”) and codified it in one location in EPA’s regulations: 40 CFR 120.2. EPA then revised all of the other references to “waters of the United States” in its regulations, including 40 CFR 110.1, 112.2, 116.3, 117.1, 122.2, 230.3, 232.2, 300.5, 302.3, 401.11, and Appendix E to 40 CFR part 300, to cross-reference the new 40 CFR 120.2 definition. EPA explained that the placement of the definition in one location in EPA’s regulations, with cross-references in other regulations back to 40 CFR 120.2, would increase the convenience for the reader and provide clarity to the public that there is a single definition of “waters of the United States” applicable to the CWA and its implementing regulations.

Programs that utilize the definition of “waters of the United States” include:

Clean Water Action Section 303(c): Water Quality Standards
Clean Water Act Section 303(d): Impaired Waters and Total Maximum Daily Loads (TMDLs)
Clean Water Act 311: Oil Spill Prevention and Preparedness Programs
Clean Water Act Section 401: Certification
Clean Water Act Section 402: National Pollutant Discharge Elimination System
Clean Water Act Section 404: Permitting Discharges of Dredged or Fill Material

As a practical matter, where the term navigable waters had previously replicated the text of 40 CFR 120.2, it now simply included a cross-reference to 40 CFR 120.2. Again, in the Oil Pollution Prevention FRP Rule, 40 CFR Subpart D, “navigable waters” is defined as “waters of the United States, including the territorial seas, as defined in § 120.2 of this chapter” (40 CFR § 112.2).

In 2023, EPA issued a revised definition of “waters of the United States” and again explained how the definition applied to the CWA, including 311 (Revised Definition of “Waters of the United States,” 88 FR 3004, January 18, 2023). Again, EPA was clear that the cross-references to 40 CFR 120.2 in regulations governing other CWA regulatory programs were maintained by the rule. Finally, EPA issued a subsequent rule to amend the January 18, 2023 rule (88 Fed. Reg. 61964, September 8, 2023). That final rule conformed the definition of “waters of the United States” to the U.S. Supreme Court’s decision in Sackett v. EPA. Because other regulatory programs that have defined the term navigable waters by cross-referencing the definition in 40 CFR 112.2, by operation of law, this rule also amended the definition of navigable waters in those regulatory programs, including the Oil Pollution Prevention program. Thus, for purposes of this rule, EPA is maintaining its approach for defining “navigable waters” in reference to the regulatory definition of “waters of the United States” and in doing so is also relying on the explanation and rationales provided in the 2015, 2020 and 2023 revisions of the definition of “waters of the United States” with respect to applying the same definition across CWA programs and statutory provisions.

Finally, EPA acknowledges concerns raised about the impact of litigation and court rulings on post-2015 definitions of “waters of the United States,” and a resulting patchwork of definitions across the country. Needless to say, this is a different rule and while EPA recognizes that due to ongoing litigation there is variation among jurisdictions as to which definition of “waters of the United States” governs, e.g., using the pre-2015 definition in the SPCC context, presumably at some point the litigation will be resolved resulting in national consistency and, in any event, introducing another variation would do nothing to advance national consistency. To the contrary, codifying yet another definition would introduce more complexity within every jurisdiction by requiring regulated entities that need to comply with different CWA act regulations to navigate two different definitions within that jurisdiction. Thus, even if currently there is variation with respect to which definition (pre- or post-2015) applies in different jurisdictions, there is merit to having the definition be consistent for regulated parties within their jurisdiction for purposes of the CWA (see Operative Definition of Waters of the United States chart at: https://www.epa.gov/wotus/definition-waters-united-states-rule-status-and-litigation-update).

The U.S. Supreme Court in County of Maui v. Hawaii Wildlife Fund, 140 S.Ct. 1462 (2020) referred to a NPDES permitting issue and is not applicable to this action.

Public receptors

Public Comment Summary:

Support

One commenter urged EPA to finalize the definition of “public receptor” as currently drafted because it is “appropriately broad,” which allows for a “full range of potential uses” (0215).

Oppose

A couple of commenters stated the definition of “public receptor” is unclear, which may lead to different interpretations of the proposed rule (0179, 0205). One commenter emphasized that the spaces included in the current definition of “public receptor” could be “almost anywhere.” The commenter also requested that EPA provide additional clarity on how the regulated community can identify items on the public receptor list and clarity on how to treat exposure of a public receptor (0205). Similarly, one commenter requested that EPA provide more clarity on the descriptions of public receptors, especially for “other public spaces inhabited” and “or used by the public at any time.” The commenter also requested clarity on what is solely considered to be “economic harm” in the context of the definition of “public receptor” as closing a shoreline playground for a day, for example, is not reasonable to consider as harm under this definition (0179).

One commenter urged EPA to include first responders in its definition of “public receptor” because first responders are “most likely to be impacted” by the release of a CWA hazardous substance. The commenter suggested that the proposed rule does not adequately acknowledge the role of local response agencies and the potential impacts to these agencies during a hazardous chemical release (0170).

One commenter stated its concern that “public receptors” is a new definition that was not part of the Oil FRPs as required under 40 CFR Part 112. The commenter recommended this definition be removed from this rulemaking and EPA should “mirror” the requirements of § 112.20(h)(4) – Vulnerability Analysis (0179).

EPA Response:

EPA agrees that the proposed definition of public receptor is appropriately broad and allows for a full range of potential impacts.

EPA’s definition of “public receptor” is intentionally broad in order to cover a wide variety of areas through which the public has access to navigable waters and could be affected by a worst case discharge. EPA will provide compliance assistance in identifying public receptors, and the hazard evaluation should identify how to treat exposure of a public receptor based on the physicochemical properties of the CWA hazardous substance released, its hazards, and the worst case discharge conditions. EPA judges that economic harm may include closing a shoreline playground, as that is a negative effect on the community that results from a worst case discharge and could be identified as an “injury.” For example, in addition to the community being unable to use the shoreline playground facility, businesses located nearby, such as food concessions and restaurants, and beach or boating equipment rental businesses, could be closed temporarily because of the discharge and thus experience economic harm.

EPA did not include first responders in the definition of public receptor, as one commenter suggested, because first responder health and safety should already be addressed in emergency planning at any facility as required under OSHA’s standards at 29 CFR 1910.120.

While the definition of “public receptor” is not part of the Oil Pollution Prevention regulation in 40 CFR Part 112, CWA hazardous substances differ from oil in important and varied ways and require different considerations. For instance, for certain CWA hazardous substances, there may be no realistic means to implement containment, protection, and recovery response tactics once the substance enters a water body, meaning that receptors must be prepared for and swiftly notified of the diluted substance as it travels downstream. As with other aspects of this rule, EPA intends to provide compliance assistance to covered facility owners or operators on types of areas they should consider when determining their ability to cause injury to public receptors.

Worst Case Discharge

Public Comment Summary:

Support

One commenter applauded EPA’s inclusion of fire and explosions as triggering events in the definition because these aspects can be overlooked from a spill standpoint (0174).

One commenter generally supported EPA’s inclusion of this definition within this rulemaking (0215).

Oppose

Several commenters asserted that the current definition of “worst case discharge” requires more clarity on how the timing of the discharge should be considered. The commenters requested EPA provide clarity on whether a worst case discharge should be considered an instantaneous discharge of the entire contents of the largest container or a timed discharge. The commenters noted that by clarifying this aspect of the definition, data will be more accurate and standardized among reporting facilities (0175, 0187, 0191, 0218).

One commenter expressed concern over the proposed rule’s reliance on the CWA definition of “worst case discharge” because it may limit the value of the FRP for response planning when adverse weather conditions exceed realistic maximum operating limits for response equipment and safe on-water operations. The commenter provided an example of how sea ice in navigable waters could impede response and safety in the event of a spill (0177).

One commenter was concerned about whether “adverse weather conditions” is too limiting in the definition. For example, the commenter questioned whether the Ashland Oil Spill in 1988 would have been covered by the proposed rule under “adverse weather” because this was a worst case discharge caused by tank failure, not adverse weather conditions (0174).

A couple of commenters stated the definition is unclear and ambiguous, specifically seeking clarification on what a “largest foreseeable discharge” is. The commenters questioned how EPA will make the determination for “largest foreseeable” based on the quantity of CWA hazardous substances discharged or if it is in reference to the dollar amount of potential damage. The commenters also questioned how far into the future regulated entities must look to determine what is foreseeable and if there are modeling systems to assist with this (0188, 0192).

One commenter requested clarification on the definition of discharge and if EPA meant only discharges that are in compliance with their permits are exempt and those that are non-compliant are not exempt from this regulation (0201).

EPA Response:

Including fire and explosions as triggering events is consistent with the statutory authority of this action. EPA disagrees that the proposed definition requires a specific timing trigger, as a worst case discharge may occur instantaneously or over time as an incident progresses, and a facility owner or operator is best situated to determine the appropriate timing scenario, which is also based on the planning distance to evaluate the impact of a worst case discharge. In general, an instantaneous discharge may be the most obvious case of a worst case discharge to come to mind. However, it is also possible that a discharge could be due to a significant leak, resulting in a worst case discharge of a hazardous substance over hours or even days.

EPA’s language is consistent with the statutory requirement, and EPA disagrees that the definition for “worst case discharge” limits the value of the FRP, since a facility owner or operator must plan for realistic maximum operating limits for response equipment and safe on water operations. Adverse weather conditions are a broad category, and the Ashland Oil Spill in 1988 is not a comparable event, since it was an oil spill that would be covered by the Oil Pollution Prevention and FRP requirements found at 40 CFR Part 112. In addition, "adverse weather" is not meant as the cause of the discharge but refers to weather conditions that make it difficult for response equipment and personnel to clean up or respond to discharged CWA hazardous substances. The largest foreseeable discharge in calm or clear conditions will look much different than the largest foreseeable discharge in adverse weather conditions and thus must be taken into consideration when identifying response systems and equipment in a response plan for the applicable operating environment. Planning for adverse weather in the event of a worst case discharge is necessary to ensure that facility owners or operators are prepared to respond in any weather environment. EPA refers commenters to 40 CFR § 118.10 for more specific language on worst case discharge calculations, which are based on the largest quantity released in a reasonable time horizon, not the dollar amount of potential damage, which would be very difficult to assess. EPA is working to identify and/or develop modeling systems to assist with implementation.

Discharges permitted under NPDES are not subject to this regulation (40 CFR Part 122).

Other Definitions

Public Comment Summary:

Oppose

Several commenters expressed general concerns over various terms and definitions in the proposed rule, ranging from overly broad to unclear. As a result, the commenters stated that EPA should release a supplementary proposed rule with more clear guidance and definition if the Agency decides to move towards promulgating a final rule (0175, 0187, 0191, 0194, 0204).

EPA Response:

EPA disagrees that various terms and definitions are overly broad and unclear and require a supplementary proposal. On a complex rulemaking covering 296 disparate CWA hazardous substances, the Agency has been deliberate in ensuring flexibility and nuance while not being overly prescriptive in order to ensure that the varying considerations critical to ensuring worst case discharges of these substances are appropriately addressed. EPA plans to provide compliance assistance to aid facilities once the rule is finalized.

Public Comment Summary:

Public Water Systems

Several commenters stated that the definition of “public water systems” in the proposed rule is overly broad, as it covers both community water systems and non-community water systems. The commenters stated that this may lead to a very wide application of this substantial harm criterion. The commenters noted that there are various minute PWSs that can be folded into this substantial harm criterion under the definition of a non-community water system. The commenters recommended EPA limit the definition of “public water systems” to only include the community water system definition (0175, 0187, 0191, 0194, 0218).

EPA Response:

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. EPA is adopting 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. There are two types of non-community water systems (see 40 CFR 141.2). First, a non-transient, non-community water system is a public water system that regularly supplies water to at least 25 of the same people at least six months per year. Some examples are schools, factories, office buildings, and hospitals which have their own water systems. Second, a transient non-community water system is a public water system that provides water in a place such as a gas station or campground where people do not remain for long periods of time. EPA disagrees that non-community water systems should be excluded from this rule, since an important goal of this rule is to ensure planning for worst case discharge effects on PWSs of all types and, in particular, on drinking water. If a facility meets the applicability criteria in 40 CFR § 118.3, they are subject to the regulation regardless as to whether the potentially adversely impacted public water system is a community water system or non-community water system.

Public Comment Summary:

Additional Terms and Clarification on Proposed Terms

One commenter recommended EPA add the following terms and definitions to the proposed rule (0167):

Downgradient – Groundwater flow from a point in the water table of higher elevation to a lower elevation.

Karst topography – Terrain with characteristics of relief and drainage arising from a high degree of rock solubility in natural waters. “Karst” refers to a characteristic of a geologic material or formation resulting from the dissolution of the formation by natural waters over time. The majority of karst occurs in limestone, but karst may also form in dolomite, gypsum, and salt deposits. Features associated with karst terrains typically include irregular topography, sinkholes, vertical shafts, abrupt ridges, caverns, abundant springs, and/or disappearing streams. The movement of CWA hazardous substances released into karst aquifers is highly unpredictable, and transport over relatively long distances can occur very rapidly.

Recharge zone – The area(s) of a watershed in which water infiltrates the subsurface and percolates to the aquifer.

Sole source aquifer protection area – The area designated under Safe Drinking Water Act (SDWA) § 1424(e) within which to protect its underground source of drinking water; for groundwater-supplied water systems, their wellhead protection areas may be within a sole source aquifer protection area.

Stormwater infiltration wells and ponds – A dug or drilled subsurface fluid distribution system and modified sinkholes including unsewered storm drains, dry wells, drainage wells, and retention/detention ponds that would allow contaminant spills and leaks to enter the subsurface environment. This type of conveyance is referred to as a “Class V” well under the Underground Injection Control Program under the Safe Drinking Water Act §§ 1421-1426, 1431, and 1442-1443 and is permitted by rule (40 CFR Part 144) but can be vulnerable to conveying pollutants carried by stormwater or spills into the subsurface. Similar stormwater control measures may also be required under the Municipal Separate Storm Sewer System (MS4) Program under the CWA § 402.

Well – Any dug hole or drilled borehole with or without casing or pipe attached to it that could convey a hazardous substance below the ground surface.

Overlying karst terrain – The facility is located over or near karst terrain and its subsurface infiltration features, such as sinkholes. Karst environments often have unique aquatic life requiring protection.

Proximity to wells and recharge zones – A map of all wells within and adjacent to the site out to at least 0.25 mile or further if site land and hard scape allow overland flow before percolation to the subsurface occurs based on calculation or modeling.

One commenter provided additional insight to the following terms currently outlined in the proposed rule (0167):

Water distribution system – As defined, this system includes private household water wells and is acceptable to the National Ground Water Association.

EPA Response

EPA disagrees that suggested definitions are necessary for the terms noted above. Including potential discharges to groundwater is outside of the scope of this final rule, which is specific to onshore non-transportation-related facilities that, because of their location, could reasonably be expected to cause substantial harm to the environment by a worst case discharge into or on navigable waters or a conveyance to navigable waters. Thus, those terms are not referenced in the regulatory language.

Screening Criteria

Public Comment Summary:

Oppose

One commenter suggested that EPA does not have enough justification to take an overly conservative and simplistic approach to ensure the maximum number of facilities are covered under the program (0192).

EPA Response:

EPA disagrees that the Agency does not have enough justification to take action under CWA § 311(j)(5). The Agency is clearly authorized under 33 USC § 1321(j)(5)). Additionally, the RIA outlines the various analyses EPA conducted for the final rule, which EPA has found sufficient for this action. EPA did not undertake this effort in order to maximize the number of facilities regulated; rather, the Agency developed the applicability criteria in 40 CFR § 118.3 so that only those onshore non-transportation-related facilities that could cause substantial harm to the environment from a worst case discharge into or on navigable waters or a conveyance to navigable waters would be subject to the rule and required to prepare, implement, and submit an FRP to EPA. Indeed, the initial screening criteria are meant to make it easier for facilities to determine that they are not covered.

Threshold Quantity

Public Comment Summary:

Oppose

Several commenters expressed concerns about EPA’s proposed requirement that a facility submit an FRP for all CWA hazardous substances even if only one substance meets the substantial harm criteria (0179, 0183, 0192, 0197, 0199, 0201, 0205, 0208, 0211, 0219). Some commenters believe this requirement is burdensome, broad, and unjustified (0179, 0183, 0199, 0205, 0208).

Another commenter noted that the proposed rule is unclear in its language regarding “applicability” because as written, it could be interpreted to mean that should any one CWA hazardous substance trigger the threshold planning quantity, an FRP must be developed for all CWA hazardous substances at the facility, regardless of quantity. The commenter strongly urged EPA to provide clarification on whether an FRP is only required to address CWA hazardous substances that individually meet the planning criteria, and which are not otherwise exempt or excluded (0178).

An example provided by one commenter is that a facility could have cleaning products or pesticides present in small quantities and containing minimal amounts of CWA hazardous substances that pose little harm to human health or the environment. In this instance, the commenter strongly disagreed with requiring that the FRP cover all CWA hazardous substances stored or used at a facility even though they do not meet the threshold quantity. The commenter believed this would diminish the focus on the substance that has the greatest potential to cause substantial harm and result in unnecessary and overly burdensome requirements (0183).

One commenter recommended EPA create a combined determination factor by adding the two initial screening criteria together instead of having the threshold quantity as the first factor, and the distance to navigable waters as the second factor (0169).

EPA Response:

EPA agrees with commenters concerned about planning for CWA hazardous substances onsite below the threshold quantity. As such, in the final rule, facility owners or operators that meet the screening and then the substantial harm criteria must prepare and submit an FRP to EPA that plans for only those CWA hazardous substances present above the threshold quantity, not all CWA hazardous substances onsite. EPA agrees that planning for CWA hazardous substances onsite below the threshold quantity would not enhance worst case discharge response efforts.

Additionally, the two initial screening criteria are not meant to be additive. First, a facility assesses the two initial screening criteria. Only if a facility satisfies both initial screening criteria does a facility assess the substantial harm criteria.

Container Capacity 10,000 Times the Reportable Quantity

Public Comment Summary:

Support

Several commenters agreed that the proposed threshold planning quantity of 10,000 times the RQ (10,000x RQ) is more appropriate than a lesser multiplier (0178, 0179, 0183, 0184, 0199, 0203, 0205, 0208, 0211, 0215, 0219). One commenter added that an RQ value of less than 10,000 would bring far too many facilities into the program with no concomitant increase in environmental protection (0178).

Oppose

Some commenters disagreed with the use of the 10,000x RQ multiplier and suggest that EPA decrease the proposed threshold quantity so that more facilities must determine if they could cause substantial harm to the environment through a worst case discharge (0170, 0215, 0216, 0217).

One commenter stated that EPA has not considered the feasibility and cost to facilities when calculating the threshold quantity of CWA hazardous substances. The commenter noted that it is practically impossible for their facility to calculate 10,000 times the RQ for each individual CWA hazardous substance in the hundreds of different hazardous wastes stored at the facility (0186).

Another commenter suggested EPA reduce the CWA hazardous substances multiplier to 1,000 times the RQ, or at most, work with a multiplier of 5,000, to fully address the range of potential releases that merit worst case discharge planning and response (0170).

One commenter asserted that, at a minimum, the proposal should be strengthened by lowering the RQ multiplier from 10,000 to 1,000. The commenter opined that a lower threshold is necessary because EPA has provided no evidence that the facilities excluded by the 10,000x RQ threshold quantity would not reasonably be expected to cause substantial harm in the case of a hazardous spill. The commenter urged EPA to take a precautionary approach and include more facilities in the initial screening by using a 1,000x RQ threshold quantity (0217).

Another commenter believes that the 10,000x multiplier is too high and the proposal’s justification for it is conclusionary. Because the quantity threshold is simply a screening tool, the commenter urged EPA to adopt the 1,000x RQ multiplier in the final rule. The commenter asserted that EPA provided no evidence that the facilities excluded when using the 10,000x multiplier could not reasonably be expected to cause substantial harm and, moreover, it is reasonable to think that at least some of those ten thousand facilities might reasonably be expected to cause substantial harm. The commenter went on to conclude that due to the lack of public data around CWA hazardous substance facilities, a lower threshold quantity and precautionary approach is appropriate (0215).

One commenter expressed concerns that step one of the two-part screening test is significantly overbroad, unduly burdensome, and will result in the inclusion of substances that are already regulated under a comparable program and/or do not necessarily pose a substantial threat. The commenter stated that the function and properties of stored CWA hazardous substances must be taken into consideration when determining whether they could cause substantial harm. The commenter added that CWA hazardous substances may be stored in powder, liquid, or granular form; they may or may not be soluble in water; they may be present in quantities too small to pose a material hazard, or they may be stored or distributed throughout the facility in a manner that would minimize the risk of a large-scale release. The commenter stated that the proposed rule ignores these considerations and recommended that the FRP requirement should be solely focused on a potential spill of substances stored in quantities that have high spill risks (0205).

Another commenter suggested the “1,000x RQ multiplier” can be paired with an opportunity for a facility to adopt a higher multiplier with the agreement of the LEPC/TEPC following coordination, given the lack of comprehensive data available on the impacts of accidental releases of CWA hazardous substances and how critical it is to understand the potentially catastrophic local consequences from even just a small release. The commenter noted that if EPA does not include this approach, it should include language as in EPCRA Tier II regulations where LEPCs may ask for information relevant to emergency planning without regard to the proposed thresholds. However, the commenter suggested this is not the best approach. The commenter also referenced the overlap of the proposed rule with EPCRA and suggested EPA “create some harmony between programs” to avoid placing “a huge burden” on local emergency responders to determine the different reporting and regulatory criteria (0170).

One commenter noted that some may interpret the definition of “maximum capacity onsite” as 5,000 times the RQ of one substance and 5,000 times the RQ of a different substance that would be added together and meet the threshold combined, requesting that EPA be more explicit in the final rule (0219).

A couple of commenters noted that EPA identified in the proposed rule the potential problems with its approach for facilities with a variable inventory of CWA hazardous substances (e.g., batch processors, warehouses) (0201, 0214). One commenter recommended that EPA consult such facilities to determine a practical approach for FRPs that have fluctuating quantities of CWA hazardous substances or temporary exceedances of threshold values (0214). Another commenter requested that EPA provide additional details on how it will help such facilities implement the regulation to avoid cumbersome requirements (0201).

EPA Response:

While EPA proposed using a 10,000x RQ multiplier for threshold quantities, EPA agrees with commenters who suggested lowering the RQ multiplier to 1,000x. For example, some commenters criticized the 10,000x multiplier citing a lack of evidence that those facilities under that threshold quantity would not be reasonably be expected to cause substantial harm to the environment from a worst case discharge. Therefore, EPA should take a more precautionary approach and not exclude these facilities from determining their ability to cause substantial harm to the environment. Since threshold quantity is a screening tool (i.e., an onshore non-transportation-related facility with less than that amount is not covered by the rule and need not consider whether it may reasonably cause a worst case discharge in the first instance), setting a lower initial screening level at this stage has merit. It is reasonably foreseeable that an onshore non-transportation-related facility could cause substantial harm from a worst case discharge with less than 10,000x RQ of a CWA hazardous substance onsite. Said another way, setting the threshold quantity too high may mean that higher risk facilities are not required to determine their ability to cause substantial harm at all, which could leave the environment more vulnerable to worst case discharges. Accordingly, the Agency has determined that a 1,000x RQ multiplier will more appropriately screen for covered facilities that could cause substantial harm to the environment from a worst case discharge. If a facility with less than 1,000x RQ of a CWA hazardous substance on site determines that it does not meet any of the substantial harm criteria, it is not required to prepare an FRP. Please see the preamble to the final rule for further discussion.

EPA considered the feasibility and cost of calculating the threshold quantity. See Chapters 2 and 5 of the RIA available in the docket for more information. Facility owners and operators with fluctuating inventories routinely calculate thresholds and report on quantities onsite for many other federal programs. This should not add significant burden to facilities, as they must already be compliant with, for example, EPCRA Tier II reporting, which requires such inventory reporting.

EPA disagrees with commenters who argued that this lower multiplier value will bring in too many covered facilities under the rule without a concomitant increase in environmental protection. First, meeting the threshold quantity does not automatically make an onshore non-transportation-related facility subject to the rule. Second, a lower threshold quantity is appropriate for an initial screening criterion, ensuring that only onshore non-transportation-related facilities that are unlikely to meet the substantial harm criteria are excluded from the scope of the rule. Accordingly, EPA has judged that the screening criteria in conjunction with the substantial harm criteria appropriately covers those onshore non-transportation-related facilities that could cause substantial harm to the environment from a worst case discharge of CWA hazardous substances into or on the navigable waters.

In response to the commenter who suggested that the 1,000x RQ multiplier could be paired with an opportunity for a facility to adopt a higher multiplier with the agreement of the LEPC/TEPC following coordination, EPA directs the commenter to the appeals provision in § 118.6 and petition provision in § 118.7. If a facility owner or operator disagrees that there is a likelihood of a worst case discharge or with a determination that the facility could cause substantial harm to the environment via a worst case discharge, the facility owner or operator may appeal to the RA or the LEPC may use the petition process.

As per § 118.12, a facility owner or operator must provide a copy of their FRP to the LEPC, State Emergency Response Commission (SERC), TEPC, Tribal Emergency Response Commission (TERC), or other local emergency planning and response organizations. EPA disagrees that there is meaningful overlap in this rule and the EPCRA provisions, as they do not require any facility planning, and refers the commenter to Section 2.3.3 in the TBD for that analysis.

EPA reaffirms here that each CWA hazardous substance maximum quantity onsite should be aggregated across the facility, but should not be aggregated across different CWA hazardous substances.

Public Comment Summary:

Request for Clarification

A couple of commenters suggested that EPA provide more information on the rationale behind determining the threshold quantity and why this is appropriate for application to CWA hazardous substances (0192, 0197).

One commenter recommended that EPA provide support for how the multiplier “reflects the range of risks posed by the listed CWA hazardous substances” because the only support it has provided is that this method “preserve[s] the underlying toxicity parameters used to establish the original RQs” (0197).

EPA Response:

To the commenters who asked for more information on the basis of the threshold quantity, the RQ multiplier reflects relative toxicity parameters used to establish the original RQs. See Section IV.A.1.a.i of the proposed rule preamble, Docket ID EPA-HQ-OLEM-2021-0585-0001, for a discussion on RQs and how they were derived. The RQs provide a means to use an existing regulatory structure that already considers risk on a scale and that has been successfully used for release notification for decades. EPA also balanced the variability among the 296 CWA hazardous substances and a tailored threshold amount against a uniform, easily applied, mass-based RQ multiplier, deciding on balance in favor of using a single RQ multiplier. In addition, while the proposal focused on capturing larger capacity covered facilities that could pose a greater risk, with additional consideration, in EPA’s judgment, a 1,000x multiplier for determining the threshold quantity as a screening criterion more effectively represents the potential risks associated with a worst case discharge.

Alternative Applicability Approaches

Public Comment Summary:

Oppose

One commenter recommended a hybrid approach to the threshold quantity criteria for the rule. The commenter agreed that all facilities that meet the criterion for the reasonable likelihood of release to a waterway and meet the 10,000 times the RQ should be subject to the rule. The commenter suggested that any facility located within a defined source water zone of concern (ZOC), as defined by EPA in a report titled “Occurrence of Releases with the Potential to Impact Sources of Drinking Water” (EPA 817-R-21-001) should also be captured under this rule if it meets or exceed 100 times the reportable quantity for any CWA Hazardous Substance (0174).

EPA Response:

EPA disagrees with that the source water ZOCs described in the report “Occurrence of Releases with the Potential to Impact Sources of Drinking Water” (EPA 817-R-21-001) are appropriate for this regulation. The ZOCs used in the study described in the referenced report were intended to provide a uniform definition for identifying whether releases captured by the NRC would be included in the analysis or not. The methodology was not designed to identify worst case discharges. As noted in Section 2.6 of the referenced report: Limitations of the Methodology, “It is possible that releases significantly impacting a source of drinking water occurred outside a zone of concern. Conversely, it is also possible that releases within a zone of concern did not significantly impact the source water.” The criteria in the final rule, which are based on whether a worst case discharge from an onshore non-transportation-related facility could cause substantial harm to a PWS, are outcome based and therefore will more appropriately target such facilities for regulation compared to the ZOCs in the referenced report. While EPA appreciates that the commenter suggested a different approach with different thresholds for differently situated facilities, EPA has decided to use one RQ multiplier for ease of implementation and compliance, especially for an initial threshold determination.

Establish New Regulatory Thresholds Based on Toxic Endpoints

Public Comment Summary:

Support

One commenter agreed that the proposed rule properly rejected alternative approaches to calculating the quantity threshold considered by EPA. The commenter noted that establishing new toxic-endpoint-based thresholds for each CWA hazardous substance would be time-consuming and could further delay the final rule, which is already 30 years overdue. The commenter added that the quantity threshold is meant to capture all the potential substantial harm facilities, and the substantial harm analyses are meant to determine which of these facilities would be required to submit an FRP (0215).

EPA Response:

EPA agrees that establishing new toxic-endpoint-based thresholds for each CWA hazardous substance would be time-consuming and could further delay the final rule.

Establish Thresholds Using Distance-Based Multipliers

Public Comment Summary:

Oppose

One commenter expressed concerns regarding the use of distance-based multipliers, arguing that this approach would be more difficult for facilities to implement and for communities and EPA to police. The commenter added that this approach would also exacerbate the problem that already exists in the half-mile threshold in the failure to account for special risks in floodplains (0215).

EPA Response:

EPA agrees that distance-based multipliers are impractical and would be difficult to implement. While EPA appreciates that the commenter suggested a different approach with different thresholds for differently situated facilities, EPA has decided to use one RQ multiplier for ease of implementation and compliance, especially for an initial threshold determination.

Thresholds From Other Hazardous Substances Regulations (Non-CWA)

No comments

Alternative Thresholds by Aggregated Category

Public Comment Summary:

Support

A couple of commenters agreed with EPA’s adjustment factor using a profiling operation based on solubility, density, volatility, and associated propensity for dispersal in the water of each CWA hazardous substance (0205, 0207). One commenter stated that this information is extremely helpful for supporting source water protection assessments and may inform response actions and planning for a community water system (0207). Another commenter agreed with EPA’s approach but believes that it might be difficult to conduct a material classification for mixtures because the list could go far beyond 296 individual chemicals belonging to different physical, chemical, or dispersal categories (0205).

Oppose

A couple of commenters disagreed with EPA’s rejection of the approach to aggregate CWA hazardous substances within categories to determine whether a facility has reached the threshold quantity for applicability (0215, 0216). One commenter suggested EPA decrease the CWA hazardous substance threshold and base a facility’s compliance with that threshold on the facility’s aggregate storage capacity for all CWA hazardous substances onsite (0216). Another commenter added that by limiting the capacity threshold to consideration of one chemical at a time, see § 118.3(a) (proposed), the proposed rule understates the risk of facilities with capacity to store large amounts of many dangerous chemicals, none of which individually eclipse the high threshold quantity that EPA has proposed (0215).

EPA Response:

EPA decided not to use the adjustment factor to penalties using a profiling operation based on solubility, density, volatility, and associated propensity for dispersal in the water of each CWA hazardous substance, though this data could be useful for a hazard evaluation and emergency response planning. EPA agrees that it would be difficult to conduct a material classification for mixtures because the list could go far beyond 296 individual chemicals belonging to different physical, chemical, or dispersal categories.

EPA disagrees that a CWA hazardous substance threshold should be aggregated for all CWA hazardous substances onsite. The Agency has no data to support this approach or information that doing so would further reflect the risk of a worst case discharge. EPA disagrees that this understates the risk of facilities with capacity to store large amounts of many dangerous chemicals, none of which individually eclipse the high threshold quantity that EPA is finalizing since there is some flexibility in appropriate circumstances for an RA to determine that a facility could cause substantial harm to the environment even if it does not meet the threshold quantity requirement for any one CWA hazardous substance.

Maximum Quantity Onsite versus Maximum Capacity Onsite

Public Comment Summary:

Support

A few commenters provided support for using the maximum capacity onsite to determine whether the threshold quantity has been met or exceeded (0168, 0201, 0215). One commenter stated that given the fluctuations in the total amounts of chemicals stored at a facility over time, the only way to adequately plan for prevention and response to worst case discharges is to account for the full storage capacity for CWA hazardous substances. The commenter added that basing the applicability criteria on fluctuating levels of chemicals stored at a facility could permit gamesmanship by facilities seeking to avoid compliance with response planning obligations. The commenter also said that EPA should base the approach on the Oil Pollution Prevention FRP regulation, which is focused on planning for worst case spills (0215).

Oppose

Several commenters expressed concern with using the maximum capacity onsite to determine whether the threshold quantity has been met or exceeded and suggested that EPA screen facilities based on actual quantities stored onsite (0169, 0175, 0176, 0179, 0184, 0186, 0187, 0189, 0194, 0199, 0201, 0204, 0205, 0211). One commenter noted that using the maximum capacity would make facilities that will never house enough CWA hazardous substances meet the threshold and be subject to the rule.

Several commenters referenced the definition of capacity to store and how it requires facilities to have the capacity to store 10,000x RQ instead of the actual amount of a CWA hazardous substance that is stored onsite. The commenters raised concerns that this will create confusion among facilities trying to determine if they are subject to the rule and that there will be facilities that will never house enough of a CWA hazardous substance to meet the threshold as facilities often use additional storage capacity to stow chemicals (0191, 0218). Some commenters noted that it is unclear how the definition of “capacity” applies to warehouse space, as many facilities would be included in the rule regardless of whether they were to ever actually house anywhere close to the 10,000x RQ amount of a CWA hazardous substance (0191, 0204, 0214). As a result, the commenters suggested that EPA should “screen facilities based on what they physically store on-site” instead of using a maximum capacity criterion (0191, 0218). One commenter added that this would mean that a facility with anhydrous ammonia containers—which are prohibited to be filled beyond 85 percent liquid volume to allow for expansion and contraction—would be subject to the rule because the container would be assumed to be 100 percent full of anhydrous ammonia (0204).

One commenter noted that the definition of “maximum capacity” is subject to misinterpretations and inconsistent calculation because it is dependent on how containers are defined, on a minimum size container and the definition of container capacity, and on the compositions of the CWA hazardous substances within mixtures located not just in storage but also in the various process vessels and operational equipment (0179).

Another commenter suggested that the screening criteria should be revised to reflect that facilities are only subject to the regulation if actual storage of a chemical exceeds the threshold levels (0206).

A couple of commenters recommended EPA narrow its definition of capacity to “house CWA hazardous substances” to avoid unnecessarily adding facilities (0191, 0218).

Another commenter requested that stormwater conveyances should also be exempt from the capacity threshold (0197).

EPA Response:

In the final rule, EPA has adjusted its approach to use maximum quantity onsite (inventory) at any given time rather than maximum container capacity onsite as the basis for assessing risk to the environment. EPA based this decision largely on the fact that risk determinations using maximum quantity onsite will more accurately reflect the hazard posed and has been used successfully in other EPA chemical regulations, such that this is standard business practice. Additionally, since containers are typically measured by volume and CWA hazardous substances may vary dramatically in weight due to their physical properties, there is not a clear association between container size and quantity of CWA hazardous substances onsite. Thus, a facility owner or operator or inspector of an onshore non-transportation-related facility would have to convert the volume of each CWA hazardous substance container onsite to a chemical-specific weight in order to compare reported values and determine if the facility meets the threshold quantity..

While the Oil Pollution Prevention FRP regulation uses container capacity for applicability threshold determination, this is consistent with how oil is measured and regulated, using volume (gallons). On the chemical side, CWA hazardous substances (and all chemicals that EPA and other federal agencies regulate) are measured and regulated by weight, typically in pounds. CWA RQs are also weight-based (1, 10, 100, 1,000, and 5,000 pounds). The OPA Conference Report (H.R. Rep. No. 101-653, 101^st Cong., 2d Sess. 1990) specifically directed EPA to account for oil storage capacity, but it has no corresponding language for CWA hazardous substances. As oil and the 296 CWA hazardous substances differ in important and myriad ways, it is reasonable to pursue a different approach in terms of determining the appropriate amount that should be used for determining threshold quantities and as a planning factor.

In so doing, EPA is responding to commenter concerns about covered facilities that may have capacity for but will never actually have CWA hazardous substances onsite in quantities sufficient to meet the threshold quantity but (if capacity were the metric) could be subject to the rule. This is especially true when considering some CWA hazardous substances will never be stored at the full capacity of a container due to their physical properties. For example, several commenters noted that for one of the highest volume and occurrence CWA hazardous substances, anhydrous ammonia, containers are prohibited to be filled beyond 85 percent liquid volume to allow expansion and contraction. Similarly, if a number of CWA hazardous substances are stored in a warehouse, determining what the maximum capacity is for chemical storage and for which chemical it should be calculated becomes needlessly complex and seemingly less reflective of realistic risks.

For mixtures, using capacity gets even more complicated, since a facility owner or operator or EPA inspector would have to convert varying volumes of CWA hazardous substances into weights, then extrapolate based on their proportions to the full capacity of the container. This also seems needlessly complex and potentially introduces calculation errors into threshold applicability determinations and worst case discharge scenario quantities. To add to the complexity, CWA hazardous substance and mixtures can be present onsite in numerous types of containers and configurations.

EPA understands the concern regarding fluctuating quantities and numbers of containers, particularly at certain batch processors and in some industries, and also the use of mobile storage containers. EPA notes that the maximum quantity onsite must reflect the aggregated quantity at the facility across all containers, including but not limited to rail cars or other mobile storage not under active shipping papers (not regulated under 49 CFR Parts 171-185), process vessels, canisters, drums, bulk storage tanks, dumpsters, totes, or bulk cargo containers positioned on land. However, EPA disagrees with commenters who asserted that the only way to adequately plan for response to worst case discharges is to account for the full storage capacity for CWA hazardous substances. Indeed, EPA and other federal regulators routinely use actual chemical inventory quantities for a variety of regulatory and planning purposes. EPA intends that an FRP for CWA hazardous substances be forward-looking and account for the maximum quantity onsite at any time. On balance, EPA believes that choosing quantity over capacity is appropriate in terms of feasibility of implementation and the risks presented. Moreover, covered facilities have many incentives to accurately track their inventories over time.

Since EPA has changed its approach, there is no need to adjust the definition of capacity to “house CWA hazardous substances” nor to address the capacity of stormwater conveyances.

Mixtures (118.9)

Public Comment Summary:

Support

One commenter provided support for the proposed rule’s approach to calculating mixtures to determine the capacity threshold. The commenter noted that this approach mirrors existing regulations on how to treat mixtures of CWA hazardous substances under the CWA and the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). The commenter added that the approach is familiar to regulated entities and appropriately assumes the entire mixture is composed of the most hazardous of the CWA hazardous substances (0215).

Oppose

Several commenters expressed concerns with the proposed rule’s approach to calculating mixtures to determine the capacity threshold (0179, 0183, 0184, 0186, 0197, 0199, 0201, 0205, 0206, 0211, 0214). A couple of commenters argued that requiring the use of the lowest RQ when the exact mixture composition is unknown is overly conservative, unrealistic, and does not reflect the actual risk of harm (0183, 0184, 0186, 0206, 0211, 0214). One commenter suggested EPA give regulated facilities the opportunity to provide information about the substances in the mixture, which should inform the threshold quantity for the mixture. The commenter stated that if a facility can provide counterevidence that their mixture composition does not meet the lowest RQ, a different level can be used in the toxic endpoint calculation (0211).

One commenter suggested that the proposed rule on mixtures should be updated for process vessels. The commenter stated that the current plan requires facilities to account for CWA hazardous substance spills for transition vessels, where no chemicals are mixed. The commenter added that the proposed rule should be updated for process vessels in which chemicals are added and mixed. The commenter noted that control malfunctions can occur at the mixture point and requiring a plan for the worst case scenario outlined could account for the control malfunction (0346).

Another commenter referenced that EPA is proposing the same requirements to determine reportable quantities for mixtures or solution under CERCLA § 103(a) in § 118.9 of the proposed rule. The commenter requested EPA explicitly note that if using the mixture rule as suggested, a container does not contain an RQ of a CWA hazardous substance, it be excluded from the proposed requirements. The commenter noted that as currently written, language from § 118.9 would result in the inclusion of many units with trace amount of CWA hazardous substance or idling emptied vessels erroneously reaching the threshold determination. The commenter also mentioned that in the preamble, EPA stated that “if a facility has a mixture with unknown constituent quantities, 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.” The commenter noted that this would significantly increase the number of regulated facilities required to submit FRP under the regulation, well beyond the estimate from Tier II reporting described in the RIA provided in the proposed rule, and this reporting increase would occur even though it is likely that the actual makeup of relevant mixtures is well below threshold quantities (0205).

EPA Response:

In § 118.9, EPA proposed and is retaining in this final action a mixture provision for determining the CWA hazardous substance maximum quantity onsite at the facility, under § 118.3(a), and mixture worst case discharge quantities under § 118.10. This provision is based on CERCLA Notification Requirements, found in CERCLA § 103(a) (40 CFR § 302.6). EPA agrees with a commenter that noted the chosen approach mirrors existing regulations on how to treat mixtures of CWA hazardous substances under the CWA and CERCLA. Regulated facilities are familiar with the mixture rule and how to apply it.

EPA disagrees with commenters who argued that requiring the use of the lowest RQ when the exact mixture composition is unknown is overly conservative, unrealistic, and does not reflect the actual risk of harm. If there are known and unknown substance constituent quantities, the facility owner or operator must only apply the lowest RQ to the unknown portion of the mixture, not the entire quantity. The quantity of the known CWA hazardous substances should be calculated and included in threshold quantity calculations. This approach is properly conservative and reflective of risk. If a facility owner or operator can provide evidence that the mixture composition does not meet the lowest RQ, they may use the appeals provision in § 118.6 to adjust their maximum quantity onsite or worst case discharge scenario quantity, or for reconsideration of their status. EPA has no information to indicate that this would expand the number of regulated facilities beyond what is estimated in the RIA.

EPA disagrees that the mixture rule for process vessels should be adjusted. First, the commenter did not provide a rationale or alternative for how it should be updated. Second, EPA currently has no evidence or data to find that this is necessary.

EPA disagrees with the commenter who asserted that if a container does not contain an RQ of a CWA hazardous substance, it should be excluded from the proposed requirements, setting a de minimis container quantity. The threshold quantity screening criterion is based on the maximum quantity onsite and includes all CWA hazardous substances aggregated across a facility, including mixtures. RQs can be as high as 5,000 lbs. To exclude as much as 4,999 lbs. of a CWA hazardous substance from consideration in threshold calculations aggregated across a facility could lead to gross mischaracterizations of the risk of worst case discharge. As a screening tool, the threshold quantity is designed to exclude only those facilities that are most unlikely to have the ability to cause substantial harm to the environment from a worst case discharge into or on the navigable waters. As such, it is appropriate to account for all substances onsite. The Agency notes that this is one part of an initial screening; it does not mean that a facility is subject by the rule. Rather, it means that if an onshore non-transportation-related facility does not meet either of these initial screening thresholds, it is not subject to the rule and need not do any further analysis. Only facilities within one-half mile to navigable water or a conveyance that also meets or exceeds a threshold quantity must then determine whether they satisfy any of the substantial harm criteria.

Within One-Half Mile of Navigable Water or Conveyance to Navigable Water

Public Comment Summary:

Support

A couple of commenters provided support for the one-half mile to navigable water or conveyance to navigable water applicability requirement (0203, 0207). One commenter stated that this criterion is important to minimize harms that can affect both human health and the environment (0203). Another commenter noted that this criterion is workable but suggested it be combined with consideration of the potential to adversely impact a PWS (0207).

Oppose

Several commenters expressed concerns about the one-half mile to navigable water or conveyance to navigable water applicability requirements (0151, 0159, 0167, 0179, 0216, 0227). Some of the commenters suggested that the distance should be extended farther for complete protection of the nation’s waters (0151, 0266, 0227).

A few commenters noted that using the half-mile distance could be problematic due to differences in topography across the nation (0185, 0192, 0205). One commenter stated that for example, topography can greatly impact whether or how a discharge can reach a WOTUS. The commenter added that EPA provides no accounting for this important distinction and instead only relies on the factor of mere distance to make this determination. The commenter also mentioned that a facility could be located within one-half mile of a navigable water, but because the topography causes the water to flow in the opposite direction, discharges may never reach WOTUS. The commenter recommended EPA reference the Oil Pollution Prevention regulation under 40 CFR § 112.1(5) for the determination of distance (0205).

One commenter stated that a purely distance-based standard is not sufficient because it cannot be assumed that if a CWA hazardous substance is released, it will reach navigable waters. The commenter added that for example, a CWA hazardous substance could have certain physical properties (e.g., viscosity, vapor pressure) that impact its potential to reach navigable waters (0183).

One commenter suggested that EPA use a risk-based approach as the second screening criterion instead of a distance threshold. The commenter stated that, if EPA retains a distance-based threshold, EPA justify the specific distance interval and allow exceptions where engineering analysis or modeling demonstrate site-specific considerations that make release to navigable waters unlikely (e.g., topography, flow direction, secondary containment). The commenter suggested that, using this approach, EPA retain the half-mile distance but allow companies to conduct their own robust analysis if they wish. The commenter discouraged EPA from requiring modeling due to the burden and cost but asked EPA to still allow it for companies with sufficient resources due to its higher accuracy (0219).

One commenter requested that EPA add to the proposed rule a more extensive consideration of groundwater and altitude as they pertain to the half-mile distance from navigable water, and specifically how geographies may vary from city to city (0153).

Request for Clarification

One commenter requested clarification on how conveyance to navigable water should be considered for facilities with only gaseous CWA hazardous substances over the FRP threshold (0177).

EPA Response:

EPA is retaining the proposed location-based screening criterion that covered facilities must determine whether they are located within one-half mile of navigable waters or a conveyance to navigable waters. The Agency again notes that this is one part of an initial screening; it does not mean that a facility is subject by the rule. Rather, it means that if an onshore non-transportation-related facility does not meet either of these initial screening thresholds, it is not subject to the rule and need not do any further analysis. Only facilities within one-half mile to navigable water or a conveyance that also meets or exceeds a threshold quantity must then determine whether they satisfy any of the substantial harm criteria.

This distance is based on research related to the Oil Pollution Prevention FRP regulation. While the Agency agrees that there are significant differences between oil and CWA hazardous substances, one-half mile is an appropriate distance to infer that a facility has a reasonable expectation to discharge to navigable water or a conveyance to navigable water in the event of a worst case discharge (58 FR 8832, February 17, 1993). EPA has determined that straightforward, bright-line initial screening criteria are appropriate to determine if facilities are not subject to the rule. All bright lines can have an under- and over-inclusive impact given particular circumstances, but on the whole, for purposes of an initial, straightforward screening criterion, one-half mile strikes the right balance.

Risk-based approaches or those taking into account distance intervals and allowing exceptions due to engineering analysis or modeling are more appropriate to the application of the substantial harm criteria, discussed below.

Some commenters argued that the distance should be extended farther for more complete protection of the nation’s waters and in the context of CWA hazardous substances. However, in EPA’s analysis, 80 percent of covered facilities with CWA hazardous substances onsite were within one-half mile to navigable waters (see Chapter 2 of the RIA in the rulemaking docket). To extend the distance would make the criterion effectively meaningless because nearly every onshore non-transportation-related facility that meets or exceeds the threshold quantity would meet this screening criterion. While commenters were concerned about differences in topography complicating determinations of whether a facility is within one-half mile of navigable waters or a conveyance to navigable waters, this distance should be measured from the nearest opportunity for discharge, and topography should not be taken into account. Industry will be able to comply using widely available electronic mapping tools. EPA has determined that the one-half mile distance is protective and straight forward, and facility owners or operators will have the opportunity to model a worst case discharge in evaluating the substantial harm criteria that depend on planning distance. Additionally, an owner or operator may appeal to the RA if they believe there is no reasonable expectation to discharge into or on navigable waters or a conveyance to navigable waters from their facility.

EPA recognizes commenter concerns regarding CWA hazardous substances that have physical properties (e.g., viscosity, vapor pressure) that preclude the substance from reaching navigable waters or a conveyance to navigable waters. However, a facility owner or operator will consider these properties, and their implications for the ability of the substance to impact water, when they evaluate the substantial harm criteria, not in the initial screening criteria. For purposes of the initial screen (intended to help easily identify whether an onshore non-transportation-related facility is outside the scope of the rule), an onshore non-transportation-related facility will need to determine its distance to navigable waters or a conveyance to navigable waters regardless of the route or method of travel of a CWA hazardous substance in a worst case discharge.

Groundwater impacts are outside of the scope of this rule, which is specific to onshore facilities that, because of their location, could reasonably be expected to cause substantial harm to the environment by discharge into or on the navigable waters.

Alternatives to One-Half Mile to Navigable Water or Conveyance to Navigable Water

Public Comment Summary:

Oppose

Several commenters offered alternatives and suggestions to the one-half mile to navigable waters or conveyance to navigable waters criterion (0159, 0168, 0169, 0183, 0185, 0208, 0219). One commenter recommended that the final rule require facilities within a certain distance from intakes or wells (including riverbank and riverbed filtration wells) to prepare an FRP (0169).

One commenter expressed concern that the one-half-mile distance threshold is taken from EPA’s oil regulations, which is not sufficiently comprehensive in the context of CWA hazardous substances. The commenter noted that there are significant differences between oil and CWA hazardous substances and recommends EPA establish proximity distances specific to CWA hazardous substances (0159).

Another commenter recommended that EPA allow facilities the flexibility to pursue two options: (1) the proposed one-half-mile standard, or (2) spill modeling (not solely based on distance) to determine whether CWA hazardous substances onsite may reach navigable waters (0183).

EPA Response:

EPA notes that unless a facility meets both screening criteria, it does not have to conduct further analysis. Only if a facility meets both screening criteria (including being within one-half mile of navigable waters or a conveyance to navigable waters) will the owner or operator need to determine their ability to cause substantial harm to the environment, including the ability to adversely impact a PWS, which will include assessing impacts to water intakes. Whether a well or wellhead acts as a conveyance to navigable water will be a factual question.

EPA disagrees that the one-half-mile distance threshold, as used in EPA’s Oil Pollution Prevention regulation, is not sufficiently comprehensive in the context of CWA hazardous substances. While the Agency agrees that there are significant differences between oil and CWA hazardous substances, one-half mile is an appropriate distance to infer that a facility has a reasonable expectation to discharge into or on the navigable waters in the event of a worst case discharge (58 FR 8832, February 17, 1993). EPA has determined that straightforward, bright-line initial screening criteria are appropriate to determine if facilities are not subject to the rule. All bright lines can have an under- and over-inclusive impact given particular circumstances, but on the whole, for purposes of an initial, straightforward screening criterion, one-half mile strikes the right balance.

EPA has determined that the one-half-mile distance is straightforward and protective, and facilities will have the opportunity to model a worst case discharge in evaluating the substantial harm criteria that depend on planning distance.

Substantial Harm Criteria

Public Comment Summary:

Support

One commenter supports all four substantial harm criteria in the proposed rule and believes it is extremely important that facilities create an FRP to enhance the safety of these criteria (0153).

Oppose

Several commenters disagree that only facilities that meet the substantial harm criterion would be covered by the rule. These commenters believe that many facilities that would ultimately not be covered by this rule would still be required to go through extensive efforts to assess whether they meet the substantial harm criteria (0175, 0191, 0192, 0194, 0204, 0218). One commenter stressed the time, money, and resources needed to complete the analysis to determine if a facility meets any of the substantial harm criteria (0192). The commenters urge EPA to make the substantial harm assessments simple to avoid burdensome requirements (0175, 0191, 0192, 0194, 0204, 0218).

A couple of commenters offered several recommendations for EPA to strengthen the substantial harm criteria in the proposed rule (0170, 0183, 0198, 0215, 0217). One commenter stressed that EPA should establish the impacts on communities of color and low-income communities as an independent substantial harm criterion. The commenter added that because of the disproportionate co-location of historically marginalized populations and CWA hazardous substances, and the fact that these communities are often in flood-prone areas with deficient infrastructures, communities of color and low-income communities are vulnerable to worst case releases from CWA hazardous substance facilities (0217). One commenter urged EPA to list the density of facilities and co-location of CWA hazardous substances as a criterion for EPA to consider under § 118.3(b) (0215).

A couple of commenters recommended that EPA expand the substantial harm criteria to include facilities in storm surge zones, floodplains, earthquake hazard zones, or fire hazard zones, or that are close to communities with environmental justice concerns (0182, 0215).

One commenter agreed with EPA’s four screening criteria to assess the potential for substantial harm, but suggested EPA align the order in which a facility must consider these criteria. The commenter added that even if all criteria must be reviewed, there is an implied sequence in Figure 1 of 87 FR 17898 (March 28, 2022) that is slightly different from the preamble explanation (0207).

One commenter suggested that EPA add a fifth substantial harm criterion—risk to first responders. The commenter added that emergency responders are placed at great risk of harm from an accidental release of CWA hazardous chemicals because these situations are inherently volatile (0170).

One commenter recommended EPA take into consideration that property devaluation could occur in the areas around a facility that has a risk of a worst case discharge. The commenter asks EPA to not overestimate worst case discharges by making conservative assumptions (0183).

Another commenter suggests that the term water intake be clarified for a groundwater system to be the point at which water is withdrawn from the aquifer at the wellhead—consistent with §§ 118.5(b)(4) and (5) (0198).

Request for Clarification

One commenter requested that EPA clarify whether the regulated community is responsible for completing an analysis of all four substantial harm criteria or just one, following the sequence in § 118.3(c) (0179).

EPA Response:

EPA appreciates the support for all four substantial harm criteria in the proposed rule and agrees it is extremely important that facilities create an FRP to enhance response planning.

Several commenters asserted that the extensive efforts to assess whether they meet the substantial harm criteria were essentially requiring compliance with the rule. EPA disagrees with this premise; indeed, the reason for the initial screening criteria is to mitigate the regulatory burden on onshore non-transportation-related facilities that would not meet the substantial harm criteria. However, given the variability of the CWA hazardous substances at issue (including variations in transport, fate, and other chemical characteristics), it is inevitable that some facilities that meet the screening criteria will nonetheless not meet any of the substantial harm criteria. Because of the myriad of variables involved, the analysis is necessarily case-by-case. And while simplicity can reduce costs, it also often faces the dilemma of being either over- or under-inclusive. So, while EPA has determined that straightforward, bright-line initial screening criteria to determine if facilities are not subject to the rule satisfy the requirements of the statute in terms of adequately protecting the environment, a more nuanced analysis of the substantial harm criteria to determine which onshore non-transportation-related facilities must incur the added cost of preparing an FRP is warranted. Nevertheless, in principle, EPA agrees that making it as easy as possible to conduct these assessments is an important goal and will facilitate the successful implementation of this rule. EPA intends to continue to identify and provide tools to the regulated community and the public to support these determinations.

To the commenter who suggested a standalone substantial harm criterion based on the potential impacts of worst case discharges to navigable waters or a conveyance to navigable waters on communities with environmental justice concerns, EPA recognizes the unique risks faced by these communities. On the one hand, because these facilities are often located near communities with environmental justice concerns, this regulation will benefit those very same communities. In addition, in § 118.5(b), an RA may determine that an onshore non-transportation-related facilities facility could cause substantial harm to the environment due to its potential impacts on communities with environmental justice concerns. Another issue for communities with environmental justice concerns is the potential cumulative impact of multiple onshore non-transportation-related facilities in one area where any one facility may not have a maximum quantity onsite that meets or exceeds the threshold quantity of CWA hazardous substances, but it seems likely that if one facility experienced a worst case discharge due to extreme weather conditions, others could be similarly impacted and the collective effects could cause substantial harm to the environment. Upon consideration and in response to commenter concerns, an RA may now consider concerns regarding co-located covered facilities when determining whether an onshore non-transportation-related facility has the potential to cause substantial harm to the environment.

A worst case discharge is defined in this action as the largest foreseeable discharge in adverse weather conditions, where adverse weather must account for the potential for increased and more severe extreme weather events and other impacts due to climate change as well as natural hazards. Thus, a facility must already examine things like storm surge zones, floodplains, earthquake hazard zones, and fire hazard zones when evaluating the potential effects of a worst case discharge in the context of response requirements and the ability to cause substantial harm to the environment.

EPA did not intend to imply there is an order in which the substantial harm criteria should be evaluated; rather, all substantial harm criteria must be evaluated independently and with equal weight, since each criterion establishes whether a facility could cause substantial harm to the environment from a worst case discharge into or on the navigable waters or a conveyance to navigable waters. The Agency considered whether a substantial harm criterion specific to risks to first responders is necessary. However, responder health and safety should already be addressed in emergency planning at any facility as required under OSHA’s standards at 29 CFR 1910.120.

EPA disagrees the requirement of additional planning will result in property devaluation. To the contrary, increased facility response planning and public information around risks may increase the property values.

Ability to cause injury to fish, wildlife, and sensitive environments

Public Comment Summary:

Support

One commenter asked if the ability to cause injury to FWSE includes the ability to injure these environments by conveyance through groundwater, specifically as addressed by the U.S. Supreme Court in 2019 in County of Maui v. Hawaii Wildlife Fund, 140 S.Ct. 1462 (2020) (0167). Two commenters noted the unique habitat and aquatic life, which may be endangered, that reside in karst environments (0167, 0198). One of these commenters stated that prompt responses to releases in karst topography are critical because of the rapid contaminant flow in solution channels (0167), while the other urged EPA to require the notification of the U.S. Fish and Wildlife Service (FWS) and those implementing habitat conservation plans under the FRPs if the worst case CWA discharge concentrations would adversely impact the habitat area (0198).

One commenter supported EPA’s proposed definition for FWSE and the use of ACPs to ensure facility responsiveness to local planning needs. The commenter was concerned that facilities may not consider all FWSE receptors impacted by a worst case discharge because the “other areas” mentioned in the definition of FWSE are determined by facilities and it may not be transparent as to what a facility considers or does not consider. To mitigate this concern, the commenter supported the requirement of noting the “type of fish, wildlife, and sensitive environment receptor(s)” on the substantial harm certification form and recommended requiring that facilities list the specific names (e.g., national or state park) or geographic coordinates if names are not available of FWSE receptors considered in the facility’s analysis on their certification form (0215).

One commenter recommended EPA consider FWSE in the proposed rule because it complements the goal of protecting sources of drinking water (0207).

Oppose

One commenter requested that the EPA acknowledge that “not all navigable waters identify fish, wildlife, and sensitive environments and public receptors in their Area Contingency Plans.” The commenter claimed that this is especially true for ACPs created for inland water bodies. The commenter asked that EPA provide flexibility in these determinations because of these situations and suggested the Oil Pollution Prevention FRP regulation’s vulnerability analysis, § 112.20(h)4 and § 1.4.1 of Appendix F, as one possible alternative (0179).

One commenter stated the EPA needs to address in the proposed rule or associated guidance how to consider the distance-to-FWSE criterion under scenarios when direct discharge to navigable water is not expected. Specifically, the commenter noted that it is not clear how to apply the provision to a gaseous state CWA-listed substance when mitigation planning is already addressed under EPA’s RMP program and OSHA’s General Duty Clause and PSM regulations. The commenter claimed that preparing an FRP under these circumstances would duplicate measures required under the RMP and that the proposed rule “does not recognize the benefits provided by the RMP to mitigate risk to surrounding area that includes FWSE and the general public.” Citing the proposed rule’s exemption for USTs to reduce the burden of overlapping requirements on a facility, the commenter requested that EPA provide a similar exemption or mechanism to cite RMPs at facilities with a CWA listed substance that have implemented protective measures to mitigate a release under the RMP per the Clean Air Act § 112I (0207).

One commenter noted that the provision in § 118.5(b)(3) creates conflicting applicability criteria to § 118.3(c), since the RA determination is if it is “proximate” “to fish, wildlife, and sensitive environments and other areas determined by the Regional Administrator to possess ecological value” and the rule has not defined “proximity,” “other areas,” or “ecological value” (0181).

EPA Response:

First, the U.S. Supreme Court’s decision in County of Maui v. Hawaii Wildlife Fund, 140 S.Ct. 1462 (2020) addressed an issue specific to NPDES permitting. Determining if groundwater could serve as a conveyance of a CWA hazardous substance worst case discharge to navigable water that causes injury to FWSE will have to be done on a case-by-case basis and through examination of the facts of specific scenarios. EPA is clarifying that it considers a conveyance to navigable waters in the context of this rule to be a means of transport that provides a direct pathway to navigable waters. In the majority of cases, a means of transport will be discernible, confined, and discrete, and thus will present a straightforward factual scenario. Some examples are a storm drain, pipe, or channel that discharge directly into navigable waters. While EPA could make some generalization that it does or does not expect that groundwater would serve as a direct means of transport, the reality is there will inevitably be situations where it will depend on the specific facts to determine whether a given situation serves as a direct means of transport to navigable waters.

For identification of FWSE, facilities must use the applicable ACP prepared pursuant to § 311(j)(4) of the CWA, in addition to identifying other areas pursuant to the definition in § 118.2. This regulation does not alter how those are determined or what constitutes FWSE. Notification requirements will differ based on the expected effects of a worst case discharge on FWSE, and could include notification to FWS or those implementing habitat conservation plans.

The Substantial Harm Certification Form found in Appendix A requires a facility to note the type of FWSE, and full FRPs will include further identification of and planning for potential impacts in the hazard evaluation.

To the commenter concerned with identification of FWSE in ACPs, EPA is aware that ACPs currently may not reflect impacts of worst discharge of CWA hazardous substances to navigable waters. Working with federal response partners, the Agency intends to provide compliance assistance to facilities to ensure these areas are properly identified and impacts are assessed. In addition, the owner or operator is responsible for identifying public receptors, not just ACPs.

EPA agrees with commenters who noted that there are chemicals on the CWA hazardous substance list at 40 CFR § 116.4 that may be in either a solid or gaseous form upon release and may be physically unable to reach navigable waters or a conveyance to navigable waters. Specifically, facility circumstances and methods of storage vary widely, so the facility owner or operator must use their best professional judgment based on the physicochemical properties and characteristics of the substance at issue and best available information and practice in determining if a worst case discharge substance that releases as a gas or solid could, in adverse weather conditions, could reach navigable waters or a conveyance to navigable waters, cause injury to a public receptor or FWSE, or adversely impact a PWS. This may mean that for a substance released as a gas in adverse weather conditions and without consideration of passive mitigation, secondary containment, or administrative controls, the distance to endpoints cannot be calculated. Solid CWA hazardous substances may be miscible in water, and, as such, a planning distance may be calculated. Thus, if a solid stored as a powder or in pellets has the ability to release in a flood scenario and reach navigable waters or a conveyance to navigable waters, the facility owner or operator must make a substantial harm determination, and if the solid CWA hazardous substance is determined to be able to cause substantial harm to the environment from a worst case discharge into or on navigable waters or a conveyance to navigable waters, submit an FRP to EPA.

EPA disagrees that CWA hazardous substances covered by EPA’s RMP program and OSHA’s General Duty Clause and PSM regulations adequately plan for a worst case discharge to navigable water. These programs are not specific to worst case discharges of CWA hazardous substances into or on the navigable waters, do not cover all the required program elements under CWA § 311(j)(5), and are not an appropriate substitute. Please see Sections 2.3.2 and 2.4.2 in the TBD in the docket for more information.

EPA disagrees that that the provision in § 118.5(b)(3) creates conflicting applicability criteria to § 118.3(c) The RA determination can correct for the criteria in § 118.3 being both under or over inclusive. So, while a facility may meet the criteria, an owner or operator might nonetheless appeal to the RA that the facility should not be subject to the rule, for instance, because for topological reasons it is infeasible that a worst case discharge could cause injury to FWSE. On the other hand, a facility owner or operator might model that a worst case discharge could not cause injury to FWSE, but upon examining other data sources of sensitive areas, the RA could determine that the facility could cause substantial harm to the environment from a worst case discharge into or on the navigable waters.

RAs have extensive local knowledge of vulnerable areas and considerations under their purview, and a facility owner or operator may always appeal a determination of substantial or significant and substantial harm should the facility owner or operator disagree with the RA’s decision.

FWSE planning distance calculation (118.10)

Public Comment Summary:

Support

One commenter provided support for the proposed rule’s use of 10 percent of a range of concentrations that are lethal to 50 percent of a measured population after a specified time (LC₅₀) to calculate toxic endpoints, agreeing that this method would provide a more conservative and relevant concentration of concern and one that is preferable to using CWA RQs (0215).

Oppose

One commenter requested that if EPA does not use a planning distance basis similar to the Oil Pollution Prevention FRP regulation, they should allow the regulated community to identify endpoints for individual chemicals (as opposed to a class of chemicals) and incorporate these facility-defined endpoint concentrations given EPA approval. The commenter stated that the “one-size-fits-all” solution in the proposed rule was not justified for different water body classifications and uses. The commenter provided an acid or base spill as an example, where the commenter claimed that pH would be the endpoint of concern, not the concentration of the acid or base. The commenter claimed that added flexibility would allow facilities an opportunity to better account for toxicological data for species within the impacted water body. Relatedly, the commenter requested that the EPA clarify whether the fathead minnow-based endpoints used for FWSE evaluation are appropriate for facilities proximate to marine or brackish water (0179).

One commenter requested additional clarification and provided recommendations on the following terms currently outlined in the proposed rule (0167):

“Planning distance – How does this distance address underground conveyance by the subsurface and groundwater environments, as addressed by the U.S. Supreme Court in County of Maui v. Hawaii Wildlife Fund, 140 S.Ct. 1462 (2020) …? For groundwater, consideration should be given to potential discharge sites in relation to source water protection/wellhead protection areas, water wells, stormwater infiltration wells, recharge zones, karst terrain and near-surface fractured bedrock. Planning distance should include areas within one to five-year groundwater time of travel.”

EPA Response:

EPA disagrees with the commenter who requested that the regulated community should identify endpoints for individual CWA hazardous substances (as opposed to categories of CWA hazardous substances) and incorporate these facility-defined endpoint concentrations given EPA approval. Assessing and approving these on a site-by-site and CWA hazardous substance-by-substance basis would be prohibitively difficult (i.e., resource intensive and time consuming) given varying substance formulations and site and waterbody-specific conditions used to determine distance from the point of release to the receptor(s) of concern. Moreover, the regulated community’s review of scientific literature and studies would involve different judgments of the relative importance of various hazard factors while gaps in the data may make it difficult, if not impossible, to compare CWA hazardous substances on the same objective basis, potentially subjecting decisions to criticism due to different perceptions as to the relative importance of factors. On a case-by-case basis, a covered facility owner or operator may appeal a substantial harm determination to the RA if they disagree with the planning distance calculations. EPA maintains that the LC50-based endpoints appropriately model for effects on wildlife, regardless of the type of hazardous substance discharge or type of waterbody. EPA intends to provide compliance assistance at the facility level addressing specific CWA hazardous substances and potential impacts to receptors.

Regarding endpoints for acids or bases, EPA recognizes that some acids and bases are toxic primarily because of their ability to lower or raise pH (i.e., concentration is not indicative of toxic thresholds so much as resulting intolerable pH levels), however, some acids may kill aquatic organisms before pH is meaningfully altered via inherent toxicity and/or soluble salts that are toxic at low concentrations after hazardous substance dissolves and is neutralized following spillage and characteristics. Although EPA intends to provide compliance assistance to covered facility owners or operators (e.g., differentiating between acids and alkalinity whose potential level for harm are high due to their ability to lower or raise pH versus inherent toxicity; distinguishing between acidity and alkalinity as a property of substance versus total waterbody concentration), it is incumbent upon facility owners or operators to assess toxicity mechanism(s) and the predicted exposure point concentration(s) to determine whether a worst case discharge could cause injury to FWSE.

EPA notes that the fathead minnow is widely distributed in North America, found in a wide range of habitats but most abundant in muddy brooks, streams, creeks, ponds, and small lakes. They have, however, been found in fresh-to-brackish marshes and caught in small, brackish tidal tributaries. EPA recommends considering species more appropriate for the potentially impacted water body (e.g., marine species such as sheepshead minnow instead of fathead minnow for situations where the release might be to a marine system). An unpublished analysis by EPA’s research arm using the Ecotoxicology (ECOTOX) Knowledgebase compared 96-h fathead minnow LC50s to 96-h sheepshead minnow LC50s found there is no systematic difference in acute sensitivity between these species (i.e., a paired T test of the log LC50 pairs for 163 chemicals showed no significant difference in the sensitivity of the two species).

EPA is clarifying that it considers a conveyance to navigable waters in the context of this rule to be a means of transport that provides a direct pathway to navigable waters. In the majority of cases, a means of transport will be discernible, confined, and discrete, and thus will present a straightforward factual scenario. Some examples are a storm drain, pipe, or channel that discharge directly into navigable waters. While EPA could make some generalization that it does or does not expect that groundwater would not serve as a direct means of transport, the reality is there will inevitably be situations where it will depend on the specific facts to determine whether a given situation serves as a direct means of transport to navigable waters. The above cited case is specific to NPDES permitting procedures.

Available models/whether EPA should develop a tool

Public Comment Summary:

Support

Several commenters requested that EPA develop and provide a model, methodology, and/or formulas to aid in endpoint calculations for substantial harm determinations (0175, 0179, 0183, 0185, 0187, 0191, 0194, 0196, 0197, 0201, 0204, 0205, 0219). One commenter requested, if EPA does not provide such assistance, that they otherwise remove the requirement (0197). Several of these commenters stated that performing planning distance and endpoint modeling to determine where substance concentrations no longer pose the ability to injure is one of the most difficult aspects of assessing the substantial harm criteria (0204, 0175, 0187, 0194, 0191). Several commenters claimed that leaving such modeling to the discretion of the facility creates opportunities for inconsistency, and that facilities incur additional costs due to the time and resources required to develop models in-house or find an appropriate third-party model (0204, 0175, 0187, 0194, 0191).

Several commenters urged EPA to provide support (in the form of a tool or otherwise) to reduce cost burdens on facilities, ensure consistency, and/or avoid issues created by a lack of private firms to provide modeling (0204, 0175, 0187, 0194, 0191, 0179, 0185, 0201). One commenter noted that, without modeling software from the EPA, compliance will be difficult in part because only a small number of individuals can adequately perform such modeling, which may drive up cost as many entities race towards compliance deadlines (0196). One commenter added that the implementation of New Jersey’s regulation “Discharges of Petroleum and Other Hazardous Substances Rules,” which requires that facilities map their location and route a discharge would take, resulted in such a situation where few firms could provide the required modeling, making it difficult for facilities to acquire needed services (0191). One commenter stated their concern that EPA may not approve of a facility’s model or methodology after they develop it, which could force them to re-complete work (0183), while another was concerned that current EPA guidance is not sufficient to achieve results comparable to those achieved by the RMP (0205).

Regarding the design of an EPA tool, many commenters requested that the resources be similar to the approach taken with the RMP program (0204, 0175, 0187, 0194, 0191), and a couple of commenters suggested that EPA develop a comprehensive tool specifically comparable to the existing RMP*Comp Tool (0205, 0201). One commenter requested that EPA allow for public review and comment on such an EPA model to minimize ambiguity and uncertainty (0183). A couple of commenters requested that an EPA tool take into account preventative measures (e.g., containment, retention ponds) to contain discharges (0185) or that that a modeling exemption be included given engineering controls (e.g., secondary containment, double walled tanks) or specific location information (e.g., materials inside and no direct stormwater drains) (0197). One commenter additionally supported a facility’s flexibility to use an alternative model if the facility identifies it as more representative (0197).

EPA Response:

The Agency is aware that CWA hazardous substance planning distance modeling is a critical component of successful implementation of this regulation and is engaged with its research arm to identify additional data and resources to aid the regulated community in compliance. That said, EPA disagrees that having facilities exercise their professional judgment and applying best modeling practices creates opportunities for inconsistency, as it provides flexibility and allows for those most familiar with the substance, facility, and site conditions to examine the event of a worst case discharge and its potential effects. EPA expects that the potential increase in demand for these services caused by the rule will result in greater competition and increased market entry by new contractors. Please see Chapter 5 the RIA in the docket for a discussion of estimated costs to the regulated community.

EPA is working on identifying solutions to enhance planning for worst case discharges and has built in a 36-month ramp-up period to anticipate for an adjustment period. EPA appreciates the example of implementation of New Jersey’s regulation “Discharges of Petroleum and Other Hazardous Substances Rules,” which requires that facilities map their location and route a discharge would take, which shows such implementation is possible and resources are available. EPA will work with facility owners or operators to ensure requirements are clear at the outset, such that work need not be completed more than once, and is working with the RMP program to identify best practices. Again, unless facilities wait until the last minute, a 36-month implementation period should be ample time to plan for and do the requisite analysis.

EPA agrees that RMP*Comp is an excellent implementation tool and is working internally to research and disseminate best practices. Stakeholder engagement and review is critical to success and EPA will provide compliance assistance to the regulated community. EPA disagrees that a tool should take into account preventative measures, as these could fail in a severe weather event. That said, a facility owner or operator may use other alternative models that fit the stated parameters in 40 CFR § 118.10.

Alternative approaches

No comments

Ability to adversely impact a public water system

Public Comment Summary:

Support

Several commenters provided support for EPA’s approach to assessing a CWA hazardous substance’s ability to adversely impact a PWS (0169, 0174, 0180, 0198, 0207, 0215). One commenter agreed with the approach but insisted that the facilities, rather than the PWS, should be responsible for all aspects of planning, including any research, modeling or data analysis, or any other action necessary for determining impacts (0180). Another commenter expressed support for EPA’s approach but provided several recommendations to improve it, including requiring facilities to consult with potentially affected PWSs as part of the substantial harm analysis and requiring facilities to describe how they will monitor the impacts of the discharge on public health and the environment in their FRPs (0215).

Another commenter recommended that if a PWS declines to participate or respond, the facility should be required to provide the water system with the facility’s emergency contact information along with access to data about all onsite CWA hazardous substances and their potential health and environmental impacts in case of discharges and spills (0169).

Oppose

Several commenters expressed concern with EPA’s approach to assessing a CWA hazardous substance’s ability to adversely impact a PWS (0167, 0169, 0177, 0179, 0191, 0205, 0216). A couple of commenters requested that EPA provide detailed, transparent, and clear guidance about the applicable drinking water standards to prevent inconsistencies in implementation and confusion for facilities (0179, 0205).

One commenter suggested EPA add to § 118.3(c)(ii) “and to communities solely supplied by private household groundwater wells” (0167).

Another commenter noted that Alaska lacks statewide hydrographic data, especially in remote areas, which places a disproportional economic burden on existing and proposed facilities that would be regulated under the proposed rule (0177).

Several commenters suggested that EPA allow facilities to show a good-faith effort of coordination with PWSs through documented attempts, especially in certain circumstances where coordination is difficult or not possible (0175, 0187, 0191, 0194, 0218).

EPA Response:

EPA agrees with the commenters who support for EPA’s approach to assessing a CWA hazardous substance’s ability to adversely impact a PWS. EPA also agrees that facilities are responsible for all aspects of planning, including any research, modeling or data analysis, or any other action necessary for determining impacts. EPA also believes there is value in facility coordination with downstream PWS(s) to evaluate the potential of a worst case discharge to cause substantial harm; however, EPA recognizes that coordination with PWS may be out of the facility’s control. Therefore, EPA is revising the requirement to more clearly state that facility owner or operators may show a good-faith effort of coordination with PWSs through documented attempts, especially in certain circumstances where coordination is not possible. The regulation requires facilities to monitor the impacts of the discharge on public health and the environment in their FRP response actions per 40 CFR § 118.11.

If a PWS declines to participate or respond to a facility’s request to coordinate on the substantial harm determination, they will still be part of a facility’s notification list in the event of a spill, and a facility will still need to plan for impacts to the PWS.

Where drinking water standards are available on the federal or state level, facilities will use those to guide their substantial harm determinations. Information about National Primary Drinking Water Standards is available online at https://www.epa.gov/ground-water-and-drinking-water/national-primary-drinking-water-regulations. Regardless of whether a drinking water standard has been established for a specific hazardous substance, a facility owner or operator must assess the possibility of a worst case discharge to cause any of the impacts enumerated in §§ 118.3(c)(2)(ii), (iii), (iv), and (v). EPA agrees with commenters who requested that EPA provide detailed, transparent, and clear compliance assistance to assess the potential of a worst case discharge of a hazardous substance to cause substantial harm to a PWS. Due to the site-specific nature of these determinations, it is not practical to specify all details of this process in a regulation. Rather, EPA plans to provide compliance assistance to support the assessment of substantial harm to PWSs. EPA feels this is necessary to provide flexibility in assessing the site-specific details for the potential impacts of a worst case discharge on a PWS.

For states that lack hydrographic data, their EPA Region can be a source of assistance in determining downstream impacts. Since the existing Oil Pollution Prevention Program requires this type of modeling currently, EPA can provide support to co-regulators who lack these data. In 40 CFR Part 112, Appendix C, it is noted that maps and the average slope of a river can be ordered/obtained from the U.S. Geological Survey.

Using Source Water Protection Areas

Public Comment Summary:

Support

Several commenters provided support for requiring facilities within Source Water Protection Areas (SWPAs) to prepare an FRP (0169, 0198, 0215, 0216). One commenter listed several reasons why using SWPAs would be beneficial, including eliminating the need for covered facilities to conduct distance planning and adequately protecting drinking water. The commenter stated that EPA’s concerns with the SWPA approach are unconvincing. Although some states do not make their SWPAs available to the public, the commenter noted that responding to requests for SWPAs from facilities would likely not place a significant burden on state drinking programs, as they could create streamlined systems for facilities to request SWPAs for this purpose. The commenter added that states may also choose to make SWPAs publicly available, or facilities could simply reach out to the state drinking water program and potentially affected water systems to determine whether they are located within an SWPA (0215).

Oppose

Several commenters expressed concerns with requiring facilities within SWPAs to prepare an FRP (0175, 0191, 0194, 0218). Some commenters stated that this requirement would expand the rule to include facilities that do not pose a legitimate risk of discharging CWA hazardous substances to these water systems (0187, 0191, 0194, 0218).

Request for Clarification

One commenter requested that the final rule clarify whether Drinking Water Protection Areas or Critical Water Management Areas would be considered SWPAs (0177).

EPA Response:

EPA disagrees with requiring facilities within SWPAs to prepare an FRP for the reasons enumerated in the proposed rule’s preamble at IV.A.2.b.ii. On the one hand, SWPAs would be a useful tool that could eliminate the need for distance planning; however, they are not universally available and uniformly applied. Moreover, EPA is concerned with the burden that would be placed on state drinking water programs to respond to requests for SWPAs from covered facilities if this were a requirement of the rule. Commenters provided no data or information to support the assertion that responding to requests for SWPAs from covered facilities would likely not place a significant burden on state drinking water programs. One purpose of this final regulation is to implement congressional intent by shifting the responsibility for planning from public resources to private covered facilities that pose a substantial risk to the environment in the event of a worst case discharge into or on the navigable waters or a conveyance to navigable waters, not create new burdens for state drinking water programs or PWSs. Furthermore, requiring additional updating of SWPAs or uniformity in their application so that they could be used as a substantial harm criterion is outside the scope of this rulemaking. That said, to the extent being in a SWPA is important to the substantial-harm analysis, EPA RAs may use SWPAs to determine that a facility could cause substantial harm to the environment under the provisions in § 118.5.

Additionally, SWPAs are intended to capture a wide range of threats to source water quality, and thus can be expansive beyond the threat of worst case discharges that could adversely impact a PWS within the specific planning distance for the facility. In any case, EPA is concerned that that the categorial use of SWPAs would be overinclusive and would expand the rule to include facilities that do not pose a legitimate risk of discharging CWA hazardous substances to these water systems. Finally, EPA is clarifying that SWPAs are not Critical Water Management Areas.

Self-determination model

No comments

Groundwater impacts

Public Comment Summary:

Several commenters requested that EPA include groundwater as a protected entity under the proposed rule (0151, 0167, 0207, 0266). One commenter recognized that while groundwater is not jurisdictional WOTUS under the CWA, the proposed rule affects the quality of groundwater drawn by groundwater-supplied PWSs regulated under SDWA as well as nearby groundwater users and other downstream surface water users if the groundwater discharges to surface water (0167). Another commenter urged EPA to clarify how overland transport factors into consideration for impacts on groundwater, as the current proposed rule does not directly address such a scenario (0207).

A couple of commenters highlighted that PWSs should be limited to those that are under the direct influence of surface water or groundwater. The commenters added that PWSs that have groundwater as their only source should not be considered in a substantial harm evaluation (0192, 0199).

EPA Response:

Including potential discharges to groundwater is outside of the scope of this final rule, which is specific to onshore non-transportation-related facilities that, because of their location, could reasonably be expected to cause substantial harm to the environment by a worst case discharge into or on navigable waters or a conveyance to navigable waters. Navigable waters do not, by definition, include groundwater. Regardless, EPA maintains that if an onshore non-transportation-related facility meets the substantial harm criterion of adversely impacting a PWS from a worst case discharge to navigable waters or a conveyance to navigable waters while also meeting the screening criteria, it is subject to the regulation.

Ability to cause injury to public receptors

Public Comment Summary:

Support

One commenter provided support for EPA’s proposal to have a separate substantial harm criterion for facilities that could cause injury to public receptors through a worst case discharge to navigable waters. The commenter noted that contaminating waterways used or occupied by people would injure human health and certainly cause substantial harm (0215).

Oppose

Several commenters expressed concern with EPA’s proposal to have a separate substantial harm criterion for facilities that could cause injury to public receptors through a worst case discharge to navigable waters (0175, 0179, 0187, 0191, 0194, 0199, 0204, 0205, 0207, 0211, 0218).

A few commenters stated that this substantial harm criterion does not fall under the scope of the CWA or the stated purpose of this proposed rule. The commenters recommended that the proposed rule only applies to facilities that pose a significant risk of discharging a CWA hazardous substance into a navigable waterway and that any risk posed to a public receptor is not applicable to the objective of the proposed rule (0175, 0187, 0191, 0194, 0204, 0218).

EPA Response:

EPA disagrees that this substantial harm criterion does not fall under the scope of the CWA or the stated purpose of this final rule. The scope of the rule is onshore non-transportation-related facilities that, because of their location, could reasonably be expected to cause substantial harm to the environment by a worst case discharge into or on navigable waters or a conveyance to navigable waters. Public receptors are defined as areas through which the public has access to navigable waters, thus tying this criterion to the statutory authority. For this action, EPA decided that including a separate harm factor for public receptors, particularly for recreational areas along navigable waters, such as parks and campgrounds where the public may be present in or on the waterways and could be impacted by a worst case discharge of a CWA hazardous substance, is necessary.

Toxic endpoints

Public Comment Summary:

Oppose

One commenter expressed concerns with EPA’s proposal to codify parameters and toxic endpoints to be used by facilities when determining whether a worst case CWA hazardous substance could cause injury to public receptors. The commenter posited that using 10 percent of the lethal dose 50 (LD₅₀) assigned to each RQ category is restrictive for a spill scenario and appears to be a one-size-fits-all approach, which they believe is not justified for different water body classifications and uses by public receptors (0179).

The commenter requested clarification on the 10 percent of LD₅₀ concentration. The commenter noted that it appears that the 10 percent was applied to the upper toxicity and not the midpoint between the upper and lower. The commenter suggested EPA provide flexibility to alternatively identify the endpoints for each CWA hazardous substance on a site-specific basis (0179).

The commenter also mentioned that it is not appropriate to use the same parameter and toxic endpoints for both public receptors and FWSE. The commenter added that simple contact with any of the CWA hazardous chemicals listed in Table 3, especially when diluted by the time any concentration reaches a public receptor one-half-mile away, would not likely result in an injury (0179).

EPA Response:

EPA disagrees that using the 10 percent of a range of LC50 concentrations is restrictive for a spill scenario and appears to be a one-size-fits-all approach, and is not justified for different water body classifications and uses by FWSE and public receptors. EPA recognizes the commenter’s interest in flexibility to address site-specific considerations, however, RQs exist for all CWA hazardous substances and EPA is currently curating the latest toxicity, hazard, and safety data to be considered when determining impacts to communities, including drinking water. Thus, prescribing concentration-based endpoints for public receptors and FWSE applicable to all waters based on RQ relative toxicities provide clear and definitive metrics that can be used when determining a CWA hazardous substance ability to cause injury and thus meet the substantial harm criteria. To differentiate from one-size-fits-all approach, owners or operators can model their worst case discharge scenarios using waterbody-specific conditions and characteristics (e.g., mean flow and velocity, hardness, natural buffer capacity, temperature, salinity, alkalinity, dissolved oxygen, turbidity, biological population, etc.) and consult ACPs, local maps, local authorities, their LEPC or TEPC, or any other available information to identify water body classifications and uses by public (e.g., parks, recreational areas, docks, or other public spaces). Working with federal response partners, the Agency intends to provide compliance assistance to covered facilities to ensure these areas are properly identified and impacts are assessed. These considerations should tailor the discharge scenario and waterbody-specific public receptors, resulting in discharge-specific predicted concentrations for comparison against the appropriate concentration-based endpoint values found in Appendix B.

When establishing and adjusting RQs for CWA hazardous substances, EPA selected the lowest LC50/LD50 value available across relevant aquatic and mammalian species evaluated against five lethality concentration/dose rating scales for aquatic toxicity and for mammalian toxicity, which included separate scales for oral, inhalation, and dermal (Technical Background Document to Support Rulemaking Pursuant to CERCLA Section 102: Volume 1, March 1985, available in the docket). For this action, EPA proposed a factor of 10 percent to be applied to the RQ’s “upper” toxicity level, which was selected as a policy decision to address uncertainties stemming from (1) interspecies variability since toxicity tests were conducted on standard laboratory species and few on species of direct interest in the wild, and (2) extrapolating from laboratory animals to humans given statistically valid human LD50 values were available in only isolated cases (p. 2-76, Technical Background Document to Support Rulemaking Pursuant to CERCLA Section 102: Volume 1, March 1985, available in the docket). No data demonstrating the use of 10% of the upper toxicity level for each of the five-tier ranges (i.e., 0-0.1, 0.1-1, 1-10, 10-100, or 100-500 mg/L or mg/kg) is inappropriate or unprotective was submitted. Thus, EPA is finalizing this approach as proposed but reiterates that it is working on curating the latest toxicity/hazard and safety data to be considered. EPA disagrees with the commenter who requested that the regulated community should identify endpoints for individual CWA hazardous substances (as opposed to classes of CWA hazardous substances) and incorporate these facility-defined endpoint concentrations given EPA approval. Assessing and approving these on a site-by-site and CWA hazardous substance-by-substance basis would be prohibitively difficult (resource intensive, and time consuming) given varying substance formulations and site and waterbody-specific conditions. Moreover, the regulated community’s review and selection of scientific literature and studies of toxicity/hazard data could involve different judgments on the relative importance of various toxicities/hazards while gaps in the data may make it difficult, if not impossible, to compare CWA hazardous substances on the same objective basis, potentially subjecting decisions to criticism on the basis of different perceptions as to the relative importance of factors. In contrast, EPA is working on assembling the updated toxicity/hazard and safety data across the six primary criteria, underpinning the data-driven RQs such that facilities only need leverage the expertly curated data/RQ scores. On a case-by-case basis, a facility owner or operator may appeal a substantial harm determination to the RA if they disagree with the planning distance calculations.

The parameters being finalized are widely applicable to any worst case discharge event given there are different endpoints within each endpoint category (please see Appendix B). As per the planning distance calculations, a CWA hazardous substance may be diluted by the time it reaches an endpoint, which is why a facility owner or operator must calculate the relevant concentration.

Air releases/inhalation toxicity

Public Comment Summary:

Oppose

A couple of commenters expressed concerns with requiring facilities to include potential inhalation risks in the CWA hazardous substance FRPs. The commenters recommended that, in general, air releases and inhalation toxicity be covered and managed under the CAA (0171, 0201).

One commenter expressed concern that EPA does not include inhalation toxicity in its substantial harm criterion for facilities that could cause injury to public receptors through a worst case discharge to navigable water. The commenter added that a worst case discharge that causes the air above navigable water to be toxic when inhaled would certainly cause substantial harm to the environment and does not believe this should solely be regulated under the CAA (0215).

EPA Response:

EPA agrees that air releases and inhalation toxicity are generally covered and managed under the CAA. However, once a facility determines that it could cause substantial harm to the environment due to a worst case discharge into or on the navigable waters, the facility hazard evaluation must include an analysis of potential air effects of such a discharge. It is critical that facility owners or operators plan for all of the potential outcomes from a worst case discharge.

Alternative approaches

No comments

Reportable discharge history

Public Comment Summary:

Support

A few commenters provided support for including reportable discharge history as a substantial harm criterion and agree with the overall approach in the proposed rule (0168, 0215).

Oppose

Several commenters expressed concern that the reportable discharge history approach as a substantial harm criterion is unnecessary and creates additional work (0175, 0179, 0187, 0191, 0194, 0197, 0204, 0205, 0211, 0218). One commenter opposed this because it unjustly assumes that the mere fact of a past reportable CWA hazardous substance discharge is evidence of substantial harm to the environment or that such harm is “reasonably to be expected” to occur, regardless of the amount of the CWA hazardous substance kept onsite (0205).

One commenter requested clarification on whether companies would still be required to submit an FRP if they had previously triggered the substantial harm criteria due to their reportable discharge history but subsequently completed five years without any discharge (0179).

The commenter also requested that reportable discharges from CWA hazardous substances contained in NPDES effluents, and from oil containing CWA hazardous substances, be excluded from the criteria as these substances are regulated under 40 CFR Part 122 and 40 Part CFR 112, respectively (0179).

While one commenter noted that the recommendation to include facilities with reportable discharges in the last five years is reasonable, they thought that EPA made some assumptions on reporting that overlook the concept of timeliness. The commenter stated that EPA may be able to use the recent Information Collection Request on how states are implementing America’s Water Infrastructure Act (AWIA) 2018 to provide insights on how well protocols for notification of downstream drinking water systems are being implemented. The commenter noted that it is important for EPA to have a clear understanding of what challenges must be overcome to ensure proper notification in a timely manner (0207).

A couple of commenters stated that the five-year timespan of reportable discharges of CWA hazardous substances is too short a timeframe to adequately protect drinking water sources. The commenters suggested that the requirements should be expanded to 10 years and include reportable discharges of any reportable substance, not just CWA hazardous substances (0174, 0215).

EPA Response:

EPA agrees with commenters providing support for including reportable discharge history as a substantial harm criterion and the overall approach in the proposed rule.

EPA disagrees that including reportable discharge history approach as a substantial harm criterion is unnecessary. EPA notes that the fact that the spill is reportable means that the spill entered navigable waters in quantities that may be harmful. These discharges are required to be reported to the NRC, so evaluating if a facility has had one in the last five years should add minimal burden. Additionally, discharge history may indicate deficiencies at a facility and so warrant further care and additional planning, as shown in the related study of oil spills discussed in the preamble to the Oil Pollution Prevention FRP regulation (58 FR 8832, February 17, 1993).

EPA maintains that five years is a reasonable look-back window and ample time for a facility to improve spill resilience as demonstrated through the lack of reportable discharges into or on navigable waters. EPA agrees with commenters that limiting the reportable discharge releases into or on navigable waters or a conveyance to navigable waters is reasonable and has added clarifying text to the final rule, which is also consistent with the Oil Pollution Prevention FRP regulation. The Agency is not expanding the discharge history criterion to cover other reportable discharges (e.g., to land or non-CWA hazardous substances) given that the authority for this action is specific to discharges on or to navigable waters or conveyances to navigable waters, adjoining shorelines, or exclusive economic zones and those substances listed at 40 CFR Part 116. Reportable discharge history will be limited to the preceding five years, so if a covered facility has had a reportable discharge outside of that date range, it does not meet that substantial harm criterion.

AWIA’s amendments to EPCRA, which include notification requirements, are an important element of emergency response planning and will complement the requirements under this regulation.

EPA reiterates that discharges permitted under NPDES (40 CFR Part 122) and oil containing CWA hazardous substances (covered under 40 CFR Part 112) are not subject to this rule.

Time horizon

Public Comment Summary:

Oppose

Several commenters recommended EPA expand the time horizon for discharge history from 5 years to 10 years (0168, 0169, 0215, 0216). One commenter added that given the under-reporting of discharges in the past, a more protective time horizon of 10 years is appropriate (0215).

Request for Clarification

One commenter requested clarification on whether the “last five years” is from the effective date of the rule or a rolling five-year dataset (0179).

EPA Response:

EPA disagrees that the time horizon should be extended. Five years is an appropriate time frame for a facility to improve spill resilience and demonstrate additional response planning and is also consistent with the Oil Pollution Prevention FRP program. Extending the time horizon would not affect under or over-reporting, and EPA has no data to suggest that extending the reportable discharge history time horizon would increase safety. The “last five years” is a rolling five-year dataset.

If release reached water

Public Comment Summary:

Oppose

One commenter suggested EPA improve the proposed rule by limiting the reportable discharge of a CWA hazardous substance to releases to water. The commenter added that, while the preamble describes this, this is not explicitly stated in the proposed regulatory text (0205).

Another commenter recommended EPA expand the discharge history criterion to cover any discharge above the RQ, regardless of whether it has impacted or reached water. The commenter added that self-reported data on whether spills actually reach water are not reliable, as EPA has repeatedly conceded (0215).

EPA Response:

EPA agrees that limiting the reportable discharge to releases to navigable water is appropriate and has added clarifying text to the final rule. The Agency disagrees with expanding the discharge history criterion to cover any reportable discharge, since the authority for this action is specific to impacts to navigable water. While NRC data may be incomplete, the facility owner or operator will have information on any impacts and will be able to accurately report on whether a discharge reached navigable water. This approach is also consistent with the Oil Pollution Prevention FRP regulation.

Alternative approaches

No comments

Passive mitigation, administrative controls, secondary containment

Public Comment Summary:

Oppose

Several commenters expressed concerns with EPA’s proposal to disregard passive mitigation, administrative controls, and secondary containment (0175, 0183, 0184, 0187, 0189, 0191, 0192, 0194, 0199, 0204, 0205, 0208, 0211, 0215, 0218, 0219). Some of the commenters stated that passive mitigation is a highly effective measure to prevent discharges from impacting surrounding communities. The commenters added that not considering these when assessing the substantial harm criteria would significantly increase the number of facilities covered by the rule and put unnecessary burdens on facilities that pose no risk of substantial harm, while also distorting EPA data (0175, 0187, 0194, 0204, 0218).

One commenter suggested that EPA’s argument to disregard this criterion is unconvincing. The commenter mentioned that EPA could address its concern about secondary containment not being an appropriate discharge prevention measure for all CWA hazardous substances by allowing facilities to explain, with supporting evidence, why secondary containment is an appropriate discharge prevention measure. The commenter added that if EPA agrees with the facility, no FRP would be required, and if they disagree, then an FRP would be required. The commenter also noted, with regards to EPA’s second argument against this criterion, the ability of facilities to raise secondary containment as an appeal to their substantial harm determination in no way means that lack of secondary containment should not be a reason to consider a facility a substantial harm facility (0215).

Another commenter suggested that if EPA determines that secondary containment will reduce the occurrence of hazardous discharges that cause substantial harm and a facility installs the secondary containment, EPA should allow up to two years to design and install the containment system (0206).

One commenter stated that they already employ various practices at facilities to prevent spills and potential discharges of CWA hazardous substances including secondary containment, passive mitigation, and retention basins. The commenter stated that if preventive measures are not incorporated in the initial screening criteria, models or methodology to assess toxicity endpoints should take into account preventive measures such as containment and/or stormwater retention ponds that are sized to contain spills from chemicals stored at the facility. The commenter noted that while the proposed rule recognizes this, it would require facilities to go through an appeal process in order to be relieved of the obligation to file an FRP. The commenter stated that instead of requiring an appeals process, EPA should account for prevention practices during the screening process or in substantial harm criteria determinations. The commenter added that to facilitate this exemption process during screening, EPA should request that facilities report any and all spill-prevention regulations and requirements currently followed, and practices employed at the facility. The commenter added that if practices employed at a facility properly prevent the potential for the discharge of CWA hazardous substances to navigable waters and facilities have appropriate plans for if a spill does occur, the facility should be deemed compliant with any final rule and not be required to submit an FRP (0185).

One commenter recommended EPA exempt manmade structures such as secondary containment structures (0197). Another commenter urged EPA to consider mitigation measures already in place, particularly under SPCC and other federal law. The commenter referenced 40 CFR Part 112, Appendix C, which EPA allows the use of man-made structures (0179).

The commenter referenced EPA’s decision to include the clause about determination of facilities that could not reasonably expect a discharge, “must exclude consideration of manmade features such as dikes, equipment, or other structures, which may serve to restrain, hinder, contain, or otherwise prevent a discharge.” The commenter noted that it is counterproductive not to include structures that are specifically designed to contain a CWA hazardous substance discharge and may offer a disincentive to install additional containment equipment (0197).

A couple of commenters noted that some facilities have wastewater treatment facilities that could reduce the likelihood of the release of CWA hazardous substances into navigable waters (0208, 0219). One commenter recommended that EPA consider the presence of such systems in the proposed applicability criteria in lieu of distance (0208).

One commenter recommended that facilities with structural or other protective measures in place that would be expected to minimize any risk of discharge and/or mitigate any risk thereof and substances with chemical characteristics that render a significant discharge to CWA Impact Areas unlikely be exempt from the final rule (0219).

EPA Response:

EPA disagrees with commenters who believe passive mitigation, administrative controls, and secondary containment considerations should be included in the final rule. Congress has stated that the purpose of response planning is to prepare for a worst case discharge, in which secondary containment or passive mitigation measures could fail. The Conference Report states that in defining a worst case discharge as the largest foreseeable discharge at a facility, Congress intended to describe a spill that is worse than either the largest spill to date or the maximum probable spill for the facility type (Conference Report No. 101-653, p. 147.) Further, Congress’s intent was that the worst case discharge reflect the partial failure of various preventive systems, and that the private sector be encouraged to increase its spill response capability (H.R. Rep. No. 101-653, 101^st Cong., 2d Sess. 1990). Relatedly, in extreme weather events, mitigation systems may fail. In addition, written administrative controls may be overridden or overlooked, making it foreseeable that a worst case discharge could occur notwithstanding such controls. EPA disagrees that not considering passive mitigation and secondary containment is an unnecessary burden on a significant number of facilities, nor that this approach will distort EPA’s data for these reasons.

While the Oil Pollution Prevention FRP regulation includes substantial harm criterion for a "lack of adequate secondary containment” in 40 CFR 112.20, regulatory requirements for oil spill prevention, countermeasure, and control exist in 40 CFR 112. Thus, the Oil Spill Pollution Prevention SPCC regulation provides a basis for evaluating that oil discharge secondary containment is adequate. For CWA hazardous substances, there is no uniform standard for taking into account passive mitigation or secondary containment. Accordingly, it is inappropriate to have those considerations as part of the initial screen as opposed to a case-by-case determination through the appeals process.

Furthermore, although EPA encourages covered facilities to implement additional release prevention, detection, and mitigation measures such as those cited by commenters, the Agency believes that the effects of these measures on the size and impact of a potential spill are not readily quantifiable, nor easily supported with historical spill evidence. CWA hazardous substances vary widely in physicochemical properties, and prevention and response strategies correspondingly differ based on the substance. EPA maintains that incorporating factors into the worst case discharge calculation that consider the risks associated with a variety of site-specific conditions regarding passive mitigation or administrative controls will, in general, be too complex for this rulemaking, and will require a very detailed verification and inspection processes. Requirements to prevent CWA hazardous substance discharges are based on many different regulatory regimes and industry standards and thus may be difficult for an inspector to assess, and requiring installation or operation of such systems is outside the scope of this final action. As a result, EPA does not believe that it is feasible or warranted to include a calculation of mitigation measures tied to a reduction in the worst case discharge volume. Nonetheless, if an owner or operator believes that the circumstances of the facility are such that it could not cause substantial harm to the environment from a worst case discharge to navigable waters or a conveyance to navigable waters, EPA is nonetheless providing a mechanism for them to make that case; namely, by appealing the substantial harm determination to their RA.

Transfers Over Water

Public Comment Summary:

Support

One commenter supported the adoption of criterion for transfers of CWA hazardous substances over water (0215). The commenter noted that the Oil Pollution Prevention FRP regulation contains such a requirement and that the USCG designated facilities that transfer any bulk CWA hazardous substances to vessels as substantial harm facilities. The commenter noted that transferring CWA hazardous substances over water creates a risk of discharge into waterways, and when combined with capacity requirements, the risk is high enough to create a reasonable expectation that a worst case discharge would cause substantial harm. The commenter suggested that EPA either make a determination that these facilities threaten significant and substantial harm to the environment or adopt the approach of the Oil Pollution Prevention FRP regulation and consider facilities meeting initial screening criteria and transferring approximately 4 percent of the 10,000x RQ multiplier over water to meet the substantial harm criteria. The commenter also urged EPA to address transfers below navigable waters that are not currently addressed by 40 CFR Part 280 or state equivalents as part of a criterion for transfers over water or a separate provision (0215).

Oppose

Two commenters opposed developing a substantial harm criterion for facilities that transfer CWA hazardous substances over water (0179, 0205). One commenter noted that transfers over water are covered by other regulatory agencies. The commenter also noted that § 118.5(b)(1) does not reference this exemption, given that in §§ 118.9 and 118.5(b)(10) EPA does not clearly differentiate between reportable discharges to water and those to other media (0205). Another commenter noted that transfers over water are highly variable and EPA lacks information on these activities (0179). The commenter also pointed out the USCG withdrew its part of the rulemaking in 2019 pertaining to “Marine Transportation-Related Facility Response Plans for Hazardous Substances” (0179).

EPA Response:

EPA disagrees that this regulation should include additional criteria for facilities transferring CWA hazardous substances over water. First and foremost, EPA agrees with the commenter that noted that the USCG has primary responsibility for Marine Transportation-Related facilities and would be the implementing agency for any CWA hazardous substance FRP regulations for that type of facility. Should the USCG initiate a rulemaking for facilities over which they and the Agency share jurisdiction, the two will collaborate to ensure consistency. Moreover, EPA did not receive data or information to support adding this as a substantial harm criterion.

Other Comments on Applicability Criteria (118.3)

Public Comment Summary:

Oppose

A couple of commenters were concerned with the amount of responsibility put onto owners and operators to determine if their facility is required to submit a CWA hazardous substance FRP. The commenters were concerned that given this responsibility, some owners and operators may cut corners or even misunderstand how to properly adhere to the proposed rule. The commenters recommended EPA work directly with facilities to help verify information about CWA hazardous substances (0229, 0234).

One commenter disagreed with EPA’s comparison in the proposed rule with the requirements applicable to the FRP program for petroleum products about the need for FRPs for CWA hazardous substances (0192).

Request for Clarification

One commenter appreciated Figure 1 in the preamble of 87 FR 17898 (March 28, 2022), as it provided helpful information to understand EPA’s intent of the proposed rule for the regulated community. The commenter requested EPA expand on this figure to help the regulated community fully understand the steps necessary to assess the applicability and also to establish worst case discharge. The commenter requested that EPA verify whether their interpretation of the steps that a regulated entity would need to take to assess the applicability and develop a worst case discharge scenario are correct, providing a detailed summary of the steps (0179).

EPA Response:

EPA disagrees that the amount of responsibility put onto owners and operators to determine if their facility is required to submit a CWA hazardous substance FRP is onerous. Facility owner or operators are responsible for safeguarding their materials and for planning. The OPA Conference Report (H.R. Rep. No. 101-653, 101^st Cong., 2d Sess. 1990) made clear that the responsibility for planning for worst case discharges of CWA hazardous substances belongs to these facility owners or operators. EPA staff will be available to provide compliance assistance. This rule strikes the right balance of flexibility to leverage the knowledge and expertise of facility owners or operators with appropriate requirements.

The Agency notes that the CWA § 311(j)(5) requires promulgation of this regulation for CWA hazardous substances as listed in 40 CFR § 116.4, which is the same authorizing legislation as the Oil Pollution Prevention FRP regulation found in 40 CFR § 112.20. EPA disagrees that noting this is inappropriate.

Please see the preamble of the final rule for a detailed discussion of the steps to determine applicability.

Compliance dates (§ 118.4)

Public Comment Summary

FRP Submission Compliance Dates

Support

Several commenters supported EPA’s timeline of 12 months to prepare and submit an FRP and substantial harm certification form (0205, 0214, 0215). To ensure this timeline is feasible, one commenter recommended EPA adopt the calculation methodologies in 40 CFR Part 112, Appendix C, Attachment C-III, or develop a modeling platform prior to the rule effective date (0205). One commenter agreed that facilities should be required to submit an FRP within one year of whenever a CWA hazardous substance meets/exceeds the maximum threshold of 10,000 times the RQ (0201).

Oppose

Several commenters expressed concern with the timeline outlined in the proposed rule to prepare and submit substantial harm certification forms and FRPs (0175, 0187, 0191, 0192, 0194, 0196, 0199, 0201, 0204, 0205, 0206, 0211, 0218), contending that they are short and insufficient. Several of these commenters asserted that due to the different modeling, training, needed facility changes, and administrative recordkeeping that is required to update FRPs, additional time is required for compliance and implementation (0175, 0187, 0191, 0192, 0194, 0199, 0204, 0205, 0218). A few commenters requested that facilities should not be required to submit FRPs until EPA has finalized the proposed rule (0199, 0206, 0211). One commenter emphasized that the creation, development, and implementation of new modeling techniques alone will take at least 12 months to complete. The commenter added that new resources will be required at the facility level, which further extends past the proposed 12-month timeframe. Further, the commenter noted that FRP would require consultation with Regional EPA staff, local officials, and communities and additional analysis of overlapping mandates under other air, water, and water statutory provisions would be needed. The commenter recommended EPA allow a minimum of 6 months if modeling is required (0205).

A few commenters noted that a timeline of four years is more realistic and more closely aligns with OSHA’s PSM and EPA’s RMP regulations, which allotted four years and three years, respectively. The commenters urged EPA to allow facilities enough time to fill out substantial harm certification forms and facility response forms carefully and accurately for this proposed rule to have the desired effect (0175, 0187, 0191, 0192, 0194, 0204, 0218). One commenter noted that 12 months is not enough time to comply because a site may have multiple chemicals subject to the proposed rule and the list of required actions would have to be repeated if a site has multiple chemicals (0196). A few commenters added that by extending the timeframe, it will promote compliance and ensure that FRPs are well-developed (0199, 0206, 0211). One commenter requested EPA extend the compliance dates by at least 12 months (0211). Another commenter requested EPA to allow 12 months rather than 6 months for newly regulated facilities to submit plans in accordance with §§ 118.4(a)(2) and 118.4(a)(3) in the proposed rule. This commenter also noted that EPA should provide clearer language as to what newly constructed facilities should consider as their start of operations and when the threshold quantity is exceeded (0205).

One commenter requested clarification from EPA about the applicability requirements of criteria mentioned in 118.3 because as currently written, it is difficult to follow. The commenter recommended the following language to enhance clarification:

“a facility response plan is to be submitted ‘...after one year from the effective date of this regulation. If a notification request by the EPA Regional Administrator is received, a facility response plan is to be submitted within six months given it is after one year from the effective date of this regulation. If a notification request by the EPA Regional Administrator is received prior to the one-year effective date of this regulation and a facility response plan is subject to be submitted within six months but the six-month submittal period is before the one-year effective date, the facility response plan is to be submitted after one year from the effective date of this regulation.” (0213)

One commenter expressed their inability to interpret EPA’s proposal that a facility initially subject to the Hazardous Substances Worst Case Discharge Planning Regulations must prepare and submit an FRP within 12 months of “meeting the criteria or notification [by the Regional Administrator].” The commenter stated that on the date the final rule is published in the Federal Register, a facility may “meet the criteria” for preparation and submission of an FRP but may not be aware of its obligation because it has to evaluate the applicability criteria articulated in the final rule. Thus, the commenter suggested the time period for submission of a plan must be based on when a facility “determines” that it meets the applicability criteria and that EPA must develop and make available a model, model guidance, and other guidance (e.g., adverse weather) to help facilities evaluate applicability criteria. The commenter also suggested that EPA establish an “effective date” for its final rule (preferably 12 months from publication in the Federal Register and after necessary guidance is released) to allow facilities time to review and assess applicability and then, require facilities initially subject to the final rule to prepare and submit their plans within 12 months of the effective date (0197).

A few commenters requested that EPA allow a two-year process for a facility to install secondary containment systems if EPA decides that secondary containment will reduce the occurrence of discharges that can cause substantial harm to the environment (0199, 0205, 0211).

One commenter supported the requirement for an initially regulated facility to submit an FRP no sooner than 12 months after the effective date of the final rule but noted that within one month for all other new facilities is not achievable. This commenter supports 12 months for newly regulated facilities and facilities with unplanned events or changes. The commenter suggested providing up to 12 months for newly regulated facilities to prepare the CWA hazardous substances FRP once a facility triggers “meeting the criteria” due to the complexity of self-determining planning distance formulas and/or methodologies to use for calculating the planning distance, which may require external contracting with third-party consultants. The commenter asked that EPA clearly define the timing framework and the timing on submission dates using the same groupings as in §§ 118.4(a)(1) to (5) – initially regulated, newly regulated, newly constructed, planned changes, and unplanned changes (0179).

One commenter expressed that “an operational trial period of 60 days” is not realistic and should be increased to one year since an initial “preliminary” plan can be prepared prior to the startup of operations, but threshold values and other logistics may change once the operations reach normal conditions. The commenter stated that even though the proposed timing is the same for Oil FRPs, CWA hazardous substances FRPs will be more complex and therefore would need a minimum of 12 months to prepare and submit a final plan for newly constructed facilities (0179).

One commenter noted that a “planned event or change” will require submission of the FRP prior to commencing operations. The commenter suggested that the EPA limit this provision to significant changes, such as for capital projects resulting in new process units and not for minor changes such as maintenance or operational activities. The commenter also suggested clarification of the timeframe of a “planned event or change” since it would be burdensome to go through the process of updating a CWA hazardous substances FRP for a short-lived change. The commenter suggests a timeframe of six months or more for determining a “planned event or change” (0179).

Regarding § 118.4 General requirements for initially regulated facilities, one commenter asked EPA to clarify what is meant by “meeting the criteria” to trigger the 12-month FRP deadline to avoid confusion. The commenter questioned whether this means submitting the Substantial Harm Certification form or submitting a letter of acknowledgement. The commenter also stated that timing for “initially regulated facilities” is unclear. The commenter noted that they support a total of 24 months: 12 months to complete and submit the Substantial Harm Certification form and another 12 months to prepare the chemical FRP (0179).

One commenter recommended that the EPA clarify their interpretation of “unplanned event or change” and clarify the difference between a facility with an “unplanned event or change” versus a newly regulated facility under § 118.4(a)(2). The commenter also recommended extending the timing from six months to one year after “meeting the criteria” for “an unplanned event or change” since they will not have been prepared for and will take longer to manage and develop plans for such an event or change (0179).

Regarding § 118.4 General requirements for newly regulated facilities, one commenter noted that the timing for newly regulated facilities is unclear, and the commenter noted that once a facility meets the criteria, it would be necessary to provide up to 12 months to prepare the FRP. The commenter also asked EPA to clearly define the timing associated with meeting the criteria so there is no confusion (0179).

One commenter noted that six months is not adequate time and recommended 12 months for FRP preparation and submittal both under § 118.5(a) and § 118.6(a) (0179).

One commenter raised concern over the 60-day timeframe in the appeals process to an RA determination in § 118.6 because it is insufficient for plan formulation and development. The commenter recommended this timeframe be extended to 12 months to allow facilities adequate time to submit a plan following the RA decision. The commenter added that an FRP should not be required until all appeals options are exhausted, and the Agency decision is final (0205). Another commenter, referencing § 118.5(a) in cases when the RA requires an FRP, requested 12 months for the facility to prepare and submit their FRP (0179).

Proposed New Regulatory Text

Regarding “an unplanned event or change” requiring submission of the FRP within six months, one commenter recommended that the EPA change the wording from “that renders the facility subject to the criteria in § 118.3” to “meeting the criteria in § 118.3” (0179).

EPA Response

EPA recognizes that some commenters believe that the proposed timelines were too short or insufficient for FRP development and submission. In response, all facilities now have 36 months following the effective date of the final rule to comply with the requirements in 40 CFR Part 118. On the other hand, some commenters would prefer a swifter implementation period. However, due to resource constraints and the complexity of implementing a new regulatory program, EPA had judged a 36-month implementation period to be warranted. Moreover, as this is a new program, albeit modeled on an existing program, EPA is prepared to provide necessary compliance assistance as facilities determine their applicability and develop plans for the first time. A facility “meeting the criteria” is materially the same as “determining” that it meets the criteria. EPA clarifies that “meeting the criteria” for FRP submission refers to the applicability criteria listed in § 118.3. Facilities meeting the criteria in §§ 118.3(a) and (b) (threshold quantity and proximity to navigable water) must submit the substantial harm certification form.

As detailed in the proposal, all timelines are roughly based on OPA transition provisions, which directed EPA to issue regulations for oil worst case discharge response plans (oil FRPs) under § 311(j)(5) of the CWA within 24 months. Facilities could submit the oil FRPs beginning 30 months from enactment (6 months after the deadline for EPA to issue the regulation) and were required to be submitted by 36 months of enactment (12 months after the deadline for EPA to issue a regulation). For existing and new facilities, oil FRPs were to be submitted within six months from the time of discovery or notification that a facility could cause “substantial harm.”

Initially regulated facilities are facilities in operation 30 months after the effective date of the final rule and that meet the criteria in § 118.3 or are notified by an RA as in § 118.5. These facilities must submit their FRPs by 36 months after the effective date.

EPA disagrees that the 60-day operational trial period is insufficient; this period has been in effect under the Oil Pollution Prevention FRP regulation for more than 30 years. A facility may submit their full FRP after 60 days and then submit amendments if conditions at the facility have changed.

Those planned events or changes requiring submission prior to commencing operation are those in design, construction, operation, or maintenance that now mean the facility meets the criteria in 40 CFR § 118.3. EPA disagrees that this should be limited to “significant changes”, since the provision is meant to capture facilities or portions of facilities that formerly did not meet the criteria in 40 CFR § 118.3 but now do. The facility has 60 days to submit their FRP to EPA, which should be ample time since the facility owner or operator would know the ramifications of their planned change well prior to commencing operations. Additionally, changes made within 60 days can have a significant impact on a worst case discharge scenarios and potential impacts of releases, therefore it is imperative that EPA, local emergency responders, and PWSs have accurate information in a timely manner.

An unplanned event or change includes a reportable discharge of a CWA hazardous substance that reached navigable water, so that a facility now meets the criteria in 40 CFR § 118.3. EPA disagrees that extending the timing to one year is necessary, since timely information is imperative for effective emergency response.

Newly regulated facilities refers to facilities that do not meet the applicability criteria in § 118.3 within 30 months of the effective date of this final rule, but do at a later date. These facilities have six months to submit an FRP to EPA. Additionally, EPA maintains that six months should be sufficient for a facility to prepare an FRP following notification from an RA, since this is the same timeline for newly regulated facilities and is a timeline that has been successfully implemented by EPA's Oil Pollution Prevention FRP regulation. This time frame balances the burden of preparing a plan with the needs of the community to be aware of the risks of a worst case discharge for local emergency planning efforts.

To provide flexibility to Regions to manage their workloads, the Agency is not setting timelines for reviewing and approving plans.

EPA is not requiring installation of secondary containment in this regulation.

To the commenter concerned with the appeals timeline, EPA agrees that a 12-month timeframe for FRP preparation and submittal under both § 118.5(a) and § 118.6(a) is appropriate and has adjusted its approach in the final rule.

EPA has adjusted the regulatory text for clarity, but is not including the specific proposed regulatory text, as it is unnecessary with the other edits made..

Public Comment Summary

Facility Response Plan Amendments Compliance Dates

Support

A commenter noted that they generally support EPA’s approach to require FRP revisions and resubmission within 60 days of a “facility change” that may materially affect the facility’s response to a worst case discharge. The commenter also stated that they believe the specific examples of “facility change” that EPA has provided are reasonable and further the purpose of FRP revision – ensuring the facility remains prepared, to the maximum extent practicable, to respond to worst case discharge and that EPA, response officials, and the public understand the current risks and response plans. The commenter suggested that the final rule, however, should set forth additional explicit examples that would trigger a revision. The commenter stated that first, the final rule should require revision within 60 days of the occurrence of an adverse weather event (including wildfires) onsite or in the immediate vicinity that the original hazard evaluation did not consider. The commenter added that the actual occurrence of that adverse weather event makes its reoccurrence reasonably foreseeable and thus something that should be considered in the FRP’s hazard evaluation. The commenter also stated that the final rule should require revision within 60 days of the release of a relevant jurisdiction’s updated local hazard mitigation plan and the final rule should require revision within 60 days of a change in ownership or management (operator) at the facility (0215).

Oppose

A few commenters requested that EPA revise its requirement that updated FRPs be submitted within 60 days of a change (0201, 0205, 0214). One of these commenters recommended that EPA extend this timeframe to a minimum of six months because modelling may require more than 60 days (0205). A couple of these commenters recommended this timeframe be updated to once every five years, with supplemental annual updates when significant changes in CWA hazardous substance quantities or other FRP changes occur (0201, 0214). One commenter added that 60 days is not practical because a lot can change at a facility, including frequent staff changes, relocation of chemicals, and constantly changing or multiple threshold exceedances at separate times. The commenter also recommended that EPA consider larger and more complex industries, laboratories, and facilities because these facilities use, move, and dispose of substances, often daily (0201).

One commenter recommended EPA only require annual updates to the QI list for an FRP plan rather than the proposed 60-day timeframe. The commenter noted that requiring an update to the existing plan every time a facility qualifies a new shifting refinery or chemical plant superintendent does not add value if the contact information does not change (0205).

One commenter stated that the facilities response plan amendments list from (i) to (v) is too broad and can be misinterpreted by the many triggers. The commenter recommended that a “facility change that materially may affect the response to or potential for a worst case discharge” needs to be limited to “facility change that materially may affect the worst case discharge determination” and not a change in any other CWA hazardous substance maximum capacity onsite (0179).

One commenter acknowledged that changes that do not result in a material change or change in response capabilities can be made by the facility as they occur; however, the need to provide a copy of changes to the RA as they occur is an administrative burden on the facility. The commenter suggested that the changes would be submitted to EPA as part of an annual revision and recommended changing the wording from “as the revisions occur” to “as part of an annual review.” The commenter recommended that the EPA change the wording for “each significant change” to “change that may materially affect the response to or potential for a worst case discharge” per § 118.4(b)(1). The commenter stated that this change will make plan re-submittals consistent and would be much clearer for facility operators (0179).

The proposed rule has two provisions that address FRP updates: 40 CFR §§ 118.4(b) and 118.11(a)(5) (proposed). One commenter stated that, at best, when the two proposed provisions 40 CFR 118.4(b) and 118.11(a)(5) are read together, these provisions are vague and confusing; at worst, they are contradictory. The commenter stated that while proposed § 118.4(b) sets forth some triggers that would require an FRP revision, proposed § 118.11(a)(5) merely requires “review and update” of FRPs “periodically” for resubmission to EPA. The commenter suggested the final rule should get rid of proposed § 118.11(a)(5) and its “periodic[]” standard, and focus on strengthening the review and revision provisions in proposed § 118.4(b) (0215).

One commenter stated that the 60-day timeframe for updates to the impacted section of the FRP is shorter than the 90 days provided under SARA 311 to update information (e.g., LEPC) on changes to chemical inventory and Safety Data Sheets (SDS). The commenter also stated that 60 days is insufficient time to update planning distances, coordinate with the public drinking water supply, and assess impacts and suggested EPA should follow the 90-day framework developed under SARA 312 for changes in chemical inventories and reporting CWA hazardous substances to keep in alignment with already established programs that the industry is familiar with. The commenter observed that the 90-day framework applies to the supplier and their SDS, but the supplier is not obligated to send updated SDS until their next shipment or upon customer request, which complicates the timeline to update plans with changes received from vendors on third-party SDSs. The commenter stated that therefore, a receiving facility may not get a new SDS until their next shipment, even though the vendor updated their SDS within the 90-day requirement (0179).

One commenter suggested the need to set parameters on timing for EPA’s review and approval of submitted changes to the CWA hazardous substances FRP. The commenter stated that this has been an issue with the Oil FRPs in that EPA reviews and approvals have not been provided in a timely manner. The commenter added that USCG regulations provide deadlines for the Agency to conduct its reviews and provide approvals. The commenter recommends that EPA should follow the USCG’s framework developed under 33 CFR § 154.1065 for Agency reviews and approvals (0179).

EPA Response

Although EPA understands that current practices at some covered facilities may present challenges with meeting the 60-day window for changes to FRPs, facilities must document and adjust material changes swiftly to ensure that plans adequately prepare for worst case discharges of CWA hazardous substances. Longer timelines could render the FRP unusable as a response plan. Larger and more complex batch processors, laboratories, and facilities require proactive planning for the anticipated maximum quantities onsite. This is similar to the Oil Pollution Prevention FRP regulation, under which an oil FRP must be resubmitted within 60 days of each material change in facility or plan that could affect the adequacy of a facility’s response capabilities, such as the ability to respond to a worst case discharge.

EPA disagrees that the response plan amendments listed in 40 CFR §§ 118(b)(1)(i) to (v) is too broad; these are critical elements that drive an FRP and planning for worst case discharges of CWA hazardous substances. Timely updating of these elements will ensure comprehensive planning and coordination. Indeed, the changes must materially alter information in the plan, required response resources, capabilities of Spill Response Organizations (SROs), mitigation and response equipment, or emergency response procedures to require an amendment. EPA disagrees that providing to the RA changes that do not result in a material change or change in response capabilities is an administrative burden on the facility. Electronic submission will make the process straightforward, and an annual review is insufficient to reflect changes that could affect a worst case discharge response operation.

EPA disagrees that 40 CFR 118.4(b) and 118.11(a)(5) are contradictory; they are complementary and reiterate that updates must be made in a timely manner and that the facility owner or operator has the responsibility to periodically review operations to determine if updates or amendments are required.

While the 60-day period differs from that provided under the EPCRA regulations (90 days), the EPCRA regulation is for notification while this regulation is focused on planning for worst case discharges of CWA hazardous substances into or on the navigable waters. EPCRA Section 302 requires emergency planning notification of any extremely hazardous substances present on site at or above their threshold planning quantities. Using this information, LEPCs and TEPCs are required to develop local emergency response plans.

For this final rule, if any new CWA substance is present on-site, then the facility has 60 days to notify EPA. Due to the potentially catastrophic effects of such releases, EPA maintains that extending the time period beyond 60 days to update FRPs when conditions onsite change is unwarranted. The facility owner or operator will already have an understanding of operations and the requirements of the FRP. Related to the concern above, changes made can have a significant impact on a worst case discharge calculation and potential impacts of releases; therefore, it is imperative that EPA, local emergency responders, and PWSs have accurate information in a timely manner.

EPA disagrees with the commenter suggestion to add to § 118.4(b)(1) the occurrence of an adverse weather event (including wildfires) onsite or in the immediate vicinity that the original hazard evaluation did not consider. A facility owner or operator will need to certify their consideration of these events every five years in terms of their worst case discharge calculations, and an RA may require consideration sooner due to local concerns in the area, which will account for those types of events. Consistency with local hazard mitigation plans is required in § 118.12(c), and a notification of a change in ownership or management (operator) at the facility is required as it occurs, as per § 118.4(b)(2), so additional requirements are not necessary to ensure planning is sufficient.

To the commenter concerned about the QI listing updates, the Agency notes that the QI does not have to be an individual; it could also be a management structure, which could allow less frequent updating of the information.

Public Comment Summary

Resubmission

One commenter requested that the period for plan review in § 118.11(a)(5) be consistent with the FRP for discharges of oil not to exceed the specified timeframe of five years (0213).

Two commenters suggested that the EPA should expand its criteria for when facilities must update response plans and require annual plan reviews to ensure plans are based on up-to-date information, and require, in any event, plan amendments every five years (0215, 0216). One commenter suggested that the final rule should mandate the regular reviews proposed in § 118.4(b) by requiring facilities to review their FRPs for “currentness” – including changes in ownership or management, updated hazard-related data, material changes in surrounding operations, and the existence of any material “facility change” – at least annually and confirm their completion of these annual reviews through an online attestation form. The commenter added that the final rule should also make clear that compliance with the annual review requirement does not excuse a failure to revise and resubmit an FRP within 60 days of a material facility change, but rather serves as a backstop to ensure the facilities are regularly evaluating the “currentness” of their FRPs (0215).

The commenter suggested that the final rule should also contain a backstop provision that requires thorough review, full updates, and resubmission that is not tied to a specific change at the facility, but instead requires the facility to respond to external changes that affect the facility’s response capabilities and obligations, including changes in technology, scientific advancements, surrounding operations, and climate. The commenter proposed that these full reviews, updates, and resubmissions of FRPs be required every five years consistent with the five-year resubmission requirement EPA has proposed for substantial harm analyses (40 CFR 118.4(c)(3)). The commenter stated that this will require facilities to regularly and directly assess the practicability (and thus necessity) of new or improved discharge-prevention, containment, or response measures to address worst case discharges and it will require facilities – particularly through the hazard evaluation – to continuously account for the most recent information regarding current and projected risks from climate change as well as demographic changes in the surrounding community that might not otherwise trigger a revision under the “facility change” provision (0215).

One commenter suggested the proposed rule needs to set a time period for the owner or operator to “review and update facility response plan periodically.” The commenter stated that the EPA needs to provide clearer descriptions of the terms “periodically” and “each significant change,” as these terms could be applied inconsistently by the regulated community. The commenter also stated that for consistency, reviews every five years from the date of plan approval (such as USCG FRPs) would be sensible and consistent across agencies (0179).

EPA Response

EPA has added § 118.4(a)(6), whereby a facility owner or operator must review and recertify their plan to the Agency every five years. This will ensure that FRPs stay updated and that owners or operators remain cognizant of their responsibilities under this regulation. A five-year review period is common in EPA programs, and the Agency judges this to be a necessary component of an effective program. A shorter recertification period may unnecessarily add burden to facility owners or operators, while a longer period may fail to reflect changes that the facility that warrant updating the FRP.

Owners or operators are already required to update their plans as minor revisions occur and must evaluate changes that materially affect the implementation of the facility response plan and update the FRP accordingly, as in § 118.4(b)(1). In terms of periodic reviews outside this time frame, EPA is not dictating facility requirements as they should be following normal business practices for reviewing operations by evaluating potential for worst case discharge and changing conditions around their facilities. As part of the five-year recertification process, a facility owner or operator will need to review their operations and outside circumstances that would affect their applicability criteria in § 118.3 or the FRP itself as in § 118.11.

Public Comment Summary

Substantial Harm Certification Form

Several commenters recommended an 18-month timeframe for substantial harm certifications in order to meet the requirements of assessing worst case discharge scenarios, creating endpoint modeling, coordinating with PWSs, and fully assessing the possibility of meeting a criterion (0175, 0187, 0191, 0192, 0194, 0204, 0218). One commenter asserted that for newly constructed facilities, submitting the substantial harm certification form within one month of meeting the criteria if the FRP must be prepared prior to operations does not make sense (0179).

EPA Response

To the commenter concerned about the one-month submission timeline, this was proposed as the timeline for the substantial harm certification form. EPA has adjusted its approach to require submission within 60 days of meeting the criteria, but not before the initial 36-month implementation period. To address concerns or questions about the timeline, EPA provided further clarifications in the preamble to the rule. EPA will strive to provide compliance assistance to aid the regulated community. Facilities that meet the criteria in 40 CFR § 118.3 may still submit their substantial harm certification forms along with their FRPs after six months.

Substantial harm certification form (§ 118.4(c), Appendix A)

Public Comment Summary:

Support

One commenter agreed with the timeframe for substantial harm certification form initial submission within one month of the compliance date and with updates every five years (0201). Another commenter stated support for the requirement to note the type of FWSE receptor(s) considered in the substantial harm analysis, the requirement to state the type and description of the public receptors, and the framework to update and submit revised substantial harm certifications every five years or within 60 days of events. The commenter urged EPA to also require the specific names of the FWSE receptors (e.g., state or national parks, wildlife refuges) or the geographic coordinates in cases where receptors do not have names. The commenter suggested EPA put the FWSE criterion, the requirement to state the type and description of public receptors, and the requirement to state the names or geographic coordinates of the public receptor in the regulatory text (0215).

The commenter stated that they support EPA’s proposal that all facilities that pass the initial screening phase will be required to prepare and submit to EPA a substantial harm certification form, and to submit updates to the form every five years or within 60 days of a change on- or off-site that impacts the facility’s potential to cause substantial harm. The commenter also supported the requirement that facilities submit supporting documentation, as it is only through submission of these forms to EPA that the very basic information they contain will be made available to the public, and that the public will be able to use that information to help implement the final rule, including through the stakeholder petition process. The commenter suggested requiring reviews of forms at least annually using an online attestation form and requiring updates within 60 days of a reportable CWA hazardous substance discharge onsite. The commenter noted that this requirement would be in addition to the requirement to revise and resubmit forms within 60 days of changes that would impact the facility’s potential to cause substantial harm. The commenter also suggested that the final rule should require forms and updates to be submitted to local emergency response organizations (0215).

One commenter suggested that the form should be limited to listing CWA hazardous substances at least 10,000x the RQ and that are not already regulated elsewhere. The commenter also suggested that the form identify the one CWA hazardous substance that triggers the worst case discharge and the basis to determine the worst case discharge capacity, with frequent updates as this list will change. This commenter also suggested that EPA make the form simple like the one used for Oil Pollution Prevention regulation FRPs, as the form will become a burden as written for both the regulated community and EPA Regional office. The commenter made the same suggestions regarding Question 1 and proposed that EPA clarify its intent by rephrasing the last sentence to “If so, list the names, CAS no., and the maximum quantities (lbs.) of CWA hazardous substances present in the worst case discharge that are greater than the CWA Reportable Quantity (RQ) × 10,000” (0179).

Oppose

One commenter suggested that EPA limit the information in the certification form for applicability criteria to yes/no questions and have detailed information and backup calculations in the FRP for facilities that are required to have one. The commenter suggested that the form be submitted with the CWA hazardous substance FRP and that the FRP be the documentation supporting decisions in the form. The commenter also suggested that for sites that do not trigger questions 3 through 6, the form be kept onsite similar to the requirement in 40 CFR § 112.20(e) (0179).

Two commenters stated that EPA should clarify the purpose and value of the Substantial Harm Certification Form, as the proposed rule does not clarify how it would achieve the objectives of the rulemaking and it would increase the burden to facilities required to complete the form (0199, 0211). The commenters pointed out that the information in the form overlaps with information required for other documentation, such as the FRP. One of the commenters also stated that the forms could cause confusion for the public (0199).

One commenter suggested that the final rule allow for voluntary submissions of FRPs in circumstances where threshold quantity and geographic proximity are met but substantial harm criteria are not met or are uncertain (0211).

One commenter noted that the requirement to submit the substantial harm certification form when criteria in §§ 118.3(a) and (b) have been met, even if no substantial harm is identified, is different from the requirement in 40 CFR § 112.20(e). The commenter recommends using the same submission requirements as the Oil Pollution Prevention FRP regulation. The commenter also pointed out that re-submitting the form every five years is not consistent with the Oil Pollution Prevention FRP regulation, and the commenter stated that resubmittals would cause confusion and potential non-compliance issues. The comments suggesting removing “every five years” from the rule (0179).

One commenter stated that the potential for impairment of taste, odor, or aesthetic characteristics could vary broadly among PWSs, and the commenter suggested removing this requirement from the substantial harm certification form. The commenter did agree with retaining use restrictions in actual events that occur in a reportable discharge history and suggested that if EPA retain the requirement, the item should be changed from “(iv) Impairs the taste, odor, or other aesthetic characteristics of the water entering a drinking water distribution system to a degree that could make the water unacceptable to consumers and that could prompt the public water system to issue use restrictions” to “(v) Prompt the public water system to issue use restrictions” (0179).

Request for Clarification

Two commenters sought confirmation that facilities that do not meet the reportable quantity threshold or substantial harm criteria do not need to demonstrate that they do not meet the criteria, as this would be unnecessary and a burden on facilities (0199, 0211).

One commenter asked that EPA clarify in Appendix A to Part 118: Certification Form in number 4 that intake for a groundwater system includes the well (0198).

One commenter asked if the Substantial Harm Certification Form needs to be updated when a reportable discharge occurs and whether EPA applies the criteria as a rolling five-year dataset (0179). The commenter noted that if that is the case, then a facility that has triggered the threshold quantity and proximity to navigable water criteria would also trigger the substantial harm criteria for reportable discharge history and need to submit an FRP.

The commenter asked for clarification about several aspects of the requirement to submit the substantial harm certification form updates to the EPA RA every five years or within 60 days of a change. The commenter asked that the 60-day timing framework (which is different from the one month cited in § 118.4(c)(1)) and that “every five years” be clearly defined. The commenter also pointed out inconsistencies between the Substantial Harm Certification Form in Appendix A and the flow logic in Figure 1 (87 FR 17898, March 28, 2022) and suggested that EPA review both for consistency. The commenter also suggested that EPA clarify its intent for both Question 3 and Question 5 if the answer is yes and change the last phrase for each of these to “names, CAS no. and worst case discharge quantity (lbs.) for the CWA hazardous substance(s) that would be released in the worst case discharge scenario” or eliminate the inclusion of the request (0179).

One commenter suggested that for Question 4, EPA should develop a table with all CWA hazardous substances, the National Primary Drinking Water Standards, and Maximum Contaminant Levels (MCLs) to assist facilities with the analysis. The commenter also asked that EPA clarify in item (iii) if the assessment is meant to use MCLs in finished water, and if not, if EPA could provide specific concentrations for each chemical that would result in adverse health impacts. The commenter also pointed out that the five conditions in Question 4 may be misnumbered as the last item is labeled iv instead of v. The commenter also asked if a facility needs to assess all five conditions impacting a PWS in Question 4, or if they can stop once determining the potential for substantial harm. The commenter asked how EPA proposed to assess items without PWS participation (0179).

For Question 5, one commenter suggested changing the first sentence to “Has the facility experienced a discharge of CWA hazardous substance discharge that reached navigable water greater than the reportable quantity within the last five years?” The commenter also asked if EPA would accept answers of “unknown impact” or “impact not documented” for discharges that occurred prior to the effective date of this rule. For discharges after the effective date of this rule, the commenter asked how EPA proposed sites obtain information to assess these impacts, if there is regulatory language to provide guidance on tracking this information or if facilities are expected to provide anecdotal information, if EPA anticipates that information following a reportable spill will be collected by the facility or by EPA, and if the adverse impacts are limited to the five items in Question 4 (0179).

Proposed Rule Language Edits

One commenter suggested the following edits to Appendix A to Part 118: Certification Form (0167):

Add a question 2(b) “Does the facility contain water wells and stormwater infiltration wells or is located such that water wells and stormwater infiltration wells are within one-half mile of the facility?”
Add after “discharge from the facility” the words “conveyed over the land surface or, after infiltration to the subsurface, by groundwater.”
Add before “public water system intake” the words “public water system source water protection area,” and after “public water system intake” the words “and/or water well(s) and stormwater infiltration wells”; similarly in (iv) after “intake structures” add the words “and/or water wells and stormwater infiltration wells”; and in “Attach documentation attesting . . .” after “intake” add the words “and/or water well and stormwater infiltration wells”.
Add after “documentation of formulas” the punctuation and word “, modeling”.

EPA Response:

The purpose of the Substantial Harm Certification Form is for the facility to “show their work” in terms of determining if they could cause substantial harm to the environment. The value of this information is, for EPA, to assess compliance and risks to a community and, to the wider community, as an emergency preparedness and information tool. If the CWA hazardous substance maximum quantity onsite at a facility meets or exceeds the threshold quantity and it is located within one-half mile of navigable waters or a conveyance to navigable waters, but does not meet any substantial harm criteria, the owner or operator must still submit a Substantial Harm Certification Form (Appendix A) to EPA, including supporting calculations and modeling. If the facility meets at least one of the substantial harm criteria, the owner or operator must complete and submit an FRP to EPA that includes information on each CWA hazardous substance onsite above the threshold quantity, along with their Substantial Harm Certification Form. If a facility does not meet either screening criterion in 40 CFR § 118.3(a) (threshold quantity) and 40 CFR § 118.3(b) (proximity to navigable water), the facility owner or operator need not proceed and does not need to submit anything to EPA. EPA will accept voluntary FRP submissions.

EPA has adjusted the initial submission date of the substantial harm certification form to within 60 days of meeting the criteria in §§ 118.3(a) and 118(3)(b). Because substantial harm calculations and modeling may be involved, the Agency recognizes that additional time may be necessary. Those submitting an FRP will still need to submit a Substantial Harm Certification Form, which should add minimal burden, since this information will be included in their FRP. EPA has determined that having this information on hand will aid EPA and local emergency planners in assessing risks across communities, which does differ from the approach in 40 CFR § 112.20(c) to have the form onsite rather than submit it to EPA. The Agency maintains that the increased availability of this data justifies the burden of submittal. Additionally, the form provides the basis for the FRP.

Facilities submitting their FRPs may submit their Appendix A Substantial Harm Certification Form at the same time they submit the FRP. EPA agrees with the commenter who supported the FWSE data elements, and EPA has added a requirement to detail the ACP(s) consulted in Question 3, as well as including the FWSE and public receptors potentially affected by a worst case discharge. This will allow reviewers to cross-check entries against the ACP. EPA is not requiring submission of forms to local emergency response organizations, though they will be made available upon request.

Substantial Harm Certification Forms must be recertified every five years. EPA disagrees that recertification will cause confusion and potential non-compliance issues. On the contrary, requiring updated information will allow facilities and EPA to have updated and timely information on risks to the environment and public health.

EPA disagrees that yes/no questions are sufficient to assess applicability calculations for this regulation. To ensure facilities are properly measuring their potential impacts due to a worst case discharge, it is necessary to collect the supporting documentation. Facilities that do not meet both initial screening criteria are not required to send any information to EPA.

EPA understands why facilities are interested in keeping the form as simple as possible and has made efforts to that effect. However, there are countervailing reasons for including more robust information. Completing and submitting Appendix A ensures that the facility reviews their potential to cause substantial harm to the environment and that EPA has access to updated information in a timely manner. This approach is based on the Oil Pollution Prevention FRP regulation, in which facility personnel must complete, and maintain at the facility, a certification form that identifies substantial harm information for the facility (see 40 CFR Part 112 Appendix C, Attachment C-II). The form is required of all SPCC-regulated facilities and requires signature by the certifier for the facility. The inclusion of information that demonstrates the reliability and analytical soundness of the substantial harm evaluation as well as a review of potential receptors that could be impacted as a result of a CWA hazardous substance discharge will assist EPA in making compliance determinations as well as provide sufficient information to identify those facilities that could reasonably be expected to cause significant and substantial harm to the environment. Again, while EPA recognizes that the form will require time and resources to complete and submit, the Agency maintains that this information is critical for protecting the environment and can help facility owner or operators identify risks at their facilities.

EPA is not removing the potential for impairment of taste, odor, or aesthetic characteristics as an element of the substantial harm criterion in 40 CFR § 118.3(c)(2)(v) or adjusting the language, as the additional specificity includes important considerations. A facility owner or operator will work with the PWS to determine these types of effects. EPA agrees with the commenter and is retaining use restrictions in actual events that occur in a reportable discharge history, but maintains the existing language is appropriately thorough and descriptive. Additionally, EPA will provide compliance assistance for facilities if they must assess the elements in 40 CFR § 118.3(c)(2) without PWS participation.

EPA has adjusted its approach to only include those CWA hazardous substances that meet the threshold quantity, as requested by one commenter. However, a facility owner or operator must still consider all CWA hazardous substances onsite in the initial screen even if they are subject in some respect to other regulations for other purposes. In order to minimize duplicative requirements, EPA has revised the exemptions in § 118.8. That said, notwithstanding commenters assertions to the contrary, other regulations, such as RMP, have not been included in § 118.8 because they do not satisfy the required program elements from CWA § 311(j)(5). The form also requires information on worst case discharge scenarios and has been reworded for clarity.

EPA disagrees that these forms will cause confusion for the public. Appendix A will be used as a public information, enforcement, and compliance tool for this regulation; thus, the relevant information on CWA hazardous substances present onsite must be readily available.

EPA has revised Appendix A in the final rule to aid in clarity. For discharges after the effective date of this rule, EPA expects that facility owners or operators will collect this information routinely in order to improve their business practices and minimize accidental discharges. The adverse impacts reported are limited to what is listed in Appendix A. In addition, EPA made conforming changes regarding the requirement to analyze all CWA hazardous substances above the threshold level onsite (if both initial screening criteria have been met). Finally, EPA has adjusted the certification statement for clarity as to its expectations of the certifier.

EPA has adjusted the language in Question 5 to clarify that the reportable discharge must have been to navigable water. For discharges after the effective date of this rule, EPA expects that facility owners or operators should be collecting this information routinely in order to improve their business practices and minimize accidental discharges. Additionally, facilities should have information regarding the impact of any reportable CWA hazardous substance discharge that reached navigable water to include in their FRP, based on their reporting requirements to the NRC. The adverse impacts reported are limited to what is listed in Appendix A.

The Substantial Harm Certification Form needs to be updated if a reportable discharge occurs, since this is a rolling five-year period. EPA confirms that if that is the case, then a facility that has triggered the threshold quantity and proximity to navigable water criteria would also trigger the substantial harm criteria for reportable discharge history and need to submit an FRP within six months. EPA is not requiring updates within 60 days of a reportable CWA hazardous substance discharge that did not reach navigable water, since it is unclear what relevance that data element would have on worst case discharges to navigable water.

EPA has adjusted Appendix A to reduce confusion and duplicative entries. Additionally, the Agency will provide compliance assistance including information on all CWA hazardous substances, the National Primary Drinking Water Standards, and MCLs to assist facilities with the analysis. To clarify, item (iii) is to be assessed at the point of SDWA compliance, which in most cases will be the finished water or the distribution system. In addition, a facility needs to assess all five conditions impacting a PWS in Question 4. Finally, EPA has adjusted the requirements for coordinating with a PWS. Specifically, a facility must make good faith efforts to coordinate with PWSs. If a facility is unable to coordinate with a PWS, the facility owner or operator must document that it made a good faith effort to do so.

EPA is not making the suggested language changes as they do not reflect the substantial harm criterion in 118.3(c)(3). . Additionally, for the reasons enumerated above, EPA is not using SWPAs to delineate impacts to PWSs.

Public Comment Summary:

Electronic Submission

Two commenters asked that EPA develop the ability to electronically submit Substantial Harm Certification Forms and FRPs (0201, 0215). The commenters stated that requiring electronic submission of forms would be easier for industry, EPA, and the public. One commenter stated that there may be a cost for setting up and maintaining an electronic submission system, but EPA only needs to commit to require electronic submission of information and not to the exact system right now (0215).

EPA Response:

EPA agrees that an electronic submission system will be preferable and is working to secure resources to develop one.

Public availability

Public Comment Summary:

Support

One commenter requested that EPA not make forms available to the public, as information in the forms would be both under- and over-inclusive and would be confusing for members of the public with no background on the disclosures. The commenter stated that this could create unsafe situations for businesses, would provide little benefit, and would potentially be a burden on regulated facilities (0199).

Oppose

Several commenters stated that EPA should make FRPs and Substantial Harm Certification Forms available to the public in a searchable, online database (0177, 0215, 0216, 0217). One commenter also asked that EPA share methods, systems, and data elements as well as alternatives to the proposed approach such as supporting data and rationale (0177). Two commenters specifically requested that current and historic plans and forms be available (0215, 0216).

One commenter suggested that such a database could be built onto an existing database or function on its own, and information should include and be searchable by, at least, facility name, facility identification number (TRI ID and EPA Facility ID), geography/address, parent company name, NAICS code, and CWA hazardous substance onsite. The commenter also suggested that EPA incorporate basic facility information into databases (like EJScreen) based on geographic information systems (GIS), as possible. The commenter suggested that, if it is not feasible to develop a database that would allow on-demand downloads of non-Confidential Business Information (CBI) information, then there should be a simple process for the public to make targeted requests for information available in a database, including facility ID numbers, city or county information, and parent company. The commenter suggested that the database should at least allow for on-demand downloads of the most recent FRP or substantial harm analysis for a facility (0215).

One commenter stated that state and local governments have advocated for EPA to better communicate information on risks and emergency preparedness with communities living near RMP facilities and obtaining information about the facilities is difficult for some community members. The commenter stated that a searchable online database would make information readily available (0217). Another commenter stated that a searchable online database would have many benefits and pointed to the public’s experience with the Oil Pollution Prevention FRP regulation as an example. The commenter stated that a searchable online database would make it possible to avoid burdensome and overly broad steps such as Freedom of Information Act (FOIA) requests and would make information available in real time for community members and those needing the information for decision-making (0215).

Electronic Submission

One commenter noted that the proposed rule does not require the electronic submission or public availability of substantial harm certification forms. The commenter suggested that EPA make substantial harm certification forms and FRPs publicly accessible in an online database, particularly noting that fence-line communities may have difficulty obtaining facility information (0217).

One commenter stated that EPA should require electronic submission of FRPs and substantial harm analyses and make the information available in an online database (0215).

EPA Response:

EPA disagrees that making FRPs and Substantial Harm Certification Forms public would unduly burden facilities; EPA would maintain and share the information. EPA agrees that, to the extent possible, it is important to share this data with the potentially impacted public so they are aware of risks in their communities, and that a searchable, online database would be the most efficient way to provide access. However, the Agency recognizes the unique risks that certain types of information may pose and will work with the Department of Justice and DHS to determine the safest way to provide important risk information to communities through a searchable database.

Regional Administrator (RA) Determinations of Substantial Harm and Significant and Substantial Harm (118.5)(a)(b)(d))

Public Comment Summary:

Support

One commenter strongly supported the proposed rule’s provisions granting RAs authority to require FRPs based on site-specific factors for a facility under § 118.5. The commenter believed that it is crucial for RAs to retain this authority because site-specific reasons may be difficult to capture using generally applicable criteria and because such authority is needed to adequately protect communities with environmental justice concerns (0215). One commenter supported the RA determinations given in § 118.5(b)(4) and § 118.5(b)(5) (0198).

One commenter suggested adding the text “or within all or a portion of a sole source aquifer protection area” to § 118.5(b)(5) following “area.” The commenter also suggested adding the text “including drought” to § 118.5(b)(9) after “adverse weather conditions” (0167).

Oppose

One commenter is concerned that § 118.5, which allows the RA to define whether a facility is “reasonably expected to cause substantial harm” and thereby subject to the rule, could inject uncertainties and affect the objectivity of the screening criteria. The commenter noted that the RA’s determination of whether a facility is subject to the rule and required to submit a response plan is based on multiple subjective factors for determining “substantial harm.” The commenter add that these factors create uncertainties, which are amplified by the fact that the rule could be applied to facilities that meet just one of the substantial harm factors (0181).

Several commenters urged EPA to remove the provision to give RAs discretion to determine whether a facility must comply with regulation. The commenters stated that such discretion is unprecedented and that the absence of mechanisms to require consistency in RA determinations sets a dangerous precedent. The commenters noted that two identical facilities could be evaluated differently and have different FRP requirements based on their RA. Further, the commenters hypothesized that a facility initially determined not to be covered by the proposed rule could suddenly be covered, despite no changes at the facility, if the RA has a perspective that differs from their predecessor (0175, 0187, 0191, 0194, 0204, 0218).

Several commenters supported the EPA’s intention to address environmental justice concerns but requested additional clarity on the discretion of the RA and what they must consider (i.e., factors, criteria) in evaluations (0199, 0211, 0212). One commenter noted that clear criteria would provide guidance to the regulated community, making implementation predictable and uniform in application (0212). Two commenters claimed that the proposed rule did not explain why the RA’s discretion is necessary, noting that if a facility does not meet substantial harm criteria it is not clear how a community with environmental justice concerns would be adversely impacted, particularly given that comprehensive substantial harm criteria should protect all communities. Because of this, the commenters claimed that the RA’s authority to require FRPs for facilities not meeting substantial harm criteria due to environmental justice concerns is improper and should be limited through clear factors that the RA will consider (0199, 0211).

A few commenters stated their concern that in their view RA determinations are subjective and open-ended instead of clearly defined criteria, and therefore the proposed rule fails to provide certainty to the regulated community regarding applicability and allows inequitable and/or inconsistent application (0171, 0178, 0185, 0192, 0196, 0197). One of these commenters recommended that all facilities be assessed based on the same criteria, whether by EPA, a by a third party, or a self-assessment (0178). One commenter was concerned that the authority of RAs to designate facilities was subjective and could apply the rule to facilities even if they do not meet substantial harm criteria, and requested that EPA remove the designation process under § 118.5 (0190). Another commenter claimed that the factors are so broad and subjective that an RA could seemingly determine that a facility meets criteria under any circumstances. The commenter noted that EPA established no specific need for such authority, and that the burdens, inconsistencies, and uncertainties for potentially regulated facilities outweigh the benefits. The commenter recommended that EPA remove the provision from the proposed rule unless it can more specifically document the need in terms of actual risks (0192). One commenter stated that the proposed rule’s RA discretion could result in substantially larger costs than estimated by EPA (0197). Another commenter noted concern over the risk of subjective applicability designations at the EPA regional level. The commenter requested that EPA use the applicability criteria in § 118.3 and drop the subjective designation process in § 118.5 (0190).

A few commenters claimed that the authority granted to the RA was seemingly unlimited and subjective due to the lack of clear site-specific factors. The commenters noted that the RA determinations provision seems to authorize arbitrary and capricious decisions by the RA, which is illegal under the APA. The commenters stated that the RA’s unilateral authority renders the substantial harm criteria meaningless and exceeds the EPA’s statutory authority under the CWA. The commenters recommended limiting the RA’s authority and clearly identifying substantial harm criteria (0199, 0206, 0208, 0211). Two commenters recommended clarifying that the EPA Administrator’s secondary decision review of the RA’s initial decision is the final Agency action and is appealable to the federal courts (0199, 0211).

One commenter stated that RA determinations are based on subjective factors and create uncertainty in one of the most fundamental issues for a facility. The commenter claimed that the language given in § 118.5(b)(8) could be directly opposed to EPA’s methodology to determine worst case discharges and substantial harm in § 118.3. The commenter requested EPA clarify the interrelation between these two provisions. The commenter claimed that § 118.3 establishes a focus on the facility and the potential downstream harm, in addition to providing somewhat objective measures of risk, via “worst case discharge” and “substantial harm,” while § 118.5(b)(8) assigns worst case risk and substantial harm to facility activity. Given this, the commenter stated that it is not clear how “concerns” of a downstream community, which is not at risk, could be the basis for reversing the risk and harm analysis (0181).

Relatedly, the commenter claimed that climate change is already accounted for as part of the basic definitions in the rule under “worst case weather” and should not be re-inserted under RA discretion factors under § 118.5(b)(7) and § 118.5(b)(9). The commenter stated that it was not clear how the RA could require a facility, which does not meet applicability criteria for planning for a worst case discharge, to plan for the risk of a discharge based on some undefined standard for facility enhancement or vulnerability. Further, the commenter claimed that § 118.5(b)(11) grants the RA unlimited discretion to find facility applicability and that the proposed rule does not specify the interrelation with § 118.3. The commenter claimed that the ability of the RA to supplant the regulatory definition of applicability based on their own judgement renders § 118.3 meaningless and deprives facilities of any certainty regarding the rule’s applicability. The commenter believe that the RA discretion provisions are well beyond what is defensible under the CWA and recommended that EPA strike § 118.5(b)(11) and eliminate all other uncertainty and RA discretion regarding applicability of the rule to a facility (0181).

Another commenter stated that, because several of the factors that the RA must consider are the same as those used in the two-part screening process, the proposed rule would allow RAs to require FRPs specifically for facilities that do not meet criteria. The commenter claimed that this is a duplicative requirement giving RAs arbitrary power to override facility determinations. The commenter believed that such discretionary authority would generate significant uncertainty for facilities about their regulatory status and may cause inconsistent enforcement and application. The commenter noted that this ambiguity may create confusion among RAs and other EPA regional staff, which will make consistent implementation challenging (0171).

One commenter challenged EPA’s authority to delegate to the RA broad discretion in the substantial harm criteria determination process beyond uniform criteria promulgated through the notice-and-comment process. The commenter claimed that such discretion lacks appropriate statutory authority, pointing to the plain language of CWA § 311(j)(5) indicating that regulations required in CWA § 311(j)(5)(A)(i) are to set up criteria establishing which facilities must prepare FRPs. The commenter claimed that the legislative history confirms that Congress expected EPA to issue nationwide criteria. The commenter was concerned that the proposed rule’s delegation of case-by-case applicability decisions to the RA would rely on ill-defined and subjective criteria, aggravating the potential for disparate treatment of similar facilities and selective imposition of FRPs (0205).

In addition to the lack of statutory authority, the commenter claimed that EPA has not justified the need for RA determinations. The commenter cited Utility Air Regulatory Group v. EPA, 134 S. Ct. 2427, 2443-46 and Center for Biological Diversity v. EPA, 722 F.3d 401, 414-15 (D.C. Cir. 2013) (Kavanaugh, J, concurring) to support their claim that EPA cannot promulgate rules not authorized by Congress and urged EPA, should they include RA determinations in the final rule, to at least provide corresponding authority to allow RA determinations on a case-by-case basis such that facilities meeting applicability criteria need not prepare and submit an FRP. The commenter stated that this would allow RAs to recognize that, because of facility activity and location specifics, a hazardous substance discharge from a facility could not reasonably be expected to cause substantial harm. The commenter claimed that this would act as a “safety valve” to avoid facility costs of FRP requirements given what the commenter claimed were unrealistic assumptions about storage and mixture quantities (0205).

Another commenter stated RA discretion would allow RAs to ignore operator or owner efforts made to prepare their analysis of applicability criteria and the potential for substantial harm, which are time, effort, and cost intensive. The commenter requested that EPA remove the provision for RA discretion from the proposed rule. If the EPA maintained some RA discretion, the commenter recommended that such discretion be limited to unusual and relevant site-specific considerations relative to substantial harm potential. The commenter recommended that the proposed rule require written identification from the RA of a facility’s perceived risk of release and how such a release would reasonably be expected to cause substantial harm. The commenter noted that this would be consistent with language requiring the RA to state why an owner or operator must prepare an SPCC plan. The commenter noted that specific reasons accompanying RA determination will assist in streamlining appeals and reconsideration requests (0183).

One commenter claimed that the proposed provision does not allow an opportunity for a facility to review the RA’s basis or correct potentially inaccurate information used as the basis for the decision. The commenter believed the appeals process in § 118.6 to be inefficient and potentially unfair when the underlying decision-making process is opaque and subjective. The commenter was concerned that the authority given to the RA would create a patchwork of FRP requirements, which will create regulatory uncertainty and confusion and resulting compliance costs. The commenter urged EPA to remove the broad RA discretion, or base decision making for the RA and clearly defined criteria given in § 118.3 (0219). One commenter requested that EPA tie RA authority to criteria in § 118.3 and clarify the right to third-party petitions regarding RA determinations (0185).

Another commenter believed that factors given in § 118.5(b) are too open ended and can be arbitrarily applied and misused by the RA, which can create discrepancy between regions. The commenter suggested that the determination in § 118.5(a) state that the RA must provide a reasonable basis for determination (0179).

The commenter additionally suggested adding text to § 118.5(b)(11) to incorporate “reasonably”:

“Other site-specific characteristics and environmental factors that the Regional Administrator ‘reasonably’ determines to be relevant” (0179).

One commenter noted that under the proposed rule, EPA RAs have the authority to deem a facility meets a substantial harm criterion even if no thresholds were met in the outcome of the facility's assessment. The commenter suggested this provision be removed from the proposed rule, as it creates opportunities for inconsistent implementation (0188).

One commenter noted that the RA could require an FRP based on proximity to a community with environmental justice concerns and regardless of risk posed to the community by any CWA hazardous substance release. The commenter recommended that the RA should only evaluate facilities based on the same self-determined factors used to determine FRP submission (0183).

Request for Clarification

One commenter requested clarification on the newer factors for the RA substantial harm determinations, in § 118.5(b)(7). The commenter requested guidance on the EPA requirements on measures that enhance resilience to climate change as part of passive mitigation measures. The commenter also requested more information on what the RA should consider and accept when evaluating environmental concerns that adversely impact communities in § 118.5(b)(8) (0213).

EPA Response:

EPA understands that § 118.5 creates some uncertainty for owners and operators. With respect to determining whether covered facilities could cause substantial harm to the environment in the first instance, EPA decided to implement a rule with two components (an initial screen followed by an analysis of substantial harm criteria). The criteria in 40 CFR § 118.3 are designed to capture the bulk of those covered facilities that could reasonably be expected to cause substantial harm to the environment. However, because of the size and diversity of the types of facilities within the regulated community, EPA believes that there are facilities that may not meet the criteria in § 118.3, but nonetheless may, due to facility-specific or location-specific circumstances, pose sufficient risk to the environment to be designated as being able to cause substantial harm to the environment. Accordingly, EPA has included an adjudicatory process whereby the RA can make a case-by-case determination. Similarly, although EPA has made every effort to avoid being overly broad in terms of covered facilities that must submit an FRP, EPA understands that there may be circumstances where the regulatory criteria are over-inclusive. In such cases, an owner or operator may seek a determination by the RA that the facility does not have the potential to cause substantial harm to the environment despite meeting the initial screen and substantial harm criteria.

In 40 CFR 118.5(b), EPA enumerates the factors RAs may consider when determining if a facility could cause substantial harm to the environment from a worst case discharge into or on the navigable waters or a conveyance to navigable water. While some commenters asserted that these criteria are subjective or without basis, EPA disagrees. The factors as enumerated limit the discretion of the RA, but allow for consideration for the relevant elements that could influence whether a facility could cause substantial harm to the environment on a case-by-case basis. By their very nature, these are case-specific fact-driven situations and the criteria appropriately bound the scope and nature of the inquiry.

The Agency recognizes that RAs possess unique knowledge of Region-specific considerations, and it is consistent with EPA’s responsibility to designate covered facilities on a case-by-case basis that could reasonably be expected to cause substantial harm to the environment. That said, these case-by-case determinations will be made judiciously and in manner that is reserved to ensure adequate protection of the environment. This type of process is not without precedent; indeed, the Oil Pollution Prevention FRP regulation has a similar provision in 40 CFR § 112.20. To EPA’s knowledge, the inclusion of such a provision in the Oil Pollution Prevention FRP has not resulted in the types of uncertainties, inconsistencies, or costs that some commenters claim. Nor has it rendered the triggering requirements of the Oil Pollution Prevention FRP rule meaningless. Moreover, establishing an adjudicatory component to consider the applicability of the rule on a case-by-case basis (either in terms of whether a facility should be exempt or subject to the rule because the rule criteria are, for that given situation either under or over inclusive) is not outside the scope of EPA’s authority or inconsistent with establishing uniform, nationwide regulations. Consistent with an adjudicatory scheme, EPA confirms that the Administrator’s secondary decision review of the RA’s initial decision is the final Agency action and is appealable to the federal courts.

The Agency does not agree that it is necessary to include drought-specific language in this provision, since it is included under the umbrella of adverse weather conditions.

To the commenter who cited Utility Air Regulatory Group v. EPA,, 134 S. Ct. 2427, 2443-46 and Center for Biological Diversity v. EPA, 722 F.3d 401, 414-15 (D.C. Cir. 2013), the statute (33 USC 1321(j)(5)) provides authority for issuing this rule, including an administrative appeals and petition process for determining whether facilities are regulated under this action and their status as having the ability to cause substantial harm or significant and substantial harm to the environment in the event of a worst case discharge into or on the navigable waters or a conveyance to navigable waters.

Moreover, EPA agrees with commenters who stressed that communities with environmental justice concerns may have unique circumstances that are not captured in the applicability criteria. To commenters who requested additional information on what RAs will consider, the Agency will consult available resources, which could include EPA’s EJScreen, the Federal Emergency Management Agency’s (FEMA) National Risk Index, or other publicly available databases and mapping systems as well as their unique knowledge of local conditions and vulnerabilities. For example, these communities are disproportionately located near ASTs, as discussed in the preamble to the final rule, and, as such, more likely to be adversely impacted by a worst case discharge into or on the navigable waters or a conveyance to navigable water. To be sensitive to these specific issues, of which RAs are uniquely positioned to have knowledge, EPA maintains that considering these concerns and circumstances is necessary to protect these communities from a worst case discharge to navigable waters. Similarly, the impacts of climate change may be difficult to anticipate and vary widely; thus, having an adjudication process whereby location specific and other case-specific information can be taken into account is warranted in order to protect the environment.

EPA has decided to augment § 118.5(b)(2) to specifically reference CWA hazardous substance characteristics, such as ignitability and reactivity. Thus, RAs may take such considerations into account when determining if a facility could cause substantial harm to the environment in the event of a worst case discharge to navigable waters. This addition is important in certain instances to account for the wide variety of CWA hazardous substances and their physicochemical properties, including CWA hazardous substances present in waste, especially in combination with the other substantial harm factors in § 118.5(b), of which the RA is uniquely situated to be knowledgeable. In addition, and with further consideration of public comments, EPA has decided to add § 118.5(b)(10), whereby an RA may consider facility density and potential cumulative impacts of co-located facilities in requiring an onshore non-transportation-related facility to prepare and submit an FRP. EPA agrees with commenters concerned about cascading effects of a worst case discharge and submits that the RA is best positioned to evaluate this potential in the regulated community.

Some commenters also urged EPA to remove the provision regarding the process by which RAs determine that a facility could cause significant and substantial harm through a worst case discharge into or on navigable waters or a conveyance to navigable waters. However, the CWA directs the President to develop criteria to identify a subset of substantial-harm facilities that could reasonably be expected to cause both significant and substantial harm to the environment. As such, EPA proposed factors for the RA to consider when determining that a facility could cause significant and substantial harm to the environment in § 118.5(d), along with the substantial harm criteria found in §§ 118.3(c) and 118.5(b). To assist RAs in achieving nationwide consistency, EPA intends to outline specific screening procedures for use by RAs to foster consistency in how the substantial harm and significant and substantial harm factors are applied. These will be made available to the regulated community, as will compliance assistance.

Also, in § 118.5(d)(3), EPA has expanded the factors an RA may consider when designating a facility as a significant and substantial harm facility to include the condition of containers or equipment onsite, as deteriorating or poor quality containers or equipment could more readily fail. In addition, EPA removed a duplicative provision referring to plan reviews.

Further, to the commenter who suggested that “concerns” of a downstream community, which is not at risk, could be the basis for reversing the risk and harm analysis, EPA disagrees that this is the case. In fact, all of the impacts to be assessed to determine substantial harm through §§ 118.3 or 118.5 are based on impacts of a worst case discharge, many of which in, if not all cases, will be those downstream of a discharge to navigable water.

EPA has further clarified that RAs will provide a written basis for the determination of substantial harm or significant and substantial harm, which will be made available to the facility owner or operator. An owner or operator or may use the appeals provision in § 118.6 to request reconsideration and ultimately appeal to the Administrator the decision that their facility could cause substantial harm or significant and substantial harm to the environment from a worst case discharge into or on navigable waters or a conveyance to navigable waters. Requiring RAs to provide the basis for a decision in writing will further national consistency. In addition, the adjudicatory scheme provides facilities an opportunity to seek reconsideration as well as appeal that decision before having to submit an FRP.

EPA is not incorporating the suggested addition of “reasonably” to § 118.5(b)(11) as all RA decisions must be made with a firm factual basis and documentation; thus, the inclusion of this language is unnecessary.

Substantial Harm

No comments

Significant and Substantial Harm

Public Comment Summary:

Oppose

One commenter noted that timing has been an issue with oil FRPs due to reviews and approvals not being provided in a timely manner and requested that EPA set limits on timing for EPA to “promptly review” and approve of submitted plans under § 118.5(c)(1). The commenter suggested that EPA follow USCG’s framework under 33 CFR § 154.1065. The commenter stated that EPA must provide clearer descriptions for “periodically” and “on a schedule established by the Regional Administrator” under § 118.5(c)(4) because these terms could be applied inconsistently across Regions. The commenter suggested using every five years after the date of plan approval, which is consistent with USCG’s FRPs (0179).

The commenter stated that listed factors in § 118.5(d)(1) through § 118.5(d)(5) are too open-ended and should be clearly identified with clear triggers to ensure consistent application by the RAs across regions. The commenter additionally requested that EPA provide clearer descriptions for natural disasters given in § 118.5(d)(4), how their potential could cause a worst case discharge, and how the hazard is toxicologically relevant, particularly because of their uncertain impacts and the risk for inconsistent application by the RA (0179).

EPA Response:

Because this is a new program and to provide flexibility to Regions to manage their workloads given limited resources and uncertain budgets, the Agency is not, at this time, setting definitive timelines for reviewing and approving plans.

In § 118.5(d), EPA enumerates the factors RAs may consider when determining if a facility could cause significant and substantial harm to the environment from a worst case discharge into or on the navigable waters or a conveyance to navigable water. While a commenter asserted that these criteria are open ended, EPA has determined that, on balance, providing broader language will allow RAs the needed latitude to consider a wide array of factors that could influence whether a facility could cause significant and substantial harm to the environment on a case-by-case basis. For example and in regard to natural hazards, some facilities may be located in earthquake-prone areas while other facilities are situated where the risk of a worst case discharge may be lower. EPA must approve plans for facilities that could cause significant and substantial harm to the environment from a worst case discharge into or on the navigable waters or a conveyance to navigable waters and will provide compliance assistance in terms of identifying appropriate location-based natural hazards facility owners or operators must consider in their FRPs.

Appeals (§ 118.6)

Public Comment Summary:

Support

One commenter generally provided support for the appeals process set forth in the proposed rule but urged EPA, however, to enshrine in the process assurances of transparency. First, the commenter suggested that EPA should require facilities that seek to claim CBI protections for any of their appeal documents to file unredacted and sanitized versions of those appeal documents, as well documentation substantiating the claim of CBI. The commenter added that these requirements should mirror those EPA included in proposed §§ 118.4(d)(iii) and (e). Second, the commenter suggested EPA should make all appeals documents, RA decisions, and Administrator decisions publicly available online (0215).

Oppose

A few commenters expressed appreciation that EPA has provided an appeals process to challenge decisions made by the RA but think that the process should not be the first opportunity for a facility’s mitigation measures or secondary containment systems to be considered. The commenters believe these aspects of a facility should be considered first in the initial substantial harm determination. The commenters added that on appeal of that determination, the facility should be entitled to present additional evidence and information relating to its prevention measures and secondary containment systems, but facilities should not have to appeal a substantial harm determination simply to present this preliminary information, which should be considered at the outset (0199, 0211).

One commenter stated that while the proposed rule includes an appeals process to allow a regulated facility to appeal the RA’s determination of substantial harm and significant and substantial harm or disapproval of a CWA hazardous substance FRP, there must be objective criteria and a transparent process for an appeal to be effective. Commenters opined that as proposed, § 118.6 of the proposed rule has neither. The commenter noted that the outcome of the appeals process is limited only to the subject discretion of the RA and suggested that there needs to be more substance to the appeals process; otherwise, it becomes an illusory activity with a predetermined outcome. The commenter added that without any objective criteria that a facility can point to during the appeal, there is no known basis for when or why an appeal may be warranted. The commenter suggested the EPA should provide objective criteria supporting the basis of an appeal and provide specific guidance as to what, other than the subjective decision of the RA, will impact the outcome of the appeal (0189).

Another commenter noted that although EPA proposes an appeal process, that process appears to shift the burden to affected facilities to disprove the need for a plan (0190).

One commenter expressed concern at the unprecedented and expansive power given to RAs, and the lack of a meaningful appeals process. EPA’s proposed two-step appeals process is insufficient and does not appear to provide enough information about how the process would work to ensure fairness and transparency for operators (0192).

Another commenter stated that the proposed provision allows no opportunity for the subject facility to review the proposed requirement and the RA’s basis thereof, or to correct any potential inaccurate information upon which the RA may be basing the decision. The commenter added that the appeals process is likely to be inefficient and potentially unfair when the underlying decision-making process is so subjective and opaque (0219).

Another commenter stated that the proposed § 118.6 provides owners and/or operators with 60 days to request reconsideration of the RA’s determination and, if denied, 60 days to appeal the decision to the EPA Administrator. The commenter suggested that if an owner and/or operator’s request for reconsideration and/or appeal is made in good faith, then the obligation to submit an FRP should be deferred while the RA’s determination is being reconsidered and/or appealed. The commenter requested that EPA consider and include this deferment in its final rule (0183).

EPA Response:

The appeals provision allows facilities that may meet the criteria but could not reasonably be expected to cause substantial harm to the environment from a worst case discharge into or on navigable waters or a conveyance to navigable waters to appeal to the RA that the owner or operator is not required to submit an FRP, or otherwise engage with EPA on determinations. EPA agrees that if, through the appeals process and working with the RA, it is determined that practices employed at a facility prevent discharges to navigable waters, the facility would not be required to submit an FRP. The Agency has provided more details as to the appeals process in the final rule, as requested by commenters, as well as requiring that any such determination be documented in writing and opportunities for facility owners or operators to review documentation and provide their own. The two-step appeals process is similar to one that has been available in the Oil Pollution Prevention FRP regulation for close to 30 years and is intended to provide owners or operators with an avenue to present their data and information to EPA through an appeals process.

If a facility disagrees that it could cause substantial harm to the environment from a worst case discharge into or on the navigable waters or a conveyance to navigable waters, either through secondary containment and/or passive mitigation, or for some other reason, and should not be required to prepare, submit, and implement an FRP, the facility owner or operator may appeal through the two-step process. First, the owner or operator submits a request for reconsideration, including supporting data and information, to the RA. Then, the RA evaluates the submitted information and data and decides whether to grant the facility’s appeal and adjust its evaluation of the ability to cause substantial harm to the environment. The RA then issues a written decision, including the basis for the determination, as soon as practicable. Depending on the outcome, the owner or operator either must submit a plan following the timelines in § 118.4 or is not required to submit a plan. After the RA issues a written decision, the owner or operator may appeal the decision to the EPA Administrator within 60 days. If the EPA Administrator determines that the facility is subject to this rule, the owner or operator shall follow the timelines in § 118.4. The requirement to submit an FRP is suspended until the administrative appeals process is completed.

If a facility disagrees with an RA determination through the provisions in § 118.5 that it could cause substantial harm or significant and substantial harm to the environment from a worst case discharge into or on the navigable waters or a conveyance to navigable waters, the facility owner or operator may also appeal through the two-step process. First, the owner or operator submits a request for reconsideration, including supporting data and information, to the RA. Then, the RA evaluates the submitted information and data and decides whether to grant the facility’s appeal and adjust its evaluation of the ability to cause substantial harm or significant or substantial harm to the environment. The RA then issues a written decision, including the basis for the determination, as soon as practicable. Depending on the outcome, the owner or operator either must submit a plan or amendments to a plan following the timelines in § 118.4 or is not required to submit a plan or amendments. After the RA issues a written decision, the owner or operator may appeal the decision to the EPA Administrator within 60 days. If the EPA Administrator determines that the facility is subject to this rule, the owner or operator shall follow the timelines in § 118.4. The requirement to submit an FRP is suspended until the administrative appeals process is completed.

CBI provisions for appeals will follow the same procedures in 40 CFR § 118.4(d), whereby an owner or operator can claim information as confidential but must submit to EPA the information claimed confidential, a sanitized copy of the information, and documentation that demonstrates that the CBI claim meets the substantive criteria set forth in § 2.302. In consultation with other federal partners, EPA will determine what, if any, portions of appeals documentation should be made publicly available.

EPA recognizes that RAs possess unique knowledge of Region-specific considerations that should have a bearing on whether to identify a facility as a "significant and substantial harm facility." Factors determining that a facility may pose a significant and substantial harm may vary materially between Regions and facilities. For example, some facilities may be located in earthquake-prone areas while other facilities are situated where the risk of discharge may be lower. Thus, identically designed and built facilities located in different Regions may vary in the risk that they pose to the environment based on locational factors. Thus, inclusion of an adjudicatory component allowing an RA to make case-by-case determination is warranted and in some cases necessary to implement the OPA which, through EO 12777, directs EPA ultimately to determine which facilities are "substantial harm facilities" and "significant and substantial harm facilities." Furthermore, consistent with an adjudicatory process, an appeals process is included to allow owners or operators the opportunity to challenge the RA's determination.

As per the OPA amendments to the CWA, the intent of this regulation is to shift the burden of planning and response to facilities rather than public resources; thus, putting the onus on the facility owner or operator to disprove the need for a plan is appropriate.

Petitions (§ 118.7)

Public Comment Summary:

Support

One commenter provided support for the provision that will limit members of the public in determining if a facility can reasonably be expected to cause substantial harm based on the factors in § 118.3. The commenter suggested that such determinations, if agreed to by the RA, should require full disclosure of reviewed materials and clear reasoning behind the decision. The commenter also recommended that in addition to the plan development timeframes already in the proposed rule, the subject facility should have 90 days to review and respond to a ruling prior to being committed to moving forward with planned development (0179).

One commenter expressed strong support for the proposed rule’s inclusion of a stakeholder petition process, whereby the public and state or local government agencies can petition EPA to determine whether a facility should be required to submit an FRP. The commenter agreed with EPA that “availability of the petition process is important for public involvement in the designation of substantial harm facilities and could be an important mechanism for communities with environmental justice concerns and those impacted by climate change to participate in the CWA hazardous substance FRP process.” The commenter suggested ensuring submitted information is available through public, online searchable database. The commenter stated that the petition process could be strengthened by allowing stakeholders to base their petitions on the full set of factors that an RA can consider independently, including those factors set forth in §§ 118.5(a) and (b). Finally, the commenter suggested that the final rule should set a 180-day deadline for EPA to act on a petition (0215).

Oppose

Several commenters expressed concern about EPA’s inclusion of stakeholder petitions in the proposed rule. The commenters argued that the rule needs clear measures to best guide facilities on whether they are covered by the regulation. Allowing petitions to the RAs to include a facility would open even more possibility of the rule being unevenly applied. The commenters stated that under this approach, two identical facilities may or may not be covered by the rule simply because an individual or group petitioned the RA. The commenters noted that facilities should not be treated differently based on such factors. Similarly, the commenters added that communities at risk of a CWA hazardous substance discharge should not depend on public petitions to ensure that facilities follow federal regulations. Instead, the commenters suggested the rule should be codified in a clear and concise way that makes facility owners and operators abundantly aware of their obligations without the fear of a petition changing those obligations (0175, 0185, 0187, 0191, 0194, 0204, 0218).

Many commenters also expressed concern that the petition process is based on subjective opinion and lacks evidence-based standards for determining facility applicability based on the proposed regulatory criteria in § 118.3 (0181, 0183, 0185, 0199, 0208, 0211, 0219). One commenter noted that EPA’s intention of the petition process to engage the public on whether a facility should be subject to the proposed rule based on claims of environmental justice and climate change implications. However, the commenter asserted that such claims are not among the applicability factors, not defined, highly subjective, and potentially controversial. The commenter opined that these factors state EPA policy preferences; they are not science-based features that can be accounted for by objective analysis. The commenter added that applicability should be a core regulatory element that should be settled during the rulemaking process, not debated by the public after the rule is finalized (0181).

A few commenters suggested that the proposed rule should require petitioners to provide supporting evidence and allow facilities an opportunity to respond before an RA decides how the Agency will proceed in response to such a petition (0199, 0208, 0211).

Several commenters expressed concern that the proposed rule provides no procedures for facilities that are the subject of a petition to test the claims made in the petition, submit data or information, raise questions, or challenge EPA’s responses to the petition, which creates unjustified uncertainties and burdens for potentially regulated facilities (0181, 0183, 0185, 0192, 0211). A couple of commenters suggested that EPA post all petitions on their website, require timely notification of petitions to facility operators, and provide a copy of any petition received for facility operators (0185, 0219).

One commenter requested that EPA remove the provision in § 118.7 from the proposed rule because no criteria are provided for the RA to make such determinations, which creates opportunities for inconsistent application (0188).

Another commenter expressed concern about the unprecedented and expansive power given to RAs, the public stakeholder petition process, and the lack of sufficient information provided in the two-step appeals process to ensure fairness and transparency for operators (0192).

One commenter requested that EPA authorize SERCs to make facility designations—due to their greater local capacity to address environmental justice and responder and public safety—unless the RA disagrees. The commenter opposed § 118.7 with regards to the petition process because it provides no mechanism for a petitioner to pursue their request or appeal a decision denying a petition. The commenter objected to the language “as practicable” and believes that the safety of the community and first responders, not to mention the potential for environmental harm, merits a more meaningful process to address community concerns with the risks presented by facilities with hazardous materials (0170).

EPA Response:

EPA proposed and is retaining in this final rule a petition provision in § 118.7 whereby the public and other government agencies may petition EPA to determine whether an onshore non-transportation-related facility should be required to submit an FRP to EPA. Petitions are submitted to the RA, who in turn reviews the submissions as soon as practicable. Petitions must include a reasonable basis for asserting that the onshore non-transportation-related facility may pose a risk of substantial harm to the environment. Specifically, a petition must include a discussion of how the factors in § 118.3 apply to the facility. Although including quantitative or other data as to the substantial harm criteria would be ideal, petitioners are not required to submit such data. EPA will make the petition available to the owner or operator that is the subject of the petition and provide an opportunity to respond. RAs may render a decision based solely on the information in the petition (e.g., dismiss a petition that does not contain a sufficient basis to find the facility may pose a risk of substantial harm to the environment) or in conjunction with the response provided by the owner or operator that is the subject of the petition, but may also gather additional information before rendering a decision. Once subject to the regulation, a facility owner or operator has six months to develop their FRP, which is ample time and the same provided to newly regulated facilities. An additional 90 days, as suggested by a commenter, will delay plan implementation and important information from being conveyed to local emergency responders. A facility owner or operator may use the appeals provision in § 118.6 to appeal the RAs determination and the requirement to submit an FRP is suspended until the administrative appeals process is completed.

The petition provision is a mechanism for community involvement so that co-regulators, potentially affected community members, and stakeholders can engage with EPA about facilities of concern. However, EPA retains the final authority on applicability determinations based on the factors in 40 CFR §§ 118.3 and 118.5. RAs are reasonable and understand that this is an unusual, likely seldom used provision, and will use the data available to them to determine facility applicability as per § 118.3.

The criteria in § 118.3 are designed to capture the bulk of those facilities that could reasonably be expected to cause substantial harm to the environment. However, because of the size and diversity of the types of facilities within the regulated community, EPA believes that there are facilities that will not meet the criteria in § 118.3, but may, due to facility- or location-specific circumstances, pose sufficient risk to the environment to be designated as being able to cause substantial harm to the environment. Accordingly, EPA has included the ability of the RA to make a case-by-case determinations and the public to bring potential facilities of interest to EPA’s attention through § 118.7. The Agency recognizes that RAs possess unique knowledge of Region-specific considerations, and it is consistent with EPA’s responsibilities under EO 12777 to designate covered facilities on a case-by-case basis that could reasonably be expected to cause substantial harm to the environment. That said, EPA expects these case-by-case determinations will be made judiciously and in manner that is reserved to ensure adequate protection of the environment. Following the criteria in 40 CFR § 118.3, RAs have the expertise to ensure that identical facilities are regulated in the same way.

EPA disagrees with commenters who assert that petitions will lead to the regulation being unevenly applied. It is not unusual for executive agencies to have a process that develops and establishes applicability norms over time. A few commenters suggested that the rule should require petitioners to provide supporting evidence and allow facility owners or operators an opportunity to respond before an RA decides how the Agency will proceed in response to such a petition. Other commenters expressed concern that the rule does not provide procedures for facilities that are the subject of a petition to test the claims made in the petition, to submit data or information, or rebut the petition in other ways. In response to these concerns, EPA has revised § 118.7 to specify EPA will make the petition available to the owner or operator of the facility in question and provide an opportunity to respond. In addition, the RA will work with the owner or operator to substantiate the petition, as appropriate. The appeals and petitions provisions are complementary: on the one hand, the appeals provision allows for stakeholder participation in whether EPA determines if an onshore non-transportation-related facility poses a risk of substantial harm to the environment through a worst case discharge into or on navigable waters or a conveyance to navigable waters and must prepare an FRP. The appeals provision allows facilities that may meet the criteria but could not reasonably be expected to cause substantial harm to the environment from a worst case discharge into or on navigable waters or a conveyance to navigable waters to appeal to the RA that the owner or operator is not required to submit an FRP, or otherwise engage with EPA on determinations.

EPA clarifies here that it is not necessary for petitioners to provide detailed analyses and calculations as to whether the onshore non-transportation-related facility meets one of the specific criteria in § 118.3 but rather must provide a reasonable basis for asserting that the facility may pose a risk of substantial harm to the environment. For example, if an onshore non-transportation-related facility is located near a wildlife sanctuary and appears to store significant quantities of a CWA hazardous substance, then the petition need only include such observations. That said, a petition that fails to provide a basis for why an onshore non-transportation-related facility should be determined to reasonably be expected to cause substantial harm to the environment from a worst case discharge into or on navigable waters or a conveyance to navigable waters (e.g., the facility is near a PWS or a priority sensitive environment listed in an ACP, or has a history of unreported discharges to water or poor maintenance, leading to corroded tanks) may not receive immediate action by the RA or may be summarily denied. The purpose of the requirement to provide some basic information based on knowledge of EPA’s criteria is to help screen out frivolous, unfounded petitions. Additionally, EPA is not expanding the criteria subject to petitions to those factors set forth in §§ 118.5(a) and (b), as the RA is best positioned to evaluate those, as discussed above.

The RA will use his or her discretion in following up on petitions that do not include a reasonable basis to believe a facility could cause substantial harm to the environment from a worst case discharge into or on navigable waters or a conveyance to navigable waters. In terms of public availability, EPA does not believe that making all petitions public would serve to protect the environment. Some materials may contain sensitive information or be inaccurate; once an onshore non-transportation-related facility is subject to FRP requirements, EPA will make public those parts of the FRP that can be shared as determined in conjunction with federal partners like DHS and the FBI. EPA is also not adding a deadline for acting on petitions, since they and the subject facilities may be complex, and it is important to allow ample time for review and to work with both petitioners and owners or operators to address any concerns.

To commenters concerned that communities at risk of a CWA hazardous substance discharge would be dependent on petitions in order to protect themselves, EPA maintains that the applicability criteria in § 118.3 appropriately screen for onshore non-transportation-related facilities that could cause substantial harm to the environment from a worst case discharge into or on navigable waters or a conveyance to navigable waters. Nonetheless, to the extent there are onshore non-transportation-related facilities that may not be captured using that mechanism, the public may submit a petition asking EPA to pursue the matter. The RA then follows the processes in §§ 118.3 and 118.5 to determine whether a facility could cause substantial harm to the environment.

EPA disagrees that SERCs should be authorized to make facility designations, as this is EPA’s authority. The SERC may use the petition process to work with the RA in determining whether an onshore non-transportation-related facility could cause substantial harm to the environment through a worst case discharge into or on navigable waters or a conveyance to navigable waters.

Finally, EPA disagrees that the petitions process is unprecedented and expansive; the petitions process is similar to one that has been available in the Oil Pollution Prevention FRP regulation for close to 30 years and is intended to provide stakeholders and the public with an avenue to participate in the FRP determination process with EPA through a formal process.

EPA agrees that during the administrative process, of an owner and/or operator’s request for reconsideration and/or appeal, the obligation to submit an FRP is deferred.

Exceptions and Exemptions (§ 118.8)

Public Comment Summary:

Support

One commenter agreed with the exceptions and exemptions listed on page 17931 of § 118.8 (0201).

Several commenters agreed with EPA’s decision to exempt USTs regulated under 40 CFR Part 280 or 281 in § 118.8(a)(4) as defined in 40 CFR Part 280 (0179, 0205, 0209, 0214).

One commenter provided support for EPA’s decision to exclude transfer of CWA hazardous substances over water if they are regulated by USDOT or USCG. The commenter added that § 118.5(b)(1) does not reference this exemption, given in § 118.9 (0205).

EPA Response:

EPA agrees with the commenters who support the exceptions and exemptions listed in § 118.8, specifically for USTs regulated under 40 CFR Part 280 or 281 in § 118.8(a)(4) as defined in 40 CFR Part 280.

EPA’s jurisdiction in this action is onshore non-transportation-related facilities while the USCG has primary responsibility for Marine Transportation-Related facilities and would be the implementing agency for any CWA hazardous substance FRP regulations for that type of facility. Should the USCG initiate a rulemaking for facilities over which they and the Agency share jurisdiction, the two will collaborate to ensure consistency. That said, if a facility that transfers CWA hazardous substances over water also is a non-transportation related onshore facility meeting the criteria in § 118.3, it would be subject to this regulation.

Public Comment Summary:

Chemicals

Several commenters noted that some chemicals on the CWA hazardous substance list are in either a solid or gaseous form upon release and are unable to reach navigable waters. The commenters requested that any such chemical be exempt in the final rule (0175, 0176, 0178, 0179, 0183, 0185, 0187, 0191, 0194, 0197, 0204, 0206, 0211, 0218, 0219). Many of these commenters noted that if these types of chemicals are included, it would be costly and time consuming (0175, 0176, 0187, 0191, 0194, 0197, 0204, 0218). A couple of commenters attached a list of these substances in a separate document (0191, 0204). One commenter requested clarification on how conveyance to navigable water should be considered for facilities with only gaseous CWA hazardous substances over the quantity threshold (0177).

Several commenters referenced specific examples including chlorine (0175, 0178, 0206, 0211, 0219); solid chemicals when not mixed into substances (0175); ammonia (0178, 0219); anhydrous ammonia (0183, 0211); and adipic acid because it is solid at ambient temperature, has a melting point of 152°C, and is normally stored as a powder (0211).

Many commenters noted that several of the chemicals are stored under pressure and are primarily released via volatilization, which would not flow to jurisdictional water (0178, 0183, 0184, 0185, 0199, 0206, 0211, 0219). A couple of commenters requested clarification that CWA hazardous substances that volatize at ambient temperatures and pressures are excluded from the proposed rule (0184, 0199). One of these commenters was unclear about whether the proposed rule only applies to CWA hazardous substances in a liquid form because some CWA hazardous substances, such as anhydrous ammonia, are stored in liquid form but volatize at ambient temperature and pressure. The commenter also requested EPA provide clarification as to what constitutes a liquid (0184).

A few commenters explicitly requested EPA only include CWA hazardous substances that are in the liquid phase (0179, 0197, 0214). One commenter added that these substances should be liquid at temperatures ranging between 0° and 35°C and at or near atmospheric pressure (0179).

A couple of commenters requested EPA clarify what constitutes a liquid. These commenters requested that EPA clarify that the form of substances covered expressly excludes CWA hazardous substances that volatilize at ambient temperatures and pressures (0206, 0211).

One commenter requested clarification as to whether nitrogen dioxide (NO₂), a CWA hazardous substance listed in Table 40 at CFR § 117.3, is exempt from this regulation. The commenter noted that because this is a gas, it should be exempt from the rule (0201).

One commenter recommended EPA should not regulate manufacturing and operational equipment filled with CWA hazardous substances filled because the chemistry and compositional changes “would be extremely difficult if not impossible to characterize.” The commenter noted that CWA hazardous substances “can be neat (pure)” and “may be present in production, mid-stream, refining, and petrochemical plants as raw materials, products, process intermediaries, byproducts, wastes, process catalysts, lubricants, or fuels” as well as in “additives, corrosion inhibitors, and other process chemicals used in production, refining, product enhancements, water treatment, wastewater treatment, etc.” As a result, the commenter recommended that EPA should only regulate CWA hazardous substances that are stored in bulk storage containers. The commenter added that EPA should add the definition for Bulk CWA Hazardous Substances Storage to be consistent with the approach in 40 CFR Part 112 where that term means a bulk storage container where any CWA hazardous substance is stored. The commenter added that these containers store CWA hazardous substances “prior to use, while being used, or prior to further distribution in commerce” and highlighted that electrical, operating, or manufacturing equipment filled with CWA hazardous substances is not a bulk storage container (0179).

EPA Response:

EPA agrees with commenters who noted that there are chemicals in the CWA hazardous substance list that are in either a solid or gaseous form upon release and are unable to reach navigable waters. However, the Agency has determined that these situations are best dealt with through the worst case discharge scenarios. This may mean that for a substance released as a gas in adverse weather conditions and without consideration of passive mitigation, secondary containment, or administrative controls, the distance to endpoints cannot be calculated. Solid CWA hazardous substances may be miscible in water and, as such, a planning distance may be calculated. Thus, if a solid stored as a powder or in pellets has the ability to release in a flood scenario and reach navigable waters or a conveyance to navigable waters, the covered facility owner or operator must make a substantial harm determination, and if the solid CWA hazardous substance is determined to be able to cause substantial harm to the environment from a worst case discharge into or on navigable waters or a conveyance to navigable waters, submit an FRP to EPA. However, EPA stresses that adverse weather conditions, including extreme events due to climate change, must be considered. Accordingly, should a worst case discharge consist of a CWA hazardous substance releasing as a gas that could mix with rainwater and then reach navigable waters or a conveyance to navigable waters, the covered facility owner or operator would need to examine that outcome in their worst case discharge scenario(s).

Relatedly, EPA is not choosing to set a temperature range or define the form of the substance as it releases; instead, the covered facility owner or operator should make a similar determination as described above.

EPA disagrees with the commenter who recommends EPA only regulate CWA hazardous substances in bulk containers. Some CWA hazardous substances may be harmful at quantities as low as one pound. While the Agency recognizes that some facilities may be complex and contain CWA hazardous substances in several forms and in many containers that are not bulk, EPA is confident that facilities will be able to aggregate quantities across their sites, as is required by several other federal regulations.

Public Comment Summary:

Regulatory overlap

Several commenters asserted that the proposed rule overlaps with other regulations or programs (0175, 0178, 0179, 0184, 0186, 0187, 0191, 0199, 0201, 0205, 0209, 0211, 0214, 0218, 0219).

One commenter stated that because the proposed rule exempts USTs regulated under 40 CFR Part 280, EPA has set a precedent to expand the list of exceptions to include substances managed under other regulations such as FRPs (40 CFR Part 112), PSM, RMP, hazardous waste, and the NPDES programs (0179).

Another commenter mentioned that these programs already have good reference points for timeline procedures, information sharing, and other general facility requirements (0205).

Several commenters asserted that EPA must avoid any new or duplicative requirements to these regulations or programs (0179, 0187, 0191, 0199, 0205, 0207, 0209, 0214, 0218, 0219).

Another commenter referenced the approach taken by the USCG on the OPA amendments promulgated after the Deepwater Horizon oil spill and recommended that EPA follow a similar approach to consider modifying existing regulations to include CWA hazardous substances (0179).

EPA Response:

EPA has considered the issue of exemptions and which regulatory programs do not just nominally overlap but serve the same function such that an exemption for the covered substances is appropriate. Notwithstanding commenters statements regarding overlap, many other EPA and federal programs are not specific to worst case discharges of CWA hazardous substances into or on the navigable waters and, more importantly, do not cover all the required program elements under CWA § 311(j)(5). Many of these programs are, therefore, not an appropriate substitute. However, where appropriate, EPA has created exemptions and taken measures to limit duplicative regulatory requirements. Chapter 2 of the TBD available in the docket details potential regulatory overlap in related programs, and EPA has adjusted some exemptions in § 118.8 to account for existing programs. The Agency has fully researched existing regulatory programs to streamline the administrative burden.

Please see the list of programs under Section 2.2 of this Response to Comments for a short, program-by-program list of reasons why cited regulations are insufficient to plan for worst case discharges of CWA hazardous substances, as well as below.

For reasons discussed in section 3.3.5 of this document EPA is not including considerations of secondary containment, passive mitigation, or administrative controls in this final rule.

To commenter who raised the approach taken by USCG, EPA notes that in March 2000, USCG published an NPRM in the Federal Register entitled “Marine Transportation-Related Facility Response Plans for Hazardous Substances” (65 FR 17416, March 31, 2000) under the same CWA authority as this final rule. USCG then withdrew that rulemaking in February 2019 (84 FR 2799, February 8, 2019). Given that nearly 20 years elapsed between the proposal and withdrawal, it is unsurprising that USCG found the proposed rule was no longer appropriate to the current state of spill response in the chemical industry. USCG also noted that their NPRM may overlap with existing local and state regulatory schemes as well as current industry practice. EPA has reviewed USCG’s actions, reports, and findings. As such, EPA did not find sufficient overlap for onshore non-transportation-related facilities to not promulgate this regulation as per Chapter 2 of the TBD, available in the docket.

Public Comment Summary:

Resource Conservation and Recovery Act

Several commenters referenced the overlapping of the proposed rule with the RCRA (0186, 0199, 0201, 0205, 0209, 0211, 0214).

Many commenters recommended that an exemption be allowed for facilities covered under 40 CFR Part 264 (0199, 0205, 0209, 0211, 0214). One of these commenters added that the exemption should cover tanks and containers accounted for in existing RCRA Contingency Plans, Use and Management of Containers, and Tank Systems (0205).

A couple of commenters noted that under 40 CFR § 264.50, large quantity generators are required to have contingency plans to address emergency response to fires, explosions, or any unplanned sudden or non-sudden release of hazardous waste or hazardous waste constituents to air, soil or surface water (0199, 0211).

One commenter referenced the definition of “container” in the proposed rule, stating that it is currently unclear and could be interpreted to include solid waste, solid waste management units, and landfills. The commenter recommended that EPA make it clear that non-hazardous waste under the RCRA definition is exempt from the final rule, as these wastes are already covered under RCRA (0211).

Another commenter recommended EPA exempt RCRA-permitted TSDFs. The commenter referenced the preamble of the proposed rule and noted that RCRA regulations are the exception in that they fully address all the worst case discharge requirements. The commenter added that the TBD for the proposed rule fully supports this conclusion. The commenter mentioned that RCRA addresses all of the requirements for preventing and responding to worst case discharges and suggested that all RCRA-permitted TSDFs must have secondary containment systems for drums and containers that are designed and operated in accordance with regulatory standards, including an impervious base sloped to remove liquids, with sufficient capacity to contain the largest container or 10 percent of the total container volume (0186).

A couple of commenters referenced the exception of USTs in the proposed rule and suggested that it extend to TSDFs that are currently regulated under RCRA Subtitle C (0186, 0209). One of these commenters added that EPA should allow exceptions for TSDFs regulated under 40 CFR Parts 264 and 265 because 40 CFR Part 264 Subpart D requires the development of contingency plans and emergency procedures for all such TSDFs. The commenter mentioned that under 40 CFR Part 270, the Part B permit application requires a facility to show how they meet these requirements on a day-to-day basis. The commenter also added that TSDFs are covered under SPCC (40 CFR Part 112), Stormwater Pollution Prevention Plans (40 CFR Part 122), and Clean Air Act Risk Management Plans (40 CFR Part 68), and many must comply with the OSHA PSM Standards at 29 CFR § 1910.119. The commenter suggested that additional requirements for TSDFs “would provide only minimal incremental value.” The commenter also mentioned that in 2019, “EPA determined this for spill containment requirements under § 311(j)(1) and the same set of facts apply to ‘worst case’ plan requirements under 311(j)(5)(D)” (0209).

Another commenter referenced specific examples of how the current RCRA regulations satisfy the statutory requirements in § 311(j)(5)(D) (0209).

One commenter recommended that the OEM work with ORCR to understand the requirements of the RCRA regulations for TSDFs (0186). Another commenter noted that liquid CERCLA/RCRA “hazardous wastes” are currently regulated under CERCLA/RCRA regulations and should be exempt from the proposed rule (0201).

One commenter strongly urged EPA to include a new subsection (a)(5) in § 118.8 in the final rule that would read (0186):

118.8(a) Exceptions. This part does not apply to the owner or operator of any facility, equipment, or operation that is not subject to the jurisdiction of the EPA under 33 USC § 1321(j)(5)(C), as follows:

….

(5) Any storage container or tank system and connected piping, ancillary equipment, and containment systems, at any hazardous waste treatment, storage or disposal facility that is subject to all of the technical requirements of parts 264 or 265 of this chapter or a state program approved under part 272 of this chapter.

EPA Response:

After examining the RCRA regulations and commenter concerns, as well as working closely with ORCR, EPA is adding an exemption at § 118.8(b)(2)(viii) for the storage and accumulation of hazardous waste subject to the “Standards for Owners and Operators of Hazardous Waste Treatment, Storage, and Disposal Facilities (TSDF),” 40 CFR Part 264 and Part 265, and “Standards Applicable to Generators of Hazardous Waste,” 40 CFR Part 262, subpart M. For covered facilities subject to the TSDF requirements under 40 CFR Part 264 and Part 265, these regulations comprehensively address the program elements required under CWA § 311(j)(5)(D). For hazardous waste generators covered under 40 CFR Part 262, EPA is exempting those generators subject to subpart M (i.e., large quantity generators) for the same reason; the contingency plan and emergency procedures requirements therein comprehensively address the program elements required under CWA § 311(j)(5)(D).

While small quantity generators have preparedness and prevention requirements, these do not cover all required program elements under CWA § 311(j)(5)(D), and very small quantity generators are not subject to prevention and preparedness requirements nor required to develop a contingency plan and emergency procedures. Since hazardous waste at these generators may contain CWA hazardous substances and are not subject to all RCRA hazardous waste requirements, EPA has decided that hazardous waste generators not subject to RCRA part 262, subpart M requirements must follow the applicability criteria at § 118.3 to determine if they could cause substantial harm to the environment through a worst case discharge into or on navigable waters or a conveyance to navigable waters. Non-hazardous solid waste is also subject to this final rule.

Public Comment Summary:

EPCRA

A few commenters recommended that EPA use the existing exemptions under 40 CFR § 370.13 in the EPCRA regulations because many of these are similar to the exemptions listed in § 118.8 of the proposed rule (0179, 0199, 0211).

A couple of commenters noted that the RIA for the proposed rule utilized EPCRA 312 Tier II reports to estimate the number of regulated facilities subject to the rulemaking and that exemptions from EPCRA should be considered. The commenters added that facilities under this exemption are not required to have a Material Safety Data Sheet (MSDS) under OSHA regulations and hazardous waste is excluded from the MSDS requirements under OSHA regulations (0199, 0211).

EPA Response:

The exemptions under 40 CFR § 370.13 in the EPCRA regulation concern a reporting rule and are not applicable to worst case discharge planning regulations. Additionally, EPA used reporting under this statute for the RIA analysis because it is the most comprehensive listing of hazardous substances available, not because the regulation itself is related to this final rule. Thus, there is no justification to bring over the exemptions listed in 40 CFR § 370.13 on that basis.

Public Comment Summary:

Risk Management Plan

Several commenters asserted that there is overlap with the RMP regulation (0178, 0179, 0180, 0187, 0191, 0205, 0207, 0218, 0219). Many commenters recommended EPA exclude or exempt facilities that already have an RMP on file with EPA for a substance or already subject to RMP (0178, 0179, 0185, 0187, 0191, 0207, 0218, 0219).

One commenter similarly noted that releases to air are regulated under other programs (0206).

One commenter recommended that EPA allow the ability to cite RMPs at facilities with a CWA hazardous substance that have implemented protective measures to mitigate a release under the RMP per CAA § 112(r), similar to the exemption granted for USTs (0207).

Another commenter referenced several chemicals that are covered under the RMP and the proposed rule, including ammonia, chlorine, formaldehyde, hydrochloric acid, and sulfuric acid (0219).

One commenter noted that large water utilities rely on chlorine for water disinfection to ultimately supply safe drinking water to the public. The commenter noted it is possible for a water utility to meet the threshold and location criteria, as well as the substantial harm criteria of “ability to adversely impact a public water system.” The commenter stated that if a discharge of chlorine at a water utility could interfere with a its ability to disinfect water, then it seems the utility would be required to submit an FRP under this proposed rulemaking. The commenter stated that requiring utilities to submit an FRP under this rule, as well as under the RMP, would lead to duplicated efforts that redirect resources away from other important operations especially since an accidental discharge of chlorine, which would be in gaseous form, would not flow into WOTUS and is already covered under the RMP. The commenter recommended that EPA explicitly state in the final rule that PWSs are not subject to this rulemaking based on the storage of chlorine if the water system is already required to submit an RMP through the CAA (0180).

EPA Response:

The RMP program under the CAA’s authority is for accidental air releases; for that reason alone, it is insufficient to rely upon to determine if a facility could cause substantial harm to the environment by discharging into navigable water. A regulated facility owner or operator is welcome to augment an existing plan with the requirements in the final rule but may not assume they are compliant due to their regulation under other programs. For example, of the 296 CWA hazardous substances listed in 40 CFR § 116.4, 30 are listed at 40 CFR § 68.130 and covered by RMP. For facilities that meet the applicability criteria in 40 CFR § 118.3 for those CWA hazardous substances that are also regulated under RMP, their RMP will require additional items to meet the requirements of 40 CFR 118 but may be augmented include requiring qualified individual (QI)identification and duties; identifying and ensuring removal and mitigation personnel and equipment; and describing training, equipment testing, periodic unannounced drills, and response actions for worst case discharges of CWA hazardous substances into or on the navigable waters or a conveyance to navigable waters. Therefore, that fact that RMP “covers” to some extent some of the same chemicals is not a sufficient basis to exempt facilities based on compliance with the RMP program.

PWSs that meet the applicability requirements in § 118.3 are subject to the requirements of the rule. While these facilities perform vital functions, they may still pose a risk of release.

Public Comment Summary:

Underground Storage Tanks

A few commenters provided support and recommended that EPA finalize its proposal to exempt USTs in § 118.8(a)(4) as defined in 40 CFR Part 280 (0179, 0205, 0214). One commenter added that these types of equipment are subject to separate UST regulatory programs for CWA hazardous substances (0205).

One commenter also requested clarification for facilities that have CWA hazardous substances legally stored below ground in tanks, pipelines, or other storage. The commenter was unclear whether these facilities should be exempt since they are located underground (0201).

EPA Response:

EPA agrees with the commenter that supports its proposal to exempt USTs in § 118.8(a)(4) as defined in 40 CFR Part 280 and retains this exemption in the final rule. CWA hazardous substances stored underground in compliance with 40 CFR Part 280 are not subject to this final rule.

Public Comment Summary:

Oil Pollution Prevention (40 CFR Part 112) Spill Prevention, Control, and Countermeasure

Several commenters asserted that there is the overlap of the proposed rule with the SPCC regulation (0179, 0184, 0205, 0211).

One commenter suggested that EPA add an exemption for “motive power containers” from the maximum capacity onsite calculation similar to 40 CFR § 112.1. The commenter suggested that if added, the following definition of “motive power containers” should be added to 40 CFR § 112.2 (0201):

“Motive Power Container means any onboard bulk storage container used primarily to power the movement of a motor vehicle, or ancillary onboard oil-filled operational equipment. An onboard bulk storage container which is used to store or transfer oil for further distribution is not a motive power container. The definition of motive power container does not include oil drilling or workover equipment, including rigs.”

Several commenters asserted that the proposed rule overlaps with the Oil Pollution Prevention FRP regulation (0179, 0201, 0205, 0219).

A few commenters recommended EPA offer an exemption for oils that are regulated under 40 CFR Part 112 (0179, 0205, 0219). One commenter noted that this exemption is similar to the one offered in the facilities to update an existing SPCC Plan and/or FRP to take into account the CWA hazardous substance (0219).

One commenter stated that EPA should exempt or accept management and response measures currently in place for all 40 CFR § 116.4 substances already regulated as oils under 40 CFR § 112. The commenter added that many materials such as produced water, condensates, gasoline, distillates, and others would be inappropriately regulated without this exemption (0179).

Another commenter recommended that hazardous waste oil and authorized PCBs be exempt because they are already regulated under separate regulations (0201).

EPA Response:

The Oil Pollution Prevention FRP regulation is comprehensive for oils and covers oil that is mixed with CWA hazardous substances but does not cover CWA hazardous substances that are not mixed with oil. Similarly, the Oil Pollution Prevention Program SPCC program regulates oils, specifically the prevention of oil discharges. This action is being undertaken under the same authority under which the oil FRP rule was promulgated, which accounts for the similarities. However, this action is specific to CWA hazardous substances listed in 40 CFR § 116.4. A facility owner or operator may augment an existing oil FRP or SPCC plan with the requirements under this regulation. USTs regulated under 40 CFR Part 280 are exempt under this action since that regulation covers the required program elements under CWA § 311(j)(5). Oil is regulated under 40 CFR Part 112. PCBs as a whole are also not exempt, unless they are stored in a manner that is compliant under 40 CFR Part 280.

There is no need for “motive power containers” to be exempted since they would be filled with oil, which is not covered by this regulation.

Public Comment Summary:

Comprehensive Environmental Response, Compensation, and Liability Act

A couple of commenters suggested that the proposed rule overlaps with CERCLA (0205, 0214).

One commenter stated that certain CWA hazardous substances may be covered under CERCLA (0214).

EPA Response:

EPA disagrees that this action overlaps with CERCLA. CERCLA provides a federal "Superfund" to clean up uncontrolled or abandoned hazardous waste sites as well as accidents, spills, and other emergency releases of pollutants and contaminants into the environment. It also authorizes EPCRA and includes a notification requirement. CERCLA is not a planning regulation, nor does it cover any of the required elements in CWA § 311(j)(5). All CWA hazardous substances are also CERCLA hazardous substances, so a facility that releases an RQ of a CWA hazardous substance does need to follow the CERCLA reporting requirements.

Public Comment Summary:

Occupational Safety and Health Administration’s Process Safety Management Standard

A few commenters asserted that the proposed rule overlaps with OSHA’s PSM standard (0179, 0207, 0219).

One commenter stated potential overlap with OSHA’s PSM standard, which promotes safe management of hazardous chemicals and requires contingency planning for emergencies. The commenter noted that the PSM program is designed to “prevent[] or minimize[e] the consequences of catastrophic releases of toxic, reactive, flammable, or explosive chemicals” and requires employers to “establish and implement an emergency action plan for the entire plant.” The commenter recommended that facilities and/or substances that are already subject to the PSM program be exempt from the final rule (0219).

A couple of commenters recommended EPA exclude facilities that are already covered under PSM (0179, 0207).

EPA Response:

OSHA’s PSM program sets requirements for preventing or minimizing the consequences of catastrophic releases of toxic, reactive, flammable, or explosive chemicals in order to protect workers. The provisions of the PSM standard were written to assure safe and healthful working conditions for employees, not to protect the environment from discharges of CWA hazardous substances.

Public Comment Summary:

National Pollutant Discharge Elimination System

A few commenters asserted that the proposed rule overlaps with NPDES (0179, 0201, 0205, 0214).

One commenter recommended that sanitary (municipal) and industrial wastewater discharged under an NPDES permit or a publicly owned treatment works (POTW) user agreement should be explicitly exempt from the final rule because they are already regulated under 40 CFR Part 122 and the NPDES program (0179).

Another commenter noted that the definition of “discharge” contains an exclusion for discharges “in compliance” with NPDES permits. The commenter requested that the definition be clarified so that the exclusion remains even if a facility has violations of its NPDES permit and is not in full compliance with the permit (0214).

One commenter noted that impoundments, wastewater tanks, or other permitted structures covered by existing NPDES or other permits should also be exempt from the final rule (0205).

One commenter noted that “wastewater discharges” are currently regulated under the CWA NPDES permitting program and should be exempt in the proposed rule (0201).

EPA Response:

The CWA NPDES Permit Program, authorized by the CWA, controls water pollution by regulating point sources that discharge pollutants into WOTUS. An NPDES permit establishes limits on what can be discharged, monitoring and reporting requirements, and other provisions to protect water quality. In essence, the permit translates general requirements of the CWA into specific provisions tailored to the operations of the facility discharging pollutants. A NPDES general permit may be written to establish requirements that apply to eligible facilities with similar operations and types of discharges that obtain authorization to discharge under the general permit. It does not require response planning.

The requirements in this final rule do not include discharges regulated under NPDES, even in cases when the discharge is in violation of a NPDES permit. In the event of an NPDES permit violation, enforcement and penalties are addressed through NPDES.

Public Comment Summary:

Pipeline and Hazardous Materials Administration

One commenter requested EPA provide an exemption for facilities already subject to USDOT’s Pipeline and Hazardous Materials Administration (PHMSA) and/or equivalent state authority (0205).

Another commenter recommended EPA clearly identify changes in jurisdictional boundaries and suggested it be consistent with PHMSA and USCG. The commenter added that EPA should use the definitions that are in the SPCC Guidance for Regional Inspectors Memorandum of Understanding documents (0179).

EPA Response:

USDOT regulations for product and waste shipping apply to items in transportation. This proposal applies explicitly to onshore non-transportation-related facilities. Should USCG and USDOT finalize rulemakings under the same authority as this final rule, EPA will coordinate with those federal partners.

Public Comment Summary:

Process Waters and Wastewater

One commenter requested EPA clarify which “process waters” are exempt from the rule (0214).

Another commenter requested clarification on the definition of process waters and the use of CWA hazardous substances that are present in these streams, as process water is not defined in the proposed rule. The commenter questioned whether process water means potable and non-potable water used in manufacturing and utility operations or process wastewater (contact or non-contact) generated from industrial operations (e.g., desalter brine, sour waters, condensates) and discharged under NPDES permits (0179).

A few commenters suggested that wastewater treatment chemicals be exempt from maximum capacity determinations. The commenters recommended EPA clarify that exempt chemicals are exempt both for purposes of determining maximum capacity and for purposes of preparing FRPs. The commenters added that these chemicals are often stored in quantities less than the proposed threshold quantities and present low risk. The commenters also recommended EPA clarify that this exemption applies to chemicals used in water or wastewater treatment processes including ferric/ferrous chloride, aluminum sulfate, sulfuric acid, hydrochloric acid, sodium hydroxide, sodium hypochlorite, ammonia, and sodium bisulfite (0199, 0211, 0212). A couple of these commenters added that EPA must clarify the meaning of the phrase “as drawn from the environment or municipal sources” and requested clarification as to whether wastewater treatment chemicals present in a facility are exempt from maximum capacity determinations where those chemicals are used for treating process water and cooling water (0199, 0211).

Several commenters recommended EPA exclude wastewater treatment facilities and equipment that prepare water for use in a process from the final rule (0184, 0197, 0199, 0205, 0208, 0211). Many of these commenters added that these facilities are exempt within the SPCC regulation under 40 Part CFR 112.1(6) (0199, 0205, 0208, 0211).

One commenter requested EPA exclude wastewater being treated at POTW be exempt (0214).

Another commenter recommended EPA exclude process vessels from the final rule. The commenter added that vessels in which a physical, chemical, or biological change is intended to occur should not be considered the same as bulk storage, including water/wastewater treatment components and manufacturing processes (0211).

A couple of commenters recommended that basins and lagoons used for wastewater treatment be excluded from the final rule (0199, 0211). One of these commenters suggested tanks be exempt (0199). Another commenter suggested impoundments and ponds or used for storing process intermediates, such as pulping liquor, also be exempt in the final rule. The commenter noted that these systems present a very low risk of catastrophic spilling or rupture because they maintain liquid levels below maximum capacity and are most commonly integrated with a gravity-fed process flow system (0211).

One commenter requested process waters and process ponds be excluded (0192).

A few commenters noted that the exemption under 40 CFR § 118.9(b)(iv) does not explicitly include wastewater under process water, nor does it include items such as onsite treated drinking water, reverse osmosis water, or de-ionized water (0205, 0208, 0211). A couple of these commenters suggested adding fire protection water to the list of items that should be excluded (0205, 0211). One of these commenters suggested adding boiler feedwater to the list (0211) while another commenter suggested adding wastewater generated onsite (0205).

One commenter requested clarification on how the exemption in the proposed rule applies to the presence of CWA hazardous substances in process water or non-contact cooling water as drawn from the environment or municipal sources. The commenter asked whether the exemption includes CWA hazardous substances such as wastewater treatment chemicals used for treating process water and cooling water, and if not, requested EPA to explain what this exemption is intended to cover (0183).

Another commenter requested that EPA substantiate its proposed process and cooling water exemption because the exemption currently includes products such as janitorial services; food, drug, and cosmetics in retail settings; process water or cooling water; and personal uses. The commenter noted that it is unclear whether this is the case for processing and cooling water. If EPA cannot substantiate this claim, the commenter suggested the facility should be required to evaluate the applicability of the rule and, if necessary, undertake a substantial harm analysis (0215).

EPA Response:

EPA is adding an exemption under § 118.8(b)(2)(v) for wastewater, whereby a POTW does not need to include CWA hazardous substances present in wastewater entering their collection system prior to treatment under an NPDES permit in their threshold quantity determinations. The Agency, however, notes the pretreatment program oversight requirements in 40 CFR § 403.8(f) for any industrial users that may be subject to this rule, and recommends control authorities evaluate whether program elements such as slug control plans or local limits expressed as best management practices should be issued or revised in coordination with the requirements of this rule.

EPA clarifies that the exemption under § 118.8(b)(2)(iv) for use of process water or cooling water is specific to amounts of a CWA hazardous substance present in water drawn into a covered facility from the environment or municipal sources. For example, chlorine present in water taken from municipal sources does not have to be considered for threshold determination. This is consistent with the approach taken by other chemical regulations, including TRI and RMP, and DHS’s CFATS program and reflects the low level of risk of such waters.

EPA is not exempting wastewater treatment chemicals, as they could cause substantial harm to the environment from a worst case discharge into or on the navigable waters. Commenters did not provide an adequate rationale as to why such an exemption would be warranted. EPA also is not excluding wastewater treatment facilities, process vessels, basins, lagoons, impoundments, or ponds, nor the other items commenters suggested (i.e., onsite treated drinking water, reverse osmosis water or de-ionized water, fire protection water, or wastewater generated onsite). Although commenters asserted that they are low risk, they admittedly present a risk, and EPA does not have data or reliable information upon which to base a categorical exemption for these types of storage.

Public Comment Summary:

Other Considerations

One commenter recommended EPA consider the miscibility of chemicals in water in the final rule. The commenter noted that whether a material floats or sinks will change the response approach. The commenter added that this level of detail would require onerous recordkeeping because the list of CWA hazardous substances would well exceed 296 individual chemicals depending on various mixtures (0205).

One commenter urged EPA not to exclude the agricultural industry in the final rule. The commenter referenced the 2017 National Water Quality Inventory, which notes that the agricultural industry was a leading source of impairments to surveyed rivers and lakes. The commenter added that due to its high economic value, the agricultural industry is often excluded from regulations (0266).

Another commenter recommended EPA offer an exemption for tailings storage facilities at mine sites. The commenter noted that as written, tailings storage facilities could be considered “containers.” The commenter noted tailings are already regulated under federal and state programs and therefore should be exempt (0192).

The commenter also urged EPA to exempt those facilities that have not had a reportable discharge for a period of five years or another reasonable timeframe, which would ensure that facilities that do not have these issues are not inappropriately swept under coverage without justification (0192).

The commenter also requested EPA exempt any equipment or operation of a vessel or onshore or offshore facility subject to the authority and control of DHS (0197).

A couple of commenters recommended that process tanks used specifically for research and development that are “idle” but not “permanently closed” should not be included in the full capacity calculation toward the RQ threshold. The commenters noted that these tanks are rarely used, have varying concentrations of CWA hazardous substances, and are stored inside buildings (0205, 0211).

One commenter recommended EPA remove the proposed requirement for facilities to report maximum site capacity for containers because it is not practical to require a facility to count a theoretical amount of material across all equipment and maximum site capacity varies each day. The commenter instead recommended that EPA change this requirement to allow facilities to report the maximum number of portable containers stored onsite because it would be more accurate and less burdensome for a facility, and would allow facility staff and emergency responders to focus on key risk areas. The commenter noted that alternatively, EPA could require that facilities report the “typical or representative quantity onsite” for these substances because it would allow the facility to calculate a more realistic average amount of the substance maintained onsite that better accounts for daily variances in storage. The commenter suggested EPA could require a facility to maintain an inventory that would be available upon inspection. The commenter noted that by setting the requirement this way, it would allow facilities flexibility to account for shifting daily inventory. The commenter also added that EPA could go one step further by setting a size threshold for portable containers (0205).

One commenter also stated that EPA should consider whether, for threshold purposes, in-use substances should be considered, noting that in-use transformers can contain the applicability threshold amount of PCBs. The commenter noted that this would result in applying the new requirements to many facilities with transformers even though the risk of discharge of PCBs from transformers is small. The commenter requested that EPA specify that mineral oil containing electrical equipment can be evaluated in accordance with the procedures specified in the PCB regulations, and if the PCB regulations to not require reporting, then an FRP plan similarly should not be required (0211).

EPA Response:

EPA agrees that miscibility is an important characteristic to consider when creating an FRP, and notes that this final rule will aid facilities and communities in being prepared for worst case discharges of CWA hazardous substances with various chemical and physical properties. EPA disagrees that tracking a facility’s inventory of CWA hazardous substances, including mixtures, will be onerous; this should be part of regular business practice, and these facilities are already subject to reporting rules that require similar calculations.

EPA is not excluding the agricultural industry in the final rule, as such facilities may pose a risk of causing substantial harm to the environment through a worst case discharge into or on the navigable waters or a conveyance to navigable waters.

EPA is not exempting tailings storage facilities at mine sites, as existing regulations do not cover all the required elements under the CWA § 311 (j)(5).

EPA is not exempting facilities that have not had a reportable discharge for a period of five years. However, EPA clarifies that the reportable discharge history substantial harm criterion is a rolling five-year period. If a facility no longer meets that substantial harm criterion and does not meet any of the other substantial harm criteria in 40 CFR § 118.3(c), the owner or operator is no longer regulated under this action. Regardless, if the facility still meets the criteria in § 118.3(a) and (b), the owner or operator must still submit their substantial harm certification form.

DHS regulations do not require planning for worst case discharges of CWA hazardous substance into navigable water; rather, they identify and regulate high-risk facilities to ensure security measures are in place to reduce the risk that certain dangerous chemicals are weaponized by terrorists. Thus, they do not require planning for a worst case discharge of a CWA hazardous substance and are not exempt from this action. Additionally, vessels (boats/ships) are outside the scope of this action.

To the commenters concerned about process tanks used specifically for research and development that are “idle” but not “permanently closed,” EPA notes that the use of quantity instead of capacity in the final rule should allay their concerns about counting the full capacity of the container.

EPA agrees with the commenter who recommended EPA remove the proposed requirement for facilities to report maximum site capacity for containers because it is not practical to require a facility to count a theoretical amount of material across all equipment and because maximum site capacity varies each day. Instead, the Agency is requiring the maximum quantity onsite for threshold quantity computation. EPA disagrees that the maximum number of portable containers stored onsite would be more accurate, less burdensome for a facility, and facility staff and emergency responders to focus on key risk areas, since there is uncertainty around what is actually stored in those containers.

EPA notes the concerns of the commenter who raised that in-use transformers can contain the applicability threshold quantity of PCBs. If a facility meets the threshold quantity due to the presence of PCBs in transformers, the facility will still need to determine whether it meets any of the substantial harm criteria. The existing PCB regulations under 40 CFR Part 761 do not contain all the required program elements under CWA § 311(j)(5), so a facility owner or operator still needs to submit a plan if they meet the applicability criteria in § 118.3. In terms of in-use substances, those CWA hazardous substances may pose a risk of release regardless of whether they are in use or not, and EPA disagrees that they should not be accounted for.

Public Comment Summary:

Proposed New Regulatory Text

One commenter proposed replacing the regulatory language of “do not include any exemptions” with “do not include any of the items exempted by § 118.8(b) in thresholding calculations" to increase clarity and avoid confusion. The commenter also noted that EPA needs to add “exceptions” as discussed in § 118.8(a) to the requirement in § 118.3(a) and proposed the language be changed to: “Do not include any of the items excepted or exempted by § 118.8 in thresholding calculations” (0179).

EPA Response:

EPA has added clarifying language to § 118.3 on how exemptions and exceptions are treated for threshold calculations.

Worst Case Discharge Scenarios
1. Proposed Approach

Public Comment Summary:

Support

One commenter agreed with EPA’s decision not to apply a credit against the worst case discharge quantity for facilities with secondary containment since secondary containment may fail, especially in worst case scenarios caused or exacerbated by adverse weather. The commenter also stated that EPA should not take written administrative controls that limit the maximum quantity in a container into account because written administrative controls may be overridden or overlooked, making it foreseeable that a worst case discharge could exceed the amounts stated such controls (0215).

Oppose

One commenter recommended that if several substances trigger threshold maximum capacities, EPA should include in the final rule a step to identify the single substance meeting the “worst case discharge quantity” per § 118.10(a) and only perform substantial harm determinations for that substance. The commenter noted that this would reduce the burden on the facility owner and be simpler (0179).

The commenter requested that EPA clarify the proposed rule’s requirement regarding the worst case discharge quantity, asking if EPA sought the substance with the largest amount based on the container size and lowest RQ, or substance in the largest container regardless of RQ. The commenter noted the relevance of this for facilities that trigger threshold maximum capacities for multiple substances with different RQ values. The commenter suggested that EPA intended to refer to the CWA hazardous substances in the largest container. The commenter requested guidance, in the form of examples, on which CWA hazardous substances would be the basis for the FRP when multiple substances have the same RQ. The commenter additionally asked EPA to explain what the proposed rule intended regarding a plan for all CWA hazardous substances in an FRP. The commenter noted that the intent was to identify the greatest worst case discharge quantity of all threshold values, not plan for every individual substance (0179).

The commenter also requested that EPA clarify the definition of containers and describe the “maximum capacity” of a container. The commenter asked for clarification on the understanding of “largest container” and suggested that EPA provide examples or state in § 118.9 that only the unknown quantity of a mixture must be accounted for as a CWA hazardous substance (0179).

The commenter recommended that EPA remove the requirement for calculating the worst case discharge capacity for piping systems or pipes and remove the requirement for providing sufficient evidence in FRPs that containers with piping systems are not operated as one unit from the rule. The commenter recommended that EPA instead rely on the largest container. The commenter noted that this requirement would be a burden for the owner to identify the quantity and dimensions of piping and calculate the volume. The commenter mentioned that such a requirement is not included in the Oil Pollution Prevention FRP regulation and that constituents appear and disappear along process lines and have unknown or highly variable compositions. The commenter stated that EPA must provide clearer guidance on calculating quantities, especially for interconnected pipes, if it retains this provision in the final rule to provide consistent application across the regulated community. The commenter also noted that EPA must clearly describe expectations for sufficient evidence in preparing FRPs to establish that containers with piping systems are not operated as one unit. The commenter added that where two tanks are interconnected with valves open with one filling from empty, the tanks are not operating as one unit until a steady state is achieved (0179).

Additionally, the commenter stated that interconnected containers must be clearly defined and suggested that they be limited to permanently manifolded storage tanks designed, installed, and/or operated such that the tanks function as one storage unit during operations. The commenter noted that multiple tank volumes are equalized in such systems and stated that only equalized bulk storage tanks should meet this definition. The commenter claimed that infrequent and emergency interconnections should not be an appropriate basis for establishing interconnected containers, including process vessels connected by piping, because such vessels are not equalized (0179).

One commenter requested that EPA remove the discussion of piping under § 118.10(a)(3), which requires facilities to calculate the worst case discharge quantity for substances in pipes or interconnected pipes. The commenter suggested that this interpretation implies that the proposed rule defines piping as a container. The commenter recommended that EPA not define piping as a container, and not regulate it as such, because piping has different operating considerations compared to a container (0179).

A few commenters emphasized the importance of a clear and straightforward definition for the worst case discharge scenario to avoid unintended burdens. The commenters asked EPA to make clear whether a worst case discharge should be considered a timed or instantaneous discharge to ensure accurate data standardization across substantial harm certification forms and FRPs (0194, 0204).

One commenter noted that the proposed rule did not address differing worst case discharge scenarios of discharges into two or more bodies of water and requested that EPA clarify how facilities should handle this (0201).

A couple of commenters noted the definition of “worst case discharge” is too “narrow” (0215, 0216). One commenter noted the rule does not capture the largest foreseeable discharge in adverse weather conditions. The commenter recommended EPA should define “worst case discharge” based on total facility capacity to capture the foreseeable occurrence of multi-tank discharges caused by natural hazards like floods, hurricanes, and earthquakes. The commenter added that facilities should also have to separately analyze the worst case discharge for each CWA hazardous substance onsite, unless the analysis prepared for another CWA hazardous substance adequately accounts for the risks involved and the necessary response (0216).

One commenter recommended EPA should broaden its definition of a “worst case discharge scenario” to ensure facilities are accurately assessing their potential to cause substantial harm in the event of a worst case discharge and recommended that EPA define worst case discharge based on the total hazardous substance capacity onsite because the statutory definition is clear that it is for the largest foreseeable discharge. The commenter emphasized that EPA has not explained how the largest foreseeable discharge is always the same as the single largest container or group of containers of a substance at a facility since smaller containers within a single facility could also discharge during adverse weather events. The commenter added that the entire capacity of a facility, rather than just the capacity of the single largest container, should be considered during a worst case discharge event and clearly defined in the final rule (0215).

Another commenter also disagreed with EPA’s decision to limit the definition of “worst case discharge” as the “worst case discharge scenario for the container with the largest capacity of a CWA hazardous substance” because it does not consider the worst case discharge scenario to be one in which multiple vessels containing a given qualifying substance fail. The commenter highlighted two scenarios in which multiple tank failures at a single facility occurred during an extreme weather event (Shell Deer Park during Hurricane Harvey and the Freeport McMoRan Port Sulphur facility during Hurricane Katrina) (0168).

EPA Response:

EPA has adjusted its approach to worst case discharge quantity to use the maximum quantity of a single container for substances stored in separate containers or the maximum quantity of a group of interconnected containers, rather than capacity. EPA based this decision largely on the fact that risk determinations using maximum quantity onsite will more accurately reflect the hazard posed and has been used successfully in other EPA chemical regulations, such that this is standard business practice. Additionally, since containers are typically measured by volume and CWA hazardous substances may vary dramatically in weight due to their physical properties, there is not a clear association between container size and quantity of CWA hazardous substances onsite. The Agency disagrees that using capacity is “more practicable”; facility circumstances and methods of storage vary widely, and facility owner or operators should know their inventories and largest tanks. Additionally, this simplifies procedures for facilities’ accounting for mixtures.

In this final action, once a covered facility determines it meets one of the substantial harm criteria, the owner or operator must plan for all CWA hazardous substances onsite above the threshold quantity, including worst case discharge analyses for each. EPA has adjusted its approach from the proposed rule, where only one worst case discharge scenario for the container with the largest capacity of a CWA hazardous substance was required. This change is consistent with EPA’s statutory authority under this action to require plans for facilities that, because of their location, could cause substantial harm to the environment from a worst case discharge into or on the navigable waters or a conveyance. This approach also recognizes that response and/or recovery actions may vary widely depending on the physicochemical properties of the substance, so one CWA hazardous substance at facilities with multiple CWA hazardous substances that meet or exceed the threshold quantity cannot adequately inform that facility’s FRP.

EPA is not requiring planning for all CWA hazardous substances onsite to be released in a single event. In consultation with the Agency’s regional responders, this eventuality is exceedingly rare and therefore EPA’s approach to determining the largest foreseeable discharge is based on the largest quantity in a single container or group of interconnected containers. While there have been historic incidents of more than one tank or container failing during an event, these are also rare and EPA has judged that planning for the worst case discharge as in 40 CFR § 118.10 for each CWA hazardous substance above the threshold quantity should sufficiently prepare a facility for multiple potential events, especially since for some CWA hazardous substances there may be no realistic means to implement containment, protection, and recovery response tactics once the substance enters a water body, meaning that receptors must be prepared for and swiftly notified of the diluted substance as it travels downstream. Regardless, planning for the worst case discharge will also prepare facilities for less than worst case discharges, enhancing facility and community resilience.

A facility owner or operator should follow the mixture rule in 40 CFR § 118.9 to determine the quantity of CWA hazardous substances for worst case discharge quantity calculations.

While a few commenters were concerned about piping and measuring the contents of piping systems, EPA maintains that, in general, if a covered facility owner or operator has two or more containers that contain a CWA hazardous substance and are connected through piping or hoses to transfer the CWA hazardous substance, the owner or operator must consider the total quantity of the CWA hazardous substance in all the connected containers and piping when determining the maximum worst case discharge scenario quantity. If the containers are connected for transfer of the CWA hazardous substance using hoses that are sometimes disconnected, the owner or operator still must consider the contents of the containers as one process, because if one container were to rupture while a hose was attached or a hose were to break during the transfer, both containers could be affected. Again, the statute directs EPA to address the worst case discharge scenarios – even in situations where the conditions are not static (i.e., sometimes containers are connected but not always). Therefore, the owner or operator must count the quantities in both containers and in any connecting piping or hoses. Similarly, the presence of automatic shutoff valves or other devices that can limit flow do not change the analysis because these are assumed to fail for the purpose of determining the worst case discharge scenario quantity. This is consistent with and required under other regulations, such as onshore oil pipelines regulated by USDOT PHMSA.

Owners or operators of regulated facilities will need to plan for the maximum quantity in a single container or interconnected containers of a CWA hazardous substance onsite at any one time and forecast when such occasions may occur. Due to the potentially catastrophic effects of a worst case discharge, the Agency does not see these requirements as overly burdensome. EPA notes that plans can and should be updated if, for example, there is an unexpected increase in demand such that the worst case discharge scenario quantity is outside of anticipated fluctuations and necessitates different or more response resources, requiring an amendment to the FRP as in § 118.4(b).

While some commenters asked for clarification on the timing of a discharge, EPA maintains that a worst case discharge may occur instantaneously or over time, e.g., a complete failure and discharge of an entire container or a slow leaking container or pipe that cannot or is not stopped immediately, and a covered facility owner or operator is best situated to determine the appropriate timing scenario based on onsite-specific considerations and the physicochemical properties of the CWA hazardous substances in question. The timing used for the worst case discharge scenario should reflect reasonable conditions that have the greatest potential to cause substantial harm.

If a facility owner or operator determines that a facility could reach more than one navigable water in a worst case discharge, the facility owner or operator must evaluate the potential to cause substantial harm under in both scenarios.

Additional Worst Case Scenarios if Response Equipment Differs

Public Comment Summary:

Oppose

Several commenters stated that including planning for additional scenarios (e.g., different response equipment, different receptors, different hazard class) would add significant burdens to facilities complying with the rule. The commenters noted that each scenario would require expensive and time-consuming endpoint modeling while providing limited benefit. The commenters also added that planning for worst case scenarios means that they have adequate planning established to respond to different scenarios (0175, 0187, 0191, 0194, 0204, 0218).

One commenter suggested that the final rule requires facilities to prepare worst case scenarios for all onsite CWA hazardous substances. Beginning with the first CWA hazardous substances, the commenter suggested requiring modeling unless additional substances affect only the same receptors as the initially modeled substance and do not require alternative or additional response procedures, equipment, or resources given a worst case discharge. The commenter noted that this would be more protective by requiring facilities to plan for each CWA hazardous substance, while providing flexibility when the discharge of an additional substance would not change the necessary response (0215).

EPA Response:

EPA understands that including planning for additional scenarios (e.g., different response equipment, different receptors, different hazard class) does increase the burden on facilities complying with the rule. In this final action, once a covered facility determines it meets one of the substantial harm criteria, the owner or operator must plan for all CWA hazardous substances onsite above the threshold quantity, including worst case discharge analyses for each. EPA has adjusted its approach from the proposed rule, where only one worst case discharge scenario for the container with the largest capacity of a CWA hazardous substance was required. This change is consistent with EPA’s statutory authority under this action to require plans for covered facilities that, because of their location, could cause substantial harm to the environment from a worst case discharge into or on the navigable waters or a conveyance. This approach also recognizes that response and/or recovery actions may vary widely depending on the physicochemical properties of the substance, so one CWA hazardous substance at facilities with multiple CWA hazardous substances that meet or exceed the threshold quantity cannot adequately inform that facility’s FRP. This will also address the concerns of the commenter who suggested that facilities should be required to do additional analysis unless the same receptors would be affected.

Planning Distance Determinations/Distance to Endpoints/Toxic Endpoints (§ 118.10(b), Appendix B)

Public Comment Summary:

Support

One commenter provided support for the proposed rule’s overall approach to planning distance determinations and agreed with EPA that planning distance calculations should not consider passive mitigation and administrative controls. The commenter added that although they believe EPA should require facilities to adopt secondary containment or other prevention measures in certain circumstances, the existence of these protections is less relevant in the worst case discharge context and therefore should not be included in planning distance calculations (0215).

Oppose

One commenter urged EPA to include parameters for aerial deposition on waterways and require facilities to consider volatilization in planning distance calculations. Specifically, the commenter noted that because discharge includes any emitting of a CWA substance, this includes volatilization. The commenter requested that EPA consider discharge onto land and subsequent volatilization. The commenter noted the importance of evaluating substantial harm no matter how a discharge reaches waters and claimed that the final depositing of a substance on water and focus on CWA hazardous substances makes this distinct from CAA jurisdiction (0215).

The commenter also expressed concern that facilities are able to determine their planning distance calculation methodology under the proposed rule, as they believe that this creates a risk that facilities might manipulate their calculation to avoid preparing an FRP. The commenter urged EPA to develop a tool like RMP*Comp to provide uniformity. The commenter requested that, if EPA finalizes the proposed rule to allow facilities to determine their planning distance calculations, it require supporting documentation, rationale, and assumptions so that EPA can review this information. Specifically, the commenter recommended that EPA finalize this information requirement in Appendix A to Part 118 and only allow proprietary models if EPA has access to the model and related documentation. The commenter requested that such documentation also be available to the public and local emergency planners to provide transparency and enable stakeholders and the public to file petitions if necessary (0215).

One commenter stated that the proposed rule does not specify any reason why the calculation of concentrations over distances is necessary for each CWA hazardous substance for the FRP submission, claiming that it is not clear how it will aid in FRP formulation or response. The commenter noted the proposed rule’s acknowledgement that such calculations are very expensive and challenging, particularly for small businesses and facilities in remote areas lacking resources (e.g., consultants, analysts) needed for these calculations (0171).

Another commenter noted the difficulty of assessing substantial harm criteria via planning distance and endpoint modeling. The commenter stated that the lack of a tool or guidance creates an opportunity for inconsistency and puts additional costs on facilities to develop a model or find a third party to assist them. The commenter requested that EPA follow the approach taken in the RMP and provide modeling tools for facilities to reduce the cost burden, avoid issues due to a lack of private firms to provide modeling, and ensure consistency (0218).

A couple of commenters appreciated the proposed rule’s flexibility to allow facilities to use their own models and methodologies for substantial harm but requested that EPA allow other methods that do not use modeling (like those used under the RMP program under the CAA). The commenters also requested EPA guidance on models and methodologies for calculating distance to endpoints (0199, 0211).

One commenter stated that, if a facility believes endpoints for a specific CWA hazardous substance are overly stringent, the facility should be able to submit a justification for alternative endpoints for approval. The commenter provided an example of a sulfuric acid or sodium hydroxide spill as a common discharge event (citing recent EPA analysis) where the true endpoint would be pH instead of the LC₅₀ from the adult fathead minnow test. The commenter noted that this supported adding flexibility for facilities to propose alternate endpoints to reference toxicological data for species more appropriate for a potentially impacted body of water (0179).

The commenter mentioned that developing realistic scenarios for worst case discharge in all adverse weather conditions given in § 118.10(b)(3)(iii) is impractical and noted that severe weather may in some cases render an event less harmful. The commenter stated that this requirement creates a cost and labor burden to facilities with little benefit and asked that EPA to establish clear national guidance by defining the conditions to model, including concise assumptions regarding weather conditions. The commenter strongly recommended that EPA limit adverse conditions analysis to a vulnerability paper study of different scenarios, allowing a facility to better understand their impacts on response. The commenter noted that this approach is used in the Oil Pollution Prevention FRP regulation and that using it for planning distances would maintain consistency and ensure practicability in response planning. The commenter recommended the Chezy-Manning calculations from the Oil Pollution Prevention FRP regulation (0179).

The commenter noted that EPA did not find a single model for planning distance calculations that met all of EPA’s criteria. The commenter recommended that EPA withdraw detailed modeling requirements for endpoint and planning distances or develop an advisory peer group to create predictive tools (like RMP*Comp) or allow alternatives like those used in the Oil Pollution Prevention FRP regulation. The commenter added that developing a model would be an impossible task at this stage of rulemaking for the regulated community (0179).

The commenter suggested that EPA use planning distances as discussed in 40 CFR Part 112, Appendix C, Attachment C-III, as a calculation methodology for substantial harm criteria, using clearly identified receptors and CWA hazardous substances parameters in the calculation. The commenter noted these formula’s provision of transport mechanisms over land and water (e.g., still water, tidal water, navigable water). The commenter stated that oil transport formulas given in 40 CFR Part 112 are compatible with identifying receptors due to their basis using water body velocity and response time intervals and believed that a planning distance of 27 hours (24-hour arrival and 3-hour deployment) would be conservative and familiar to the regulated community. The commenter also added that such a methodology may be easier for EPA to enforce and evaluate due to its consistent application across facilities, while allowing facility operators and owners to still use more sophisticated formulates as desired (0179).

The commenter specifically suggested the use of planning distance formulas used in the Oil Pollution Prevention regulation FRPs in 40 CFR Part 112, Appendix C, Attachment C-III, for calculating planning distances for FWSE and PWS and encouraged EPA to develop timeframe inputs matching those in the Oil Pollution Prevention FRP regulation (e.g., 27 hours and 15 hours to non-high-volume and high-volume ports, respectively). The commenter separately noted that attempting to accurately reflect conditions under normal streamflow for each CWA hazardous substance is already challenging, and additionally suggested that EPA or USCG develop response planning tools that could be executed at the time of a discharge based on publicly available data (e.g., solubility, vapor pressure, toxicity data in Chemical Data Guidebook for Bulk Shipment in Water) and factors (e.g., humidity, wind speed, air/water temperature) (0179).

Additionally, with respect to the use of RQs in the proposed rule, the commenter noted that RQs were not intended to represent Agency judgment regarding the specific degree of hazard with a given release; rather, they focus on simplicity and administrative convenience, as given in 50 FR 13466 (April 4, 1985). The commenter stated that, while EPA’s original intent was not to use RQs to represent a specific degree of hazard, the proposed rule uses RQs to represent judgments on the specific degree of hazard. The commenter noted the single RQ approach’s aim towards simplicity but stated that modeling based on RQs using self-identified methodologies will burden EPA with the need to validate models and methods and burden the regulated community as they define representations in an endpoint calculation. The commenter also noted that the proposed rule does not leverage the simplicity of discharge calculation given in the Oil Pollution Prevention regulation despite the legislative history emphasizing simplicity for RQs. The commenter requested the 1985 Technical Background Document to Support Rulemaking Pursuant to CERCLA Section 102, Volume 1, be included in the docket to allow review and comment on the technical basis for the mammalian toxicity data (0179).

Regarding planning distance calculations for mixtures, a couple of commenters requested that EPA allow facilities to document that an entire container does not contain a given CWA hazardous substance with the lowest RQ and use a different level for calculations (0199, 0211).

EPA Response:

EPA agrees with the commenter who provided support for the proposed rule’s overall approach to planning distance determinations and agreed with EPA that planning distance calculations should not consider passive mitigation and administrative controls.

To the commenter concerned with volatilization and aerial deposition on waterways, EPA notes that a facility owner or operator is already required to consider the properties of the CWA hazardous substance as listed in 40 CFR 118.10(b)(3)(i) for overland transport and 118.10(b)(3)(iv) for the worst case discharge in general. Should a worst case discharge consist of a CWA hazardous substance releasing as a gas that could mix with rainwater and then reach a navigable water, for example, that facility would need to examine that outcome in their worst case discharge scenario. EPA agrees that air releases and inhalation toxicity are generally covered and managed under the CAA. Once a facility determines that the CWA hazardous substance could cause substantial harm to the environment due to a worst case discharge to navigable water, the facility hazard evaluation must include an analysis of potential air effects of such a discharge.

For the commenter who suggested requiring use of the Chezy-Manning equation as in the Oil Pollution Prevention FRP regulation (40 CFR Part 112, Appendix C, Attachment C-III, Section 2.0 Oil Transport on Moving Navigable Waters), this approach may be applicable to estimate stream velocities for certain water bodies near CWA hazardous substance facilities, such as rivers, creeks, and streams. Other approaches for calculating planning distances for still waters or tidally influenced water bodies may require different methodologies (see 40 CFR Part 112, Appendix F, Sections 3.0 and 4.0 for insight into how the Oil Pollution Prevention FRP regulation addresses these water body types). EPA will accept a vulnerability paper study of different worst case release scenarios of CWA hazardous substance worst case discharges, as long as it meets the specifications in 40 CFR § 118.10 and is incorporated into the FRP.

The Agency is aware that the planning distance modeling is a critical component of successful implementation of this regulation and is engaged with its research arm to identify data and resources to aid the regulated community in compliance. EPA disagrees that leaving modeling to the discretion of the facility creates opportunities for manipulation, as it provides flexibility and allows for those most familiar with the substance and the facility to examine the event of a worst case discharge and its potential effects. EPA agrees that RMP*Comp is an excellent implementation tool and is working internally to research and disseminate best practices and compliance assistance. For the commenter who requested that EPA allow other methods that do not use modeling, facility owners or operators may follow the methodology of their choosing, as long as it fulfills the requirements in 40 CFR § 118.10 and EPA has access to that methodology.

If a facility believes endpoints for a specific CWA hazardous substance are inappropriate, a facility may appeal to their RA using the mechanism in 40 CFR § 118.6.

EP A agrees with the commenter’s suggestion that facilities submit documentation to substantiate their substantial harm criteria findings. 40 CFR § 118.10 requires EPA to have access to any proprietary or other model used, submit documentation substantiating the methodology, and describe the features to local emergency planners. EPA will work with other federal partners to determine the feasibility and safety of providing such information to the public.

EPA disagrees that the proposed rule does not specify any reason why the calculation of concentrations over distances is necessary for each CWA hazardous substance for FRP submission. Facility owner or operators will need to determine if they meet the substantial harm criteria and then plan for a worst case discharge based on those impacts, which includes modeling overland in and in-water transport of a worst case discharge. These potential impacts and this analysis then provide the basis for the FRP as a whole and, as such, underpin the FRP. As noted above, EPA is engaged with its research arm to identify resources to aid the regulated community in compliance.

EPA disagrees that RQs were not meant to represent a specific degree of hazard; RQs are the quantity that, when released to water, “may be harmful.” They are assigned by category and thus reflect relative risk (40 CFR § 117.3). The Agency recognizes that administrative convenience and simplicity were an element to the adoption of RQs and has adopted a similarly administratively convenient mechanism with respect to RQs in this action, namely using an easy-to-apply multiplier factor that appropriate calibrates the concern over risk appropriate for RQs to the risk associated with a worst case discharge. The Agency is committed to identifying and disseminating tools, resources, data, and information to implement a successful program and assist the regulated community in compliance.

EPA has added requirements in 40 CFR § 118.11(b) for response actions to be taken within one and two hours of discharge detection. Within one hour of discharge detection, actions include making notifications, mobilizing facility personnel, identifying the extent of the incident, coordinating with the SRO, consulting the hazard evaluation to determine potential effects of the discharge, ensuring containment and neutralization systems are working, making an evacuation assessment, and coordinating with PWSs and local responders. Within two hours, resources and monitoring must be deployed. Explicitly stating EPA’s expectations within these critical response time frames will ensure resources are ready and available, and guide exercise and training programs as well as government initiated unannounced exercises, further enabling readiness. EPA is not following the Oil Pollution Prevention FRP regulation here due to the differing response requirements for oils and CWA hazardous substances.

EPA refers commenters concerned with mixtures to the mixture requirements in 40 CFR § 118.9, which do not require extrapolation to the capacity of a container. However, if constituents of a mixture are unknown, a facility owner or operator must assume the unknown portions consist of the CWA hazardous substance with the lowest RQ.

Response Planning (118.11)

Public Comment Summary:

Support

One commenter noted that the proposal will allow facilities subject to multiple regulatory programs to have the flexibility to modify existing plans, rather than create a new, single plan to meet the requirements of the Hazardous Substances Worst Case Discharge Planning Regulations (0197).

One commenter supported EPA’s inclusion of impact evaluation and monitoring and suggested that FRPs provide a detailed explanation of how to do impact monitoring and harm evaluation for FWSE, public receptors, and PWSs if discharge occurs. The commenter requested that FRPs include a description of onsite and third-party resources for monitoring and evaluation, as well as a detailed description of testing and monitoring protocols, to ensure that this aspect of facility responses is not overlooked. Relatedly, the commenter requested that the final rule include requirements that facilities obtain third-party community health impact assessments (publicly available as permissible by law) if discharges reach PWSs or public receptors to ensure that communities understand the risks of discharge and to prevent facilities from concealing impacts (0215).

Oppose

One commenter expressed concerns about regulating chemicals with different properties. The commenter provided an example of chlorine, which reacts with the environment so rapidly that recovery is impossible (0196).

Another commenter noted, referencing the reporting quantity in 40 CFR § 117.3, that under the proposed rule these facilities would be required to prepare and submit FRPs that would not recognize the preventative measures taken, secondary containment employed, or site-specific considerations members already exercised to comply with other regulatory requirements that serve to minimize the risk of a worst case hazardous substance discharge. The commenter expressed concern that the proposed rule may overwhelm emergency planning efforts that would result in minimal, if any, prevention of discharges. The commenter recommended EPA allow companies to report their compliance with other requirements or other efforts already employed to be deemed compliant. The commenter added that if already compliant, the facility should not be required to submit another FRP. The commenter also suggested that this approach will allow for a more efficient and effective prevention program (0185).

One commenter suggested that the FRP should not be solely drafted by an owner or operator of a facility since they may not know what to look for and how to plan for a CWA hazardous substance discharge occurrence in the water. The commenter suggested that the proposed rule should require collaboration between the owner/operator and an environmental inspector or health expert who is educated on the issue and knows the signs of CWA hazardous substances being discharged into the water in order to prevent damage to both the ecosystem and the people that rely on the water supply (0250).

EPA Response:

EPA agrees with the commenter who noted that the proposal will allow facilities subject to multiple regulatory programs to have the flexibility to modify existing plans, rather than create a new, single plan to meet the requirements of the CWA Hazardous Substance FRPs.

To the commenter who supported inclusion of impact evaluation and monitoring, the Agency notes that facilities must create a robust hazard evaluation, including a risk-based decision support system that will expand upon analysis of discharges that affect FWSE, public receptors, and PWSs. This will include the following response resources: sampling, monitoring, and discharge detection systems. EPA is not requiring third-party community health impact assessments. If there is a worst case discharge; the responding authority could require this type of assessment.

The Agency is aware that planning for 296 CWA hazardous substances with disparate characteristics and impacts may be complex. Response and/or recovery actions may vary widely depending on the physicochemical properties of the substance and the reality that on-water recovery techniques similar to those used for oil responses may not be possible in all instances. In fact, there may be no realistic means to implement containment, protection, and recovery response tactics once some CWA hazardous substances enter a water body, meaning that receptors must be prepared for and swiftly notified of the diluted substance as it travels downstream. This action is authorized as a response planning action, not a prevention regulation. Nonetheless, if an owner or operator believes that the circumstances of the facility are such that it could not cause substantial harm to the environment from a worst case discharge to navigable waters or a conveyance to navigable waters, notwithstanding that it meets the criteria in § 118.3, EPA is providing a mechanism for them to make that case; namely by appealing the substantial harm determination to their RA.

EPA disagrees that this regulation should require collaboration between the facility owner or operator and an environmental inspector or health expert who is educated on the issue and knows the signs of CWA hazardous substances being discharged into the water. A facility owner or operator may well have this expertise onsite; otherwise, they will need to engage with a third-party contractor or expert to make these determinations. In addition, facility owners or operators are already required to work with PWSs, who will have this type of expertise for impacts to those PWSs.

Consistency With the National Contingency Plan and Area Contingency Plans

Public Comment Summary:

Support

One commenter stated that they recognize the value of emergency response planning and preparation, including drills, as they currently devote substantial resources to their emergency response programs, providing training and implementation opportunities to employees and in coordination with designated emergency responders (0179).

One commenter supported EPA’s proposal that all FRPs must be consistent with requirements of the NCP and applicable ACPs. The commenter stated that the CWA explicitly requires that all FRPs be consistent with the NCP and applicable ACPs (33 USC 1321(j)(5)(D)(i)), and it makes sense for the proposed rule to reiterate that requirement in the worst case discharge planning regulations for owners or operators to annually review their plans for consistency with the NCP and applicable ACPs, and to revise their plans accordingly (0215).

Despite supporting the overall proposed rule, one commenter requested EPA add a provision to § 118.11(a)(1) to provide a way to evaluate owner or operator compliance. The commenter proposed that EPA include the following provision, which would require all FRPs to contain: (1) a signed affirmation that the owner or operator of the facility reviewed the NCP when preparing the FRP to ensure consistency; (2) a signed affirmation that the owner or operator of the facility reviewed applicable ACP(s) when preparing the FRP to ensure consistency; and (3) a list of the applicable ACP(s) for the facility (0215).

EPA Response:

EPA appreciates the commenter who recognizes the value of emergency response planning and preparation as well as the commenter who supports EPA’s requirement that all FRPs must be consistent with requirements of the NCP and applicable ACPs. In response to the commenter who suggested including a way to evaluate owner or operator compliance, this seems like a commonsense addition, and EPA has added 118.11(a)(1)(ii), requiring a signed affirmation of review of relevant plans and 118.11(a)(1)(iii), requiring a list of area and sub-area plans reviewed.

Local Emergency Planning Committee or Tribal Emergency Planning Committee Coordination

Public Comment Summary:

Oppose

One commenter disagreed with EPA’s designation in § 118.12(c) that state and local emergency response officials should set the schedule; rather, the Preparedness for Response Exercise Program (PREP) manual should. The commenter requested EPA remove the reference to § 118.12(c) from this part of the rule. The commenter also noted its opposition to “conducting joint drills” with the LEPC (0179).

EPA Response:

As state and local emergency response officials are vital participants in community and facility response planning, EPA disagrees with the commenters who requested that EPA remove § 118.12(c) as well as the requirement to coordinate drills and exercises with local public emergency response officials and invite them to participate § 118.13(c)(1). The Agency maintains that such coordination is critical for planning for worst case discharges since public entities are often involved in response efforts, and, as such, EPA has added language to include local emergency planning and response organizations outside of SERCs, TERCs, LEPCs, and TEPCs in coordination activities. Additionally, the rule does not contain language that state and local emergency response officials should set drill and exercise schedules; rather, it states that facility owner or operators shall consult with the appropriate officials to establish schedules and plans.

Public Comment Summary:

Coordination with LEPCs

Several commenters commented on the annual coordination requirement with LEPCs (0174, 0175, 0179, 0187, 0191, 0194, 0215, 0218).

Several commenters agreed that it is important to closely coordinate with LEPCs; however, it has been difficult to do so while adhering to other regulations, as LEPCs tend to have “many priorities” and “may have a small number of members with many competing obligations,” citing specific examples. Instead of requiring annual coordination with LEPCs, these commenters recommended that facilities make “a good-faith effort” to coordinate annually. The commenters referenced the 1980 emergency preparedness regulations for hazardous waste generators (40 CFR § 265.37, Arrangements with local authorities), which required that an owner or operator must only attempt to make arrangements with local responders and document any inability to complete these arrangements as precedent. The commenters recommended that the same approach should be applied to requirements to conduct drills and exercises with the response community (0175, 0187, 0191, 0194, 0218).

One commenter recommended that the facility operators located in a published ZOC should be required to coordinate with the downstream drinking water utilities in that ZOC on an annual basis to review emergency contact information and during the development of the initial FRP and during any major plan revisions (0174).

One commenter suggested that EPA require facilities to regularly share information and consult with nearby public drinking water systems (0216).

One commenter requested EPA ensure the recordkeeping requirements for annual LEPC coordination meetings are streamlined between rules to prevent burdening the LEPCs and facilities with overlapping recordkeeping requirements. The commenter also questioned EPA’s intent for the requirement under § 118.12(d)(ii) which requires “Signed agreements on activities and resources, identified by the facility.” The commenter emphasized it does not support “the need to obtain ‘signed agreements’ with the LEPC” (0179).

One commenter supported EPA’s general proposal that all FRPs be consistent with the applicable local emergency response plan and the proposed requirement that owners or operators coordinate with their LEPC or TEPC to ensure consistency. The commenter also supported EPA’s requirement for facilities to coordinate “at least annually with local emergency response organizations.” The commenter stated that by doing so, it will be clear how their facilities are addressed in the community emergency response plan and ensure local response organizations are aware of risks that the facility presents. However, the commenter recommended that EPA further strengthen the coordination requirements in the proposed rule “to improve the flow of information between facilities and critical emergency response stakeholders and help ensure compliance with coordination requirements.” The commenter also recommended EPA require owners and operators to submit FRPs and any revised FRPs to state, local, or tribal emergency response organizations, including LEPCs and TEPCs, because they hold useful information that local emergency response organizations may not know otherwise. They stated that the proposed rule is “ambiguous” as to whom facilities must provide FRPs “upon request” (0215).

The commenter also recommended EPA require FRPs to include certification of compliance with coordination requirements as well as documentation of coordination due to the difficultly “to police a facility’s compliance with coordination obligations leading up to completion of an FRP.” The commenter requested EPA to require that all FRPs contain: (1) a signed affirmation that the owner or operator of the facility coordinated with local emergency response organizations and, as appropriate, public drinking water supplies, in preparing the FRP (or update); and (2) a list documenting those coordination activities, including the information required to be maintained under proposed 40 CFR §§ 118.12(d)(i) and (ii) (0215).

The commenter noted that the proposed rule does not appear to require coordination with public drinking water systems that may be harmed during a worst case CWA hazardous substance discharge. The commenter recommended EPA should require coordination with public drinking water systems. The commenter added that while the requirements for coordination with a public drinking water system do not need to match what is required for local emergency response organizations, EPA should require facilities to (1) coordinate with that system while preparing an FRP or updating an FRP; (2) provide a copy of the FRP (and any updates) to the system whenever they submit an FRP (or revisions) to EPA; and (3) provide any other information necessary for the system to prepare for the potential of a worst case discharge, including annual updates to chemical inventories and safety data sheets prepared under 42 USC 11021-11022. The commenter stated that ensuring public drinking water systems are part of the FRP process will help PWSs as they undertake their own emergency planning requirements, including preparing and updating their Risk & Resilience Assessments and Emergency Response Plans required under 42 USC 300i–2 (0215).

One commenter emphasized that while facilities often know more information about their operations than LEPCs or first responders, the “burden of dealing with planning” falls on the community because facilities “rarely respond to releases off their sites.” The commenter noted that each situation is different depending on the facility and chemicals involved, so it is best if details are left to the community and facility to decide. The commenter stated that given that this is a “life/safety issue,” they believe a “good faith cooperation will prevail” (0170).

One commenter centered its comments around the needs of local emergency planners and responders. The commenter recommended that designated facilities of local concern be included in the regulatory program regardless of chemical thresholds and in support of regulations that put greater responsibility on facilities to cooperate with emergency planning and preparedness programs by providing relevant information. The commenter highlighted that “overtaxed emergency managers or volunteers” are often the people who work on community emergency preparedness, and, as such, EPA needs to create a program that promotes cooperation between facilities and communities in planning and preparedness. The commenter noted that EPA must also accommodate communities that engage in thorough and aggressive planning to ensure they are not denied access to adequate information. The commenter noted that the proposed rule seems to anticipate that coordination is about what the facility will determine are the response needs it requires from the community, which they disagreed with. The commenter stated that releases from a facility will impact the community and “a facility is not the judge” as to how or when a community will respond to the release (0170).

The commenter stated that as seen under other programs like the CAA, RMP, and RCRA generator regulations, facilities are not prepared, highlighting a disconnect between facilities and local emergency responders. The commenter added that facilities rely on local services, and personnel are unfamiliar with contents of the plans they have submitted. The commenter also disagreed with the term “coordination” as proposed in § 118.12 because as written, a facility does not need to “consider or respond to a comment on the plan from the LEPC/TEPC or responders.” The commenter added that because EPA is “unlikely to enforce this requirement,” the regulation should at least provide the tools so that local groups can meaningfully create the necessary relationship. The commenter suggested that LEPCs/TEPCs and responders must be the ones to coordinate with the facilities to ensure that plans are workable. The commenter emphasized that the regulation must clearly outline the relationship between facilities, LEPCs/TEPCs, and responders and ensure these agencies are equipped with the “necessary tools to keep themselves and communities safe” (0170).

The commenter urged EPA to require facilities, LEPCs/TEPCs, and responders to follow ASTM E3241-20, “Standard Guide for Coordination and Cooperation between Facilities, Local Emergency Planning Committees, and Emergency Responders,” as it clarifies the relationship and lines of communication necessary between facilities, LEPCs, and emergency responders for emergency planning and preparedness, emphasizes broad community involvement in the prevention of chemical accidents through awareness and education, and allows for flexibility and adaptation to fit different communities as they develop emergency preparedness and planning processes (0170).

The commenter also suggested that EPA makes two mistakes in the proposed rule. The commenter suggested that EPA mistakenly assumes LEPCs/TEPCs are always preparing freestanding plans under EPCRA rather than participating in the community’s all-hazards planning. The commenter added that EPA must acknowledge that emergency preparedness functions across the boundaries of statutes or regulations as LEPCs/TEPCs strive to serve their communities and emphasized that facility plans under these proposed regulations need to fit into and complement the community’s all-hazards plans. The commenter noted that this can be accomplished by mandating coordination and cooperation as against performance criteria and expectations. The commenter suggested that the second mistake in the proposed rule is that it fails to require facilities to even “consider commenters in good faith” and there are “no consequences for a facility that simply ignores comments during coordination even though this has the potential to endanger the community’s first responders.” The commenter noted that EPA fails to require the facility to report on whether the LEPC/TEPC objected to provisions of the plan (0170).

EPA Response:

EPA recognizes that, in some cases, it may be difficult to coordinate with LEPCs, TEPCs, or other local emergency planning and response organizations due to competing priorities or limited resources. In response, the Agency has added § 118.12(d)(iii), which allows a facility owner or operator to demonstrate through documentation that they have made a good-faith effort to coordinate on the schedule required under § 118.12(a). Correspondence such as email may be used for purposes of documenting good-faith efforts, as long as it is preserved. In terms of retention, facility owners or operators are expected to maintain coordination documentation for the life of the facility. Due to the ease of storing electronic records, the Agency does not expect this to be burdensome, and past agreements and discussions may be valuable tools in response planning, revision, and augmentation. If a facility fails to implement the requirements of this section, EPA may pursue enforcement action.

EPA disagrees with commenters who posited that the source water ZOCs described in the report “Occurrence of Releases with the Potential to Impact Sources of Drinking Water” (EPA 817-R-21-001) are appropriate for this regulation. The ZOCs used in the study described in the referenced report were intended to provide a uniform definition for identifying whether releases captured by the NRC would be included in the analysis or not. The methodology was not designed to identify worst case discharges. As noted in Section 2.6 of the referenced report: Limitations of the Methodology, “It is possible that releases significantly impacting a source of drinking water occurred outside a zone of concern. Conversely, it is also possible that releases within a zone of concern did not significantly impact the source water.” The criteria in the final rule, which are based on whether a worst case discharge from an onshore non-transportation-related facility could cause substantial harm to a PWS, are outcome based and therefore will more appropriately target covered facilities for regulation compared to the ZOCs in the referenced report.

EPA does not intend to create overlapping recordkeeping requirements, and the facility owner or operators are welcome to cross-reference existing records in their FRPs. The Agency is retaining the requirement to maintain signed agreements as a compliance tool and to encourage in-depth, practicable coordination.

EPA disagrees that § 118.12 is ambiguous as to whom owner or operators shall provide copies of their plan, as it states: “Upon request, the owner or operator shall provide a copy of the facility response plan to the Local Emergency Planning Committee, Tribal Emergency Planning Committee, State Emergency Response Commission, or Tribal Emergency Response Commission.” Section 118.12(d) includes documentation requirements as proposed and finalized in this action. Coordination with PWSs is required through § 118.3(c)(2) and the complementary hazard evaluation under § 118.10(b)(3). EPA does not find it necessary to add coordination requirements in § 118.12 when a facility owner or operator is already required to do extensive analysis in coordination with their local PWS through those provisions. A PWS may access information required to be submitted per 42 USC 11021-11022 through their LEPC. EPA is not adding a requirement for plans or amendments to be automatically provided to PWSs or LEPCs so those organizations can control the flow of information on a schedule of their choosing.

EPA recognizes that historically, planning and response has been a public function. However, as stated in the OPA Conference Report (H.R. Rep. No. 101-653, 101^st Cong., 2d Sess.), a major purpose of this action is to shift the burden of worst case discharge planning from public resources to private resources and ensure that facility owners and operators are properly planning for worst case discharges of CWA hazardous substances into or on navigable waters or a conveyance to navigable waters. EPA agrees that facility and community plans should work in concert to plan for these events, and all hazards plans can be effective response planning tools. However, this regulation does not put requirements on local emergency responders because that is beyond the scope and authority for this action. Nonetheless, EPA notes that ASTM E3241-20, “Standard Guide for Coordination and Cooperation between Facilities, Local Emergency Planning Committees, and Emergency Responders,” is a valuable guide and resource, and the Agency encourages LEPCs or TEPCs and emergency responders to familiarize themselves with the standard. The Agency is aware that many communities prepare all-hazards plans and reiterates that this regulation does not require additional planning by emergency planners. Instead, facilities must reach out to these planners and coordinate FRPs. Community planners then have access to this information and any other types of information they may need to strengthen their community plans. With respect to the concern that a facility could ignore LEPC input or coordination responsibilities, concerned stakeholders could bring this to their EPA Region’s attention, and the Region could then provide compliance assistance to the owner or operator in question. In addition, the rule provides the petition mechanism in § 118.7 for the public to engage with EPA regarding FRPs.

Similarly, to the commenter concerned with facilities of local concern that may not meet the quantity threshold, the public may petition the RA to require a facility to submit an FRP under § 118.7. This regulation does not put requirements on local emergency responders beyond coordination as they are able to perform.

Public Comment Summary:

Documentation

A few commenters provided recommendations regarding documentation practices (0205, 0179, 0215).

A few commenters agreed that the requirements for documenting facility coordination activities with local emergency and response organizations described in the RMP rule are warranted (0177, 0179, 0215). One of these commenters noted that they agreed with EPA’s decision to align with the requirements in the RMP rule more than the less-specific requirements in the Oil Pollution Prevention FRP rule (0215).

One commenter supported EPA’s proposal to require a facility to document any agreement between it and local emergency response organizations as to discharge-response actions or resources for which the response organization will be responsible. The commenter noted that the documentation is “critical in this context” and the responsibility falls on the facility to identify and ensure the availability of resources to remove a worst case hazardous substance discharge. The commenter added that without documentation of agreements with third parties (including local emergency response organizations) to provide such resources, it will be impossible for EPA, the public, and other stakeholders to evaluate a facility’s preparedness and the FRP’s compliance with 33 USC 1321(j)(5)(D)(iii) (0215). One commenter recommended EPA allow email communication when documenting coordination discussions due to COVID-19. The commenter also noted that when coordinating the FRP, responsibilities for sharing information from samples or air monitoring are already utilized for EPCRA release reporting duties, and EPA should not require sites to replicate procedures in this document if they can be incorporated by reference, as this will prevent having two sets of procedures and practices (0205). One commenter requested EPA require facilities to maintain coordination documentation for 10 years because that timeframe would cover at least two FRP update cycles. The commenter noted that the proposed rule does not specify how long facilities must maintain their documentation of coordination activities, as required under proposed 40 CFR § 118.12(d) as it does in 40 CFR § 118.13(b)(4) for the proposed five-year retention policy for response plan meeting, training, and drill logs. The commenter recommended that a similar retention policy timeframe should apply to documentation of coordination activities, except for documentation of any signed agreement described in proposed 40 CFR § 118.12(d)(ii), in which case the facility should be required to maintain such documentation for the longer of 10 years or 2 years after the termination of the agreement (0215).

EPA Response:

EPA agrees with commenters who support the approach to documentation of coordination activities. Email is permissible as documentation, as long as it is preserved. The Agency is not requiring duplicative release reporting requirements, and existing plans may be augmented by the requirements of this regulation. In terms of retention, facility owners or operators are expected to maintain coordination documentation for the life of the facility. Due to the ease of storing electronic records, the Agency does not expect this to be burdensome, and past agreements and discussions may be valuable tools in response planning, revision, and augmentation.

Public Comment Summary:

Request for Clarification

One commenter stated that the logistics in §§ 118.12(a) through (d) are overly stringent regarding the coordination of the CWA hazardous substance FRP with the LEPC. The commenter referenced the proposed rule’s requirement that the FRP shall be provided to the LEPC upon request in § 118.12, but parts (a) – (d) are very detailed regarding the required coordination activities, using “shall” as the command. The commenter requested clarification on whether a facility is out of compliance with the proposed rule if the LEPC does not request a copy of the CWA hazardous substance FRP and “does not want to follow” parts (a) – (d). The commenter requested EPA remove or revise the language to allow flexibility in coordinating the plan with the LEPC (0179).

One commenter requested clarification of the role LEPCs and TEPCs play in the final rule, since LEPCs and TEPCs are planning organizations, not response organizations (0177).

EPA Response:

EPA disagrees that §§ 118.12(a)-(d) are overly stringent. If the LEPC does not request a copy of the FRP, the facility will not be out of compliance. Similarly, EPA has added § 118.12(d)(iii), which allows a facility owner or operator to demonstrate through documentation that he or she has shown a good-faith effort to coordinate on the schedule required under § 118.12(a).

LEPCs and TEPCs are critical local emergency planning bodies, and they must account for risks to their communities, including worst case discharges of CWA hazardous substances. They have an inherent stake in this rulemaking and are valuable planning and coordination partners.

Qualified Individual: Designation and Duties

Public Comment Summary:

Support

One commenter supported EPA’s requirements for the designation and duties of a QI. The commenter stated that these requirements are appropriate to ensure action through a single chain-of-command. The commenter strongly supported the requirement that QIs notify and provide information to PWSs in the event of a discharge. The commenter noted that the difference between avoiding impacts for many people may be measured in minutes and claimed that other laws’ notification chains take too long or do not work (0215).

To ensure adequate mitigation in the event of a release, one commenter urged EPA to expand the scope of parties identified, mapped, and notified to include entities, groups, and individuals including groundwater-supplied water systems having Underground Injection Control Program Class V wells, NPDES MS4 control measures and any site of more rapid percolation and infiltration into the subsurface on their property that are downgradient. The commenter also requested that any release above a sole source aquifer should be announced to communities if they rely only on private water wells, claiming that this would allow residents to respond to mitigate danger to their groundwater supply. The commenter specifically cited karst topography as a land type where releases are highly problematic (0167).

One commenter suggested adding text to § 118.11(a)(2)(vii) after “appropriate monitoring” to incorporate:

“including installation of monitoring wells or other subsurface monitoring mechanisms or devices” (0167).

Oppose

Several commenters stated that the requirements for a QI are extremely difficult to meet. These commenters claimed that requiring that the QI have the authority to immediately access company funds to begin cleanup activities, maintain incident commander training requirements, and be able to immediately assess the spill and coordinate its cleanup is not practical. The commenters stated that placing all these responsibilities on one individual is inconsistent with most facilities’ operational structures (0175, 0187, 0191, 0194, 0204, 0218). One commenter added that typically only one or two senior officers have access to company finances, and that these individuals may not be readily available when a discharge occurs, but that they are likely reachable by phone or other form of communication (0191).

Several commenters recommended that EPA accept a management system, which the commenters claimed would provide more flexibility to facilities. The commenters described the management system as one in which several identified individuals collectively meet the designation and duties of the QI to fulfill the intended effects of the requirement. The commenters stated that the current rule does not provide guidance on how a facility should continue if the QI is “not present, unreachable, or incapacitated.” The commenters claimed that a management system would allow facilities to meet the QI requirements in more varied scenarios (0175, 0187, 0191, 0194, 0204, 0218).

EPA Response:

EPA agrees with the commenter that supported EPA’s requirements for the designation and duties of a QI. To the commenter concerned about groundwater-supplied water systems, EPA’s response is that groundwater impacts are outside of the scope of this rule, which is specific to onshore facilities that, because of their location, could reasonably be expected to cause substantial harm to the environment by discharge into or on the navigable waters. Notifications to the proper authorities as per the requirements in this section should mitigate some of this concern. EPA disagrees that including specific language as to the type of monitoring is necessary, as this will be determined through the planning process and may vary based on facility circumstances and the properties of the CWA hazardous substance.

Several commenters stated that the requirements for a QI are extremely difficult to meet and impractical, while placing all these responsibilities on one individual is inconsistent with most facilities’ operational structures. On the one hand, EPA understands that this is a new program and these requirements may be foreign compared to how owners or operators currently do business. On the other hand, such requirements have been in operation for close to 30 years in the Oil Pollution Prevention FRP regulation, so there is precedent and a successful model for this approach. Accordingly, EPA is keeping in place the requirements for a QI as required by statute at 311(j)(5)(D). However, in response to the concerns raised in the comments, EPA is clarifying that a documented management system that can perform the stated functions may take the place of a single individual. For example, as in the Oil Pollution Prevention FRP regulation, duties may be spread across corporate departments and consist of a regional QI structure, corporate call center, and corporate media relations department.

Proposed New Regulatory Text

One commenter suggested two separate changes to the text of the rule. First, the commenter suggested that the language in § 118.11(a)(2) change to:

“Identify the qualified individual having full authority to implement response actions. Following a release of a CWA hazardous substance to navigable water in excess of the Reportable Quantity, require immediate communications between that individual and the appropriate federal official and the persons providing personnel and equipment. Include into the FRP the following description of duties for a QI:”

The commenter also suggested EPA remove the phrase “necessary information” in § 118.11(a)(2)(v) and requested that the notification be limited only to information on the notification form (0179).

EPA Response:

EPA disagrees that the language suggested by the commenter is applicable. This regulation is for worst case discharges of CWA hazardous substances, not a release of an RQ, which, by statutory definition, is a quantity that “may be harmful,” not a discharge that could cause substantial harm to the environment. EPA is also not limiting “necessary information” to information on the notification form, since additional data elements may be required for a robust response.

Training Requirement

Public Comment Summary:

Support

Two commenters supported EPA’s requirement that the QI have incident commander training (0170, 0215). One commenter urged the EPA to require that facilities keep records demonstrating Hazardous Waste Operations and Emergency Response (HAZWOPER) certification for the onsite QI and document the QI’s certifications in the FRP submitted to EPA (0215).

One commenter requested that the rule require that the QI be trained under the National Incident Management System; specifically, the IS200, IS700, and Incident Command System (ICS) 300 courses in addition to the HAZWOPER requirement. The commenter stated that the QI will rarely be the overall incident commander and instead will need to integrate into and cooperate with the community’s responders per the community’s incident response plans. The commenter urged that EPA require training under the National Incident Command System to enable the QI to effectively participate and cooperate and avoid a situation where a facility or the QI “pretends that they can control the actions of responders in the midst of a hazardous chemical release” (0170).

Oppose

Several commenters requested that the requirement for an employee at the facility to have incident commander training be removed (0175, 0179, 0187, 0191, 0194, 0218). Several of these commenters stated that the requirement is unnecessary because, following a discharge, a member of the public sector typically becomes the incident commander, while facilities must liaise with the commander to communicate facility-specific information and coordinate efforts with the facility’s employees. The commenters also claimed that the incident commander training was “impractical” (0175, 0187, 0191, 0194, 0218). Similarly noting that the QI may regularly not be the incident commander, one commenter supported using the same regulatory requirement for QIs given in the OPA Pollution Prevention FRP regulation (0179).

Two commenters believed that the HAZWOPER training is unnecessary because OSHA’s standard necessitates HAZWOPER only when there is an uncontrolled release. The commenters cited U.S. Department of Labor v. Tampa Electric Company (June 2020), which determined that HAZWOPER training is not necessary when passive mitigation is in place because a spill is not uncontrolled (i.e., it is controlled). The commenters argued that the likelihood of discharges occurring where passive mitigation is used (making a discharge controllable due to the cited precedent) should mean that HAZWOPER should not be required. Further, the commenters believed that facilities should be able to use a contractor with HAZWOPER training to respond. This would alleviate the cost burden caused by ensuring that several employees are HAZWOPER trained despite the low likelihood of discharge, while still ensuring that properly trained personnel can respond if a discharge occurs (0187, 0194).

EPA Response:

EPA agrees with commenters who supported the EPA’s requirement that the QI have incident commander training, and the Agency is requiring QIs to acquire incident commander training and meet requirements consistent with § 29 CFR 1910.120(q)(6)(v). While a management system may fulfill the duties of the QI, an individual must still meet this training requirement. Training recordkeeping requirements are in § 118.13. In § 118.11(a)(2)(xii). A QI must have knowledge of chemical response to be able to characterize the nature of the incident to responders, and this training will ensure that is the case. Commenters asserted that this is inappropriate because OSHA’s HAZWOPER standard at 29 CFR § 1910.120 is for uncontrolled releases, which could be mitigated by passive mitigation and thus be controlled. EPA maintains that a worst case discharge into or on navigable waters or a conveyance to navigable waters that causes substantial harm to the environment is, by definition, an uncontrolled release and is not including consideration of passive mitigation as a component of planning (although it may provide a basis for seeking reconsideration by the RA). EPA maintains that proper facility personnel training is critical to an effective response program.

EPA disagrees with the commenter who recommended that the QI be trained under the National Incident Management System. Training under 29 CFR § 1910.120(q)(6)(v) is on-scene incident commander training, including how to control the incident scene beyond the first responder awareness level, with the following requirements: know and be able to implement the employer’s ICS, know how to implement the employer’s emergency response plan, know and understand the hazards and risks associated with employees working in chemical protective clothing, know how to implement the local emergency response plan, know of the state emergency response plan and of the Federal Regional Response Team, and know and understand the importance of decontamination procedures. These are all critical functions the QI must perform, so this training will ensure the QI has this skill set ready to deploy. EPA judges that the facility is best positioned to determine if the QI requires further National Incident Command System training.

As stated in the OPA Conference Report (H.R. Rep. No. 101-653, 101^st Cong., 2d Sess.), a main objective of this statutory mandate is to shift the burden of response from public to private resources. A sufficiently trained QI can be a valuable member of the incident response team who has intimate knowledge of the facility and its operations, allowing the QI to make better and informed decisions for the facility if the plan needs to be put into action as well as how the facility response fits into the larger community response. Assuming public responders will take on this role is inappropriate to this action.

EPA agrees that contractors are sufficient to fill the role of QI as long as the process is properly documented and they meet all the requirements of § 118.11(a)(2).

CWA Hazardous Substance FRP Components

Public Comment Summary:

Support

A couple of commenters provided support for the proposed FRP requirements as long as they mirror those requirements currently in place and applicable to FRPs for the Oil Pollution Prevention FRP regulation (0179, 0219).

Oppose

Several commenters suggested that EPA use more concise language in the proposed FRP requirements, outlining specific metrics and timelines that owners and operators can use to ensure their plan is adequate. The commenters requested that EPA outline the process an owner or operator will have to go through if the RA determines their plan is not acceptable, because currently there is no such process in the proposed rule (0175, 0187, 0191, 0194, 0204, 0218).

Several commenters suggested that the FRP should only be required for CWA hazardous substances that exceed the threshold quantity set out in the proposed rule (0179, 0184, 0185, 0188, 0200, 0206). One commenter shared that under this proposed rule, even if a facility only has one CWA hazardous substance that triggers the threshold quantity, and all other CWA hazardous substances are present at 5 percent or less of the threshold quantity, the facility would still be required to prepare an FRP for each of the 19 CWA hazardous substances onsite. The commenter noted that this is a significant burden with no corresponding reduction in risk of substantial harm to the environment (0184).

A few commenters expressed concern that the requirement for facilities to prepare an FRP for all CWA hazardous substances onsite, even if only one meets the substantial harm criteria, will place an extreme burden on facilities (0199, 0205, 0211).

One commenter suggested that EPA mandate consideration of, and possibly the implementation of, inherently safer technologies and designs related to CWA hazardous substance storage, discharge prevention, and discharge response onsite (0216).

One commenter recommended a requirement for inclusion of documentation on spill mitigation and prevention measures in place, adopted vessel design codes, and the list of hazards considered in vessel design and inspection (e.g., surge, wave, and wind loads) (0168).

Another commenter suggested that EPA should describe in sufficient detail in the final rule all criteria that would be applied to facilities that contain multiple CWA hazardous substances that individually fall under the threshold for requiring an FRP (0177).

The commenter also recommended that EPA complete further analysis of the FRP requirements’ potential impact on state authorities and the overall impacts on rural communities and affected industries (0179).

One commenter requested that EPA confirm that the requirements in § 118.11 appropriately differentiate expectations for the single CWA hazardous substance that forms the basis of the worst case discharge model versus what is expected in the FRP for other CWA hazardous substances that are present at the facility in amounts above thresholds (0183).

Another comment suggested the following addition to § 118.4:

(6) Response plans for all facility types (1-5 above). Response plans for all facility types shall address pollutant release in the context of the entire hydrologic cycle of the potential site of release, including precipitation, runoff, infiltration and percolation to and conveyance by groundwater, natural and structural conveyances to groundwater (including water wells and stormwater infiltration wells) and/or surface water (including natural or engineered water courses and infiltration and exfiltration by pipe or conduit), and evaporation (0167).

One commenter suggested that EPA strengthen the FRP requirements to ensure plans fully reflect, and facilities are undertaking, all steps necessary to respond, to the maximum extent practicable, to a threatened or actual worst case discharge (0215).

Another commenter requested that EPA consider subsurface and groundwater conditions in the FRP planning and guidance, such as (0198):

Where publicly available, identification of source water protection/wellhead protection areas that supply PWSs.
Identification of contacts to notify for public water wells supplying water systems.
Identification of locations of potential rapid infiltration (such as cave openings and abandoned wells) in karst terrain and near-surface fractured bedrock. These geologic settings may be of greatest concern for protection because groundwater flow may be very rapid with potentially fast movement of contaminants to aquifers.
Identification of stormwater infiltration structures on the facility, including unsewered storm drains, dry wells, and drainage wells, as well as any subsurface distribution system that would allow worst case discharges to enter the subsurface vadose zone or shallow subsurface groundwater.
Identification of down groundwater hydraulic gradient areas, which may not be downstream of worst case releases because groundwater flow does not always follow surface topography and surface water drainage divides.

Another commenter suggested that FRPs should take into account underground aquifers, a facility’s altitude, internet submission databases, people supply chain technology, and emergency financial budgets for individuals living nearby (0272).

Electronic Submission

One commenter stated that while EPA determined that electronic submissions and management of CWA hazardous substance FRPs are not feasible at this time, EPA should revisit online submissions and maintenance of FRPs at a future date to improve FRP submission, plan amendments, plan review, approval, and public transparency. The commenter added that EPA should consider providing public access to approved FRPs under this proposal (0177).

Another commenter suggested that an online database should be a necessity at this point. The commenter added that creating an online database would create a community right to know and create a lot of transparency (0153).

EPA Response:

The requirements in § 118.11 are designed to address concerns specific to CWA hazardous substances; as such they are not exactly the same as requirements under the Oil Pollution Prevention FRP regulation. A written plan that complies with other federal contingency plan regulations or is consistent with the approach in the National Response Team’s ICP Guidance (“One Plan”) and includes the elements required, will satisfy the requirements of this final rule. Facilities may augment an existing response plan with requirements that are specific to this action. EPA will provide compliance assistance to aid in implementation.

In this final action, once a covered facility determines it meets one of the substantial harm criteria, the owner or operator must plan for all CWA hazardous substances onsite above the threshold quantity, including worst case discharge scenarios and response planning. EPA has adjusted its approach from the proposed rule, where one CWA hazardous substance worst case discharge scenario provided the basis for the FRP. This change is consistent with EPA’s statutory authority under this action to require plans for facilities that, because of their location, could cause substantial harm to the environment from a worst case discharge into or on the navigable waters. It also recognizes that response and/or recovery actions may vary widely depending on the physicochemical properties of the substance, so one CWA hazardous substance at facilities with multiple CWA hazardous substances that meet or exceed the threshold quantity cannot adequately inform that facility’s FRP.

EPA has endeavored to be concise and specific in the proposed and final regulation and will provide compliance assistance to the regulated community. As a general matter, EPA will review submitted plans and provide compliance assistance should there be issues that need to be addressed. If issues remain unresolved, the RA can issue a determination that the facility could cause substantial harm or significant and substantial harm. If the facility owner or operator disagrees with that determination, the owner or operator may then appeal the determination using the mechanism in § 118.6.

As per the statutory authority of this action under CWA § 311(j)(5), this is a response planning regulation. Inherently safer technologies and designs related to CWA hazardous substance storage are outside the scope of this rule. Section 118.11(b)(15) includes requirements for measures to provide adequate containment and drainage of discharged CWA hazardous substances in a response scenario. That said, use of such technologies, like passive mitigation, may provide the basis for seeking reconsideration of the rule’s applicability.

Facilities that contain multiple CWA hazardous substances that individually fall under the 1,000x RQ threshold are not required to develop or submit an FRP.

To the commenter who recommended that EPA complete further analysis of the FRP requirements potential impact to affected industries, please see Section 5.1 of the RIA in the docket. As to state authorities and rural communities, additional emergency response planning should enhance the relationships between industry, their state regulators, and rural communities. EPA is operating under its statutory authority in § 311(j)(5).

EPA is not including groundwater impacts, underground aquifers, people supply chain technology, and emergency financial budgets for individuals in this regulation as they are outside the scope of this action. Specifically, groundwater impacts are outside of the scope of this rule, which is specific to onshore facilities that, because of their location, could reasonably be expected to cause substantial harm to the environment by discharge into or on the navigable waters. EPA is including identification of location in or drainage to wellhead protection areas to be consistent with the Oil Pollution Prevention FRP regulation. Identification of locations of potential rapid infiltration and Identification of groundwater hydraulic downgradient areas are outside the scope of this action. Emergency response personnel will be best positioned to determine additional notifications that need to be made at the time of an incident. A facility owner or operator would identify potential conveyances when determining their worst case discharge scenario.

EPA agrees that electronic submission is preferable for plan submission, review, amendment, management, and approval. Since resources are not currently allocated to such a system, EPA is not including it in regulatory text. The Agency is committed to transparency and will work with its federal security partners to determine what portions of FRPs should be publicly available.

Facility Information

Public Comment Summary:

Support

One commenter supported EPA’s proposed facility information requirements for FRPs and noted that each of the requirements in the proposal is necessary to ensure the facility can be quickly located in the event of a discharge (0215).

Oppose

One commenter suggested that EPA require FRPs to include the facility’s TRI ID, if it (or any larger property it is located on) has one. The commenter noted that providing such numbers would make it easier for EPA, response officials, and stakeholders to cross-reference other relevant information about the facility related to discharge response and preparedness (0215).

EPA Response:

EPA agrees with the commenter who noted that each of the requirements in the proposal is necessary to ensure the facility can be quickly located in the event of a discharge. The Agency has added “EPA identification numbers” as a data element to report so facility owner or operators can report various EPA ID numbers they may use, such as TRI IDs or Facility Registry Service (FRS) numbers. This will aid in cross-referencing submissions across programs.

Owner or Operator Information

Public Comment Summary:

Oppose

One commenter suggested that EPA expand the proposed owner and operator information requirements for FRPs by requiring information for both the owner and operator of a facility and requiring identification of related facilities nearby. The commenter noted that the final rule should require contact information for both the owner and the operator, given both are ultimately responsible for hazardous substance discharges at a facility. The commenter stated that the final rule should also indicate which, of the owner or operator, is the principal contact for the facility (0215).

The commenter also suggested that EPA should require each FRP to list, for both its owner and its operator, all facilities within a three-mile radius (from the facility boundary) that are under common ownership or operation. The commenter suggested that the FRP should include, for each facility, the TRI ID; whether the facility prepared (or is preparing) a substantial harm analysis; and whether the facility prepared (or is preparing) an FRP (0215).

EPA Response:

EPA is not requiring notification of related facilities nearby and disagrees that listing all facilities within a three-mile radius that are under common ownership would enhance response planning efforts. Related information should be included in the hazard evaluation, where a facility owner or operator would identify nearby businesses that could be affected by a worst case discharge. The Agency also maintains that information for the owner or the operator is sufficient. The Agency has added “EPA identification numbers” as a data element to report so facility owner or operators can report various EPA ID numbers they may use, such as TRI IDs or FRS numbers. FRPs all include a substantial harm analysis.

Hazard Evaluation

Public Comment Summary:

Support

One commenter provided support for the approach that the hazard evaluation should include only those CWA hazardous substances whose maximum capacity onsite meets or exceeds the threshold quantity (0201).

Another commenter provided strong support for EPA’s general proposal that all FRPs include a hazard evaluation for a worst case discharge scenario and a risk-based decision support process to guide responding to worst case discharges (0215).

Oppose

Several commenters stated that requiring additional endpoint calculations poses significant cost concerns, as this would likely require additional modeling. The commenters requested that EPA remove the proposed requirements to model endpoints for all CWA hazardous substances, examine environmental justice communities, and consider climate change impacts in hazard evaluations (0175, 0187, 0191, 0194, 0204, 0218).

Several commenters requested that EPA not add a requirement regarding cascading failures to FRPs and instead take the responsibility of assessing any risks of cascading failures itself, as the Agency has access to sensitive information that two facilities would likely not be willing to disclose to one another (0175, 0187, 0191, 0194, 0204, 0218). With regards to cascading failures, one commenter noted that listing onsite fire equipment and local resources (i.e., the fire department) should suffice for this requirement. The commenter stated that if EPA requires an analysis to address cascading failures, EPA needs to define the risk EPA is trying to mitigate (0179).

One commenter suggested that EPA should strengthen the required hazard evaluation by mandating consideration of all CWA hazardous substances stored at a facility, as well as cascading effects on co-located or proximate facilities. The commenter added that EPA should require in the final rule that hazard evaluations use up-to-date projections of climate risks as determined by EPA to guide climate-risk assessments and prescribe specific types of analysis and consultation required to assess hazards to environmental justice communities (0216).

One commenter recommended that EPA strengthen the hazard evaluation requirements in the following ways (0215):

EPA should specify that facilities cannot rely solely on historical data, must consult forward-looking climatological data when available, and must describe the data sources and information considered in the FRP.
The final rule should require facilities in coastal areas to assess the 90^th percentile sea level rise projections for the year 2050, or some other reasonable time frame, including projections of regional variation, as documented by the National Oceanic and Atmospheric Administration (NOAA).
EPA should provide guidance on specific data sources or other resources that regulated facilities should consider in the hazard evaluation.
EPA should require facilities to consider impacts on any “community with environmental justice concerns” with a boundary located within one mile of the boundary of the facility.
The final rule should require facilities to consult with those communities through public fora and provide opportunities to submit written feedback.
The final rule should require hazard evaluations to consider potential risks for all CWA hazardous substances at a facility.
To the extent facilities lack sufficient information about proximate facilities, EPA should consider delaying the compliance date for the requirement regarding cascading failures until EPA is able to gather the information necessary to develop Density Hazard Zones.

EPA Response:

EPA agrees with the commenter who supported the hazard evaluation including only those CWA hazardous substances whose maximum capacity onsite meets or exceeds the threshold quantity, though the final rule uses maximum quantity onsite. The hazard evaluation must consider all CWA hazardous substances onsite above the threshold quantity and evaluate climate risks within worst case discharge scenarios.

The Agency is aware of the complexity and cost of modelling endpoints for all CWA hazardous substances above the threshold quantity, examining environmental justice communities, and considering climate change impacts in hazard evaluations. EPA intends to provide tools and compliance assistance to help the regulated community comply with these requirements and maintains that their inclusion is critical to protect the environment in the event of a worst case discharge. The hazard evaluation will additionally serve to inform equipment selection (i.e., based on physicochemical characteristics of the CWA hazardous substance as floater, sinker, or soluble in water) and response actions to be taken, since those will all depend on what risks are identified and characterized, the necessary control methods, and communications required. Additionally, EPA has added a requirement that, when identifying risks, facility owners or operators must assess the age of CWA hazardous substance containers, since older containers may be more susceptible to failure. Facility owners or operators must also identify taste or odor thresholds in water in their assessment of the ability to adversely impact a PWS in order to more fully inform the relevant PWS of the risks.

For the commenters concerned about assessing cascading failures, EPA regions may have access to facility-specific risk information, though the Agency is not requiring facilities to assess these impacts across facilities. In part, because EPA is not requiring facilities to assess cascading failures, EPA has added the risks associated with facility density (and thereby cascading failures) as a factor the RA may consider in § 118.5(b)(10) when determining if a facility could cause substantial harm to the environment through a worst case discharge into or on navigable waters or a conveyance to navigable waters. That said, it is incumbent upon the facility owner or operator to identify nearby schools, businesses, places of worship, or other areas that could be impacted by a worst case discharge.

In addition, the hazard evaluation must examine the effects of CWA hazardous substance worst case discharges on communities with environmental justice concerns as well as the effects of climate change, including those that result in low flow conditions in receiving water bodies, on the likelihood, duration, and impacts of a CWA hazardous substance worst case discharge into or on navigable waters or a conveyance to navigable waters. EPA is not specifying specific climatological data or scenarios in the regulation in order to be flexible and in recognition that climate change impacts are occurring in unexpected ways and with impacts varying based on locational factors. Indeed, climate change considerations may include the increased frequency and intensity of extreme weather events, temperature fluctuations, rising seas, storm surges, inland and coastal flooding, drought, wildfires, and permafrost melt in northern areas. Instead, the Agency will continue to provide compliance assistance for assessing both climate change impacts and effects on communities. Developing the suggested Density Hazard Zones is outside the scope of this action. Communities may engage in community planning through participation in their LEPC.

Risk-based decision support system

Public Comment Summary:

Oppose

One commenter recommended that § 118.11(a)(3) should be rewritten to use the same language as § 1.4, Appendix F to 40 CFR Part 112 of the Oil Pollution Prevention regulation. The commenter added that using this methodology with the ability to refer to the SDS, Chemical Hazards Response Information System manual, USDOT Emergency Response Guide (ERG), or USCG blue book for hazard evaluations will promote consistency in the hazard evaluations (0179).

EPA Response:

EPA disagrees that § 118.11(a)(3) should be re-written to use the same language as § 1.4, Appendix F to 40 CFR Part 112 of the Oil Pollution Prevention regulation. The facility owner or operator is free to refer to the SDS, Chemical Hazards Response Information System manual, USDOT ERG, or USCG blue book for hazard evaluations in some cases where those resources are appropriate to the characteristics of the CWA hazardous substances in question, but the Agency maintains that planning for most CWA hazardous substances is materially different from planning for oil discharges and has different hazard evaluation requirements.

Reportable Discharge History

Public Comment Summary:

Support

One commenter provided support for EPA’s general proposal that all FRPs include a section detailing past discharges at the facility, including information about the onsite and offsite impacts of those discharges, response actions taken, and steps taken to prevent recurrence (0215).

Oppose

Several commenters requested that EPA remove the inclusion of a facility’s history of reportable discharges as an FRP requirement. The commenters stated that this information is not relevant to ensuring that a facility is prepared for a future worst case discharge (0175, 0187, 0191, 0194, 0218).

One commenter suggested that EPA set a time period for documenting reportable discharge history information. The commenter noted that records are to be retained for five years so the time period should be limited to this duration. The commenter recommended that EPA revise the rule to add “within the last five years” (0179).

The commenter also noted that reportable discharges of CWA hazardous substances contained in NPDES effluents and reportable discharges of oil containing CWA hazardous substances should be excluded from this requirement since these substances are regulated under 40 CFR Part 112 (0179).

One commenter noted that in the proposed rule, § 118.11(b)(4) requires that facilities include in their CWA hazardous substance FRP all discharges above an RQ of a CWA hazardous substance with a maximum capacity onsite above the threshold quantity that reached water in the last five years. The commenter added that any discharge above an RQ is already required to be reported under the CWA or the ancillary state program, so it should be sufficient for the CWA hazardous substance FRP to simply reference the RQ Notification submitted to EPA or the state (0189).

Another commenter requested that that final rule should expand the requirements in the following ways (0215):

EPA should require FRPs to include information about all reportable CWA hazardous substance discharges, regardless of whether they were confirmed to have reached water.
EPA should expand upon the requirements to disclose “onsite impacts” and “offsite impacts” to clarify that such impacts would specifically include disclosure of any impacts on the environment, drinking water supplies, or public receptors.
EPA should require FRPs to disclose any regulatory, administrative, or legal action taken by a local, state, or federal official or entity in response to a reported discharge.

EPA Response:

EPA agrees with the commenter who supported EPA’s inclusion of reportable discharge history. EPA maintains that reportable discharge history is not only relevant but also an appropriate substantial harm criterion; this information is critical to scenario development, including lessons learned from past CWA hazardous substance discharges and response efforts. In terms of a timeline for reporting, EPA is following the lead of the Oil Pollution Prevention FRP regulation and requiring this information to be retained for the life of the facility. EPA notes that permitted discharges under NPDES and reportable discharges under 40 CFR Part 112 are not covered under this action. EPA is not requiring information on non-CWA hazardous substance discharges, since it is unclear at best how relevant they are or would be to worst case discharges of CWA hazardous substances. Similarly, EPA is only including reportable discharges that reach navigable waters, since other discharges are outside the scope of this action.

EPA has decided that specifically referencing impacts on the environment, drinking water supplies, or public receptors is unnecessary, since those are captured under onsite and offsite impacts.

EPA disagrees that current discharge reporting is an adequate substitute for purposes of using the information as a planning tool since those reports may not include all the relevant data required by § 118.11(b)(4). These data will provide important context and scenario planning for real world discharges at the facility and enhance planning efforts.

EPA disagrees that FRPs should disclose regulatory, administrative, or legal action since this would be readily available to EPA through other avenues.

Response Personnel and Equipment

Public Comment Summary:

Support

One commenter provided their support for the requirement that FRPs include the identity of private personnel and equipment necessary to respond to the maximum extent practicable to a worst case discharge, including qualifications and training (0215).

Oppose

Several commenters noted that the requirement to include private personnel’s identity when outlining response to a spill is unnecessary and creates complications as the provision is very specific to individuals. The commenters suggested that EPA accept a management system that clearly outlines the spill response roles, which allows for flexibility (0175, 0187, 0191, 0194).

One commenter also mentioned that the proposed rule places a lot of emphasis on having response contractors. The commenter acknowledged that in some scenarios, contractor support may not be applicable to the type of response needed, so EPA needs to recognize these scenarios in the proposed rule. The commenter also suggested that EPA needs to provide guidance on identifying the necessary response resources that are acceptable to the Agency (0179).

With regards to response personnel, one commenter suggested that response support personnel, such as air modelers, water modelers, and water and air sampling and analyses, be identified as a source and not as a person since they will be situationally dependent (0179).

EPA Response:

EPA agrees with the commenter who supported proposed § 118.11(b)(5). The Agency has adjusted its approach to address other commenter concerns so that a management system will be sufficient, as long as it is properly documented, as will identifying the source and position titles for air or water modeling and water sampling and analyses instead of specific personnel identification.

If contracted response resources are not available, a facility owner or operator will need to procure them to keep onsite or ensure through documentation that the local fire department is willing and equipped to respond to a worst case discharge.

Contracts

Public Comment Summary:

Support

One commenter provided support for EPA’s proposal to require FRPs to contain “evidence of contracts or other approved means . . . to ensure the availability” of response personnel and equipment needed to respond to a worst case discharge (0215).

Oppose

One commenter recommended that EPA develop a form for signed agreements on activities, which would establish consistency across the regulated community (0205).

One commenter recommended that Oil Spill Removal Organizations (OSROs) expand their capacities to adequately respond to CWA hazardous substance discharges. The commenter suggested that EPA provide phase-in timing for SROs to develop their capabilities, including identification of the available resources and personnel for CWA hazardous substance discharges, and provide a time schedule in which OSROs and regulated facilities must acquire the necessary equipment to avoid compliance issues on day one. The commenter also encouraged EPA to develop a list of SROs, similar to the USCG approved list of OSROs, and allow OSROs to serve as SROs in the interim. The commenter also stated that even though the proposed rule requires a contract with SROs, it does not take into consideration that nationally, most facilities only have equipment suitable for oil response (0179).

One commenter suggested that EPA should replace the word “proper” with “necessary” in the final rule’s contract provision when describing response personnel and equipment. The commenter requested clarification on what it means for a contract to “ensure” the availability of response equipment or personnel. The commenter noted that the final rule should specify the evidence needed to show a contract does “ensure” availability of necessary response resources, including (1) that the contract is fully pre-paid; (2) that the cost of the contract is secured by a bond; or (3) that the contractor will accept any remaining payment after providing all contracted-for, necessary response resources. The commenter also suggested that that FRPs must ensure the availability of monitoring, testing, and evaluation resources (0215).

EPA Response:

EPA agrees with the commenter who supported EPA’s proposal to require FRPs to contain “evidence of contracts or other approved means . . . to ensure the availability” of response personnel and equipment needed to respond to a worst case discharge.

EPA disagrees that it should develop a form for signed agreements; business relationships are the responsibilities of the parties under contract.

EPA recognizes that, in many cases, contracting resources will need to be identified to fill the role of SROs. Most large OSROs already have the capability to respond to hazardous material incidents, particularly if they have been contracted by truck and rail carriers. EPA expects that the potential increase in demand for SROs caused by the rule will result in greater competition and increased market entry by new contractors. Additionally, in § 118.4, EPA is providing a 36-month implementation period before facility owner or operators must submit plans. Finally, EPA will work with USCG to identify SROs that can fulfill this role.

The Agency disagrees that it should show payment and execution of contracts. This is the responsibility of the facility owner or operator. Additionally, the facility owner or operator is responsible for identifying the appropriate response personnel and equipment. Ensuring the availability of response equipment and personnel means that these resources are either available onsite or under contract. Monitoring, testing, and evaluation can all be categorized under response resources.

Notification Lists

Public Comment Summary:

Support

One commenter provided support for the inclusion of downstream PWSs in the required spill notification (0174).

Another commenter provided support for EPA’s proposed requirement that FRPs include the identity, contact information, and a description of communication methods for all parties that should be contacted in the event of a discharge. The commenter also supported the non-exclusive list of stakeholders that the notification list must cover (0215).

One commenter urged EPA to expand the scope of parties identified, mapped, and notified to include entities, groups, and individuals, including groundwater-supplied water systems having Underground Injection Control Program Class V wells, NPDES MS4 control measures, and any site of more rapid percolation and infiltration into the subsurface on their property that are downgradient to ensure adequate mitigation in the event of a release. The commenter also requested that any release above a sole source aquifer should be announced to communities if they rely only on private water wells, claiming that this would allow residents to respond to mitigate danger to their groundwater supply. The commenter specifically cited karst topography as a land type where releases are highly problematic (0167).

Oppose

One commenter recommended that the appropriate state, federal, local, and tribal land managers be identified in FRPs and notified in the event of a discharge (0177).

Another commenter suggested that all notifications should follow the same approach as the Oil Pollution Prevention regulation in § 1.3(A)(1) and (2), Appendix F of 40 CFR Part 112. The commenter also suggested that EPA remove the requirement of adding “preferred communication” from the rule because it is not necessary, as the commenter believes that all communication will be conducted using the telephone (0179).

One commenter suggested that the contacts for notices of contaminant releases should include well owners and operators, water system and source water protection managers, persons living in or managing commercial/industrial activity over recharge zones, and county and municipal sanitarians who permit wells in their jurisdictions (0167).

Another commenter suggested EPA consider the following, in relation to including direct notification to the PWS under the FRP related to groundwater (0198):

Contaminants that infiltrate the soil zone and percolate through the vadose (unsaturated) zone to the aquifer may take many years to reach a human receptor or key environmental receptor. Because some groundwater SWPA areas may be large, the commenter recommended that using one-year time of travel in slower groundwater flow systems may be sufficient for a worst case notification under the FRP.
SWPAs located in a geologic setting where the source of the water is from karst or fractured aquifers, or a system that has been determined to be using groundwater that is under the influence of surface water, can have quick travel times and be potentially affected by worst case discharges. The commenter suggested that PWS in these geologic settings should be identified in the FRP for direct notification.
Some groundwater karst systems are habitat to FWS listed endangered species. The commenter stated that notification of FWS and those implementing habitat conservation plans should be part of the FRP if the concentrations from a CWA hazardous substance worst case discharge would result in scenarios adversely impacting the designated habitat area.

The commenter also suggested editing the proposed rule language in § 118.11(b)(7) to be more consistent with the definition of SWPA from “downstream public water systems” to “downstream surface water public water systems.” The commenter also suggested adding “downgradient groundwater public water systems” to § 118.11(b)(7) (0198).

One commenter suggested that EPA require facilities to regularly share information and consult with nearby public drinking water systems (0216).

EPA Response:

EPA agrees with the commenters who provided support for this section. EPA is not expanding the scope of the notification list, since federal, tribal, state, and local responders, as well as the non-specific listing of potential receptors or interested parties is inclusive of all of these suggestions. Federal, state, and local responders will be best positioned to determine whether additional types of notifications are necessary. EPA is not adjusting the language in § 118.11(b)(7) since the SWPA language serves a different purpose that is outside the scope of this action.

EPA disagrees with commenters who argued that “preferred communication” should be removed, since telephone call is not the only method of notification. The reason telephone communication has been historically preferred is because the “sender” knows that they have gotten through, or just as importantly, that they have not gotten through and need to continue trying. That said, as long as receipt of the communication is confirmed, notification can take any number of electronic forms, including text or email.

This provision is not the same as the Oil Pollution Prevention regulation in § 1.3(A)(1) and (2), Appendix F of 40 CFR Part 112, since CWA hazardous substances require different response resources and techniques than oil.

Discharge Information

Public Comment Summary:

Support

One commenter provided support for EPA’s proposed requirement that FRPs include a list of initial information that will be provided to response personnel in the event of a discharge (0215).

Oppose

One commenter requested that EPA make clear in the final rule that QIs have an obligation to provide response officials with material updates to discharge information as the facility learns more about the scope and nature of the discharge (0215).

EPA Response:

EPA agrees with the commenter who supports the list of discharge information to be included. The final rule requires that a facility will provide response officials with material updates to discharge information as the facility learns more about the scope and nature of the discharge and as it becomes available to aid response efforts.

Personnel Roles and Responsibilities

Public Comment Summary:

Support

One commenter provided support for EPA’s proposed requirement that FRPs identify onsite response personnel and describe their duties to respond to a worst case CWA hazardous substance discharge, as well as their training and qualifications (0215).

Oppose

One commenter asserted that EPA’s requirement to include private personnel identities when outlining response to a spill is unnecessary and creates complications as the provision is very specific to individuals. The commenter recommended that EPA accept a management system that clearly outlines the spill response roles (0218).

Another commenter suggested that EPA make clear in the final rule that in the event any necessary onsite personnel are temporarily unavailable, the owner or operator must contract with a third party to provide the response capacity of those missing personnel to ensure that total personnel training, qualifications, and response times match those stated in the FRP (0215).

One commenter suggested that for facilities with shifting schedules, the FRP should identify general positions rather than the specific individuals assigned to gather information and provide response. The commenter stated that these changes would ensure that EPA is collecting the most useful information to promote consistency across industry, while avoiding the creation of unnecessary administrative burdens following staffing and planning changes (0205).

EPA Response:

EPA agrees with the commenter who supports the contents of this section. In response to the concerns of other commenters, the final rule allows that a documented management system and position descriptions of personnel that can perform the stated functions may take the place of a specific individual. All specified personnel and resources must be available as per the FRP.

Response Equipment Information

Public Comment Summary:

Support

One commenter provided support for EPA’s proposed requirement that FRPs include information about the facility’s response equipment that is needed to respond to a worst case discharge, including information about the equipment’s condition, location, response time, and testing and drill history and frequency. The commenter noted that the provision should be finalized as written (0215).

Oppose

A few commenters suggested that the lists of response equipment information only “live” in one location. The commenters noted that if a facility has an Oil Pollution Prevention FRP, they should be able to provide reference to the Oil Pollution Prevention FRP to satisfy any requirement for information. The commenters added that this would allow the site to focus on updating a single list in one location and avoid unnecessary confusion or redundancy by requiring the facility to update the same information in multiple places (0179, 0205).

A commenter suggested that the equipment lists should be limited to equipment onsite that is applicable to response actions for CWA hazardous substances. The commenter noted that additional equipment such as monitoring and sampling equipment should be specified as “can be made available” but should not be part of the list that must be inspected, deployed, etc., for drills/exercises. The commenter also suggested that EPA should provide a phase-in period, maybe 12 months, to allow SROs and facility owners to acquire the necessary equipment (0179). The commenter added that EPA needs to develop equipment requirements (types, quantities, operational area capacities/capabilities) and response requirements (volume/number of items, timeframes), to prevent compliance uncertainties on day one (0179).

Another commenter noted that during COVID-19, there were huge supply chain issues, and equipment planning is an important part of the FRP. The commenter mentioned that there needs to be a lot more transparency on what equipment would be available along with how quickly equipment would be received (0153).

EPA Response:

EPA agrees with the commenter who supported the provision as proposed.

In order to avoid unnecessary confusion or redundancy, EPA notes that CWA hazardous substance FRPs may reference lists in other plans as long as they meet the requirements of § 118.11. For example, holders of oil FRPs could reference their existing response equipment and update the narrative to meet the CWA hazardous substance FRP requirements in an ICP.

EPA disagrees with a commenter who asserted that monitoring and sampling equipment should be specified as “can be made available.” Since time will always be of the essence in responding to a worst case discharge, these items are an important component of CWA hazardous substance response and should be actually available rather than possibly available. Additionally, plan holders should refer to their ACP, which contains equipment and response resource requirements in some areas. In § 118.4, EPA is providing a 36-month implementation period before the facility owner or operators must submit plans. Additionally, plan holders should refer to their ACP, which contains equipment and response requirements in some areas. Regardless, developing these resources is a plan holder responsibility.

Determining the type, quantity, etc., of response resources may vary widely given the range of facilities and chemicals at issue, which is one reason EPA has decided that facility owners and operators should have the latitude to make these types of determinations.

EPA recognizes the reality of supply chain issues. Plan holders should contact the relevant RA if they have difficulty obtaining needed resources. In addition, EPA notes that the Agency has adjusted the implementation period in § 118.4 to allow for 36-months for implementation. Following the implementation period, newly regulated facilities will have 6 months to prepare and submit their plans.

Evacuation Plans

Public Comment Summary:

Support

One commenter provided support for EPA’s proposed requirement that FRPs include evacuation plans that coordinate with community evacuation plans and account for myriad factors including the often-unpredictable behavior of CWA hazardous substance discharges, particularly in adverse weather (0215).

Oppose

One commenter suggested that the final rule explicitly require FRPs to identify the community evacuation plan(s) with which they coordinated and how that coordination was conducted (0215).

A couple of commenters noted that in large facilities, there can be multiple evacuation paths through the facility. A diagram’s usefulness may be limited in a response scenario since weather and other conditions will impact the exact path. The commenters agreed that including a diagram with significant features makes sense, but explicit pathways do not make sense. The commenters suggested that EPA allow flexibility in developing evacuation plans appropriate for the facility and in conformance with OSHA’s emergency action plan requirements (0179, 0205).

One commenter recommended that EPA allow facilities to cross-reference, in their FRPs, OSHA’s emergency action plans that are in conformance with 29 CFR § 1910.38, or other relevant documents. The commenter also recommended that the requirements for evacuation plans follow the same approach as the Oil Pollution Prevention regulation in § 1.3.5, Appendix F, of 40 Part CFR 112 (0179).

EPA Response:

EPA agrees with the commenter who supports the approach to evacuation plans and also has adjusted its approach to require FRPs to list the community evacuation plans consulted in § 118.11(b)(11).

The Agency recognizes that evacuation routes may vary, which is why § 118.11(b)(11) includes “limitations on evacuation routes” as a plan element. A facility may include more than one diagram to reflect different scenarios as necessary. Facility owner or operators may include evacuation plans prepared in accordance with 29 CFR § 1910.38, but they must reflect the requirements of this section.

To the commenter who suggested cross-referencing evacuation plans prepared under other statutes, while EPA understands there is some redundancy in submitting a plan and in some cases cross-referencing is appropriate, the Agency maintains that submitting the evacuation plan here allows On-Scene Coordinators to have plans readily available in the event of a worst case discharge and to inform coordinated response. However, a facility owner or operator may combine their plans in a single ICP to reduce the administrative burden.

Discharge Detection Systems

Public Comment Summary:

Support

One commenter provided support for EPA’s proposed requirement that FRPs include descriptions of the procedures and equipment used to detect CWA hazardous substance discharges (including air releases from discharges), as well as reliability checks and inspection frequency for automated systems (0215).

Oppose

One commenter recommended that EPA should avoid inflexible release monitoring approaches because a mandate would create an unnecessary backlog for monitor components and burdens the site with process reconfiguration (0205).

Another commenter suggested that the requirements for discharge detection systems should follow the same approach as the Oil Pollution Prevention regulation in § 1.6, Appendix F of 40 CFR Part 112. The commenter also suggested that the list of discharge detection systems be limited to equipment onsite that is applicable to response actions for CWA hazardous substances and not related to facility operations. The commenter added that EPA should confirm that “personnel or automatic discharge detection for regular and after-hours operations” should also be limited to spill response activities (0179).

One commenter stated that the discharge detection systems requirement is problematic because the technology for the detection of certain hazardous chemicals may not exist or may be a measurement method that is unreliable. The commenter noted that another issue is that the installation and maintenance of such discharge detection systems are usually expensive, especially when compared to the potential environmental benefit. The commenter recommended that “discharge detection systems” be removed as an FRP requirement (0188).

Another commenter suggested that the following be added to § 118.1(12): “or to the subsurface and/or groundwater” after “from discharges to navigable water” (0167).

One commenter suggested that EPA consider a less formal method of detection that is easier for facility owners or operators to manage. The commenter added that EPA should research a standard method of discharge detection and provide recommendations for implementation under this proposed regulation (0201).

Another commenter recommended that the final rule go further to ensure discharge detection systems do in fact facilitate expeditious response times in the event of discharge. The commenter suggested that EPA require annual discharge detection system reliability checks and inspections as part of the final rule. The commenter also added that the final rule should also require facilities to evaluate and describe in the FRPs whether new or updated discharge detection systems (1) would materially improve facility response time in the event of a CWA hazardous substance discharge during either regular hours and after-hours operations; and, if so, (2) would be practicable to install and operate. The commenter added that for any facility that answers both questions in the affirmative for a specific discharge detection system, the final rule should require the facility to install and begin operating that system within one year (0215).

EPA Response:

EPA agrees with the commenter who supported EPA’s proposed requirements at § 118.11(b)(12). The Agency disagrees that the requirements therein are inflexible; in the event of a worst case discharge that could cause impacts, it is incumbent on the facility to have the proper detection and monitoring equipment onsite in order to know the extent and character of the discharge and its potential effects.

The Agency maintains that in the event of a worst case discharge, discharge detection systems are critical to initiate responses in an event. If a facility has the ability to cause substantial harm to the environment, it must also have the ability to detect when such a discharge is occurring. EPA notes, however, that the facility owner or operator may include personnel procedures (e.g., visual examination) designed to detect discharges. EPA recognizes that this may increase costs but maintains that the effects of worst case discharges can be catastrophic and costly (see Chapter 3 of the RIA in the docket).

EPA disagrees with a commenter who argued that discharge detection systems for the 296 CWA hazardous substances should follow the same requirements as for oils. The context of this regulation is for worst case discharges of CWA hazardous substances; as such, discharge detection systems should be sufficient for those events. Additionally, the Agency notes that these systems should not be limited to response actions, as they may alert a facility owner operator of a discharge in the first place.

Groundwater or subsurface water impacts are outside of the scope of this rule, which is specific to onshore facilities that, because of their location, could reasonably be expected to cause substantial harm to the environment by discharge into or on the navigable waters.

It is outside the scope of this rulemaking to require facility owners or operators to assess the costs and benefits new or updated discharge detection systems and require their installation. Routine walk-around visual inspection can be an appropriate discharge detection technique. Self-inspection under § 118.11(b)(12) includes reliability checks and inspection, and EPA will provide compliance assistance.

Response Actions

Public Comment Summary:

Support

One commenter provided support for EPA’s proposed requirement that FRPs explain in detail how the facility will respond in the event of a discharge or substantial threat of a discharge to mitigate harm to the facility, public health, and the environment, including air and water sampling or monitoring (0215).

Oppose

One commenter recommended that EPA require facilities to contract with a third party to assess and monitor the community health effects following a hazardous discharge to a PWS and make this information publicly available (0216).

Another commenter suggested that EPA make response actions generic and applied based on the real case scenario, just like the generic approach used in the Oil Pollution Prevention FRP regulation. The commenter noted that the current response actions appear to be very descriptive, requiring supporting data and rationale. The commenter also mentioned that air and water sampling plans are part of the 21^st Century ACPs, and currently there are plans to elevate these to the Regional Response Plan Level. The commenter added that USEPA’s Region 6 Regional Response Team is already moving in this direction and the plans should be referenced by FRPs (0179).

One commenter noted that the proposed § 118.11(b)(13) is ambiguous on whether the FRP would need to include the facility’s plan for how to respond to a known risk of an imminent natural hazard. The commenter suggested that the final rule should explicitly state that FRPs must describe the actions facilities would take in response to an imminent risk of adverse weather to prevent or limit the impact of a worst case discharge (0215).

EPA Response:

EPA agrees with the commenter who provided support for proposed § 118.11(b)(13).

EPA has adjusted the language in this section to clarify that air monitoring and water sample collection, including analytical methods and laboratory support, must be described in this section. Monitoring and sampling are critical components of CWA hazardous substance release responses, since for some CWA hazardous substances, there may be no realistic means to implement containment, protection, and recovery response tactics once the substance enters a water, in contrast to oil discharges, where recovery is more likely feasible. Therefore, it is imperative that CWA hazardous substances be planned for accordingly.

Additionally, and in the same vein, EPA has added a requirement to identify types of environmental monitoring to be collected, including method collection techniques, parameter of interest measurement, a description of how the data will be used in a response, and personal protection and safety considerations. As part of the planning process, plan holders should be able to use the physical and chemical properties of their regulated CWA hazardous substances to meet the environmental monitoring requirements of the rule and to ensure the efficient collection of representative and useful data capable supporting incident-specific decisions. EPA recognizes the dynamic nature of a response and the need to maintain flexibility. Therefore, the rule does not require the use of specific monitoring equipment or collection of specific data or information. However, all FRPs should be coordinated with the relevant ACPs, as mentioned by one commenter.

A facility owner or operator; PWS; or responding federal, state, or local agency can determine whether it is necessary to contract with a third party to assess and monitor the community health effects following a hazardous discharge to a PWS and make this information publicly available. This will be part of the response actions to a discharge.

One commenter recommended that EPA require facilities to develop a safety plan prior to conducting sampling that considers variable factors like weather conditions, chemical hazards, and situational awareness. EPA notes provisions for worker health and safety are found at § 300.150 of the NCP. The Agency emphasizes that the NCP requires compliance with applicable worker health and safety regulations, including OSHA, under § 300.150(b) during a response action taken by the responsible party; the responsible party must ensure that an occupational safety and health program consistent with 29 CFR § 1910.120 is made available for protection of workers at the response site. EPA has clearly stated throughout this action that a worst case discharge is the largest foreseeable discharge in adverse weather conditions, including those due to climate change, where adverse weather means weather conditions that make it difficult for response equipment and personnel to clean up or respond to discharged CWA hazardous substances. Conditions may also be due to a natural hazard, such as one caused by, for example, an earthquake.

Disposal Plans

Public Comment Summary:

Support

One commenter provided support for the requirement for disposal plans of CWA hazardous substances following the same approach as provided in Oil Pollution Prevention regulation § 1.7.2, Appendix F of 40 CFR Part 112 (0179).

Another commenter provided support for EPA’s proposed requirement that FRPs explain how the facility plans to handle contaminated materials after a CWA hazardous substance discharge. The commenter added that EPA should finalize the disposal plans provision as written (0215).

Oppose

One commenter suggested that EPA should add the words “including groundwater” after “contaminated soil and water” (0167).

Another commenter suggested that in the preamble on page 87 FR 17919 (March 28, 2022), EPA should just state, “in accordance with federal (i.e., 40 CFR Part 260), state, and local regulations, where applicable” instead of “These plans must be prepared in accordance with federal (i.e., RCRA), state, and local regulations, where applicable. For example, a facility could follow the EPA publication, A Guidance Manual: Waste Analysis at Facilities that Generate, Treat, Store, and Dispose of Hazardous Wastes and Pre Incident All-Hazards Waste Management Plan Guidelines: Four-Step Waste Management Planning Process” (0179).

EPA Response:

EPA agrees with the commenter who supported proposed § 118.11(b)(14). The requirements are not exactly the same as those in the Oil Pollution Prevention regulation § 1.7.2, Appendix F of 40 CFR Part 112, since CWA hazardous substances are regulated differently than oils due to their disparate physicochemical properties.

EPA will provide compliance assistance on implementation of disposal plans. The preamble referred to ways a facility could comply with the requirements using EPA resources. There is no requirement to use the document referenced.

Containment Measures

Public Comment Summary:

Support

One commenter provided support for the containment measures provision if the intent is similar to the Oil Pollution Prevention regulation as noted under § 1.7.3, Appendix F of 40 CFR Part 112 (0179).

Another commenter provided support for EPA’s proposed requirement that FRPs describe all measures to provide adequate containment and drainage of discharged CWA hazardous substances to limit the threat of harm to human health and the environment (0215).

Oppose

One commenter recommended that EPA define the term “adequate containment” to prevent industry confusion and differences in interpretations by the Regions (0179).

Another commenter suggested that EPA add the words “that are designed and implemented to be protective of groundwater” after “discharged CWA hazardous substances” (0585).

One commenter stated that the final rule should go further to ensure containment measures do in fact limit the threat of harm to human health and the environment in the event of discharge. The commenter suggested that EPA should require FRPs to describe for each containment measure whether such a measure would be effective in the event of adverse weather or other hazards, including (1) during flooding onsite in the area of the containment or drainage measures; (2) in the event of a power outage; and (3) in the event of a discharge caused by an explosion. The commenter also suggested that EPA should require facilities to evaluate and describe in FRPs whether new or updated containment measures (1) would materially improve facility response capabilities in the event of a CWA hazardous substance worst case discharge (including by limiting the likely risk of harm to human health or the environment); and, if so, (2) would be practicable to construct, install, adopt, or contract for. The commenter added that for any facility that answers both questions in the affirmative for a specific containment measure, the final rule should require the facility to construct, install, adopt, or contract for that measure within one year (0215).

EPA Response:

The requirements in § 118(b)(15) are not exactly the same as those in the Oil Pollution Prevention regulation in Appendix F of 40 CFR Part 112, since CWA hazardous substances must be treated differently from oils due to their disparate physicochemical properties. EPA agrees with the commenter who supported the proposed containment measures requirements.

Adequate containment will vary based on the worst case discharge scenario and associated response actions as well as the physicochemical properties of the substance at issue and will consist of sufficient resources to contain the items described in § 118.11(b)(15). As per the statutory authority of this action under CWA § 311(j)(5), this is a response planning regulation, not a discharge prevention regulation. Inherently safer technologies and designs related to CWA hazardous substance storage and discharge prevention are outside the scope of this rule. Nonetheless, EPA notes that § 118.11(b)(15) includes requirements for measures to provide adequate containment and drainage of discharged CWA hazardous substances in a response scenario, as this is a response function.

Training Procedures

Public Comment Summary:

Support

One commenter provided support for EPA’s proposed requirement that facilities develop, and FRPs describe, the training program for response personnel, including EPA’s proposal to incorporate the OSHA standards for emergency response operations in 29 CFR § 1910.120 (0215).

Oppose

Several commenters suggested that the provision that requires facilities to work with and train volunteers and casual laborers who may respond to a discharge should be removed from the FRP requirements, and instead a public entity such as the LEPC should coordinate volunteer and casual laborer response activities (0175, 0187, 0194, 0204, 0218).

A few commenters noted that the requirement for facility employees to have HAZWOPER training if responding to a discharge is not necessary. The commenters suggested that HAZWOPER training should not be required as there is the likelihood of instances where responding to a discharge covered by the proposed rule would not require HAZWOPER training since there will be circumstances where passive mitigation is used, making the discharge controllable. The commenters also added that facilities should have the option of using a contractor with HAZWOPER training to respond (0175, 0191, 0218). One commenter noted that HAZWOPER training needs to be flexible and determined based on the onsite logistics and responders’ roles and responsibilities (0179).

One commenter requested that EPA consider that while facilities are responsible for training their onsite employees, they cannot be responsible for the training of separate individuals associated with SROs. The commenter suggested that facilities can inform their SROs that they require training, and can audit the training, but the obligation to keep and maintain those records must belong to the SRO and not the facility. The commenter also added that they do not support additional training for the QI requiring information collection training per 29 CFR § 1910.120(q)(6)(v). Since this is already required in the Oil Pollution Prevention regulation, the commenter suggested EPA reference those requirements where applicable for a relevant facility site (0205).

Another commenter stated that the requirements of 29 CFR 1910.120 are not applicable to all facility response personnel. The commenter recommended that EPA add flexibility to the rule by adding “or as appropriate for the responders’ roles and responsibilities,” which is consistent with the Oil Pollution Prevention regulation (0179).

The commenter noted that the training requirements for private response personnel and volunteer or casual laborers will prevent the use of these personnel in the response. The commenter suggested that the facility may say that these personnel should be trained in accordance with the requirements of 29 CFR § 1910.120, but the facility should not be responsible for the recordkeeping of non-company personnel. The commenter added that this would be consistent with the Oil Pollution Prevention regulation (0179).

The commenter also stated that the proposed rule does not clearly define the training program for facility response personnel; it implies that OSHA’s 29 CFR § 1910.120 training specific to CWA hazardous substances is required for facility personnel, but facility personnel are not specifically mentioned in § 118.13(b). The commenter noted that § 118.13(b) only specifies the requirements for volunteers or casual laborers and private response personnel. The commenter suggested that EPA needs to address this omission in the final rule (0179).

The commenter recognized that EPA is following the Oil Pollution Prevention regulation recordkeeping requirements under § 1.8.3 (Appendix F to 40 CFR Part 112) for maintaining training records “as an annex to the facility response Plan.” The commenter noted that this approach was changed in the promulgation of the SPCC rule to “Records of inspections and tests kept under usual and customary business practices will suffice for purposes of this paragraph” (40 CFR § 112.7(e)). The commenter recommended that EPA allow the same flexibility in this rulemaking (0179).

EPA Response:

EPA is retaining a reference to OSHA's 29 CFR § 1910.120 training specific to hazardous substances, while also ensuring that training is conducted for facility personnel, private personnel, casual laborers, and volunteer responders. This additional training will ensure that the full population of those who could respond to a worst case discharge are prepared. The Agency notes that OSHA's 29 CFR § 1910.120 already applies to emergency response operations for releases of, or substantial threats of release of, hazardous substances without regard to the location of the hazard (29 CFR § 1910.120(a)(1)(v)) and facility owners or operators should already be complying with these requirements. EPA has added language to § 118.13(b) to clarify that facility personnel are also subject to these requirements. However, in response to commenter concerns and consistent with the Oil Pollution Prevention FRP program, training may be specific to job tasks and personnel roles.

While some commenters suggested that the provision that requires facilities to work with and train volunteers and casual laborers who may respond to a discharge should be removed from the FRP requirements and instead a public entity such as the LEPC or TEPC should coordinate volunteer and casual laborer response activities, EPA disagrees, as this shifts the burden of properly training response personnel to the public, which is counter to the intent of the OPA. Additionally, there may be LEPCs or TEPCs that are inactive or do not have time, personnel, resources, or capabilities to provide this type of training. Should casual laborers or volunteers be participating in responses to CWA worst case discharges, they need adequate training to ensure their safety in an emergency situation. Moreover, demonstrating proper training a is both good a business practice and a critical safety component to emergency planning and preparedness.

EPA also disagrees that HAZWOPER training is not necessary for facility employees if responding to a discharge. As per OSHA, their HAZWOPER standards apply to emergency response operations for releases of, or substantial threats of releases of, hazardous substances regardless of the location of the hazard.

Under the terms of their contracts with an SRO, a facility owner or operator must verify that personnel are appropriately trained. The QI for a CWA hazardous substance FRP may not necessarily be the same person as the QI for the Oil Pollution Prevention FRP. Also, QI duties for a facility with a CWA hazardous substance FRP are not exactly the same as QI duties for an Oil Pollution Prevention FRP.

The Oil Pollution Prevention FRP regulation requires a training log for facility response personnel, which includes both facility employees and those under contract to the facility (§ 1.3.4 of Appendix F to 40 CFR Part 112). EPA has added language to § 118.13(b) to clarify that facility personnel are also subject to these requirements.

To account for modern business practices and the ease of electronic record storage, EPA has adjusted the documentation provision in § 118.13(b)(4) to allow records to be maintained under usual and customary business practices and either as an annex or included in the FRP.

Drills and Exercises

Public Comment Summary:

Oppose

Several commenters noted that in the hazardous waste generator emergency preparedness regulations, implemented in 1980, an owner or operator must only attempt to make arrangements with local responders and document any inability to complete these arrangements. These commenters recommended that the same standard be applied to requirements to conduct drills and exercises with the response community (0155, 0175, 0187, 0194, 0218).

One commenter expressed concerns that the requirement for responding facilities to conduct both tabletop exercises annually and full-scale field exercises every five years could overwhelm facility personnel and the local emergency response entity. The commenter recommended that facilities be given the option to conduct either an annual tabletop exercise or a full-scale field exercise once every five years. The commenter suggested that facilities should also be able to combine and be given credit for other emergency response exercises required by other authorities (0205).

Another commenter suggested that EPA should make clear in the final rule that the incorporation of the PREP standards includes those standards’ exercise-frequency requirements, including those applicable to plan holders (0215).

One commenter noted that facilities that are located in one or more drinking water ZOCs must be required to invite those utilities to participate in training exercises and drills, along with other public response officials, and the utilities must be given the option to participate in the drill if they so choose (0174).

EPA Response:

In § 118.13(c)(1), a facility owner or operator must coordinate with local public emergency response officials when appropriate and they shall be invited to participate. EPA has added language in § 118.13(c)(1) which allows a facility owner or operator to demonstrate through documentation that he or she has made a good-faith effort to coordinate. EPA notes that the PREP guidelines will be updated to reflect the requirements under 40 CFR Part 118, CWA Hazardous Substance FRPs.

The proposed rule contains language that states a program following PREP will be deemed compliant with the drill and exercise requirements of this section, and this provision is retained in the final action. The PREP guidelines state the frequency of exercises. Adjusting those is not within the scope of this rulemaking.

EPA disagrees with commenters who posited that utilities located in source water ZOCs described in the report “Occurrence of Releases with the Potential to Impact Sources of Drinking Water” (EPA 817-R-21-001) should be invited to participate in drills and exercises. The ZOCs used in the study described in the referenced report were intended to provide a uniform definition for identifying whether releases captured by the NRC would be included in the analysis or not. The methodology was not designed to identify worst case discharges to navigable waters or a conveyance to navigable water, nor utilities that would be affected by such a discharge. As noted in Section 2.6 of the referenced report: Limitations of the Methodology, “It is possible that releases significantly impacting a source of drinking water occurred outside a zone of concern. Conversely, it is also possible that releases within a zone of concern did not significantly impact the source water.” Thus, using ZOCs is not an effective or appropriate way to identify utilities that could potentially be affected by a worst case discharge of a CWA hazardous substance into or on the navigable waters or a conveyance to navigable water.

Self-Inspection

Public Comment Summary:

Support

One commenter suggested that EPA provide owner/operators with a “standard self-inspection checklist” so that all facilities are using the same format, and that the checklist be electronically submitted in the same manner as the substantial harm certification form and FRP (0201).

Another commenter provided support for the proposal to include written procedures and records of inspections of response-related measures, systems, and equipment in the FRP, but suggested the following (0215):

Require self-inspection procedures and records for all major response components covered in the FRP
Require retention of self-inspection findings for 10 years
Require disclosure of third-party inspection protocols and findings
Require facilities to maintain the results of any evaluations onsite for 10 years and provide copies with FRP updates

Oppose

One commenter noted that the areas or items that require self-inspection are not included in the proposed regulation and requested clarification (0188).

Another commenter mentioned that they did not understand the applicability of this requirement, because the scope seems to be limited to just response equipment, which is covered elsewhere (0179).

A commenter noted that non-transportation-related facilities that do a self-inspection would not be held accountable as they should be for the CWA hazardous substances that they may release. The commenter also suggested that a facility’s owner or operators should not be the only ones to inspect the facility. The commenter stated that there should be an inspector outside of the facility that visits to conduct the inspection (0250).

EPA Response:

EPA will provide compliance assistance with the requirements in § 118.11(b)(18) and is not adding additional requirements since response resources and equipment may vary widely. EPA has decided that five years in an appropriate retention period, which is consistent with the Oil Pollution Prevention FRP regulation. The scope of self-inspection is the facility’s CWA hazardous substance operations that could contribute to or be affected by a worst case discharge to navigable waters. EPA is not requiring third-party inspections, though there will be an EPA inspection program.

Alternative Approaches

Public Comment Summary:

Oppose

One commenter suggested that EPA require FRPs to disclose whether the facility is subject to any of the discharge-prevention requirements the Agency relied upon in 2019 to refuse to issue general discharge-prevention regulations for CWA hazardous substances (0215):

CWA NPDES Pretreatment Standards
TSCA PCB regulations
CWA Effluent Guidelines and Standards for specified industries
CWA NPDES Multi-State General Permit for Industrial Stormwater
CAA Risk Management Plan regulations
CWA oil SPCC regulations
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Management regulations
FIFRA Worker Protection Standards
RCRA Generators regulations
RCRA Treatment Disposal and Storage Facility regulations
SDWA UST regulations

Another commenter noted that there should be a plan within the FRP addressing emergency relocation of affected individuals living around a facility (0153).

EPA Response:

EPA disagrees that facilities need to disclose other programs under which a facility may be regulated. Using facility information or EPA ID numbers, a user can look up this information using EPA tools like the FRS. The 2019 action is separate from this action, which is under a different statutory authority, and thus prevention is outside the scope of this rulemaking.

Emergency relocation for affected individuals living around a facility is outside the scope of this action.

Require ICS/organizational structure

No comments

Responding v. non-responding facility requirements

No comments

Resources/equipment time requirements

No comments

Emergency Response Action Plan

Public Comment Summary:

Support

One commenter agreed that EPA should incorporate an Emergency Response Action Plan (ERAP) requirement into the final rule and the ERAP should at least include the information required for ERAPs in the Oil Pollution Prevention FRP regulation context. The commenter noted that the ERAP should require a facility to prepare an ERAP for each CWA hazardous substance stored onsite above the applicability threshold that has either a distinct receptor or response-equipment requirement (0215).

EPA Response:

EPA agrees with the commenter and has added a provision requiring an ERAP, similar to the provision under the Oil Pollution Prevention FRP regulation at 40 CFR § 112.20(h)(1) in § 118.11(c). This requirement will provide important site-specific information for facility personnel and responders. EPA has found ERAPs to be important to plan holders responding to oil spills and expects that a CWA hazardous substance FRP ERAP will be similarly critical for responders to a CWA hazardous substance worst case discharge into or on navigable waters or a conveyance to navigable waters. EPA disagrees that an ERAP should be prepared for each CWA hazardous substance stored onsite above the threshold quantity, since multiple plans could prove confusing and duplicative.

Implementation and Enforcement
1. Office Delegation

No comments

Confidential Business Information (§ 118.4(d))

Public Comment Summary:

Support

One commenter offered general support of EPA’s approach to CBI in the proposed rule, which would require facilities that seek to claim CBI protections for portions of their FRP to submit an unredacted version of the FRP; a version that redacts the claimed CBI; and a separate document supporting its claim of confidentiality. The commenter recommended EPA also apply this to substantial-harm analyses, to the extent a facility seeks CBI protections for any supporting documentation submitted with the substantial-harm analysis. The commenter suggested that it will make it easier for EPA to provide undisputed non-CBI information to the public if facilities are required to submit both complete and sanitized (or redacted) versions of documents. The commenter urged EPA to finalize the CBI claims process in proposed § 118.4(d)(2)(iii) and apply the same principles to cover substantial harm analyses and supporting documentation (0215).

The commenter supported the CBI claims in 40 CFR § 118.4(e) as written, including the requirement that any claims must be accompanied by a signed certification attesting to accuracy of the substantiating information and that the claimed CBI, if disclosed, would be likely to cause substantial harm to the business’s competitive position. The commenter stated that incorporating these requirements will help reduce the incidence of frivolous CBI claims and help EPA police those claims, resulting in broader public access to critical information about the safety of their communities and better public oversight in the CBI process (0215).

The commenter supported EPA’s decision to fully exempt from CBI claims certain information that does not convey any sensitive business information. However, the commenter added that EPA must clarify the term “data” in the proposed rule because the difference between “information” and “data” is currently unclear. The commenter requested EPA be more specific as to that distinction so that the facilities and the public understand precisely what EPA has exempted from CBI claims. The commenter urged EPA to exempt all information included in substantial-harm analysis Appendix A from CBI claims, and to otherwise define “data” broadly so that core FRP information remains exempt from the CBI process (0215).

The commenter agreed with EPA’s proposal to require robust substantiation of CBI claims and to exempt certain information from CBI claims altogether. The commenter urged EPA to develop and announce a CBI audit plan to ensure facilities are limiting their CBI claims to information that is actually likely to cause substantial harm to the business’s competitive position. The commenter noted that this will fall on the public, often through disputes in the FOIA process or reverse-FOIA lawsuits, if EPA does not provide oversight. The commenter stated that a commitment and plan to audit CBI claims for FRPs and substantial-harm analyses will help further prevent CBI abuses and ensure that EPA and the public have access to critical emergency planning information, while preserving industry competitiveness (0215).

Oppose

One commenter expressed their concern about certain data being publicly available. The commenter noted that some regulated facilities are also currently regulated under CFATS/Maritime Transportation Security Act security regulations and could be exposing vulnerabilities under the proposed regulations. The commenter recommended EPA understand the sensitivity of this information and provide safeguards to ensure access is limited (0179).

One commenter emphasized that there should not be any impediments to providing drinking water utilities with toxicity information related to the treatment of any of the listed chemicals. The commenter recommended that chemical names and properties should be excluded from CBI claims because utilities may have little time to react. The commenter also recommended that information about the chemicals’ toxicity and treatability be offered to the utilities, or at least be provided if requested by a downstream utility before any spills so the utility can proactively develop contingency plans (0174).

Security Concerns

Several commenters highlighted security concerns if certain information is publicly available (0175, 0179, 0187, 0191, 0192, 0194, 0197, 0204, 0205, 0206, 0218). Several of these commenters emphasized their concern over the potential release of sensitive information that is contained in FRPs and substantial harm criteria assessments (0175, 0187, 0191, 0194, 0204, 0218). Several commenters are concerned that information about the location of dangerous chemicals could be made publicly available (0175, 0179, 0187, 0191, 0194, 0204, 0206, 0218). The commenters stated that this information is important because it contains sensitive business information and locations of several potentially dangerous chemicals that are regulated under CFATS. The commenters expressed concern that if this information is publicly available, it could present serious consequences from a business and security perspective (0175, 0187, 0191, 0194, 0204, 0218).

While one commenter generally supported making relevant information available to LEPCs, the commenter expressed concern over the balance with potential information security risks given the current threat environment. The commenter strongly encouraged EPA to consult with the appropriate security authorities before proceeding with requiring the disclosure of such information. The commenter referenced the historical collaboration of EPA with the Department of Justice (DOJ) during the development of the RMP information disclosure requirements. The commenter strongly encouraged EPA to conduct a similar exercise, especially given the growing threat of cybersecurity attacks directed toward operational technology. The commenter noted that release of this information would enable cyber hackers to selectively target infrastructure that would have high value and high impact consequences. The commenter recommended EPA work with DHS, DOJ, and other appropriate agency security and cybersecurity experts. If these meetings have already occurred, the commenter was curious to understand what recommendations were made, whether EPA adopted these recommendations in whole or in part and whether there are any inconsistencies between the current recommendations and the prior DOJ assessment (0197).

A couple of commenters added that the proposed rule should follow similar provisions consistent with EPCRA (0179, 0205). One commenter explicitly noted EPCRA § 312 reports as these reports keep information regarding locations of chemical storage facilities confidential. Additionally, the commenter noted that under EPCRA § 324, a facility may elect to withhold location information on a specific chemical from disclosure to the public. The commenter recommended EPA handle this information as sensitive security information, like a USCG Facility Security Plan (0179). One commenter referenced the 1997/1998 RMP Rule that notes facility risk modeling information should be treated confidentially because it may provide information about the location of hazardous chemicals (0206).

Several commenters recommended that EPA only allow information to be made available to those who truly have a need to know (0175, 0187, 0191, 0194, 0204, 0218).

Personnel

A couple of commenters stressed concern over protecting the privacy of a facility’s personnel (0192, 0205). One of these commenters recommended EPA not require contact information of individual employees to be publicly available and that the proposed rule should remain consistent with EPCRA to ensure the safety of personnel (0205). One of these commenters is concerned that EPA has not taken sufficient steps to inform the regulated community about how this extensive and detailed information will be stored, used, and safeguarded (0192).

EPA Response:

EPA agrees with the commenter who supports § 118.4(d) and notes that § 118.4(d)(2) allows a facility owner or operator to seek CBI protection for their Appendix A supporting documentation, but not data required by Appendix A, which include substantial-harm analyses. Additionally, a facility owner or operator may not seek CBI protection for data in § 118.11(b), “Emergency response information,” which includes the substantial-harm analyses in § 118.11(b)(3), “Hazard evaluation.” These data and information are critical to EPA, SERCs, and LEPCs for emergency response planning and preparedness. Moreover, they do not convey any business sensitive information. The Agency has used the terms “data” and “information” interchangeably, and the regulated community should interpret them as such.

To the commenter who suggested EPA initiate an audit plan, the Agency will evaluate the need for such a program as implementation progresses.

EPA agrees with commenters concerned about security and the sensitivity of certain types of information and will work with its federal partners such as DHS and DOJ and other appropriate agency security and cybersecurity experts to determine which parts of the FRP may not be made publicly available. Additionally, the Agency takes personal privacy seriously and will ensure the safety of individual information and data. This type of data is routinely collected and safeguarded by EPA and other federal agencies.

EPA agrees that that there should not be any impediments to providing drinking water utilities with toxicity and information related to the treatment of any of the listed chemicals. The type of information about which the commenter is concerned is in § 118.11(b)(3) Hazard evaluation, for which an owner or operator may not seek CBI protection.

Consistency with the NCP/Adjustments to 40 CFR Part 300

No comments

Additional Considerations
1. Communities with Environmental Justice Concerns

Public Comment Summary:

Several commenters supported EPA’s intention to address environmental justice concerns but requested additional clarity on the discretion of the RA and what they must consider (i.e., factors, criteria) in evaluations (0183, 0199, 0205, 0211, 0212, 0213). Two commenters noted that clear criteria would provide guidance to the regulated community, making implementation predictable and uniform in application (0205, 0212). One of these commenters stated that EPA should implement clear, scientifically credible, risk-based processes that refrain from duplicating requirements and avoid added burdens. The commenter urged the development of risk-based criteria through an open and transparent public process with notice and comment. The commenter urged EPA and RAs to account for existing stewardship programs and industry-community relationships, including referencing existing FRPs under the SPCC program as well as company-specific programs before proposing new requirements (0205).

Two commenters claimed that the proposed rule did not explain why the RA’s discretion is necessary, noting that if a facility does not meet substantial harm criteria it is not clear how a community with environmental justice concerns would be adversely impacted, particularly given that comprehensive substantial harm criteria should protect all communities. Because of this, the commenters claimed that the RA’s authority to require FRPs for facilities not meeting substantial harm criteria due to environmental justice concerns is improper, beyond EPA’s authority under the CWA statute, and should be limited through clear factors that the RA will consider (0199, 0211). One commenter noted that the RA could require an FRP based on proximity to a community with environmental justice concerns and regardless of risk posed to the community by any CWA hazardous substance release. The commenter recommended that the RA should only evaluate facilities based on the same self-determined factors used to determine FRP submission (0183).

One commenter requested that EPA prescribe specific analysis and consultation for assessing hazards to communities with environmental justice concerns, stating that the proposed rule does not sufficiently address impacts in communities with environmental justice concerns (0216). Several commenters called for the EPA to add specific substantial harm criteria to assess CWA hazardous substance discharge risks that may disproportionally impact communities with environmental justice concerns (0169, 0182, 0215, 0217). Citing the disproportionate proximity of people of color and people living in poverty to RMP facilities as well as flooding vulnerability in these communities, one commenter suggested that EPA put the onus on facilities to determine if they are located within one-half mile of a community of color and/or low-income community as an independent substantial harm criterion (0217). Another commenter suggested the same criterion based on a one-mile distance to any census tract identified as having communities with environmental justice concerns (0182).

Two commenters suggested requiring the use of best available environmental justice screening and mapping tools, including EJScreen, the White House Council on Environmental Quality’s Climate and Economic Justice Screening Tool, and state-based tools (0182, 0217). One commenter suggested a default analysis using EJScreen, specifically defining communities with environmental justice concerns based on EJScreen’s “people of color” and “low income” indicators as compared to state-wide averages. The commenter suggested that the rule define these communities as any census tract or block group with either “(a) a “People of Color” indicator value greater than or equal to the average within its state or (b) a “Low Income” indicator value greater than or equal to the average within its state, and that facilities with boundaries within one mile of such a community meet initial screening criteria. The commenter noted that EJScreen is easy to use, transparent, and dynamic, and that using proximity to communities with environmental justice concerns as defined would allow community access to substantial harm certifications even when facilities may not need to prepare an FRP (0215). This commenter requested that EPA include impacts to communities with environmental justice concerns within hazard evaluations using the definition that they provided, and that the rule require facilities to consult communities via public fora with opportunities for written feedback, as well as considering the ability of a community to evacuate and how to communicate with the communities with environmental justice concerns in the event of a discharge (0215).

Two commenters addressed communication both before and in the event of a discharge (0170, 0217). One commenter noted the importance of LEPCs in worst case discharge planning and requested that EPA include in § 118.11 that, upon a request by a LEPC, facilities make provision to provide plan and release notification information in the predominant languages spoken (other than English) and by communication methods predominantly used by a community, following best practices in emergency planning and public health (0170).

Via a mass comment campaign, many commenters reiterated the disproportionate burden on black, brown, and poor communities from pollution due to their residency adjacent to facilities producing and storing hazardous chemicals (0172). A separate commenter requested that EPA include a structure to provide reparations to communities with environmental justice concerns who have been previously impacted by imperfect planning for CWA hazardous substance worst case discharges in the past (0147). One commenter requested that EPA specifically enforce the rule in communities with environmental justice concerns due to the increased economic power that facilities may have in these areas (0293).

One commenter stressed the challenge of remediating groundwater once polluted, and how this may disproportionately impact underserved communities. The commenter noted that the preamble’s claim that applying drinking water standards (MCLs) at the water intake is unnecessary does not account for the fact that many small groundwater PWSs only disinfect water (i.e., they do not have sophisticated treatment options), and these vulnerable systems are commonly found in underserved communities that depend on groundwater (0198).

Several commenters requested that EPA remove requirements to examine communities with environmental justice concerns from hazard evaluations. The commenters stated their concern that extensive hazard evaluations will be very difficult to carry out and put unnecessary costs on facilities. The commenters suggested that examining “impact” to communities with environmental justice concerns is vague, and it is therefore unclear how facilities are expected to utilize this information. The commenters claimed that examining impacts to environmental justice communities goes beyond the scope of the CWA (0175, 0187, 0191, 0194, 0204, 0218).

EPA Response:

EPA recognizes the commenter support for addressing communities with environmental justice concerns. The Agency will provide compliance assistance as to what facility owners or operators must consider in their evaluations and provide resources, which could include EPA’s EJScreen, FEMA’s National Risk Index, or other publicly available databases and mapping systems. Existing stewardship programs through partnerships or company initiatives may fulfill the hazard evaluation (§ 118.11(b)(3)) requirement to examine impacts on these communities or be augmented to do so.

The Agency is not including a specific substantial harm criterion for impacts to communities with environmental justice concerns due to the breadth of considerations necessary. Instead, as per § 118.5, RAs may determine that a facility could cause substantial harm to the environment based on impacts for communities with environmental justice concerns, thereby triggering the need to develop an FRP. This could be based on the location of the facility in relation to the community with environmental justice concerns and the characteristics of the CWA hazardous substance in question on site and its potential impacts in a worst case discharge into or on the navigable waters or a conveyance to navigable waters on that community. Additionally, as per § 118.7, a member of the public may petition the RA to consider requiring submission of an FRP based on those concerns. EPA maintains that these two mechanisms allow flexibility beyond the generally applicable criteria.

The criteria in 40 CFR § 118.3 are designed to capture the bulk of those facilities that could reasonably be expected to cause substantial harm to the environment. However, because of the size and diversity of the types of facilities within the regulated community, EPA believes that there are facilities that will not meet the criteria in § 118.3, but may, due to facility-specific or location-specific circumstances, pose sufficient risk to the environment to be designated as being able to cause substantial harm to the environment. Accordingly, EPA has included the ability of the RA to make a case-by-case determination. The Agency recognizes that RAs possess unique knowledge of Region-specific considerations, and it is consistent with EPA’s responsibilities under EO 12777 to designate facilities on a case-by-case basis that could reasonably be expected to cause substantial harm to the environment.

Additionally, once a facility is subject to the regulation, the facility owner or operator must consider impacts to communities with environmental justice concerns in their hazard evaluation as per § 118.11(b)(3). EPA is not defining those communities here but will provide compliance assistance. Facility owners or operators may also consult publicly available tools such as EJScreen or FEMA’s National Risk Index as a resource. This final rule does not require consultation with communities with environmental justice concerns; other avenues of participation for the public in the response planning process include involvement in the ACP development process or participation in the LEPC or TEPC. The Agency is requiring evacuation plans to be coordinated with community evacuation plans.

In terms of public health messaging and communications, these decisions are typically made during responses by an incident commander who may or may not be affiliated with the facility; this regulation is not the mechanism for determining exactly how announcements should be made.

Requiring reparations is outside the scope of this rulemaking.

EPA disagrees with commenters who urged removal of requirements to examine communities with environmental justice concerns from hazard evaluations. Communities with environmental justice concerns have been historically disadvantaged and disproportionately impacted by industrial operations. Continuing to disregard their concerns is counter to EPA’s mission to protect the environment. As discussed in the Preamble to the proposed rule, there is clear evidence of co-location of historically marginalized populations and hazardous substances. Specifically, the co-location assessment confirms that industrial facilities and ASTs are disproportionately located in these communities and RA authority for case-by-case assessments will add protection for this historically disadvantaged communities.

Climate Change Risk Considerations

Public Comment Summary:

Support

Several commenters requested that EPA provide guidance and clarification on how to consider climate change (0172, 0179, 0197, 0199, 0211, 0213). One such commenter generally claimed that the proposed rule does not provide sufficient direction for facility compliance and requested EPA provide clarification and develop guidance on climate change-related impacts and associated vulnerabilities for facilities (0197). Another commenter referred to the United Nations conception of climate change as referring to long-term wind and temperature shifts and claimed that changes in weather pattern and temperature change would occur over time periods longer than the FRP’s proposed five-year cycle. The commenter requested that EPA clarify the procedure that facilities should use to address climate change in planning distances and specify the climate change-induced adverse weather effects, as well as chronological constraints, that facilities are to consider when establishing planning distances (0179). Relatedly, two commenters noted the unpredictability and breadth encompassed by climate change as a concept and sought guidance as to what kinds of weather events, which may be highly unpredictable, should be considered and how to model them. The commenters suggested following the definition for “adverse weather” in 40 CFR § 112.2 and requested guidance from EPA both on how climate change impacts should influence FRPs and how to evaluate potential vulnerabilities that are not necessarily extreme weather events, such as sea level rise (0199, 0211). One commenter noted their support for climate change resiliency but requested specific clarification on § 118.5(b)(7), including passive mitigation systems that enhance resilience to climate change, and requested general guidance on the requisites from EPA that must be considered for climate change resiliency (0213).

One commenter suggested that EPA should strengthen the proposed rule by providing additional guidance to facilities on how to consider climate change in FRPs. The commenter added that EPA should require hazard evaluations to use the best available climate data when evaluating climate risks because the climate is changing rapidly compared to historical conditions (0217).

One commenter was concerned that the wide authority given to the RA could be used to require that all facilities in a floodplain prepare an FRP regardless of the risk involved. The commenter claimed that this broad authority is unnecessary if the facility accurately assesses the risks of a worst case discharge scenario and recommended that the RA only have the authority to evaluate facilities based on the same factors considered in a facility’s self-determination of the need to submit an FRP (0183).

Several commenters stated their concern regarding climate change impacts (0172, 0182, 0308, 0347). One commenter stated that climate change is making extreme weather events more frequent and more severe, which increases the risk of discharge and subsequent threats to public health and the environment (0172). One commenter noted the potential for long-term health effects following a worst case discharge and stated that the actions in the proposed rule were a step in the right direction to ensure safety (0308). One commenter stated their concerns regarding increasing flooding, specifically the risks of discharges from chemical and fertilizer manufacturers into the Gulf and noted their strong support for the proposed rule as one step towards planning for and safely managing flooding (0347).

One commenter noted their specific concerns regarding the risks for non-petroleum ASTs due to climate change. The commenter cited several studies on ASTs, finding that AST releases often resulted in evacuations, represented around one tenth of spills reported to the NRC between 1990 and 2008, and occurred due to tank flotation during floods or hurricanes. The commenter cited a report finding that one-third of facilities regulated under RMP are already exposed to adverse weather risks but noted that coastal regions face the greatest risk of harm due to AST releases, particularly because of flooding and storm surge. The commenter identified several state regulations specifying planning for adverse weather with respect to ASTs that vary in their individual requirements and the concluded that the proposed rule would be instrumental in closing regulatory gaps (0182).

One commenter stated that, because climate change could impact factors such as the distance to navigable waters, EPA could plan to reassess risks of a CWA hazardous substance worst case discharge scenario at a regular interval to see if the proposed action requirements remain effective (0346). One commenter supported the preventative measures included in the rule and claimed that sufficient investment in worst case scenario planning and response will prevent the need for additional resources in environmental protection (0220).

Several commenters requested that EPA strengthen the proposed rule’s consideration of climate change through additional guidance and criteria (0168, 0169, 0215, 0216, 0217). One commenter stated that extreme weather is causing “natech incidents” (i.e., natural hazards triggering technological disasters) with increasing frequency and cited a General Accountability Office report that recommended EPA provide guidance for RMP facilities on incorporating climate change into risk management. The commenter then asked EPA to additionally provide guidance for facilities to assess their vulnerability to climate change impacts and how to account for that in their FRPs (0217).

A few commenters requested that EPA require that hazard evaluations use up-to-date projections of climate risks as specified by EPA (0215, 0216, 0217). Two of these commenters suggested the NOAA tidal flooding and sea level rise projections, FEMA’s National Risk Index, and the U.S. Department of Agriculture’s Fire Hazard Potential datasets as examples (0215, 0217). One of these commenters asked that the final rule require coastal facilities to assess NOAA’s 90^th percentile sea level risk projections for 2050 or another reasonable time frame. The commenter noted that EPA should require facilities to consider simultaneous hazards as well, which increase discharge severity and may inhibit facility response capability. The commenter urged EPA to specify that facilities cannot rely solely on historical data and must describe the data that they considered in their FRPs to enable EPA and stakeholders to evaluate the adequacy of a facility’s climate risk evaluation. The commenter suggested that EPA provide additional direction for facilities on how to integrate climate change and natural hazards into their risk management. The commenter stated that this would aid facilities in effectively evaluating climate risks and aid EPA staff when evaluating facility plans (0215).

One commenter suggested that EPA utilize a well-established future climate scenario for relative sea level change as an additional substantial harm criterion to determine facility vulnerability (0168).

Oppose

Several commenters requested that EPA remove requirements to consider climate change impacts from hazard evaluations. The commenters stated their concern that extensive hazard evaluations will be very difficult to carry out and put unnecessary costs on facilities. The commenters indicated that the proposed requirements are ambiguous due to their not providing a standard threshold for “consider.” The commenters questioned if they were required to model how climate change may affect endpoint distances or simply acknowledge changing environments. They claimed that it was not clear if it was even possible for facilities to accurately predict the impacts of climate change on their surroundings and that attempting to do so would be a monumental, or even impossible, task, especially for small businesses (0175, 0187, 0191, 0194, 0204, 0218).

EPA Response:

EPA appreciates the concerns raised by the commenters and understands that the unpredictability of the breadth of the impacts of climate change makes them challenging to assess. Because the impacts of climate change continue to expand, EPA expects to provide ongoing compliance assistance to help facilities with the climate change considerations in the final rule. That said, EPA disagrees that climate change impacts are occurring on a longer-term scale than can be considered within the FRP’s five-year cycle. For example, the increase in severity and frequency of severe weather, including conditions resulting in flooding or drought, is a clear impact of climate change that should be considered by a facility owner or operator when evaluating their worst case discharge scenarios.

While some might argue that historical data are the best available, the Agency agrees with commenters who stated that owners or operators should use the best available climate data and projections when evaluating climate risks because the climate is changing rapidly compared to historical conditions. The commenter-cited resources including NOAA’s tidal flooding and sea level rise projections, FEMA’s National Risk Index, and the U.S. Department of Agriculture’s Fire Hazard Potential datasets are all valuable resources for these analyses. As part of ongoing compliance assistance, EPA expects to make existing and evolving data sources and tools available. The Agency recognizes that these evaluations are not without costs; however, due to the known risks of increasing and more frequent severe weather and other climate change impacts, their inclusion in this action is vital to ensure protection of the environment.

To the commenter concerned about RA authority, EPA maintains that there are facilities that do not meet the criteria in § 118.3, but may, due to facility-specific or location-specific circumstances, pose sufficient risk to the environment to require the preparation and submission of an FRP. To assist RAs in achieving nationwide consistency, EPA intends to outline specific screening procedures for use by RAs and to foster consistency in how the substantial harm and significant and substantial harm factors are applied.

EPA agrees with commenters who are concerned with climate change and who support this action. The Agency also notes that FRPs must be recertified every five years as per § 118.4(a)(6), which will give facility owners or operators the opportunity to reassess their worst case discharge scenarios. EPA appreciates the suggested data and information sources suggested by commenters and will evaluate them for use in compliance assistance.

Facility Density

Public Comment Summary:

Support

Two commenters stated that the final rule should consider facility and co-located chemical density for substantial harm criteria and FRPs (0215, 0216). One commenter stated that EPA should strengthen the required hazard evaluation by mandating consideration of cascading effects on co-located or proximate facilities (0216).

One commenter noted that EPA has recognized that the risk of cascading effects on co-located or proximate facilities, especially since many CWA hazardous substances are flammable, as well as chain-reaction failures, which are not only possible, but such incidents have occurred. The commenter suggested that EPA delay the compliance date for this specific requirement until the Agency can gather all necessary information to develop geographic Density Hazard Zones. These would be defined based on the density of CWA hazardous substance facilities in the area; the nature of those facilities and the chemicals they store; nearby FWSE, public drinking water intakes, and/or public receptors; and the risk of adverse weather and other natural hazards that increase the risk of multiple or cascading discharges from facilities within the area. The commenter suggested that any facility that meets the initial screening criteria and is located at least partially within a Density Hazard Zone be required to prepare an FRP.

The commenter noted that EPA-defined Density Hazard Zones would have several benefits, including ensuring consistent treatment of facilities within an area. The commenter stated that an EPA-led approach would also make sense because EPA would already have necessary information, such as substantial harm analyses and FRPs and TRI data, to make determinations, and it could facilitate a community-driven process by allowing stakeholders to petition EPA to define proximate areas as Density Hazard Zones. The commenter suggested that EPA define any Density Hazard Zones after receiving the first batch of substantial harm certification forms, within one year of the deadline for the first substantial harm certification forms, because then EPA will be able to determine where dense concentrations of CWA hazardous substance facilities are located and how many are preparing FRPs. The commenter suggested EPA review, update, and define new Density Hazard Zones periodically. The commenter also suggested that EPA consider incorporating Density Hazard Zones as part of the initial screening phase, such as requiring facilities within Density Hazard Zones to use a lower RQ multiplier (0215).

Oppose

One commenter opposed requiring coordination based on facility density as there are many factors, including greenbelts, facility design, spacing requirements, facility size, and manufacturing processes, that complicate considerations for facility density and make it so facility density does not predicate higher risk. The commenter also pointed out that there are no requirements for facilities that do not share common ownership to coordinate thresholding activities in other emergency preparedness regulations (e.g., EPCRA). The commenter urged EPA to be mindful that there are already existing agreements and relationships in place when there is a need for additional support to a facility during an emergency (0205).

EPA Response:

EPA recognizes the increased risk of worst case discharges in areas with a high density of CWA hazardous substance facilities that could be involved in an incident impacting multiple sites. EPA also recognizes that there are many factors, including greenbelts, facility design, spacing requirements, facility size, and manufacturing processes, that complicate considerations for facility density. Accordingly, EPA has determined that this is best considered on a case-by-case basis and that RAs are best positioned to evaluate the potential effects of cascading failures at multiple co-located facilities due to their unique knowledge of their Regions. Therefore, in § 118.5(b)(10), EPA has included density of facilities in the immediate area with CWA hazardous substances onsite as a factor that an RA may consider in determining whether to require that a covered facility owner or operator to submit an FRP. EPA notes, however, that the hazard evaluation (§ 118.11(b)(3)) must already consider local businesses that could be affected by a worst case discharge. Accordingly, the RA must take all these site-specific circumstances into account when making a determination.

Developing Density Hazard Zones is outside the scope of this rulemaking.

Statutory and Executive Orders Reviews
1. Executive Order 12866: Regulatory Planning and Review; Executive Order 13563: Improving Regulation and Regulatory Review

Public Comment Summary:

Support

Several commenters stated that EPA released an estimate showing the potential benefits of the proposed rule outweigh the costs (0151, 0166, 0249, 0256). One commenter stated that despite being skeptical of governmental regulations, the proposed rule asks the bare minimum of facility owners or operators, does not appear to have an exorbitant financial cost to the facility owners and operators, and the cost/benefit analysis favors the facility owners or operators because they will be able to plan for worst case scenarios and hopefully mitigate any potential environmental contaminations (0249).

Oppose

Many commenters stated the proposed rule will result in extreme and unnecessary costs to regulated parties, asserted EPA has severely underestimated costs, and urged EPA to work with impacted facilities to assess the economic burden more accurately (0175, 0179, 0187, 0191, 0192, 0194, 0199, 0204, 0205, 0218).

Several commenters emphasized that the estimates are too low, particularly for chemical distributors with the NAICS code of 4246 (0175, 0187, 0191, 0194, 0218).

Several commenters stated that costs of comprehensive endpoint modeling and training are higher than the costs EPA estimated (0175, 0191, 0194, 0204), potentially higher than $10,000 per year (0175).

Two commenters stated that facilities not covered by the proposed rule but satisfying the first two criteria are still required to submit substantial harm certification forms, which forces them to invest significant capital and undergo expensive endpoint modeling (0191, 0204).

One commenter stated that facilities will need to spend significant resources and time to: (1) determine whether they meet the initial screening criteria; (2) determine whether they meet one of the substantial harm criteria; (3) prepare an FRP and complete complex hazard evaluations; and (4) potentially revise the FRP (0192).

One commenter stated that EPA’s designation of “lack of passive mitigation” as a substantial harm criterion forces facilities to retrofit their site, a cost that could reach up to $500,000 for a small facility, and EPA’s requirements to assess additional endpoints is not necessary because EPA acknowledges earlier in the proposed rule that planning for a worst case discharge ensures that facilities are equipped for any foreseeable discharge that may occur (0191).

One commenter requested that EPA review its cost estimates because they are not reflective of actual scenarios at current facilities (0205), and two commenters stated that EPA greatly underestimated the number of facilities implicated under the proposed rule (0205, 0179).

One commenter stated that applying the special federal response planning requirements to thousands of facilities conflicts with the targeted nature of the EPA’s statutory authority and undercuts the CWA’s purpose by diluting the focus and reducing public and private planning resources (0205).

One commenter stated that the EPA’s one-time cost estimate of $44 million to the regulated community and recurring cost of $25 million is a gross underestimate for the following reasons:

Threshold capacity values indicate that most refining petrochemical and terminal facilities subject to 40 CFR § 112.20 will also be subject to the proposed rule, implicating many more facilities than EPA estimated.
The hours required for facilities to familiarize themselves with new regulations is likely to take many more hours at a higher rate than EPA estimated.
The number of reported discharges from 2010 to 2019 is significantly small (131) compared to the number of facilities that were storing CWA hazardous substances (102,917) and does not justify the need to add a significant cost burden to the regulated community
Developing response plans for the “most frequently” reported discharges (sulfuric acid, sodium hydroxide, hydrochloric acid, sodium hypochlorite, and chlorine) will be limited to containing the release before it reaches navigable waters and does not justify the need to add a significant cost burden to the regulated community.
EPA underestimates the burden of creating an initial FRP on a facility by 54 percent—the estimated hours to complete the FRP should not be reduced due to overlap between Oil Pollution Prevention FRPs and RMPs because there are differences in the regulations.
EPA underestimates the cost of manpower for environmental engineers who will develop the FRPs because this support will likely be provided by third-party consulting firms and not developed in-house; thus, consultant rates of $125–$165 per hour rather than $67.41/hour should have been used.
EPA’s assumption that 2,233 facilities would trigger the threshold capacities and would require further evaluation of the substantial harm determination and require 11 hours per facility for rule familiarization is a drastic underestimate of the time required.
EPA’s estimate of its burden—37 reviewing and approving hours—grossly underestimates the Agency’s needs, manpower, and planning for implementation guidance, which will impact other programs over a series of years (0179).

One commenter stated EPA has not satisfied its duty to weigh the costs and benefits of the proposed action under case law and EOs 12866 (Clinton) and 13563 (Obama). The commenter stated that while EPA has provided an estimate of costs (this commenter believes they are not accurate), EPA has not provided a comparable estimate of benefits that the proposed action would produce as required (citing Entergy Corp. v. Riverkeeper, Inc., 556 U.S. 208, 222 (2009); Michigan v. EPA, 576 U.S. 743 (2015); Motor Vehicle Mfrs. Ass’n, Inc. v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 43 (1983)) (0205).

One commenter stated EPA abrogated its obligation to comply with the notice and comment procedures of the APA by failing to provide sufficient, and sufficiently robust, data on potential costs of the rule and potential benefits to enable commenters to assess the relationship between costs and benefits and to judge the adequacy of EPA’s consideration of those factors (citing Portland Cement Ass’n v. Ruckelshaus, 486 F. 2d 375, 393 (1973); Banner Health v. Price, 867 F.3d 1323, 1336 (D.C. Cir. 2017); Owner-Operator Independent Drivers v. FMCSA, 494 F.3d 188, 199, 202-203 (D.C. Cir. 2007)) (0205).

One commenter stated the proposed rule should require FRPs only for CWA hazardous substances that meet the threshold quantity (in excess of 10,000x RQ) because EPA provides no support for its conclusion that a single CWA hazardous substance present at a facility should trigger the applicability of the Hazardous Substances Worst Case Discharge Planning Regulations, requiring application of onerous regulations to all CWA hazardous substances at the facility regardless of the maximum storage capacity for those CWA hazardous substances. This commenter noted it is unclear whether EPA’s cost analysis captures these compliance costs (0197).

EPA Response

The Agency recognizes commenters’ support for the final rule.

The Agency disagrees that the EPA has severely underestimated costs. EPA recognizes commenters’ concern that facilities will need to spend time and resources to determine whether they meet the initial screening criteria and beyond that, if needed, additional time and resources to determine whether they meet one of the substantial harm criteria and, if so, to prepare an FRP and complete complex hazard evaluations as well as potentially revise the FRP. Nonetheless, the Agency has accounted for these costs, as well as all other aspects of the regulatory program, in the final RIA.

The Agency disagrees that EPA abrogated its obligation to comply with the notice and comment procedures of the APA by failing to provide sufficient, and sufficiently robust, data on potential costs of the rule. The proposal was clear and the comment period was ample. Indeed, the Agency extended the comment period to 120 days to accommodate commenters who requested additional time. As required under § 3(f) of EO 12866, as amended by EO 14094, “Modernizing Regulatory Review” (88 FR 21879, April 11, 2023), the Agency has prepared an RIA of the final rule’s costs and potential benefits. This RIA, Clean Water Act Hazardous Substance Facility Response Plans, is available in the docket for this action.

To the commenter concerned with the “lack of passive mitigation, EPA has not included this substantial harm criterion in this rule. The Agency agrees that requiring such capital improvements without a single national standard is not a reasonable approach. EPA disagrees with the commenter assertion that endpoint calculation is unnecessary; indeed the distance to endpoints factors into whether a facility could cause substantial harm to the environment from a worst case discharge into or on the navigable waters or a conveyance, as well as the hazard evaluation which provides the basis for the response plan as a whole.

The Agency is aware of the complexity and cost of assessing the distance to endpoints for all CWA hazardous substances onsite above the threshold quantity, examining environmental justice communities, and considering climate change impacts in hazard evaluations. EPA is committed to providing compliance assistance to help the regulated community comply with these requirements and maintains that their inclusion is critical to protect the environment in the event of a worst case discharge.

The Agency maintains that in the event of a worst case discharge, this planning is critical to inform response timelines. If a facility has the ability to cause substantial harm to the environment, it must also have the ability to detect and respond if such a discharge is occurring. EPA recognizes that this may increase costs but maintains that the effects of worst case discharges can be catastrophic and costly (see the RIA, Docket ID EPA-HQ-OLEM-2021-0585-0143).

The Agency proposed that if the maximum capacity onsite exceeds 10,000x RQ, a facility would meet the threshold quantity screening criterion. While EPA proposed a 10,000x RQ multiplier, the Agency has determined that to fully address the range of potential releases that merit worst case discharge planning and response, a 1,000x RQ multiplier will more appropriately screen facilities that could cause substantial harm to the environment from a worst case discharge. This results in substantially more facilities regulated by the final rule. Accordingly, the Agency revised the economic analysis for the final rule, estimating annualized costs for complying facilities of approximately $122 million per year, as documented in the final RIA.

The Agency disagrees that EPA underestimates the burden and cost of creating an initial FRP for a facility and with the notion that the Agency inappropriately accounted for other programs, including the Oil Pollution Prevention FRP and RMP. EPA estimated the total costs of the final action by combining the per-facility estimates with the estimate of the affected facility universe. To provide information about the scale of costs that facilities could incur, EPA compiled estimates of unit compliance costs for each of the program elements in the final action. EPA developed unit burden estimates for individual elements of the response plan on a first- and subsequent-year basis. EPA also estimated the extent of baseline compliance for facilities subject to the rule due to the overlap in facilities and program elements in the existing Oil Pollution Prevention FRP, RMP, and RCRA regulatory requirements, as these three programs have the most significant crossover. EPA estimated an average compliance cost per facility after accounting for baseline compliance with existing regulations by multiplying labor rates and unit burdens. EPA calculated the annualized total cost to complying facilities of the final action over a 20-year analysis period, using the 3 percent and 7 percent discount rates.

EPA also notes that the majority of labor burden for complying facility staff is estimated using labor rates of $93.50 and $70.84, based on U.S. Bureau of Labor Statistics wage data, and the Agency also recognizes the role of consultants in facility planning efforts. This cost is accounted for as an annually recurring cost of $18,471 per facility for contractor support.

EPA also disagrees that it failed to tie the proposed applicability provisions to reasonable potential for substantial harm and failed to support its conclusion that a single CWA hazardous substance present at a facility should trigger applicability. The Agency proposed four substantial harm criteria to address exactly that issue and ensure the rule covers facilities that could cause substantial harm to the environment by discharging to or on navigable waters or a conveyance to navigable waters. Additionally, EPA proposed location-based criteria (using both distance from navigable waters or a conveyance and planning distance calculations) to ensure facilities are regulated based on their location, as required by statute. EPA's definition of “injury” is consistent with the Oil Pollution Prevention Program’s definitions at 40 CFR § 112.2. In combination with the screening criteria, EPA determined that the proposed criteria reflect real world scenarios whereby a worst case discharge could cause substantial harm to the environment.

Paperwork Reduction Act

No comments

Regulatory Flexibility Act

Public Comment Summary:

Oppose

One commenter stated that EPA estimates over 40 percent of the facilities subject to the proposed regulation are owned by small entities and noted that their comments are consistent with congressional intent underlying the RFA, that “[w]hen adopting regulations to protect the health, safety, and economic welfare of the nation, federal agencies should seek to achieve statutory goals as effectively and efficiently as possible without imposing unnecessary burdens on the public” (0200).

One commenter stated smaller facilities will face cost pressures because the EPA failed to consider the cumulative effect of additional proposed rules and associated costs (e.g., EPA’s Proposed Rule on the Regulation of Certain Conditions of Use for Chrysotile Asbestos Under § 6(a) of TSCA), and the proposed rule has administrative obligations with associated expenses, which could be lessened by leveraging similar regulatory frameworks currently in place (0189).

EPA Response:

The RFA of 1980 (5 USC 601 et. seq.) requires federal agencies to assess the effects of regulations on small entities, including small businesses, small nonprofit organizations, and small governments, and to examine alternatives to the regulations that may reduce adverse economic effects on significantly impacted small entities. Section 604 of the RFA, as amended by the Small Business Regulatory Enforcement Fairness Act of 1996, requires an agency to perform a final regulatory flexibility analysis for a final rule unless the agency certified under § 605(b) that the final action would not have a “significant impact on a substantial number of small entities” (SISNOSE). The percentage of entities that are small does not indicate a SISNOSE for those small entities, as suggested by the commenter.

After considering the number of affected entities, the size of the economic impacts, and whether the number of entities or the size of the impacts justifies the certification, the Agency has found a factual basis for concluding that the final rule will not have a SISNOSE, and therefore, the Agency has not prepared an Initial Regulatory Flexibility Act analysis for the final rule.

As documented in the Agency’s RIA, Section 7.3, EPA identified the set of entities affected by the final rule using available facility data and then calculated economic impacts on affected small businesses using the direct compliance cost method, and applied the “sales test” by estimating annualized compliance costs for affected small businesses as a percentage of those businesses’ annual revenue to determine whether there is a SISNOSE based on costs exceeding 1 or 3 percent of annual revenues. As indicated in Small Business Administration and EPA guidance, for small businesses it is appropriate to compare the annualized costs as a percentage of sales (“sales test”) to examine significant economic effect.

The Agency has certified that this action will not have a SISNOSE under the RFA. For the final action, the Agency identified 1,509 small entities affected by the final rule, out of the 5,354 regulated facility universe. The cost-to-revenue screening test results indicated that both the number and percentage of small entities experiencing significant impacts is low. EPA estimates that 47 entities may experience an impact in the range of 1 percent to 3 percent of revenues, and that 21 entities may experience an impact greater than 3 percent of revenue (or, about 1.4 percent of all small entities). Based on the results of the cost-to-revenue test, EPA concludes that the final action’s requirements will not have a SISNOSE.

With respect to the commenter’s reference to additional proposed rules by the Agency, EPA recognizes its authority to finalize this rulemaking and has judged the underlying data as sufficient to warrant a regulatory program (see the RIA available in the docket). Other EPA and federal programs are not specific to worst case discharges of CWA hazardous substances into or on the navigable waters and do not cover all the required program elements under CWA § 311(j)(5); thus, they are not an appropriate substitute. That said, where appropriate, EPA has created exemptions and taken measures to limit duplicative regulatory overlap. Chapter 2 of the TBD available in the docket details potential regulatory overlap in related programs, and EPA has adjusted some exemptions in § 118.8 to account for existing programs.

Unfunded Mandates Reform Act

No comments

Executive Order 13132: Federalism

Public Comment Summary:

One commenter urged EPA to make sure that nothing would limit or impede any state or tribal effort to protect state or tribal waters. This commenter noted that states and tribes are in the best position to understand their own legal frameworks; appropriately implement the proposed CWA Hazardous Substance Worst Case Discharge Planning Regulations; and harmonize the various federal, state, and tribal laws that may cover the discharge of pollutants to groundwater (0198).

The commenter requested that EPA consider including notification requirements under the FRP or by the RA to news media when a facility identifies a potential groundwater impact in a non-PWS scenario, which would offer protection to self-supplied domestic well owners, especially in underserved communities (0198).

The commenter also requested that the EPA collaborate and cooperate with states to effectively address issues that may arise from the proposed rule. In the spirit of cooperative federalism, the commenter recommended that the EPA communicate the concepts contained within the proposed rule to the delegated drinking water programs under SDWA to minimize or eliminate misunderstanding that could inhibit rather than support the communication between the two different delegated programs and allow for cost-effective, coordinated, and appropriate regulatory implementation strategies (0198).

EPA Response:

EPA is not limiting or impeding any state or tribal effort to protect state or tribal waters and will work collaboratively with co-regulators to implement this action and share relevant information. Federal, tribal, state, and local responders will be best positioned to determine whether additional types of notifications are necessary. EPA will coordinate with drinking water programs to aid in implementation.

Executive Order 13175: Consultation and Coordination with Indian Tribal Governments

No comments

Executive Order 13045: Protection of Children from Environmental Health Risks and Safety Risks

No comments

Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution or Use

No comments

National Technology Transfer and Advancement Act

No comments

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

No comments

Outside Current Rulemaking Scope

Public Comment Summary:

One commenter provided comments on how electric companies are leading the transition to clean energy by increasing the amount of renewable energy, which decreases the sector’s emissions of carbon dioxide, hazardous air pollutants, sulfur dioxide, and nitrogen oxides (0185).

EPA Response:

This comment is outside the scope of this action.

Prevention

Public Comment Summary:

Several commenters stated that EPA should shift to a proactive focus and look at how it can work with industry to assist in facilitating the continued decline in discharges rather than proposing this rule (0175, 0191).

Several commenters suggested that EPA should develop complementary spill prevention regulations to require facilities to implement inherently safer practices related to ASTs and CWA hazardous substance storage, spill prevention, and onsite spill response in addition to the worst case discharge planning and FRP components in the rule (0169, 0182, 0216).

A couple of commenters urged EPA to reconsider the “no action” decision promulgated under CWA § 311(j)(1)(C) for hazardous substance discharge prevention and containment (0207, 0215). One commenter stated that that rulemaking, if revised, would provide for more substantive source water protection benefits. The commenter stated that the failure by EPA to exercise that authority was disappointing relative to Agency pronouncements regarding source water protection and statutory obligations under provisions of the 2016 TSCA Amendments (0207). One commenter stated that EPA’s failure to revisit the rule is an unjustifiable dereliction of its statutory duties and reflects an abandonment of the communities that are harmed by hazardous substance discharges, including from facilities too small to trigger the specific planning requirements anticipated in this rulemaking (0215).

One commenter noted that their state has created various programs and communication networks between agencies to identify hazmat concerns before they turn into major incidents (0333).

EPA Response:

As per the statutory authority of this action under CWA § 311(j)(5), this regulation is for response planning, not discharge prevention. Inherently safer technologies and designs related to CWA hazardous substance storage and discharge prevention are outside the scope of this rule.

To commenters who pointed to the no action final rule under CWA § 311(j)(1)(C) (84 FR 46100, October 3, 2019), that rulemaking is outside the scope of this final rule, and the Agency conclusion there has no bearing here.

CWA Hazardous Substance List Adjustment

Public Comment Summary:

A couple of commenters suggested that EPA update the CWA list of hazardous substances since there has been much advancement in science and technology since 1978. The commenters urged EPA to undertake a separate rulemaking to update and expand the list of CWA hazardous substances in accordance with the CWA to ensure that the list is comprehensive and captures contaminants of emerging concern, specifically noting 4-methylcyclohexane methanol, perfluorooctanoic acid, perfluorooctane sulfonate, or other PFAS (0215, 0217).

Another commenter stated that EPA should initiate a process for adding more chemicals to the CWA hazardous substances list to ensure all communities in need of protections from harmful chemical discharges receive the benefits of the final rule (0216).

Two commenters stated that EPA should aid the regulated community by updating the CWA “List of Lists” to include the RQs of the CWA hazardous substances, (0170, 0179). One commenter stated that EPA should develop a framework for CWA hazardous substances listed in proprietary blends and should provide a provision in the rule for situations when EPA amends the 40 CFR § 116.4 list of CWA hazardous substances and/or their RQs in 40 CFR § 117.3 (0179).

EPA Response:

While some commenters suggested updating the CWA hazardous substances covered by the rule, changing the list of CWA hazardous substances in 40 CFR Part 116 is outside the scope of this action. EPA plans to update the “List of Lists” once this action is final with CWA hazardous substance RQ and 1,000x RQ information.

1 EPCRA Reporting Rule (40 CFR Part 370), RMP regulation (40 CFR Part 68), DHS Chemical Facility Anti-Terrorism Standards (CFATS) (6 CFR Part 27), and OSHA’s PSM (29 CFR § 1910.119).

2 “Device.” Merriam-Webster.com Dictionary, Merriam-Webster, https://www.merriamwebster.com/dictionary/device. Accessed 3 Jan. 2024.

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Summary of Public Comments

2710rtc02.docx

Clean Water Act Hazardous Substance Worst Case Discharge Planning Regulations (Final Rule)

Summary of Public Comments

OMB: 2050-0228

Table of Contents

Acronyms and Abbreviations

General Comments

Support Proposed Approach

Oppose Proposed Approach

Regulatory Process

Statutory Authority

Background Analyses

CWA Hazardous Substance Discharge History and Impacts Analysis

Discharge History and Reported Impacts

Most Frequently Discharged CWA Hazardous Substance

Impacts to Waterways and Sensitive Environments

National Response Center Data Limitations

Data Sources Examined

Analysis of Existing Programs/Technical Background Document/Other Programs or Standards with Potential Overlap

Proposed Actions

Definitions

Facilities Located Offshore Landward of the Coastline

Adverse Weather

Container

Conveyance

Endpoint and Distance to Endpoint

Facility

Fish, Wildlife, and Sensitive Environments

Injury

Navigable Waters

Public receptors

Worst Case Discharge

Other Definitions

Screening Criteria

Threshold Quantity

Container Capacity 10,000 Times the Reportable Quantity

Alternative Applicability Approaches

Establish New Regulatory Thresholds Based on Toxic Endpoints

Establish Thresholds Using Distance-Based Multipliers

Thresholds From Other Hazardous Substances Regulations (Non-CWA)

Alternative Thresholds by Aggregated Category

Maximum Quantity Onsite versus Maximum Capacity Onsite

Mixtures (118.9)

Within One-Half Mile of Navigable Water or Conveyance to Navigable Water

Alternatives to One-Half Mile to Navigable Water or Conveyance to Navigable Water

Substantial Harm Criteria

Ability to cause injury to fish, wildlife, and sensitive environments

FWSE planning distance calculation (118.10)

Available models/whether EPA should develop a tool

Alternative approaches

Ability to adversely impact a public water system

Using Source Water Protection Areas

Self-determination model

Groundwater impacts

Ability to cause injury to public receptors

Toxic endpoints

Air releases/inhalation toxicity

Alternative approaches

Reportable discharge history

Time horizon

If release reached water

Alternative approaches

Passive mitigation, administrative controls, secondary containment

Transfers Over Water

Other Comments on Applicability Criteria (118.3)

Compliance dates (§ 118.4)

Substantial harm certification form (§ 118.4(c), Appendix A)

Public availability

Regional Administrator (RA) Determinations of Substantial Harm and Significant and Substantial Harm (118.5)(a)(b)(d))

Substantial Harm

Significant and Substantial Harm

Appeals (§ 118.6)

Petitions (§ 118.7)

Exceptions and Exemptions (§ 118.8)

Worst Case Discharge Scenarios

Proposed Approach

Additional Worst Case Scenarios if Response Equipment Differs

Planning Distance Determinations/Distance to Endpoints/Toxic Endpoints (§ 118.10(b), Appendix B)

Response Planning (118.11)