PT Notes
EPA RMP Rule Amendments - Safer Technology and Alternatives Analysis
PT Notes is a series of topical technical notes on process safety provided periodically by Primatech for your benefit. Please feel free to provide feedback.
This PT Note describes an amendment to EPA's Risk Management Program regulation that requires a safer technology and alternatives analysis to be performed as part of process hazard analysis (PHA).
Safer Technology and Alternatives Analysis (STAA)
EPA noted that current PHA studies can identify opportunities to make new and existing processes and operation inherently safer. However, the amended rule specifically requires that PHA studies address safer technology and alternative risk management measures applicable to eliminating or reducing risk from process hazards. It applies to processes in North American Industrial Classification System (NAICS) codes 322 (paper manufacturing), 324 (petroleum and coal products manufacturing), and 325 (chemical manufacturing).
EPA intends that STAA should identify potential process changes that, if implemented, would result in owners or operators using less hazardous substances; minimizing the amount of regulated substances present in a process; moderating process conditions; reducing process complexity; or implementing passive, active, or procedural changes to make processes safer. Such changes help prevent accidents by eliminating or reducing a hazard; making a process more fault-tolerant, such that a minor process upset or equipment malfunction does not result in a serious accidental release; making releases less likely; and/or reducing the severity of releases that do occur.
EPA believes that where feasible, reducing or eliminating hazards through change in materials, chemistry, or process variables is preferable to adding layers of safety to a process. While layers of passive, active or procedural controls will reduce the risk, they will do nothing to reduce the nature of the hazard itself. Failure of control devices or human error can result in an accidental release. However, an inherently safer strategy seeks to preferentially remove the hazard at the source, as opposed to accepting the hazard and attempting to mitigate the effects.
The amended rule requires owners or operators to consider risk management measures in the following order of preference:
- Inherently safer technology or design (IST and ISD).
- Passive measures.
- Active measures.
- Procedural measures.
The rule defines inherently safer technology or design as risk management measures that:
- Minimize the use of regulated substances,
- Substitute less hazardous substances,
- Moderate the use of regulated substances, or
- Simplify covered processes in order to make accidental releases less likely, or the impacts of such releases less severe.
Passive measures are defined in the rule as risk management measures that use design features that reduce either the frequency or consequence of the hazard without human, mechanical, or other energy input. Examples of passive measures include pressure vessel designs, dikes, berms, and blast walls.
Active measures are defined in the rule as risk management measures or engineering controls that rely on mechanical, or other energy input to detect and respond to process deviations. Examples include alarms, safety instrumented systems, and detection hardware (such as hydrocarbon sensors).
Procedural measures are defined in the rule as risk management measures such as policies, operating procedures, training, administrative controls, and emergency response actions to prevent or minimize incidents.
EPA noted that industries change and update their processes over time for a variety of reasons and, when possible, EPA believes that opportunities should be considered to improve chemical process safety using all available means, not only passive, active, and procedural measures.
EPA noted that IST is widely recognized as a concept or principle that can be used in process safety management, along with other types of hazard reduction measures, to eliminate or reduce the frequency and/or impact of accidents. As recognized in the process safety technical literature, the benefit of using practicable ISTs as the first choice for accident prevention is more likely permanent risk reduction. Since the original RMP rule was promulgated in 1996, EPA has seen that advances in ISTs and safer alternatives are becoming more widely available and are being adopted by some companies. Voluntary implementation of some ISTs has been identified by EPA through surveys and studies and potential opportunities have been identified through EPA enforcement cases and U.S. Chemical Safety Board incident investigations.
For those facilities that have not considered adopting any ISTs or have only done so in limited fashion, EPA believes that there is value in requiring facilities with extremely hazardous substances to evaluate whether they can improve risk management of current hazards through potential implementation of ISTs or risk management measures that are more robust and reliable than ones currently in use at the facility. For those facilities that have already considered ISTs, EPA believes they should reevaluate whether any improvements in hazard or risk reduction can be made and that the five-year revalidation time frame for PHA is appropriate for such reevaluation.
EPA does not expect facility owners or operators to research and create new process designs or conduct research into all possibilities for the use of new chemicals. Instead, the STAA should focus on the known and existing substitute processes and chemicals that have been demonstrated to be in use commercially.
EPA is not adopting an approval process for STAA reviews, either by an independent board, by the implementing agency, or by any emergency planning entity.
The STAA requirements are not prescriptive in nature, but are similar to a performance-based standard (like other provisions of the RMP regulations). Thus, EPA believes that the approach is consistent with the overall approach of the RMP rule to rely on the development and assessment of information to lead owners and operators to adopt reasonable measures to prevent accidents.
Also, EPA believes that determining effective risk management strategies for a facility is a site-specific determination and EPA encourages any improvement that could lead to inherently safer conditions.
EPA expects that these regulatory requirements will raise industry awareness of IST possibilities and will reduce risk.
Risk Management Measures
The purpose of the STAA requirement is to ensure that facilities consider the available options and find the best method to address accidental releases. The hierarchy of risk management methods systematically provides for the identification of practicable methods while also recognizing that the regulation must be reasonable. This approach is consistent with PHA requirements in the current rule which provide flexibility for the owner or operator to decide which safeguards are appropriate to prevent accidental releases. The current rule already requires PHA to consider active, passive and procedural risk management measures. However, the requirements do not prescribe exactly which type or exactly what engineering and administrative controls must be implemented. The current rule allows facilities to use their specific knowledge and expertise with the process to meet the PHA requirement to identify, evaluate and control the hazard. The same is true for STAA.
EPA is not prescribing that facilities adopt any particular safer alternative and is allowing any decision on implementation of IST to be made based upon a facility’s judgement using accepted hazard analysis and their knowledge of their processes, hazards, risks and methods to control hazards. EPA is requiring facilities only to consider IST as a possibility for addressing hazards because IST is a relative concept dependent on the hazard, the technology, and the facility. The amended rule allows the use of industry expertise to best decide which safer technologies and alternatives to consider, and to determine the practicability of the IST or ISD considered. The rule does not mandate the implementation or adoption of any particular IST found to be practicable.
EPA will rely on sources to make rational decisions to select prevention approaches that optimize the cost of the measures taken and costs avoided (e.g., liability, operational efficiency, image). While EPA recognizes that companies have moved away from certain processes, such as those that involve the storage of large quantities of methyl isocyanate, in order to make facilities safer, EPA leaves process design decisions to the reasonable judgment of owners and operators.
EPA believes that the facility is in the best position to decide what safeguards or risk reduction measures can be employed to eliminate or reduce process hazards and mitigate risk without causing undesirable consequences such as reducing product quality or transferring risk to some other point in the supply chain. Only the facility has the expertise and resources to determine whether implementation of any IST or ISD should be undertaken, taking into account that many factors must be considered when substituting a chemical or modifying a process, including cost, risk transfers, technological hurdles, etc. Thus, facilities only will incur additional costs beyond the analysis when the benefits of the change make adoption of the change reasonable for the facility. EPA expects STAA to lead to new control approaches at sources when management finds such approaches to be reasonable and practicable.
Owners or operators can consider the appropriateness of the technology for their process, costs, risk transfer, and other requirements that would have to be met, along with possible integration issues with existing risk reduction measures in place.
While EPA believes that facility owners or operators should consider IST first in the hierarchy of measures to reduce and/or control the hazards of a process, EPA recognizes that, for any particular hazard, any one of the four types of safeguards may not exist or may not be practicable for a variety of reasons. The amended rule does not automatically require the facility to implement risk management measures preferentially in the order of the hierarchy.
EPA recognizes that IST is not the only way to prevent accidents. The STAA requirement allows for a combination of risk management measures to be used to achieve the desired risk reduction. Therefore, the use of existing controls and safeguards is not necessarily precluded. This flexibility acknowledges that there is not always an absolute safer alternative to a chemical, which is highly dependent on the process or application and the chemical involved. Indeed, sometimes IST can be impractical, especially for existing sources. Also, a passive measure or other approach in the STAA hierarchy may be effective at risk reduction.
EPA recognizes that facilities may wish to employ more than one safeguard. EPA also recognizes that IST will not eliminate all hazard or risk and that reliance on other risk reduction measures probably still will be needed.
EPA has not established a required time frame for any planned implementation of IST because planning, design, equipment modification and cost to implement IST can vary tremendously depending on the technology and scope of the project and can only best be determined by the facility involved in the implementation.
STAA Applicability
EPA determined that it was reasonable to require STAA for sectors that have had a high per facility incidence of reportable accidental releases and where the complexity and variety of methods of chemical handling demonstrate the potential for process safety revisions. Thus, EPA limited the applicability of the STAA provisions to sources involved in complex manufacturing operations because EPA believes these sources have the greatest range of opportunities to identify and implement safer technology, particularly in the area of inherent safety. These sources generally produce, transform, and consume large quantities of regulated substances under sometimes extreme process conditions and using a wide range of complex technologies. EPA believes that such sources often can consider the full range of inherent safety options, including IST, as well as passive, active, and procedural measures. Furthermore, EPA noted that RMP facilities in the three selected sectors have been responsible for a relatively large number of accidents, deaths, and injuries, and the most costly property damage. Facilities in these sectors also have significantly higher accidents rates as compared to other sectors.
EPA noted that, even though some facilities in these sectors already may have voluntarily undertaken an STAA, at least at new facilities, accidental release rates remain higher for these industries and also technologies advance over time. Consequently, EPA believes that ensuring a minimum level of application of STAA limits the disincentives for sector members to be leaders in adoption of safer technologies.
While EPA does not believe it is necessary to require all sources, all Program 3 sources, or all sources in industry sectors where feasible safer technology alternatives have been identified, to perform an STAA, EPA encourages such sources to consider performing an STAA, and to determine the practicability of IST or ISD considered, even if they are not subject to the STAA provisions of the amended rule.
EPA expects that the adoption of STAA requirements will advance IST not only in the sectors targeted by the rule, but also more generally as experience is gained and opportunities for technology transfer are developed.
Practicability of IST/ISD
EPA believes a practicability determination is necessary for any IST or ISD considered to ensure the facility owner or operator seriously considers whether IST or ISD modifications could further reduce risks and prevent accidents at the facility. EPA recognizes that requiring facilities to implement IST instead of using passive, active, or procedural safeguards can involve extensive and very expensive changes to a facility’s process, depending on the IST, especially if it involves substitution of alternative chemicals and/or major process redesign. Consequently, EPA believes that a practicability consideration should address whether an IST or ISD can be accomplished technologically, is economically possible, does not result in an increase in hazards or other risks that cannot be controlled, or cannot be successfully accomplished because of other considerations.
Practicability is defined in the rule as the capability of being successfully accomplished within a reasonable time, accounting for economic, environmental, legal, social, and technological factors. Environmental factors include consideration of potential transferred risks for new risk reduction measures. Minimization frequently involves the decrease of on-site storage and could result in the potential for additional shutdowns and startups due to insufficient raw materials with an increase in process risks as well as an increase in transportation requirements for hazardous materials with increased risks of incidents outside of the facility. Similarly, substitution of a purportedly safer alternative may introduce new environmental or safety risks. Facilities should consider carefully whether an IST could create new risks including security concerns such as terrorism.
EPA does not believe that economic or social factors should be defined in the rule because specificity for these terms would likely be too prescriptive and would not encompass all the possible conditions and outcomes that might be encountered when determining the practicability of an IST or ISD considered in the STAA.
EPA noted that further explanation of the economic, environmental, legal, social and technological factors included in the practicability definition of the rule can be found in Guidance for Toxic Catastrophe Prevention Act (TCPA) - Inherently Safer Technology (IST) Review, Attachment 1, Feasibility guidance published by the New Jersey Department of Environmental Protection.
EPA believes that the definition of practicability provides sufficient flexibility for the owner or operator to determine whether an IST or ISD considered could be successfully implemented. The definition is not intended to be used to judge the reasonableness or effectiveness of existing risk reduction measures, but rather whether new IST measures could be implemented.
STAA Methods
EPA does not expect to see a one-size-fits-all implementation of STAA by sources. However, definitions provided in the rule for several terms related to STAA, such as inherently safer technology or design, passives measures, active measures, procedural measures, and practicability are intended to help ensure a consistent understanding of EPA’s expectations for conducting an STAA and determining practicability of the IST and ISD considered.
EPA recognizes that there may be multiple rational approaches to STAA. EPA believes that the same tools and methods that facilities currently use for their PHA can be used to identify and measure hazards and risks of any safer alternative options. Also, EPA believes various resources and guidance exist that can assist facilities in understanding how IST can reduce hazards and risk and in determining practicability of IST or ISD considered in the STAA. EPA cited various references and technical sources of information that explain the concepts and principles of STAA and provide examples including the CCPS book, Inherently Safer Chemical Processes: A Life Cycle Approach, 2nd edition (2009).
EPA believes that IST analysis can be incorporated in the existing RMP PHAs by using PHA techniques such as the hazard and operability (HAZOP) study, What-If, or checklists, or a combination of them as discussed in Chapter 8 of the CCPS book. These techniques themselves are not requirements but tools available to help the facility owner or operator to identify, evaluate and control the hazards involved in the process.
EPA believes that opportunities for the application of the inherently safer strategy of simplification can be evaluated for each safety device or procedure during a PHA as well as in review of mechanical integrity program practices and procedures and references the CCPS book for examples.
Commenters on the proposed amendments raised various objections to addressing STAA in PHA. These objections included:
- Requiring PHA teams to evaluate the feasibility of IST has the potential to undermine the effectiveness of the PHA process. It may detract from the goal and focus of the PHA.
- None of the standard PHA methods requires this type of analysis.
- The structure of PHA does not facilitate STAA.
- The node-to-node approach of the hazard and operability study, and similar PHA methods, reduces the impact of IST to localized risk reduction measures rather than making the whole process inherently safer.
- Teams for PHA and an IST analysis are staffed differently. Design engineers are required for IST analysis.
- An IST review is different from a PHA. A PHA review considers the adequacy of the existing controls for the process while an IST review involves a comparison of different technologies.
- PHA and an IST analysis serve two entirely different engineering functions.
- Additional process safety information would need to be compiled for IST alternatives.
- The already lengthy time required to perform PHAs may be increased significantly.
EPA stated that if the facility owner or operator is concerned that an IST assessment could preclude other aspects of the PHA, or determines that two different teams should conduct the PHA and STAA, then they may choose to conduct a separate STAA of each process outside of the PHA as long as it is performed within the same time frame as the PHA and the results are documented.
EPA noted that the facility owner or operator is responsible for ensuring that facility personnel have the proper training to conduct STAAs. EPA stated that if a facility does not have staff capable to identify and evaluate alternatives, the facility owner or operator may require outside assistance from engineering firms or consultants with the appropriate qualifications. EPA expects that some facilities in NAICS codes 322, 324, and 325 will have staff qualified to conduct the analysis.
EPA stated that it will develop guidance for complying with STAA requirements before sources must comply with them and that a draft of the guidance will be available for public comment.
Practicability Analysis
EPA believes that it is appropriate for a facility to consider the five feasibility factors (economic, environmental, legal, social and technological) for evaluating the appropriateness of implementing potential IST measures because some IST can involve significant costs or involve impacts that go beyond the facility. Facilities can consider the effects in their supply chain (downstream and upstream) when evaluating potential IST options.
EPA expects that facility owners or operators will seriously consider the merits and consequences of ISTs for their facilities and use their expertise and judgement to ensure safety while not severely affecting the economic viability of their businesses.EPA also expects that facility owners and operators will use their expertise and make reasonable judgements when considering the appropriate meaning of economic or social factors so that any decisions regarding possible implementation of IST is not driven towards changes that would cause unintended adverse consequences.
The owner or operator can consider the potential for quantitative risk reduction, risk transfers, and tradeoffs when determining whether it is practicable to implement the ISTs or ISDs considered. Some technologies may not be inherently safer with respect to all hazards, may not be capable of implementation for all situations, and may involve multiple tradeoffs in the decision making process. The amended rule gives the facility owner or operator the flexibility to assess IST as well as passive, active, and procedural measures to reduce risk associated with a process and to determine the practicability of any IST considered based on various factors, including those involving risk transference.
The definition of practicability allows for consideration of technological factors, which could include whether the potential safer alternative can be designed and operated to meet the process functions needed. EPA noted that the practicability assessment considers the extent of process redesign, its engineering implications, and possible costs. If a facility is considering a chemical substitution or process change that involves a significant redesign of their process, such efforts involved with redesign and its evaluation may need to be undertaken as part of a practicability study.
While some facilities may choose to conduct an economic analysis of potential liabilities, costs, avoided costs, and savings associated with each major STAA option evaluated, EPA is only requiring facilities to determine whether IST is practicable and document this determination. It may not be possible always to estimate avoided costs and savings for a particular IST.
EPA noted that chemical substitution or whole design processes may be not practicable for some processes for a variety of reasons and that facilities should document these reasons for any particular IST that were considered by the facility for purposes of complying with the STAA requirements.
EPA noted that an owner or operator would be in compliance with the STAA requirement to consider potential chemical substitution as part of the analysis if they determine that a chemical substitution is not practicable because the substitution is prohibited by another regulation. The owner or operator would still need to consider other types of IST (minimization, moderation, or simplification), and passive, active, and procedural measures in the analysis.
EPA expects that facilities will only evaluate chemical substitutes that have already been shown to be commercially viable and does not expect facility owners or operators to expend a major effort on hypothetical or untested chemical substitutes or uses. EPA does not expect facilities to spend resources evaluating hypothetical untested alternatives that they believe are not proven within their industry. IST measures that have not been tested or used commercially should not be considered. It may be difficult to evaluate the practicability of hypothetical technologies or those that are still undergoing research and testing.
EPA allows that where a practicability evaluation is complex and resource intensive and may not be completed within the five years between PHA reviews, a facility should document during their PHA review that IST is under consideration and the practicability of implementing the technology is unknown and still undergoing evaluation.
The results of the practicability determination must be documented as part of the PHA requirements which require the owner or operator to document actions to be taken and resolution of recommendations.
Application of STAA
EPA views STAA as applicable throughout the life-cycle of a facility including operations, maintenance and modification. Every process must undergo an STAA every five years because STAA is integrated with PHA. EPA believes that five-year revalidation will give the owner or operator the opportunity to identify new risk reduction strategies, as well as revisit strategies that were previously evaluated to determine whether they are now practicable.
Owners and operators of new construction facilities that will be subject to the RMP rule should consider performing the STAA well enough in advance of facility construction so that the full range of inherently safer designs is considered. This evaluation should be included in the initial PHA for the process.
EPA believes that while the greatest potential opportunities for using IST occur early in process design and development, many IST options may still be practicable after the initial design phase. Also, STAA involves more than just IST. Safer technology alternatives also include passive measures, active measures, and procedural measures, and these measures can be modified and improved after the initial design of a facility.
Some facilities have evaluated IST as a best practice for some time and, in many cases, have already taken steps to implement beneficial technologies where it is practicable and cost-effective to do so. In such cases, EPA stated that the owner or operator should consider these analyses when updating or revalidating their PHAs and determine whether there is new information that should be considered as part of conducting the current STAA. In situations where IST was previously evaluated but not implemented, EPA noted that facilities should review the analysis to determine if new information is available that would affect the analysis.
EPA noted that a facility’s recent implementation of a safer technology alternative should not foreclose consideration of additional safer technologies in the future. Facilities that have already implemented safer technology alternatives should document their implementation in their next PHA, determine whether there is additional information that should be considered in their STAA, and continue to consider additional safer alternatives during subsequent PHA revalidation cycles.
The facility owner or operator determines whether an IST would achieve a reduction in risk specific to the hazard being addressed. EPA noted that some ISTs involving chemical substitution or significant process redesign can result in new hazards or risks being introduced, and these should be considered when deciding the practicability of an IST.
If a risk management measure identified by an STAA cannot be implemented within a reasonable time, then the facility should ensure that other safeguards are in place to prevent accidents instead of facing the uncertainty of completing a long-term project that is dependent on future conditions such as process design, operating budgets, etc.
EPA encourages owners and operator also to consider safer technology alternatives whenever major process changes are planned. EPA believes that the PHA with its requirement to encompass IST review as part of the PHA process, will cover all process changes whether they result from an incident investigation, management of change action, or other process change.
Documentation
EPA expects the STAA review to be documented. For IST/ISD measures considered, facilities should document the analysis and methodology used to evaluate or consider IST, its practicability, and the recommendations of the review team including reasoning for not adopting practicable IST/ISD.
EPA is not specifying any particular form of documentation given the potential complexity of the analysis, the variety of risk reduction measures involved, and the factors that may be considered for feasibility and/or implementation. EPA stated that facilities can follow, for example, guidance for inherently safer review documentation found in the CCPS book, Inherently Safer Chemical Processes: A Life Cycle Approach, which suggests documenting the summary of the approach used for the review (i.e., methodology, checklist, etc.); names and qualifications of the review team; inherently safer alternatives considered, as well as those already implemented or included in the design; results of each consideration including those not considered and why; feasibility; and the rationale for rejection of inherently safer opportunities.
Facilities should retain any reports, analysis, findings and recommendations used to comply with the STAA requirements for the life of the process as is required by the current rule for PHA.
EPA is not requiring automatic submission of STAA information or documentation to EPA or anyone else, or that it be made available to the public. However, the analysis and documentation must be kept as records under the record keeping requirements of the rule and be available for inspection or review by EPA.
EPA stated that documentation that could reveal vulnerabilities at an RMP-regulated facility must be secured. Therefore, although EPA is requiring facility owners and operators to document STAAs and practicability determinations, EPA is not requiring that this information be submitted to implementing agencies, LEPCs, or local emergency response officials. These entities have the ability to request documentation, at which point representatives of the facility and the requesting agency can discuss any security concerns and involve security agencies as appropriate.
EPA believes that the primary utility of STAA information for the public is whether or not facilities are implementing IST and the nature of that change. EPA is requiring that basic information on IST being implemented be provided in the Risk Management Plan submission in accordance with the requirements of the rule. Facilities must provide in their Risk Management Plan any inherently safer technology or design measures implemented since the last PHA and the technology category (substitution, minimization, simplification and/or moderation).
In the event of a public meeting held after an accident, EPA encourages facilities to provide information about any IST or other safer technology alternatives that the facility is using or could be using and suggests that the public use this forum to inquire about ISTs implemented at the facility.
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