PT Notes
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 proposed amendments to EPA's Risk Management Program regulation relating to Safer Technology and Alternatives Analysis (STAA).
EPA is proposing to add an element to process hazard analysis (PHA). Specifically, owners or operators of facilities with Program 3 regulated processes in North American Industrial Classification System (NAICS) codes 322 (paper manufacturing), 324 (petroleum and coal products manufacturing), and 325 (chemical manufacturing) would be required to conduct a safer technology and alternatives analysis (STAA) as part of their PHA, and to evaluate the feasibility of any inherently safer technology (IST) identified.
The current PHA requirements include consideration of active, passive, and procedural measures to control hazards. The proposed modernization effort continues to support the analysis of those measures and adds consideration of IST alternatives. The proposed provision is intended to reduce the risk of serious accidental releases by requiring facilities in these sectors to conduct a careful examination of potentially safer technology and designs that they could implement in lieu of, or in addition to, their current technologies. Data compiled from RMPs suggest processes in these NAICS codes have a disproportionate share of reportable releases.
The proposed amendments are described below.
Meaning of STAA
Safer technology and alternatives refers to risk reduction strategies developed through analysis using a hierarchy of process risk management strategies, or hierarchy of controls. It consists of inherent, passive, active, and procedural controls. This philosophy can be applied initially to all design phases and then continuously throughout the life cycle of a process by identifying and assessing hazards and developing a control strategy.
STAA includes concepts known as IST, or inherently safer design (ISD), which are those strategies that permanently reduce or eliminate the hazards associated with materials and operations used in a process.
The four major inherently safer strategies are:
- Minimization: Using smaller quantities of hazardous substances.
- Substitution: Replacing a material with a less hazardous substance.
- Moderation: Using less hazardous conditions or a less hazardous form, or designing facilities that minimize the impact of a release of hazardous material or energy.
- Simplification: Designing facilities to eliminate unnecessary complexity and make operating errors less likely.
The hierarchy establishes that inherently safer options are preferable and occupy the top of the hierarchy. Passive controls are preferable to active controls, which are preferable to procedural controls that require human action. However, risk reduction of a process hazard also may be achieved by using a combination of strategies, known as layers of protection. EPA is proposing to require analysis of safer technology and alternatives as part of the PHA for a subset of Program 3 processes.
EPA believes that there is a benefit in requiring that some facilities 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. While EPA believes that facilities should look for additional opportunities to increase safety, the Agency believes that facility owners or operators are in the best position to identify which changes are feasible to implement for their particular process. As a result, EPA is not proposing to require that a facility implement a particular technology or design.
EPA is not proposing to require sources affected by this provision to implement an evaluated IST or ISD. The decision to implement such measures must consider the numerous factors related to processes, facilities, and society at large. Improper implementation of a seemingly safer alternative may lead to undesired consequences.
While EPA believes that sources should look for additional opportunities to increase safety, the Agency believes that facility owners or operators are in the best position to identify which changes are feasible to implement for their particular processes. This decision should be based on a careful analysis and take into account:
- The chemicals present and their associated hazards.
- The operations and process conditions involved.
- Consequences to workers, nearby populations, and the environment.
- The types of equipment used that are specific to the facility's process.
The analysis may consider the potential to shift risk between populations, locations, environmental media (air, water, land), etc.
New Definitions
EPA is proposing to add several definitions that relate to a STAA. EPA is adding these definitions to describe risk reduction strategies that the owner or operator may use when considering safer technology and alternatives.
First, EPA is proposing to define “inherently safer technology or design” to mean “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”.
Second, EPA is proposing to define “passive measures” to mean “risk management measures that use design features that reduce the hazard without human, mechanical, or other energy input”. Examples of passive measures given by EPA include pressure vessel designs, dikes, berms, and blast walls.
Third, EPA is proposing to define “active measures” to mean “risk management measures or engineering controls that rely on mechanical or other energy input to detect and respond to process deviations”. Examples of active measures given by EPA include alarms, safety instrumented systems, and detection hardware, such as hydrocarbon sensors.
Fourth, EPA is proposing to define “procedural measures” to mean “risk management measures such as policies, operating procedures, training, administrative controls, and emergency response actions to prevent or minimize incidents”. Examples of procedural measures given by EPA include administrative limits on process vessel fill levels, and procedural steps taken to avoid releases.
EPA is requesting comments on these proposed definitions.
In order to evaluate the ISTs and ISDs considered, EPA is proposing to define “feasible” to mean “capable of being successfully accomplished within a reasonable time, accounting for economic, environmental, legal, social, and technological factors”. Environmental factors could include consideration of risks transferred elsewhere if a new risk reduction measure is adopted.
EPA is proposing to use the term “feasible” to characterize the viability of IST alternatives being considered because it is already widely used in the context of IST. However, this term has a distinct meaning under the Occupational Safety and Health Act, where the courts look to whether a safety measure is capable of being done. In the enforcement context, feasibility means that technical know-how about materials and methods is available or adaptable to specific circumstances, which when applied creates a reasonable possibility that employee exposure to occupational hazards will be reduced, and that the firm is financially able to implement the measure without severe adverse economic effect. Because of the potential for confusion, OSHA has indicated that it would be unable to adopt this definition of the term under its PSM standard if OSHA considers similar revisions involving IST. Therefore, EPA is seeking comments on whether it would be better if EPA used another term, such as “practicable”, that may be more appropriate.
Process Hazard Analysis (PHA)
EPA is proposing to modify the PHA provisions of the RMP rule to require the owner or operator to address STAA risk management measures applicable to eliminating or reducing risk from process hazards. EPA is proposing to specify that the analysis include, in the following order of preference: IST or ISD, passive measures, active measures, and procedural measures. The owner or operator may evaluate a combination of risk management measures to reduce risk. EPA is limiting the proposed provisions to Program 3 processes in the petroleum and coal products manufacturing (NAICS 324), chemical manufacturing (NAICS 325), and paper manufacturing (NAICS 322) sectors.
EPA is also proposing to require owners or operators to determine the feasibility of implementing any IST or ISD considered. EPA believes a feasibility analysis of any considered IST or ISD is necessary to ensure the facility owner or operator seriously considers whether IST or ISD modifications could further reduce risks and prevent accidents at the facility. The results of the feasibility analysis must be documented as part of the current PHA requirements, which requires the owner or operator to document actions to be taken and the resolution of recommendations.
EPA is seeking comments on whether the proposed requirements to document feasibility are adequate or if these requirements should be modified to require a more extensive documentation of feasibility. For example, EPA could require that the source document the basis for this conclusion in meaningful detail similar to California's Contra Costa County's Industrial Safety Ordinance requirements.
PHAs must be updated and revalidated every five years in accordance with existing requirements, and, as such, this provides the owner or operator opportunities to evaluate the feasibility of IST or ISD considered since the last PHA review. 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 feasible.
EPA is seeking comments on these proposed revisions. Additionally, EPA is requesting comments on whether to require STAA documentation be submitted to EPA and/or the implementing agency.
STAA Applicability
EPA is proposing to limit the applicability of the STAA provisions to sources in the petroleum and coal products manufacturing (NAICS 324), chemical manufacturing (NAICS 325), and paper manufacturing (NAICS 322) sectors for two reasons.
First, EPA believes that while most sectors regulated under the RMP rule could identify safer technology and alternatives, sources involved in complex manufacturing operations 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. Therefore, such sources can often consider the full range of inherent safety options, including minimization, substitution, moderation, and simplification, as well as passive, active, and procedural measures.
This contrasts with regulated sources that simply sell or distribute a particular regulated substance, such as bulk anhydrous ammonia. Although such sources also may have opportunities to identify and implement IST, the existence of such sources is predicated on handling and distributing a specific regulated substance. Therefore, their opportunities to implement certain IST strategies such as substitution or minimization may be limited. Similarly, sources involving relatively simpler chemical processes may have opportunities to implement chemical substitution strategies but may be limited in their ability to apply moderation and simplification strategies.
Second, EPA notes that RMP facilities in the three selected sectors have been responsible for a relatively large number of accidents, deaths, injuries, and property damage. EPA compared the number of RMP accidents that occurred between January 1, 2004, and December 31, 2013, reported by twelve industry sectors, to the number of facilities in each sector. Each sector was composed of industries based on similar operations involving the RMP substances and complexity. The twelve sectors were:
- Petroleum and coal products manufacturing (NAICS 325)
- Paper manufacturing (NAICS 322)
- Chemical manufacturing (NAICS 324)
- Food and beverage manufacturing (NAICS 311, 312)
- Other manufacturing (all other NAICS 31-33)
- Agricultural chemical distributors (NAICS 11, 42491)
- Chemical/petroleum wholesalers (NAICS 4246, 4247)
- Other wholesalers (all other NAICS 423, 424)
- Warehouses (NAICS 493)
- Water supply/wastewater treatment (NAICS 22131, 22132, 924)
- Oil/gas extraction (NAICS 211)
- All other (NAICS 211 (except 22131 and 22132), 44, 45, 48, 54, 56, 61, 72).
The sector accident rates, that is, the number of accidents divided by the number of facilities in each sector, ranged from 1.08 to 0.04. Three sectors have significantly higher accidents rates compared to other sectors: 1.08 (petroleum and coal products manufacturing), 0.66 (paper manufacturing) and 0.36 (chemical manufacturing). The petroleum and coal products manufacturing accident rate was 6-27 times higher, the paper manufacturing accident rate was about 4-6 times higher, and the chemical manufacturing accident rate was 2-9 times higher than other sectors. Therefore, implementation of safer technology and alternatives by these facilities in the pulp/paper manufacturing, chemical manufacturing, and petroleum refining sectors may prevent serious accidental releases in the future.
EPA is seeking comments on whether the proposal to limit the STAA provisions to Program 3 regulated processes in NAICS 322, 324, and 325 is appropriate. EPA also is seeking comments on whether the Agency should further limit applicability of the STAA provisions, for example, to apply only during the design stage of new processes or facilities, or only to certain processes.
EPA has noted that the approach may limit the flexibility to evaluate alternatives for custom formula blends and compliance with FDA approval requirements. Therefore, EPA is seeking comments on eliminating this provision and/or exempting batch toll manufacturers from this requirement.
Lastly, EPA is seeking comments on whether there are other sectors that should be subject to the proposed STAA provision. For example, should EPA require RMP regulated water supply/wastewater treatment facilities to analyze safer technology and alternatives and document feasibility of the alternatives?
Guidance on Evaluating Safer Technologies and Alternatives
EPA believes that some owners or operators have already made process changes considered to be inherently safer, but others may not have sufficient information available to effectively assess whether their existing processes can incorporate inherently safer measures. To assist owners or operators with evaluating options for safer alternatives, EPA and OSHA developed a chemical safety alert in June 2015 illustrating the concepts and principles and providing examples of safer technology and alternatives to make industry more aware of this information, while providing sources of information for further investigation and review.
EPA and OSHA have said owners or operators may use any available method or guidance to conduct their STAA, such as approaches discussed by CCPS (e.g. Hazard and Operability Study (HAZOP), What-If?, Checklist, and consequence-based methods), the NJ Toxic Catastrophe Prevention Act IST guidance materials, the Inherently Safer Systems (ISS) Checklist provided by the Contra Costa Hazardous Materials Program, or information on OSHA's web page, “Transitioning to Safer Chemicals: A Toolkit for Employers and Workers.”
CCPS provides guidelines for what should be provided in an inherent safety analysis and provides example rationales for why inherent safety review recommendations were rejected. Examples for why inherent safety review recommendations may not be feasible, include when the recommendation:
- Is in conflict with existing Federal, state and local laws.
- Is in conflict with recognized and generally accepted good engineering practices (RAGAGEP).
- Is economically impractical, such that the process unit would stop being fiscally feasible. This can include consideration of:
- Capital investment.
- Product quality.
- Total direct manufacturing costs.
- Operability of the plant.
- Demolition and future clean-up and disposal cost.
- Negative social impact. Some examples include an unacceptable visual or noise impact on the community, or increased traffic congestion.
- Violation of a license agreement that cannot be modified, and so must remain in effect.
- May decrease the hazard, but would increase the overall risk.
- Provides less risk reduction than an alternative recommendation.
Alternative Options
As an alternative option, EPA is seeking comments on whether to require facility owners or operators to implement any of the feasible options identified in the facility's analysis. This option would rely on the owner or operator to select the specific technology or design to implement. EPA is seeking comment on the factors EPA should consider when determining whether to require implementation of feasible options.
EPA evaluated the NJ Department of Environmental Protection’s (DEP’s) and Contra Costa Health Services’ (CCHS’s) IST analysis programs as possible models to use in the Risk Management Program requirements. EPA is seeking comments on whether the Agency should include the following in the proposed STAA provisions:
- Aspects of the NJ DEP's program, such as more prescribed documentation of STAA.
- Other aspects of CCHS's program, such as requiring ISS analysis during the design of new processes, for PHA recommendations, or for major changes from incident investigation recommendations, root cause analysis, or MOC review that could reasonably result in a major chemical accident or release.
Lastly, EPA is seeking comment on whether either EPA or a third party should create a clearinghouse of safer technology and alternatives that allows source owners or operators to share useful information and/or consult to identify technologies to evaluate for their process. EPA notes that the concept of a clearinghouse has drawn support in comments on the RFI from state and local officials, labor and environmental stakeholders, academics, and industry representatives.
One mechanism for collecting relevant information could be the National Working Group on Chemical Safety and Security's best practices website, which collects and shares chemical safety and security best practices, including safer alternatives.
Alternatively, EPA could require submission of STAA analyses, or information from those analyses, directly to EPA, and develop its own website. The information shared on such a website may include practicable risk reduction measures that could be applied at various facilities to mitigate threats to the public, workers, the environment, and facility during the production, transport, and use of chemicals.
Further details can be found at:
https://www.regulations.gov/#!documentDetail;D=EPA-HQ-OEM-2015-0725-0001
Comments on the proposed amendments must be submitted on or before May 13, 2016. Comments should be identified by docket EPA-HQ-OEM-2015-0725 and submitted through to the Federal eRulemaking Portal: http://www.regulations.gov.
