Section 118.5 - Regional Administrator determination of substantial harm and significant and substantial harm(a)Regional Administrator authority to require facility response plans and amendments. After considering the factors in paragraph (b) of this section, the Regional Administrator may at any time require the owner or operator of any non-transportation-related onshore facility to prepare and submit a facility response plan under this section. If such a determination is made, the Regional Administrator shall notify the owner or operator in writing and shall provide a basis for the determination and the owner or operator shall submit the facility response plan to the Regional Administrator as per the preparation, submission, and implementation guidelines in § 118.4 . The Regional Administrator may require amendments to any facility response plan that does not meet the requirements § 118.11 .(b)Regional Administrator substantial harm determination. To determine whether a non-transportation-related onshore facility could, because of its location, reasonably be expected to cause substantial harm to the environment by a discharge, or substantial threat of a discharge, of CWA hazardous substances into or on the navigable waters or a conveyance to navigable waters, the Regional Administrator may consider the following: (1) Type of transfer operation(s);(2) CWA hazardous substance quantity and category as determined in 40 CFR 117.3 and characteristics (e.g., ignitability or reactivity) stored onsite;(3) Proximity to fish, wildlife, and sensitive environments and other areas determined by the Regional Administrator to possess ecological value;(4) Ability to adversely impact public water systems as described in § 118.3(c)(ii) ;(5) Location in a source water protection area;(6) Ability to cause injury to public receptors;(7) Lack of passive mitigation measures or systems, including those that enhance resilience to climate change;(8) Potential to adversely impact communities with environmental justice concerns;(9) Potential vulnerability to adverse weather conditions resulting from climate change;(10) Density of facilities with CWA hazardous substances onsite in the immediate area;(11) Reportable discharge history; or(12) Other site-specific characteristics and environmental factors that the Regional Administrator determines to be relevant to recovery, shoreline protection, and cleanup.(c)Regional Administrator responsibilities for significant and substantial harm facilities. The Regional Administrator shall review facility response plans submitted by facilities meeting the applicability requirements of § 118.3 to determine whether the non-transportation-related onshore facility could, because of its location, reasonably be expected to cause significant and substantial harm to the environment by a discharge, or a substantial threat of discharge, of CWA hazardous substances into or on the navigable waters or a conveyance to navigable waters based on the factors identified in paragraph (d) of this section. If such a determination is made, the Regional Administrator shall notify the owner or operator in writing and: (1) Approve any facility response plan that meets the requirements of § 118.11 ; and(2) Review each facility response plan periodically thereafter on a schedule established by the Regional Administrator.(d)Regional Administrator significant and substantial harm determination. To determine whether a non-transportation-related onshore facility could, because of its location, reasonably be expected to cause significant and substantial harm to the environment by discharging a CWA hazardous substance into or on the navigable waters or a conveyance to navigable waters, the Regional Administrator shall consider the factors in paragraph (b) of this section and § 118.3(c) , as well as the following: (1) Frequency of past reportable discharges;(2) Proximity to navigable waters or a conveyance to navigable waters;(3) Age or condition of containers and equipment;(4) Potential for hazards such as flooding, hurricanes, earthquakes, or other disasters that could result in a worst case discharge; and(5) Other facility- and Region-specific information, including local impacts on public health.