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PT Notes

EPA RFI - Safety Case Regulatory Model and Streamlining RMP Requirements

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On July 24, 2014, the U.S. Environmental Protection Agency (EPA) announced a Request for Information (RFI) seeking comments on potential revisions to its Risk Management Program (RMP) regulations and related programs to modernize its regulations. Multiple issues were addressed in the RFI.

One of the issues addresses the use of the safety case regulatory model. This regulatory approach is used in the process industries by some countries outside the U.S., including the United Kingdom, Australia, Norway, and others, and is similar in practice to the U.S. regulatory regime employed for nuclear reactor facilities.

The safety case model is a framework for regulating high-risk industries where owners or operators of industrial facilities are required to demonstrate to the regulator that
they have reduced risks to a level that is "as low as reasonably practicable", or ALARP. Operators must present a structured argument, supported by a body of evidence that provides a compelling, comprehensible and valid case, that a process is sufficiently safe.

Completely replacing the current RMP rule (and the Occupational Safety and Health Administration's (OSHA's) Process Safety Management (PSM) standard) with a safety case approach would require significant changes to the existing regulatory regime for chemical process safety in the United States. Nevertheless, EPA is requesting public comment on whether EPA and OSHA should consider these actions. As an alternative to a wholesale adoption of the safety case approach, EPA and/or OSHA potentially could implement selected aspects of the approach within the current regulatory framework. For example, EPA and OSHA could require owners and operators to submit a PHA or a similar document to EPA and OSHA, and require approval of the PHA by EPA and OSHA. Also, EPA and OSHA could limit the applicability of the safety case approach to selected categories of high-risk facilities, such as petroleum refineries.

EPA is requesting information on the advantages and disadvantages of adopting a safety case approach to replace the RMP rule and PSM standard, or alternatively, incorporating aspects of the approach into current regulations or for selected categories of facilities.

Questions posed by EPA on this issue include:

  1. If you own or operate any RMP-covered or PSM-covered facilities and also own or operate facilities in countries that use a safety case regulatory regime, please describe the process of developing and obtaining approval for your safety case. How long does development and approval of a safety case take for a large petroleum refinery or chemical processing facility? What are the advantages and disadvantages of the safety case approach in comparison to the existing U.S. regulatory regime for chemical process safety? Is there any evidence that the safety case approach reduces the frequency and severity of accidental releases and near misses? If so, please provide any information, data, or studies to EPA that demonstrate these effects. How expensive is it for facility owners to implement the safety case approach in comparison to implementing RMP or PSM? Do you already incorporate aspects of the safety case approach in your risk management program?
  2. The U.S. Nuclear Regulatory Commission (NRC) has established a safety case approach for licensing and oversight of commercial nuclear power plants. The NRC oversees approximately 100 nuclear reactor and 3,000 nuclear materials facilities in the U.S. and has nearly 4,000 employees and an annual budget of over $1 billion. What additional resources would be required by EPA and OSHA in order to establish and oversee a safety case regulatory regime for RMP-covered and PSM-covered facilities?
  3. Is the safety case approach suitable for all RMP-covered and PSM-covered facilities, or, if adopted, should it be limited to only the most high-risk facilities, such as petroleum refineries and other high-risk chemical processing facilities?
  4. What would be the economic impacts of moving to a safety case regulatory regime for chemical facility safety? Are there any special circumstances involving small entities that EPA should consider with respect to the safety case approach?

Another issue addresses streamlining RMP requirements. EPA is inviting comments on other areas within the RMP rule that should be modernized, strengthened, or clarified. In particular, EPA is interested in any potential revisions that would make it easier for regulated sources to comply with RMP rule requirements.

Questions posed by EPA on this issue include:

  1. Are there steps that EPA could take to simplify the process of determining whether the RMP rule applies to particular facilities? Are there other potential revisions to the rule that would make it easier for regulated entities to comply with its provisions?
  2. Are there steps that EPA could take to simplify the RMP submission process? For example, are there advances in electronic reporting or information technology that EPA could use in order to make RMP submissions easier?
  3. Should EPA require that RMP submissions be certified by a senior corporate official, such as the Chief Executive Officer, Chief Financial Officer, Chief Operations Officer, or the equivalent, to ensure corporate-wide awareness and accountability in the RMP submission?
  4. Is the three-tiered program level structure of the RMP regulation appropriate, or should EPA consider simplifying the rule to make only two program tiers, or only a single prevention program, applicable to all facilities?
  5. Are the accident prevention program elements clearly defined? Should EPA further clarify any of the existing elements?
  6. Are the regulatory terms and definitions contained in the RMP rule sufficiently clear? Are there additional terms that EPA should define?
Further details on this issue are provided in EPA's RFI which can be accessed by clicking here.

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