58, No. 201 / Wednesday, October 20, 1993 / Proposed Rules
ENVIRONMENTAL PROTECTION

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 68
[A-91-73; FRL-4790--11

RiskManagement Programs for Chemical Accidental Release Prevention

AGENCY: Environmental Protection Agency. ACTION: Proposed rule.

SUMMARY: Under the Clean AirAct, as amended, the U.S. Environmental Protection Agency (EPA) is proposing regulations that would require development and implementation of risk management programs at facilities that manufacture, process, use, store, or otherwise handle regulated substances in quantities that exceed specified thresholds. EPA has proposed a list of regulated substances and thresholds separately. Risk management programs provide facilities with an integrated approach to identifying and managing the hazards posed by these regulated substances. The risk management plans developed under such programs would be registered with EPA, provided to the Chemical Safety and Hazard Investigation Board, state governments, and local planning authorities, and made available to the public. The proposed rule would assist facilities and communities in efforts tolessen the number and severity of serious chemical accidents. DATES: Comments mustbe submitted on

orbefore February 16,1994. A public hearing will be held in Washington, DC,

on November 30, 1993, from 9 a.m. to 5 p.m.Persons interested in appearing
at a public hearing should register with EPA at (703) 218-2570 by November 23, 1993; a copy ofthe testimony should be submitted by November 23, 1993, to Dr. Lyse Helsing (see the FOR FURTHER INFORMATION section).

Docket: Supporting documentation used in developing this proposed rule is contained in Docket No. A-91-73. This docket is available for public inspection and copying between 8:30 a.m. and 12

noon, and between 1:30 'and3:30 p.m., Monday through Friday, at the address listed below. A reasonable fee may be charged for copying. ADDRESSES: Comments may be mailed

or submitted to: Environmental Protection Agency, AirDocket (LE-131), Attn: Docket No. A-91-73, Waterside Mall, 401 M St. SW., Washington, DC 20460. Comments must be submitted in duplicate. The public hearing will be held at Temple Micah, 600 M Street, SW., Washington, DC. FOR FURTHER INFORMATION CONTACT: Dr. Lyse Helsing, Chemical Emergency Preparedness and Prevention Office, Environmental Protection Agency, OS120, 401 M St. SW., Washington, DC 20460, (202) 260-6128; or dhe Emergency Planning and Community Right-to-Know Hotline, (800) 535-0202; Innorthern Virginia and Alaska, (703) 920-9877.

SUPPLEMENTARY INFORMATION:
Table ofContents 1.

Introduction A.Statutory Authority B.

Background C.CleanAir Act Amendments of1990 II.Rilsk Management Programs

A.CleanAir Act Requirements B.Other CAA Provisions for Regulations C.Relationship to OSHA's Process Safety

Management Standard III. Discussion oftheProposed Rule

A.Introduction B.Applicability C.Definitions D.Risk Management Program Elements E.

RMP and Documentation F. Registration G.

Prohibitions H.

Timing IV. Comparison ofEPA's Proposed Rule to OSHKs Standard A.Differences between EPA's Proposed

Rule andOSHA's Standard B.Section by SectionComparison ofthe

EPA Prevention Program and the OSHA Standard V.Relationship to Other Federal and State Aequirements V1. Other Approaches Considered VII. Guidance VIII.Information Gathering Efforts IX. Section by Section Discussion ofthe Proposed Rule X.Regulatory Costs and Benefits XI. Required Analyses

A.Executive Order 12291 B.Regulatory Flexibility Act C.Paperwork Reduction Act

I. Introduction

A. StatutoryAuthority

This notice ofproposed rulemaking (NPRM) is being issued under sections 112(r)(7) and 301(a)(1) ofthe Clean Air Act (CAA) as amended (42 U.S.C. 7412(r)(7) and 7601(a)(1)).

B.Background

Public awareness ofthe potential danger from accidental releases of hazardous chemicals has increased over the years as serious chemical accidents have occurred around the world (e.g., the 1974 explosion inFlixborough, England, and the 1976 release ofdioxin in Seveso, Italy). Public concern intensified following the 1984 release of methyl isocyanate inBhopal, India, that. killedmore than 2,000 people living

near the facility. A subsequent release from a chemical facility in Institute, West Virginia, sent more than 100 people to the hospital and made Americans aware that such incidents

can and do happen in the U.S.

In response to this public concern and the hazards that exist, the United States Environmental Protection Agency (EPA) began its Chemical Emergency Preparedness Program (CEPP} in 1985,

aspart ofthe Agency's AirToxics Strategy. CEPP was a voluntary program to encourage state and local authorities
to identify hazards in their areas and to plan for chemical emergency response actions. In 1986, Congress enacted many ofthe elements ofCEPPin the Emergency Planning and Community Right-to-Know Act of1986 (EPCRA), also known as Title III ofthe Superfund Amendments and Reauthorization Act of 1986 (SARA). SARA Title III requires
states to establish state and local
emergency planning groups to develop chemical emergency response plans for each community. SARA Title IIIalso requires facilities to provide information

on the hazardous chemicals theyhave

on site to the states, local planners, and fire departments, and, through them, the public. This information forms the foundation ofboth the community
emergency response plans and the public-industry dialogue on risks and riskreduction.

SARA TitleIII did not mandate that facilities establish accident prevention
programs. However, Congress acknowledged the importance of accident prevention by requiring EPA, under SARA section 305(b), to conduct

a review ofemergency systems to monitor, detect, and prevent chemical accidents. The final report to Congress, Review ofEmergency Systems (EPA, 1988), stated that

* * * prevention does not depend on a single piece ofequipment or asingle technique. Prevention mustbe part ofa comprehensive,-integrated system that considers the hazards of the chemicals involved, the hazards ofthe process, the hazards to the community, andthe capabilities offacility personnel. None ofthe elements should be considered in isolation

nor should any single technical solution be considered acomplete solutionto a particular problem. Each change in afacility, process, or procedure will have multiple effects that must beassessed in the context ofthe entire operation.

The report concluded that the key to a successful process safety management system is the commitment of management (facility and corporate) to safety.

Although SARA Title III did not directly address accident prevention except through section 305(b), EPA 54190 Federal Register / Vol.Federal Register / Vol. 58, No. 201 / Wednesday, October 20, 1993 / Proposed Rules

recognized that prevention, preparedness, and response form a continuum. In 1986, therefore, EPA established a chemical accident prevention program to collect information on chemical accidents and
to work with other groups to increase knowledge ofprevention practices,
encourage industry to improve safety at facilities, and foster increased

awareness ofprevention, preparedness, and response at the local level. Under this program, EPA developed its Accidental Release Information Program (ARIP) to collect data on the causes of chemical accidents and the steps facilities take to prevent recurrences. EPA also developed a program for conducting chemical safety audits at facilities to learn more about how facilities develop systems to prevent accidents. Through the audit program, EPA has trained its regional staffas well

as state officials on how to conduct audits. EPA has worked with trade associations, professional organizations, labor, environmental groups, and other Federal agencies to determine how best
to reach smaller operations, which the SARA section 305(b) study indicated are less aware ofrisks than larger facilities. EPA has also been an active participant in international efforts related to chemical accident prevention, particularly through the Organisation for Economic Cooperation and Development, which has held five international workshops from 1989 through 1991 to discuss issuesrelated to accident prevention, preparedness, and
response, and has developed guidelines for member countries.

In addition to EPA's work in this area, other agencies, states, industries, trade associations, and professional organizations have developed programs related to chemical accident prevention. On February 24, 1992, the U.S. Occupational Safety and Health Administration (OSHA) promulgated a standard on chemical process safety management (57 FR 6356). Four statesNewJersey, California, Delaware, and Nevada-have regulations requiring facilities to prepare and implement risk management plans. The American Institute ofChemical Engineers (AIChE), through its Center for Chemical Process Safety, has published guidance on the management ofchemical process safety

as well as guidelines on topics related
to hazard evaluation, vapor cloud dispersion modeling, handling and storage practices, and vapor cloud mitigation. The Chemical Manufacturers' Association (CMA) has adopted its Responsible CareTm

- program, with whiclh all CMA members must comply to maintain membership. The American Petroleum Institute has developed a similar program (RP 750) for its members. In 1982, the European Community adopted the Seveso Directive (82/501/EEC, as amended), which requires facilities handling certain chemicals to develop a safety report that is similar to arisk management plan. Congress also recognized the need for a chemical accident prevention program at the Federal level and included prevention provisions in the Clean Air Act Amendments of 1990.

C. CleanAirAct Amendments of1990

The Clean Air Act Amendments of 1990, signed into law on November 15, 1990, amend Clean AirAct (CAA) section 112 by adding a new subsection (r), which includes requirements related

to chemical accidentprevention. The goal of CAA section 112(r) is to prevent accidental releases of regulated substances and other extremely hazardous substances to the air and to minimize the consequences ofreleases by focusing preventive measures on those chemicals that pose the greatest risk.

Section 112(r)has a number of provisions. It establishes a general duty for facilities (i.e., stationary sources) to identify hazards that may result from releases, to design and maintain a safe facility, and to minimize the

consequences ofreleases when they

occur. Section 112(r)(3) requires EPA to promulgate a list ofat least 100 substances that are known to cause, or may be reasonably anticipated to cause, death, injury, or serious adverse effects

to human health or the environment whenreleased to air.EPA is required to
set thresholds for each listed substance. The proposed rule for the list and thresholds was published on January 19, 1993 (58 FR 5102). The proposed list includes 100 substances listed based on acute toxicity, 62 flammable gases and highly flammable liquids, and high explosives as a class.

CAA section 112(r)(7) requires EPA to promulgate, by November 15, 1993, "reasonable regulations and appropriate guidance" to provide for the prevention and detection ofaccidental releases and forresponses to such releases. These regulations shall include, as appropriate, provisions concerning the

use, operation, repair, and maintenance ofequipment to monitor, detect, inspect, and control releases, including training ofpersonnel in the use and maintenance ofequipment or in the conduct ofperiodic inspections. The regulations shall require facilities to
prepare and implement risk management plans that shallprovide for compliance with regulations for managjng risk (the "risk management program") and shall include a hazard assessment, a prevention program, and

an emergency response program. The list and thresholds promulgated under CAA section 112(r)(3) will determine which facilities must comply with the accident prevention regulations,

The CAA, as amended, establishes a Chemical Safety and Hazard Investigation Board to investigate or

cause to be investigated the causes of chemical accidents and to report its findings to Congress, Federal, state, and local authorities, and the public. Under the CAA, EPA is also required to conduct studies related to accidental releases, including research on hazard assessments, hydrogen fluoride, and air dispersion modeling.

In addition, section 304 ofthe Clean Air Act Amendments of1990 requires OSHAto promulgate, under the Occupational Safety and Health Act (29 U.S.C. 655), a chemical process safety standard in orderto protect employees from hazards associated with accidental releases ofhighly hazardous chemicals in the work place. OSHA promulgated its standard for process safety management for highly hazardous chemicals on February 24, 1992 (57 FR ,6356). Sections RC and IV ofthis preamble discuss the relationship between EPA's proposed risk management program and the OSHA standard on chemical process safety management.

Finally, CAA section 112(1) requires EPA to develop guidance for states, especially for the registration ofsources (facilities). This CAA section also contains the statutory authority for EPA
to approve and delegate Federal authority to the states. For further information on EPA's proposed rule on CAA section 112(1), see 58 FR 29296, May 19, 1993.

II. Risk Management Programs

A. CleanAirActRequirements

Today's proposed requirements to develop and implement arisk .management program are in response to CAA section 112(r)(7)(B). Specifically, CAA section 112(r)(7)(B)(i) requires EPA
to adopt "reasonable regulations and appropriate guidance" to provide for the prevention and detection ofaccidental releases and forresponse to such releases. As appropriate, the requirements shall address the use, operation, repair, replacement, and maintenance ofequipment to monitor, detect, inspect, and control accidental releases, including the training of 5419154192 Federal Register / Vol. 58, No. 201 / Wednesday, October 20, 1993 / Proposed Rules

persons in the use and maintenance of equipment and in the conduct of periodic inspections. The regulations shall include procedures and measures foremergency response afteran accidental release. The Act requires that the regulations be promulgated by November 15, 1993.

CAA section 112(r}{7)(B)Iii) states:
The regulations under this subparagraph shall require the owner or operator of stationary sources at which a regulated substance is present inmore than athreshold quantity toprepare and implement arisk management plan to detect and prevent or minimize accidental releases of such substances from the stationary source, and to provide a prompt emergency response to any such releases in order to protect human health and the environment. The riskmanagement plans must include a hazard assessment that evaluates potential effects ofan accidental release ofany regulated substance. The hazard assessmentmust include an estimate ofpotential release quantities and downwind effects. including potential exposure to populations. The assessment also must include a five-year release history, including the size, concentration, and duration ofreleases, and must consider

worst-case release scenarios. The risk management plan must also document a prevention program including safety

. precautions, maintenance, monitoring, and employee training measures. The final specified element that must be documented in the risk management plan is an emergency response program that provides specific actions to be taken in response to arelease to protect human health and the environment, including informing the public and local agencies, emergency health care, and employee training.

CAA section 112(r)[7)(B)(iii) requires that the risk management plans be registered with EPA. The plans must be submitted to the implementing agency. the Chemical Safety and Hazard Investigation Board, the state emergency response commission (SERC), and the local emergency planning committee (LEPC). These plans shall be available to the public under CAA section 114(c). EPA must establish a system for auditing the risk management programs. EPA must also ensure that plans are updated periodically.

The proposed rule would require facilities to do three things-

(1)Register with-EPA three years after publication ofthe final rule in the Federal Register. The registration would consist ofa written form to be sent to EPA headquarters indicating that the facility is covered by the rule, identifying the regulated substances triggering the registration and the quantity ofthose substances (inranges) in a process. Ifthe information on the registration changes (e.g., because new chemicals ere added, chemicals are dropped, or the quantity changes), facilities would be required to submit an amended registration form;

(2) Develop and implement a risk management program that includes a hazard assessment, prevention program, and emergencyresponse program, and maintain onsite documentation of the implementation. The hazard assessment would include offsite consequence analyses and a five-year accident history. The prevention program would consist ofa process hazard analysis,
process safety information, standard operating procedures (SOPs), training, maintenance, pre-startup reviews, management ofchange, safety audits, accident investigations, and a management system. The emergency response program would require emergency response plans, drills or exercises, and coordination with public
emergency response plans; and

(3)Develop and submit to the Chemical Safety and Hazard Investigation Board, the implementing
agency, SERC, andLEPC, arisk management plan (RMP) thatwould document the results ofthe risk management program including a summary ofthe offsite consequence analysis, a list ofmajor hazards, steps being taken to address thosehazards (i.e., a summary ofthe facility's prevention program), a five-year accident history, adescription ofthe emergency response program, and a description ofthe management system that ensures the safety ofthe facility and the implementation ofthe required elements. This plan will be available to the public.

The riskmanagement program addresses the general requirements of CAA section 112(r)(7)(B)(i) for regulations to provide for accidental release detection and prevention. The risk management plan, referred to as the RMP inthis preamble, addresses the specific requirements ofCAA section 112(r)(7}{B)(ii) for a plan that provides governmental entities and thepublic with information on thehazards found
at facilities and the facilities' plans for addressing thehazards. These hazards wouldbe identified and addressed through-implementation ofthe risk management program elements. Therefore, the RMP would summarize the results ofhazard assessments and analyses and the implementation ofthe risk management program requirements. The submission requirements (registration and the RMP) address the requirements ofCAA section 112(r)(7)(B)(iii), as does the requirement for a system to auditRMPs.

B. OtherCAA Provisions forRegulations

In addition to CAA section 112(r)(7)(B),CAA section 112(r)(7)(A) authorizes EPA to promulgate "release prevention, detection, and correction requirements which may include monitoring, record-keeping, reporting, training, vapor recovery, secondary containment, and other design, equipment, work practice, and operational requirements." EPA is investigating whether regulations, other than today's proposed rule on risk management programs, are necessary to prevent and detect accidental releases.

C.Relationshipto OSHA's Process SafetyManagementStandard

The Clean Air Act Amendments of 1990 (CAAA) section 304 requires OSHA to promulgate a chemical process safety standard and a list ofhighly hazardous chemicals. To meet this mandate, OSHA promulgated its process safety management standard. The OSHA standard is intended toprotect workers from chemical accidents at facilities using highly toxic, reactive, flammable,

or explosive substances. EPA's mandate under section 112(r) ofthe CAA is to protect public health and the environment.

EPA and OSHA have met regularlyto coordinate their rules to minimize conflicting requirements. To minimize confusion for facilities covered byboth rules, the elements and language of EPA's proposed prevention program are, to the maximum extent possible, identical to the parallel elements in OSHA's process safety management standard. The main differences between the EPA's proposed rule and OSHA's standard are those mandated by the CAA, such as thehazard assessment (offsite consequence analysis, the fiveyear accident history), the emergency response requirements, registration, and the RMP submission to the Board, implementing agency, SERC, and LEPC. In addition, for some elements ofthe

two programs, OSHA's focus is on workplace impacts.while EPA's focus is

on offsite consequences, reflecting the differing statutory mandates of-thetwo
programs. The OSHA standard includes elements specific to worker issues that EPA has notincluded in its proposed rule. EPA anticipates that facilities in compliance with the requirements in the OSHA rule also will be in compliance with EPA's proposed prevention program elements. That is, for mosi prevention program elements, facilities that are in compliance withFederal Register / Vol. 58, No. 201 / Wednesday, October 20, 1993 / Proposed Rules

OSHA's process safety management standard willnot need to do anything different orcreate different onsite documentation to comply with EPA's proposed prevention program requirements. Section IV ofthis preamble describes the differences that existbetween the OSHA standard and EPA's proposed rule and outlines the correspondence between EPA's proposedrule elements and the OSHA standard.

Because EPA's proposed list of chemicals and thresholds and OSHA's list and thresholds are not identical (EPAcovers more substances with acute toxic effects, fewer flammables and explosives, and no reactives) and because OSHA does not cover state and localgovernment employees, the universes offacilities covered bythe
two rules are not identical, although they substantially overlap. See Section X ofthis preamble for a discussion of the universe offacilities covered by today's proposed rule.

L.Discussion ofthe Proposed Rule

A. Introduction

AIChE, in its TechnicalManagement ofChemicalProcessSafety, says:

Management systems for chemical process safety are comprehensive sets ofpolicies, procedures, and practices designed toensure that barriers to major incidents are in place, inuse, andeffective. The management systems serve to integrate process safety concepts intothe ongoing activities of everyone involved in operations-from the chemical process operators to thechief executive officer. * * *Effective process safety management systems can,and do, vary
agreat deal inhow they ae implemented. However, they alwaysaddress theneed for managing theprocess safety-related aspects oftechnology, facilities, personnel, hazardous materials, and emergency responses.

The purpose oftoday's proposed rule is torequire industryto develop such an integrated, holistic approach to managing the risks posedby the
presence and use ofregulated substances. EPA's proposed rulebuilds

on process safety management elements included in OSHA's standard: process information, processhazard analysis, standard operating procedures,.training, pre-startup reviews, mechanical integrity, management ofchange, accident investigation, safety audits, and emergency response. The implementation ofthese elements and the development ofthe RMP that willbe submitted to governmental authorities will assist the owners and operators of facilities toidentify hazards and
construct amanagement system that addresses the hazards ina manner that is most effective for the specific circumstances and complexity ofthe facility.

EPA's proposed rule, particularly the prevention program, emphasizes the importance ofmanagement and management commitment fortwo

reasons. First,without management commitment and an integrated system formanaging process safety, it is unlikely that safety will be consistently recognized as apriority. Second, although for some facilitiesbetter or different technologies maybe the most effective methods ofaddressing hazards, the technologies, by themselves, cannot

ensure safety. Equipment must be maintained and workers trained in its
proper uses. Changes in the process or procedires may affect the safe operation oftechnologies. Only with an integrated management systemthat continually evaluates the safety ofa facility can the hazards posed by regulated substances be managed to minimize the likelihood ofaccidental releases.

Besides lessening the likelihood and severity ofaccidents, the implementation ofprocess safety management can help facilitiesrun

more efficiently. Companies thathave instituted risk management programs report reductions in injuries, lost-time accidents, mechanical breakdowns, maintenance costs, andmaterial losses. Safety improvements will result in lower insurance costs. By preventing accidental releases, companies may minimize environmental damage and
necessary cleanup costs. See Section X ofthispreamble fora discussion ofthe benefits ofthisrule.

B.Applicability

The CAA states that facilities covered by the riskmanagement program regulations are thosethat have more than a threshold quantity ofa regulated substance based onthe final list and thresholds EPA will promulgate. In Its list andthreshold rule, EPA is proposing to exempt ammonia when used as an agricultural nutrient and held by a farmer. EPA requests comments on the proposed exemption andrequests information on whether EPA should develop an accident prevention rule directed strictly to farmers using ammonia as a fertilizer. EPA notesthat farm contractors who sell and apply ammonia as a fertilizer wouldbe coveredby today's proposed rule.

EPA estimates that approximately 140,425 facilities would be affected by today's proposed rule. Approximately 87,800 ofthose facilities would also be coveredby OSHA's process safety management standard. The largest sectors coveredby the rules would be cold storage facilities (which use ammonia as a refrigerant), public drinking water systems and publicly owned treatment works, manufacturers, and propane retailers. Some wholesalers and service industries would also be covered. See Section X ofthispreamble for a discussion ofthe estimated
coverage and costs ofthisproposed rule.

The risk management program rules would affect only those areas at facilities where regulated substances are manufactured, processed, used, stored,

orotherwise handled. Ifa facility uses

aregulated substance in quantities above a threshold in only one process (e.g., wastewater treatment or refrigeration), only thatprocess (aswell

as any unloading, transferring, and storing ofthe substance) would be covered by the rule. Ifa single process at a facility includes morethan one regulated substance, a single process hazard analysis may cover all regulated substances for that process. EPA realizes that some facilities, such asbatch
processors (e.g., specialty chemical manufacturers), may have regulated substances on sitefor limited periods duringthe year; forexample, abatch
processor may use a regulated substance for only one month duringthe year. In

some cases,these facilities may not be able to predict accurately which substances they will be handling. However, the Agency believes it is important for any facility that handles a regulated substance to have in place a program to manage risks and ensure safe operations. Because regulated substances would notbe covered ifthey represent less than one percent by weight ofa solution, EPA does not expectthat the risk management program ofpublicly owned treatment works would needto coverthe substances they receive from facilities fortreatment.

C.Definitions

A "significant accidental release"

means any accidental release ofa regulated substance thathas caused or has the potential to cause offsite
consequences such as death, injury, or adverse effects to human health or the environment orto cause the public to shelter in place orbe evacuated to avoid such consequences.

"Worst-case release" wouldmean the loss ofall ofthe regulated substance from the process in an accidental release that leads to the worst offsite
consequences.
D.RiskManagement Program Elements
The Clean AirAct mandates that the risk management plan documentthree 5419354194 Federal Register / Vol. 58, No. 201 / Wednesday, October 20, 1993 / Proposed Rules

elements: ahazard assessment, a prevention program, and an emergency response program. This section discusses the elements EPA is proposing forthe risk management program to develop each ofthe plan requirements.

Hazard Assessment

As discussed above, the Clean Air Act requires a hazard assessment that includes evaluation ofa range of releases including worst-case accidental releases; analyses ofpotential offsite
consequences; and a five-year accident history. The language in the Conference Report suggests a more extensive
assessment that would require a formal
process hazard analysis (e.g,, basic data

on the source, identification ofpotential points ofrelease, review ofthe efficacy ofrelease and control measures). To allow EPA's prevention program requirements to parallel OSHA's process safety management standard, EPA is proposing to separate the offsite
consequence analysis and five-year accident history from the formal process hazard analysis requirement. The proposed rule would require ahazard
assessment that examines arange of accidental release scenarios, selects a worst-case accidental release scenario, analyzes offsite consequences for selected release scenarios including
worst case, and documents a five-year history of significant accidental releases and accidental releases with the potential for offsite consequences. The other elements suggested inthe Conference Report wouldbe included under the prevention program In the
processhazard analysis requirement.

EPA is proposing that facilities complete a hazard assessment foreach regulated substance present above the threshold quantity. Facilities that use the regulated substance above its threshold in several locations or processes would need to evaluate a range ofaccidental releases and determine aworst-case release scenario foreach location. The range ofreleases should include only those events that could lead to significant releases (i.e., accidental releases that have the potential to cause offsite death, injury,

or serious adverse effects to human health or the environment). EPA' requests comments on this issue.

EPA is proposing to define the worstcase release as the instantaneous loss of all ofthe regulated substance in a process, with failure ofall mitigation systems (active and passive). EPA recognizes that this definition may require facilities to consider release scenarios that are highly unlikely. Such

a definition will, however, define for the public the extreme worst-case. The proposed definition will also reduce the urden onregulated facilities; a requirement for analysis ofa "credible worst-case" would lead to more analyses and documentation to defend the selected scenario. In addition, if each facility defined its own worst-case, local authorities could find it difficult to compare the results.EPA requests
comments on the worst-case definition.

The Agency recognizes that this approach differs from the approach EPA used inits Technical Guidance for Hazards Analysis forlocal planners to

assess credible worst-case releases for
purposes of screening out situations with little orno impact. The credible
worst case in the guidance assumed that the entire quantity of asubstance was released from the largest vessel or group ofinterconnected vessels. Gases were assumed to be released in 10 minutes while liquidswere assumed to be spilled on theground orin adiked area and allowed to volatilize. Downwind impacts were assessed using conservative meteorological conditions. The Agency still supports this approach for screening, however, the methodology does not fully account for site-specific conditions that affect the
rate ofrelease. For example, gases may be stored in a liquefied state or a liquid
maybe handled in largequantities at higher than ambient temperatures giving much different release rates.The Agency believes that the worst-case analysis should account for site-specific conditions and physical chemical properties.

The Agency considered defining
worst case as the instantaneous loss of the regulated substance from the largest containment vessel orpipeline on site. This approach is similar to the Technical Guidance approach. However, because the threshold quantity applies to the quantity in a process and the definition ofa process defines the vessels and pipingto be considered, the worst case should reflect the accidental release that could

occur from catastrophic vessel and piping failures. The Agency requests
comments on this approach.

In addition to the worst-case release scenarios, EPA would require facilities
to analyze other more likely significant accidental release scenarios foreach
process in which the regulated substance is used above the threshold quantity. The proposed rule specifies several possible accident causes that facilities should consider when defining these more likely release scenarios. The list,however, should not beviewed as allinclusive. Each facility should examine its processes to determine the
event or sequence ofevents that may lead to significant accidental releases. When examining these potential release scenarios, facilities would be allowed to

assume that passive mitigation systems, such as containment dikes, functioned properly. Active mitigation systems, such as excess flow valves, fail-safe systems, scrubbers, flares, deluge systems, and water curtains, would be assumed to fail. EPA requests comments

on this approach. The Agency plans to issue guidance on the evaluation ofa range ofaccidental releases and determination ofthe worst-case scenario.

The proposed rule does not specify the number ofother more likely significant accidental release scenarios facilities would be required to analyze. Although this approach provides flexibility, itmay create uncertainty about what EPA will consider an adequate number ofscenarios. EPA requests comments on whether it should specify a minimum number of scenarios
to be analyzed, whether the minimum should vary with the complexity ofthe facility, and what the minimum(s) should be,

Once the worst-case and more likely significant accidental release scenarios

are identified, the facility would be required to analyze the potential offsite
consequences associated with these scenarios. The offsite analyses would estimate, using models or other approaches specific to each substance, the possible rate ofrelease, quantity released, and duration ofthe release, and the distances in any direction that the substance could travel before it dispersed enough to no longer pose a hazard to the public health or environment. Facilities would be required to analyze the releases under
average weather conditions for the facility and worst-case weather conditions, which would be defined as

a wind speed of 1.5 meters per second and F stability (moderately stable weather conditions). For flammables and explosives, the analyses should consider the distances in all directions that might be affected by pressure
waves, fire, or debris. The analyses would also identify all populations that could be affected by such a release, including sensitive populations (e.g., schools, hospitals), and would detail potential environmental damage. EPA requests comments on the level ofdetail needed to define the population potentially exposed.

The fate andtransport ofthe regulated substances can be evaluated using air dispersion models. EPA has published guidance on conducting similar analyses inits TechnicalGuidance for Hazards Analysis,much ofwhich couldFederal Register / Vol. 58, No. 201 / Wednesday, October 20, 1993 / Proposed Rules

be useful in developing the offsite
consequence analyses. Computer models to estimate the impacts ofvapor cloud explosions also are available. EPA, the Department ofTransportation (DOT), and the Federal Emergency Management Agency have developed a model-the Automated Resources for Chemical Hazard Incident Evaluation (ARCHIE)--for vapor cloud explosion evaluation. The World Bank's WHAZAN model also evaluates this type ofincident, as do other commercially available models. Simple equations can be used to calculate the impacts ofexplosions at various distances. EPA plans to develop additional guidanceto assist facilities in analyzing offsite impacts.

Although the worst-case scenario is specifically defined, facilities are likely
to use different models and approaches
to estimate offsite impacts.. Inaddition, facilities may need to use different models and analytical techniques to account forsite-specific conditions in assessing offsite impacts associated with other scenarios. The Agency recognizes that facilities will need to have inhouse expertise orhire consultants with such expertise to complete these offsite impact analyses. This maypose a significant resource burden on some facilities, andthe different approaches and models can make the offsite consequence results more difficult for local emergency planners to use. The Agency is working on ways tominimize thisburden and make the results useful for local emergency planners. For example, the statute requires the Administrator to issue RMP guidance and model RMPs. The Agency is considering the development ofa set of simple, generic tools that would be included inthe guidance and that could be used for the assessment ofoffsite impacts. EPA could develop, for example, a genericmethodology for assessing the offsite impacts similarto the methodology included in the TechnicalGuidance forHazards Analysiscited above. Using ageneric methodology for assessing the offsite impacts would allow a more direct comparison among facilities ofpotential offsite consequences. At the sametime, this approach could reduce the resource burden imposed by the rule on many facilities, particularly smaller businesses byreducing the need for consultants to perform the offsite
consequence analysis.

The Agency recognizes the limitations associated with simple, generic tools that will need to cover a potentially wide variety ofscenarios. Itwould be difficult to construct ageneric methodology which includes assumptions aboutthe characteristics of chemicals, the range ofchemical

processes (e.g., conditions involving high temperatures and pressures), and other site-specific parameters. As a result, a generic methodology will generally be less sensitive to these conditions (orattributes) and may yield overly conservative or less realistic estimates ofoffsite impacts. The Agency requests comments on this approach and requests Input on possible innovative waysto assist facilities in offsite impact analysis that might reduce the burden and provide meaningful, useful results.

Specific information on the worstcase scenario will help public
emergency planners andresponders recognize the maximum hazard potential surrounding the facility. The Agency recognizes, however, that the

worst-case scenario may often be highly unlikely in comparison to other release scenarios with lesser potential

consequences. Focusing on theworstcase scenario alone, therefdre, could lead public agencies and the public to overestimate thethreat posed by a facility. For thisreason, EPA believes that facilities must examine arange of

events in addition to the worst-case scenario and communicate information

on these events to public agencies and the public to provide additional information on the hazards posed by the facility. In addition, EPA does not want facilities to focus solely on the worstcase release because other release scenarios are of concern, are generally far more likely than aworst-case release scenario, and must be addressed in the prevention program. Therefore, EPA is requiring facilities to analyze hazards associated not onlywith the worst-case scenario, but also with more likely significant releases.

EPA would require that facilities update the offsite consequence analyses
every five years, with the RMP update,

or sooner ifchanges at the facility or its surroundings mightreasonably be expected to make the results inaccurate
to a significant degree. For example, a substantial increase or decrease Inthe quantity ofa regulated substance could significantly change the distance a substance couldtravel before dispersing and posing no hazard. Major changes in housing or land-use patterns, such as the construction ofnow, large-scale housing developments or commercial

areas, could change substantially the population potentially affected.

Afinal element ofthe hazard

assessment specified in the Act is a fiveyear history ofreleases ofregulated substances. EPA interprets the accident history requirement to cover significant accidental releases and incidents that had the potential foroffslte
consequences because CAA section 112(r)Is directed at preventing such releases. EPA isproposing to requirethe history to document releasesthat caused

orhad the potential to cause offsite
consequences. As mandatedby statute, the history must include the substance and quantityreleased, the concentration ofthe substance when released, and the duration ofthe release. EPA is also proposing that the date ofthe release, time ofthe release, and any offsite
consequences (e.g., evacuations, injuries, environmental effects)be included. EPA believes that forreleases oftoxic substances, most ofthe releases that meet the criteria are already reported to the Federal or state governments underCERCLA and SARA TitleIII. Therefore, development ofthe five-year history ofsignificant accidental releases would create little additional burden on facilities beyond maintaining records.

Prevention Program "The Act requires that the risk management plan include a prevention
program that covers safety precautions and maintentance, monitoring, and employee training measures. Although the Act's requirements forthe prevention program are general, a

consensus exists among industry, professional organizations, labor, public interest groups, and government on what constitutes a good risk management program. In its Review of EmergencySystems, EPA listed elements ofgood management programs. The American Institute of Chemical Engineers (AIChE)has published Guidelines for Technical ManagementofChemical Process Safety, which includes basically the

same elements. Delaware, New Jersey, California. and Nevada have each adopted staterisk management program regulations that again cover a similar set ofelements. TheOSHA chemical process safety management standard

covers this same set ofelements. Labor and environmental groups recommended similarrequirements to Congress and the agencies. Therefore, the prevention program EPA is proposing today consists ofelements that the Federal government and several
state agencies, as well astrade associations, professional organizations, labor, andpublic interest groups believe

are necessary in order tohave an integrated approach tounderstanding and managing risks associated with regulated substances at a facility. The elements ofthis integrated approach are 5419554196 Federal Register / Vol. 58, No. 201 / Wednesday, October 20, 1993 / Proposed Rules

consistent with and fulfill the requirements ofthe statute.

EPA is proposing a prevention
program that adopts and builds on OSHA's process safety management standard and covers nine procedural

areas: Process hazard analysis, process safety information, standard operating procedures (SOPs), training, maintenance, pre-startup review, management ofchange, safety audits, and accident investigation. The degree ofcomplexity required for compliance foreach element will depend on the complexity ofthe facility. For example, development ofprocess safety information would take far more time and would require greater expertise at a large petrochemical facility than it would ata small drinking water system. As they develop plans forimplementing the elements, facility owners or operators would have to consider the complexity oftheir chemical use,the hazards potentially posed by the chemicals, and potential consequences ofan accidental release.

The prevention program elements

mustbe integrated with each other on

an ongoing basis. For example, each time a new substance is introduced to

a process ornew equipment is installed, the process hazard analysis mustbe reviewed, SOPs updated, training and maintenance programs revised, with

new training ifneeded. An investigation ofanear miss or a safety audit may reveal the need for revised operating and maintenance'procedures, which will lead to revisions to SOPs, training, and maintenance. The investigation or audit may also indicate a needto review the process hazard analysis. The management system should ensure that

a change in any single element leads to

a review ofother elements to identify
any impacts caused by the change.
Management System

Because it is essential that allofthe prevention program elements be integrated into a management system that is implemented on an ongoing basis, EPA is proposing that the owner

or operator ofthe facility designate a single person or position to be responsible forthe development and implementation ofthe overall program. At facilities where individual elements ofthe program are handled by different people or divisions,.the names or positions ofthe people responsible for each element would also be specified and an organization chart or similar dotument required to define the lines of authority. At a small facility, a single
person may be responsible for all elements. At alarge company, separate divisions may handle emergency response, training, and maintenance; SOPs may be developed separately for each process area; safety audits may be conducted by corporate officials. In such a situation, it is essential that the involved divisions communicate with each other regularly so that the people incharge oftraining know when SOPs have been revised and that the
emergency responsepersonnel know when changes to processes may affect the hazards in a location. The purpose ofthe proposed management requirement isto have facility management define a system that integrates the implementation ofthe elements and assigns responsibility for that implementation.

Process Hazard Analysis

The AIChE's Guidelines forHazard EvaluationProcedures(AIChE, 1985) defines a hazard evaluation (alsoknown

as a process hazard analysis) as a procedure intended "to identify the

azards that exist, the consequences that may occur asa result ofthe hazards, the likelihood that events may take placethat would cause an accident with such a consequence, and the likelihood that safety systems, mitigating systems, and emergency alarms and evacuation plans would function properly and eliminate or reduce the consequences."

A process hazard analysis Involves the application of aformal technique, such as a "What If" ora hazards and operability study (HAZOP). (AIChE's Guidelines forHazard Evaluation Procedures provides descriptions of these techniques.) Formal techniques provide a method for a rigorous, stepby-step examination ofprocesses, process equipment and controls, and procedures to identify eachpoint at which amishap may occur (e.g., avalve failing, a gauge malfunctioning, human error) and examine the possible
consequences ofthat mishap, by itself and in combination with other possible mishaps. The result ofaproperly conducted process hazard analysis is a list ofpossible hazards ofthe process at the facility that could lead to a lossof containment and release ofa regulated substance. Process hazard analyses must be conducted by people trained in the techniques and knowledgeable about the process and facility being examined. Such evaluations usually require at least
two people, with other experts contributing to the process when
necessary; a HAZOP may require a core team offive to seven people. For a simple process, the process hazard analysis maytake a day or two; for complex processes, the evaluation may take six weeks to three months. Although each prevention program requirement is important, EPA considers the process hazard analysis the critical element in developing a risk management program. When EPA analyzed the data collected forthe Reviewof EmergencySystems, it was clear that a substantial number of respondents did not recognize the hazards associated with either the chemicals involved orthe processes used. For the most commonly used, high-volume chemicals, such as ammonia and chlorine, a large number offacilities were relatively unaware of the hazards involved. A process hazard analysis would help facilities identify hazards and ways to address them. For example, a 1989 explosion and fire at a facility in Baton Rouge, Louisiana, led
to a partial lossofpressure, power, and fire waterbecause the power, steam, and
water lines were co-located with the lines carrying flammable gases. The losses complicated and prolonged the
process ofresponding to the release, thereby increasing the damage caused by the release. Similar problems occurred at a facility in Norco, Louisiana, where an explosion led to the loss ofall utilities. A thorough and properly done process hazard analysis should identify these types ofpotential hazards and allow facilities to determine how to mitigate the problems. Process hazard analyses also identify situations where major accidents due to control failure (e.g., pressure gauges, overfill alarms) couldbe prevented by redundant or backup controls orby frequent maintenance and inspection practices.

Many other elements ofa risk management program should flow from,

or at leastbe revised based on,the results oftheprocess hazard analysis. Existing standard operating procedures, training and maintenance programs, and pre-startup reviews may need to be revised to reflect changes in either practices or equipment that derive from the process hazard analysis. The process hazard analysis may help define critical equipment that requires preventive maintenance, inspection, and testing
programs. It may also help a facility focus its emergency response programs

on the most likely and most serious release scenarios. For many facilities, the process hazard analysis may be
necessary to help define the worst-case release scenario that generates the worst offsite consequences. A secondary benefit ofthe process hazard analysis is that it also can be used to identify pollution prevention opportunities. The

same changes in procedures, equipment, controls, or chemicals that may lessen

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the likelihood ofan accidental release often increase the efficiency of operations and result in waste minimization. These changes may reduce costs forfacilities by improving the consistency and quality ofproducts and by decreasing the amount ofwaste that needs to be treated.

The proposed rule would require facilities to conduct process hazard analyses after determining a priority order forthe analyses based on the degree ofhazard posed bythe processes covered bythe rule; that is,the facility would have to conduct its analyses on the most hazardous processes first, where the degree ofhazard isrelated to potential offsite consequences, operating history ofthe process, and the age ofthe process. Facilities would be required to use one ormore ofsix techniques: What If, Checklist, What If/ Checklist, HAZOP, failure mode and effects analysis, orfault tree analysis. Facilities could also use an equivalent methodology provided the facility could demonstrate that the methodology is equivalent to the listed methods.

The complexity ofthe process hazard analysis procedure will depend on the complexity ofthe processes to which it is applied. Any ofthe listed techniques

can be used for simple and complex
processes although, for simple processes, the simpler procedures, such

as the What If, maybe more appropriate. Facilities such as wholesalers who load, unload, store, and sometimes repackage regulated substances would be able to

use a simple technique such as a checklist to ensure that the substances

are stored and handled properly and that fire suppression systems are appropriate for the substances at the facility. Application ofthe more complex procedures, such asthe HAZOP or fault tree, requires considerable technical expertise and
may be more appropriate forcomplex
processes, such asthose at petrochemical facilities. In some cases, facilities willwant to use several techniques; forexample, a facility might
start with aWhat If analysis to identify ' high hazard areas, then use a HAZOP or faulttree method to examine those areas in greater detail. EPA isplanning to develop guidance to help facilities select and use process hazard analysis techniques.

The process hazard analysis would require facilities to conduct a systematic examination ofthe process and procedures to identify ways inwhich equipment malfunction, human error, or external events could lead to an accidental release. The evaluation would also review the efficacy of prevention and control measures to prevent accidental releases. The team conducting the process hazard analysis would include at least one person knowledgeable in the technique and one knowledgeable in the process. EPA requests comments on whether the requirement for aperson knowledgeable in the technique should be waived for facilities using checklists and what if questions from a model RMP. The team would be required to submit findings and recommendations to the owner or operator, who then would have to document all actions taken inresponse to the findings and recommendations, including schedules for implementing changes. In response to the CAA's requirement that the prevention
program include monitoring, EPA is proposing thatthe owner oroperator. investigate and document a plan for (or

a rationale fornot) installing systems to detect, contain, or mitigate accidental releases ifsuch systems are not already inplace. Because accidental releases

can be limited ormitigated by the use ofdetection, secondary containment, and mitigation systems, facilities should consider whether the hazards they have identified could be addressed through such systems. The decision on'whether such systems are the bestway to address the hazard must,however, rest,in the first instance, with the facility's , management. In some cases,monitors and detectors do not exist; mitigation systems may not betechnically feasible forcertain types ofreleases. In other
cases, steps such asimproved procedures .andmaintenance may provide a more cost-effective approach
to controlling the hazards. The purpose ofthe requirement isto ensure that facilities consider the available options and find the best method forthe facility
to address accidental releases.

As required by the CAA, the process hazard analysis mustbe reviewed and updated periodically. EPA is proposing that the process hazard analysis be reviewed and updated at least every five
years, which is the sameinterval specified in the OSHA process safety management standard.

Process Safety Information

The process hazard analysis mustbe based on up-to-date chemical and process information, including information onphysical and chemical hazards, process technology (e.g.,
process chemistry, process parameters), and equipment (e.g., equipment specifications and design, piping and instrumentation drawings). As per OSHA, after the effective date ofthe rule, facilities would also have to document material and energy balances for new equipment in a process that involve a regulated substance abovethe threshold quantity to ensure that the equipment is appropriately designed for the process. The material balance is intended only forensuring the proper design basis forthe equipment and is
notuseful forprocess inventory accounting or measurement ofchemical loss. For example, itis necessary to knowthe flowrate inmassper unittime to properly design a heat exchanger;however, this flow rate does
not give the mass ofthe substance consumed or lost in areaction system. All required process safety information would apply only to affected equipment, notthe facility as awhole. Chemical information is available from Material SafetyData Sheets (MSDSs) mandated under OSHA's hazard communication standard (29 CFR 1910.1200). The level ofprocess technology and equipment information would vary with the type offacility. For warehouses, wholesalers, and service industries, little equipment information would be needed unless special equipmentis used with the regulated substances. Formanufacturers, more extensive information would be required, including flow charts, piping and instrumentation diagrams ofthe facility as it currently exists, and electrical, relief,ventilation, and safety system specifications.

Standard Operating Procedures (SOPs)

The results ofthe process hazard analysis, information developed during the design ofa process, and industry and facility experience combine to define theproper way to conduct operations and maintainequipment. SOPs describe the tasks tobe performed bythe operator, the operating parameters (e.g., temperature, pressure) that mustbe maintained, and safety precautions needed forboth operations and maintenance activities. SOPsmust specify the consequences ofdeviations from safe operating limits (e.g., ifthe safe operating temperatures are between 100 and 1500C,the SOPs should indicate what happens ifthe temperature is above orbelow those limits). Written SOPsprovide a guide to safe operations in a form that can be used by employees. Lack ofSOPs and inadequate SOPs have been implicated in anumber of catastrophic accidents. For example, improper maintenance procedures have beenblamed for a release and explosion at a facility in New Castle, Delaware, in 1980, which killed six people, injured 27 others, and caused more than $63 million in property damage to the facility.

SOPs, which define the proper steps to take in these emergency situations, 5419754198 

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provide a quick source ofinformation that can prevent or mitigate the effects ofaccidents. SOPs also provide workers and management a standard against which to assess performance; the procedures clarify forboth operators and supervisors howoperations should be carried outat the facility. Application ofSOPs can result in more cost-effective operations by ensuring that operators adhere to procedures that maximize boththe safety and efficiency ofa process.

EPA isproposing that each facility develop written SOPs for each process and operation involving the regulated substance above the threshold. The SOPswould include instructions on steps foreach operating phase (e.g., initial startup, normal operation, emergency shutdowns, normal shutdowns, emergency operations), operating limits, safety and health considerations, and safety systems. The facility would also be required to provide for control ofhazards during operations involving lockout/tagout, confined space entry, and opening process equipment or lines.The facility would also need SOPs to control
entrance to the facilityby support personnel

The level ofdetail included in the SOP should be appropriate forthe operation covered. For example, instructions forproper storage of chemicals maybe relatively brief,while procedures for routine startup ofa complex process mayrequire considerable detail to ensure that each action required is detailed and explained. EPAemphasizes that the SOPs should beusable by the operators inrunning theprocess; that is,the SOPs should be written in a language and at

a levelappropriate forthe operators. 

### Training

Training provides employees with the information neededto understand what they must do to operate safely and why safe operations are necessary. The required training program is the keyto ensuring the effectiveness ofother
program elements such as SOPs, maintenance programs, pre-startup reviews, and emergency response. Refresher training ensures that employees arereminded ofappropriate procedures periodically. Training programs often provide immediate benefits to facilities because trained employees have fewer accidents, damage less equipment through mishandling, and conduct more efficient operations. Inadequately trained maintenance workers have been implicated in the 1989 disaster in Pasadena, Texas, which killed 23 people, injured 130 others, and destroyed $750 million ofproperty at the facility. In 1988, ata plating facility inAuburn, Indiana, untrained workers used hydrochloric acid to clean a tank that had held zinc cyanide. The resulting hydrogen cyanide killed five workers and sent morethan ten others
tothe hospital.

The proposed rule would require each

owner or operator totrain employees in applicable and appropriate SOPs and provide refresher training at least once every three years. Employers would also be required to ensure that each employee is competent to operate the process safely. EPA is not proposing specific standards for the training requirements because the Agency believes that each facility should have the flexibility to develop a training
program thatreflects its individual situation. Facilities that handle but do
notprocess regulated substances (e.g., many facilities in thenonmanufacturing sector) mayprovide relatively brieftraining because the procedures tobe taught involve afew simple steps. For a complex manufacturing facility, training may take much longer for some operations. For some facilities, formalgroup training programs maybe feasible; for small facilities, one-on-one training may be more appropriate. The form ofthe training program is less important than thatrelevant training is delivered ina
manner most likely tobe understood. Facilities would be required to document their training programs to indicate when employees were trained. EPA is also not proposing specific

means ofensuring that the training is understood, such astesting, but would simply require that the owner or operator develop a system for ensuring competence anddocument that system. The proposed rule would require facilities to evaluate the effectiveness of the training and develop a schedule for reviewing and revising the training. EPA requests comments on this approach to training requirements.

Maintenance (Mechanical Integrity)

The Act specifies that the prevention program mustinclude requirements for equipment maintenance. Preventive maintenance, inspection, and testing of equipment arecritical to safe operations
at afacility. Waiting for equipment to fail oftenmeans waitinguntil an accidental release occurs before addressing a problem. This approach is
not acceptable, especially considering the extremely hazardous characteristics ofthe regulated substances. Preventive maintenance, inspection, andtesting are needed because many ofthe potential 

### failures are not obvious from visual inspections. For example, failed alarm systems or detectors may need to be tested to determine ifthey are functioningproperly; detectors and monitors, which can provide early warnings ofreleases, mustbe brated periodically; corrosion ofvessels and piping, ahazard with many chemicals,

can be detected through testing well before the vessels orpipes fail; scheduled cleaning, oiling, or replacement ofparts can prevent equipment failure. A large number of the accidents reported inthe Marsh and McLennan review ofthe 100 largest losses inthe petrochemical industry (Large Property Damage Losses in the Hydrocarbon-Chemical Industries, a Thirty-Year Review, 1990) were the result ofequipment failure that might have been avoided through preventive maintenance. A 1978 fir, and explosion
at aTexas City,Texas, facility that led
to almost $100 million in property damage was attributed to instrument failure and a faulty reliefvalve. A 1989 accident inRichmond, California, that injured workers and responders was caused by a failed weld.

Besides preventing accidental releases, maintenance programs also provide directbenefits to facilities by decreasing the amount ofcosly downtime that can result from failed equipment. Even in incidents where thereis serious property damage, the lostbusiness costs can be significantly greaterthan the property damage resulting directly from an accident.

EPA is proposing that facilities develop and implement a maintenance
program, with written maintenance procedures and training for maintenance workers, for equipment and controls whose failure could lead to

a significant accidental release. This equipment may include pressure vessels, storage tanks,piping systems, relief and venting systems, emergency shutdown systems, and controls such as monitors, alarms, sensors, and interlocks. Covered equipment should be inspected, tested, and subject to preventive maintenance. The intervals for suchmaintenance would depend on the equipment and how it isused. Manufacturers' recommendations may be used to set such schedules and determine testingprocedures, but the applicability ofthose recommendations should be reviewed in light ofindustry and facility experience and the results ofthe process hazard analysis. In some cases, facilities willneed to schedule

more frequent inspections based on their specific uses or experience with equipment failure rates, or because the
process hazard analysis indicated thatFederal Register / Vol. 58, No. 201 / Wednesday, October 20. 1993 / Proposed Rules 54199

failure ofa particular piece of equipment could resultin a catastrophic loss ofcontainment. Facilities would be required to replace or repair in atimely

manner any equipment thatis found to be outside acceptable limits. Facilities would also berequired to develop procedures to ensure that replacement equipment and parts meetdesign specifications. Owners and operators would be required to document their maintenance program, including the written procedures, the schedules used, and the results ofeach inspection and
testperformed. The level ofcomplexity and detail in the maintenance program would be directly related to the complexity ofthe operations and equipment. Pre-Startup Review Startup ofa new or modified system

can be aparticularly hazardous time for facilities, especially forcomplex
processes and those that require high temperatures, highpressures, or [Iotentially exothermic reactions. However, even simple facilities needto conduct such reviews. For example, before a chemical distributor accepts a
newregulated substance, the distributor should check that the fire suppression system is appropriate for the substance, that workers know how to handle and
store the substance, and that emergency response procedures are in place to handle an accidental release.

To help ensure safety during startup, EPA is proposing that all critical systems be checked prior to startup of

a new or substantially modified process. A new system would require aprocess hazard analysis prior to startup. A substantially modified process would include anyprocess where the changes
to the process are significant enough to require areevaluation ofthe hazards involved because new hazards may have been created as a result ofthe changes. This review would include a list of items that operators would need to check ortestbefore beginning an operation. Each pre-startup review should ensure that SOPs are in place and training has been conducted. Management ofChange

Chemical processes are integrated systems; changes in one part ofthe
process can have unintended effects in other parts ofthe system. For example, installation ofbetter seals may increase the pressure in vessels. It is, therefore, important that all changes in processes, chemicals, and procedures be reviewed prior to theirimplementation to identify
any potential hazards that maybe created by the modification. Although
most changes at facilities are intended to improve safety and efficiency, any modification can have unintended effects and requires a specific review of the safety implications ofthe change. Other process modifications are instituted in response to a specific problem that arises unexpectedly. It was such an unexamined change in the' installation ofa temporary bypass at Flixborough, England,that ed to the 1974 release and explosion that killed 28 employees, injured 89 people, and damaged almost 2,000 properties off site.

Therefore, EPA is proposing to require management ofchange procedures. These procedures are important for two

reasons: (1)They help facilities evaluate changes and prevent accidents caused by unintended effects from alterations of equipment, procedures, and chemicals; and (2) they ensurethat the process safety information and process hazard analyses are kept up-to-date. Under the proposed rule, the owner or operator of

a facility would be required to evaluate
every change in equipment (except changes that satisfy the design specifications ofthe device replaced), processes, chemicals, orprocedures to

ensure that the technical basis ofthe change is documented-and that the change does not create new hazards; if

newhazards are created orifthe change results in different procedures being needed, these hazards and changes would need to be addressed prior to implementation. Training, SOPs, and maintenance programs may need to be revised as a result ofchanges; the
process hazard analysis and hazard
assessment may need to be revised as well. Safety Audits

Animportant tool in ensuring that the
process safety management elements are beingimplemented is theperiodic safety audit.The safety audit provides management with a mechanism for oversight ofthe implementation ofthe safety elements and ofthe overall safety ofthe facility. Safety audits may take many different forms; some facilities use audits to check on compliance with specific regulations, some do spotchecks ofsafety practices, while others review all key aspects of safety management.

The proposed regulations would require facilities to conduct a complete safety audit once every three years to

ensure that the process safety management elements are in place, updated, andbeing implemented properly. Although compliance with the proposed elements will provide an indication ofsafe operations, other considerations are important as well. For example, itis not enough to develop and train employees on standard operatingprocedures; the facility must check to see that procedures arebeing followed. Therefore, a safety audit is

more than a review ofregulatory compliance; itis a check, by management, that the facility isbeing operated safely. Facilities would be required to document their audits in a report that includes findings and recommendations. Management's
response to the findings would also be documented. EPA chose the three-year interval to be consistent withthe OSHA requirement for safety audits. EPA notes that forlarge facilities and those with a numberof covered processes, the audit would notneed to-be performed at one time.The facility may choose to audit different processes on different schedules. The proposed rule would require only that over each three-year period, all covered processes are audited.

Accident Investigation

Accidents can provide valuable information abouthazards and the steps needed to prevent accidental releases. Many times,the immediate cause ofan accident is the result ofa series ofother problems that need to be addressed to preventrecurrences. For example, an operator's mistake may bethe result of
poortraining, inappropriate SOPs, or poordesign ofcontrol systems; equipment failure may result from improper maintenance, misuse of equipment (operating attoo high a temperature), or use ofincompatible materials. Without a thorough investigation, facilities may miss the opportunity to identify and solve the
root problems.

Therefore, EPA is proposing that facilities investigate each significant accidental release. As discussed above,

a significant accidental release is one that caused or hadthe potential to cause offsite death, injury, or serious adverse effects on human health and the environment. EPA notesthat significant accidental release does notinclude near misses. EPA agrees with AIChEthat "while itis important to investigate all incidents, asthe lessons learned in preventing future incidents are notat all related tothe magnitude ofthe

occurrence, it is unquestionable that, at the very least, 'major incidents' should be investigated" (Guidelines for Technical Management ofChemical Process Safety). EPA encourages facilities to investigate all accidental releases, but would require only that significant accidental releases be investigated. EPA defines significant accidental release as "any accidental54200 Federal Register / Vol. 58, No. 201 / Wednesday, October 20, 1993 / Proposed Rules

release ofa regulated substance that has caused or has the potential to cause offsite consequences such asdeath, injury, or adverse effects to human health orthe environment orto cause the public to shelter-in-place orbe evacuated to avoid such consequences." EPA requests comments on this approach to define the range of incidents requiring accident investigation. In particular, the Agency is interested in whether this definition

coverstoo broad or too narrow a setof incidents, and requests comments on any alternative definition that provides greater regulatory certainty.

The accident investigation would determine, to the extent possible, the initiating event that led to the release, and the root cause(s); EPA emphasizes that identification ofthe root causes (e.g., misdesigned pipingrun) may be

more important than identification of the initiating event (e.g., failed flange). The investigation would be summarizedin a report to management; the report would include recommendations for steps that needto betaken to prevent

recurrences (e.g., piping design review) and improve emergency response and mitigation measures. Management would be required to document its decisions on the recommendations. As with the management ofchange procedures, the degree ofthe accident investigation and documentation will
varywith the potential seriousness of the accident. For example, a minor release that was prevented from becoming a majorrelease only by prompt action ofoperators may require

more investigation than a large release that can be quickly attributed to single failure (e.g., a faulty high-level alarm).

EPA is also concerned about near misses. Investigation ofsuch incidents
may provide facilities with important information onproblems that shouldbe addressed before a significant accidental release occurs. Information onnear misses could help the Agency and facilities understand how accidents

occur and how they can be prevented. EPA does not consider a release that occurred, but did notaffect the public

orthe environment because offavorable weather conditions atthe time ofthe release, a near miss. EPA considers this incident a significant accidental release and,therefore, itneeds to be investigated. A near misswould refer to mishaps that did notresult in a release for some reason other than explicit system design. For example, a release from a pressure reliefvalve that is vented to a scrubberwould notbe a near missbecause the system is designed to

ensure that reliefvalve releases are contained and treated. A near miss is a mishap that did not result in arelease because ofemployee actions orluck. For example,-a runaway reaction that is brought under control by operators is a

near miss and shouldbe investigated to determine whythe problem occurred. EPA requests comments on whether facilities shouldbe required to investigate near misses and on how near miss shouldbe defined.
Emergency Response

CAA specifies thatthe emergency response program include actions to be taken to protect human health and the environment in response to a release, including informing the public and local agencies, emergency health care, and employee training. Emergency
response procedures are anecessary 9art ofarisk management program

ecause accidents do happen even with the best safety systems in place. Emergency response procedures can reduce the severity ofa release and protect employees, emergency responders, and the public from harmful
exposure to the regulated substances. As discussed above, the damage from accidents and risks to responders can be increased ifreleaseshave the potential
to damage or destroy-utilities and equipmentneeded to respond to the incident. The emergency response plan helps define these worstcases and develop an approach to prevent potential problems.

EPAis proposing that each facility develop an emergency response plan that defines the steps the facility and each employee should take during an accidental release ofa regulated substance. The plan would include both evacuation or protective action procedures for employees not directly involved inthe response to the release, and the actionstaken by employees responsible forresponding to and mitigating the release. All employees would be trained in applicable
emergency response procedures. The
emergency response plan would include descriptions of allresponse and mitigation systems.

The emergency response plan would also include procedures for notifying the public ofreleases and of appropriate protective actions and procedures for notifying public agencies.The facility would be required to develop information on proper first-aid and
emergency medical care necessary to treat accidental human exposure. EPA is also proposing that the facility
emergency response plan be coordinated with the local emergency planning committee (LEPC) plans required under EPCRA for chemical releases. Upon request ofthe LEPC, the facility would be required to provide the LEPC with information necessary to develop and implement the LEPCplan. This requirement is a restatement ofthe mandate ofEPCRA section 303(d)(3) and would be included in this rule to

ensure that the facility and community planning efforts are coordinated, which will improve both plans, thereby facilitating effective response actions when releases occur. Facilities would be required to develop written procedures forthe use ofemergency response equipment and for its maintenance, inspection, and testing. Facilities would be required to conduct drills or exercises to test facility plans and revise the plans based on the results; facilities would be responsible for determining the number and type of drills or exercises they need to conduct and the frequency ofthese tests.

Mostfacilities are already required to have at least part ofthe emergency response plan in place. OSHA requires
emergency action plans (29 CFR 1910.38(a)). Facilities that are subject to OSHA's and EPA's Hazardous Waste Operations and Emergency Response (HAZWOPER)rules (29 CFR 1910.120 and 40 CFR Part 311) also must conduct training fortheir facility response personnel. Facilities covered by EPA's RCRA regulations (40 CFRParts 264 and 265) orby Spillprevention Control and Countermeasure rules (40 CFRPart 112) also are required to have many of the
emergency response elements in place. EPA requests comments on how the proposed requirements can be best integrated with these existing programs to minimize duplication.

E.RMPandDocumentation

EPA is proposing that a risk management plan (RMP)be submitted
to the implementing agency, Chemical Safety and Hazard Investigation Board, the SERC, and to the LEPC, andbe made available to the public. EPA is proposing to make adistinction between the RMPthat is submitted to these agencies (andthrough them to the public) andthe documentation supporting the implementation ofthe risk management program elements that

a facility would be required to maintain

on site for inspection by EPA and other agencies.

The purpose ofthe RMP is two-fold: First,to provide government agencies and the public with sufficient information to understand the hazards
at the facility and the approach the facility Isusing tomanage the risks and, second, to have the facility develop an ongoing system for managing implementation of safetypractices and procedures. The information provided

### Federal Register / Vol. 58, No. 201 / Wednesday' October 20, 1993 / Proposed Rules

in the RMPwill assist government agencies in assessing the quality and 

### thoroughness ofa facility's risk management program. Because ofthe largenumber ofpotentially affected facilities, itis unlikely that EPA or the
state implementing agency will audit a substantial percentage ofthe facilities in
any one year. Consequently, itis important that government agencies have enough information inthe RMP to identify those facilities thatpose the greatest potentialhazards, either because ofthe quantity and kind of substances in use orbecause of prevention practices. The RMP information also will assist local
emergency planners. Under SARA Title I, local planners have received information on substances and quantities at facilities. The RMP will addto these databy providing information on hazards andpractices. Forexample, a large facilitywith a wellimplemented risk management system may pose less ofa hazard than smaller facilities, with smaller quantities of chemicals, that have weak programs. With this information, local planners will be better able to focus onfacilities that pose the greatest risk and target theirwork with facilities to improve prevention practices. The public willbe ableto Identify hazards and risk management procedures from the RMP without having important information obscured by detailed submissions.

The secondpurpose ofthe RMP is to assist facilities in integrating the risk management program elements. Each facilitywill approach the management ofits hazards in away that is appropriate for its specific situation.'For small facilities, one person maybe responsible for implementing and integrating the elements. In large corporations, many ofthe elements may be handled by different operating divisions. The RMP would include information on the management system the facility uses to integrate the elements and ensure responsibility for the program. EPA thinksthat thisis an essential step in successful implementation ofthe programbecause unless management Is accountable for safety andmakes it a priority, other employees may not consider safety important. Equally important, by reporting onhow it is addressing each ofits majorhazards, the facility would have to explain how ithas applied the various risk management program elements to prevent accidental releases.

The proposed rule would require facilities to submit an RMP that includes the following information:

* A copy ofthe registration form; * A summary ofthe offsite
consequence analyses including worstcase and other more likely release scenarios;

* The five-year history ofsignificant accidental releases foreach regulated substance;

* A list ofthe major hazards defined through the process hazard analysis, the
consequences offailure to control each majorhazard,the steps management is taking orplanning to take to address the hazards, and an implementation schedule foreach step listed;

e A summary ofany risk management program elements notcovered under the steps taken to address specific hazards (e.g., iftraining has notbeen revised to respond to any listed hazard, a summary ofthe training program would be neeued);

e A summary ofthe facility's
emergency response program, including dates and schedules fordrills completed andplanned, information on coordinatipn with the public, procedures fornotifying and alerting the public ofa release, and the name of
person responsible forcoordinating with public agencies;

*Adescription ofthemanagement system used to implement and integrate the elements ofthe hazard assessment, prevention program, and emergency response program; and

* A certification ofthe accuracy and completeness ofthe information.

EPA envisions the RMP tobe comprehensive and succinct. The offsite
consequence analysis information should be a summary ofthe documentation already developed during the hazard assessment. To keep the size ofthe RMP manageable, EPA requests comments onwhether itshould specify amaximum number ofrelease scenarios a facility may submit aspart ofits offsite consequence analyses. Complex facilities mayconduct a substantial number ofsuch scenarios; submission ofevery scenario analyzed could overwhelm theuser and makethe information less useful.

The accident histories can be presented as tables or lists. EPA is not proposing that facilities include every hazard identified through a process hazard analysis, butrather thatthe RWP include only those hazards that havethe potential to lead to significant accidental releases with offsite
consequences. For each item included in the RMP, the documentation required by the rule would serve as supporting information.

The information provided should be brief.For example, ifcorrosion in pipingis a hazard, the facility would list corrosion in piping followedby any steps taken to control corrosion andto

ensure that corroded pipes are replaced before a release occurs. These steps might include periodic ultrasonic testing, replacement ofpipes, or sometIng similar. Forfacilities where the stepstaken to address hazards apply
to several hazards, the hazards can be grouped under the steps. For example, ifrevised operating procedures and training were used to control and prevent anumber ofhazards, the facility could list operatingprocedures and training followedby the hazards to which they apply. In this way, duplicative entries can be minimized. The length ofthe list ofhazards would
vary with the complexity ofthe facility and with the current state ofprevention practices.

EPA isproposing anRMP that summarizes the program because the Agency believes that the information of
most use to the public and local agencies willbe related to the hazard
assessment and consequence analysis,

as well as general descriptions of hazards atthe facility. Other detailed information is likely to be oflittle interest and, ifsubmitted, could overwhelm the ability oflocal agencies
to manage and use the information. EPA also believes that the RMPs should not include information -thatfacilities can legitimately claim as confidential business information under CAA section 114(c). The RIMP should provide local and stateagencies and the public with sufficient information to determine ifadditional information is needed. The * information will beavailable, ifneeded,
to EPA or state officials conducting audits or compliance inspections. EPA requests comments on the RMP and particularly on the information communities, local authorities, and public interest groups will finduseful in assessing the hazards posed by facilities. EPAalso requests comments on the kinds ofinformation facilities consider confidential (and how facilities can report on hazards without revealing confidential data).

EPA is proposing thatthe RMP shall be submitted to the Chemical Safety and Hazard Investigation Board, tothe implementing agency, the state, andto local emergency planning committees. EPA asks forcomments onother local agencies thatmay want a copy ofthe RMP. EPA is concerned aboutthe burden such submissions mayplace on the entities receiving the RMPs. Ifeach RMP is submitted, the Board could receive more than 140,000 plans; some states could receive several thousand documents. At the local level, the number could vary froma few tomore than 50 plans. 5420154202 Federal Register / Vol. 58, No. 201 / Wednesday, October 20, 1993 / Proposed Rules

EPA isconsidering three options that mightlessen theburden. First,EPA could develop computer software that would provide facilities with standard formats forcompleting the information required inthe RMP. The RMP could then be submitted on diskin a format that would allow the government agency to locate information quickly. EPA recognizes that.while this approach might ease storage problems and related burdens forthe Board andthe states, many local entities are not equipped to receive documents ondisk. In addition,
many ofthe smaller facilities covered by the rule may not yet be computerized. Therefore, this approach would work for only part ofthe facilities and recipients. The second option would be to allow local authorities to designate the state as the receiving entity, thereby lessening theburden on the local authorities. The third approach would be to require that the RMPbe submitted only on request from the Board, state, or localentity. Facilities would be required to develop the RMP and keep a copy available on site, butwould submit it only if requested. EPA solicits comments on these approaches and specifically asks for suggestions on other waysEPA mightbe ableto facilitate the management and use ofthe RMP information by state and local agencies.

Section 112(r)(7)(B)(iii) requires EPA
to establish, byrule, a system for auditing RMPs and requiring revisions where necessary. EPA is proposing that facilities be selected for audits based on

a number ofcriteria. Specific accidents

at a facility orthe facility's five-year history of accidents would be one criterion used to select a facility for an audit; similarly, ifother facilities inthe

same industry show a pattern of accidents with regulated substances, a facility mightbe selected for an audit to

ensure that it is addressing the kinds of hazards causing releases at similar facilities. The quantities ofregulated substances or the presence ofspecific regulated substances would also be criteria. For example, facilities with high volumes ofone ormore regulated substance might be selected, orthe audits mightfocus on particular substances. The location ofthe facility would be a criterion for selection; facilities close to populated areas, or sensitive populations or ecosystems might be audited because ofthe potential hazard they pose. The hazards Identified inthe RMPwould be a criterion for selection. Finally,facilities mightbe randomly selected to provide neutral oversight. EPA requests
comments on the proposed criteria. EPA also requests comments on whether major facilities should be audited on a regular schedule (e.g., every three to five years).

The audit is designed to cover the adequacy ofthe RMP. If,based on the audit, the implementing agency decides that revisions to the RMP are needed, the agency would issue apreliminary determination explaining the basisfor the revision and atimetable. This preliminary determination shall include

an explanation for the basis forthe revisions, reflecting industry standards and guidelines (such as AIChE/CCPS guidelines and ASME and API standards) to the extent that such standards and guidelines are applicable, and shall include a timetable for their implementation. The owner or operator would have 90 daysto respond to the preliminary determination inwriting, either agreeingto implement the changes orrejecting the revisions, in whole or in part, with an explanation for any rejection. Inits response, the

owner or operator may develop substitute revisions addressing the same issues addressed inthe preliminary determination. After providing the

owner or operator an opportunity to .respond, the agency would issue a final determination, which may adopt or modify proposed revisions, or may adopt substitute revisions proposed by the facility. A final determination that rejects a substitute revision would explain the reason for the rejection. Thirty days after the final determination, the facility would be considered to be inviolation ofthe rule unless the RMP is revised. The public would be assured access to preliminary determinations, responses, and final determinations.

In addition to the RMP, the facility would be required to maintain onsite documentation ofits process hazard analysis, offsite consequence analysis,
process information (e.g., P&IDs, MSDSs), training and maintenance
programs, SOPs, pre-startup review list, management of-change procedures and records, compliance audits, accident investigation procedures and reports, and emergency response plans. This documentation would include schedules for starting and completing actions based on the recommendations ofthe process hazard analysis, safety audit, and accident investigation. These documentation requirements are similar
tothose imposed under OSHA's standard.

F.

Registration

Information Required

The Act requires that RMPs be registered with EPA prior to the effective date ofthe regulation. EPA is proposing that, within three years ofthe date ofpublication ofthe final rule, all facilities register with EPA ifthey have

a regulated substance in a quantity that exceedsthe threshold quantity. EPA is proposing a simpleregistration that would require most facilities to complete a one-page form; facilities with large numbers ofregulated substances may need an additional page to list the substances. The registration would ask for the name and address of the facility, the facility's Dun and Bradstreet number, the regulated substances on site, quantities ofthe substances (inranges), and the facility's Standard Industrial Classification (SIC) code(s) that apply to the use ofeach substance. If, at any time after the registration is submitted, the information becomes inaccurate, the facility would be required to file an amended registration within 60 days with the Administrator and the implementing agency. Re association ofSIC codes with specific substances would allowEPA to identify the types ofprocesses in which

a facility mayuse the substance without requiring the facility to provide detailed information during registration. The Dun and Bradstreet number is a

common identifier forfacilities and would allow EPA to cross-reference the data with other EPA databases. Most of the information requested is already reported under SARA Title I. The reporting ranges proposed are the same ranges used for SARA Title I reporting.

EPA is proposing a registration requirement for several reasons. First, the statute requires that RMPs be registered with EPA. Second, EPA is requiredto establish a system for auditing RMPs. To implement an auditing system, EPA and state agencies that implement the program need to know which facilities are covered by the rule as well as the chemicals they have

on site. Facilities may be selected for auditing based on location, quantities of chemicals on site, specific chemicals, or other criteria. A central source of information on which facilities are covered, forwhich chemicals, and in which industries is essential to apply criteria for selecting facilities for audits in an equitable manner. Finally, although many ofthe facilities file similar information with EPA, no current source of data includes all facilities likely tobe affected by the proposed rule.EPCRA section 313, for which a national database exists, covers only manufacturers and does not include many ofthe chemicals proposed forlisting. Some ofthe facilities will be permitted underRCRA, but most willFederal Register / Vol. 58, No. 201 / Wednesday, October 20, 1993 / Proposed Rules

notbe. Except for facilities not covered

- by OSHA's Hazard Communications Standard, most other facilities potentially affected by thisproposed rule are also covered byEPCRA section 312. However, EPA does notreceive section 312 data. Because these data are primarily used at the local level, only a few states have created section 312 databases. In addition, in many states facilities are notrequired to file chemical-specific information under section 312. Evenifevery state had a section 312 database, itwould notbe possible to identify facilities potentially covered by this proposed rule with the section 312 data. Consequently, a separate registration is needed.

EPA considered reuiring an earlier registration to help identify potentially affected facilities and disseminate guidance to them. Anearlier registration (either 12 months or 24 months after the date ofpromulgation) would also help
states determine the scope oftheir implementation programs. EPArequests comments on whether anearlier registration would be beneficial. Implementation

EPA has two main concerns about the implementation ofthe registration requirement that multiple or duplicative filings be avoided to the maximum extent possible andthatthe burden for processing the information be minimized. EPA requests suggestions

on how the registration information mightbe combined with other forms facilities arerequired to fileto limitthe repetitive reportingrequired of facilities. For example, EPA is consideringusing the EPCRA section 312 Tier IIform as a substitute because the Agencybelieves thiswould facilitate integration ofCAA activities with SARA TitleIII activities andwould lessen the burden on facilities.

EPA's second concern involves the burden onthe government to process the information filed. Each registration will include information that would need tobe screened foraccuracy. For example, the Chemical Abstract Service (CAS) number and chemical name would need tobe checked tomake sure that they match and arecovered by the rule. SICcodes, Dun andBradatreet numbers, and quantity range codes would need tobe reviewed to ensure that the format (numberof digits) and codes were acceptable (i.e., that valid codes were used). Such review could place a substantial burden on EPA and
states. EPA is,therefore, considering developing software that wouldallow electronic filin ofthe information. The software would perform the quality control function automatically. CAS 

### numbers would be checked to see if they were on thelist;the chemical name could then be entered automatically. A list ofknown synonyms for the listed substances could be included. SIC codes could be checked to ensure that the codes entered actually exist; the format forDun & Bradstreet numbers could also be reviewed. Messages alerting the facilitythat theinformation entered was not acceptable wouldbe provided. Such

a computerized form would lessen the time neededto process the information; itwould alsoprovide facilities with a quick check on the accuracy oftheir information andassure them that the data would be accurately represented in EPA's database. Iffacilities used,such a computerized filing, however,they would stillneed to submit a signed certification. EPArecognizes that some facilities may notbe computerized or may prefer tofile a printed form. Although EPA wouldprefer a computerized filing, printed forms wouldbe acceptable.

EPArequests comments onitsplan to encourage computerized filings and specifically solicits suggestions onhow such filings couldbe coordinated with other information filed on disk.For example, are there other software packages forcomputerized EPA filings that theRP registration shouldbe compatible withto facilitate data sharing and limit the amount of rekeying facilities would haveto do?

G.Prohibitions



### CAA section 112(r)(7)(E) statesthat after the effective date oftherisk management program regulations it shall be unlawful forany person to operate any stationary source subjectto theregulations inviolation ofthe requirements oftheregulation. Violations oftherisk management program and otherregulations promulgated under CAA section 112(r)(7)are subject tothe same penalties as violations ofNational Emissions Standards forHazardous Air Pollutants (NESHAPs)promulgated under CAA section 112(d). Persons in violation ofthe requirements maybe subject tocivil penalties ofnot more than $25,000 per dayperviolation as well as criminal penalties. Civil penalties maybe assessedthrough court actionsor through administrative orders under section 113 ofCAA.

H. Timing



### Theproposed rule mustbe promuated byNovember 15, 1993, and will be effectivethree years afterthe date ofpromulgation. EPAis setting a 120-day comment period andwill hold a public hearing in Washington, DC, to solicit comments.

IV.Comparison ofEPA'sProposed Rule
to OSHA's Standard

A. DifferencesBetween EPA'sProposed Rule andOSHA'sStandard

The primary differences between today's proposed rule and OSHA's
process safety management standard are the resultofthe different statutory requirements forthe two rules.The CAA requires EPA to include several elements in itsregulation that are not mandated forOSHA. Specifically, EPA's rule must include a hazard assessment,

an emergency response program with certain elements, registration, andthe submittal and auditing ofthe RMP. The only other elementEPA isproposing that is not included in the OSHA standard is the requirement for the

owner oroperator of a facility to define its management system andname the
person orposition responsible forthe
program. EPA considers the management requirement critical to ensuring that the risk management program elements are integrated with each other on an ongoing basis.EPA expects that thisrequirement willcreate

no additionalburden for facilities because theproposed section would only require facilities to provide the

name ornames ofpeople orpositions responsible forimplementing the

progrm.

EPA'sproposed hazard assessment

includes an offsite consequence analysis and a five-year accident history, as required by the CAA. Under the OSHA standard, facilities are required to develop an onsite consequence analysis. Most ofthe information needed to I define accidental release scenarios will be derived from the processhazard analysis, which would be the same underthe two rules. The main differences underthe EPA rule would be the need to use air dispersion models
to analyze the distances-releases might migrate and the need to documentthe

areas potentially affected by the releases. EPA's z assessment also isrequired to include a five-year release history, which would overlap to some degree with arequirement inthe OSHA's process hazard analysis.

EPA'sproposed emergency response provisions respond to the language in the CAA and are somewhat different from the OSHA requirement Under the OSHA standard, facilities mustcomply with one oftwo existing OSHA standards. Facilities that are currently in. compliance with OSHA's Hazardous Waste Operations andEmergency Response standard (29 CFR 1910.120) 5420354204 Federal Register / Vol. 58, No. 201 / Wednesday, October 20, 1993 / Proposed Rules

are likely to be in substantial compliance with EPA's proposed rule. OSHA's emergency action plan regulation (29 CFR 1910.38(a)) basically requires an evacuation plan. The CAA requires EPA's emergency response program to include "specific actions to betaken in response to an accidental release ofa regulated substance so asto protect human health and the environment" (CAA section 112(r)(7)(B)(ii)). Therefore, facilities that currently have only an emergency action plan required under29 CFR 1910.138(a) would, under EPA's proposed rule, need to develop amore extensive emergency response plan that details howthe facility would respond
to arelease to limit offsite
consequences. EPA is also proposing that facilities conduct drills and exercises to test their plans. Without such exercises, a facility will notbe certain that a plan can be implemented properly during an emergency. All facilities covered by the EPA rule would need to coordinate their plans with the LEPC, which is notrequired by the OSHA standard. EPA considers this coordination essential to protect the public. Many facilities are already coordinating their plans with the LEPC plans and with local emergency responders. Therefore, EPA does not anticipate that this requirement will add substantially to the burden for most facilities.

The final differences between the two rules are the proposed requirements for registration, submission, and auditing of the RMP. CAA section 112(r)(7)(B)(iii) mandates these requirements. The information in the RMP would be derived from the documentation required elsewhere under the EPA proposed rule or OSHA's standard. Consequently, EPA expects that the RMP will not add substantially to the burden ofcomplying with the rules. See Section Xofthis Preamble for a discussion ofthe incremental burden imposed by the EPA rule over the OSHA rule.

B.Section by Section Comparisonofthe EPA PreventionProgramandthe OSHA Standard

Except forthe management system requirement discussed above, the proposed EPA prevention program

covers the same elements as OSHA's
process safety management standard and generally uses identical language except where the statutory mandates of the two agencies dictate differences. EPA has added introductory paragraphs
to most sections to provide further information to the regulated community; these paragraphs impose no additional requirements and are intended to clarify the purpose ofthe section's requirements and the level of detail expected ofdifferent types of facilities. In addition, EPA has made editorial changes in the OSHA language
to make the rule consistent with the CAA's statutory language. Specifically, where OSHA uses the word "employer," EPA would use "owner or operator," which is defined in the CAA. Where OSHA uses "highly hazardous chemicals," EPA would use "regulated substance." Where OSHA uses "facility," EPA would use "stationary source." Where OSHA uses "standard," EPA would use "rule." Finally, where OSHA references workplace impacts, EPA would reference offsite
consequences, reflecting the different statutory mandates ofthe two agencies.

The specific parallel elements ofthe
two rules are asfollows:

9 EPA's pocess hazard analysis requirement (§68.24) is the same as OSHA's process hazard analysis requirements (29 CFR 1910.119(e)), with the following changes: (1)An introductory paragraph; (2)the priority order for conducting the analysis would consider offsite consequences rather than thenumber ofpotentially affected employees; (3)OSHA's schedule for implementation would notbe included because the CAA requires that facilities comply with EPA's rule within three
years ofthe date ofpromulgation and, therefore, OSHA's five-year schedule could not be used; (4)the identification ofprevious incidents would be limited
to those with offsite consequences rather than those with catastrophic
consequences in the workplace; and (5) the qualitative evaluation ofsafety and health impacts would focus on impacts

on public health and the environment rather than on employees. EPA expects that, in most cases, fewer incidents will need to be considered under EPA's proposed rule because releases are generally more likely to affect workers rather than the public. However, some types ofreleases, such asthe release at Bhopal, have their primary impact off site. EPA's rule would ensure thatthese potential releases are evaluated. Finally, in response to the statutory requirement that the prevention program include monitoring, EPA would add a paragraph (j)requiring facilities to evaluate monitors, detectors, containment or control devices, and mitigation systems.

* EPA's proposed process safety information 

### (§68.26) is identical to OSHA's process safety information system (29 CFR 1910.119(d)) except for editorial changes and the requirement, in paragraph (c)(5), that the evaluation ofthe consequences ofprocess deviations include those affecting public health and the environment rather than workers.

e EPA's standard operating procedures requirement (§68.28) is identical to OSHA's operating procedures (29 CFR 1910.119([)) except for the introductory paragraph and editorial changes.

* EPA's training section (§68.30) is identical to OSHA's training section (29 CFR 1910.119(g)), except for the introductory paragraph, editorial changes, and arequirement that facilities evaluate the effectiveness of their training programs and revise the
programs, ifnecessary, based on the evaluation,

* EPA's maintenance requirements §68.32) usesthe same language as OSHA's mechanical integrity paragraph (29CFR 1910.119(j)) with certain exceptions. EPA would use theterm "maintenance" rather than "mechanical integrity" to parallel its statutory language. EPA would add an introductory paragraph and make editorial changes. In paragraph 68.32(b), EPA would require the facility to develop a list ofequipment that requires maintenance; the OSHA standard provides a list ofequipment. EPA's paragraph (b) includes the OSHA list,

utEPA is concerned that for some facilities the list maybe too extensive and forothers itmay not be comprehensive. For example, for warehouses, the only equipment that
may need maintenance may be the sprinkler system and the forklifts, neither ofwhich are on the list. EPA believes the responsibility shouldbe on the facility to develop alist, based on specific facility concerns. EPA would also add an opening paragraph to the OSHA paragraph on inspections and testing and include the word "maintenance" before inspection and testing throughout the paragraph. The inclusion ofthe word "maintenance" would clarify that equipment shouldbe maintained on a regularbasis; for some equipment simpleroutine maintenance, such as cleaning and oiling, may be all that is necessary; other equipment, such

as seals, may be replaced on a regular schedule. EPA's revision would clarify that such maintenance is included in the inspection and testing requirement. EPA would also add language to clarify that training ofmaintenance workers would be documented inthe same

manner as other training.

* EPA's pre-startup review requirement (§68.34) is identical to OSHA's pre-startup review paragraph (29 CFR 1910.199(i)) except for editorial changes, the introductory paragraph, and the requirement in paragraph

### Federal Register / Vol. 58, No. 201 / Wednesday, October 20, 1993 / Proposed Rules

68.34(c)(4) that maintenance as well as operating employees are trained prior to startup and that all employees are trained on any new emergency response procedures. EPA believes these additions are necessary to ensure the safety ofthe facility.

e EPA's management ofchange requirements 

### (§68.36) are identical to OSHA's paragraph (29CFR 1910.119(1)), except forthe introductory paragraph, editorial changes, and a new paragraph (b)in which EPA defines alterations that do not constitute a change. Paragraph 68.36(b) is intended to clarify what constitutes a replacement in kind.EPA would also change paragraph (d)(2) to replace OSHA's "impact ofchange on health and safety" to "impact ofchange

on likelihood ofa significant accidental release."



### * EPA's safety auditrequirement §68.38) is identical to OSHA's compliance audit paragraph (29 

### CFR 1910.119(o)), except for the introductory paragraph and editorial changes.

* EPA's accident investigation 

### requirements (§68.40) areidentical to OSHA's incident investigation paragraph (29CFR 1910.119(m)), except for: (1) The introductory paragraph and editorial changes to substitute the phrase "significant accidental release" for the word "incident"; (2) the addition, in paragraph (b), ofa requirement that the procedures be written; (3) the requirement in paragraph (c) that incidents thatrequire investigation are those that caused or could have caused offsite consequences rather than catastrophic releases in the work place; and (4) the addition, in paragraph (f)(4), that the facility identify
rootcauses as well as initiating events.

The OSHA standard includes several requirements that are not covered by EPA's proposed rule-worker consultation, hotwork permits,
contractor rules, and trade secrets.EPA believes that worker consultation and hot work permits are worker protection issues and are, therefore, properly in OSHA's area of concern. EPA's trade
secret rules forthe CAA already are covered in 40 CFRpart 2.

Finally, although EPA recognizes the importance ofcontractor competence on safety, EPAbelieves this issue is primarily one that OSHA should address, as it has inits section on contractors. In addition, EPA believes that contractors are mainly an issue at larger companies, most ofwhich are covered by the OSHA standard. EPA requests comments on whether EPA should adopt OSHA's contractor paragraph as part of the risk management program requirements. As specified in CAA section 112(r)(7)(B)(i), EPA's rule would become effective three years after the date of promulgation. OSHA's rule will allow facilities up to five years to conduct
process hazard analyses. Because the OSHA standard was promulgated prior
to EPA's rule, however, EPA does not anticipate that the actual compliance dates for the two rules will differ significantly.

V. Relationship to Other Federal and StateRequirements

Federal Regulations
A number ofthe facilities potentially affected by today's proposed rule are also covered by other Federal , requirements that may relate to practices that will be included inthe risk management program. As discussed in the section on emergency response, several EPA programs require facilities
to develop emergency responseplans. These programs include the Resource Conservation and Recovery Act requirements and the Spill Prevention, Control,'and Countermeasure requirements under the Clean Water Act. In addition, loading and unloading ofhazardous materials for transportation are covered byDOT regulations, as are storage incident to transportation and repackaging for resale andtransportation. The DOT regulations are particularly likely to affect distributors and warehouses. EPA requests comments on how these requirements can be harmonized to eliminate conflicts and minimize duplication. Specifically, EPA requests comments on whether compliance with other Federal regulations will meet

some or allofthe requirements ofthe proposed rule and, ifso, how therule should acknowledge this fact to ensure that facilities understand what, ifany, additional steps they must taketo come into compliance with the risk management program requirements.

StateLaws

Four states--California, NewJersey, Delaware, and Nevada-have implemented state laws that require certain facilities to develop risk management programs. Although the existing state programs differ in some respects, they addressthe same basic elements that EPA is proposing in this rulemaking, except that the California
program does not specify a management ofchange procedure. The NewJersey Toxic Catastrophe Prevention Act (TCPA) program is the mostdetailed program, specifying to a considerable degree the information required tobe developed and submitted; New Jersey also requires that workers pass competency tests after training. The Delaware program provides facilities with more flexibility by specifying less detailed requirements. The California
program is the most general ofthe
programs; the California risk management plan program developed by each affected facility is driven by the results ofthe process hazard analysis, rather than responding to a set of specific mandated requirements.

The primary differences in the state programs relate to their implementation and the chemicals covered. New Jersey, Delaware, and Nevada have implemented their programs atthe state level. California has delegated implementation authority to more than 100 administering agencies, which are usually the fire orhealth departments. New Jersey, California, and Nevada require facilities to submit their plans to the administering agencies for review and approval. Delaware requires facilities to maintain the plan and documentation on site for state inspectors. California also allows the administering agencies to exempt facilities that meet the thresholds ifthe
agency determines that the facility does
not pose a significant risk to the community.

Each ofthe states has a different list ofchemicals and thresholds. New Jersey's list covers 109 acutely toxic substances; Delaware covers 90 toxic substances, aswell as flammables and explosives; California covers all 360 of the EPCRA section 302 list ofextremely hazardous substances; Nevada adopted OSHA's list ofhighly hazardous chemicals. California uses EPA's threshold planning quantities (TPQs) as thresholds for notification and allows local agencies to decide whether a facility must comply; New Jersey and Delaware developed separate and different methodologies for calculating thresholds; Nevada adopted OSHA's thresholds. None ofthe state lists is entirely consistent with EPA's proposed list.

EPA anticipates that facilities currently in compliance with the New Jersey, Delaware, and Nevada regulations will be in compliance with
most elements oftoday's proposed rule. Because the California rules are more general and because different administering agencies have interpreted the requirements differently, it is not

Sossible to determine, except on a casey-casebasis, to what extent a California facility will be in compliance with EPA's rule.

The Clean AirAct section 112(1) allows EPA to delegate the implementation ofthe risk management 5420554Z06 Federal Register 

### I Vol. 58, No. 201 / Wednesday, October 20, 1993 / Proposed Rules

program to states that have an approved
progm. The criteria forstate programs

are isted in CAA section 112(l)(5). The Act allows statesto adopt the Federal
program or implement a program that is

more stringent. Consequently, the existing state programs will require

some revisions to meetEPA's requirements or setmore stringent requirements than those established by the EPA rule. EPA expects that most of the needed changes will involve the listing ofchemicals and adjusting of thresholds. Other statesthat are developing state programs to implement these regulations should determine whether they have sufficient statutory authority under their air or emergency planning/community right-to-know SARA Title 

### M programs toadopt the requirements ofthese regulations. EPA will provide additional guidance for
statesbefore the final rule is promulgated.

VI. OtherApproaches Considered

The CAA requires facilities that have

a regulated substance in quantities greater than the threshold to develop and submli RMPs. EPA recognizes that, for small facilities, even the less complex risk management program that would be needed for simple processes could create asubstantial burden. EPA considered three approaches, therefore, that mightreduce this burden.Each of these approaches would create two tiers ofrisk management programs, a minimal program and an expanded risk management program. The approaches differ on how facilities would be divided between the two tiers.

The first approach considered would. be to develop criteria for determining when facilities needed an expanded risk management program. The criteria could be as simpleas a multiple of threshold quantity (e.g., an expanded riskmaiagement program would be required at 10 times the threshold quantity), or would combine the quantity on site with other factors such

as distance to the fenceline, proximity ofsensitive populations (e.g., hospitals, schools, residences), similartothe approach used inDelaware. EPA decided not to propose this approach for several reasons. Facility operators in Delaware and state officials report that this approach is difficult to implement because considerable technical expertise Is needed and many smaller facilities and non-manufacturers do not have the expertise in house. In addition, developing a set ofcriteria that would be appropriate in all situations may not be possible because too many factors influence the hazard posed by a particular process and substance. Using the simple multiple ofthe threshold quantity would ignore the dangers posed by relatively small quantities of regulated substances in specific circumstances.

The second approach considered would be to have facilities determine whether they needed an expanded risk management programbased on the offsite consequence analysis: Ifthe
worst-case release could not expose the public or the environment to significant risks, the facility would notneed an expanded riskmanagement program. Although this approach is a betterway to determine whether the potential risks ofa facility merit an expanded risk management program, it isfraught with problems. This approach would create consid3rable potential for debate and legal disputes over the assumptions facilities use to determine offsite
consequences. Assumptions appropriate for one facility or area may notbe appropriate for others. EPA believes that this approach would leave facilities uncertain ofthe legal status oftheir decisions and create difficulties for enforcement by governments and citizens. In addition, given the experience ofDelaware facilities, itis likely that many smaller facilities and those outside the manufacturing sector would have substantial difficulty understanding andimplementing this approach. EPA notes that most of the facilities potentially affected by the proposed rule arenon-manufacturers; lessthan five percent ofthe potentially affected facilities are chemical manufacturers orpetroleum refineries.

The final approach considered would be to follow the California model and let local or state agencies decide which facilities pose the greatest threatand, therefore, require an expandedrisk management program. EPA believes that local agencies are inthebest position to Identify and evaluate local hazards. However, the viability ofthisapproach
rests on the ability and willingness of
state or local groupsto make these decisions. This approach would impose

a considerable burden on state andlocal authorities. It could also lead to the

uneven imposition ofrequirements on facilities ifstates or localities chose to

cover facilities differently. Some facilities already coveredby risk management program rules believe that they have been placed ata substantial competitive disadvantage because they

are complying with the state law, while similarfacilities in other states arenot. An uneven implementation also leaves the protection ofthe public uneven.

EPA requests comments on these approaches and methods that could be used to create tiers inrisk management program requirements. EPA also requests comments on what a 'minimalprogram" would be, given the Congressional mandate thatrequires the riskmanagement program to include a hazard assessment, a prevention
program that includes safety procedures, maintenance, monitoring, andtraining, and an emergency response plan.

VII. Guidance

The CAA requires EPA topublish, when the final rule Is promugated, guidelines to assist facilities inthe preparation ofrisk management programs. The guidelines shall, tothe
extent possible, include modelRMPs. EPA is aware that formany facilities, especially those outside the chemical and petroleum refining industry and
many smaller facilities, therisk management program approach and

some ofthe elements will be unfamiliar. EPA intends, therefore, to provide as much guidance aspossible andto encourage trade associations, professional organizations, labor, and others to develop and disseminate appropriate guidance aswell. EPA requests comments on areaswhere _guidance is needed (e.g., processhazard

analyses, maintenance programs), the levels at which guidance should be directed, and appropriate formats forthe guidance.

EPA has Identified industry sectors that may be candidates formodel risk management programs. Generally, most ofthe covered facilities in these sectors

are using the same chemical inthe same way, with similar types ofequipment. The similarity will allow EPA to develop guidance on the chemical and
process hazards, identify typical hazards that need tobe considered in the processhazard analysis, suggest

areas that should be covered in SOPs and training, identify critical equipment for maintenance programs, and describe model emergency response procedures. The purpose ofthe guidance will notbe

to provide facilities with an "off-theshelf" plan,butratherto provide a framework thatthe facility can use to analyze its own operations and develop

a program to manage risks.

Industry sectors that maybe -appropriate for model riskmanagement programs include chlorine and ammonia users such as public drinking
water systems and wastewater treatment works, cold storage facilities, wholesalers, andpropane retailers. EPA requests suggestions for other industry
groups forwhich modal risk management programs maybe possible.Federal Register / Vol. 58, No. 201 / Wednesday, October 20, 1993 / Proposed Rules

VIII. Information Gathering Efforts

Before EPA began writing its proposed rule onrisk management programs, the Agency decided to seek information from those already implementing risk management program regulations. EPA staffmet extensively with officials inthe three states and held interviews with seven facilities that have developed risk management programs under state laws. To gather

more information, EPA held eight focus
groups, five with facilities (twoeach in New Jersey and California, one in Delaware), and three with administering
agency officials in California, to elicit their opinions ofthe risk management program regulations in theirrespective
states and their ideas about what EPA should consider as itdevelops its
program. After analyzing the results of these meetings, EPA and the National Governors' Association sponsored a two-day seminar on issues that have arisen atthe state level. Officials from California,Delaware, and New Jersey, as well asNew York,Minnesota, and Wisconsin attended the meetings. On the second day, other groups including trade associations, professional organizations, labor, and environmentalists joined the discussion.

Several industry participants believed that the risk management program process is improving safety, although the initial costs are high. Many considered the most costly element, the
process hazard analysis, the most important because it identifies hazards and allows facilities to setpriorities. Larger facilities, especially those in the chemical and petroleum industries, currently have more risk management program elements inplace than do smaller facilities. Larger facilities are also more able to implement the
program with their own staff; smaller facilities often lack the in-house expertise to develop and implement all riskmanagement program elements. Various industryparticipants recommended that the risk management program regulations give facilities the flexibility to tailor aprogram to their

own situations. According to these participants, the regulations should tell

a facility what to do, not how to do it. Many participants with various perspectives recommended that regulations be specific enough to limit inconsistent interpretation either across states oramong inspectors. Inconsistently applied regulations create competitive disadvantages and undermine the willingness offacilities
to comply. Many participants from various sectors expressed the view that guidance and technical assistance will be needed atthe state, local, and facility levels, and that education and outreach efforts willbe necessary. Several industrial and governmental participants said that to the extent possible, the OSHA, EPA, and state regulations and chemical lists should be consistent. The same participants believed that facilities would like to

ensure that ifthey are in conxpliance with one rule, they would automatically be in compliance with allrules, at least fora specific chemical. There was a general concern that the expertise to implement the program may notbe uniformly available in the short-term. This lack ofexpertise will affect both facilities and government a~encies.

A report on this information gathering effort entitled CleanAirAct of 1990, ChemicalAccidentReleaseProvisions, ReportonFocusGroupsandRound TableDiscussions is available in the docket as are transcripts ofthe eight focus groups.
IX. Section by Section Discussion ofthe Proposed Rule

EPA is proposing to add a newpart 68 to 40 CFR, which would include the riskmanagement program requirements,

aswell as the list ofregulated substances and related regulations, and
any additional chemical accident prevention regulations that EPA may promulgate in the future. This section reviews the regulations that would be added in thisrulemaking.

Proposed §68.1 would define the
scope ofthe part.

Proposed §68.3 would provide definitions applicable tothe Part.

Proposed §68.10 would define the applicability ofthe risk management plan requirements to all stationary

sources where a regulated substance is present in a process atany one time in

morethan the threshold quantity. The section also includes the effective dates forthe risk management program elements. Facilities would be required
to develop and implement all risk management program elements within three years ofthe date ofpromulgation ofthe rule orwithin threeyears of becoming subject to the rule (i.e., three
years after the facility introduces a new regulated substance to its operations or

a new substance is listed).

Proposed §68.12 would define the requirements forregistration. Facilities would be required to register three years after the date ofpromulgation ofthe rule

or within three years ofdate on which the facility becomes subject to the rule (eitherbecause the facility introduces a

new regulated substance to its operations ora new substance is listed). Ifthe information submitted on a registration form is no longer accurate, facilities would be required to update the information within 60 days ofthe change.

Proposed §68.15 would provide the requirements for the hazard assessment. Facilities would be required to complete

ahazard assessment foreach regulated substance present in greater than a threshold quantity. For each such substance, a worst-case release scenario would have to be defined. The offsite
consequences ofa range ofrelease scenarios, including the worst-case and other more likely significant accidental release scenarios, would have to be analyzed. The proposed section specifies a number ofscenarios that should be considered and the information that mustbe included in the offsite consequence analyses. The section also would require the facility to develop and maintain a five-year history ofsignificant accidental releases and releases with the potental for offsite
consequences foreach regulated substance. The hazard assessment would have to be reviewed and updated
every five years, unless changes necessitated an update sooner. The section would detail the documentation that would be required to be maintained

on site.

Proposed §68.20 would explain the
purpose ofthe prevention program and specify that the ten elements of the
program mustbe tailored to suit the degree ofhazard present at a facility and the degree of complexity ofthe operations.

Proposed § 68.22 would require facilities to designate a person or position responsible for overseeing the development and implementation ofthe prevention program elements. Where other individuals are responsible for separate elements, an organization chart showing lines ofauthority would be required.

Proposed § 68.24 would detail the requirements for the process hazard analysis. A process hazard analysis would be required for each location where regulated substances are present above the threshold quantity. Formal
process hazard analysis techniques would have tobe applied, with the complexity ofthe process and potential
consequences ofa release to be considered in selecting an appropriate technique. The section would require facilities to conduct evaluations on the
most hazardous locations first.

The process hazard analysis team wouldbe required to report findings and recommendations to management. The facility management would be required to document its response to each finding and recommendation, and 5420754208 Federal Register / Vol. 58, No. 201 / Wednesday, October 20, 1993 / Proposed Rules

maintain a schedule for implementing actions to address findings. Ifthe facility management decides not to implement certain recommendations, a rationale for the decision would have to be documented.

Based on the process hazard analysis results, the facility would be required to evaluate and develop a plan for (ora rationale for not) installing detection and alarm systems, secondary containment and control systems, and mitigation systems. The process hazard analysis would have to be reviewed and updated every five years unless changes ofchemical use,process technology, or equipment require anearlier review and revision.

Proposed §68.26 would require the facility to develop and maintain up-todate chemical, technology, and equipment information. Technology information would include process flow diagrams aAd process chemistry information, maximum intended inventories forvessels, process parameters, and consequences of deviations from parameters. Equipment information would include materials of construction, electrical classifications, material and energy balances, design bases and codes, safety equipment designs, and diagrams ofpiping, equipment, and controls. The owner or operator would have to document that equipment complies with good enineering practices.

Proposed § 68.28 would require facilities to develop and maintain written procedures for operations.

Proposed §68.30 would require facilities to develop and implement training programs to ensure that all employees are trained in SOPsthat apply to them. Refresher training would berequired at least every three years. The facility would have to develop a method ofensuring that each employee is competent. In addition, facilities would berequired to evaluate the effectiveness oftheir training. Based on this evaluation, the facility would be required to develop and maintain a schedule for revising the training
program. All training conducted at the facility would be documented. In lieu of Initial training, the facility could certify thatcurrent employees have the knowledge and skillsto carry out the SOPs.

Proposed §68.32 would require facilities to develop a list ofequipment and controls whose failure could lead to

a significant accidental release of a regulated substance. Foritems on the list, amaintenance program that included a schedule for inspections, testing, and maintenance would be required. IL~pection and testing rocedures and schedules would be ed on manufacturers' recommendations unless industry or facility experience indicated that more frequent inspections and tests, or different procedures were needed. Written maintenance procedures and training ofmaintenance workers would also be required. Equipment found to be outside acceptable limits would have to be replaced orrepaired prior to being used again or in a timely manner that

ensures safety. Procedures to ensure that replacement equipment is installed properly and consistent with design specifications wouldbe required. Records ofeach inspection, test, repair, and replacement would be required.

Proposed §68.34 would require facilities to develop procedures to

ensure that apre-startup review is conducted before a new ormodified
process is brought online. This section would notapply to routine startups after shutdowns for maintenance provided standard procedures are developed for such startups. The pre-startup review would confirm that all installations and -changes meet design specifications, that SOPs and maintenance programs are in place for the new processes, and that employees have been trained. Records ofeach startup, including actions taken
to address any problems uncovered during the review, would be maintained
at the facility under §68.55.

Proposed §68.36 would require facilities to develop management of change procedures to ensure that any alteration ofchemicals, processes, and procedures are reviewedprior to implementation. Replacement of equipment orcontrols with a device that
meets the design specifications ofthe replaced device would not be considered achange. The procedures would ensure that the technical basis of the change is documented and thatthe
consequences ofthe change are evaluated. Process safety information and the process hazard analysis would be updated asneeded, as would SOPs, training, and maintenance programs. The results ofeach such review would be maintained at the facility under §68.55.

Proposed §68.38 would require facilities to conduct safety audits every three years. Each audit would be documented in areport with findings and recommendations. Management's
response to each finding and recommendation would be documented, with a schedule forimplementation or

a rationale fornot implementin$.

Proposed §68.40 would require facilities to develop andimplement procedures to investigate each significant accidental release. Investigations would haveto start within 48 hours ofthe accident. The investigation would document, in a report to management, the initiating event, rootcauses, and recommendations forpreventing

recurrences. Management wouldbe required to document its response to each recommendation, with either a schedule for implementation or a rationale fornot implementing the recommendation. The results ofthe investigation would have to be reviewed with allpotentially affected employees.

Proposed §68.45 would require facilities to develop a written emergency responseplan that would specify procedures for employees not involved in a response action, procedures for responders, a list ofall response and mitigation technologies. The plan would also include procedures for notifying and alerting the public and public
response agencies. The facility wouldbe required to have procedures forthe use, inspection, testing, and maintenance of
response equipment. The facility would also develop information on first aid and emergency health care related to potential exposures. Employees would be trained in applicable response procedures. Facilities would be required
to conduct drills or exercises to testthe plan. Any drillor exercise would be documented, with findings relevant to plan revisions; management wouldbe required to document responses to the findings, with schedules for implementation. The emergency response plan would be coordinated with the local emergency planning committee's community plan prepared under SARA Title 

### m.

Proposed §68.50 would require submission ofthe RMP containing a copy ofthe facility's registration form, hazard assessments foreach regulated substance (i.e., worst-case scenario, offsite consequences for arange ofmore likely significant accidental release scenarios, and five-year history of significant accidental releases), a list of major hazards identified through the
process hazard analysis, the
consequences offailure to control each major hazard, steps being taken to address the hazards, implementation schedules, a summary ofother prevention elements, a description of the emergency response plan, a description ofthe management system forimplementing and integrating the risk management program, and a certification ofaccuracy and completeness. The RMP would be revised and resubmitted every five years unless changes dictate a more frequent revision.Federal Register 

### I Vol. 58, No. 201 / Wednesday, October 20, 1993 /-Proposed Rules

Proposed §68.55 would specify which records would need tobe maintained and that records would be maintained for five years. Facilities would also be required to maintain implementation schedules for recommendations from the process. hazard analysis, safety audit, and accident investigation.

Proposed § 68.60 would specify the audit system for reviewing RMPs.

X. Regulatory Costs andBenefits

Agencies proposing and promulgating regulations must consider both the costs and benefits ofthoserules on the affected community. This section summarizes the analyses conducted in support of this proposed rule and the list and threshold rule.The full regulatory impact analysis (RIA), entitled "Regulatory Impact Analysis in Support ofListing Regated Substances and Thresholds and Mandating Risk Management Programs for Chemical Accident Release Prevention, as Required by Section 112(r) ofthe Clean Air Act." is available in the docket.

As mentioned above, the cost information inthis section is based on

an analysis ofthis proposed rule andthe list and threshold rule. Since the RIA

was completed, the Agency has collected new cost information from

comments to the proposed list and threshold rule and has conducted additional analyses. The revised cost information is contained in an addendum to the RIA, which is available in the docket. The Agency recognizes thatthe costs/benefits and the universe ofaffected facilities are difficult to estimate accurately and requests comments and input on the RIA and the addendum. Specifically, EPA requests comments on the unit-cost estimates for theprevention program elements and rate ofcurrent compliance with these elements.
OptionsConsidered

To evaluate alternatives, EPA analyzed five list and threshold options and two risk management program options. Thefive list options were: List 1-101 acute toxics at the proposed thresholds; List 2-EPA's proposed list (100 toxics, 62 flammables, and high explosives) at the proposed thresholds; List 3-EPA's proposed list atthe EPCRA section 302 threshold planning quantities (TPQs) where applicable; List 4-the full EPCRA section 302 list atthe TPQs; and List 5--the full EPCRA' section 302 list ofextremely hazardous substances atthe threshold planning quantities, plus 62 flammables and high explosives. The options were selected to bound thedifferent combinations of chemicals and threshold quantities that

were under consideration by EPA during development ofthe proposed list regulation. The OSHA list was not included as a listing option because it includes some substances that EPA is statutorily prohibited from listing,it does notinclude many acutelytoxic chemicals that meetEPA's criteriafor listing, nor does itinclude all statutorily mandated regulated substances. In addition, many ofthe substances listed by OSHA are reactives, which EPA has
not determined pose a significant hazard to thepublic in the event ofan accidental release.

The RIA also considered two options for risk management program requirements: EPA's proposed rule; and

amore stringent version ofthe proposed rule, modeled on the NewJersey state regulations, which are more detailed and impose more specific requirements for many ofthe riskmanagement program elements. The OSHA standard

was not consideredbecause it does not fully meetthe statutory mandate for EPA's risk management regulation.
Methodology
To estimate the universe of potentially affected facilities under each ist and threshold option, EPA used 1988 data from the New Jersey Right-toKnow database. Under the New Jersey Right-to-Know statute (New Jersey Pub. L. 1983, Chapter 315), facilities are required to complete surveysof chemical inventories iftheyhave any amount ofthe listed substances on site. Facilities are required to report the maximum quantity on site for each covered substance and the CAS number for the substance; all ofthe toxic substances EPA considered for listing

are on the New Jersey list Facilities also

are required to report applicable fourdigit SIC codes and the number of facility employees. Although there are limitations and cautions that must be exercised when extrapolating state data
to estimate national impacts, EPA believes that the NewJersey data provide comprehensive coverage ofSIC codes, including the majority offourdigit SIC codes across both the manufacturing and non-manufacturing sectors, and are reasonablyrepresentative ofchemical use patterns throughout the nation. In addition, New Jersey facilities are required to report on inventories ofall acutely toxic chemicals covered by EPA's listing options. Further, the information inthe New Jersey database on number of employees allows disaggregation ofthe data by facility size.There are,however, limitations to theNew Jersey data; to the
extent possible, EPA augmented the NewJersey data to adjust for these limitations.For example, because facilities in New Jersey arenotrequired
to report on flammables, data from Louisiana'sEPCRA section 312 database

were used to develop estimates ofthe number ofadditional facilities that would becovered because ofthe listed flammables. Similarly, certain industrial
sectors were clearly underrepresented in the New Jersey data; adjustments were made wherever possible tocorrect for these limitations.

The New Jersey database was searched by four-digit SIC code to identify for each such code thenumber offacilities thatreported a listed toxic chemical above the threshold. The number ofreports ofregulated substances per four-digit SIC code was also obtained from the New Jersey data. The information obtained fromthese searches was compared with the number offacilities in each four-digit SIC codein New Jersey (based on 1988 County BusinessPattern data). The ratio ofthe number offacilities reporting the
presence ofthe chemicals above the proposed thresholds to the number of facilities in the SIC code in the state was extrapolated to the nation to estimate the number offacilities in each SIC code potentially affectedby the proposed rule. The ratio ofthe number of regulated substances reported per facility in New Jersey in each four-digit SIC code was used to estimate the number ofhazard assessments that would likely be required under each listing option. The Louisiana data were used to identify those four-digit SIC codes where the addition of flammables would result in additional facilities and additional chemicals per facility covered by EPA's regulatory options.

Three industry sectors were substantially underrepresented inthe
state databases: public facilities, cold storage facilities, and propane retailers. To adjust forthis underrepresentation of public facilities, the analysis used EPA data on public drinking water systems and publicly owned treatment works to estimate the number ofpublic facilities potentially affected by the proposed rule. Industry information was used to estimate the number ofcold storage facilities (i.e., food processors, food distributors, and refrigerated warehouses) and the number ofpropane retailers.

In Delaware andNew Jersey, 30 percent and 52 percent ofthe facilities (respectively)that initiallyregistered under the state laws lowered inventories

or switched chemicals to avoidhaving
to comply with the riskmanagement program requirements, Based on this experience, EPA assumed that 30 5420954210 Federal Register / Vol. 58, No. 201 / Wednesday, October 20, 1993 / Proposed Rules

percent ofthe facilities in most manufacturing, utility, and service industries would take similar steps to avoid being affected by EPA's proposed rule. The final estimates ofthe number ofaffected facilities in these sectors

were adjusted to account for this expected change in chemical use. The number ofchemical manufacturers, wholesalers, and propane distributors

was not adjusted downward; facilities in these sectors were assumed tobe unable
to reduce inventories sufficiently to avoid coverage because ofthe nature of their businesses.

To develop cost estimates, affected manufacturing facilities (SIC codes 20- 39) were classified as small, medium, and large, based on the number of employees. For each SIC code, manufacturing facilities were also categorized as likely to have simple, moderately complex, and complex
processes, based on categories developed by OSHA for its process safety management standard. Facilities outside the manufacturing sector were divided into six categories: public drinking water and treatment works; private utilities (SIC code 49--electric and gas utilities); cold storage facilities that use ammonia as arefrigerant (SIC codes 20, 4222, 514); wholesalers (SIC codes 50-51); retailers, which are primarily propane distributors; and others (primarily service industries (SIC codes 70-89)). Non-manufacturers were assumed to handle theregulated substances in simple ways and to have available EPA model riskmanagement programs orguidance, described in Section VII ofthis preamble, that would lessen the burden ofcompliance. Wholesalers and cold storage facilities

were divided into small andlarge facilities based on the quantity of chemicals on site because the complexity ofimplementing the rule is assumed more likely to be related to the quantity ofthe chemicals on site rather than the number ofemployees at a facility. For example, some chemical distributors have more than 100 million pounds ofa substance on site, but employ fewer than 20people, only some ofwhom handle the substance. Public and private utilities were assumed to be smali because alimited number of employees are assumed to handle regulated substances.

Using industry experience and engineering expertise, cost estimates

were developed for each risk management program element for each class and category offacility. Costs were developed on a per chemical, per process, perrelease, or per facility basis for each element ofthe program, as appropriate. Because many facilities already implement some ofthe risk management program requirements (e.g., training, emergency response plans), costs were adjusted to account forcurrent compliance, based on compliance estimates foreach risk management program element developed by EPA, OSHA, an American Paper Institute study ofthe actual level ofcurrent compliance among its members, and experts inthe cold storage industry.

For final costcalculations, facilities

were divided into two further groups: those covered only by the EPA rule, who would be subject to the full cost of complying with all elements ofthe proposed rule, and those covered by EPA and OSHA, who would incur costs only to implement the additional elements covered inEPA's proposed regulation (i.e.,registration, hazard assessments, and the RMP). Different
cost estimates were developed for publicly owned drinking water systems and wastewater treatment systems, depending on the states where the systems are located. For systems in
states with delegated OSHA health and safety programs (i.e., state-plan states), only incremental costs associated with performing the hazard assessment and developing the RMP were attributed to the EPA proposed rule; these systems must already comply with state standards at least as stringent as the Federal OSHA standards. For systems not in state-plan states, the full cost of the proposed rule was assumed to be incurred. Table I presents the estimated numberoffacilities covered by each list option.

TABLE 1.-ESTIMATED NUMBER OF FACILITIES AFFECTED BY EPA'S LIST AND THRESHOLD OPTIONS

Manufacturers Manufacturers Non-manufac- Non-manufacOptions not otherwise previously regu- turers not other- turers pre- Total regulated latedi wise regulated lated

List I

......................................................................... 3,975 18,960 28,650 64,060 115,645 List 2

......................................................................... 3,975 18,960 48,650 68,840 140,425 List 3

......................................................................... 13,640 19,940 54,560 68,840 156,980 List 4

......................................................................... 19,530 20,470 37,830 64,060 141,890 List5

......................................................................... 19,530 20,470 57,830 68,840 166,670

1"Previously regulated" refers to facilities subject to the OSHA standard or to a state standard at least as stringent as the Federal OSHA standard.

EPA estimates that approximately 140,425 facilities would be affected by EPA's proposed rule. Of thisuniverse, 87,800 would also be covered by the OSHA rule or an equivalent state standard; the costs estimated for these facilities reflect only the costs for registering and developing the hazard
assessment and RMP. The remaining 52,625 facilities will only be covered by EPA's proposed rule; the estimated costs reflect the costs ofimplementing allrisk management program requirements. The total universe of covered facilities includes 22,935 manufacturers (coveringall manufacturing sectors except tobacco); 3,360 private utilities (electric and gas utilities, drinking water systems, and treatment works); 33,250 public drinking water and treatment works; 50,000 cold storage facilities; 9,460 wholesalers; 20,000 propane retailers, and 1,240 service industry facilities.

EPA estimates that the costs per facility will vary, for facilities covered solely by the EPA rule, from approximately $1,700 for a facility in the service industry sector, to approximately $153,000 for a large complex manufacturing facility. EPA didnot estimate the cost ofcompliance for a highly complex facility such as a petroleum refinery because all ofthese facilities are covered by the OSHA standard. The most costly items in the prevention program for manufacturers include the process hazard analysis, which varies from $6,600 perprocess for a simple facility to $35,000 per evaluation fora complex facility; training costs,which vary from $2,400 for a small simple facility to $61,000 for

a large (150-employee) complex facility;
process and equipment information, which may cost a large facility $36,000Federal Register I Vol. 58, No. 201 1 Wednesday, October 20, 1993 / Proposed Rules

perprocess; and SOPs which vary from Benefits $2,500 for a simple processto $14,000 The proposed riskmanagement rule is for acomplex process. Costs fornonmanufacturers are estimated to be expctd to generate benefits to the considerably lower both because their regulated community and to society at operations frequently do notinvolve large. EPA has estimated a dollar value special equipment andbecause model formany ofthese benefits; the
RlJPs and guidance are assumed to be methodology used to generate these
available tothem, thus lessening the estimates is presented in chapter 7of
burden. The cost ofconducting the the RIA. hazard assessment is estimated to vary The benefits ofthe proposed risk from $70 perassessment fornon- managementrule were estimated using manufacturers to $280 per assessment several quantitative techniques to for large complex manufacturers; the investigate each ofthe different types of number ofassessmentslikelytobe benefits expected to occur. First,the required isestimated to vary from one proposedrisk management rule is (for acold storage facility with only expected to reduce the number of ammonia on site)to 10 fora significanthazardous chemical releases petrochemical facility. The cost of occurring eachyear atfacilities affected developing the RMPis estimated to bythe five list options. This reduction
range from $156 to more than $1,000 for inthenumber ofreleases was estimated

ahighly complex facility. Registration using Accidental Release Information
costs are estimated to varybetween $43 Program (ARIP) data forthe four-year and $105, depending on the number of period 1987-1990. The trend in the substances on site.Table 2 presents the number ofhazardous chemical releases
average cost per facility for inNew Jersey, where many ofthe manufacturers andnon-manufacturers. riskmanagement program elements are EPAestimates that theinitial cost ofthe required tobe inplace already, was proposed rulewould be $503 million, compared with thetrend in the number

EPA estimated subsequent year total ofreleases inthe rest ofthe nation. The costs for a period oftenyears. Costs difference between the two, trends, vary from yearto yearbecause certain approximately 27 percent atthe end of risk management program elements are the four-year period, provided an not required tobe updated yearly.For estimate ofthe magnitude ofthe example, safety audits wouldbe reduction inthe number ofhazardous conducted every three years;hazard chemical releases that could be assessments andprocess hazard expected to occur as a result ofEPA's analyses wouldbe updated every five proposedrisk management rule. years.Table 3 presents the estimated The proposed rule is also expected to costs for yearsone through five forthe reduce the number ofincidents of five listingoptions. environmental damage (e.g., soil contamination, vegetation damage, and property damage), human impacts (e.g., injuries, hospitalizations, and deaths), and response actions (e.g., evacuations and sheltering in place) occurring each
year asa result ofreleases ofhazardous chemicals. These reductions were estimated by using a regression analysis with ARIP data topredict the probability that each type of environmental damage, human impact,

or response action would occur as a result ofa hazardous chemical release. both withandwithoutthe proposed risk management program in effect. The estimated probability that each typeof incident would occur was then multiplied by the estimated number of releases under each scenario (i.e., with and without the riskmanagement program in effect) to derive anestimate ofthenumber ofincidents causing environmental damage, human impact,

orresponse actions that would be avoided each year atfacilities affected by the proposed risk management rule. The analysis indicated that the number ofincidents would decline by 35 percent or more. depending on the type ofincident andthe ListOption selected, following implementation ofthe proposed riskmanagement program. For human impacts and response actions, the estimatednumber ofincidents was multiplied bythe average number of people injured, hospitalized, evacuated,

or sheltered inplace to derive an estimate ofthe number ofpeople affected per yearby incidents ofeach type.

TABLE 2.-ESTIMATED AVERAGE COST PER FACILITY MANUFACTURERS

Small-sized facilities Medium-sized-faclllftes Large-sized faci lites I

# I IHighly

Simple Moderate Simple Moderate Simple Moderate Complex oomplex

Not Othervise Regulated

.............................. $15,430 $27,760 $33,430 $81.920 $53,760 $93,750 $153,470 Prevbouly Re lae

....................... ............. 760 1,070, 910 1,680, 1,500 1,960 3,280' $5,720

NON-MANUFACTURERS

Public fa- Private Cold storage facilities Whole- Service

cilities utiltes sa L salem industries Retailers

Not Otherwlee Regulated

................................................ $8,200 $8,250" $9,400

................ $2,220 $1,860 $1,670 Previously Regulated

....... 530 580

................ $510 650 560

................

TABLE 3.-SUBSEQUENT-YEAR COSTS BY LIST OPTION FOR PROGRAM OPTION 1

- J$millions]

Year ULst Listt 

### I List 

### I Lst option I option 2 r 3 1 option 4 option 5 

### 0

...................................................................... ........ 1I................................................

....... . .... 2.................................................................................. $460 $503 58J $1.0041 791 92 14 159 84 98 152 '1 167| $1.046 171 181 5421154212 Federal Register / Vol. 58, No. 201 / Wednesday, October 20, 1993 / Proposed Rules

TABLE 3.-SUBSEQUENT-YEAR COSTS BY LIST OPTION FOR PROGRAM OPTION 1--Continued [$mnillions)

Ust List List List List Year option I option 2 option 3 option 4 option 5

3

.......................................................... 109 126 213 241 258
4

....................................................................... ................................................. 84 98 152 167 181 5

........................................................................................................................ 195 217 338 383 404

Finally, the dollar value ofthe benefits ofthe proposed risk management program were estimated by developing an estimate ofthe cost of each type ofincident, and then by multiplying the estimated cost ofeach type ofincident by the number of incidents avoided that may be attributed
to the presence ofarisk management program. Thebenefits ofthe proposed rule are estimated to be approximately $890 million per year.Table 4 presents the estimated costs and benefits for each ofthe list options considered by EPA during the rule development.

TABLE 4.-ESTIMATED FIRST YEAR COSTS AND BENEFITS
[$

Millions]

Estimated Estimated

costs benefits

List option 1

...... $460 $836 List option 2

...... 503 890 List option 3

...... 858 1,539 List option 4

...... 1,004 1,615 List option 5

...... 1,046. 1,670

XI. Required Analyses

A. Executive Order12291

Under Executive Order 12291, the Agency mustjudge whether a regulation is "major" and thus subject to the requirement for a Regulatory Impact' Analysis. Under E.O. 12291, a major rule is one that is likely to result in: (1) An adverse (cost)impact in the
economy of$100 million ormore, (2)a major increase in cost or prices to
consumers, individual industries, Federal, state, or local government, or geographic region, or (3)significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S.based enterprises in domestic or export markets. EPA has determined that today's proposed rule is a major rule for the purposes ofE.O. 12291 because the first year cost ofthe rule is estimated to be $503 million. An RIA entitled, "Regulatory Impact Analysis in Support ofListing Regulated Substances and Thresholds and Mandating Risk Management Programs forChemical Accident Release Prevention, as Required by Section 112(r) ofthe Clean Air Act," hasbeen prepared and is available in the docket.

B. Regulatory Flexibility Act

In accordance with the Regulatory Flexibility Act of 1980, Federal agencies

must evaluate the effects ofthe rule on small entities and examine alternatives that may reduce these effects. EPA has prepared an analysis ofthe effects on small entities. The analysis employed three measures for assessing the effects ofthe proposed rule, and the alternatives, on small business: the before-tax cost ofcompliance as a percentage offirm sales; the after-tax

cost ofcompliance as apercentage of

net income; and the percent change in the debt-to-asset ratio. The results indicated that for 90 percent ofthe small businesses affected, the economic burden for initial costs would be mild.
For the remaining 10percent, the
program would impose a significant adverse effect in the first year, as measured by theratio ofafter-tax compliance costs to net income. This burden is an upper-bound estimate because, in actuality, many firms are likely to finance compliance in a variety ofways, such as debt, current earnings, and increased prices, rather than finance compliance in one way. Consequently, the impact ofcompliance

costs is likely to be less severe than estimated in the analysis. For subsequent years, the economic impact

as measured by the after-tax ratio is estimated to be small for businesses. The impact on small governments also is estimated to be small based on the ratio ofcompliance costs to revenues. The full regulatory flexibility analysis is included, as Chapter 8, in the RIA, available in the docket.

C.Paperwork ReductionAct

The information collection requirements in this proposed rule have been submitted for approval to the Office ofManagement and Budget (OMB) under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. An Information Collection Request document has been prepared by EPA (ICR No. 1656.1) and a copy may be obtained from Sandy Farmer, Information Policy Branch, EPA, 401 M St. SW., (PM-223Y), Washington, DC 20460, or by calling (202) 260-2740.

Public reporting burden for this collection ofinformation, which will take place three years after the rule is final, will vary depending on the size and complexity ofthe facility and the number ofsubstances affected: between 1.25 and 3 hours for the registration form, another .2 to 341.2 hours for the burden to maintain onsite documentation, and a range ofbetween 4.25 and 31.5 hours to prepare and submit a risk management plan. These hours reflect time forreviewing instructions, searching existing data

sources, gathering and maintaining data needed, and completing and reviewing the collection ofinformation.

Send comments regarding the burden estimate or any other aspect ofthis collection ofinformation, including suggestions for reducing the burden, to Chief, Information Policy Branch, PM223, U.S. EPA, 401 M St. SW., Washington, DC 20460; and to the Office ofInformation and Regulatory Affairs, Office ofManagement and Budget, Washington, DC 20503, Attn: Desk Officer for EPA. The final rule will respond to any OMB or public

comments on the information collection requirements contained in this proposal.

List ofSubjects in 40 CFR Part 68

Environmental protection, Accidental release prevention, Chemicals, Chemical accident prevention, Emergency

response, Extremely hazardous substances, Hazardous substances, Intergovernmental relations, Process safety management, Risk management.

Dated: October 7, 1993.
Carol M. Browner, Administrator.

For the reasons set out in the preamble, title 40, chapter I, subchapter C, part 68 ofthe Code ofFederal Regulations is proposed to be added to read as follows:

PART 68--ACCIDENTAL RELEASE

PREVENTION PROVISIONS
Subpart A-General Provisions

Sec. 68.1 Scope.

### Federal Register / Vol. 58, No. 201 / Wednesday, October 20, 1993 / Proposed Rules

Sec.
68.3 Definitions. 68.5 Threshold Determination [Reserved). Subpart

-- Risk Management Plan Requirements 68.10 Applicability. 68.12 Registration. 68.15 Hazard assessment. 68.20 Prevention program purpose. 68.22 Prevention program-management system. 68.24 Prevention program-process hazard analysis. 68.26 Prevention program--process safety information. 68.28 Prevention program--standard operating procedures. 68.30 Prevention program-training. 68.32 Prevention program-maintenance (mechanical integrity). 68.34 Prevention program--pre-startup review. 68.36 Prevention program-management of change.
68.38 Prevention program--safety audits, 68.40 Prevention program--accident investigation.,
68.45 Emergency response program. 68.50 Risk-management plan. 68.55 Recordkeeping requirements.
68.60 Audits. Subpart C-Listof Regulated Substances and Thresholds forAccidental Releaae
Prevention [Reserved]

Authority: 42 U.S.C. 7412(r) and 7601(a)(1).
Subpart A-General Provisions

168.1 Scope.

Thispart sets forthrequirements for chemical accident prevention stepsthat
mustbe taken by the owner or operator of stationary sources.

§68.3 Definitions.

As used inthis part, all termsnot defined shall have the meaning given to them by the Clean Air Act 

### (42U.S.C.. 7401 etseq.).

Act means the Clean Air Act as amended (42 U.S.C. 7401 et seq.).

Administrator means the administrator ofthe U.S. Environmental Protection Agency.

Analysis ofoffsite consequences

means a qualitative or quantitative analysis ofa range ofaccidental releases, including worst-case releases,
to determine offsite effects including potential exposures of affected populations.

Mitigationsystem means specific equipment, substances or personnel designed or deployed to mitigate an accidental release; examples of mitigation systems include water curtain sprays, foam suppression systems, and emergency response teams.

Offsite means areas beyond the property boundary ofthe stationary source orareas within the property boundary to whichthe publichas routine and unrestricted access.

Owneroroperator means any person who owns, leases, operates, or controls

a stationary source.

RMP means the risk management plan requiredunder §68.50.

SIC means Standard Industrial Classification.

Significantaccidentalreleasemeans any accidental release ofa regulated substance that has caused or has the potential to cause offsite consequences such as death, injury, oradverse effects
to human health orthe environment or to causethe public to shelter-in-place or be evacuated to avoid such
consequences. Worst-casereleasemeans the loss of all ofthe regulated substance from the
process in an accidental release that

eads to the worst offsite consequences. §68.5 Threshold determination. (Reserved]
Subpart B-Risk Management Program Requirements

§64.10 Appicability.

(a)The requirements in this subpart apply to all stationary sources that, after [three years from the date offinal rule publication] have a regulated substance present in a process in more than a threshold quantity as determined under 

### §68.5.

(b)Stationary sources coveredby this subpart shall comply with §§ 68.12 through 68.60 no later than (three years after the date of finalrule publication]

or within three years after the date on which a regulated substance first becomes present in a process in more than a threshold quantity.
§68.12 Registration.

(a)By [three years after the publication date ofthe final rule], or within three years ofthe date on which

a stationary sourcebecomes subject to this subpart, the owner or operator of each stationary source covered by this part shall register with the Administrator.

(b) The registration shall include the following:

(1)The name ofthe stationary source, its street address, its mailing address, and telephone number;

(2) The names and CAS numbers of all regulated substances that are present atthe stationary source in greater than the threshold quantities, andthe maximum amount present in a process at any one time (inranges);

(3) For each regulated substance, the four-digit SICcode(s) that apply to the use ofthe substance at the stationary

source;

(4) The Dun and Bradstreet number of the stationary source;

(5) The name ofacontact person; and (6)The following certification signed by the owner oroperator: "The undersigned certifies that, to the best of
my knowledge, information, and belief formed afterreasonable inquiry, the information submitted is true, accurate, and complete. Icertify that Iprepared

or caused tobe prepared a risk management plan tatcomplies with40 CFR 68.50 [and, when applicable: "and the provisions of40 CFR 68.60"] and that I submitted or caused to be submitted copies ofthe risk management plan to each ofthe entities listed in 40 CFR 68.50(a). [Signature]."

(c)Ifat any time after the submission ofthe registration, information in the registration is no longer accurate, the

owner oroperator shall submit an amended notice within 60 days to the Administrator and implementing
agency. After a final determination of
necessary revisions under §68.60(f), the

owner or operator shall register the revised risk management plan by the date required in §68.60(g).

168.15 Hazard assessment.

(a)The purpose ofthe hazard
assessment isto evaluate the impact of significant accidental releases on the public health and environment and to develop a history ofsuch releases.

(b) Hazard assessments shallbe conducted for each regulated substance present atthe stationary source above the threshold quantity. For each regulated substance, the hazard
assessment shall include the following steps:

(1)Determine a worst-case release scenario forthe regulated substance at the stationary source;

(2) Identify other more likely significant accidental releases for each
process where the regulated substance is present above the threshold quantity. including processes where the substance is manufactured, processed,

or used, and where the regulated substance is stored, loaded, or unloaded;

(3)Analyze the offsite consequences ofthe worst-case release scenario and the other more likely significant. accidental release scenarios identified in § 68.15(b)(2); and (4)Develop a history ofaccidental releases ofthe regulated substance. (c)To determine aworst-case release scenario, the owner or operator shall examine each process handling each regulated substance and assume that all ofthe regulated substance in theprocess 5421354214 Federal Register / Vol. 58, No. 201 

### I Wednesday, October 20, 1993 / Proposed Rules

is instantaneously released and all mitigation systems fail to minimize the
consequences ofthe release.

(d) The owner or operator shall determine other more likely significant accidental releases such as butnot limited to:

(1) Transfer hose failure, excess flow valve oremergency shutofffailure and subsequent loss ofpiping and shipping container contents (truckor rail);

(2)Process piping failure andlo of

contents from both directions from the break; and (3) Reactor or other process vessel failure where the contents are at temperatures and pressures above ambient conditions. In these situations, passive mitigation systems are assumed

to work to minimize the consequences ofthe release.

(e) For each regulatedsubstance, the offsite consequences ofthe worst case or

more likely significant accidental release scenarios shall be analyzed as follows:

(1) The rate and quantity of substance lost to the air and the duration ofthe event;

(2)The distance, in all directions, at which exposure to the substance or damage to offaite property orthe environment from the release could

occur using both worst-case meteorological conditions (i.e., F stability and 1.5 m/sec wind speed) and meteorological conditions most often occurring at the stationary source;

(3) Populations within these distances that could be exposed tothe vapor cloud, pressure wave, or debris, depending on wind direction and meteorological conditions; and

(4) Environmental damage that could be expected within these distances, including consideration ofsensitive ecosystems, migration routes, vulnerable natural areas, and critical habitats for threatened or endangered species.

(f) The owner or operator shall
prepare a five-year history of significant accidental releases andreleases with potential foroffste consequences for each regulated substance handled atthe stationary source. The history shall list the release date, time, substance and quantity released, the duration ofthe release, the concentration ofthe substance released, and any offsite

consequences such asdeaths, injuries, hospitalizations, medical treatments, evacuations, sheltering in-place, and major off-site environmental impacts such as soil, groundwater, or drinking
water contamination, fish kills, and vegetation damage.

(g) The hazard assessment shallbe reviewed and updated at leastonce every five years. Ifchanges inprocess, management, or any other relevant aspect ofthe stationary source orits surroundings (e.g. new housing developments or improved emergency response services) mightreasonably be expected tomake theresults ofthe hazard assessment inaccurate (i.e., if either the worst-case release scenario or the estimate ofoffsite effects might reasonably be expected tochange), the

owner or operator shall complete a new

or revised hazard assessment within 60 days of such change.

(h) The owner or operator shall maintain the following records documenting the hazard assessment and analysis ofoffsite consequences: (1)A description ofthe worst-case scenario;

(2) A description ofthe other more likely significant accidental release scenarios identified in §68.15(b)(2), assumptions used, analyses or worksheets used to derive the accident scenarios, and the rationale for selection ofspecificscenarios; and

(3)Documentation for how the offsite
consequences foreach scenario were determined including:

(I)Estimated quantity ofsubstance released, rate ofrelease, and duration of the release; (ii)Meteorological data used for typical conditions at the stationary

source;

(iii) Fortoxic substances, the concenftration used to determine the level ofexposure and the data used for that concentration;

(iv) Calculations for determination of the distances downwind to the acute toxicity concentration; and

(v)Dataused forestimation ofthe populations exposed or area damaged.

(i) A summary ofthe information required under paragraph (h)ofthis section and atable showing the data for the five-year accident history under paragraph 

### (0 ofthis section shallbe included inthe RMP required under §68.50.

§68.20 Prevention program purpose.

The owner oroperator of astationary

source havingone ormore regulated substance above the threshold quantity shall develop and implement an integrated management system to evaluate the hazards present at the stationary source and to find the best
ways to control these hazards. The prevention program includes ten required elements that mustbe tailored
to suit the degree ofhazards present at the stationary source and the degree of complexity ofthestationary source's operations and that should work together under management control to

ensure safe operations.
§68.22 Prevention program mn gemet system.

(a)The owner or operator ofthe stationary source shall develop a management systkm to oversee the implementation ofthe risk management program elements. Thepurpose ofthe management system is to ensure that the elements ofthe riskmanagement program are integrated and implemented on an ongoing basis and that the responsibility for the overall program and for each element is clear.

(b) As part ofthemanagement system, the owner or operator shall identify a singleperson or position that has the overall responsibility forthe development, implementation, and integration ofthe riskmanagement program requirements.

(c)When responsibility for implementing individual requirements ofthe risk management program is assigned to persons other than the
person designated underparagraph (b) ofthis section, the names orpositions ofthese people shallbe documented and the lines ofauthority defined through an organization chart or similar document.
§68.24 Prevention program--process hazard analysis.

(a)The purpose ofthe process hazard analysis (hazard evaluation) is to examine, in a systematic, step-by-step
way, the equipment,.systems, and procedures forhandling regulated substances and to identify the mishaps that could occur, analyze the likelihood that mishaps will occur, evaluate the
consequences ofthese mishaps, and analyze the likelihood that safety systems, mitigation systems, and
emergency alarms will function properly to eliminate orreduce the
consequences ofa mishap. A thorough
process hazard analysis is the foundation forthe remaining elements ofthe prevention program.

(b)The owner oroperator shall perform an initialprocess hazard analysis on processes covered by this part. The processhazard analysis shall be appropriate to the complexity ofthe
process and shall identify, evaluate, and control the hazards involved in the
process. The owner or operator shall' determine and document thepriority order for conducting process hazard analyses based on a rationale which includes such considerations as the
extent ofprocess hazards, offsite
consequences, age ofthe process, and operating history oftheprocess. The
process hazard analysis shallbeFederal Register / Vol. 58, No. 201 / Wednesday, October 20, 1993 / Proposed Rules

completed nolater than [three years after the date offinal rule publication].

(c)Process hazard analyses completed after (Insert date 5 years before the effective date ofthe final rule) which
meet the requirements ofthis section are acceptable as initialprocess hazard analyses. These processhazard analyses shall be updated and revalidated, based

on theircompletion date, in accordance with paragraph (h)ofthis section.

(d)The owner or operator shall use

one or more ofthe following methodologies that are appropriate to determine and evaluate the hazards of the process being analyzed: {}What-If-, (2) Checklist; (3) What-If/Checklist; (4) Hazard and Operability Study (HAZOP);

(5) Failure Mode and Effects Analysis 

### (FMEA);

(6) FaultTree Analysis; or (7)An appropriate equivalent methodology.

(e)The process hazard analysis shall address:

(1)The hazards ofthe'process; (2) The identification ofany previous incident which had a likely potential for significant offsite consequences;

(3)Engineering and administrative controls applicable tothe hazards and their interrelationships such as appropriate application ofdetection methodologies to provide early warning ofreleases. Acceptable detection methods might include process monitoring and control instrumentation with alarms, and detection hardware such ashydrocarbon sensors;

(4) Consequences of failure of engineering and administrative controls;

(5) Stationary source siting; (6) Human factors; and (7) A qualitative evaluation ofa range ofpossible safety and health effects of failure ofthe controls on public health and the environment.

(f) The process hazard analysis shall be performed by a team with expertise in engineering and process operations, and the team shall include at least one employee who has experience and knowledge specific tothe process being evaluated. Also, one member ofthe
team must be knowledgeable in the specific process hazard analysis methodology being used. (g)The owner or operator shall establish a system to promptly address the team's findings and recommendations; assure that the recommendations areresolved in a timely manner and that the resolution is documented; document what actions are tobe taken; complete actions as soon as possible; develop a written schedule of when these actions are to be completed; and communicate the action to operating, maintenance, and other employees whose work assignments are in the process and who are affected by the recommendations or actions.

.(h)At least every five (5)years after the completion ofthe initial process hazard analysis, the process hazard analysis shallbe updated and revalidated by ateam meeting the requirements in paragraph (f)ofthis section, to assurethat the process hazard analysis is consistent with the
currentprocess.

(i)The owner oroperator shall retain
process hazard analyses and updates or revalidations for eachprocess covered by this section, as well asthe documented resolution of recommendations described in paragraph (g) ofthis section for the life ofthe process. j)Based onthe findings and recommendations ofthe process hazard analysis,the owner or operator shall also investigate, evaluate, and document

a plan for, or rationale fornot, installing (ifnot already inplace):

(1) Monitors, detectors, sensors, or alarms for early detection of accidental releases;

(2) Secondary containment or control devices such as, but not limited to, flares, scrubbers, quench, surge, or dump tanks, to capture releases; and

(3)Mitigation systemsto reduce the downwind consequences ofthe release.

168.26 Prevention program-process safety Information.

(a)The owner oroperator shall complete acompilation ofwritten
process safety information before conducting any process hazard analysis required in §68.24. The compilation of written process safety information is to enable the owner or operator and the employees involved in operating the
process to identify and understand the hazards posed bythose processes involving regulated substances. This
process safety information shall include informationpertaining to the hazards of the regulated substancesused or produced by the process, information pertaining to the technology ofthe processrand information pertaining to the equipment inthe process. (b)Information pertaining tohazards ofthe regulated substance in the
process. Thisinformation shall consist ofat least the following:

(1)Toxicity information; (2) Permissible exposure limits; (3) Physical data; (4) Reactivity data; (5) Corrosivity data; (6) Thermal and chemical stability data; and (7) Hazardous effects ofinadvertent mixing ofdifferent materials that could foreseeably occur.

Note: MSDSs meeting therequirements of 29CFR 1910.1200(g) maybe used to comply with this requirement to the extent they contain the information requiredbythis paragraph. (c)Information pertaining to the technology of the process. Information concerning the technology ofthe
process shall include at least the following:



### (1) A block flow diagram or simplified
process flow diagram; (2) Process chemistry; (3)Maximum intended inventory; (4) Safe upper and lower limits for such items as temperatures, pressures, flows, or compositions; and,

(5) An evaluation ofthe consequences ofdeviations, including those affecting public health and the environment. (d)Where the original technological information required by paragraph (c)of this section no longer exists, such information maybe developed in conjunction with the processhazard analysis in sufficient detail to support the analysis.

(e)Information pertaining to the equipment inthe process. Information pertaining to the equipment in the
process shall include:

(1)Materials ofconstruction; (2) Piping and instrument diagrams (P&ID's);

(3)Electrical classification; (4) Reliefsystem design and design basis;

(5)Ventilation system design; (6) Design codes and standards employed;

(7)Material and energy balances for
-processesbuilt after the effective date of rule; and

(8) Safety systems (e.g., interlocks, detection, orsuppression systems).

(f) The owner or operator shall document that equipment complies with recognized and generally accepted good engineering practices.

(g) For existing equipment designed and constructed in accordance with codes, standards, or practices that are no longerin general use,the owner or operator shall determine and document that the equipment is designed, maintained, inspected, tested, and operating in a safe manner.
§68.28 Prevention program-standard operating procedures.

(a)The purpose ofwritten standard operating procedures isto document the safe and proper way to operate and maintain processes and equipment, and
to handle and store regulated substances
at a stationary source. Procedures may 54215

I54216 Federal Register / Vol. 58, No. 201 / Wednesday, October 20, 1993 / Proposed Rules

be based on the process hazard analysis (hazard evaluation) information, successful past operating experience, manufacturers' recommendations, and applicable and appropriate codes and standards. The owner or operator shall consider the complexity ofthe process

or stationary source to develop standard procedures. (b) The owner or operator shall develop and implement written operating procedures thatprovide clear instructions for safely conducg activities involved in each covered
process consistent with the process safety information and shall address at least the follow elements:

(1)Steps for each operating phase: (i)Initial startup; (ii) Normal operations; (iii)Temporary operations; (iv)Emergency shutdown including the conditions under which emergency shutdown isrequired, and the assignment ofshutdown responsibility
to qualified operators to assurethat
emergency shutdown Is executed in a safe and timely manner;

(v) Emergency operations; (vi) Normal shutdown; and (vii) Startup following a turnaround,

or after an emergency shutdown.

(2) Operating limits: (I)Consequences ofdeviation; and (ii) Steps required to correct or avoid deviation.

(3)Safety andhealth considerations: (I)Properties of, andhazards presented by, the substances used in the
process;

(ii)Precautions necessary to prevent exposure, including engineering controls, administrative controls, and personal protective equipment;

(iii)Control measures to be taken If physical contact or airborne exposure
occurs;

(iv) Quality control for raw materials and control ofregulated substance inventory levels; and,

(v) Any special orunique hazards. (4) Safety systems and theirfunctions. (c)Operating procedures shall be readily accessible to employees who work in or maintain aprocess.

(d)The operating procedures shall be reviewed asoften as necessary to assure that they reflect current operating practice, including changes thatresult from changes in process chemicals, technology, and equipment, and changes to stationary sources. The

owner or operator shall certify annually that these operating procedures are current andaccurate.

(e)The owner or operator shall develop andimplement safe work practices to provide forthe control of hazards during operations involving lockout/tagout; confined space entry; opening process equipment orpiping; and control over entrance into a stationary source by maintenance, contractor, laboratory, or other support personnel. These safe work practices shall apply to employees and contractor employees working on a facility.
§68.30 Prevention program.-tralning.

(a)The purpose ofthe training
program is to ensure that each employee involved with regulated substances has learned and understands the procedures developed under §68.28. The owner or operator shall consider the complexity ofthe procedures, andthe complexity of the process orstationary sources when developing training programs.

(b Initialtraining.(1)Each employee presently operating a process, and each employee before operating a newly assigned process shallbe trained in an overview ofthe process and in the operating procedures as specified in §68.28. The training shall include emphasis on the specific safety and health standards, emergency operations including shutdown, and safe work practices applicable to the employee's jobtasks.

(2)In lieu ofinitialtraining forthose employees already involvedin operating a process onthe effective date ofthis rule, an owner oroperator may certify in writing that the employee has therequired knowledge, skills, and abilities to safely carry outthe duties and responsibilities as specified inthe operating procedures.

(c)Refreshertraining. Refresher training shallbe provided atleast every three years and more often ifnecessary to each employee involved in operating

a covered processto assure that the employee understands and adheres to the current operating procedures in the
process. The owner or operator, in consultation with the employees involved in operating the process, shall determine the appropriate frequency of refresher training.

(d) Trainingdocumentation.The

owner oroperator shall ascertain that each employee involved in operating a process has received and understood the training required by this section. The

owner or operator shall prepare a record which contains the identity ofthe employee, the date oftraining, and the

means used to verifythat the employee understood the training.

(e) The owner or operator shall evaluate the effectiveness ofthe training
program. A schedule for reviewing and revising the program shall be maintained at the stationary source. §68.32 Prevention program--maintenance (mechanical ntegrlty)

(a)The purpose ofthe maintenance
program isto determine andtarget the specific equipment that is identified through the process hazard analysis (hazardevaluation) or through operating experience as needing regular maintenance because failure ofthe equipment would lead to a significant accidental release. The owner or operator shall consider the complexity ofthe process or stationary source in developing the maintenance program.

(b) The owner or operator shall develop a list ofequipment and controls the failure ofwhich could result in a significant accidental release. As applicable, the equipment list shall include:

(1)Pressure vessels and storage tanks; (2) Piping systems (including piping components such as valves);

(3) Reliefand vent systems and devices;

(4) Emergency shutdown systems; (5)Controls (includingmonitoring devices and sensors, alarms, and interlocks); and,°

(6) Pumps. (c) Writtenprocedures. The owner or operator shall establish and implement written procedures tomaintain the ongoing integrity ofprocess equipment.

(d) Training for processmaintenance activities.The owner or operator shall train each employee involved in maintaining the.on-going integrity of
process equipment in an overview of that process and its hazards and inthe procedures applicable tothe employee's jobtasks to assure that the employee can perform the jobtasks in a safemanner and shalldocument the training as required in §68.30(d). "

(e) Maintenance,inspections, and testing.For every item ofequipment required to be listedunder paragraph (b) ofthis section, the owner or operator shall develop a maintenance program to inspect, test, and maintain the equipment on an appropriate schedule
to ensure that the equipment and controls continue to function according
to specifications.

(1)Maintenance, inspections, and
tests shall be performed onprocess equipment.

(2) Maintenance, inspection, and testingprocedures shall follow recognized and generally accepted good engineering practices.

(3) The frequency ofmaintenance, inspections, and tests ofprocess equipment shall be consistent with applicable manufacturers' recommendations and good engineering practices, and more frequently ifFederal Register / Vol. 58, No. 201 / Wednesday, October 20, 1993 / Proposed Rules

determined to be necessary by prior operating experience.

(4) The owner or operator shall document each maintenance procedure. inspection, and testthat has been performed on process equipment. The documentation shall identify the date of the maintenance/inspection/test; the

name ofthe person who performed the maintenance/inspection/test; the serial number orother identifier of the equipment on which the maintenance, inspection, or testwas performed; a description ofthe maintenance, inspection, and test that is performed; and the results ofthe inspection ortest.

(0)

Equipmentdeficiencies:The owner

or operator shall correct deficiencies in equipment that are outside acceptable limits (defined in the process safety information in § 68.26(c)(4) and (e)) before further use or in a safe and timely

manner when necessary means are taken to assure safe operations.

(g)Qualityassurance. (1)In the construction ofnew plants and equipment, the owner or operator shall assure that equipment as itis fabricated is suitable for the process application forwhich they will be used. (2) Appropriate checks and inspections shall be performed to assure that equipment is installed properly and consistent with design specifications and manufacturer's instructions.

(3) The owner or operator shall assure that maintenance materials, spare parts, and equipment are suitable forthe
process application for which they will be used.

§68.34 Prevention program-pr.-startup review.

(a) The purpose ofthe pre-startup review is to ensure that new or modified equipment is ready to properly and ,safely contain any new or previously handled regulated substance before that substance is introduced into the system. The owner or operator shall consider the complexity ofthe process or stationary source in developing the prostartup review.

(b) The owner or operator shall perform a pro-startup safety review for

new stationary sources andfor modified stationary sources when the modification is significant enough to require a change in the process safety information.

(c) The pro-startup safety review shall confirm that prior to the introduction of regulated substances to a process:

(1) Construction and equipment is in accordance with design specifications;

(2) Safety, operating, maintenance, and emergency procedures are in place and are adequate;

(3) For new stationary sources, a process hazard analysis has been performed and recommendations have been resolved or implemented before startup; and modified stationary sources meet the requirements contained in management ofchange, §68.36; and

(4) Training ofeach employee involved in operating or maintaining a process hasbeen completed and that employees are trained in any new emergency response procedures.
§68.36 Prevention prograrm-management of change.

(a)The purpose ofa management of change program is to ensure that any alteration ofequipment, procedures, substances, or processes are thoroughly analyzed to identify hazards, the
consequences offailures, and impacts of the change on existing equipment, procedures, substances, and processes prior to implementation ofthe change.

(b)For process equipment, devices, or controls, replacement is not a change if the design, materials of construction, and parameters for flow,pressure, and temperature satisfy the design specifications ofthe device replaced.

(c)The owner or operator shall establish and implement written procedures to manage changes to process chemicals, technology, equipment, and procedures; and changes to stationary sources that affect

acovered process.

(d)The procedures shall assure that the following considerations are addressed priorto any change:

(1)The tehnical basis forthe proposed change;

(2) Impact ofchange onlikelihood of

a significant accidental release;

(3) Modifications to operating procedures;

(4) Necessary time period for the change; and,

(5) Authorization requirements forthe
proposed change'.

(e)Employees involved in operating a process and maintenance and contract employees whose job tasks will be directly affected by a change inthe
process shallbe informed ofand trained in the change prior to the startup ofthe
process oraffected part ofthe process.

(f)Ifa change covered bythis section results in a change in the process safety information required by 

### S68.26, such information shall be updated accordingly.

(g)If achange covered by this section results in a change in the operating procedures or practices required by §68.28, such procedures orpractices shallbe updated accordingly. 

### §

68.38 Preventlen pregram-eey audits.

(a)The safety audit consists ofa periodic examination ofthe management systems and programs at the stationary source. The examination shall include a review ofthe documentation and implementation of the requirements ofthis subpart. The

owner or operator shall consider the complexity ofthe process and ofthe

process safety management program to develop the safety audit procedures, plans, and timing.

(b) The owners or operators shall certify that they have evaluated compliance withthe provisions ofthis section at least every three years, to verify that the procedures and practices developed under this part are adequate and are being followed.

(c) The safety audit shall be conducted by at least one person knowledgeable in the process.

(d)A report ofthe findings ofthe audit shall be developed.

(e) The owner or operator shall promptly determine and document an appropriate response to each ofthe findings ofthe audit, and document that deficiencies have been corrected.

(f)The owner or operator shall retain the two most recent safety audit reports.

as well as the documented actions in paragraph (e) ofthis section.

§68.40 Prevention program--accident Investigation.

(a) The purpose ofthe accident investigation is to learn the underlying

.causes of accidents to take steps to prevent them or similar accidental releases from recurring.

(b)The owner or operator shall establish and implement written procedures to investigate each significant accidental release.

{c) The owner or operator shall investigate each significant accidental release.

(d)An accident investigation shallbe initiated as promptly as possible, but

not later than 48 hours following the significant accidental release.

Te) An accident investigation team shallbe established and consist ofat least one person knowledgeable in the

process involved, including a contract employee ifthe incident involved work ofthe contractor, and other persons with appropriate knowledge and experience to thoroughly investigate and analyze the significant accidental release.

(f)A report shallbe prepared at the conclusion ofthe investigation which includes at aminimum:

(1) Date ofsignificant accidental release;

(2) Date investigation began; (3) A description ofthe significant accidental release;

(4) The factors that contributed to the significant accidental release, including I54-21754218 Federal Register / Vol. 58, No. 201 / Wednesday, October 20, 1993 / Proposed Rules

its initiating event, and root cause or

causes that mayhave increased the likelihood ofthe initiating event; and,

(5) Any recommendations resulting from the investigation.

(g)The owner or operator shall establish a system to promptly address and resolve the accident report findings and recommendations. Resolutions and corrective actions shall be documented.

(h)The report shall be reviewed with all affected personnel whose jobtasks

are relevant tothe significant accidental release findings including contract employees where applicable.

(I)Significant accidental release investigation reports shall be retained forfive years.
§68.45 Emergency response program.

(a)The purpose ofthe emergency response program is to prepare for
response to and mitigation of accidental releases to limit the severity of such releases andtheir impact on the public health and environment.

(b)The owner or operator of a stationary source shall establish and implement an emergency response plan forresponding to and mitigating accidental releases ofregulated substances. The plan shall detail the steps all employees shalltake in
response to accidental releases and shall include:

(1)Evacuation routes or protective actions foremployees not directly involved inresponding to the release;

(2) Procedures for employees responding to the release, including protective equipment use;

(3) Descriptions ofall response and mitigationtechnologies available atthe stationary source; and

(4)Procedures for informing the public and emergency response agencies aboutreleases.

(c)The owner or operator shall develop written procedures forthe use ofemergency response equipment and forits inspection, testing, and maintenance. The maintenance program foremergency response equipment shall be documented asrequired in §68.32(e)(4).

(d)For each regulated substance, the

owner or operator shall document the
proper first-aid and emergency medical
treatment necessary to treat accidental human exposure.

(e) The owner or operator shall train allemployees in relevant emergency response procedures and document the training as required under § 68.30(d).

(f)The owner or operator shall conduct drills or exercises totest the plan and evaluate its effectiveness. Each drill or exercise shall be documented in writing and shall include findings ofthe drillor exercise thatindicate aspects of the plan aid procedures whichneed to be revised. Plans shallbe revised based

on the findings ofthe drills or exercises. The owner or operator shall document the response to each finding from a drill

orexercise. For each findingrequiring a change that is implemented, the schedule for implementing the change shallbe documented.

(g)Each emergency response plan shallbe coordinated with local
emergency response plans developed under part 355 ofthischapter bythe local emergency planning committees andlocal emergency response agencies. Upon request ofthe local emergency planning committee, the owner or operator shall promptly provide information to the local emergency planning committee necessary for developing and implementing the community emergency response plan.

(h)The owner and operator shall maintain a copy ofthe emergency response plan, including descriptions of all mitigation systems inplace, at the stationary source. §68.50 Risk management plan.

(a)The owner or operator of a stationary source covered by thispart shall submit a risk management plan (report) summarizing the key elements ofits risk management program to the implementing agency and shall submit copies tothe State Emergency Response Commission, the Local Emergency Planning Committee withjurisdiction for the area where the source is located, and the Chemical Safety and Hazard Investigation Board. Each report submitted bythe stationary source shall address all regulated substances present at the stationary source in quantities above the threshold quantity.

(b) The report shall include a copy of the registration form, with updated information to ensure that the registration information is accurate.

(c} The report shall include, foreach regulated substance, a summary ofthe hazard assessment and analysis of offsite consequences and accident history data required by §68.15(1). (d)Thereport shall include, forthe stationary source, a description ofthe majorhazards (e.g., equipment failure, human error,natural phenomena, or otherfactors or a combination ofsuch factors which could lead to a significant accidental release) identified through the processhazard analyses, a description ofthe consequences ofa failure to control for each Identified majorhazard, a summary of all actions taken or planned to address these hazards, andhow significant accidental releases areprevented ormitigated, or the consequences reduced bythese actions. The purpose ofthe summary is
to identify majorhazards and provide

an overview ofthe prevention program being implemented by the stationary

source to prevent significant accidental, releases. Foreach action taken to address ahazard, the report shall include the date onwhich the action

was started (oris scheduled to start) and the actual or scheduled completion date. Where the same actions (e.g., training, certain controls, preventive maintenance programs, improved
emergency response plan) address a number ofhazards, the description may be organized by actions rather than hazards. Ifany requirement forthe risk management program specified in this subpart is not covered in the summary ofactions taken to address hazards, the report shall include a briefdescription ofthe stationary source's implementation ofthe requirement.

(e) The report shall include a summary ofthe stationary source's
emergency response plan. The summary shall include:

(1)The procedures adopted to inform
emergency response authorities and the public;

(2) The name orposition ofthe point ofcontact between the stationary source and the public authorities;

(3)The dates ofdrills and exercises completed and planned andthe results ofcompleted drills; and

(4) A description ofcoordination with the local emergency planning committee.

(f0 The report shallinclude a description ofthe management system developed to implement and coordinate the elements ofthe hazard assessment, prevention program, and emergency response program at the stationary

source. The description shall define the
person orposition at the stationary

source that isresponsible for the overall implementation and coordination ofthe riskmanagement program requirements. Where regulated substances arepresent abovetheir threshold quantities at several locations atthe stationary source

orwhere responsibility for implementing individual requirements is delegated to separate groups at the stationary source, an organization chart shallbe included to describe the lines ofresponsibility.

(g)The report shall include a certification by the owner or operator that, to the best ofthe signer's knowledge, information, andbelief formed after reasonable inquiry, the information submitted is true, accurate, and complete.

(h) The report shall be reviewed and updated at least every five years andFederal Register / Vol. 58, No. 201 / Wednesday, October 20, 1993 / Proposed Rules

resubmitted to the implementing agency and copies shall be submitted to the State Emergency Response Commission, the LocaLEmergency Planning Committee, and the Chemical Safety

- and Hazard Investigation Board. Ifa

change such asthe introduction ofa

new regulated substance orprocess

occurs that requires arevised or updated hazard assessment orprocess hazard analysis, then the report shallbe updated and resubmitted within six months of the introduction ofthe new process or substance.

(i)The report shallbe available tothe public under section 114(c) ofthe Clean Air Act.

§68.55 Recordkeeplng requirements.

(a)The owner or operator ofa stationary source covered by this part shall develop and maintain at the stationary source, for five years, records supporting the implementation ofthe risk management program and the development ofthe riskmanagement plan.

(b) Forthe,process hazard analysis, safety audit, and accident investigation, the records required to be maintained under paragraph (a) ofthis section shall include management's response to each recommendation that is required to be made, addressed, and documented under §§ 68.24(g), 68.38(e), 68.40(f), and 68.40(g). For implemented recommendations and recommendations to be implemented, the documentation shall include the date (orscheduled date) for starting implementation and the date (or scheduled date) forcompletion ofthe implementation. For each recommendation not implemented, the documentation shall include an explanation ofthe decision.

(c)For pre-startup reviews and management ofchange, the documentation shall include the findings ofthe review and any additional steps (including a description ofthe steps and the reasons they were implemented) that were taken prior to implementation ofthe startup or change.

(d)The owner oroperator shall maintain copies ofall standard operating, maintenance, management of change, emergency response, and accident investigation procedures required underthis part. 

### §68.60 Audits.

(a)In addition to inspections for the
purpose ofregulatory development and enforcement ofthe Act, the implementing agency shall periodically audit RMPs registered under § 68.12 in order to review the adequacy ofsuch RMPsand require revisions ofRMPs whennecessary to assure compliance with §68.50.

(b) Stationary sources shall be selected for auditsbased on any ofthe following criteria:

(1)Accident history ofthe stationary

-source; (2) Accident history of other stationary sources in the sameindustry;

(3) Quantity ofregulated substances present at the stationary source;

(4) Location ofthe stationary source and its proximity tothe public and sensitive environments;

(5) The presence ofspecific regulated substances;

(6)The hazards identified in the RMP;

or(7) A plan providing for neutral, random oversight.

(c The implementing agency shall have access to the stationary source, supporting documentation, and any area where an accidental release could occur. (d)Based on the audit, the implementing agency may issue an

owner or operator of astationary source

awritten preliminary determination of
necessary revisions to the source's RMP in order to assure that the RMP meets the criteria of§ 68.50 and reflects the
purposes ofsubpart B ofthispart. This preliminary determination shall include

an explanation for the basisfor the revisions,reflecting industry standards and guidelines (such as AIChE/CCPS guidelines andASME andAPI standards) to the extent that such standards and guidelines are applicable, and shall include a timetable for their implementation.

(e) Written response to apreliminary determination:

(1)The owner oroperator shall respond in writing to a preliminary determination made inaccordance with paragraph (d)of this section. The
response shall state that the owner or operator willimplement the revisions contained in the preliminary determination in accordance with the timetable included in the preliminary determination or shall state that the

owner rejects the revisions in whole or inpart. For eachrejected revision, the

owner oroperator shall explain'the basis for rejecting such revision. Such explanation may include substitute revisions.

(2) The writtenresponse under paragraph (e)(1) ofthis section shall be received by the implementing agency within 90 days ofthe issuance ofthe preliminary determination or a shorter period oftime asthe-implementing
agency specifies in the preliminary determination asnecessary to protect human health and the environment. Prior to the written response being due and upon written request fromthe

owner or operator, the implementing
agency may provide inwriting additional time forthe response to be received.

(f)After providing the owner or operator an opportunity torespond under paragraph (e) ofthis section, the implementing agency may issue the

owner or operator awritten final determination ofnecessary revisions to the source's RMP. The final determination may adopt ormodify the revisions contained in the preliminary determination under paragraph (d) of this section or may adopt the substitute revisions provided in the response under paragraph (e) ofthis section. A final determination that adopts a revision rejected by the owner or operator shall include an explanation.of the basis forthe revision. A final determination that fails to adopt a substitute revision provided under paragraph (e)ofthis section shall include an explanation ofthe basis for finding such substitute revision unreasonable.

(g)Thirty (30) days after the issuance ofafinal determination under paragraph (f)ofthis section, the owner

oroperator shall be in violation of §§ 68.12, 68.50(a), and 88.60 unless the

owner or operator revises the RMP prepared under §68.50 as required by the final determination, submits copies ofthe revisedRMP to the entities identified in§68.50(a), and registers the revised plan asprovided in §68.12 (b) and c).

(h)The public shall have access to the preliminary determinations, responses, and final determinations underthis section.

(i)Nothing inthis section shall preclude, limit, orinterfere in any way withthe authority of EPA orthe state to exercise its enforcement, investigatory, and information gathering authorities concerning this partunder the Clean Air Act.
Subpart C-Listof Regulated Substances and Thresholds for Accidental Release Prevention [Reserved]

[FRDec. 93-25642 Filed 10-19-93; 8:45 am]

BILLING CODE 6560-60-P 54219