Accidental Release Prevention Requirements: Risk Management Programs Under Clean Air Act Section 112(r)(7)
[Federal Register: June 20, 1996 (Volume 61, Number 120)] [Rules and Regulations] [Page 31667-31730] From the Federal Register Online via GPO Access [wais.access.gpo.gov]
ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 68 [FRL-5516-5] RIN 2050-AD26 Accidental Release Prevention Requirements: Risk Management Programs Under Clean Air Act Section 112(r)(7) AGENCY: Environmental Protection Agency. ACTION: Final rule.
SUMMARY: The Clean Air Act requires EPA to promulgate regulations to prevent accidental releases of regulated substances and reduce the severity of those releases that do occur. EPA is promulgating rules that apply to all stationary sources with processes that contain more than a threshold quantity of a regulated substance. Processes will be divided into three categories based on: the potential for offsite consequences associated with a worst-case accidental release; accident history; or compliance with the prevention requirements under OSHA's Process Safety Management Standard. Processes that have no potential impact on the public in the case of an accidental release will have minimal requirements. For other processes, sources will implement a risk management program that includes more detailed requirements for hazard assessment, prevention, and emergency response. Processes in industry categories with a history of accidental releases and processes already complying with OSHA's Process Safety Management Standard will be subject to a prevention program that is identical to parallel elements of the OSHA Standard. All other processes will be subject to streamlined prevention requirements. All sources must prepare a risk management plan based on the risk management programs established at the source. The source must submit the plan to a central point specified by EPA; the plan will be available to state and local governments and the public. These regulations will encourage sources to reduce the probability of accidental releases of substances that have the potential to cause immediate harm to public health and the environment and will stimulate the dialogue between industry and the public to improve accident prevention and emergency response practices. DATES: The rule is effective August 19, 1996. ADDRESSES: Supporting material used in developing the proposed rule, supplemental notice, and final rule is contained in Docket No. A-91-73. The docket is available for public inspection and copying between 8:00 a.m. and 5:30 p.m., Monday through Friday (except government holidays) at Room 1500, 401 M St. SW, Washington, DC 20460. A reasonable fee may charged for copying. FOR FURTHER INFORMATION CONTACT: Craig Matthiessen at (202) 260-8600, Chemical Emergency Preparedness and Prevention Office, U.S. Environmental Protection Agency, 401 M St. SW, Washington, DC 20460, or the Emergency Planning and Community Right-to-Know Hotline at 1-800- 424-9346 (in the Washington, DC, metropolitan area, (703) 412-9810). SUPPLEMENTARY INFORMATION: Judicial Review. Accidental Release Prevention Requirements: Risk Management Programs Under Clean Air Act Section 112(r)(7) were proposed in the Federal Register on October 20, 1993 (58 FR 54190). A supplemental notice was issued on March 13, 1995 (60 FR 13526). This Federal Register action announces the EPA's final decisions on the rule. Under section 307(b)(1) of the Act, judicial review of the Accidental Release Prevention Requirements: Risk Management Programs is available only by the petition for review in the U.S. Court of Appeals for the District of Columbia Circuit within 60 days of today's publication of this final rule. Under section 307(b)(2) of the Act, the requirements that are the subject of today's notice may not be challenged later in civil or criminal proceedings brought by the EPA to enforce these requirements. Regulated Entities Entities potentially regulated by this action are those stationary sources that have more than a threshold quantity of a regulated substance in a process. Regulated categories and entities include:Category Examples of regulated entities Chemical Manufacturers............ Industrial organics & inorganics, paints, pharmaceuticals, adhesives, sealants, fibers Petrochemical..................... Refineries, industrial gases, plastics & resins, synthetic rubber Other Manufacturing............... Electronics, semiconductors, paper, fabricated metals, industrial machinery, furniture, textiles Agriculture....................... Fertilzers, pesticides Public Sources.................... Drinking and waste water treatment works Utilities......................... Electric and Gas Utilities Others............................ Food and cold storage, propane retail, warehousing and wholesalers Federal Sources................... Military and energy installations
This table is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be regulated by this action. This table lists the types of entities that EPA is now aware could potentially be regulated by this action. Other types of entities not listed in the table could also be regulated. To determine whether a stationary source is regulated by this action, carefully examine the provisions associated with the list of substances and thresholds under Sec. 68.130 (59 FR 4478), the proposed modifications (61 FR 16598, April 15, 1996) and the stay of implementation of the affected provisions until the proposed modifications are final published elsewhere in today's Federal Register, and the applicability criteria in Sec. 68.10 of today's rule. If you have questions regarding the applicability of this action to a particular entity, consult the person listed in the preceding FOR FURTHER INFORMATION CONTACT section. The following outline is provided to aid in reading this preamble: I. Introduction and Background
A. Statutory Authority
B. Background
II. Discussion of Final Rule
A. Applicability
B. Program Criteria and Requirements
C. Hazard Assessment
D. Prevention Programs
E. Emergency Response
F. Risk Management Plan (RMP)
G. Air Permitting
H. Other Issues
III. Discussion of Comments
A. Tiering
- Rationale
- Program 1 vs. Program 2 and Program 3 Criteria
[[Page 31669]] a. Potential for Offsite Impact
b. Accident History
c. Other
3. Program 2 vs. Program 3 Criteria
a. Number of Employees
b. SIC Code
c. Site-specific, Risk-based Criteria
d. Accident History
e. Other
4. Program 1 Requirements
a. Certification of No Environmental Impact
b. Signs
c. Emergency Response Program
d. Other
5. Program 2 Requirements
a. Streamlined Program
b. Other Regulations
c. Emergency Response Program
B. Offsite Consequence Analysis
- Worst-Case Release Scenario
- Mitigation Systems
a. Worst-Case Release Scenario
b. Alternative Scenarios
- Populations Affected
- Number of Scenarios
- Technical Guidance
- Modeling Parameters
a. Endpoints
b. Meteorology
C. Consideration of Environmental Impact
- Inclusion of Environmental Impacts
- Environments to be Considered
- Level of Analysis Required
D. Program 3 Consistency with OSHA PSM Standard
- Prevention Program
- Enforcement
- Exemptions
E. Relationship to Air Permits
- General Relationship between the Part 68 and Part 70 programs
- Impact of EPA's Proposal on Air Permitting Programs
- Part 68 as an ``Applicable Requirement'' under Part 70
- Role of the Air Permitting Authority
- Air Permit Application Contents
- Air Permit Contents
- Completeness Review
- Interaction of the Implementing Agency and the Permitting Authority
- Designated Agency
- Reopening Air Permits to Incorporate Section 112(r) Requirements
- Use of Air Funds
- Other Issues
F. General Definitions
- Significant Accidental Release
- Stationary Source
- Process
- Offsite
- Other Definitions
G. Risk Management Plan (RMP)
- Level of Detail
- RMP Content
- Submission
- Other Issues
H. Prevention Program
I. Accident History
J. Emergency Response Program
K. Registration
L. Model Risk Management Programs
M. Implementing Agency Audits
N. Public Participation
O. Inherently Safer Technologies
P. Coverage by Other Regulations
- General Issues
- DOT Transportation Regulations
- Other EPA Regulations
- Other Federal Regulations
- State and Local Regulations
Q. Industry-Specific Issues
- Oil and Gas Facilities
- Retail Facilities
a. Propane Retailers
b. Ammonia Retailers
- Refrigeration Systems
- Other Operations
R. Implementing Agency Delegation
S. Accident Reporting
T. Other Issues
- OSHA VPP
- Qualified Third Party
- Documentation
IV. Section-by-Section Analysis of the Rule
V. Required Analyses
A. E.O. 12866
B. Regulatory Flexibility Act
C. Unfunded Mandate Reform Act
D. Paperwork Reduction Act
E. Submission to Congress and the General Accounting Office
I. Introduction and Background A. Statutory Authority This rule is promulgated under sections 112(r), 301(a)(1), Title V of the Clean Air Act (CAA) as amended (42 U.S.C. 7412(r), 7601(a)(1), 7661-7661f). B. Background The CAA Amendments of 1990 amend section 112 and add paragraph (r). The intent of section 112(r) is to prevent accidental releases to the air and mitigate the consequences of such releases by focusing prevention measures on chemicals that pose the greatest risk to the public and the environment. Section 112(r)(3) mandates that EPA promulgate a list of regulated substances, with threshold quantities; this list defines the stationary sources that will be subject to accident prevention regulations mandated by section 112(r)(7). EPA promulgated its list of substances on January 31, 1994 (59 FR 4478) (``List Rule'').
As noted elsewhere in today's Federal Register, EPA has stayed certain provisions of part 68 that were promulgated as part of the List Rule. The stayed provisions are being addressed in amendments to the List Rule, which were proposed in 61 FR 16598 (April 15, 1996). Therefore, EPA has not taken final action on provisions of the Risk Management Program rule that apply to regulated substances, mixtures, and stationary sources addressed by the stayed provisions. Final action will be deferred until EPA takes final action on the proposed amendments to the List Rule.
Section 112(r)(7) mandates that EPA promulgate regulations and develop guidance to prevent, detect, and respond to accidental releases. Stationary sources covered by these regulations must develop and implement a risk management program that includes a hazard assessment, a prevention program, and an emergency response program. The risk management program must be described in a risk management plan (RMP) that must be registered with EPA, submitted to state and local authorities, and made available to the public. On October 20, 1993, EPA published a Notice of Proposed Rulemaking (NPRM) for the section 112(r)(7) regulations (58 FR 54190). (For a summary of the statutory requirements of section 112(r) and related statutory provisions, see the October 20, 1993, NPRM).
Following publication of the proposed rule, EPA held four public hearings and received approximately 770 written comments. Because of these comments, EPA issued a supplemental notice of proposed rulemaking (SNPRM) on March 13, 1995 (60 FR 13526) for comment on: approaches for setting different requirements for sources that pose different levels of hazard (tiering); worst-case releases and other hazard assessment issues; accident information reporting; public participation; inherently safer approaches; and implementation and integration of section 112(r) with state programs, particularly state air permitting programs. EPA held a public hearing on March 31, 1995, in Washington, DC, and received more than 280 written comments. Today's rule reflects EPA's consideration of all comments; major issues raised by commenters and EPA's response are briefly discussed in Section III of this preamble. A summary of all comments submitted and EPA's response to them is available in the Docket (see ADDRESSES). EPA has proposed to delist explosives from Sec. 68.130. Consequently, explosives are not addressed in this rule. EPA had also requested at the time of the final List Rule comments on whether flammable substances, when used as fuel, posed a lesser intrinsic hazard than the same substance handled otherwise (59 FR 4500, January 31, 1994). The comments submitted lacked data that would justify a lesser level of hazard consideration for flammable fuels; hence, the Agency will not adopt a fuel use exemption for purposes of threshold quantity determination.
With today's rule, EPA continues the philosophy that the Agency embraced in implementing the Emergency Planning and Community Right-toKnow Act of [[Page 31670]] 1986 (EPCRA). Specifically, EPA recognizes that regulatory requirements, by themselves, will not guarantee safety. Instead, EPA believes that information about hazards in a community can and should lead public officials and the general public to work with industry to prevent accidents. For example, today's rule requires covered sources to provide information about possible worst-case scenarios. EPA intends that officials and the public use this information to understand the chemical hazards in the community and then engage in a dialogue with industry to reduce risk. In this way, accident prevention is focused primarily at the local level where the risk is found. Further, today's rule builds on existing programs and standards. For example, EPA has coordinated with Occupational Safety and Health Administration (OSHA) and the Department of Transportation (DOT) in developing this regulation. To the extent possible, covered sources will not face inconsistent requirements under these agencies' rules. EPA is encouraging sources to use existing emergency response programs, rather than develop a separate and duplicative program under this rule. In addition, today's rule scales requirements based on the potential risk posed by a source and the steps needed to address the risk, rather than imposing identical requirements on all sources. To accommodate the concerns of small businesses, EPA is providing guidance with reference tables that covered sources can use to model the offsite consequences of a release. EPA is providing a model RMP guidance for the ammonia refrigeration industry, and will develop similar guidance for propane handlers and drinking water systems. As today's rule is implemented, EPA hopes that other industry sectors will work with EPA to develop model RMPs for other processes, thereby reducing costs for individual sources. Finally, today's rule requires industry to submit RMPs centrally in a format and method to be determined by EPA. Working with stakeholders, EPA will develop mechanisms to allow industry to use appropriate electronic technology to register with EPA and submit RMPs. In turn, all interested parties will be able to access electronically the data in RMPs. This method of submission and access avoids a potentially significant amount of paperwork for all involved parties and promotes uniformity. Users will be able to develop databases for specific purposes and compare RMPs for various sites across the country. In turn, industries' use of the data will promote continuous improvement, for example, through new safety technologies. As the method for submitting RMPs is developed, EPA invites the participation of all stakeholders, including industry, state and local governments, local emergency planning committees, environmental groups, and the general public. II. Discussion of Final Rule A. Applicability The owner or operator of a stationary source that has more than a threshold quantity of a regulated substance in a process must comply with these requirements no later than June 21, 1999; three years after the date on which a regulated substance is first listed under Sec. 68.130; or the date on which a regulated substance is first present in more than a threshold quantity in a process, whichever is later. B. Program Criteria and Requirements Under today's rule, processes subject to these requirements are divided into three tiers, labeled Programs 1, 2, and 3. EPA has adopted the term ``Program'' to replace the term ``Tier'' found in the SNPRM to avoid confusion with Tier I and Tier II forms submitted under EPCRA, also known as Title III of the Superfund Amendments and Reauthorization Act of 1986 (SARA Title III). Eligibility for any given Program is based on process criteria so that classification of one process in a Program does not influence the classification of other processes at the source. For example, if a process meets Program 1 criteria, the source need only satisfy Program 1 requirements for that process, even if other processes at the source are subject to Program 2 or Program 3. A source, therefore, could have processes in one or more of the three Programs.
Program 1 is available to any process that has not had an accidental release with offsite consequences in the five years prior to the submission date of the RMP and has no public receptors within the distance to a specified toxic or flammable endpoint associated with a worst-case release scenario. Program 3 applies to processes in Standard Industrial Classification (SIC) codes 2611 (pulp mills), 2812 (chloralkali), 2819 (industrial inorganics), 2821 (plastics and resins), 2865 (cyclic crudes), 2869 (industrial organics), 2873 (nitrogen fertilizers), 2879 (agricultural chemicals), and 2911 (petroleum refineries). Program 3 also applies to all processes subject to the OSHA Process Safety Management (PSM) standard (29 CFR 1910.119), unless the process is eligible for Program 1. Owners or operators will need to determine individual SIC codes for each covered process to determine whether Program 3 applies. All other covered processes must satisfy Program 2 requirements. Program requirements and differences are illustrated on Tables 1 and 2:Table 1--Program Eligibility Criteria
Program 1 Program 2 Program 3
No offsite accident history. .................. Process is subject to OSHA PSM. No public receptors in worst- The process is not Process is in SIC case circle. eligible for code 2611, 2812, Program 1 or 3. 2819, 2821, 2865, 2869, 2873, 2879, or 2911. Emergency response .................. coordinated with local responders.
Table 2--Comparison of Program Requirements[[Page 31671]]
Program 1 Program 2 Program 3
Hazard Assessment: Worst-case analysis......... Worst-case analysis. Worst-case analysis. Alternative releases Alternative releases. 5-year accident history..... 5-year accident 5-year accident history. history. Management Program: Document management Document management system. system.Prevention Program: Certify no additional steps Safety Information.. Process Safety needed. Information. Hazard Review....... Process Hazard Analysis. Operating Procedures Operating Procedures. Training............ Training. Maintenance......... Mechanical Integrity. Incident Incident Investigation. Investigation. Compliance Audit.... Compliance Audit. .................. Management of Change. .................. Pre-startup Review. .................. Contractors. .................. Employee Participation. .................. Hot Work Permits. Emergency Response Program: Coordinate with local Develop plan and Develop plan and responders. program. program. Risk Management Plan Contents: Executive Summary........... Executive Summary... Executive Summary Registration................ Registration........ Registration. Worst-case data............. Worst-case data..... Worst-case data. 5-year accident history..... Alternative release Alternative release data. data. Certification............... 5-year accident 5-year accident history. history. Prevention program Prevention program data. data. Emergency response Emergency response data. data. Certification....... Certification.
The owner or operator of a covered process must: (1) prepare and submit a single risk management plan (RMP), including registration that covers all affected processes and chemicals; (2) conduct a worst-case release scenario analysis, review accident history, ensure emergency response procedures are coordinated with community response organizations to determine eligibility for Program 1 and, if eligible, document the worst case and complete a Program 1 certification for the RMP; (3) conduct a hazard assessment, document a management system, implement a more extensive, but still streamlined prevention program, and implement an emergency response program for Program 2 processes; and (4) conduct a hazard assessment, document a management system, implement a prevention program that is fundamentally identical to the OSHA PSM Standard, and implement an emergency response program for Program 3 processes.
Measures taken by sources to comply with OSHA PSM for any process that meets OSHA's PSM standard are sufficient to comply with the prevention program requirements of all three Programs. EPA will retain its authority to enforce the prevention program requirements and the general duty requirements of CAA Section 112(r)(1). EPA and OSHA are working closely to coordinate interpretation and enforcement of PSM and accident prevention programs. EPA will also work with state and local agencies to coordinate oversight of worker and public safety and environmental protection programs. C. Hazard Assessment EPA has adopted the worst-case definition proposed in the SNPRM. For all substances, the worst-case release scenario will be defined as the release of the largest quantity of a regulated substance from a vessel or process line failure, including administrative controls and passive mitigation that limit the total quantity involved or the release rate. For most gases, the worst-case release scenario assumes that the quantity is released in 10 minutes. For liquids, the scenario assumes an instantaneous spill; the release rate to the air is the volatilization rate from a pool 1 cm deep unless passive mitigation systems contain the substance in a smaller area. For flammables, the worst case assumes an instantaneous release and a vapor cloud explosion.
For the final rule, EPA has adopted the term ``alternative release scenarios'' to replace the term ``other more likely scenarios'' found in the NPRM and SNPRM. The non-worst-case accidental releases for the hazard assessment portion of the risk management plan were presumed ``more likely to occur'' and ``more realistic'' than the worst case. EPA believes sources should have flexibility to select non-worst-case scenarios that are the most useful for communication with the public and first responders and for emergency response preparedness and planning. Catastrophic accidental releases are typically rare events; the words ``more likely'' suggests certainty of occurrence. Consequently, the scenarios other than worst case provided in the hazard assessment are called alternative release scenarios. For alternative scenarios, sources may consider the effects of both passive and active mitigation systems.
One worst-case release scenario will be defined to represent all toxics, and one worst-case release scenario will be defined to represent all flammables held above the threshold at the source. Additional worst-case release scenario(s) must be analyzed and reported if such a release from another covered process at the source potentially affects public receptors that would not be potentially affected by the first scenario. EPA recognizes that this approach may be problematic for some sources such as batch processors and warehouses where use of listed substances or inventory may vary considerably within an RMP reporting period. EPA suggests that owners or operators of such processes develop a worst-case scenario for future chemical use and inventory based on past practices to minimize the need for frequent revision of their worst-case scenario. For alternative release scenarios, one scenario is required for each toxic substance and one to represent all flammable substances held in covered processes at the source.
An endpoint is needed for the offsite consequence analysis. Appendix A of today's rule lists the endpoints for toxic substances that must be used in worst-case and alternative scenario assessment. The endpoint for a toxic substance is its Emergency Response Planning Guideline level 2 (ERPG-2) developed by the American Industrial Hygiene Association (AIHA). If a substance has no ERPG-2, then the endpoint is the level of concern (LOC) from the Technical Guidance for Hazards Analysis, updated where necessary to reflect new toxicity data. EPA recognizes the limitations associated with ERPG-2 and LOC values and is working with other agencies to develop Acute Exposure Guideline Limits (AEGLs). When these values have been developed and peer-reviewed, EPA intends to adopt them through rulemaking as the toxic endpoints for this rule. For flammables, vapor cloud explosion distances will be based on an overpressure of 1 psi; for alternative flammable releases, radiant heat distances will be based on an exposure of 5 kW/m\2\ for 40 seconds. For vapor cloud fires and jet fires, the lower flammability limit provided by the National Fire Protection Association (NFPA) or other sources shall be used.
EPA selected 1.5 meter per second (m/s) wind speed and F atmospheric stability class as the default worst-case scenario meteorological conditions. If the owner or operator has meteorological data that show that higher minimum wind speeds or less stable atmospheric class conditions existed at the source at all times in the previous three years, then the higher wind speed and different stability class may be used. Alternative release analyses may use sitespecific, typical meteorological conditions. If the owner or operator has no data on typical meteorological conditions, then conditions used in the RMP Offsite Consequence Analysis Guidance (3 m/s and D stability), may be used. Although EPA is providing technical guidance and reference tables for worst-case and alternative release scenario assessments, owners or operators may use any generally recognized, commercially or publicly available air dispersion modeling techniques, provided the modeling parameters specified in the rule are used. For the hazard assessment and the RMP, populations potentially affected are defined as those within a circle that has as its center the point of release and its radius the distance to the toxic or flammable endpoint. Owners or operators may use Census data to define this population, and may update those data if they are inaccurate. EPA suggests that owners or operators use LandView, an electronic publication of environmental, geographic and demographic information published by EPA and the Bureau of Census. The presence of schools, hospitals, other institutions, public arenas, recreational areas, and large commercial and industrial developments that can be identified on street maps within this circle must be noted in the RMP, but the number of people occupying them need not be enumerated. The presence of environmental receptors within this circle must also be listed. EPA has defined environmental receptors as natural areas such as national or state parks, forests, or monuments; officially designated wildlife sanctuaries, preserves, refuges, or areas; and Federal wilderness areas, that can be exposed to an accidental release. All of these can be identified on local U.S. Geological Survey maps or maps based on USGS data.
The five-year accident history will cover all accidents involving regulated substances, but only from covered processes at the source that resulted in serious on site or certain known offsite impacts in the five years prior to the submission of each RMP. EPA has replaced the definition of significant accidental release with specific definitions of the types of releases to be covered under each of the specific requirements previously associated with this definition. D. Prevention Programs EPA has retained the management system requirement proposed in the NPRM, but only for Program 2 and 3 processes. EPA has moved the management system requirement from the prevention program section to the general requirements section because it should be designed to oversee the implementation of all elements of the risk management program. The owner or operator must designate a qualified person or position with overall responsibility for the program and specify the lines of authority if responsibility for implementing individual requirements is assigned to other persons or positions. In the SNPRM, EPA proposed a Program 2 prevention program that covered training, maintenance, safety precautions, and monitoring, but did not specify any particular actions. EPA solicited comment on whether specific prevention activities should be required for Program 2 sources, such as any of the specific activities initially proposed in the NPRM. For today's rule, EPA has developed seven specific elements for the Program 2 prevention program: safety information (Sec. 68.48), hazard review (Sec. 68.50), operating procedures (Sec. 68.52), training (Sec. 68.54), maintenance (Sec. 68.56), compliance audits (Sec. 68.58), and incident investigation (Sec. 68.60). Most Program 2 processes are likely to be relatively simple and located at smaller businesses. EPA believes owners or operators of Program 2 processes can successfully prevent accidents without a program as detailed as the OSHA PSM, which was primarily designed for the chemical industry. EPA combined and tailored elements common to OSHA's PSM and EPA's NPRM to generate Program 2 requirements and applied them to non-petrochemical industry processes. EPA is also developing model risk management programs (and RMPs) for several industry sectors that will have Program 2 processes. These model guidances will help sources comply by providing standard elements that can be adopted to a specific source. EPA expects that many Program 2 processes will already be in compliance with most of the requirements through compliance with other Federal regulations, state laws, industry standards and codes, and good engineering practices. The Program 3 prevention program includes the requirements of the OSHA PSM standard, 29 CFR 1910.119 (c) through (m) and (o), with minor wording changes to address statutory differences. This makes it clear that one accident prevention program to protect workers, the general public, and the environment will satisfy both OSHA and EPA. For elements that are in both the EPA and OSHA rules, EPA has used OSHA's language verbatim, with the following changes: the replacement of the terms ``highly hazardous substance,'' ``employer,'' ``standard'' and ``facility'' with ``regulated substance,'' ``owner or operator,'' ``part or rule,'' and ``stationary source''; the deletion of specific references to workplace impacts or to ``safety and health;'' changes to specific schedule dates; and changes to references within the standard. The ``safety and health'' and ``workplace impacts'' references occur in OSHA's PSM standard in process safety information (29 CFR 1910.119 (d)(2)(E)), process hazards analysis (29 CFR 1910.119(e)(3)(vii)), and incident investigation (29 CFR 1910.119(m)(1)). These changes are designed to ensure that OSHA retains its oversight of actions designed to protect workers while EPA retains its oversight of actions to protect public health and the environment and to remove possible interpretations that certain elements of process safety management fail to account for offsite impacts. Commenters were particularly concerned about the phase-in of process hazard analyses [[Page 31673]] (PHAs). Under the final rule, PHAs conducted for OSHA are considered adequate to meet EPA's requirements. They will be updated on the OSHA schedule (i.e., by the fifth anniversary of their initial completion). This approach will eliminate any need for duplicative analyses. Documentation for the PHA developed for OSHA will be sufficient to meet EPA's purposes.
EPA anticipates that sources whose processes are already in compliance with OSHA PSM will not need to take any additional steps or create any new documentation to comply with EPA's Program 3 prevention program. Any PSM modifications necessary to account for protection of public health and the environment along with protection of workers can be made when PSM elements are updated under the OSHA requirements. EPA has modified the OSHA definition of catastrophic release, which serves as the trigger for an incident investigation, to include events ``that present imminent and substantial endangerment to public health and the environment.'' As a result, this rule requires investigation of accidental releases that pose a risk to the public or the environment, whereas the OSHA rule does not. EPA recognizes that catastrophic accidental releases primarily affect the workplace and that this change will have little effect on incident investigation programs already established. However, EPA needs to ensure that deviations that could have had only an offsite impact are also addressed. E. Emergency Response EPA has adopted the emergency response requirements found in the statute, without additional specific planning requirements beyond those necessary to implement the statute. This action is consistent with the Agency's effort to develop a single Federal approach for emergency response planning. The Presidential Review of Federal release prevention, mitigation, and response authorities (required under section 112(r)(10) of the Clean Air Act) found that there is seldom harmony in the required formats or elements of response plans prepared to meet various Federal regulations. Accordingly, EPA has committed not to specify new plan elements and/or a specific plan format in today's rule beyond those that are statutorily required. EPA believes that plans developed to comply with other EPA contingency planning requirements and the OSHA Hazardous Waste and Emergency Operations (HAZWOPER) rule (29 CFR 1910.120) will meet most of the requirements for the emergency response program. In addition, EPA and other National Response Team agencies have prepared Integrated Contingency Plan Guidance (``one plan'') (NRT, May 1996). The NRT and the agencies responsible for reviewing and approving federal response plans to which the one plan option applies agree that integrated response plans prepared in the format provided in this guidance will be acceptable and be the federally preferred method of response planning. An emergency response plan that includes the elements specified in this guidance can be used to meet the requirements in today's rule. The final rule also provides relief for sources that are too small to respond to releases with their own employees; these sources will not be required to develop emergency response plans provided that procedures for notifying nonemployee emergency responders have been adopted and that appropriate responses to their hazards have been addressed in the community emergency response plan developed under EPCRA (42 U.S.C. 11003) for toxics or coordinated with the local fire department for flammables. F. Risk Management Plan (RMP) Owners or operators must submit their first RMP by the date specified in Sec. 68.10. After the RMP is submitted, changes at the source may require updates to the RMP other than the standard update every five years. If a new substance or new process is added, the RMP will need to be revised and submitted by the date the substance is first in the process above the threshold quantity. If changes to processes require revised hazard assessments or PHAs, or if a process changes Program level, the source must submit a revised RMP within six months.
EPA intends that the RMP will be submitted in a method and format to a central point as specified by EPA. States, local entities including local emergency planning committees (LEPCs), and the public will be able to access all RMPs electronically. This process will relieve states and local entities of the burden of filing documents and providing public access to them without limiting these agencies' or the public's access to the information.
The RMP is a multi-purpose document. The CAA requires that the RMP indicate compliance with the regulations and also include the hazard assessment, prevention program, and emergency response program. EPA is mandated to develop a program for auditing RMPs and requiring revisions, where appropriate. The RMP, therefore, must include enough data to allow the implementing agency to determine, through review of the RMP, whether the source is in compliance with the rule. EPA, however, believes that the RMP must serve another function; to provide information to the public in a form that will be understandable and will encourage the public to use the information to improve the dialogue with sources on issues related to prevention and preparedness. To meet both of these purposes, the RMP will consist of the source's registration; an executive summary that will provide a brief description of the source's activities as they relate to covered processes and program elements; and data elements that address compliance with each of the rule elements. While the public and implementing agencies could make use of all sections of the RMP, the executive summary will provide text descriptions and give the source a chance to explain its programs in a format that will be easy for communities to read and understand. The data elements will provide the implementing agency with the basic data it needs to assess compliance without asking for detailed documentation. The Agency is considering development of an RMP form where the data elements of the form would provide the implementing agency with the basic data it needs to assess compliance without asking for detailed documentation. All data elements would be checkoff boxes, yes/no answers, or numerical entries. This approach will provide data that anyone can download or search. States, communities, trade associations, or public interest groups may want to use the data or a subset of the data to create databases that allow them to compare sources in the same industry or same area. For example, a local entity will be able to download data from all reporting sources that are similar to ones in its community to determine whether the quantities stored and process controls used are typical. The information will provide the public with data that will enhance their dialogue with sources. It will also help sources and trade associations to understand practices in their industries and identify practices that could be used to reduce risks. The risk management program documentation will remain at the source and will be available for review by EPA and the implementing agency. G. Air Permitting The SNPRM discussed the relationship between section 112(r) and CAA air permitting requirements for sources subject to both provisions. Under the CAA, air permitting authorities must ensure that sources are [[Page 31674]] in compliance with applicable requirements to issue a permit. Because section 112(r) is an applicable requirement, EPA has identified in the final rule the permit conditions and the actions owners or operators and air permitting authorities must take to ensure compliance. The permit must identify part 68 as an applicable requirement and establish conditions that require the owner or operator of the source to submit either a compliance schedule for meeting the requirements of part 68 by the date specified in Sec. 68.10(a) or, as part of the compliance certification submitted under 40 CFR 70.6(c)(5), a certification statement that, to the best of the owner or operator's knowledge, the source is in compliance with all requirements of this part, including the registration and submission of the RMP. The owner or operator must also submit any additional relevant information requested by the air permitting authority or designated agency to ensure compliance with the requirements of this section. If a permit is already issued that does not contain the provisions described above, then, the owner or operator or air permitting authority shall initiate permit revision or reopening according to the procedures in 40 CFR 70.7 or 71.7 to incorporate the terms and conditions as described above. EPA also allows the state to assign the authority to implement and enforce these requirements to another agency or agencies (the ``designated agency'') to take advantage of resources or accident prevention expertise that might be available in these other agencies. Finally, the air permitting authority or designated agency must: (1) Verify that the source owner or operator has registered and submitted an RMP or a revised plan when required; (2) verify that the source owner or operator has submitted the proper certification or compliance schedule; (3) for some or all sources, use one or more mechanisms such as, but not limited to, a completeness check, source audits, record reviews or facility inspections to ensure that permitted sources are in compliance; and (4) initiate enforcement action, based on the requirements of this section, as appropriate. H. Other Issues In the SNPRM, EPA discussed three other issues raised by commenters: accident information reporting, public participation, and inherently safer technologies. EPA has decided not to develop any requirements related to these issues at this time. Although EPA continues to believe that accident reports that provide more detail on the causes and impacts of accidents could be useful, the Agency has decided to limit such reporting required under this rule to the fiveyear accident history mandated by the CAA. When necessary, EPA will use its authority to investigate individual accidents and to seek additional information to the extent authorized by CAA section 114 (i.e., to determine compliance with this rule and CAA section 112(r)(1), to support further rule development, and to assist research on hazard assessment).
Secondly, the Agency encourages sources, the public, and local entities to work together on accident prevention issues, but believes that the wide variety and large number of sources subject to this rule make any single mandatory approach to public participation inappropriate. RMP information should be used as the basis for dialogue between the community and sources on accidental release prevention, risk reduction and preparedness for emergency response. Industry and the public should continue to use the LEPC as a mechanism for this dialogue.
Finally, EPA does not believe that a requirement that owners or operators conduct searches or analyses of alternative process technologies for new or existing processes will produce significant additional benefits. Many commenters, including those who support these analyses, indicated that an assessment of inherently safer design alternatives has the most benefit in the development of new processes. Industry generally examines new process alternatives to avoid the addition of more costly administrative or engineering controls associated with a design that may be more hazardous in nature. Although some existing processes may be judged to be inherently less safe than others, EPA believes most of these processes can be safely operated through management and control of the hazards without spending resources searching for unavailable or unaffordable new process technologies. Application of good PHA techniques often reveals opportunities for continuous improvement of existing processes and operations without a separate analysis of alternatives. EPA encourages owners or operators to continue to examine and adopt viable alternative processing technologies, system safeguards, or process modifications to make new and existing processes and operations inherently safer. Through the process and prevention program information in the RMP, sources can demonstrate, and users of the RMP information can observe and promote, progress toward safer processes and operations. EPA is considering the development of incentives and awards to stimulate inherently safer alternative research and development, public outreach and education, and risk communication efforts. The Agency welcomes ideas and participation in this effort. III. Discussion of Comments EPA received 1220 comments, including 180 relevant comments submitted for the List Rule, 757 comments on the NPRM, and 283 comments on the SNPRM. The commenters represented 92 chemical manufacturers, 81 other chemical users, 111 petroleum industry companies, 174 industry trade associations, 40 other trade associations, 58 agricultural supply retailers, 102 propane retailers, 132 explosives users, 29 water treatment facilities, 26 utilities, 66 state agencies, 63 local governments, 8 other Federal agencies, 52 academics and consultants, 61 environmental groups, 6 labor unions, and 31 private citizens. The remaining 88 letters were requests for extensions of the comment period, interim or duplicate sets of comments, or had been sent to the incorrect docket. The major issues raised by the commenters are briefly addressed below; a complete presentation of the Agency's response to the comments received on this rulemaking is available in the Risk Management Program Rule: Summary and Response to Comments in the docket (see ADDRESSES).
Many commenters requested that EPA's list be identical to OSHA's list of highly hazardous substances and no thresholds should be less than OSHA's. These comments were addressed in the final list rule (59 FR 4478; January 21, 1994) and background material related to these issues is available in docket number A-91-74 (see ADDRESSES). A. Tiering Commenters on the NPRM suggested that EPA create different levels of requirements for sources that pose different risks. In the SNPRM, EPA proposed three tiers: a low hazard tier for sources whose worstcase release would not affect any public or environmental receptors of concern; a medium hazard tier for sources that were not eligible or covered by the low or high hazard tiers; and a high hazard tier based on either industry sector accident history and number of employees or simply based on the number of employees. Generally, commenters were concerned that all processes at a source would need to be eligible for Program 1 before any process could be. EPA has revised the rule to clarify that eligibility for any tier [[Page 31675]] (Program) is based on process criteria, not source. If a process meets Program 1 criteria, the owners or operators need only meet Program 1 requirements for that process even if other processes at the source are subject to Program 2 or Program 3.
[[Page 31676]] emergency planners, first responders or the public have concerns about processes in Program 1 because of a past evacuation or sheltering-inplace event, then mechanisms under EPCRA could be used to gather more information from the source about its prevention program (such as EPCRA sections 302(b)(2) [designation of a facility if it does not already handle extremely hazardous substances listed under section 302] and 303(d)(3) [provision of information to the emergency planning committee]) and involve the source in emergency planning. Sources and local first responders should be discussing evacuation and shelteringin -place criteria and decisions as part of emergency response planning. c. Other. Many commenters asked that specific industries such as ammonia refrigeration, retail fertilizer outlets, all flammables, and all non-PSM sources be assigned to Program 1. EPA disagrees because each source has unique surroundings that must be considered in the worst-case assessment and each source must demonstrate favorable accident history. All ammonia refrigeration units covered by this rule are already subject to OSHA PSM; many of these have had accidents that affected the community and should be required to complete the requirements of the hazard assessment and emergency response program and provide the community with full RMP information. According to the industry, a typical ammonia fertilizer retailer handles 200 tons of ammonia. Some retailers may be very geographically isolated and can qualify for Program 1, but EPA expects that most will be subject to Program 2. Given the large quantity of ammonia involved, EPA considers it important that the community have information on offsite consequences from these sources and that the owner or operator takes the necessary steps to address accidental release prevention and emergency response.
- Rationale. Only 2 of the 57 commenters opposed tiering arguing that the CAA mandates that all covered sources be required to complete a full prevention program and that Congress had considered and rejected exemptions. One commenter argued that EPA had already accounted for ``differences in size, operations, processes, class and categories of sources'' in developing the list and thresholds. Most commenters supported tiering as an appropriate way to recognize different levels of risks and to allow sources and emergency responders to focus on the highest risk processes.
EPA disagrees that the CAA requires all covered processes to comply with the same detailed risk management program. EPA listed regulated substances because of their inherent hazards, such as toxicity and volatility. EPA did not consider, nor does the CAA indicate that it may consider, ``differences in size, operations, processes, class and categories of sources'' in selecting chemicals or setting thresholds. In establishing section 112(r)(7) requirements, however, Congress clearly recognized that a ``one-size-fits-all'' approach may not be appropriate for these regulations and directed EPA to consider these factors in the development of the accident prevention regulations. Furthermore, EPA strongly disputes the assertion that it has exempted any source from regulation by creating different programs for different sources. As noted below, all covered processes will be addressed in RMPs that contain hazard assessment, prevention, and response information, as required by statute.
- Program 1 vs. Program 2 and Program 3 Criteria. Commenters generally supported Program 1 for low-risk sources, but argued that few, if any, sources would qualify because the requirements were too stringent.
a. Potential for Offsite Impact. Commenters generally agreed that sources that can demonstrate no offsite impact should be eligible for Program 1, but only public health should be considered, not environmental impacts. Others stated that only sources posing a threat of ``considerable'' impacts should not be eligible for Program 1. One commenter stated that EPA's worst-case scenario is unrealistic and its use as a Program 1 trigger is unreasonable. Other commenters want EPA to allow site-specific modeling for the offsite consequence analysis, rather than look-up tables.
In today's rule, EPA specifically allows owners or operators to use site-specific air dispersion modeling for their offsite consequence analyses. EPA disagrees that offsite impacts should be limited to ``considerable'' impacts. When offsite impacts are possible, it may be reasonable to implement some additional measures to reduce accidental releases, especially when the burden of measures such as additional training or safety precautions is low. Programs 2 and 3 provide flexibility to allow source-specific consideration of the appropriate level of effort. Program 1 requires no additional prevention measures, which is only categorically justifiable if such measures would not reduce offsite impact. It is reasonable to couple a no impact criterion with a conservative worst-case scenario to conclude categorically the public would not benefit from additional prevention measures. If no impact can be demonstrated for a conservative worst-case release, then no impact is likely to occur for any other release event, and the process could be judged to pose a low threat to the surrounding area. EPA has decided that potential impact on environmental receptors resulting from a worst-case scenario will not be a criterion to determine eligibility for Program 1. EPA agrees that very little, if any, data exist on the potential acute environmental impacts or environmental endpoints associated with listed chemicals upon accidental release. In addition, the offsite consequence distances estimated using human acute toxicity or overpressure effects may not be directly relevant to environmental effects. However, owners or operators will be required to document in the RMP the presence of such receptors within the distance determined for the worst case. EPA believes that natural resource agencies and the public will be able to benefit from the environmental receptors information in the RMP in discussions with the source.
b. Accident History for Program 1. Many commenters objected to accident history as a Program 1 criterion, arguing that a process that had a significant accidental release in the previous five years may have been changed to reduce or eliminate future events and public impact. Several commenters suggested that such processes that otherwise meet Program 1 criteria should remain eligible, but be required to justify and document the changes. Some commenters also objected to EPA's proposed definition of significant accidental release, arguing that many companies and emergency responders conservatively evacuate or shelter-in-place during minor incidents. Under the proposed definition, these actions disqualify a process from Program 1 even if there were no offsite impacts. Some commenters stated that the accident history provision was unnecessary because, by definition, a Program 1 process is not capable of an accidental release that could affect public receptors.
EPA has decided to retain the accident history criterion for Program 1 processes, excluding events with evacuations and shelterings in place, and to drop the definition of significant accidental release. Program 1 eligibility is not a one-time exercise; owners or operators must certify in each RMP that no qualifying releases have occurred since the previous RMP submission and provide current worst-case release data indicating no offsite impacts are anticipated in the future. Program 1 criteria and accident history provide owners or operators an opportunity to demonstrate to the community ongoing excellence in accident prevention and an incentive to search for and implement ways, such as inventory reduction, to reduce the potential for offsite impacts associated with large scale accidental releases. Further, the unique circumstances surrounding past accidents can provide a reality check on the theoretical modeling and worst-case scenario claims used for the offsite consequence assessment and serve to verify that administrative controls and passive mitigation measures work as intended. EPA decided to delete public evacuations or shelterings-in-place as criteria for Program 1 eligibility. EPA is that inclusion of these criteria in Program 1 eligibility may create a perverse incentive not to report releases and it may encourage sources and local emergency officials to take more chances during an event when there may be potential exposures that do not rise to the endpoint specified in this rule but would otherwise be worthy of precautionary actions by the source or by local officials. If the evacuation or sheltering takes place because of a concern for public exposure to an endpoint as specified in this rule, then public receptors necessarily would be under the worst case distance and the process would not be eligible for Program 1 under the criteria of the rule. Owners or operators of processes that meet Program 1 eligibility requirements are required to report a 5 year accident history for that process. If local
EPA expects that some sources handling flammables will qualify for Program 1 because the distance to a 1 psi overpressure is generally less than distances to toxic endpoints. Nonetheless, those sources handling flammables in sufficient quantity to generate a potential offsite impact should provide the community with information on hazards and address prevention and response steps. Many sources handling flammables are already subject to PSM; the only additional steps required under this rule are completion of the hazard assessment and emergency response programs and submission of an RMP. EPA does not agree that non-PSM sources should be assigned to Program 1. Many of these sources could have an accidental release that can affect the community. OSHA exempted retailers because they are covered by other OSHA or state regulations that address workplace safety, not because they are incapable of having offsite impacts. All retailers are in Program 2 unless they can meet Program 1 criteria; thus, they should be taking prevention steps and will be providing the community with information. Compliance with other existing Federal and state programs may satisfy many Program 2 prevention requirements, thereby limiting the burden. In addition, EPA expects to develop model risk management programs for these sectors. Public sources in states without delegated OSHA programs are not covered by OSHA PSM because OSHA is barred by law from regulating them. Nonetheless, these sources may pose a threat to the community. Today's rule places these sources in Program 2.
3. Program 2 vs. Program 3 Criteria. In the SNPRM, EPA's preferred approach assigned sources to Program 3 based on SIC code and number of employees; sources in specified SIC codes with 100 or more full-time employees (FTE) would have been subject to the full program in 3 years; sources in a subset of these SIC codes with 20 to 99 FTEs would have been subject to the full program in 8 years. The alternative was to impose the full program on all sources with more than 100 FTEs. Most SNPRM commenters submitted suggestions and arguments about this approach.
a. Number of Employees. Only two commenters supported using the number of employees as the sole criterion, arguing it would be the easiest approach to implement with the greatest amount of industry participation. Commenters opposed it because the number of employees proposed does not reliably correlate with risk, hazard, or quantity on site, and because it could act as an incentive to reduce employment. In addition, some commenters stated that smaller sources may have fewer resources to manage hazards and, therefore, may pose a greater risk to the public.
EPA agrees and has deleted the number of employees as a Program 3 criterion. Although size of a source in the manufacturing sectors may be related to the quantities on site and complexity of the processes, many other sources may have similar characteristics with fewer employees. Complexity is more directly associated with the type of industry (i.e., SIC code) than with number of employees; a highly automated process may involve fewer employees and be more complex than a more labor intensive process. Quantity, if relevant, can be directly measured rather than indirectly by number of employees. In addition, EPA was concerned that the data on which the Agency based its proposed approach may not be representative of all accidental releases. These data, drawn from reports to the National Response Center and EPA regions, appear to indicate that larger sources have more and larger accidental releases than do smaller sources. This finding, however, may in part reflect different levels of reporting, rather than different levels of accidents. Both Federal and state officials report that the number of releases has risen in recent years as more sources learn about their reporting obligations. EPA has decided that, because the processes within the SIC codes basically handle the same chemicals in the same way, smaller sources should not be moved to a different Program based on the number of employees. b. SIC Code. Fifty-seven commenters, particularly those in the oil industry, utilities, and public systems, supported the use of SIC codes based on accident history; 28 commenters opposed it. Supporters argued that industry accident records represented a reasonable criterion for identifying high-risk sources. If an entire industry has a long history without accidental release, it may indicate that the materials handled and handling conditions generate a smaller potential for serious releases or that the industry is effectively controlled by government or industry standards. Some commenters argued that industry accident histories reflect underlying risk better than individual source accident histories because accidents are rare events; a source with no accidental releases over the previous five years is not necessarily safe.
Commenters opposing the use of SIC codes stated that the approach is arbitrary, that accidents with only onsite effects should not be used, that sources in other industry sectors handle similar quantities and pose similar risks, and that sources within an industry that have successful risk management practices are penalized by a few isolated sources within the industry.
EPA has decided to retain the use of SIC codes, adding SIC 2865 based on further review of accident histories, and to add coverage by the OSHA PSM standard as a separate criterion for Program 3. EPA selected the SIC codes by analyzing accident data filed by [[Page 31677]] sources in response to EPA's request for information in the Accidental Release Information Program (ARIP). ARIP collects data from certain sources that report releases under CERCLA section 103. EPA selected the SIC codes that showed a high frequency of the most serious accidents across a significant percentage of all sources within the SIC code to avoid mischaracterizing an industry based on isolated, problematic sources. Data on the selection criteria were summarized in the SNPRM and the docket at the time of the SNPRM. The accident history of the cyclic crudes industry (SIC code 2865) is similar to that of the categories selected. EPA disagrees that only offsite impacts should be considered; accidental releases that caused death, hospitalizations, or injuries on site are also of concern because they indicate significant safety problems that could lead to releases that cause impacts offsite. The SIC codes selected by EPA are basically the same ones OSHA selected for its PSM program inspection focus. EPA disagrees that sources are ``penalized'' by this approach because owners or operators of processes in these SIC codes have an opportunity to present their safety record, demonstrate the success of their accident prevention programs, and communicate with the local community the basis for their risk management practices. Sources that receive Merit or Star status in the OSHA Voluntary Protection Program will be favorably distinguished from others in the same industry when implementing agencies are selecting sources for audits (see section III.T.1 below). EPA agrees that serious accidents occur infrequently even at sources with poor safety practices and that industry-wide accident records provide a better mechanism than the accident history at a single source for identifying those sectors whose chemicals and processes may lead to serious releases. A high proportion of the sources in some SIC codes reported releases; EPA's analysis specifically took into account the number of reports from individual sources to avoid selecting an SIC code because of a small number of sources with serious safety problems.
The OSHA PSM already applies to most covered processes in the selected SIC codes. EPA expects that there will be fewer than 400 additional processes assigned to Program 3 that are not already subject to the OSHA PSM standard at the approximately 1,400 sources in these SIC codes and that all of these sources will already have other processes covered by OSHA PSM. Consequently, fulfilling the RMP requirements imposes little additional burden. EPA decided to include all covered processes currently subject to the OSHA PSM standard in Program 3 to eliminate any confusion and inconsistency between the prevention requirements that the owners or operators of such processes must meet. EPA's Program 3 prevention program is identical to the OSHA PSM standard. Including OSHA PSM processes in Program 3, therefore, imposes no additional burden on these processes; the only new requirements for such processes are the hazard assessment, emergency response program, and the RMP, which are the same under Programs 2 and 3.
c. Site-Specific, Risk-based Criteria. Many commenters stated that Program assignment should be based on site-specific risk-based criteria. Accident history is one such criterion and is discussed separately in Section III.A.3.d. Other criteria suggested include population density or proximity, quantity on site, number of substances held above the threshold, process conditions, toxicity, volatility, alternative release scenario results, or combinations of these factors as a risk index.
EPA agrees with commenters that Program assignments should be riskbased to the extent possible; however, as the variety of suggestions indicates, a considerable number of variables would need to be considered. EPA knows of no standard approach or equation that is used and generally accepted. The variety of suggestions indicate the likelihood that any proposed formula would meet opposition. No commenter provided a method to comprehensively address these factors on a nation-wide basis.
An important consideration for EPA in developing the rule provisions for Program assignment was to avoid undue complexity, confusion, and resource expenditure by sources and implementing agencies implementing the rule's criteria. To some extent, EPA has incorporated risk factors, including site-specific factors, in determining which sources are eligible for which Program. For example, Program 1 eligibility already considers the potential for offsite impacts; any process for which there are no public receptors within the distance to an endpoint from a worst-case release may be eligible for Program 1, provided there have been no releases with certain offsite consequences within the previous five years. Today's rule allows sources to consider passive mitigation and administrative controls in conducting the worst-case release analysis. Such site-specific considerations affect the extent of potential exposure to a worst-case release, and thus are reflected in the Program 1 eligibility criteria. Elements of risk such as process complexity and accident history are also reflected the design of Program 2 and Program 3 requirements and the assignment of processes to these Programs. Program 2 sources generally handle and store regulated substances, but do not react or manufacture them. EPA believes Program 2 sources can take prevention steps that are less detailed than those in the OSHA PSM standard and still accomplish accident prevention that is protective of any population nearby. Program 3 is reserved for processes already subject to the OSHA PSM standard and processes with high accidental release histories. The SIC codes with an accident history selected by EPA for Program 3 are typically complex processes. The PSM standard was designed for, and is particularly appropriate for, these processes. EPA takes issue with the appropriateness of some of the suggested factors. Meteorological conditions vary too much to be considered in determining a risk level. Chemical quantity alone does not accurately relate to risk because the location and handling conditions can dramatically change the potential for exposures. In addition, EPA has implementation concerns about a detailed, national, multi-factor, risk-based approach, were it to be feasible. States such as Delaware have used a simple version of a risk-based approach and found that it created serious problems for the state and the sources. Smaller sources and those without technical staff have had great difficulty in implementing the approach and have had to rely on state officials to determine applicability for them. Delaware specifically recommended that EPA not attempt implementing a similar approach on a national basis because of the burden it imposes on the state and the confusion and uncertainty it creates for sources. Delaware has fewer than 100 sources; nationally, EPA estimates that 66,000 sources will be subject to the rule, approximately 62,000 of which are outside of the chemical and refining sectors. If implementing agencies had to help most of these sources determine the index score and Program for each process, not only would the burden on the agencies be extreme, but implementation would also be delayed. Furthermore, were EPA to simply identify risk factors without an index and leave the determination of Program [[Page 31678]] level to sources or implementing agencies, the process for such sitespecific determinations would be even more complex and resource intensive for sources and implementing agencies; it would create disincentives for a state to become involved and to take on the role of an implementing agency. EPA believes it is better to have sources and agencies focus their resources on prevention activities. EPA considered, but decided against, a less comprehensive riskbased approach using proximity or population density as criteria for distinguishing between Program 2 and 3. EPA recognizes that accidental releases from sources near or in densely populated areas may harm more individuals and be perceived to pose a greater risk than other sources. However, as stated above, EPA believes that the type of process, its complexity and accident history should be considered for Program 2 or 3 assignment, regardless of the number of people potentially exposed. In other words, EPA does not believe the streamlined Program 2 prevention elements should apply to a complex Program 3 process just because fewer persons could be potentially exposed or that the Program 3 prevention elements should apply to a Program 2 process because more people could be potentially exposed. EPA believes that populations offsite should be protected from harm based on the type of process; the Program 2 prevention elements, properly applied to the expected types of Program 2 processes, serves to protect off-site populations, just as the Program 3 prevention elements for complex processes serves to protect offsite populations.
If Program assignments were based on the alternative release scenario results, sources would not have the flexibility and latitude in today's rule for these scenarios because more definite criteria would need to be considered to ensure the proper scenarios and results are assessed. This places more emphasis and burden for sources on the offsite consequence assessment rather than on accident prevention and communication with the public and first responders. Furthermore, because active mitigation includes process and control equipment that may fail, considering such equipment in evaluating risk would not be appropriate without detailed review by the source and oversight by the implementing agency.
Some commenters suggested yet another variation of a less comprehensive, ``risk''-based approach that would have EPA use a sitespecific analysis of likelihood of release to assign Program levels. Many of the same difficulties in developing a ``risk index'' for determining Program assignments would apply to an attempt to incorporate likelihood in a more sophisticated manner than EPA was able to do in its analysis of accident history by SIC code. In addition to the substance-specific properties considered as part of the chemical listing criteria, the site-specific likelihood of a release depends on a number of factors, including the appropriateness of the equipment in use, the maintenance of that equipment, operator performance, and safety systems and their performance. Evaluating site-specific likelihood of release requires data on each of these items; such data rarely exist especially for complex processes where a variety of equipment must be evaluated along with the performance of multiple operators and maintenance workers. Using surrogate data (e.g., manufacturer's failure rate data) introduces error of an unknown magnitude to the analysis. Such analyses are very costly and produce results that are, at best, questionable. EPA also believes that assessing the likelihood of a release at most sites for site-specific individualized Program-level determinations is neither technically feasible nor cost-effective. In most cases, the data do not exist to conduct a meaningful analysis; where they do exist, the cost of developing a defensible analysis and overseeing it could well exceed the cost of compliance with the rule. Such an approach would resemble a permit program, which would be resource-intensive for sources and implementing agencies. EPA determined that the simpler approach for assigning sources to Program 1 would provide regulatory relief for those sources that could not affect the public while allowing other sources to devote their resources to prevention activities rather than to analyses that would be subject to legal challenges.
EPA notes that sources have the flexibility to implement appropriate accident prevention measures based on the hazards and risks discovered in the hazard review or process hazard analysis. The structure of Programs 2 and 3, therefore, reflect site-specific risk criteria. Further, the purpose of the risk management program and RMP effort is to prevent accidents and facilitate local level dialogue about the risks, prevention measures, and emergency response effort in place at the source. The local community and first responders may have far different concerns that should, and can be addressed better through today's approach than those reflected by a risk index approach. d. Accident History. Some commenters argued that EPA should assign sources to Program 3 based on the accident history of the source. One commenter suggested that any source with no accidental release that exceeded a reportable quantity (as defined in CERCLA) for the previous five years should be in Program 2. Others argued that a source should be in Program 2 if it had no significant accidental release in the previous five years. Some commenters said that a one-release standard was too stringent and that two or more significant accidental releases should be allowed before a source was assigned to Program 3. Another commenter suggested that a source with no significant accidental releases in the past five years and with few potentially impacted neighbors should be placed in Program 2. Other commenters opposed this approach, arguing that, in many cases, sources take steps to prevent recurrences following a serious release. In some cases, the offsite impacts from releases are minor and would not justify assigning a source to a particular Program. Other commenters stated that the absence of an accidental release can be indicative of lower risk, but it can also simply mean that a release has not yet occurred. Several commenters noted that a five-year time period is statistically insignificant because accidental releases are infrequent events.
EPA agrees that source-specific accident history is not a reasonable basis for assigning processes to Programs 2 and 3. Given the relative infrequency of serious accidents, a five- or even ten-year period without an accident may not be indicative of safe operations. In addition, the criteria necessary to define the types of past accidental release for the purposes of program classification would need to be based on a wide variety of variables and site-specific factors, which would lead to confusion and unnecessary complexity. Factors such as weather conditions at the time of the release, rather than the size of a source or its management practices, often determine whether a release has offsite consequences. EPA believes that accident history is appropriately used on an industry-wide basis as described above for selection of Program 3 sources. If accidental releases with consequences appear to occur at a large proportion of sources within an SIC code, where similar processes, equipment and chemicals are used, then it is reasonable to conclude that [[Page 31679]] processes in that SIC code pose a greater likelihood of a high hazard release than others. This approach removes the need for at least one accident to occur at every source that EPA believes ought to be assigned to a particular Program, especially when such accidents are rare events. EPA is also concerned that using source-specific accident history as a criterion would create an incentive for sources to fail to report releases. Finally, as EPA has stated, assignments to Program 2 and 3 also consider the appropriateness of the prevention steps for the types of sources. EPA believes that both Programs move sources to greater accident prevention.
e. Other. Some commenters asked that the implementing agency be given discretion to move a source into a different Program based on local concerns and knowledge. EPA notes that states have the authority, under the CAA, to impose more, but not less, stringent standards than EPA (see CAA section 112(r)(11)).
A few commenters suggested that Program 2 be limited to sources for which a model risk management program had been developed. The models would be designed to reflect risks associated with categories of sources that all use the same type of equipment and handle the substances in the same way (e.g., propane retailers and users, ammonia retailers). EPA considered this approach and decided that the Program 2 prevention program provides a better, generic prevention approach for processes for which the more detailed PSM program would be inappropriate. Limiting Program 2 to those industrial sectors where industry-specific models are feasible would place some manufacturing sources at a disadvantage simply because their chemical uses, processes, and equipment were too varied to allow development of a model or because there are too few sources to justify use of EPA or industry resources to develop a model. In addition, if EPA were to limit Program 2 to sources with model programs, Program 2 regulations would need sufficient specificity to enforce the use of these models; otherwise, sources would be able to ignore both PSM and the models. EPA is also concerned that codifying the model plans could stifle innovation in safety practices. If industry codes or other Federal regulations on which parts of the models may be based were updated, EPA would have to revise its models; given the time needed to propose and adopt regulations, sources might have to delay implementation of new systems and, in some cases, might be caught between complying with a revised EPA or OSHA regulation or state law or complying with the model. Consequently, EPA decided it was better to have models available as guidance, but not require compliance with them. Further, EPA believes that the key elements of good accident prevention practices are captured within the requirements of the Program 2 prevention program. Model programs and plans are likely to build on these approaches, making it easier for sources in Program 2 to use models that are later developed by others.
EPA is working with industry to develop model risk management programs and RMPs for ammonia refrigeration systems, propane distributors and users, and water treatment systems. EPA also expects to develop models for ammonia retailers and wastewater treatment systems. EPA encourages other industrial sectors to work together on additional model development.
4. Program 1 Requirements. Commenters were generally opposed to posting signs, and certification of no environmental impact. a. Certification of No Environmental Impact. Many commenters stated that it would be ``virtually impossible'' to certify ``no potential for environmental impacts,'' as required by the SNPRM. Commenters said that the definition of environmental impact was too vague, that the list of environments suggested in the SNPRM was too broad, and that the language seemed to require a full environmental consequence assessment, making the requirement impossible. One commenter noted that companies would find it difficult to assert that there could be ``no environmental impacts'' even after an environmental consequence assessment reveals insignificant impacts. Two commenters suggested that EPA substitute ``low potential for environmental impact'' or ``no potential for long-term, adverse environmental impact.'' Other commenters requested that environmental impact be dropped or that the requirement be changed to mirror the Program 1 eligibility criteria with an indication in the RMP that no environmental receptors of concern were within the worst-case distance to an endpoint. As described above in section III.A.2.a. Potential for Offsite Impact, EPA has decided not to make the presence of environmental receptors a part of the eligibility criteria for Program 1 and has deleted the certification requirement. Instead, owners or operators of all covered processes will have to identify in the RMP any environmental receptors that are within the distance potentially affected by the worst case.
b. Signs. Commenters generally opposed the SNPRM requirement that sources with Program 1 processes post signs warning of the hazards on site if the only regulated substances present at the site above the threshold quantity were listed for flammability. Commenters stated that local and state fire and safety codes often already require such signs. In addition, sources are already required under EPCRA section 312 to file annual inventories with the LEPC and fire department that identify hazards on site. Signs would have fulfilled the emergency response program requirements for a source. Because Program 1 eligibility will now be determined on a by-process basis rather than by source-wide criteria and because EPA has revised the emergency response program provisions as noted below, EPA has dropped the requirement for signs. c. Emergency Response Program. In the SNPRM, EPA asked whether additional emergency response planning and coordination should be required for Program 1 processes. Some commenters supported this requirement, while others stated that most sources are already covered by EPCRA and participate in community response planning. Commenters stated that because the worst-case release could not reach public receptors, such efforts were not necessary. In the final rule, EPA is requiring the owner or operator of a Program 1 process to ensure that any necessary response actions have been coordinated with local response agencies. EPA believes that local responders may become involved in an incident, even if the public is not threatened. No additional CAA-related planning activities are required, however.
d. Other. Many commenters stated that, since Program 1 processes generate no offsite impact, they should be exempt from this rule. One commenter objected to Program 1 because members of the public, particularly first responders and business visitors, could still be hurt by a release. Other commenters suggested that the annual EPCRA section 312 form could be amended to indicate that a source was covered by the rule, replacing the RMP registration form. The CAA requires that all sources with more than a threshold quantity of a listed substance register an RMP, perform a hazard assessment, and develop accidental release prevention and emergency response programs. Therefore, total exemption of processes that meet Program 1 criteria is not [[Page 31680]] possible. See S. Rep. No. 228, 101st Cong., 1st session, at 208 (``Senate Report'') (precursor of RMP provision mandating hazard assessments for sources that exceed threshold for listed substance); 136 Congressional Record S16927 (daily ed. October 27, 1990) (remarks of Sen. Durenburger, sources with more than a threshold quantity are subject to regulations); 136 Cong. Rec. H12879 (daily ed. Oct. 26, 1990)(remarks of Rep. Barton)(all users of hazardous chemicals are required to plan for accidents). Moreover, even if an exemption for processes that exceed a threshold were permissible, the owner or operator would need to take steps that are equivalent to the hazard assessment to establish eligibility for the exemption. The offsite consequence analysis is the most significant burden for a Program 1 process under this rule. The minimal additional actions required in today's rule for Program 1 simply establish a record of eligibility and a response coordination mechanism.
EPA recognizes that emergency responders and site visitors could be hurt by an accidental release from any process, but notes that responder safety is covered by OSHA and EPA under the HAZWOPER regulations. It is the owners' or operators' responsibility to inform visitors about the hazards and the appropriate steps to take in the event of an accidental release from any process subject to today's rule.
Finally, EPA has based the registration information requirements in today's rule on the EPCRA section 312 Tier II form. The CAA requires that the RMP be registered with EPA. Because the EPCRA form is not submitted to EPA, it would not substitute for registration with EPA either in its present or amended form. Completion of the registration portion of the RMP should impose little additional burden on owners or operators. However, EPA recognizes the information overlap between the Tier II form and the RMP registration and is considering use of the RMP registration for the Tier II reporting requirement. 5. Program 2 Requirements. Commenters were generally concerned about the lack of specific requirements for the Program 2 streamlined prevention program and emergency response requirements, and how compliance with other regulations would be incorporated. a. Streamlined Program. Commenters stated that the Program 2 prevention program does not provide much, if any, regulatory relief because sources would need to address most of the ten elements of the Program 3 prevention program. Others said that the majority of the sources affected by the rule are already covered by OSHA PSM and chemical industry standards, the Program 2 requirements do not satisfy the CAA mandate, and that only a full process hazard analysis would meet the hazard assessment requirements under section 112(r). Another commenter argued that EPA's statement that sources must comply with the CAA's general duty clause was inadequate because EPA has not used, and has no policy about, the clause.
EPA agrees that the preferred approach in the SNPRM did not provide sufficient detail on Program 2 prevention requirements to distinguish it from Program 3. EPA solicited comments on whether Program 2 should require additional, specific prevention steps. Today's rule provides specific requirements as discussed in section I.D above and in Section IV below. In the RMP, the owner or operator will be required to report on other Federal or state regulations, industry codes, and standards used to comply with prevention elements as well as any major hazards, process controls, mitigation systems, monitoring and detection systems examined in the hazard review. This streamlined prevention program addresses many of the PSM elements as the basis for sound prevention practices, but is tailored to processes with less complex chemical uses; this program provides considerable regulatory relief by substantially reducing the documentation and recordkeeping burden of PSM. In addition, EPA will provide guidance and model risk management programs to further assist Program 2 processes in developing and maintaining good prevention program practices. EPA disagrees that only a full PHA would meet the requirements of the Act. Section 112(r) does not contain detailed requirements for the hazard assessment, beyond the key components of accidental release scenarios and a five-year accident history. EPA believes that a PHA is more appropriately considered an element of a prevention program, such as PSM. The statute does not mandate detailed PHA engineering analyses for all sources, whether as part of the hazard assessment or the prevention program. EPA believes PHAs involve a more detailed engineering analysis than is necessary to prevent accidents at Program 2 sources. The ``hazard review'' provisions of Program 2 should be sufficient to detect process hazards at these simpler processes. EPA recognizes that although hazard assessments and PHAs or process hazard reviews are discreet elements that can be performed independently, hazard assessment results can enhance PHA or process hazards reviews and in turn, the results of the PHA or review can enhance the hazard assessment. EPA encourages owners or operators to make maximum use of the PHA or review and hazard assessment information to manage risks and prevent accidents.
Finally, sources with Program 2 requirements, as well as sources with Program 1 or 3 requirements, must comply with the general duty clause of CAA Section 112(r)(1). The general duty clause provides that owners and operators have a general duty to identify hazards that may result from accidental releases, design and maintain a safe facility, and minimize the consequences of any releases that occur. The general duty clause is a self-executing statutory requirement: it requires no regulations or other EPA action to take effect. The clause provides a separate statutory mechanism that EPA will use in appropriate circumstances to ensure the protection of public health and the environment. To date, EPA has undertaken several inspections designed in part to determine compliance with Section 112(r)(1). As appropriate at a future date, EPA may issue policies or guidance on application of the general duty clause.
b. Other Regulations. Commenters generally agree that OSHA PSM, HAZWOPER, the OSHA hazard communication standard (29 CFR 1910.1200), and NFPA-58 are examples of other regulations or voluntary industry standards that could be cited to meet the requirements of a Program 2 prevention program. Commenters requested that EPA provide a matrix or crosswalk that indicates which other regulations, standards, and codes met specific requirements. One commenter opposed the use of other regulations or referencing of voluntary industry standards, stating that, other than OSHA PSM, no other OSHA standard addresses safety precautions or maintenance. Another commenter objected that this approach creates another documentation burden without any commensurate benefit.
EPA agrees that the SNPRM preferred approach for Program 2 was not specific enough and has provided more detailed requirements in this rule as noted above. EPA continues to believe that many of the Program 2 prevention requirements are already met through industry compliance with existing regulations and voluntary standards. For example, ammonia retailers whose processes are designed to meet the OSHA ammonia handling rule (29 CFR [[Page 31681]] 1910.111) should be able to meet the Program 2 requirement that the process design meets good engineering practices. This effectively allows sources to cite compliance with these other regulations and standards instead of developing specific, duplicative elements solely to comply with Program 2. EPA will also use these existing regulations and standards as it develops model programs. c. Emergency Response Program. Commenters supported considering HAZWOPER programs as adequate to meet the Program 2 emergency response program. A few commenters said that HAZWOPER is inadequate because it does not consider offsite impacts or the environment. Some commenters also said that coverage of a source by an EPCRA community emergency response plan should be sufficient. Others said that any contingency plan developed under Federal or state law should be considered sufficient because the requirements under these programs are generally consistent with EPA's proposed emergency response program; one commenter noted that, for flammable processes, compliance with 29 CFR 1910.38 should be adequate because the response is usually evacuation of employees. Five commenters opposed any requirement that sources with Program 2 processes conduct drills or exercises because they represent lower hazards.
Consistent with its efforts to consolidate Federal emergency planning requirements, EPA has included language in the final rule that will allow any source in compliance with another Federal emergency response program that includes the elements specified in this rule to use that program to meet these requirements. In particular, this applies to response plans prepared in accordance with the National Response Team's Integrated Contingency Plan Guidance (``one plan'') (NRT, May 1996). EPA believes that sources should have a single response plan; creation of multiple response plans to meet slightly different Federal or state standards is counterproductive, diverting resources that could be used to develop better response capabilities. EPA recognizes that some sources will only evacuate their employees in the event of a release. For these sources, EPA will not require the development of emergency response plans, provided that appropriate responses to their hazards have been discussed in the community emergency response plan developed under 42 U.S.C. 11003 for toxics or coordinated with the local fire department for flammables. B. Offsite Consequence Analysis[[Page 31682]] amount of substance that could potentially drain or flow from process equipment interconnected with the failed vessel or pipeline. Many commenters opposed this option, suggesting that it is technically uncertain and would have little value in terms of what they saw as EPA's intended purpose for the worst-case assessment. Other commenters requested that ``interconnected equipment'' be defined and clarified. Given the assumption of rapid release associated with initial equipment failure, EPA agrees that determination of the spill rate from connected piping and equipment is likely to be technically complex, very different from that of the quantity in the vessel or failed pipeline, and likely to extend the duration of volatilization rather than affecting the rate overall. Therefore, EPA has not included this requirement in the final rule.
- Worst-Case Release Scenario. EPA proposed in the NPRM to define the worst-case release as the ``loss of all of the regulated substance from the process * * * that leads to the worst offsite consequences'' and that the scenario should assume ``instantaneous release.'' Hundreds of commenters stated that instantaneous loss of the total process contents is not technically feasible for complex systems and, therefore, represents a non-credible worst case that would provide no useful information to the public or the source for risk communication, accident prevention, and emergency preparedness. Many commenters also argued that this approach differed from the release modeling assumptions contained in EPA's Technical Guidance for Hazards Analysis, which has been the basis for community emergency planning activities under EPCRA. Although some commenters were generally opposed to the concept of worst case, most of the commenters were supportive of an approach similar to that taken in the Technical Guidance. In response to these comments, EPA proposed in the SNPRM to redefine a worst-case scenario as the release, over a 10-minute period, of the largest quantity of a regulated substance resulting from a vessel or process piping failure. The 10-minute release time is drawn from the Technical Guidance for Hazards Analysis. EPA believes this duration is reasonable and accounts for comments arguing that an ``instantaneous'' release is unrealistic for large-scale releases. EPA has decided to adopt the SNPRM approach for worst-case toxic vapor releases in the final rule because most of the SNPRM comments agreed that the redefinition is generally more credible and that the 10-minute time frame particularly applies to vapor releases. Although some commenters argued that this approach still does not account for all process-specific conditions, EPA believes it is reasonable and representative of accident history. EPA notes that owners or operators may use air dispersion modeling techniques that better account for site-specific conditions, provided modeling parameters as specified in the rule are applied. This release scenario will apply to substances that are gases at ambient conditions, including those liquefied under pressure. Gases liquefied by refrigeration only may be analyzed as liquids if the spill would be contained by passive mitigation systems to a depth greater than 1 cm.
Under the SNPRM, worst-case liquid spills were assumed to form a pool in 10 minutes, with the release rate to the air determined by volatilization rate. EPA recognized that this approach differs from the use of an instantaneous release in the Technical Guidance, which EPA cited as an alternative to its favored approach. The few comments received were divided between support of this approach and arguments that the 10-minute time frame was unrealistic for liquid releases (particularly for pipelines and connected equipment) and thus did not properly account for process-specific conditions. EPA's approach for the liquid worst-case scenario in the final rule is similar to the Technical Guidance methodology, in which the total quantity of liquid in a vessel or pipeline is instantaneously spilled upon failure, considering administrative controls or passive mitigation discussed below. The rate of release to the air is not instantaneous; it is determined by the volatilization rate of the spilled liquid, which depends on the surface area of the pool formed after the spill. The pool surface area is determined by assuming the spilled liquid rapidly spreads out and forms a one-centimeter deep pool, unless passive mitigation systems contain the pool to a smaller area. EPA believes this approach is reasonable because total vessel or pipeline failure will generally lead to immediate and rapid spillage followed by pool volatilization. Further, if the liquid were assumed to spill over a particular time frame rather than instantaneously, owners or operators would need to calculate the amount of vapor emitted to the air as the liquid is spilled, in addition to the volatilization rate as the pool spreads out and reaches its maximum size. Computer-based models are available for such calculations, but they are complex and require considerable data input to use. EPA believes that liquid spillage from a worst-case scenario is likely to be extremely rapid such that the most significant portion of the release rate is given by pool volatilization; consequently, liquid release time is not necessary. Liquid spill rates and times could be reflected in alternative scenarios discussed below.
As proposed, the worst-case for flammables assumes that the total quantity of the substance in the vessel or pipeline vaporizes, resulting in a vapor cloud explosion. If the vapor cloud explosion is modeled using a TNT-equivalent methodology, then a 10 percent yield factor must be used.
EPA requested comment in the SNPRM on whether the worst-case scenario should include an additional
EPA also sought comment in the SNPRM on options for the determination of the relevant quantity of regulated substance in a vessel or process piping for a worst-case release scenario: the maximum possible vessel inventory (design capacity) at any time without regard for operational practices and administrative controls; the maximum possible vessel inventory unless there are internal administrative controls (written procedural restrictions) that limit inventories to less than the maximum; or historic or projected maximum operating inventories without regard to administrative controls. EPA preferred that the maximum vessel inventory including administrative controls that might limit or raise the vessel quantity to be used in the worstcase assessment and reported in the worst-case release analysis section of the RMP. If the quantity used in the assessment were exceeded (e.g., an administrative control were ignored), then the source would be in violation of the rule (i.e., failure to perform a worst-case analysis) and RMP reporting unless the administrative control was revised, the worst-case analysis updated to reflect any changes in the analysis, and a revised RMP submitted. This approach acknowledges the efforts by sources to increase process safety by intentionally reducing the inventory of regulated substances (e.g., vessels kept at half capacity to allow for process upsets, emergency shutdowns, and deinventorying or maintenance turnarounds). EPA notes that at some sources, as a result of inventory reduction measures, the largest quantity may be held in a transportation container that is loaded or unloaded at the source (See section P.2).
A few commenters supported the other options, noting that administrative controls may fail, potentially generating a larger scenario. However, the majority of commenters supported EPA's preferred approach based on the historical reliability of such controls at many sources and the role that such a provision could play in encouraging their use at additional locations. Other commenters asked whether mechanical controls, alone or in combination with administrative controls, should be incorporated into the proposal. Although mechanical controls may also serve to limit the quantity, EPA has decided not to include them in the quantity determination for the worst-case release scenario because the definition for administrative control as ``written procedural mechanisms used for hazard control'' provides a backup for possible failure of mechanical controls. For more discussion of mechanical controls, see section III(B)(2), mitigation systems, below. In the SNPRM, EPA considered providing the implementing agency with the discretion to determine the appropriate quantity for the worst-case release scenario on a site-specific or industry-specific basis. EPA noted in the SNPRM, and most of the few comments received on this issue agreed, that implementing agency discretion would result in increased administrative burden on the implementing agency and crossjurisdictional differences in the methodology used for the worst-case analyses. EPA has decided not to incorporate this approach in the final rule. States, however, may impose more stringent requirements, such as additional modeling, under state authority. In the NPRM worst-case definition, EPA did not specify what constitutes or how to determine the worst offsite consequences. Some commenters indicated that without clear direction, EPA's proposed worst case might not actually capture the scenario that leads to the most severe offsite impact. In the SNPRM, EPA indicated that the worst-case scenario should be the scenario that generates the greatest distance to a specified endpoint (i.e., the toxic vapor cloud or blast wave from a vapor cloud explosion that travels the farthest). EPA recognizes that there may be other release scenarios that could generate a greater distance than the release from the largest vessel or pipeline. Consequently, EPA has added paragraph (h) to Sec. 68.25 to require owners or operators to consider other scenarios if those scenarios generate greater distances to the endpoint than the distance generated by the largest vessel or pipeline scenario. Owners or operators need to consider releases from smaller vessels if those vessels contain the substance at higher temperature or pressures or if they are closer to public receptors. In some cases, the largest vessel will be a storage vessel where the substance is held at ambient conditions. A reactor vessel may hold a smaller quantity, but at high pressures and temperatures, generating a release that could travel farther offsite to an endpoint. Vessel location is important, especially at large sources. A smaller vessel located nearer to the stationary source boundary may generate a greater impact distance than a larger vessel farther away. This difference may be particularly important for flammables, because impact distances for flammables are generally shorter than those for toxic releases.
2. Mitigation Systems
a. Worst-case scenario. In the NPRM worst-case scenario, EPA indicated that sources must assume that both active and passive systems fail to mitigate the release. Commenters were generally split between those who wanted passive (as well as certain redundant active) mitigation systems to be included and those who argued that historical evidence from catastrophic releases suggests that the worst case should assume the failure of all such systems. Those who supported mitigation argued that inclusion provides a more credible scenario for improved risk communication, accident prevention, and emergency planning. EPA proposed in the SNPRM to include passive mitigation systems in the worst-case release scenario as long as the system is capable of withstanding, and continuing to function as intended during and after a destructive event, such as an earthquake, storm, or explosion, which causes a vessel or pipeline to fail. Passive systems such as dikes, catch basins, and drains for liquids, and enclosures for both liquids and gases, could be assumed to mitigate the release. Some commenters opposed this approach, arguing again that the worst case should account for the possibility of passive mitigation failure. The majority supported this approach because the assumption that passive systems specifically designed and installed as protection against a potential catastrophe fail is unrealistic. Furthermore, the approach recognizes and encourages prevention through additional passive mitigation and supports more realistic emergency [[Page 31683]] planning. A few commenters also suggested that active mitigation measures that were unlikely to fail (e.g., redundant or backup systems) should be considered, for similar reasons. Historical data, however, indicate that certain events compromise active mitigation systems (e.g., explosions have destroyed fire water piping systems).
For the final rule, EPA has decided to adopt the SNPRM approach. Passive mitigation systems would be defined as those systems that operate without human, mechanical, or other energy input and would include building enclosures, dikes, and containment walls. EPA also agrees that reservoirs or vessels sufficiently buried underground are passively mitigated or prevented from failing catastrophically. In this case, sources should evaluate the failure of piping connected to underground storage for the worst case or alternative case scenarios. In addition to the requirements outlined in Sec. 68.25, EPA provides guidance on how passive mitigation would affect release rate and distance to endpoints in its RMP Offsite Consequence Analysis Guidance.
b. Alternative scenarios. EPA initially proposed that sources could include passive mitigation systems in their alternative scenario assessments, but that active mitigation systems (e.g., excess flow valves, fail-safe and automatic shutdown valves, scrubbers, flares, deluge systems, and water curtains) would be assumed to fail. Some commenters generally opposed inclusion of any mitigation systems in the hazard assessment, while other commenters noted that the alternative release scenario should recognize and encourage industry accident prevention efforts, specifically the installation of additional mitigation systems, and support more realistic emergency planning.
EPA proposed in the SNPRM to allow sources to consider passive and active mitigation measures in the alternative release scenario assessment. Commenters supported this approach and EPA has decided to retain it in the final rule. EPA agrees that the assumption that both passive and active mitigation measures fail when such measures are specifically designed and installed to mitigate catastrophic releases is unrealistic for the alternative scenarios. Although not required, EPA notes that sources may choose to apply passive and active mitigation measures to a worst-case type scenario to illustrate the capabilities of such systems to reduce the potential impact of a worstcase accidental release. In addition to the requirements outlined in Sec. 68.28, EPA provides guidance in its RMP Offsite Consequence Analysis Guidance on how passive and active mitigation would affect release rate and distance to endpoints.
3. Populations Affected. EPA described in the NPRM preamble certain locations (e.g., schools and hospitals) where sensitive populations might be present and proposed in the rule that owners or operators identify potentially exposed populations as part of the offsite consequence assessment. Commenters generally opposed requirements for population surveys; several commenters suggested that Census data or other readily available population information should be sufficient, while other commenters indicated that the LEPC or other local planning entities were the appropriate entity to prepare these data.
EPA believes owners or operators need to be aware of the magnitude of impact on populations associated with the worst-case and alternative scenarios. However, EPA learned that, although much of this information is readily available, identification of some sensitive populations could require considerable effort, especially if the distance to an endpoint generated in the offsite consequence assessment is large or crosses several jurisdictions. Consequently, EPA proposed in the SNPRM that offsite populations be defined using available Census data; information on the number of children and people over 65 could be considered a proxy for sensitive populations, thereby accomplishing the same objective as the proposed rule. EPA also indicated that it has developed a geographic information system, LandView, that will facilitate analysis of resident populations. (LandView can be ordered from the U.S. Bureau of the Census customer service at (301) 457-4100.) In general, commenters agreed with the SNPRM approach. However, some commenters questioned the accuracy of potentially ten-year-old Census data and requested additional flexibility, or a greater role for local government, in this analysis.
EPA has decided to adopt the approach outlined in the SNPRM for the final rule. Sources will be allowed to use available Census data to estimate populations potentially affected. Sources may update these data if they believe the data are inaccurate, but are not required to do so. Populations shall be reported to two significant digits. Because Census data are limited to residential populations, sources will also have to note in the RMP whether other, non-residential populations, such as schools, hospitals, prisons, public recreational areas or arenas, and major commercial or industrial areas, are within the distance to an endpoint. These institutions and areas are those that can generally be found on local street maps. Sources will not be required to estimate the number of people who might be present at these locations. EPA provides further guidance on the identification of affected populations in its RMP Offsite Consequence Analysis Guidance.
4. Number of Scenarios In the NPRM. EPA required a worst-case release scenario for each regulated substance. Commenters requested clarification, because one substance could be present in more than one process at the source and sources would need to select the ``worst'' worst case for substances in multiple processes. In addition, one process may have several, similar listed substances and multiple worstcase analyses of similar substances (e.g., flammables) would not provide additional useful information to the public.
EPA proposed in the SNPRM that sources report in the RMP one worstcase release scenario representative of all toxic substances present at the source and one worst-case release scenario representative of all flammable substances present at the source. Even though additional screening analyses to determine the appropriate worst-case scenario might be necessary, this approach reduces to a maximum of two the number of worst-case analyses reported in the RMP by a source. In general, commenters favored this approach, particularly for flammables, which do not produce markedly different adverse effects. A few commenters argued that a single toxic substance should not be considered representative of all toxic substances at a source, since there are considerable differences in toxic endpoint and adverse affect.
EPA has decided to adopt the approach outlined in the SNPRM for the final rule: report one worst-case release scenario for all flammables and one worst-case release scenario for all toxics at the source. EPA notes that the worst-case scenario is designed principally to support a dialogue between the source and the community on release prevention, and not to serve as the sole or primary basis for local emergency planning. The ``worst'' worst-case release scenario will inform the broadest range of individuals that they may be impacted by the source so that they may participate in dialogue with the source about prevention, preparedness, and emergency response actions. Lesser worstcase release scenarios would not [[Page 31684]] inform any person not already within the range of the ``worst'' worst case even though the health effects may be different; consequently, EPA believes that only a single toxic worst case is necessary. However, sources must also analyze and report another worst-case release scenario (for flammables or toxics) if such a release from another location at the source potentially affects public receptors different from those potentially affected by the first scenario (e.g., if a large-sized source is located between two communities and has a covered process adjacent to each community).
In the NPRM, EPA did not specify the number of alternative scenarios to be reported for each regulated substance. EPA noted in the preamble that this approach, while providing flexibility, may also create uncertainty about what EPA will consider to be an adequate number of scenarios. While a few commenters argued against scenarios beyond the worst case, many commenters supported a requirement for a maximum of two: the worst case plus one additional scenario; others supported a maximum of three. Many of the commenters noted that local entities could request further information under EPCRA section 303(d)(3) authority if they desired. At the same time, a number of commenters suggested that this determination should be made by the source based on their scenario analysis, perhaps in coordination with a local agency.
In the SNPRM, EPA proposed to require one alternative release scenario for all flammable substances at the source and one alternative scenario for each toxic substance at the source. As discussed above, the listed flammable substances behave similarly upon release and have the same endpoint, while each toxic substance has a different endpoint and different atmospheric behavior. EPA sought comment on whether one toxic substance alternative scenario could represent all toxic substances at a source or in a process. Although commenters generally agreed with the approach for flammables, only a few argued that a single alternative scenario for all toxics was also appropriate; most others supported EPA's proposal.
Upon review of the comments, EPA has decided to adopt the approach outlined in the SNPRM: an alternative release scenario must be reported in the RMP for each toxic held above
![[logo] US EPA](http://www.epa.gov/epafiles/images/logo_epaseal.gif)