W(
October 20, 1993
Part H
Environmental
Protection Agency
40 CFR Part 68
Rfsk Management Programs for Chemical
Accidental Release Prevention; Proposed
Rule
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54190 Federal Register / Vol. 58, No. 201 / Wednesday, October 20, 1993 / Proposed Rules
ENVIRONMENTAL PROTECTION
AGENCY
40CFRPart68
[A-91-73; FRL-4790-1]
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 (ETA) 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 befora'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 oy November 23,1993, to Dr.
Lysa 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 3:3Op.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, Ai* Docket (LE-131),
Attn: Docket No. A-91-73, Waterside
Mall, 401M St SW., Washington, DC
20460. Comments must ba 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, OS-
120, 401M St. SW., Washington. DC
20460, (202) 260^6128; or the
Emergency Planning and Community
Right-to-Know Hotline, (800) 535-0202;
in northern Virginia and Alaska, (703)
920-9877.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Introduction
A. Statutory Authority
B. Background
C. Clean' Air Act Amendments of 1990
II. Risk 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
E. 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
OSHA's 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
Requirements
VI. Other Approaches Considered
VH. Guidance
Vffl. Information Gathering Efforts
DC. 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 30}(a)(l) of the Clean Air
Act'(CAA) as amended (42.U.S.C.
7412(r)(7) and 760l(a)(l)).
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 (a.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 ispcyanate inBhopal, India, that
killed more 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 in 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 HI 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
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 fecility personnel. None, of the
elements should be considered hi 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 m did not
directly address accident prevention'
except through section 305(b),EPA
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Federal Register / VoL 58. No. 201 / Wednesday, October 20. 1993 / Proposed lales gtttl'
recognized that prevention,
preparedness, and response form a
continuum. In 1996, 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,
en courage 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 leant more about how
facilities develop systems to prevent
accidents. Through the audit program,
EPA has trained-its regional staff as weE
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 now best
to reach smaller operations, which the
SARA section 305CbJ 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. 1983
through 19S1 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,
associations, and professional
organizations have developed programs
related to chemical accident prevention.
On February 24.1992, the U.S.
Occupational Safety and Health
Administration (OSHAJ promulgated a
standard on chemical process safety
management (.57 PR 6356). Four states-
New Jersey, California* Delaware, and
Nevada—have regulations requiring
facilities to prepare* andImplement risk
management plans. The American
-Institute of Chemical Engineers (AICfaE).
through its Center for Chemical Process
Safety, has published guidance on the
m<
as we& as guidelines on topics related"
to hazard evaluation, vapor cloud
dispewioa modelling, handling and
storage practices, and vapor doud
mitigation. The Chemical
Manufacturers' Association (CMA) has
adopted its Responsible Cora™*
program, with which all CMA members
must comply to maintain membersMp
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 1390.
C. Clean AffAct Amendments of!99O
The Clean Air Act Amendments of
19,90, signed into law on November 15.
1990, amend Clean Air Act CCAA}
section 112 by adding a new subsection
(r), which includes requirements related
to chemical accident prevention. The
goal of CAA section 112(rJ 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 (Le.. stationary sources} to
Identify hazards that may result from
releases, to design and maintain! a safe
facility, and to nfriTtfowfft the
consequences of releases when they
occur. Section tl2fr)(3) requires EPA to
promulgate & list of at least 10O
substances that are known to cause, or
may be reasonably anticipated to causa,
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 toxkity, 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 detectkm.of accidental releases and
for responses to such releases. These
regulations shall include, as
appropriat»cpTovisioD8concesningthe
use, operation, repair, and maintenance
of equipment to monitor, detect,
inspect, and control releases, including
training of personnel in the use sad
maintenance of equipnseflt or. & the
conduct of periodic inspections. The
regulations aball require facilities to
prepare and implement risk
compliance with: regulations for
managing risk (the '^isk 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&H3} wiB 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 1390 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 nighty hazardous
chemicals on February 24,1992 (57 FK
6356}. Sections EC and FV of this
preamble discuss the relationship
between EPA's propwsed rfsk
management .program and the OSHA
standard on chemical process safety
management. . • =
Finally, CAA sect!on 1120} requires
EPA te 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 furtrisF
information on EPA's proposed rule on
CAA section 112(1?, see 58 FR 29298,
May 19V1993;
A. Cfsoit Air Act Rffqofremejtts
Today's proposed reqatrements'to
develop, and implement a risk
management program are irtresponse to
CAA section 112(rK7MB). Specifically,
CAA section 112M{7HBKi}requke»EPA
to adopt "reasonable regulations and ,
appropriate guidance" to provide for «hs
prevention and detection of aecadetttal
releases. As.
requirement
the
address the usg,
operation; repair, replacement, and
maintenance.of eqaipro€Rit to monitor,
detect, inspect, and control accidentsE
releases, fachiding tha training of
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54192 Federal Register / Vol. 58, No. 201 / Wednesday, October 20, 1993 / Proposed Rules
parsons 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){ii) 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 >o 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 are 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 jubmit 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 Regulation*
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 five-
year 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 most prevention program elements,
facilities that are in compliance with
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Federal Register / Vol. 58i No. 201 /Wednesday, October 20, 1689 / Proposed Rate M1S3
sectors coveted by the rales would be
cold storage faciKties (which use
ammonia as a refrigerant), public ^
drinking water systems and publicly
owned treatment works, manufacturers,
OSHA's process safety management
standard will not need fo da anything
different or create different onsife
documentation fo comply with EPA's
proposed prevention, program,
requirements. Section IV of this
preamble describes the differences that
exist between the QSHA 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 slate 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,
m. Discussion of the Proposed Rale
A. Introduction
AIChE, In its Technical Management
of ChenncaiFimcess Safety, say&
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,
hi use, and effective. The management
com . „
everyone faivohted ia fcpesfatfons-^Broia the
chemical process operators to the chief
executive officer. * * * Effective process
safety management systems can, and do, vary
a great deal In haw they are implemented.
However, they always address the need for
managing the process safety-related aspects'
of technology, facilities, personnel,
responses,
Hie porpose 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
circumstanoas end 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
procedures 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 tha> 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.
IB, 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 cute. Approximately
87,800 of those facilities would also be
covered by OSHA's process safety
management standard. The largest
and service industries would also be
covered. See Section X of this preamble
for a discussion of the estimated
would affect only those areas at
facilities where regulated substances ore
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 faciMty 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, fo
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
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 offsita
consequences such as death, injury, or
adverse effects to human1 health or the
environment or to cause the public to
shelter in place or be evacuated to avoid
such consequences'.
"Worst-ease release" would mean the
loss of all of the regulated substance
that leads to the worst offsite
consequences.
D. Bisk Management Program Elements
The dean Air Act mandates that the
risk management plan document: three
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54194 Federal Register 7 Vol. 58, No. 201 / Wednesday, October 20, 1993 /Proposed Rules
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
rang* of accidental releases and
determine a worst-case release scenario
foreach location. The range of releases
should include only those events that
could lead to significant releases (Let,
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 worst-
case 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
iroposed definition will also reduce the
imden on regulated facilities; a
requirement for analysis of a "credible
worsfccase" 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 and transport 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
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accidental releases and incidents that
had the potential for offsite
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
Titie HI. 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 maintenance, 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 *
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. Tha
elements of this integrated approacksmi
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
POT), 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 technique!} to
account for site-specific conditions in
assessing offsite impacts associated with
other scenarios. The Agency recognizes
tiiat 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 tha
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 m
offsite impact analysis that might reduce
the burden and provide meaningful,
useful results. .
Specific information on the worst-
case scenario will help public
emergency planners and responders
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 worst-
case scenario alone, therefore, 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 worst-
case 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 new, large-scale
housing developments or commercial
areas, could change substantially the
population potentially affected.
A final element of the hazard
assessment specified in the Act is a five-
substances. EPA interprets the accident
history requirement to cover significant
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54186 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
QSHA'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 acddent 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
largo 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
document 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
hazards 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
operatylity study (HAZOP). (AIChE's
Guidelines for Hazard Evaluation
Procedures provides descriptions of
these techniques.) Formal techniques
provide a method for a rigorous, step-
by-step examination of processes,
process equipment and controls, and
procedures to identify each point 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 worsbcase
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
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Federal Register / Vol. 58, No. 201 / Wednesday, October 20, 1993 / Proposed Rules 54197
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 end 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
faciUties 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
mat 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
Uot useful for process inventory
accounting or .measurement of'chemical
loss. For example, it is necessary to
know the flow rate hi mass per unit-
time 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°C, 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 cm prevent br 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
bo 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
ofaprocess.
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, toe 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.
Tfa.e 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 non-
manufacturing 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 and document 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 calibrated
periodically; corrosion of vessels arid
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. A1978 fire and explosion
at a Texas City, Texas, facility that led
to almost $100 million hi property
damage was attributed to instrument.
failure and a faulty relief valve. A1989
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 Costly down-
time 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
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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
potentially 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 ba reviewed
prior to their implementation to identify
• any potential V|"Miyig 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 led 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 fatuities use
audits to check on compliance with
specific regulations, some do spot-
checks 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 top 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
reteases, but would require only that
significant accidental, releases be .
investigated. EPA defines significant
accidental refea*e as "any accidental
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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 summarized
in 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 bs 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
v*nted to a scrubber would not be a near
miss because the system is designed to
ensure that relief valve releases are
containod-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
part of a risk management program
because 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 axe 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. BMP 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 die 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
procadures. The information provided
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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 hi use or because of
prevention practices. The RMP
information also will assist local
emergency planners. Under SARA Title
m, 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 well-
implemented 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
then* 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
tiie 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 on how 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 ride 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 woist-
case 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;
• 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
needed);
• A summary of the facility's
emergency response program, including
dates and schedules for drills completed
and planned, information on
coordination with the public,
procedures for notifying and alerting the
public of a release, and the name of
person responsible for coordinating
with public agencies;
• A description 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 RMP
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
something 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 RMP 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.
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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 BMP. The BMP 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 stataas
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 ba 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 wiuxregulated 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
iJhat 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. TEe 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 hi 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, pro-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.
The 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 HI. The
reporting ranges proposed are the same
ranges used for SARA Title IE 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
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Federal Register /Vol. 58, No. 201 / Wednesday, October 20, 1993 / Proposed Rules 54203
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 requiring an earlier
registration to help identify potentially
affected facilities and disseminate
guidance to them. An earlier registration
(either 1.2 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
faculties are required to file to limit the
repetitive reporting required of
faculties. For example, EPA is
considering using the EPCRA section
312 Tier n form as a substitute because
the Agency believes this would facilitate
integration of CAA activities with SARA
Title m 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 Bradstreet
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 filing 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 RMP 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 unkwful 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 amd 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 civU 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
promulgated by November IS, 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 hi Washington, DC, to
solicit comments.
IV. Comparison of EPA's Proposed Rule
to OSHA's Standard
A. Differences Between EPA's Proposed
Bale 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
suhmittal and auditing of the RMP. The
only other element EPA is proposing
that is not included hi 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 faculties to provide the
name or names of people or positions
responsible for implementing the
program.
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
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 hazard assessment also
is. required to include a five-year release
history, which would overlap to some
degree with a requirement hi 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 Emargency .
Response standard (29 CFR 1910.120)
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54204 Federal Register / Vol. 58, No. 201 / Wednesday, October 20, 1993 / Proposed Rules
4—— .
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 then- 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
EPAfrevention 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 tp 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:
• EPA's process hazard analysis
requirement (§ 68.24) is the same as
OSHA's process hazard analysis
requirements (29 CFR 1910.119fe)), 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 then* 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 safely
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.
• EPA's standard operating
procedures requirement (§ 68.28) is
identical to OSHA's operating
procedures (29 CFR 1910.119(1)) 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,
but 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 facih'ty.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
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Federal Register / Vol. 58, No. 201 / Wednesday, October 20, 1993 / Proposed Rules 54205
•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.
• 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 hot
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 hi 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,
father 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 arid 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
Eossible to determine, except on a case-
y-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 die risk management
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54206 Federal Register I Vol. 58,. NBU 201 / Wednesday, OctoSer 20, 11993 f Proposed Rules
program to states that have an approved
program. The criteria for statejprograins;
oro listed in CAA section 1120X5)', The
Act allows states tp adopt the Federal
program or Implement ax program that is
more stringent. Consequently, the
existing state programs: wilt require
some revisions to meet EPA's-
requirements or set mors stringent
requirements than those, established by
tho EPA rule. EPA expects-that most of
the needed changes wilt involve the
listing of chemicals and adjusting of
threshold?. Other state? thai 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
5 AHA. Title in programs ta adopt the
requirements of these regulations. EPA
will provide additional guidancefor
states before the final rule is
promulgated.
VI. Other Approaches Considered
The CAA requires feeiKties that have
a regulated substance la quantities
greater than the* threshold to develop
and submit RMPs. EPA recognises mat,
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
those- 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 management 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
bo possible because too many factors
influence the hazard posed by a
particular process and substance. Using
the simple) multiple of the threshold
quantify would ignore tire dangers'
posed by relatively small quantities of
regulated substances in specific
circumstances.
The second approach: considered
would be tot have facilities determine
whether they needed an expandea 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
considerable potential for debate and
legal disputes over the assumptions
facilities use to determine off site
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 o£ their
decisions and create difficulties foe
enforcement b j 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 thia
approach.. EPA notes mat 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
theprotection 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 "minimal-
program" would be, given the
Congressional mandate thai 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.
VH. Guidance
The CAA requires EPA to publish,,
when the final rule is promulgated,.
guidelines to assist facilities in the;
preparation of risk management
programs; The guidelines, shall,, to the
extent possible, include model' RMPs,
EPA is aware tiiat 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 provMe* a»
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)1, 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, moat
of the covered facilities in these sectors
are using the seme 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-the-
shelf* plan, but rather to provide a
framework that the facility can u
analyze its own operations and develo^
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 model risk
management programs may De possible.
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. 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 hi 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 faculties. 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 mat 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 compliance
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 agencies.
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 rulemaMng.
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 forxegistration. 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 ho longer accurate,
facilities would be required to update
the information within 60 days of the
change.
Proposed § 68.15 would provide iiie
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 potential 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 halve to be applied, with tile
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
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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-to-
date chemical, technology, and
equipment information. Technology
information would include process flow
diagrams and 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
enginearine 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 oe 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.
tasting, and maintenance would be
required. Inspection and testing
:er
procedures and schedules would be
based 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 aft
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 reviewed prior to
implementation. Replacement of
equipment or controls with & 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 faciJitv 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 implementing.
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 mow
likely significant accidental releas<*
scenarios, and five-year history q.
significant accidental releases), a list 01
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.
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Federal Register / Vol. 58, No. 201 / Wednesday, October 20, 1993 / Proposed guJes 542O9
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 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," 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 hew cost information from
comments to the proposed list and
threshold rale 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
list and threshold option, EPA used
1988 data from the New Jersey Right-to-
Know 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 four-
digit 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 four-
digit SIC codes across both the
manufacturing and non-manufacturing
sectors, and are reasonably
representative 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
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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 VH 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
small 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 1 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
Options
Ust1 „. - ,
Ust2 _ „ _
List 3 „
Uet4
Ust5
Manufacturers
not otherwise
regulated
3,975
3975
13640
19,530
19,530
Manufacturers
previously regu-
lated 1
18,960
18960
19940
20,470
20,470
Non-manufac-
turers not other-
wise regulated
28650
48650
54560
37,830
57,830
Non-manufac-
turers pre-
viously regu-
lated
64060
68840
68840
64,060
68,840
Total
115645
140425
156 980
141,890
166,670
t "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 faculties would be affected by
EPA's proposed rule. Of this universe,
87,800 would also be covered by tEe
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 (ISO-employee) complex facility;
process and equipment information,
which may cost a large facility $36,000
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Federal Register / Vol. 58, No. 201 / Wednesday, October 20. 1993 / Proposed Rules 54211
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 AREP 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.
per process; and SOPs, which vary from
$2,500 for a simple process to $14,000
for a complex process. Costs for non-
manufacturers arp estimated to be
considerably lower both because their
.operations frequently do not involve
special equipment and because model
RMPs and guidance are assumed to be
.available to them, thus lessening the
burden. The cost of conducting the
hazard assessment is estimated to vary
from $70 per assessment for non-
manufacturers to $280 per assessment
for large complex manufacturers; the
number of assessments likely to be
required is estimated to vary from one
(for a cold storage facility with only
ammonia on site) to 10 for, a
petrochemical facility. The cost of
developing the RMP is estimated to
range from $156 to more than $1,000 for
a highly complex facility. Registration
costs are estimated to vary between $43
and $105, depending on the number of
substances on site. Table 2 presents the
average cost per facility for
manufacturers and non-manufacturers.
EPA estimates that the initial cost of the
proposed rule would be $503 million.
EPA estimated subsequent year total
costs for a period of ten years. Costs
vary from year to year because certain
risk management program elements are
not required to be updated yearly. For
example, safety audits would be
conducted every three years; hazard
assessments and process hazard
analyses would be updated every five
years. Table 3 presents the estimated
costs for years one through five for the
five listing options.
Benefits
The-proposed risk management rule is
expected to generate benefits to the
regulated community and to society at
large. EPA has estimated a dollar value
for many of these benefits; the
methodology used to generate these
estimates is presented in chapter 7 of
the RIA.
The benefits of the proposed risk
manafgement rule were estimated using
several quantitative techniques to
investigate each of the different types of
benefits expected to occur. Fust, the
proposed risk management rule is
expected to reduce the number of
significant hazardous chemical releases
occurring each year at facilities affected
by the five list options. This reduction
in the number of releases was estimated
using Accidental Release Information:
Program (ARIP) data for the four-year
period 1987-1990. The trend in vie
number of hazardous chemical releases
in New Jersey, where many of the
riskmanagement program elements are
required to be in place already, was
compared with the trend in the number
of releases in the rest of the nation. The
difference between the two trends,
approximately 27 percent at the end of
the four-year period, provided an
estimate of the magnitude of the
reduction in the number of hazardous
chemical releases that could be
expected to occur as a result of EPA's
proposed risk management rule.
The proposed rule is also expected to
reduce the number of incidents of
environmental damage (e.g., soil
TABLE 2.—ESTIMATED AVERAGE COST PER FACILITY MANUFACTURERS
Previously Regulated .,...
Small-sized facilities
Simple
$15,430
760
Moderate
$27,760
1,070
Medium-sized facilities
Simple
$33,430
910
Moderate
$81,920
1,680
Large-sized facilities
, Simple
$53,760
1,500
Moderate
$93.750
1,960
Complex
$153,470
3,280
Highly
complex
$5,720
NON-MANUFACTURERS
Previously Regulated
Public fa-
cilities
$8,200
530
Private
.utilities
$8,250
580
Cold storage facilities
Small
$9,400
Large
$51.0
Whole-
salers
$2,220
650
Service
industries
$1,860'
560
Retailers
.....!! **
TABLE 3.—SUBSEQUENT-YEAR COSTS BY LIST OPTION FOR PROGRAM OPTION 1
[$ millions!
Year
0 ....„;....*.• ».
1 -. •' ' ' • ' - ' '•'-'• • • ' ' '
2 - •' ' • ' '
List
option 1
$460
79
84
List
option 2
$503
92;
98
List
option -3
$858
144
152
Ust :
option 4
$1*004
159
187
VOP^I..
$1,0
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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 I—Continued
[SmtlHons]
Year
3 „.
4 v..
8
List
option 1
109
flA
185
List
option 2
19&
217
List
option 3
A4O
4 CQ
338
List
option 4
383
Usi
options
ZOO
181
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 inddent by the number of
incidents avoided that may be attributed
to the-presence of a risk management
program. The benefits of the proposed
tula are estimated to be approximately
$890 million per year. Table 4 presents
the estimated costs and benefits for each
of the list options considered by EPA
during the rule development.
TABLE 4.—ESTIMATED FIRST YEAR
COSTS AND BENEFITS
t$ Millions]
Urt option 1 —
LW option 2 —
Urt optton3......
LW option 4. —
Ust option 5
Estimated
costs
$460
503
858
1.004
1,046
Estimated
benefits
$838
890
1.539
1.615
1.870
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.0.12291, 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.0.12291 because the
first year cost of the rule is estimated to
be $503 million. Aa RIA entitled,
"Regulatory Impact Analysis in Support
of listing Regulated Substances and
Thiaiholds and Mandating Risk
Management Programs for Chemical
Accident Relotie Prevention, as
Required by Section 112(r) of the dean
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
OCR No. 1656.1) and a copy may be
obtained from Sandy Fanner,
Information Policy Branch, EPA, 401M
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, PM-
223, U.S. EPA, 401M 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
road as follows:
PART 68—ACCIDENTAL RELEASE
PREVENTION PROVISIONS
Subpart A—General Provletone
Sec.
68.1 Scope.
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Federal Register / Vol. 58. No. 201 / Wednesday. October 20, 1993 / Proposed Rules .54213
Sec.
68.3 Definitions.
68.5 Threshold Determination [Reserved].
Subpart B—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 Ragulattd Substance*
and Threshold* for Accidental Release
Prevention [Reserved]
Authority: 42 U.S.C. 7412(r) and
7601(a)(l).
Subpart A—General Provisions
§68.1 Scop*.
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.
7401erseq.).
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 off site 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. .
BMP means the risk management plan
required under S 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
ail of the regulated substance from the
process in an accidental release that .
leads to the. worst offsite consequences.
§68.5 Threshold determination.
[Reserved]
Subpart B—Risk Management Program
Requirements
§68.10 Applicability.
(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 mat 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 § 63.15(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 /. 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 loss 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 regulated substance, the
offslte 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, hi all directions, at
which exposure to the substance or
damage to offslte 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 offsite 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 fire 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 offslte 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
concentration 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 (f) 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.
f 68.22 Pravwiiion program—management
•ystam.
(a) The owner or operator of the
stationary source shall develop a
management system 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 die 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 analyst*.
(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
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Federal Register / Vol. 58, No. 201 / Wednesday, October 20, 1993 / Proposed Rules 54215
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:
(l)What-Ifj
(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 an$ 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
.'•« -^ .' ™ ''. ; *.'. * "*' ' ' ' •'•••- ' .'-•;«
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
(i!not already in place):
(l).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.
$6&26 Pravention program—proses*
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
enablq the owner or operator and the
employees involved in operating the
«*~~BSS to identify and understand the
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
process, and 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:
ii ixftaplete actions as soon as
da
1
2
3
4
5
6
««
Toxicity information;
Permissible exposure limits;
Physical data;
Reactivity data;
Corrbsmty data;
Thermal and chemical stability
;and
(7) Hazardous effects of inadvertent
mixing of different materials that could
foreseeably occur.
Note: MSDSs meeting the requirements of
• 29 CFR 1910.120D(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
(PMD'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 Pravwtelori program—standard
operating procedures,
(a) The purpose of written standard
operating procedures is to document the
safe and proper way to operate and. ,
' ' ""•'••' •pinent.and
to handle and store; regulated substances
at a stationary source. Procedures may
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54216 Federal Register / VoL 58, No, 201 / Wednesday> October 2O, 199S /Proposed Rules
be based on the process hazard analysis
(hazard evaluation J 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 procedure? that provide clear
Instructions for safely conducting
activities involved in each covered
process consistent with the process
safety Information and shall address af
least the following elements:
(1) Steps for each operating phase:
(ijmitfd startup;
(ii) Normal operations;
(ill) Temporary operations,
fir) Emergency shutdovi
Sutdovm Including
the conditions under which emergency
shutdown is required, and the-
assfgnmentof shutdown responsibility
to qualified operators to assure-that
emergency shutdown is executed fn a
safe and timely manner;
(v) Emergency operations;
fvij Normal shutdown; and
(vii) Startup following a turnaround,
or after ar> emergency shutdown.
(2) Operating amits:
(i) Consequences-of deviation; and
(ii) Steps required to correct or wold
deviation,
(3) Safety and rieahb considerations:
(i) Properties of, and hazards
presented by> the substance? used fa 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 IB veKj: and,
(v) Any special as unique hazards.
(4) Safety systems and their functions.
(c) Operating pocsdoies shall be
re«Jily accessible to eiBpIoyees who ,
work fe or BMintain a process; *
(d}Th» operating procedure* shall be
ro vi awed a* often «*nec86S*rj to assure
tiuK thayrofioct current operating
practice, lndadnigch»ngB»tb3trefHlt
from dMBg«*k» process chemical*,
technology, and equipment, «od
changes to stationary-sources. The
own WOT operator «™Ty certify annually
that these operating procedures-are.
otoz B
lockaut/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 oni a facility.
§68.39 Prevention program—Draining*.
(a) The purpose of the training.
program is to ensure that each employee
involved with regulated substances lias
learned and understands the procedures
developed under § 68.28, The owner or
operator shall consider tha complexity
of the procedures* and tha complexity of
the process or stationary sources when;
developing training programs,
(b} Initial training. (1) Bach employe©
presently operating a process, and eacfe
employee before operating a newly
assigned process shall be trained in art
overview of tbaprocessand in the
operating' procedures asr specified in*
§ 68.29. The training stall include
emphasis on the> specifier safety and
beaKfr standards* emergency operati«m»
including shutdown, and safe work
practices applicable to fee employee's
jobtasfe.
U) la lieu, of initial training for those
employees already involved in.
operating a process on tha effective date
of this rule* an. ownec ot operator may
certify in writing that tae. employee has
the. required knowledge, skills, sad
abilities to safely carry out the duties
and responsibiKffes a* specified in the
operating .procedures.
(c) Reficshsr tftuning. Refresher
training sbaB be provide^ af feast ewary
three years and more; ofteii if nacessary
to each empfoyee involved in> operating
ff covered process to assure-that the
employse understands and adheres- to
the curfgut' operaliug pDacedures fn the-
process. The owner or operator, in
consultation with the employees'
involved in operating tire process, shall
determine fee appropriate fimjueucy of
refresher training.
fd) Ttofnihg dacumeatafian* The
owner or opeiator shall ascertain, that
each enaplajjee involved la operating, a
process has. received and undarstQod the
training required by this sectfori. The
awn£r. be operator shall pceparo a. record
which cootains. tha Identity of the
QTnplnyaM^ tlifl ttato nf trfltnfng1 fltl J tTiff
means used to varlfy that th» einpktyas
understood the ttainiBg.
evaluate the effectiviww of ti» training
, program. A schedule1fcr rwrfewfeg; sad
revising the program i' ~"
§68.32 Prevention program— maintenance
(mechanfcaf rnflogrftyji
fej The purpose of the maintenaiice>
program is to determine and target the
specific equipment that is Identified
through, tha process hazard.analysls
(hazard evalUationJ 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 iSte maintenance program.
£bl The ownex or operator shall
develop a list of equipment and controls
the failure of which could resuH m a
significant accidental release. As
applicable, tha equipment 1st shall
include:
(1) Pressure vessels and storage tanks;
UJ Piping s;f stem* tinehiding piping '
components such as valves);
(3) Relief imd vent systems ami!
devices;
(4) Emergency shutdown ftysteras;
devices and sensors,: alarms, and
interlocks^ andr
(6) Pumps,
(ej> Written* procedures, Th» mmamm
operator shall cstlabbsfa and teplemaat
written proce^tore* to o^ntairttfee on-
going integritjr of proces*
(d) Training forpecceasBktinteaance
trafo each enn rtoyee uwolved f»
maintateii^ Ore on-going integrity of
process equripaaent la *n averwievf at
iiiaf process and Kahaaardaaatid fottb»
procedures *pp'Eeabteto&eeBiplpyee'
job tasks to asinrfetliattij0eiirplay«e
perform the Job tedism a safe> laanne*-
required in $ 63,3O(d).
(e) Maintenance, Inspections, and
testing. For every item of eqtrijanent
required to be fisted? under paragraph fb)
c^ this section, the owner or operator
shall develop a maintenance prograjn to
inspect, test, and mamtam fee
equip
tcr ensure that th^e-qufpment and
controls' continue ~ '—*- '
to specificatronff.
on*, and
testssfiafl be
equipraent.
(2) Marafentrace^
testingprocedure* ™~ .„.„..
recog)SrBdan
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Federal Register / Vol. 58, No. 201 / Wednesday, October 20, 1993 / Proposed Rules 54217
determined to be necessary by prior
operating experience.
(4) The owner of 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.
(f) 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) QpalityflssuTaifce.
(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.
12) 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—pro-startup
review.
(a) The purpose of the pro-startup
review is to ensure that new of 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 pre-
startup review.
(b) The owner or operator shall
perfprm a pre-startup safety review for
new stationary sources and for modified
stationary sources when the
modification is significant enough to
require a change in the process safety
information.
(c) The pre'-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) Fornew stationary sources, a
process hazard analysis has been
performed and recommendations have
been resolved or implemented before
startup; and modified stationary sources
meet die requirements contained in
management of chance, § 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 program—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 technical basis for the
proposed change;
(2) Impact of change oh likelihood of
a significant accidental release;
(3) Modifications to operating
procedures;
(4) Necessary time period for the
change; and,
(5) Authorization requirements for the
proposed 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 hi a change in the process safety
information required by § 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 of practices
shall be updated accordingly.
§68.38 Prevention program—safety
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.
(e) Ah accident investigation team
shall be established and consist of at
least one person knowledgeable hi 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
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S4218 Federal Register / Vol. 58, No. 201 / Wedeeaday, October 20, 1993 F Proposed Rules
its Initiating event, «nd root cause or
cause* that may t*v» Increased the
likelihood of the initiating event; and,
(5) Any rectmiHMmdatiops resulting
from the investigation.
(g) The owner ox operator shall
establish t system to promptly address
and resolve the accident report findings
and recofmnendationsr Resolutions and
corrective actions shall be documented.
(h) Hw report shall fee reviewed with
all affected personnel whose job tasks
are relevant to the significant aceidantal
release findings including contract
employee* wae»appKcal)fe.
(t) Significant accidental release
investigation reports saaH be retained
for five years.
168.45 Enwca«w/r«spcr««proflHHw.
(a) The purpose1 of the emergency
response program fsto prepare for
response to and mitigation of accidental
releases to limit the severity of suck
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
substaiK^Jt The pkn shall detail the
steps all employees shall take to
response to tctidenbti releases and shall
Include:
(1) Eracuatknircutaa or protective
actions far employees net directly
involved.in respondingto the release;
(2) Procedures for employees
responding to the release,- inrfnding.
protective equipment us»f
(3) Descriptions of alt response'find
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 for the 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(eK4).
£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.
(0) The owner or operator shaft train
all employees in relevant emergency
response procedures and document the
training as required nnriflt § 68.3tf(dl.
(fj The owner or operator shall
conduct drills or exercises to test the
plan and evaluate its effectiveness. Each
drill or excrcisa shall b& documented &s
writing and shall include findings of the
drill or exercise that indicate aspects of
the plan and procedures which need to
be revised. Plans shall be revised based!
on the findings of the drill* 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). Rnf?h emergency response, plan
shall be coordinated with local
emergency response plans, developed
under part 355 of this, chapter by Sis
local emergency planning committees
and local emergency response agencies,,
Upon request of the local emergency
planning committee, the owner at
operator shall promptly provide.
information to the local emergency
planning committee necessary for
developing and Implementing the
community emergency response plan.
(hj The owner and operator shall
maintain a copy of the emergency
response plan* including descriptions ol
all mitigation systems In place, at the.
stationary source.
§68.50 Rfslt management plan.
(a) The owner or operator of a
stationary source covered by this part
shall submit a- rislc mn-nflgftrnont pl The report shall include a
summary of the stationary source's
emergency response plan. The summary
shall include!,
(1\ The procedures adopted to infeuaa
emergency .response authorities and the
public;
(2) The name ot position; of the point
and the public authorities;
1st The dates of drills and exercises
completed and planned and the resuMs
of completed drills;, and
(4) A description of coordination with
the local emergency planning
committee.
ft) The report shaH 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 ox operator
that, to the best of th& signer's
knowledge; iufbnnation* and belief
information submitted is true, accurate,
and completes
(h) The report sfeaB be reviewed and
updated at least every five years and
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Federal Register / Vol. 58, No. 201 /Wednesday, October 20, 1893 / Proposed Rules 54219
resubmitted to the implementing agency
and copies shall be submitted to the
State Emergency Response Commission,
the Local Emergency 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 Recordkeeplhg 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 responseto 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
(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 Audit*.
(a) In addition to inspections for the
purpose of regulatory development and
enforcement pf 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 hi 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
implementation.
fe) 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 hi 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)(l) 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 of necessary 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 sectiop. 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 hi violation of
§§ 68.12,68.50(a), and 68.60 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]'
[FRDoc. 93-25642 Filed 10-i9-93; 8:45 atol
BMJJNO CODE ««0-«W»
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