---
kind: "section"
citation: "40 C.F.R. § 118.5"
title: "40"
number: "118.5"
heading: "Regional Administrator determination of substantial harm and significant and substantial harm."
url: "https://uscodex.org/cfr/40/118.5"
---

# §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)](#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](/cfr/40/118.4.md). The Regional Administrator may require amendments to any facility response plan that does not meet the requirements [§ 118.11](/cfr/40/118.11.md).
- (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](/cfr/40/117.3.md) 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)](/cfr/40/118.3.md?p=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](/cfr/40/118.3.md) 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)](#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](/cfr/40/118.11.md); 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)](#b) of this section and [§ 118.3(c)](/cfr/40/118.3.md?p=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.**

## Notes

### Authority

Authority: 33 U.S.C. 1251 et seq., and Executive Order 11735, superseded by Executive Order 12777, 56 FR 54757.

### Source

Source: 89 FR 21955, Mar. 28, 2024, unless otherwise noted.