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

ENVIRONMENTAL PROTECTION

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 68

[A-91-73; FRL-4790--11

Risk Management Programs for

Chemical Accidental Release

Prevention

AGENCY: Environmental Protection

Agency.

ACTION: Proposed rule.

SUMMARY: Under the Clean Air Act, 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 to lessen the

number and severity of serious chemical

accidents.

DATES: Comments must be submitted on

or before 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 of the 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 'and 3:30 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, Air Docket (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;

In northern Virginia and Alaska, (703)

920-9877.

SUPPLEMENTARY INFORMATION:

Table of Contents

1. Introduction

A. Statutory Authority B. Background C. Clean Air Act Amendments of 1990

II.Rilsk Management Programs A. Clean Air Act Requirements

B. Other CAA Provisions for Regulations C. Relationship to OSHA's Process Safety Management Standard

III. Discussion of the Proposed Rule

A. Introduction

B. Applicability C. Definitions

D. Risk Management Program Elements

E. RMP and Documentation

F. Registration G. Prohibitions

H. Timing IV. Comparison of EPA's Proposed Rule to

OSHKs Standard

A. Differences between EPA's Proposed Rule and OSHA's Standard

B. Section by Section Comparison of the

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 of the

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. Statutory Authority

This notice of proposed rulemaking

(NPRM) is being issued under sections

112(r)(7) and 301(a)(1) of the Clean Air

Act (CAA) as amended (42 U.S.C.

7412(r)(7) and 7601(a)(1)).

B. Background

Public awareness of the 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 in Flixborough,

England, and the 1976 release of dioxin

in Seveso, Italy). Public concern

intensified following the 1984 release of

methyl isocyanate in Bhopal, 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,

as part of the Agency's Air Toxics

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

of the elements of CEPP in the

Emergency Planning and Community

Right-to-Know Act of 1986 (EPCRA),

also known as Title III of the 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 III also

requires facilities to provide information

on the hazardous chemicals they have

on site to the states, local planners, and

fire departments, and, through them, the

public. This information forms the

foundation of both the community

emergency response plans and the

public-industry dialogue on risks and

risk reduction.

SARA Title III 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 of emergency systems to

monitor, detect, and prevent chemical

accidents. The final report to Congress,

Review of Emergency Systems (EPA,

1988), stated that

* * * prevention does not depend on a

single piece of equipment or a single technique. Prevention must be part of a

comprehensive,-integrated system that

considers the hazards of the chemicals

involved, the hazards of the process, the

hazards to the community, and the

capabilities of facility personnel. None of the

elements should be considered in isolation

nor should any single technical solution be

considered a complete solution to a

particular problem. Each change in a facility,

process, or procedure will have multiple effects that must be assessed in the context

of the 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

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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 of prevention practices,

encourage industry to improve safety at

facilities, and foster increased

awareness of prevention, 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 staff as 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 of risks 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 issues related 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 statesNew Jersey, California, Delaware, and

Nevada-have regulations requiring

facilities to prepare and implement risk

management plans. The American

Institute of Chemical Engineers (AIChE),

through its Center for Chemical Process

Safety, has published guidance on the

management of chemical 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 a risk

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. Clean Air Act Amendments of 1990

The Clean Air Act Amendments of

1990, signed into law on November 15,

1990, amend Clean Air Act (CAA)

section 112 by adding a new subsection

(r), which includes requirements related

to chemical accident prevention. 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 of releases

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 of releases when they

occur. Section 112(r)(3) requires EPA to

promulgate a list of at 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

when released 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 of accidental releases and

for responses to such releases. These

regulations shall include, as

appropriate, provisions concerning the

use, operation, repair, and maintenance

of equipment to monitor, detect,

inspect, and control releases, including

training of personnel in the use and

maintenance of equipment or in the

conduct of periodic inspections. The

regulations shall require facilities to

prepare and implement risk

management plans that shall provide 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 of the Clean

Air Act Amendments of 1990 requires

OSHA to promulgate, under the

Occupational Safety and Health Act (29

U.S.C. 655), a chemical process safety

standard in order to protect employees

from hazards associated with accidental

releases of highly 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 of this

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 of sources

(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. Clean Air Act Requirements

Today's proposed requirements to

develop and implement a risk

.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 of accidental

releases and for response to such

releases. As appropriate, the

requirements shall address the use,

operation, repair, replacement, and

maintenance of equipment to monitor,

detect, inspect, and control accidental

releases, including the training of

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persons in the use and maintenance of

equipment and in the conduct of

periodic inspections. The regulations

shall include procedures and measures

for emergency response after an

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 in more than a threshold

quantity to prepare and implement a risk

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 risk management plans must

include a hazard assessment that

evaluates potential effects of an

accidental release of any regulated

substance. The hazard assessment must

include an estimate of potential 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 of releases, 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 a release 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 of the final rule in the

Federal Register. The registration would

consist of a 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 of those substances (in ranges)

in a process. If the 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 emergency response 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 of a process hazard analysis,

process safety information, standard

operating procedures (SOPs), training,

maintenance, pre-startup reviews,

management of change, 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, and LEPC, a risk

management plan (RMP) that would

document the results of the risk

management program including a

summary of the offsite consequence

analysis, a list of major hazards, steps

being taken to address those hazards

(i.e., a summary of the facility's

prevention program), a five-year

accident history, a description of the

emergency response program, and a

description of the management system

that ensures the safety of the facility and

the implementation of the required

elements. This plan will be available to

the public.

The risk management 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 in this preamble, addresses the

specific requirements of CAA section

112(r)(7}{B)(ii) for a plan that provides

governmental entities and the public with information on the hazards found

at facilities and the facilities' plans for

addressing the hazards. These hazards

would be identified and addressed

through-implementation of the risk

management program elements.

Therefore, the RMP would summarize

the results of hazard assessments and

analyses and the implementation of the

risk management program requirements.

The submission requirements

(registration and the RMP) address the

requirements of CAA section

112(r)(7)(B)(iii), as does the requirement

for a system to audit RMPs.

B. Other CAA Provisions for Regulations

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. Relationship to OSHA's Process

Safety Management Standard

The Clean Air Act Amendments of

1990 (CAAA) section 304 requires

OSHA to promulgate a chemical process

safety standard and a list of highly

hazardous chemicals. To meet this

mandate, OSHA promulgated its process

safety management standard. The OSHA

standard is intended to protect workers

from chemical accidents at facilities

using highly toxic, reactive, flammable,

or explosive substances. EPA's mandate

under section 112(r) of the CAA is to

protect public health and the

environment.

EPA and OSHA have met regularly to

coordinate their rules to minimize

conflicting requirements. To minimize

confusion for facilities covered by both

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 the hazard 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 of the

two programs, OSHA's focus is on

workplace impacts. while EPA's focus is

on offsite consequences, reflecting the

differing statutory mandates of -the two

programs. The OSHA standard includes

elements specific to worker issues that

EPA has not included 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 with
Federal Register / Vol. 58, No. 201 / Wednesday, October 20, 1993 / Proposed Rules

OSHA's process safety management

standard will not need to do anything

different or create different onsite

documentation to comply with EPA's

proposed prevention program

requirements. Section IV of this

preamble describes the differences that

exist between the OSHA standard and

EPA's proposed rule and outlines the

correspondence between EPA's

proposed rule elements and the OSHA

standard.

Because EPA's proposed list of

chemicals and thresholds and OSHA's

list and thresholds are not identical

(EPA covers more substances with acute

toxic effects, fewer flammables and

explosives, and no reactives) and

because OSHA does not cover state and

local government employees, the

universes of facilities covered by the

two rules are not identical, although

they substantially overlap. See Section

X of this preamble for a discussion of

the universe of facilities covered by

today's proposed rule.

L. Discussion of the Proposed Rule

A. Introduction

AIChE, in its Technical Management

of Chemical Process Safety, says:

Management systems for chemical process safety are comprehensive sets of policies, procedures, and practices designed to ensure

that barriers to major incidents are in place, in use, and effective. The management

systems serve to integrate process safety

concepts into the ongoing activities of

everyone involved in operations-from the

chemical process operators to the chief

executive officer. * * * Effective process safety management systems can, and do, vary

a great deal in how they ae implemented. However, they always address the need for

managing the process safety-related aspects of technology, facilities, personnel,

hazardous materials, and emergency

responses.

The purpose of today's proposed rule

is to require industry to develop such an

integrated, holistic approach to

managing the risks posed by the

presence and use of regulated

substances. EPA's proposed rule builds

on process safety management elements

included in OSHA's standard: process

information, process hazard analysis,

standard operating procedures,.training,

pre-startup reviews, mechanical

integrity, management of change,

accident investigation, safety audits,

and emergency response. The

implementation of these elements and

the development of the RMP that will be

submitted to governmental authorities

will assist the owners and operators of

facilities to identify hazards and

construct a management system that

addresses the hazards in a manner that

is most effective for the specific

circumstances and complexity of the

facility.

EPA's proposed rule, particularly the

prevention program, emphasizes the

importance of management and

management commitment for two

reasons. First, without management

commitment and an integrated system

for managing process safety, it is

unlikely that safety will be consistently

recognized as a priority. Second,

although for some facilities better or

different technologies may be the most

effective methods of addressing 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

of technologies. Only with an integrated

management system that continually

evaluates the safety of a facility can the

hazards posed by regulated substances

be managed to minimize the likelihood

of accidental releases.

Besides lessening the likelihood and

severity of accidents, the

implementation of process safety

management can help facilities run

more efficiently. Companies that have

instituted risk management programs

report reductions in injuries, lost-time

accidents, mechanical breakdowns,

maintenance costs, and material 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

of this preamble for a discussion of the

benefits of this rule.

B. Applicability

The CAA states that facilities covered

by the risk management program

regulations are those that have more

than a threshold quantity of a regulated

substance based on the final list and

thresholds EPA will promulgate. In Its

list and threshold 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

and requests information on whether

EPA should develop an accident

prevention rule directed strictly to

farmers using ammonia as a fertilizer.

EPA notes that farm contractors who

sell and apply ammonia as a fertilizer

would be covered by today's proposed

rule.

EPA estimates that approximately

140,425 facilities would be affected by

today's proposed rule. Approximately

87,800 of those facilities would also be

covered by OSHA's process safety

management standard. The largest

sectors covered by 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 of this preamble

for a discussion of the estimated

coverage and costs of this proposed rule.

The risk management program rules

would affect only those areas at

facilities where regulated substances are

manufactured, processed, used, stored,

or otherwise handled. If a facility uses

a regulated substance in quantities

above a threshold in only one process

(e.g., wastewater treatment or

refrigeration), only that process (as well

as any unloading, transferring, and

storing of the substance) would be

covered by the rule. If a single process

at a facility includes more than one

regulated substance, a single process

hazard analysis may cover all regulated

substances for that process. EPA realizes

that some facilities, such as batch

processors (e.g., specialty chemical

manufacturers), may have regulated

substances on site for limited periods

during the year; for example, a batch

processor may use a regulated substance

for only one month during the 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 not be covered if they

represent less than one percent by

weight of a solution, EPA does not

expect that the risk management

program of publicly owned treatment

works would need to cover the

substances they receive from facilities

for treatment.

C. Definitions

A "significant accidental release"

means any accidental release of a

regulated substance that has caused or

has the potential to cause offsite

consequences such as death, injury, or

adverse effects to human health or the

environment or to cause the public to

shelter in place or be evacuated to avoid

such consequences.

"Worst-case release" would mean the

loss of all of the regulated substance

from the process in an accidental release

that leads to the worst offsite

consequences.

D. Risk Management Program Elements

The Clean Air Act mandates that the

risk management plan document three

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elements: a hazard assessment, a

prevention program, and an emergency

response program. This section

discusses the elements EPA is proposing

for the risk management program to

develop each of the plan requirements.

Hazard Assessment

As discussed above, the Clean Air Act

requires a hazard assessment that

includes evaluation of a range of

releases including worst-case accidental

releases; analyses of potential 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 of potential

points of release, review of the efficacy

of release 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 a hazard

assessment that examines a range 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 in the

Conference Report would be included

under the prevention program In the

process hazard analysis requirement.

EPA is proposing that facilities

complete a hazard assessment for each

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 of accidental releases and

determine a worst-case release scenario

for each location. The range of releases

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 of the regulated substance in a

process, with failure of all 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 on regulated facilities; a

requirement for analysis of a "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 in its Technical Guidance for

Hazards Analysis for local planners to

assess credible worst-case releases for

purposes of screening out situations

with little or no impact. The credible

worst case in the guidance assumed that

the entire quantity of a substance was

released from the largest vessel or group

of interconnected vessels. Gases were

assumed to be released in 10 minutes

while liquids were assumed to be

spilled on the ground or in a diked 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 of release. For example, gases may

be stored in a liquefied state or a liquid

may be handled in large quantities 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 or pipeline 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 of a process

defines the vessels and piping to 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 for each

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 be viewed as

all inclusive. Each facility should

examine its processes to determine the

event or sequence of events 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 of a

range of accidental releases and

determination of the worst-case

scenario.

The proposed rule does not specify

the number of other more likely

significant accidental release scenarios

facilities would be required to analyze.

Although this approach provides

flexibility, it may create uncertainty

about what EPA will consider an

adequate number of scenarios. EPA

requests comments on whether it should

specify a minimum number of scenarios

to be analyzed, whether the minimum

should vary with the complexity of the

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 of release, quantity

released, and duration of the 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 of detail

needed to define the population

potentially exposed.

The fate andtransport of the regulated

substances can be evaluated using air

dispersion models. EPA has published

guidance on conducting similar

analyses in its Technical Guidance for

Hazards Analysis, much of which could
Federal 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 of vapor cloud explosions also are available.

EPA, the Department of Transportation

(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 of incident, as do other

commercially available models. Simple

equations can be used to calculate the

impacts of explosions at various

distances. EPA plans to develop

additional guidance to 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.. In addition,

facilities may need to use different

models and analytical techniques to

account for site-specific conditions in

assessing offsite impacts associated with

other scenarios. The Agency recognizes

that facilities will need to have inhouse

expertise or hire consultants with such

expertise to complete these offsite

impact analyses. This may pose a

significant resource burden on some

facilities, and the different approaches

and models can make the offsite

consequence results more difficult for

local emergency planners to use. The

Agency is working on ways to minimize

this burden 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 of a set of

simple, generic tools that would be

included in the guidance and that could

be used for the assessment of offsite

impacts. EPA could develop, for

example, a generic methodology for

assessing the offsite impacts similar to

the methodology included in the

Technical Guidance for Hazards

Analysis cited above. Using a generic

methodology for assessing the offsite

impacts would allow a more direct

comparison among facilities of potential

offsite consequences. At the same time,

this approach could reduce the resource

burden imposed by the rule on many

facilities, particularly smaller

businesses by reducing 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 of scenarios. It would be

difficult to construct a generic

methodology which includes

assumptions about the characteristics of

chemicals, the range of chemical

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 (or attributes) and may yield

overly conservative or less realistic

estimates of offsite impacts. The Agency

requests comments on this approach

and requests Input on possible

innovative ways to 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 the worstcase scenario alone, therefdre, could

lead public agencies and the public to

overestimate the threat posed by a

facility. For this reason, EPA believes

that facilities must examine a range 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 a worst-case release

scenario, and must be addressed in the

prevention program. Therefore, EPA is

requiring facilities to analyze hazards

associated not only with 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 if changes at the facility or its

surroundings might reasonably be

expected to make the results inaccurate

to a significant degree. For example, a

substantial increase or decrease In the

quantity of a regulated substance could

significantly change the distance a

substance could travel before dispersing

and posing no hazard. Major changes in

housing or land-use patterns, such as

the construction of now, large-scale

housing developments or commercial

areas, could change substantially the

population potentially affected.

Afinal element of the hazard

assessment specified in the Act is a fiveyear history of releases of regulated

substances. EPA interprets the accident

history requirement to cover significant

accidental releases and incidents that

had the potential for offslte

consequences because CAA section

112(r) Is directed at preventing such

releases. EPA is proposing to require the

history to document releases that caused

or had the potential to cause offsite

consequences. As mandated by statute,

the history must include the substance

and quantity released, the concentration

of the substance when released, and the

duration of the release. EPA is also

proposing that the date of the release,

time of the release, and any offsite

consequences (e.g., evacuations,

injuries, environmental effects) be

included. EPA believes that for releases

of toxic substances, most of the releases

that meet the criteria are already

reported to the Federal or state

governments under CERCLA and SARA

Title III. Therefore, development of the

five-year history of significant

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 for the

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

Emergency Systems, EPA listed

elements of good management

programs. The American Institute of

Chemical Engineers (AIChE) has

published Guidelines for Technical

Management of Chemical Process

Safety, which includes basically the

same elements. Delaware, New Jersey,

California. and Nevada have each

adopted state risk management program

regulations that again cover a similar set

of elements. The OSHA chemical

process safety management standard

covers this same set of elements. Labor

and environmental groups

recommended similar requirements to

Congress and the agencies. Therefore,

the prevention program EPA is

proposing today consists of elements

that the Federal government and several

state agencies, as well as trade

associations, professional organizations,

labor, and public interest groups believe

are necessary in order to have an

integrated approach to understanding

and managing risks associated with

regulated substances at a facility. The

elements of this integrated approach are

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54196 Federal Register / Vol. 58, No. 201 / Wednesday, October 20, 1993 / Proposed Rules

consistent with and fulfill the

requirements of the 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 of change, safety audits,

and accident investigation. The degree

of complexity required for compliance

for each element will depend on the

complexity of the facility. For example,

development of process safety

information would take far more time

and would require greater expertise at a

large petrochemical facility than it

would at a small drinking water system.

As they develop plans for implementing

the elements, facility owners or

operators would have to consider the

complexity of their chemical use, the

hazards potentially posed by the

chemicals, and potential consequences

of an accidental release.

The prevention program elements

must be integrated with each other on

an ongoing basis. For example, each

time a new substance is introduced to

a process or new equipment is installed,

the process hazard analysis must be

reviewed, SOPs updated, training and

maintenance programs revised, with

new training if needed. An investigation

of a near 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 need to review

the process hazard analysis. The

management system should ensure that

a change in any single element leads to

a review of other elements to identify

any impacts caused by the change.

Management System

Because it is essential that all of the

prevention program elements be

integrated into a management system

that is implemented on an ongoing

basis, EPA is proposing that the owner

or operator of the facility designate a

single person or position to be

responsible for the development and

implementation of the overall program.

At facilities where individual elements

of the program are handled by different

people or divisions,. the names or

positions of the 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 a large 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

in charge of training know when SOPs

have been revised and that the

emergency response personnel know

when changes to processes may affect

the hazards in a location. The purpose

of the proposed management

requirement is to have facility

management define a system that

integrates the implementation of the

elements and assigns responsibility for

that implementation.

Process Hazard Analysis

The AIChE's Guidelines for Hazard

Evaluation Procedures (AIChE, 1985)

defines a hazard evaluation (also known

as a process hazard analysis) as a

procedure intended "to identify the

azards that exist, the consequences

that may occur as a result of the

hazards, the likelihood that events may

take place that 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 a formal technique,

such as a "What If" or a hazards and

operability study (HAZOP). (AIChE's

Guidelines for Hazard Evaluation

Procedures provides descriptions of

these techniques.) Formal techniques

provide a method for a rigorous, stepby-step examination of processes,

process equipment and controls, and

procedures to identify eachpoint at

which a mishap may occur (e.g., a valve

failing, a gauge malfunctioning, human

error) and examine the possible

consequences of that mishap, by itself

and in combination with other possible

mishaps. The result of a properly

conducted process hazard analysis is a

list of possible hazards of the process at

the facility that could lead to a loss of

containment and release of a 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 of five to seven people. For a

simple process, the process hazard

analysis may take 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 for the

Review of Emergency Systems, it was

clear that a substantial number of

respondents did not recognize the

hazards associated with either the

chemicals involved or the processes

used. For the most commonly used,

high-volume chemicals, such as

ammonia and chlorine, a large number

of facilities 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 loss of pressure, power, and

fire water because the power, steam, and

water lines were co-located with the

lines carrying flammable gases. The

losses complicated and prolonged the

process of responding 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 of all utilities. A thorough and

properly done process hazard analysis

should identify these types of potential

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) could be prevented by

redundant or backup controls or by

frequent maintenance and inspection

practices.

Many other elements of a risk

management program should flow from,

or at least be revised based on, the

results of the process 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 of the 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
Federal Register / Vol. 58, No. 201 / Wednesday, October 20, 1993 / Proposed Rules

the likelihood of an accidental release

often increase the efficiency of

operations and result in waste

minimization. These changes may reduce costs for facilities by improving

the consistency and quality of products

and by decreasing the amount of waste

that needs to be treated.

The proposed rule would require

facilities to conduct process hazard

analyses after determining a priority order for the analyses based on the

degree of hazard posed by the processes

covered by the rule; that is, the facility

would have to conduct its analyses on

the most hazardous processes first,

where the degree of hazard is related to

potential offsite consequences,

operating history of the process, and the

age of the process. Facilities would be

required to use one or more of six

techniques: What If, Checklist, What If/

Checklist, HAZOP, failure mode and

effects analysis, or fault 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 of the process hazard

analysis procedure will depend on the

complexity of the processes to which it

is applied. Any of the listed techniques

can be used for simple and complex

processes although, for simple

processes, the simpler procedures, such

as the What If, may be 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 of the more

complex procedures, such as the

HAZOP or fault tree, requires

considerable technical expertise and

may be more appropriate for complex

processes, such as those at

petrochemical facilities. In some cases,

facilities will want to use several

techniques; for example, a facility might

start with a What If analysis to identify ' high hazard areas, then use a HAZOP or

fault tree method to examine those areas

in greater detail. EPA is planning 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 of the process and

procedures to identify ways in which

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 a person 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 in response

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 that the owner or operator.

investigate and document a plan for (or

a rationale for not) installing systems to

detect, contain, or mitigate accidental

releases if such systems are not already

in place. Because accidental releases

can be limited or mitigated by the use

of detection, 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 best way 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 be technically feasible

for certain types of releases. In other

cases, steps such as improved

procedures .and maintenance may

provide a more cost-effective approach

to controlling the hazards. The purpose

of the requirement is to ensure that

facilities consider the available options

and find the best method for the facility

to address accidental releases.

As required by the CAA, the process

hazard analysis must be reviewed and

updated periodically. EPA is proposing

that the process hazard analysis be

reviewed and updated at least every five

years, which is the same interval

specified in the OSHA process safety

management standard.

Process Safety Information

The process hazard analysis must be

based on up-to-date chemical and

process information, including

information on physical 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 of the

rule, facilities would also have to

document material and energy balances

for new equipment in a process that

involve a regulated substance above the

threshold quantity to ensure that the

equipment is appropriately designed for

the process. The material balance is

intended only for ensuring the proper

design basis for the equipment and is

not useful for process inventory

accounting or measurement of chemical

loss. For example, it is necessary to

know the flow rate in mass per unittime to properly design a heat

exchanger; however, this flow rate does

not give the mass of the substance

consumed or lost in a reaction system.

All required process safety information

would apply only to affected

equipment, not the facility as a whole.

Chemical information is available from

Material Safety Data Sheets (MSDSs)

mandated under OSHA's hazard

communication standard (29 CFR

1910.1200). The level of process

technology and equipment information

would vary with the type of facility. For

warehouses, wholesalers, and service

industries, little equipment information

would be needed unless special

equipment is used with the regulated

substances. For manufacturers, more

extensive information would be

required, including flow charts, piping

and instrumentation diagrams of the

facility as it currently exists, and

electrical, relief, ventilation, and safety

system specifications.

Standard Operating Procedures (SOPs)

The results of the process hazard

analysis, information developed during

the design of a process, and industry

and facility experience combine to

define the proper way to conduct

operations and maintain equipment.

SOPs describe the tasks to be performed

by the operator, the operating

parameters (e.g., temperature, pressure)

that must be maintained, and safety

precautions needed for both operations

and maintenance activities. SOPs must

specify the consequences of deviations

from safe operating limits (e.g., if the

safe operating temperatures are between

100 and 150 0C, the SOPs should

indicate what happens if the

temperature is above or below those

limits). Written SOPs provide a guide to

safe operations in a form that can be

used by employees. Lack of SOPs and

inadequate SOPs have been implicated

in a number of catastrophic accidents.

For example, improper maintenance

procedures have been blamed 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,

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54198 Federal Register / Vol. 58, No. 201 / Wednesday, October 20, 1993 / Proposed Rules

provide a quick source of information

that can prevent or mitigate the effects

of accidents. SOPs also provide workers

and management a standard against

which to assess performance; the

procedures clarify for both operators

and supervisors how operations should

be carried out at the facility. Application of SOPs can result in more

cost-effective operations by ensuring that operators adhere to procedures that

maximize both the safety and efficiency

of a process. EPA is proposing that each facility

develop written SOPs for each process

and operation involving the regulated

substance above the threshold. The

SOPs would include instructions on

steps for each 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 of hazards 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 facility by support

personnel The level of detail included in the

SOP should be appropriate for the

operation covered. For example, instructions for proper storage of

chemicals may be relatively brief, while

procedures for routine startup of a

complex process may require considerable detail to ensure that each

action required is detailed and

explained. EPA emphasizes that the

SOPs should be usable by the operators in running the process; that is, the SOPs

should be written in a language and at

a level appropriate for the operators.

Training

Training provides employees with the

information needed to understand what

they must do to operate safely and why safe operations are necessary. The

required training program is the key to

ensuring the effectiveness of other

program elements such as SOPs,

maintenance programs, pre-startup reviews, and emergency response.

Refresher training ensures that

employees are reminded of appropriate

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 of property at

the facility. In 1988, at a plating facility

in Auburn, Indiana, untrained workers

used hydrochloric acid to clean a tank

that had held zinc cyanide. The

resulting hydrogen cyanide killed five

workers and sent more than ten others

to the hospital.

The proposed rule would require each

owner or operator to train 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 that reflects its individual

situation. Facilities that handle but do

not process regulated substances (e.g.,

many facilities in the nonmanufacturing sector) may provide

relatively brief training because the

procedures to be taught involve a few

simple steps. For a complex

manufacturing facility, training may

take much longer for some operations. For some facilities, formal group

training programs may be feasible; for

small facilities, one-on-one training may be more appropriate. The form of the

training program is less important than

that relevant training is delivered in a

manner most likely to be understood.

Facilities would be required to

document their training programs to

indicate when employees were trained.

EPA is also not proposing specific

means of ensuring that the training is

understood, such as testing, 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 must include requirements for

equipment maintenance. Preventive

maintenance, inspection, and testing of

equipment are critical to safe operations

at a facility. Waiting for equipment to

fail often means waiting until an

accidental release occurs before

addressing a problem. This approach is

not acceptable, especially considering the extremely hazardous characteristics

of the regulated substances. Preventive

maintenance, inspection, and testing are

needed because many of the potential

failures are not obvious from visual

inspections. For example, failed alarm

systems or detectors may need to be

tested to determine if they are

functioning properly; detectors and

monitors, which can provide early warnings of releases, must be brated

periodically; corrosion of vessels and

piping, a hazard with many chemicals,

can be detected through testing well

before the vessels or pipes fail;

scheduled cleaning, oiling, or

replacement of parts can prevent

equipment failure. A large number of

the accidents reported in the Marsh and

McLennan review of the 100 largest

losses in the petrochemical industry

(Large Property Damage Losses in the

Hydrocarbon-Chemical Industries, a

Thirty-Year Review, 1990) were the

result of equipment failure that might

have been avoided through preventive

maintenance. A 1978 fir, and explosion

at a Texas City, Texas, facility that led

to almost $100 million in property

damage was attributed to instrument

failure and a faulty relief valve. A 1989

accident in Richmond, California, that

injured workers and responders was

caused by a failed weld.

Besides preventing accidental

releases, maintenance programs also

provide direct benefits to facilities by

decreasing the amount of cosly downtime that can result from failed

equipment. Even in incidents where

there is serious property damage, the

lost business costs can be significantly

greater than 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 such maintenance would depend on

the equipment and how it is used.

Manufacturers' recommendations may

be used to set such schedules and

determine testing procedures, but the

applicability of those recommendations

should be reviewed in light of industry and facility experience and the results

of the process hazard analysis. In some

cases, facilities will need to schedule

more frequent inspections based on

their specific uses or experience with

equipment failure rates, or because the

process hazard analysis indicated that
Federal Register / Vol. 58, No. 201 / Wednesday, October 20. 1993 / Proposed Rules 54199

failure of a particular piece of

equipment could result in a catastrophic

loss of containment. Facilities would be

required to replace or repair in a timely

manner any equipment that is found to

be outside acceptable limits. Facilities

would also be required to develop

procedures to ensure that replacement

equipment and parts meet design

specifications. Owners and operators

would be required to document their

maintenance program, including the

written procedures, the schedules used,

and the results of each inspection and

test performed. The level of complexity

and detail in the maintenance program

would be directly related to the

complexity of the operations and

equipment.

Pre-Startup Review

Startup of a new or modified system

can be a particularly hazardous time for

facilities, especially for complex

processes and those that require high

temperatures, high pressures, or

[Iotentially exothermic reactions.

However, even simple facilities need to

conduct such reviews. For example,

before a chemical distributor accepts a

new regulated 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 a process

hazard analysis prior to startup. A

substantially modified process would

include any process where the changes

to the process are significant enough to

require a reevaluation of the hazards

involved because new hazards may have

been created as a result of the changes.

This review would include a list of

items that operators would need to

check or test before beginning an

operation. Each pre-startup review

should ensure that SOPs are in place

and training has been conducted.

Management of Change

Chemical processes are integrated

systems; changes in one part of the

process can have unintended effects in

other parts of the system. For example,

installation of better seals may increase

the pressure in vessels. It is, therefore,

important that all changes in processes,

chemicals, and procedures be reviewed

prior to their implementation to identify

any potential hazards that may be

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 of the change.

Other process modifications are

instituted in response to a specific

problem that arises unexpectedly. It was

such an unexamined change in the'

installation of a 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 of change 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 ensure that 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 of the device replaced),

processes, chemicals, or procedures to

ensure that the technical basis of the

change is documented-and that the

change does not create new hazards; if

new hazards are created or if the 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 of changes; the

process hazard analysis and hazard

assessment may need to be revised as

well.

Safety Audits

An important tool in ensuring that the

process safety management elements are

being implemented is the periodic

safety audit. The safety audit provides

management with a mechanism for

oversight of the implementation of the

safety elements and of the overall safety

of the facility. Safety audits may take

many different forms; some facilities use

audits to check on compliance with

specific regulations, some do spotchecks of safety 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, and being implemented

properly. Although compliance with the

proposed elements will provide an

indication of safe operations, other

considerations are important as well.

For example, it is not enough to develop

and train employees on standard

operating procedures; the facility must

check to see that procedures are being

followed. Therefore, a safety audit is

more than a review of regulatory

compliance; it is a check, by

management, that the facility is being

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 with the OSHA

requirement for safety audits. EPA notes

that for large facilities and those with a

number of covered processes, the audit

would not need 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 about hazards and the steps

needed to prevent accidental releases.

Many times, the immediate cause of an

accident is the result of a series of other

problems that need to be addressed to

prevent recurrences. For example, an

operator's mistake may be the result of

poor training, inappropriate SOPs, or

poor design of control systems;

equipment failure may result from

improper maintenance, misuse of

equipment (operating at too high a

temperature), or use of incompatible

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 had the potential to cause

offsite death, injury, or serious adverse

effects on human health and the

environment. EPA notes that significant

accidental release does not include near

misses. EPA agrees with AIChE that

"while it is important to investigate all

incidents, as the lessons learned in

preventing future incidents are not at all

related to the magnitude of the

occurrence, it is unquestionable that, at

the very least, 'major incidents' should

be investigated" (Guidelines for

Technical Management of Chemical

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 accidental
54200 Federal Register / Vol. 58, No. 201 / Wednesday, October 20, 1993 / Proposed Rules

release of a regulated substance that has

caused or has the potential to cause

offsite consequences such as death,

injury, or adverse effects to human

health or the environment or to cause

the public to shelter-in-place or be

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

covers too broad or too narrow a set of

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 of the root causes

(e.g., misdesigned piping run) 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 need to be taken 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 of change

procedures, the degree of the accident

investigation and documentation will

vary with the potential seriousness of

the accident. For example, a minor

release that was prevented from

becoming a major release only by

prompt action of operators 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 of such incidents

may provide facilities with important

information on problems that should be

addressed before a significant accidental

release occurs. Information on near

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 not affect the public

or the environment because of favorable

weather conditions at the time of the

release, a near miss. EPA considers this

incident a significant accidental release

and, therefore, it needs to be

investigated. A near miss would refer to

mishaps that did not result in a release

for some reason other than explicit

system design. For example, a release

from a pressure relief valve that is

vented to a scrubber would not be a near

miss because the system is designed to

ensure that relief valve releases are

contained and treated. A near miss is a

mishap that did not result in a release

because of employee actions or luck. For

example,-a runaway reaction that is

brought under control by operators is a

near miss and should be investigated to

determine why the problem occurred.

EPA requests comments on whether

facilities should be required to

investigate near misses and on how near

miss should be defined.

Emergency Response

CAA specifies that the 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 a necessary

9art of a risk management program

ecause accidents do happen even with

the best safety systems in place.

Emergency response procedures can

reduce the severity of a 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 if releases have the potential

to damage or destroy-utilities and

equipment needed to respond to the

incident. The emergency response plan

helps define these worst cases and

develop an approach to prevent

potential problems. EPA is proposing that each facility

develop an emergency response plan

that defines the steps the facility and

each employee should take during an

accidental release of a regulated

substance. The plan would include both

evacuation or protective action

procedures for employees not directly

involved in the response to the release,

and the actions taken by employees

responsible for responding to and

mitigating the release. All employees

would be trained in applicable

emergency response procedures. The

emergency response plan would include

descriptions of all response and

mitigation systems. The emergency response plan would

also include procedures for notifying

the public of releases 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 of the LEPC, the

facility would be required to provide the

LEPC with information necessary to

develop and implement the LEPC plan.

This requirement is a restatement of the

mandate of EPCRA 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

for the use of emergency 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 of these tests.

Most facilities are already required to

have at least part of the 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 for their facility response

personnel. Facilities covered by EPA's

RCRA regulations (40 CFR Parts 264 and

265) or by Spill prevention Control and

Countermeasure rules (40 CFR Part 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. RMP and Documentation

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, and be made

available to the public. EPA is

proposing to make a distinction between

the RMP that is submitted to these

agencies (and through them to the

public) and the documentation

supporting the implementation of the

risk management program elements that

a facility would be required to maintain

on site for inspection by EPA and other

agencies. The purpose of the 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 Is using to manage the risks and,

second, to have the facility develop an

ongoing system for managing

implementation of safety practices and

procedures. The information provided
Federal Register / Vol. 58, No. 201 / Wednesday' October 20, 1993 / Proposed Rules

in the RMP will assist government

agencies in assessing the quality and

thoroughness of a facility's risk

management program. Because of the

large number of potentially affected

facilities, it is unlikely that EPA or the

state implementing agency will audit a

substantial percentage of the facilities in

any one year. Consequently, it is

important that government agencies

have enough information in the RMP to

identify those facilities that pose the

greatest potential hazards, either

because of the quantity and kind of

substances in use or because 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

add to these data by providing

information on hazards and practices.

For example, a large facility with a wellimplemented risk management system

may pose less of a hazard than smaller

facilities, with smaller quantities of

chemicals, that have weak programs.

With this information, local planners

will be better able to focus on facilities

that pose the greatest risk and target

their work with facilities to improve

prevention practices. The public will be

able to Identify hazards and risk

management procedures from the RMP

without having important information

obscured by detailed submissions.

The second purpose of the RMP is to

assist facilities in integrating the risk

management program elements. Each

facility will approach the management

of its hazards in a way that is

appropriate for its specific situation.'For

small facilities, one person may be

responsible for implementing and

integrating the elements. In large

corporations, many of the 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 thinks that this is an

essential step in successful

implementation of the program because

unless management Is accountable for

safety and makes it a priority, other

employees may not consider safety

important. Equally important, by

reporting onhow it is addressing each

of its major hazards, the facility would

have to explain how it has 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 of the registration form;

* A summary of the offsite

consequence analyses including worstcase and other more likely release

scenarios;

* The five-year history of significant

accidental releases for each regulated

substance;

* A list of the major hazards defined

through the process hazard analysis, the

consequences of failure to control each

major hazard, the steps management is

taking or planning to take to address the

hazards, and an implementation

schedule for each step listed;

e A summary of any risk management

program elements not covered under the

steps taken to address specific hazards

(e.g., if training has not been revised to

respond to any listed hazard, a summary

of the training program would be

neeued);

e A summary of the facility's

emergency response program, including

dates and schedules for drills completed

and planned, information on

coordinatipn with the public,

procedures for notifying and alerting the

public of a release, and the name of

person responsible for coordinating

with public agencies; * Adescription of the management

system used to implement and integrate

the elements of the hazard assessment,

prevention program, and emergency

response program; and

* A certification of the accuracy and

completeness of the information.

EPA envisions the RMP to be

comprehensive and succinct. The offsite

consequence analysis information

should be a summary of the

documentation already developed

during the hazard assessment. To keep

the size of the RMP manageable, EPA

requests comments on whether it should

specify a maximum number of release

scenarios a facility may submit as part

of its offsite consequence analyses.

Complex facilities may conduct a

substantial number of such scenarios;

submission of every scenario analyzed

could overwhelm the user and make the

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, but rather that the RWP

include only those hazards that have the

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, if corrosion in

piping is a hazard, the facility would list

corrosion in piping followed by any

steps taken to control corrosion and to

ensure that corroded pipes are replaced

before a release occurs. These steps

might include periodic ultrasonic

testing, replacement of pipes, or

sometIng similar. For facilities where

the steps taken to address hazards apply

to several hazards, the hazards can be

grouped under the steps. For example,

if revised operating procedures and

training were used to control and

prevent a number of hazards, the facility

could list operating procedures and

training followed by the hazards to

which they apply. In this way,

duplicative entries can be minimized.

The length of the list of hazards would

vary with the complexity of the facility

and with the current state of prevention

practices.

EPA is proposing an RMP that

summarizes the program because the

Agency believes that the information of

most use to the public and local

agencies will be related to the hazard

assessment and consequence analysis,

as well as general descriptions of

hazards at the facility. Other detailed

information is likely to be of little

interest and, if submitted, could

overwhelm the ability of local agencies

to manage and use the information. EPA

also believes that the RMPs should not

include information -that facilities can

legitimately claim as confidential

business information under CAA

section 114(c). The RIMP should provide

local and state agencies and the public

with sufficient information to determine

if additional information is needed. The

* information will be available, if needed,

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 find useful in

assessing the hazards posed by facilities.

EPA also requests comments on the

kinds of information facilities consider

confidential (and how facilities can

report on hazards without revealing

confidential data). EPA is proposing that the RMP shall

be submitted to the Chemical Safety and

Hazard Investigation Board, to the

implementing agency, the state, and to

local emergency planning committees.

EPA asks for comments on other local

agencies that may want a copy of the

RMP. EPA is concerned about the

burden such submissions may place on

the entities receiving the RMPs. If each

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 from a few to more

than 50 plans.

54201
54202 Federal Register / Vol. 58, No. 201 / Wednesday, October 20, 1993 / Proposed Rules

EPA is considering three options that

might lessen the burden. First, EPA

could develop computer software that

would provide facilities with standard

formats for completing the information

required in the RMP. The RMP could

then be submitted on disk in 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 for the Board and the states,

many local entities are not equipped to

receive documents on disk. In addition,

many of the smaller facilities covered by

the rule may not yet be computerized.

Therefore, this approach would work for

only part of the facilities and recipients.

The second option would be to allow

local authorities to designate the state as

the receiving entity, thereby lessening

the burden on the local authorities. The

third approach would be to require that

the RMP be submitted only on request

from the Board, state, or local entity.

Facilities would be required to develop

the RMP and keep a copy available on

site, but would submit it only if

requested. EPA solicits comments on

these approaches and specifically asks

for suggestions on other ways EPA

might be able to facilitate the

management and use of the RMP

information by state and local agencies.

Section 112(r)(7)(B)(iii) requires EPA

to establish, by rule, a system for

auditing RMPs and requiring revisions

where necessary. EPA is proposing that

facilities be selected for audits based on

a number of criteria. Specific accidents

at a facility or the facility's five-year

history of accidents would be one

criterion used to select a facility for an

audit; similarly, if other facilities in the

same industry show a pattern of

accidents with regulated substances, a

facility might be selected for an audit to

ensure that it is addressing the kinds of

hazards causing releases at similar

facilities. The quantities of regulated

substances or the presence of specific

regulated substances would also be

criteria. For example, facilities with

high volumes of one or more regulated

substance might be selected, or the

audits might focus on particular

substances. The location of the facility

would be a criterion for selection;

facilities close to populated areas, or

sensitive populations or ecosystems

might be audited because of the

potential hazard they pose. The hazards

Identified in the RMP would be a

criterion for selection. Finally, facilities

might be 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 of the RMP. If, based on the

audit, the implementing agency decides

that revisions to the RMP are needed,

the agency would issue a preliminary

determination explaining the basis for

the revision and a timetable. This

preliminary determination shall include

an explanation for the basis for the

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 days to respond to the

preliminary determination in writing,

either agreeing to implement the

changes or rejecting the revisions, in

whole or in part, with an explanation

for any rejection. In its response, the

owner or operator may develop

substitute revisions addressing the same

issues addressed in the 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 in violation of the 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 of its 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

of the process hazard analysis, safety

audit, and accident investigation. These

documentation requirements are similar

to those imposed under OSHA's

standard.

F. Registration

Information Required

The Act requires that RMPs be

registered with EPA prior to the

effective date of the regulation. EPA is

proposing that, within three years of the

date of publication of the final rule, all

facilities register with EPA if they have

a regulated substance in a quantity that

exceeds the threshold quantity. EPA is

proposing a simple registration that

would require most facilities to

complete a one-page form; facilities

with large numbers of regulated

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 of the

substances (in ranges), and the facility's

Standard Industrial Classification (SIC)

code(s) that apply to the use of each

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 of SIC codes with

specific substances would allow EPA to

identify the types of processes in which

a facility may use the substance without

requiring the facility to provide detailed

information during registration. The

Dun and Bradstreet number is a

common identifier for facilities 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

required to 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, for which chemicals, and in

which industries is essential to apply

criteria for selecting facilities for audits

in an equitable manner. Finally,

although many of the facilities file

similar information with EPA, no

current source of data includes all

facilities likely to be affected by the

proposed rule. EPCRA section 313, for

which a national database exists, covers

only manufacturers and does not

include many of the chemicals proposed

for listing. Some of the facilities will be

permitted under RCRA, but most will
Federal Register / Vol. 58, No. 201 / Wednesday, October 20, 1993 / Proposed Rules

not be. Except for facilities not covered - by OSHA's Hazard Communications

Standard, most other facilities

potentially affected by this proposed rule are also covered by EPCRA section

312. However, EPA does not receive

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 not required to file

chemical-specific information under

section 312. Even if every state had a

section 312 database, it would not be

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. An earlier registration

(either 12 months or 24 months after the

date of promulgation) would also help

states determine the scope of their

implementation programs. EPA requests

comments on whether an earlier

registration would be beneficial.

Implementation

EPA has two main concerns about the

implementation of the registration

requirement that multiple or

duplicative filings be avoided to the

maximum extent possible and that the

burden for processing the information

be minimized. EPA requests suggestions

on how the registration information

might be combined with other forms

facilities are required to file to limit the

repetitive reporting required of

facilities. For example, EPA is

considering using the EPCRA section

312 Tier II form as a substitute because

the Agency believes this would facilitate

integration of CAA activities with SARA

Title III activities and would lessen the

burden on facilities.

EPA's second concern involves the

burden on the government to process

the information filed. Each registration

will include information that would

need to be screened for accuracy. For

example, the Chemical Abstract Service

(CAS) number and chemical name

would need to be checked to make sure

that they match and are covered by the

rule. SIC codes, Dun and Bradatreet

numbers, and quantity range codes

would need to be reviewed to ensure

that the format (number of 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 would allow

electronic filin of the information. The

software would perform the quality

control function automatically. CAS

numbers would be checked to see if

they were on the list; the chemical name

could then be entered automatically. A

list of known synonyms for the listed

substances could be included. SIC codes

could be checked to ensure that the

codes entered actually exist; the format

for Dun & Bradstreet numbers could also

be reviewed. Messages alerting the

facility that the information entered was

not acceptable would be provided. Such

a computerized form would lessen the

time needed to process the information;

it would also provide facilities with a

quick check on the accuracy of their

information and assure them that the

data would be accurately represented in

EPA's database. If facilities used, such a

computerized filing, however, they would still need to submit a signed

certification. EPA recognizes that some

facilities may not be computerized or

may prefer to file a printed form.

Although EPA would prefer a

computerized filing, printed forms

would be acceptable.

EPA requests comments on its plan to

encourage computerized filings and

specifically solicits suggestions on how

such filings could be coordinated with

other information filed on disk. For

example, are there other software

packages for computerized EPA filings that the RP registration should be

compatible with to facilitate data

sharing and limit the amount of

rekeying facilities would have to do?

G. Prohibitions

CAA section 112(r)(7)(E) states that

after the effective date of the risk

management program regulations it

shall be unlawful for any person to

operate any stationary source subject to

the regulations in violation of the

requirements of the regulation. Violations of the risk management

program and other regulations

promulgated under CAA section

112(r)(7) are subject to the same

penalties as violations of National

Emissions Standards for Hazardous Air

Pollutants (NESHAPs) promulgated under CAA section 112(d). Persons in

violation of the requirements may be

subject to civil penalties of not more

than $25,000 per day per violation as

well as criminal penalties. Civil

penalties may be assessed through court

actions or through administrative orders

under section 113 of CAA.

H. Timing

The proposed rule must be

promuated by November 15, 1993, and

will be effective three years after the

date of promulgation. EPA is setting a

120-day comment period and will hold

a public hearing in Washington, DC, to

solicit comments.

IV. Comparison of EPA's Proposed Rule

to OSHA's Standard

A. Differences Between EPA's Proposed

Rule and OSHA's Standard

The primary differences between

today's proposed rule and OSHA's

process safety management standard are

the result of the different statutory

requirements for the two rules. The

CAA requires EPA to include several

elements in its regulation that are not

mandated for OSHA. Specifically, EPA's

rule must include a hazard assessment,

an emergency response program with

certain elements, registration, and the

submittal and auditing of the RMP. The

only other element EPA is proposing

that is not included in the OSHA

standard is the requirement for the

owner or operator of a facility to define

its management system and name the

person or position responsible for the

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 this requirement will create

no additional burden for facilities

because the proposed section would

only require facilities to provide the

name or names of people or positions

responsible for implementing the

progrm. EPA's proposed 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 of the information needed to I

define accidental release scenarios will

be derived from the process hazard

analysis, which would be the same

under the two rules. The main

differences under the EPA rule would

be the need to use air dispersion models

to analyze the distances-releases might

migrate and the need to document the

areas potentially affected by the

releases. EPA's z assessment also

is required to include a five-year release

history, which would overlap to some

degree with a requirement in the

OSHA's process hazard analysis.

EPA's proposed emergency response

provisions respond to the language in

the CAA and are somewhat different

from the OSHA requirement Under the

OSHA standard, facilities must comply

with one of two existing OSHA

standards. Facilities that are currently in.

compliance with OSHA's Hazardous

Waste Operations and Emergency

Response standard (29 CFR 1910.120)

54203
54204 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

be taken in response to an accidental

release of a regulated substance so as to

protect human health and the

environment" (CAA section

112(r)(7)(B)(ii)). Therefore, facilities that

currently have only an emergency

action plan required under 29 CFR

1910.138(a) would, under EPA's

proposed rule, need to develop a more

extensive emergency response plan that

details how the facility would respond

to a release to limit offsite

consequences. EPA is also proposing

that facilities conduct drills and

exercises to test their plans. Without

such exercises, a facility will not be

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 not required 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 of complying with the rules.

See Section X of this Preamble for a

discussion of the incremental burden

imposed by the EPA rule over the OSHA

rule.

B. Section by Section Comparison of the

EPA Prevention Program and the OSHA

Standard

Except for the 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 of the

section's requirements and the level of

detail expected of different 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 of the two agencies. The specific parallel elements of the

two rules are as follows:

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 the number of potentially affected

employees; (3) OSHA's schedule for

implementation would not be included

because the CAA requires that facilities

comply with EPA's rule within three

years of the date of promulgation and,

therefore, OSHA's five-year schedule

could not be used; (4) the identification

of previous incidents would be limited

to those with offsite consequences

rather than those with catastrophic

consequences in the workplace; and (5)

the qualitative evaluation of safety 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 of releases, such as the release at

Bhopal, have their primary impact off

site. EPA's rule would ensure that these

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

of the consequences of process

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 a requirement that

facilities evaluate the effectiveness of

their training programs and revise the

programs, if necessary, based on the

evaluation,

* EPA's maintenance requirements

§ 68.32) uses the same language as

OSHA's mechanical integrity paragraph

(29 CFR 1910.119(j)) with certain

exceptions. EPA would use the term "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 of equipment that requires

maintenance; the OSHA standard

provides a list of equipment. EPA's

paragraph (b) includes the OSHA list,

ut EPA is concerned that for some

facilities the list may be too extensive

and for others it may not be

comprehensive. For example, for

warehouses, the only equipment that

may need maintenance may be the

sprinkler system and the forklifts,

neither of which are on the list. EPA

believes the responsibility should be on

the facility to develop a list, 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 of the word "maintenance"

would clarify that equipment should be

maintained on a regular basis; for some

equipment simple routine 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 of maintenance workers

would be documented in the 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 of the facility.

e EPA's management of change

requirements (§ 68.36) are identical to

OSHA's paragraph (29 CFR 1910.119(1)),

except for the 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 of change on

health and safety" to "impact of change

on likelihood of a significant accidental

release."

* EPA's safety audit requirement § 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) are identical to

OSHA's incident investigation

paragraph (29 CFR 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), of a

requirement that the procedures be

written; (3) the requirement in

paragraph (c) that incidents that require

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

root causes as well as initiating events.

The OSHA standard includes several

requirements that are not covered by

EPA's proposed rule-worker

consultation, hot work 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 for the CAA already are

covered in 40 CFR part 2.

Finally, although EPA recognizes the

importance of contractor competence on

safety, EPA believes this issue is

primarily one that OSHA should

address, as it has in its section on

contractors. In addition, EPA believes

that contractors are mainly an issue at

larger companies, most of which 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

State Requirements

Federal Regulations

A number of the facilities potentially

affected by today's proposed rule are

also covered by other Federal , requirements that may relate to

practices that will be included in the

risk management program. As discussed

in the section on emergency response,

several EPA programs require facilities

to develop emergency response plans.

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

of hazardous materials for

transportation are covered by DOT

regulations, as are storage incident to

transportation and repackaging for

resale and transportation. 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 all of the requirements of the

proposed rule and, if so, how the rule

should acknowledge this fact to ensure

that facilities understand what, if any,

additional steps they must take to come

into compliance with the risk

management program requirements.

State Laws

Four states--California, New Jersey,

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 address the same basic

elements that EPA is proposing in this

rulemaking, except that the California

program does not specify a management

of change procedure. The New Jersey

Toxic Catastrophe Prevention Act

(TCPA) program is the most detailed

program, specifying to a considerable

degree the information required to be

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 of the

programs; the California risk

management plan program developed

by each affected facility is driven by the

results of the 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 at the state

level. California has delegated

implementation authority to more than

100 administering agencies, which are

usually the fire or health 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 if the

agency determines that the facility does

not pose a significant risk to the

community. Each of the states has a different list

of chemicals and thresholds. New

Jersey's list covers 109 acutely toxic

substances; Delaware covers 90 toxic

substances, as well as flammables and

explosives; California covers all 360 of

the EPCRA section 302 list of extremely

hazardous substances; Nevada adopted

OSHA's list of highly 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 of the 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 of today'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-case basis, to what extent a California

facility will be in compliance with

EPA's rule.

The Clean Air Act section 112(1)

allows EPA to delegate the

implementation of the risk management

54205
54Z06 Federal Register I Vol. 58, No. 201 / Wednesday, October 20, 1993 / Proposed Rules

program to states that have an approved

progm. The criteria for state programs

are isted in CAA section 112(l)(5). The

Act allows states to adopt the Federal

program or implement a program that is

more stringent. Consequently, the

existing state programs will require

some revisions to meet EPA's

requirements or set more stringent

requirements than those established by

the EPA rule. EPA expects that most of

the needed changes will involve the

listing of chemicals and adjusting of

thresholds. Other states that 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 to adopt the

requirements of these regulations. EPA

will provide additional guidance for

states before the final rule is

promulgated.

VI. Other Approaches 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 a substantial burden. EPA

considered three approaches, therefore,

that might reduce this burden. Each of

these approaches would create two tiers

of risk 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 simple as a multiple of

threshold quantity (e.g., an expanded

risk maiagement 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

of sensitive populations (e.g., hospitals,

schools, residences), similar to the

approach used in Delaware. 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 of criteria 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 of the 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 program based on the

offsite consequence analysis: If the

worst-case release could not expose the

public or the environment to significant

risks, the facility would not need an

expanded risk management program.

Although this approach is a better way

to determine whether the potential risks

of a facility merit an expanded risk

management program, it is fraught 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 not be

appropriate for others. EPA believes that

this approach would leave facilities

uncertain of the legal status of their

decisions and create difficulties for

enforcement by governments and

citizens. In addition, given the

experience of Delaware facilities, it is

likely that many smaller facilities and

those outside the manufacturing sector

would have substantial difficulty

understanding and implementing this

approach. EPA notes that most of the

facilities potentially affected by the

proposed rule are non-manufacturers;

less than five percent of the potentially

affected facilities are chemical

manufacturers or petroleum refineries.

The final approach considered would

be to follow the California model and let

local or state agencies decide which

facilities pose the greatest threat and,

therefore, require an expanded risk

management program. EPA believes that

local agencies are in the best position to

Identify and evaluate local hazards.

However, the viability of this approach

rests on the ability and willingness of

state or local groups to make these

decisions. This approach would impose

a considerable burden on state and local

authorities. It could also lead to the

uneven imposition of requirements on

facilities if states or localities chose to

cover facilities differently. Some

facilities already covered by risk

management program rules believe that

they have been placed at a substantial

competitive disadvantage because they

are complying with the state law, while

similar facilities in other states are not.

An uneven implementation also leaves

the protection of the public uneven.

EPA requests comments on these

approaches and methods that could be

used to create tiers in risk management

program requirements. EPA also

requests comments on what a 'minimalprogram" would be, given the

Congressional mandate that requires the

risk management program to include a

hazard assessment, a prevention

program that includes safety

procedures, maintenance, monitoring,

and training, and an emergency

response plan.

VII. Guidance

The CAA requires EPA to publish,

when the final rule Is promugated,

guidelines to assist facilities in the

preparation of risk management

programs. The guidelines shall, to the

extent possible, include model RMPs.

EPA is aware that for many facilities,

especially those outside the chemical

and petroleum refining industry and

many smaller facilities, the risk

management program approach and

some of the elements will be unfamiliar.

EPA intends, therefore, to provide as

much guidance as possible and to

encourage trade associations,

professional organizations, labor, and

others to develop and disseminate

appropriate guidance as well. EPA

requests comments on areas where

_guidance is needed (e.g., process hazard

analyses, maintenance programs), the

levels at which guidance should be

directed, and appropriate formats for the

guidance.

EPA has Identified industry sectors

that may be candidates for model risk

management programs. Generally, most

of the covered facilities in these sectors

are using the same chemical in the same

way, with similar types of equipment.

The similarity will allow EPA to

develop guidance on the chemical and

process hazards, identify typical

hazards that need to be considered in

the process hazard 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 of the guidance will not be

to provide facilities with an "off-theshelf" plan, but rather to provide a

framework that the facility can use to

analyze its own operations and develop

a program to manage risks.

Industry sectors that may be

-appropriate for model risk management

programs include chlorine and

ammonia users such as public drinking

water systems and wastewater treatment

works, cold storage facilities,

wholesalers, and propane retailers. EPA

requests suggestions for other industry

groups for which modal risk

management programs may be possible.
Federal Register / Vol. 58, No. 201 / Wednesday, October 20, 1993 / Proposed Rules

VIII. Information Gathering Efforts

Before EPA began writing its

proposed rule on risk management

programs, the Agency decided to seek

information from those already

implementing risk management program

regulations. EPA staff met extensively

with officials in the 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 (two each in

New Jersey and California, one in

Delaware), and three with administering

agency officials in California, to elicit

their opinions of the risk management

program regulations in their respective

states and their ideas about what EPA

should consider as it develops 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 at the state level. Officials from

California, Delaware, and New Jersey, as

well as New 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 set priorities.

Larger facilities, especially those in the

chemical and petroleum industries,

currently have more risk management

program elements in place 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

risk management program elements.

Various industry participants

recommended that the risk management

program regulations give facilities the

flexibility to tailor a program 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 or among inspectors.

Inconsistently applied regulations create

competitive disadvantages and

undermine the willingness of facilities

to comply. Many participants from

various sectors expressed the view that

guidance and technical assistance will

be needed at the state, local, and facility

levels, and that education and outreach

efforts will be 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 if they are in conxpliance

with one rule, they would automatically

be in compliance with all rules, at least

for a specific chemical. There was a

general concern that the expertise to

implement the program may not be

uniformly available in the short-term.

This lack of expertise will affect both

facilities and government a~encies.

A report on this information gathering

effort entitled Clean Air Act of 1990,

Chemical Accident Release Provisions,

Report on Focus Groups and Round

Table Discussions is available in the

docket as are transcripts of the eight

focus groups.

IX. Section by Section Discussion of the

Proposed Rule

EPA is proposing to add a new part

68 to 40 CFR, which would include the

risk management program requirements,

as well as the list of regulated

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 this rulemaking. Proposed § 68.1 would define the

scope of the part.

Proposed § 68.3 would provide

definitions applicable to the Part.

Proposed § 68.10 would define the

applicability of the risk management

plan requirements to all stationary

sources where a regulated substance is

present in a process at any one time in

more than the threshold quantity. The

section also includes the effective dates

for the risk management program

elements. Facilities would be required

to develop and implement all risk

management program elements within

three years of the date of promulgation

of the rule or within three years 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 for registration. Facilities

would be required to register three years

after the date of promulgation of the rule

or within three years of date on which

the facility becomes subject to the rule

(either because the facility introduces a

new regulated substance to its

operations or a new substance is listed).

If the information submitted on a

registration form is no longer accurate,

facilities would be required to update

the information within 60 days of the

change.

Proposed § 68.15 would provide the

requirements for the hazard assessment.

Facilities would be required to complete

a hazard assessment for each 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 of a range of release

scenarios, including the worst-case and

other more likely significant accidental

release scenarios, would have to be

analyzed. The proposed section

specifies a number of scenarios that

should be considered and the

information that must be included in

the offsite consequence analyses. The

section also would require the facility to

develop and maintain a five-year history

of significant accidental releases and

releases with the potental for offsite

consequences for each 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 of the prevention program and

specify that the ten elements of the

program must be tailored to suit the

degree of hazard present at a facility and

the degree of complexity of the

operations.

Proposed § 68.22 would require

facilities to designate a person or

position responsible for overseeing the

development and implementation of the

prevention program elements. Where

other individuals are responsible for

separate elements, an organization chart

showing lines of authority 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 to be applied, with the

complexity of the process and potential

consequences of a 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

would be required to report findings

and recommendations to management.

The facility management would be

required to document its response to

each finding and recommendation, and

54207
54208 Federal Register / Vol. 58, No. 201 / Wednesday, October 20, 1993 / Proposed Rules

maintain a schedule for implementing

actions to address findings. If the

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 (or a

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

of chemical use, process technology, or

equipment require an earlier 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 for vessels, 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 of piping,

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 SOPs that

apply to them. Refresher training would

be required at least every three years.

The facility would have to develop a

method of ensuring that each employee

is competent. In addition, facilities

would be required to evaluate the

effectiveness of their 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

that current employees have the

knowledge and skills to carry out the

SOPs.

Proposed § 68.32 would require

facilities to develop a list of equipment

and controls whose failure could lead to

a significant accidental release of a

regulated substance. For items on the

list, a maintenance 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 of maintenance workers would

also be required. Equipment found to be

outside acceptable limits would have to

be replaced or repaired 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 would be required.

Records of each inspection, test, repair,

and replacement would be required.

Proposed § 68.34 would require

facilities to develop procedures to

ensure that a pre-startup review is

conducted before a new or modified

process is brought online. This section

would not apply 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

of each 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 of chemicals, processes, and

procedures are reviewedprior to

implementation. Replacement of

equipment or controls with a device that

meets the design specifications of the

replaced device would not be

considered a change. The procedures would ensure that the technical basis of

the change is documented and that the

consequences of the change are

evaluated. Process safety information

and the process hazard analysis would

be updated as needed, as would SOPs,

training, and maintenance programs.

The results of each 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 a report with findings

and recommendations. Management's

response to each finding and

recommendation would be documented,

with a schedule for implementation or

a rationale for not implementin$. Proposed § 68.40 would require

facilities to develop and implement

procedures to investigate each

significant accidental release.

Investigations would have to start

within 48 hours of the accident. The

investigation would document, in a

report to management, the initiating

event, root causes, and

recommendations for preventing

recurrences. Management would be

required to document its response to

each recommendation, with either a

schedule for implementation or a

rationale for not implementing the

recommendation. The results of the

investigation would have to be reviewed

with all potentially affected employees.

Proposed § 68.45 would require

facilities to develop a written emergency

response plan that would specify

procedures for employees not involved

in a response action, procedures for

responders, a list of all response and

mitigation technologies. The plan would

also include procedures for notifying

and alerting the public and public

response agencies. The facility would be

required to have procedures for the 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 test the

plan. Any drill or exercise would be

documented, with findings relevant to

plan revisions; management would be

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 of the RMP containing a

copy of the facility's registration form,

hazard assessments for each regulated

substance (i.e., worst-case scenario,

offsite consequences for a range of more

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 of failure to control each

major hazard, steps being taken to

address the hazards, implementation

schedules, a summary of other

prevention elements, a description of

the emergency response plan, a

description of the management system

for implementing and integrating the

risk management program, and a

certification of accuracy 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 to be

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 and Benefits

Agencies proposing and promulgating

regulations must consider both the costs

and benefits of those rules 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 of Listing Regated Substances

and Thresholds and Mandating Risk

Management Programs for Chemical

Accident Release Prevention, as

Required by Section 112(r) of the Clean

Air Act." is available in the docket.

As mentioned above, the cost

information in this section is based on

an analysis of this proposed rule and the

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 that the costs/benefits and

the universe of affected 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 the prevention program

elements and rate of current compliance

with these elements.

Options Considered

To evaluate alternatives, EPA

analyzed five list and threshold options

and two risk management program

options. The five 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 at the

EPCRA section 302 threshold planning

quantities (TPQs) where applicable; List

4-the full EPCRA section 302 list at the

TPQs; and List 5--the full EPCRA'

section 302 list of extremely hazardous

substances at the threshold planning

quantities, plus 62 flammables and high

explosives. The options were selected to

bound the different combinations of

chemicals and threshold quantities that

were under consideration by EPA

during development of the 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 not include many acutely toxic

chemicals that meet EPA's criteria for

listing, nor does it include all statutorily

mandated regulated substances. In

addition, many of the substances listed

by OSHA are reactives, which EPA has

not determined pose a significant

hazard to the public in the event of an

accidental release.

The RIA also considered two options

for risk management program

requirements: EPA's proposed rule; and

a more stringent version of the proposed

rule, modeled on the New Jersey state

regulations, which are more detailed

and impose more specific requirements

for many of the risk management

program elements. The OSHA standard

was not considered because it does not

fully meet the 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 surveys of

chemical inventories if they have any

amount of the 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 of the 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 New Jersey data

provide comprehensive coverage of SIC

codes, including the majority of fourdigit SIC codes across both the

manufacturing and non-manufacturing

sectors, and are reasonablyrepresentative of chemical use patterns

throughout the nation. In addition, New

Jersey facilities are required to report on

inventories of all acutely toxic

chemicals covered by EPA's listing

options. Further, the information in the

New Jersey database on number of

employees allows disaggregation of the

data by facility size. There are, however,

limitations to the New Jersey data; to the

extent possible, EPA augmented the

New Jersey data to adjust for these

limitations. For example, because

facilities in New Jersey are not required

to report on flammables, data from

Louisiana's EPCRA section 312 database

were used to develop estimates of the

number of additional facilities that

would be covered because of the listed

flammables. Similarly, certain industrial

sectors were clearly underrepresented in

the New Jersey data; adjustments were

made wherever possible to correct for

these limitations.

The New Jersey database was

searched by four-digit SIC code to

identify for each such code the number

of facilities that reported a listed toxic

chemical above the threshold. The

number of reports of regulated

substances per four-digit SIC code was

also obtained from the New Jersey data.

The information obtained from these

searches was compared with the

number of facilities in each four-digit

SIC code in New Jersey (based on 1988

County Business Pattern data). The ratio

of the number of facilities reporting the

presence of the 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 of facilities in each SIC code

potentially affected by the proposed

rule. The ratio of the number of

regulated substances reported per

facility in New Jersey in each four-digit

SIC code was used to estimate the

number of hazard 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 in the

state databases: public facilities, cold

storage facilities, and propane retailers.

To adjust for this underrepresentation of

public facilities, the analysis used EPA

data on public drinking water systems

and publicly owned treatment works to

estimate the number of public facilities

potentially affected by the proposed

rule. Industry information was used to

estimate the number of cold storage

facilities (i.e., food processors, food

distributors, and refrigerated

warehouses) and the number of propane

retailers.

In Delaware and New Jersey, 30

percent and 52 percent of the facilities

(respectively) that initially registered

under the state laws lowered inventories

or switched chemicals to avoid having

to comply with the risk management

program requirements, Based on this

experience, EPA assumed that 30

54209
54210 Federal Register / Vol. 58, No. 201 / Wednesday, October 20, 1993 / Proposed Rules

percent of the facilities in most

manufacturing, utility, and service

industries would take similar steps to

avoid being affected by EPA's proposed

rule. The final estimates of the number

of affected facilities in these sectors

were adjusted to account for this

expected change in chemical use. The

number of chemical manufacturers,

wholesalers, and propane distributors

was not adjusted downward; facilities in

these sectors were assumed to be unable

to reduce inventories sufficiently to

avoid coverage because of the 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 a refrigerant (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 the regulated

substances in simple ways and to have

available EPA model risk management

programs or guidance, described in

Section VII of this preamble, that would

lessen the burden of compliance.

Wholesalers and cold storage facilities

were divided into small and large

facilities based on the quantity of

chemicals on site because the

complexity of implementing the rule is

assumed more likely to be related to the

quantity of the chemicals on site rather

than the number of employees at a

facility. For example, some chemical

distributors have more than 100 million

pounds of a substance on site, but

employ fewer than 20 people, only some

of whom handle the substance. Public

and private utilities were assumed to be

smali because a limited 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 of facility. Costs were

developed on a per chemical, per

process, per release, or per facility basis

for each element of the program, as

appropriate. Because many facilities

already implement some of the risk

management program requirements

(e.g., training, emergency response

plans), costs were adjusted to account

for current compliance, based on

compliance estimates for each risk

management program element

developed by EPA, OSHA, an American

Paper Institute study of the actual level

of current compliance among its

members, and experts in the cold

storage industry.

For final cost calculations, 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 of the

proposed rule, and those covered by

EPA and OSHA, who would incur costs

only to implement the additional

elements covered in EPA'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

number of facilities 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 List 5 ......................................................................... 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 this universe,

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 of implementing all risk

management program requirements. The

total universe of covered facilities

includes 22,935 manufacturers

(covering all 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

did not estimate the cost of compliance

for a highly complex facility such as a

petroleum refinery because all of these

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 per process

for a simple facility to $35,000 per

evaluation for a 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 $36,000
Federal Register I Vol. 58, No. 201 1 Wednesday, October 20, 1993 / Proposed Rules

per process; and SOPs which vary from Benefits

$2,500 for a simple process to $14,000 The proposed risk management rule is

for a complex 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 not involve large. EPA has estimated a dollar value

special equipment and because model for many of these benefits; the

RlJPs and guidance are assumed to be methodology used to generate these

available to them, thus lessening the estimates is presented in chapter 7 of

burden. The cost of conducting the the RIA.

hazard assessment is estimated to vary The benefits of the proposed risk

from $70 per assessment for non- management rule were estimated using

manufacturers to $280 per assessment several quantitative techniques to

for large complex manufacturers; the investigate each of the different types of

number of assessments likely to be benefits expected to occur. First, the

required is estimated to vary from one proposed risk management rule is

(for a cold storage facility with only expected to reduce the number of

ammonia on site) to 10 for a significant hazardous chemical releases

petrochemical facility. The cost of occurring each year at facilities affected

developing the RMP is estimated to by the five list options. This reduction

range from $156 to more than $1,000 for in the number of releases was estimated

a highly complex facility. Registration using Accidental Release Information

costs are estimated to vary between $43 Program (ARIP) data for the four-year

and $105, depending on the number of period 1987-1990. The trend in the

substances on site. Table 2 presents the number of hazardous chemical releases

average cost per facility for in New Jersey, where many of the

manufacturers and non-manufacturers. riskmanagement program elements are

EPA estimates that the initial cost of the required to be in place already, was

proposed rule would be $503 million, compared with the trend in the number

EPA estimated subsequent year total of releases in the rest of the nation. The

costs for a period of ten years. Costs difference between the two, trends,

vary from year to year because certain approximately 27 percent at the end of

risk management program elements are the four-year period, provided an

not required to be updated yearly. For estimate of the magnitude of the

example, safety audits would be reduction in the number of hazardous

conducted every three years; hazard chemical releases that could be

assessments and process hazard expected to occur as a result of EPA's

analyses would be updated every five proposed risk management rule.

years. Table 3 presents the estimated The proposed rule is also expected to

costs for years one through five for the reduce the number of incidents of

five listing options. 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 as a result of releases of hazardous

chemicals. These reductions were

estimated by using a regression analysis

with ARIP data to predict the

probability that each type of

environmental damage, human impact,

or response action would occur as a

result of a hazardous chemical release.

both with and without the proposed risk

management program in effect. The

estimated probability that each type of

incident would occur was then

multiplied by the estimated number of

releases under each scenario (i.e., with

and without the risk management

program in effect) to derive an estimate

of the number of incidents causing

environmental damage, human impact,

or response actions that would be

avoided each year at facilities affected

by the proposed risk management rule.

The analysis indicated that the number

of incidents would decline by 35

percent or more. depending on the type

of incident and the List Option selected,

following implementation of the

proposed risk management program. For

human impacts and response actions,

the estimated number of incidents was

multiplied by the average number of

people injured, hospitalized, evacuated,

or sheltered in place to derive an

estimate of the number of people

affected per year by incidents of each

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

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54212 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 of the

benefits of the proposed risk

management program were estimated by

developing an estimate of the cost of

each type of incident, and then by

multiplying the estimated cost of each

type of incident by the number of

incidents avoided that may be attributed

to the presence of a risk management

program. The benefits of the proposed

rule are estimated to be approximately

$890 million per year. Table 4 presents

the estimated costs and benefits for each

of the 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 Order 12291

Under Executive Order 12291, the

Agency must judge 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 or more, (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 of E.O. 12291 because the

first year cost of the rule is estimated to

be $503 million. An RIA entitled,

"Regulatory Impact Analysis in Support

of Listing Regulated Substances and

Thresholds and Mandating Risk

Management Programs for Chemical

Accident Release Prevention, as

Required by Section 112(r) of the Clean

Air Act," has been 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 of the rule on

small entities and examine alternatives

that may reduce these effects. EPA has

prepared an analysis of the effects on

small entities. The analysis employed

three measures for assessing the effects

of the proposed rule, and the

alternatives, on small business: the

before-tax cost of compliance as a

percentage of firm sales; the after-tax

cost of compliance as a percentage of

net income; and the percent change in

the debt-to-asset ratio. The results

indicated that for 90 percent of the

small businesses affected, the economic

burden for initial costs would be mild.

For the remaining 10 percent, the

program would impose a significant

adverse effect in the first year, as

measured by the ratio of after-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

of ways, such as debt, current earnings,

and increased prices, rather than

finance compliance in one way.

Consequently, the impact of compliance

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 of compliance costs to revenues.

The full regulatory flexibility analysis is

included, as Chapter 8, in the RIA,

available in the docket.

C. Paperwork Reduction Act

The information collection

requirements in this proposed rule have

been submitted for approval to the

Office of Management 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 of information, which will

take place three years after the rule is

final, will vary depending on the size

and complexity of the facility and the

number of substances 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 of between

4.25 and 31.5 hours to prepare and

submit a risk management plan. These

hours reflect time for reviewing

instructions, searching existing data

sources, gathering and maintaining data

needed, and completing and reviewing

the collection of information.

Send comments regarding the burden

estimate or any other aspect of this

collection of information, 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 of Information and Regulatory

Affairs, Office of Management 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 of Subjects 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 of the Code of Federal

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-List of Regulated Substances

and Thresholds for Accidental Releaae

Prevention [Reserved]

Authority: 42 U.S.C. 7412(r) and

7601(a)(1).

Subpart A-General Provisions

168.1 Scope.

This part sets forth requirements for

chemical accident prevention steps that

must be taken by the owner or operator

of stationary sources.

§ 68.3 Definitions.

As used in this part, all terms not

defined shall have the meaning given to

them by the Clean Air Act (42 U.S.C..

7401 et seq.).

Act means the Clean Air Act as

amended (42 U.S.C. 7401 et seq.).

Administrator means the

administrator of the U.S. Environmental

Protection Agency. Analysis of offsite consequences

means a qualitative or quantitative

analysis of a range of accidental

releases, including worst-case releases,

to determine offsite effects including

potential exposures of affected

populations.

Mitigation system 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 of the stationary

source or areas within the property

boundary to which the public has

routine and unrestricted access.

Owner or operator means any person

who owns, leases, operates, or controls

a stationary source.

RMP means the risk management plan

required under § 68.50.

SIC means Standard Industrial

Classification.

Significant accidental release means

any accidental release of a regulated

substance that has caused or has the

potential to cause offsite consequences

such as death, injury, or adverse effects

to human health or the environment or

to cause the public to shelter-in-place or

be evacuated to avoid such

consequences.

Worst-case release means the loss of

all of the 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 of final rule

publication] have a regulated substance

present in a process in more than a

threshold quantity as determined under

§68.5.

(b) Stationary sources covered by this

subpart shall comply with §§ 68.12

through 68.60 no later than (three years

after the date of final rule 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 of the final rule], or

within three years of the date on which

a stationary source becomes 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 of the stationary source,

its street address, its mailing address,

and telephone number;

(2) The names and CAS numbers of

all regulated substances that are present

at the stationary source in greater than

the threshold quantities, and the

maximum amount present in a process

at any one time (in ranges);

(3) For each regulated substance, the

four-digit SIC code(s) that apply to the

use of the substance at the stationary

source;

(4) The Dun and Bradstreet number of

the stationary source;

(5) The name of a contact person; and

(6) The following certification signed

by the owner or operator: "The

undersigned certifies that, to the best of

my knowledge, information, and belief

formed after reasonable inquiry, the

information submitted is true, accurate,

and complete. I certify that I prepared

or caused to be prepared a risk

management plan tat complies with 40

CFR 68.50 [and, when applicable: "and

the provisions of 40 CFR 68.60"] and

that I submitted or caused to be

submitted copies of the risk

management plan to each of the entities

listed in 40 CFR 68.50(a). [Signature]."

(c) If at any time after the submission

of the registration, information in the

registration is no longer accurate, the

owner or operator 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 of the hazard

assessment is to evaluate the impact of

significant accidental releases on the

public health and environment and to

develop a history of such releases.

(b) Hazard assessments shall be

conducted for each regulated substance

present at the 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 for the 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

of the worst-case release scenario and

the other more likely significant.

accidental release scenarios identified

in § 68.15(b)(2); and

(4) Develop a history of accidental

releases of the regulated substance.

(c) To determine a worst-case release

scenario, the owner or operator shall

examine each process handling each

regulated substance and assume that all

of the regulated substance in the process

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54214 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 of the release.

(d) The owner or operator shall

determine other more likely significant

accidental releases such as but not

limited to:

(1) Transfer hose failure, excess flow

valve or emergency shutoff failure and

subsequent loss of piping and shipping

container contents (truck or rail); (2) Process piping failure and lo 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

of the release.

(e) For each regulatedsubstance, the

offsite consequences of the 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 of the

event;

(2) The distance, in all directions, at

which exposure to the substance or

damage to offaite property or the

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 to the 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 of sensitive

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 and releases with

potential for offste consequences for

each regulated substance handled at the

stationary source. The history shall list

the release date, time, substance and

quantity released, the duration of the

release, the concentration of the

substance released, and any offsite

consequences such as deaths, 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 shall be

reviewed and updated at least once

every five years. If changes in process,

management, or any other relevant

aspect of the stationary source or its

surroundings (e.g. new housing

developments or improved emergency

response services) might reasonably be

expected to make the results of the

hazard assessment inaccurate (i.e., if

either the worst-case release scenario or

the estimate of offsite effects might

reasonably be expected to change), 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 of offsite consequences:

(1) A description of the worst-case

scenario;

(2) A description of the 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

of specific scenarios; and

(3) Documentation for how the offsite

consequences for each scenario were

determined including:

(I) Estimated quantity of substance

released, rate of release, and duration of

the release;

(ii) Meteorological data used for

typical conditions at the stationary

source;

(iii) For toxic substances, the

concenftration used to determine the

level of exposure and the data used for

that concentration;

(iv) Calculations for determination of

the distances downwind to the acute

toxicity concentration; and

(v) Data used for estimation of the

populations exposed or area damaged.

(i) A summary of the information

required under paragraph (h) of this

section and a table showing the data for

the five-year accident history under

paragraph (0 of this section shall be

included in the RMP required under

§68.50.

§68.20 Prevention program purpose.

The owner or operator of a stationary

source having one or more 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 must be tailored

to suit the degree of hazards present at

the stationary source and the degree of

complexity of the stationary 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 of the

stationary source shall develop a

management systkm to oversee the

implementation of the risk management

program elements. The purpose of the

management system is to ensure that the

elements of the risk management

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 of the management system,

the owner or operator shall identify a

single person or position that has the

overall responsibility for the

development, implementation, and

integration of the risk management

program requirements.

(c) When responsibility for

implementing individual requirements

of the risk management program is

assigned to persons other than the

person designated under paragraph (b)

of this section, the names or positions

of these people shall be documented

and the lines of authority defined

through an organization chart or similar

document.

§68.24 Prevention program--process hazard analysis.

(a) The purpose of the process hazard

analysis (hazard evaluation) is to

examine, in a systematic, step-by-step

way, the equipment,.systems, and

procedures for handling regulated

substances and to identify the mishaps

that could occur, analyze the likelihood

that mishaps will occur, evaluate the

consequences of these mishaps, and

analyze the likelihood that safety

systems, mitigation systems, and

emergency alarms will function

properly to eliminate or reduce the

consequences of a mishap. A thorough

process hazard analysis is the

foundation for the remaining elements

of the prevention program. (b) The owner or operator shall

perform an initial process hazard

analysis on processes covered by this

part. The process hazard analysis shall

be appropriate to the complexity of the

process and shall identify, evaluate, and

control the hazards involved in the

process. The owner or operator shall'

determine and document the priority

order for conducting process hazard

analyses based on a rationale which

includes such considerations as the

extent of process hazards, offsite

consequences, age of the process, and

operating history of the process. The

process hazard analysis shall be
Federal Register / Vol. 58, No. 201 / Wednesday, October 20, 1993 / Proposed Rules

completed no later than [three years

after the date of final rule publication].

(c) Process hazard analyses completed

after (Insert date 5 years before the

effective date of the final rule) which

meet the requirements of this section are

acceptable as initial process hazard

analyses. These process hazard analyses

shall be updated and revalidated, based

on their completion date, in accordance

with paragraph (h) of this section.

(d) The owner or operator shall use

one or more of the 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) Fault Tree Analysis; or

(7) An appropriate equivalent

methodology.

(e) The process hazard analysis shall

address:

(1) The hazards of the'process;

(2) The identification of any previous

incident which had a likely potential for

significant offsite consequences;

(3) Engineering and administrative

controls applicable to the hazards and

their interrelationships such as

appropriate application of detection

methodologies to provide early warning

of releases. Acceptable detection

methods might include process

monitoring and control instrumentation

with alarms, and detection hardware

such as hydrocarbon sensors;

(4) Consequences of failure of

engineering and administrative controls;

(5) Stationary source siting;

(6) Human factors; and

(7) A qualitative evaluation of a range

of possible safety and health effects of

failure of the 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 to the process being

evaluated. Also, one member of the

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 are resolved in a

timely manner and that the resolution is

documented; document what actions are

to be 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 of the initial process

hazard analysis, the process hazard

analysis shall be updated and

revalidated by a team meeting the

requirements in paragraph (f) of this

section, to assure that the process

hazard analysis is consistent with the

current process.

(i) The owner or operator shall retain

process hazard analyses and updates or

revalidations for each process covered

by this section, as well as the

documented resolution of

recommendations described in

paragraph (g) of this section for the life

of the process. j) Based on the findings and

recommendations of the process hazard

analysis, the owner or operator shall

also investigate, evaluate, and document

a plan for, or rationale for not, installing

(if not already in place):

(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 systems to reduce the

downwind consequences of the release.

168.26 Prevention program-process safety Information.

(a) The owner or operator shall

complete a compilation of written

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 by those processes

involving regulated substances. This

process safety information shall include

information pertaining to the hazards of

the regulated substances used or

produced by the process, information

pertaining to the technology of the

processrand information pertaining to

the equipment in the process. (b) Information pertaining to hazards

of the regulated substance in the

process. This information shall consist

of at 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 of inadvertent

mixing of different materials that could

foreseeably occur.

Note: MSDSs meeting the requirements of

29 CFR 1910.1200(g) may be used to comply with this requirement to the extent they contain the information required by this

paragraph.

(c) Information pertaining to the

technology of the process. Information

concerning the technology of the

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 of the consequences

of deviations, 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 may be developed in

conjunction with the process hazard

analysis in sufficient detail to support

the analysis.

(e) Information pertaining to the

equipment in the process. Information

pertaining to the equipment in the

process shall include:

(1) Materials of construction;

(2) Piping and instrument diagrams

(P&ID's);

(3) Electrical classification;

(4) Relief system design and design

basis;

(5) Ventilation system design;

(6) Design codes and standards

employed;

(7) Material and energy balances for

-processes built after the effective date of

rule; and

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

detection, or suppression 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

longer in 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 of written standard

operating procedures is to 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 I
54216 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 of the process

or stationary source to develop standard

procedures.

(b) The owner or operator shall

develop and implement written

operating procedures that provide 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 is required, and the

assignment of shutdown responsibility

to qualified operators to assure that

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 of deviation; and

(ii) Steps required to correct or avoid

deviation.

(3) Safety and health considerations:

(I) Properties of, and hazards

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 of regulated substance

inventory levels; and,

(v) Any special or unique hazards.

(4) Safety systems and their functions.

(c) Operating procedures shall be

readily accessible to employees who

work in or maintain a process.

(d) The operating procedures shall be

reviewed as often as necessary to assure

that they reflect current operating

practice, including changes that result

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 and accurate.

(e) The owner or operator shall

develop and implement safe work

practices to provide for the control of

hazards during operations involving

lockout/tagout; confined space entry;

opening process equipment or piping;

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 of the 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

of the procedures, and the complexity of

the process or stationary sources when

developing training programs.

(b Initial training. (1) Each employee

presently operating a process, and each

employee before operating a newly

assigned process shall be trained in an

overview of the 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

job tasks.

(2) In lieu of initial training for those

employees already involved in

operating a process on the effective date

of this rule, an owner or operator may

certify in writing that the employee has

the required knowledge, skills, and

abilities to safely carry out the duties

and responsibilities as specified in the

operating procedures.

(c) Refresher training. Refresher

training shall be provided at least every

three years and more often if necessary

to each employee involved in operating

a covered process to 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) Training documentation. The

owner or operator 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 of the

employee, the date of training, and the

means used to verify that the employee

understood the training.

(e) The owner or operator shall

evaluate the effectiveness of the 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 of the maintenance

program is to determine and target the

specific equipment that is identified

through the process hazard analysis

(hazard evaluation) or through operating

experience as needing regular

maintenance because failure of the

equipment would lead to a significant

accidental release. The owner or

operator shall consider the complexity

of the process or stationary source in

developing the maintenance program.

(b) The owner or operator shall

develop a list of equipment and controls

the failure of which 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) Relief and vent systems and

devices;

(4) Emergency shutdown systems;

(5) Controls (including monitoring

devices and sensors, alarms, and

interlocks); and,°

(6) Pumps.

(c) Written procedures. The owner or

operator shall establish and implement

written procedures to maintain the ongoing integrity of process equipment.

(d) Training for process maintenance

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 in the

procedures applicable to the employee's

job tasks to assure that the employee can

perform the job tasks in a safe manner

and shall document the training as

required in § 68.30(d). " (e) Maintenance, inspections, and

testing. For every item of equipment

required to be listed under paragraph (b)

of this 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 on process

equipment.

(2) Maintenance, inspection, and

testing procedures shall follow

recognized and generally accepted good

engineering practices.

(3) The frequency of maintenance,

inspections, and tests of process

equipment shall be consistent with

applicable manufacturers'

recommendations and good engineering

practices, and more frequently if
Federal 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 test that has been

performed on process equipment. The

documentation shall identify the date of

the maintenance/inspection/test; the

name of the person who performed the

maintenance/inspection/test; the serial

number or other identifier of the

equipment on which the maintenance,

inspection, or test was performed; a

description of the maintenance,

inspection, and test that is performed;

and the results of the inspection or test.

(0) Equipment deficiencies: 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) Quality assurance.

(1) In the construction of new plants

and equipment, the owner or operator

shall assure that equipment as it is

fabricated is suitable for the process

application for which 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 for the

process application for which they will

be used.

§ 68.34 Prevention program-pr.-startup review.

(a) The purpose of the 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 of the 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 of change, § 68.36; and

(4) Training of each employee

involved in operating or maintaining a

process has been completed and that

employees are trained in any new

emergency response procedures.

§68.36 Prevention prograrm-management of change.

(a) The purpose of a management of

change program is to ensure that any

alteration of equipment, procedures,

substances, or processes are thoroughly

analyzed to identify hazards, the

consequences of failures, and impacts of

the change on existing equipment,

procedures, substances, and processes

prior to implementation of the 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 of the 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

a covered process. (d) The procedures shall assure that

the following considerations are

addressed prior to any change: (1) The tehnical basis for the

proposed change; (2) Impact ofchange on likelihood of

a significant accidental release;

(3) Modifications to operating

procedures;

(4) Necessary time period for the

change; and,

(5) Authorization requirements for the

pro posed change'. (e) Employees involved in operating a

process and maintenance and contract

employees whose job tasks will be

directly affected by a change in the

process shall be informed of and trained

in the change prior to the startup of the

process or affected part of the process.

(f) If a change covered by this section

results in a change in the process safety

information required by S 68.26, such

information shall be updated

accordingly. (g) If a change covered by this section

results in a change in the operating

procedures or practices required by

§ 68.28, such procedures or practices

shall be updated accordingly.

§ 68.38 Preventlen pregram-eey audits.

(a) The safety audit consists of a

periodic examination of the

management systems and programs at

the stationary source. The examination

shall include a review of the

documentation and implementation of

the requirements of this subpart. The

owner or operator shall consider the

complexity of the process and of the

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 with the provisions of this

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 of the findings of the

audit shall be developed.

(e) The owner or operator shall

promptly determine and document an

appropriate response to each of the

findings of the 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) of this section.

§ 68.40 Prevention program--accident

Investigation.

(a) The purpose of the 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 shall be

initiated as promptly as possible, but

not later than 48 hours following the

significant accidental release.

Te) An accident investigation team

shall be established and consist of at

least one person knowledgeable in the

process involved, including a contract

employee if the incident involved work

of the contractor, and other persons

with appropriate knowledge and

experience to thoroughly investigate

and analyze the significant accidental

release.

(f) A report shall be prepared at the

conclusion of the investigation which

includes at a minimum:

(1) Date of significant accidental

release;

(2) Date investigation began;

(3) A description of the significant

accidental release;

(4) The factors that contributed to the

significant accidental release, including

I54-217
54218 Federal Register / Vol. 58, No. 201 / Wednesday, October 20, 1993 / Proposed Rules

its initiating event, and root cause or

causes that may have increased the

likelihood of the 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 job tasks

are relevant to the significant accidental

release findings including contract

employees where applicable.

(I) Significant accidental release

investigation reports shall be retained

for five years.

§68.45 Emergency response program.

(a) The purpose of the emergency

response program is to prepare for

response to and mitigation of accidental

releases to limit the severity of such

releases and their impact on the public

health and environment.

(b) The owner or operator of a

stationary source shall establish and

implement an emergency response plan

for responding to and mitigating

accidental releases of regulated

substances. The plan shall detail the

steps all employees shall take in

response to accidental releases and shall

include:

(1) Evacuation routes or protective

actions for employees not directly

involved in responding to the release;

(2) Procedures for employees

responding to the release, including

protective equipment use;

(3) Descriptions of all response and

mitigation technologies available at the

stationary source; and

(4) Procedures for informing the

public and emergency response agencies

about releases.

(c) The owner or operator shall

develop written procedures forthe use

of emergency response equipment and

for its inspection, testing, and

maintenance. The maintenance program

for emergency response equipment shall

be documented as required 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

all employees 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 to test the

plan and evaluate its effectiveness. Each

drill or exercise shall be documented in

writing and shall include findings of the

drill or exercise that indicate aspects of

the plan aid procedures which need to

be revised. Plans shall be revised based

on the findings of the drills or exercises.

The owner or operator shall document

the response to each finding from a drill

or exercise. For each finding requiring a

change that is implemented, the

schedule for implementing the change

shall be documented.

(g) Each emergency response plan

shall be coordinated with local

emergency response plans developed

under part 355 of this chapter by the

local emergency planning committees

and local emergency response agencies.

Upon request of the 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 of the emergency

response plan, including descriptions of

all mitigation systems in place, at the

stationary source.

§68.50 Risk management plan.

(a) The owner or operator of a

stationary source covered by this part

shall submit a risk management plan

(report) summarizing the key elements

of its risk management program to the

implementing agency and shall submit

copies to the State Emergency Response

Commission, the Local Emergency

Planning Committee with jurisdiction

for the area where the source is located,

and the Chemical Safety and Hazard

Investigation Board. Each report

submitted by the 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, for each

regulated substance, a summary of the

hazard assessment and analysis of

offsite consequences and accident

history data required by § 68.15(1).

(d)The report shall include, for the

stationary source, a description of the

major hazards (e.g., equipment failure,

human error, natural phenomena, or

other factors or a combination of such

factors which could lead to a significant

accidental release) identified through

the process hazard analyses, a

description of the consequences of a

failure to control for each Identified

major hazard, a summary of all actions

taken or planned to address these

hazards, and how significant accidental

releases are prevented or mitigated, or

the consequences reduced by these

actions. The purpose of the summary is

to identify major hazards and provide

an overview of the prevention program

being implemented by the stationary

source to prevent significant accidental,

releases. For each action taken to

address a hazard, the report shall

include the date on which the action

was started (or is 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 of hazards, the description may

be organized by actions rather than

hazards. If any requirement for the risk

management program specified in this

subpart is not covered in the summary

of actions taken to address hazards, the

report shall include a brief description

of the stationary source's

implementation of the requirement.

(e) The report shall include a

summary of the 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 or position of the point

of contact between the stationary source

and the public authorities;

(3) The dates of drills and exercises

completed and planned and the results

of completed drills; and

(4) A description of coordination with

the local emergency planning

committee.

(f0 The report shall include a

description of the management system

developed to implement and coordinate

the elements of the hazard assessment,

prevention program, and emergency

response program at the stationary

source. The description shall define the

person or position at the stationary

source that is responsible for the overall

implementation and coordination of the

risk management program requirements.

Where regulated substances are present

above their threshold quantities at

several locations at the stationary source

or where responsibility for

implementing individual requirements

is delegated to separate groups at the

stationary source, an organization chart

shall be included to describe the lines

of responsibility.

(g) The report shall include a

certification by the owner or operator

that, to the best of the signer's

knowledge, information, and belief

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 and
Federal 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. If a

change such as the introduction of a

new regulated substance or process

occurs that requires a revised or

updated hazard assessment or process

hazard analysis, then the report shall be

updated and resubmitted within six

months of the introduction of the new

process or substance.

(i) The report shall be available to the

public under section 114(c) of the Clean

Air Act.

§68.55 Recordkeeplng requirements.

(a) The owner or operator of a

stationary source covered by this part

shall develop and maintain at the

stationary source, for five years, records

supporting the implementation of the

risk management program and the

development of the risk management

plan.

(b) For the, process hazard analysis,

safety audit, and accident investigation,

the records required to be maintained

under paragraph (a) of this 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 (or scheduled date) for starting

implementation and the date (or

scheduled date) for completion of the

implementation. For each

recommendation not implemented, the

documentation shall include an

explanation of the decision.

(c) For pre-startup reviews and

management of change, the

documentation shall include the

findings of the review and any

additional steps (including a description

of the steps and the reasons they were

implemented) that were taken prior to

implementation of the startup or

change.

(d) The owner or operator shall

maintain copies of all standard

operating, maintenance, management of

change, emergency response, and

accident investigation procedures

required under this part.

§ 68.60 Audits.

(a) In addition to inspections for the

purpose of regulatory development and

enforcement of the Act, the

implementing agency shall periodically

audit RMPs registered under § 68.12 in

order to review the adequacy of such

RMPs and require revisions of RMPs

when necessary to assure compliance

with § 68.50.

(b) Stationary sources shall be

selected for audits based on any of the

following criteria:

(1) Accident history of the stationary

-source; 

(2) Accident history of other

stationary sources in the same industry;

(3) Quantity of regulated substances

present at the stationary source;

(4) Location of the stationary source

and its proximity to the public and

sensitive environments;

(5) The presence of specific 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 a stationary source

a written 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 of subpart B of this part. This

preliminary determination shall include

an explanation for the basis for the

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

imp lementation.

(e) Written response to a preliminary

determination:

(1) The owner or operator shall

respond in writing to a preliminary

determination made in accordance with

paragraph (d) of this section. The

response shall state that the owner or

operator will implement 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

in part. For each rejected revision, the

owner or operator shall explain'the

basis for rejecting such revision. Such

explanation may include substitute

revisions.

(2) The written response under

paragraph (e)(1) of this section shall be

received by the implementing agency

within 90 days of the issuance of the

preliminary determination or a shorter

period of time as the -implementing

agency specifies in the preliminary

determination as necessary to protect

human health and the environment.

Prior to the written response being due

and upon written request from the

owner or operator, the implementing

agency may provide in writing

additional time for the response to be

received.

(f) After providing the owner or

operator an opportunity to respond

under paragraph (e) of this section, the

implementing agency may issue the

owner or operator a written final

determination ofnecessary revisions to

the source's RMP. The final

determination may adopt or modify 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) of this section. A

final determination that adopts a

revision rejected by the owner or

operator shall include an explanation. of

the basis for the revision. A final

determination that fails to adopt a

substitute revision provided under

paragraph (e) of this section shall

include an explanation of the basis for

finding such substitute revision

unreasonable.

(g) Thirty (30) days after the issuance

of a final determination under

paragraph (f) of this section, the owner

or operator 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

of the revised RMP to the entities

identified in § 68.50(a), and registers the

revised plan as provided in § 68.12 (b)

and c).

(h) The public shall have access to the

preliminary determinations, responses,

and final determinations under this

section.

(i) Nothing in this section shall

preclude, limit, or interfere in any way

with the authority of EPA or the state to

exercise its enforcement, investigatory,

and information gathering authorities

concerning this part under the Clean Air

Act.

Subpart C-List of Regulated Substances and Thresholds for

Accidental Release Prevention

[Reserved]

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

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