# 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.