Section 118.4 - General requirements(a)Preparation, submission, and implementation of facility response plans. The owner or operator of any non-transportation-related onshore facility meeting the applicability requirements of § 118.3 shall prepare, submit, and implement a facility response plan according to the following provisions: (1)Initially regulated facilities. The owner or operator of a non-transportation-related onshore facility in operation on November 30, 2026 that satisfies the criteria in § 118.3 shall prepare and submit a facility response plan that satisfies the requirements of this section and Appendix A: Substantial Harm Certification Form to the Regional Administrator by June 1, 2027.(2)Newly regulated facilities. The owner or operator of a non-transportation-related onshore facility that did not satisfy the criteria in § 118.3 on November 30, 2026, but satisfies the criteria in § 118.3 after November 30, 2026 or that is notified by the Regional Administrator pursuant to § 118.5 shall prepare and submit a facility response plan that satisfies the requirements of this section and Appendix A: Substantial Harm Certification Form to the Regional Administrator within six months of meeting the criteria or notification.(3)Newly constructed facilities. For a newly constructed non-transportation-related onshore facility that commences operation after June 1, 2027, and is required to prepare and submit a facility response plan based on the criteria in § 118.3 , the owner or operator shall submit the facility response plan and Appendix A: Substantial Harm Certification Form to the Regional Administrator prior to the start of operations. Adjustments to the facility response plan to reflect changes that occur during the start-up phase of operations must be submitted to the Regional Administrator after an operational trial period of 60 days.(4)Facilities regulated as a result of a planned event or change. For a non-transportation-related onshore facility required to prepare and submit a facility response plan after June 1, 2027, as a result of a planned change in design, construction, operation, or maintenance so that the non-transportation-related onshore facility now meets the criteria in § 118.3 of this part, the owner or operator shall submit the facility response plan and Appendix A: Substantial Harm Certification Form to the Regional Administrator before the portion of the non-transportation-related onshore facility undergoing the planned change commences operations. Adjustments to the facility response plan to reflect changes that occur during the start-up phase of operations must be submitted to the Regional Administrator after an operational trial period of 60 days.(5)Facilities regulated as a result of an unplanned event or change. For a non-transportation-related onshore facility required to prepare and submit a facility response plan after June 1, 2027, as a result of an unplanned event or change in facility characteristics that renders the non-transportation-related onshore facility subject to the criteria in § 118.3 , the owner or operator shall submit the facility response plan and Appendix A: Substantial Harm Certification Form to the Regional Administrator within six months of the unplanned event or change.(6)Recertification. Owners or operators must review and recertify their facility response plans and Appendix A: Substantial Harm Certification Forms every five years.(7)Updated CWA hazardous substance information in 40 CFR 116.4 or 40 CFR 117.3 . If a CWA hazardous substance is added or removed from the list maintained at 40 CFR 116.4 or a reportable quantity adjusted as listed at 40 CFR 117.3 , an owner operator shall update their facility response plan accordingly within six months.(b)Facility response plan amendments.(1) The owner or operator of a non-transportation-related onshore facility for which a facility response plan is required under this part shall revise and resubmit revised portions of the facility response plan within 60 days of each change that materially may affect the response to or potential for a worst case discharge, including: (i) A change in the non-transportation-related onshore facility's configuration that materially alters the information included in the facility response plan;(ii) A change in the CWA hazardous substance maximum quantity onsite (i.e., increase or decrease in the maximum quantity stored onsite) that materially alters the required response resources;(iii) A material change in capabilities of the spill response organization(s) that provide equipment and personnel to respond to discharges of CWA hazardous substances described in § 118.11(a)(3) ;(iv) A material change in the non-transportation-related onshore facility's discharge mitigation and response equipment or emergency response procedures; and(v) Any other changes that materially affect the implementation of the facility response plan.(2) Except as provided in paragraph (b) of this section, amendments to information in the facility response plan (such as personnel, contact information, or changes in the spill response organization(s)) that do not result in a material change in response capabilities do not require review and approval by the Regional Administrator. Owners or operators shall provide a copy of such changes to the Regional Administrator as the revisions occur.(3) The owner or operator of a non-transportation-related onshore facility that submits changes to a facility response plan as provided in the preceding paragraphs of this section shall provide an EPA-issued facility identification number (where one has been assigned, such as Facility Registry Service number) with the changes.(4) The Regional Administrator shall review and approve or disapprove changes to a facility response plan submitted pursuant to the requirements in paragraph (b)(1) of this section for a non-transportation-related onshore facility that he or she has determined pursuant to § 118.5(c) to have the potential to cause significant and substantial harm to human health or the environment.(c)Substantial harm certification form submission. If the non-transportation-related onshore facility meets the criteria in § 118.3(a) and (b) but not (c): (1) If the non-transportation-related onshore facility is in operation on March 30, 2027, complete and submit to the EPA Regional Administrator the Substantial Harm Certification Form in Appendix A to this part by June 1, 2027, or, for facilities meeting the criteria in § 118.3(a) and (b) after March 30, 2027, within 60 days. Owner or operators must retain their completed Appendix A and supporting documentation for the duration that the CWA hazardous substance maximum quantity onsite meets or exceeds the threshold quantity and for an additional 10 years.(2) Attach to the form documentation, calculations, and any other information necessary to demonstrate the reliability and analytical soundness of the substantial harm determination as well as a review of potential receptors that could be impacted as a result of a CWA hazardous substance discharge.(3) Submit to the EPA Regional Administrator a recertification of the Substantial Harm Certification Form every five years, or within 60 days of a change at or outside the non-transportation-related onshore facility that impacts the potential to cause substantial harm to the environment in accordance with the criteria in § 118.3 .(4) Provide the Substantial Harm Certification Form in Appendix A to this part to local emergency response organizations upon request.(d)Assertion of claims of confidential business information.(1) Except as provided in paragraph (2) of this section, an owner or operator of a non-transportation-related onshore facility required to submit a facility response plan or otherwise provide information under this part may make a claim of confidential business information for any such information that meets the criteria set forth in § 2.302 of this chapter.(2) Notwithstanding the provisions of 40 CFR part 2, an owner or operator of a facility subject to this part may not claim as confidential business information the following information: (i) Data required by § 118.11 (b) ; and(ii) Data required in Appendix A of this part, excluding the supporting documentation.(iii) Notwithstanding the procedures specified in 40 CFR part 2, an owner or operator asserting a claim of confidential business information with respect to information contained in its facility response plan as per § 118.11 , shall submit to EPA at the time it submits the facility response plan the following: (A) The information claimed confidential, provided in a format to be specified by EPA;(B) A sanitized (redacted) copy of the facility response plan, with the notation "CBI" substituted for the information claimed confidential, except that a generic category or class name shall be substituted for any chemical name or identity claimed confidential; and(C) The document or documents substantiating each claim of confidential business information, as described in paragraph (e) of this section.(e)Substantiating claims of confidential business information.(1) An owner or operator claiming that information is confidential business information must substantiate that claim by providing documentation that demonstrates that the claim meets the substantive criteria set forth in § 2.302 of this chapter.(2) Information that is submitted as part of the substantiation may be claimed confidential by marking it as confidential business information. Information not so marked will be treated as public and may be disclosed without notice to the submitter. If information that is submitted as part of the substantiation is claimed confidential, the owner or operator must provide sanitized and unsanitized versions of the substantiation.(3) The owner, operator, or senior official with management responsibility at the non-transportation-related onshore facility shall sign a certification that the signer has personally examined the information submitted and that based on inquiry of the persons who compiled the information, the information is true, accurate, and complete, and that those portions of the substantiation claimed as confidential business information would, if disclosed, reveal trade secrets or other confidential business information.